Development of Guidelines to Inform the Content of Summarized Patient Information Forms (SPIFs) Regarding Cancer-Related, Clinical Trials (#176)
Background/Objectives: Summarized patient information forms (SPIFs) have been used extensively to assist patients’ understanding of trial participation. However, little evidence supports the style and content of this document. The aim of the study was to develop consensus guidelines for a SPIF regarding cancer-related clinical trials.
Methods: The Delphi technique was followed using progressive rounds of an e-survey to answer the question: “If you were asked to take part as a patient in a cancer clinical drug trial today, please list what information would be essential to help you decide to take part or not.” The theory of communicative action was used to inform the study. Four groups of participants were recruited, including cancer patients, physicians, other health professionals, and other significant people, in order to achieve a balance in different perspectives.
Results: In phase one, 208 participants completed the screening survey and 156 participants were eligible. In round two (response rate: 96.8%), 74 statements was generated regarding the essential information in a cancer clinical trial. In round two (response rate: 76%), participants rated the importance of 74 statements when considering participation in a trial. In round 3 (response rate: 74%), participants were asked to identify the essential information for a SPIF from the remaining 30 statements. A final list of 15 statements was generated and formed the content of draft instructions. In phase 2, a recently completed RCT with the consent form was chosen to test the SPIF guideline document. Over 70% of participants agreed the summarized document was able to support patient decisions about trial participation.
Conclusion: The findings will help health professionals to design a SPIF and to support improved patient understanding of cancer trial participation.