Bias in obtaining broad consent in a German general practice? - Preliminary results from a cross-sectional study.

Abstract

Background: The growing importance of collecting Broad Consent (BC) for research utilizing electronic health records in Germany has brought attention to the need for a deeper understanding of potential selection bias in the process. Since 2020, the BeoNet-Halle outpatient database has been collecting anonymous and pseudonymous patient data from primary care and specialty practices throughout Germany, with the practice being an integral part of this data collection effort. The primary objective of the pilot study is to explore potential socioeconomic discrepancies between patients who provided BC and the general practice population.

Method: This is a single-center, cross-sectional study. The study was performed with patients from one Medical Care Center including eight GPs. We categorized patients with at least one interaction with a general practitioner from March 2021 to January 2023 into two sets: patients who approved BC versus a randomly chosen representative sample (RS) of non-BC inquirers. We mailed a sociodemographic survey to both groups.

Results: A total of 561 patients were analyzed, with the BC group responding more actively (60.7%) than the RS group (29.7%). Age and gender were similar between the BC group and RS group. Being widowed, divorced, or unmarried and being neither open nor hostile toward research was associated with an increased likelihood of giving consent. Analysis of personality traits did not show any impact on giving consent.

Conclusions: Overall, this study outlines that there is some bias between BC and RS. Possible associations in BC decisions that offer insights into complex decisions to participate in medical research are marital status, immigrant background, income, and age. Findings emphasize the potential of BC for outpatient research, warranting further investigation to optimize its application in the general practice setting.