Consensus on Language for Advance Informed Consent in Health Care–Associated Pneumonia Clinical Trials Using a Delphi Process | Zendy

Amy Corneli | Zendy; Sara B. Calvert | Zendy; John H. Powers | Zendy; Teresa Swezey | Zendy; Deborah Collyar | Zendy; Brian Perry | Zendy; John Farley | Zendy; Jonas Santiago | Zendy; Helen K. Donnelly | Zendy; Carisa De Anda | Zendy; Katelyn Blanchard | Zendy; Vance G. Fowler | Zendy; Thomas L Holland | Zendy

Open Access

Consensus on Language for Advance Informed Consent in Health Care–Associated Pneumonia Clinical Trials Using a Delphi Process

Author(s) -

Amy Corneli,

Sara B. Calvert,

John H. Powers,

Teresa Swezey,

Deborah Collyar,

Brian Perry,

John Farley,

Jonas Santiago,

Helen K. Donnelly,

Carisa De Anda,

Katelyn Blanchard,

Vance G. Fowler,

Thomas L Holland

Publication year - 2020

Publication title -

jama network open

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 3.278

H-Index - 39

ISSN - 2574-3805

DOI - 10.1001/jamanetworkopen.2020.5435

Subject(s) - informed consent , delphi method , clinical trial , family medicine , delphi , medicine , health care , nursing , psychology , alternative medicine , political science , pathology , statistics , mathematics , computer science , law , operating system

Key Points Question What information do key stakeholders want in informed consent forms for noninferiority clinical trials on hospital-acquired and/or ventilator-associated bacterial pneumonia, and how should such information be described? Findings In this Delphi study of 52 key stakeholders (patients at risk of pneumonia, caregivers, representatives of institutional review boards, investigators, and study coordinators), consensus was reached on how to describe reassurances on patient health and treatment, a rationale for advance consent and early enrollment, and noninferiority. Meaning Results of this study suggest that inclusion of information on these concepts in informed consent forms may help potential participants make informed decisions about participating in noninferiority trials of health care–associated pneumonia treatment.

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