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

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

The Proportion of Randomized Controlled Trials That Inform Clinical Practice: A Longitudinal Cohort Study of Trials Registered on ClinicalTrials.gov

“…14,21–23 The fraction of trials at low risk of bias is similar to prior estimates. 8,24,25 Our estimate for the fraction of studies fulfilling reporting requirements (90.0%) is in line with prior studies that evaluated both ClinicalTrials.gov results deposition and publication, 26,27 both of which were deemed acceptable means of results reporting in our study. To our knowledge, our study is the first to apply these conditions jointly to a sample of trials, in addition to assessing importance via citation in clinical synthesizing documents.…”

A systematic review of the quality of conduct and reporting of survival analyses of tuberculosis outcomes in Africa

“…These deficiencies may lead to bias in reported measures of effect estimates and inaccurate conclusions. These are not isolated findings, as previous studies focusing on the quality of reporting SAMs [1,16,17,19,20], observational studies [63,64] and even clinical trials [22,65,66] Fig. 2 Trend of the annual number of papers using SAMs from 2010 to 2019.…”

“…All reviews identified significant deficiencies in reporting SAMs including non-reporting of sample size estimation and testing of the PH assumption in the CPH regression models. In addition, there have been reports of inadequate and incomplete reporting of randomized trials and studies on infectious diseases without statisticians/epidemiologists in Africa [ 21 , 22 ].…”

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

“…In the original publication [ 1 ] the last sentence in the last paragraph under ‘Perspectives and implications’ in the Discussions section needs to be removed. The correct version can be found in this Erratum.…”