ArticleThe American journal of bioethics : AJOB2020
Misrepresenting "Usual Care" in Research: An Ethical and Scientific Error.
Article in The American journal of bioethics : AJOB, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 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
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Effects of physical therapy modalities for motor function, functional recovery, and post-stroke complications in patients with severe stroke: a systematic review update.Systematic reviews · 2024Pooled it
- Current perspectives and updates on transfusion strategies in critically ill anemic patients.Frontiers in medicine · 2026Review
- Evolution of Critical Care Cardiology: An Update on Structure, Care Delivery, Training, and Research Paradigms: A Scientific Statement From the American Heart Association.Journal of the American College of Cardiology · 2025Article
- Review
- Article
- Review
- Controls, comparator arms, and designs for critical care comparative effectiveness research: It's complicated.Clinical trials (London, England) · 2024Article
- Modeling current practices in critical care comparative effectiveness research.Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine · 2022Article
- Protecting the mental and physical well-being of frontline health care workers during COVID-19: Study protocol of a cluster randomized controlled trial.Contemporary clinical trials · 2022Article
- Designing provider-focused implementation trials with purpose and intent: introducing the PRECIS-2-PS tool.Implementation science : IS · 2021Article
- Comparative effectiveness research in critically ill patients: risks associated with mischaracterising usual care.Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine · 2020Article
Corrections and comments
- Commented on by
- Commented on by
- Commented on by
- Commented on by
- Commented on by
- Commented on by
- Commented on by
- Commented on by
- Commented on by
- Commented on by
- Commented on by
Authors and funding
2 authors.
Funding
Abstract
Comparative effectiveness studies, referred to here as "usual-care" trials, seek to compare current medical practices for the same medical condition. Such studies are presumed to be safe and involve only minimal risks. However, that presumption may be flawed if the trial design contains "unusual" care, resulting in potential risks to subjects and inaccurately informed consent. Three case studies described here did not rely on clinical evidence to ascertain contemporaneous practice. As a result, the investigators drew inaccurate conclusions, misinformed research participants, and subjects' safety was compromised. Before approving usual-care protocols, IRBs and scientific review committees should evaluate the quality and completeness of information documenting usual-care practices. Guidance from governmental oversight agencies regarding evidence-based documentation of current clinical practice could prevent similar occurrences in future usual-care trials. Accurate information is necessary to ensure that trials comply with government regulations that require minimizing research risks to subjects and accurate informed consent documents.
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.