SynthesisPLoS medicine2006
Does random treatment assignment cause harm to research participants?
Synthesis in PLoS medicine, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 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
16 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- A systematic review and meta-analysis of weight loss in control group participants of lifestyle randomized trials.Scientific reports · 2022Pooled it
- Outcomes for patients with the same disease treated inside and outside of randomized trials: a systematic review and meta-analysis.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2014Pooled it
- An Approach to Assess Generalizability in Comparative Effectiveness Research: A Case Study of the Whole Systems Demonstrator Cluster Randomized Trial Comparing Telehealth with Usual Care for Patients with Chronic Health Conditions.Medical decision making : an international journal of the Society for Medical Decision Making · 2015Trial
- The Future is Local: the Role of Decentralised Clinical Trials in Patients with Advanced Cancer Receiving Palliative Care.Current treatment options in oncology · 2026Review
- Benefits of Participation in Clinical Trials: An Umbrella Review.International journal of environmental research and public health · 2022Review
- Randomized Controlled Trials 1: Design.Methods in molecular biology (Clifton, N.J.) · 2021Article
- Innovative approaches to informed consent for randomized clinical trials: Identifying the ethical challenges.Clinical trials (London, England) · 2018Article
- Improved in-hospital outcomes and care for patients in stroke research: An observational study.Neurology · 2016Observational
- The impact of socioeconomic status on access to cancer clinical trials.British journal of cancer · 2014Review
- What should be disclosed to research participants?The American journal of bioethics : AJOB · 2013Article
- Predicting harms and benefits in translational trials: ethics, evidence, and uncertainty.PLoS medicine · 2011Article
- Parent and medical professional willingness to enroll children in a hypothetical pediatric optic neuritis treatment trial.Frontiers in neurology · 2011Article
- Osteoporosis therapies: evidence from health-care databases and observational population studies.Calcified tissue international · 2010Review
- If children understand drawing straws and flipping coins, research participants can understand randomization.The American journal of bioethics : AJOB · 2009Article
- The "number needed to treat" turns 20--and continues to be used and misused.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2008Article
- Proband race/ethnicity affects pedigree completion rate in a genetic study of ischemic stroke.Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association · 2008Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
backgroundSome argue that by precluding individualized treatment, randomized clinical trials (RCTs) provide substandard medical care, while others claim that participation in clinical research is associated with improved patient outcomes. However, there are few data to assess the impact of random treatment assignment on RCT participants. We therefore performed a systematic review to quantify the differences in health outcomes between randomized trial participants and eligible non-participants. METHODS AND
findingsStudies were identified by searching Medline, the Web of Science citation database, and manuscript references. Studies were eligible if they documented baseline characteristics and clinical outcomes of RCT participants and eligible non-participants, and allowed non-participants access to the same interventions available to trial participants. Primary study outcomes according to patient group (randomized trial participants versus eligible non-participants) were extracted from all eligible manuscripts. For 22 of the 25 studies (88%) meeting eligibility criteria, there were no significant differences in clinical outcomes between patients who received random assignment of treatment (RCT participants) and those who received individualized treatment assignment (eligible non-participants). In addition, there was no relation between random treatment assignment and clinical outcome in 15 of the 17 studies (88%) in which randomized and nonrandomized patients had similar health status at baseline.
conclusionsThese findings suggest that randomized treatment assignment as part of a clinical trial does not harm research participants.
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.