Deliberative Engagement Methods for Patient-Centered Outcomes Research

Morain, Stephanie R.; Whicher, Danielle; Kass, Nancy E.; Faden, Ruth R.

doi:10.1007/s40271-017-0238-8

Cited by 24 publications

(36 citation statements)

References 22 publications

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“…Rather, our inferences concern the nature of families’ perspectives and the value of these in informing the design of JIA trials. Similar to deliberative engagement methods [ 42 ], we used stimulus materials (see Additional file 2 : Appendix B) and discursive interviews to enable families to raise matters of importance to them, and for us to inform families about trials and clarify any key misunderstandings.…”

Section: Discussionmentioning

confidence: 99%

Protective parents and permissive children: what qualitative interviews with parents and children can tell us about the feasibility of juvenile idiopathic arthritis trials

et al. 2018

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BackgroundPatient recruitment can be very challenging in paediatric studies, especially in relatively uncommon conditions, such as juvenile idiopathic arthritis (JIA). However, involving children and young people (CYP) in the design of such trials could promise a more rapid trajectory towards making evidence-based treatments available. Studies involving CYP are advocated in the literature but we are not aware of any early stage feasibility studies that have qualitatively accessed the perspectives of parents and CYP with a long term condition to inform design and conduct of a trial. In the context of a feasibility study to inform the design of a proposed randomised controlled trial of corticosteroid induction regimen in JIA, we explored families’ perspectives on the proposed trial and on JIA trials generally.MethodsWe analysed interviews with 27 participants (8 CYP aged 8–16 years and 19 parents) from four UK paediatric rheumatology centres. CYP had recently received corticosteroids to treat JIA. Audio-recorded interviews were transcribed and analysed thematically, drawing on the Framework Method.ResultsBoth parents and CYP were capable of engaging with the logic of the proposed trial but pointed to challenges with its design. Treatment preferences influenced willingness to participate in the proposed trial. The preferences of older children and their parents often differed, with CYP being more willing to participate in the proposed trial than parents. Families’ current treatment preferences were largely informed by past positive and negative treatment experiences. Some participants also indicated that their treatment preferences were influenced by those of their clinicians.ConclusionPrevious research has typically focused on deficits in patients’ understandings of trials. We found that both parents and CYP understood trial concepts and were able to identify potential flaws in the proposed trial. We propose recommendations to optimise the design of a planned corticosteroid induction regimen trial in JIA. Accessing both parents’ and CYP’s perspectives helps to identify and address recruitment challenges, which will ultimately optimise informed consent and future recruitment.Electronic supplementary materialThe online version of this article (10.1186/s12969-018-0293-2) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Protective parents and permissive children: what qualitative interviews with parents and children can tell us about the feasibility of juvenile idiopathic arthritis trials

et al. 2018

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“…The Center for Medical Technology Policy and the Johns Hopkins Berman Institute of Bioethics hosted a full‐day, in‐person, DES in April 2014 in Baltimore, MD with a broad sample of health care stakeholders. This multi‐stakeholder DES was part of a larger study that used the same methods to capture patients' views on this topic …”

Section: Methodsmentioning

confidence: 99%

“…This multi-stakeholder DES was part of a larger study that used the same methods to capture patients' views on this topic. 12,21…”

Section: Methodsmentioning

confidence: 99%

Stakeholder perspectives regarding alternate approaches to informed consent for comparative effectiveness research

Morain

Tambor

Moloney

et al. 2017

Learning Health Systems

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Introduction Traditional informed consent approaches, involving separate discussions and lengthy consent forms, may be an imperfect fit for comparative effectiveness research (CER) that is integrated into usual care and compares non‐investigational treatments. However, systematic efforts to collect broad stakeholder perspectives about alternative streamlined approaches to disclosure and consent in this context have been limited. Methods We used a deliberative engagement method to solicit the views of a multi‐stakeholder group regarding 3 alternative models of disclosure, consent, and authorization in CER studies: Opt‐In, Opt‐Out, and “General Approval”. Participants considered the acceptability of these 3 models for observational and randomized CER studies of hypertension medications and for alternative treatments for spinal stenosis, all conducted in the context of a learning health care system. Results Fifty‐eight stakeholders participated in the all‐day deliberative engagement session. Following deliberation, a majority of stakeholders (67%) liked the General Approval model for the observational hypertension study, more than the number who reported liking Opt‐Out or Opt‐In (45% and 36%, respectively). Support was lower for General Approval model in the context of a randomized hypertension study, with 80% liking a traditional Opt‐In approach, compared with 54% liking Opt‐Out, and 11% liking General Approval. Similarly, for the spinal stenosis CER studies, while most stakeholders preferred a streamlined Opt‐Out approach for the observational design, most preferred a traditional Opt‐In approach for the randomized version. Conclusions This multi‐stakeholder group was more favorable towards streamlined models for disclosure and authorization for observational CER than randomized designs. These findings are consistent with arguments that informed consent requirements should be tailored to the context of the research design, rather than a standard “one size fits all” approach.

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“…There is growing interest in incorporating the patient voice in healthcare policies regarding ethically controversial issues that impact health [7][8][9][10][11][12]. Because complex healthcare decisions tend to require a sophisticated level of knowledge and are often emotionally charged, traditional opinion surveys are of little value.…”

Section: Introductionmentioning

confidence: 99%

Eliciting patient views on the allocation of limited healthcare resources: a deliberation on hepatitis C treatment in the Veterans Health Administration

Waljee

Ryan

Krenz

et al. 2020

BMC Health Serv Res

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Background: In response to the development of highly effective but expensive new medications, policymakers, payors, and health systems are considering novel and pragmatic ways to provide these medications to patients. One approach is to target these treatments to those most likely to benefit. However, to maximize the fairness of these policies, and the acceptance of their implementation, the values and beliefs of patients should be considered. The provision of treatments for chronic hepatitis C (CHC) in the resource-constrained context of the Veterans Health Administration (VHA) offered a real-world example of this situation, providing the opportunity to test the value of using Democratic Deliberation (DD) methods to solicit the informed opinions of laypeople on this complex issue. Methods: We recruited Veterans (n = 30) from the VHA to attend a DD session. Following educational presentations from content experts, participants engaged in facilitated small group discussions to: 1) identify strategies to overcome CHC treatment barriers and 2) evaluate, vote on, and modify/improve two CHC treatment policies-"first come, first served" (FCFS) and "sickest first" (SF). We used transcripts and facilitators' notes to identify key themes from the small group discussions. Additionally, participants completed pre-and post-DD surveys. Results: Most participants endorsed the SF policy over the FCFS policy, emphasizing the ethical and medical appropriateness of treating the sickest first. Concerns about SF centered on the difficulty of implementation (e.g., how is "sickest" determined?) and unfairness to other Veterans. Proposed modifications focused on: 1) the need to consider additional health factors, 2) taking behavior and lifestyle into account, 3) offering education and support, 4) improving access, and 5) facilitating better decision-making.

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Deliberative Engagement Methods for Patient-Centered Outcomes Research

Cited by 24 publications

References 22 publications

Protective parents and permissive children: what qualitative interviews with parents and children can tell us about the feasibility of juvenile idiopathic arthritis trials

Protective parents and permissive children: what qualitative interviews with parents and children can tell us about the feasibility of juvenile idiopathic arthritis trials

Stakeholder perspectives regarding alternate approaches to informed consent for comparative effectiveness research

Eliciting patient views on the allocation of limited healthcare resources: a deliberation on hepatitis C treatment in the Veterans Health Administration

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