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

Abstract

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.

Making an Advance Research Directive: An Interview Study with Adults Aged 55 and Older with Interests in Dementia Research

“…Measures are also needed to evaluate proxy decisions for research. Shepherd et al have proposed a core set of outcomes 51 and make a strong case for focusing on authenticity, rather than accuracy, of decision‐making to account for the nuanced exercise of leeway 52 …”

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)

“…Building on previous conceptual and empirical work, this paper reports on the development and first phase of the validation for the CONCORD scale, a self-reported combined measure of the quality of proxy consent decisions made in non-emergency settings on behalf of other adults. Higher scores indicate a higher quality decision, defined as one in which the proxy is prepared and supported to make a decision and feels satisfied they have made a decision based on the preferences of the person they are representing, and where they accept the uncertainty they may experience [ 22 ]. This novel questionnaire is intended to measure a complex and—when compared to decisions about healthcare or participation in a trial made for oneself—relatively under-developed construct.…”

“…The first step in the development process of any new scale is to establish a theoretical definition of the focal concept [ 21 ]. 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 ].…”

Feasibility, effectiveness and costs of a decision support intervention for consultees and legal representatives of adults lacking capacity to consent (CONSULT): protocol for a randomised Study Within a Trial

“…As it progresses to the main SWAT, an embedded process evaluation will address issues regarding reach, contamination, context, adaptation and delity to the intervention [30] and an economic evaluation will also be embedded to identify and measure the resources involved in delivering the intervention [31]. If effective, the DA would support families of adults who lack capacity to consent to make more informed decisions about participation, and reduce the decisional burden they experience through addressing uncertainty [32], and so support greater inclusiveness in research.…”