1. Methodological quality of malaria RCTs conducted in Africa Vittoria Lutje*^, Annette Gerritsen**, Nandi Siegfried***. *Cochrane Infectious Diseases Group (CIDG), Liverpool, UK; **Department of Public Health, University of Venda, Thohoyandou, South Africa *** South African Cochrane Centre, Medical Research Council, CapeTown, South Africa. ^ Corresponding author, email: vlutje@liv.ac.uk Malaria RCTs conducted in African countries were identified through systematic searches of electronic databases (Medline, Embase, CENTRAL, LILACS) run in August 2007. From the total abstract dataset we extracted key characteristics on each trial and then drew a random sample of these. Reports of RCTs in the random sample were analysed using a standardized data extraction form. We evaluated trial reports published between 1997 and 2007 for risk of bias according to 4 domains (randomized sequence generation, allocation concealment, blinding, and loss to follow-up). Methods Good methodological quality is necessary to reduce risk of bias (RoB) in randomized controlled trials (RCTs) and in meta-analysis. As part of a review of clinical and methodological characteristics of malaria RCTs conducted in Africa, we assessed RoB of trials conducted after the publication of the original CONSORT statement in 1996 (1). This was a novel analysis that can highlight training needs for clinicians conducting trials in potentially resource-limited settings. Background Risk of bias of malaria RCTs run in Africa between 1997 and 2007 The quality of African malaria trials reports was not consistent among the 4 domains analysed: a large proportion of RCTs had a high risk of bias for blinding and allocation concealment, but loss to follow-up was mostly adequately reported. Methods of randomization were adequate in most reports. Suboptimal reporting of methodological characteristics has been widely reported for trials in different healthcare areas, potentially affecting the validity of the results and the estimate of treatment effects. A high RoB is not only associated with trials conducted in resource- poor settings or with older trials: recent RCTs have often been found to be also poorly reported. There is still a need for education about the CONSORT statement. Prospective registration of trials and detailed instructions to trialists may help. Conclusions To analyse the RoB of malaria RCTs conducted in Africa between 1997 and 2007, according to 4 characteristics (sequence generation, allocation concealment, blinding, and loss to follow-up). Objectives Results We identified 943 reports of malaria trials run in Africa from 1948 to 2007, and we drew a random sample of 176 records. Trial key characteristics in the sample were representative of the overall dataset. The geographical distribution of the trials is shown in Fig 1; main clinical characteristics of the trials are reported elsewhere (2). There were 60 RCTs published between 1997 and 2007 and included in the Risk of bias analysis (Table 1). Sequence generation was considered adequate (done by using a random numbers table or electronically generated) in 35 reports. It was not clearly reported in 21 trials. Many RCTs reports did not mention methods of allocation concealment or whether participants or intervention providers were blinded. In contrast, loss to follow-up was accounted for in most trial reports (49 out of 60). Country distribution of malaria RCTs Acknowledgements: This work was supported by the Cochrane Infectious Diseases Group and Effective Health Care Research Programme Consortium (at LSTM) funded by the Department for International Development UK (DFID); and the PACTR grant funded by the European and Developing Countries Clinical Trials Partnership (EDCTP). AdequateNot adequate UnclearNot doneNot possible Sequence generation 3532100 Allocation concealment 14036100 Blinding2302782 Loss to follow up 4901100 References 1.Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al (1996). Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 276: 637-9. 2.Lutje V, Gerritsen A, Siegfried N (2011). Randomized controlled trials of malaria intervention trials in Africa, 1948 to 2007: a descriptive analysis. Malaria Journal 10:61