Abstract
BackgroundA substantial proportion of the psychiatric burden of disease falls on the world's poorest nations. Despite this, relatively little is known about the quality and content of clinical research undertaken in these countries, or the relevance of the interventions evaluated and specifically that of randomised trials.This project aims to survey the content, quality and accessibility of a sample of trials relevant to mental health conducted within low and middle-income countries; to compare these with studies conducted in high-income countries; and to assess their relevance for the needs of low and middle-income countries.MethodsAn extensive search for all trials, or possible trials, published in 1991, 1995 and 2000 with participants in low and middle-income countries has already been conducted. Studies evaluating prevention or treatment of a mental health problem within these three years will be identified and further searches conducted to assess completeness of the initial search. Data on study quality and characteristics will be extracted from each report. Accessibility will be estimated based on whether each citation is available on MEDLINE. Trials relevant to schizophrenia will be compared with a random sample of schizophrenia trials from high-income countries in the same years. Topics covered by the trials will be compared with the estimated burden of disease.ConclusionTrials and systematic reviews of trials are the gold standard of evaluation of care and increasingly provide the basis for recommendations to clinicians, to providers of care and to policy makers. Results from this study will present the first assessment of the scope, quality and accessibility of mental health trials in low and middle-income countries.
Highlights
A substantial proportion of the psychiatric burden of disease falls on the world's poorest nations
According to the World Health Organisation (WHO) "Most low/middle income countries devote less than 1% of their health expenditure to mental health
10% of the total spent on health research is directed towards the diseases which are responsible for 90% of the global burden of disease [6]
Summary
The search for randomised trials, or possible randomised trials, relevant to health care, with participants from low and/or middle income countries and published in the years 1991, 1995 or 2000 was performed for the main Practihc project. The purpose is to assess the completeness of the original search and identify any reports missed This is thought to be a more useful strategy than checking reference lists of eligible articles which are less likely to have come from low or middle income countries and are less likely to have come from the sample year. Analyses The following analyses will be conducted (for detailed dummy tables see Additional File 6): Studies will be described in terms of type of report, country of first author, country/ies of recruitment, language of full report, age of participants, sex of participants, problems being addressed, main aims, number randomised, type of intervention, setting of interventions, site of intervention, duration of intervention, follow up duration, funding source, funding country, ethics approval, consent, concealment of allocation, sequence generation, blinding, number of participants with outcome data and types of outcome and accessibility (tables 1–24). Results from this study will present the first assessment of the scope, quality and accessibility of mental health trials in low and middle-income countries
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