ArticleBMC medical ethics2022
Development of a core outcome set for informed consent for therapy: An international key stakeholder consensus study.
Article in BMC medical ethics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 3 of them syntheses that pooled it.
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Who cites it
8 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Operationalizing and Measuring Informed Choice in Health Care: An Umbrella Review.Medical decision making : an international journal of the Society for Medical Decision Making · 2026Pooled it
- Acupuncture for nausea and vomiting induced by highly emetogenic chemotherapy: a systematic review and meta-analysis.Frontiers in neurology · 2025Pooled it
- Efficacy and safety of acupuncture for chemotherapy-induced nausea and vomiting: a systematic review and meta-analysis of randomized controlled trial.Frontiers in neurologyPooled it
- Diagnostic Biopsy for Small Renal Tumours: A Survey of Current European Practice.European urology open science · 2024Article
- A survey of surgical patients' perspectives and preferences towards general anesthesia techniques and shared-decision making.BMC anesthesiology · 2023Article
- [Ethics considerations on brain-computer interface technology].Sheng wu yi xue gong cheng xue za zhi = Journal of biomedical engineering = Shengwu yixue gongchengxue zazhi · 2023Article
- Development of a Core Outcome Set for Randomised Controlled Trials of Nursing Education: A Methodological Framework.Journal of nursing management · 2023Article
- Development of a core outcome set for cardiovascular diabetology: a methodological framework.Frontiers in endocrinology · 2023Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
background300 million operations and procedures are performed annually across the world, all of which require a patient's informed consent. No standardised measure of the consent process exists in current clinical practice. We aimed to define a core outcome set for informed consent for therapy.
methodsThe core outcome set was developed in accordance with a predefined research protocol and the Core OutcoMes in Effectiveness Trials (COMET) methodology comprising systematic review, qualitative semi structured interviews, a modified Delphi process and consensus webinars to ratify outcomes for inclusion in the final core outcome set. (Registration- https://www.comet-initiative.org/Studies/Details/1024 ). Participants from all key stakeholder groups took part in the process, including patients and the public, healthcare practitioners and consent researchers.
results36 outcome domains were synthesised through systematic review and organised into a consent taxonomy. 41 semi-structured interviews were performed with all consent stakeholders groups. 164 participants from all stakeholder groups across 8 countries completed Delphi Round 1 and 125 completed Round 2. 11 outcomes met the 'consensus in' criteria. 6 met 'consensus in' all stakeholder groups and were included directly in the final core outcome set. 5 remaining outcomes meeting 'consensus in' were ratified over two consensus webinars. 9 core outcomes were included in the final core outcome set: Satisfaction with the quality and amount of information, Patient feeling that there was a choice, Patient feeling that the decision to consent was their own, Confidence in the decision made, Satisfaction with communication, Trust in the clinician, Patient satisfaction with the consent process, Patient rated adequacy of time and opportunity to ask questions.
conclusionThis international mixed-methods qualitative study is the first of its kind to define a core outcome set for informed consent for intervention. It defines what outcomes are of importance to key stakeholders in the consent process and is a forward step towards standardising future consent research.
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