Operationalizing a patient engagement plan for health research: Sharing a codesigned planning template from a national clinical trial

AbstractWe describe our efforts to overcome barriers to patient engagement in facioscapulohumeral muscular dystrophy (FSHD), and offer a roadmap that can be replicated in other rare neurological disorders. We implemented an engagement plan during Clinical Trial Readiness to Solve Barriers to Drug Development for FSHD (ReSolve), an 18-month, multi-site, observational study of individuals with FSHD. Elements of our engagement plan included conducting focus groups during protocol development, patient involvement on the ReSolve external advisory committee, creation of a patient advisory committee, and collaboration with patient advocacy groups. Patient feedback led to adaptations in the study protocol and to changes in recruitment and retention methods. Patient engagement ensures the patient voice contributes to multiple aspects of trial design and implementation. Our engagement efforts exemplify how collaboration with patients and families can be accomplished in FSHD and the resultant roadmap process may be replicable in other rare neurological diseases.

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Patient engagement in Canada: a scoping review of the ‘how’ and ‘what’ of patient engagement in health research

Health Research Policy and Systems ◽

10.1186/s12961-018-0282-4 ◽

2018 ◽

Vol 16 (1) ◽

Cited By ~ 58

Author(s):

Elizabeth Manafo ◽

Lisa Petermann ◽

Ping Mason-Lai ◽

Virginia Vandall-Walker

Keyword(s):

Scoping Review ◽

Patient Engagement ◽

Health Research

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Biobank/Genomic Research in Nigeria: Examining Relevant Privacy and Confidentiality Frameworks

The Journal of Law Medicine & Ethics ◽

10.1111/jlme.12319 ◽

2015 ◽

Vol 43 (4) ◽

pp. 776-786

Author(s):

Obiajulu Nnamuchi

Keyword(s):

Clinical Trial ◽

Health Research ◽

Scientific Discovery ◽

Scientific Progress ◽

Genomic Research ◽

Research Subjects ◽

Easy Task ◽

Legal Nature ◽

Privacy And Confidentiality ◽

Societal Interest

Health research raises profound concerns of an ethical and legal nature — concerns primarily centered on how to balance researchers’ quest for scientific discovery against societal interest in protecting individuals whose participation makes the discovery possible. Particularly in a country such as Nigeria, which, not too long ago, suffered major abuse of research subjects (Pfizer’s clinical trial of Trovafloxacin and resulting death of eleven children in 1996), deploying a robust ethicolegal regime capable of curbing excesses and protecting research participants whilst contemporaneously not frustrating scientific progress is not an easy task. This is even more critical in the context of novel scientific endeavors, such as biobanking and genomic research, particularly when a significant pool of potential donors are inadequately informed about the processes involved in their participation or the result.

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SUN-215 PATIENT ENGAGEMENT IN KNOWLEDGE TRANSLATION: A COLLABORATIVE MODEL FOR MOVING KIDNEY HEALTH RESEARCH INTO PRACTICE

Kidney International Reports ◽

10.1016/j.ekir.2019.05.619 ◽

2019 ◽

Vol 4 (7) ◽

pp. S248-S249

Author(s):

M. Beaucage ◽

S. Allu ◽

M. Elliott ◽

A. Levin

Keyword(s):

Knowledge Translation ◽

Patient Engagement ◽

Health Research ◽

Collaborative Model ◽

Kidney Health

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Development of the patient-oriented research curriculum in child health (PORCCH)

Research Involvement and Engagement ◽

10.1186/s40900-021-00276-z ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Colin Macarthur ◽

Catharine M. Walsh ◽

Francine Buchanan ◽

Aliza Karoly ◽

Linda Pires ◽

...

Keyword(s):

Child Health ◽

Patient Engagement ◽

Health Research ◽

Healthcare Professionals ◽

Research Process ◽

Decision Makers ◽

Core Element ◽

Research Curriculum ◽

Child Health Research ◽

Oriented Research

Abstract Background The Canadian Institutes for Health Research launched a national ‘Strategy for Patient-Oriented Research’ (SPOR) in 2011. Patient-oriented research is defined as a continuum of research that engages patients as partners, focuses on patient-identified priorities, and improves patient outcomes. Capacity development is a core element of SPOR. Barriers to patient-oriented research include unfamiliarity with the research process for patients and families and unfamiliarity with the methods of patient and family engagement for researchers. Methods The aim of the Patient-Oriented Research Curriculum in Child Health (PORCCH) is to build capacity in patient-oriented research in child health among patients and families, researchers, healthcare professionals, decision-makers, and trainees through a curriculum delivered via a series of interactive online modules (e-learning). A multi-disciplinary, multi-stakeholder steering committee, which included patients and families, guided the development of the curriculum and provided feedback on individual modules. The content, design, and development of each module were co-led by a parent and researcher in an equal partnership. Results PORCCH consists of a series of five modules. All modules are interactive and include video vignettes and knowledge comprehension questions. Access to the modules is free and each module takes approximately 30 min to complete. The five modules are: Research 101 (an Introduction to Patient-Oriented Research, parts 1 and 2), Patient Engagement 101 (an Introduction to Patient Engagement in Child Health Research, parts 1 and 2), and Research Ethics 101. Conclusions PORCCH was developed specifically to overcome recognized barriers to the engagement of patients and families in child health research. The aim of the curriculum is to build capacity in patient-oriented research in child health. The goal is for PORCCH to be a useful resource for all stakeholders involved in patient-oriented research: patients and families, researchers, healthcare professionals, decision-makers, and trainees.

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Advancing collaborations in health research and clinical trials in Sub-Saharan Africa: development and implementation of a biostatistical collaboration module in the Masters in Biostatistics Program at Stellenbosch University

Trials ◽

10.1186/s13063-021-05427-x ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Tonya M. Esterhuizen ◽

Guowei Li ◽

Taryn Young ◽

Jie Zeng ◽

Rhoderick Machekano ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Health Research ◽

Research Capacity ◽

Communicable Diseases ◽

National Institutes Of Health ◽

Sub Saharan Africa ◽

Sub Saharan ◽

Fogarty International Center ◽

Program Grant

Abstract Background Sub-Saharan Africa continues to carry a high burden of communicable diseases such as TB and HIV and non-communicable diseases such as hypertension and other cardiovascular conditions. Although investment in research has led to advances in improvements in outcomes, a lot still remains to be done to build research capacity in health. Like many other regions in the world, Sub-Saharan Africa suffers from a critical shortage of biostatisticians and clinical trial methodologists. Methods Funded through a Fogarty Global Health Training Program grant, the Faculty of Medicine and Health Sciences at Stellenbosch University in South Africa established a new Masters Program in Biostatistics which was launched in January 2017. In this paper, we describe the development of a biostatistical and clinical trials collaboration Module, adapted from a similar course offered in the Health Research Methodology program at McMaster University. Discussion Guided by three core principles (experiential learning; multi-/inter-disciplinary approach; and formal mentorship), the Module aims to advance biostatistical collaboration skills of the trainees by facilitating learning in how to systematically apply fundamental statistical and trial methodological knowledge in practice while strengthening some soft skills which are necessary for effective collaborations with other healthcare researchers to solve health problems. We also share some preliminary findings from the first four cohorts that took the Module in January–November 2018 to 2021. We expect that this Module can provide an example of how to improve biostatistical and clinical trial collaborations and accelerate research capacity building in low-resource settings. Funding source Fogarty International Center of the National Institutes of Health.

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