Improved screening of retinopathy of prematurity (ROP): development of a target product profile (TPP) for resource-limited settings.

BACKGROUND: As more preterm infants survive, complications of preterm birth, including retinopathy of prematurity (ROP), become more prevalent. ROP rates and blindness from ROP are higher in low-income and middle-income countries, where exposure to risk factors can be higher and where detection and treatment of ROP are under-resourced or non-existent. Access to low-cost imaging devices would improve remote screening capabilities for ROP. METHODS: Target product profiles (TPPs) are developed early in the medical device development process to define the setting, target user and range of product requirements. A Delphi-like process, consisting of an online survey and consensus meeting, was used to develop a TPP for an ROP imaging device, collecting feedback on a proposed set of 64 product requirements. RESULTS: Thirty-six stakeholders from 17 countries provided feedback: clinicians (72%), product developers (14%), technicians (6%) and other (8%). Thirty-six per cent reported not currently screening for ROP, with cited barriers including cost (44%), no training (17%) and poor image quality (16%). Among those screening (n=23), 48% use more than one device, with the most common being an indirect ophthalmoscope (87%), followed by RetCam (26%) and smartphone with image capture (26%). Consensus was reached on 53 (83%) product requirements. The 11 remaining were discussed at the consensus meeting, and all but two achieved consensus. CONCLUSIONS: This TPP process was novel in that it successfully brought together diverse stakeholders to reach consensus on the product requirements for an ROP imaging devices. The resulting TPP provides a framework from which innovators can develop prototypes.

Universal newborn eye screening: a systematic review of the literature and review of international guidelines.

Background: This systematic review assessed the effectiveness of universal screening for newborn eye abnormalities compared with no screening in improving infant vision and health outcomes. Methods: We searched CENTRAL (Cochrane Library), MEDLINE, Embase, Global Health, Global Index Medicus, clinical trials databases, and bibliographies of relevant articles. We included randomized and observational studies of all newborns, regardless of illness or risk factors, that compared universal screening for any eye abnormality by eight weeks of age with no universal screening. Two authors independently selected studies, extracted data, and evaluated the risk of bias. We used GRADE to assess the certainty of evidence. We also reviewed available recommendations on newborn eye screening. Results: Fourteen studies were identified but only three compared universal red reflex screening with no screening. Findings suggest that universal red reflex testing in maternity wards (MWs) may increase the number of newborns with congenital cataracts referred for eye care from MWs or well-baby clinics (WBCs) in the first year of life (risk ratio (RR) = 9.83, 95% confidence interval (CI) = 1.36-71.20; low certainty evidence). However, the effect of screening in WBC is uncertain (RR = 6.62, 95% CI = 0.87-50.09). The effect of MW or WBC screening on referral from any health care facility (MWs, WBCs, paediatrician clinic, other) in the first year is uncertain (MW screening: RR = 1.22, 95% CI = 0.63-2.39; WBC screening: RR = 0.97, 95% CI = 0.46-2.05). However, referral or surgery by 6 weeks of age may be higher with universal MW screening (early referral: RR = 4.61, 95% CI = 1.12-19.01; early surgery: RR = 8.23, 95% CI = 1.13-59.80; low certainty evidence). The effect of WBC screening on early referral and surgery is uncertain (early referral: RR = 1.98, 95% CI = 0.43-9.19; early surgery: RR = 3.97, 95% CI = 0.50-31.33; very low certainty evidence). Universal red reflex testing may increase clinical conjunctivitis (OR = 1.22, 95% CI = 1.01-1.47; low certainty evidence) but the effect on confirmed bacterial conjunctivitis is uncertain (OR = 1.20, 95% CI = 0.76-1.90; very low-certainty evidence). Nine guidelines recommended universal newborn eye screening using red reflex testing. Conclusions: Evidence supports the role of red reflex testing shortly after birth to increase early identification, referral, and surgery for congenital cataracts.

Strengthening retinopathy of prematurity screening and treatment services in Nigeria: a case study of activities, challenges and outcomes 2017-2020.

OBJECTIVES: Retinopathy of prematurity (ROP) will become a major cause of blindness in Nigerian children unless screening and treatment services expand. This article aims to describe the collaborative activities undertaken to improve services for ROP between 2017 and 2020 as well as the outcome of these activities in Nigeria. DESIGN: Descriptive case study. SETTING: Neonatal intensive care units in Nigeria. PARTICIPANTS: Staff providing services for ROP, and 723 preterm infants screened for ROP who fulfilled screening criteria (gestational age <34 weeks or birth weight ≤2000 g, or sickness criteria). METHODS AND ANALYSIS: A WhatsApp group was initiated for Nigerian ophthalmologists and neonatologists in 2018. Members participated in a range of capacity-building, national and international collaborative activities between 2017 and 2018. A national protocol for ROP was developed for Nigeria and adopted in 2018; 1 year screening outcome data were collected and analysed. In 2019, an esurvey was used to collect service data from WhatsApp group members for 2017-2018 and to assess challenges in service provision. RESULTS: In 2017 only six of the 84 public neonatal units in Nigeria provided ROP services; this number had increased to 20 by 2018. Of the 723 babies screened in 10 units over a year, 127 (17.6%) developed any ROP; and 29 (22.8%) developed type 1 ROP. Only 13 (44.8%) babies were treated, most by intravitreal bevacizumab. The screening criteria were revised in 2020. Challenges included lack of equipment to regulate oxygen and to document and treat ROP, and lack of data systems. CONCLUSION: ROP screening coverage and quality improved after national and international collaborative efforts. To scale up and improve services, equipment for neonatal care and ROP treatment is urgently needed, as well as systems to monitor data. Ongoing advocacy is also essential.

Integrating eye health training into the primary child healthcare programme in Tanzania: a pre-training and post-training study.

OBJECTIVES: To evaluate a primary child eye care training module for use in the WHO/UNICEF Integrated Management of Newborn and Childhood Illness (IMNCI) programme by primary healthcare workers. DESIGN: Pre-training and post-training study. SETTING: Primary healthcare facilities in a semirural district, central Tanzania. PARTICIPANTS: 54 primary healthcare workers selected by the Ministry of Health were trained during routine IMNCI training. All these healthcare workers were assessed pre-intervention and post-intervention. A subgroup of 40 were also assessed 6 months after the completion of training. INTERVENTION: Training in an IMNCI eye module, developed for child primary healthcare workers with the Tanzania Ministry of Health and eye care experts. MAIN OUTCOME MEASURES: Knowledge, skills and attitudes were assessed using multiple choice questions, case studies and a self-assessment of skills using a Likert scale before and immediately after training, and 6 months later. A total score was derived. At 6 months, attitudes were assessed in semistructured interviews. RESULTS: 69% PHWs trained were nurses. The baseline (before training) score was 29.9 (95% CI 27.5 to 32.4) and increased by 11.2 points (95% CI 8.3 to 14) immediately after training, and by 12.4 points (95% CI 9.2 to 15.6) at 6 months post the training. Therefore, the post-training scores increased and there was no evident difference in scores from immediately after training to 6 months later. Self-assessed confidence in skills decreased from 9/18 (95% CI 9 to 10) to 6/18 (95% CI 6 to 7). At 6 months, the module was reported as easy to understand and use, with challenges including difficulties in examining children's eyes and poor referral systems. CONCLUSIONS: The module increased knowledge of child eye health in primary healthcare workers, which was maintained, and was acceptable. The module has since been included into the national IMNCI health policy in Tanzania.

Epidemiology of ROP update - Africa is the new frontier.

Several epidemics of blindness due to retinopathy of prematurity (ROP) have been described, with the most recent (the third) occurring in middle income countries in Latin America and Eastern Europe initially, and more recently in the more advanced economies in Asia. In these settings, which are characterized by variation in the quality of neonatal care and inadequate coverage of ROP screening and treatment, larger, more mature infants are affected as well as extremely preterm infants. In 2010 the annual incidence of blindness and visual impairment from ROP globally was estimated to be 32,300, with the lowest incidence in sub-Saharan countries. However, ROP is likely to become an increasingly important cause of blindness in children in sub-Saharan Africa as neonatal care expands unless policies and programmes for control are included at the outset.

Integrating primary eye care into global child health policies.

Globally, approximately 75% of blind children live in low-income countries (LICs). Almost half of blindness and low vision in LICs is due to avoidable causes such as corneal scarring from measles infection, vitamin A deficiency disorders, use of harmful traditional eye remedies, ophthalmia neonatorum and cataract.

Expanding the Phenotype of TRNT1-Related Immunodeficiency to Include Childhood Cataract and Inner Retinal Dysfunction.

IMPORTANCE: A multiorgan syndromic disorder characterized by sideroblastic anemia, immunodeficiency, periodic fever, and developmental delay with an uncharacterized retinal dystrophy is caused by TRNT1. This report of a family with a homozygous mutation in TRNT1 expands the ocular phenotype to include cataract and inner retinal dysfunction and details a mild systemic phenotype. OBSERVATIONS: A consanguineous family with 3 affected children was investigated. Key clinical features comprised hypogammaglobulinemia, short stature with microcephaly, cataract, and inner retinal dysfunction without sideroblastic anemia or developmental delay. Two siblings had poor balance and 1 sibling had sensorineural hearing loss. The oldest sibling had primary ovarian failure diagnosed at age 14.5 years. Exome sequencing identified a homozygous missense variant in TRNT1, c.295C>T (p.Arg99Trp) in all 3 patients. The sibling with hearing loss also harbored a homozygous mutation in GJB2, c.71G>A (p.Trp24*), which is an established cause of sensorineural hearing loss. CONCLUSIONS AND RELEVANCE: This family expands the ocular and systemic phenotypes associated with mutations in TRNT1, demonstrating phenotypic variability and highlighting the need for ophthalmic review of these patients.

Time trends over five decades, and recent geographical variation, in rates of childhood squint surgery in England.

AIMS: To study trends in rates of childhood squint surgery in England over five decades, and to study recent geographical variation in England. METHODS: Use of routine hospital statistics to analyse trends in squint surgery in the Oxford record linkage study area 1963-2010, and England 1968-2010; analysis of geographical variation in England 1999-2010. All rates, numerators and population denominators were restricted to people aged under 15 years. RESULTS: The study included 519 089 admissions for operations on squint. Annual admission rates for squint surgery in England fell from 188.8 episodes per 100 000 population (95% CI 180.9 to 196.8) in 1968 to 64.1 (62.4 to 65.7) episodes per 100 000 population in 2010. A similar decline was seen in the Oxford region, from 213.2 (181.3 to 245.2) episodes per 100 000 population in 1963 to 61.3 (54.8 to 67.9) episodes in 2010. There was wide variation across local authorities in annual rates of squint surgery from 28.2 (95% CI 22.7 to 34.8) admissions per 100 000 population to 138.6 (123.0 to 155.7) admissions per 100 000, a 4.9-fold difference between areas with the highest and lowest rates. CONCLUSIONS: Squint surgery rates have decreased substantially over time. The current wide geographical variation in rates raises questions about whether this scale of variation is clinically warranted, whether it reflects variation in needs for surgery and patient/parental choice, whether it is a result of inequalities in the availability of ophthalmic services, or whether it results from variation between clinicians in clinical decision making about the likely benefits of squint surgery.

Better value eye care for the 21st century: the population approach.

Health services globally and in the UK face challenges from increasing need and rising expectations to inequalities and financial constraints. The UK government has recently published a Public Health Framework for the first time. This has included preventable sight loss as an outcome measure for the nation's public health reflecting increasing recognition of eye health issues in the broader public health agenda. This presents a real opportunity to improve eye care services at a population level. However, the chief executive of the National Health Service (NHS) has set his own challenge to the NHS to find £20 billion in efficiency savings in the next 3 years in order to maintain services within the available healthcare budget. We have reviewed national routine healthcare data in order to understand the current financial expenditure, activity and outcomes in ophthalmology. Our results have found a wide variation in expenditure in healthcare and activity across the country. We discuss a population based, value-orientated approach to dealing with healthcare issues which will provide a sustainable framework for the future.

Geographical variation in certification rates of blindness and sight impairment in England, 2008-2009.

OBJECTIVES: To examine and interpret the variation in the incidence of blindness and sight impairment in England by PCT, as reported by the Certificate of Vision Impairment (CVI). DESIGN: Analysis of national certification data. SETTING: All Primary Care Trusts, England. PARTICIPANTS: 23 773 CVI certifications issued from 2008 to 2009. MAIN OUTCOME MEASURES: Crude and Age standardised rates of CVI data for blindness and sight loss by PCT. METHODS: The crude and age standardised CVI rates per 100 000 were calculated with Spearman's rank correlation used to assess whether there was any evidence of association between CVI rates with Index of Multiple Deprivation (IMD) and the Programme Spend for Vision. RESULTS: There was high-level variation, almost 11-fold (coefficient of variation 38%) in standardised CVI blindness and sight impairment annual certification rates across PCTs. The mean rate was 43.7 and the SD 16.7. We found little evidence of an association between the rate of blindness and sight impairment with either the IMD or Programme Spend on Vision. CONCLUSIONS: The wide geographical variation we found raises questions about the quality of the data and whether there is genuine unmet need for prevention of sight loss. It is a concern for public health practitioners who will be interpreting these data locally and nationally as the CVI data will form the basis of the public health indicator 'preventable sight loss'. Poor-quality data and inadequate interpretation will only create confusion if not addressed adequately from the outset. There is an urgent need to address the shortcomings of the current data collection system and to educate all public health practitioners.