Resources from Trials Journal

  • "Flogging dead horses": evaluating when have clinical trials achieved sufficiency and stability? A case study in cardiac rehabilitation

    Most systematic reviews conclude that another clinical trial is needed. Measures of sufficiency and stability may indicate whether this is true. The objectives of the review was to show how evidence accumulated on centre-based versus home-based cardiac rehabilitation, including estimates of sufficiency and stability. The evidence points to a relatively small effect difference which was stable but not sufficient in terms of the suggested thresholds. Sufficiency should arguably be based on substantive significance and decided by patients. Research on patient preferences should be the priority. Sufficiency and stability measures are useful tools that need to be tested in further case studies.

    Trials Journal - Mon, 21 March 2011
    http://www.trialsjournal.com/

  • Modified versus standard intention-to-treat reporting: Are there differences in methodological quality, sponsorship, and findings in randomized trials?

    Randomized controlled trials (RCTs) that use the modified intention-to-treat (mITT) approach are increasingly being published. Such trials have a preponderance of post-randomization exclusions, industry sponsorship, and favourable findings, and little is known whether in terms of these items mITT trials are different with respect to trials that report a standard intention-to-treat.Methods To determine differences in the methodological quality, sponsorship, authors' conflicts of interest, and findings among trials with different "types" of intention-to-treat, we undertook a cross-sectional study of RCTs published in 2006 in three general medical journals (the Journal of the American Medical Association, the New England Journal of Medicine and the Lancet) and three specialty journals (Antimicrobial Agents and Chemotherapy, the American Heart Journal and the Journal of Clinical Oncology). Results found that the mITT trials were significantly more likely to perform post-randomization exclusions and were strongly associated with industry funding and authors' conflicts of interest.

    Trials Journal - Tue, 1 March 2011
    http://www.trialsjournal.com/
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