Co-creation of patient engagement quality guidance for medicines development: an international multistakeholder initiative

Deane, Katherine; Delbecque, Laure; Gorbenko, Oleksandr; Hamoir, Anne Marie; Hoos, Anton; Nafría, Begonya; Pakarinen, Chi; Sargeant, Ify; Richards, Dawn P.; Skovlund, Søren E.; Brooke, Nicholas

doi:10.1136/bmjinnov-2018-000317

Cited by 52 publications

(95 citation statements)

References 28 publications

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“…We emphasise the importance of co-creationas a collective process developing and agreeing on content together with a group of stakeholders and experts-to establish a common understanding of public involvement among stakeholders in this process. Involving a broad variety of stakeholders ranging from young people, citizens, patients and researchers in a co-creative manner has shown to produce a different kind of output, also in the context of research [25].…”

Section: Purpose Of the Ppie Guidementioning

confidence: 99%

Co-creating a patient and public involvement and engagement ‘how to’ guide for researchers

Kaisler

Missbach

2020

Res Involv Engagem

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Research should benefit society at large. Involving citizens those who are affected by research may not only increase the quality, but can also push research towards generating greater societal benefits and relevant outcomes for citizens. Including citizens in research also has ethical implications, which necessitate structured guidance on 'how to' meaningfully involve them. In our project, we invited a multi-stakeholder group consisting of researchers from multiple disciplines, citizen scientists, youth and patient advocates to co-create a guide on 'how to' meaningfully involve citizens in research. In five consecutive workshops, we discussed how the characteristics of interactions between researchers and citizens (e.g., building trustful relationships and communication) and what a possible project steering structure enabling meaningful public involvement in research could look like. As a result of these workshops, the PPIE 'How to' Guide for Researchers was developed to support the implementation of 'Patient and Public Involvement and Engagement' (PPIE) activities and informed a PPIE Implementation Programme funding public involvement activities in Austria.

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Section: Purpose Of the Ppie Guidementioning

confidence: 99%

Co-creating a patient and public involvement and engagement ‘how to’ guide for researchers

Kaisler

Missbach

2020

Res Involv Engagem

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“…The principal strength of the framework is that it is evidence‐informed and iteratively developed with all relevant stakeholders. We integrated literature and existing frameworks 33‐36 as well as quality guidance documents such as PFMD Quality Guidance, 37 the TransCelerate Toolkit 38 and EUPATI guidance 39 with case studies. We have incorporated dimensions of realist evaluation in order to acknowledge the importance of context and mechanisms in evaluating outcomes 40 .…”

Section: Discussionmentioning

confidence: 99%

Evaluation of patient engagement in medicine development: A multi‐stakeholder framework with metrics

Vat

Finlay

Robinson

et al. 2021

Health Expectations

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Background Patient engagement is becoming more customary in medicine development. However, embedding it in organizational decision‐making remains challenging, partly due to lack of agreement on its value and the means to evaluate it. The objective of this project was to develop a monitoring and evaluation framework, with metrics, to demonstrate impact and enhance learning. Methods A consortium of five patient groups, 15 biopharmaceutical companies and two academic groups iteratively created a framework in a multi‐phase participatory process, including analysis of its application in 24 cases. Results The framework includes six components, with 87 metrics and 15 context factors distributed among (sub)components: (a) Input: expectations, preparations, resources, representativeness of stakeholders; (b) Activities/process: structure, management, interactions, satisfaction; (c) Learnings and changes; (d) Impacts: research relevance, study ethics and inclusiveness, study quality and efficiency, quality of evidence and uptake of products, empowerment, reputation and trust, embedding of patient engagement; (e) Context: policy, institutional, community, decision‐making contextual factors. Case study findings show a wide variation in use of metrics. There is no ‘one size fits all’ set of metrics appropriate for every initiative or organization. Presented sample sets of metrics can be tailored to individual situations. Conclusion Introducing change into any process is best done when the value of that change is clear. This framework allows participants to select what metrics they value and assess to what extent patient engagement has contributed. Patient contribution Five patient groups were involved in all phases of the study (design, conduct, interpretation of data) and in writing the manuscript.

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“…Shared purpose and purposeful involvement with defined goals are two of the quality criteria developed by the multi-stakeholder group ‘Patient Focused Medicine Development’ for patient engagement in drug development [ 21 ]. Other quality criteria are respect for the resources and energy required for providing patient input, representativeness of stakeholders with agreed roles and responsibilities, the resources and capabilities to enable meaningful engagement, transparency in communication and documentation, and continuity and sustainability.…”

Section: Introductionmentioning

confidence: 99%

Patients and public are important stakeholders in health technology assessment but the level of involvement is low – a call to action

Wale¹,

Thomas

Hamerlijnck

et al. 2021

Res Involv Engagem

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Background Health technology assessment (HTA) agencies have an important role in the evaluation and approval of new technologies. They determine their value within a health system so to promote equitable, quality care with available healthcare resources. Many HTA agencies have some mechanism for involving patients in their processes, but there is great variability and an absence of comprehensive, robust practices for involvement. The accelerating pace of medical innovation creates a need to improve the depth and breadth of patient involvement in the HTA process. Main body In this ‘Call to action’, we present ideas from three HTA expert commentaries calling for collaborative learning and to share innovative ideas for changes in HTA. We also draw on examples of HTA agencies creatively pursuing this goal. We propose a ‘Call to action’ for HTA stakeholders to undertake serious dialogue with patient advocates aimed at creating shared goals. HTA agencies can use these goals to ensure meaningful patient involvement at every step of the HTA process. Five elements are explored. In ‘Recognizing the value of shared purpose’, we highlight examples of HTA agencies that have patients working in partnership with medical practitioners and HTA staff. Results include improved processes that instil confidence. ‘Committing to patient involvement as part of HTA culture’ highlights several initiatives aimed at changes in HTA organisational culture to be more inclusive of patients. In ‘Aligning patient and HTA goals’ we cite work in Belgium and New Zealand which places a greater emphasis on quality of life rather than life expectancy and cost-effectiveness. By ‘Integrating patient involvement at every step of the HTA process’ patients can make vital contributions at every stage of the HTA process. We provide two examples of where HTA agencies have successfully involved patients early in the process in order to broaden the scope of evaluations. ‘Developing a common language and working together’ can support transformative dialogue through ‘unified language’. Conclusion The authors of this commentary ask that agencies and stakeholders involved in HTA take up this call to work together for visionary and transformative elevation of the voice of patients in HTA worldwide.

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Co-creation of patient engagement quality guidance for medicines development: an international multistakeholder initiative

Cited by 52 publications

References 28 publications

Co-creating a patient and public involvement and engagement ‘how to’ guide for researchers

Co-creating a patient and public involvement and engagement ‘how to’ guide for researchers

Evaluation of patient engagement in medicine development: A multi‐stakeholder framework with metrics

Patients and public are important stakeholders in health technology assessment but the level of involvement is low – a call to action

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