TY - JOUR
T1 - Transparency, trust and minimizing burden to increase recruitment and retention in trials
T2 - a systematic review
AU - Natale, Patrizia
AU - Saglimbene, Valeria
AU - Ruospo, Marinella
AU - Gonzalez, Andrea Matus
AU - Strippoli, Giovanni FM
AU - Scholes-Robertson, Nicole
AU - Guha, Chandana
AU - Craig, Jonathan C.
AU - Teixeira-Pinto, Armando
AU - Snelling, Tom
AU - Tong, Allison
PY - 2021/6
Y1 - 2021/6
N2 - 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.
AB - 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.
KW - Barriers
KW - Clinical trials
KW - Patient recruitment
KW - Patient retention
KW - Research
KW - Strategies
UR - http://www.scopus.com/inward/record.url?scp=85101056877&partnerID=8YFLogxK
U2 - 10.1016/j.jclinepi.2021.01.014
DO - 10.1016/j.jclinepi.2021.01.014
M3 - Article
C2 - 33515656
AN - SCOPUS:85101056877
VL - 134
SP - 35
EP - 51
JO - Journal of Clinical Epidemiology
JF - Journal of Clinical Epidemiology
SN - 0895-4356
ER -