Longitudinal Andhra Pradesh Eye Disease Study: rationale, study design and research methodology.

BACKGROUND: The rationale, objectives, study design and procedures for the longitudinal Andhra Pradesh Eye Disease Study are described. DESIGN: A longitudinal cohort study was carried out. PARTICIPANTS: Participants include surviving cohort from the rural component of Andhra Pradesh Eye Disease Study. METHODS: During 1996-2000, Andhra Pradesh Eye Disease Survey was conducted in three rural (n = 7771) and one urban (n = 2522) areas (now called Andhra Pradesh Eye Disease Study 1). In 2009-2010, a feasibility exercise (Andhra Pradesh Eye Disease Study 2) for a longitudinal study (Andhra Pradesh Eye Disease Study 3) was undertaken in the rural clusters only, as urban clusters no longer existed. In Andhra Pradesh Eye Disease Study 3, a detailed interview will be carried out to collect data on sociodemographic factors, ocular and systemic history, risk factors, visual function, knowledge of eye diseases and barriers to accessing services. All participants will also undergo a comprehensive eye examination including photography of lens, optic disc and retina, Optic Coherence Tomography of the posterior segment, anthropometry, blood pressure and frailty measures. MAIN OUTCOME MEASURES: Measures include estimates of the incidence of visual impairment and age-related eye disease (lens opacities, glaucoma and age-related macular degeneration) and the progression of eye disease (lens opacities and myopia) and associated risk factors. RESULTS: Of the 7771 respondents examined in rural areas in Andhra Pradesh Eye Disease Study 1, 5447 (70.1%) participants were traced in Andhra Pradesh Eye Disease Study 2. These participants will be re-examined. CONCLUSIONS: Andhra Pradesh Eye Disease Study 3 will provide data on the incidence and progression of visual impairment and major eye diseases and their associated risk factors in India. The study will provide further evidence to aid planning eye care services.

Prevalence of refractive errors among school-going children in a multistate study in India.

AIM: Much existing data on childhood refractive error prevalence in India were gathered in local studies, many now dated. The aim of this study was to estimate the prevalence, severity and determinants of refractive errors among school-going children participating in a multistate vision screening programme across India. METHODS: In this cross-sectional study, vision screening was conducted in children aged 5-18 years at schools in five states using a pocket vision screener. Refractive error was measured using retinoscopy, and subjective refraction and was defined both by spherical equivalent (SE) and spherical ametropia, as myopia ≤-0.5 diopters (D), hyperopia ≥+1.0 D and/or astigmatism as >0.5 D. Data from the eye with less refractive error were used to determine prevalence. RESULTS: Among 2 240 804 children (50.9% boys, mean age 11.5 years, SD ±3.3), the prevalence of SE myopia was 1.57% (95% CI 1.54% to 1.60%) at 5-9 years, 3.13% (95% CI 3.09% to 3.16%) at 10-14 years and 4.8% (95% CI 4.73% to 4.86%) at 15-18 years. Hyperopia prevalence was 0.59% (95% CI 0.57% to 0.61%), 0.54% (95% CI 0.53% to 0.56%) and 0.39% (95% CI 0.37% to 0.41%), respectively. When defined by spherical ametropia, these values for myopia were 0.84%, 2.50% and 4.24%, and those for hyperopia were 2.11%, 2.41% and 2.07%, respectively.Myopia was associated with older age, female gender, private school attendance, urban location and state. The latter appeared to be driven by higher literacy rates. CONCLUSIONS: Refractive error, especially myopia, is common in India. Differences in prevalence between states appear to be driven by literacy rates, suggesting that the burden of myopia may rise as literacy increases.

Family-led rehabilitation in India (ATTEND)-Findings from the process evaluation of a randomized controlled trial.

BACKGROUND: Training family carers to provide evidence-based rehabilitation to stroke patients could address the recognized deficiency of access to stroke rehabilitation in low-resource settings. However, our randomized controlled trial in India (ATTEND) found that this model of care was not superior to usual care alone. AIMS: This process evaluation aimed to better understand trial outcomes through assessing trial implementation and exploring patients', carers', and providers' perspectives. METHODS: Our mixed methods study included process, healthcare use data and patient demographics from all sites; observations and semi-structured interviews with participants (22 patients, 22 carers, and 28 health providers) from six sampled sites. RESULTS: Intervention fidelity and adherence to the trial protocol was high across the 14 sites; however, early supported discharge (an intervention component) was not implemented. Within both randomized groups, some form of rehabilitation was widely accessed. ATTEND stroke coordinators provided counseling and perceived that sustaining patients' motivation to continue with rehabilitation in the face of significant emotional and financial stress as a key challenge. The intervention was perceived as an acceptable community-based package with education as an important component in raising the poor awareness of stroke. Many participants viewed family-led rehabilitation as a necessary model of care for poor and rural populations who could not access rehabilitation. CONCLUSION: Difficulty in sustaining patient and carer motivation for rehabilitation without ongoing support, and greater than anticipated access to routine rehabilitation may explain the lack of benefit in the trial. Nonetheless, family-led rehabilitation was seen as a concept worthy of further development.

Statistical analysis plan for the family-led rehabilitation after stroke in India (ATTEND) trial: A multicenter randomized controlled trial of a new model of stroke rehabilitation compared to usual care.

Background In low- and middle-income countries, few patients receive organized rehabilitation after stroke, yet the burden of chronic diseases such as stroke is increasing in these countries. Affordable models of effective rehabilitation could have a major impact. The ATTEND trial is evaluating a family-led caregiver delivered rehabilitation program after stroke. Objective To publish the detailed statistical analysis plan for the ATTEND trial prior to trial unblinding. Methods Based upon the published registration and protocol, the blinded steering committee and management team, led by the trial statistician, have developed a statistical analysis plan. The plan has been informed by the chosen outcome measures, the data collection forms and knowledge of key baseline data. Results The resulting statistical analysis plan is consistent with best practice and will allow open and transparent reporting. Conclusions Publication of the trial statistical analysis plan reduces potential bias in trial reporting, and clearly outlines pre-specified analyses. Clinical Trial Registrations India CTRI/2013/04/003557; Australian New Zealand Clinical Trials Registry ACTRN1261000078752; Universal Trial Number U1111-1138-6707.