Patient Orientation and Shared Decision-Making—Implementing Patients’ Rights in Routine Clinical Practice

Editorial on the articles: An Online Decision Aid for Patients With Metastatic Melanoma—Results of the Randomized Controlled Trial “PEF-Immun” by Pia Grabbe, M.Sc. et al. and “Decision Coaching for Healthy Women With BRCA1/2 Pathogenic Variants—Findings of the Randomized Controlled EDCP-BRCA Trial” by Prof. Dr. med. Stephanie Stock et al. on the following pages

With the Patients’ Rights Act of 2019 the German legislative codified patients’ involvement in decisions affecting their treatment. The law lays down requirements for participation, duties of information, and explanation (1). The ethical obligation to enable shared decision-making (SDM) had already been underlined by the German Ethics Council in 2016. The Ethics Council calls for physicians to communicate with patients in a way that encourages them towards autonomy (2). The code of medical ethics also calls for patients’ autonomy to be respected (3). No healthcare stakeholder would dissent with the demand for patient orientation and SDM.

Randomized controlled trials

Two randomized controlled trials published in this issue of Deutsches Ärzteblatt International concern themselves with the improvement of communication in situations where difficult decisions have to be made. Patients with advanced malignant melanoma have the choice between two types of drug treatment that differ especially with regard to severe adverse effects. In the study by Grabbe et al. (4), the intervention group was given access to an evidence-based decision aid prior to their discussion with a physician, while the control group only received information on their options during the consultation. The intervention group scored 3 points higher on a scale of 40 points than the control group in a knowledge test comprising multiple-choice questions. Although this small increase in knowledge is statistically significant, it was not associated with greater involvement in decision-making or with a higher degree of satisfaction with the decision made. It seems debatable whether the marginal benefit of this decision aid warrants its routine use.

Stock et al. (5) took a different approach to improving decisions. They investigated the use of decision coaching (DC) in female carriers of BRCA1/2 gene variants who were healthy but at elevated risk of breast cancer and/or ovarian cancer. These patients are confronted with the choice between intensified surveillance and risk-reducing surgery, two options with comparable aims but very different benefit–harm profiles. The DC program consisted of one or two sessions with a trained nurse in which fact sheets, a decision guidance document, and an evidence-based decision aid were used. A discussion with a physician ensued. The control group received only the medical consultation. The authors’ chosen endpoint was congruence of role preference, i.e., conformity between the extent to which participation in decision-making was desired before the intervention and the actual degree of involvement, measured before and after the intervention. No difference was found between the intervention group and the control group. However, the reasons for selecting this endpoint are not clear. Is it not the case that such an intervention has the aim of enhancing this desire? With regard to the secondary endpoints, such as an active role in decision-making, satisfaction with the role taken, and satisfaction with the knowledge imparted, there were statistically significant differences in favor of the intervention group. These effects can probably be attributed to the intensity of the intervention.

Patchy implementation

Both studies explored factors that can contribute to shared decision-making but cannot guarantee it.

The authors of a comprehensive overview of the situation in Germany come to the conclusion that many steps still have to be taken to enable reliable introduction of SDM (6). With regard to the Patients’ Rights Act, implementation remains patchy.

What now? By means of the Share to Care project supported by the Innovation Fund of the German Federal Joint Committee (G-BA), an intervention program for delivery of SDM in entire hospitals has been successfully implemented. The program comprises four elements:

• Training of all physicians
• Activation of all patients
• Integration of nurses as decision coaches
• Decision aids for every department (7)

Initial adaptations to the care of general practitioners appear promising (8). In February 2023, the G-BA recommended that Share to Care be integrated into standard care (9). The Government Committee for Modern and Needs-Based Hospital Care (Regierungskommission für eine moderne und bedarfsgerechte Krankenhausversorgung) has proposed that the Institute for Quality Assurance and Transparency in Healthcare (Institut für Qualitätssicherung und Transparenz im Gesundheitswesen, IQTIG) should develop the Share to Care certificate into a certificate that meets IQTIG’s demanding quality criteria for certificates (10).

The conditions seem favorable

The conditions for a broader introduction of SDM seem favorable, but this will not just happen by itself. Further implementation-related research along the lines of the two trials published in this issue will be needed. Furthermore, a decisive commitment from the medical profession, patient organizations and joint self-administration in practice will be required.

Not least, politicians will need to draw attention to the gaps in implementation of the Patients’ Rights Act and demand its universal application.

Conflict of interest statement
The author declares that no conflict of interest exists.

Received on 21 May 2024, revised version accepted on 21 May 2024.

Translated from the original German by David Roseveare

Corresponding author
Prof. Dr. med. David Klemperer

10019 Berlin, Germany

Cite this as:
Klemperer D: Patient orientation and shared decision-making—implementing patients’ rights in routine clinical practice. Dtsch Arztebl Int 2024; 121: 383–4. DOI: 10.3238/arztebl.m2024.0112

References

1. Gesetz zur Verbesserung der Rechte von Patientinnen und Patienten vom 20.2.2013 (Patientenrechtegesetz), Bundesgesetzblatt (BGBl). Bundesanzeiger Verlag, 25. Februar 2013, 277–82.

2. Deutscher Ethikrat: Patientenwohl als ethischer Maßstab für das Krankenhaus. Berlin; 2016, 05.04.2016.

3. Bundesärztekammer (BÄK): (Muster-) Berufsordnung für die deutschen Ärztinnen und Ärzte. Berlin, 2021.

4. Grabbe P, Borchers MS, Gschwendtner KM, et al.: An online decision aid for patients with metastatic melanoma—results of the randomized controlled trial „PEF-Immun“. Dtsch Ärztebl Int 2024; 121: 385−92

5. Stock S, Isselhard A, Shukri A, et al.: Decision coaching for healthy women with BRCA1/2 pathogenic variants—findings of the randomized controlled EDCP-BRCA trial. Dtsch Arztebl Int 2024; 121: 393–400

6. Hahlweg P, Bieber C, Levke Brütt A, et al.: Moving towards patient-centered care and shared decision-making in Germany. Z Evid Fortbild Qual Gesundhwes 2022: 171: 49–57

7. Geiger F, Novelli A, Berg D, et al.: The hospital-wide implementation of shared decision-making—initial findings of the Kiel SHARE TO CARE program. Dtsch Arztebl Int 2021; 118: 225–6

8. SDM in der Hausärztlichen Versorgung: www.sdm-bremen.de (last accessed on 1 May 2024).

9. Gemeinsamer Bundesausschuss (G-BA): Beschluss MAKING SDM A REALITY – Vollimplementierung von Shared. https://innovationsfonds.g-ba.de/beschluesse/making-sdm-a-reality-vollimplementierung-von-shared-decision-making-im-krankenhaus.137 (last accessed on 28 May 2024).

10. Regierungskommission für eine moderne und bedarfsgerechte Krankenhausversorgung. Siebente Stellungnahme und Empfehlung. Weiterentwicklung der Qualitätssicherung, des Qualitäts- und des klinischen Risikomanagements. Berlin 2023.