Informed consent in Sri Lanka: A survey among ethics committee members

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>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.</p> <p>Conclusion</p> <p>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.</p

Understanding the explanatory model of the patient on their medically unexplained symptoms and its implication on treatment development research: a Sri Lanka Study

<p>Abstract</p> <p>Background</p> <p>Patients with medically unexplained symptoms (MUS) are often distressed, disabled and dissatisfied with the care they receive. Illness beliefs held by patients have a major influence on the decision to consult, persistence of symptoms and the degree of disability. Illness perception models consist of frameworks to organise information from multiple sources into distinct but interrelated dimensions: identity (the illness label), cause, consequences, emotional representations perceived control and timeline.</p> <p>Our aim was to elicit the illness perceptions of patients with MUS in Sri Lankan primary care to modify and improve a CBT intervention.</p> <p>Method</p> <p>An intervention study was conducted in a hospital primary care clinic in Colombo, Sri Lanka using CBT for MUS. As a part of the baseline assessment, qualitative data was collected using; the Short Explanatory Model Interview (SEMI), from 68 patients (16–65 years) with MUS. We categorised the qualitative data in to key components of the illness perception model, to refine CBT intervention for a subsequent larger trial study.</p> <p>Results</p> <p>The cohort was chronically ill and 87% of the patients were ill for more than six months (range six months to 20 years) with 5 or more symptoms and 6 or more visits over preceding six months. A majority were unable to offer an explanation on identity (59%) or the cause (56%), but in the consequence domain 95% expressed significant illness worries; 37% believed their symptoms indicated moderately serious illness and 58% very serious illness. Reflecting emotional representation, 33% reported fear of death, 20% fear of paralysis, 13% fear of developing cancer and the rest unspecified incurable illness. Consequence and emotional domains were significant determinants of distress and consultations. Their repeated visits were to seek help to alleviate symptoms. Only a minority expected investigations (8.8 %) or diagnosis (8.8%). However, the doctors who had previously treated them allegedly concentrated more on identity than cause. The above information was used to develop simple techniques incorporating analogies to alter their perceptions</p> <p>Conclusion</p> <p>The illness perception model is useful in understanding the continued distress of patients with persistent symptoms without an underlying organic cause. Hence it can make a significant contribution when developing and evaluating culturally sensitive patient friendly interventions.</p

Common mental disorders among adult members of 'left-behind' international migrant worker families in Sri Lanka

BACKGROUND: Nearly one-in-ten Sri Lankans are employed abroad as International migrant workers (IMW). Very little is known about the mental health of adult members in families left-behind. This study aimed to explore the impact of economic migration on mental health (common mental disorders) of left-behind families in Sri Lanka. METHODS: A cross-sectional survey using multistage sampling was conducted in six districts (representing 62% of outbound IMW population) of Sri Lanka. Spouses and non-spouse caregivers (those providing substantial care for children) from families of economic migrants were recruited. Adult mental health was measured using the Patient Health Questionnaire. Demographic, socio-economic, migration-specific and health utilization information were gathered. RESULTS: A total of 410 IMW families were recruited (response rate: 95.1%). Both spouse and a non-spouse caregiver were recruited for 55 families with a total of 277 spouses and 188 caregivers included. Poor general health, current diagnosed illness and healthcare visit frequency was higher in the non-spouse caregiver group. Overall prevalence of common mental disorder (CMD; Depression, somatoform disorder, anxiety) was 20.7% (95%CI 16.9-24.3) with 14.4% (95%CI 10.3-18.6) among spouses and 29.8% (95%CI 23.2-36.4) among non-spouse caregivers. Prevalence of depression (25.5%; 95%CI 19.2-31.8) and somatoform disorder 11.7% (95%CI 7.0-16.3) was higher in non-spouse caregiver group. When adjusted for age and gender, non-returning IMW in family, primary education and low in-bound remittance frequency was associated with CMD for spouses while no education, poor general health and increased healthcare visits was significantly associated in the non-spouse caregiver group. CONCLUSIONS: To our knowledge, this is one of the first studies to explore specific mental health outcomes among adult left-behind family members of IMW through standardized diagnostic instruments in Sri Lanka and in South Asian region. Negative impact of economic migration is highlighted by the considerably high prevalence of CMD among adults in left-behind families. A policy framework that enables health protection whilst promoting migration for development remains a key challenge for labour-sending nations

TREND IN USAGE OF CFC'S IN SRI LANKA AND PHASE OUT UNDER MONTREAL PROTOCOL

With the development of halogenated hydrocarbons by E.I.Du Pont deNemours &amp; Co (USA) as refrigerants, there had been an increase in usage ofthese chloroflurocarbons (CFCs) in refrigeration applications worldwidesince 1950, mainly because these substances have excellent thermodynamicand safety characteristics. In Sri Lanka the consumption of CFC wasincreased rapidly up to 1995 (Table 1). Scientists had discovered the effectsof CFCs on the earth's ozone layer in nineteen seventies and it was agreed bylarge number of countries to phase out the production and usage of CFCs bybecoming party to the Montreal Protocol. The Montreal Protocol on OzoneDepleting Substances (ODS) was signed in 1987 to implement the phase outprogramme. Sri Lanka became a party to this Protocol in 1989 and is boundto implement phase out ODSs by dates. specified by the Protocol. In order toreach that target, National Ozone Unit (NOU) was established in the Ministryof Environment and Natural Resources in 1994. NOU has implementedseveral projects in order to reduce consumption of CFC with the assistance ofMultilateral Fund (MLF) of the Protocol.Sri Lanka has introduced a licensing system in 1998 to control the imports ofCFCs and so far achieved successful reduction of CFC consumption. Thetable 1 shows the downward trend of CFC consumption as a result of actiontaken by the NOU. As an Article 5 country under the Montreal Protocol SriLanka need to phase out CFC consumption by 2010. However, Sri Lanka hastaken steps to phase out CFC by the end of 2007.To achieve phase out as planned, three refrigerator manufacturers werefunded to con vert from CFC -11 to HCFC -141 b and from CFC 12 to R 134a,converted an aerosol manufacturing plant from CFC 12 to Hydrocarbons andlaunched a scheme to pay incentives for converting CFC refrigeration plants to non-Cf'Cs. In addition the NOU has taken steps in awareness creation,training of refrigeration technicians and recovery and recycling of CFC. As aresult, consumption of CFC in the manufacturing sector has been phased outand remaining consumption in the servicing sector could be eliminatedthrough projects already planned.Apart from ozone layer depletion, CFCs are powerful greenhouse gases muchstronger than C02. Therefore it is important to reduce emission of CFC notonly to save the ozone layer but also to prevent global warming and climatechange.

The Colombo Twin and Singleton Follow-up Study: a population based twin study of psychiatric disorders and metabolic syndrome in Sri Lanka

BACKGROUND: The disease burden related to mental disorders and metabolic syndrome is growing in low-and middle-income countries (LMIC). The Colombo Twin and Singleton Study (COTASS) is a population-based sample of twins and singletons in Colombo, Sri Lanka. Here we present prevalence estimates for metabolic syndrome (metS) and mental disorders from a follow-up (COTASS-2) of the original study (COTASS-1), which was a mental health survey. METHODS: In COTASS-2, participants completed structured interviews, anthropometric measures and provided fasting blood and urine samples. Depressive disorder, depressive symptoms, anxiety symptoms, post-traumatic stress disorder (PTSD) and hazardous alcohol use were ascertained with structured psychiatric screens (Composite International Diagnostic Interview (CIDI), Beck Depression Inventory (BDI-II), Generalised Anxiety Disorder Questionnaire (GAD-7), PTSD Checklist - Civilian Version (PCL-C), and Alcohol Use Disorders Identification Test (AUDIT)). We defined metS according to the International Diabetes Federation (IDF) criteria and the revised National Cholesterol Education Programme Adult Treatment Panel (NCEP ATP III) criteria. We estimated the prevalence of psychiatric disorders and metS and metS components, and associations with gender, education and age. RESULTS: Two thousand nine hundred thirty-four twins and 1035 singletons were followed up from COTASS-1 (83.4 and 61.8% participation rate, respectively). Prevalence estimates for depressive disorder (CIDI), depressive symptoms (BDI ≥ 16), anxiety symptoms (GAD-7 ≥ 10) and PTSD (PCL-C DSM criteria) were 3.8, 5.9, 3.6, and 4.5% respectively for twins and 3.9, 9.8, 5.1 and 5.4% for singletons. 28.1 and 30.9% of male twins and singletons respectively reported hazardous alcohol use. Approximately one third met the metS criteria (IDF: 27.4% twins, 44.6% singletons; NCEP ATP III: 30.6% twins, 48.6% singletons). The most prevalent components were central obesity (59.2% twins, 71.2% singletons) and raised fasting blood glucose or diabetes (38.2% twins, 56.7% singletons). CONCLUSION: MetS was highly prevalent in twins, and especially high in singletons, whereas the prevalence of mental disorders was low, but consistent with local estimates. The high levels of raised fasting plasma glucose and central obesity were particularly concerning, and warrant national diabetes prevention programmes

The Sri Lankan twin registry biobank: South Asia's first twin biobank

Introduction: Biobanks are a valuable resource for creating advancements in science through cutting-edge omics research. Twin research methods allow us to understand the degree to which genetics and environmental factors contribute to health outcomes. Methods: The Sri Lankan Twin Registry biobank (SLTR-b) was established in 2015 as part of Colombo Twin and Singleton Follow-up Study. Venous blood and urine were collected from twins and comparative sample of singletons for clinical investigations and biobanking. Results: The SLTR-b currently houses 3369 DNA and serum samples. Biobank specimens are linked to longitudinal questionnaire data, clinical investigations, anthropometric measurements, and other data. Discussion: The SLTR-b aims to address gaps in health and genetics research. It will provide opportunities for academic collaborations, local and international, and capacity building of future research leaders in twin and omics research. This paper provides a cohort profile of the SLTR-b and its linked data, and an overview of the strategies used for biobanking

Genetic overlap between type 2 diabetes and depression in a Sri Lankan population twin sample.

OBJECTIVES: Results from twin studies examining the genetic overlap between type 2 diabetes and depression are currently inconclusive. This question has not been addressed in non-western populations. We aimed to examine whether there are common genetic factors between type 2 diabetes and depression in a Sri-Lankan population, using genetic model-fitting analysis. METHOD: The Colombo Twin and Singleton Study-Phase 2 consists of 2019 singletons, 842 monozygotic and 578 dizygotic twin-pairs. The primary outcomes were self-reported type 2 diabetes diagnosis and Beck Depression Inventory scores. Standard bivariate twin models were fitted to estimate the genetic and environmental (co)variance of type 2 diabetes and depression. RESULTS: In the best-fitting model, the phenotypic correlation between type 2 diabetes and depression was significant in females only (r=0.15 (0.08-0.21)). This association was primarily attributed to a significant genetic correlation between the traits (rA=0.53 (0.19-0.98)). CONCLUSIONS: In females, but not males, we found a significant genetic overlap between type 2 diabetes and depression in the context of a modest phenotypic correlation

Environmental exposures and their genetic or environmental contribution to depression and fatigue: a twin study in Sri Lanka

Background There is very little genetically informative research identifying true environmental risks for psychiatric conditions. These may be best explored in regions with diverse environmental exposures. The current study aimed to explore similarities and differences in such risks contributing to depression and fatigue. Methods Home interviews assessed depression (lifetime-ever), fatigue and environmental exposures in 4,024 randomly selected twins from a population-based register in the Colombo district of Sri Lanka. Results Early school leaving and standard of living showed environmentally-mediated effects on depression, in men. In women, life events were associated with depression partly through genetic pathways (however, the temporal order is consistent with life events being an outcome of depression, as well as the other way around). For fatigue, there were environmentally mediated effects (through early school leaving and life events) and strong suggestions of family-environmental influences. Conclusions Compared to previous studies from higher-income countries, novel environmentally-mediated risk factors for depression and fatigue were identified in Sri Lanka. But as seen elsewhere, the association between life events and depression was partially genetically mediated in women. These results have implications for understanding environmental mechanisms around the world