Responsiveness to clinically important change is a key feature of any outcome measure. Throughout Europe, health-related quality of life following total knee arthroplasty (TKA) is routinely measured with EuroQol five-dimension (EQ-5D) questionnaires. The Patient-Reported Outcomes Measurement Information System 10-Question Short-Form (PROMIS-10 Global Health) score is a new general heath outcome tool which is thought to offer greater responsiveness. Our aim was to compare these two tools. We accessed data from a prospective multicentre cohort study in the United Kingdom, which evaluated outcomes following TKA. The median age of the 721 patients was 69.0 years (interquartile range, 63.3 to 74.6). There was an even division of sex, and approximately half were educated to secondary school level. The preoperative EQ-5D, PROMIS-10, and Oxford Knee Scores (OKS) were available and at three, six, and 12 months postoperatively. Internal responsiveness was assessed by standardized response mean (SRM) and effect size (Cohen’s Aims
Patients and Methods
This paper describes the methods applied to assess the cost-effectiveness of cemented versus uncemented hemiarthroplasty among hip fracture patients in the World Hip Trauma Evaluation Five (WHiTE5) trial. A within-trial cost-utility analysis (CUA) will be conducted at four months postinjury from a health system (National Health Service and personal social services) perspective. Resource use pertaining to healthcare utilization (i.e. inpatient care, physiotherapy, social care, and home adaptations), and utility measures (quality-adjusted life years) will be collected at one and four months (primary outcome endpoint) postinjury; only treatment of complications will be captured at 12 months. Sensitivity analysis will be conducted to assess the robustness of the results.Aim
Methods
The aim is to assess the cost-effectiveness of patellofemoral arthroplasty (PFA) in comparison with total knee arthroplasty (TKA) for the treatment of isolated patellofemoral osteoarthritis (OA) based on prospectively collected data on health outcomes and resource use from a blinded, randomized, clinical trial. A total of 100 patients with isolated patellofemoral osteoarthritis were randomized to receive either PFA or TKA by experienced knee surgeons trained in using both implants. Patients completed patient-reported outcomes including EuroQol five-dimension questionnaire (EQ-5D) and 6-Item Short-Form Health Survey questionnaire (SF-6D) before the procedure. The scores were completed again after six weeks, three, six, and nine months, and again after one- and two-year post-surgery and yearly henceforth. Time-weighted outcome measures were constructed. Cost data were obtained from clinical registrations and patient-reported questionnaires. Incremental gain in health outcomes (quality-adjusted life-years (QALYs)) and incremental costs were compared for the two groups of patients. Net monetary benefit was calculated assuming a threshold value of €10,000, €35,000, and €50,000 per QALY and used to test the statistical uncertainty and central assumptions about outcomes and costs.Aims
Methods
This 501-patient, multi-centre, randomised controlled trial sought
to establish the effect of low-intensity, pulsed, ultrasound (LIPUS)
on tibial shaft fractures managed with intramedullary nailing. We
conducted an economic evaluation as part of this trial. Data for patients’ use of post-operative healthcare resources
and time taken to return to work were collected and costed using
publicly available sources. Health-related quality of life, assessed
using the Health Utilities Index Mark-3 (HUI-3), was used to derive
quality-adjusted life years (QALYs). Costs and QALYs were compared
between LIPUS and control (a placebo device) from a payer and societal
perspective using non-parametric bootstrapping. All costs are reported
in 2015 Canadian dollars unless otherwise stated.Aims
Patients and Methods
The aim of this study was to compare the cost-effectiveness of
intramedullary nail fixation and ‘locking’ plate fixation in the
treatment of extra-articular fractures of the distal tibia. An economic evaluation was conducted from the perspective of
the United Kingdom National Health Service (NHS) and personal social
services (PSS), based on evidence from the Fixation of Distal Tibia
Fractures (UK FixDT) multicentre parallel trial. Data from 321 patients
were available for analysis. Costs were collected prospectively
over the 12-month follow-up period using trial case report forms
and participant-completed questionnaires. Cost-effectiveness was
reported in terms of incremental cost per quality adjusted life
year (QALY) gained, and net monetary benefit. Sensitivity analyses
were conducted to test the robustness of cost-effectiveness estimates.Aim
Patients and Methods
The aim of this study was to compare the cost-effectiveness of
treatment with an osseointegrated percutaneous (OI-) prosthesis
and a socket-suspended (S-) prosthesis for patients with a transfemoral
amputation. A Markov model was developed to estimate the medical costs and
changes in quality-adjusted life-years (QALYs) attributable to treatment
of unilateral transfemoral amputation over a projected period of
20 years from a healthcare perspective. Data were collected alongside
a prospective clinical study of 51 patients followed for two years.Aims
Patients and Methods
The aim of this study was to compare the functional and radiological
outcomes in patients with a displaced fracture of the hip who were
treated with a cemented or a cementless femoral stem. A four-year follow-up of a randomized controlled study included
141 patients who underwent surgery for a displaced femoral neck
fracture. Patients were randomized to receive either a cemented
(n = 67) or a cementless (n = 74) stem at hemiarthroplasty (HA;
n = 83) or total hip arthroplasty (THA; n = 58).Aims
Patients and Methods
The PROximal Fracture of the Humerus Evaluation by Randomisation
(PROFHER) randomised clinical trial compared the operative and non-operative
treatment of adults with a displaced fracture of the proximal humerus
involving the surgical neck. The aim of this study was to determine
the long-term treatment effects beyond the two-year follow-up. Of the original 250 trial participants, 176 consented to extended
follow-up and were sent postal questionnaires at three, four and
five years after recruitment to the trial. The Oxford Shoulder Score
(OSS; the primary outcome), EuroQol 5D-3L (EQ-5D-3L), and any recent
shoulder operations and fracture data were collected. Statistical
and economic analyses, consistent with those of the main trial were
applied.Aims
Patients and Methods
There is a paucity of information on the pre-operative coronal
imbalance in patients with degenerative lumbar scoliosis (DLS) and
its influence on surgical outcomes. A total of 284 DLS patients were recruited into this study, among
whom 69 patients were treated surgically and the remaining 215 patients
conservatively Patients were classified based on the coronal balance
distance (CBD): Type A, CBD <
3 cm; Type B, CBD >
3 cm and C7
Plumb Line (C7PL) shifted to the concave side of the curve; Type
C, CBD >
3 cm and C7PL shifted to the convex side.Aims
Patients and Methods
The aims of this study were to describe the prevalence of previous
lumbar surgery in patients who undergo total hip arthroplasty (THA)
and to investigate their patient-reported outcomes (PROMs) one year
post-operatively. Data from the Swedish Hip Arthroplasty Register and the Swedish
Spine Register gathered from 2002 to 2013 were merged to identify
a group of patients who had undergone lumbar surgery before THA
(n = 997) and a carefully matched one-to-one control group. We investigated
differences in the one-year post-operative PROMs between the groups.
Linear regression analyses were used to explore the associations
between previous lumbar surgery and these PROMs following THA. The
prevalence of prior lumbar surgery was calculated as the ratio of
patients identified with previous lumbar surgery between 2002 and
2012, and divided by the total number of patients who underwent
a THA in 2012.Aims
Patients and Methods
This study describes and compares the operative management and outcomes in a consecutive case series of patients with dislocated hemiarthroplasties of the hip, and compares outcomes with those of patients not sustaining a dislocation. Of 3326 consecutive patients treated with hemiarthroplasty for fractured neck of femur, 46 (1.4%) sustained dislocations. Of the 46 dislocations, there were 37 female patients (80.4%) and nine male patients (19.6%) with a mean age of 83.8 years (66 to 100). Operative intervention for each, and subsequent dislocations, were recorded. The following outcome measures were recorded: dislocation; mortality up to one-year post-injury; additional surgery; residential status; mobility; and pain score at one year.Aims
Patients and Methods
Hip fracture is a global public health problem.
The National Hip Fracture Database provides a framework for service evaluation
in this group of patients in the United Kingdom, but does not collect
patient-reported outcome data and is unable to provide meaningful
data about the recovery of quality of life. We report one-year patient-reported outcomes of a prospective
cohort of patients treated at a single major trauma centre in the
United Kingdom who sustained a hip fracture between January 2012
and March 2014. There was an initial marked decline in quality of life from baseline
measured using the EuroQol 5 Dimensions score (EQ-5D). It was followed
by a significant improvement to 120 days for all patients. Although
their quality of life improved during the year after the fracture,
it was still significantly lower than before injury irrespective
of age group or cognitive impairment (mean reduction EQ-5D 0.22;
95% confidence interval (CI) 0.17 to 0.26). There was strong evidence
that quality of life was lower for patients with cognitive impairment.
There was a mean reduction in EQ-5D of 0.28 (95% CI 0.22 to 0.35)
in patients <
80 years of age. This difference was consistent
(and fixed) throughout follow-up. Quality of life does not improve
significantly during recovery from hip fracture in patients over
80 years of age (p = 0.928). Secondary measures of function showed
similar trends. Hip fracture marks a step down in the quality of life of a patient:
it accounts for approximately 0.22 disability adjusted life years
in the first year after fracture. This is equivalent to serious
neurological conditions for which extensive funding for research
and treatment is made available. Cite this article:
The routine use of patient reported outcome measures
(PROMs) in evaluating the outcome after arthroplasty by healthcare
organisations reflects a growing recognition of the importance of
patients’ perspectives in improving treatment. Although widely embraced
in the NHS, there are concerns that PROMs are being used beyond
their means due to a poor understanding of their limitations. This paper reviews some of the current challenges in using PROMs
to evaluate total knee arthroplasty. It highlights alternative methods
that have been used to improve the assessment of outcome. Cite this article:
This review summarises the evidence for the treatment
of displaced fractures of the femoral neck in elderly patients.
Results from randomised clinical trials and national register studies are
presented when available. The advantages of arthroplasty compared with internal fixation
are supported by several studies. A number of studies contribute
to the discussions of total hip arthroplasty (THA) The direct lateral approach reduces the risk of dislocation compared
with the posterior approach. Cemented implants lower the risk of
periprosthetic fracture and its subsequent morbidity and mortality.
As the risk of peri-operative death related to bone cement can be reduced
by adequate measures, cemented implants are recommended in fracture
cases. Take home message: There remains a great variation in the surgical
management of patients with a hip fracture, and an evidence-based
approach should improve the outcomes for this vulnerable patient
group. Cite this article:
This study compared the clinical outcomes following
mini-open rotator cuff repair (MORCR) between early mobilisation
and usual care, involving initial immobilisation. In total, 189
patients with radiologically-confirmed full-thickness rotator cuff
tears underwent MORCR and were randomised to either early mobilisation
(n = 97) or standard rehabilitation (n = 92) groups. Patients were
assessed at six weeks and three, six, 12 and 24 months post-operatively.
Six-week range of movement comparisons demonstrated significantly
increased abduction (p = 0.002) and scapular plane elevation (p
= 0.006) in the early mobilisation group, an effect which was not
detectable at three months (p >
0.51) or afterwards. At 24 months
post-operatively, patients who performed pain-free, early active mobilisation
for activities of daily living showed no difference in clinical
outcomes from patients immobilised for six weeks following MORCR.
We suggest that the choice of rehabilitation regime following MORCR
may be left to the discretion of the patient and the treating surgeon. Cite this article:
Approximately half of all hip fractures are displaced intracapsular fractures. The standard treatment for these fractures is either hemiarthroplasty or total hip arthroplasty. The recent National Institute for Health and Care Excellence (NICE) guidance on hip fracture management recommends the use of ‘proven’ cemented stem arthroplasty with an Orthopaedic Device Evaluation Panel (ODEP) rating of at least 3B (97% survival at three years). The Thompsons prosthesis is currently lacking an ODEP rating despite over 50 years of clinical use, likely due to the paucity of implant survival data. Nationally, adherence to these guidelines is varied as there is debate as to which prosthesis optimises patient outcomes. This study design is a multi-centre, multi-surgeon, parallel, two arm, standard-of-care pragmatic randomised controlled trial. It will be embedded within the WHiTE Comprehensive Cohort Study (ISRCTN63982700). The main analysis is a two-way equivalence comparison between Hemi-Thompson and Hemi-Exeter polished taper with Unitrax head. Secondary outcomes will include radiological leg length discrepancy measured as per Bidwai and Willett, mortality, re-operation rate and indication for re-operation, length of index hospital stay and revision at four months. This study will be supplemented by the NHFD (National Hip Fracture Database) dataset.Background
Design
We present the development and results of a nationwide, prospective, observational follow-up programme including patient-reported outcome measures (PROMs) for the Swedish Hip Arthroplasty Register. The programme started in 2002 and has gradually expanded to include all units performing total hip replacement in Sweden. The self-administered PROMs protocol comprises the EQ-5D instrument, the Charnley class categorisation and visual analogue scales for pain and satisfaction. These current analyses include 34 960 total hip replacements with complete pre- and one-year post-operative questionnaires. Patients eligible for total hip replacement generally report low health-related quality of life and suffer from pain. One year post-operatively the mean EQ-5D index increased to above the level of an age- and gender-matched population, with a considerable reduction of pain (p <
0.001). Females, younger patients and those with Charnley category C reported a lower EQ-5D index pre-operatively than males, older patients and Charnley category A or B, respectively (all p <
0.001). In a multivariable regression analysis Charnley category C, male gender and higher age were associated with less improvement in health-related quality of life (p <
0.001). Nationwide implementation of a PROMs programme requires a structured organisation and effective data capture. Patients’ response rates to the Registry are good. The continuous collection of PROMs permits local and national improvement work and allows for further health-economic evaluation.
