Reporting quality of randomized controlled trials in patients with HIV on antiretroviral therapy: a systematic review

Abstract

BackgroundTo allow for correct evaluation of clinical trial results, readers require comprehensive, clear, and highly transparent information on the methodology used and the results obtained. This study aimed to evaluate the quality of reporting in articles on randomized controlled trials (RCTs) of antiretroviral therapy (ART) in the field of HIV/AIDS.MethodsWe searched for original articles on RCTs of ART developed in the field of HIV/AIDS in PubMed database by 5 April 2016. Searched articles were divided into three groups based on the revision year in which the Consolidated Standards of Reporting Trials (CONSORT) guidelines were published: Period 1 (1996–2001); Period 2 (2002–2010); and Period 3 (2011–2016). We evaluated the articles using the reporting rates of the 37 items in the CONSORT 2010 checklist, five items in the protocol deviation, and the three items in the ethics.ResultsFifty-two articles were extracted and included in this study. Many of the reporting rates calculated using the CONSORT 2010 checklist showed a significantly increasing trend over the successive periods (65% in Period 1, 67% in Period 2, 79% in Period 3; p < 0.0001). The items with reporting rates < 50% were “the presence or absence of a protocol change and the reason for such a change,” “randomization and blinding,” and “where the full trial protocol can be accessed.” Reporting rates of deviations were as low as < 30%, while the reporting rates for patient compliance were the highest (>80% in Period 3) among the five items. The reporting rates for obtaining informed consent and approval by the ethics committee or institutional review board were high (>88%), regardless of the time period assessed.ConclusionIn terms of representative RCT articles in the field of HIV/AIDS, the reporting rate of the items defined by CONSORT was approximately 70%, improving over the successive CONSORT statement revision periods.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2360-2) contains supplementary material, which is available to authorized users.

Risk of Bias in Iranian Randomized Trials Included in Cochrane Reviews

“…Research generally suggests inadequately-performed blinding in the RCTs conducted in Iran and other countries. 15,33,35 Low RoB was assigned to attrition bias in 56.3% of cases, suggesting a small number of patients failing to follow up in the Iranian RCTs. In line with studies assessing Iranian RCTs in this domain, the present study found that Iranian researchers are relatively successful in providing data on the patients withdrawing from the study.…”

The Risk of Bias in Iranian Randomized Controlled Trials Included in Cochrane Reviews

“…One-third of the studies were also evaluated as low-risk in terms of detection bias, which can be explained by the unwillingness of Iranians to participate in completely-blinded trials and failure to report the study details, which made it di cult for the reviewers to assess bias. Research generally suggests inadequately-performed blinding in the RCTs conducted in Iran and other countries [15,29,30].…”

The Risk of Bias in Iranian Randomized Controlled Trials Included in Cochrane Reviews

“…Other studies which evaluated Iranian or RCTs from other countries have also pointed out that blinding is usually not adequately performed. 15, 28, 29…”