ReviewBMJ (Clinical research ed.)2010
Inconsistent reporting of surrogate outcomes in randomised clinical trials: cohort study.
Review 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 23 papers, 2 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
23 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Outcome switching in randomized controlled oncology trials reporting on surrogate endpoints: a cross-sectional analysis.Scientific reports · 2017Pooled it
- Does intravascular ultrasound provide clinical benefits for percutaneous coronary intervention with bare-metal stent implantation? A meta-analysis of randomized controlled trials.Systematic reviews · 2012Pooled it
- More Than a Question of Correlation: Characterization of the Evidentiary Basis for Biomarker Surrogates Used in European Marketing Authorizations.Clinical pharmacology and therapeutics · 2026Review
- Use of surrogate endpoints in health technology assessment and reimbursement of treatments for the management of chronic kidney disease.EClinicalMedicine · 2025Review
- Reporting of surrogate endpoints in randomised controlled trial protocols (SPIRIT-Surrogate): extension checklist with explanation and elaboration.BMJ (Clinical research ed.) · 2024Article
- Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration.BMJ (Clinical research ed.) · 2024Article
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- Need for better reporting of trials with surrogate endpoints: SPIRIT|CONSORT-SURROGATE extensions.Journal of epidemiology and community health · 2022Article
- A call for better reporting of trials using surrogate primary endpoints.Alzheimer's & dementia (New York, N. Y.) · 2022Article
- Reply to Commentary by Cummings (2022): Surrogate endpoints extend beyond biomarkers.Alzheimer's & dementia (New York, N. Y.) · 2022Article
- Effects of Septal Reduction Therapy on Acute Cardiovascular Events and All-Cause Mortality in Patients with Hypertrophic Cardiomyopathy.International heart journal · 2021Observational
- A method to determine if more than surrogate outcomes were improved: The EMR glitch experiment.Research and practice in thrombosis and haemostasis · 2020Article
- Outcomes, Interventions and Funding in Randomised Research Published in High-Impact Journals.Trials · 2018Article
- Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review.Contemporary clinical trials communications · 2018Review
- Scientific Opinion of the PPR Panel on the follow-up of the findings of the External Scientific Report 'Literature review of epidemiological studies linking exposure to pesticides and health effects'.EFSA journal. European Food Safety Authority · 2017Article
- Article
- Two Decades of Cardiovascular Trials With Primary Surrogate Endpoints: 1990-2011.Journal of the American Heart Association · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess if authors of randomised clinical trials convey the fact that they have used surrogate outcomes and discussed their validity.
designCohort study.
settingSix major general medical journals.
participantsRandomised clinical trials published in 2005 and 2006 that used a surrogate as a primary outcome.
resultsOf 626 published randomised clinical trials, 109 (17%) used a surrogate as a primary outcome. Of these trials, 62 (57%, 95% confidence interval 47% to 67%) clearly reported that the primary outcome was a surrogate. Only 38 (35%, 26% to 45%) also discussed the validity of the surrogate.
conclusionOnly about one third of authors of randomised clinical trials that used a surrogate as a primary outcome reported adequately on the surrogate. Better reporting is needed.
Indexed as
Identifiers
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.