1 / 1

True methodological quality of trials are not reflected in their reporting

True methodological quality of trials are not reflected in their reporting Rahul Mhaskar , PhD, MPH, ¹ Anja Magazin 2 , Heloisa P. Soares 2 , Ambuj Kumar, MD, MPH, 1 Benjamin Djulbegovic, MD, PhD 1

madge
Download Presentation

True methodological quality of trials are not reflected in their reporting

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. True methodological quality of trials are not reflected in their reporting • Rahul Mhaskar, PhD, MPH,¹Anja Magazin2, Heloisa P. Soares2, Ambuj Kumar, MD, MPH,1 • Benjamin Djulbegovic, MD, PhD1 • University of South Florida College of Medicine, Center for Evidence-Based Medicine and Health Outcomes Research • Moffitt Cancer Center, Tampa, Florida • Biased results from poorly designed and reported randomized controlled trials (RCTs) can mislead decision making. • Whether publications accurately reflect the actual methodological quality of RCTs has not been comprehensively evaluated. • Additionally, it has been hypothesized that trial sample size is associated with better methodological quality. • The objective of this study was To compare the reported methodological quality of a RCT as reflected in publications with actual methodological quality as depicted in the protocols, and assess association of RCT sample size with published versus actual methodological quality. METHODS • All consecutive terminated phase III RCTs published by 8 National Cancer Institute sponsored Cooperative Groups until year 2006 were eligible for inclusion. • Two reviewers independently extracted data on methodological quality domains relevant to minimizing bias and random error were extracted from protocols and publications for each study. • The effect of methodological quality domains in RCTs on sample size was tested using Kruskal–Wallis one-way analysis of variance test. RESULTS • A total of 429 RCTs met the inclusion criteria. • Overall reporting of elements of methodological quality domains relevant to minimizing bias (figure 1A) and random error (figure 1B) was poor and did not reflect the actual high methodological quality of RCTs. • Similarly, the results showed a positive correlation between RCT sample size and reported methodological quality domains of adequacy of blinding procedures and the choice of the comparator (table 1). • However, this correlation disappeared when actual methodological quality was considered (table 2). Table 1 Figure 1 Table 2 CONCLUSIONS • This largest study to-date comparing published versus actual methodological quality of RCTs shows that poor quality of reporting by NCICOGs does not reflect the actual high methodological quality. • Similarly, we found no association between RCT sample size and its actual methodological quality. • The positive correlation between methodological quality of reporting and RCT sample size is misleading. • Our findings underline the need for adherence to the CONSORT statement by authors and journal editors for transparent evaluation of RCTs and highlight the importance of publication of RCT protocols in public domain. BACKGROUND AND OBJECTIVE

More Related