Development and evaluation of decision aids for people considering taking part in a clinical trial: a conceptual framework

Gillies, Katie; Campbell, Marion K

doi:10.1186/s13063-019-3489-y

Cited by 22 publications

(40 citation statements)

References 32 publications

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“…A small number of interventions have been developed to promote informed decision-making about participation in clinical trials [20][21][22]. Of the small number of DAs that aim to improve decisionmaking for trial participation (rather than aiming to improve the presentation of information or mode of delivery) most focus on specific oncology trials [23]. These DAs show some potential promise in improving key decision outcomes such as knowledge, values clarification, and decision conflict, while not negatively impacting recruitment or intention to participate [20,21,24].…”

Section: Methodsmentioning

confidence: 99%

“…As the interest in DAs for trial participation grows, so does the importance that their development is both rigorous and evidence-based [23]. The development of this DA for proxy decision-making was informed by a recently proposed framework for the development and evaluation of decision aids for people considering taking part in a clinical trial [23]…”

Section: Development Of the Decision Support Interventionmentioning

confidence: 99%

“…This theoretical framework consists of three components: decisional needs; decisional support; and decisional quality. The framework for the development and evaluation of decision aids for people considering taking part in a clinical trial outlined by Gillies and Campbell identified the ODSF as being a highly relevant theoretical framework to use when developing decision aids for trial participation [23]. This is because the ODSF asserts that decisional needs affect decisional quality, such as making informed and values-based choices, which in turn affect action, behaviour, and emotions such as regret [18].…”

Section: Decision Aid Development Frameworkmentioning

confidence: 99%

“…This is because the ODSF asserts that decisional needs affect decisional quality, such as making informed and values-based choices, which in turn affect action, behaviour, and emotions such as regret [18]. These concepts are considered by Gillies and Campbell to map well onto the known issues within trial participation decisions [23] which are known to be preference-sensitive decisions [29] as is also the case for proxy decisions.…”

Section: Decision Aid Development Frameworkmentioning

confidence: 99%

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Development of a decision support intervention for family members of adults who lack capacity to consent to trials

Shepherd

Wood

Griffith

et al. 2019

Preprint

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Background Informed 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 they can experience an emotional and decisional burden as a result. Decisions made on behalf of others are conceptually different from those we make for ourselves. Despite innovations to improve informed consent processes for research, including the development of decision aids, there are no interventions for proxies who arguably are faced with more complex decisions. This article outlines the development of a novel decision aid aimed at supporting families making decisions about research participation on behalf of an adult who lacks capacity to consent. Methods Decision support interventions should be developed using rigorous and evidence-based methods. This intervention was developed using the 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 had acted as proxies enabled the development of a theoretical framework to underpin the intervention. The intervention was iteratively developed in conjunction with lay advisors and relevant stakeholders. Results Previous 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 uses 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 and helped to ensure that it would be acceptable for use. Conclusions Frameworks 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 but requires feasibility testing and outcome measure development prior to any evaluation of its effectiveness.

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Section: Methodsmentioning

confidence: 99%

Section: Development Of the Decision Support Interventionmentioning

confidence: 99%

Section: Decision Aid Development Frameworkmentioning

confidence: 99%

Section: Decision Aid Development Frameworkmentioning

confidence: 99%

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Development of a decision support intervention for family members of adults who lack capacity to consent to trials

Shepherd

Wood

Griffith

et al. 2019

Preprint

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“…Privacy almost doesn't exist with the tools and stuff that are out there, so at least they're making an effort … I like to see the multi-layered security. (29) Other commonly highlighted sentences in this section included:…”

Section: What Are My Options?mentioning

confidence: 99%

Developing model biobanking consent language: what matters to prospective participants?

Beskow

Hammack-Aviran

Brelsford

2020

BMC Med Res Methodol

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Background Efforts to improve informed consent have led to calls for providing information a reasonable person would want to have, in a way that facilitates understanding of the reasons why one might or might not want to participate. At the same time, advances in large-scale genomic research have expanded both the opportunities and the risks for participants, families, and communities. To advance the use of effective consent materials that reflect this landscape, we used empirical data to develop model consent language, as well as brief questions to assist people in thinking about their own values relative to participation. Methods We conducted in-person interviews to gather preliminary input on these materials from a diverse sample (n = 32) of the general population in Nashville, Tennessee. We asked them to highlight information they found especially reassuring or concerning, their hypothetical willingness to participate, and their opinions about the values questions. Results Consent information most often highlighted as reassuring included the purpose of the biobank, the existence and composition of a multidisciplinary oversight committee, the importance of participants’ privacy and efforts to protect it, and controlled access to a scientific database. Information most often highlighted as concerning included the deposition of data in a publicly accessible database, the risk of unintended access to data, the potential for non-research use of data, and use of medical record information in general. Seventy-five percent of participants indicated initial willingness to participate in the hypothetical biobank; this decreased to 66% as participants more closely considered the information over the course of the interview. A large majority rated the values questions as helpful. Conclusions These results are consistent with other research on public perspectives on biobanking and genomic cohort studies, suggesting that our model language effectively captures commonly expressed reasons for and against participation. Our study enriches this literature by connecting specific consent form disclosures with qualitative data regarding what participants found especially reassuring or concerning and why. Interventions that facilitate individuals’ closer engagement with consent information may result in participation decisions more closely aligned with their values.

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Development and evaluation of shared decision-making tools in rheumatology: A scoping review

Aref,

Turk,

Dhanani

et al. 2024

Seminars in Arthritis and Rheumatism

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Development and evaluation of decision aids for people considering taking part in a clinical trial: a conceptual framework

Cited by 22 publications

References 32 publications

Development of a decision support intervention for family members of adults who lack capacity to consent to trials

Development of a decision support intervention for family members of adults who lack capacity to consent to trials

Developing model biobanking consent language: what matters to prospective participants?

Development and evaluation of shared decision-making tools in rheumatology: A scoping review

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