SynthesisJournal of medical ethics2001
Methodological quality and reporting of ethical requirements in clinical trials.
Synthesis in Journal of medical ethics, 2001. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 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
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The efficacy of a rubber bristles interdental cleaner on parameters of oral soft tissue health-a systematic review.International journal of dental hygiene · 2022Pooled it
- Article
- Identification of ethics committees based on authors' disclosures: cross-sectional study of articles published in the European Journal of Anaesthesiology and a survey of ethics committees.BMC medical ethics · 2018Article
- Ethics reporting practices in randomized controlled trials of physical therapy interventions after stroke.Archives of physiotherapy · 2018Article
- Important statistical points to improve and promote the methodology of the articles on medical sciences, particularly nephrology and kidney; a review article.Journal of renal injury prevention · 2015Review
- Reporting ethics committee approval in public administration research.Science and engineering ethics · 2014Article
- Methodological and ethical quality of randomized controlled clinical trials in gastrointestinal surgery.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2012Article
- Conflicts among multinational ethical and scientific standards for clinical trials of therapeutic interventions.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2012Article
- A taxonomy of multinational ethical and methodological standards for clinical trials of therapeutic interventions.Journal of medical ethics · 2011Article
- Inadequate reporting of research ethics review and informed consent in cluster randomised trials: review of random sample of published trials.BMJ (Clinical research ed.) · 2011Review
- African HIV/AIDS trials are more likely to report adequate allocation concealment and random generation than North American trials.PloS one · 2008Article
- Assessing ethics of trials in systematic reviews.BMJ (Clinical research ed.) · 2004Review
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
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo assess the relationship between the approval of trials by a research ethics committee (REC) and the fact that informed consent from participants (ICP) was obtained, with the quality of study design and methods.
designSystematic review using a standardised checklist. MAIN MEASURES: Methodological and ethical issues of all trials published between 1993 and 1995 in the New England Journal of Medicine, the Lancet, the Journal of the American Medical Association and the British Medical Journal were studied. In addition, clinical trials conducted in Spain and published by at least one Spanish author during the same period in any other journal were also included.
resultsWe studied the published articles of 767 trials and found the following indicators of lower methodological quality to be independent predictors for failure to disclose REC approval or ICP: absence of concealment of allocation, lack of justification for unblinded trials, not using a treatment for the patients in the control group, absent information on statistical methods, not including sample size estimation, not establishing the rules to stop the trial, and omitting the presentation of a baseline comparison of groups.
conclusionTrials of higher methodological and scientific quality were more likely to provide information about their ethical aspects.
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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.