Dataset Information

Stimulating Patient Engagement in Medical Device Development in Kidney Disease: A Report of a Kidney Health Initiative Workshop.

ABSTRACT: New technologies challenge current dialysis treatment paradigms as devices become smaller, more portable, and increasingly used outside the dialysis clinic. It is unclear how patients will view this care transition, and it will be important to consider patient and care partner perspectives during all aspects of development for novel dialysis therapies, from design and clinical trials to regulatory approval. To gain insight into this area, the Kidney Health Initiative, a public-private partnership between the American Society of Nephrology, the US Food and Drug Administration, and nearly 80 member organizations and companies dedicated to enhancing patient safety and fostering innovation in kidney disease, convened a workshop of patients, care partners, and other kidney community stakeholders. The workshop included background presentations followed by focused small group discussions in 3 areas (device design, clinical trials, and regulatory approval). Participants explored how to involve patients throughout the life cycle of a medical device, including discussions of how patients can influence device design, assist in the planning and implementation of clinical trials, and provide input to affect regulatory decisions. Patients were engaged in the workshop discussion and interested in sharing their perspectives, but they recommended additional efforts around education, communication, and outreach in these areas.

SUBMITTER: Hurst FP

PROVIDER: S-EPMC5610919 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Stimulating Patient Engagement in Medical Device Development in Kidney Disease: A Report of a Kidney Health Initiative Workshop.

Hurst Frank P FP Chianchiano Dolph D Upchurch Linda L Fisher Benjamin R BR Flythe Jennifer E JE Castillo Lee Celeste C Hill Terri T Neuland Carolyn Y CY

American journal of kidney diseases : the official journal of the National Kidney Foundation 20170427 4

New technologies challenge current dialysis treatment paradigms as devices become smaller, more portable, and increasingly used outside the dialysis clinic. It is unclear how patients will view this care transition, and it will be important to consider patient and care partner perspectives during all aspects of development for novel dialysis therapies, from design and clinical trials to regulatory approval. To gain insight into this area, the Kidney Health Initiative, a public-private partnershi ...[more]

PMID: 28457656

Similar Datasets

Project description:Background and objectivePatients with early chronic kidney disease (CKD) face challenges in accessing healthcare, including delays in diagnosis, fragmented speciality care and lack of tailored education and psychosocial support. Patient navigator programmes have the potential to improve the process of care and outcomes. The objective of this study is to describe the experiences of patients on communication, access of care and self-management and their perspectives on patient navigator programmes in early CKD.Design, setting and participantsWe convened a workshop in Australia with 19 patients with CKD (all stages including CKD Stage 1 to 5 not on dialysis, 5D (dialysis), and 5T (transplant)) and five caregivers. All of them were over 18 years and English-speaking. Transcripts from the workshop were analysed thematically.ResultsFour themes that captured discussions were: lost in the ambiguity of symptoms and management, battling roadblocks while accessing care, emotionally isolated after diagnosis and re-establishing lifestyle and forward planning. Five themes that focussed on patient navigator programmes were: trust and credibility, respecting patient choices and readiness to accept the programme, using accessible language to promote the programme, offering multiple ways to engage and communicate and maintaining confidentiality and privacy. Of the 17 features identified as important for a patient navigator programme, the top five were delivery of education, psychosocial support, lifestyle modification, communication and decision-making support and facilitating care.ConclusionPatient navigator services can address gaps in services around health literacy, communication, psychosocial support and coordination across multiple healthcare settings. In comparison to the existing navigator programmes, and other services that are aimed at addressing these gaps, credible, accessible and flexible patient navigator programmes for patients with early CKD, that support education, decision-making, access to care and self-management designed in partnership with patients, may be more acceptable to patients.

Project description:BackgroundPatient engagement in research (also commonly referred to as patient or patient and public involvement in research) strives to transform health research wherein patients (including caregivers and the public) are regularly and actively engaged as multidisciplinary research team members (i.e. patient partners) working jointly towards improved health outcomes and an enhanced healthcare system. To support its mindful evolution into a staple of health research, this participatory study aimed to identify future directions for Canadian patient engagement in research and discusses its findings in the context of the international literature.MethodsThe study met its aim through a multi-meeting pan-Canadian virtual workshop. Participants (n = 30) included Strategy for Patient-Oriented Research-funded academic researchers and patient partners identified through a publicly available database, personal and professional networks and social media. All spoke English, could access the workshop virtually, and provided written informed consent. The workshop was composed of four, 1.5-3-h virtual meetings wherein participants discussed the current and preferred future states of Canadian patient engagement in research. Workshop discussions (i.e. data) were video and audio recorded. Themes were generated through an iterative process of inductive thematic analysis that occurred concurrently with the multi-week workshop.ResultsOur participatory and iterative process identified 10 targetable areas of focus for the future of Canadian patient engagement in research. Five were categorized as system-level (systemic integration; academic culture; engagement networks; funding models; compensation models), one as researcher-level (engagement processes), and four crossed both levels (awareness; diversity and recruitment; training, tools and education; evaluation and impact). System level targetable areas called for reshaping the patient engagement ecosystem to create a legitimized and supportive space for patient engagement to be a staple component of a learning health system. Researcher level targetable areas called for academic researchers and patient partners to collaboratively generate evidence and apply knowledge to inform values and behaviours necessary to foster and sustain supportive health research spaces that are accessible to all.ConclusionsFuture directions for Canadian patient engagement in research span 10 interconnected targetable areas that require strong leadership and joint action between patient partners, academic researchers, and health and research institutions if patient engagement is to become a ubiquitous component of a learning health system.

Dataset Information

Stimulating Patient Engagement in Medical Device Development in Kidney Disease: A Report of a Kidney Health Initiative Workshop.

Publications

Stimulating Patient Engagement in Medical Device Development in Kidney Disease: A Report of a Kidney Health Initiative Workshop.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets