Socio-demographic and clinical factors affecting General Consent status and choice: insights from a cross-sectional study of University Hospital Zurich patients.

Background: Hospitals in Switzerland accumulate substantial clinical data with enormous potential for medical research. The General Consent concept allows patients to contribute their health-related data and biological samples for future research projects. However, General Consent is a complex, multi-disciplinary concept influenced by ethical and legal considerations. At the University Hospital Zurich, Switzerland, General Consent status (known/unknown) and choice (yes/no) have been documented since 2015 and have demonstrated consistent increases in coverage rates. This study investigated socio-demographic factors influencing General Consent status and choice to enhance patient communication and refine the General Consent process at the University Hospital Zurich.

Methods: We assessed the effect of socio-demographic and clinical factors on General Consent status (known/unknown) and General Consent choice (yes/no) through logistic models and volcano plots. Patients who first visited University Hospital Zurich between January 1, 2018 and June 30, 2019 (pre COVID-19), or between July 1, 2020 and December 31, 2021 (during the COVID-19 pandemic) were included for analysis. Investigated factors included the type of visit, sex, age, nationality, religion, civil status, resuscitation preferences and living-will status, health insurance category and number of International Statistical Classification of Diseases and Related Health Problems, Version 10 (ICD-10) diagnoses. De-identified data from the University Hospital Zurich's clinical record system (KISIM) were used.

Results: A total of 162,168 patients were included for analysis. The type of visit (in-patient or out-patient), number of diagnoses, existence of a living will and religious preference were associated with General Consent status (known/unknown). Religious preferences were also found to influence General Consent choice.

Conclusion: This study identified significant differences in General Consent status between in-patients and out-patients at the University Hospital Zurich, with in-patients more likely to have an unknown General Consent status. To address this, we recommend reviewing the administrative process and documentation practices related to General Consent. Our results also indicated that patients actively involved in their medical decisions and those with multiple co-morbidities were more likely to have a known General Consent status. This is likely attributable to their increased health concerns and more frequent interactions with healthcare providers. Enhancing patient and physician understanding of General Consent can improve coverage rates and promote informed consent. However, further research is needed to explore cultural differences that may influence General Consent decisions. Ultimately, streamlining administrative procedures and implementing targeted educational initiatives will improve the understandability of the General Consent process and encourage greater participation in medical research.