The challenges of patient and public involvement in medical technology and in-vitro diagnostic research

Patient and public involvement (PPI) in research is defined as 'research being carried out "with" or "by" members of the public rather than "to", "about" or "for" them'. A knowledge transfer event (KTE) was planned to share the experience of organizations who carry out medical technology research. The KTE was attended by organizations with an interest in the effective application of PPI in health-care research, including organizations from academia, industry and charities. The aim was to share current PPI experience and to discuss the development of a PPI impact measurement framework to support future growth in PPI application within medical technology research.

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The challenges of patient and public involvement in medical technology and in-vitro diagnostic research

Research for All ◽

10.18546/rfa.02.2.11. ◽

2018 ◽

Vol 2 (2) ◽

pp. 335-346

Author(s):

Ijeoma Uchegbu ◽

Momoko Sato ◽

Alison Allam ◽

Peter Buckle ◽

George Hanna

Keyword(s):

Medical Technology ◽

Public Involvement ◽

Patient And Public Involvement ◽

In Vitro Diagnostic ◽

Diagnostic Research

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Patient engagement in fertility research: bench research, ethics, and social justice

Research Involvement and Engagement ◽

10.1186/s40900-021-00278-x ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Perry R. Fleming ◽

Makayla M. Swygert ◽

Coen Hasenkamp ◽

Jessica Sterling ◽

Ginny Cartee ◽

...

Keyword(s):

Patient Engagement ◽

Public Involvement ◽

Science Research ◽

Patient And Public Involvement ◽

Main Body ◽

Vitro Fertilization ◽

Unique Nature ◽

Meaningful Engagement ◽

Verbal Agreement

Abstract Background Patient and Public Involvement (PPI) in research is increasingly being utilized to better connect patients and researchers. The Patient Engagement Studio (PES) supports PPI in research by working directly with researchers throughout various stages of their projects. Recently, two researchers presented to the PES for assistance with their project, Embryo+™. The purpose of Embryo+™ is to decrease miscarriage rates using RNA sequencing technology that screens for the most viable embryos. To date, no examples of PPI directly in the planning or implementation of bench research concerning in vitro fertilization and embryo transfer have been identified. Main body Embryo+™ researchers met in-person with the PES two times (fall 2019; each meeting had 9 PES members in attendance) for initial feedback and protocol development. After these meetings, PES leadership and Embryo+™ researchers decided that the unique nature of the project merited a PPI evaluation. Subsequent evaluation of engagement efforts occurred by reviewing the PES reports for the Embryo+™ researchers, conducting two recorded web-based discussion meetings with the PES (summer 2020; meeting 1 n = 7; meeting 2 n = 6), and a brief survey (n = 13). The discussion meetings provided an opportunity for the PES members to define engagement themes through consensus via verbal agreement to the studio director’s periodic summaries during the discussions. Combining survey results and PES themes allowed for a broad discussion for meaningful engagement. The Embryo+™ researchers established trust with the patients by changing some of their language in response to patient suggestions, allowing for unintended ethical conversations, and implementing the patient developed protocols. Overall, the patient experts thought this project was very meaningful and valuable, quantified by a mean loyalty score 89.43 (s.d. 10.29). Conclusion Bench science researchers may need additional PPI training prior to engaging with patient groups. PPI in this project was successful in large part due to this training, where the director emphasized the importance of gaining trust with the patients. The researchers applied what they learned and several examples of how to develop trust with patients are discussed. If trust is established, PPI in an ethically charged, basic science research study can be both valuable and successful.

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How to Ease the Pain of Taking a Diagnostic Point of Care Test to the Market: A Framework for Evidence Development

Micromachines ◽

10.3390/mi11030291 ◽

2020 ◽

Vol 11 (3) ◽

pp. 291 ◽

Cited By ~ 4

Author(s):

Sara Graziadio ◽

Amanda Winter ◽

B. Lendrem ◽

Jana Suklan ◽

William Jones ◽

...

Keyword(s):

Development Strategy ◽

Public Involvement ◽

Care Pathway ◽

Point Of Care ◽

Patient And Public Involvement ◽

Product Management ◽

Point Of Care Test ◽

Value Propositions ◽

On Line

Bringing a diagnostic point of care test (POCT) to a healthcare market can be a painful experience as it requires the manufacturer to meet considerable technical, financial, managerial, and regulatory challenges. In this opinion article we propose a framework for developing the evidence needed to support product development, marketing, and adoption. We discuss each step in the evidence development pathway from the invention phase to the implementation of a new POCT in the healthcare system. We highlight the importance of articulating the value propositions and documenting the care pathway. We provide guidance on how to conduct care pathway analysis as little has been published on this. We summarize the clinical, economic and qualitative studies to be considered for developing evidence, and provide useful links to relevant software, on-line applications, websites, and give practical advice. We also provide advice on patient and public involvement and engagement (PPIE), and on product management. Our aim is to help device manufacturers to understand the concepts and terminology used in evaluation of in vitro diagnostics (IVDs) so that they can communicate effectively with evaluation methodologists, statisticians, and health economists. Manufacturers of medical tests and devices can use the proposed framework to plan their evidence development strategy in alignment with device development, applications for regulatory approval, and publication.

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Involving patients and publics in medical and health care research studies: an exploratory survey on participant recruiting and representativeness from the perspective of study authors

10.1101/410480 ◽

2018 ◽

Author(s):

Jonas Lander ◽

Holger Langhof ◽

Marie-Luise Dierks

Keyword(s):

Health Care ◽

Social Science ◽

Empirical Data ◽

Public Involvement ◽

Health Care Research ◽

Patient And Public Involvement ◽

Descriptive Statistics ◽

Participant Recruitment ◽

Electronic Survey ◽

Exploratory Survey

AbstractResearch on patient and public involvement so far concentrates on defining involvement, describing involvement methods, and analyzing involvement practice in various individual research disciplines. There is little empirical data on the process of and aims for selecting participants, and to what extend lay people involved in research can and should be representative of the population at large. To explore practices and perceptions on these issues and on future PPI conduct more generally, we sent an electronic survey to authors who published involvement activities as part of their studies in medical and social science journals. We identified such authors with a systematic search of five databases and applied descriptive statistics for analysis. Of those who returned the survey (n=127 of 315; 40%), most had previously conducted involvement activities (73%). 45% reported more than one type of involvement, e.g. consultation and deliberation and participation (14%) and to have recruited more than one type of participant for their PPI activity (56%), e.g. ‘lay publics’ and ‘expert publics’ (33% of 71). Representativeness was seen by most respondents as a crucial objective when recruiting participants, while less than half found the recruitment of suitable participants very easy (9%) or rather easy (34%). Many respondents found it generally difficult (52%) or very difficult (17%) to achieve good representativeness. They identified significant respective challenges and desired more guidance on various aspects of planning and conducting PPI (56%). 55% thought that the concept of “involvement” should be changed or improved. We conclude that participant recruitment and representativeness are controversial in current PPI practice given the manifold challenges mentioned by the survey respondents. Our findings may inform further research particularly regarding– the potentially large number of – unpublished PPI activities.

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