Decision aids for randomised controlled trials: a qualitative exploration of stakeholders' views

Gillies, Katie; Skea, Zoë; Campbell, Marion K

doi:10.1136/bmjopen-2014-005734

Cited by 36 publications

(41 citation statements)

References 25 publications

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“…These proposals include using novel communication strategies (e.g. audio or video platforms), decision-aids and question prompt lists [11,17,[40][41][42][43]. It has also been suggested that information could be given out in smaller quantities, over varied periods, and that investigators should systematically ask individuals to recall the information given when decisions are confirmed, and consent taken [36].…”

Section: Discussionmentioning

confidence: 99%

The challenges of making informed decisions about treatment and trial participation following a cancer diagnosis: a qualitative study involving adolescents and young adults with cancer and their caregivers

Hart

Cameron

Cowie

et al. 2020

BMC Health Serv Res

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Background: Limited attention has been paid to adolescents and young adults' (AYA's) experiences in the aftermath of a cancer diagnosis, despite this being a time when potentially life-changing decisions are made. We explored AYA's and caregivers' experiences of, and views about, making treatment and trial participation decisions following a cancer diagnosis, in order to understand, and help facilitate, informed treatment decision-making in this age group. Methods: Interviews were undertaken with 18 AYA diagnosed, or re-diagnosed, with cancer when aged 16-24 years, and 15 parents/caregivers. Analysis focused on the identification and description of explanatory themes. Results: Most AYA described being extremely unwell by the time of diagnosis and, consequently, experiencing difficulties processing the news. Distress and acceleration in clinical activity following diagnosis could further impede the absorption of treatment-relevant information. After referral to a specialist cancer unit, many AYA described quickly transitioning to a calm and pragmatic mind-set, and wanting to commence treatment at the earliest opportunity. Most reported seeing information about short-term side-effects of treatment as having limited relevance to their recovery-focused outlook at that time. AYA seldom indicated wanting to make choices about front-line treatment, with most preferring to defer decisions to health professionals. Even when charged with decisions about trial participation, AYA reported welcoming a strong health professional steer. Parents/caregivers attempted to compensate for AYA's limited engagement with treatment-relevant information. However, in seeking to ensure AYA received the best treatment, these individuals had conflicting priorities and information needs.

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Section: Discussionmentioning

confidence: 99%

The challenges of making informed decisions about treatment and trial participation following a cancer diagnosis: a qualitative study involving adolescents and young adults with cancer and their caregivers

Hart

Cameron

Cowie

et al. 2020

BMC Health Serv Res

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“…The content was presented in the order used in other examples of DAs for decisions about clinical trials [20,25]. This presented information about their role (including clarifying whether they were being asked to provide advice or consent), understanding any advantages and disadvantages of participation, followed by structured guidance in deliberation or 'making a decision' that was adapted from existing clinical trial DAs [20,25]. The suggested decision-making process was through the six steps detailed in Figure 5.…”

Section: Resultsmentioning

confidence: 99%

“…The reviewers concluded that more high quality randomised controlled trials of decision aids to support the informed consent process for clinical trials are needed [16]. In non-oncology conditions, a qualitative exploration of stakeholders' perceptions of decision aids for randomised controlled trials that are currently in development suggested that decision aids have the potential to better engage potential participants in the decision-making process and allow them to make more personally relevant decisions about their participation [25].…”

Section: Methodsmentioning

confidence: 99%

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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“…Decision aids are delivered using diverse formats (e.g., web-based, video, audio, print), and have been shown to be effective in controlled contexts. However, their implementation in routine clinical settings remains difficult, partly due to a lack of attention to end-user acceptability [11]. Is it possible to design patient decision aids that are acceptable, feasible, and beneficial to underserved patients?…”

Section: Introductionmentioning

confidence: 99%

Assessing the acceptability and feasibility of encounter decision aids for early stage breast cancer targeted at underserved patients

Alam¹,

Elwyn²,

Percac‐Lima³

et al. 2016

BMC Med Inform Decis Mak

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BackgroundWomen of low socioeconomic status (SES) diagnosed with early stage breast cancer are less likely to be involved in treatment decisions. They tend to report higher decisional regret and poorer communication. Evidence suggests that well-designed encounter decision aids (DAs) could improve outcomes and potentially reduce healthcare disparities. Our goal was to evaluate the acceptability and feasibility of encounter decision aids (Option Grid, Comic Option Grid, and Picture Option Grid) adapted for a low-SES and low-literacy population.MethodsWe used a multi-phase, mixed-methods approach. In phase 1, we conducted a focus group with rural community stakeholders. In phase 2, we developed and administered a web-based questionnaire with patients of low and high SES. In phase 3, we interviewed patients of low SES and relevant healthcare professionals.ResultsData from phase 1 (n = 5) highlighted the importance of addressing treatment costs for patients. Data from phase 2 (n = 268) and phase 3 (n = 15) indicated that using both visual displays and numbers are helpful for understanding statistical information. Data from all three phases suggested that using plain language and simple images (Picture Option Grid) was most acceptable and feasible. The Comic Option Grid was deemed least acceptable.ConclusionOption Grid and Picture Option Grid appeared acceptable and feasible in facilitating patient involvement and improving perceived understanding among patients of high and low SES. Picture Option Grid was considered most acceptable, accessible and feasible in the clinic visit. However, given the small sample sizes used, those findings need to be interpreted with caution. Further research is needed to determine the impact of pictorial and text-based encounter decision aids in underserved patients and across socioeconomic strata.

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Decision aids for randomised controlled trials: a qualitative exploration of stakeholders' views

Cited by 36 publications

References 25 publications

The challenges of making informed decisions about treatment and trial participation following a cancer diagnosis: a qualitative study involving adolescents and young adults with cancer and their caregivers

The challenges of making informed decisions about treatment and trial participation following a cancer diagnosis: a qualitative study involving adolescents and young adults with cancer and their caregivers

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

Assessing the acceptability and feasibility of encounter decision aids for early stage breast cancer targeted at underserved patients

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