A randomised controlled trial evaluating the utility of a patient Decision Aid to improve clinical trial (RAVES 08.03) related decision-making

Sundaresan, Puma; Ager, Brittany; Turner, Sandra; Costa, D. S. J.; Kneebone, Andrew; Pearse, Maria; Woo, Henry H.; Tesson, Stephanie; Juraskova, Ilona; Butow, Phyllis

doi:10.1016/j.radonc.2017.08.013

Cited by 20 publications

(25 citation statements)

References 29 publications

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“…Studies have also shown that patients may base their decision to participate in a clinical trial on inadequate facts and misunderstandings [4, 29, 30], although they consider themselves to understand the trial information. In order to improve patient understanding of clinical trials, several kinds of interventions have been shown to be effective: enhanced consent documents, decisional aids and extended consent conversations seem to be of particular interest [9, 31]. To optimise the informed consent process, the physicians need to assess better what each patient understands in order to tailor their information better and individually.…”

Section: Discussionmentioning

confidence: 99%

Patients’ and physicians’ disagreement on patients’ understanding of clinical cancer trial information: a pairwise pilot study of mirroring subjective assessments compared with objective measurements

Dellson

Carlsson

Nilbert

et al. 2019

Trials

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Background: Informed consent is a prerequisite for patients included in clinical trials. Trial design, inclusion criteria and legal requirements are increasingly complex. This complexity challenges design and delivery of written and oral trial information to ensure understandable information. To evaluate the level of concordance between patients' and informing physicians' assessments regarding patient understanding of trial information, we carried out a study based on paired questionnaire data from patients and their physicians. These assessments of patient understanding were further correlated with patients' factual knowledge of the information provided. Methods: This pilot study included patients and physicians immediately after the patients had received information on one of 23 ongoing phase III randomised cancer trials at two Swedish sites. In total, 46 patients and 17 physicians contributed data based on two new questionnaires with seven mirroring questions, where concordance was analysed with McNemar's test. These assessments of patients' self-estimated understanding were further correlated with the Patient Understanding of Research (Q-PUR) questionnaire that assesses factual knowledge of the information provided. Results: For each question, 47-61% of the patient-physician pairs were in concordance regarding their assessments of patients' 'fully understanding' or 'not fully understanding' various aspects of the trial information. For the discordant pairs, the physicians rated patient understanding lower than the patients themselves, for all seven questions. This difference was significant for five of the questions (P ≤ 0.017). The median Q-PUR knowledge score was 11 out of 12, but this score did not significantly correlate with the assessments, either from patients or from physicians. Conclusions: This study demonstrated a trend for physicians to rate the level of understanding of trial information among potential trial patients lower than the patients themselves. Application of Q-PUR revealed high knowledge scores, but without correlation to the assessments. These findings need validation in an independent setting, with an improved instrument with mirroring questions, and a better-matched measurement of patients' factual knowledge. These results suggest that physicians need to improve their ability to assess patient understanding of clinical trial information, in order to be able to tailor the patients' information individually.

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Section: Discussionmentioning

confidence: 99%

Patients’ and physicians’ disagreement on patients’ understanding of clinical cancer trial information: a pairwise pilot study of mirroring subjective assessments compared with objective measurements

Dellson

Carlsson

Nilbert

et al. 2019

Trials

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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].…”

Section: Methodsmentioning

confidence: 99%

“…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]. A recent systematic review of decision aids for trials only identified one study that evaluated the effectiveness of decision aids compared to standard information in the informed consent process for clinical trials [16].…”

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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“…A handful of feasibility or full trials evaluating decision aids to inform decisions about trial participation are reported in the literature and others are in the planning stage [11–17]. Early randomised comparisons show that, in this setting, decision aids have potential promise with regard to improving key decision outcomes (knowledge, values clarification, and decision conflict) and not negatively affecting recruitment or intention to participate [14–16]. However, most examples of decision aids for trial participation are currently set within an oncology context; there is a paucity of examples in other disease areas and across a range of intervention choices.…”

Section: Introductionmentioning

confidence: 99%

“…It is also important to consider what type of randomised design (e.g., an individually randomised design and a cluster trial design) is most appropriate to assess the effectiveness of these interventions. Of the randomised comparisons of trial participation decision aids (defined using the IPDAS [34]) conducted to date, all have been conducted as individually randomised two-arm parallel trials [14–16]. However, the use of a stepped-wedge or cluster design, where groups/clusters (e.g., sites) are randomised to use the decision aid (or the traditional consent process), may be more appropriate as it would minimise any contamination effect that might be introduced through the training of staff in the use of the decision aid.…”

Section: Introductionmentioning

confidence: 99%

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

Gillies

Campbell

2019

Trials

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Ethical requirements of informed consent stipulate that patients approached to participate in a clinical trial be provided with written information that must cover key aspects of the trial. For consent to be deemed “informed”, potential participants should be provided with a range of information about the trials (e.g., the trial aims, the anticipated benefits and potential risks of the trial, and their right to withdraw consent at any time). However, it is well documented that simple provision of this information does not ensure that participants make truly informed decisions. Decision aids, tools that have been shown in a treatment and screening context to support better-quality decisions, are emerging as a possible vehicle to support decision making about trial participation. However, information on how they should best be developed and evaluated in a clinical trial context is lacking. Therefore, this article, drawing on theoretical and empirical insights, outlines a framework for the development and evaluation of decision aids for people considering taking part in a clinical trial.

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A randomised controlled trial evaluating the utility of a patient Decision Aid to improve clinical trial (RAVES 08.03) related decision-making

Cited by 20 publications

References 29 publications

Patients’ and physicians’ disagreement on patients’ understanding of clinical cancer trial information: a pairwise pilot study of mirroring subjective assessments compared with objective measurements

Patients’ and physicians’ disagreement on patients’ understanding of clinical cancer trial information: a pairwise pilot study of mirroring subjective assessments compared with objective measurements

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

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

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