Implementing stakeholder engagement to explore alternative models of consent: An example from the PREP-IT trials

被引：0

作者：

Pechero, Guillermo, Jr. ^{[1
]}

Pfaff, Branden ^{[2
]}

Rao, Mayank ^{[1
]}

Pogorzelski, David ^{[3
]}

McKay, Paula ^{[3
]}

Spicer, Ella ^{[4
]}

Howe, Andrea ^{[5
,15
]}

Demyanovich, Haley K. ^{[5
,15
]}

Sietsema, Debra L. ^{[6
]}

McTague, Michael F. ^{[7
]}

Ramsey, Lolita ^{[8
]}

Holden, Martha ^{[9
]}

Rudnicki, Joshua ^{[5
,15
]}

Wells, Jeff ^{[10
]}

Medeiros, Michelle ^{[11
]}

Slobogean, Gerard P. ^{[5
,13
,15
]}

Sprague, Sheila ^{[3
,12
,14
]}

Wells, Jeffrey ^{[10
]}

Bhandari, Mohit ^{[14
]}

O'Toole, Robert, V ^{[15
]}

D'alleyrand, Jean-Claude ^{[15
]}

Eglseder, Andrew ^{[15
]}

Johnson, Aaron ^{[15
]}

Langhammer, Christopher ^{[15
]}

Lebrun, Christopher ^{[15
]}

Manson, Theodore ^{[15
]}

Nascone, Jason ^{[15
]}

Paryavi, Ebrahim ^{[15
]}

Pensy, Raymond ^{[15
]}

Pollak, Andrew ^{[15
]}

Sciadini, Marcus ^{[15
]}

Degani, Yasmin ^{[15
]}

O'Hara, Nathan N. ^{[15
]}

Joseph, Katherine ^{[15
]}

机构：

[1] Univ Texas Houston, Hlth Sci Ctr Houston, McGovern Med Sch, 7000 Fannin St, Houston, TX 77004 USA

[2] Sanford USD Med Ctr & Hosp, 1305 W 18th St, Sioux Falls, SD USA

[3] McMaster Univ, Dept Surg, 293 Wellington St N,Suite 110, Hamilton, ON, Canada

[4] Fraser Hlth Author Royal Columbian Hosp, 403-233 Nelsons Crescent, New Westminster, BC, Canada

[5] Univ Maryland, Sch Med, Dept Orthopaed Surg, 655 W Baltimore St S, Baltimore, MD 21201 USA

[6] CORE Inst, 6501 North 19th Ave, Phoenix, AZ USA

[7] Brigham & Womens Hosp, Harvard Med Sch Orthoped Trauma Initiat, Dept Orthopaed Surg, 75 Francis St, Boston, MA 02115 USA

[8] Inova Fairfax Med Campus,3300 Gallows Rd, Falls Church, VA USA

[9] Wake Forest Baptist Hlth, Dept Orthopaed Surg, 1 Med Ctr Blvd, Winston Salem, NC USA

[10] Trauma Survivors Network, 8110 Gatehouse Rd, Falls Church, VA USA

[11] Univ Maryland, Sch Pharm, PATIENTS Program, 220 Arch St, Baltimore, MD 21201 USA

[12] McMaster Univ, Dept Hlth Res Methods Evidence & Impact, 1280 Main St W, Hamilton, ON, Canada

[13] Univ Maryland, Sch Med, Baltimore, MD 21201 USA

[14] McMaster Univ, Hamilton, ON, Canada

[15] Univ Maryland, Sch Med, R Adams Cowley Shock Trauma Ctr, Baltimore, MD 21201 USA

来源：

CONTEMPORARY CLINICAL TRIALS COMMUNICATIONS | 2021年 / 22卷

基金：

加拿大健康研究院;

关键词：

Cluster randomized crossover; Stakeholder engagement; Consent; Deferred consent; Trial design; Patient advisors; MULTICENTER; PREVENTION; FRACTURES;

D O I：

10.1016/j.conctc.2021.100787

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Introduction: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent. Methods: The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have. Results: Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation. Discussion: Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.

引用

页数：4

共 19 条

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Journal of Business Ethics, 2019, 160 : 913 - 936
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AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, 2014, 189
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BMC MEDICAL ETHICS, 2019, 20 (1)
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BMC Medical Ethics, 20

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