Health economic evaluations potentially provide
valuable information to clinicians, health care administrators,
and policy makers regarding the financial implications of decisions
about the care of patients. The highest quality research should
be used to inform decisions that have direct impact on the access
to care and the outcome of treatment. However, economic analyses
are often complex and use research methods which are relatively unfamiliar
to clinicians. Furthermore, health economic data have substantial
national, regional, and institutional variability, which can limit
the external validity of the results of a study. Therefore, minimum
guidelines that aim to standardise the quality and transparency
of reporting health economic research have been developed, and instruments
are available to assist in the assessment of its quality and the
interpretation of results. The purpose of this editorial is to discuss the principal types
of health economic studies, to review the most common instruments
for judging the quality of these studies and to describe current
reporting guidelines. Recommendations for the submission of these
types of studies to Cite this article:
Current studies on the additional benefit of using computed tomography
(CT) in order to evaluate the surgeons’ agreement on treatment plans
for fracture are inconsistent. This inconsistency can be explained
by a methodological phenomenon called ‘spectrum bias’, defined as
the bias inherent when investigators choose a population lacking
therapeutic uncertainty for evaluation. The aim of the study is
to determine the influence of spectrum bias on the intra-observer
agreement of treatment plans for fractures of the distal radius. Four surgeons evaluated 51 patients with displaced fractures
of the distal radius at four time points: T1 and T2: conventional
radiographs; T3 and T4: radiographs and additional CT scan (radiograph
and CT). Choice of treatment plan (operative or non-operative) and
therapeutic certainty (five-point scale: very uncertain to very
certain) were rated. To determine the influence of spectrum bias,
the intra-observer agreement was analysed, using Kappa statistics,
for each degree of therapeutic certainty. Objectives
Methods
Wrist block has been used to provide pain relief
for many procedures on the hand and wrist but its role in arthroscopy
of the wrist remains unexplored. Chondrotoxicity has been a concern
with the intra-articular infiltration of local anaesthetic. We aimed
to evaluate and compare the analgesic effect of portal and wrist
joint infiltration with a wrist block on the pain experienced by
patients after arthroscopy of the wrist. A prospective, randomised, double-blind trial was designed and
patients undergoing arthroscopy of the wrist under general anaesthesia
as a day case were recruited for the study. Levo-bupivacaine was
used for both techniques. The effects were evaluated using a ten-point
visual analogue scale, and the use of analgesic agents was also
compared. The primary outcomes for statistical analyses were the
mean pain scores and the use of analgesia post-operatively. A total of 34 patients (63% females) were recruited to the portal
and joint infiltration group and 32 patients (59% males) to the
wrist block group. Mean age was 40.8 years in the first group and
39.7 years in the second group (p >
0.05). Both techniques provided
effective pain relief in the first hour and 24 hours post-operatively
but wrist block gave better pain scores at bedtime on the day of
surgery (p = 0.007) and at 24 hours post-operatively (p = 0.006). Wrist block provides better and more reliable analgesia in patients
undergoing arthroscopy of the wrist without exposing patients to
the risk of chondrotoxicity. Cite this article:
There is no consensus on the benefit of arthroscopically
assisted reduction of the articular surface combined with fixation
using a volar locking plate for the treatment of intra-articular
distal radial fractures. In this study we compared the functional
and radiographic outcomes of fluoroscopically and arthroscopically
guided reduction of these fractures. Between February 2009 and May 2013, 74 patients with unilateral
unstable intra-articular distal radial fractures were randomised
equally into the two groups for treatment. The mean age of these
74 patients was 64 years (24 to 92). We compared functional outcomes
including active range of movement of the wrist, grip strength and Disabilities
of the Arm, Shoulder, and Hand scores at six and 48 weeks; and radiographic
outcomes that included gap, step, radial inclination, volar angulation
and ulnar variance. There were no significant differences between the techniques
with regard to functional outcomes or radiographic parameters. The
mean gap and step in the fluoroscopic and arthroscopic groups were
comparable at 0.9 mm (standard deviation Arthroscopic reduction conferred no advantage over conventional
fluoroscopic guidance in achieving anatomical reduction of intra-articular
distal radial fractures when using a volar locking plate. Cite this article:
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:
Patients from a randomised trial on resurfacing
hip arthroplasty (RHA) (n = 36, 19 males; median age 57 years, 24
to 65) comparing a conventional 28 mm metal-on-metal total hip arthroplasty
(MoM THA) (n = 28, 17 males; median age 59 years, 37 to 65) and
a matched control group of asymptomatic patients with a 32 mm ceramic-on-polyethylene
(CoP) THA (n = 33, 18 males; median age 63 years, 38 to 71) were
cross-sectionally screened with metal artefact reducing sequence-MRI
(MARS-MRI) for pseudotumour formation at a median of 55 months (23
to 72) post-operatively. MRIs were scored by consensus according
to three different classification systems for pseudotumour formation. Clinical scores were available for all patients and metal ion
levels for MoM bearing patients. Periprosthetic lesions with a median volume of 16 mL (1.5 to
35.9) were diagnosed in six patients in the RHA group (17%), one
in the MoM THA group (4%) and six in the CoP group (18%). The classification
systems revealed no clear differences between the groups. Solid
lesions (n = 3) were exclusively encountered in the RHA group. Two patients
in the RHA group and one in the MoM THA group underwent a revision
for pseudotumour formation. There was no statistically significant
relationship between clinical scoring, metal ion levels and periprosthetic
lesions in any of the groups. Periprosthetic fluid collections are seen on MARS-MRI after conventional
CoP THA and RHA and may reflect a soft-tissue collection or effusion. Currently available MRI classification systems seem to score
these collections as pseudotumours, causing an-overestimatation
of the incidence of pseudotumours. Cite this article:
Clinical studies of patients with bone sarcomas have been challenged
by insufficient numbers at individual centres to draw valid conclusions.
Our objective was to assess the feasibility of conducting a definitive
multi-centre randomised controlled trial (RCT) to determine whether
a five-day regimen of post-operative antibiotics, in comparison
to a
24-hour regimen, decreases surgical site infections in patients
undergoing endoprosthetic reconstruction for lower extremity primary
bone tumours. We performed a pilot international multi-centre RCT. We used
central randomisation to conceal treatment allocation and sham antibiotics
to blind participants, surgeons, and data collectors. We determined
feasibility by measuring patient enrolment, completeness of follow-up,
and protocol deviations for the antibiotic regimens. Objective
Methods
The purpose of this study was to undertake a
meta-analysis to determine whether there is lower polyethylene wear and
longer survival when using mobile-bearing implants in total knee
replacement when compared with fixed-bearing implants. Of 975 papers
identified, 34 trials were eligible for data extraction and meta-analysis
comprising 4754 patients (6861 knees). We found no statistically
significant differences between the two designs in terms of the incidence
of radiolucent lines, osteolysis, aseptic loosening or survival.
There is thus currently no evidence to suggest that the use of mobile-bearing
designs reduce polyethylene wear and prolong survival after total
knee replacement. Cite this article:
Femoral stem version has a major influence on
impingement and early post-operative stability after total hip arthroplasty
(THA). The main objective of this study was to evaluate the validity
of a novel radiological method for measuring stem version. Anteroposterior
(AP) radiographs and three-dimensional CT scans were obtained for
115 patients (female/male 63/72, mean age 62.5 years (50 to 75))
who had undergone minimally invasive, cementless THA. Stem version was
calculated from the AP hip radiograph by rotation-based change in
the projected prosthetic neck–shaft (NSA*) angle using the mathematical
formula ST = arcos [tan (NSA*) / tan (135)]. We used two independent
observers who repeated the analysis after a six-week interval. Radiological
measurements were compared with 3D-CT measurements by an independent,
blinded external institute. We found a mean difference of 1.2° ( We found that femoral tilt was associated with the mean radiological
measurement error (r = 0.22, p = 0.02). The projected neck–shaft angle is a reliable method for measuring
stem version on AP radiographs of the hip after a THA. However,
a highly standardised radiological technique is required for its
precise measurement. Cite this article:
Most patients with a nightstick fracture of the
ulna are treated conservatively. Various techniques of immobilisation or
early mobilisation have been studied. We performed a systematic
review of all published randomised controlled trials and observational
studies that have assessed the outcome of these fractures following
above- or below-elbow immobilisation, bracing and early mobilisation.
We searched multiple electronic databases, related bibliographies and
other studies. We included 27 studies comprising 1629 fractures
in the final analysis. The data relating to the time to radiological
union and the rates of delayed union and nonunion could be pooled
and analysed statistically. We found that early mobilisation produced the shortest radiological
time to union (mean 8.0 weeks) and the lowest mean rate of nonunion
(0.6%). Fractures treated with above- or below-elbow immobilisation
and braces had longer mean radiological times to union (9.2 weeks,
9.2 weeks and 8.7 weeks, respectively) and higher mean rates of
nonunion (3.8%, 2.1% and 0.8%, respectively). There was no statistically
significant difference in the rate of non- or delayed union between
those treated by early mobilisation and the three forms of immobilisation
(p = 0.142 to p = 1.000, respectively). All the studies had significant
biases, but until a robust randomised controlled trial is undertaken
the best advice for the treatment of undisplaced or partially displaced
nightstick fractures appears to be early mobilisation, with a removable
forearm support for comfort as required. 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:
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:
Femoroacetabular Junction Impingement (FAI) describes abnormalities
in the shape of the femoral head–neck junction, or abnormalities
in the orientation of the acetabulum. In the short term, FAI can
give rise to pain and disability, and in the long-term it significantly increases
the risk of developing osteoarthritis. The Femoroacetabular Impingement
Trial (FAIT) aims to determine whether operative or non-operative
intervention is more effective at improving symptoms and preventing
the development and progression of osteoarthritis. FAIT is a multicentre superiority parallel two-arm randomised
controlled trial comparing physiotherapy and activity modification
with arthroscopic surgery for the treatment of symptomatic FAI.
Patients aged 18 to 60 with clinical and radiological evidence of
FAI are eligible. Principal exclusion criteria include previous
surgery to the index hip, established osteoarthritis (Kellgren–Lawrence
≥ 2), hip dysplasia (centre-edge angle <
20°), and completion
of a physiotherapy programme targeting FAI within the previous 12
months. Recruitment will take place over 24 months and 120 patients
will be randomised in a 1:1 ratio and followed up for three years.
The two primary outcome measures are change in hip outcome score
eight months post-randomisation (approximately six-months post-intervention
initiation) and change in radiographic minimum joint space width
38 months post-randomisation. ClinicalTrials.gov: NCT01893034. Cite this article: Aims
Methods
Opinion remains divided as to whether the development
of pathological fracture affects the prognosis of patients with
an osteosarcoma of the extremities. We conducted a comprehensive systematic review and meta-analysis
of papers which reported the outcomes of osteosarcoma patients with
and without a pathological fracture. There were eight eligible papers
for final analysis which reported on 1713 patients, of whom 303
(17.7%) had a pathological fracture. The mean age for 1464 patients in
six studies was 23.2 years old (2 to 82). The mean follow-up for
1481 patients in seven studies was 90.1 months (6 to 240). The pooled estimates of local recurrence rates in osteosarcoma
patients with and without pathological fractures were 14.4% (8.7
to 20.0) The development of a pathological fracture is a negative prognostic
indicator in osteosarcoma and is associated with a reduced five-year
event-free survival and a possibly higher rate of local recurrence.
Our findings suggest that there is no absolute indication for amputation,
as similar rates of local recurrence can be achieved in patients
who are carefully selected for limb salvage. 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 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:
Data on early morbidity and complications after
revision total hip replacement (THR) are limited. The aim of this nationwide
study was to describe and quantify early morbidity after aseptic
revision THR and relate the morbidity to the extent of the revision
surgical procedure. We analysed all aseptic revision THRs from 1st
October 2009 to 30th September 2011 using the Danish National Patient
Registry, with additional information from the Danish Hip Arthroplasty
Registry. There were 1553 procedures (1490 patients) performed in
40 centres and we divided them into total revisions, acetabular
component revisions, femoral stem revisions and partial revisions.
The mean age of the patients was 70.4 years (25 to 98) and the median
hospital stay was five days (interquartile range 3 to 7). Within 90
days of surgery, the readmission rate was 18.3%, mortality rate
1.4%, re-operation rate 6.1%, dislocation rate 7.0% and infection
rate 3.0%. There were no differences in these outcomes between high-
and low-volume centres. Of all readmissions, 255 (63.9%) were due
to ‘surgical’ complications Cite this article:
The surgical community is plagued with a reputation
for both failing to engage and to deliver on clinical research.
This is in part due to the absence of a strong research culture, however
it is also due to a multitude of barriers encountered in clinical
research; particularly those involving surgical interventions. ‘Trauma’
amplifies these barriers, owing to the unplanned nature of care,
unpredictable work patterns, the emergent nature of treatment and
complexities in the consent process. This review discusses the barriers
to clinical research in surgery, with a particular emphasis on trauma.
It considers how barriers may be overcome, with the aim to facilitate
future successful clinical research. Cite this article: