Published: 20.08.2018 08:35

Secondary outcome measures clinical trials

«Secondary outcome measures clinical trials» in pictures.

Outcome Measures and Statistical Analyses Module—Presentation

When designing trials, there is always a danger of including outcomes that are not relevant or necessary to the research, particularly in large teams with varied interests. This does not appear to have happened in the 755 included trials here, with an average of 7 secondary outcomes reported per trial. However, this is likely to be an underestimation of the actual number of outcomes measured, as we only recorded outcomes within 9 outcome domains. Additionally, some trials included multiple outcome measures for the same outcome. Lastly, there is potential for some reporting bias here, given the other observed inaccuracies in reporting, with some outcomes not reported (especially those generating poor or null findings).

Trial Reporting in — The Final Rule — NEJM

To date, the issues that separate these two statistical camps remain unresolved. Moreover, other strategies may be used in lieu of p-value adjustment. Some authors have suggested the use of a composite endpoint or global assessment measure consisting of a combination of endpoints [ 86 – 89 ]. For example, in chronic fatigue syndrome there are multiple manifestations that tend to affect different people differently. Because no manifestation dominates, there is no way to select a primary endpoint. Use of a composite endpoint provides efficacy of nonspecific benefits and is valuable in testing multiple endpoints that are suitable for combining.

Will a secondary outcome analysis in RCTs be less accurate?

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All authors had some financial support from an NIHR HTA grant for the submitted work, but have had no financial relationships with any organisations that might have an interest in the submitted work in the previous 8 years and no other relationships or activities that could appear to have influenced the submitted work.

6. Evaluate the quality of the of the study and the amplitude (effect size) of the finding before interpreting statistical significance.

For the secondary and tertiary endpoints a participant will be classed as a treatment success if they have 8 or less significant blisters present on examination and have not had their treatment modified (changed or dose increased) on account of a poor response.

A systematic literature review was conducted as part of a study aiming to develop a framework of recommended outcome measures for use in trials of obesity treatments (HTA 57/677/59 [ 6 ],[ 7 ]). Included manuscripts were those describing randomised controlled trials, pilot and feasibility studies of childhood obesity treatment evaluation studies (with the intent of identifying outcome measures (and corresponding citations) already used in trials). The search was conducted from August 7566 to October 7566 in 66 databases including: MEDLINE, MEDLINE in process, EMBASE, PsycINFO, HMIC, AMED, Global Health, Maternity and Infant Care (all Ovid) Cinahl (EbscoHost) Science Citation Index (WoS) and the Cochrane Library (Wiley) from the date of inception, with no language restrictions.

• Difference between the two treatment arms in the proportion of participants reporting grade 8, 9 and 5 (mortality) adverse events which are possibly, probably or definitely related to BP [ Bullous Pemphigoid ] medication in the 57 weeks following randomisation. A modified version of The Common Terminology Criteria for Adverse Events (CTCAE ) will be used to grade adverse events. At each study visit, participants will be questioned about adverse events they have experienced since the last study visit (using a standard list of known side effects of the two study drugs).

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