Patrizia Natale1, Valeria Saglimbene2, Marinella Ruospo2, Andrea Matus Gonzalez3, Giovanni Fm Strippoli2, Nicole Scholes-Robertson3, Chandana Guha3, Jonathan C Craig4, Armando Teixeira-Pinto3, Tom Snelling5, Allison Tong3. 1. Sydney School of Public Health, University of Sydney, Sydney, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, NSW, Australia; Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy. Electronic address: natale.patrizia@gmail.com. 2. Sydney School of Public Health, University of Sydney, Sydney, Australia; Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy. 3. Sydney School of Public Health, University of Sydney, Sydney, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, NSW, Australia. 4. College of Medicine and Public Health, Flinders University, Adelaide, Australia. 5. Sydney School of Public Health, University of Sydney, Sydney, Australia.
Abstract
OBJECTIVE: To describe patient perspectives on recruitment and retention in clinical trials. STUDY DESIGN AND SETTING: Systematic review of qualitative studies that reported the perspective of adult patients with any health condition who accepted or declined to participate in clinical trials. RESULTS: Sixty-three articles involving 1681 adult patients were included. Six themes were identified. Four themes reflected barriers: ambiguity of context and benefit - patients were unaware of the research question and felt pressured in making decisions; lacking awareness of opportunities - some believed health professionals obscured trials opportunities, or felt confused because of language barriers; wary of added burden - patients were without capacity because of sickness or competing priorities; and skepticism, fear and mistrust - patients feared loss of privacy, were suspicious of doctor's motivation, afraid of being a guinea pig, and disengaged from not knowing outcomes. Two themes captured facilitators: building confidence - patients hoped for better treatment, were supported from family members and trusted medical staff; and social gains and belonging to the community - altruism, a sense of belonging and peer encouragement motivated participation in trials. CONCLUSION: Improving the visibility and transparency of trials, supporting informed decision making, minimizing burden, and ensuring confidence and trust may improve patient participation in trials.
OBJECTIVE: To describe patient perspectives on recruitment and retention in clinical trials. STUDY DESIGN AND SETTING: Systematic review of qualitative studies that reported the perspective of adult patients with any health condition who accepted or declined to participate in clinical trials. RESULTS: Sixty-three articles involving 1681 adult patients were included. Six themes were identified. Four themes reflected barriers: ambiguity of context and benefit - patients were unaware of the research question and felt pressured in making decisions; lacking awareness of opportunities - some believed health professionals obscured trials opportunities, or felt confused because of language barriers; wary of added burden - patients were without capacity because of sickness or competing priorities; and skepticism, fear and mistrust - patients feared loss of privacy, were suspicious of doctor's motivation, afraid of being a guinea pig, and disengaged from not knowing outcomes. Two themes captured facilitators: building confidence - patients hoped for better treatment, were supported from family members and trusted medical staff; and social gains and belonging to the community - altruism, a sense of belonging and peer encouragement motivated participation in trials. CONCLUSION: Improving the visibility and transparency of trials, supporting informed decision making, minimizing burden, and ensuring confidence and trust may improve patient participation in trials.
Authors: Allison Tong; Nicole Scholes-Robertson; Carmel Hawley; Andrea K Viecelli; Simon A Carter; Adeera Levin; Brenda R Hemmelgarn; Tess Harris; Jonathan C Craig Journal: Nat Rev Nephrol Date: 2022-06-06 Impact factor: 42.439
Authors: Carla Martins; Ricardo Assunção; Ana Costa; Débora Serrano; Lia Visintin; Marthe De Boevre; Carl Lachat; Arnau Vidal; Sarah De Saeger; Sónia Namorado; Cristina Vidigal; Elisabete Almeida; Paula Alvito; Carla Nunes Journal: Int J Environ Res Public Health Date: 2022-06-23 Impact factor: 4.614