¹Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany
²National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg, Germany
³Heidelberg University Hospital, Heidelberg, Germany
⁴Medizinische Fakultät Heidelberg / Universitätsklinikum Heidelberg, Heidelberg, Germany
⁵Nationales Centrum für Tumorerkrankungen (NCT), Deutsches Krebsforschungszentrum (DKFZ) Heidelberg, Heidelberg, Germany

Text

Introduction: The German Medical Informatics Initiative (MII) has successfully developed a nationally-harmonized standard for patient information and consent [1], [2], allowing research use of routine patient data. Since implementing the MII Broad Consent (BC) at the University of Heidelberg Department of Radiation Oncology, extensive experience has been gained, both in terms of positive patient feedback and difficulties arising from the practice of recruiting patients for the BC. We here report challenges, for instance patients’ coping with the 12-page information text, and lessons learnt from practice. Responding more sensitively to patients’ needs and addressing their insecurities should be a primary goal when asking for patients’ consent.

Methods: Our report is based on the subjective and first-hand experiences of the research nurse responsible for piloting the rollout at the Heidelberg University Hospital. Since 2021, 15567 patients have been approached at the Department of Radiation Oncology, 8949 (57.5%) of those patients have given their consent and 793 (5.1%) have categorically refused consent. The patient cohort was heterogeneous with varied ages, level of functioning and life expectancy. The challenges and lessons were drawn on personal experiences with patients. Regular exchange of information with the local rollout taskforce group enhanced the information input.

Result: Pitfalls and difficulties in the process of informing patients about BC range from communicatory issues over organizational aspects to responding to personal wishes and concerns. The process of informing patients typically takes place in the context of clinical admissions, where uncertainty or anguish over the upcoming consultations are often present and where tactfulness and discretion are of the essence. It is important to anticipate and be responsive to the needs of patients and to adjust the conversation, e.g., in terms of the consultation site or information materials used. Certain parts of the consent form have shown to raise more questions than others. The biomaterial module frequently sparks questions and unease, making the information process more time consuming and often is a deterring factor for patient consent. Some patients worry that they will be required to undergo further obligatory examinations for research. On the organizational level, difficulties can arise when patients receive multiple consent documents from different research projects during the course of their treatment. This highlights the risk of burdening and confusing patients with several information and consent documents from different research projects and stresses the importance of good research coordination.

Discussion: Information materials and other resources are pivotal for the success of the information process, as are factors such as the personal experience and empathy of the informing staff. A more patient-friendly consent could encourage participation or at the least lessen the patients’ anxiety. By sharing firsthand experiences from the consenting process, we not only aim to offer valuable insights for other practitioners, but to also broadly share a patient-oriented view with those working on the ethical underpinnings of consent. The intention is to have a nuanced discussion and open dialog on future challenges. Our goal is to increase patient acceptance and decrease the number of patients needing time for participation consideration.

The authors are involved in the HiGHmed Consortium of the Medical Informatics Initiative (MII), including funding from the MII. CS and JS are involved in the Consent Working Group of the MII National Steering Committee.

The authors declare that an ethics committee vote is not required.

Literatur

[1] Consent Working Group of the German Medical Informatics Initiative. Guide to the Use of Nationally Harmonised Patient Information and Consent Documents for the Secondary Use of Patient Data (English). Available from: https://www.medizininformatik-initiative.de/sites/default/files/2020-11/MII_WG-Consent_Guide-Patient-Consent-Form_v0.9d_engl.-version.pdf
[2] Consent Working Group of the German Medical Informatics Initiative. Patient Consent Form Template (English). Version 1.6d. Available from: https://www.medizininformatik-initiative.de/sites/default/files/2020-11/MII_WG-Consent_Patient-Consent-Form_v1.6d_engl-version.pdf