ArticleTrials2022
Getting it wrong most of the time? Comparing trialists' choice of primary outcome with what patients and health professionals want.
Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 1 of them a synthesis 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
24 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Person-centred integrated care for people living with Parkinson's, Huntington's and Multiple Sclerosis: A systematic review.Health expectations : an international journal of public participation in health care and health policy · 2024Pooled it
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- Put purpose before process: lessons from evaluating patient involvement in governance structures in health research organisations.Research involvement and engagement · 2026Article
- Expertise or representation: What gives people with lived experience authority and legitimacy in involvement in research?Research involvement and engagement · 2026Article
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- Who Should Decide the Outcome for a Clinical Trial? Comparing the Views of Stakeholders on Intervention Benefit Using Multi-Criteria Decision Modelling of Cognitive Remediation.Schizophrenia bulletin · 2026Article
- Patient and public involvement (PPI) reporting in maternal and neonatal clinical trials: an exploratory review.Trials · 2026Review
- The undue burdens of clinical trial participation: implications for equity, diversity, and inclusion.Trials · 2026Article
- Occupational Therapy Group Interventions Within the Area of Time Use and Occupational Balance: A Scoping Review.Occupational therapy international · 2026Article
- Treatment effects in orthopaedic trials are underestimated by applying patient-level PRO thresholds for meaningful differences at the group level.Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA · 2025Article
- Article
- Review
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- Widening Patient Engagement for Rare Disease Drug Trials: The Perspectives of Patients With Idiopathic Pulmonary Fibrosis on Participating in Clinical Drug Trials and Drug Trial Design.Health expectations : an international journal of public participation in health care and health policy · 2025Article
- Timing of Stoma Closure in Neonates: the ToSCiN mixed-methods study.Health technology assessment (Winchester, England) · 2024Observational
- Reporting of surrogate endpoints in randomised controlled trial protocols (SPIRIT-Surrogate): extension checklist with explanation and elaboration.BMJ (Clinical research ed.) · 2024Article
- When describing harms and benefits to potential trial participants, participant information leaflets are inadequate.Trials · 2024Article
- How do trial teams plan for retention during the design stage of the trial? A scoping review.Trials · 2023Article
- 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
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
Abstract
backgroundRandomised trials support improved decision-making through the data they collect. One important piece of data is the primary outcome - so called because it is what the investigators decide is the most important. Secondary outcomes provide additional information to support decision-making. We were interested in knowing how important patients and healthcare professionals consider the outcomes (especially the primary outcome) measured in a selection of published trials.
methodsThe work had three stages: (1) We identified a body of late-stage trials in two clinical areas, breast cancer management and nephrology. (2) We identified the primary and secondary outcomes for these trials. (3) We randomly ordered these outcomes and presented them to patients and healthcare professionals (with experience of the clinical area), and we asked them to rank the importance of the outcomes. They were not told which outcomes trial authors considered primary and secondary.
resultsIn our sample of 44 trials with 46 primary outcomes, 29 patients, one patient representative and 12 healthcare professionals together ranked the primary outcome as the most important outcome 13/46 times or 28%. Breast cancer patients and healthcare professionals considered the primary outcome to be the most important outcome for 8/21 primary outcomes chosen by trialists. For nephrology, the equivalent figure was 5/25. The primary outcome appeared in a respondent's top 5 ranked outcomes 151/178 (85%) times for breast cancer and 225/259 (87%) times for nephrology even if the primary was not considered the most important outcome.
conclusionsThe primary outcome in a trial is the most important piece of data collected. It is used to determine how many participants are required, and it is the main piece of information used to judge whether the intervention is effective or not. In our study, patients and healthcare professionals agreed with the choice of the primary outcome made by trial teams doing late-stage trials in breast cancer management and nephrology 28% of the time.
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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.