ArticleBMC medical informatics and decision making2021
Development of a decision support intervention for family members of adults who lack capacity to consent to trials.
Article in BMC medical informatics and decision making, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 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
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.
- A decision aid to support family carers of people living with dementia towards the end-of-life: Coproduction process, outcome and reflections.Health expectations : an international journal of public participation in health care and health policy · 2021Pooled it
- Trial
- Supporting Informed Surrogate Decision-Making in Deceased Donor Intervention Research: Co-Creating Educational Materials With Families.Critical care explorations · 2026Article
- SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials.BMJ (Clinical research ed.) · 2025Article
- Enhancing Informed Consent Forms for Medical Devices: International Regulatory Guidance and Ethical Recommendations.Medical devices (Auckland, N.Z.) · 2025Article
- Enhancing recruitment of individuals living with frailty, multimorbidity and cognitive impairment to Parkinson's research: experiences from the PRIME-UK cross-sectional study.Age and ageing · 2024Article
- Decision aids to assist patients and professionals in choosing the right treatment for kidney failure.Clinical kidney journal · 2023Review
- Article
- Article
- Article
- Article
- (Re)Conceptualising 'good' proxy decision-making for research: the implications for proxy consent decision quality.BMC medical ethics · 2022Article
- Article
- 'Do I have the capacity to make capacity judgements?' Researcher reflections from a person-centred dementia support study.Dementia (London, England) · 2022Article
- Article
- Advances and challenges in conducting ethical trials involving populations lacking capacity to consent: A decade in review.Contemporary clinical trials · 2020Article
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 at 3 institutions in 1 country.
Funding
Abstract
backgroundInformed consent is required for participation in clinical trials, however trials involving adults who lack capacity to consent require different enrolment processes. A family member usually acts as a proxy to make a decision based on the patient's 'presumed will', but these decisions can be challenging and families may experience an emotional and decisional burden. Decisions made on behalf of others are conceptually different from those made for ourselves. Innovations have been developed to improve informed consent processes for research, including a number of decision aids, however there are no interventions for proxies who are faced with more complex decisions. This article outlines the development of a novel decision aid to support families making decisions about research participation on behalf of an adult who lacks capacity to consent.
methodsDecision support interventions should be developed using rigorous and evidence-based methods. This intervention was developed using MRC guidance for the development of complex interventions, and a conceptual framework for the development and evaluation of decision aids for people considering taking part in a clinical trial. The intervention was informed by a systematic review and analysis of existing information provision. Previous qualitative research with families who acted as proxies enabled the development of a theoretical framework to underpin the intervention. The intervention was iteratively developed with the involvement of lay advisors and relevant stakeholders.
resultsPrevious research, theoretical frameworks, and decision aid development frameworks were used to identify and develop the intervention components. The decision aid includes information about the proxy's role and utilises a values clarification exercise and decision support methods to enable a more informed and better-quality decision. Stakeholders, including those representing implementers and receivers of the intervention, contributed to the design and comprehensibility of the decision aid to ensure that it would be acceptable for use.
conclusionsFrameworks for the development of decision aids for people considering participating in a clinical trial can be used to develop interventions for family members acting as proxy decision-makers. The decision support tool is acceptable to users. Feasibility testing and outcome measure development is required prior to any evaluation of its effectiveness.
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.