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A systematic review of the quality of trials evaluating biomedical HIV prevention interventions shows that many lack power.

ABSTRACT: PURPOSE:Several randomized, controlled trials (RCTs) have tested strategies to prevent sexual acquisition of HIV infection, but their quality has been variable. We aimed to identify, describe, and evaluate the quality of RCTs studying biomedical interventions to prevent HIV acquisition by sexual transmission. METHOD:We conducted a systematic review to identify all RCTs evaluating the efficacy of biomedical HIV prevention interventions. We assessed seven generic and content-specific quality components important in HIV prevention trials, factors influencing study power, co-interventions provided, and trial ethics. RESULTS:We identified 26 eligible RCTs. The median number of quality components judged to be in adequate or unclear was 3 (range 1-4) in 1992-1998, 3 (range 1-4) in 1999-2003, and 0 (range0-2) in 2004-2008 (p < .001). Common problems that may have biased results included low retention (median 84%), poor adherence to interventions requiring on going use (median < or =78%), and lower HIV incidence than expected a priori (in 8 of 11 trials where evaluable). CONCLUSION:Reporting of trials of biomedical HIV prevention interventions has improved over time. However, quality improvement is needed in several key areas that influence study power, including participant retention, adherence to interventions, and estimation of expected HIV incidence.

SUBMITTER: Graham SM

PROVIDER: S-EPMC3086665 | biostudies-literature | 2009 Nov-Dec

REPOSITORIES: biostudies-literature

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A systematic review of the quality of trials evaluating biomedical HIV prevention interventions shows that many lack power.

Graham Susan M SM Shah Prakesh S PS Aesch Zoë Costa-von ZC Beyene Joseph J Bayoumi Ahmed M AM

HIV clinical trials 20091101 6

<h4>Purpose</h4>Several randomized, controlled trials (RCTs) have tested strategies to prevent sexual acquisition of HIV infection, but their quality has been variable. We aimed to identify, describe, and evaluate the quality of RCTs studying biomedical interventions to prevent HIV acquisition by sexual transmission.<h4>Method</h4>We conducted a systematic review to identify all RCTs evaluating the efficacy of biomedical HIV prevention interventions. We assessed seven generic and content-specifi ...[more]

PMID: 20133272

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Project description:Computerised clinical decision support (CDS) can potentially better inform decisions, and it can help with the management of information overload. It is perceived to be a key component of a learning health care system. Despite its increasing implementation worldwide, it remains uncertain why the effect of CDS varies and which factors make CDS more effective.To examine which factors make CDS strategies more effective on a number of outcomes, including adherence to recommended practice, patient outcome measures, economic measures, provider or patient satisfaction, and medical decision quality.We identified randomised controlled trials, non-randomised trials, and controlled before-and-after studies that directly compared CDS implementation with a given factor to CDS without that factor by searching CENTRAL, MEDLINE, EMBASE, and CINAHL and checking reference lists of relevant studies. We considered CDS with any objective for any condition in any healthcare setting. We included CDS interventions that were either displayed on screen or provided on paper and that were directed at healthcare professionals or targeted at both professionals and patients. The reviewers screened the potentially relevant studies in duplicate. They extracted data and assessed risk of bias in independent pairs or individually followed by a double check by another reviewer. We summarised results using medians and interquartile ranges and rated our certainty in the evidence using the GRADE system.We identified 66 head-to-head trials that we synthesised across 14 comparisons of CDS intervention factors. Providing CDS automatically versus on demand led to large improvements in adherence. Displaying CDS on-screen versus on paper led to moderate improvements and making CDS more versus less patient-specific improved adherence modestly. When CDS interventions were combined with professional-oriented strategies, combined with patient-oriented strategies, or combined with staff-oriented strategies, then adherence improved slightly. Providing CDS to patients slightly increased adherence versus CDS aimed at the healthcare provider only. Making CDS advice more explicit and requiring users to respond to the advice made little or no difference. The CDS intervention factors made little or no difference to patient outcomes. The results for economic outcomes and satisfaction outcomes were sparse.Multiple factors may affect the success of CDS interventions. CDS may be more effective when the advice is provided automatically and displayed on-screen and when the suggestions are more patient-specific. CDS interventions combined with other strategies probably also improves adherence. Providing CDS directly to patients may also positively affect adherence. The certainty of the evidence was low to moderate for all factors.PROSPERO, CRD42016033738.

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A systematic review of the quality of trials evaluating biomedical HIV prevention interventions shows that many lack power.

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A systematic review of the quality of trials evaluating biomedical HIV prevention interventions shows that many lack power.

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