Prior cost-effectiveness analyses on osseointegrated prosthesis for transfemoral unilateral amputees have analyzed outcomes in non-USA countries using generic quality of life instruments, which may not be appropriate when evaluating disease-specific quality of life. These prior analyses have also focused only on patients who had failed a socket-based prosthesis. The aim of the current study is to use a disease-specific quality of life instrument, which can more accurately reflect a patient’s quality of life with this condition in order to evaluate cost-effectiveness, examining both treatment-naïve and socket refractory patients. Lifetime Markov models were developed evaluating active healthy middle-aged male amputees. Costs of the prostheses, associated complications, use/non-use, and annual costs of arthroplasty parts and service for both a socket and osseointegrated (OPRA) prosthesis were included. Effectiveness was evaluated using the questionnaire for persons with a transfemoral amputation (Q-TFA) until death. All costs and Q-TFA were discounted at 3% annually. Sensitivity analyses on those cost variables which affected a change in treatment (OPRA to socket, or socket to OPRA) were evaluated to determine threshold values. Incremental cost-effectiveness ratios (ICERs) were calculated.Aims
Methods
To compare the cost-effectiveness of high-dose, dual-antibiotic cement versus single-antibiotic cement for the treatment of displaced intracapsular hip fractures in older adults. Using data from a multicentre randomized controlled trial (World Hip Trauma Evaluation 8 (WHiTE-8)) in the UK, a within-trial economic evaluation was conducted. Resource usage was measured over 120 days post randomization, and cost-effectiveness was reported in terms of incremental cost per quality-adjusted life year (QALY), gained from the UK NHS and personal social services (PSS) perspective in the base-case analysis. Methodological uncertainty was addressed using sensitivity analysis, while decision uncertainty was handled using confidence ellipses and cost-effectiveness acceptability curves.Aims
Methods
Aims. The purpose was to compare operative treatment with a volar plate and nonoperative treatment of displaced distal radius fractures in patients aged 65 years and over in a
Patients receiving cemented hemiarthroplasties after hip fracture have a significant risk of deep surgical site infection (SSI). Standard UK practice to minimize the risk of SSI includes the use of antibiotic-loaded bone cement with no consensus regarding type, dose, or antibiotic content of the cement. This is the protocol for a randomized clinical trial to investigate the clinical and cost-effectiveness of high dose dual antibiotic-loaded cement in comparison to low dose single antibiotic-loaded cement in patients 60 years and over receiving a cemented hemiarthroplasty for an intracapsular hip fracture. The WHiTE 8 Copal Or Palacos Antibiotic Loaded bone cement trial (WHiTE 8 COPAL) is a multicentre, multi-surgeon, parallel, two-arm, randomized clinical trial. The pragmatic study will be embedded in the World Hip Trauma Evaluation (WHiTE) (ISRCTN 63982700). Participants, including those that lack capacity, will be allocated on a 1:1 basis stratified by recruitment centre to either a low dose single antibiotic-loaded bone cement or a high dose dual antibiotic-loaded bone cement. The primary analysis will compare the differences in deep SSI rate as defined by the Centers for Disease Control and Prevention within 90 days of surgery via medical record review and patient self-reported questionnaires. Secondary outcomes include UK Core Outcome Set for hip fractures, complications, rate of antibiotic prescription, resistance patterns of deep SSI, and resource use (more specifically, cost-effectiveness) up to four months post-randomization. A minimum of 4,920 patients will be recruited to obtain 90% power to detect an absolute difference of 1.5% in the rate of deep SSI at 90 days for the expected 3% deep SSI rate in the control group.Aims
Methods
The aim of this study was to estimate the cost-effectiveness of negative-pressure wound therapy (NPWT) in comparison with standard wound management after initial surgical wound debridement in adults with severe open fractures of the lower limb. An economic evaluation was conducted from the perspective of the United Kingdom NHS and Personal Social Services, based on evidence from the 460 participants in the Wound Management of Open Lower Limb Fractures (WOLLF) trial. Economic outcomes were collected prospectively over the 12-month follow-up period using trial case report forms and participant-completed questionnaires. Bivariate regression of costs (given in £, 2014 to 2015 prices) and quality-adjusted life-years (QALYs), with multiple imputation of missing data, was conducted to estimate the incremental cost per QALY gained associated with NPWT dressings. Sensitivity and subgroup analyses were undertaken to assess the impacts of uncertainty and heterogeneity, respectively, surrounding aspects of the economic evaluation.Aims
Patients and Methods
The primary aim of this study was to establish the cost-effectiveness of the early fixation of displaced midshaft clavicle fractures. A cost analysis was conducted within a randomized controlled trial comparing conservative management (n = 92) 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
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 paper is to review the evidence relating to the
anatomy of the proximal femur, the geometry of the fracture and
the characteristics of implants and methods of fixation of intertrochanteric
fractures of the hip. Relevant papers were identified from appropriate clinical databases
and a narrative review was undertaken.Aims
Materials and Methods
A pragmatic multicentre randomised controlled trial (PROFHER)
was conducted in United Kingdom National Health Service (NHS) hospitals
to evaluate the clinical effectiveness and cost effectiveness of
surgery compared with non-surgical treatment for displaced fractures
of the proximal humerus involving the surgical neck in adults. A cost utility analysis from the NHS perspective was performed.
Differences between surgical and non-surgical treatment groups in
costs and quality adjusted life years (QALYs) at two years were
used to derive an estimate of the cost effectiveness of surgery
using regression methods. Aims
Methods
This study compares the cost-effectiveness of
treating dorsally displaced distal radial fractures with a volar
locking plate and percutaneous fixation. It was performed from the
perspective of the National Health Service (NHS) using data from
a single-centre randomised controlled trial. In total 130 patients
(18 to 73 years of age) with a dorsally displaced distal radial
fracture were randomised to treatment with either a volar locking
plate (n = 66) or percutaneous fixation (n = 64). The methodology
was according to National Institute for Health and Care Excellence guidance
for technology appraisals. . There were no significant differences in quality of life scores
between groups at any time point in the study. Both groups returned
to baseline one year post-operatively. NHS costs for the plate group were significantly higher (p <
0.001, 95% confidence interval 497 to 930). For an additional £713,
fixation with a volar locking plate offered 0.0178 additional quality-adjusted
life years in the year after surgery. The incremental cost-effectiveness
ratio (ICER) for plate fixation relative to percutaneous fixation
at list price was £40 068. When adjusting the prices of the implants
for a 20% hospital discount, the ICER was £31 898. Patients who
underwent plate fixation did not return to work earlier. We found no evidence to support the cost-effectiveness, from
the perspective of the NHS, of fixation using a volar locking plate
over percutaneous fixation for the operative treatment of a dorsally
displaced radial fracture. Cite this article:
A rigorous approach to developing, delivering and documenting
rehabilitation within randomised controlled trials of surgical interventions
is required to underpin the generation of reliable and usable evidence.
This article describes the key processes used to ensure provision
of good quality and comparable rehabilitation to all participants
of a multi-centre randomised controlled trial comparing surgery
with conservative treatment of proximal humeral fractures in adults. These processes included the development of a patient information
leaflet on self-care during sling immobilisation, the development
of a basic treatment physiotherapy protocol that received input
and endorsement by specialist physiotherapists providing patient
care, and establishing an expectation for the provision of home
exercises. Specially designed forms were also developed to facilitate
reliable reporting of the physiotherapy care that patients received.Objectives
Methods
