The core outcomes for open lower limb fracture study.

Aims: A core outcome set for adult, open lower limb fracture has been established consisting of 'Walking, gait and mobility', 'Being able to return to life roles', 'Pain or discomfort', and 'Quality of life'. This study aims to identify which outcome measurement instruments (OMIs) should be recommended to measure each core outcome. Methods: A systematic review and quality assessment were conducted to identify existing instruments with evidence of good measurement properties in the open lower limb fracture population for each core outcome. Additionally, shortlisting criteria were developed to identify suitable instruments not validated in the target population. Candidate instruments were presented, discussed, and voted on at a consensus meeting of key stakeholders. Results: The Wales Lower Limb Trauma Recovery scale was identified, demonstrating validation evidence in the target population. In addition, ten candidate OMIs met the shortlisting criteria. Six patients, eight healthcare professionals, and 11 research methodologists attended the consensus meeting. Consensus was achieved for the EuroQol five-dimension five-level questionnaire (EQ-5D-5L) and the Lower Extremity Functional Scale (LEFS) to measure 'Quality of life' and 'Walking, gait and mobility' in future research trials, audit, and clinical assessment, respectively. No instrument met consensus criteria to measure 'Being able to return to life roles' and 'Pain or discomfort'. However, the EQ-5D-5L was found to demonstrate good face validity and could also be used pragmatically to measure these two outcomes, accepting limitations in sensitivity. Conclusion: This study recommends the LEFS and EQ-5D-5L to measure the core outcome set for adult open lower limb fracture.

What outcomes have been reported on patients following open lower limb fracture, and how have they been measured?

Open lower limb fracture is a life-changing injury affecting 11.5 per 100,000 adults each year, and causes significant morbidity and resource demand on trauma infrastructures. This study aims to identify what, and how, outcomes have been reported for people following open lower limb fracture over ten years. Systematic literature searches identified all clinical studies reporting outcomes for adults following open lower limb fracture between January 2009 and July 2019. All outcomes and outcome measurement instruments were extracted verbatim. An iterative process was used to group outcome terms under standardized outcome headings categorized using an outcome taxonomy. A total of 532 eligible studies were identified, reporting 1,803 outcomes with 786 unique outcome terms, which collapsed to 82 standardized outcome headings. Overall 479 individual outcome measurement instruments were identified, including 298 outcome definitions, 27 patient- and 18 clinician-reported outcome measures, and six physical performance measures. The most-reported outcome was 'bone union/healing' reported in over 50% of included studies, while health-related quality of life was only measured in 6% of included studies. Outcomes reported for people recovering from open lower limb fracture are heterogeneous, liable to outcome reporting bias, and vary widely in the definitions and the measurement tools used to collect them. Outcomes likely to be important to patients, such as quality of life and measures of physical functioning, have been neglected. This systematic review identifies the need to unify outcome measures reported on patients recovering from open lower limb fracture; this may be addressed by creating a core outcome set.

Development of a core outcome set for open lower limb fracture.

Open lower limb fracture is life-changing, resulting in substantial morbidity and resource demand, while inconsistent outcome-reporting hampers systematic review and meta-analysis. A core outcome set establishes consensus among key stakeholders for the recommendation of a minimum set of outcomes. This study aims to define a core outcome set for adult open lower limb fracture. Candidate outcomes were identified from a previously published systematic review and a secondary thematic analysis of 25 patient interviews exploring the lived experience of recovery from open lower limb fracture. Outcomes were categorized and sequentially refined using healthcare professional and patient structured discussion groups. Consensus methods included a multi-stakeholder two-round online Delphi survey and a consensus meeting attended by a purposive sample of stakeholders, facilitated discussion, and voting using a nominal group technique. Thematic analysis and systematic review identified 121 unique outcomes, reduced to 68 outcomes following structured discussion groups. Outcomes were presented to 136 participants who completed a two-round online Delphi survey. The Delphi survey resulted in 11 outcomes identified as consensus 'in' only. All outcomes were discussed at a consensus meeting attended by 15 patients, 14 healthcare professionals, 11 researchers, and one patient-carer. Consensus was achieved for a four-core outcome set: 'Walking, gait and mobility', 'Being able to return to life roles', 'Pain or discomfort', and 'Quality of life'. This study used robust consensus methods to establish a core outcome set that should be measured in all future research studies and audits of clinical practice without precluding the measurement of additional outcomes.

Timing of antibiotic administration, wound debridement, and the stages of reconstructive surgery for open long bone fractures of the upper and lower limbs.

BACKGROUND: Open fractures of the major long bones are complex limb-threatening injuries that are predisposed to deep infection. Treatment includes antibiotics and surgery to debride the wound, stabilise the fracture and reconstruct any soft tissue defect to enable infection-free bone repair. There is a need to assess the effect of timing and duration of antibiotic administration and timing and staging of surgical interventions to optimise outcomes. OBJECTIVES: To assess the effects (risks and benefits) of the timing of antibiotic administration, wound debridement and the stages of surgical interventions in managing people with open long bone fractures of the upper and lower limbs. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and clinical trial registers in February 2021. We also searched conference proceedings and reference lists of included studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) or quasi-RCTs that recruited adults with open fractures of the major long bones, comparing: 1) timings of prophylactic antibiotic treatment, 2) duration of prophylactic antibiotic treatment, 3) timing of wound debridement following injury or 4) timing of the stages of reconstructive surgery. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. We aimed to collect data for the following outcomes: limb function, health-related quality of life (HRQoL), deep surgical site infection, delayed or non-union, adverse events (in the short- and long-term course of recovery), and resource-related outcomes. MAIN RESULTS: We included three RCTs of 613 randomised participants with 617 open fractures. Studies were conducted in medical and trauma centres in the USA and Kenya. Where reported, there was a higher proportion of men and a mean age of participants between 30 and 34 years old. Fractures were in the upper and lower limbs in one study, and were tibia fractures in two studies; where reported, these were the result of high-energy trauma such as road traffic accidents. No studies compared the timing of antibiotic treatment or wound debridement. Duration of prophylactic antibiotic treatment (1 study, 77 participants available for analysis) One study compared antibiotic treatment for 24 hours with antibiotic treatment for five days. We are very uncertain about the effects of different durations of antibiotic treatment on superficial infections (risk ratio (RR) 1.19, 95% CI 0.49 to 2.87, favours 5 day treatment; 1 study, 77 participants); this was very low-certainty evidence derived from one small study with unclear and high risks of bias, and with an imprecise effect estimate. This study reported no other review outcomes. Reconstructive surgery: timing of the stages of surgery (2 studies, 458 participants available for analysis) Two studies compared the timing of wound closure, which was completed immediately or delayed. In one study, the mean time of delay was 5.9 days; in the other study, the time of delay was not reported. We are very uncertain about the effects of different timings of wound closure on deep infections (RR 0.82, 95% CI 0.37 to 1.80, favours immediate closure; 2 studies, 458 participants), delayed union or non-union (RR 1.13, 95% CI 0.83 to 1.55, favours delayed closure; 1 study, 387 participants), or superficial infections (RR 6.45, 95% CI 0.35 to 120.43, favours delayed closure; 1 study, 71 participants); this was very low-certainty evidence. We downgraded the certainty of the evidence for very serious risks of bias because both studies had unclear and high risks of bias. We also downgraded for serious imprecision because effect estimates were imprecise, including the possibility of benefits as well as harms, and very serious imprecision when the data were derived from single small study. These studies reported no other review outcomes. AUTHORS' CONCLUSIONS: We could not determine the risks and benefits of different treatment protocols for open long bone fractures because the evidence was very uncertain for the two comparisons and we did not find any studies addressing the other possible comparisons. Well-designed randomised trials with adequate power are needed to guide surgical and antibiotic treatment of open fractures, particularly with regard to timing and duration of antibiotic administration and timing and staging of surgery.

Clinical Anatomy and Assessment of the Elbow.

BACKGROUND: The elbow is a complex synovial hinge joint comprising of three articulations. Satisfactory function and stability are provided by bony and soft tissue stabilising structures. Injuries around the elbow joint are common. METHODS: A literature search was performed and the authors' personal experiences reported. RESULTS: The article discusses the osseous and ligamentous anatomy around the elbow joint and their relevance when assessing and managing elbow injuries. CONCLUSION: Knowledge of the intricate anatomy around the elbow joint is essential to successfully assessing and managing elbow injuries and restoring good function.

Distal femoral fractures: The need to review the standard of care.

BACKGROUND: Hip fracture care has evolved, largely due to standardisation of practice, measurement of outcomes and the introduction of the Best Practice Tariff, leading to the sustained improvements documented by the National Hip Fracture Database (NHFD). The treatment of distal femoral fractures in this population has not had the same emphasis. This study defines the epidemiology, current practice and outcomes of distal femoral fractures in four English centres. PATIENTS AND METHODS: 105 patients aged 50 years or greater with a distal femoral fracture, presenting to four UK major trauma centres between October 2010 and September 2011 were identified. Data was collected using an adapted NHFD data collection tool via retrospective case note and radiograph review. Local ethics approval was obtained. RESULTS: Mean age was 77 years (range 50-99), with 86% female. 95% of injuries were sustained from a low energy mechanism, and 72% were classified as either 33-A1 or 33-C1. The mean Parker mobility score and Barthel Independence Index were 5.37 (0-9) and 75.5 (0-100) respectively. Operative management was performed in 84%, and 86% had their surgery within 36 h. Three quarters were fixed with a peri-articuar locking plate. There was no consensus on post operative rehabilitation, but no excess of complications in the centres where weight bearing as tolerated was the standard. 45% were seen by an orthogeriatrician during their admission. Mean length of stay was 29 days. Mortality at 30 days, 6 months, and 1 year was 7%, 16% and 18% respectively. DISCUSSION: This study demonstrates that the distal femoral and hip fracture populations are similar, and highlights the current disparity in their management. The metrics and standards of care currently applied to hip fractures should be applied to the treatment of distal femoral fractures. Optimal operative treatment and rehabilitation remains unclear, and is in need of further research.

Survivorship, patient reported outcome and satisfaction following resurfacing and total hip arthroplasty.

Resurfacing (RA) and total hip arthroplasty (THA) are options in the treatment of debilitating hip pathology. 381 patients that had undergone arthroplasty with a BHR RA, ASR RA, metal-on-metal (MoM) THA or ceramic-on-ceramic (CoC) THA were reviewed for satisfaction, function, health and survivorship at a median follow up of 50 months. Significantly lower survivorship for revision and reoperation was observed in the ASR group. The BHR and CoC demonstrated better outcome scores than the ASR (OHS and SAPS) and the BHR better scores than the MoM (OHS and SF12 PCS). In the short to medium term, survivorship and outcomes for the best performing RA (BHR) and THA (CoC) were comparable. There was a non-significant trend towards poorer outcome scores in the MoM THA group.

Direct thrombin inhibitor (DTI) vs. aspirin in primary total hip and knee replacement using wound ooze as the primary outcome measure. A prospective cohort study.

The latest NICE guidance dictates that all patients undergoing lower-limb arthroplasty should be prescribed potent venous thromboembolic (VTE) prophylaxis. However, use of potent anti-thrombotics is likely to lead to increased post-operative wound ooze. Postoperative wound ooze is associated with increased risk of infection. This study used a prospective, consecutive, multi-surgeon sample of 110 patients undergoing primary total hip replacement (THR) and total knee replacement (TKR) prescribed either direct thrombin inhibitor (DTI) (n=51, 26 males: 25 females, age 69 ±18) or aspirin (n=59, 25 males: 34 females, age 69 ± 19). Hospital stay, body mass index (BMI), wound length and patient demographics were documented along with a daily assessment of wound ooze. The use of DTI's was associated with a significant increase in mean days to dryness in both THR (6.2 ± 0.98, 95% C.I. 5.2-7.1) and TKR (6.6 ± 1.89, 95% C.I. 4.7-8.5) compared to aspirin in THR (3.0 ± 1.03, 95% C.I 1.9-4.0) and TKR (3.4 ± 1.21, 95% C.I 2.2-4.6) with p-values of <0.0001 and 0.0024 for THR and TKR respectively. Age, gender and wound length were not found to be significant confounding variables. DTI's proven benefit in lowering venous thromboembolism when compared with aspirin needs to be balanced with their increased cost and increased duration of wound ooze.