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

Abstract

Background: Randomized 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.

Methods: We 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.

Results: Among 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%).

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

Keywords: Randomized controlled trials; Reporting; Research implementation; Risk of bias; Sub-Saharan Africa.

Fig. 1

Flow diagram

Fig. 2

Risk of bias in 121 randomized controlled trials (RCTs) performed in Sub-Saharan Africa. Initial risk of bias (a) and risk of bias after applying easy methodological adjustments with no or minor additional cost (b). Vertical bars represent domains assessed according the Risk of Bias tool of the Cochrane Collaboration

Fig. 3

Reporting of interventions evaluated in randomized controlled trials (RCTs) performed in Sub-Saharan African (n = 121). Pharmacological treatments, n = 74 RCTs (a) and nonpharmacological treatments, n = 47 RCTs (b). For both type of interventions, the percentage of interventions rated as completely reported for each item in initial trial reports is illustrated in blue. The additional percentage after author reply is in green. (*) items assessed only for participative interventions. (#) items assessed only for devices or surgical procedures