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. 2010 Nov 1:341:c5707.
doi: 10.1136/bmj.c5707.

Outcome selection and role of patient reported outcomes in contemporary cardiovascular trials: systematic review

Kazem Rahimi  1 , Aneil Malhotra, Adrian P Banning, Crispin Jenkinson
Affiliations

Outcome selection and role of patient reported outcomes in contemporary cardiovascular trials: systematic review

Kazem Rahimi et al. BMJ. .

Abstract

Objectives: To systematically assess the type of outcomes selected and the prevalence of patient reported outcomes in contemporary cardiovascular trials and to quantify any misuse or underuse of patient reported outcomes using a specially developed tool that would allow estimation of the relevance of such outcomes to clinical decision making.

Design: Systematic review.

Data sources: Medline and Embase.

Study selection: Randomised controlled trials of the treatment for or prevention of cardiovascular disease published in 10 leading general medical and cardiology journals from January 2005 to December 2008.

Results: Primary outcomes were patient important (death, morbidity, or patient reported outcomes) in only 93 of 413 trials (23%, SE 2%), whereas another 92 (22%, SE 2%) combined these outcomes with other less important ones into a composite. Sixty five trials (16%; SE 2%) used at least one instrument to measure patient reported outcomes, mostly in trials where such information would have been important or crucial for clinical decision making (52 trials). Patient reported outcomes were judged to be of little incremental value to a large number of, mostly explanatory, cardiovascular trials (152 trials). However, many trials in which patient reported outcomes would have been important or crucial for clinical decision making did not report such outcomes (122 of 174 trials, 70%). These included several trials that primarily aimed to improve symptoms or functional status, trials that tested interventions with a considerable potential for causing harm (mainly bleeding) that were not meaningfully measured, and trials with composite outcomes that were dominated by outcomes of questionable importance to patients.

Conclusions: Despite a continued rise in the reporting of patient reported outcomes with no evidence for their misuse in more recent cardiovascular trials, they seem to be still underused once their relevance to clinical decision making has been taken into account. This was largely explained by inappropriate use of composite outcomes and inadequate measurement of harms.

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Conflict of interest statement

Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare that (1) none has received financial support for the submitted work; (2) none has any relationships with companies that might have an interest in the submitted work in the previous 3 years; (3) none of their spouses, partners, or children has any financial relationships that may be relevant to the submitted work; and (4) none has any non-financial interests that may be relevant to the submitted work.

Figures

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Fig 1 Search retrieval and study selection process
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Fig 2 Flow chart for assessment of relevance of patient reported outcomes in clinical trials. Percentages only apply to trials that used composite outcomes
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Fig 3 Prevalence of cardiovascular trials that also mentioned “quality of life”
See this image and copyright information in PMC

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