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

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 respondents to the online survey agreed that a sample SPIF generated by the draft guideline could support patient decision making. After the draft guideline revision, the researcher and four health professionals used the guideline to independently create a SPIF. The Flesch-Kincaid reading ease scores of the sample SPIFs were between 61.3 and 66.5, with reading levels between 7.8 and 8.8, indicating that the guideline document can assist health professionals with the generation of an understandable SPIF. The reference group members provided positive feedback on the guideline document, and an expert on plain language in healthcare information proofread the guideline document. Conclusion: The approach used in the study ensured the potential of the guideline document developed to enable generation of SPIFs that provide patients considering participation in a cancer clinical trial with essential and understandable information to support their decision making.