SynthesisBMJ (Clinical research ed.)2010
Outcome selection and role of patient reported outcomes in contemporary cardiovascular trials: systematic review.
Synthesis in BMJ (Clinical research ed.), 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
48 citing papers in PubMed, 6 syntheses or guidelines pooled it.
- Immediate versus staged revascularization in acute coronary syndrome and multivessel disease: a meta-analysis and meta-regression of RCTs.Internal and emergency medicine · 2026Pooled it
- Patient perceptions of outcomes used to evaluate in-hospital handover interventions: a rapid review of qualitative data.BMJ open · 2025Pooled it
- Patient-centered care in Coronary Heart Disease: what do you want to measure? A systematic review of reviews on patient-reported outcome measures.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2023Pooled it
- Intervention effect estimates in randomised controlled trials conducted in primary care versus secondary or tertiary care settings: a meta-epidemiological study.BMC medical research methodology · 2022Pooled it
- Temporal Trends and Factors Associated With the Inclusion of Patient-Reported Outcomes in Heart Failure Randomized Controlled Trials: A Systematic Review.Journal of the American Heart Association · 2021Pooled it
- Measuring the success of interventions for caregivers: a focussed systematic review.Current opinion in supportive and palliative care · 2019Pooled it
- Impact of MyDiabetesPlan, a Web-Based Patient Decision Aid on Decisional Conflict, Diabetes Distress, Quality of Life, and Chronic Illness Care in Patients With Diabetes: Cluster Randomized Controlled Trial.Journal of medical Internet research · 2020Trial
- Symptom relief and not cyst reduction determines treatment success in aspiration sclerotherapy of hepatic cysts.European radiology · 2019Trial
- Avoidable waste of research related to outcome planning and reporting in clinical trials.BMC medicine · 2018Trial
- Should patients perception of health status be integrated in the prognostic assessment of heart failure patients? A prospective study.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2014Trial
- Redefining endpoints in heart failure clinical trials: the emerging role of wearable technologies in contemporary trial design.Heart failure reviews · 2025Review
- Adding the patient perspective: the necessity of patient reported outcomes in cardiac surgery clinical trials.Current opinion in cardiology · 2025Review
- Predicting Heart Failure Outcomes Using Patient-Reported Health Status: Real-World Validation of the KCCQ-12.Journal of the American College of Cardiology · 2025Article
- Physical and Mental Components of Quality of Life after a Cardiac Rehabilitation Intervention: A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2024Review
- Patient listening on social media for patient-focused drug development: a synthesis of considerations from patients, industry and regulators.Frontiers in medicine · 2024Article
- Reasons for missing evidence in rehabilitation meta-analyses: a cross-sectional meta-research study.BMC medical research methodology · 2023Article
- Exploring the perspectives of selectors and collecters of trial outcome data: an international qualitative study.BMC medical research methodology · 2023Article
- Article
- Completeness and Mismatch of Patient-Important Outcomes After Trauma.Annals of surgery open : perspectives of surgical history, education, and clinical approaches · 2022Article
- Patient-Centered Core Impact Sets: What They are and Why We Need Them.The patient · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo 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.
designSystematic 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.
resultsPrimary 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.
conclusionsDespite 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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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.