ArticleTrials2014
Making a decision about trial participation: the feasibility of measuring deliberation during the informed consent process for clinical trials.
Article in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 3 of them syntheses that pooled it.
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
16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 26 citations in OpenAlex.
- Parental Views of Facilitators and Barriers to Research Participation: Systematic Review.Pediatrics · 2023Pooled it
- Patient reported measures of informed consent for clinical trials: A systematic review.PloS one · 2018Pooled it
- Decision aids for people considering taking part in clinical trials.The Cochrane database of systematic reviews · 2015Pooled it
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- A Proposal for Addressing Bioethical Concerns Along the 10-Step Framework for Community Engagement.Health expectations : an international journal of public participation in health care and health policy · 2025Article
- Piloting the better research interactions for every family (BRIEF) researcher intervention to support recruitment for a neonatal clinical trial: parent experience and infant enrollment.Journal of perinatology : official journal of the California Perinatal Association · 2025Article
- Article
- Experiences and preferences for learning about neonatal research: insights from parent interviews.Journal of perinatology : official journal of the California Perinatal Association · 2024Article
- Article
- (Re)Conceptualising 'good' proxy decision-making for research: the implications for proxy consent decision quality.BMC medical ethics · 2022Article
- The effectiveness of digital multimedia presentation of trial information on recruitment and retention of patients: Protocol for a study within a trial (SWAT).HRB open research · 2020Article
- "Tell me what you suggest, and let's do that, doctor": Patient deliberation time during informal decision-making in clinical trials.PloS one · 2019Article
- Article
- Efficacy and effectiveness trials have different goals, use different tools, and generate different messages.Pragmatic and observational research · 2015Article
- The perceived information in obtained from the informed consent in Iranian patients with cancer in clinical studies.Global journal of health science · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundInformed consent of trial participants is both an ethical and a legal requirement. When facing a decision about trial participation, potential participants are provided with information about the trial and have the opportunity to have any questions answered before their degree of 'informed-ness' is assessed, usually subjectively, and before they are asked to sign a consent form. Currently, standardised methods for assessing informed consent have tended to be focused on aspects of understanding and associated outcomes, rather than on the process of consent and the steps associated with decision-making.
methodsPotential trial participants who were approached regarding participation in one of three randomised controlled trials were asked to complete a short questionnaire to measure their deliberation about trial participation. A total of 136 participants completed the 10-item questionnaire (DelibeRATE) before they made an explicit decision about trial participation (defined as signing the clinical trial consent form). Overall DelibeRATE scores were compared and investigated for differences between trial consenters and refusers.
resultsNo differences in overall DelibeRATE scores were identified. In addition, there was no significant difference between overall score and the decision to participate, or not, in the parent trial.
conclusionsTo our knowledge, this is the first study to prospectively measure the deliberation stage of the informed consent decision-making process of potential trial participants across different conditions and clinical areas. Although there were no differences detected in overall scores or scores of trial consenters and refusers, we did identify some interesting findings. These findings should be taken into consideration by those designing trials and others interested in developing and implementing measures of potential trial participants decision making during the informed consent process for research.
trial registrationInternational Standard Randomised Controlled Trial Number (ISRCTN) Register ISRCTN60695184 (date of registration: 13 May 2009), ISRCTN80061723 (date of registration: 8 March 2010), ISRCTN69423238 (date of registration: 18 November 2010).
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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.