Aims. The primary aim of this study was to assess the independent association of the coronavirus disease 2019 (COVID-19) on postoperative mortality for patients undergoing orthopaedic and
Several aspects of the management of an orthopaedic surgical patient are not directly related to the surgical technique but are nevertheless essential for a successful outcome. Blood management is one of these. This paper considers the various strategies available for the management of blood loss in patients undergoing orthopaedic and
The spread of viral diseases such as HIV has highlighted the importance of protecting medical personnel against contamination from blood. We have assessed the frequency of the perforation of surgical gloves during orthopaedic and
The aim of this study was to validate the use of three models of fracture fixation in the assessment of technical skills. We recruited 21 subjects (six experts, seven intermediates, and eight novices) to perform three procedures: application of a dynamic compression plate on a cadaver porcine model, insertion of an unreamed tibial intramedullary nail, and application of a forearm external fixator, both on synthetic bone models. The primary outcome measures were the Objective Structural Assessment of technical skills global rating scale on video recordings of the procedures which were scored by two independent expert observers, and the hand movements of the surgeons which were analysed using the Imperial College Surgical Assessment Device. The video scores were significantly different for the three groups in all three procedures (p <
0.05), with excellent inter-rater reliability (α = 0.88). The novice and intermediate groups specifically were significantly different in their performance with dynamic compression plate and intramedullary nails (p <
0.05). Movement analysis distinguished between the three groups in the dynamic compression plate model, but a ceiling effect was demonstrated in the intramedullary nail and external fixator procedures, where intermediates and experts performed to comparable standards (p >
0.6). A total of 85% (18 of 21) of the subjects found the dynamic compression model and 57% (12 of 21) found all the models acceptable tools of assessment. This study has validated a low-cost, high-fidelity porcine dynamic compression plate model using video rating scores for skills assessment and movement analysis. It has also demonstrated that Synbone models for the application of and intramedullary nail and an external fixator are less sensitive and should be improved for further assessment of surgical skills in trauma. The availability of valid objective tools of assessment of surgical skills allows further studies into improving methods of training.
In the UK, the agricultural, military, and construction sectors have stringent rules about the use of hearing protection due to the risk of noise-induced hearing loss. Orthopaedic staff may also be at risk due to the use of power tools. The UK Health and Safety Executive (HSE) have clear standards as to what are deemed acceptable occupational levels of noise on A-weighted and C-weighted scales. The aims of this review were to assess the current evidence on the testing of exposure to noise in orthopaedic operating theatres to see if it exceeds these regulations. A search of PubMed and EMBASE databases was conducted using PRISMA guidelines. The review was registered prospectively in PROSPERO. Studies which assessed the exposure to noise for orthopaedic staff in operating theatres were included. Data about the exposure to noise were extracted from these studies and compared with the A-weighted and C-weighted acceptable levels described in the HSE regulations.Aims
Methods
Artificial intelligence (AI) is, in essence, the concept of ‘computer thinking’, encompassing methods that train computers to perform and learn from executing certain tasks, called machine learning, and methods to build intricate computer models that both learn and adapt, called complex neural networks. Computer vision is a function of AI by which machine learning and complex neural networks can be applied to enable computers to capture, analyze, and interpret information from clinical images and visual inputs. This annotation summarizes key considerations and future perspectives concerning computer vision, questioning the need for this technology (the ‘why’), the current applications (the ‘what’), and the approach to unlocking its full potential (the ‘how’). Cite this article:
We prospectively studied the outcome of a protocol of prophylaxis for deep vein thrombosis (DVT) in 103 consecutive patients undergoing surgical stabilisation of pelvic and acetabular fractures. Low-molecular-weight heparin (LMWH) was administered within 24 hours of injury or on achieving haemodynamic stability. Patients were screened for proximal DVT by duplex ultrasonography performed ten to 14 days after surgery. The incidence of proximal DVT was 10% and of pulmonary embolus 5%. Proximal DVT developed in two of 64 patients (3%) who had received LMWH within 24 hours of injury, but in eight of 36 patients (22%) who received LMWH more than 24 hours after the injury (p <
0.01). We conclude that LMWH, when begun without delay, is a safe and effective method of thromboprophylaxis in high-risk patients with major pelvic or acetabular fractures.
Aims. The aims of this study were to assess the pre- and postoperative incidence of deep vein thrombosis (DVT) using routine duplex Doppler ultrasound (DUS), to assess the incidence of pulmonary embolism (PE) using CT angiography, and to identify the factors that predict postoperative DVT in patients with a pelvic and/or acetabular fracture. Methods. All patients treated surgically for a pelvic and/or acetabular fracture between October 2016 and January 2020 were enrolled into this prospective single-centre study. The demographic, medical, and surgical details of the patients were recorded. DVT screening of the lower limbs was routinely performed using DUS before and at six to ten days after surgery. CT angiography was used in patients who were suspected of having PE. Age-adjusted univariate and stepwise multiple logistic regression analysis were used to determine the association between explanatory variables and postoperative DVT. Results. A total of 191 patients were included. A DVT was found preoperatively in 12 patients (6.3%), of which six were proximal. A postoperative DVT was found in 42 patients (22%), of which 27 were proximal. Eight patients (4.2%) had a PE, which was secondary to a DVT in three. None of the 12 patients in whom a vena cava filter was implanted prophylactically had a PE. Multivariate logistic regression analysis indicated that the association with the need for spinal surgery (odds ratio (OR) 19.78 (95% confidence interval (CI) 1.12 to 348.08); p = 0.041), intramedullary nailing of a long bone fracture (OR 4.44 (95% CI 1.05 to 18.86); p = 0.043), an operating time > two hours (OR 3.28 (95% CI 1.09 to 9.88); p = 0.035), and additional
Dual-mobility acetabular components (DMCs) have improved total hip arthroplasty (THA) stability in femoral neck fractures (FNFs). In osteoarthritis, the direct anterior approach (DAA) has been promoted for improving early functional results compared with the posterolateral approach (PLA). The aim of this study was to compare these two approaches in FNF using DMC-THA. A prospective continuous cohort study was conducted on patients undergoing operation for FNF using DMC by DAA or PLA. Functional outcome was evaluated using the Harris Hip Score (HHS) and Parker score at three months and one year. Perioperative complications were recorded, and radiological component positioning evaluated.Aims
Methods
The aim of this study was to perform the first population-based description of the epidemiological and health economic burden of fracture-related infection (FRI). This is a retrospective cohort study of operatively managed orthopaedic trauma patients from 1 January 2007 to 31 December 2016, performed in Queensland, Australia. Record linkage was used to develop a person-centric, population-based dataset incorporating routinely collected administrative, clinical, and health economic information. The FRI group consisted of patients with International Classification of Disease 10th Revision diagnosis codes for deep infection associated with an implanted device within two years following surgery, while all others were deemed not infected. Demographic and clinical variables, as well as healthcare utilization costs, were compared.Aims
Methods
The aim of this study was to assess the safety and clinical outcome of patients with a femoral shaft fracture and a previous complex post-traumatic femoral malunion who were treated with a clamshell osteotomy and fixation with an intramedullary nail (IMN). The study involved a retrospective analysis of 23 patients. All had a previous, operatively managed, femoral shaft fracture with malunion due to hardware failure. They were treated with a clamshell osteotomy between May 2015 and March 2020. The mean age was 42.6 years (26 to 62) and 15 (65.2%) were male. The mean follow-up was 2.3 years (1 to 5). Details from their medical records were analyzed. Clinical outcomes were assessed using the quality of correction of the deformity, functional recovery, the healing time of the fracture, and complications.Aims
Methods
The aim of this study was to perform a systematic review of the evidence for the use of intraoperative cell salvage in patients undergoing revision hip arthroplasty, and specifically to analyze the available data in order to quantify any associated reduction in the use of allogenic blood transfusion, and the volume which is used. An electronic search of MEDLINE (PubMed), Embase, Scopus, and the Cochrane Library was completed from the date of their inception to 24 February 2022, using a search strategy and protocol created in conjunction with the PRISMA statement. Inclusion criteria were patients aged > 18 years who underwent revision hip arthroplasty when cell salvage was used. Studies in which pre-donated red blood cells were used were excluded. A meta-analysis was also performed using a random effects model with significance set at p = 0.05.Aims
Methods
Weightbearing instructions after musculoskeletal injury or orthopaedic surgery are a key aspect of the rehabilitation pathway and prescription. The terminology used to describe the weightbearing status of the patient is variable; many different terms are used, and there is recognition and evidence that the lack of standardized terminology contributes to confusion in practice. A consensus exercise was conducted involving all the major stakeholders in the patient journey for those with musculoskeletal injury. The consensus exercise primary aim was to seek agreement on a standardized set of terminology for weightbearing instructions.Aims
Methods
Periacetabular osteotomy (PAO) is widely recognized as a demanding surgical procedure for acetabular reorientation. Reports about the learning curve have primarily focused on complication rates during the initial learning phase. Therefore, our aim was to assess the PAO learning curve from an analytical perspective by determining the number of PAOs required for the duration of surgery to plateau and the accuracy to improve. The study included 118 consecutive PAOs in 106 patients. Of these, 28 were male (23.7%) and 90 were female (76.3%). The primary endpoint was surgical time. Secondary outcome measures included radiological parameters. Cumulative summation analysis was used to determine changes in surgical duration. A multivariate linear regression model was used to identify independent factors influencing surgical time.Aims
Methods
External fixation is widely used in orthopaedic
and
The purpose of this study was to determine the weightbearing practice of operatively managed fragility fractures in the setting of publically funded health services in the UK and Ireland. The Fragility Fracture Postoperative Mobilisation (FFPOM) multicentre audit included all patients aged 60 years and older undergoing surgery for a fragility fracture of the lower limb between 1 January 2019 and 30 June 2019, and 1 February 2021 and 14 March 2021. Fractures arising from high-energy transfer trauma, patients with multiple injuries, and those associated with metastatic deposits or infection were excluded. We analyzed this patient cohort to determine adherence to the British Orthopaedic Association Standard, “all surgery in the frail patient should be performed to allow full weight-bearing for activities required for daily livingAims
Methods
Medium-term results of the Discovery elbow replacement
are presented. We reviewed 51 consecutive primary Discovery total
elbow replacements (TERs) implanted in 48 patients. The mean age
of the patients was 69.2 years (49 to 92), there were 19 males and
32 females (37%:63%) The mean follow-up was 40.6 months (24 to 69).
A total of six patients were lost to follow-up. Statistically significant
improvements in range movement and Oxford Elbow Score were found
(p <
0.001). Radiolucent lines were much more common in, and
aseptic loosening was exclusive to, the humeral component. Kaplan–Meier
survivorship at five years was 92.2% (95% CI 74.5% to 96.4%) for
aseptic loosening. In four TERs, periprosthetic infection occurred
resulting in failure. A statistically significant association between
infection and increased BMI was found (p = 0.0268). Triceps failure
was more frequent after the Mayo surgical approach and TER performed
after previous
The use of tourniquets in lower limb trauma surgery to control bleeding and improve the surgical field is a long established practice. In this article, we review the evidence relating to harms and benefits of tourniquet use in lower limb fracture fixation surgery and report the results of a survey on current tourniquet practice among trauma surgeons in the UK.
The stress response to trauma is the summation of the physiological response to the injury (the ‘first hit’) and by the response to any on-going physiological disturbance or subsequent
The use and variety of stemless humeral components in anatomical total shoulder arthroplasty (TSA) have proliferated since their advent in 2004. Early outcomes are reassuring but independent mid-term results are scarce. This independent study reports a consecutive series of 143 Eclipse stemless shoulder prostheses with a minimum five-year (5 to 10) follow-up. Outcomes of 143 procedures undertaken for all indications in 131 patients were reviewed, with subset analysis of those for osteoarthritis (OA) (n = 99). The primary outcome was the Oxford Shoulder Score (OSS) at a minimum of five years. Secondary outcomes were ranges of motion and radiological analysis of humeral radiolucency, rotator cuff failure, and glenoid loosening.Aims
Methods
Deep surgical site infection (SSI) is common after lower limb fracture. We compared the diagnosis of deep SSI using alternative methods of data collection and examined the agreement of clinical photography and in-person clinical assessment by the Centers for Disease Control and Prevention (CDC) criteria after lower limb fracture surgery. Data from two large, UK-based multicentre randomized controlled major trauma trials investigating SSI and wound healing after surgical repair of open lower limb fractures that could not be primarily closed (UK WOLLF), and surgical incisions for fractures that were primarily closed (UK WHiST), were examined. Trial interventions were standard wound care management and negative pressure wound therapy after initial surgical debridement. Wound outcomes were collected from 30 days to six weeks. We compared the level of agreement between wound photography and clinical assessment of CDC-defined SSI. We are also assessed the level of agreement between blinded independent assessors of the photographs.Aims
Methods
We report the long-term outcomes of the UK Heel Fracture Trial (HeFT), a pragmatic, multicentre, two-arm, assessor-blinded, randomized controlled trial. HeFT recruited 151 patients aged over 16 years with closed displaced, intra-articular fractures of the calcaneus. Patients with significant deformity causing fibular impingement, peripheral vascular disease, or other significant limb injuries were excluded. Participants were randomly allocated to open reduction and internal fixation (ORIF) or nonoperative treatment. We report Kerr-Atkins scores, self-reported difficulty walking and fitting shoes, and additional surgical procedures at 36, 48, and 60 months.Aims
Methods
Patients who sustain neck of femur fractures are at high risk of malnutrition. Our intention was to assess to what extent malnutrition was associated with worse patient outcomes. A total of 1,199 patients with femoral neck fractures presented to a large UK teaching hospital over a three-year period. All patients had nutritional assessments performed using the Malnutrition Universal Screening Tool (MUST). Malnutrition risk was compared to mortality, length of hospital stay, and discharge destination using logistic regression. Adjustments were made for covariates to identify whether malnutrition risk independently affected these outcomes.Aims
Methods
The aim of this study was to explore whether time to surgery affects functional outcome in displaced proximal humeral fractures A total of 250 patients presenting within three weeks of sustaining a displaced proximal humeral fracture involving the surgical neck were recruited at 32 acute NHS hospitals in the United Kingdom between September 2008 and April 2011. Of the 125 participants, 109 received surgery (fracture fixation or humeral head replacement) as per randomization. Data were included for 101 and 67 participants at six-month and five-year follow-up, respectively. Oxford Shoulder Scores (OSS) collected at six, 12, and 24 months and at three, four, and five years following randomization was plotted against time to surgery. Long-term recovery was explored by plotting six-month scores against five-year scores and agreement was illustrated with a Bland-Altman plot.Aims
Methods
In 2013, we introduced a specialized, centralized, and interdisciplinary team in our institution that applied a standardized diagnostic and treatment algorithm for the management of prosthetic joint infections (PJIs). The hypothesis for this study was that the outcome of treatment would be improved using this approach. In a retrospective analysis with a standard postoperative follow-up, 95 patients with a PJI of the hip and knee who were treated with a two-stage exchange between 2013 and 2017 formed the study group. A historical cohort of 86 patients treated between 2009 and 2011 not according to the standardized protocol served as a control group. The success of treatment was defined according to the Delphi criteria in a two-year follow-up.Aims
Patients and Methods
The primary aim of this retrospective study was to identify the
incidence of heterotopic ossification (HO) following elective and
trauma elbow arthroplasty. The secondary aim was to determine clinical
outcomes with respect to the formation of heterotopic ossification. A total of 55 total elbow arthroplasties (TEAs) (52 patients)
performed between June 2007 and December 2015 were eligible for
inclusion in the study (29 TEAs for primary elective arthroplasty
and 26 TEAs for trauma). At review, 15 patients (17 total elbow
arthroplasties) had died from unrelated causes. There were 14 men
and 38 women with a mean age of 70 years (42 to 90). The median
clinical follow-up was 3.6 years (1.2 to 6) and the median radiological follow-up
was 3.1 years (0.5 to 7.5).Aim
Patients and Methods
Deep infection was identified as a serious complication in the earliest days of total hip arthroplasty. It was identified that airborne contamination in conventional operating theatres was the major contributing factor. As progress was made in improving the engineering of operating theatres, airborne contamination was reduced. Detailed studies were carried out relating airborne contamination to deep infection rates. In a trial conducted by the United Kingdom Medical Research Council (MRC), it was found that the use of ultra-clean air (UCA) operating theatres was associated with a significant reduction in deep infection rates. Deep infection rates were further reduced by the use of a body exhaust system. The MRC trial also included a detailed microbiology study, which confirmed the relationship between airborne contamination and deep infection rates. Recent observational evidence from joint registries has shown that in contemporary practice, infection rates remain a problem, and may be getting worse. Registry observations have also called into question the value of “laminar flow” operating theatres. Observational evidence from joint registries provides very limited evidence on the efficacy of UCA operating theatres. Although there have been some changes in surgical practice in recent years, the conclusions of the MRC trial remain valid, and the use of UCA is essential in preventing deep infection. There is evidence that if UCA operating theatres are not used correctly, they may have poor microbiological performance. Current UCA operating theatres have limitations, and further research is required to update them and improve their microbiological performance in contemporary practice. Cite this article:
Prophylactic antibiotics can decrease the risk
of wound infection and have been routinely employed in orthopaedic surgery
for decades. Despite their widespread use, questions still surround
the selection of antibiotics for prophylaxis, timing and duration
of administration. The health economic costs associated with wound
infections are significant, and the judicious but appropriate use
of antibiotics can reduce this risk. This review examines the evidence behind commonly debated topics
in antibiotic prophylaxis and highlights the uses and advantages
of some commonly used antibiotics. Cite this article:
Calcium sulphate (CaSO4) is a resorbable material
that can be used simultaneously as filler of a dead space and as
a carrier for the local application of antibiotics. Our aim was
to describe the systemic exposure and the wound fluid concentrations
of vancomycin in patients treated with vancomycin-loaded CaSO4 as
an adjunct to the routine therapy of bone and joint infections. A total of 680 post-operative blood and 233 wound fluid samples
were available for analysis from 94 implantations performed in 87
patients for various infective indications. Up to 6 g of vancomycin
were used. Non-compartmental pharmacokinetic analysis was performed
on the data from 37 patients treated for an infection of the hip.Aims
Patients and Methods
Surgical site infection can be a devastating complication of
hemiarthroplasty of the hip, when performed in elderly patients
with a displaced fracture of the femoral neck. It results in a prolonged
stay in hospital, a poor outcome and increased costs. Many studies
have identified risk and prognostic factors for deep infection.
However, most have combined the rates of infection following total
hip arthroplasty and internal fixation as well as hemiarthroplasty, despite
the fact that they are different entities. The aim of this study
was to clarify the risk and prognostic factors causing deep infection
after hemiarthroplasty alone. Data were extracted from a prospective hip fracture database
and completed by retrospective review of the hospital records. A
total of 916 patients undergoing a hemiarthroplasty in two level
II trauma teaching hospitals between 01 January 2011 and
01 May 2016 were included. We analysed the potential peri-operative
risk factors with univariable and multivariable logistic regression
analysis.Aims
Patients and Methods
We reviewed 59 bone graft substitutes marketed
by 17 companies currently available for implantation in the United Kingdom,
with the aim of assessing the peer-reviewed literature to facilitate
informed decision-making regarding their use in clinical practice.
After critical analysis of the literature, only 22 products (37%)
had any clinical data. Norian SRS (Synthes), Vitoss (Orthovita),
Cortoss (Orthovita) and Alpha-BSM (Etex) had Level I evidence. We question
the need for so many different products, especially with limited
published clinical evidence for their efficacy, and conclude that
there is a considerable need for further prospective randomised
trials to facilitate informed decision-making with regard to the
use of current and future bone graft substitutes in clinical practice. Cite this article:
The best time for definitive orthopaedic care is often unclear
in patients with multiple injuries. The objective of this study
was make a prospective assessment of the safety of our early appropriate
care (EAC) strategy and to evaluate the potential benefit of additional
laboratory data to determine readiness for surgery. A cohort of 335 patients with fractures of the pelvis, acetabulum,
femur, or spine were included. Patients underwent definitive fixation
within 36 hours if one of the following three parameters were met:
lactate <
4.0 mmol/L; pH ≥ 7.25; or base excess (BE) ≥ -5.5 mmol/L.
If all three parameters were met, resuscitation was designated full
protocol resuscitation (FPR). If less than all three parameters
were met, it was designated an incomplete protocol resuscitation
(IPR). Complications were assessed by an independent adjudication
committee and included infection; sepsis; PE/DVT; organ failure;
pneumonia, and acute respiratory distress syndrome (ARDS). Aims
Patients and Methods
Patellar instability most frequently presents
during adolescence. Congenital and infantile dislocation of the
patella is a distinct entity from adolescent instability and measurable
abnormalities may be present at birth. In the normal patellofemoral
joint an increase in quadriceps angle and patellar height are matched
by an increase in trochlear depth as the joint matures. Adolescent
instability may herald a lifelong condition leading to chronic disability
and arthritis. Restoring normal anatomy by trochleoplasty, tibial tubercle transfer
or medial patellofemoral ligament (MPFL) reconstruction in the young
adult prevents further instability. Although these techniques are
proven in the young adult, they may cause growth arrest and deformity
where the physis is open. A vigorous non-operative strategy may
permit delay of surgery until growth is complete. Where non-operative
treatment has failed a modified MPFL reconstruction may be performed
to maintain stability until physeal closure permits anatomical reconstruction.
If significant growth remains an extraosseous reconstruction of
the MPFL may impart the lowest risk to the physis. If minor growth
remains image intensifier guided placement of femoral intraosseous
fixation may impart a small, but acceptable, risk to the physis. This paper presents and discusses the literature relating to
adolescent instability and provides a framework for management of
these patients. Cite this article:
The use of robots in orthopaedic surgery is an
emerging field that is gaining momentum. It has the potential for significant
improvements in surgical planning, accuracy of component implantation
and patient safety. Advocates of robot-assisted systems describe
better patient outcomes through improved pre-operative planning
and enhanced execution of surgery. However, costs, limited availability,
a lack of evidence regarding the efficiency and safety of such systems
and an absence of long-term high-impact studies have restricted
the widespread implementation of these systems. We have reviewed
the literature on the efficacy, safety and current understanding of
the use of robotics in orthopaedics. Cite this article:
The aim of this study was to inform a definitive trial which
could determine the clinical effectiveness of the X-Bolt Dynamic
Hip Plating System compared with the sliding hip screw for patients
with complex pertrochanteric fragility fractures of the femur. This was a single centre, participant blinded, randomised, standard-of-care
controlled pilot trial. Patients aged 60 years and over with AO/ASIF
A2 and A3 type femoral pertrochanteric fractures were eligible.Aims
Patients and Methods
Between 2005 and 2012, 50 patients (23 female, 27 male) with
nonunion of the humeral shaft were included in this retrospective
study. The mean age was 51.3 years (14 to 88). The patients had
a mean of 1.5 prior operations ( All patients were assessed according to a specific risk score
in order to devise an optimal and individual therapy plan consistent
with the Diamond Concept. In 32 cases (64%), a change in the osteosynthesis
to an angular stable locking compression plate was performed. According
to the individual risk an additional bone graft and/or bone morphogenetic
protein-7 (BMP-7) were applied. A successful consolidation of the nonunion was observed in 37
cases (80.4%) with a median healing time of six months (IQR 6).
Younger patients showed significantly better consolidation. Four
patients were lost to follow-up. Revision was necessary in a total
of eight (16%) cases. In the initial treatment, intramedullary nailing
was most common. Methods
Results
We summarise and highlight the safety concerns
within the field of trauma and orthopaedic surgery with particular
emphasis placed on current controversies and reforms within the United
Kingdom National Health Service.
The poor reporting and use of statistical methods in orthopaedic papers has been widely discussed by both clinicians and statisticians. A detailed review of research published in general orthopaedic journals was undertaken to assess the quality of experimental design, statistical analysis and reporting. A representative sample of 100 papers was assessed for compliance to CONSORT and STROBE guidelines and the quality of the statistical reporting was assessed using a validated questionnaire. Overall compliance with CONSORT and STROBE guidelines in our study was 59% and 58% respectively, with very few papers fulfilling all criteria. In 37% of papers patient numbers were inadequately reported; 20% of papers introduced new statistical methods in the ‘results’ section not previously reported in the ‘methods’ section, and 23% of papers reported no measurement of error with the main outcome measure. Taken together, these issues indicate a general lack of statistical rigour and are consistent with similar reviews undertaken in a number of other scientific and clinical research disciplines. It is imperative that the orthopaedic research community strives to improve the quality of reporting; a failure to do so could seriously limit the development of future research.
Hip fracture is a common injury associated with
high mortality, long-term disability and huge socio-economic burden.
Yet there has been relatively little research into best treatment,
and evidence that has been generated has often been criticised for
its poor quality. Here, we discuss the advances made towards overcoming
these criticisms and the future directions for hip fracture research:
how co-ordinating existing national infrastructures and use of now
established clinical research networks will likely go some way towards
overcoming the practical and financial challenges of conducting
large trials. We highlight the importance of large collaborative
pragmatic trials to inform decision/policy makers and the progress
made towards reaching a consensus on a core outcome set to facilitate data
pooling for evidence synthesis and meta-analysis. These advances and future directions are a priority in order
to establish the high-quality evidence base required for this important
group of patients. Cite this article: