ArticleJournal of medical ethics2002
Patients' perceptions of information provided in clinical trials.
Article in Journal of medical ethics, 2002. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
What it found
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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
14 citing papers in PubMed.
- "Cold calling" in psychiatric follow up studies: is it justified?Journal of medical ethics · 2003Trial
- What information and the extent of information to be provided in an informed assent/consent form of pediatric drug trials.BMC medical ethics · 2022Article
- Article
- Informational needs for participation in bioequivalence studies: the perspectives of experienced volunteers.European journal of clinical pharmacology · 2019Article
- "Tell me what you suggest, and let's do that, doctor": Patient deliberation time during informal decision-making in clinical trials.PloS one · 2019Article
- What information and the extent of information research participants need in informed consent forms: a multi-country survey.BMC medical ethics · 2018Article
- Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study.PloS one · 2017Article
- [Informed consent process in clinical trials: Insights of researchers, patients and general practitioners].Atencion primaria · 2016Article
- A survey of study participants' understanding of informed consent to participate in a randomised controlled trial of acupuncture.BMC complementary and alternative medicine · 2016Article
- Article
- Continuing review of ethics in clinical trials: a surveillance study in Iran.Journal of medical ethics and history of medicine · 2013Article
- Measuring the process and quality of informed consent for clinical research: development and testing.Oncology nursing forum · 2011Article
- Attitudes of health-care providers towards research with newborn babies.Journal of perinatology : official journal of the California Perinatal Association · 2004Article
- Protection of children in research.Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & PractitionersArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAccording to the Declaration of Helsinki, patients who take part in a clinical trial must be adequately informed about the trial's aims, methods, expected benefits, and potential risks. The declaration does not, however, elaborate on what "adequately informed" might amount to, in practice. Medical researchers and Local Research Ethics Committees attempt to ensure that the information which potential participants are given is pitched at an appropriate level, but few studies have considered whether the patients who take part in such trials feel they have been given adequate information, or whether they feel able to understand that information.
objectivesTo explore trial participants' views (i) on the amount of information provided, and (ii) of their own understanding of that information.
designStructured interviews of patients participating in clinical trials for the treatment of chronic medical condition.
findingsPatients generally felt they were given an appropriate amount of information, and that they were able to understand all or most of it. They felt they were given adequate time to ask questions before agreeing to take part. In comparison with treatment given out with the research setting, patients generally felt they received more information when participating in a clinical trial.
conclusionsResearchers sometimes complain that patients are given too much information during clinical trials, and have limited understanding of that information. The present study shows that this perception is not necessarily shared by patients. More research is needed in this area, particularly to gauge whether patient understanding is indeed accurate.
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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.