Background: Clinician-based reporting of adverse events leads to underreporting and underestimation of the impact of adverse events. To overcome the gap between what clinicians report and what patients experience, interest grows in capturing adverse events directly from patients using patient-reported outcomes (PROs), which may enhance its precision and comprehensiveness. Patient Reported Outcomes Safety Event Reporting (PROSPER) developed a guideline that refers to capturing adverse events in PROs, PRO-AEs–related data that can be valuable for monitoring and managing adverse events. Only the American Institute for Cancer Research has developed a PRO-CTCAE measurement tool for oncology patients. A universal scale for PRO-AEs that is widely used in patients discharged from hospital is lacking. Objective: To develop a set of generalized PRO-AEs for discharged patients and validate the reliability in a tertiary general hospital in China, followed by an empirical study in three hospitals of different grades to investigate the effect of health care team members’ traits on the occurrence of adverse events in patients through a two-stage postdischarge follow-up with the inclusion of patient demographics, disease conditions and in-hospital treatment received using a random effects model, and a composite index method for risk adjustment.
Methods: We used a mixed-method approach based on the ‘phase I guideline for developing questionnaire modules’ by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life group. Our approach included a comprehensive literature study and semistructured interviews with patients (n=30) and healthcare providers (n=26) to identify the items most relevant for patients. Subsequently, we used a modified Delphi procedure to reach consensus on the final selection of items.
Results: The Delphi method has high expert positivity coefficients, Kendall’s W coefficients showing good expert agreement, and pre-experimental findings showing good reliability of the scale to reflect adverse events. The empirical study is ongoing, and data analysis will be completed by September. Conclusion: There is a significant difference between the incidence and type of patient-reported in-hospital adverse events and the self-reported occurrence of common adverse events by healthcare professionals in the interviews.