Beyond study participants: a framework for engaging patients in the selection or development of clinical outcome assessments for evaluating the benefits of treatment in medical product development

Wilson, Hilary; Dashiell-Aje, Ebony; Anatchkova, Milena D.; Coyne, Karin S.; Hareendran, Asha; Leidy, Nancy Kline; McHorney, Colleen A.; Wyrwich, Kathy

doi:10.1007/s11136-017-1577-6

Cited by 12 publications

(23 citation statements)

References 15 publications

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“…A total of 56 frameworks were written up in 55 academic papers. 5,10,12,31,[33][34][35][36][38][39][40][41][42][43][44][45][47][48][49][50]52,53,[55][56][57][60][61][62][63][64][65][66][67][69][70][71][72][73][74][75][76][77][78][79][80][81][82][83][84][87][88][89][90]…”

Section: Description Of Data Setmentioning

confidence: 99%

“…Most frameworks had been developed using a systematic approach with substantial input from patients or lay people, though approaches used varied considerably. Some groups had used primary qualitative research 50,55-57,81,84 and/or qualitative, thematic or narrative literature review, 5,10,[33][34][35][39][40][41][42]44,47,58,[62][63][64]70,74,76,81,82,85,87 realist review (asking "what works for whom in what circumstances"), 48,79,80 a consensus-building process such as Delphi 34,38,52,58,69 or economic modelling. 71 Other frameworks had been developed in a more pragmatic way by working groups (typically involving lay people, researchers and/or research funders) with extensive consultation but without an in-depth review of the relevant academic literature.…”

Section: Description Of Data Setmentioning

confidence: 99%

“…68 Pollock et al 36 50 and one on the involvement of patients in setting clinical outcomes. 74 One considered the economic costs and benefits of lay involvement in different phases of a clinical trial 71 ; and one addressed how to maintain recruitment to successive trials over time. 49 A framework for improving patient engagement in Alzheimer's disease trials highlighted specific challenges with this target population and offered solutions based on a literature review.…”

Section: Priority-setting Frameworkmentioning

confidence: 99%

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Frameworks for supporting patient and public involvement in research: Systematic review and co‐design pilot

Greenhalgh

Hinton

Finlay

et al. 2019

Health Expectations

579

650

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Background Numerous frameworks for supporting, evaluating and reporting patient and public involvement in research exist. The literature is diverse and theoretically heterogeneous. Objectives To identify and synthesize published frameworks, consider whether and how these have been used, and apply design principles to improve usability. Search strategy Keyword search of six databases; hand search of eight journals; ancestry and snowball search; requests to experts. Inclusion criteria Published, systematic approaches (frameworks) designed to support, evaluate or report on patient or public involvement in health‐related research. Data extraction and synthesis Data were extracted on provenance; collaborators and sponsors; theoretical basis; lay input; intended user(s) and use(s); topics covered; examples of use; critiques; and updates. We used the Canadian Centre for Excellence on Partnerships with Patients and Public (CEPPP) evaluation tool and hermeneutic methodology to grade and synthesize the frameworks. In five co‐design workshops, we tested evidence‐based resources based on the review findings. Results Our final data set consisted of 65 frameworks, most of which scored highly on the CEPPP tool. They had different provenances, intended purposes, strengths and limitations. We grouped them into five categories: power‐focused; priority‐setting; study‐focused; report‐focused; and partnership‐focused. Frameworks were used mainly by the groups who developed them. The empirical component of our study generated a structured format and evidence‐based facilitator notes for a “build your own framework” co‐design workshop. Conclusion The plethora of frameworks combined with evidence of limited transferability suggests that a single, off‐the‐shelf framework may be less useful than a menu of evidence‐based resources which stakeholders can use to co‐design their own frameworks.

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Section: Description Of Data Setmentioning

confidence: 99%

Section: Description Of Data Setmentioning

confidence: 99%

Section: Priority-setting Frameworkmentioning

confidence: 99%

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Frameworks for supporting patient and public involvement in research: Systematic review and co‐design pilot

Greenhalgh

Hinton

Finlay

et al. 2019

Health Expectations

579

650

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“…In order for the patient voice to be integrated throughout the development, implementation and dissemination of a PRO, it needs to be included from the outset . This enables a truly collaborative approach with patients, patient advocates and in some cases caregivers as patient partners, moving beyond traditional roles as consultants or providers of information and into roles as advisers, co‐creators and even drivers of the process, as shown in the model of the participation ladder (Figure ) …”

Section: The Patient and Patient Advocate Contributionmentioning

confidence: 99%

Including the patient voice in the development and implementation of patient‐reported outcomes in cancer clinical trials

Addario

Geißler²,

Horn³

et al. 2019

Health Expectations

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Portfolio Chair 4 | Deborah Maskens MA, MSM, Vice Chair 5 | Kathy Oliver BA, Chair and Co-Director 6 | Ananda Plate Chief Executive Officer 7 | Erin Schwartz MSW, VP of Global Engagement 8 | Nicole Willmarth PhD, Chief Mission Officer 9This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited. Abstract Context: Patient-reported outcomes (PROs) are used in parallel with clinical evidence to inform decisions made by industry, clinicians, regulators, health technology assessment bodies and other health-care decision-makers. In addition, PRO data can also guide shared decision making and individual patient choice. Yet, the quality of many PROs in cancer clinical trials is suboptimal and requires improvement to add value to health care and policy decision making. Objective: To show how the integration of the patient and/or patient advocate at all stages of PRO development can help to realize the full potential of PROs. Methods: We examined the literature to show that the patient voice is often absent from the planning and implementation of PROs in cancer clinical trials. Good practice examples from the literature were combined with guideline recommendations, training or educational resources, and our own experience to create detailed practical steps for the inclusion of patients and/or patient advocates throughout PRO development.Results: Patient or patient advocates can play an active role in shaping PROs that are meaningful to the patient. They can contribute to content, choice of medium and implementation in a way that may support PRO completion and minimize missing data. Patients and their advocates can work to ensure PRO findings are disseminated appropriately in a way that is accessible to patients. Conclusion:This practical guidance aims to optimize PRO development and implementation in clinical trials, resulting in robust, relevant data that reflect the patient experience and that support decisions made by all stakeholders involved in research and health care.

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“…They offer a conceptual framework for expanding the role that patients (and their representatives) play in the selection and development of clinical outcome assessments, including patient-reported outcomes. In addition, they offer recommended best practices and practical considerations for engaging patients in the development of a PRO measurement strategy [10]. Forsyth et al provide an update from the Patient-Centered Outcomes Research Institute (PCORI) on how PCORI evaluates the impact of patient engagement in the design and conduct of PCORIfunded research.…”

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confidence: 99%

Introduction to special section: measuring what matters

et al. 2017

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Beyond study participants: a framework for engaging patients in the selection or development of clinical outcome assessments for evaluating the benefits of treatment in medical product development

Cited by 12 publications

References 15 publications

Frameworks for supporting patient and public involvement in research: Systematic review and co‐design pilot

Frameworks for supporting patient and public involvement in research: Systematic review and co‐design pilot

Including the patient voice in the development and implementation of patient‐reported outcomes in cancer clinical trials

Introduction to special section: measuring what matters

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