Understanding of research: a Sri Lankan perspective.

BACKGROUND: Lack of proper understanding on the part of researchers about public understanding of research and informed consent will increase the potential for malpractice. As a part of a larger study on ethics and informed consent in Sri Lanka, this study aimed to ascertain the level of understanding of 'research' by exploring the views of the public and professionals. METHODS: Convenience sampling and snow ball technique were used for recruitment with an emphasis on balanced age and gender representation, diverse educational, socio-cultural and professional backgrounds, and previous research experience, either as researchers or participants. Content analysis of the data was carried out. RESULTS: 66 persons (37 males, 29 females) participated. Although fundamentally a qualitative study, themes were also quantitatively analysed for informative results. Most participants thought that the word 'research' meant searching, looking, inquiring while some others thought it meant gathering information, gaining knowledge and learning.A third of participants did not offer an alternative word for research. Others suggested the words survey, exploration, search, experiment, discovery, invention and study as being synonymous. Doctors, health professionals, health institutions, scientists, professionals, businessmen, pharmaceutical companies, students, teachers were identified as people who conduct research.Participants indicated that crucial information on deciding to participate in research included objectives of the research, project importance and relevance, potential benefits to individuals and society, credibility & legitimacy of researchers, what is expected of participant, reason for selection, expected outcome, confidentiality and ability to withdraw at any time. A majority (89%) expressed their willingness to participate in future research. CONCLUSIONS: The results show that with or without prior experience in research, participants in this study had a reasonable understanding of research. The findings show that a decision about taking part in research is dependent on knowledge, education and also on social networks.The results demonstrate that the majority were supportive of health research and believe that research is beneficial to the welfare of society.

Correction to: Systematic review and meta-analysis of diagnostic accuracy of detection of any level of diabetic retinopathy using digital retinal imaging.

Following publication of the original article [1], the authors reported an error in Fig. 4 in the PDF version. Figure 4 is the duplicate image of Fig. 3 and the correct figure is missing. The authors would like to apologize for this error. The correct figure is shown below.

Systematic review on barriers and enablers for access to diabetic retinopathy screening services in different income settings.

BACKGROUND: Diabetic retinopathy (DR) can lead to visual impairment and blindness if not detected and treated in time. Knowing the barriers/enablers in advance in contrasting different country income settings may accelerate development of a successful DR screening (DRS) program. This would be especially applicable in the low-income settings with the rising prevalence of DR. OBJECTIVES: The aim of this systematic review is to identify and contrast the barriers/enablers to DRS for different contexts using both consumers i.e., people with diabetes (PwDM) and provider perspectives and system level factors in different country income settings. METHODS: We searched MEDLINE, Embase, CENTRAL in the Cochrane Library from the databases start date to December 2018. We included the studies reported on barriers and enablers to access DRS services based at health care facilities. We categorised and synthesized themes related to the consumers (individuals), providers and the health systems (environment) as main dimensions according to the constructs of social cognitive theory, supported by the quantitative measures i.e., odds ratios as reported by each of the study authors. MAIN RESULTS: We included 77 studies primarily describing the barriers and enablers. Most of the studies were from high income settings (72.7%, 56/77) and cross sectional in design (76.6%, 59/77). From the perspectives of consumers, lack of knowledge, attitude, awareness and motivation were identified as major barriers. The enablers were fear of blindness, proximity of screening facility, experiences of vision loss and being concerned of eye complications. In providers' perspectives, lack of skilled human resources, training programs, infrastructure of retinal imaging and cost of services were the main barriers. Higher odds of uptake of DRS services was observed when PwDM were provided health education (odds ratio (OR) 4.3) and having knowledge on DR (OR range 1.3-19.7). CONCLUSION: Knowing the barriers to access DRS is a pre-requisite in development of a successful screening program. The awareness, knowledge and attitude of the consumers, availability of skilled human resources and infrastructure emerged as the major barriers to access to DRS in any income setting.

Colombo Twin and Singleton Study (CoTASS): a description of a population based twin study of mental disorders in Sri Lanka.

BACKGROUND: The Sri Lankan twin registry is one of the first to be established in a developing country, and its design has ensured sampling from a wide range of environmental conditions. It thus has great potential to examine environmental and genetic influences on diverse phenotypes, including psychiatric disorders, in the context of a diversity of environmental exposures, which may not have been fully explored in previous twin studies in developed countries. This paper presents the rationale for the study, describes its context, and the methods for twin ascertainment and data collection. METHODS: A population-based twin register was established in the Colombo district of Sri Lanka using infrastructure designed to periodically update the electoral register. We invited a subsample from this register to participate in the project on common mental disorders, using random ascertainment. A separate non-twin sample was randomly selected from the geographical areas where twins were found. Home interviewers collected diagnostic information on common mental disorders, as well as environmental exposures including life events, socio-economic conditions, and the impact of the civil war and the Tsunami of 2004. RESULTS: We identified 19,302 individuals in the creation of the population based twin register. We randomly selected a subsample, of whom 4,387 were eligible to participate and 4,024 agreed to be interviewed (including data on 1,954 complete pairs of twins and 5 sets of triplets). Those who refused consent had a similar mean age and sex ratio to those who were interviewed. We invited 2,485 singletons to participate and 2,019 were interviewed. CONCLUSION: Initial exploration of the data suggests the samples are very representative of the Colombo district of Sri Lanka, so we have created a unique resource for understanding the influences on mental disorders in developing countries, and to compare to the influences found in developed countries.

Informed consent in Sri Lanka: a survey among ethics committee members.

BACKGROUND: Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. METHODS: We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important. RESULTS: Twenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important. CONCLUSION: The number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed consent.

Systematic review and meta-analysis of diagnostic accuracy of detection of any level of diabetic retinopathy using digital retinal imaging.

BACKGROUND: Visual impairment from diabetic retinopathy (DR) is an increasing global public health concern, which is preventable with screening and early treatment. Digital retinal imaging has become a preferred choice as it enables higher coverage of screening. The aim of this review is to evaluate how different characteristics of the DR screening (DRS) test impact on diagnostic test accuracy (DTA) and its relevance to a low-income setting. METHODS: We conducted a systematic literature search to identify clinic-based studies on DRS using digital retinal imaging of people with DM (PwDM). Summary estimates of different sub-groups were calculated using DTA values weighted according to the sample size. The DTA of each screening method was derived after exclusion of ungradable images and considering the eye as the unit of analysis. The meta-analysis included studies which measured DTA of detecting any level of DR. We also examined the effect on detection from using different combinations of retinal fields, pupil status, index test graders and setting. RESULTS: Six thousand six hundred forty-six titles and abstracts were retrieved, and data were extracted from 122 potentially eligible full reports. Twenty-six studies were included in the review, and 21 studies, mostly from high-income settings (18/21, 85.7%), were included in the meta-analysis. The highest sensitivity was observed in the mydriatic greater than two field strategy (92%, 95% CI 90-94%). The highest specificity was observed in greater than two field methods (94%, 95% CI 93-96%) where mydriasis did not affect specificity. Overall, there was no difference in sensitivity between non-mydriatic and mydriatic methods (86%, 95% CI 85-87) after exclusion of ungradable images. The highest DTA (sensitivity 90%, 95% CI 88-91%; specificity 95%, 95% CI 94-96%) was observed when screening was delivered at secondary/tertiary level clinics. CONCLUSIONS: Non-mydriatic two-field strategy could be a more pragmatic approach in starting DRS programmes for facility-based PwDM in low-income settings, with dilatation of the pupils of those who have ungradable images. There was insufficient evidence in primary studies to draw firm conclusions on how graders' background influences DTA. Conducting more context-specific DRS validation studies in low-income and non-ophthalmic settings can be recommended.

Update from Sri Lankan Twin Registry: establishment of a population-based twin register and ongoing project on common mental disorders, alcohol abuse and suicidal ideations.

The Sri Lankan Twin Registry began as a volunteer register in 1997. Previously, we have shown door-to-door surveys as the best option to build a population-based twin register of older, adult twins. Our aim was to build a population-based twin register in the Colombo district and use it for twin studies on common mental disorders. We aimed to identify a random sample of 4000 twins ascertained through the twin census. The Colombo district is divided into 13 divisional secretariat divisions (DSDs) and each division is further divided into Grama Niladari divisions administratively. Grama niladaris (GNs) are civil servants and visit each household in order to update the electoral register. GNs were used to do a census of twins while they updated the electoral register. The correlation between population density and twin rate among DSDs was .81, and between twin rate and the percentage of returned forms (from each DSD) was .74. We received 9648 forms notifying about twins and multiples. After removing the duplicates and information about twins who live in other districts, there were 17,406 multiples remaining. After incorporating twins and multiples from various other feasibility studies we now have 19,040 multiples with 8.46 twins per 1000 people in the Colombo district.