Avoidable waste related to inadequate methods and incomplete reporting of interventions: a systematic review of randomized trials performed in Sub-Saharan AfricaReport as inadecuate




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Trials

, 18:291

First Online: 05 July 2017Received: 07 December 2016Accepted: 17 May 2017

Abstract

BackgroundRandomized controlled trials RCTs are needed to improve health care in Sub-Saharan Africa SSA. However, inadequate methods and incomplete reporting of interventions can prevent the transposition of research in practice which leads waste of research. The aim of this systematic review was to assess the avoidable waste in research related to inadequate methods and incomplete reporting of interventions in RCTs performed in SSA.

MethodsWe performed a methodological systematic review of RCTs performed in SSA and published between 1 January 2014 and 31 March 2015. We searched PubMed, the Cochrane library and the African Index Medicus to identify reports. We assessed the risk of bias using the Cochrane Risk of Bias tool, and for each risk of bias item, determined whether easy adjustments with no or minor cost could change the domain to low risk of bias. The reporting of interventions was assessed by using standardized checklists based on the Consolidated Standards for Reporting Trials, and core items of the Template for Intervention Description and Replication. Corresponding authors of reports with incomplete reporting of interventions were contacted to obtain additional information. Data were descriptively analyzed.

ResultsAmong 121 RCTs selected, 74 61% evaluated pharmacological treatments PTs, including drugs and nutritional supplements; and 47 39% nonpharmacological treatments NPTs 40 participative interventions, 1 surgical procedure, 3 medical devices and 3 therapeutic strategies. Overall, the randomization sequence was adequately generated in 76 reports 62% and the intervention allocation concealed in 48 39%. The primary outcome was described as blinded in 46 reports 38%, and incomplete outcome data were adequately addressed in 78 64%. Applying easy methodological adjustments with no or minor additional cost to trials with at least one domain at high risk of bias could have reduced the number of domains at high risk for 24 RCTs 19%. Interventions were completely reported for 73-121 60% RCTs: 51-74 68% of PTs and 22-47 46% of NPTs. Additional information was obtained from corresponding authors for 11-48 reports 22%.

ConclusionInadequate methods and incomplete reporting of published SSA RCTs could be improved by easy and inexpensive methodological adjustments and adherence to reporting guidelines.

KeywordsSub-Saharan Africa Randomized controlled trials Risk of bias Reporting Research implementation AbbreviationsAHILAAssociation for Health Information and Libraries in Africa

AIMAfrican Index Medicus

CONSORTConsolidated Standards of Reporting Trials

EQUATOREnhancing the QUAlity and Transparency Of health Research

HICsHigh-income countries

HIV-AIDSHuman immunodeficiency virus-acquired immunodeficiency syndrome

IQRInterquartile range

NPTsNonpharmacological treatments

PTsPharmacological treatments

RCTRandomized controlled trial

RoBRisk of bias

SSASub-Saharan Africa

TIDieRTemplate for Intervention Description and Replication

WHOWorld Health Organization

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-017-2034-0 contains supplementary material, which is available to authorized users.

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Author: Lee Aymar Ndounga Diakou - Francine Ntoumi - Philippe Ravaud - Isabelle Boutron

Source: https://link.springer.com/







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