Development of a core outcome set for the evaluation of shared decision-making interventions in healthcare: a study protocol

Introduction Shared decision-making (SDM) is a process whereby patients are supported to reach decisions about their healthcare in collaboration with healthcare professionals. Despite decades of SDM research, the impact of using SDM interventions (eg, patient decision aids, decision coaching, question prompt lists, training and feedback or service changes) on clinical and health service outcomes remains uncertain. This is partly because synthesis of the existing literature is hindered by substantial heterogeneity in the evaluation of interventions to facilitate SDM. A core outcome set (COS) is an agreed standardised set of outcomes that should be measured and reported in all effectiveness studies. The aim of this study is to develop a generic COS for evaluating the impact of SDM interventions (COS-SDMi).

Ethics and dissemination Research ethics approval has been granted in the UK for undertaking qualitative interviews (University of Exeter Faculty Ethics Committee, ref: 8207624) and the Delphi survey and consensus meeting activities (University of Bristol Faculty Ethics Committee, ref: 7741). Written informed consent will be obtained digitally from all participants in the qualitative interviews, the Delphi surveys and the consensus meetings. The final COS will be disseminated through presentations at international conferences, briefing notes to key organisations and publication in a peer-reviewed journal. Further dissemination is planned through our patient/public advisory group, professional networks and executive group channels, as well as publications to patient groups, funders, journal editors, international regulatory bodies and health technology assessment boards.