Patient autonomy and shared decision-making in the context of clinical trial participation.

Dennstädt, Fabio; Putora, Paul Martin; Iseli, Thomas; Treffers, Theresa; Panje, Cédric; Fischer, Galina Farina (2024). Patient autonomy and shared decision-making in the context of clinical trial participation. (In Press). European journal of clinical investigation, e14291. Wiley 10.1111/eci.14291

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AIMS

This study aimed to explore how incorporating shared decision-making (SDM) can address recruitment challenges in clinical trials. Specifically, it examines how SDM can align the trial process with patient preferences, enhance patient autonomy and increase active patient participation. Additionally, it identifies potential conflicts between SDM and certain clinical trial aspects, such as randomization or blinding, and proposes solutions to mitigate these issues.

MATERIALS AND METHODS

We conducted a comprehensive review of existing literature on patient recruitment challenges in clinical trials and the role of SDM in addressing these challenges. We analysed case studies and trial reports to identify common obstacles and assess the effectiveness of SDM in improving patient accrual. Additionally, we evaluated three proposed solutions: adequate trial design, communication skill training and patient decision aids.

RESULTS

Our review indicates that incorporating SDM can significantly enhance patient recruitment by promoting patient autonomy and engagement. SDM encourages physicians to adopt a more open and informative approach, which aligns the trial process with patient preferences and reduces psychological barriers such as fear and mental stress. However, implementing SDM can conflict with elements such as randomization and blinding, potentially complicating trial design and execution.

DISCUSSION

The desire for patient autonomy and active engagement through SDM may clash with traditional clinical trial methodologies. To address these conflicts, we propose three solutions: redesigning trials to better accommodate SDM principles, providing communication skill training for physicians and developing patient decision aids. By focussing on patient wishes and emotions, these solutions can integrate SDM into clinical trials effectively.

CONCLUSION

Shared decision-making provides a framework that can promote patient recruitment and trial participation by enhancing patient autonomy and engagement. With proper implementation of trial design modifications, communication skill training and patient decision aids, SDM can support rather than hinder clinical trial execution, ultimately contributing to the advancement of evidence-based medicine.

Item Type:

Journal Article (Review Article)

Division/Institute:

04 Faculty of Medicine > Department of Haematology, Oncology, Infectious Diseases, Laboratory Medicine and Hospital Pharmacy (DOLS) > Clinic of Radiation Oncology

UniBE Contributor:

Dennstädt, Fabio, Putora, Paul Martin, Panje, Cédric, Fischer, Galina Farina

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1365-2362

Publisher:

Wiley

Language:

English

Submitter:

Pubmed Import

Date Deposited:

12 Aug 2024 14:01

Last Modified:

13 Aug 2024 00:17

Publisher DOI:

10.1111/eci.14291

PubMed ID:

39086071

Uncontrolled Keywords:

communication skills training patient autonomy patient decision aids shared decision‐making trial design trial participation

BORIS DOI:

10.48350/199435

URI:

https://boris.unibe.ch/id/eprint/199435

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