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An assessment of randomized controlled trials (RCTs) for non-communicable diseases (NCDs): more and higher quality research is required in less developed countries.

ABSTRACT: Research is crucial to implement evidence-based health interventions for control of non-communicable diseases (NCDs). This study aims to assess main features of randomized controlled trials (RCTs) for control of NCDs, and to identify gaps in clinical research on NCDs between high-income and less developed countries. The study included 1177 RCTs in 82 Cochrane Systematic reviews (CSRs) and evaluated interventions for adults with hypertension, diabetes, stroke, or heart diseases. Multivariate logistic regression analyses were conducted to explore factors associated with risk of bias in included RCTs. We found that 78.2% of RCTs of interventions for major NCDs recruited patients in high-income countries. The number of RCTs included in the CSRs was increasing over time, and the increasing speed was more noticeable for RCTs conducted in middle-income countries. RCTs conducted in less developed countries tended to be more recently published, less likely to be published in English, with smaller sample sizes, and at a higher risk of bias. In conclusion, there is still a lack of research evidence for control of NCDs in less developed countries. To brace for rising NCDs and avoid waste of scarce research resources, not only more but also higher quality clinical trials are required in low-and-middle-income countries.

SUBMITTER: Fan H

PROVIDER: S-EPMC4642521 | biostudies-other | 2015

REPOSITORIES: biostudies-other

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Project description:ObjectiveTo compare treatment effects from randomised trials conducted in more developed versus less developed countries.DesignMeta-epidemiological study.Data sourcesCochrane Database of Systematic Reviews (August 2012).Data extractionMeta-analyses with mortality outcomes including data from at least one randomised trial conducted in a less developed country and one in a more developed country. Relative risk estimates of more versus less developed countries were compared by calculating the relative relative risks for each topic and the summary relative relative risks across all topics. Similar analyses were performed for the primary binary outcome of each topic.Results139 meta-analyses with mortality outcomes were eligible. No nominally significant differences between more developed and less developed countries were found for 128 (92%) meta-analyses. However, differences were beyond chance in 11 (8%) cases, always showing more favourable treatment effects in trials from less developed countries. The summary relative relative risk was 1.12 (95% confidence interval 1.06 to 1.18; P<0.001; I(2)=0%), suggesting significantly more favourable mortality effects in trials from less developed countries. Results were similar for meta-analyses with nominally significant treatment effects for mortality (1.15), meta-analyses with recent trials (1.14), and when excluding trials from less developed countries that subsequently became more developed (1.12). For the primary binary outcomes (127 meta-analyses), 20 topics had differences in treatment effects beyond chance (more favourable in less developed countries in 15/20 cases).ConclusionsTrials from less developed countries in a few cases show significantly more favourable treatment effects than trials in more developed countries and, on average, treatment effects are more favourable in less developed countries. These discrepancies may reflect biases in reporting or study design as well as genuine differences in baseline risk or treatment implementation and should be considers when generalising evidence across different settings.

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An assessment of randomized controlled trials (RCTs) for non-communicable diseases (NCDs): more and higher quality research is required in less developed countries.

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