International perspectives on suboptimal patient-reported outcome trial design and reporting in cancer clinical trials: A qualitative study.

ABSTRACT:

Purpose

Evidence suggests that the patient-reported outcome (PRO) content of cancer trial protocols is frequently inadequate and non-reporting of PRO findings is widespread. This qualitative study examined the factors influencing suboptimal PRO protocol content, implementation, and reporting, and use of PRO data during clinical interactions.

Methods

Semi-structured interviews were conducted with four stakeholder groups: (1) trialists and chief investigators; (2) people with lived experience of cancer; (3) international experts in PRO cancer trial design; (4) journal editors, funding panelists, and regulatory agencies. Data were analyzed using directed thematic analysis with an iterative coding frame.

Results

Forty-four interviews were undertaken. Several factors were

SUBMITTER: Retzer A 

PROVIDER: S-EPMC8366078 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature