Use the SPIRIT-PRO Extension, SISAQOL and PRO Alert guidelines to guide protocol development.
Clinical trial protocols are a vital blueprint for how a trial is conducted and reported. Contemporary research suggests the inclusion of ‘good-quality’ PRO protocol components facilitates more robust data collection, lower rates of avoidable missing data, and more informative data with which to generate meaningful, publishable, PRO reports.
- The SPIRIT-PRO Extension includes a checklist of PRO-specific components recommended for inclusion in a clinical trial protocol including a PRO as a primary or secondary outcome. PMID: 29411037
- The SISAQOL (Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data) consortium have developed recommendations for standardizing the analysis and interpretation of PRO and quality of life data in cancer randomized trials. SISAQOL Website
- PRO data may reveal signs of psychological distress or physical symptoms that may require an immediate response, known as ‘PRO alerts’. Having a clear PRO alert management plan in place in the protocol will help reduce the risk of co-intervention bias. See the following paper for guidance: ‘Patient-reported outcome alerts: ethical and logistical considerations in clinical trials.’ PMID: 24065005
4. Kyte D, Retzer A, Ahmed K, et al. Systematic evaluation of Patient-Reported Outcome protocol content and reporting in cancer trials. J Natl Cancer Inst. Volume 111, Issue 11, November 2019, Pages 1170–1178, https://doi.org/10.1093/jnci/djz038
5. Sackett DL. Clinician-trialist rounds: 5. Cointervention bias − how to diagnose it in their trial and prevent it in yours. Clinical Trials 2011;8:440-42. doi: DOI: 10.1177/1740774511410995