In 2003, the QUADAS tool for systematic reviews of diagnostic accuracy studies was developed. Experience, anecdotal reports, and feedback suggested areas for improvement; therefore, QUADAS-2 was developed. This tool comprises 4 domains: patient selection, index test, reference standard, and flow and timing. Each domain is assessed in terms of risk of bias, and the first 3 domains are also assessed in terms of concerns regarding applicability. Signalling questions are included to help judge risk of bias. The QUADAS-2 tool is applied in 4 phases: summarize the review question, tailor the tool and produce review-specific guidance, construct a flow diagram for the primary study, and judge bias and applicability. This tool will allow for more transparent rating of bias and applicability of primary diagnostic accuracy studies.

https://www.meyer.it/images/pdf/cto-quadas2-quality-assessment-of-studies-of-diagnostic-accuracy.pdf

QUADAS-2: A Revised Tool for the Quality Assessment of Diagnostic Accuracy Studies

Bone regeneration is a complex, well-orchestrated physiological process of bone formation, which can be seen during normal fracture healing, and is involved in continuous remodelling throughout adult life. However, there are complex clinical conditions in which bone regeneration is required in large quantity, such as for skeletal reconstruction of large bone defects created by trauma, infection, tumour resection and skeletal abnormalities, or cases in which the regenerative process is compromised, including avascular necrosis, atrophic non-unions and osteoporosis. Currently, there is a plethora of different strategies to augment the impaired or 'insufficient' bone-regeneration process, including the 'gold standard' autologous bone graft, free fibula vascularised graft, allograft implantation, and use of growth factors, osteoconductive scaffolds, osteoprogenitor cells and distraction osteogenesis. Improved 'local' strategies in terms of tissue engineering and gene therapy, or even 'systemic' enhancement of bone repair, are under intense investigation, in an effort to overcome the limitations of the current methods, to produce bone-graft substitutes with biomechanical properties that are as identical to normal bone as possible, to accelerate the overall regeneration process, or even to address systemic conditions, such as skeletal disorders and osteoporosis.

/pdf/bone-regeneration-current-concepts-and-future-directions-34hm4n0z0i.pdf

Bone regeneration: current concepts and future directions

The European Hernia Society (EHS) is proud to present the EHS Guidelines for the Treatment of Inguinal Hernia in Adult Patients. The Guidelines contain recommendations for the treatment of inguinal hernia from diagnosis till aftercare. They have been developed by a Working Group consisting of expert surgeons with representatives of 14 country members of the EHS. They are evidence-based and, when necessary, a consensus was reached among all members. The Guidelines have been reviewed by a Steering Committee. Before finalisation, feedback from different national hernia societies was obtained. The Appraisal of Guidelines for REsearch and Evaluation (AGREE) instrument was used by the Cochrane Association to validate the Guidelines. The Guidelines can be used to adjust local protocols, for training purposes and quality control. They will be revised in 2012 in order to keep them updated. In between revisions, it is the intention of the Working Group to provide every year, during the EHS annual congress, a short update of new high-level evidence (randomised controlled trials [RCTs] and meta-analyses). Developing guidelines leads to questions that remain to be answered by specific research. Therefore, we provide recommendations for further research that can be performed to raise the level of evidence concerning certain aspects of inguinal hernia treatment. In addition, a short summary, specifically for the general practitioner, is given. In order to increase the practical use of the Guidelines by consultants and residents, more details on the most important surgical techniques, local infiltration anaesthesia and a patient information sheet is provided. The most important challenge now will be the implementation of the Guidelines in daily surgical practice. This remains an important task for the EHS. The establishment of an EHS school for teaching inguinal hernia repair surgical techniques, including tips and tricks from experts to overcome the learning curve (especially in endoscopic repair), will be the next step. Working together on this project was a great learning experience, and it was worthwhile and fun. Cultural differences between members were easily overcome by educating each other, respecting different views and always coming back to the principles of evidence-based medicine. The members of the Working Group would like to thank the EHS board for their support and especially Ethicon for sponsoring the many meetings that were needed to finalise such an ambitious project.

/pdf/european-hernia-society-guidelines-on-the-treatment-of-3gpmvq0mxo.pdf

European Hernia Society guidelines on the treatment of inguinal hernia in adult patients

Severe trauma continues to represent a global public health issue and mortality and morbidity in trauma patients remains substantial. A number of initiatives have aimed to provide guidance on the management of trauma patients. This document focuses on the management of major bleeding and coagulopathy following trauma and encourages adaptation of the guiding principles to each local situation and implementation within each institution. The pan-European, multidisciplinary Task Force for Advanced Bleeding Care in Trauma was founded in 2004 and included representatives of six relevant European professional societies. The group used a structured, evidence-based consensus approach to address scientific queries that served as the basis for each recommendation and supporting rationale. Expert opinion and current clinical practice were also considered, particularly in areas in which randomised clinical trials have not or cannot be performed. Existing recommendations were reconsidered and revised based on new scientific evidence and observed shifts in clinical practice; new recommendations were formulated to reflect current clinical concerns and areas in which new research data have been generated. This guideline represents the fourth edition of a document first published in 2007 and updated in 2010 and 2013. The guideline now recommends that patients be transferred directly to an appropriate trauma treatment centre and encourages use of a restricted volume replacement strategy during initial resuscitation. Best-practice use of blood products during further resuscitation continues to evolve and should be guided by a goal-directed strategy. The identification and management of patients pre-treated with anticoagulant agents continues to pose a real challenge, despite accumulating experience and awareness. The present guideline should be viewed as an educational aid to improve and standardise the care of the bleeding trauma patients across Europe and beyond. This document may also serve as a basis for local implementation. Furthermore, local quality and safety management systems need to be established to specifically assess key measures of bleeding control and outcome. A multidisciplinary approach and adherence to evidence-based guidance are key to improving patient outcomes. The implementation of locally adapted treatment algorithms should strive to achieve measureable improvements in patient outcome.

/pdf/the-european-guideline-on-management-of-major-bleeding-and-50g3zxrre8.pdf

The European guideline on management of major bleeding and coagulopathy following trauma: fourth edition

Primary osteoarthritis of the hip, often referred to as idiopathic, may be secondary to mechanical causes. There have been numerous studies on the measurement of torsion of the bones of the lower extremity1,3,8,13,14,31,34,39,44,45,47,48,54,63,79,80,84. Some studies have supported the hypothesis that a persistent increase in femoral anteversion predisposes to osteoarthritis of the hip29,53,54,62, whereas others have not35,40,61. Menke et al.45 found an association between decreased acetabular anteversion and osteoarthritis of the hip, and Eckhoff23 found a similar association between femoral anteversion and osteoarthritis of the knee. Increased femoral torsion also has been documented in patients who have pain or osteoarthritis of the knee and patellar instability5,22.

There have been few reports on the potential problems that are associated with decreased femoral anteversion15,21,36,37,51,69. In 1959, Crane15 noted that decreased femoral anteversion or retroversion was associated with a toeing-out gait whereas increased femoral anteversion was associated with a toeing-in gait. Decreased femoral anteversion has been consistently observed in patients who have a slipped capital femoral epiphysis25,28,38,52,58,59 as well as in those who have congenital hypoplasia of the femur60,73.

There is some evidence to suggest a congenital etiology for increased or decreased anteversion of the femur and acetabulum19. Watanabe77 examined 144 embryos and stillborn fetuses between six and twenty-four weeks of gestation. At the completion of the first half …

Acetabular and femoral anteversion: relationship with osteoarthritis of the hip.

Background: Proponents of navigated knee arthroplasty stress its potential to increase the precision of component placement. We conducted a systematic review and meta-analysis to substantiate the validity and relevance of this contention.

Methods: We searched major medical and publishers' databases for randomized trials and any other studies comparing navigated with conventional knee arthroplasty. Major periodicals were searched manually. We made no restrictions for types of studies or language. Methodological features were rated independently by two reviewers. After testing for publication bias and heterogeneity was done, the data were aggregated by random-effects modeling. We estimated the weighted mean differences of mechanical limb axes and functional scales and the risk ratios of deviations from the straight axis with 95% confidence intervals.

Results: We included thirty-three studies (eleven randomized trials) of varying methodological quality involving 3423 patients with a mean age (and standard deviation) of 67.3 ± 4.1 years (62.6% were women, and 83.7% had primary osteoarthritis). The mean preoperative deviation from the mechanical axis was 2.3° ± 5.1°. There was no evidence of publication bias, but there was strong statistical heterogeneity. The alignment of the mechanical axes did not differ between the navigated and conventional surgery group (weighted mean difference, 0.2°; 95% confidence interval, -0.2° to 0.5°). Patients managed with navigated surgery had a lower risk of malalignment at critical thresholds of >3° (risk ratio, 0.79; 95% confidence interval, 0.71 to 0.87) and >2° (risk ratio, 0.76; 95% confidence interval, 0.71 to 0.82). No conclusive inferences could be drawn on functional outcomes or complication rates. Navigation lengthened the mean duration of surgery by 23%.

Conclusions: Navigated knee replacement provides few advantages over conventional surgery on the basis of radiographic end points. Its clinical benefits are unclear and remain to be defined on a larger scale.

Level of Evidence: Therapeutic Level III. See Instructions to Authors for a complete description of levels of evidence.

Navigated total knee replacement. A meta-analysis.

The results of periacetabular osteotomy, with and without intertrochanteric osteotomy, performed between January 1984 and December 1990, were reviewed for forty-two patients who had osteoarthrosis in a congenitally dysplastic hip. There were eight male and thirty-four female patients. The average age of the patients at the time of the operation was thirty-seven years (range, eleven to fifty-six years). Ten patients had combined periacetabular and intertrochanteric osteotomies. The preoperative severity of the osteoarthrosis, according to the criteria of Tonnis, was grade 1 in fifteen patients, grade 2 in eighteen, and grade 3 in nine. The average duration of follow-up was four years (range, two to eight years). Complications included heterotopic ossification in fourteen patients (33 per cent), non-union of the pubic osteotomy in two patients (5 per cent), and pain related to the hardware that led to its removal in nine patients (21 per cent). There were no major neurovascular complications. One patient had dysesthesias in the area supplied by the lateral femoral cutaneous nerve. Six patients had a subsequent total hip arthroplasty and three patients had an additional intertrochanteric osteotomy. five of the nine patients who had a second major operation had had grade-3 osteoarthrosis before the periacetabular osteotomy. The Harris hip score improved from an average of 62 points (range, 33 to 95 points) preoperatively to an average of 86 points (range, 29 to 100 points) postoperatively (p < 0.0001, paired t test). The result was excellent or good for thirty-two of the thirty-three patients who had had grade-1 or 2 osteoarthrosis. Eight of the nine patients who had had grade-3 osteoarthrosis had a Harris hip score of less than 70 points at the latest follow-up evaluation.

Periacetabular and intertrochanteric osteotomy for the treatment of osteoarthrosis in dysplastic hips

Objective To determine whether total hip arthroplasty is associated with lower reoperation rates, mortality, and complications, and better function and quality of life than hemiarthroplasty for displaced fractures of the femoral neck in older patients. Design Systematic review and meta-analysis of randomised trials, quasirandomised trials, and cohort studies. Data sources Medline, Embase, Cochrane register of controlled trials, publishers’ databases, and manual search of bibliographies. Study selection Randomised controlled trials, quasirandomised trials, and cohort studies (retrospective and prospective) comparing hemiarthroplasty with total hip arthroplasty for treating displaced femoral neck fractures in patients aged more than 60 years. Data extraction Relative risks, risk differences, and mean differences from each trial, aggregated using random effects models. Analyses were stratified for experimental and non-experimental designs, and two way sensitivity analyses and tests for interaction were done to assess the influence of various criteria of methodological quality on pooled estimates. Data synthesis 3821 references were identified. Of the 202 full papers inspected, 15 were included (four randomised controlled trials, three quasirandomised trials, and eight retrospective cohort studies, totalling 1890 patients). Meta-analysis of 14 studies showed a lower risk of reoperation after total hip arthroplasty compared with hemiarthroplasty (relative risk 0.57, 95% confidence interval 0.34 to 0.96, risk difference 4.4%, 95% confidence interval 0.2% to 8.5%), although this effect was mainly driven by investigations without concealed treatment allocation. Total hip arthroplasty consistently showed better ratings in the Harris hip score (three studies, 246 patients, weighted mean difference 5.4, 95% confidence interval 2.7 to 8.2) after follow-up periods of 12 to 48 months. The standardised mean difference of different scores from five studies was 0.42 (95% confidence interval 0.24 to 0.61), indicating a medium functional advantage of total hip arthroplasty over hemiarthroplasty. Total hip arthroplasty was associated with a slightly higher risk of dislocation (relative risk 1.48, 95% confidence interval 0.89 to 2.46) and general complications (1.14, 0.87 to 1.48). Conclusion Single stage total hip arthroplasty may lead to lower reoperation rates and better functional outcomes compared with hemiarthroplasty in older patients with displaced femoral neck fractures. However, heterogeneity across the available trials and distinct subgroup effects preclude definitive statements and require further research in this area.

https://www.bmj.com/content/bmj/340/bmj.c2332.full.pdf

Primary total hip arthroplasty versus hemiarthroplasty for displaced intracapsular hip fractures in older patients: systematic review

Background
Ultrasonography (performed by means of a four-quadrant, focused assessment of sonography for trauma (FAST)) is regarded as a key instrument for the initial assessment of patients with suspected blunt abdominal and thoraco-abdominal trauma in the emergency department setting. FAST has a high specificity but low sensitivity in detecting and excluding visceral injuries. Proponents of FAST argue that ultrasound-based clinical pathways enhance the speed of primary trauma assessment, reduce the number of unnecessary multi-detector computed tomography (MDCT) scans, and enable quicker triage to surgical and non-surgical care. Given the proven accuracy, increasing availability of, and indication for, MDCT among patients with blunt abdominal and multiple injuries, we aimed to compile the best available evidence of the use of FAST-based assessment compared with other primary trauma assessment protocols.

Objectives
To assess the effects of diagnostic algorithms using ultrasonography including in FAST examinations in the emergency department in relation to the early, late, and overall mortality of patients with suspected blunt abdominal trauma.

Search methods
The most recent search was run on 30th June 2015. We searched the Cochrane Injuries Group Specialised Register, The Cochrane Library, MEDLINE (OvidSP), EMBASE (OvidSP), ISI Web of Science (SCI-EXPANDED, SSCI, CPCI-S, and CPSI-SSH), clinical trials registers, and screened reference lists. Trial authors were contacted for further information and individual patient data.

Selection criteria
We included randomised controlled trials (RCTs). Participants were patients with blunt torso, abdominal, or multiple trauma undergoing diagnostic investigations for abdominal organ injury. The intervention was diagnostic algorithms comprising emergency ultrasonography (US). The control was diagnostic algorithms without US examinations (for example, primary computed tomography (CT) or diagnostic peritoneal lavage (DPL)). Outcomes were mortality, use of CT or invasive procedures (DPL, laparoscopy, laparotomy), and cost-effectiveness.

Data collection and analysis
Two authors (DS and CG) independently selected trials for inclusion, assessed methodological quality, and extracted data. Methodological quality was assessed using the Cochrane Collaboration risk of bias tool. Where possible, data were pooled and relative risks (RRs), risk differences (RDs), and weighted mean differences, each with 95% confidence intervals (CIs), were calculated by fixed-effect or random-effects models as appropriate.

Main results
We identified four studies meeting our inclusion criteria. Overall, trials were of poor to moderate methodological quality. Few trial authors responded to our written inquiries seeking to resolve controversial issues and to obtain individual patient data. Strong heterogeneity amongst the trials prompted discussion between the review authors as to whether the data should or should not be pooled; we decided in favour of a quantitative synthesis to provide a rough impression about the effect sizes achievable with US-based triage algorithms. We pooled mortality data from three trials involving 1254 patients; the RR in favour of the FAST arm was 1.00 (95% CI 0.50 to 2.00). FAST-based pathways reduced the number of CT scans (random-effects model RD -0.52, 95% CI -0.83 to -0.21), but the meaning of this result was unclear.

Authors' conclusions
The experimental evidence justifying FAST-based clinical pathways in diagnosing patients with suspected abdominal or multiple blunt trauma remains poor. Because of strong heterogeneity between the trial results, the quantitative information provided by this review may only be used in an exploratory fashion. It is unlikely that FAST will ever be investigated by means of a confirmatory, large-scale RCT in the future. Thus, this Cochrane Review may be regarded as a review which provides the best available evidence for clinical practice guidelines and management recommendations. It can only be concluded from the few head-to-head studies that negative US scans are likely to reduce the incidence of MDCT scans which, given the low sensitivity of FAST (or reliability of negative results), may adversely affect the diagnostic yield of the trauma survey. At best, US has no negative impact on mortality or morbidity. Assuming that major blunt abdominal or multiple trauma is associated with 15% mortality and a CT-based diagnostic work-up is considered the current standard of care, 874, 3495, or 21,838 patients are needed per intervention group to demonstrate non-inferiority of FAST to CT-based algorithms with non-inferiority margins of 5%, 2.5%, and 1%, power of 90%, and a type-I error alpha of 5%.

Emergency ultrasound‐based algorithms for diagnosing blunt abdominal trauma

The reputation of total ankle arthroplasty for treating end-stage ankle arthritis of different origin is dubious. Newer generation meniscal-bearing prostheses may have overcome the known problems with earlier implants. There is, however, no systematic approach to the available scientific evidence allowing for a critical appraisal of their benefits and risks. We conducted a systematic review meta-analysis of studies exploring the efficacy of three-component total ankle prostheses. We demanded a minimum sample size of 20 subjects, at least 1 year of follow-up, and a clinically relevant study endpoint (for example, results of ankle scoring, ranges of motion [ROM], complications, and survival rates). We identified citations by electronic medical databases and a manual search. We made no restrictions for language. We used an eight-point quality scale to appraise methodological standards, and modeled outcomes by random-effects meta-regression analysis. Eighteen of 1830 citations including 1086 patients fulfilled our eligibility criteria. Studies met a median of four quality items (interquartile range 2–5). Outcome estimates did not depend on methodological quality. There was no evidence of strong heterogeneity or publication bias. With standardized 100-point ankle and hindfoot scores, formal data pooling was possible for 10 trials ( n =497), showing a mean improvement of 45.2 points (95% confidence interval [CI] 39.3–51.1). Overall ROM improved slightly (6.3°, 95%CI 2.2–10.5°). Weighted complication rates ranged from 1.6% (deep infections) to 14.7% (impingement). Secondary surgery had to be performed in 12.5%, whereas secondary arthrodesis was necessary in 6.3%. The weighted 5-year prosthesis survival rate averaged 90.6%. Ankle arthroplasty improves pain and joint mobility in end-stage ankle arthritis. Its performance in comparison to the current reference standard (that is, ankle fusion) remains to be defined in a properly designed randomized trial.

Axel Ekkernkamp

Papers

Navigated total knee replacement. A meta-analysis.

Periacetabular and intertrochanteric osteotomy for the treatment of osteoarthrosis in dysplastic hips

Primary total hip arthroplasty versus hemiarthroplasty for displaced intracapsular hip fractures in older patients: systematic review

Emergency ultrasound‐based algorithms for diagnosing blunt abdominal trauma

Efficacy of total ankle replacement with meniscal-bearing devices: a systematic review and meta-analysis