Objectives The use of drugs beyond their marketing authorisation, that is, off-label use, is common practice in palliative care with over 70% of off-label use having little or no scientific support. The lack of evidence makes recommendations for off-label use essential, in order to increase the safety of drug therapy and thus patient safety. The aim of this study was to develop a guide for preparing and consenting drug-specific recommendations for off-label use in palliative care.
Methods Group Delphi Study with three rounds and a prior online survey to identify topics of dissent. Participants represented professional groups working in palliative care involved in direct patient care and/or drug management and various care settings. Furthermore, representatives of relevant professional associations, experts with academic, non-clinical background and experts with international expertise were invited.
Results 18/20 invited professionals participated in the prior online-survey. 15 experts participated in the Group Delphi process. Six domains, including identification of drugs, drug uses, assessment of evidence, formulation, consensus and updating of recommendations were generated and respective statements were included in the Group Delphi process. The consensus process resulted in 28 statements forming the guide for recommendations.
Conclusions The resultant systematic approach for preparing and consenting drug-specific recommendations for off-label use will allow the development of recommendations with transparent and reproducible monographs. This will help to increase treatment quality and patient safety as well as security of decision-making in palliative care. The developed guide is part of a larger project aiming to provide therapy recommendations for areas that have little or no scientific evidence.
- clinical decisions
- drug administration
- hospice care
- symptoms and symptom management
- terminal care
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Contributors Obtaining funding: CR with support of CB. Overall concept and design of the study: CR and FH with support of CB. Preparation of preliminary questionnaire, questionnaire and supporting material for the workshop: CR and FH with support of KW and VH. Data collection and analysis: CR and FH with support of KW. Interpretation of data: all authors. Draft of the manuscript: CR and FH. All authors critically commented on and contributed to the draft. All authors read and approved the final manuscript.
Funding The organisation of Group Delphi Workshop was funded by the non-profit foundation Dr Werner Jackstädt-Stiftung (travel expenses and accommodation of the participants, catering, professional moderator).
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The Ethics Committee of the Ludwig-Maximilians-Universität Munich confirmed that no approval was required for this study. Potential participants of the preparatory online survey were informed in the email invitation to participate that the survey was voluntary and anonymous. They were furthermore informed that by submitting the online questionnaire, they automatically gave their consent to participate.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.
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