Development and testing of a guideline document to provide essential information for patient decision making regarding cancer clinical trials

Abstract

Objective: To develop and test a guideline document to advise the content of a summarised patient information form (SPIF) regarding cancer clinical trials. Methods: A two-phase study was undertaken to inform the development of the guideline document. In phase 1, 15 statements drawn from an international Delphi study and participant commentary were used to draft content for the guideline document. In phase 2, Delphi participants were invited to contribute to a five-step process via an online survey, to feedback on the guideline document, including the process for guideline formulation, testing application, revision, utility and clarity assessment, and completion. Results: Over 73% of responde..