Inadequate methods and incomplete reporting lead to waste of research in Sub-Saharan Africa

系统评价published todayin试验looks at 121 randomized control trials (RCTs) performed in Sub-Saharan Africa (SSA) in order to find ways to reduce research waste, a major problem in an area with limited research resources. Here to tell us about the findings and how the value of RCTs in SSA can be improved is author of the study, Lee Aymar Ndounga Diakou.

Sub-Saharan Africa (SSA) is defined as the region of the African continent excluding Maghreb countries. In that area extensively characterized by a burden of disease due to both tropical infections and chronic or non-communicable diseases, research is needed to improve health status of the local population.

In the context of biomedical research, randomized controlled trial (RCT) is the gold standard for evaluating the effectiveness or harms of health care interventions, including drugs or non-pharmacological treatments (surgery, implementable devices, physical exercises etc.).

However, we know that because of constrained resources, few RCTs are carried out in SSA compared to high-income countries (HICs).

In 2009,Ian Chalmers and colleagues表明,约有85%的生物医学研究投资,即2010年的2000亿美元投资被浪费了。

In a previous study published in theJournal of Clinical Epidemiology(JCE),我和我的同事们表明,SSA RCT专注于SSA的高负担疾病,但经常由HIC资助和领导。这项研究提出了有关SSA研究自治的重要辩论,并暗示是一个长期目标,这是当地利益相关者和社区组织的更大参与。

此外,2009年Ian Chalmers and colleagues表明,约有85%的生物医学研究投资,即2010年的2000亿美元投资被浪费了。这尤其发生在进行研究以及不完整或无法使用的研究报告中。

In addition,Yordanov及其同事证明大多数不足的方法(即导致缺陷偏见的高风险的方法)可以通过应用无需或仅较小的成本(即试验总成本的≤5%)来纠正。

I believe that waste of research related to inadequate methods or an incomplete reporting of SSA RCTs must be avoided because of the shortage of research resources in that area. This means that SSA RCTs should genuinely minimize risk of bias related to its inherent methods (i.e., randomization procedure, allocation concealment, blinding, and incomplete outcome assessment). Equally, reports interventions evaluated should be used in current clinical practice to bridge the gap with research.

评估方法不足和干预措施报告不佳

In our study published in试验我们根据2014年1月至2015年3月发布的121个SSA RCT的样本进行了系统的审查,并以前包括在JCE研究中。我们的目标是评估方法不足以及如何完全评估的医疗干预措施。

我们通过包括PubMed,Cochrane图书馆和非洲指数Medicus在内的三个数据库确定了SSA RCT的报告。为了评估这两个方法学方面,我们分别使用Cochrane risk of bias toolthat assesses the risk of bias as being high, low or unclear; and the配偶指南(consolidated standards of reporting trials) or the清单清单(template for intervention description and replication).

The results highlighted that applying simple methodological adjustments with no or minor cost could have avoided a high risk of bias in 24 RCTs (19%).

The results highlighted that applying simple methodological adjustments with no or minor cost could have avoided a high risk of bias in 24 RCTs (19%). These adjustments included for example a computer random number generator, sequentially numbered opaque sealed envelopes, and an intention to treat analysis, respectively related the randomization and the allocation concealment procedures, as well as the incomplete outcome data.

关于干预措施的报告,最描述的方面主要涉及非药理学干预措施,包括所涉及的实际程序或技术的测序,所使用的物理或信息材料以及护理提供者的背景。

Additional information requested to authors of incomplete RCT reports overall improved the completeness of the intervention description from 60 to 69% (i.e. an avoidable waste of 9%). Interventions published in journals requiring adherence to the CONSORT guidelines were more completely described than those published in journals not requiring any one reporting guidelines (62% vs 51%).

In summary, to increase the value of SSA RCTs, we must help local investigators to be informed of the feasibility of easy and inexpensive methods and publishers to use reporting guidelines when planning their RCTs or drafting their reports. Indeed, this will limit flaws in methods and poor reporting of interventions at an early stage.

查看latest posts on the On Medicine homepage

注释