Patient and public involvement in the design and conduct of a large, pragmatic observational trial to investigate recurrent, high-risk non-muscle-invasive bladder cancer.

Autor: Smith AB; Department of Urology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina., Lee JR; Department of Urology, University of Washington, Seattle, Washington., Lawrence SO; Department of Surgery, University of Washington, Seattle, Washington., Ho O; Virginia Mason Franciscan Health, Seattle, Washington., Lavallee DC; British Columbia Academic Health Science Network, Vancouver, British Columbia, Canada.; Department of Health Services, University of Washington, Seattle, Washington., Chisolm S; Bladder Cancer Advocacy Network, Bethesda, Maryland., MacLean DB; Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer Advocate Advisory Board, Seattle, Washington., Louwers RK; Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer Advocate Advisory Board, Seattle, Washington., Wolff EM; Department of Urology, University of Washington, Seattle, Washington., Kessler LG; Department of Health Services, University of Washington, Seattle, Washington., Follmer KM; Department of Urology, University of Washington, Seattle, Washington., Gore JL; Department of Urology, University of Washington, Seattle, Washington.
Jazyk: angličtina
Zdroj: Cancer [Cancer] 2022 Jan 01; Vol. 128 (1), pp. 103-111. Date of Electronic Publication: 2021 Sep 08.
DOI: 10.1002/cncr.33897
Abstrakt: Background: Patient-centered approaches to research design are particularly important for diseases with complex treatment decision-making, such as recurrent, high-grade non-muscle-invasive bladder cancer (NMIBC). The objective of this article is to describe patient and public involvement (PPI) in designing a large, pragmatic observational trial and to articulate barriers, challenges, and lessons learned for future design.
Methods: Through multistakeholder involvement, a large, pragmatic observational trial was designed to investigate the outcomes of high-risk, recurrent NMIBC, and it was titled Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer (CISTO). CISTO's design used the Guidance for Reporting Involvement of Patients and the Public 2 reporting checklist for PPI and built on prior engagement infrastructure in partnership with the Bladder Cancer Advocacy Network.
Results: CISTO's PPI began with research prioritization to identify the highest priority questions facing patients with NMIBC. A pragmatic observational study design was selected and refined through stakeholder input. PPI included patients and caregivers organized into an advocate advisory board and clinicians, researchers, payers, and industry representatives organized into an external advisory board. An engagement plan was created to define the stages of PPI and the level and nature of the involvement of each group. PPI was measured quantitatively and qualitatively through evaluation surveys and iterative feedback from board members, with changes made for continuous improvement.
Conclusions: Through intentional PPI, CISTO aims to produce pragmatic and generalizable results that will allow patients to make informed decisions for recurrent, high-risk NMIBC based on their personal experiences.
Lay Summary: Involving patients and other stakeholders in research ensures that it reflects the outcomes that matter most to them. This is especially important when research focuses on conditions in which patients face difficult decisions about treatment options. This article describes the key role that stakeholders played in shaping the Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer (CISTO) study. It compares treatments for recurrent noninvasive bladder cancer and describes how stakeholders were engaged to design and develop the study and the practices that supported their involvement.
(© 2021 American Cancer Society.)
Databáze: MEDLINE
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