ReviewJournal of clinical epidemiology2021
A review of pragmatic trials found a high degree of diversity in design and scope, deficiencies in reporting and trial registry data, and poor indexing.
Review in Journal of clinical epidemiology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
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
22 citing papers in PubMed.
- Fidelity, pragmatism and the "grey line" in between-exploring the delivery of a pragmatic physical activity randomised controlled trial-a secondary analysis.BMC medical research methodology · 2024Trial
- Patient and public involvement in pragmatic trials with older adults: a multi-methods study of researchers' experiences.BMC geriatrics · 2026Article
- Empirical research related to the ethics of pragmatic clinical trials: A scoping review.Learning health systems · 2026Article
- Recognition, remuneration and reimbursement of patient and public involvement partners in pragmatic randomised controlled trials. A survey of author practices.Research involvement and engagement · 2025Article
- Patient and Public Involvement in Paediatric Pragmatic Randomized Controlled Trials: A Mixed Methods Study.Children (Basel, Switzerland) · 2025Article
- Adherence to key recommendations for design and analysis of stepped-wedge cluster randomized trials: A review of trials published 2016-2022.Clinical trials (London, England) · 2024Review
- Selecting outcomes for pragmatic clinical trials in dementia care: The IMPACT Collaboratory iLibrary.Journal of the American Geriatrics Society · 2024Article
- Embedding clinical trial elements into clinical practice: Experiences from trial designers and implementers.Journal of clinical and translational science · 2024Article
- A scoping review described diversity in methods of randomization and reporting of baseline balance in stepped-wedge cluster randomized trials.Journal of clinical epidemiology · 2023Article
- Worldwide Trends in Registering Real-World Studies at ClinicalTrials.gov: A Cross-Sectional Analysis.International journal of general medicine · 2023Article
- Article
- An analysis of published trials found that current use of pragmatic trial labels is uninformative.Journal of clinical epidemiology · 2022Review
- Machine learning algorithms to identify cluster randomized trials from MEDLINE and EMBASE.Systematic reviews · 2022Article
- Update on the clinical trial landscape: analysis of ClinicalTrials.gov registration data, 2000-2020.Trials · 2022Article
- A review identified challenges distinguishing primary reports of randomized trials for meta-research: A proposal for improved reporting.Journal of clinical epidemiology · 2022Review
- Review of pragmatic trials found that multiple primary outcomes are common but so too are discrepancies between protocols and final reports.Journal of clinical epidemiology · 2022Review
- Methodological challenges in pragmatic trials in Alzheimer's disease and related dementias: Opportunities for improvement.Clinical trials (London, England) · 2022Article
- Patient-reported outcomes and target effect sizes in pragmatic randomized trials in ClinicalTrials.gov: A cross-sectional analysis.PLoS medicine · 2022Review
- The representation of Indigenous peoples in chronic disease clinical trials in Australia, Canada, New Zealand, and the United States.Clinical trials (London, England) · 2022Article
- Ethical considerations within pragmatic randomized controlled trials in dementia: Results from a literature survey.Alzheimer's & dementia (New York, N. Y.) · 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
12 authors.
Funding
Abstract
objectiveWe established a large database of trials to serve as a resource for future methodological and ethical analyses. Here, we use meta-data to describe the broad landscape of pragmatic trials including research areas, identification as pragmatic, quality of trial registry data and enrolment. STUDY DESIGN AND
settingTrials were identified by a validated search filter and included if a primary report of a health-related randomized trial published January 2014-April 2019. Data were collated from MEDLINE, Web of Science, ClinicalTrials.gov, and full text.
results4337 eligible trials were identified from 13,065 records, of which 1988 were registered in ClinicalTrials.gov. Research areas were diverse, with the most common being general and internal medicine; public, environmental and occupational health; and health care sciences and services. The term "pragmatic" was seldom used in titles or abstracts. Several domains in ClinicalTrials.gov had questionable data quality. We estimated that one-fifth of trials under-accrued by at least 15%.
conclusionThere is a need to improve reporting of pragmatic trials and quality of trial registry data. Under accrual remains a challenge in pragmatic RCTs despite calls for more streamlined recruitment approaches. The diversity of pragmatic trials should be reflected in future ethical analyses.
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.