DEVELOPMENT, DIAGNOSTIC ACCURACY AND FEASIBILITY OF A SCREENING TOOL FOR EARLY DETECTION OF BLINDING EYE DISEASES AMONG INFANTS IN IBADAN, NIGERIA RY A BY R LIB N BOLUTIFE AYOKUNNUD OALUSANYA MBBS (Ibadan), M.Sc. Epid &IB Me Adical Statistics (Ibadan) MATRIC NFUMBER: 65466 O TY A thesis subSmIitted to the Department of Epidemiology and Medical StRatistics, Faculty of Public Health, College of Medicine, in pVarEtial fulfilment of the requirements for the award of the NI Degree of DOCTOR OF PHILOSOPHY (Ph.D.) in U EPIDEMIOLOGY of the UNIVERSITY OF IBADAN MARCH 2021 CERTIFICATION We certify that this work is original and the research project was carried out under our supervision by Bolutife Ayokunnu OLUSANYA in the Department of Epidemiology and Medical Statistics, Faculty of Public Health, College of Medicine, University of Ibadan. We also certify that the work has neither been presented for any purpose to any other Institution or examination body nor has it been submitted elsewhere for other purpose. Y R ……………………………………………. ………………………………………………….. RA PROF. IkeOluwapo O. AJAYI IB MBBS, M.Cl.Sc., MPH, PhD, FMCGP, FWACP (Fam.Med .)L Department of Epidemiology and Medical Statistics,A FaNculty of Public Health, College of Medicine, University of Ibadan D BA OF I ………………………………………Y……. ………………………………………………….. PROF. Aderonke MI. TBAIYEROJU MBBS, DO (GRlasSgow), FRCS, FRCOph, FWACS PaediatVric EOphthalmology Unit, Department of Ophthalmology, Faculty of Clinical ScienIces, College of Medicine, University of Ibadan UN ii DEDICATION This thesis is dedicated to the Almighty God, my teachers, my parents and my family. Y RA R LI B N A D IB A F O TY I S ER V NI U iii ACKNOWLEDGEMENT I glorify the Almighty God, my Lord and my Saviour for His enduring mercy and limitless grace that enabled me to start and complete this research project and this thesis. I am eternally grateful to both of my supervisors, Professor IkeOluwapo O. Ajayi and Professor Aderonke M. Baiyeroju, for their support, assistance, constructive criticism and professional guidance during the conduct of this research work. I am thankful to the current Head of Department, Dr. A.S. Adebowale and aYll my other teachers in the Department of Epidemiology and Medical StatisticsA forR imparting knowledge to me in several ways, especially: Professor O. AyenRi, Professor O.I. Fawole, Dr. O.B. Yusuf, Dr. M.D. Dairo, Dr. O. M. Akpa, Dr. BJ. Akinyemi, Dr. B. Adedokun, Dr. A. Fabgamigbe, Dr. I. Adeoye, Dr. E. BamgbLoyIe, Dr. S. Bello, Dr. A. Salawu, Dr. B. Gbadebo, and Dr. R. Afolabi. My gratitNude also goes to Mr Ogunlabi, Mrs Aileru, and all the non-teaching staff of the DAepartment of Epidemiology and Medical Statistics for their support. D I also acknowledge my teachers andB seAnior colleagues in the Department of Ophthalmology including: ProfessoFr C .OI. Bekibele, (the current Head of Department), Professor A.I. Ajaiyeoba; ProfeOssor A.O. Ashaye; Dr. T.S. Oluleye, Dr. O. Fasina, Dr A.O. Ogundipe, Dr. O.O. Og un and Dr. O.O. Olawoye for their advice and support throughout the period of Ymy pursuit of this PhD degree. In addition, I give special thanks to Dr. O.M. IUTgalahi as well as all the resident doctors in Ophthalmology Department who aSssisted with some of my clinical and teaching responsibilities while I was awayE onR the field collecting data and writing up my thesis. I amI Vvery grateful to the Medical officers of Health of Ibadan North, Ibadan NNortheast, Ibadan Southeast, and Ibadan Southwest Local Government Areas as well Uas the Primary health care coordinators and the Matrons in charge of the primary health care centres where the study was carried out. I am indeed also grateful to all the members of staff of the primary health care centres for their cooperation and assistance during the conduct of this study. I am particularly grateful to Mrs Adeyinka, Mrs Iyioku, Mrs Oluniyi, Mrs Adesola, Mrs Olatunde, Mrs Akinbowale, Mrs Faleye, and Mrs Fatumobi. iv I am very grateful to all the mothers and infants who participated in the research project. Without their cooperation, it would not have been possible to write this thesis. I also thank the members of my research team especially, Mr Faleye, Mrs Boladale and Mrs Adewusi. I acknowledge the Consortium for Advanced Research Training in Africa (CARTA) for the funding of this research project as well as the support to attend the four Joint Advanced Seminars that significantly enhanced my capacity with regards to t he conduct of research as well as academic writing. My gratitude also goes to ProYfessor A. Omigbodun and Dr Funke Fayehun, the CARTA focal persons at the UnRiversity of Ibadan, for their support and encouragement. RA I also thank my parents, Dr. and Mrs S.K. Olusanya, and my siblBings, Ope and Moyo. Finally, I appreciate my beautiful darling wife, Adeola, anLd mI y children, Tife and Tetisimi, for their unconditional love and support durNing this study and indeed all through my quest for the PhD degree. A This research was supported by the ConsortiumD for Advanced Research Training in Africa (CARTA). CARTA is jointly led byB the African Population and Health Research Center and the University of the WIitwatersrand and funded by the Carnegie Corporation of New York (GrOant FNo--B 8606.R02), Sida (Grant No:54100113), the DELTAS Africa Initiative (G rant No: 107768/Z/15/Z) and Deutscher Akademischer Austauschdienst (DAATD).Y The DELTAS Africa Initiative is an independent funding scheme of the ASfricIan Academy of Sciences (AAS)’s Alliance for Accelerating Excellence inR Science in Africa (AESA) and supported by the New Partnership for Africa’s DEevelopment Planning and Coordinating Agency (NEPAD Agency) with fundinIgV from the Wellcome Trust (UK) and the UK government. The statements made anNd views expressed are solely the responsibility of the Author. U v ABSTRACT Approximately seventy per 100,000 children are blind worldwide. Early detection and prompt treatment play vital roles in prevention of blindness from cataract and other eye diseases in children. However, there are no established screening programmes for blinding eye diseases among infants in Nigeria. This has contributed to delayed presentation to hospital among children with blinding eye diseases. Therefore, this study was conducted to develop and validate a simple screening tool for the early detection of blinding eye diseases among infants as well as assess the perceptions of health care workers regarding the feasibility of using the tool. Y This cross-sectional study was conducted in 3 phases. The first phaseR was the development and validation of a screening checklist. This entailed a literAature review, expert opinion, stakeholders‟ input, content validation and pretesting of the checklist. The second phase was a diagnostic accuracy study which comRpared the newly developed checklist to a gold standard, which was eLyeI Bexamination by an ophthalmologist. This phase was carried out on 1214 infants receiving immunisation in eight primary health care centres located in four urban L ocal Government Areas in Ibadan metropolis. Each infant was first screened Nby a primary health worker (immunisation staff) using the checklist and Asubsequently examined by the ophthalmologist. The sensitivity, specificity, posDitive and negative predictive values as well as reliability indices of the checklist were determined. The third phase was a questionnaire survey to assess the perceptioAns of all the participating immunisation staff (38 in number) about the feasibilityB of using the checklist. Data were analysed using descriptive statistics. Level oFf sig nIificance was set at α0.05. A checklist with two sections and 11 items was developed. The first section consisted of six questions that the health Oworkers asked the infants‟ mothers or caregivers; while the second section containYed five questions that were answered by the health workers after a quick examinaTtion of the children‟s eyes. The mean age of the infants was 5.2±3.8 months and 52.5% were males. The screening checklist had a sensitivity of 70.0% for detection oIf blinding eye disease. In addition, it had a specificity of 94.8% for detection oRf blSinding eye disease. The inter-observer agreement was 96.6% (Kappa = 0.71); wEhile test-retest reliability showed an intra-class correlation coefficient of 0.90. All the immunisation staff were females, with a mean age of 43.1±7.6 years. They IaVll reported that the checklist was useful in screening for eye diseases among infants. Majority (81.6%) reported that the checklist was very easy to use. About one- thNird (34.2%) experienced challenges, such as poor cooperation from mother or child, Uwhile using the checklist. A screening tool with good sensitivity, high specificity and high reliability was developed for the early detection of blinding eye diseases in infants. Primary health care workers found the checklist to be easy to administer and useful for screening. Adoption of this checklist as a screening tool at the primary health care level could be instrumental in the establishment of screening programmes and early detection of blinding eye diseases among children. vi Keywords: Childhood blindness, Eye disease screening checklist, Primary eye care, Sensitivity and Specificity Word count: 498 TABLE OF CONTENTS Contents Page Title page i Certification ii Dedication Y iii Acknowledgement A R iv Abstract R vi Table of contents IB vii List of tables L xi List of figures A N xiii D CHAPTER ONE INTRODUCTION A 1.1 Background IB 1 1.2 Problem statement F 4 1.3 Justification for th e Ostudy 6 1.4 Aim and obTjecYtives of the study 7 1.4.1 StudSy aiIm 7 1.4.2 SRpecific objectives 7 V1.5E Delimitation of the study 7 CNHAIPTER TWO LITERATURE REVIEW U 2.1 Epidemiology and impact of childhood blindness 8 2.2 Aetiology of childhood blindness 12 2.3 Risk factors and clinical features of some blinding eye diseases of childhood 14 2.4 Detection of childhood eye diseases 20 2.5 Importance of early detection and treatment of childhood eye diseases 21 2.6 Delayed detection of childhood eye diseases in developing countries 23 vii 2.7 Interventions for early detection of childhood eye diseases 25 2.8 Principles of screening for diseases 31 2.9 Techniques of screening for eye disease in infants and young children 32 2.10 Development, validation and feasibility of checklists used for screening 39 2.11 Conceptual framework 46 CHAPTER THREE METHODS 3.1 Study setting Y 48 3.2 Study design R 49 3.2.1 Phase 1: Development and validation of the screening toRol A 49 3.2.2 Phase 2: Diagnostic accuracy testing of the screeninIgB tool 53 3.2.2.1 Study population L 53 3.2.2.2 Sample size determination N 53 3.2.2.3 Sampling strategy DA 55 3.2.2.4 Pre- study activities A 57 3.2.2.5 Study team IB 57 3.2.2.6 Study materiFals 57 3.2.2.7 Data co llOection procedure 58 3.2.2.8 ETxaYmination procedure 59 3.2S.2.9I Study flow chart for infants 59 R3.2.2.10 Case definitions 61 V3.2E.3 Phase 3: Survey of immunisation clinic staff perception on feasibility of the I checklist 61 UN 3.3 Data management and analysis 62 3.4 Ethical considerations 65 CHAPTER FOUR RESULTS 4.0 Overview of results 66 4.1 Phase 1: Checklist Development and Validation 66 4.1.1 Initial drafts of screening checklist 66 viii 4.1.2 Stakeholder input 66 4.1.3 Content validation 70 4.1.4 Results of Pretesting of the checklist 73 4.1.5 Description of the final version of checklist 73 4.2 Phase 2: Diagnostic Accuracy Study 73 4.2.1 Immunisation clinic staff characteristics 73 4.2.2 Infants characteristics Y 80 4.2.3 Diagnostic accuracy of the newly developed checklist R 90 4.2.4 Reliability indices of the newly developed checkRlist A 99 4.3 Phase 3: Survey of Immunisation Clinic Staff PercepItiBon of Checklist 103 4.3.1 Perception of immunisation clinic staff aLbout usefulness 103 and ease of use of the screening checklistN 4.3.2 Reported average period of DtimeA spent per child 103 4.3.3 Challenges experienced Aby immunisation staff while 104 using the checklist durin gI Bthe study 4.3.4 Knowledge anFd skills acquired while using the 104 checklist duringO the study 4.3.5 CoTnfiY dence of immunisation staff regarding their ability 104 to deteIct eye diseases in children RS4.3.6 Suggestions and recommendations for modifying 104 VE or improving the checklist CNHAIPTER FIVE DISCUSSION, CONCLUSION AND RECOMMENDATIONS U 5.1 Discussion 108 5.1.1 Development of the screening tool 109 5.1.2 Sensitivity, specificity and reliability of the screening tool 111 5.1.3 Feasibility of using the checklist to detect childhood blinding eye diseases 112 5.1.4 Limitations of the study 113 5.2 Conclusion 113 ix 5.3 Recommendations 114 5.4 Contribution to knowledge 114 5.5 Suggestions for further research 115 REFERENCES 116 APPENDICES 140 APPENDIX A. QUESTIONNAIRE FOR INFANTS‟ MEDICAL HISTORY Y 140 IWE IBEERE LATI WADI ILERA AWON OMODE A R 143 APPENDIX B. QUESTIONNAIRE FOR IMMUNISATION R 146 CLINIC STAFF IB APPENDIX C. FINAL VERSION OF THE SCREE NLING 148 CHECKLIST USED FOR THE STUDYN APPENDIX D. PROFORMA FOR OPHDTHALMIC 149 EXAMINATION OF INFANATS APPENDIX E. REFERRAL FO IRBM 152 APPENDIX F. POST-STUDFY QUESTIONNAIRE 153 FOR IMMUNI SOATION CLINIC STAFF APPENDIX G.T ETYHICAL APPROVAL 156 APPENDISX HI. CONSENT FORMS RA. Informed consent form - Immunisation staff 157 VE B. Informed consent form – Infants‟ mothers/ caregivers 160 NI B. Iwe Erongba – Iya Omo/alagbato 163 UPLATES 166 x LIST OF TABLES Page Table 2.1 Ten key activities to promote healthy eyes in children 30 Table 2.2. Vision screening checklists in use in developed countries 37 Table 2.3. Description of some screening checklists that have been developed and validated for other childhood diseases RY 43 Table 3.1 Selected immunisation clinics and allocated number of infants A per local government area R 56 Table 3.2 Example of contingency table for calculating sensitiviItyB, specificity, predictive values and likelihood ratios L 64 Table 4.1 Ranking of the 18 items on second draft of chNecklist based on relevance scores as assigned by expert Apanel 71 Table 4.2 Frequency distribution of the immunisDation staff who participated in the screening of infants across the PHACs and the local government areas 75 Table 4.3 Comparison of mean age and IyeBars of experience of immunisation staff who participated in PhasFe 2 of the study with those who did not participate 76 Table 4.4 Comparison of char aOcteristics of immunization staff who participated in Phase 2 of the stYudy with those who did not participate (N=55) 77 Table 4.5 Frequency IdiTstribution of eye problems noticed by immunisation staff at the mSost recent occasion 79 Table 4.6 FEreqRuency distribution of the infants who completed all stages of Phase 2 V across the PHCs and the local government areas 81 TNableI 4.7 Frequency distribution of complaints reported by mothers /care givers U regarding infants‟ eyes (N=1214) 84 Table 4.8 Frequency distribution of abnormal features that respondents had noticed in the infants‟ eyes (N=1214) 85 Table 4.9 Frequency distribution of checklist scores obtained by immunisation staff during screening of 1214 infants 87 Table 4.10 Frequency distribution of eye diseases diagnosed by ophthalmologist among 1214 infants 89 Table 4.11 Diagnostic accuracy of the newly developed checklist using Category C xi classification in the presence of abnormal Red reflex test 91 Table 4.12 Diagnostic accuracy of the newly developed checklist using Category B or C classification in the presence of abnormal Red reflex test 92 Table 4.13 Diagnostic accuracy of the newly developed checklist using Category C classification in the presence of eye disease 94 Table 4.14 Diagnostic accuracy of the newly developed checklist using Category B or C classification in the presence of eye disease 95 Table 4.15 Diagnostic accuracy of the newly developed checklist using Category C classification in the presence of blinding eye disease RY 97 Table 4.16 Diagnostic accuracy of the newly developed checklist using CAategory B or C classification in the presence of blinding eye disease R 98 Table 4.17 Frequency distribution of checklist scores obtained bIy Bimmunisation staff st nd during 1 and 2 screening of 88 infants L 100 st Table 4.18 Number of infants classified into Category CN based on 1 screening nd versus 2 screening A 101 Table 4.19 Number of infants classified into CateDgory B or C based on 1st screening versus 2nd screening A 102 Table 4.20 Challenges experienced by imIBmunisation staff while using the checklist during the study (N=38F) 106 Table 4.21 Knowledge and sk ilOls acquired by immunisation staff while using the checklist during the TstudYy (N=38) 107 SI VE R I U N xii LIST OF FIGURES Page Figure 2.1 A conceptual framework showing the benefit of screening in early detection of eye diseases 47 Figure 3.1 Study flow chart for infants 60 Figure 4.1 First draft of screening checklist for eye diseases among infants RY 68 Figure 4.2 Second draft of screening checklist for eye diseases among infAants 69 Figure 4.3 Third draft of screening checklist for eye diseases among iRnfants 72 Figure 4.4 Age and sex distribution of infants who participated iInB the screening 82 Figure 4.5 Distribution of the reported average duration of t imLe spent by immunisation staff while screening an infantN using the checklist 105 AD A F I B O SI TY R VE UN I xiii Y ARR LIB AN AD IB O F ITY ER S V UN I xiv CHAPTER ONE INTRODUCTION Y 1.1 Background R At the global level, the prevalence of childhood blindness is estimateRd toA be about 0.7 per 1000 children with about half a million children becomiBng blind every year (Gilbert and Awan, 2003). In addition, children are estimatedL toI account for 4% of the total population of blind individuals worldwide (KonNg, F ry, Al-Samarraie, Gilbert, and Steinkuller, 2012). Specifically, the number of cAhildren with bilateral blindness is estimated to be 1.14 million globally (Rahi andD Gilbert, 2017; Gilbert, Bowman, and Malik, 2018), with over 75% of these chiBldreAn living in developing countries (Kong et al., 2012). I Despite the relatively low preOvaleFnce of blindness in children, it is still of public health significance becausYe of the concept of “blind person years”. (Kong et al., 2012) Blind children who IsTurvive childhood have a life of blindness awaiting them, therefore, childhoSod blindness is responsible for a huge number of “blind person years”, that isR, the number of years that a blind person remains alive after becoming blind (MurEthy, John, Gupta, Vashist, and Rao, 2008). In fact, the sum of “blind person yearsI” Vcaused by childhood blindness is second only to that caused by cataract in adNults (Gogate and Gilbert, 2007). UMoreover, blindness from childhood has significant impact on the child, the family and the society. A blind child potentially has a lifetime of „darkness‟ ahead of him or her (Murthy et al., 2008). Apart from the fact that childhood blindness delays the psychomotor and social development of the affected infant, it also has a negative effect on the child‟s educational and occupational prospects (Pring and Tadic, 2010; Singh, 2015; Vervloed, van den Broek, and van Eijden, 2020). Besides, the care of blind children can be burdensome as well as expensive to the family (Kong et al., 1 2012). Beyond the affected child and the family, the community also indirectly bears the burden of childhood blindness with regards to lost productivity and significant health care costs. Blindness in childhood is an important public health problem, particularly in developing countries. With the present level of technological advancement, however, no child should remain blind. Indeed, the major proportion of the blindness that occurs in children is either preventable or treatable (Courtright, Hutchinson, and Lewall en, 2011). Notwithstanding, in sub-Saharan Africa, a large number of children areY blind due to childhood cataract, especially as the disease is becoming a majorR cause of blindness in childhood within the region (Courtright, 2012). RA Unfortunately, a significant proportion of these children IreBmain blind despite treatment (Randrianotahina and Nkumbe, 2014). A major re aLson for the poor outcome of treatment is the delay that occurs before the child preNsents to hospital for treatment (You et al., 2011). When children who have cataraAct are treated late, the outcome is often poor because the visual developmeAntaDl processes have been irreversibly disrupted by the time the treatment is gBiven. On the other hand, if the treatment is administered in a timely fashion, thFe n oIrmal visual development is restored, the child regains vision and the treatment is effective. A previous study from Southeast Nigeria reported that delay in prYesen t Oation is one of the challenges in the management of childhood cataract in INTigeria (Ezegwui, Aghaji, Uche, and Onwasigwe, 2011). Early detection anSd prompt referral for surgical treatment is, therefore, very crucial in the succesEsfulR management of children who are born with cataract or develop the condiItiVon during childhood (Kim, Kim, Kim, and Yu, 2012; DeSantis, 2014; Lenhart etN al., 2015; Khokhar, Pillay, and Agarwal, 2018). Several studies have shown that Uearly surgery for congenital cataract is associated with better surgical outcomes (Forbes and Guo, 2006; Gouws, Hussin, and Markham, 2006; Birch, Cheng, Stager, Weakley, and Stager, 2009; Kim et al., 2012; Khanna, Foster, Krishnaiah, Mehta, and Gogate, 2013). Surgery can only be performed early if the visual problem is detected early, and the child is brought to hospital immediately, following appropriate referral. Other causes of eye disease in infancy including congenital glaucoma, corneal opacity, congenital ptosis and strabismus also require early detection and prompt treatment. 2 Understandably, early detection, appropriate counselling and prompt referral are dependent upon adequate knowledge and skills of the health care provider to whom the child initially presents. It is important to note, however, that the role of the parents in noticing that there is a problem with the child‟s eye and then seeking help immediately is even more vital than the role of health workers. Studies have shown that the health seeking behaviour of parents is a significant factor in the delayed presentation of children with cataract (Bronsard, Geneau, Shirima, Courtright, and Mwende, 2008; Leite and Zin, 2011). The negative impact of delayed paren tal detection of the problem can be mitigated by screening for eye diseases in inRfanYts and children during well-child clinic visits such as immunisation visits. In Aaddition, key informants within the community have been shown to play a piRvotal role in the detection and referral of children with eye diseases (Mackey, IMBurthy, Muhit, Islam, and Foster, 2012; Duke et al., 2013). L While early detection and treatment of congenital eyAe dNiseases is the standard practice in developed countries, late treatment is commonDplace in developing countries such as Nigeria (Bodunde and Ajibode, 2006; LaBwanA, 2008; Ezegwui et al., 2011). One major factor that ensures early detection an dI treatment in developed countries is neonatal screening for congenital abnormaFlities and vision screening of infants and young children by primary care healtOh providers during well-child clinic visits (Solebo and Rahi, 2014; Lenhart et Yal., 2015). Screening has been shown to improve the promptness of surgicTal intervention and is well established in many developed countries (MagnuSssonI et al., 2003; You et al., 2011). Unfortunately, the same cannot be said about Rdeveloping countries in Africa including Nigeria. E The sIcVreening programmes in developed countries are performed at the primary care leNvel usually by primary care providers or nurses. These primary care staff are able to Ucounsel parents and caregivers properly and then refer them appropriately and promptly. The programmes also incorporate good referral systems which, ensure that children who require further examination by the specialist receive urgent attention and care. Screening for eye disease at birth and during the neonatal period has been recommended in the literature (Lennerstrand, Jakobsson, and Kvarnstrom, 1995; Weinstock, Weinstock, and Kraft, 1998; Cagini, Tosi, Stracci, Rinaldi, and Verrotti, 3 2016; Mansoor, Mansoor, and Ahmed, 2016). Certain professional bodies such as the American Academy of Ophthalmology, American Academy of Paediatrics, American Association for Paediatric Ophthalmology and Strabismus as well as the Canadian Society for Paediatrics have all published recommended guidelines for vision screening in neonates, infants and young children (Committee on Practice Ambulatory Medicine Section on Ophthalmology, American Association of Certified Orthoptists, American Association for Pediatric Ophthalmology and Strabismus, and American Academy of Ophthalmology, 2003a; Committee on Practice Ambulatory Medici ne Section on Ophthalmology, American Association of Certified Orthoptists, RAmYerican Association for Pediatric Ophthalmology Strabismus, and American AAcademy of Ophthalmology, 2003b; Canadian Paediatric Society, 2009; DonahuRe et al., 2016a). These guidelines specifically recommend that the new born babIieBs and infants should be screened using the red reflex test (Bruckner tes tL) with the aid of an ophthalmoscope. AN The ophthalmoscope is a hand-held optical instrDument that can be used to examine the back of the eye and it is a medical deBviceA that is expected to be available at the primary health care level (World Heal thI Organization, 2015). The red reflex test when performed by primary care provideFrs using the ophthalmoscope has been shown to be effective in ensuring the early dOetection of eye diseases in new born babies and infants (Litmanovitz and Dolfin, Y2010). It is routinely practised in many developed countries which have well estaIbTlished vision screening programs and it is probably a major factor contributingS to the prompt treatment of congenital cataracts in those countries. To the besEt ofR the author‟s knowledge, red reflex testing is not routinely performed on neonateVs in Nigeria and it appears that there are no well-structured programs in place toN ensIure the detection of eye disease at birth. This lack of screening programs might Uhave contributed to the late presentation of congenital cataracts and other congenital eye diseases in our setting. Therefore, early screening for eye diseases in neonates is advocated. 1.2 Problem statement Late detection and delayed presentation are important problems among Nigerian children with cataract (Ezegwui et al., 2011; Umar, Abubakar, Achi, Alhassan, and 4 Hassan, 2015; Abuh, Brennan, Congdon, and Jin, 2018; Musa et al., 2018; Olusanya, Ugalahi, Adeyemo, and Baiyeroju, 2020b). Similarly, reports from other African countries have documented that significant proportions of patients with childhood cataract present late for treatment as a result of delayed diagnosis (Mwende et al., 2005; Bronsard et al., 2008; Randrianotahina and Nkumbe, 2014). A study from a tertiary hospital in Kaduna, Northern Nigeria conducted between 2008 and 2009 reported that only 22.6% of congenital cataracts were detected at birth and 37.1% were diagnosed after the child‟s first birthday (Umar et al., 2015). Another rep ort from University College Hospital Ibadan in southwest Nigeria conductedR beYtween 2011 and 2015 stated that only 28.4% of children with congenital cataracAt presented to hospital within the first 3 months of life (Olusanya et al., 2020b). BR In a country like Nigeria, where, to the best of the author‟ sL knIowledge, there are no established screening programs for eye disease in inNfants, the lack of functioning ophthalmoscopes in primary care settings further coAmpounds the problem and leads to delayed diagnosis and treatment of congenitaDl cataracts and other eye diseases. Delayed treatment is associated with pooBr treAatment outcomes with a large proportion of treated children remaining blind Idespite intervention (Randrianotahina and Nkumbe, 2014). Studies on visual Foutcome after cataract surgery in different African countries, including Nigeria, haOve reported that between 11.5% and 88.9% of children who had undergone catarYact surgery had a postoperative visual outcome worse than 3/60 in their better eTye, that is, they were still blind after treatment (Olusanya, Baiyeroju, and FSajolIa, 2006; Ezegwui et al., 2011; Randrianotahina and Nkumbe, 2014; Umar eRt al., 2015; Aghaji, Okoye, and Bowman, 2018). Such poor outcomes can be attrEibuted to delayed presentation and treatment of the children. MNoreI V over, it appears that a significant proportion of the primary care workers who Ushould be involved in the screening may not be aware of the necessity of such programs and do not know how to perform vision screening or use an ophthalmoscope for red reflex testing (Mafwiri, Kisenge, and Gilbert, 2014). There is dearth of literature on the knowledge and skills of primary health care staff with respect to the need for early detection and treatment of eye diseases in children, particularly, congenital cataract. Besides, there are no previous studies on screening methods for 5 eye disease among infants in Nigeria reported in the literature as far as the author searched. Furthermore, to the best of the author‟s knowledge, there is no tool that has been developed for vision screening of neonates and infants in low-resource settings where ophthalmoscopes are not readily available at the primary health care level. Consequently, there is an urgent need to develop a screening tool that can be used by primary health care workers to detect eye diseases in this category of children wYitho ut the need for an ophthalmoscope. R 1.3 Justification for the study RA In view of the economic challenges facing the country anIdB the low budgetary allocation to health in Nigeria, it is unlikely that scre enLing equipment such as ophthalmoscopes will be readily available in primary hNealth care facilities within the foreseeable future. It is therefore desirable to have aA simple screening tool that can be used by primary care providers without theD need for such equipment as the ophthalmoscope. The availability of such a sAcreening tool may be instrumental in the development and establishment of vi siIoBn screening programs at the primary health care level and ultimately enable eaFrly detection and treatment of congenital cataracts and other ophthalmic probl emOs in infants leading to better treatment outcomes. Successful establishment oYf screening programs should enable recommendations to be made towards policieIsT that will ensure that most infants with eye disease especially cataract are treateSd early, have good vision and live productive lives. R In addVitioEn, parents of these children and their healthcare providers are potential benefIiciaries of this research. The benefit to the parents will be a direct extension of thNe benefit to the child in addition to better value for money spent on the child‟s care Uas well as less anxiety about the child‟s future. For the health care providers, especially the ophthalmologists who care for the children, the satisfaction of achieving a successful treatment outcome and preventing a lifetime of blindness should be a significant benefit. Moreover, the establishment of neonatal screening policies, laws and programmes that ensure early detection of childhood cataracts will be of public health benefit to the society at large. 6 1.4 Aim and objectives of the study 1.4.1 Study aim The aim of this study is to develop and validate a simple screening tool that does not require the use of an ophthalmoscope for the early detection of blinding eye diseases among infants with a view towards recommending it as a screening tool for blindi ng eye diseases in childhood. RY 1.4.2 Specific objectives RA The specific objectives of the study are: LIB 1. To develop a simple screening tool that can beN us ed by primary health care workers to detect eye diseases in infants withAout the use of ophthalmoscopes. 2. To determine the diagnostic accuracy (Dsensitivity, specificity and predictive values) of the screening tool whenA compared with the gold standard for detection of eye diseases i n IBinfants, namely, eye examination by an ophthalmologist F 3. To determine the reliabiOlity of the screening tool 4. To assess the perYcep tions of immunisation clinic staff on the feasibility of using the tool IbTased on their experience of using it during the study S 1.5. DelimitaRtion of the study The eaVrly Edetection of common causes of childhood blindness is the focus of this researIch. The specific blinding eye diseases that would be considered are childhood caNtaract, corneal opacity, childhood glaucoma, blepharoptosis, strabismus, and Uretinoblastoma. The geographical scope of the study is Ibadan, particularly, the following Local Government areas: Ibadan Northeast, Ibadan North, Ibadan Southeast, and Ibadan Southwest. 7 Y R CHAPTER TWO RA LITERATURE REVIEW LI B 2.1 EPIDEMIOLOGY AND BURDEN OF CHILDHNOOD BLINDNESS A 2.1.1 Definition of childhood blindness D Childhood blindness is classically definIeBd as A a condition of severe visual impairment characterized by a visual acuity thaFt is less than 3/60 in the better eye of a person who is less than 16 years of age (OGilbert, 2001). This definition of childhood blindness apparently stems from Ythe World Health Organization (W.H.O.) definition of blindness as a visual aTcuity of less than 3/60 in combination with the United Nations Children‟s Fund S(UNIICEF) definition of a child as an individual aged less than 16 years (GilbertR and Foster, 2001b). In lay termEs, however, the W.H.O. describes childhood blindness as “a group of diseasIeVs and conditions occurring in childhood or early adolescence, which, if left UunNtreated, result in blindness or severe visual impairment that are likely to be untreatable later in life” (World Health Organization, 2018a). This definition highlights one of the reasons why childhood blindness has often been considered separately from adult blindness; which is that, childhood blindness is usually caused by diseases or conditions that are amenable to cost-effective interventions which can avert irreversible blindness when administered promptly. 8 2.1.2 Prevalence and magnitude of childhood blindness Childhood blindness is relatively uncommon. At the global level, the prevalence of childhood blindness is about 0.7 per 1000 children with about 1.14 million blind children worldwide (Rahi and Gilbert, 2017; Gilbert et al., 2018). Children are estimated to account for about 4% of the total population of blind individuals all over the world (Gogate and Gilbert, 2007; Kong et al., 2012). The vast majority of these children are thought to be living in developing countries (Gilbert, 2007; Kong et a l., 2012). In addition, more than half of the cases of childhood blindness in low-reYsource countries is avoidable, that is, blindness from causes that can either be preRvented or treated (Aghaji, Okoye, and Bowman, 2015; Muhit et al., 2018; KiRlangAalanga et al., 2020). IB The prevalence of childhood blindness in sub-Saharan A frLica has been reported to range between 0.9 and 1.5 per 1000 children (CourtriNght et al., 2011; Kong et al., 2012; du Toit, Courtright, and Lewallen, 2017; RahAi and Gilbert, 2017; Kilangalanga et al., 2020). As at 2010, an estimated 420A,00D0 blind children were living in sub- Saharan Africa (Chandna and Gilbert, 20B10). With regards to Nigeria, only a handful of population-based studies have repor teId on the prevalence of childhood blindness in the country. Muhammad, MaisOhanuF, Jabo, and Rabiu (2010) reported a prevalence of 0.2 per 1000 children in SYoko to, north-western Nigeria. Duke et al. (2013) estimated the prevalence in Cross River State to be 0.09-0.22 per 1,000 children, while Aghaji et al. (2017) found aS preIv Talence of 0.12 per 1000 children in Nsukka Local Government Area (LGA), Rone of the 17 LGAs in Enugu State, south-eastern Nigeria. It is important Eto point out, however, that these studies were conducted using the key informIVant method to identify the blind children. This may be influenced by selection biNas and the accuracy of the prevalence estimates is heavily dependent on the accuracy Uof the census figures which the authors used for their calculations. Nevertheless, approximately 75,000 Nigerian children are estimated to be blind (Adio and Komolafe, 2013). With regards to the incidence of childhood blindness, limited data is available and very few studies have reported on the incidence of childhood blindness (Rahi and Gilbert, 2017; World Health Organisation, 2019). A W.H.O. report in 2002 stated that every minute a child becomes blind (World Health Organisation, 2002). This was 9 based on an estimate that about half a million children become blind every year (World Health Organization, 1997). More recently, however, Rahi, Cable, and British Childhood Visual Impairment Study (2003) reported a cumulative incidence of 5.9 per 10000 by the age of 16 years for childhood blindness in the United Kingdom. While another study from Kuwait documented an incidence of 7.35 per 100,000 person years among individuals aged less than 20 years old (Al-Merjan, Pandova, Al-Ghanim, Al- Wayel, and Al-Mutairi, 2005). 2.1.3 The burden of the childhood blindness RY The prevalence of blindness in children is only about one-tenth of the Aprevalence of blindness in adults (Kilangalanga et al., 2020). Despite this fact, prevRenting childhood blindness is a public health priority (Yorston, 1999). This is mIBainly because of the concept of “blind person years” (Gogate and Gilbert, 2007 ;L Kong et al., 2012). This concept describes the number of years that a blind inNdividual has to live with the disability of blindness (Murthy et al., 2008). ThDe eAstimated number of “blind person years” caused blindness from childhood Ais 70 million years (Shamanna and Muralikrishnan, 2004). This representsI Ba huge number of Disability Adjusted Life Years (DALYs) and adult cataracFt i s the only condition that is responsible for a greater number than this (GogaOte and Gilbert, 2007; Kong et al., 2012). Accordingly, it has been suggested that Yrest oring sight to a blind child corresponds to the restoration of sight in 10 adults (IGTilbert and Foster, 2001a; Gudlavalleti, 2017). Furthermore, a Sdirect correlation between childhood blindness and childhood mortality hEas Rbeen described (Maida, Mathers, and Alley, 2008; Chandna and Gilbert, 2010)I. VBlind children have been reported to have a higher likelihood of dying during chNildhood compared with sighted children (Kilangalanga et al., 2020). It has been Uestimated that about 6 out of every 10 blind children in developing countries die within one year of the onset of blindness (Courtright et al., 2011; Kong et al., 2012) (World Health Organization, 2000). This further underscores the reason why the prevalence of childhood blindness greatly underestimates the burden (Gilbert and Awan, 2003). Actually, the under-five mortality rates of many countries have been used as an indirect means for estimating the prevalence of childhood blindness in developing 10 countries (Gogate, Kalua, and Courtright, 2009). This correlation exists because some of the conditions associated with blindness in children, such as measles, vitamin deficiency and congenital rubella syndrome, are also causes of child mortality (Gilbert and Foster, 2001b; Kemmanu et al., 2018a). Thus, the prevention and treatment of blindness in children has a direct positive impact on child survival (Gilbert and Foster, 2001b). This buttresses the significance of childhood blindness as a public health problem despite its relative rarity. Moreover, the disability due to childhood blindness has significant impact oYn the child, the family and the society. A blind child potentially has a lifetime of R„darkness‟ ahead of him or her (Murthy et al., 2008). Childhood blindness doeRs nAot only retard the psychomotor and social development of the affected infant,I iBt also has a negative effect the child‟s educational and occupational prospects L(Pring and Tadic, 2010; Singh, 2015; Vervloed et al., 2020). Besides, the cNare of blind children can be burdensome as well as expensive to the family (KAong et al., 2012). Furthermore, having to raise such a child whose blindnessD could have been prevented can be considered a tragedy (Yorston, 1999). BA Beyond the affected child and the fa mIily, the community also indirectly bears the burden of childhood blindness Oin teFrms of lost productivity and significant health care costs (Li et al., 2019). TheY es timated global financial cost of childhood blindness with regards to the of loss of earning capacity (per capita GNP), is greater than the cost of adult blindness anSd hIa Ts been projected to be between US$ 6 billion and $27 billion (Rahi, 2007). RAs a matter of fact, childhood blindness is thought to be responsible for over one Ethird of the total economic cost of blindness (Maida et al., 2008). It is therefIoVre pertinent that prevention and treatment of blindness from childhood should reNceive priority attention especially when such blindness is avoidable (preventable or Ucurable). The burden of childhood blindness informed the inclusion of the control of childhood blindness as one of the major priorities of “VISION 2020: The right to sight” (Gilbert and Awan, 2003). This global initiative for the elimination of avoidable blindness was jointly launched in 1999 by The World Health Organization (W.H.O.) and the International Agency for the Prevention of Blindness (IAPB) (Gilbert and Foster, 2001a). The major objective of the initiative is to reduce the global burden of 11 avoidable blindness by half by the year 2020 and to reduce the prevalence of childhood blindness from 0.75 per 1000 children to 0.4 per 1000 by 2020. It remains to be seen whether the later objective has been achieved. 2.1.4 Historical trends in the literature on epidemiology of childhood blindness The discussion in the literature on childhood blindness has a relatively short histo ry. Childhood blindness only became an important concept in the early 1990s followYing a ground breaking meeting on the Prevention of childhood blindness held at thRe instance of the World Health Organization in May 1990 (Gilbert, Foster, ANegrel, and Thylefors, 1993). Initially, the discussion mainly revolved aroundB theR epidemiology of childhood blindness with most of the attention being paid to tLhe Iprevalence and causes of childhood blindness as well as its prevention. N Among the pioneers in the early literature on chilAdhood blindness were Foster and Gilbert (Foster and Gilbert, 1992; Gilbert Aet aDl., 1993) whose articles brought the importance of studying childhood blindness to the fore. Their innovation in designing a form for recording causes of childh ooIdB blindness was instrumental in harmonizing the methods of collecting data oFn childhood blindness. This led to a significant increase in the literature on ch ilOdhood blindness. Y Subsequently, as a rIesTult of information that was generated on its magnitude and burden, childhoodS blindness was included as one of the priority areas for the control of blindness iRn the global initiative “VISION 2020: The Right to Sight” (Gilbert and Awan, V200E3). This aspect of the history of the research on childhood blindness is typifiIed by another paper by Gilbert and Foster (2001b) in which they discussed the stNrategies needed to control childhood blindness within the setting of VISION 2020. U More recently, attention has shifted to the changing patterns in the epidemiology of childhood blindness. This shift in the literature is exemplified by publications by Gogate et al. (2009) and Kong et al. (2012). These articles addressed the global and regional changes in the prevalence and causes of childhood blindness that presumably have occurred as a result of preventive measures that were instituted in the late 1990s. 12 2.2 AETIOLOGY OF CHILDHOOD BLINDNESS A variety of eye diseases that occur in children can result in childhood blindness. Such diseases are generally referred to as blinding eye diseases (Gilbert et al., 2018). Examples of blinding eye diseases include childhood cataract, childhood glaucoma, corneal opacity, blepharoptosis, strabismus, and retinopathy of prematurity (Courtright et al., 2011). Other causes of childhood blindness include high uncorrected refractive errors, uveitis, cerebral visual impairment, congeni tal hydrocephalus as well as other congenital abnormalities such as anYiridia, microphthalmia, colobomas, retinal dystrophies, and optic nerve hypoplasia R(Rahi and Gilbert, 2017). In addition, neoplasms such as retinoblastoma, rhaRbdoAmyosarcoma, and brain tumours can lead to childhood blindness. IB Globally, the commonest causes of childhood blindness are Lcataract, corneal opacity, retinopathy of prematurity and glaucoma (Courtright eNt al., 2011; Solebo and Rahi, 2014). At the regional level, however, there is a mAarked variation in the causes of childhood blindness (Rahi and Gilbert, 20A17; DWorld Health Organization, 2018a; Kilangalanga et al., 2020). This variationB is thought to be mainly related to differences in the level of socioeconomic deve loIpment in different countries (World Health Organization, 2018a). It is aOlso Fa reflection of the balance between the various determinants of the occuYrren ce of eye diseases in children such as the quality of primary health care aIndT preventive services (Solebo and Rahi, 2014; Rahi and Gilbert, 2017). These facStors also influence the regional differences in the prevalence of childhood blinRdness. In adIdVitio En to the regional variation in the aetiology of childhood blindness, a teNmporal variation has been observed in the epidemiology of childhood blindness Uglobally (Gogate et al., 2009; Kong et al., 2012). Over the past decade, changes in regional patterns of the prevalence and causes of childhood blindness have been described (Kong et al., 2012). Previous studies reported the commonest cause to be corneal opacity as a consequence of vitamin A deficiency and measles infection (Foster and Gilbert, 1992; Gogate et al., 2009). More recent studies, however, have shown that the prevalence of corneal opacity has reduced significantly because of effective vitamin A supplementation and measles vaccination programmes (Gilbert and Muhit, 2008; Gogate et al., 2009; Courtright et al., 2011). As a result of the 13 changing epidemiology, childhood cataract is now becoming more important as a cause of childhood blindness (Gilbert and Muhit, 2008; Courtright, 2012). Thus, in low-income countries, mainly in the sub-Saharan region, the major causes are: 1) corneal opacities secondary to measles, vitamin A deficiency, and use of harmful traditional eye medications; 2) congenital cataract often due to congenital rubella; and 3) other congenital conditions such as congenital glaucoma (Courtright et al., 2011; World Health Organization, 2018a). Retinopathy of prematurity and catar act are the leading causes in mid-income countries while optic nerve diseaseYs and hereditary retinal dystrophies are the common causes in the high-incomeR countries (Solebo, Teoh, and Rahi, 2017; World Health Organization, 2018a). RA Besides, the common causes of childhood blindness in NigerLia IhBave been reported by a few population-based studies. The major causes in SNoko to state, northwest Nigeria were corneal scarring (55%) and childhood cataract (15%) (Muhammad et al., 2010). Cataract (28%) was the commonest cause in CrossA River state, followed by corneal scars (16%) and glaucoma (8%) (Duke et aAl., D2013). This was similar to the report from Enugu state where cataract (40%) aBnd corneal scar (13%) were the commonest causes of blindness in childhood (AFgha jIi et al., 2017). 2.3 RISK FACTORS AND OCLINICAL FEATURES OF SOME BLINDING EYE DISEASES OFT CYHILDHOOD The early detectiSon Iof common causes of childhood blindness is the focus of this research. AccRordingly, the risk factors as well as clinical features (symptoms and signs) Vof sEome of these diseases, as described in the literature, are discussed in this sectioIn. The blinding eye diseases that would be discussed are childhood cataract, coNrneal opacity, childhood glaucoma, blepharoptosis, strabismus, and retinoblastoma. UAlthough retinoblastoma is not as common as the other diseases, it has been included because it is the commonest cause of cancer of the eye in children and, in addition to childhood blindness, it can lead to death of an affected child particularly when it is diagnosed late. 14 2.3.1 Childhood cataract Childhood cataract may be defined as the presence of an opacity in the lens of a child‟s eye that interferes with vision (Shrestha, 2012; Sheeladevi, Lawrenson, Fielder, and Suttle, 2016). It is becoming the major cause of childhood blindness in sub-Saharan Africa and other developing countries (Courtright et al., 2011; Courtright, 2012; Bronsard et al., 2018). The literature on childhood cataract as a cause of childhood blindness increased only in the last few years. This is becau se childhood cataract became more prominent following the observed changes Yin the epidemiology of childhood blindness (Gogate et al., 2009). Some of the puRblications which have focused on the control of childhood cataract include GRilbeArt and Muhit (2012) and Courtright (2012). These papers are good examples ofB the discussion of the increasing need to focus more attention on the control of bLlinIdness from childhood cataract through the provision of affordable and accNess ible high quality surgical services. A Notwithstanding, the available data on theA epDidemiology of childhood cataract is considered to be limited (Sheeladevi eItB al., 2016; He and Li, 2017). This paucity appears to be partly responsible Ffor the variation in global prevalence estimates. Sheeladevi et al. (2016) in theiOr systematic review reported that the overall prevalence of cataract in childhood raYnge d from 0.32 – 22.9 per 10,000 children across the globe. While another reviewI Treported that the global prevalence was between 0.01- 0.15 per 100 children (He Sand Li, 2017). Another reason for the wide range is the regional variation in tRhe prevalence of childhood cataract; the prevalence being higher in developingE countries of Africa and Asia in comparison to the developed economies of EuropIeV and America (Khokhar et al., 2017). Furthermore, the burden of visual imNpairment and blindness due to childhood cataract in low income countries is ten Utimes the burden in developed countries (He and Li, 2017). Meanwhile, the global incidence of childhood cataract is reported to range between 1.8 – 3.6 per 10,000 per annum (Sheeladevi et al., 2016). The common causes of childhood cataract include familial (inherited) cataracts, intrauterine infections such as Rubella, eye trauma, as well as chromosomal and genetic abnormalities (Johar, Savalia, Vasavada, and Gupta, 2004; Khokhar et al., 2017; Lambert, 2017). Childhood cataract may also be associated with some 15 syndromes such as Down syndrome and Marfan syndrome (Zetterstrom, Lundvall, and Kugelberg, 2005; Adio and Nwachukwu, 2016). There is a global variation in the causes and risk factors for childhood cataracts. The most common identifiable cause in Europe and North America is heritable cataract, usually autosomal dominant (Chan, Biswas, Ashworth, and Lloyd, 2012; Wu, Long, Lin, and Liu, 2016; Lambert, 2017). While in Asia and Africa, cataracts caused by trauma and those associated with presumed congenital Rubella syndrome represent a significant proportion of the identified causes of childhood cataract (Courtright, 2012; Borrell, Dabideen, Mekon en , and Øverland, 2013; Babber, Saraswat, Ojha, Tandon, and Sharma, 2016R). RYubella cataract and traumatic cataract have also been found to be common in NAigeria (Duke, Oparah, Adio, Eyo, and Odey, 2015; Musa et al., 2018). BR Childhood cataracts can be classified according to the age oLf thIe child at onset of the disease. Congenital cataracts are present at birth or becom e obvious within the first one year of life; while developmental cataracts mAanifNest after the age of 1-2 years (Courtright, 2012). In addition, childhood cataraDcts can affect only one eye (unilateral cataract) or both eyes (bilateral cataracts)B. AnAother classification system for childhood cataracts is based on the structure, loc atIion and density of the lens opacity, that is, the morphology of the cataract. The mForphological types include total, nuclear, posterior, lamellar, membranous and sutOural cataracts among others (Amaya, Taylor, Russell- Eggitt, Nischal, and LengyYel, 2003; Zetterstrom et al., 2005). The common symSptoIm Ts for childhood cataract include white spot(s) in the eye(s), poor vision, aRnd shaky unsteady eyes (Lambert, 2017). Poor vision in infants and young chilEdren may be suspected when they fail to make eye contact with the mother and oIthVer individuals or fail to return smiles, as well as when they bump into objects orN fall over items easily (Adio and Nwachukwu, 2016). For older children, poor Uperformance at school may suggest poor vision. Clinical signs of childhood cataract that can be detected on examination include leukocoria (white pupil), nystagmus, and strabismus (Lambert, 2017). In addition, features of associated ocular or systemic disease may be found during examination (Zetterstrom et al., 2005; Adio and Nwachukwu, 2016). 16 2.3.2 Corneal opacity A corneal opacity is the presence of a white scarred area in the cornea of the eye which results in a loss of its transparency (Ashaye and Oluleye, 2004). The transparent nature of the normal cornea is vital for clear vision. When there is an opaque area in the cornea, the vision of the affected eye is impaired depending on the density and the size of the opacity (World Health Organization, 2018b). Corneal opacity was previously the leading cause of childhood blindness bYut the changes in the epidemiology of childhood blindness have brought about a Rdecline in the frequency of corneal opacity in children (Gogate et al., 2009; RCouArtright et al., 2011). Across the globe, there are regional variations in the epidBemiology of corneal opacity as a cause of childhood blindness. The proportion oIf childhood blindness caused by corneal opacity is much higher in sub-SahaNran A Lfrica and southeast Asia compared to Europe and south America (Kong et al., 2012). Furthermore, within each of these regions, the proportion varies within and bAetween countries according to the level of development; with less developed anAd ruDral areas having higher proportions of childhood blindness that is attributed to cBorneal opacity (Gupta et al., 2015; Hashemi, Pakzad, Yekta, and Khabazkhoob, 2 0I18).The common causes and risk factors of corneal opacity in children includFe measles keratopathy with associated vitamin A deficiency, microbial kerYatiti s O (corneal infections), trauma and the use of harmful traditional eye medications (Panjiyar, Gautam, Rai, and Puri, 2016; Solebo et al., 2017; Tuft, 2017S). InI Tsub-Saharan Africa, corneal infections, the use of traditional remedies and Rvitamin A deficiency are the major risk factors for corneal opacity in children (SEolebo et al., 2017); while in southeast Asia, the major causes are trauma and cIorVneal infections (Wang, Zhang, Li, Wang, and Liu, 2014; Gupta et al., 2015). In ENurope and North America, however, genetic and congenital corneal diseases are the Umajor causes (Tuft, 2017). The symptoms of corneal opacity include white spot in the eye(s) and poor vision, while the main clinical sign is an opacity in the cornea (Tuft, 2017). Other signs that may be present include irregularities both in the depth of the anterior chamber of the eye and in the shape of the pupil (Tuft, 2017). 17 2.3.3 Childhood glaucoma Glaucoma has been defined as a group of heterogeneous eye diseases in which there is progressive optic neuropathy characterized by pallor and cupping of the optic nerve head, as well as visual field loss in which elevated intraocular pressure is a risk factor (Foster, Buhrmann, Quigley, and Johnson, 2002; World Health Organization, 2018c). Childhood glaucoma refers to eye diseases characterized by ocular damage due to elevated intraocular pressure (Thau et al., 2018). There are different forms of glaucoma in children (Kipp, 2003; Papadopoulos and Khaw, 2017). The commYonest form is primary congenital glaucoma (Ho and Walton, 2004; PapadopoulRos, Cable, Rahi, Khaw, and Investigators, 2007). Other types are pRrimaAry juvenile/ developmental glaucoma, secondary glaucoma such as glaucomBa following trauma, uveitis or cataract surgery and glaucoma associated wiLth Ieye disease such as congenital anomalies or intraocular tumours (Kipp, 2003; Papadopoulos et al., 2007; Thau et al., 2018). The primary forms of childhoodA glaNucoma are idiopathic in origin and the main risk factors include parental consaDnguinity, positive family history and genetic mutations (Papadopoulos and KhBaw,A 2017). While, the causes and risk factors for secondary childhood glaucoma are oIcular trauma, uveitis, cataract surgery, as well as congenital eye diseases such as FAniridia, Axenfeld-Rieger‟s syndrome and Peter‟s anomaly (Kipp, 2003; Papado pOoulos and Khaw, 2017). The main symptoms IoTf coYngenital glaucoma have been described as a classical triad of watering of theS eye(s), photophobia and blepharospasm (Papadopoulos and Khaw, 2017). Photophobia is sensitivity of the eyes to light which causes the individual to avoid brigEht Rlights. Blepharospasm means spasm of the eye lids with associated difficIulVty in opening the eyes. A child who presents with this triad of symptoms is veNry likely to have congenital glaucoma. Other common symptoms of childhood Uglaucoma are poor vision, white spots in the eye(s) and large eyeballs (Papadopoulos and Khaw, 2017). Clinical signs of childhood glaucoma include buphthalmos (bull‟s eye), corneal haziness, elevated intraocular pressure as well as optic disc pallor and cupping (Kipp, 2003; Papadopoulos and Khaw, 2017).. 18 2.3.4 Blepharoptosis Blepharoptosis, simply referred to as ptosis, is defined as drooping of the upper eyelid (Pavone et al., 2018). It is can affect one eye (unilateral) or both eyes (bilateral) (Weaver, 2018). The drooping upper lid may impair vision by causing obstruction of the visual axis of the eye or by distorting the curvature of the cornea with resulting astigmatism (Marenco et al., 2017). The severity as well as the laterality of ptosis determines the impact of the condition on the vision of the affected child (Pavone et al., 2018; Weaver, 2018). RY There are 2 main types of ptosis namely congenital ptosis and acquired pAtosis (Pavone et al., 2018). Congenital ptosis, which is the more common type, iRs usually present from birth or develops within the first year of life (Marenco et aIlB., 2017). Risk factors for congenital ptosis include genetic mutations and a positiv eL family history (SooHoo, Davies, Allard, and Durairaj, 2014). Congenital ptoAsis mNay be caused by birth trauma and could occur in association with conditions such as Bleharophimosis syndrome, Duane syndrome and Marcus Gunn syndromAe (DSooHoo et al., 2014; Marenco et al., 2017). Acquired ptosis occurs any timBe after the first birthday and may occur following trauma, upper lid infectiFons , Iparalysis of the elevators of the upper lid and brain tumours (Pavone et al., 2O018; Weaver, 2018). The main symptom ofT ptoYsis is drooping of the upper eyelid(s) (Kersten and Collin, 2017). Another sympItom is elevation of the chin, especially in patients with bilateral ptosis. Clinical sSigns of ptosis include reduced palpebral aperture (the distance between thEe uRpper and lower lids), furrowing of the forehead, and abnormal head postuIreV (Kersten and Collin, 2017).. 2.N3.5 Strabismus U Strabismus is defined as a misalignment of the visual axes of the eyes which is a consequence of abnormal deviation of one or both eyes (Kanski, 2003). In normal circumstances, the two eyes look towards the same object of regard. When there is a misalignment of the visual axes, the two eyes look towards different directions or objects, and this is associated with the presence of an angle of deviation between the visual axes of the eyes. 19 Strabismus may be classified into primary and secondary types depending on the cause (von Noorden and Campos, 2002). Primary strabismus is idiopathic and occurs without any apparent cause or organic pathology affecting the eyes (Wright, Spiegel, and Thompson, 2006). Risk factors for primary strabismus include a positive family history, prematurity, cerebral palsy and seizure disorders. (Pennefather and Tin, 2000; Kristjansdottir, Sjostrom, and Uvebrant, 2002; Holmstrom, Rydberg, and Larsson, 2006; Donahue, 2007). Secondary strabismus has an identifiable cause which can either be an eye disease with associated visual impairment or neuromuscular dYisea se (von Noorden and Campos, 2002). Causes of secondary strabismus incRlude high refractive errors, amblyopia, cranial nerve palsy, intraocular tumourAs, and visual impairment from any cause (von Noorden and Campos, 2002; TichoR, 2003; Wright et al., 2006). LIB Symptoms of strabismus include deviation of one or both eyes, double vision, poor vision and abnormal head position (von Noorden aAnd NCampos, 2002; Wright et al., 2006). Clinical signs of strabismus include Dconvergent or divergent deviation, limitation or restriction of eye movements, dAiplopia, abnormal head posture and visual impairment (Wright et al., 2006; AzIonBobi, Olatunji, and Addo, 2009; Bodunde, Onabolu, and Fakolujo, 2014). F 2.3.6 Retinoblastoma OY Retinoblastoma is an IaTbnormal proliferation of the precursor cells of the photoreceptor cells of the retinaS (Mehta et al., 2012). It is an intraocular malignancy and is the commonesEt inRtraocular tumour in children (Ortiz and Dunkel, 2016; AlAli, Kletke, GallieI,V and Lam, 2018). It is relatively uncommon and accounts for about 3% of all chNildhood cancers (Rodriguez-Galindo, Orbach, and VanderVeen, 2015; Rao and UHonavar, 2017). Risk factors for retinoblastoma include genetic mutation, positive family history and older paternal age (Mehta et al., 2012; Mills, Hudgins, Balise, Abramson, and Kleinerman, 2012; Cassoux et al., 2017). Apart from being a cause of blindness in affected children, the disease can lead to death in the absence of treatment (Rao and Honavar, 2017). Retinoblastoma usually presents in early childhood and one of the earliest symptoms is a “cat‟s eye reflex” (Gallie and Soliman, 2017). This is an abnormal reflection of 20 light that is seen from the affected eye especially in the dark. It is very similar to the reflection seen from the eyes of cats at night. Other symptoms of retinoblastoma include squint (abnormal deviation of the eye), white spot in the eye and poor vision (Mehta et al., 2012; Ortiz and Dunkel, 2016; Rao and Honavar, 2017; AlAli et al., 2018). Advanced retinoblastoma may present with protrusion of the eye and multiple masses on the scalp (Mehta et al., 2012; Gallie and Soliman, 2017). The clinical signs of the early stages of the disease include leukocoria, strabismus, and detection of retinal mass(es) on fundoscopy (Ortiz and Dunkel, 2016; AlAli et al., 2018). In l ate stages, there may be extraocular spread of the tumour with associated RproYptosis, orbital masses as well as features of intracranial extension (Mehta et al.A, 2012; Gallie and Soliman, 2017). BR 2.4 DETECTION OF CHILDHOOD EYE DISEASE SL I Identification of eye disease or visual impairment in Ninfants and young children is challenging (Nirmalan et al., 2004a). One reason foAr this is that infants and toddlers are unlikely to complain about visual sympAtomDs or inability to see well. Especially, since they may be unaware that their visIuBal experience is abnormal. In fact, it has been reported that even older children wFith visual impairment perceive their vision to be equivalent to that of their colleaOgues with normal vision (Nirmalan et al., 2004a) Another reason for thTe dYifficulty with detection of eye disease in children is the inability of parents Ito notice when there is a problem with their child‟s vision (Kemmanu et al.,S 2018b). Several studies have demonstrated the fact that parents and care giversE maRy be unaware or have misconceptions about causes, signs and treatment of chiIldVhood eye diseases (Nirmalan et al., 2004b; Muhit, Shahjahan, Hassan, Wazed, anNd Ahmed, 2011; Balasubramaniam, Kumar, Kumaran, and Ramani, 2013; USenthilkumar, Balasubramaniam, Kumaran, and Ramani, 2013; Donaldson, Subramanian, and Conway, 2018; Sukati, Moodley, and Mashige, 2018). Furthermore, parents are not likely to seek routine eye examinations for their children. Amiebenomo et al. (2016) reported that majority of parents in Benin city sought eye care for their children only after he or she had a complaint. Therefore, in a situation where the child does not complain and the parents are unaware, the presence of eye disease or visual impairment may go unnoticed. This 21 usually leads to delayed detection of the eye problem and late presentation of the child to the health care provider. It is in view of the possibility that a young child with visual impairment may not be detected early that efforts to identify such children should not depend on the decision and action of the parents or care giver only. Health care providers need to actively seek to identify children with features suggestive of visual impairment or eye diseases. The following sections discuss the importance of early detection, the factors associated with delayed detection as well the techniques and methods used for early detection of childhood eye diseases. Y 2.5 IMPORTANCE OF EARLY DETECTION AND TREATAMERNT OF CHILDHOOD EYE DISEASES R The sense of vision in humans is not fully developed at birth (MIBills, 1999; Bremond- Gignac et al., 2011). In fact, it takes about 7-8 yeNars fo Lr the process of visual development to reach completion (Day, 1997; WrigAht et al., 2006). Normally, visual development is an intricate process that requiresD appropriate stimulation of the visual system in order to achieve the best visual potAential in an individual. Appropriate visual stimulation involves three basic componeBnts namely: (i) the formation of clear retinal images in each eye (ii) the proper alig nIment of the visual axes of both eyes and (iii) comparably equal image clarity bFetween the two eyes (von Noorden and Campos, 2002; Wright et al., 2006)Y. O Therefore, whenever IthTere is abnormal visual stimulation due to disruption of any of these componentsS during early childhood, the process of visual development does not follow theE norRmal course and optimal visual maturation is not achieved (Mills, 1999). AbnoIrmVal visual stimulation occurs when indistinct images are perceived by one or boNth eyes, and/or when there is misalignment of the visual axes of the eyes (Bremond-UGignac et al., 2011). Thus, eye diseases such as cataract, corneal opacity, glaucoma, ptosis, and strabismus can all result in abnormal visual stimulation and subsequently, abnormal visual development. And this implies that a child who suffers any of such diseases is subject to a “double jeopardy” phenomenon. In other words, the eye disease not only causes poor vision directly, it also indirectly diminishes the best visual potential by disrupting the process of visual maturation. 22 Apart from the failure to achieve maturity of visual function, other consequences of abnormal visual development include structural abnormalities in the visual centres of the brain, lack of binocular vision and amblyopia (von Noorden and Campos, 2002; Wright et al., 2006). Some fallouts of these consequences include poor visual acuity, poor depth perception and low contrast sensitivity (Mills, 1999; Levi, Knill, and Bavelier, 2015). These result in a worse degree of visual impairment than that which is directly due to the eye disease that caused the abnormal visual stimulation in the first place. Thus, the severity of visual loss in a child is actually worse than in an ad ult with the same disease of similar severity because the adult had attainRed Yvisual maturity before the onset of the disease. RA The implication for the child with such eye disease is that, treatmeBnt of the eye disease alone is not sufficient to restore normal vision. In addition toL thIe treatment of the eye disease, consideration has to be given to the institution of m easures that will foster the reinstatement of normal visual development (WrigAht eNt al., 2006). These measures, however, can only be effective if initiated Dduring the early period of visual development when the abnormal processes cAan still be “normalised”. This means that the treatment of the eye disease muIstB also be administered during that period. Moreover, when treatment of the eFye disease is delayed beyond the period of visual development, the conseque nOces of the abnormal visual stimulation become irreversible leading to peYrmanent visual impairment irrespective of the quality of treatment (Mills, 199I9;T Bremond-Gignac et al., 2011; Park, 2019). Although visual dSevelopment continues until the age of 7-8 years, it is most active and vulnerableE durRing the first 3 months of life. Therefore, this period is referred to as the criticalV period of visual development (Daw, 1998). Thereafter, the developmental prNoceIsses progress less rapidly and are less modifiable (Mills, 1999). It is because of Uthe critical period that congenital eye diseases can cause severe and permanent visual impairment when they are not detected early and treatment is delayed beyond the first st few months of life. In addition, diseases with onset during the latter half of the 1 year th of life up till the 8 year, must be identified on time and treated promptly. Furthermore, the visual impairment in childhood has a negative impact on mental and educational development of the affected child (Dale and Salt, 2007). Children learn mostly by copying others and about 80% of learning is based on the sense of vision 23 (Zaba, 2011). This further indicates the urgency that is required in the treatment of childhood eye diseases that cause blindness. Early treatment of such diseases does not only improve the child‟s vision; it also enhances the mental development and educational prospects of the affected child (Gogate, Gilbert, and Zin, 2011). Therefore, the need for early detection and prompt intervention in childhood eye diseases cannot be overemphasised. 2.6 DELAYED DETECTION OF CHILDHOOD EYE DISEASES I N DEVELOPING COUNTRIES RY Based on the foregoing, it is quite clear that early detection and prompAt treatment of childhood eye diseases is vital for achieving the best visual BoutcRome in affected children. In developed countries, most children with eye LdiIseases that can cause blindness are identified early and treatment is usually Nadm inistered promptly (Rahi, Cumberland, Peckham, and British Childhood ViAsual Impairment Interest, 2010). Unfortunately, the same cannot be said about deDveloping countries, particularly those in Sub Saharan Africa, where delayed detAection of eye diseases and blindness in childhood is common. This delay, undoBubtedly, leads to late presentation of such children to hospital for treatment. Sev eIral studies on the late presentation of children with eye diseases, especially, cataraFcts have been published from developing countries (Mwende et al., 2005; BrYons a Ord et al., 2008; Gogate et al., 2010; Courtright et al., 2011; Ezegwui et al., 2011; Leite and Zin, 2011; You et al., 2011; Randrianotahina and Nkumbe, 201S4; SIc Thulze Schwering, Finger, Barrows, Nyrenda, and Kalua, 2014; Sheeladevi et Ral., 2018). One ofV theEI reasons for the delayed detection of childhood eye diseases is the lack of scNreening programs in developing countries (You et al., 2011; Sheeladevi et al., U2018). This is contrary to what obtains in the developed countries where well-coordinated screening programmes facilitate the early detection of blinding eye diseases in neonates and infants (Rahi et al., 2010). Another reason is the parental awareness and attitude to eye problems of children, as has been mentioned earlier. In addition, poor knowledge and skills of primary health care provider may contribute to the delay in detecting blinding eye diseases in children (Kishiki, Hogeweg, Dieleman, Lewallen, and Courtright, 2012). Thus, even when a parent seeks eye care on account 24 of a suspicion that there is a problem with a child‟s eye, wrong advice from the health care provider can lead to delay in diagnosis and treatment (Courtright et al., 2011). The major concern with delayed detection as well as late presentation and treatment of children with eye disease is the associated poor outcome. The poor outcome of treatment is due to the disruption of visual development caused by the eye disease and the subsequent amblyopia (Sheeladevi et al., 2018). Amblyopia may be simply defined as inability of an eye to see optimally in the absence of any organic patholo gy or despite complete treatment of eye disease (American Academy of OphthalmYology, 2008). It is usually associated with any eye disease that causes abnormRal visual stimulation during early childhood. The earlier the onset of the diseaRse, Athe worse the amblyopia (Gogate et al., 2011). When diagnosed early, amblyopBia can also be treated effectively with resultant improvement in vision to normLal Ior near-normal levels (Park, 2019). However, when it is diagnosed after the Nperi od of visual development, the visual impairment due to amblyopia is permaneAnt (Bremond-Gignac et al., 2011). For this reason, early detection and treatment Dof blinding eye diseases, especially during the first year of life, is very cruBciaAl in the prevention of permanent visual impairment from amblyopia. I 2.7 INTERVENTIONS FOOR FEARLY DETECTION OF CHILDHOOD EYE DISEASES Y In view of the imporItaTnce of early detection of childhood eye diseases, a number of measures or intervSentions have been developed or recommended by some professional societies EandR non-governmental organisations including the World Health OrganIiVsation. Examples of these interventions include the following: 2.N7.1 Eye examination at birth and during well baby visits U Routine examination of the eye of new-borns soon after birth or in the early neonatal period has been broadly recommended by several professional bodies in developed countries. These societies include the American Academy of Paediatrics, the American Academy of Ophthalmology, the American Association for Paediatric Ophthalmology and Strabismus, American Academy of Family Physicians, American Optometric Association and the Canadian Paediatric Society (Committee on Practice 25 Ambulatory Medicine Section on Ophthalmology et al., 2003a; Committee on Practice Ambulatory Medicine Section on Ophthalmology et al., 2003b; Canadian Paediatric Society, 2009; Donahue et al., 2016a; Donahue et al., 2016b; Earley and Fashner, 2019). These examinations are often performed by a physician or nurse soon after delivery or during infant welfare clinic visits. Specifically, in the United States of America (U.S.A.), new born babies routinely undergo a comprehensive new-born examination within the first 48 to 72 hours of li fe; the assessment, which includes examination of the eyes, is usually performedY by a paediatrician (Lowe and Woolridge, 2007; Lewis, 2014). In addition, infantRs undergo periodic examinations by either a family physician or a paediatrician RduriAng well-child visits that usually take place at the ages of one, two, four, six, nIinBe and twelve months (Bell, Rodes, and Collier Kellar, 2013; Committee On PLractice and Ambulatory Medicine and Bright Futures Periodicity Schedule WoNrkgroup, 2017; Moreno, 2018; Turner, 2018). Furthermore, the American OptAometric Association offers free comprehensive eye examinations to all infants aDged between 6 and 12 months through the InfantSEE program (Miller, 2007). BA Furthermore, the United Kingdom (UIK) Government through the UK National Screening Committee has laid oOut gFuidelines for examination of the eyes of new-borns and infants (Carr and FostYer, 2014; Public Health England, 2019). Thus, in the United Kingdom, all babiesI gTo through a New-born Infant Physical Examination (NIPE) within 72 hours oSf birth and this incorporates an eye examination to detect congenital abnormalities R(Mansoor et al., 2016). This examination is usually performed by paediatriciEan or a midwife; and a follow-up examination is conducted when the child is 6 tIo V8 weeks old by a general practitioner (Green and Oddie, 2008; Parish, Tailor, anNd Gandhi, 2018). Moreover, many European countries including Sweden, Denmark, UItaly, Netherlands and Norway have established programs in which neonates and infants undergo routine comprehensive assessments with eye examination performed by paediatricians or general practitioners (Haargaard, Nystrom, Rosensvard, Tornqvist, and Magnusson, 2015; Perilli, Lanci, Romanzo, Sabatini, and Fusilli, 2015; Sloot et al., 2015). Unfortunately, the same cannot be said about many of the countries in Asia and Africa, with specific regards to full term normal neonates. Reports from India and 26 China suggest that most full-term babies do not undergo routine eye examination in the neonatal period or during infancy (Li and Lin, 2013; Vinekar et al., 2015; Ma et al., 2018). In the same vein, most African countries, Nigeria inclusive, do not have routine eye screening examinations for neonates and infants (Atowa, Wajuihian, and Hansraj, 2019; Jac-Okereke, Jac-Okereke, Ezegwui, and Okoye, 2020). In the Nigerian health system, there are some opportunities for such eye examinations to be carried out on neonates and infants such as during examination of new-bo rns immediately after birth and at post-natal clinic visits as well as during immuniYsation visits. Indeed, the National Eye Health policy recommends that frontlinRe primary health care workers should be adequately trained to recognise and reRfer cAhildhood eye diseases within the total provision of child healthcare packagBe, that is, neonatal examination, immunisation and growth monitoring (FedeLraIl Ministry of Health Nigeria, 2019). However, there is the no evidence to that eye examinations are done routinely or that children detected to have eye dAiseaNse are referred promptly and appropriately. AD On the other hand, there are relativelIyB well-established programmes that provide screening for Retinopathy of PremaFtur ity (ROP) among premature babies born in Asia (Mora, Waite, Gilbert, BreiOdenstein, and Sloper, 2018; Adams, 2020). Such programmes, which are gYene rally limited to premature and low birth weight babies, usually lead to the IeaTrly detection of other ophthalmic conditions in such babies (Jayadev et al., 20S15). Over the last few years, similar programmes have been set up and are expanding across African countries, including Nigeria, such that a good proportionE ofR premature African babies have the opportunity to undergo ROP screenIiVng examinations (Ademola-Popoola and Oluleye, 2017; Wang, Duke, Chan, anNd Campbell, 2019; Olusanya et al., 2020a). U2.7.2 Preschool vision screening Preschool vision screening of children between the ages of 3 and 5 years is also recommended by various professional societies including those mentioned above (Earley and Fashner, 2019). In addition, the government of the United States of America through the U.S. Preventive Services Task Force (USPSTF) has a well 27 outlined policy for examination of the eyes of children of preschool age (Jonas et al., 2017; U. S. Preventive Services Task Force et al., 2017). Preschool vision screening facilitates the early detection of poor vision and eye diseases that may lead to visual impairment such as refractive errors, amblyopia, and media opacities in children before they start school. Evidence exists that visual impairment may have a negative impact on learning and educational development of an affected child (Atkinson et al., 2002; Roch-Levecq, Brody, Thomas, and Brow n, 2008; VIP-HIP Study Group et al., 2016).Therefore, it is pertinent to ensure thYat any vision disorder or eye disease is detected before school entry. Indeed, there aRre reports about the usefulness of these programs in early detection of amblyopRia aAnd the impact of early treatment on education and learning (Azizoglu et al., B2017; Joint Clinical Practice Guideline Expert Committee of the Canadian AssLociIation of Optometrists and the Canadian Ophthalmological Society et al., 2019; Th orisdottir, Faxen, Blohme, Sheikh, and Malmsjo, 2019; O'Colmain, Neo, GilmoAur, Nand MacEwen, 2020). Such preschool vision screening programs arAe wDell established in developed countries. However, none of these screening progrBams exist in sub-Saharan African countries (Atowa et al., 2019). A few studiesF ha vIe been reported from Asia and Latin America but none from Africa (Latorre-AOrteaga et al., 2014; Jeong and Kim, 2015; Chew et al., 2018; de Venecia, BradYfiel d, Trane, Bareiro, and Scalamogna, 2018; Paul and Sathyan, 2018). IT 2.7.3 Primary eSye care services (in sub-Saharan Africa) R PrimarVy heEalth care workers should play an important role in the early detection of eye diseasIes in children (Olowoyeye, Musa, and Aribaba, 2019). This is because they are ofNten the first port of call for mothers and children in their search for health care. UUnfortunately, this role does not appear to have been well established in many African countries as a result of the poor knowledge and skills which health workers possess regarding primary eye care (Byamukama and Courtright, 2010; Kishiki et al., 2012; Kalua et al., 2014; AbdulRahman, Rabiu, and Alhassan, 2015). This is contrary to the expectation that these health workers should actually be knowledgeable and skilled in primary eye care, since they are taught about eye diseases during their basic training programmes. In Nigeria, for example, the curriculum and the standing orders of 28 community health officers (CHOs) and community health extension workers (CHEWs) contain modules on eye care including the identification and prompt referral of children with cataract (Shodehinde, Kila, Akinrolabu et al, 1995; Community Health Practitioners Registration Board of Nigeria, 2006a; Community Health Practitioners Registration Board of Nigeria, 2006b). Various reasons have been suggested for this mismatch between the basic training and the practice of primary eye care by primary health workers. They include lack of supervision and retraining; lack of equipment for basic examination such as visual acuity charts, pen torches a nd ophthalmoscopes; lack of medications; and poor referral systems (CRourYtright, Seneadza, Mathenge, Eliah, and Lewallen, 2010; AbdulRahman et al., A2015; Aghaji, Gilbert, Ihebuzor, and Faal, 2018; Olowoyeye et al., 2019). BR As far back as the year 2002, the World Health OrganisatioLn inI conjunction with the Lions Sight First project for the prevention of blindnesNs in children recommended 10 Key activities, which if implemented by primary Ahealth workers would promote Healthy eyes in children (World Health OrganizDation, 2002). The activities are listed in Table 2.1. Some of the activities promBote Athe general health of children and are not specific to eye health while some acti vIities, such as detection and prompt referral of children with white pupil and eyFe injuries, are directly related to eye health. In addition, the nature and spect ruOm of the activities strongly suggest that strengthening primary health care plays Ya vital role in the prevention of childhood blindness. Sadly, there is little evidenceI Tthat this recommendation by the World Health Organisation has been adopted byS most African countries (Mafwiri et al., 2014). This has had a negative impaRct on the implementation of the policy of early detection of eye disease in childrenE at primary health care level. V MNafwIiri et al. (2014). conducted some studies on the implementation of these Uactivities and their integration into primary health care in Tanzania. They found that prior to training, primary health workers were only performing some activities but after training, all 10 activities were being performed by the primary health workers. This demonstrates the fact that training and retraining of primary health workers and integration of primary health care activities may go long way in ensuring the children with eye diseases are detected early. 29 Furthermore, studies on the prevalence and causes of childhood blindness have used a case finding approach for the detection of eye diseases in children (du Toit et al., 2017). Volunteer health workers are trained on some of the features of eye diseases and blindness in children. These workers, who have been termed “Key informants”, then go into communities which they are familiar with, to identify children who may be blind or visually impaired. All the identified children are subsequently brought for examination by an ophthalmologist on a particular day to confirm the presence of eye disease or blindness. However, this method of detecting eye disease in children is n ot sustainable and may not achieve the aim of early identification and prompt reRferrYal. BR A LI AN AD IB F Y O T Table 2.1 Ten keSy acItivities to promote healthy eyes in children 1. Give vitamiRn A supplements to children routinely 2. GiveV vitEamin A supplements to mothers after delivery 3. ProImote breast feeding and good nutrition U4 NGive vitamin A supplements to children with measles or malnutrition 5. Immunize children against measles 6. Clean the eyes of babies at delivery and apply antibiotic eye drops 7. Keep children‟s faces clean 8. Refer children with poor vision or white pupils to an eye worker 9. Avoid the use of traditional eye medicines 10. Refer children with history of injury to an eye worker 30 Source: (World Health Organization, 2002) Y AR R LI B N AD A IB O F 2.8 PRINCIPLES OFT SCYREENING FOR DISEASES I Wald (1994) defiSned screening as “the systematic application of a test or inquiry to identify thoseR individuals at sufficient risk of a specific disorder to benefit from furtherV invEestigation or direct preventive action, among persons who have not sought medicIal attention on account of symptoms of that disorder”. Essentially, the unNderlying principle of screening for any disease is that early detection is deemed to Ube beneficial at the individual level as well as to the community, from a public health perspective. 2.8.1 Criteria for screening The most popular set of screening criteria is the Wilson and Jungner criteria, first published by the World Health Organisation in 1968. These criteria, which are listed 31 below, are a set of requirements that should be met before screening may be considered appropriate for a disease. 1. The disease condition should be an important health problem. 2. There should be an accepted treatment for patients with recognized disease. 3. Facilities for diagnosis and treatment should be available. 4. There should be a recognizable latent or early symptomatic stage. Y 5. There should be a suitable test or examination. R 6. The test should be acceptable to the population. RA 7. The natural history of the condition, including develoIpBment from latent to declared disease, should be adequately understood. L 8. There should be an agreed policy on whom toA treNat as patients. 9. The cost of case-finding (including dDiagnosis and treatment of patients diagnosed) should be economBicalAly balanced in relation to possible expenditure on medical care as aI whole. 10. Case-finding should beO a Fcontinuing process and not a 'once and for all' project. Y Although, these criteIriTa have been modified and improved upon by different authors and health agencieSs, they still form the traditional criteria for justification of screening for diseases. BRlindness and visual impairment in childhood fulfil these criteria to a large extenEt and therefore screening for causes and risk factors of visual impairment and bIliVndness among infants and young children is justified. UN2.8.2 Screening tools in health care Screening has been used for the early detection of various types of diseases including cancer, genetic conditions, infections, vascular conditions and psychological disorders. There are various forms of tests or tools used for screening. These tools include blood tests, urinalysis, radiological investigations such as X-rays and ultrasonography, endoscopy as well as clinical and pathological examinations. These 32 tests may be based on the measurement of a specific chemical or substance in body fluids or the detection of a particular characteristic or feature during examination or investigation (Maxim, Niebo, and Utell, 2014). Checklists have also been used as screening tools in health care. Checklists are cognitive tools that are used in various fields of endeavour to aid memory and decision making (Winters et al., 2009; Kramer and Drews, 2017). In the field of health care, they have been particularly useful in the reduction of medical errors a nd optimisation of patient safety as well as in performance evaluation of healthY care providers (Hales and Pronovost, 2006; Rosen and Pronovost, 2014). With Rrespect to screening, however, the role of checklists appears to be less promineRnt. AEven so, their use has been well studied with regards to screening forB autism and other developmental disabilities (Petrocchi, Levante, and LecciLso,I 2020). Examples of checklists that have been in employed in screening for dif ferent diseases include the Modified-Checklist for Autism in Toddlers (M-CHAAT),N the Baby Paediatric Symptom Checklist (BPSC), the Preschool PaediatricD Symptom Checklist (PPSC), the Temporomandibular disorders (TMD) checAklist, the Posttraumatic stress disorder (PTSD) Checklist, and the Hypomania CIhBecklist. 2.9 TECHNIQUES OF SCREFENING FOR EYE DISEASE IN INFANTS AND YOUNG CHILDRYEN O Examination of younIgT children is not easy because of poor cooperation. Objective vision assessmentS is also difficult and often requires special equipment or instruments. SubjectiveE asRsessments may also be prone to misinterpretation. Therefore, some technIiqVues have been identified to be useful in screening for eye disease or visual imNpairment among infants and young children. These techniques include the Red Ureflex (Bruckner) test, photo-screening instruments, and use of checklists. These techniques generally involve brief examination of the child, require minimal cooperation of the children and can provide enough information to determine the presence or absence of eye disease. 33 2.9.1 Red reflex test (Bruckner test) The red reflex test is a very important screening technique for eye disease in infants and young children (Loh and Chiang, 2018). It is performed with the aid of a direct ophthalmoscope. A direct ophthalmoscope is a special equipment used to examine the posterior aspect of the eye. It is routinely used by ophthalmologists and general physicians to examine the vitreous, retina and optic nerve of the eye. When the light from the instrument is shown on the eye, a reflection of light is perceived by t he examiner as he/she looks through the instrument. This reflection has an orange Yor red colour (that is, a red reflex) and the quality of the reflection gives an indicatRion of the transparency of cornea, the lens and other internal structures of theR eyeA. In addition, the reflexes from both eyes can be viewed simultaneously andI Bcompared (Bruckner test) for differences between the two eyes. L This test is very valuable for the detection of media opaNcities such as cataract, corneal opacity. It can also detect strabismus, ptosis, conDgenAital glaucoma and retinoblastoma. In addition, high degrees of refractive errorsA can also be detected using the red reflex test. IB It is the recommended test for sFcreening among neonates and infants especially because it does not depend on tOhe child‟s cooperation (Loh and Chiang, 2018). And is widely practised in thTe dYeveloped countries. In those settings, the test is usually performed by primarIy care providers. Various studies have been conducted on the sensitivity and spSecificity of the test in detecting eye diseases in infants and young children. TEhe Rreported sensitivity of the Red reflex test ranged between 13.9% and 85%,I wVhile the specificity ranged between 38.5% and 98.7% (Eventov-Friedman, LNeiba, Flidel-Rimon, Juster-Reicher, and Shinwell, 2010; Saiju, Yun, Yoon, Shrestha, Uand Shrestha, 2012; Mussavi, Asadollahi, Janbaz, Mansoori, and Abbasi, 2014; Sun et al., 2016). Challenges with the use of the Red reflex test, in developing countries, include the fact that the direct ophthalmoscope is a relatively expensive instrument, and the test requires some degree of expertise for performing it and interpreting the various results. Consequently, direct ophthalmoscopes are not readily available in many health 34 care facilities especially primary and secondary centres. Moreover, the health workers in these facilities lack the knowledge and skill required to perform the test. 2.9.2 Photo-screening Photo screening is the use of instruments to screen for refractive errors, amblyopia and other eye diseases among preschool children usually between the ages of 3 and 5 years. Children at this age may not be able to cooperate for objective visu al assessment that require matching of optotypes such as the Lea and HOTV cYharts. Examples of the instruments that been developed for photo-screening incAludRe iScreen, SPOT, PlusOPtiX, MTI, and remote autorefractors (Retinomax, Suresight). They are more or less based on the red reflex test, in that they project a lighRt into the child‟s eye, evaluate the red reflex and interpret the findings. Their IliBmitation is cost and availability. In addition, they are not very useful in neonates aLN nd infants. 2.9.3 Checklists DA A number of checklists have been used for Athe screening of young children for eye disease (Table 2.2.). These have beIenB developed by various non-governmental organisations and government agenFcie s in developed countries to aid parents, teachers and other lay individuals in tOhe identification of children that require referral for comprehensive eye examiYnation by an optometrist or ophthalmologist. A total of 11 vision checklists werIeT identified and retrieved during a web search using the terms “vision OR eye” ASND “screening” AND “checklist OR tool” AND “infant OR child". However, a seRarch of medical literature databases including PubMed, Google Scholar, EmbasVe, MEedline, and CINAHL, using the same search terms, did not reveal any reporIts of studies on any of the identified vision screening checklists. Therefore, there arNe no literature describing the development nor validation of these checklists, as far Uas the author searched. Majority (seven) of the 11 checklists are from organisations in the United States of America (U.S.A.), two are from Canadian organisations, while there is one each from the United Kingdom and Australia. Not one of the checklists is from Africa, Asia or any other developing country. The number of items in the checklists ranges from 10 to 46 items; while the number of sections ranges from 1 to 7 sections. Only one of the 35 checklists has a clearly defined scoring system while the interpretation of the screening result and the recommended action were not described for three checklists. Six of the 11 vision checklists are designed mainly for parental use and they include the Red Flags Vision Checklist (Child Development Programs, 2007); the Vision checklist for young children (Mayfair Eye Care, 2018) and the Parent checklist (Children's Eye Foundation, 2019). Others are Children’s Vision Checklist from the Family Vision Development Centre (2019) based in Illinois, U.S.A; the Vision a nd Learning Checklist (VisionHelp Group, 2015) and the Vision Checklist designYed by Dr. Lynn Hellerstein (2010) a developmental optometrist in the U.S.A. ThesRe parental checklists essentially contain lists of items or questions that can poinRt toA the presence of features of eye disease or poor vision in children. They rangeI Bfrom questions about the appearance of the child‟s eyes to the visual behaviour o f Lthe child. However, most of the questions are applicable to toddlers and preschoNol children and not infants. In addition, some of the concepts/questions are specifAic to the culture of the countries that the checklists are designed for and may, thDerefore, not be applicable in our own setting. BA Other checklists which are desigFned Ifor use by teachers in schools include the Teacher’s Classroom VisionO Checklist (Australasian College of Behavioural Optometrists, 2015); the E ducator’s Checklist (Optometric Extension Program Foundation, 1985); tIhe TYeacher’s checklist of observable clues to classroom vision problems (VisionCareT Optometry, 2012); the Vision Screening Checklist of the Arizona StateR SchSools for the Deaf and the Blind (2007); and the ABC Checklist for Vision ObEservation and History (Texas School for the Blind and Visually Impaired, 2016)I. VThe “ABC” in the last checklist is an acronym for “Appearance, Behaviour and CNomplaints”. Indeed, all these teacher checklists include questions or items related to Uthe appearance of the eyes, the visual behaviour the child and complaints about vision problems by the child. Thus, they are similar to the parent checklists except that they enquire about the presence of visual complaints and are, therefore, designed for use in school aged children and not infants. Also, the questions are largely culture-specific. One major drawback of these checklists is that the process of their development and validation was not documented and their collective or individual sensitivity and specificity in the detection of blinding eye disease in children have not been evaluated. 36 A possible reason for this is that, in those countries where they have been put to use, they simply serve as adjuncts to the main techniques for early detection of eye diseases in children which are: (i) the red reflex performed by physicians or nurses during routine neonatal and well child examinations; (ii) photo-screening tests and devices. Other drawbacks of these checklists include the fact that they were developed primarily for use at home or in school by lay people to screen toddlers and old er children for eye diseases. Thus, they are not designed for use in health facilitYies by health professionals and may not be appropriate for use in infants. In addiRtion, they may not be culturally applicable to the Nigerian setting. Moreover,R theA use of these checklists is generally limited to developed countries such asI Bthe United States of America, Canada, United Kingdom, Australia and EuropeaLn countries. And to the knowledge of the author, there are no similar checklisNts th at have been designed for use in developing countries, especially Sub-Saharan Acountries such as Nigeria. AD F I B O ITY RS IV E UN 37 Y R Table 2.2. Vision screening checklists in use in developed countries RA S/N Name of checklist Organisation & Person Number of Number Scoring InterpreItatBion/ Development Validation of Country required to sections/ of items system DeciLsion of checklist checklist (Citation) complete domains making/ checklist Re commended action 1 Red Flags Vision Child Parent 1 section 17 None Stated Not described Not reported Checklist Development Not classified N Programs (2007) into domains Canada A 2 Vision checklist Mayfair Eye Care Parent/ 2 domains 13 DNone Not stated Not described Not reported for young children (2018) Teacher (Appearance & Canada Behaviour) A 3 Parent checklist Children's Eye Parent 4 sections IB32 None Stated Not described Not reported Foundation (2019) Not classified U.S.A. into doFmains 4 Children‟s Vision Family Vision Parent 3O sections 23 None Stated Not described Not reported Checklist Development Y Not classified Centre (2019) into domains U.S.A. 5 Vision and VisionHelp Group PIarTent 1 section 10 Yes Not stated Not described Not reported Learning Checklist (2015) S Not classified U.S.A. into domains 6 Vision Screening Hellerstein R& Parent 3 sections 19 None Stated Not described Not reported Checklist BrennEer Vision Not classified center (2010) into domains U.S.A. 7 Teacher‟s IAVustralasian Teacher 5 sections 42 None Stated Not described Not reported 38 Classroom VisNion College of 3 domains U Y R Checklist Behavioural (Appearance, Optometrists Behaviour & A (2015) Complaints) Australia R 8 Educator‟s Optometric Teacher/ 7 sections 46 None Not stated B Not described Not reported Checklist Extension Program School 3 domains I Foundation (1985) nurse/ (Appearance, L U.S.A. Psychologist Behaviour & Complaints) N 9 Teacher‟s checklist VisionCare Teacher 3 domains 43 NonAe Stated Not described Not reported of observable clues Optometry (2012) (Appearance, to classroom vision U.K. Behaviour & problems Complaints) D 10 Vision Screening Arizona State Teacher/ 3 domains 26 A None Stated Not described Not reported Checklist Schools for the Early (Appearance, Deaf and the Blind childhood Behaviour & B(2007) care staff Complaints) IU.S.A. F 11 ABC Checklist for Texas School for Teacher 3 domains 23 None Stated Not described Not reported Vision Observation the Blind and (Appearance, and History Visually Impaired BOehaviour & (2016) Y Complaints) U.S.A. IT RS VE 39 UN I 2.10 DEVELOPMENT, VALIDATION AND FEASIBILITY OF CHECKLISTS USED FOR SCREENING 2.10.1 Development of screening checklists The processes of development of the various checklists that have been previously used in screening for childhood eye diseases were not described by the institutions and organisations who developed such checklists. Furthermore, it has also been observ ed that there is no universal or standardised procedure for the development of cheYcklists used in healthcare generally (Hales, Terblanche, Fowler, and Sibbald, 200R8; Burian, Clebone, Dismukes, and Ruskin, 2018). As such, there are differences inA the processes and steps used to develop many of the checklists currently utiliBsedR in screening for medical conditions. LI The process of development of a checklist affects its quNality and utilisation. (Schmutz, Eppich, Hoffmann, Heimberg, and Manser, 2014).A A poorly conceived or designed checklist is less likely to be properly implemDented; while a checklist developed through a systematic process has a highBer cAhance of being used for the purpose for which it was created. Thus, payinFg a ttIention to the process is important in ensuring that an effective checklist is deOveloped. A few authors have suggYested stepwise processes for developing medical checklists (Winters et al., 2009;I STchmutz et al., 2014; Burian et al., 2018). Broadly, these steps include: conceptioSn/identifying the purpose of the checklist; determining the checklist design; selectiRon of checklist items; and pilot testing of the checklist. It is important to note thVat thEese steps were described mainly for the development of checklists designed for peIrformance evaluation and patient safety. Nevertheless, developers of a number UscNreening checklists have used different combination of these steps in the process of developing their checklists. The conception of a medical checklist requires identifying the specific disease condition, patient population, clinical procedure, training scenario or outcome for which it is being created (Winters et al., 2009). The design of the checklist usually depends on various factors including the type of clinical setting (e.g. emergency ward, theatre, out-patient clinic); the expected level of competence of the users (e.g. novice, 40 intermediate, expert); and the method of completing the checklist (e.g. “Do and confirm” or “Read and do”) (Burian et al., 2018). In designing screening checklists, it is also important to consider incorporating and utilising a flow of items that would facilitate both memory and decision making. Selection of checklist items is essentially the process of deciding which questions would be included in the checklist. This step usually involves a review of existing literature in addition to drawing on the clinical experience of physicians Yand /or patients as well as obtaining a consensus opinion of experts in the relevanRt field. In addition, this step is necessary for ascertaining the content validity of the checklist (DeVon et al., 2007; Kimberlin and Winterstein, 2008). ExampRles Aof screening checklists that have used a combination of literature review IanBd expert opinion in selecting checklist items include: the Fibromyalgia Rapid LScreening Tool (FiRST) (Perrot, Bouhassira, Fermanian, and Cercle d'Etude de lNa Douleur en, 2010); the Baby Paediatric Symptom Checklist (BPSC) (Sheldrick Aet al., 2013); and the Preschool Paediatric Symptom Checklist (PPSC) (SheldriDck et al., 2012). FibroDetect, on the other hand, is a screening checklist forB fibAromyalgia that was developed based on information obtained from face-to-fa cIe interviews with patients and focus group discussions with clinicians in additiFon to literature review (Baron et al., 2014). Pilot testing entails the tesYting o Of a beta-version of the checklist by potential users with subsequent revision bIaTsed on the findings of the test (Winters et al., 2009). This can be achieved by coSnducting the tests using real-life scenarios in the clinical units where the checklist Rwill be used or in a simulated setting. During this step, some types of checklists,E especially those for performance evaluation or screening, should also underIgVo psychometric analyses and validation. According to findings from a review byN Burian et al. (2018), this important step was either not performed or was not Ureported by a significant proportion of publications that described the process of development of various medical checklists. 2.10.2 Validation of screening checklists The process of validating a screening checklist is usually accomplished during the pilot-testing phase of its development. The validation often involves the comparison of the diagnostic accuracy of the checklist with that of a well-established gold 41 standard for detecting the disease, risk factor or condition in question. This step provides evidence of the ability of the checklist to detect the disease in a population of screened individuals. It represents a form of criterion-related validity, specifically, concurrent validity (Bolarinwa, 2015); and is measured in terms of the sensitivity and specificity of the screening checklist. Sensitivity is the proportion of individuals that are truly positive within the group which a screening test classifies as positive; while specificity is the proportion that are truly negative among those classified as negative by the screening test (Camp, Y2006). In other words, sensitivity is a measure of the ability of a screening tesAt toR correctly identify individuals with the disease or risk factor; and specificity meRasures the ability of a test to correctly identify those who do not have the dIiBsease or risk factor (Trevethan, 2017). A number of studies on validation o f Lscreening checklists for different diseases or conditions have reported the sensNitivity and specificity of such checklists. Examples include: the Modified ChAecklist for Autism in Toddlers (MCHAT) (Coelho-Medeiros et al., 2019; SaDngare et al., 2019), the Hypomania Checklist-32 (HCL-32) (Meyer, CastelaoB, GAholamrezaee, Angst, and Preisig, 2017; Kim, Lee, Kim, and Kim, 2018), the IIntensive Care Delirium Screening Checklist (ICDSC) (George et al., 2011), anFd t he Basic Foot Screening Checklist (Bower and Hobbs, 2009). O Reliability is anotherI TaspYect of checklist validation that can be assessed during the pilot study. Reliability refers to the ability of a screening checklist to produce consistent resRults Supon repeated testing of the same individual (DeVon et al., 2007; KimberlinE and Winterstein, 2008). The various aspects of the reliability of a checklist includIeV: test-retest reliability, interrater reliability and internal consistency. Test-retest reNliability, also known as stability, measures the correlation between the results of the Uscreening checklist when administered on two different occasions. It is relevant for characteristics or attributes that are not expected to change significantly with passage of time (DeVon et al., 2007). Interrater reliability or inter-observer agreement is a measure of the correlation or agreement of results obtained by different raters or observers when using the checklist on the same individual. While the internal consistency of a checklist refers to the extent to which different sets of items within the checklist are measuring the same concept or construct. The Cronbach alpha 42 coefficient is the most commonly reported measure of internal consistency (Kimberlin and Winterstein, 2008). Table 2.3. contains a description of the development and validation of some checklists that have been used in screening for various childhood diseases other than eye diseases. 2.10.3 Feasibility of screening checklists Feasibility generally refers to the degree to which an objective or a goal can be achieved or a program put into practice. In public health research, feasibility sYtudies are usually conducted to determine the prospects of implementing an intervRention or project. According to Bowen et al. (2009) the concept of feasibility in hAealth research encompasses several components including: acceptability, demand,R implementation, practicality and adaptation. Therefore, the essence of assessinIgB the feasibility of a screening tool should include an evaluation of its acceptNabil it Ly and ease of use in order to envisage its uptake in real-life situations. Such assessment may be performed along with the pilot study conducted for validation of tDhe sAcreening checklist. While there is a dearth of literature onI Bthe A feasibility of available vision screening checklists, a good number of reports h ave been published with respect to the different components of the feasibility of scrFeening checklists for other diseases. For example, Ewers et al. (2020) studied t hOe feasibility of the Intensive Care Delirium Screening Checklist (ICDSC) by TexpYloring Intensive Care Unit staff perceptions of the usability of the checklist. In aIddition, Keetarut et al. (2017) conducted a feasibility study on patients with inSflammatory bowel disease to determine the ease of use and acceptabiliEty Rof the patient-administered malnutrition universal screening tool (MUSTV). UN I 43 RY Table 2.3. Description of some screening checklists that have been developed and valid ated for other chAildhood diseases R S/N Name of checklist Disease/ Number of Number Scoring Interpretation DevelopmIenBt Reference Psychometric condition sections/ of items system of score (ItemL selection) standard(s) used properties screened for domains for Validation reported 1 Baby Paediatric Social/emotional 3 12 Yes Described Literature Ages & Stages ICC >0.70; Symptom problems Nrev iew, Questionnaire: Cronbach α = 0.70; Checklist Expert Opinion, Social/Emotional r = 0.51 (p <0.01) (Sheldrick et al., A Factor analysis (ASQ:SE) 2013) 2 Preschool Social/emotional 4 18 Yes DescDribed Literature Child Behavior ICC = 0.75; Paediatric problems A review, Checklist Cronbach α = 0.88; Symptom Expert Opinion, (CBCL) Sensitivity = 0.88; Checklist B Factor analysis Specificity = 0.89 (Sheldrick et al., 2012) I 3 Modified Checklist Autism spectrum 4 23 Y es Described Literature Complete Cronbach α = 0.85; for Autism in disorders (ASD) F review, developmental Sensitivity = 0.87; Toddlers (M- O Authors‟ clinical evaluation Specificity = 0.99 CHAT) (Robins, experience, Fein, Barton, and Y Discriminant Green, 2001) function analysis 4 Quantitative- Autism spectrum 1 IT 25 Yes Described Literature Clinical diagnosis ICC = 0.82; Checklist for conditions (ASC) review, revision of ASC Autism in Toddlers of a previous (Q-CHAT) S checklist (Allison et al., 2008) R IV E 44 UN Y R 5 Simple behavioral– Developmental 1 7 Yes Described Derived from AgeAs & Stages Sensitivity = 0.83; developmental delay and unstandardized RQuestionnaires, Specificity = 0.88 checklist (Eom, behavioral parent Third Edition Dezort, Fisher, disorders in questionnaire, (ASQ-3) Zelko, and Berg, Epilepsy Expert opIinion, 2015) Item responsBe rate and sensitLivity ana lysis 6 Child Evaluation Neurodevelopmen 2 40 Yes Described NLiterature Behavior Rating Cronbach α = 0.90 Checklist tal disorders review, review Inventory of to 0.92; (CHECK) A of previous Executive r = −0.23 to −0.62 (Rosenblum, screening Function- (p < .001) Zandani, Deutsch- D questionnaires, Preschool Castel, and Meyer, A Interviews with Version (BRIEF-2019) B parents of P) patients 7 Developmental Autism among 1 17 FY esI Described Selection of Clinical ICC = 0.772; Behaviour children with items from the evaluation for Cronbach α = 0.87; Checklist-Early developmental Developmental Autism Sensitivity = 0.83; Screen (DBC-ES) delay O Behaviour Specificity = 0.48 (Gray, Tonge, Checklist Sweeney, and (Primary carer Einfeld, 2008) Y version, DBC-P) T using I Confirmatory factor analysis S 8 Checklist for Early AutismE speRctrum 1 25 Yes Described Literature Developmental Sensitivity = 0.80; Signs of dVisorders (ASD) review, review assessment for Specificity = 0.94 NI 45 U Y R Developmental of previous ASD Disorders checklists, A (CESDD) (Dereu Authors‟ et al., 2010) experience, R Stakeholders‟ opinion IB 9 The Preschool Depression in 1 20 Yes Described Det aiLls not Diagnostic Cronbach α = 0.76; Feelings Checklist young children Nreported Interview Sensitivity = 0.92; (PFC) (Luby, Schedule for Specificity = 0.84 Heffelfinger, A Children Version Koenig-McNaught, modified Brown, and for young Spitznagel, 2004) D children and the A Child Behavior Checklist (CBCL) 10 Checklist of the Developmental 4 48 Y esI B Described Details not Movement Cronbach α = 0.96; Movement co-ordination F available Assessment Sensitivity = 0.79; Assessment disorder Battery for Specificity = 0.65 Battery for Children Children (M-ABC) O Test (M-ABC) (Schoemaker, test Smits-Engelsman, and Jongmans, 2003) ITY ER S V 46 UN I 2.11 CONCEPTUAL FRAMEWORK FOR THE STUDY Bronsard et al. (2008) in their study on the reasons for delayed presentation among children with cataract observed that the factors which explain the delay involve “complex interactions of sociocultural barriers at the family and community level as well as socio-organizational barriers within the health care system”. The proposed conceptual framework (Figure 2.1) for this study is derived from their report. The major focus of this study is the early detection of blinding eye diseases in chYildren by developing a simple tool that primary health workers can use to screen Rinfants. In developed countries, screening plays a very important role in the earlyA detection of childhood eye diseases. However, in developing countries, whereB theRre are no routine screening programmes, delayed detection and late presentatLionI of children with eye diseases for treatment is a common occurrence. N In addition to lack of screening programmes, there aAre other health system factors that are considered important in the context of dAelayDed detection and late presentation of children with eye disease. These include Black of equipment as well as poor knowledge and skills among health workers whic hI lead to incorrect diagnosis, wrong advice to parents, and inappropriate or delayFed referrals. Family and community factors such as awareness, attitude, beliefs an dO care-seeking behaviour also interact with these health system factors to infTluenYce the detection and presentation of children with eye diseases. SI The poor oEutcRome of the treatment received following late presentation for care also has theV potential to have a negative impact on the beliefs and attitudes of members of thNe coImmunity thereby increasing the likelihood of late presentation of other children. UOn the other hand, the establishment of routine screening programmes with resultant early detection, presentation and good treatment outcome can generate increased awareness and positive attitudes towards childhood eye diseases within the community. In addition, the screening activities by health workers would be expected to lead to an improvement in their knowledge and skills which would also result in positive feedback towards the awareness and attitudes at the family and community levels. Overall, developing a simple screening tool for use by primary health care 47 workers for the detection eye diseases in children may have significant implications for the reduction of avoidable childhood blindness. Community factors Family factors Health care system factors Awareness Health worker factors Attitudes and beliefs about eye diseases in Gender inequity Knowledge and skills children and treatment Care-seeking Availability of equipment of these diseases behavior Incorrect diagnosis and advic Ye Poverty Inappropriate referrRal Education A R IB Screening for eye disease in Early Early detection L children using appropriate presentation of eye disease screening techniques for treatment AN D Good treatment outcome A IB Figure 2.1. A conceptual framewFork showing the benefit of screening in early detection of eye diseases Y O IT ER S V UN I 48 Y CHAPTER THREE AR METHODS BR 3.1 Study setting LI This study was conducted in Oyo State which is loAcateNd in the South-West region of Nigeria. Oyo State is divided administrativelDy into 33 Local Government Areas (LGAs) and had a projected population of 7,A840,864 people in 2016 (National Bureau of Statistics, 2017). IB Specifically, the study was carrOied Fout in Ibadan, the capital city of Oyo State. Ibadan metropolitan area consists of 11 LGAs, five of which are urban and six are semi- urban. The urban LGAsY are Ibadan North, Ibadan Northeast, Ibadan Northwest, Ibadan Southeast, anIdT Ibadan Southwest LGAs. While the semi-urban ones are Akinyele, EgbRedaS, Ido, Lagelu, Ona Ara, and Oluyole LGAs. Ibadan Metropolis had a projected Epopulation of 3,596,500 people in 2016 according to the National census figureIsV, with Ibadan Northeast and Ibadan North LGAs being the most populous (City PNopulation, 2020). UOrthodox health services in Oyo State are predominantly provided by the three tiers of government (Federal, State and Local) as well as private health facilities. There are four teaching hospitals, 43 secondary health facilities including 28 state general hospitals and one children‟s hospital. In addition, there are 11 comprehensive health centres and 558 primary health care centres in Oyo State (Oyo state government, 2020). There are also several mission hospitals and numerous private hospitals, clinics and maternity homes. 49 Most hospitals are located in urban centres. The University College Hospital (UCH) located in Ibadan, is the largest of the hospitals, and is a referral centre for the other facilities. It is a training centre for specialists in several medical specialties in Internal Medicine, Surgery, Paediatrics, and Ophthalmology. The Paediatric ophthalmology unit of the Ophthalmology Department has been designated a Child Eye Health Tertiary Facility (CEHTF) by the World Health Organisation. The State hospital, located at Ring road, Ibadan has an eye clinic which is manned by a Consultant Ophthalmologist and operates as a secondary eye care centre. In addition, the El eta Eye institute which is owned by the Catholic Archdiocese of Ibadan is a RsecoYndary eye care centre in Ibadan. RA The study was conducted in selected public immunisation clinicsB in four of the urban local government areas, namely Ibadan Northeast, Ibadan LNoIrth, Ibadan Southeast, and Ibadan Southwest LGAs. These LGAs were selected b ecause of their size as well as their proximity to the tertiary health centre (UCHA) wNhich would enable easy access for children who were identified to have eye disDeases and were referred for specialist care. BA Only public facilities were selected fo r Ithis study because their immunisation services are largely free making them relaFtively more accessible to the general population when compared to private f acOilities. Apart from administration of vaccines, other activities that take plIacTe aYt these immunisation clinics include health promotion talks and growth monitSoring of infants and young children. 3.2 Study EdesRign A croIsVs-sectional study design conducted in three phases was used. The first phase inNvolved the development and validation of the screening tool; the second phase Uentailed a diagnostic accuracy study in which the screening tool was compared to a gold standard; while the third phase was a survey to assess the perceptions of immunisation clinic staff on the use of the checklist based on their experience of using it during the second phase. 50 3.2.1 Phase 1: Development and validation of the screening tool In developing the checklist, a series of steps were followed, as described below. These steps are based on a harmonisation of three different sets of steps described by previous authors for the development of medical checklists (Winters et al., 2009; Schmutz et al., 2014; Burian et al., 2018). The reason for the harmonisation was that those descriptions were not specifically for developing screening checklists but were either for developing checklists for assessing clinical performance of traine es (Schmutz et al., 2014) or general medical checklists such as those designeYd for improving patient safety and reducing medical errors (Winters et al., 2009;R Burian et al., 2018). Furthermore, previous descriptions of the developmRent Aof screening checklists were not comprehensive and did not include all the nIeBcessary steps for the development of medical checklists. Accordingly, the s tLeps described below are comparable to the steps described by Odole et alN. (2013) for the process of development of health outcome measuring instrumeAnts. The main difference is based on the fact that the process they described Dwas specifically for developing an instrument for the assessment of a therBapeuAtic intervention, while the focus of the present study is the development of a s cIreening tool for blinding eye disease. The steps followed were: OF 1. Justification for theY de velopment of the screening tool. The first step IinT the development of a screening tool is to justify the need for a new instruSment or tool. It is certainly unnecessary to develop a new instrument if one Ralready exists that can serve the same specific purpose as the proposed VinsEtrument. I Currently, the recommended screening program for the early diagnosis of eye N disease at birth and during infancy involves the Bruckner test (Red reflex test) U which requires the use of an ophthalmoscope. In resource-limited settings, such as Nigeria, ophthalmoscopes are not available at the primary health care level where screening should be conducted. And even if ophthalmoscopes are provided, maintaining them in good working condition is likely to be a challenge. Therefore, in order to establish screening programs for eye diseases in infancy, a screening tool that does not require the use of an ophthalmoscope is highly desirable. 51 2. Defining the purpose and the conceptual basis of the screening tool The screening tool is to serve as a checklist which primary health care workers especially immunisation clinic staff can use to detect the presence of eye disease in children. The purpose of the checklist is to function as a simple and handy guide for primary health care workers who may not have received any specific training in primary eye care. The conceptual basis of the tool is that early detection of eye disease in children is necessary for early presentation and treatment which is required for optimal visual outcome and prevention of amblyopia following intRerveYntion. Such early detection is hampered by lack of screening programs aAs well as lack of equipment (ophthalmoscopes) at the primary health care ceRntres. 3. Devising the items on the screening tool IB The items were devised in three steps: L a. Literature review to identify the cliniNcal features of infantile eye diseases which health workers whAo are not ophthalmic personnel should be able to detect without tDhe use of an ophthalmoscope. The eye diseases which the literaturAe review focussed on were congenital cataract, congenital gla uIcoBma, corneal opacity, strabismus, congenital ptosis, and retinobFlastoma. These are the common causes of eye disease in infa ncOy and childhood that require early detection to prevent blindnesTs oYr death (in the case of retinoblastoma). b. ExpertI opinion: Items were also included based on the clinical expSerience of experts (general ophthalmologists) who are familiar with ERthe clinical features of these diseases in Nigerian children. A total of V 10 general ophthalmologists were selected from across the country, NI each of them having at least 10 years post-qualification experience. U The first draft was sent to them individually by email. Their input was solicited and feedback received via the same mode of communication. In addition, during face-to-face meetings, the opinion of seasoned experts on the process of development of health measuring instruments was sought with regards to the appropriateness of the items. c. Stakeholder input: Meetings were organised with immunisation staff to explain the purpose and conceptual basis of the screening tool to them. They were requested to make suggestions for the modification of the 52 items identified in first two steps above, with a view to making the items meaningful and relevant to them. Three meetings were held in different primary health care centres in Ibadan North Local Government Area. 4. Content validation To ascertain content validity, the list of items identified was reviewed by a panel of paediatric ophthalmologists, different from the initial group of general ophthalmologists. A total of five paediatric ophthalmologists were select ed from across the country with a minimum of 2 years‟ experience in thRe prYactice of paediatric ophthalmology and strabismus. Detailed explanAation on the purpose and conceptual basis of the screening tool was provRided to them and they were asked to assess the content coverage and reIlBevance of the items. They were asked to rate the relevance of each item L using a 5 point scale as follows (Streiner and Norman, 1989): N A 5. Essential: Item is essential and musAt beD included in the screening tool 4. Important: Item is important anBd should be included in the screening tool 3. Acceptable: Item is acceptab leI and may be included in the screening tool 2. Marginally relevant: ItemF is only marginally relevant and does not need to be included in the s cOreening tool. 1. Not relevant:T IteYm is irrelevant and should not be included in the screening tool I S ThEe exRpert panel were also asked to indicate items that had not been included Vwhich they thought were essential or important in screening for eye diseases NI among infants by immunisation clinic staff. U Based on the feedback from the panel of experts, a consensus was arrived at and those items deemed to be irrelevant were deleted from the list while items recommended for inclusion were added to the list. The consensus meeting was held via a telephone conference call with the panel of experts. 5. Items selection Following content validation, a draft of the screening checklist was pretested among 30 infants by immunisation staff at the Sango Primary health care 53 centre of Ibadan North local government Area. These 30 infants were not involved in the second phase of the study. The aim of the pre-test was to identify and rephrase or remove ambiguous and incomprehensible items as well as double-barrelled items (items asking more than one question). Such items were identified by debriefing the health workers after the pre-test and reviewing the responses to all items on the checklist. Subsequently, only items that were unambiguous, comprehensible and single-barrelled were selected and included in the checklist. Y 3.2.2 Phase 2: Diagnostic accuracy testing of the screening tool (validatioRn) A This phase of the study involved comparison of the newly developRed screening tool with the gold standard for detection of eye diseases in infaInBts, in this case eye examination by an ophthalmologist. L 3.2.2.1 Study population AN The participants for the diagnostic accuracy AstudDy were children aged 12 months and below who presented to the selected cliIniBcs for immunisation during the period of the study. F Inclusion criteria O 1. Children agedI T0-1Y2 months who were brought for immunisation in selected immunisatSion clinics during the study period. 2. WillinRgness of mother / caregiver to participate in the study. Exclusion Ecriteria N1.I VChildren who were ill and were unable to receive immunisation or undergo U ocular examination, for example, children who had fever, vomiting and diarrhoea or other early childhood illnesses. 3.2.2.2 Sample size determination In determining the minimum number of infants that were to be screened for validation of the screening tool, the sample size was calculated using the formula below (Buderer, 1996): 54 2 Minimum sample size (n) based on expected sensitivity = Zα x SN (1-SN) 2 D x P OR 2 Minimum sample size (n) based on expected specificity = Zα x SP (1-SP) 2 D x (1-P) Where: RY SN = expected sensitivity. This was set at 82.5% for this sRtudyA, based on a previous study that reported a sensitivity of 82.5% for the red reflex test (Bruckner test) (Saiju et al., 2012). B LI SP = expected specificity. This was set at 98.7N% for this study, based on a previous study that reported a specificity Aof 98.7% for the red reflex test (Bruckner test) (Saiju et al., 2012). AD Zα = standard normal deviate coIrBresponding to 95% confidence interval = 1.96 F D = absolute preciYsion d Oesired for sensitivity or specificity, 10% for this study P = prevalencIeT of condition/disease being screened for. A prevalence of 5.7% RforS eye diseases in early childhood was used as a proxy for this study E (Cumberland, Pathai, Rahi, and Millennium Cohort Study Child IV Health, 2010). Although, the study was carried out in the United N Kingdom, the prevalence was used to calculate the sample size for this U study because there were no similar studies on the prevalence of eye diseases infants and young children in Africa or other developing countries, as far as the author searched. This gave a minimum of 983 infants to be screened in order to achieve a precision of 10% for 82.5% sensitivity and a minimum of 6 infants to achieve a precision of 10% for 98.7% specificity. 55 The calculated sample size for sensitivity was much larger than for specificity. Therefore, a minimum sample of 983 infants was required for screening using the tool. However, to account for the possibility that some of the recruited infants may not complete all the 3 stages of the study, a non-completion rate of 20% was estimated; and the sample size was adjusted using the following formula: Target sample size = Minimum sample size = 983 = 1229 infants 100% – Non-completion rate 0.8 RY The number of infants screened in each of the 4 LGAs was determinAed using the proportional allocation procedure based upon the average numRber of children immunised in each of the clinics annually as obtained from theIirB records at the Local government headquarters. N L 3.2.2.3 Sampling strategy A The selection of immunisation clinics in eachA of Dthe local government areas was based on the records of the monthly averagBe of the number of infants who receive immunisation in the clinics. The top 2 Iclinics in each LGA with the highest monthly average were selected. This w aOs to F ensure that a larger number of children would be screened within a short time. Thus, a total of 8 immunisation clinics were involved in the study. All eligible TimmYunisation clinic staff in each selected immunisation clinic were recruited intSo thIe study. All consecEutivRe eligible children presenting for immunisation in each of the eight selectIeVd immunisation clinics were recruited and screened by the immunisation staff unNtil the number of infants apportioned to be screened in each clinic was achieved. In Uaddition, participating immunisation staff in each clinic were allocated an equal proportion of infants to screen based on the number of staff and the number of infants apportioned to the clinic. The immunisation clinics that were selected in each LGA as well as the number of infants allocated to each LGA are shown in Table 3.1. 56 Y Table 3.1 Selected immunisation clinics and allocated number of infaAntsR per local Local Selected Number of NBumRber of government area immunisation infants ( (LGA) clinics [LGA leve nL) Iinfants (n) l] [Clinic level] Ibadan North Agbowo PHC* AN 177 D 340 Idi Ogungun PHC 163 A Ibadan Northeast Iwo road PIHBC 190 F 310 Oke Adu PHC 120 O Ibadan SouthwestY Awodife PHC 141 IT 298 Foko PHC 157 RS IbEadan Southeast Agbongbon PHC 159 281 IV Oranyan PHC 122 N Total 1229 1229 Ugovernment area 57 *PHC – Primary healthcare centre RY BR A LI N AD A IB OF TY 3.2.2.4 Pre- study actIivities 1. EthicaRSl approval was sought and obtained from the University of VIbaEdan/University College Hospital Ethical Review Board. 2.I Approval was sought and obtained from the Oyo State Ministry of Health and UN the consent of the Director of Primary health care was sought. 3. The Medical officer for health as well as the Primary Health care coordinator in all the selected local governments were informed and their cooperation sought. 4. Advocacy meetings were held with the Officers in charge of each of the selected immunisation clinics to inform them about the project and to seek their approval and cooperation. 58 5. During the pre-study visits to the immunisation clinics, meetings were held with the immunisation clinic staff to train them on the use of the screening tool and to recruit them into the study. Specifically, they were given copies of the checklist and were taught on how to administer it and record their findings. They were also educated on the scoring system and its interpretation. 6. Training of research assistants on administration of questionnaire. 3.2.2.5 Study team Y 1. Ophthalmologist (PhD student) R 2. 3 research assistants RA 3.2.2.6 Study materials IB 1. Data collection instruments L a. Infant medical history questionnaire (AppNendix A) b. Immunisation staff questionnaire (ApApendix B) c. Screening checklist (screeningA tooDl developed in Phase 1 of the study) (Appendix C) B d. Eye examination proFfor mIa (Appendix D) 2. Pen torches 3. Direct Ophthalmoscop eO 4. Binocular indirect Yophthalmoscope 5. Dilating eySe dIro Tps (Tropicamide 1% and Phenylephrine 5% eye drops) R 3.2.2.7 DaEta collection procedure V TNhe dIata for this Phase of the study was collected in three stages as follows: U 1. Firstly, the demographic information and clinical history such as antenatal, birth, neonatal, past medical and developmental history of participating infants were collected using a structured questionnaire (Appendix A). This was translated to Yoruba by a linguist for easy communication with the mothers/ caregivers who did not understand English. The Yoruba version was back translated into English by another linguist to check for consistency of translations. The questionnaire was administered by trained research assistants 59 to each child‟s mother/caregiver while waiting for immunisation. In addition, a self-administered structured questionnaire (Appendix B) was used to obtain the demographic and other individual characteristics of the immunisation staff. 2. Secondly, immunisation staff administered the screening tool (Appendix C) on each infant during vaccination in order to detect the presence of eye disease. The result of the screening was recorded on the screening tool sheet. The staff were instructed to use a light source, specifically, a pen torch light while examining the infants. Picture cards containing images of the eye diseas es being screened for were provided to assist the staff in the administraRtionY of the tool. A The immunisation staff were blinded to the information that Rwas collected by the research assistants using the questionnaire. They weIrBe also blinded to the subsequent examination findings by the ophthalmolo gList. Every tenth baby screened by an immunisation Nclinic staff, was also screened by another randomly selected immunisation Astaff in the clinic during the same immunisation visit (Figure 3.1). This AwasD to test the inter-observer variation of the screening tool. The second imBmunisation staff was blinded to the result of the screening by the first immu nIisation staff. 3. Finally, each infant was exFamined by an ophthalmologist for the presence of eye disease. The opht hOalmologist was blinded to the result of the preceding screening by thTe iYmmunisation staff. The findings of the examination by the ophthalmologIist were recorded in a proforma (Appendix D). Each infant wRas aSssigned a unique serial number that was recorded on each of the 3 data collecEtion instruments for each child, namely, the questionnaires, screening tool sheetsI Vand proforma. Similarly, each immunisation staff was assigned a unique idNentification number that was recorded on their questionnaires and the screening tool Usheets that they administered on the infants. 3.2.2.8 Examination procedure The procedure for examination of the infants by the ophthalmologist was as follows:  Assessment of visual acuity using Fix and Follow method  Examination of ocular adnexae (facial symmetry, eye lids and eye lashes) using a pen torch 60  Examination of anterior segment (conjunctiva, cornea, iris, lens) of the eye using a pen torch  Red reflex test and dilated fundus examination using an indirect ophthalmoscope. Dilation of the pupils was achieved with the instillation of Tropicamide and Phenylephrine eye drops into both eyes. Children who were found to have eye disease during examination by the ophthalmologist were referred to the Paediatric ophthalmology unit of UC H Ibadan using a referral form (Appendix E). RY 3.2.2.9 Study flow chart for infants RA The sequence of movement of the infants through the study is prIeBsented in Figure 3.1. N L A AD F I B O ITY S VE R U N I Administration of questionnaire to mother/care giver Screening by Second screening by immunisation staff another using checklist Every 10th infant immunisation staff 61 Y AR BR LI AN AD Figure 3.1. Study flow chart for infa nItsB F Y O IT RS 3.2.2.10 CEase definitions V TNhe sItudy‟s operational definitions for the common eye diseases that occur and can be Udetected during eye examination of infants are as follows: 1. Cataract – opacity of the crystalline lens of the eye 2. Congenital glaucoma – enlarged eye ball with corneal haziness and photophobia with or without optic disc pallor and cupping 3. Corneal opacity - clouding or opacification of the cornea that obscures the view of the anterior chamber and iris/pupil 4. Ptosis – downward drooping of the upper eye lid 62 5. Nasolacrimal duct obstruction – persistent tearing or mucoid discharge from one or both eyes starting about 4-6 weeks after birth without associated redness, corneal opacity or photophobia 6. Conjunctivitis – redness of the eyes with associated watering and discharge in the presence of a clear cornea 7. Strabismus – obvious misalignment of the eyes 8. Optic atrophy – pallor of the optic disc (optic nerve head) without cupping 9. Cerebral visual impairment – visual impairment associated with a history suggestive of perinatal brain injury from hypoxia or infection, in the RabseYnce of any ocular pathology A 10. Delayed visual maturation – poor fixation and following of viRsual targets in the absence of any ocular pathology or history suggestive ofI pBerinatal brain injury L 3.2.3 Phase 3: Survey of immunisation clinic staff perNcep tion on feasibility of the checklist A After the completion of the second phase ofA theD study in each immunisation clinic, a survey was conducted among the staff wBho participated in the screening of infants using the checklist. The aim of thFe s uIrvey was to evaluate their perceptions on the feasibility of using the checklisOt based on their experience of using it during the study. SI TY 3.2.3.1 StuEdy Rpopulation TNhe pIa Vrticipants for phase 3 were members of staff who administer vaccines to infants Uat the immunisation clinics in the 4 local government areas (LGAs) selected for the study. Inclusion criteria 1. Clinic staff directly involved with the administration of vaccines to infants at the immunisation clinics, especially nurses, community health extension workers and community health officers. 2. Willingness to participate in the study 63 Exclusion criteria 1. Staff who were on leave during the period of the study 3.2.3.2 Sample size The total population of eligible immunisation clinic staff in the selected immunisation clinics were recruited and trained on the use of the screening checklist during the pre- study visits. All those who participated in the use of the checklist in phase 2 were a lso invited to participate in phase 3 of the study. RY 3.2.3.3 Study instrument and data collection. RA Data was collected with the use of a questionnaire (Appendix BF). This was a self- administered structured questionnaire that was used to obtaLin Iinformation about the perceptions of the immunisation staff regarding the eas e of use as well as the usefulness of the checklist. AN 3.3 Data management and analysis AD All completed questionnaires, screenin gI tBool sheets and proformas were collected and safely kept in a confidential place Funder lock and key. They were reviewed daily and checked for errors and any imOplausible entries were removed. Data collected was entered into a spread shYeet and analysed using IBM SPSS software version 22. Quantitative variableIs Twere summarised using means and standard deviations and categorical vaRriabSles were summarised using frequencies and proportions. The chVaraEcteristics of immunisation staff who participated in Phase 2 of the study were Icompared with the characteristics of staff who were recruited but did not paNrticipate in the study, in order to detect any bias in participation of the staff. UQuantitative variables were compare using T-test, while categorical variables were compared using Chi square test. The Fisher‟s exact test was used when the expected values in any of the cells of a contingency table was less than 5. Statistical validation of the screening tool was performed by determining its sensitivity, specificity, positive and negative predictive values as well as positive and negative likelihood ratios. These values were calculated with the use of contingency 64 (2x2) tables in which the outcome the screening was cross-tabulated with the outcome of the red reflex test or the ophthalmologist‟s examination (see Table 3.2). Internal consistency reliability of the tool was tested using Cronbach‟s alpha, while test-retest reliability was assessed using intra-class correlation coefficient (ICC). st nd Spearman correlation test was used to compare the scores of the 1 and 2 screenings among the infants who were screened by a second immunisation staff. Also, the level of inter-observer agreement between clinic staff beyond the agreement due to chan ce was evaluated using Kappa statistic. The level of significance for all tests wasY set at α=0.05 AR R LI B N DA A IB OF ITY RS Table V3.2 Example of contingency table for calculating sensitivity, specificity, pNrediIctive values and likelihood ratios U Gold standard YES NO TOTAL Screening test YES a b a+b NO c d c+d TOTAL a+c b+d a+b+c+d Where: 65 a= number of diseased individuals who test positive with screening test (true positives) b= number of disease-free individuals who test positive with screening test (false positives) c= number of diseased individuals who test negative with screening test (false negatives) d= number of disease-free individuals who test negative with screening test (true negatives) Y The formulae for calculating the various values are as follows: R Sensitivity = A Specificity = BR Positive predictive value = LI Negative predictive value = N Positive likelihood ratio = ( A Negative likelihood ratio = ( A D B F I O 3.4 Ethical considerationYs T Ethical approval SwasI sought and obtained from the University of Ibadan/University College HospRital Ethical Review Board (Appendix G) and the study adhered to the tenets of thEe Helsinki Declaration. N I VConfidentiality: The information collected from the participants was kept U confidential and completed questionnaires and proformas were stored in a locked file cabinet. Collected information was entered and stored in password protected computer. Only the principal investigator, study team members and supervisors had access to the computer and the file cabinet. Individuals who were not involved in the study were not given access to any part of the data.  Beneficence to participants: The immunisation staff received training that enhanced their capacity to detect eye diseases in infants. The infants underwent detailed ophthalmic examination. Infants with minor eye problems 66 were treated as necessary while those requiring specialist attention were referred to the Paediatric ophthalmology clinic, UCH, Ibadan.  Non-Maleficence to Participants: The study procedure of asking questions from mothers (caregivers) and examining the infants did not cause any harm or injury to them.  Voluntariness: Participation in the study was entirely voluntary. Written informed consent (Appendix H) was obtained from all participants (immunisation staff and mothers/ caregivers of infants) before recruitmeYnt in to the study. Also, the participants were made to understand that they wRere free to withdraw from the study at any point in time without losing anAy benefits of being part of the study. R LI B AN BA D OF I Y SI T ER CHAPTER FOUR NI V RESULTS UThe study was conducted in three phases. The first phase was the development and validation of the screening checklist, the second phase was the diagnostic accuracy study, while the third phase was a survey to assess the perceptions of immunisation clinic staff on the use of the checklist based on their experience of using it during the second phase. The results of the first phase are presented first, followed by the results of the second and third phases of the study. 67 4.1 Phase 1: Checklist Development and Validation 4.1.1 Initial drafts of screening checklist Based on a review of relevant literature, an initial draft version of the screening checklist containing 8 items was developed (Figure 4.1). This first draft was sent individually to ten experienced general ophthalmologists, who had been practicing ophthalmology for at least 10 years, for their expert opinion. Based on their input, t en new items were included in the checklist, one of the items in the initial draYft was modified while the other 7 items were retained. Thus, the second draft of theR checklist contained 18 items (Figure 4.2). RA 4.1.2 Stakeholder input LIB Subsequently, meetings were held with immunisationN clin ic staff in three different Primary Health Care centres in Ibadan North Local AGovernment Area of Oyo State to show them the second draft of the checklist anDd to obtain their input. During these meetings the health workers were educated oAn the purpose and conceptual basis of the screening checklist as well as the need fIorB screening for eye disease among infants and young children. Some of the healtFh workers expressed concern about the likelihood that the use of the checklist w oOuld be an addition to their workload in view of short-staffing at the health centrYes. They, therefore, strongly recommended that the checklist be as brief and simpIlTe as possible. Their recommendation was well considered in further developmeSnt of the checklist. ER IV UN 68 RY RA LI B DA N IB A F Y O T SI VE R UN I Figure 4.1. First draft of screening checklist for eye diseases among infants 69 Y AR LIB R DA N IB A OF ITY S VE R UN I Figure 4.2. Second draft of screening checklist for eye diseases among infants 70 4.1.3 Content validation The expert panel of five paediatric ophthalmologists reviewed the second draft of the checklist to assess content coverage and relevance of the items. Based on their responses using the 5-point scale, each of the items was assigned a relevance value. The relevance value was the sum of the responses of the five experts regarding the relevance of each item. Thus, the 18 items were ranked in decreasing order of relevance (Table 4.1). A meeting was then convened via telephone conference c all during which a consensus was reached regarding the items as follows: RY a. Items that were removed: 7, 8, 11, 13 and 18. RA b. Items that were modified: 2, 4, 6, 9, 10, 12, 15B and 17 (Items 2 and 6 were merged into one item. Items 10 and 1 2 LweIre also merged). c. Items that were retained (without modificNation): 1, 3, 5, 14, and 16. d. No new items were added. DA In addition, the panel deliberated onI Bthe Anature of the scoring system and the allocation of scores to each of the it ems. The possible response to each item was either “YES” or “NO” and a scoFre was allocated to each response depending on whether it indicated the pre seOnce or absence of eye disease. A score of “0” was assigned when the respTonsYe was suggestive of normal eyes, that is, the absence of eye disease. While, reSspoInses which suggested the presence of eye disease were assigned either a “full Rscore” or “half score”. A full score was assigned when the response indicated aE feature whose presence, in isolation, is strongly suggestive of eye disease. A halIf Vscore was assigned when the response indicated a feature that, when present in isNolation, is not strongly suggestive of eye disease. This means that the presence of Uanother feature is necessary before a feature assigned half score becomes strongly suggestive of eye disease. Thus, the panel allocated a full score to items 2, 3, 4, 5, 6, 10, 12, 14, 15, 16 & 17 and half score to items 1 & 9. A full score was set at “10”, while half score was set at “5”. At the end of the meeting, the third draft of the checklist had 11 items (Figure 4.3). 71 Table 4.1. Ranking of the 18 items on second draft of checklist based on relevance scores as assigned by expert panel Item Relevance Rank Number value 1 28 1 2 19 15 3 28 2 4 26 5 Y 5 23 11 R 6 26 6 A 7 16 17 R 8 15 18 IB 9 21 14 L 10 24 9 N 11 22 D1A3 12 24 A 10 13 18 IB 16 14 28 3 15 25 F 7 16 O27 4 17 ITY 24 8 1S8 23 12 R IV E UN 72 RY RA LI B DA N IB A F Y O T SI VE R UN I Figure 4.3. Third draft of screening checklist for eye diseases among infants 73 4.1.4 Results of Pretesting of the third draft of the checklist None of the items were identified to be ambiguous, incomprehensible or double- barrelled during the pre-test. Therefore, all the 11 items in the third draft were selected for the final version of the checklist without any modifications. 4.1.5 Description of the final version of checklist The final version of the screening checklist is a 2-part, 11 item checklist (Append ix C). The first part consists of 6 questions which the health worker would enqRuireY of the infant‟s mother or caregiver; while the second part is made up of 5 qAuestions that would be answered by the health worker after a quick examination oRf the child‟s eyes. Each item requires a single response of either “Yes” or “No”. LIB The response to each of the items was allocated a score.N Th e score is to guide decision making by the health worker with regards to the preAsence of eye disease and the need for prompt referral to an ophthalmologist. The suDm of the scores of the responses to all 11 questions is the total score for the childB beAing screened. The minimum total score is 0 while the maximum total score is 10 0I. The total score is classified into 3 categories (A, B or C) and the category deteFrmines what action should be taken by the health worker based on the result of Othe screening. Category A refers to a total score of 0 which indicates that the chYild ‟s eyes are likely to be normal and the mother should be reassured that referralT is not required. Category B refers to a total score of 5 and suggests that screSeninIg should be repeated within 4 weeks. While, Category C refers to a total scorRe of 10 and above which points to the presence of eye disease and the need foVr reEferral to an ophthalmologist. 4.N2 PIhase 2: Diagnostic Accuracy Study U4.2.1 Immunisation clinic staff characteristics A total of 55 immunisation staff were recruited and trained during the pre-study visits. Thirty-eight (69.1%) of them were involved in screening the infants using the checklist. The remaining 17 immunisation staff did not participate in screening because they were either absent or off duty on the days that the study team visited 74 their centres for screening. The distribution of the staff across the eight primary health centres (PHCs) and the 4 local government areas is shown in Table 4.2. There were no significant differences between the 38 staff who participated and the 17 who did not participate with respect to their age, number of years since qualification and years of experience in administration of immunisation to infants (Table 4.3). Similarly, there was no statistically significant association between participation in the screening of infants and any of the following variables: gender, local governme nt area/ primary health care centre, previous training in eye care and previous expeYrience with detection of eye problems in infants (Table 4.4). However, a higher pRroportion (44.8%) of community health extension workers did not participateR in Athe screening compared to 15.4% of the other cadres of immunisation clinicB staff - Nurses and community health officers (Odds ratio = 0.22; 95% Confide nLce Interval = 0.06 – 0.82; p=0.018) [Table 4.4]. AN BA D F I OY T SI ER V U N I 75 Table 4.2. Frequency distribution of the immunisation staff who participated in Local Primary Number Number of Percent (%) government health care of staff staff who At PHC At LGA area (LGA) centre recruited participated level level (PHC) (n) (n) Ibadan North Agbowo 7 4 10.5 23.6 Idi Ogungun 7 5 13.1 RY A Ibadan Iwo road 5 3 7.9 BRI 23.8 Northeast Oke Adu 7 6 1L5.9 N Ibadan Awodife 6 6 A 15.9 26.4 Southwest Foko 7 A4 D 10.5 B Ibadan Agbongbon 7 I 5 13.1 26.2 Southeast Oranyan 9 F 5 13.1 Total OY 55 38 100 100 the screening of infaInTts across the PHCs and the local government areas RS VE NIU 76 Table 4.3. Comparison of mean age and years of experience of immunisation staff who participated in Phase 2 of the study with those who did not participate Immunisation staff Variables t-test P-value participation Yes No Mean age (years) 43.1(±7.6) 43.1(±9.6) -0.027 R0Y.979 A Mean number of years since 16.8(±9.5) 17.3(±10.8) B-0.1R84 0.855 qualification LI Mean number of years of N experience in administration 15.8(±8.0) 15.5A(±9.3) 0.141 0.889 of immunisation to infants AD IB O F TY SI ER IV UN 77 Table 4.4. Comparison of characteristics of immunization staff who participated in Phase 2 of the study with those who did not participate (N=55) 2 Variable Staff Participation χ p value YES NO n (%) n (%) IBN 9 (64.3%) 5 (35.7%) Local IBNE 9 (75.0%) 3 (25.0%) Y Government 1.046 0.790 IBSE 10 (62.5%) 6 (37.5%) R ‡ area A IBSW 10 (76.9%) 3 (23.1%) R IB Male 0 (0.0%) 2 (10 0L%) Gender 0.092^ Female 38 (71.7%) A1N5 (28.3%) CHEW 16 (55.2D%) 13 (44.8%) # Qualification A 5.565 0.018* Others I2B2 (84.6%) 4 (15.4%) Received training YES OF 25 (65.8%) 13 (34.2%) 0.627 0.428 on eye care YNO 13 (76.5%) 4 (23.5%) Had noticedS eyeI T YES 19 (65.5%) 10 (34.5%) problemRs in NO 0.367 0.545 E 19 (73.1%) 7 (26.9%) infants I‡IVBN- Ibadan North; IBNE – Ibadan Northeast; IBSE- Ibadan Southeast; IBSW - Ibadan N Southwest U ^ Fisher‟s Exact test # CHEW – Community Health extension worker; Others- Nurse, Community Health Officer * p value < 0.05 (significant) 78 4.2.1.1 Demographic characteristics of immunisation staff who participated in Phase 2 of the study The mean age of the immunisation staff was 43.1 (± 7.6) years with a range of 23 to 56 years. Twenty-five (65.8%) respondents were aged above 40 years. All of them (100.0%) were females and all (100.0%) respondents were married. 4.2.1.2 Professional qualification and eye care training of immunisation staff w ho participated in Phase 2 of the study RY Sixteen (42.1%) of the immunisation staff were community health extenAsion workers (CHEWs), 12 (31.6%) were registered nurses while seven (18.4%) Rwere community health officers. The mean number of years since their qualificIaBtion was 16.8 (±9.5) years with a range of 1 to 33 years. While the mean nLumber of years of their experience in administration of immunisation to infantsN was 15.8 (±8.0) years with a range of 2 to 30 years. DA Twenty-five (65.8%) reported that they had rAeceived some training on eye care during the course of their training, but only 1 2I (B48.0%) of these 25 respondents were trained on how to detect eye diseases in infFants and young children. 4.2.1.3 Experience of immuni saOY tion staff on detection of eye diseases in children Regarding their expIerTience on detection of eye diseases in children, 34 (89.5%) respondents stRatedS that it is possible to detect eye disease in children who are brought for immunEisation. One (2.6%) respondent thought that it is not possible while three (7.9%I)V were not sure whether it is possible. Furthermore, 19 (50.0%) of the imNmunisation staff reported that they had actually noticed eye problems in children Uwho had been brought for immunisation in the past. Among these 19 respondents, the number of times that they had observed such eye problems in the past 5 years ranged from once to 20 times with a median of 3 times. Table 4.5 summarises the frequency distribution of the eye problems that had been noticed by the immunisation staff at the most recent occasion of noticing such problems in a child that was brought for immunisation. 79 Table 4.5. Frequency distribution of eye problems noticed by immunisation staff at the most recent occasion Eye problem Frequency (n) Percent (%) Eye discharge/ Conjunctivitis/ Red eye 13 68.4 Poor vision 2 10.5 “Cataract” 1 5.3 Staff not sure of the nature of eye 3 15.8 problem Y Total 19 100A R R LI B N AD A F I B O TY RS I VE UN I 80 With regards to the action taken by the immunisation staff at the most recent occasion of noticing an eye problem, 11 (57.9%) respondents had referred the child to a secondary eye care facility such as Ring Road State hospital eye clinic, and Eleta Eye clinic or to the University College Hospital Eye clinic, a tertiary eye care facility, all in Ibadan. Five (26.3%) respondents treated the child with topical or systemic medications while two (10.5%) respondents simply advised the mother/ caregiver to clean the eyes with cotton wool and clean water. Only five (13.2%) of the 38 immunisation staff had heard about the Red reflex Ytest as a tool for screening for eye diseases in children. None of these five responRdents had performed the Red reflex test before and none of them could stateR theA name of the equipment that is used to perform the test, that is, the OphthalmoIsBcope. None of the eight primary health centres (PHCs) had a Pen t oLrch nor Ophthalmoscope. Only two (25.0%) of the PHCs had Visual acuity chaArts.N 4.2.2 Infants characteristics AD A total of 1253 infants were screened aIt Bthe eight PHCs across the four selected local government areas. Thirty-nine (3.1F%) of these infants did not complete all the stages of Phase 2 of the study and Owere found to have incomplete questionnaires and/or screening checklists. TheYy were excluded from further analysis. Thus, the study completion rate was 9I6T.9%. The frequencyR diSstribution of the remaining 1214 infants who were included in the analysis frEom the various PHCs and the local government areas is presented in Table 4.6. IV U4.N2.2.1 Demographic characteristics of infants who completed all stages of Phase 2 The mean age of the infants was 5.2 (± 3.8) months with a range of 1 week to 12 months. Six hundred and twenty-three (51.3%) were aged below 6 months. There were 637 males (52.5%) giving a male to female ratio of 1.1:1. The age and sex distribution of the infants is shown in Figure 4.4. 81 Table 4.6. Frequency distribution of the infants who completed all stages of Local Primary health Number Percent Percent government area care centre of infants (%) [PHC (%) [LGA (LGA) (PHC) (n) level] level] Ibadan North Agbowo 175 14.5 28.7 Idi Ogungun 172 14.2 Y Ibadan Northeast Iwo road 182 15.0 25.5 R Oke Adu 128 10.5 A R Ibadan Southwest Awodife 147 12.1 IB 23.6 Foko 140 11 .5L N Ibadan Southeast Agbongbon 140 DA 11.5 22.2 Oranyan 1A30 10.7 Total B1214 100 100 Phase 2 across the PHCs and the Floc aIl government areas O ITY RS VE I UN 82 35 [VALUE]% Males Females [VALUE]% 30 [VALUE]% [VALUE]% [VALUE]% [VALUE]%[V ALUE].0% 25 [VALUE]% 20 AR Y 15 10 RIB 5 L 0 < 3 3 to <6 6A to 10 LminutesN Figure 4.5. Distribution of the reported avDeraAge duration of time spent by immunisation staff while screening an infaAnt using the checklist B F I O ITY S VE R I UN 106 Table 4.20. Challenges experienced by immunisation staff while using the checklist during the study (N=38) Challenge Frequency (n)* Percent (%) Inadequate number of staff (short staffing) 9 23.7 Poor cooperation from some children / 7 18.4 Difficulty with examination of some children Poor cooperation from some mothers / 5 13.1 Y Difficulty with obtaining answers from some ARmothers Use of checklist was time consuming 1 R 2.6 Language barrier 1 IB 2.6 No challenge experienced 25 LN 65.8 * Some immunisation staff reported more than oDne cAhallenge A F I B O ITY RS VEI U N 107 Table 4.21. Knowledge and skills acquired by immunisation staff while using the checklist during the study (N=38) Knowledge/skill Frequency Percent (n)* (%) Ability to detect abnormal features in 16 42.1 children‟s eyes Knowledge on importance of screening for 14 36.8 eye disease in babies Y Use of pen torch 8 21R.1 Knowledge about cat‟s eye reflex 4 A10.5 Checking for inequality in the size of the 2 BRI 5.3 eyes Checking for squint 1 L 2.6 Checking for nystagmus AN1 2.6 Checking for cataract D 1 2.6 * Some immunisation staff reported acqIuBisiti Aon of more than one type of knowledge/skill OF Y IT RS E IV UN 108 CHAPTER FIVE DISCUSSION, CONCLUSION AND RECOMMENDATION RY S 5.1 Discussion RA The main objective of this study is to develop a simple screenIiBng tool for the early detection of blinding eye diseases in infants at primar yL health care level. The implication of describing the tool as being simple is tNo underscore the fact that the screening tool does not require any special equipmeAnt for its use. Indeed, the checklist that has been developed can be used on its oAwn Dwithout any equipment. It specifically does not require the use of an ophthalmoscope for screening. The simplicity of the tool also highlights the fact that the too lI iBs not difficult or complex to use. In addition, it is neither elaborate nor sophistFicated. Therefore, the tool is suitable for use by primary health care workers t o Odetect eye diseases that can lead to blindness in infants. The availability and useY of this newly developed screening checklist could be instrumental in the esItTablishment of screening programs for childhood eye disease at the primary healthS care level. R In additionE to being simple and suitable for use by primary health workers, the newly develIopVed checklist also has advantages over other checklists that have been used for scNreening for eye disease among children and overcomes many of their limitations. USuch advantages include its usefulness for screening of infants in addition to toddlers and preschool children as well as the fact that it is culturally applicable to our setting. The other checklists are generally not appropriate for use in infants but are designed for screening older children in foreign countries which are culturally different from Nigeria. Moreover, the process of development and the diagnostic accuracy of the checklist is being described in this thesis while the development and validation of the 109 foreign checklists have not been described by the individuals or organisations who developed them. 5.1.1 Development of the screening tool The steps taken in the process of developing the checklist involved literature review, expert opinion, stake holder input and content validation. These steps are essentially a harmonisation of three different sets of steps described by previous authors regardi ng the development of medical checklists (Winters et al., 2009; Schmutz et al., Y2014; Burian et al., 2018). In addition, the steps are similar, with slight differencRes, to the steps for the process of development of health outcome measuring inAstruments as described by (Odole et al., 2013). The modification was because Rthe process they described was specifically for developing an instrument forI Bthe assessment of a therapeutic intervention, while the focus of the present stud yL is the development of an instrument for screening for disease. AN A review of the literature and available knowDledge about the current state of the practice of child eye care in Nigeria pIroBvid Aed evidence for the justification for the development of the tool. Specifically, the need for a simple screening tool is manifest for the following reasons: the lackF of well-established screening programmes for eye diseases in children; the lack oOf ophthalmoscopes at primary health care level; and the propensity for childrenT wYith blinding eye disease to present late to hospital. The literature review alsoI revealed that there is no simple screening checklist that had previously been Sdeveloped for early detection of childhood eye diseases in low- resource seEttinRgs such as Nigeria. In addition, the literature review was instrumental in devisIinVg the items (questions) that were included in the first draft of the checklist. SNymptoms and signs of childhood eye diseases which primary health workers should Ube able to elicit and detect such as poor vision, red/watery eyes, leukocoria, squint, and nystagmus were identified during the review of literature. Literature review has also been an important step in the development of checklists for screening for other health conditions in children. In describing the process that they utilised in developing 2 different checklists for the early detection of emotional and behavioural problems in children, Sheldrick et al. (2012; 2013) emphasised the role of extensive review of the literature in identification of candidate items for inclusion and 110 the creation of the initial lists of items for both checklists, that is, the Baby Paediatric Symptom Checklist and the Preschool Paediatric Symptom Checklist. Other authors have similarly described literature review as an important step in the development of screening checklists (Baron et al., 2014; Salaffi et al., 2020). The opinion of ten general ophthalmologists was sought in devising the questions for the checklist. Each of these specialists had at least 10 years‟ experience of practising ophthalmology and this availed them with the requisite knowledge about the clini cal presentation of the childhood eye diseases of interest, particularly the features Ywhich should easily be detected or elicited by primary health workers whoR have no experience in eye care. Physician‟s clinical experience has also bReenA found to be useful in the selection of items for screening checklists for other dBiseases. Sheldrick et al. (2012; 2013) reported that some of the items in their initLial Ilists were included on the basis of the authors‟ clinical experience. Baron eNt al . (2014) also drew on the clinical experience of physicians and patients iAn the selection of items for a fibromyalgia screening checklist by conducDting focus group discussions with clinicians, and face-to-face interviews wiAth patients. In addition, the input of stakeholders, that is, the primary healthI Bcare workers, was vital in ensuring that the questions were not complicated buFt w ere appropriate for their low level of experience in eye care. O The review of the iniItiTal dYrafts of the checklist by a 5-man expert panel of paediatric ophthalmologists Swas to ascertain the content validity of the tool. The panel members are specialistsR who had undergone further training in the diagnosis and treatment of childhood Eeye disease and are expected to possess a higher level of expertise than generIalV ophthalmologists. Thus, they were able to rate the relevance of items that had beNen initially included following literature review and opinion of the general Uophthalmologists. The relevance scale that the panel members used to rate the questions was designed for developing health measurement scales and has been found to be useful for the same purpose (Streiner and Norman, 1989). As a result of the review and input of the expert panel, it can be safely concluded that the checklist has a strong content validity (DeVon et al., 2007; Kimberlin and Winterstein, 2008; Alphonso et al., 2017). 111 5.1.2 Sensitivity, specificity and reliability of the screening tool. The validity of the newly developed checklist as a screening tool for blinding eye diseases in children was determined by evaluating its diagnostic accuracy (sensitivity, specificity and predictive values) and its reliability. The checklist has fairly good sensitivity and moderately high specificity for detecting any eye disease and blinding eye disease among infants. Unfortunately, there are no similar previous studies available for comparison. Notwithstanding, the checklist compares favourably w ith the Red reflex test. Previous studies have reported that the sensitivity of the RedY reflex test ranged between 13.9% and 85%, while its specificity ranged between 3R8.5% and 98.7% (Eventov-Friedman et al., 2010; Saiju et al., 2012; Mussavi etR al.A, 2014; Sun et al., 2016). It is worthy of note that these previous studies wIeBre conducted among young children screened at secondary or tertiary levels of c aLre and not primary health care as is the case for this study. N In view of the high false positive rate and the lowA positive predictive value of the checklist, there is a significant risk of “oAverD-referral” of normal infants. This is associated with the attendant issues of paBrental anxiety and increasing the patient load at the tertiary level. The low prevalFenc eI of eye diseases in this study should, however, be borne in mind as a contributing factor to the low positive predictive value. Moreover, the relatively OYhig h positive likelihood ratio is supportive of use of the checklist despite low IpTrevalence of eye diseases at primary health care level. Changing the cut-Soff for referral to the ophthalmologist (that is, Category C compared to CategoEry BR or C) increases the sensitivity of the checklist but the associated decreIasVe in specificity and positive predictive value suggest that only Category C inNfants should be recommended for immediate referral. Therefore, Category B infants Ushould undergo a repeat screening, as originally suggested during development of the checklist. The checklist exhibits a high reliability with respect to reproducibility and inter- observer variation. There was a significant positive correlation with regards to the checklist scores obtained by the two different immunisation staff among the infants that were screened twice. Similarly, the overall agreement with respect to classifying 112 the infants was very high. This shows that the checklist has reproducible results and the inter-observer variation is low. On the other hand, the checklist demonstrates a low internal consistency reliability as shown by the low value of the Cronbach‟s alpha coefficient. This may be as a result of the fact that the various questions on the checklist address specific features of different childhood eye diseases and not just one eye disease. This, however, appears to be unavoidable given the fact that the screening tool has been designed to det ect several different eye diseases. This could be seen as a trade-off between hYaving several checklists (each for one eye disease) and one checklist that can AdeteRct several eye diseases. R 5.1.3 Feasibility of using the checklist to detect childhood LbliIndBing eye diseases In assessing the feasibility of using the newly deveNloped checklist for detecting childhood blinding eye diseases at primary health Acare level it is very important to consider the perceptions of primary health AcareD workers on the checklist as well as their acceptance of it. Such information is also vital while making any plans for upscaling the use of the checklist. Thi sI iBs because the success of screening programs for childhood eye disease at the pFrimary health care level is very dependent on its acceptance by the health work eOrs. Y In this study, the heaIltTh workers, based on their responses, were favourably disposed to the checklist. MSost of them reported that they found the checklist “very useful” and “very easy” toR administer. This perception of usefulness and ease of use is necessary to enhaVnceE the acceptability of the checklist by the workers. In addition, majority of them Ireported that they acquired new knowledge or skills while using the checklist. ANcquisition of new knowledge and skills should be a motivation for primary health Ucare workers to use the checklist. These findings are in accordance with a report by Poterio et al. (2000) that the conduct of vision screening during immunisation activities is simple and rapid. In their study, Brazilian children were screened for poor vision and eye diseases by paramedics during a vaccination campaign, and they observed that such screening provided an opportunity for children with vision disorders to be identified while they were 113 receiving preventive health care services. Furthermore, the opportunity of providing a screening program in addition to another health care service (immunisation), which caregivers have brought their children for, is beneficial and cost-saving for both the beneficiaries and the health care providers. This is an example of integration of health care services that can help to strengthen primary health care delivery systems. 5.1.4 Limitations of the study One of the limitations of the study is that the checklist may not be able to detectY some eye diseases in infants and children such as retinopathy of prematurity andR refractive errors. Another limitation is the low prevalence of eye diseases in theA study which affected the positive predictive value of the checklist. BRI Furthermore, there is a possibility of selection bias in th e Lpopulation studied. This stems from the fact that not all children routinely Nattend immunisation clinics. Therefore, the findings of this study may not beA completely generalizable to all infants. AD The possibility of “Hawthorne-like” eIffBect with respect to the participation of the immunisation clinic staff should alFso be considered as a limitation to this study. The health workers may not use thOe checklist the same way in their normal activities as they did during the study. Y Finally, this studyS didI Tnot investigate the actual uptake of referrals by the mothers or caregivers of iRnfants who were referred. It is possible that they may still present late to hospital afEter early detection using the checklist or they may not present at all to the hospiItaVl. Thereby, negating the ultimate goal of reducing late presentation. 5.N2 CONCLUSION U This study has developed a simple screening tool for the early detection of eye diseases in infants and young children. The newly developed tool is in the form of a checklist that can be used in screening for blinding eye diseases in children without any additional special equipment such as ophthalmoscopes. The main advantages of the checklist include its simplicity, its appropriateness for use in infants and the fact that it is culturally applicable to the Nigerian setting. 114 In addition, based on the input of the expert panel, the screening checklist has strong content validity. It also demonstrated fairly good criterion validity and high reliability. The checklist was reported to be useful for screening and easy to administer by immunisation clinic staff. These properties of the checklist in addition to its simplicity are suggestive of the fact that using it for screening at primary health care level is a suitable strategy in the prevention of avoidable childhood blindness in Nigeria and other developing countries. 5.3 RECOMMENDATIONS RY Taking into account the findings of this study, the adoption of the cAhecklist as a screening tool at the primary health care level is recommended. SucRh implementation could be instrumental in the establishment of eye disease screeInBing programs among children which would go a long way in reducing the burd eLn of childhood blindness among Nigerian children. Firstly, dissemination of infoNrmation about the checklist to State primary health care board as well as associatioAn of primary health care workers in Oyo state is recommended. In additionA, kDnowledge translation strategies and activities are necessary to guarantee thBe benefit of this research project towards reducing the burden of childhoodF bli nIdness at the local, national and international levels. O The opportunities for TinteYgration of the use of this checklist during examination of new-born babies, poIst-natal clinics and immunisation visits should be explored. Moreover, there Sis an urgent need for the development of a national policy on childhood EeyeR disease screening programs in Nigeria. This would pave the way for the establIisVhment of routine eye screening for infants and children and facilitate the early deNtection and treatment of children with blinding eye disease. U5.4 CONTRIBUTION TO KNOWLEDGE The major contribution to knowledge of this study is the development of a simple screening tool for early detection of blinding diseases among infants by primary health care workers. Prior to this study, there had been a lack of an appropriate tool for screening and detection of eye diseases among infants in low-resource settings at the primary health care level. The development of this checklist has provided a solution to 115 this problem and it is expected that its adoption would ultimately contribute to a reduction in the prevalence and burden of childhood blindness in developing countries. Furthermore, this study has demonstrated that the newly developed screening tool is valid, reliable and its use by primary health care staff is feasible. 5.5 SUGGESTIONS FOR FURTHER RESEARCH Additional studies may be conducted on the validation of the checklist in oth er primary health care settings different from immunisation clinics. It is also necessYary to conduct similar studies in other parts of the country that have socio-culturRal settings that are from that of Ibadan, the location of the present study. Such studAies could also investigate the effect of further refining or modification of the cBhecRklist items with a view towards increasing its sensitivity and positive predictivIe value. In addition, further studies could be conducted on the evaluation of its u sLe on a larger scale as well as to determine its cost-effectiveness. AN BA D I F O TY SI R VE I UN 116 REFERENCES AbdulRahman, A.A., Rabiu, M.M. and Alhassan, M.B. 2015. Knowledge and practice of primary eye care among primary healthcare workers in northern NYiger ia. Trop Med Int Health 20.6:766-72. Abuh, S.O., Brennan, R., Congdon, N. and Jin, L. 2018. Paediatric caAtaraRct surgery outcomes in Kano, Nigeria. Nigerian Journal of OphthalmologyR 26.1:62-66. Adams, G.G.W. 2020. ROP in Asia. Eye (Lond) 34.4:607-608. IB Ademola-Popoola, D.S. and Oluleye, T.S. 2017. RetinopathyL of Prematurity (ROP) in a Developing Economy with Improving HealthN Ca re. Curr Ophthalmol Rep 5.2:114-118. A Adio, A. and Nwachukwu, H. 2016. ComprDehensive management of paediatric cataract in Africa. Nigerian Journal Bof OAphthalmology 24.1:1. Adio, A.O. and Komolafe, R.D. 2013 . IThe State of Pediatric Eye Care in Nigeria: A Situational Review and Call fFor Action. The Nigerian Health Journal 13.1:1-6. Aghaji, A., Okoye, O. and OBowman, R. 2015. Causes and emerging trends of childhood blindnessY: findings from schools for the blind in Southeast Nigeria. Br J OphthalmoIl T99.6:727-31. Aghaji, A., OkoyeS, O. and Bowman, R. 2018. Unmet needs of cataract blind children in speciaRl schools in Southeast Nigeria. Eye (Lond) 32.2:469-470. AghajiV, A.E., Ezegwui, I.R., Shiweobi, J.O., Mamah, C.C., Okoloagu, M.N. and IOnwasigwe, E.N. 2017. Using Key Informant Method to Determine the UN Prevalence and Causes of Childhood Blindness in South-Eastern Nigeria. Ophthalmic Epidemiol 24.6:401-405. Aghaji, A.E., Gilbert, C., Ihebuzor, N. and Faal, H. 2018. Strengths, challenges and opportunities of implementing primary eye care in Nigeria. BMJ Glob Health 3.6:e000846. Al-Merjan, J.I., Pandova, M.G., Al-Ghanim, M., Al-Wayel, A. and Al-Mutairi, S. 2005. Registered blindness and low vision in Kuwait. Ophthalmic Epidemiol 12.4:251-7. 117 AlAli, A., Kletke, S., Gallie, B. and Lam, W.C. 2018. Retinoblastoma for Pediatric Ophthalmologists. Asia Pac J Ophthalmol (Phila) 7.3:160-168. Allison, C., Baron-Cohen, S., Wheelwright, S., Charman, T., Richler, J., Pasco, G. and Brayne, C. 2008. The Q-CHAT (Quantitative CHecklist for Autism in Toddlers): a normally distributed quantitative measure of autistic traits at 18-24 months of age: preliminary report. J Autism Dev Disord 38.8:1414-25. Alphonso, A., Auerbach, M., Bechtel, K., Bilodeau, K., Gawel, M., Koziel, J., Whitfill, T. and Tiyyagura, G.K. 2017. Development of a Child Abuse Checkl ist to Evaluate Prehospital Provider Performance. Prehosp Emerg Care R21.Y2:222- 232. A Amaya, L., Taylor, D., Russell-Eggitt, I., Nischal, K.K. and LengyRel, D. 2003. The morphology and natural history of childhood cataracItsB. Surv Ophthalmol 48.2:125-44. L American Academy of Ophthalmology 2008. PaedNiatric Ophthalmology and Strabismus BCSC Section 6: 2007-2008. SaAn Fransisco: American Academy of Ophthalmology, Eye MD AssociationD. Amiebenomo, O.M., Achugwo, D.C. anBd Abah, I. 2016. Parental knowledge and attitude to children's eye care se rvIices. Nigerian Journal of Paediatrics 43.3:215 -220. F Arizona State Schools for the ODeaf and the Blind. 2007. Vision Screening Checklist [Online]. Y Available: https://cms.azedI.Tgov/home/GetDocumentFile?id=585d7e20aadebe01b0ccda4e [Accessed JSune 23, 2020]. Ashaye, AE.O.R and Oluleye, T.S. 2004. Pattern of corneal opacity in Ibadan, Nigeria. AVnnals of African Medicine 3.4:85 – 187. ANtkinIson, J., Anker, S., Nardini, M., Braddick, O., Hughes, C., Rae, S., Wattam-Bell, U J. and Atkinson, S. 2002. Infant vision screening predicts failures on motor and cognitive tests up to school age. Strabismus 10.3:187-98. Atowa, U.C., Wajuihian, S.O. and Hansraj, R. 2019. A review of paediatric vision screening protocols and guidelines. Int J Ophthalmol 12.7:1194-1201. Australasian College of Behavioural Optometrists. 2015. Teacher‟s Classroom Vision Checklist [Online]. Available: https://www.acbo.org.au/images/About_Vision/Teachers_Classroom_Vision_C hecklist_-_A4-Veronicas_pc.pdf [Accessed June 23, 2020]. 118 Azizoglu, S., Crewther, S.G., Serefhan, F., Barutchu, A., Goker, S. and Junghans, B.M. 2017. Evidence for the need for vision screening of school children in Turkey. BMC Ophthalmol 17.1:230. Azonobi, I.R., Olatunji, F.O. and Addo, J. 2009. Prevalence and pattern of strabismus in Ilorin. West Afr J Med 28.4:253-6. Babber, M., Saraswat, N.K., Ojha, S., Tandon, A. and Sharma, R. 2016. Causes of pediatric cataract in rural population of North India. Indian Journal of Clinical and Experimental Ophthalmology 2.3:195-200 Balasubramaniam, S.M., Kumar, D.S., Kumaran, S.E. and Ramani, KR.K. Y2013. Factors affecting eye care-seeking behavior of parents for their chiAldren. Optom Vis Sci 90.10:1138-42. R Baron, R., Perrot, S., Guillemin, I., Alegre, C., Dias-Barbosa, CI.B, Choy, E., Gilet, H., Cruccu, G., Desmeules, J., Margaux, J., Richards, S. , LSerra, E., Spaeth, M. and Arnould, B. 2014. Improving the primary care phNysicians' decision making for fibromyalgia in clinical practice: develoApment and validation of the Fibromyalgia Detection (FibroDetectA(R))D screening tool. Health Qual Life Outcomes 12:128. Bell, A.L., Rodes, M.E. and Collier K eIllaBr, L. 2013. Childhood eye examination. Am Fam Physician 88.4:241-8. F Birch, E.E., Cheng, C., Stag eOr, D.R., Jr., Weakley, D.R., Jr. and Stager, D.R., Sr. 2009. The criticTal pYeriod for surgical treatment of dense congenital bilateral cataracts. J AAPIOS 13.1:67-71. Bodunde, O.T. anSd Ajibode, H.A. 2006. Congenital eye diseases at Olabisi Onabanjo UnivEersRity Teaching Hospital, Sagamu, Nigeria. Niger J Med 15.3:291-4. BodundVe, O.T., Onabolu, O.O. and Fakolujo, V.O. 2014. Pattern of squint NIpresentations in children in a tertiary institution in Western Nigeria. IOSR U Journal of Dental and Medical Sciences 13.5:29 - 31. Bolarinwa, O.A. 2015. Principles and methods of validity and reliability testing of questionnaires used in social and health science researches. Niger Postgrad Med J 22.4:195-201. Borrell, A., Dabideen, R., Mekonen , Y. and Øverland, L. 2013. Child eye health in Africa: status and way forward. Addis Ababa: The African child policy forum (ACPF) and ORBIS Africa 119 Bowen, D.J., Kreuter, M., Spring, B., Cofta-Woerpel, L., Linnan, L., Weiner, D., Bakken, S., Kaplan, C.P., Squiers, L., Fabrizio, C. and Fernandez, M. 2009. How we design feasibility studies. Am J Prev Med 36.5:452-7. Bower, V.M. and Hobbs, M. 2009. Validation of the basic foot screening checklist: a population screening tool for identifying foot ulcer risk in people with diabetes mellitus. J Am Podiatr Med Assoc 99.4:339-47. Bremond-Gignac, D., Copin, H., Lapillonne, A., Milazzo, S., European Network of, S. and Research in Eye, D. 2011. Visual development in infants: physiological a nd pathological mechanisms. Curr Opin Ophthalmol 22 Suppl:S1-8. RY Bronsard, A., Geneau, R., Duke, R., Kandeke, L., Nsibirwa, S.G., UlaAikere, M. and Courtright, P. 2018. Cataract in children in sub-Saharan AfriRca: an overview. Expert Review of Ophthalmology 13.6:343-350. IB Bronsard, A., Geneau, R., Shirima, S., Courtright, P. and M Lwende, J. 2008. Why are children brought late for cataract surgery? QualitNative findings from Tanzania. Ophthalmic Epidemiol 15.6:383-8. A Buderer, N.M. 1996. Statistical methodoloAgy:D I. Incorporating the prevalence of disease into the sample size calcuBlation for sensitivity and specificity. Acad Emerg Med 3.9:895-900. I Burian, B.K., Clebone, A., DismuFkes, K. and Ruskin, K.J. 2018. More Than a Tick Box: Medical Checkl isOt Development, Design, and Use. Anesth Analg 126.1:223-232. Y Byamukama, E. andI TCourtright, P. 2010. Knowledge, skills, and productivity in primary eyeS care among health workers in Tanzania: need for reassessment of expectatRions? Int Health 2.4:247-52. Cagini,V C.E, Tosi, G., Stracci, F., Rinaldi, V.E. and Verrotti, A. 2016. Red reflex NIexamination in neonates: evaluation of 3 years of screening. Int Ophthalmol. UCamp, B.W. 2006. What the clinician really needs to know: questioning the clinical usefulness of sensitivity and specificity in studies of screening tests. J Dev Behav Pediatr 27.3:226-30. Canadian Paediatric Society. 2009. Vision screening in infants, children and youth. Paediatr Child Health 14.4:246-51. Carr, N. and Foster, P. 2014. Examination of the newborn: the key skills. Part 1. The eye. Pract Midwife 17.1:26-9. 120 Cassoux, N., Lumbroso, L., Levy-Gabriel, C., Aerts, I., Doz, F. and Desjardins, L. 2017. Retinoblastoma: Update on Current Management. Asia Pac J Ophthalmol (Phila) 6.3:290-295. Chan, W.H., Biswas, S., Ashworth, J.L. and Lloyd, I.C. 2012. Congenital and infantile cataract: aetiology and management. Eur J Pediatr 171.4:625-30. Chandna, A. and Gilbert, C. 2010. When your eye patient is a child. Community Eye Health 23.72:1-3. Chew, F.L.M., Thavaratnam, L.K., Shukor, I.N.C., Ramasamy, S., Rahmat, J., Reidpath, D.D., Allotey, P. and Alagaratnam, J. 2018. Visual impairRmeYnt and amblyopia in Malaysian pre-school children - The SEGPAEDS Astudy. Med J Malaysia 73.1:25-30. R Child Development Programs. 2007. Red Flags Vision CheckliIstB [Online]. Available: https://www.childdevelopmentprograms.ca/vision/pro gLram-information/red- flags-vision-checklist/ [Accessed June 23, 2020]. N Children's Eye Foundation. 2019. Parent Achecklist [Online]. Available: https://www.childrenseyefoundation.org/ [DAccessed March 10, 2019]. City Population. 2020. NIGERIA: AdmiAnistrative Division (States and Local Government Areas) - Population sItaBtisitics, Charts and Map [Online]. Available: https://www.citypopulation.dFe/php/nigeria-admin.php [Accessed 28 June, 2020]. Coelho-Medeiros, M.E., Bro nOstein, J., Aedo, K., Pereira, J.A., Arrano, V., Perez, C.A., ValenzuelTa, PY.M., Moore, R., Garrido, I. and Bedregal, P. 2019. M-CHAT-R/F VaIlidation as a screening tool for early detection in children with autism specStrum disorder. Rev Chil Pediatr 90.5:492-499. CommitteeE onR Practice Ambulatory Medicine Section on Ophthalmology, American AVssociation of Certified Orthoptists, American Association for Pediatric NIOphthalmology and Strabismus and American Academy of Ophthalmology. U 2003a. Eye examination in infants, children, and young adults by pediatricians: organizational principles to guide and define the child health care system and/or improve the health of all children. Ophthalmology 110.4:860-5. Committee on Practice Ambulatory Medicine Section on Ophthalmology, American Association of Certified Orthoptists, American Association for Pediatric Ophthalmology Strabismus and American Academy of Ophthalmology. 2003b. Eye examination in infants, children, and young adults by pediatricians. Pediatrics 111.4 Pt 1:902-7. 121 Committee On Practice and Ambulatory Medicine and Bright Futures Periodicity Schedule Workgroup. 2017. 2017 Recommendations for Preventive Pediatric Health Care. Pediatrics 139.4. Community Health Practitioners Registration Board of Nigeria 2006a. Community eye Care. In Curriculum for Diploma in Community Health. 2nd ed. Nigeria: Miral Press. Community Health Practitioners Registration Board of Nigeria 2006b. Primary eye Care. In Curriculum for Certificate in Community Health. 2nd ed. Niger ia: Miral Press. RY Courtright, P. 2012. Childhood cataract in sub-Saharan Africa. Saudi AJ Ophthalmol 26.1:3-6. R Courtright, P., Hutchinson, A.K. and Lewallen, S. 2011. VIBisual impairment in children in middle- and lower-income countries. Arch DLis Child 96.12:1129-34. Courtright, P., Seneadza, A., Mathenge, W., Eliah, E. aNnd Lewallen, S. 2010. Primary eye care in sub-Saharan African: do we haveA the evidence needed to scale up training and service delivery? Ann TropA MDed Parasitol 104.5:361-7. Cumberland, P.M., Pathai, S., Rahi, J.S. and Millennium Cohort Study Child Health, G. 2010. Prevalence of eye dise aIsBe in early childhood and associated factors: findings from the millenniumF cohort study. Ophthalmology 117.11:2184-90 e1- 3. O Dale, N. and Salt, A. T20Y07. Early support developmental journal for children with visual impairmIent: the case for a new developmental framework for early interventionS. Child Care Health Dev 33.6:684-90. Daw, N.WE. 19R98. Critical periods and amblyopia. Arch Ophthalmol 116.4:502-5. Day, SV. 1997. Normal and abnormal visual development. In: Taylor, D. (ed.) NIPaediatric ophthalmology. 2nd ed. London: Blackwell Science. Ude Venecia, B., Bradfield, Y., Trane, R.M., Bareiro, A. and Scalamogna, M. 2018. Validation of Peek Acuity application in pediatric screening programs in Paraguay. Int J Ophthalmol 11.8:1384-1389. Dereu, M., Warreyn, P., Raymaekers, R., Meirsschaut, M., Pattyn, G., Schietecatte, I. and Roeyers, H. 2010. Screening for autism spectrum disorders in Flemish day- care centres with the checklist for early signs of developmental disorders. J Autism Dev Disord 40.10:1247-58. DeSantis, D. 2014. Amblyopia. Pediatr Clin North Am 61.3:505-18. 122 DeVon, H.A., Block, M.E., Moyle-Wright, P., Ernst, D.M., Hayden, S.J., Lazzara, D.J., Savoy, S.M. and Kostas-Polston, E. 2007. A psychometric toolbox for testing validity and reliability. J Nurs Scholarsh 39.2:155-64. Donahue, S.P. 2007. Pediatric Strabismus. N Engl J Med 356:1040-7. Donahue, S.P., Baker, C.N., Committee on Practice Ambulatory Medicine American Academy of Pediatrics, Section on Ophthalmology American Academy of Pediatrics, American Association of Certified Orthoptists, American Association for Pediatric Ophthalmology Strabismus and American Academy of Ophthalmology. 2016a. Procedures for the Evaluation of the Visual SRystYem by Pediatricians. Pediatrics 137.1. A Donahue, S.P., Nixon, C.N., Section on Opthamology AmericRan Academy of Pediatrics, Committee on Practice Ambulatory Medicine AIBmerican Academy of Pediatrics, American Academy of Ophthalmology, ALmerican Association for Pediatric Ophthalmology Strabismus and AmerNican Association of Certified Orthoptists. 2016b. Visual System AssessmenAt in Infants, Children, and Young Adults by Pediatricians. Pediatrics 137.1:2D8-30. Donaldson, L., Subramanian, A. and ConwayA, M.L. 2018. Eye care in young children: a parent survey exploring access aInBd barriers. Clin Exp Optom 101.4:521-526. du Toit, R., Courtright, P. and LewFallen, S. 2017. The Use of Key Informant Method for Identifying Childre nO with Blindness and Severe Visual Impairment in Developing CountrieYs. Ophthalmic Epidemiol 24.3:153-167. Duke, R., Oparah, S.,I ATdio, A., Eyo, O. and Odey, F. 2015. Systemic Comorbidity in Children wSith Cataracts in Nigeria: Advocacy for Rubella Immunization. J OphthalRmol 2015:927840. Duke, VR., EOtong, E., Iso, M., Okorie, U., Ekwe, A., Courtright, P. and Lewallen, S. NI2013. Using key informants to estimate prevalence of severe visual impairment U and blindness in children in Cross River State, Nigeria. J AAPOS 17.4:381-4. Earley, B. and Fashner, J. 2019. Eye Conditions in Infants and Children: Vision Screening and Routine Eye Examinations. FP Essent 484:11-17. Eom, S., Dezort, C., Fisher, B., Zelko, F. and Berg, A.T. 2015. A simple behavioral- developmental checklist versus formal screening for children in an epilepsy center. Epilepsy Behav 46:84-7. 123 Eventov-Friedman, S., Leiba, H., Flidel-Rimon, O., Juster-Reicher, A. and Shinwell, E.S. 2010. The red reflex examination in neonates: an efficient tool for early diagnosis of congenital ocular diseases. Isr Med Assoc J 12.5:259-61. Ewers, R., Bloomer, M.J. and Hutchinson, A. 2020. An exploration of the reliability and usability of two delirium screening tools in an Australian ICU: A pilot study. Intensive Crit Care Nurs:102919. Ezegwui, I.R., Aghaji, A.E., Uche, N.J. and Onwasigwe, E.N. 2011. Challenges in the management of paediatric cataract in a developing country. Int J OphthYalm ol 4.1:66-8. R Family Vision Development Center. 2019. Children‟s Vision CheckAlist [Online]. Available: http://www.fvdcpc.com/wp-content/uploads/20R19/05/Childrens- Checklist-Family-Vision.pdf [Accessed June 23, 2020]. IB Federal Ministry of Health Nigeria. 2019. National Eye He aLlth Policy: Universal Eye Care Services Towards Universal Health CoNverage [Online]. Available: https://www.health.gov.ng/doc/National-Eye-HAealth-Policy.pdf [Accessed March 2, 2021]. D Forbes, B.J. and Guo, S. 2006. UpdateB onA the surgical management of pediatric cataracts. J Pediatr Ophthalmol S tIrabismus 43.3:143-51; quiz 165-6. Foster, A. and Gilbert, C. 1992. EpFidemiology of childhood blindness. Eye (Lond) 6 ( Pt 2):173-6. O Foster, P.J., BuhrmannT, RY., Quigley, H.A. and Johnson, G.J. 2002. The definition and classification ofI glaucoma in prevalence surveys. Br J Ophthalmol 86.2:238-42. Gallie, B.L. and SSoliman, S.E. 2017. Retinoblastoma. In: Lambert, S.R., and Lyons, C.J. E(edRs.) Taylor & Hoyt‟s Pediatric Ophthalmology and Strabismus 5th ed. EVdinburgh: Elsevier. GNeorgIe, C., Nair, J.S., Ebenezer, J.A., Gangadharan, A., Christudas, A., Gnanaseelan, U L.K. and Jacob, K.S. 2011. Validation of the Intensive Care Delirium Screening Checklist in nonintubated intensive care unit patients in a resource-poor medical intensive care setting in South India. J Crit Care 26.2:138-43. Gilbert, C. 2001. New issues in childhood blindness. Community Eye Health 14.40:53-6. Gilbert, C. 2007. Changing challenges in the control of blindness in children. Eye (Lond) 21.10:1338-43. Gilbert, C. and Awan, H. 2003. Blindness in children. BMJ 327.7418:760-1. 124 Gilbert, C., Bowman, R. and Malik, A.N. 2018. The epidemiology of blindness in children: changing priorities. Community Eye Health 30.100:74-77. Gilbert, C. and Foster, A. 2001a. Blindness in children: control priorities and research opportunities. Br J Ophthalmol 85.9:1025-7. Gilbert, C. and Foster, A. 2001b. Childhood blindness in the context of VISION 2020- -the right to sight. Bull World Health Organ 79.3:227-32. Gilbert, C., Foster, A., Negrel, A.D. and Thylefors, B. 1993. Childhood blindness : a new form for recording causes of visual loss in children. Bull World HYealth Organ 71.5:485-9. R Gilbert, C. and Muhit, M. 2008. Twenty years of childhood blindness: wAhat have we learnt? Community Eye Health 21.67:46-7. R Gilbert, C. and Muhit, M. 2012. Eye conditions and blindnessI iBn children: priorities for research, programs, and policy with a focus on c hiLldhood cataract. Indian J Ophthalmol 60.5:451-5. N Gogate, P. and Gilbert, C. 2007. Blindness in chAildren: a worldwide perspective. Community Eye Health 20.62:32-3. D Gogate, P., Gilbert, C. and Zin, A. 2011B. SeAvere visual impairment and blindness in infants: causes and opportunitie sI for control. Middle East Afr J Ophthalmol 18.2:109-14. F Gogate, P., Kalua, K. and Co uOrtright, P. 2009. Blindness in childhood in developing countries: time foTr aY reassessment? PLoS Med 6.12:e1000177. Gogate, P., KhandekaIr, R., Shrishrimal, M., Dole, K., Taras, S., Kulkarni, S., Ranade, S. and DeshSpande, M. 2010. Delayed presentation of cataracts in children: are they EwoRrth operating upon? Ophthalmic Epidemiol 17.1:25-33. GouwsV, P., Hussin, H.M. and Markham, R.H. 2006. Long term results of primary NIposterior chamber intraocular lens implantation for congenital cataract in the U first year of life. Br J Ophthalmol 90.8:975-8. Gray, K.M., Tonge, B.J., Sweeney, D.J. and Einfeld, S.L. 2008. Screening for autism in young children with developmental delay: an evaluation of the developmental behaviour checklist: early screen. J Autism Dev Disord 38.6:1003-10. Green, K. and Oddie, S. 2008. The value of the postnatal examination in improving child health. Arch Dis Child Fetal Neonatal Ed 93.5:F389-93. Gudlavalleti, V.S.M. 2017. Magnitude and Temporal Trends in Avoidable Blindness in Children (ABC) in India. Indian J Pediatr 84.12:924-929. 125 Gupta, N., Vashist, P., Tandon, R., Gupta, S.K., Dwivedi, S. and Mani, K. 2015. Prevalence of corneal diseases in the rural Indian population: the Corneal Opacity Rural Epidemiological (CORE) study. Br J Ophthalmol 99.2:147-52. Haargaard, B., Nystrom, A., Rosensvard, A., Tornqvist, K. and Magnusson, G. 2015. The Pediatric Cataract Register (PECARE): analysis of age at detection of congenital cataract. Acta Ophthalmol 93.1:24-6. Hales, B., Terblanche, M., Fowler, R. and Sibbald, W. 2008. Development of medical checklists for improved quality of patient care. Int J Qual Health Care 20.1:2 2- 30. RY Hales, B.M. and Pronovost, P.J. 2006. The checklist--a tool for error manAagement and performance improvement. J Crit Care 21.3:231-5. R Hashemi, H., Pakzad, R., Yekta, A. and Khabazkhoob, M. 201I8B. The Prevalence of Corneal Opacity in Rural Areas in Iran: A Population -Lbased Study. Ophthalmic Epidemiol 25.1:21-26. N He, M. and Li, M. 2017. Epidemiology of PediaAtric Cataracts. In: Liu, Y. (ed.) Pediatric Lens Diseases. Singapore: SpringDer. Hellerstein, L. 2010. VisionB AChecklist [Online]. Available: https://lynnhellerstein.com/wp-c onItent/uploads/2010/08/Vision-Checklist.pdf [Accessed June 23, 2020]. F Ho, C.L. and Walton, D.S. 20O04. Management of childhood glaucoma. Curr Opin Ophthalmol 15.5:46Y0-4. Holmstrom, G., RydbIeTrg, A. and Larsson, E. 2006. Prevalence and development of strabismus Sin 10-year-old premature children: a population-based study. J Pediatr ORphthalmol Strabismus 43.6:346-52. Jac-OkVerekEe, C.C., Jac-Okereke, C.A., Ezegwui, I.R. and Okoye, O. 2020. Vision NIScreening in Infants Attending Immunization Clinics in a Developing Country. J U Prim Care Community Health 11:2150132720907430. Jayadev, C., Vinekar, A., Bauer, N., Mangalesh, S., Mahendradas, P., Kemmanu, V., Mallipatna, A. and Shetty, B. 2015. Look what else we found--clinically significant abnormalities detected during routine ROP screening. Indian J Ophthalmol 63.5:373-7. Jeong, S.H. and Kim, U.S. 2015. Ten-Year Results of Home Vision-Screening Test in Children Aged 3-6 Years in Seoul, Korea. Semin Ophthalmol 30.5-6:383-8. 126 Johar, S.R., Savalia, N.K., Vasavada, A.R. and Gupta, P.D. 2004. Epidemiology based etiological study of pediatric cataract in western India. Indian J Med Sci 58.3:115-21. Joint Clinical Practice Guideline Expert Committee of the Canadian Association of Optometrists and the Canadian Ophthalmological Society, Delpero, W.T., Robinson, B.E., Gardiner, J.A., Nasmith, L., Rowan-Legg, A. and Tousignant, B. 2019. Evidence-based clinical practice guidelines for the periodic eye examination in children aged 0-5 years in Canada. Can J Ophthalmol 54.6:75 1- 759. RY Jonas, D.E., Amick, H.R., Wallace, I.F., Feltner, C., Vander Schaaf, AE.B., Brown, C.L. and Baker, C. 2017. Vision Screening in Children AgeRd 6 Months to 5 Years: Evidence Report and Systematic Review for the UISB Preventive Services Task Force. JAMA 318.9:845-858. L Kalua, K., Gichangi, M., Barassa, E., Eliah, E., LewallNen, S. and Courtright, P. 2014. Skills of general health workers in primary Aeye care in Kenya, Malawi and Tanzania. Hum Resour Health 12 Suppl 1:DS2. Kanski, J.J. 2003. Clinical OphthalmoloAgy: A systematic approach, London: Butterworth- Heinemann. IB Keetarut, K., Zacharopoulou-OtapaFsidou, S., Bloom, S., Majumdar, A. and Patel, P.S. 2017. An evaluation o f Othe feasibility and validity of a patient-administered malnutrition unTiveYrsal screening tool ('MUST') compared to healthcare professional scrIeening in an inflammatory bowel disease (IBD) outpatient clinic. J Hum NutrS Diet 30.6:737-745. KemmanuE, VR., Giliyar, S.K., Shetty, B.K., Singh, A.K., Kumaramanickavel, G. and MVcCarty, C.A. 2018a. Emerging trends in childhood blindness and ocular NImorbidity in India: the Pavagada Pediatric Eye Disease Study 2. Eye (Lond) U 32.10:1590-1598. Kemmanu, V., Giliyar, S.K., Shetty, B.K., Singh, A.K., Kumaramanickavel, G. and McCarty, C.A. 2018b. Parental inability to detect eye diseases in children: barriers to access of childhood eye-care services in south India. Eye (Lond) 32.2:467-468. Kersten, R.C. and Collin, R. 2017. Lids: congenital and acquired abnormalities − practical management. In: Lambert, S.R., and Lyons, C.J. (eds.) Taylor & Hoyt‟s Pediatric Ophthalmology and Strabismus 5th ed. Edinburgh: Elsevier. 127 Khanna, R.C., Foster, A., Krishnaiah, S., Mehta, M.K. and Gogate, P.M. 2013. Visual outcomes of bilateral congenital and developmental cataracts in young children in south India and causes of poor outcome. Indian J Ophthalmol 61.2:65-70. Khokhar, S., Pillay, G. and Agarwal, E. 2018. Pediatric Cataract - Importance of Early Detection and Management. Indian J Pediatr 85.3:209-216. Khokhar, S.K., Pillay, G., Dhull, C., Agarwal, E., Mahabir, M. and Aggarwal, P. 2017. Pediatric cataract. Indian J Ophthalmol 65.12:1340-1349. Kilangalanga, N.J., Nsiangani, L.N., Dilu, A.A., Moanda, K.A., Ilunga, M .J., Makwanga, M.E., Stahnke, T. and Guthoff, R. 2020. EpidemRioloYgy of Childhood Blindness and Low Vision in Kinshasa-democratic ReApublic of the Congo. Ophthalmic Epidemiol 27.1:45-51. R Kim, B.N., Lee, E.H., Kim, H.J. and Kim, J.H. 2018. ComIpBaring the screening property of the shortened versions of the Hypoman iaL Checklist-32 (HCL-32): Cross-validation in Korean patients with bipolar Ndisorder and major depressive disorder. J Affect Disord 227:384-390. A Kim, D.H., Kim, J.H., Kim, S.J. and Yu, YA.S.D 2012. Long-term results of bilateral congenital cataract treated with eBarly cataract surgery, aphakic glasses and secondary IOL implantation. Act aI Ophthalmol 90.3:231-6. Kimberlin, C.L. and Winterstein, AF.G. 2008. Validity and reliability of measurement instruments used in rese aOrch. Am J Health Syst Pharm 65.23:2276-84. Kipp, M.A. 2003. ChildhoYod glaucoma. Pediatr Clin North Am 50.1:89-104. Kishiki, E., HogewegI, TM., Dieleman, M., Lewallen, S. and Courtright, P. 2012. Is the existing knoSwledge and skills of health workers regarding eye care in children suffiEcienRt to meet needs? Int Health 4.4:303-6. Kong, VL., Fry, M., Al-Samarraie, M., Gilbert, C. and Steinkuller, P.G. 2012. An NIupdate on progress and the changing epidemiology of causes of childhood U blindness worldwide. J AAPOS 16.6:501-7. Kramer, H.S. and Drews, F.A. 2017. Checking the lists: A systematic review of electronic checklist use in health care. J Biomed Inform 71S:S6-S12. Kristjansdottir, R., Sjostrom, A. and Uvebrant, P. 2002. Ophthalmological abnormalities in children with cerebral white matter disorders. Eur J Paediatr Neurol 6.1:25-33. 128 Lambert, S.R. 2017. Childhood cataracts. In: Lambert, S.R., and Lyons, C.J. (eds.) Taylor & Hoyt‟s Pediatric Ophthalmology and Strabismus 5th ed. Edinburgh: Elsevier. Latorre-Arteaga, S., Gil-Gonzalez, D., Enciso, O., Phelan, A., Garcia-Munoz, A. and Kohler, J. 2014. Reducing visual deficits caused by refractive errors in school and preschool children: results of a pilot school program in the Andean region of Apurimac, Peru. Glob Health Action 7:22656. Lawan, A. 2008. Congenital eye and adnexial anomalies in Kano, a five year revie w. Niger J Med 17.1:37-9. RY Leite, C. and Zin, A. 2011. Health seeking behavior of the families of Achildren with cataract attending an eye clinic in Rio de Janeiro, Brazil. ARrq Bras Oftalmol 74.4:271-8. IB Lenhart, P.D., Courtright, P., Wilson, M.E., Lewallen, S .L, Taylor, D.S., Ventura, M.C., Bowman, R., Woodward, L., Ditta, L.C.N, Kruger, S., Haddad, D., El Shakankiri, N., Rai, S.K., Bailey, T. and LambAert, S.R. 2015. Global challenges in the management of congenital cataractD: proceedings of the 4th International Congenital Cataract Symposium held oAn March 7, 2014, New York, New York. J AAPOS 19.2:e1-8. IB Lennerstrand, G., Jakobsson, P. Fand Kvarnstrom, G. 1995. Screening for ocular dysfunction in children :O approaching a common program. Acta Ophthalmol Scand Suppl.214:26Y-38; discussion 39-40. Levi, D.M., Knill, DI.CT. and Bavelier, D. 2015. Stereopsis and amblyopia: A mini- review. VisiSon Res 114:17-30. Lewis, M.EL. 2R014. A comprehensive newborn exam: part I. General, head and neck, cVardiopulmonary. Am Fam Physician 90.5:289-96. LNi, YI. and Lin, H. 2013. Progress in screening and treatment of common congenital U eye diseases. Eye Sci 28.3:157-62. Li, Y., Yan, J., Wang, Z., Huang, W., Huang, S., Jin, L., Zheng, Y., Tan, X., Yi, J., Yip, J. and Xiao, B. 2019. Prevalence and causes of childhood blindness in Huidong County, South China, primary ascertained by the key informants. BMJ Open Ophthalmol 4.1:e000240. Litmanovitz, I. and Dolfin, T. 2010. Red reflex examination in neonates: the need for early screening. Isr Med Assoc J 12.5:301-2. 129 Loh, A.R. and Chiang, M.F. 2018. Pediatric Vision Screening. Pediatr Rev 39.5:225- 234. Lowe, M.C., Jr. and Woolridge, D.P. 2007. The normal newborn exam, or is it? Emerg Med Clin North Am 25.4:921-46, v. Luby, J.L., Heffelfinger, A., Koenig-McNaught, A.L., Brown, K. and Spitznagel, E. 2004. ThePreschool Feelings Checklist: a brief and sensitive screening measure for depression in young children. J Am Acad Child Adolesc Psychiatry 43.6:708-17. Ma, Y., Deng, G., Ma, J., Liu, J., Li, S. and Lu, H. 2018. Universal ocular scRreenYing of 481 infants using wide-field digital imaging system. BMCA Ophthalmol 18.1:283. R Mackey, S., Murthy, G.V., Muhit, M.A., Islam, J.J. and Foster, IAB. 2012. Validation of the key informant method to identify children with dLisabilities: methods and results from a pilot study in Bangladesh. J Trop PeNdiatr 58.4:269-74. Mafwiri, M.M., Kisenge, R. and Gilbert, C.E. 2A014. A pilot study to evaluate incorporating eye care for children into repDroductive and child health services in Dar-es-Salaam, Tanzania: a historical cAomparison study. BMC Nurs 13:15. Magnusson, G., Jakobsson, P., Kugelb eIrBg, U., Lundvall, A., Maly, E., Tornqvist, K., Abrahamsson, M., AndreassFon, B., Borres, M.P., Broberger, U., Hellstrom- Westas, L., Kornfalt, RO., Nelson, N., Sjostrand, J. and Thiringer, K. 2003. Evaluation of screeYning procedures for congenital cataracts. Acta Paediatr 92.12:1468-73.I T Maida, J.M., MaSthers, K. and Alley, C.L. 2008. Pediatric ophthalmology in the deveElopRing world. Curr Opin Ophthalmol 19.5:403-8. MansoVor, N., Mansoor, T. and Ahmed, M. 2016. Eye pathologies in neonates. Int J NIOphthalmol 9.12:1832-1838. UMarenco, M., Macchi, I., Macchi, I., Galassi, E., Massaro-Giordano, M. and Lambiase, A. 2017. Clinical presentation and management of congenital ptosis. Clin Ophthalmol 11:453-463. Maxim, L.D., Niebo, R. and Utell, M.J. 2014. Screening tests: a review with examples. Inhal Toxicol 26.13:811-28. Mayfair Eye Care. 2018. Vision checklist for young children [Online]. Available: https://mayfaireyecare.ca/wp- 130 content/uploads/2018/10/VISION_CHECKLIST_FOR_YOUNG_CHILDREN. pdf [Accessed June 23, 2020]. Mehta, M., Sethi, S., Pushker, N., Kashyap, S., Sen, S., Bajaj, M.S. and Ghose, S. 2012. Retinoblastoma. Singapore Med J 53.2:128-35; quiz 136. Meyer, T.D., Castelao, E., Gholamrezaee, M., Angst, J. and Preisig, M. 2017. Hypomania Checklist-32 - cross-validation of shorter versions screening for bipolar disorders in an epidemiological study. Acta Psychiatr Scand 135.6:53 9-547. Miller, J.R. 2007. Marketing the InfantSEE program at the local level. ORptoYmetry 78.7:365-8. A Mills, M.B., Hudgins, L., Balise, R.R., Abramson, D.H. and KleineRrman, R.A. 2012. Mutation risk associated with paternal and maternal IaBge in a cohort of retinoblastoma survivors. Hum Genet 131.7:1115-22. L Mills, M.D. 1999. The eye in childhood. Am Fam PhysiNcian 60.3:907-16, 918. Mora, J.S., Waite, C., Gilbert, C.E., BreidensteiAn, B. and Sloper, J.J. 2018. A worldwide survey of retinopathy of pAremDaturity screening. Br J Ophthalmol 102.1:9-13. Moreno, M.A. 2018. The Well-Child V iIsiBt. JAMA Pediatr 172.1:104. Muhammad, N., Maishanu, N.MF., Jabo, A.M. and Rabiu, M.M. 2010. Tracing children with blindness aOnd visual impairment using the key informant survey in a district of northT-WYestern Nigeria. Middle East Afr J Ophthalmol 17.4:330-4. Muhit, M., Karim, TI., Islam, J., Hardianto, D., Muhiddin, H.S., Purwanta, S.A., Suhardjo, SS., Widyandana, D. and Khandaker, G. 2018. The epidemiology of childhooRd blindness and severe visual impairment in Indonesia. Br J Ophthalmol 1V02.E11:1543-1549. MNuhiIt, M.A., Shahjahan, M., Hassan, A., Wazed, A. and Ahmed, N. 2011. Parental U knowledge, attitude and practice related to blindness of children in some selected Upazilla of Bangladesh. Mymensingh Med J 20.4:671-9. Murthy, G., John, N., Gupta, S.K., Vashist, P. and Rao, G.V. 2008. Status of pediatric eye care in India. Indian J Ophthalmol 56.6:481-8. Musa, K.O., Aribaba, O.T., Rotimi-Samuel, A., Ikuomenisan, S.J., Oluwoyeye, A.O. and Onakoya, A.O. 2018. Profile of Pediatric Cataract Seen at Lagos University Teaching Hospital, Lagos, Southwest Nigeria. Pakistan Journal of Ophthalmology 34.1:52-60. 131 Mussavi, M., Asadollahi, K., Janbaz, F., Mansoori, E. and Abbasi, N. 2014. The Evaluation of Red Reflex Sensitivity and Specificity Test among Neonates in Different Conditions. Iran J Pediatr 24.6:697-702. Mwende, J., Bronsard, A., Mosha, M., Bowman, R., Geneau, R. and Courtright, P. 2005. Delay in presentation to hospital for surgery for congenital and developmental cataract in Tanzania. Br J Ophthalmol 89.11:1478-82. National Bureau of Statistics 2017. Demographic Statistics Bulletin. Abuja: National Bureau of Statistics. Nirmalan, P.K., John, R.K., Gothwal, V.K., Baskaran, S., VijayalakRshmYi, P., Rahmathullah, L. and Kariapatti Pediatric Eye Evaluation, P. 2004Aa. The impact of visual impairment on functional vision of children in ruralR South India: the Kariapatti Pediatric Eye Evaluation Project. Invest IOBphthalmol Vis Sci 45.10:3442-5. L Nirmalan, P.K., Sheeladevi, S., Tamilselvi, V., VictorN, A.C., Vijayalakshmi, P. and Rahmathullah, L. 2004b. Perceptions of eyeA diseases and eye care needs of children among parents in rural souAth DIndia: the Kariapatti Pediatric Eye Evaluation Project (KEEP). Indian JB Ophthalmol 52.2:163-7. O'Colmain, U., Neo, Y.N., Gilmour, CI. and MacEwen, C.J. 2020. Long-term visual and treatment outcomes oFf whole-population pre-school visual screening (PSVS) in children: a lo nOgitudinal, retrospective, population-based cohort study. Eye (Lond). Y Odole, A.C., OdunaiyIaT, N.A. and Akinpelu, A.O. 2013. Ibadan knee/hip osteoarthritis outcome meSasure: process of development. Ann Ib Postgrad Med 11.2:71-6. OlowoyeyEe, AR.O., Musa, K.O. and Aribaba, O.T. 2019. Outcome of training of mVaternal and child health workers in Ifo Local Government Area, Ogun State, NINigeria, on common childhood blinding diseases: a pre-test, post-test, one-group U quasi-experimental study. BMC Health Serv Res 19.1:430. Olusanya, B.A., Baiyeroju, A.M. and Fajola, A.O. 2006. Visual recovery after cataract surgery in children. Nigerian Journal of Ophthalmology 14.2:46-51. Olusanya, B.A., Oluleye, T.S., Tongo, O.O., Ugalahi, M.O., Babalola, Y.O., Ayede, A.I. and Baiyeroju, A.M. 2020a. Retinopathy of prematurity in a tertiary facility: an initial report of a screening programme. Nigerian Journal of Paediatrics 47.2:55 – 60. 132 Olusanya, B.A., Ugalahi, M.O., Adeyemo, A.O. and Baiyeroju, A.M. 2020b. Age at detection and age at presentation of childhood cataract at a tertiary facility in Ibadan, Southwest Nigeria. BMC Ophthalmology 20.1:38. Optometric Extension Program Foundation. 1985. Educator‟s Checklist [Online]. Available: https://www.alder.k12.oh.us/Downloads/EDUCATOR%20CHECKLIST- VISION%20PROBLEMS.pdf [Accessed June 23, 2020]. Ortiz, M.V. and Dunkel, I.J. 2016. Retinoblastoma. J Child Neurol 31.2:227-36. Oyo state government. 2020. List of health facilities in Oyo state [Online]. ARvaYilable: https://oyostate.gov.ng/oyo-state-list-of-health-facility/ [AccessedA March 2, 2021]. R Panjiyar, P., Gautam, V., Rai, P.G. and Puri, L.R. 2016. ChildhIooBd corneal blindness: a retrospective study in a tertiary eye hospital of east erLn region of Nepal. Nepal J Ophthalmol 8.15:18-22. N Papadopoulos, M., Cable, N., Rahi, J., Khaw, P.T. aAnd Investigators, B.I.G.E.S. 2007. The British Infantile and ChildhoodA GDlaucoma (BIG) Eye Study. Invest Ophthalmol Vis Sci 48.9:4100-6. Papadopoulos, M. and Khaw, P.T. 201 7I. BChildhood glaucoma. In: Lambert, S.R., and Lyons, C.J. (eds.) Taylor & HFoyt‟s Pediatric Ophthalmology and Strabismus 5th ed. Edinburgh: Elsevier . O Parish, E., Tailor, R. aTnd YGandhi, R. 2018. How to conduct a newborn examination. BMJ 360:j5726I. Park, S.H. 2019S. Current Management of Childhood Amblyopia. Korean J OphtEhalRmol 33.6:557-568. Paul, CV.M. and Sathyan, S. 2018. Comparison of the efficacy of Lea Symbol chart and NISheridan Gardiner chart for preschool vision screening. Indian J Ophthalmol U 66.7:924-928. Pavone, P., Cho, S.Y., Pratico, A.D., Falsaperla, R., Ruggieri, M. and Jin, D.K. 2018. Ptosis in childhood: A clinical sign of several disorders: Case series reports and literature review. Medicine (Baltimore) 97.36:e12124. Pennefather, P.M. and Tin, W. 2000. Ocular abnormalities associated with cerebral palsy after preterm birth. Eye (Lond) 14 ( Pt 1):78-81. 133 Perilli, R., Lanci, M., Romanzo, A., Sabatini, L. and Fusilli, P. 2015. Screening eye diseases in babies: an Italian experience on 5000 healthy, consecutive newborns. Ann Ist Super Sanita 51.4:387-9. Perrot, S., Bouhassira, D., Fermanian, J. and Cercle d'Etude de la Douleur en, R. 2010. Development and validation of the Fibromyalgia Rapid Screening Tool (FiRST). Pain 150.2:250-6. Petrocchi, S., Levante, A. and Lecciso, F. 2020. Systematic Review of Level 1 and Level 2 Screening Tools for Autism Spectrum Disorders in Toddlers. Brain S ci 10.3. RY Poterio, M.B., Cardillo, J.A., De Senne, F., Pelegrino, R., Jose, N.K., ANorato, D.Y. and Poterio, G.M. 2000. The feasibility of introducing a visual Rscreening test for children during vaccination campaigns. J Pediatr OpIhBthalmol Strabismus 37.2:68-72. L Pring, L. and Tadic, V. 2010. The Cognitive and NBehavioral Manifestations of Blindness in Children In: Nass, R.D., and AFrank, Y. (eds.) Cognitive and Behavioral Manifestations of PediatricA DiDseases. New York: Oxford University Press. Public Health England. 2019. Newbor nI aBnd infant physical examination: programme handbook F [Online]. Available: https://www.gov.uk/gov eOrnment/publications/newborn-and-infant-physical- examination-programYme-handbook [Accessed 07 March 2020]. Rahi, J.S. 2007. ChilIdhTood blindness: a UK epidemiological perspective. Eye (Lond) 21.10:1249-S53. Rahi, J.S.,E CabRle, N. and British Childhood Visual Impairment Study, G. 2003. Severe vVisual impairment and blindness in children in the UK. Lancet 362.9393:1359- URN I65. ahi, J.S., Cumberland, P.M., Peckham, C.S. and British Childhood Visual Impairment Interest, G. 2010. Improving detection of blindness in childhood: the British Childhood Vision Impairment study. Pediatrics 126.4:e895-903. Rahi, J.S. and Gilbert, C.E. 2017. Epidemiology and the worldwide impact of visual impairment in children. In: Lambert, S.R., and Lyons, C.J. (eds.) Taylor & Hoyt‟s Pediatric Ophthalmology and Strabismus 5th ed. Edinburgh: Elsevier. Randrianotahina, H.C. and Nkumbe, H.E. 2014. Pediatric cataract surgery in Madagascar. Niger J Clin Pract 17.1:14-7. 134 Rao, R. and Honavar, S.G. 2017. Retinoblastoma. Indian J Pediatr 84.12:937-944. Robins, D.L., Fein, D., Barton, M.L. and Green, J.A. 2001. The Modified Checklist for Autism in Toddlers: an initial study investigating the early detection of autism and pervasive developmental disorders. J Autism Dev Disord 31.2:131- 44. Roch-Levecq, A.C., Brody, B.L., Thomas, R.G. and Brown, S.I. 2008. Ametropia, preschoolers' cognitive abilities, and effects of spectacle correction. Arch Ophthalmol 126.2:252-8; quiz 161. Rodriguez-Galindo, C., Orbach, D.B. and VanderVeen, D. 2015. RetinoRblasYtoma. Pediatr Clin North Am 62.1:201-23. A Rosen, M.A. and Pronovost, P.J. 2014. Advancing the use of checkliRsts for evaluating performance in health care. Acad Med 89.7:963-5. IB Rosenblum, S., Zandani, I.E., Deutsch-Castel, T. and M eLyer, S. 2019. The Child Evaluation Checklist (CHECK): A Screening QueNstionnaire for Detecting Daily Functional "Red Flags" of UnderrecognizedA Neurodevelopmental Disorders among Preschool Children. Occup Ther InDt 2019:6891831. Saiju, R., Yun, S., Yoon, P.D., Shrestha, BM.KA. and Shrestha, U.D. 2012. Bruckner red light reflex test in a hospital sett inIg. Kathmandu Univ Med J (KUMJ) 10.38:23- 6. F Salaffi, F., Farah, S., Beci, G O., Schettino, M., Carotti, M. and Di Carlo, M. 2020. Development aTnd Yvalidation of the SImple FIbromyalgia Screening questionnaire fIor improving the recognition of fibromyalgia in daily practice. Clin Exp RhSeumatol 38 Suppl 123.1:9-16. Sangare, M., RToure, H.B., Toure, A., Karembe, A., Dolo, H., Coulibaly, Y.I., KVouEyate, M., Traore, K., Diakite, S.A., Coulibaly, S., Togora, A., Guinto, C.O., NIAwandare, G.A., Doumbia, S., Diakite, M. and Geschwind, D.H. 2019. U Validation of two parent-reported autism spectrum disorders screening tools M-CHAT-R and SCQ in Bamako, Mali. eNeurologicalSci 15:100188. Schmutz, J., Eppich, W.J., Hoffmann, F., Heimberg, E. and Manser, T. 2014. Five steps to develop checklists for evaluating clinical performance: an integrative approach. Acad Med 89.7:996-1005. Schoemaker, M.M., Smits-Engelsman, B.C. and Jongmans, M.J. 2003. Psychometric properties of the movement assessment battery for children-checklist as a 135 screening instrument for children with a developmental co-ordination disorder. Br J Educ Psychol 73.Pt 3:425-41. Schulze Schwering, M., Finger, R.P., Barrows, J., Nyrenda, M. and Kalua, K. 2014. Barriers to Uptake of Free Pediatric Cataract Surgery in Malawi. Ophthalmic Epidemiol. Senthilkumar, D., Balasubramaniam, S.M., Kumaran, S.E. and Ramani, K.K. 2013. Parents' awareness and perception of children's eye diseases in Chennai, India. Optom Vis Sci 90.12:1462-6. Shamanna, B. and Muralikrishnan, R. 2004. Childhood cataract: mRagnYitude, management, economics and impact. Community Eye Health 17.50A:17-8. Sheeladevi, S., Lawrenson, J.G., Fielder, A., Kekunnaya, R., Ali, R.R, Borah, R.R. and Suttle, C. 2018. Delay in presentation to hospital for childIhBood cataract surgery in India. Eye (Lond) 32.12:1811-1818. L Sheeladevi, S., Lawrenson, J.G., Fielder, A.R. andN Suttle, C.M. 2016. Global prevalence of childhood cataract: a systematic Areview. Eye (Lond) 30.9:1160-9. Sheldrick, R.C., Henson, B.S., Merchant, S., NDeger, E.N., Murphy, J.M. and Perrin, E.C. 2012. The Preschool Pediatric SAymptom Checklist (PPSC): development and initial validation of a new IsBocial/emotional screening instrument. Acad Pediatr 12.5:456-67. F Sheldrick, R.C., Henson, B.S .,O Neger, E.N., Merchant, S., Murphy, J.M. and Perrin, E.C. 2013. The TbaYby pediatric symptom checklist: development and initial validation of aI new social/emotional screening instrument for very young children. AcSad Pediatr 13.1:72-80. ShodehindEe, OR.A., Kila, A., Akinrolabu, V.O. and et al 1995. Eye Problems. In: SVtanding Orders for Community Health Officers and Community Health NIExtension Workers. 3rd ed. Nigeria: Federal Ministry of Health and National U Primary Health Care Development Agency; Training and manpower development division. Shrestha, U.D. 2012. Cataract surgery in children: controversies and practices. Nepal J Ophthalmol 4.1:138-49. Singh, K. 2015. Common Visual problems. In: Gupta, P., Menon, P., Ramji, S., and Lodha, R. (eds.) PG Textbook of Pediatrics: Systemic Disorders and Social Pediatrics. New Delhi: Jaypee Brothers Medical Publishers Pvt. Limited. 136 Sloot, F., Sami, A., Karaman, H., Benjamins, J., Loudon, S.E., Raat, H., Sjoerdsma, T. and Simonsz, H.J. 2015. Effect of omission of population-based eye screening at age 6-9 months in the Netherlands. Acta Ophthalmol 93.4:318-21. Solebo, A.L. and Rahi, J. 2014. Epidemiology, aetiology and management of visual impairment in children. Arch Dis Child 99.4:375-9. Solebo, A.L., Teoh, L. and Rahi, J. 2017. Epidemiology of blindness in children. Arch Dis Child 102.9:853-857. SooHoo, J.R., Davies, B.W., Allard, F.D. and Durairaj, V.D. 2014. Congenital ptos is. Surv Ophthalmol 59.5:483-92. RY Streiner, D.L. and Norman, G.R. 1989. Health Measurement Scales: A PrAactical Guide to Their Development and Use, New York: Oxford University PRress. Sukati, V.N., Moodley, V.R. and Mashige, K.P. 2018. KnowlIeBdge and practices of parents about child eye health care in the public secto r Lin Swaziland. Afr J Prim Health Care Fam Med 10.1:e1-e13. N Sun, M., Ma, A., Li, F., Cheng, K., Zhang, M., YanAg, H., Nie, W. and Zhao, B. 2016. Sensitivity and Specificity of Red ReAflexD Test in Newborn Eye Screening. J Pediatr 179:192-196 e4. Texas School for the Blind and Visua lIlyB Impaired. 2016. ABC Checklist for Vision Observation and History [FOnline]. Available: https://www.tsbvi.edu/vision- quick-check [Accessed JuOne 23, 2020]. Thau, A., Lloyd, M., FTreYedman, S., Beck, A., Grajewski, A. and Levin, A.V. 2018. New classificatIion system for pediatric glaucoma: implications for clinical care and a researSch registry. Curr Opin Ophthalmol 29.5:385-394. ThorisdottEir, R.L., Faxen, T., Blohme, J., Sheikh, R. and Malmsjo, M. 2019. The imVpact of vision screening in preschool children on visual function in the NISwedish adult population. Acta Ophthalmol 97.8:793-797. UTicho, B.H. 2003. Strabismus. Pediatr Clin N Am 50:173- 188. Trevethan, R. 2017. Sensitivity, Specificity, and Predictive Values: Foundations, Pliabilities, and Pitfalls in Research and Practice. Front Public Health 5:307. Tuft, S.J. 2017. Corneal abnormalities in childhood. In: Lambert, S.R., and Lyons, C.J. (eds.) Taylor & Hoyt‟s Pediatric Ophthalmology and Strabismus 5th ed. Edinburgh: Elsevier. Turner, K. 2018. Well-Child Visits for Infants and Young Children. Am Fam Physician 98.6:347-353. 137 U. S. Preventive Services Task Force, Grossman, D.C., Curry, S.J., Owens, D.K., Barry, M.J., Davidson, K.W., Doubeni, C.A., Epling, J.W., Jr., Kemper, A.R., Krist, A.H., Kurth, A.E., Landefeld, C.S., Mangione, C.M., Phipps, M.G., Silverstein, M., Simon, M.A. and Tseng, C.W. 2017. Vision Screening in Children Aged 6 Months to 5 Years: US Preventive Services Task Force Recommendation Statement. JAMA 318.9:836-844. Umar, M.M., Abubakar, A., Achi, I., Alhassan, M.B. and Hassan, A. 2015. Pediatric cataract surgery in National Eye Centre Kaduna, Nigeria: outcome a nd challenges. Middle East Afr J Ophthalmol 22.1:92-6. RY Vervloed, M.P.J., van den Broek, E.C.G. and van Eijden, A.J.P.M. 2A020. Critical Review of Setback in Development in Young Children Rwith Congenital Blindness or Visual Impairment. International JoIurBnal of Disability, Development and Education 67.3:336-355. L N Vinekar, A., Govindaraj, I., Jayadev, C., Kumar, AA.K., Sharma, P., Mangalesh, S., Simaldi, L., Avadhani, K., Shetty, B. anDd Bauer, N. 2015. Universal ocular screening of 1021 term infants usingA wide-field digital imaging in a single public hospital in India - a pilot s tuIdBy. Acta Ophthalmol 93.5:e372-6. VIP-HIP Study Group, Kulp, M.T.F, Ciner, E., Maguire, M., Moore, B., Pentimonti, J., Pistilli, M., Cyert, L., C aOndy, T.R., Quinn, G. and Ying, G.S. 2016. Uncorrected Hyperopia and PTresYchool Early Literacy: Results of the Vision in Preschoolers-Hyperopia in PrIeschoolers (VIP-HIP) Study. Ophthalmology 123.4:681-9. VisionCare OptomSetry. 2012. Teacher‟s checklist of observable clues to classroom visioEn Rproblems [Online]. Available: https://visioncareoptometry.co.uk/wp-cVontent/uploads/2012/03/01-A-Teachers-Guide-To-Vision-In-The- NIClassroom.pdf [Accessed June 23, 2020]. UVisionHelp Group. 2015. Vision and Learning Checklist [Online]. Available: https://wowvision.net/wp-content/uploads/2015/10/VLChecklist_Final_VH.pdf [Accessed June 23, 2020]. von Noorden, G.K. and Campos, E.C. 2002. Binocular Vision and Ocular Motility- Theory and Management of Strabismus, St. Louis: Mosby. Wang, D., Duke, R., Chan, R.P. and Campbell, J.P. 2019. Retinopathy of prematurity in Africa: a systematic review. Ophthalmic Epidemiol:1-8. 138 Wang, H., Zhang, Y., Li, Z., Wang, T. and Liu, P. 2014. Prevalence and causes of corneal blindness. Clin Exp Ophthalmol 42.3:249-53. Weaver, D.T. 2018. Current management of childhood ptosis. Curr Opin Ophthalmol 29.5:395-400. Weinstock, V.M., Weinstock, D.J. and Kraft, S.P. 1998. Screening for childhood strabismus by primary care physicians. Can Fam Physician 44:337-43. Winters, B.D., Gurses, A.P., Lehmann, H., Sexton, J.B., Rampersad, C.J. and Pronovost, P.J. 2009. Clinical review: checklists - translating evidence in to practice. Crit Care 13.6:210. RY World Health Organisation. 2002. WHO launches Project to prevent ABlindness in Children [Online]. R Available: https://www.who.int/mediacentre/news/releases/release48/IeBn/ [Accessed January 10, 2020]. L World Health Organisation 2019. World report on VNision. Geneva: World Health Organisation. A World Health Organization 1997. Global initiaDtive for the elimination of avoidable blindness. WHO/PBL/97.61, Geneva: WAorld Health Organization. World Health Organization 2000. P reIvBenting blindness in children : report of a WHO/IAPB scientific meetiFng, Hyderabad, India, 13-17 April 1999. World Health Organization. O World Health OrganizTatioYn 2002. A five year project for the prevention of childhood blindness: RepIort of a WHO consultation group. Geneva: World Health OrganizatioSn. World HeaElthR Organization 2015. Interagency List of Medical Devices for Essential IVnterventions for Reproductive, Maternal, Newborn and Child Health. Geneva: NIWorld Health Organization. UWorld Health Organization. 2018a. Priority eye diseases: Childhood blindness [Online]. Available: https://www.who.int/blindness/causes/priority/en/index3.html [Accessed January 10, 2020]. World Health Organization. 2018b. Priority eye diseases: Corneal opacities [Online]. Available: https://www.who.int/blindness/causes/priority/en/index8.html [Accessed January 30, 2020]. 139 World Health Organization. 2018c. Priority eye diseases: Glaucoma [Online]. Available: https://www.who.int/blindness/causes/priority/en/index6.html [Accessed January 30, 2020]. Wright, K.W., Spiegel, P.H. and Thompson, L.S. (eds.) 2006. Handbook of Pediatric Strabismus and Amblyopia, New York: Springer. Wu, X., Long, E., Lin, H. and Liu, Y. 2016. Prevalence and epidemiological characteristics of congenital cataract: a systematic review and meta-analysis. Sci Rep 6:28564. Yorston, D. 1999. The global initiative vison 2020: the right to sight RchilYdhood blindness. Community Eye Health 12.31:44-5. A You, C., Wu, X., Zhang, Y., Dai, Y., Huang, Y. and Xie, L. 2011. VRisual impairment and delay in presentation for surgery in chinese pediatric IpBatients with cataract. Ophthalmology 118.1:17-23. L Zaba, J.N. 2011. Children‟s Vision Care In The 21stN Century And Its Impact On Education, Literacy, Social Issues, And TheA Workplace: A Call To Action. Journal of Behavioral Optometry 22.2:3A9-4D1. Zetterstrom, C., Lundvall, A. and KugelbBerg, M. 2005. Cataracts in children. J Cataract Refract Surg 31.4:82F4-4 0I. O ITY RS VE UN I 140 Y RA R B LI APPENDICESA N APPENDIX A. QUESTIONNAIRE FOR IANFDANTS’ MEDICAL HISTORY Study Number: ___________ IBF Study title: Developing a scOreening tool for eye diseases in infants attending immunisation clinics in IYbad an, Nigeria. Dear mother/ careSgivIer T, This studyE is Raimed at improving the early detection of eye disease among infants during Vimmunisation visits in Ibadan. Be assured of utmost confidentiality, your anNsweIrs shall not be linked to you. We will not write your name or phone number or Uany other thing that can identify you on this form. Listen to the questions carefully and provide sincere and honest answers. Date: _________________________ Local Government Area: _________________________ Immunisation clinic: _____________________________ 141 Please circle or tick the appropriate answer Section A: Socio-demographic data 1. Age of child in months: _______________________ (If <1 month, state age in weeks) 2. Gender: Gender: (a) Male (b) female 3. Informant: (a) Mother (b) Caregiver (Specify relationship): _________________ Y 4. Mother‟s age: (last birthday)______________ years R 5. Father‟s age: (last birthday)______________ years A 6. Mother‟s level of education: (a) No formal educationR (b) Primary education (c) Secondary education (d) TerItiaBry education (e) Post graduate education L 7. Father‟s level of education: (a) No formNal education (b) Primary education (c) Secondary educatiDon A (d) Tertiary education (e) Post graduate education 8. Mother‟s occupation: _______A____________________ 9. Father‟s occupation: __ _I__B______________________ 10. Where was the childF delivered? (a) Governmen t Ohospital (b) Private hospital & maternity (c) MissTionY home (d) Traditional birth attendant‟s facility (e) At Ihome (f) Others (please specify): R___S______________________ 11.E Which immunisation is to be received IV today:____________________________ SNection B: Ocular history U 12. Do you have any complaint about your child‟s eye? (a) Yes (b) No 13. If Yes to Q.12, Specify _________________________________________ 14. Which of the following features have you ever noticed in your child‟s eyes? (Tick Yes or No for each item): Feature Yes No 142 a. White spot in the eye(s) b. Big eye ball(s) (Eye ball that is bigger than what you normally see in children) c. Small eye ball (s) (Eye ball that is smaller than what you normally see in children) d. Persistent watering of the eye(s) e. Eye(s) not opening well Y f. Redness of the eye(s) R g. Persistently Discharging eye(s) A h. Crossed eyes (The two eyes are looking R in different directions) IB i. Persistently shaking eyes L N 15. If your child has or had any of the fAeatures in Q.14, have you sought eye care? (a) Yes (bD) No 16. If Yes to Q.15, BwAhere did you go? (Specify) ___________________ _I_________ 17. Has your child sOustaFined any injury to the eye(s) in the past? (a) Yes (b) No 18. Has youTr cYhild received any treatment for an eye problem in the past? I (a) Yes (b) No Section C: OthRer mSedical history V19.E History of prematurity in child (a) Yes I (b) No UN 20. History of maternal fever or rash during pregnancy (a) Yes (b) No 21. History of illness in child since birth (a) Yes (b) No 22. If Yes to Q.21, specify __________________________ 23. History of delayed milestones in the child (a) Yes (b) No 143 24. Family history of eye disease in childhood (a) Yes (b) No 25. If Yes to Q.24, specify __________________________ RY A IWE IBEERE LATI WADI ILERA AWON OMODE BR Onka Leseese: ________________________ LI Iya Owon/Alagbato Owon, AN Afojusun iwadi yi ni sise agbelaruge titetese awaDri aisan oju laarin awon omode ni akoko wiwa si ile alabere ajesara ni IbadIaBn. A Efokanbale wipe aabo to daju wa, aF ko ni fi idahun yin dayin mo, ao ni ko oruko tabi nomba ero ibanisoro yin tabi a wOon nkan miran tole fi yin han lori iwe yi, e farabale gbo awon ibeere dada kie Ysi fesi ninu otito. Ojo: __________S___I_ T______________ Agbegbe IEjobaR Ibile: ______________________________ E jowIoV yi odo tabi kie fami si idahun toye UNIpele A: Ibeere lori ara eni 1. Ojo ori omo ni osu: _________________________ (Ti koba to osu kan, daruko ojo ori ni ose) 2. Eniyan wo ni: (a) Ako (b) Abo 3. Olufesi: (a) Iya (b) Alagbato (Se afihan enitiise) 4. Ojo ori iya (ojo ibi kehin) ________________ odun 5. Ojo ori baba (ojo ibi kehin) __________________ odun 144 6. Iwe ti iya ka: (a) Ko kawe rara (b) Alakobere (d) Ile eko grama (e) Ile eko giga (e) Ile eko giga agba 7. Iwe ti baba ka: (a) Ko kawe rara (b) Alakobere (d) Ile eko grama (e) Ile eko giga (e) Ile eko giga agba 8. Ise iya: ___________________________ 9. Ise baba: _________________________ 10. Ibo labi omo naa si? RY (a) Ile iwosan ijoba (b) Ile iwosan adani A (d) Ile agbebi (e) Agbebi nipa ti ibile R (e) Ni ile (f) Nibomiran (jowo darukIoB): ______________________ L 11. Abere ajesara wo lofe gba loni: N __________________________________________A___ Ipele B: Itan lori ayewo oju AD 12. Se o ri ariwisi si oju om oI rBe? (a) Beeni (b) Beeko F 13. To baje Beeni loO si Ibere Kejila, safihan _____________________Y___ ________ 14. EwSo nIin Tu eyi letikofiri ni oju omo yin? ER(Fami si beeni tabi beeko fun okookan eyi): IV Ibeere lokanjokan Beeni Beeko N a. Kele funfun ni inu oju U b. Eyinju totobi (Eyin oju totobi jojo ju eyiti a nri loju omode lo) d. Eyin oju to kere (eyin oju to kere ju eyi ti a nri loju omode lo) e. Oju to nsomi nigbogbo igba e. Oju tiko la daradara f. Oju pipon 145 g. Oju ti nsepin ni gbogbo igba gb. Oju meji to nwo ona otooto h. Oju ti ko duro soju kan 15. Ti omo yin bani okan ninu awon ibere kerinla, se e tiwa itoju oju (a) Beeni (b) Beeko Y 16. Topba je beeni, lo si ibere kedogun, ibo ni e lo (safihan) AR ____________________ R 17. Latehinwa, se omo yin ni egbo oju ri? (a) B eeLniI B (b) Beeko 18. Latehinwa, se omo yin gba itoju fun aAisanN oju ri? (a) Beeni (b) Beeko D Ipele D: Awon itan ilera miran A IB 19. Itan kogbokogbo nipFa o mo (a) Beeni (b) Beeko 20. Itan iba inu oy unO tabi kokoro ara (a) Beeni (b) Beeko Y 21. Itan aiIleTra lati igba tia bi omo (a) Beeni (b) Beeko 22. RToSba je beeni lo si ibere ketalelogun, safihan ____________________ IV23. E Itan lori aisedeede kan laye omo naa (a) Beeni (b) Beeko U N 24. Itan idile lori aisan oju lati ewe (a) Beeni (b) Beeko 25. Toba je beeni lo si ibere kerinlelogun, safihan ___________________ 146 Y APPENDIX B. QUESTIONNAIRE FOR IMMUNISATION CLINICA STRAFF Study Number: ___________ BR Study title: Developing a screening tool for eye diseases inL inIfants attending immunisation clinics in Ibadan, Nigeria. N Dear participant, DA This study is aimed at improving the Iearly A detection of eye disease among infants during immunisation visits in Ibadan . Be assured of utmost confidentiality, your answers shall not be linked to yOou. FPlease do not write your name or phone number or any other thing that can iden tify you on this form. Read the questions carefully and provide sincere and hoTnesYt answers. I Date: __________S_______________ Local GovEernRment Area: _________________________ V ImNmuInisation clinic: _____________________________ U Please circle or tick the appropriate answer Section A: Bio data, Qualification and Training 1. Age in years (last birthday): ____________ 2. Gender: (a) Male (b) female 147 3. Marital status: (a) Single (b) Married (c) Separated (d) Divorced 4. What is your qualification? (a) Registered nurse (b) Midwifery (c) Community Health extension worker (CHEW) (e) Other (Please specify):__________________________ 5. What year did you acquire this qualification? __________________ 6. For how long have you been administering immunisation to childre n? ________________________ RY 7. Did you have any course(s) on eye care during your trainAing? (a) Yes (b) No R 8. Did you receive training on how to detect eye dIiBseases in infants and young children? (a) Yes (bL) No 9. Have you had any refresher course on eNye care since you graduated? (a) Yes (b) No A 10. Do you think it is possible to AdeteDct eye diseases in children when they are brought for immunisatiBon? (a) Yes (b) No (c) Not sure I 11. Have you previouslyF noticed that a child who was receiving a vaccine had an eye pro blOem? (a) Yes (b) No 12. If Yes, TaboYut how many times in the past 5 years did you notice eye probleIms in children that were brought for immunisation? ……S……………………. 13.E RAt the most recent occasion (i.e., the last time you noticed) what eye V problem did you think the child had? I ……………………………………….. UN 14. At the most recent occasion (i.e., the last time you noticed) what action did you take? …………………………………………… 148 APPENDIX C. FINAL VERSION OF THE SCREENING CHECKLIST USED FOR THE STUDY Y AR LIB R N AD A IB O F TY RS I E IV UN 149 APPENDIX D. PROFORMA FOR OPHTHALMIC EXAMINATION OF INFANTS Study Number: ___________ Study title: Developing a screening tool for eye diseases in infants attending immunisation clinics in Ibadan, Nigeria. This proforma is to be completed by the examining ophthalmologist Y OCULAR EXAMINATION (Please fill in the correct option into the boxR for each eye) RA RIGHT LEYIEB LEFT EYE 1. Visual acuity N a) Good fixation (Central, steady, and maintAained) b) Poor fixation (Eccentric or Unsteady Dor Unmaintained) c) No fixation BA 2. Eyelids F I a) Normal O b) Ptosis Y c) Tearing IT d) DischaSrge e) OthRer abnormality (Please describe) …………….. …………… VE 3. I General eye examination N a) Eye appears normal U b) Nystagmus c) Buphthalmos d) Microphthalmos e) Leukocoria f) Strabismus 150 RIGHT EYE LEFT EYE 4. Conjunctiva a) Normal b) Injected c) Other abnormality (Please describe) …………………………… 5. Cornea RY a) Normal A b) Opacity R c) Other abnormality (Please describe) …..……………IB…………… L 6. Anterior chamber N a) Normal depth A b) Shallow D c) Deep A d) Other abnormality (Please d eIsBcribe) …………………………… 7. Pupil O F a) Normal (RoTundY and reactive to light) b) Abnormal SI c) If abnormal (Please describe) …………………………….. R 8. VLenEs NI a) Normal U b) Cataract c) Other abnormality (Please describe) …………………………… 9. Red reflex test a) Normal b) Abnormal 151 RIGHT EYE LEFT EYE 10. Fundus a) Normal fundus b) Abnormal fundus c) If abnormal (Please describe) …………………………….. 11. Conclusion Y a) Normal examination findings R b) Abnormal examination findings (Please specify)………………A……………. R 12. Other comments IB ……………………………………………………N… … L…………………… ……………………………………………………………..…………………… ………………………..............................D......A................................ BA F I O ITY S ER IV N U 152 APPENDIX E. REFERRAL FORM Study title: Developing a screening tool for eye diseases in infants attending immunisation clinics in Ibadan, Nigeria. REFERRAL FORM RY Consultant Paediatric Ophthalmologist RA Eye clinic LIB UCH, Ibadan. N Dear sir/ma, DA Patient name……………………I…B… A………………………………… Age ……….. Sex …………F… … Please urgently seYe a n Od evaluate the above-named child who was found to have T features suggestive of ……………S…I………………………………………….. during eye screening at an imRmunisation clinic. IVTh Eank you. UN ………………………………………… Dr B.A. Olusanya 153 APPENDIX F. POST-STUDY QUESTIONNAIRE FOR IMMUNISATION CLINIC STAFF Study Number: ___________ Study title: Developing a screening tool for blinding eye diseases in infants attending immunisation clinics in Ibadan, Nigeria. Dear participant, Y This questionnaire is aimed at evaluating your experience with use of the chRecklist for screening for eye diseases in children during the study period. Be aRssuAred of utmost confidentiality, your answers shall not be linked to you. Please dIoB not write your name or phone number or any other thing that can identify youL on this form. Read the questions carefully and provide sincere and honest answNers. Date: _________________________ DA Local Government Area: _____________B___AI _________ Primary Health Care centre: ______F__ _____________________ Please circle or tick the aYppr o Opriate answer IT 1. Did you Sfind the checklist for screening eye diseases in children useful? a. Yes R b. No c. Not sure E 2. IVIf yes to question 1, how useful was the checklist for screening for eye N diseases in children? U a. A bit useful b. Moderately useful c. Very Useful 3. Did you find it easy to use the checklist to screen for eye disease in children? a. Yes b. No c. Not sure 4. If yes to question 3, how easy was it to use the checklist to screen for eye diseases in children? 154 a. A bit easy b. Moderately easy c. Very easy 5. What was the average period of time that you spent using the checklist on one child? _____________ minutes 6. Did you experience any challenge or difficulty while using the checklist during the study? a. Yes b. No 7. If Yes to Question 6, which challenge(s) did you have? RY (You may select more than one option, if applicable) A a. Difficulty with understanding how to use the checklist (If Ryes, mention the section or question that you IBhad difficulty with………………………………………………… …L..) b. Difficulty with interpretation of the scores on thNe checklist c. Difficulty with obtaining answers from somAe mothers/caregivers d. Difficulty with examining some of the cDhildren e. Poor cooperation from some motBherAs/caregivers f. Poor cooperation from some c hIildren g. Use of the checklist was tiFme-consuming h. Inadequate number o f Ostaff i. Others Y (Please specify):……I…T………………………………………………… ….. S 8. DEid yRou learn any new skill(s) while using the checklist during the study? a.V Yes b. No UN I 9. If yes to question 8, mention one skill you learned while using the checklist during the study. ………………………………………………………………………………… ………………………………… 155 10. Do you feel confident that you can detect eye diseases in children by using the checklist after the study period? a. Yes b. No c. Not sure 11. If yes to question 10, how confident are you? a. A little confidence b. Moderate confidence c. Much confidence Y AR 12. Do you have any suggestion(s) for modifying or improving tRhe checklist? a. Yes b. No IB L 13. If Yes to question 12, please mention the suNggestion(s) that you have for modifying or improving the checklist. A …………………………………………D……………………………………… ………………………………………A…………………………….. ……………………………… …IB……………………………………………… ……………………………F………………………………………….. Thank Yyou fo Or your cooperation and participation in the study T RS I VE U N I 156 APPENDIX G. ETHICAL APPROVAL Y AR BR N LI A BA D I O F TY RS I E NI V U 157 APPENDIX H. CONSENT FORMS A. Informed consent form - Immunisation staff Study title: Developing a screening tool for eye diseases in infants attending immunisation clinics in Ibadan, Nigeria. INFORMED CONSENT TO PARTICIPATE IN THE STUDY Study number: ___________ RY IRB Research approval number: RA This approval will elapse on: LIB My name is Dr. Bolutife OLUSANYA, a PhD candida te of the Department of Epidemiology & Medical Statistics, University of IAbadNan. I also work as a paediatric ophthalmologist in the Department of OphthalmDology, University College Hospital, Ibadan. BA I am conducting a study on earlFy d eItection of eye disease among infants during immunisation visits. The aim oOf the study is to determine whether a newly developed screening checklist can imYpro ve the ability of immunisation clinic staff to detect eye diseases in infants. ItI iTs believed that the information generated by this study will be useful for developSing and implementing interventions that will ensure early detection, early presentaRtion and prompt treatment of eye diseases in children. As anI iVmm Eunisation clinic staff working in Ibadan, Oyo state, you are being invited to paNrtake in this study. Your participation will involve filling a short questionnaire and Uthe use of a checklist to screen infants during their immunisation clinic visits. It is expected that the screening process for each child will take about 5 minutes. You will be requested to screen between 15 and 20 babies over a period of 3 - 4 months. After you have screened an infant, a consultant ophthalmologist will also examine the child to confirm the presence of absence or eye disease. The ophthalmologist will not be allowed to have any information on the result of your screening, to avoid bias. This 158 examination by the specialist is to ascertain to what extent the screening tool can correctly guide immunisation staff in the detection of eye disease in children. There are no risks involved in your participation in this study. No harmful or invasive procedures are involved in the study; therefore, no physical harm is envisaged. The benefits that you may derive from participation in this study include improvement in your knowledge and ability to detect eye diseases in children. Participation is voluntary. Refusal to participate will involve no penalty Ror lYoss of benefits to which you are otherwise entitled. Also, you may discontinueA participation at any time without penalty or loss of benefits to which you are otherwRise entitled. B Confidentiality of the information you provide will be ens urLedI throughout the study. All information collected in this study will be given code numbers and no name will be recorded. This cannot be linked to you in anywaAy anNd your name or any identifier will not be used in any publication or reporDts from this study. As part of my responsibility to conduct this research prAoperly, officials from Research Ethics Committee may have access to these re cIoBrds. If you agree to participate in thOis stuFdy, kindly sign the attached form. Thank you. TY SI ER V UN I 159 Statement of person obtaining informed consent: I have fully explained the aim and study procedure for this research to _____________ and have provided adequate information, including the risks and benefits, to allow an informed decision to be made. DATE:_____________________SIGNATURE: _________________________ NAME: ______________________________________________ Y Statement of person giving consent: AR I have carefully read and thoroughly understand the explanation of thRe research. I have also had a satisfactory discussion with the investigator. I have fIuBll understanding that my participation is voluntary. I have adequate knowledNge ab Lout the aim, procedures, risks and benefits of the research to allow me decideA that I want to take part in it. And I understand that I may freely withdraw from theD study at any time. DATE:___________________SIGNATIUBRE A: ___________________________ NAME: ______________________F__ _____________________ WITNESS‟ SIGNATUREY (if a Opplicable): ___________________________ WITNESS‟ NAME (iIf Tapplicable): ________________________________ S Additional infRormation: In adIdiV E tion, if you have any questions about your involvement in this research, you caNn contact the researcher, Dr Bolutife OLUSANYA, Department of Ophthalmology, UUniversity College Hospital, Ibadan. (Phone No. +2348034051563; Email: bolutifeo@yahoo.com). This research has been approved by the Ethics Committee of the University of Ibadan and the Chairman of this Committee can be contacted at Biode Building, Room 210, 2nd Floor, Institute for Advanced Medical Research and Training, College of Medicine, University of Ibadan, E-mail: uiuchirc@yahoo.com and uiuchec@gmail.com 160 B. Informed consent form – Infants’ mothers/ caregivers Study title: Developing a screening tool for eye diseases in infants attending immunisation clinics in Ibadan, Nigeria. INFORMED CONSENT TO PARTICIPATE IN THE STUDY Study number: ___________ IRB Research approval number: RY This approval will elapse on: RA My name is Dr. Bolutife OLUSANYA, a PhD candidate oIfB the Department of Epidemiology & Medical Statistics, University of Ibadan. I Lalso work as a paediatric ophthalmologist in the Department of OphthalmologyN, University College Hospital, Ibadan. DA I am conducting a study on early detectioAn of eye disease among infants during immunisation visits. The aim of the st uIdyB is to determine whether a newly developed screening checklist can improve thFe ability of immunisation clinic staff to detect eye diseases in infants. It is believOed that the information generated by this study will be useful for developing andY imp lementing interventions that will ensure early detection, early presentation andI Tprompt treatment of eye diseases in children. As a mother or caSregiver who has brought your child for immunisation you are being invited to EpaRrtake in this study. Your participation will involve answering some questioVns about your child‟s medical history. Thereafter, the immunisation staff will usNe a Ichecklist to check if your child has eye disease. It is expected that this screening Uprocess will take about 5 minutes. After your child has been screened by the immunisation staff, a consultant ophthalmologist will also examine the child to confirm the presence or absence of eye disease. This examination by the specialist should take about 5 minutes and its purpose is to ascertain to what extent the screening tool can correctly guide immunisation staff in the detection of eye disease in children. 161 There are no risks involved in your participation in this study. No harmful or invasive examination procedures are involved in the study, therefore no physical harm is envisaged. The benefits that you may derive from participation in this study include reassurance that your child does not have any eye problem. However, if we detect any eye problem in your child, a referral for further evaluation and treatment at the Eye clinic, University College Hospital, Ibadan will be given to you. We promise to attend to your child immediately you present there. RY Participation is voluntary. Refusal to participate will involve no penaAlty or loss of benefits to which you are otherwise entitled. Also, you may discontRinue participation at any time without penalty or loss of benefits to which you aLre oItBherwise entitled. Your confidentiality will be ensured throughout the studNy. All information collected in this study will be given code numbers and no nameA will be recorded. This cannot be linked to you in anyway and your name or anDy identifier will not be used in any publication or reports from this study. IABs p Aart of my responsibility to conduct this research properly, officials from Resea rch Ethics Committee may have access to these records. OF If you agree to participate Yin t his study, kindly sign the attached form. Thank you. ITS ER IV UN 162 Statement of person obtaining informed consent: I have fully explained the aim and study procedure for this research to _____________ and have provided adequate information, including the risks and benefits, to allow an informed decision to be made. DATE:_____________________SIGNATURE: _________________________ NAME: ______________________________________________ Y Statement of person giving consent: AR I have carefully read and thoroughly understand the explanation of thRe research. I have also had a satisfactory discussion with the investigator. I have fIuBll understanding that my participation is voluntary. I have adequate knowledNge ab Lout the aim, procedures, risks and benefits of the research to allow me decideA that I want to take part in it. And I understand that I may freely withdraw from theD study at any time. DATE:___________________SIGNATIUBRE A: ___________________________ NAME: ______________________F__ _____________________ WITNESS‟ SIGNATUREY (if a Opplicable): ___________________________ WITNESS‟ NAME (iIf Tapplicable): _________________________________ S Additional infRormation: In adIdiV E tion, if you have any questions about your involvement in this research, you caNn contact the researcher, Dr Bolutife OLUSANYA, Department of Ophthalmology, UUniversity College Hospital, Ibadan. (Phone No. +2348034051563; Email: bolutifeo@yahoo.com). This research has been approved by the Ethics Committee of the University of Ibadan and the Chairman of this Committee can be contacted at Biode Building, Room 210, 2nd Floor, Institute for Advanced Medical Research and Training, College of Medicine, University of Ibadan, E-mail: uiuchirc@yahoo.com and uiuchec@gmail.com 163 B. Iwe Erongba – Iya Omo/alagbato Akole Iwadi: Sise agbedide irinse ti yoo tojo fun ti tete se awari awon aisan oju laarin awon omode to nwa si ile alabere ajesara ni ilu Ibadan AFIHAN ERONGBA LATI LOWO NINU IWADI NAA Iye Onka:______________ Onya Iyonda iwadi IRB: RY Iyonda yi yoo wa sopin ni: RA Dokita Bolutife OLUSANYA ni orunko mi, akeko ipele agba (PIhBD) ni eka to nwadi lori itankale ati kikapa awon orisirisi arun ati ririsi igbelewo nL eto ilera ti ile eko giga Unifasiti Ibadan. Mo si tun nsise gegebi dokita oloju ti Nawon omode ni eka itoju oju ti ile iwosan Oritamefa Ibadan. DA Mo nse iwadi lori titete se awari aisan oju laaArin awon omode lakoko tiwon wa gba abere ajesara. Afojusun lori iwadi yi ni IbBoya awon osise nile abere ajesara le ja fafa si lati se awari aisan oju loju awon omFod e nipase agbejade iwe fifowosi tuntun kan. Igbagbo wa nipe awon oro ti a Oba gba sile ni akoko iwadi yi yoo je lilo fun igbelaruge ati agbekale awon eto fun Yaridaju titete se awari, titete se afihan ati sise itoju awon aisan oju awon omodIe Tdeede. A npe yin gegRebi Siya tabi alagbato to mu omo rewa gba abere ajesara lati kopa ninu iwadi yi. IEkopa yin yoo mu yin dahun awon ibeere kan nipa ilera omo yin. LNehinIn Vaa, ni osise alabere ajesara yoo ye akosile wo boya omo yin ni. A nireti wipe Ugbogbo eto ayewo yi yoo gba to bii iseju marun. Lehin ti osise alabere ajesara bati ye omo yin wo tan Dokita agba oloju yoo tun ye omo naa wo lati fidi re mule boya omo naa ni aisan oju tabi koni. Ayewo ti akose- mose seyi yoo tun gba bii iseju marun miran, eredi re si nipe bi ohun elo ayewo se le se deede to lati se atona osise alabere ajesara nipa sise awari aisan oju lara omode. Kosi ewu kankan fun yin bie ba kopa ninu iwadi yii. 164 Igbese ayewo kankan ko lewu ninu iwadi yii nitori kosi ohunkohun to le payin lara. Awon anfaani to seese kie rigba teba kopa ninu iwadi yii ni ninu idaniloju wipe aisan kankan kosi loju omo yin ewe, ti a baganni aisan kan loju omo yin, ao kowe lati ma aba agbeyewo ati itoju oju naa lo ni ile itoju oju ti ile iwosan nla Oritamefa ibi le yin lowo. A seleri lati tete dayin lohun ni kete tie bati de ibe. Tie bafe ni e le kopa, kosi si idajo tabi adanu kankan tie ba ko. Bakanna e le da ikop a duro nigbakugba laisi adanu tabi yiya kankan. A mu dayin loju pe gbogbo oro yYin lakoko iwadi yi lao pamo, ao kan se ami onka le won lori ni ao si ni ko orukoR kankan sile. Koni seese fun enikeni lati fi eyi dayin mo, beeni a koni te oruko yinA tabi idanimo yin kankan jade tabi ninu abo iwadi yi. BRI Gegebi abala kan ojuse mi lati seto iwadi yi dada, o seese ki aLwon osise alamojuto eto iwadi ni awon akosile yi. AN Jowo buwo lu iwe yi ti o bat i gba lati kopa ninuD iwadi yi. E se pupo BA OF I SI TY ER NI V U 165 Oro eni to ngba ohun sile: Mo ti salaye kikun nipa iwadi yi fun______________________________ mo si ti bawon soro ti o to titi fimo awon ewu ati anfani, eyi tole muwon pinnu. OJO: _____________________ BUWO LUWE: _______________________ ORUKO: ________________________________________ Oro eniti a ngba ohun re sile: RY Mo ti ka apejuwe iwadi yi o si ti yemi. Mo si ti ba oluwadi so eyi totemi Alorun. O yemi wipe bimo bafe ni mole kopa, mo ti mo pupo nipa eredi, liana, eRwu ati anfani iwadi yi to nse afihan wipe mofe lati kopa nibe ati yonda lati Lse IayBewo aisan oju fun omo mi. N O yemi wipe mole da ikopa mi ninu iwadi yi durDo niAgbakugba. OJO: __________________BUWOLUWBE: _A__________________________ ORUKO: ____________________F___ _I________________ BIBUWO LUWE ELERI (to bOaye): ____________________________ Y ORUKO ELERI (to bIaTwa): _______________________________________ Afikun oro: RS Ni afikVun, Etie bani ibeere nipa ikopa yi lori iwadi yi, e lekan si. Oluwadi agba, Dokita BNolutIife OLUSANYA eka to ntoju oju ni ile iwosan nla Oritamefa, Ibadan. (Nomba UEro ibanisoro +2348034051563; Ero ayelujara: bolutifeo@yahoo.som) Iwadi yi ti gba ase lati odo awon igbimo to nri si oro iwadi ni ile-eko giga Unifasiti Ibadan, a sile kan si Alaga igbimo ti Ile Biode, yara igba-le-mewa ni aja keji, Ero ayelujara: uiuchirc@yahoo.com ati uiuchec@gmail.com 166 Y AR LIB R Plate 1. Training of primary health workers on screening Afor Nchildhood eye diseases using the screening checklist D IB A F O ITYS ER NI V U Plate 2. Research assistant administering the study questionnaire on an infant‟s mother 167 Y AR LIB R Plate 3. An immunisation staff asking questions from anA infaNnt‟s mother while using the screening checklist D BA OF I Y T RS I IV E UN Plate 4. An immunisation staff examining an infant while using the screening checklist 168 Y AR LIB R Plate 5. Examination of an infant‟s eyes by the ophthalmologNist DA BA OF I ITY ER S NI V U Plate 6. Red reflex test being performed on an infant‟s eyes by the ophthalmologist 169