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:
This study compared the demographic, clinical and patient-reported outcomes after total hip replacement (THR) and Birmingham Hip Resurfacing (BHR) carried out by a single surgeon. Patients completed a questionnaire that included the WOMAC, SF-36 scores and comorbid medical conditions. Data were collected before operation and one year after. The outcome scores were adjusted for age, gender, comorbid conditions and, at one year, for the pre-operative scores. There were 214 patients with a THR and 132 with a BHR. Patients with a BHR were significantly younger (49 vs 67 years, p <
0.0001), more likely to be male (68% vs 42% of THR, p <
0.0001) and had fewer comorbid conditions (1.3 vs 2.0, p <
0.0001). Before operation there was no difference in WOMAC and SF-36 scores, except for function, in which patients awaiting THR were worse than those awaiting a BHR. At one year patients with a BHR reported significantly better WOMAC pain scores (p = 0.04) and in all SF-36 domains (p <
0.05). Patients undergoing BHR report a significantly greater improvement in general health compared with those with a THR.
