Shared decision-making (SDM) is a collaborative process where patients and healthcare professionals make decisions together, integrating clinical evidence with patient preferences and values. Though SDM is ethically and legally recommended, existing research lacks consistency in outcome measurement, limiting the ability to assess its full impact on healthcare quality, re-source use, and patient outcomes.
An existing COS for rheumatology (rheuCOS-SDM) offers a useful starting point but is limited in scope and applicability to other health contexts. This study aims to develop a generic COS to evaluate the impact of shared decision-making in healthcare (COS-SDM) by updating and revalidating the rheuCOS-SDM to broaden its applicability.
The scope of the COS-SDM was defined through consultation with a panel of international, multi-disciplinary interest holders relevant to a broad range of healthcare contexts (including experts in SDM, clinicians, public/patient partners). It is defined as follows:
1. Health conditions
All health conditions and populations involved in healthcare decision-making. This includes decision-making for:
• treatment, illness management, health promotion (including preventative and lifestyle choice decisions), screening and diagnostic.
• maternity care, although it is recognised that pregnancy may not be considered a health condition
2. Interventions
All interventions aimed at improving and implementing shared decision-making in clinical and non-clinical contexts that target patients/public, health and allied health professionals, health systems or the interaction between them
3. Context of use
Research purposes, including:
• Clinical and non-clinical comparative effectiveness studies
• observational
• non-interventional studies
Further detail about the rationale for this COS study
A COS for SDM in the context of rheumatology research has previously been developed (COMET reference: 1894; doi: 10.1016/j.semarthrit.2021.03.017). This COS was co-developed with significant input from patients, clinicians and SDM experts in the field of rheumatology, using accepted methods to gain consensus on the COS within a rheumatology setting. It does, however, have some limitations. Initial development lacked clear conceptualisation to differentiate between SDM process and outcome measurement, although this was later clarified. Long-list generation predated large, comprehensive systematic reviews that may have identified relevant outcomes to be included in the consensus process. The rheuCOS-SDM includes three optional outcome domains and seven mandatory outcomes domains with six generic domains to be measured in all SDM intervention trials (chosen option aligned with patient’s values and preferences, confidence/adherence to the chosen option, satisfaction with the decision-making process, knowledge of options, potential negative consequences of the SDM intervention) and one domain to be measured in specific contexts (disease-specific COS). It is unclear, however, if outcomes/domains identified within a rheumatology context are relevant, comprehensive, or comprehensible when applied in other healthcare contexts. This may involve different decision types, levels of complexity, timeframes, cultural expectations, and resource provision, all of which may influence the evaluation and effectiveness of SDM. An update and revalidation of the rheuCOS-SDM is therefore needed to improve applicability and utility of a generic COS for SDM for broad healthcare contexts, enabling better synthesis of evidence and clearer conclusions about the impact of SDM on patient and health service outcomes.
Karine Toupin-April (co-lead)
Angus McNair (co-lead)
Christin Hoffmann (delivery, PPIE co-lead)
Maureen Smith (PPIE co-lead)
Jo Butterworth (delivery)
Taona Nyampfene (delivery)
Executive group:
Adrian Edwards, Hilary Bekker, Felix Wehking, Ellen Engelhardt, Dirk Ubbink, Martin Härter, Anik Giguère, Florian Naye, Kirsten McCaffery, Lilisbeth Perestelo-Perez, Karina Olling, Tammy Hoffmann, Glyn Elwyn, Arwen Pieterse, Paulina Bravo, Mirjam Garvelink, Simon Décary, Fülöp (Fritz) Scheibler, Kerry Avery, Simone Kienlin, Dawn Stacey, Juan Franco, Sang-Ho Yoo, Janneke Noordman, Bob Volk, Katherine Valentine
Disease Category: Other
Disease Name: Generic (all health conditions)
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Any
- Charities
- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Economists
- Epidemiologists
- Ethicists
- Families
- Governmental agencies
- Journal editors
- Methodologists
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Policy makers
- Regulatory agency representatives
- Researchers
- Service commissioners
- Service providers
- Service users
- Statisticians
- COS (Other)
- Consensus conference
- Consensus meeting
- Delphi process
- Interview
- Literature review
We will adhere to methods for COS development outlined in the COMET handbook and Core Outcome Set-STAndards for Development guidelines and will employ recommended evidence synthesis approaches, a sequential multi-round online Delphi and modified nominal group technique in consensus meeting(s).