Patient involvement in a scientific advisory process: Setting the research agenda for medical products

Elberse, Janneke; Pittens, Carina A. C. M.; Buning, Tjard de Cock; Broerse, Jacqueline E. W.

doi:10.1016/j.healthpol.2012.05.014

Cited by 41 publications

(78 citation statements)

References 51 publications

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“…Active involvement of patients in the health sector is growing [18,19]. Patient involvement affects procedures and decisions regarding health policy [20], treatment [21], research [18,22], health technology assessments [23], genetic testing [24], and scientific advisory processes [19].…”

Section: Discussionmentioning

confidence: 99%

An effective multisource informed consent procedure for research and clinical practice: an observational study of patient understanding and awareness of their roles as research stakeholders in a cancer biobank

et al. 2013

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BackgroundEfforts to improve patients’ understanding of their own medical treatments or research in which they are involved are progressing, especially with regard to informed consent procedures. We aimed to design a multisource informed consent procedure that is easily adaptable to both clinical and research applications, and to evaluate its effectiveness in terms of understanding and awareness, even in less educated patients.MethodsWe designed a multisource informed consent procedure for patients’ enrolment in a Cancer Institute Biobank (CRO-Biobank). From October 2009 to July 2011, a total of 550 cancer patients admitted to the Centro di Riferimento Oncologico IRCCS Aviano, who agreed to contribute to its biobank, were consecutively enrolled. Participants were asked to answer a self-administered questionnaire aim at exploring their understanding of biobanks and their needs for information on this topic, before and after study participation. Chi-square tests were performed on the questionnaire answers, according to gender or education.ResultsOf the 430 patients who returned the questionnaire, only 36.5% knew what a biobank was before participating in the study. Patients with less formal education were less informed by some sources (the Internet, newspapers, magazines, and our Institute). The final assessment test, taken after the multisource informed consent procedure, showed more than 95% correct answers. The information received was judged to be very or fairly understandable in almost all cases. More than 95% of patients were aware of participating in a biobank project, and gave helping cancer research (67.5%), moral obligation, and supporting cancer care as main reasons for their involvement.ConclusionsOur multisource informed consent information system allowed a high rate of understanding and awareness of study participation, even among less-educated participants, and could be an effective and easy-to-apply model for others to consider to contribute to a well-informed decision making process in several fields, from clinical practice to research.Further studies are needed to explore the effects on the study comprehension by each source of information, and by other sources suggested by participants in the questionnaire.

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Section: Discussionmentioning

confidence: 99%

An effective multisource informed consent procedure for research and clinical practice: an observational study of patient understanding and awareness of their roles as research stakeholders in a cancer biobank

et al. 2013

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“…61 Furthermore, PPI can ensure that the patient and carer perspectives are explicitly addressed within the research questions, 62 and may result in research questions being further refined 17,63 or even abandoning a research application if PPI suggests that the research questions are not meaningful for the target patient and service user population. 64 In addition to influencing researchers' priorities, PPI has increasingly played a part in advising funding bodies on priority setting, for example in medical products, 65 spinal cord injury 66 and burns research. 67 Lay involvement in the review of research grant applications is seen to raise issues not previously identified and challenges scientist reviewers to think more about the service user perspective within their deliberations.…”

Section: Patient and Public Involvement: The Methodological Argumentmentioning

confidence: 99%

ReseArch with Patient and Public invOlvement: a RealisT evaluation – the RAPPORT study

Wilson

Mathie

Keenan

et al. 2015

Health Serv Deliv Res

223

281

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BackgroundPatient and public involvement (PPI) is a prerequisite for many funding bodies and NHS research ethics approval. PPI in research is defined as research carried out with or by the public rather than to, about or for them. While the benefits of PPI have been widely discussed, there is a lack of evidence on the impact and outcomes of PPI in research.ObjectivesTo determine the types of PPI in funded research, describe key processes, analyse the contextual and temporal dynamics of PPI and explore the experience of PPI in research for all those involved. Mechanisms contributing to the routine incorporation of PPI in the research process were assessed, the impact of PPI on research processes and outcomes evaluated, and barriers and enablers to effective PPI identified.DesignA three-staged realist evaluation drawing on Normalisation Process Theory to understand how far PPI was embedded within health-care research in six areas: diabetes mellitus, arthritis, cystic fibrosis, dementia, public health and learning disabilities. The first two stages comprised a scoping exercise and online survey to chief investigators to assess current PPI activity. The third stage consisted of case studies tracked over 18 months through interviews and document analysis. The research was conducted in four regions of England.ParticipantsNon-commercial studies currently running or completed within the previous 2 years eligible for adoption on the UK Clinical Research Network portfolio. A total of 129 case study participants included researchers and PPI representatives from 22 research studies, and representatives from funding bodies and PPI networks.ResultsIn the scoping 51% (n = 92) of studies had evidence of PPI and in the survey 79% (n = 80), with funder requirements and study design the strongest influence on the extent of PPI. There was little transparency about PPI in publicly accessible information. In case studies, context–mechanism–outcome configurations suggested that six salient actions were required for effective PPI. These were a clear purpose, role and structure for PPI; ensuring diversity; whole research team engagement with PPI; mutual understanding and trust between the researchers and lay representatives; ensuring opportunities for PPI throughout the research process; and reflecting on, appraising and evaluating PPI within a research study. PPI models included a ‘one-off’ model with limited PPI, a fully intertwined model in which PPI was fully embedded and an outreach model with lay representatives linking to broader communities. Enabling contexts included funder, topic/design, resources, research host, organisation of PPI and, most importantly, relationships. In some case studies, lack of coherence in defining PPI persisted, with evidence of a dual role of PPI representative/study participant. Evidence of PPI outcomes included changes to study design, improvements to recruitment materials and rates, and dissemination.ConclusionsSix salient actions were required for effective PPI and were characterised by a shared understanding of moral and methodological purposes of PPI, a key individual co-ordinating PPI, ensuring diversity, a research team positive about PPI input and fully engaged with it, based on relationships that were established and maintained over time, and PPI being evaluated in a proactive and systematic approach. Future work recommendations include exploring the impact of virtual PPI, cost analysis and economic evaluation of the different models of PPI, and a longer-term follow-up study of the outcomes of PPI on research findings and impact on services and clinical practice.FundingThe National Institute for Health Research Health Services and Delivery Research programme.

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“…The consideration of all stakeholders that play a role in product adoption is key for improving the commercial success of products. The integration of users can lead to a higher level of acceptance of the products or concepts (Elberse et al, ; Jackman et al, ; Martin et al, ). An early consideration of user needs can also reduce development and post‐launch issues and costs (Martin et al, ; Bergmann et al, ; Schaeffer, ).…”

Section: Resultsmentioning

confidence: 99%

“…Non‐material drivers include all possible non‐material outcomes that benefit the stakeholders as individuals or as organizations. End consumers' most obvious benefits relate to overcoming their personal challenges (De Couvreur and Goossens, ; Herrera‐Saray et al, ) and recognizing the value of their experience (Elberse et al, ). By contrast, professional users might be driven by the desire to overcome professional challenges through the development of adequate technologies (Lettl et al, ; Füller et al, ; Money et al, ; Kesselheim et al, ).…”

Section: Resultsmentioning

confidence: 99%

Stakeholder integration in new product development: a systematic analysis of drivers and firm capabilities

2016

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In this article, we develop a conceptual model of stakeholder integration in new product development (NPD) that (i) explains the drivers of the process and (ii) proposes a framework of capabilities that firms need for successful stakeholder integration. The focus lies on external stakeholders that directly influence the adoption of new products. We conduct a systematic literature review and content analyze a sample of 96 peer-reviewed journal articles. The study is restricted to the medical device industry to enable the use of specific search terms and the consistent categorization of information. We dedicate a section to showing how the framework applies to other settings. The drivers of stakeholder integration are classified into push factors (i.e., expected benefits for the focal firm) and pull factors (i.e., expected benefits for the stakeholders). This study provides an initial model of how stakeholder integration works based on its drivers. In addition, three related stakeholder integration capabilities emerge: stakeholder identification capability, stakeholder interaction capability and stakeholder input integration capability. The paper proposes a description of these capabilities for stakeholder integration in NPD and, thus, contributes to stakeholder theory and research on the management of NPD. The results open new paths for empirical testing and offer practical guidance on how to successfully integrate stakeholders in NPD processes.

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Patient involvement in a scientific advisory process: Setting the research agenda for medical products

Cited by 41 publications

References 51 publications

An effective multisource informed consent procedure for research and clinical practice: an observational study of patient understanding and awareness of their roles as research stakeholders in a cancer biobank

An effective multisource informed consent procedure for research and clinical practice: an observational study of patient understanding and awareness of their roles as research stakeholders in a cancer biobank

ReseArch with Patient and Public invOlvement: a RealisT evaluation – the RAPPORT study

Stakeholder integration in new product development: a systematic analysis of drivers and firm capabilities

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