title: Developing a core outcome set for hip fracture trials.
abstract: The lack of a consensus for core health outcomes that should be reported in clinical research has hampered study design and evidence synthesis. We report a United Kingdom consensus for a core outcome set (COS) for clinical trials of patients with a hip fracture. We adopted a modified nominal group technique to derive consensus on 1) which outcome domains should be measured, and 2) methods of assessment. Participants reflected a diversity of perspectives and experience. They received an evidence synthesis and postal questionnaire in advance of the consensus meeting, and ranked the importance of candidate domains and the relevance and suitability of short-listed measures. During the meeting, pre-meeting source data and questionnaire responses were summarised, followed by facilitated discussion and a final plenary session. A COS was determined using a closed voting system: a 70% consensus was required. Consensus supported a five-domain COS: mortality, pain, activities of daily living, mobility, and health-related quality of life (HRQL). Single-item measures of mortality and mobility (indoor/outdoor walking status) and a generic multi-item measure of HRQL - the EuroQoL EQ-5D - were recommended. These measures should be included as a minimum in all hip fracture trials. Other outcome measures should be added depending on the particular interventions being studied. Cite this article:
authors.affiliation: Warwick Medical School, Royal College of Nursing Research Institute (RCNRI), University of Warwick, Gibbet Hill Road, CV4 7AL, UK.
authors.forename: K L
authors.initials: KL
authors.lastname: Haywood
authors.affiliation: Warwick Medical School, University of Warwick, Clifford Bridge Road, Coventry CV2 2DX, UK.
authors.forename: X L
authors.initials: XL
authors.lastname: Griffin
authors.affiliation: Warwick Medical School, Warwick Clinical Trials Unit, University of Warwick, Clifford Bridge Road, Coventry CV2 2DX, UK.
authors.forename: J
authors.initials: J
authors.lastname: Achten
authors.affiliation: Warwick Medical School, Warwick Clinical Trials Unit, University of Warwick, Gibbet Hill Road, CV4 7AL, UK.
authors.forename: M L
authors.initials: ML
authors.lastname: Costa
mesh_terms: D000203:Activities of Daily Living; D002986:Clinical Trials as Topic / Q000379:methods*; D006620:Hip Fractures / Q000601:surgery*; D006801:Humans; D010149:Postoperative Pain; D063868:Patient Outcome Assessment; D018802:Patient-Centered Care / Q000379:methods; D011788:Quality of Life; D011795:Surveys and Questionnaires
keywords: Fragility hip fracture; Core outcome sets; Clinical trials