African HIV/AIDS trials are more likely to report adequate allocation concealment and random generation than North American trials

dc.contributor.authorSiegfried, Nandien_ZA
dc.contributor.authorClarke, Michaelen_ZA
dc.contributor.authorVolmink, Jimmyen_ZA
dc.contributor.authorVan der Merwe, Lizeen_ZA
dc.identifier.citationSiegfried, N., Clarke, M., Volmink, J. & Van der Merwe, L. 2008. African HIV/AIDS trials are more likely to report adequate allocation concealment and random generation than North AmericantTrials. PLoS One, 3(10):1-11, doi:10.1371/journal.pone.0003491.en_ZA
dc.identifier.issn1932-6203 (online)
dc.descriptionThe original publication is available at http:/
dc.description.abstractBackground: Adherence to good methodological quality is necessary to minimise bias in randomised conrolled trials (RCTs). Specific trial characteristics are associated with better trial quality, but no studies to date are specific to HIV/AIDS or African trials. We postulated that location may negatively impact on trial quality in regions where resources are scarce. Methods: 1) To compare the methodological quality of all HIV/AIDS RCTs conducted in Africa with a random sample of similar trials conducted in North America; 2) To assess whether location is predictive of trial quality. We searched MEDLINE, EMBASE, CENTRAL and LILACS. Eligible trials were 1) randomized, 2) evaluations of preventive or treatment interventions for HIV/AIDS, 3) reported before 2004, and 4) conducted wholly or partly (if multi-centred) in Africa or North America. We assessed adequacy of random generation, allocation concealment and masking of assessors. Using univariate and multivariate logistic regression analyses we evaluated the association between location (Africa versus North America) and these domains. Findings: The African search yielded 12,815 records, from which 80 trials were identified. The North American search yielded 13,158 records from which 785 trials were identified and a random sample of 114 selected for analysis. African trials were three times more likely than North American trials to report adequate allocation concealment (OR = 3.24; 95%CI: 1.59 to 6.59; p<0.01) and twice as likely to report adequate generation of the sequence (OR = 2.36; 95%CI: 1.20 to 4.67; p = 0.01), after adjusting for other confounding factors. Additional significant factors positively associated with quality were an a priori sample size power calculation, restricted randomization and inclusion of a flow diagram detailing attrition. We did not detect an association between location and outcome assessor masking. Conclusions: The higher quality of reporting of methodology in African trials is noteworthy. Most African trials are externally funded, and it is possible that stricter agency requirements when leading trials in other countries and greater experience and training of principal investigators of an international stature, may account for this difference. © 2008 Siegfried et al.en_ZA
dc.format.extent11 p.
dc.publisherPublic Library of Science (PLOS)
dc.subjectAIDS (Disease) -- Research -- Africa -- Methodologyen_ZA
dc.subjectHIV infections -- Research -- Africa -- Methodologyen_ZA
dc.subjectAIDS (Disease) -- Research -- North America -- Methodologyen_ZA
dc.subjectHIV infections -- Research -- North America -- Methodologyen_ZA
dc.subjectClinical trials -- Africaen_ZA
dc.subjectClinical trials -- North Americaen_ZA
dc.titleAfrican HIV/AIDS trials are more likely to report adequate allocation concealment and random generation than North American trialsen_ZA
dc.description.versionPublishers' Version
dc.rights.holderAuthors retain the copyright

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