Development of a core outcome set for the evaluation of interventions to enhance trial participation decisions on behalf of adults who lack capacity to consent: a mixed methods study (COnSiDER Study)

Hood

Gillies

et al. 2022

Preprint

Self Cite

Background Recruitment of adults lacking capacity to consent into trials requires the involvement of an alternative ‘proxy’ decision-maker, usually a family member. This can be challenging for family members, with some experiencing emotional and decisional burden. Interventions to support proxy consent decisions in non-emergency settings are being developed. However, the ability to evaluate interventions is limited due to a lack of measures that capture outcomes of known importance, as identified through a core outcome set (COS). Methods Using established measure development principles, a four-stage process was used to develop and refine items for a new measure of proxy decision quality: 1) findings from a recent scoping review and consensus study were reviewed to identify items for inclusion in the scale and any existing outcome measures; 2) assessment of content coverage by existing measures and identification of insufficiency; 3) construction of a novel scale; 4) cognitive testing to explore comprehension of the scale and test its content adequacy through interviews with family members of people with impaired capacity. Results A range of outcome measures associated with healthcare decision-making and informed consent decisions, such as the Decisional Conflict Scale, were identified in the scoping review. These measures were mapped against the key constructs identified in the COS to assess content coverage. Insufficient coverage of areas such as proxy-specific satisfaction and knowledge sufficiency by existing instruments indicated that a novel measure was needed. An initial version of a combined measure (the CONCORD scale) was drafted and tested during cognitive interviews with eleven family members. The interviews established comprehension, acceptability, feasibility, and content adequacy of the scale. Participants suggested re-phrasing and re-ordering some questions, leading to the creation of a revised version. Conclusions The CONCORD scale provides a brief measure to evaluate the quality of decisions made on behalf of an adult who lacks capacity to consent in non-emergency settings, enabling the evaluation of interventions to improve proxy decision quality. Initial evaluation indicates it has content adequacy and is feasible to use. Further statistical validation work is being undertaken.

Section: Discussionmentioning

confidence: 99%

Section: Developing An Appropriate Outcome Measurementioning

confidence: 99%

Section: Developing An Appropriate Outcome Measurementioning

confidence: 99%

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Development of a measure to assess the quality of proxy decisions about research participation on behalf of adults lacking capacity to consent: the Combined Scale for Proxy Informed Consent Decisions (CONCORD scale)

Hood

Gillies

et al. 2022

Preprint

Self Cite

“…A concept synthesis approach was used to undertake the first conceptualisation of the construct - what constitutes a high-quality proxy consent decision [ 22 ]. Following this, a scoping review and consensus study (COnSiDER Study) was conducted to establish the core outcomes that are important to stakeholders when evaluating interventions to improve proxy decisions about research [ 23 ]. The final core outcome set (COS), which was developed with an expert stakeholder Delphi panel (patients/public and those who care for them), consists of 28 items across 11 domains including knowledge sufficiency, values clarity, self-efficacy, preparedness, and satisfaction [ 23 ].…”

Section: Introductionmentioning

confidence: 99%

“…Following this, a scoping review and consensus study (COnSiDER Study) was conducted to establish the core outcomes that are important to stakeholders when evaluating interventions to improve proxy decisions about research [ 23 ]. The final core outcome set (COS), which was developed with an expert stakeholder Delphi panel (patients/public and those who care for them), consists of 28 items across 11 domains including knowledge sufficiency, values clarity, self-efficacy, preparedness, and satisfaction [ 23 ]. Once a COS has been agreed, the next stage in COS development is to determine how the outcomes that are known to be important should be measured [ 24 ].…”

Section: Introductionmentioning

confidence: 99%

Development of a measure to assess the quality of proxy decisions about research participation on behalf of adults lacking capacity to consent: the Combined Scale for Proxy Informed Consent Decisions (CONCORD scale)

Hood

Gillies

et al. 2022

Trials

Self Cite

Background Recruitment of adults lacking the capacity to consent to trials requires the involvement of an alternative ‘proxy’ decision-maker, usually a family member. This can be challenging for family members, with some experiencing emotional and decisional burdens. Interventions to support proxy consent decisions in non-emergency settings are being developed. However, the ability to evaluate interventions is limited due to a lack of measures that capture outcomes of known importance, as identified through a core outcome set (COS). Methods Using established measure development principles, a four-stage process was used to develop and refine items for a new measure of proxy decision quality: (1) findings from a recent scoping review and consensus study were reviewed to identify items for inclusion in the scale and any existing outcome measures, (2) assessment of content coverage by existing measures and identification of insufficiency, (3) construction of a novel scale, and (4) cognitive testing to explore comprehension of the scale and test its content adequacy through interviews with family members of people with impaired capacity. Results A range of outcome measures associated with healthcare decision-making and informed consent decisions, such as the Decisional Conflict Scale, were identified in the scoping review. These measures were mapped against the key constructs identified in the COS to assess content coverage. Insufficient coverage of areas such as proxy-specific satisfaction and knowledge sufficiency by existing instruments indicated that a novel measure was needed. An initial version of a combined measure (the CONCORD scale) was drafted and tested during cognitive interviews with eleven family members. The interviews established comprehension, acceptability, feasibility, and content adequacy of the scale. Participants suggested re-phrasing and re-ordering some questions, leading to the creation of a revised version. Conclusions The CONCORD scale provides a brief measure to evaluate the quality of decisions made on behalf of an adult who lacks the capacity to consent in non-emergency settings, enabling the evaluation of interventions to improve proxy decision quality. Initial evaluation indicates it has content adequacy and is feasible to use. Further statistical validation work is being undertaken.

(Re)Conceptualising ‘good’ proxy decision-making for research: the implications for proxy consent decision quality

2022

BMC Med Ethics

Self Cite

People who are unable to make decisions about participating in research rely on proxies to make a decision based on their wishes and preferences. However, patients rarely discuss their preferences about research and proxies find it challenging to determine what their wishes would be. While the process of informed consent has traditionally been the focus of research to improve consent decisions, the more conceptually complex area of what constitutes ‘good’ proxy decision-making for research has remained unexplored. Interventions are needed to improve and support proxy decision-making for research but are hampered by a lack of understanding about what constitutes decision quality in this context. A global increase in conditions associated with cognitive impairment such as dementia has led to an urgent need for more research into these conditions. The COVID-19 pandemic and subsequent necessity to conduct research with large numbers of critically ill patients has made this need even more pressing. Much of the empirical research centres on the desire to improve decision accuracy, despite growing evidence that authenticity is more reflective of the aim of proxy decisions and concerns about the methodological flaws in authenticity-focused studies. Such studies also fail to take account of the impact of decision-making on proxies, or the considerable body of research on improving the quality of healthcare decisions. This paper reports a concept synthesis of the literature that was conducted to develop the first conceptualisation of ‘good’ proxy decisions about research participation. Elements of decision quality were identified across three stages of decision-making: proxy preparedness for decision-making which includes knowledge and understanding, and values clarification and preference elicitation; the role of uncertainty, decisional conflict, satisfaction and regret in the decision-making process; and preference linked outcomes and their effect. This conceptualisation provides an essential first step towards the future development of interventions to enhance the quality of proxy decision-making and ensure proxy decisions represent patients’ values and preferences.