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:
Cite this article:
We compared a new fixation system, the Targon
Femoral Neck (TFN) hip screw, with the current standard treatment of
cannulated screw fixation. This was a single-centre, participant-blinded,
randomised controlled trial. Patients aged 65 years and over with
either a displaced or undisplaced intracapsular fracture of the
hip were eligible. The primary outcome was the risk of revision
surgery within one year of fixation. A total of 174 participants were included in the trial. The absolute
reduction in risk of revision was of 4.7% (95% CI 14.2 to 22.5)
in favour of the TFN hip screw (chi-squared test, p = 0.741), which
was less than the pre-specified level of minimum clinically important
difference. There were no significant differences in any of the
secondary outcome measures. We found no evidence of a clinical difference in the risk of
revision surgery between the TFN hip screw and cannulated screw
fixation for patients with an intracapsular fracture of the hip. Cite this article:
The importance for observing the intention-to-treat
approach in clinical studies is explained. Cite this article:
Concerns have been reported to the United Kingdom
National Patient Safety Agency, warning that cementing the femoral component
during hip replacement surgery for fracture of the proximal femur
may increase peri-operative mortality. The National Hip Fracture Database collects demographic and outcome
data about patients with a fracture of the proximal femur from over
100 participating hospitals in the United Kingdom. We conducted
a mixed effects logistic regression analysis of this dataset to
determine whether peri-operative mortality was increased in patients
who had undergone either hemiarthroplasty or total hip replacement
using a cemented femoral component. A total of 16 496 patients from
129 hospitals were included in the analysis, which showed a small
but significant adjusted survival benefit associated with cementing
(odds ratio 0.83, 95% confidence interval 0.72 to 0.96). Other statistically
significant variables in predicting death at discharge, listed in
order of magnitude of effect, were gender, American Society of Anesthesiologists
grade, age, walking accompanied outdoors and arthroplasty. Interaction
terms between cementing and these other variables were sequentially
added to, but did not improve, the model. This study has not shown an increase in peri-operative mortality
as a result of cementing the femoral component in patients requiring
hip replacement following fracture of the proximal femur.