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BACKGROUND AND AIMS: High quality clinical research that addresses important questions requires significant resources. In resource-constrained environments, projects will therefore need to be prioritized. The Australia and New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network aimed to develop a stakeholder-based, transparent, easily implementable tool that provides a score for the 'importance' of a research question which could be used to rank research projects in order of importance. METHODS: Using a mixed-methods, multi-stage approach that included a Delphi survey, consensus workshop, inter-rater reliability testing, validity testing and calibration using a discrete-choice methodology, the Research Question Importance Tool (ANZMUSC-RQIT) was developed. The tool incorporated broad stakeholder opinion, including consumers, at each stage and is designed for scoring by committee consensus. RESULTS: The ANZMUSC-RQIT tool consists of 5 dimensions (compared to 6 dimensions for an earlier version of RQIT): (1) extent of stakeholder consensus, (2) social burden of health condition, (3) patient burden of health condition, (4) anticipated effectiveness of proposed intervention, and (5) extent to which health equity is addressed by the research. Each dimension is assessed by defining ordered levels of a relevant attribute and by assigning a score to each level. The scores for the dimensions are then summed to obtain an overall ANZMUSC-RQIT score, which represents the importance of the research question. The result is a score on an interval scale with an arbitrary unit, ranging from 0 (minimal importance) to 1000. The ANZMUSC-RQIT dimensions can be reliably ordered by committee consensus (ICC 0.73-0.93) and the overall score is positively associated with citation count (standardised regression coefficient 0.33, p<0.001) and journal impact factor group (OR 6.78, 95% CI 3.17 to 14.50 for 3rd tertile compared to 1st tertile of ANZMUSC-RQIT scores) for 200 published muscul

BACKGROUND: Clinical quality registries (CQRs) monitor compliance against optimal practice and provide feedback to the clinical community and wider stakeholder groups. Despite a number of CQRs having incorporated the patient perspective to support the evaluation of healthcare delivery, no recommendations for inclusion of patient-reported outcome measures (PROMs) in CQRs exist. The aim of this study was to develop a core set of recommendations for PROMs inclusion of in CQRs. METHOD: An online two-round Delphi survey was performed among CQR data custodians, quality of life researchers, biostatisticians and clinicians largely recruited in Australia. A list of statements for the recommendations was identified from a literature and survey of the Australian registries conducted in 2019. The statements were grouped into the following domains: rationale, setting, ethics, instrument, administration, data management, statistical methods, and feedback and reporting. Eighteen experts were invited to participate, 11 agreed to undertake the first online survey (round 1). Of these, nine experts completed the online survey for round 2. RESULTS: From 117 statements presented to the Delphi panel in round 1, a total of 72 recommendations (55 from round 1 and 17 from round 2) with median importance (MI) ≥ 7 and disagreement index (DI) < 1 were proposed for inclusion into the final draft set and were reviewed by the project team. Recommendations were refined for clarity and to read as stand-alone statements. Ten overlapped conceptually and, therefore, were merged to reduce repetition. The final 62 recommendations were sent for review to the panel members for their feedback, which was incorporated into the final set. CONCLUSION: This is the first study to develop preliminary recommendations for PROMs inclusion in CQRs. Recommendations for PROMs implementation are critically important for registries to assure meaningful PROMs data capture, use, interpretation, and reporting to improve hea

OBJECTIVES: This study aims to compare early mortality after total knee arthroplasty (TKA) using conventional intramedullary instrumentation to TKA performed using technology-assisted (non-intramedullary) instrumentation. DESIGN: Comparative observational study. Using data from a large national registry, the 30-day mortality after unilateral TKA performed for osteoarthritis was compared between procedures using conventional instrumentation and those using technology-assisted instrumentation. Firth logistic regression was used to calculate ORs, adjusting for age, sex, use of cement and procedure year for the whole period, and additionally adjusting for American Society of Anesthesiologists physical status classification system class and body mass index (BMI) for the period 2015 to 2019. This analysis was repeated for 7-day and 90-day mortality. SETTING: National arthroplasty registry. PARTICIPANTS: People undergoing unilateral, elective TKA for osteoarthritis from 2003 to 2019 inclusive. INTERVENTIONS: TKA performed using conventional intramedullary instrumentation or technology-assisted instrumentation. MAIN OUTCOME MEASURES: 30-day mortality (primary), and 7-day and 90-day mortality. RESULTS: A total of 581 818 unilateral TKA procedures performed for osteoarthritis were included, of which 602 (0.10%) died within 30 days of surgery. The OR of death within 30 days following TKA performed with conventional instrumentation compared with technology-assisted instrumentation, adjusted for age, sex, cement use, procedure year, American Society of Anesthesiologists and BMI was 1.72 (95% CI, 1.23 to 2.41, p=0.001). The corresponding ORs for 7-day and 90-day mortality were 2.21 (96% CI, 1.34 to 3.66, p=0.002) and 1.35 (95% CI, 1.07 to 1.69, p=0.010), respectively. CONCLUSIONS: The use of conventional instrumentation during TKA is associated with higher odds of early postoperative death than when technology-assisted instrumentation is used. This difference may be explained by

INTRODUCTION: Hip fractures treated with total hip arthroplasty (THA) are at high risk of prosthesis instability, and dislocation is the most common indication for revision surgery. This study aims to determine whether dual mobility THA implants reduce the risk of dislocation compared with conventional THA in patients with hip fracture suitable to be treated with THA. METHODS AND ANALYSIS: This is a cluster-randomised, crossover, open-label trial nested within the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). The clusters will comprise hospitals that perform at least 12 THAs for hip fracture per annum. All adults age ≥50 years who meet the Australian and New Zealand Hip Fracture Registry guidelines for THA will be included. The intervention will be dual mobility THA and the comparator will be conventional THA. Each hospital will be allocated to two consecutive periods, one of dual mobility THA and the other of conventional THA in random order, aiming for an average of 16 patients eligible for the primary analysis per group (32 total per site), allowing different recruitment totals between sites. Data will be collected through the AOANJRR and linked with patient-level discharge data acquired through government agencies. The primary outcome is dislocation within 1 year. Secondary outcomes include revision surgery for dislocation and all-cause, complications and mortality at 1, 2 and 5 years. If dual mobility THA is found to be superior, a cost-effectiveness analysis will be conducted. The study will aim to recruit 1536 patients from at least 48 hospitals over 3 years. ETHICS AND DISSEMINATION: Ethics approval has been granted (Sydney Local Health District - Royal Prince Alfred Hospital Zone (approval X20-0162 and 2020/ETH00680) and site-specific approvals). Participant recruitment is via an opt-out consent process as both treatments are considered accepted, standard practice. The trial is endorsed by the Australia and New Zealand Mu

The number of placebo surgical trials on musculoskeletal conditions is increasing, but little is known about the quality of their design and methods. This review aimed to (1) assess the level of placebo fidelity (ie, degree to which the placebo control mimicked the index procedure) in placebo trials of musculoskeletal surgery, (2) describe the trials' methodological features using the adapted Applying Surgical Placebo in Randomised Evaluations (ASPIRE) checklist, and (3) describe each trial's characteristics. We searched 4 electronic databases from inception until February 18, 2021, for randomised trials of surgery that included a placebo control for any musculoskeletal condition. Protocols and full text were used to assess placebo fidelity (categorised as minimal, low, or high fidelity). The adapted 26-item ASPIRE checklist was also completed on each trial. PROSPERO registration number: CRD42021202131. A total of 30,697 studies were identified in the search, and 22 placebo-controlled surgical trials of 2045 patients included. Thirteen trials (59%) included a high-fidelity placebo control, 7 (32%) used low fidelity, and 2 (9%) minimal fidelity. According to the ASPIRE checklist, included trials had good reporting of the "rationale and ethics" (68% overall) and "design" sections (42%), but few provided enough information on the "conduct" (13%) and "interpretation and translation" (11%) of the placebo trials. Most trials sufficiently reported their rationale and ethics, but interpretation and translation are areas for improvement, including greater stakeholder involvement. Most trials used a high-fidelity placebo procedure suggesting an emphasis on blinding and controlling for nonspecific effects.

BACKGROUND: Distal radial fractures in adults are common, representing a substantial burden to patients and health systems. The 2 main treatments are closed reduction and cast immobilization (CR) and volar locking plate (VLP) fixation. Our primary aim was to determine if VLP fixation leads to better patient-reported pain and function at 12 months compared with CR. METHODS: We searched systematically for randomized controlled trials (RCTs) comparing outcomes of VLP fixation with CR for the treatment of distal radial fractures in adults. The Cochrane Collaboration risk-of-bias tool was used to assess the methodological quality of each study. Meta-analyses of patient-reported outcomes, clinical outcomes, and complications were performed. Key findings were assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. RESULTS: A total of 8 RCTs (810 participants) were eligible for inclusion. Based on moderate-certainty evidence, no clinically important differences in patient-reported pain and function were found: although the mean difference (MD) in the Disabilities of the Arm, Shoulder and Hand (DASH) score at 12 months was 4.1 points (95% confidence interval [CI], 1.2 to 7.0 points) in favor of VLP fixation, this was well below the minimum clinically important difference of 10 points. There was low-certainty evidence that VLP fixation led to better Patient-Rated Wrist Evaluation (PRWE) scores at 12 months (MD, 6.9 points; 95% CI, -0.6 to 14.3 points) and better DASH scores at 24 months (MD, 8.9 points; 95% CI, 5.8 to 12.1 points) but again, these differences were not clinically important. There was very low or low-certainty evidence that VLP fixation provided better long-term radiographic outcomes, including palmar tilt (MD, 6.5°; 95% CI, 2.8° to 10.1°), radial inclination (MD, 3.4°; 95% CI, 2.5° to 4.3°), and ulnar variance (MD, 0.7 mm; 95% CI, -0.8 to 2.1 mm). CONCLUSIONS: There were no clinically important differences betwee

OBJECTIVE: Low back pain is the leading contributor to the global disability burden. The Global Spine Care Initiative (GSCI) recommend patient-centred care to stem the cost of low back pain. One way to enhance patient-centred care is by better understanding what is relevant for people with low back pain. Exploring social media posts about low back pain could offer this insight and provide valuable information for health care professionals to facilitate active participation in patient-centred care. METHODS: We used an inductive content analysis method. In the form of social media posts, data on Twitter and Instagram were collected from June to August 2018. The posts were geo-targeted to Australia. We recorded the number of status broadcasts that contained a low back pain keyword and responses. We developed a codebook to describe the data and applied it to identify low back pain themes. RESULTS: We analysed 768 posts containing 457 status broadcasts and 311 responses. Almost half (49%) of status broadcasts about low back pain seemed to seek validation. Expressing sympathy (31%) was the most common response to a status broadcast about low back pain. There were no public responses to 76% of status broadcasts about low back pain. Our analysis yielded two core themes, "hear my pain" and "I feel for you". CONCLUSIONS: Posts about low back pain on social media often seem to suggest that the person posting is seeking validation. Responses typically express sympathy or a shared experience; yet, there is no response to most social media posts about low back pain.

The study aimed to determine how much change in neurogenic claudication spinal surgeons expect in patients following lumbar decompression for lumbar spine stenosis (LSS), and radicular leg pain following microdiscectomy. Secondary aims were to identify surgeons' preferences regarding surgical techniques for lumbar decompression, and their rating of the quality of current evidence for lumbar decompression. All Australian spine surgeons were invited, of whom 71 completed the survey (31% response rate). Only registered spinal surgeons were included. The online survey, administered using REDCap, included 4 sections: demographics and background; expected change in symptoms on a +/- 100% scale (-100% worst, 0% no change and 100% best possible); surgical preference; and rating of current evidence for lumbar decompression compared with other treatments. There were 71 complete responses, 76% were neurosurgeons (N = 54), predominantly male (96%; N = 68). On average, surgeons expected an 86% (median: 87%, inter-quartile range (IQR): 80%, 91%) improvement in neurogenic claudication following lumbar decompression for LSS and 89% (median: 91%, IQR: 85%, 95%) improvement in radicular pain following microdiscectomy. A multiple linear regression found no surgeon characteristics were associated with expected change following surgery. The preferred surgical technique for LSS was full laminectomy (58%; N = 41). Thirty-five percent of surgeons accurately rated the evidence supporting the superiority of lumbar decompression compared with non-surgical care for LSS as low quality. Spine surgeons expect large symptom improvements following lumbar decompression and microdiscectomy. Understanding of the current evidence was higher for lumbar decompression with fusion, than for decompression alone for LSS.

The study aimed to determine how much change in neurogenic claudication spinal surgeons expect in patients following lumbar decompression for lumbar spine stenosis (LSS), and radicular leg pain following microdiscectomy. Secondary aims were to identify surgeons' preferences regarding surgical techniques for lumbar decompression, and their rating of the quality of current evidence for lumbar decompression. All Australian spine surgeons were invited, of whom 71 completed the survey (31% response rate). Only registered spinal surgeons were included. The online survey, administered using REDCap, included 4 sections: demographics and background; expected change in symptoms on a +/- 100% scale (-100% worst, 0% no change and 100% best possible); surgical preference; and rating of current evidence for lumbar decompression compared with other treatments. There were 71 complete responses, 76% were neurosurgeons (N = 54), predominantly male (96%; N = 68). On average, surgeons expected an 86% (median: 87%, inter-quartile range (IQR): 80%, 91%) improvement in neurogenic claudication following lumbar decompression for LSS and 89% (median: 91%, IQR: 85%, 95%) improvement in radicular pain following microdiscectomy. A multiple linear regression found no surgeon characteristics were associated with expected change following surgery. The preferred surgical technique for LSS was full laminectomy (58%; N = 41). Thirty-five percent of surgeons accurately rated the evidence supporting the superiority of lumbar decompression compared with non-surgical care for LSS as low quality. Spine surgeons expect large symptom improvements following lumbar decompression and microdiscectomy. Understanding of the current evidence was higher for lumbar decompression with fusion, than for decompression alone for LSS.

Objective: Wrist deformity in older people is common following treatment for a wrist fracture, particularly after non-surgical treatment. A cohort of older wrist fracture patients were surveyed by telephone regarding perceived deformity, bother with deformity and patient-reported wrist function. The objectives were to: (1) determine whether older patients with wrist fractures perceived a deformity of their wrist and if they were bothered by it; (2) test if there were associations between deformity and treatment-type and between deformity and function; (3) test for associations between bother and treatment-type and between bother and function; (4) measure the test-retest reliability of the 'bother' question. Results: Of 98 eligible patients who were invited to participate, 41 responded. Out of 41, 14 (34%) believed they had a deformity and 4 (10%) reported that they were bothered by the appearance of their wrist. Deformity was associated with non-surgical treatment (RR = 3.85, p = 0.006) but was not significantly associated with functional outcomes (p = 0.15). All those who were bothered belonged to the non-surgical treatment group. Bother was significantly associated with poorer functional outcomes (p = 0.006) and this association was clinically significant (MD = 35 points). The deformity and bother questions were found to have excellent test-retest reliability; κ = 1.00 and κ = 0.92, respectively.

Background: Health-related quality of life (HRQoL) is a commonly used health outcome. For many acute conditions (e.g. fractures), retrospective measurement of HRQoL is necessary to establish pre-morbid health status. However, the validity of retrospective measurement of HRQoL following an intervening significant health event has not been established. The aim of this study was to test the validity of retrospective measurement (recall) of HRQoL by using a test-retest design to measure reliability and agreement between prospective and retrospective patient-reported HRQoL before and after an intervening health event (elective orthopaedic surgery). Method: Participants were recruited from the pre-admission clinic of a metropolitan hospital. Participants were assessed for their HRQoL using the EQ-5D-5L at two time-points; prospectively at 2 weeks prior to their date of surgery and then retrospectively (recalling their pre-operative health) following elective hip or knee joint replacement surgery. Prospective measurements were compared with retrospective measurements for the five domain scores (nominal data) using intra-class correlation and for the EQ-Index score and EQ-Visual Analogue Scale (VAS) score (continuous data), using Pearson's correlation. Agreement was tested in continuous variables using Lin's coefficient of concordance (pc) and Bland-Altman plots. Results: One hundred seventy-four patients consented to participate. Eighty-eight paired prospective and retrospective scores were collected and there was a median between-test period of 15 days. At a group level, the prospective measurements were similar to the retrospective measurements; the modes and means of the five domain scores were not different and the mean differences (MD) between the scores for EQ-Index (MD = 0.02, on a scale of 0-1) and EQ-VAS (MD = 0.53, on a scale of 1-100) were negligible. However, the correlation of paired scores was varied; the range of domain score correlations was 0.52 to 0.74, t

Aims It is unknown whether kinematic alignment (KA) objectively improves knee balance in total knee arthroplasty (TKA), despite this being the biomechanical rationale for its use. This study aimed to determine whether restoring the constitutional alignment using a restrictive KA protocol resulted in better quantitative knee balance than mechanical alignment (MA). Methods We conducted a randomized superiority trial comparing patients undergoing TKA assigned to KA within a restrictive safe zone or MA. Optimal knee balance was defined as an intercompartmental pressure difference (ICPD) of 15 psi or less using a pressure sensor. The primary endpoint was the mean intraoperative ICPD at 10° of flexion prior to knee balancing. Secondary outcomes included balance at 45° and 90°, requirements for balancing procedures, and presence of tibiofemoral lift-off. Results A total of 63 patients (70 knees) were randomized to KA and 62 patients (68 knees) to MA. Mean ICPD at 10° flexion in the KA group was 11.7 psi (SD 13.1) compared with 32.0 psi in the MA group (SD 28.9), with a mean difference in ICPD between KA and MA of 20.3 psi (p < 0.001). Mean ICPD in the KA group was significantly lower than in the MA group at 45° and 90°, respectively (25.2 psi MA vs 14.8 psi KA, p = 0.004; 19.1 psi MA vs 11.7 psi KA, p < 0.002, respectively). Overall, participants in the KA group were more likely to achieve optimal knee balance (80% vs 35%; p < 0.001). Bone recuts to achieve knee balance were more likely to be required in the MA group (49% vs 9%; p < 0.001). More participants in the MA group had tibiofemoral lift-off (43% vs 13%; p < 0.001). Conclusion This study provides persuasive evidence that restoring the constitutional alignment with KA in TKA results in a statistically significant improvement in quantitative knee balance, and further supports this technique as a viable alternative to MA.

The value of a clinical quality registry is contingent on the quality of its data. This study aims to pilot methodology for data quality audits of the Australian and New Zealand Hip Fracture Registry, a clinical quality registry of hip fracture clinical care and secondary fracture prevention. Methods A data quality audit was performed by independently replicating the data collection and entry process for 163 randomly selected patient records from three contributing hospitals, and then comparing the replicated data set to the registry data set. Data agreement, as a proxy indicator of data accuracy, and data completeness were assessed. Results An overall data agreement of 82.3% and overall data completeness of 95.6% were found, reflecting a moderate level of data accuracy and a very high level of data completeness. Half of all data disagreements were caused by information discrepancies, a quarter by missing discrepancies and a quarter by time, date and number discrepancies. Transcription discrepancies only accounted for 1 in every 50 data disagreements. The sources of inaccurate and incomplete data have been identified with the intention of implementing data quality improvement. Conclusions Regular audits of data abstraction are necessary to improve data quality, assure data validity and reliability and guarantee the integrity and credibility of registry outputs. A generic framework and model for data quality audits of clinical quality registries is proposed, consisting of a three-step data abstraction audit, registry coverage audit and four-step data quality improvement process. Factors to consider for data abstraction audits include: central, remote or local implementation; single-stage or multistage random sampling; absolute, proportional, combination or alternative sample size calculation; data quality indicators; regular or ad hoc frequency; and qualitative assessment.

Introduction Soft tissue imbalance is considered to be a major surgical cause of dissatisfaction following total knee arthroplasty (TKA). Surgeon-determined manual assessment of ligament tension has been shown to be a poor determinant of the true knee balance state. The recent introduction of intraoperative sensors, however, allows surgeons to precisely quantify knee compartment pressures and tibiofemoral kinematics, thereby optimising coronal and sagittal plane soft tissue balance. The primary hypothesis of this study is that achieving knee balance with use of sensors in TKA will improve patient-reported outcomes when compared with manual balancing. Methods and analysis A multicentred, randomised controlled trial will compare patient-reported outcomes in 222 patients undergoing TKA using sensor-guided balancing versus manual balancing. The sensor will be used in both arms for purposes of data collection; however, surgeons will be blinded to the pressure data in patients randomised to manual balancing. The primary outcome will be the change from baseline to 1 year postoperatively in the mean of the four subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS 4) that are most specific to TKA recovery: pain, symptoms, function and knee-related quality of life. Secondary outcomes will include the surgeon's capacity to determine knee balance, radiographic and functional measures and additional patient-reported outcomes. Normality of data will be assessed, and a Student's t-test and equivalent non-parametric tests will be used to compare differences in means among the two groups. Ethics and dissemination Ethics approval was obtained from South Eastern Sydney Local Health District, Approval (HREC/18/POWH/320). Results of the trial will be presented at orthopaedic surgical meetings and submitted for publication in a peer-reviewed journal. Trial registration number ACTRN#12618000817246.

© Author(s) (or their employer(s)) 2019. Introduction: Central lumbar spinal stenosis (LSS) is a common cause of pain, reduced function and quality of life in older adults. Current management of LSS includes surgery to decompress the spinal canal and alleviate symptoms. However, evidence supporting surgical decompression derives from unblinded randomised trials with high cross-over rates or cohort studies showing modest benefits. This protocol describes the design of the SUrgery for Spinal Stenosis (SUcceSS) trial-the first randomised placebo-controlled trial of decompressive surgery for symptomatic LSS. Methods and analysis: SUcceSS will be a prospectively registered, randomised placebo-controlled trial of decompressive spinal surgery. 160 eligible participants (80 participants/group) with symptomatic LSS will be randomised to either surgical spinal decompression or placebo surgical intervention. The placebo surgical intervention is identical to surgical decompression in all other ways with the exception of the removal of any bone or ligament. All participants and assessors will be blinded to treatment allocation. Outcomes will be assessed at baseline and at 3, 6, 12 and 24 months. The coprimary outcomes will be function measured with the Oswestry Disability Index and the proportion of participants who have meaningfully improved their walking capacity at 3 months postrandomisation. Secondary outcomes include back pain intensity, lower limb pain intensity, disability, quality of life, anxiety and depression, neurogenic claudication score, perceived recovery, treatment satisfaction, adverse events, reoperation rate and rehospitalisation rate. Those who decline to be randomised will be invited to participate in a parallel observational cohort. Data analysis will be blinded and by intention to treat. A trial-based cost-effectiveness analysis will determine the potential incremental cost per quality-adjusted life year gained. Ethics and dissemination: Ethics approval ha

Introduction Venous thromboembolism (VTE) is a serious complication following hip arthroplasty (HA) and knee arthroplasty (KA). This study aims to determine whether aspirin is non-inferior to low molecular weight heparin (LMWH) in preventing symptomatic VTE following HA and KA. Methods and analysis This is a cluster randomised, crossover, non-inferiority, trial nested within the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). The clusters will consist of Australian hospitals performing at least 250 HA and/or KA procedures per annum. All adult patients undergoing HA or KA will be included. The intervention will be aspirin, orally, 85-150 mg daily. The comparator will be LMWH (enoxaparin) 40 mg, subcutaneously, daily. Both drugs will commence within 24 hours postoperatively and continue for 35 days after HA and 14 days after KA. Each hospital will be randomised to commence with aspirin or LMWH and then crossover to the alternative treatment after meeting the recruitment target. Data will be collected through the AOANJRR via patient-reported surveys. The primary outcome is symptomatic VTE within 90 days post surgery, verified by AOANJRR staff. The primary analysis will include only patients undergoing elective primary total hip arthroplasty and total knee arthroplasty for osteoarthritis. Secondary outcomes will include symptomatic VTE for all HA and KA (including partial and revision) within 90 days, readmission, reoperation, major bleeding and death within 90 days and reoperation, death and patient-reported pain, function and health status at 6 months. If aspirin is found to be inferior, a cost-effectiveness analysis will be conducted. The study will aim to recruit 15 562 patients from 31 hospitals. Ethics and dissemination Ethics approval has been granted. Trial results will be submitted for publication. The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12618001879257, pre-results) and is endorsed

INTRODUCTION: Central lumbar spinal stenosis (LSS) is a common cause of pain, reduced function and quality of life in older adults. Current management of LSS includes surgery to decompress the spinal canal and alleviate symptoms. However, evidence supporting surgical decompression derives from unblinded randomised trials with high cross-over rates or cohort studies showing modest benefits. This protocol describes the design of the SUrgery for Spinal Stenosis (SUcceSS) trial -the first randomised placebo-controlled trial of decompressive surgery for symptomatic LSS. METHODS AND ANALYSIS: SUcceSS will be a prospectively registered, randomised placebo-controlled trial of decompressive spinal surgery. 160 eligible participants (80 participants/group) with symptomatic LSS will be randomised to either surgical spinal decompression or placebo surgical intervention. The placebo surgical intervention is identical to surgical decompression in all other ways with the exception of the removal of any bone or ligament. All participants and assessors will be blinded to treatment allocation. Outcomes will be assessed at baseline and at 3, 6, 12 and 24 months. The coprimary outcomes will be function measured with the Oswestry Disability Index and the proportion of participants who have meaningfully improved their walking capacity at 3 months postrandomisation. Secondary outcomes include back pain intensity, lower limb pain intensity, disability, quality of life, anxiety and depression, neurogenic claudication score, perceived recovery, treatment satisfaction, adverse events, reoperation rate and rehospitalisation rate. Those who decline to be randomised will be invited to participate in a parallel observational cohort. Data analysis will be blinded and by intention to treat. A trial-based cost-effectiveness analysis will determine the potential incremental cost per quality-adjusted life year gained. ETHICS AND DISSEMINATION: Ethics approval has been granted by the NSW Health (refere

BACKGROUND: We aimed to measure the period effect (change over time) in 30-day mortality after total hip arthroplasty (THA) and total knee arthroplasty (TKA) using data from the Australian Orthopaedic Association National Joint Replacement Registry. METHODS: We performed an observational study using national registry data from all hospitals performing THA and TKA in Australia including people undergoing primary elective conventional THA and TKA for osteoarthritis from 2003 to 2017, inclusive. Data from the Australian Orthopaedic Association National Joint Replacement Registry, the National Death Index and the Australian Bureau of Statistics were used to generate unadjusted 30-day mortality, the incident rate ratio for mortality adjusted for age and gender, and the standardized mortality ratio at 30 days for each year separately. RESULTS: For the years 2003 and 2017, respectively, for THA, the unadjusted 30-day mortality was 0.23% and 0.06%, and the standardized mortality ratio was 1.11 (95% CI: 0.73, 1.49) and 0.38 (95% CI: 0.16, 0.59). The incident rate ratio was significantly higher than the reference year (2017) from 2003 to 2010, and for 2012, 2013 and 2016, decreasing over time. For the years 2003 and 2017, respectively, for TKA, the unadjusted 30-day mortality was 0.17% and 0.08%, and the standardized mortality ratio was 0.84 (95% CI: 0.55, 1.13) and 0.61 (95% CI: 0.38, 0.83). The incident rate ratio was significantly higher than the reference year (2017) from 2003 to 2009 inclusive, decreasing over time. CONCLUSIONS: Thirty-day mortality after THA and TKA declined from 2003 to 2017. This may be due to improvements in intra-operative and post-operative patient management.

BACKGROUND: Placebo-controlled trials are an important tool when assessing the efficacy of spinal surgical procedures. The most common spinal surgical procedure in older adults is decompression for lumbar spinal stenosis. Before conducting a placebo-surgical trial on decompression surgery, an investigation of patients' willingness to participate in a placebo-controlled trial of decompression surgery and barriers to participation were explored. MATERIALS: An online survey. METHODS: Descriptive analyses of demographic and clinical data, and participants' willingness to participate in a placebo-surgical trial. Logistic regression was used to examine potential predictors of willingness to participate. Two independent researchers performed a coded framework analysis of patients' barriers to participation. RESULTS: 68 patients were invited and 63 participants completed the survey (91.3% response, mean (SD) age 69.5 (10.9) years, 52% females), 71% suffered from moderate to very severe pain. Ten participants (15.9%) were willing to participate in a placebo-controlled trial. Being married was associated with decreased odds of participating (OR: 0.2; 95% CI, 0.05 to 0.8; P = 0.03), while the main barriers were a lack of information about the procedure, reassurance of a positive outcome with participation, and concerns about the risks and benefits of placebo surgery. CONCLUSIONS: A minority of patients with lumbar spinal stenosis were willing to participate in a placebo-controlled trial of surgery. The identified barriers indicate that educating eligible patients about: the need for placebo-surgical trials, the personal risks and benefits of participation, and the importance and potential benefits of placebo trials to others, may be crucial to ensure adequate recruitment into the placebo-controlled surgical trial. Conclusions should be read cautiously however, given the small sample size present in this study.

INTRODUCTION: Venous thromboembolism (VTE) is a serious complication following hip arthroplasty (HA) and knee arthroplasty (KA). This study aims to determine whether aspirin is non-inferior to low molecular weight heparin (LMWH) in preventing symptomatic VTE following HA and KA. METHODS AND ANALYSIS: This is a cluster randomised, crossover, non-inferiority, trial nested within the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). The clusters will consist of Australian hospitals performing at least 250 HA and/or KA procedures per annum. All adult patients undergoing HA or KA will be included. The intervention will be aspirin, orally, 85-150 mg daily. The comparator will be LMWH (enoxaparin) 40 mg, subcutaneously, daily. Both drugs will commence within 24 hours postoperatively and continue for 35 days after HA and 14 days after KA. Each hospital will be randomised to commence with aspirin or LMWH and then crossover to the alternative treatment after meeting the recruitment target. Data will be collected through the AOANJRR via patient-reported surveys. The primary outcome is symptomatic VTE within 90 days post surgery, verified by AOANJRR staff. The primary analysis will include only patients undergoing elective primary total hip arthroplasty and total knee arthroplasty for osteoarthritis. Secondary outcomes will include symptomatic VTE for all HA and KA (including partial and revision) within 90 days, readmission, reoperation, major bleeding and death within 90 days and reoperation, death and patient-reported pain, function and health status at 6 months. If aspirin is found to be inferior, a cost-effectiveness analysis will be conducted. The study will aim to recruit 15 562 patients from 31 hospitals. ETHICS AND DISSEMINATION: Ethics approval has been granted. Trial results will be submitted for publication. The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12618001879257, pre-results) and is endor

BACKGROUND: Periprosthetic femur fractures (PFFs) following hip arthroplasty can lead to significant morbidity due to their impact on mobility and the need for surgery. Its incidence often measured by the prosthesis revision rate reported in joint replacement registries. However, many PFFs are also treated with prosthesis retention and internal fixation. Minimally displaced and stable fractures may be treated without surgery. Knowledge of the difference between the number of femoral revisions for PFF (well reported in registries) and the number of surgeries for PFF overall would allow us to estimate the overall surgical burden. This study aims to determine the number of post-operative PFF in three hospitals and compare those treated with revision surgery to those PFF treated with internal fixation and femoral stem retention. By determining this difference, we can ascertain a more accurate estimate of the overall surgical burden of PFF. METHOD: Patients 50 years and older who sustained a post-operative PFF between 1 January 2011 and 31 December 2017 at three public hospitals were extracted from hospital records. The number of revision procedures was compared to the number of re-operations of any type. RESULTS: There were 200 patients admitted for management of PFF. One hundred and forty-three (71.5%) required an operation of which 67 (47%) were revision arthroplasty. CONCLUSION: The overall surgical burden of PFF is approximately twice that represented by the revision rate.

© Author(s) (or their employer(s)) 2019. Introduction: Central lumbar spinal stenosis (LSS) is a common cause of pain, reduced function and quality of life in older adults. Current management of LSS includes surgery to decompress the spinal canal and alleviate symptoms. However, evidence supporting surgical decompression derives from unblinded randomised trials with high cross-over rates or cohort studies showing modest benefits. This protocol describes the design of the SUrgery for Spinal Stenosis (SUcceSS) trial-the first randomised placebo-controlled trial of decompressive surgery for symptomatic LSS. Methods and analysis: SUcceSS will be a prospectively registered, randomised placebo-controlled trial of decompressive spinal surgery. 160 eligible participants (80 participants/group) with symptomatic LSS will be randomised to either surgical spinal decompression or placebo surgical intervention. The placebo surgical intervention is identical to surgical decompression in all other ways with the exception of the removal of any bone or ligament. All participants and assessors will be blinded to treatment allocation. Outcomes will be assessed at baseline and at 3, 6, 12 and 24 months. The coprimary outcomes will be function measured with the Oswestry Disability Index and the proportion of participants who have meaningfully improved their walking capacity at 3 months postrandomisation. Secondary outcomes include back pain intensity, lower limb pain intensity, disability, quality of life, anxiety and depression, neurogenic claudication score, perceived recovery, treatment satisfaction, adverse events, reoperation rate and rehospitalisation rate. Those who decline to be randomised will be invited to participate in a parallel observational cohort. Data analysis will be blinded and by intention to treat. A trial-based cost-effectiveness analysis will determine the potential incremental cost per quality-adjusted life year gained. Ethics and dissemination: Ethics approval ha

Importance: Recent publication of the largest trials to date investigating rehabilitation after total knee arthroplasty (TKA) necessitate an updated evidence review. Objective: To determine whether inpatient or clinic-based rehabilitation is associated with superior function and pain outcomes after TKA compared with any home-based program. Data Sources: MEDLINE, Embase, CINAHL, and PubMed were searched from inception to November 5, 2018. Search terms included knee arthroplasty, randomized controlled trial, physiotherapy, and rehabilitation. Study Selection: Published randomized clinical trials of adults who underwent primary unilateral TKA and commenced rehabilitation within 6 postoperative weeks in which those receiving postacute inpatient or clinic-based rehabilitation were compared with those receiving a home-based program. Data Extraction and Synthesis: Two reviewers extracted data independently and assessed data quality and validity according to the PRISMA guidelines. Data were pooled using a random-effects model. Data were analyzed from June 1, 2015, through June 4, 2018. Main Outcomes and Measures: Primary outcomes were mobility (6-minute walk test [6MWT]) and patient-reported pain and function (Oxford knee score [OKS] or Western Ontario and McMaster Universities Osteoarthritis Index) reported at 10 to 12 postoperative weeks. The GRADE assessment (Grading of Recommendations, Assessment, Development, and Evaluation) was applied to the primary outcomes. Results: Five unique studies involving 752 unique participants (451 [60%] female; mean [SD] age, 68.3 [8.5] years) compared clinic- and home-based rehabilitation, and 1 study involving 165 participants (112 [68%] female; mean [SD] age, 66.9 [8.0] years) compared inpatient and home-based rehabilitation. Low-quality evidence showed no clinically important difference between clinic- and home-based programs for mobility at 10 weeks (6MWT favoring home program; mean difference [MD], -11.89 m [95% CI, -35.94 to 12.16

Importance: Recent publication of the largest trials to date investigating rehabilitation after total knee arthroplasty (TKA) necessitate an updated evidence review. Objective: To determine whether inpatient or clinic-based rehabilitation is associated with superior function and pain outcomes after TKA compared with any home-based program. Data Sources: MEDLINE, Embase, CINAHL, and PubMed were searched from inception to November 5, 2018. Search terms included knee arthroplasty, randomized controlled trial, physiotherapy, and rehabilitation. Study Selection: Published randomized clinical trials of adults who underwent primary unilateral TKA and commenced rehabilitation within 6 postoperative weeks in which those receiving postacute inpatient or clinic-based rehabilitation were compared with those receiving a home-based program. Data Extraction and Synthesis: Two reviewers extracted data independently and assessed data quality and validity according to the PRISMA guidelines. Data were pooled using a random-effects model. Data were analyzed from June 1, 2015, through June 4, 2018. Main Outcomes and Measures: Primary outcomes were mobility (6-minute walk test [6MWT]) and patient-reported pain and function (Oxford knee score [OKS] or Western Ontario and McMaster Universities Osteoarthritis Index) reported at 10 to 12 postoperative weeks. The GRADE assessment (Grading of Recommendations, Assessment, Development, and Evaluation) was applied to the primary outcomes. Results: Five unique studies involving 752 unique participants (451 [60%] female; mean [SD] age, 68.3 [8.5] years) compared clinic- and home-based rehabilitation, and 1 study involving 165 participants (112 [68%] female; mean [SD] age, 66.9 [8.0] years) compared inpatient and home-based rehabilitation. Low-quality evidence showed no clinically important difference between clinic- and home-based programs for mobility at 10 weeks (6MWT favoring home program; mean difference [MD], -11.89 m [95% CI, -35.94 to 12.16

© Author(s) (or their employer(s)) 2019. Introduction: Central lumbar spinal stenosis (LSS) is a common cause of pain, reduced function and quality of life in older adults. Current management of LSS includes surgery to decompress the spinal canal and alleviate symptoms. However, evidence supporting surgical decompression derives from unblinded randomised trials with high cross-over rates or cohort studies showing modest benefits. This protocol describes the design of the SUrgery for Spinal Stenosis (SUcceSS) trial-the first randomised placebo-controlled trial of decompressive surgery for symptomatic LSS. Methods and analysis: SUcceSS will be a prospectively registered, randomised placebo-controlled trial of decompressive spinal surgery. 160 eligible participants (80 participants/group) with symptomatic LSS will be randomised to either surgical spinal decompression or placebo surgical intervention. The placebo surgical intervention is identical to surgical decompression in all other ways with the exception of the removal of any bone or ligament. All participants and assessors will be blinded to treatment allocation. Outcomes will be assessed at baseline and at 3, 6, 12 and 24 months. The coprimary outcomes will be function measured with the Oswestry Disability Index and the proportion of participants who have meaningfully improved their walking capacity at 3 months postrandomisation. Secondary outcomes include back pain intensity, lower limb pain intensity, disability, quality of life, anxiety and depression, neurogenic claudication score, perceived recovery, treatment satisfaction, adverse events, reoperation rate and rehospitalisation rate. Those who decline to be randomised will be invited to participate in a parallel observational cohort. Data analysis will be blinded and by intention to treat. A trial-based cost-effectiveness analysis will determine the potential incremental cost per quality-adjusted life year gained. Ethics and dissemination: Ethics approval ha

© 2019 Background: Placebo-controlled trials are an important tool when assessing the efficacy of spinal surgical procedures. The most common spinal surgical procedure in older adults is decompression for lumbar spinal stenosis. Before conducting a placebo-surgical trial on decompression surgery, an investigation of patients’ willingness to participate in a placebo-controlled trial of decompression surgery and barriers to participation were explored. Materials: An online survey. Methods: Descriptive analyses of demographic and clinical data, and participants' willingness to participate in a placebo-surgical trial. Logistic regression was used to examine potential predictors of willingness to participate. Two independent researchers performed a coded framework analysis of patients’ barriers to participation. Results: 68 patients were invited and 63 participants completed the survey (91.3% response, mean (SD) age 69.5 (10.9) years, 52% females), 71% suffered from moderate to very severe pain. Ten participants (15.9%) were willing to participate in a placebo-controlled trial. Being married was associated with decreased odds of participating (OR: 0.2; 95% CI, 0.05 to 0.8; P = 0.03), while the main barriers were a lack of information about the procedure, reassurance of a positive outcome with participation, and concerns about the risks and benefits of placebo surgery. Conclusions: A minority of patients with lumbar spinal stenosis were willing to participate in a placebo-controlled trial of surgery. The identified barriers indicate that educating eligible patients about: the need for placebo-surgical trials, the personal risks and benefits of participation, and the importance and potential benefits of placebo trials to others, may be crucial to ensure adequate recruitment into the placebo-controlled surgical trial. Conclusions should be read cautiously however, given the small sample size present in this study.

© 2019 Background: Placebo-controlled trials are an important tool when assessing the efficacy of spinal surgical procedures. The most common spinal surgical procedure in older adults is decompression for lumbar spinal stenosis. Before conducting a placebo-surgical trial on decompression surgery, an investigation of patients’ willingness to participate in a placebo-controlled trial of decompression surgery and barriers to participation were explored. Materials: An online survey. Methods: Descriptive analyses of demographic and clinical data, and participants' willingness to participate in a placebo-surgical trial. Logistic regression was used to examine potential predictors of willingness to participate. Two independent researchers performed a coded framework analysis of patients’ barriers to participation. Results: 68 patients were invited and 63 participants completed the survey (91.3% response, mean (SD) age 69.5 (10.9) years, 52% females), 71% suffered from moderate to very severe pain. Ten participants (15.9%) were willing to participate in a placebo-controlled trial. Being married was associated with decreased odds of participating (OR: 0.2; 95% CI, 0.05 to 0.8; P = 0.03), while the main barriers were a lack of information about the procedure, reassurance of a positive outcome with participation, and concerns about the risks and benefits of placebo surgery. Conclusions: A minority of patients with lumbar spinal stenosis were willing to participate in a placebo-controlled trial of surgery. The identified barriers indicate that educating eligible patients about: the need for placebo-surgical trials, the personal risks and benefits of participation, and the importance and potential benefits of placebo trials to others, may be crucial to ensure adequate recruitment into the placebo-controlled surgical trial. Conclusions should be read cautiously however, given the small sample size present in this study.

Lumbar spine fusion is a common procedure associated with a high cost burden and risk of serious complications. We aimed to summarise systematic reviews on the effectiveness of lumbar spine fusion for most diagnoses. We found no high-quality systematic reviews and the risk of bias of the randomised controlled trials in the reviews was generally high. The available evidence does not support a benefit from spine fusion compared to non-operative alternatives for back pain associated with degeneration. The available evidence does not support a clinical benefit from spine fusion compared to non-operative treatment or stabilisation without fusion for thoracolumbar burst fractures. Benefits of spine fusion compared to non-operative treatment for isthmic spondylolisthesis are unclear (one trial at high risk of bias). Surgical intervention for metastatic carcinoma of the spine associated with spinal cord compromise improves mobility and neurological outcome (based on a single trial). Better evidence is required to determine more accurately the effectiveness of spine fusion surgery for all indications. Patients contemplating spinal fusion should be fully informed about the evidence base for their particular problem, including the relative potential benefits and harms of fusion compared with non-operative treatments.

Introduction Patients with low back pain often seek care in emergency departments, but the problem is that many patients receive unnecessary or ineffective interventions and at the same time miss out on the basics of care, such as advice on self-management. This pattern of care has important consequences for the healthcare system (expensive and inefficient) and for patients (poor health outcomes). We hypothesised that the implementation of an evidence-based model of care for low back pain will improve emergency care by reducing inappropriate overuse of tests and treatments and improving patient outcomes. Methods and analysis A stepped-wedge cluster randomised controlled trial will be conducted to implement and evaluate the use of the Agency for Clinical Innovation (ACI) model of care for acute low back pain at four emergency departments in New South Wales, Australia. Clinician participants will be emergency physicians, nurses and physiotherapists. Codes from the Systematised Nomenclature of Medicine-Clinical Terms-Australian version will be used to identify low back pain presentations. The intervention, targeting emergency clinicians, will comprise educational materials and seminars and an audit and feedback approach. Health service delivery outcomes are routinely collected measures of imaging (primary outcome), opioid use and inpatient admission. A random subsample of 200 patient participants from each trial period will be included to measure patient outcomes (pain intensity, physical function, quality of life and experience with emergency service). The effectiveness of the intervention will be assessed by comparing the postintervention period with the retrospective baseline control period. Ethics and dissemination The study received ethical approval from the Sydney Local Health District (Royal Prince Alfred Hospital zone) Ethics Committee (X17-0043). The results of this study will be published in peer-reviewed journals and presented at international conferences.

OBJECTIVE: Describe research methods used in priority-setting exercises for musculoskeletal conditions and synthesise the priorities identified. DESIGN: Scoping review. SETTING AND POPULATION: Studies that elicited the research priorities of patients/consumers, clinicians, researchers, policy-makers and/or funders for any musculoskeletal condition were included. METHODS AND ANALYSIS: We searched MEDLINE and EMBASE from inception to November 2017 and the James Lind Alliance top 10 priorities, Cochrane Priority Setting Methods Group, and Cochrane Musculoskeletal and Back Groups review priority lists. The reported methods and research topics/questions identified were extracted, and a descriptive synthesis conducted. RESULTS: Forty-nine articles fulfilled our inclusion criteria. Methodologies and stakeholders varied widely (26 included a mix of clinicians, consumers and others, 16 included only clinicians, 6 included only consumers or patients and in 1 participants were unclear). Only two (4%) reported any explicit inclusion criteria for priorities. We identified 294 broad research priorities from 37 articles and 246 specific research questions from 17 articles, although only four (24%) of the latter listed questions in an actionable format. Research priorities for osteoarthritis were identified most often (n=7), followed by rheumatoid arthritis (n=4), osteoporosis (n=4) and back pain (n=4). Nearly half of both broad and specific research priorities were focused on treatment interventions (n=116 and 111, respectively), while few were economic (n=8, 2.7% broad and n=1, 0.4% specific), implementation (n=6, 2% broad and n=4, 1.6% specific) or health services and systems research (n=15, 5.1% broad and n=9, 3.7% specific) priorities. CONCLUSIONS: While many research priority-setting studies in the musculoskeletal field have been performed, methodological limitations and lack of actionable research questions limit their usefulness. Future studies should ensure they conform to

Background: The dangers of using surrogate outcomes are well documented. They may have little or no association with their patient-important correlates, leading to the approval and use of interventions that lack efficacy. We sought to assess whether primary outcomes in surgical randomized controlled trials (RCTs) are more likely to be patientimportant outcomes than surrogate or laboratory-based outcomes. Methods: We reviewed RCTs assessing an operative intervention published in 2008 and 2009 and indexed in MEDLINE, EMBASE or the Cochrane Central Register of Controlled Trials. After a pilot of the selection criteria, 1 reviewer selected trials and another reviewer checked the selection. We extracted information on outcome characteristics (patient-important, surrogate, or laboratory-based outcome) and whether they were primary or secondary outcomes. We calculated odds ratios (OR) and pooled in randomeffects meta-analysis to obtain an overall estimate of the association between patient importance and primary outcome specification. Results: In 350 included RCTs, a total of 8258 outcomes were reported (median 18 per trial. The mean proportion (per trial) of patient-important outcomes was 60%, and 66% of trials specified a patient-important primary outcome. The most commonly reported patientimportant primary outcomes were morbid events (41%), intervention outcomes (11%), function (11%) and pain (9%). Surrogate and laboratory-based primary outcomes were reported in 33% and 8% of trials, respectively. Patient-important outcomes were not associated with primary outcome status (OR 0.82, 95% confidence interval 0.63-1.1, I2 = 21%). Conclusion: A substantial proportion of surgical RCTs specify primary outcomes that are not patient-important. Authors, journals and trial funders should insist that patientimportant outcomes are the focus of study.

Background Randomized controlled trials (RCTs) of surgical interventions are often more difficult to conduct, and their quality may lag behind other trials. Objectives To compare quality domains in trials of surgical interventions, to a previously reported control sample of general medical trials from December 2006. Data sources MEDLINE, EMBASE and CENTRAL were searched in May 2009. Study eligibility English language, full text RCTs, performed on humans that compared a surgical intervention to any other intervention. Study appraisal and synthesis Records were ordered according to their date of publication. The most recently published trials were assessed first, until the required sample of 400 trials was obtained. The search and data collection were piloted by three authors, and was thereafter collected by one author. Data was checked. Results Although most quality domains were poorly reported, surgical trials compared favourably to general medical trials. Surgical trials were 24% more likely to have an adequate method of random sequence generation, and 71% more likely to have an adequate method of allocation concealment. However, blinding was 40% less likely to be adequate in surgical trials, and sources of funding were 33% less likely to be reported. Limitations A single author collected most data. Data was checked and this resulted in few changes. Conclusions Reporting of most quality domains in surgical intervention trials was better than general medical trials. Blinding was less likely due to the difficulty in conducting sham surgical trials, and reporting of sources of support should improve with adherence to reporting guidelines.

© 2017 Chua et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Objective: Early mobilisation is recommended following total hip arthroplasty (THA) or total knee arthroplasty (TKA) to prevent venous thromboembolism (VTE). We sought to determine the proportions of patients that first mobilised on post-operative day 0 (POD 0) and factors associated with earlier time to mobilisation. Methods: A prospective cohort study was conducted involving patients with hip or knee osteoarthritis who had undergone primary unilateral THA (n = 818) and TKA (n = 989) at 19 Australian hospitals. Patient-related (e.g. age, gender, body mass index), treatment-related (e.g. hospital site, presence of indwelling catheter) and mobilisation-related variables were collected on standardised forms. Time was measured by post-operative days, where POD 0 was defined as the day of surgery ending at midnight. Multivariate Poisson regression analysis identified associations between patient- and treatment-related covariates and time to mobilisation. Results: Inter-hospital variation was evident, but overall, only 9.4% of THA and 5.6% of TKA patients mobilised on POD 0. For THA patients, earlier time to mobilisation was associated with hospital site and absences of an indwelling catheter and acute complications. For TKA patients, earlier time to mobilisation was associated with hospital site and absence of donor blood transfusion. Conclusions: Few THA and TKA patients mobilise POD 0, although some hospitals appear more aggressive with their mobilisation attempts than others. Treatment-related factors, not patientrelated, are associated with post-operative day of mobilisation, indicating the potentially pivotal role of service providers in promoting early mobilisation to improve health outcomes and reduce rates of VT

Background: Whiplash injuries are among the leading injuries related to car crashes and it is important to determine the prognostic factors that predict the outcome of patients with these injuries. This meta-review aims to identify factors that are associated with outcome after acute whiplash injury. Materials and methods: A systematic search for all systematic reviews on outcome prediction of acute whiplash injury was conducted across several electronic databases. The search was limited to publications in English, and there were no geographical or time of publication restrictions. Quality appraisal was conducted with A Measurement Tool to Assess Systematic Reviews. Results: The initial search yielded 207 abstracts; of these, 195 were subsequently excluded by topic or method. Twelve systematic reviews with moderate quality were subsequently included in the analysis. Post-injury pain and disability, whiplash grades, cold hyperalgesia, post-injury anxiety, catastrophizing, compensation and legal factors, and early healthcare use were associated with continuation of pain and disability in patients with whiplash injury. Post-injury magnetic resonance imaging or radiographic findings, motor dysfunctions, or factors related to the collision were not associated with continuation of pain and disability in patients with whiplash injury. Evidence on demographic and three psychological factors and prior pain was conflicting, and there is a shortage of evidence related to the significance of genetic factors. Conclusions: This meta-review suggests an association between initial pain and anxiety and the outcome of acute whiplash injury, and less evidence for an association with physical factors. Level of evidence: Level 1.

© 2017 by the authors. Licensee MDPI, Basel, Switzerland. Background: Smoke-free hospital policies are becoming increasingly common to promote good health and quit attempts among patients who smoke. This study aims to assess: staff perceived enforcement and compliance with smoke-free policy, the current provision of smoking cessation care, and the characteristics of staff most likely to report provision of care to patients. Methods: An online cross-sectional survey of medical, nursing, and allied staff from two Australian public hospitals was conducted. Staff report of: patient and staff compliance with smoke-free policy, perceived policy enforcement, the provision of the 5As for smoking cessation (Ask, Assess, Advise, Assist, and Arrange follow-up), and the provision of stop-smoking medication are described. Logistic regressions were used to determine respondent characteristics related to the provision of the 5As and stop-smoking medication use during hospital admission. Results: A total of 805 respondents participated. Self-reported enforcement of smoke-free policy was low (60.9%), together with compliance for both patients (12.9%) and staff (23.6%). The provision of smoking cessation care was variable, with the delivery of the 5As ranging from 74.7% (ask) to 18.1% (arrange follow-up). Medical staff (odds ratio (OR) = 2.09, CI = 1.13, 3.85, p = 0.018) and full time employees (OR = 2.03, CI = 1.06, 3.89, p = 0.033) were more likely to provide smoking cessation care always/most of the time. Stop-smoking medication provision decreased with increasing age of staff (OR = 0.98, CI = 0.96, 0.99, p = 0.008). Conclusions: Smoke-free policy enforcement and compliance and the provision of smoking cessation care remains low in hospitals. Efforts to improve smoking cessation delivery by clinical staff are warranted.

© 2017 The Author(s). Background: Proximal humeral fractures are common in older patients. The majority are minimally displaced and are associated with good outcomes after nonoperative treatment. Poorer outcomes are associated with displaced, multipart fractures. There is no clear benefit from surgical fracture fixation compared to nonoperative treatment. Replacement of the fractured humeral head with a hemiarthroplasty is another treatment option, but has not been shown to be clearly superior to nonoperative treatment or internal fixation. Recently, reverse total shoulder arthroplasty has been used to treat these fractures, particularly in the older population with several case series demonstrating good outcomes. No comparative trial has been performed to test the effectiveness of reverse total shoulder arthroplasty against nonoperative treatment. Methods/design: ReShAPE (Reverse Shoulder Arthroplasty for the treatment of Proximal humeral fractures in the Elderly) is a multicenter combined randomized and observational study. The primary objective is to compare pain and function 12 months post fracture using the American Shoulder and Elbow Society (ASES) score in patients aged 70 years or older with three- and four-part proximal humeral fractures treated by either reverse shoulder arthroplasty or nonoperative treatment. Secondary outcome measures will include the DASH (Disability of the Arm, Shoulder and Hand) score, the EQ-5D (EuroQol Health Survey), the EQ-VAS, pain, radiological parameters and complications. Discussion: The study will assess the effectiveness of reverse shoulder arthroplasty for complex proximal humeral fractures and thereby guide treatment of a common injury in the older population. Trial registration: World Health Organization Universal Trial Number (WHO UTN): U1111-1180-5452. Registered on 10 March 2016. Australian and New Zealand Clinical Trials Registry (ANZCTR): 12616000345482. Registered on 16 March 2016.

© 2017 The Author(s). Background: Problems may arise during the approval process of treatment after a compensable work injury, which include excess paperwork, delays in approving services, disputes, and allegations of over-servicing. This is perceived as undesirable for injured people, health care professionals and claims managers, and costly to the health care system, compensation system, workplaces and society. Introducing an Evidence Based Medicine (EBM) decision tool in the workers’ compensation system could provide a partial solution, by reducing uncertainty about effective treatment. The aim of this study was to investigate attitudes of health care professionals (HCP) to the potential implementation of an EBM tool in the workers’ compensation setting. Methods: The study has a mixed methods design. The quantitative study consisted of an online questionnaire asking about self-reported knowledge, attitudes and behaviour to EBM in general. The qualitative study consisted of interviews about an EBM tool being applied in the workers’ compensation process. Participants were health care practitioners from different clinical specialties. They were recruited through the investigators’ clinical networks and the workers’ compensation government regulator’s website. Results: Participants completing the questionnaire (n = 231) indicated they were knowledgeable about the evidence-base in their field, but perceived some difficulties when applying EBM. General practitioners reported having the greatest obstacles to applying EBM. Participants who were interviewed (n = 15) perceived that an EBM tool in the workers’ compensation setting could potentially have some advantages, such as reducing inappropriate treatment, or over-servicing, and providing guidance for clinicians. However, participants expressed substantial concerns that the EBM tool would not adequately reflect the impact of psychosocial factors on recovery. They also highlighted a lack of timeliness in decision making

Background Abstracts are often the only read summaries of research findings, and it is essential that they accurately represent of the contents of the full text of the randomised control trial (RCT). We investigated whether outcomes in surgical trials were selectively reported in abstracts based on their statistical significance. Objective To compare the proportion of significant p-values reported in abstracts to their corresponding full texts in surgical RCTs. Method A Meta-analysis of 350 full text RCTs conducted on humans that compared a surgical intervention to any other intervention. An electronic search of MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) was conducted. All outcomes were extracted from the abstract and the full text. Frequency histograms were used to plot the distribution of numerically reported p-values across the statistical significance spectrum. For each RCT, a 2 × 2 table was populated with that trial's outcomes and whether the outcome was statistically significant (p < 0.05). From each 2 × 2 table, an odds ratio (OR) was calculated describing the association between statistical significance, and reporting in the abstract. ORs were pooled in random effects meta-analysis for an overall estimate of the association. Results A total of 8258 reported outcomes were included. Outcomes reported in a surgical RCT abstract had three times the odds of being significant when compared to the corresponding full text (OR = 3.0, 95% confidence interval 2.5–3.6, p < 0.001). This finding was consistent and not subject to heterogeneity (I2 = 0%). Both histograms demonstrated a large drop in the frequency of reported p values between 0.04 and 0.05, and after the 0.06 thresholds. Conclusions Data presented in abstracts is biased to statistically significant outcomes. Clinicians and policy makers should do not rely solely on information presented in abstracts for their decision-making.

Background Tobacco smoking can have negative health outcomes on recovery from surgery. Although it is recommended best practice to provide patients with advice to quit and follow-up support, provision of postdischarge support is rare. Developing an online smoking cessation program may help address this gap. Objectives This paper describes the development and pretesting of an online smoking cessation program (smoke-free recovery, SFR) tailored to the orthopaedic trauma population for use while in hospital and post-discharge. Methods Drawing on the DoTTI framework for developing an online program, the following steps were followed for program development: (1) design and development; (2) testing early iteration; (3) testing for effectiveness and (4) integration and implementation. This article describes the first two stages of SFR program development. Results SFR is a 10-module online smoking cessation program tailored for patients with orthopaedic trauma. Of the participants who completed testing early iterations, none reported any difficulties orientating themselves to the program or understanding program content. The main themes were that it was ‘helpful’, provision of ‘help to quit’ was low and SFR increased thoughts of ‘staying quit post discharge’. Conclusions This study found that a theory and evidence-based approach as the basis for an online smoking cessation program for patients with orthopaedic trauma was acceptable to users. A randomised controlled trial will be conducted to examine whether the online smoking cessation program is effective in increasing smoking cessation and how it can be integrated and implemented into hospital practice (stages three and four of the DoTTI framework).

Background: eHealth presents opportunities to provide population groups with accessible health interventions, although knowledge about Internet access, peoples' interest in using the Internet for health, and users' characteristics are required prior to eHealth program development. Objective: This study surveyed hospital patients to examine rates of Internet use, interest in using the Internet for health, and respondent characteristics related to Internet use and interest in using the Internet for health. For patients who smoke, preferences for types of smoking cessation programs for use at home and while in hospital were also examined. Methods: An online cross-sectional survey was used to survey 819 orthopedic trauma patients (response rate: 72.61%, 819/1128) from two public hospitals in New South Wales, Australia. Logistic regressions were used to examine associations between variables. Results: A total of 72.7% (574/790) of respondents had at least weekly Internet access and more than half (56.6%, 357/631) reported interest in using the Internet for health. Odds of at least weekly Internet usage were higher if the individual was born overseas (OR 2.21, 95% CI 1.27-3.82, P=.005), had a tertiary education (OR 3.75, 95% CI 2.41-5.84, P<.001), or was a nonsmoker (OR 3.75, 95% CI 2.41-5.84, P<.001). Interest in using the Internet for health increased with high school (OR 1.85, 95% CI 1.09-3.15, P=.02) or tertiary education (OR 2.48, 95% CI 1.66-3.70, P<.001), and if household incomes were more than AUS $100,000 (OR 2.5, 95% CI 1.25-4.97, P=.009). Older individuals were less interested in using the Internet for health (OR 0.98, 95% CI 0.97-0.99, P<.001). Conclusions: Online interventions may be a potential tool for health care in this hospitalized population.

Smoking increases the risk of complications associated with orthopaedic trauma surgery, however delivery of care is low. Online interventions may provide needed smoking cessation care and promote abstinence. This study aims to examine the engagement, acceptability, and retention of an online smoking cessation program (Smoke-Free Recovery; SFR) among a sample of orthopaedic trauma patients, as well as themes around the smoking cessation process. A pilot study of SFR with 31 orthopaedic trauma patients admitted to a public hospital in New South Wales, Australia took place. Semi-structured telephone interviews were conducted following hospital discharge. Thematic analysis and descriptive statistics were used. Engagement was high with 28 participants accessing SFR during admission. Twenty individuals completed follow-up phone calls. Program acceptability was rated favourably. After discharge, changes in smoking habits were noted, with program retention low. Themes on program use included: lack of time or need for additional support; computer illiteracy or technology issues; feeling unready or too stressed to quit; or feeling they had reached the boundary of what could be learnt from the program. This study highlights the difficulties faced by patients following hospital admission, the lack of follow-up support received, and the need for consumer testing prior to roll out. Continuing to develop interventions to promote hospital-initiated cessation attempts that continue post-discharge should be a priority.

© 2017, BMJ Publishing Group. All rights reserved. Objectives: To identify the most credible anchor-based minimal important differences (MIDs) for patient important outcomes in patients with degenerative knee disease, and to inform BMJ Rapid Recommendations for arthroscopic surgery versus conservative management Design: Systematic review. Outcome measures: Estimates of anchor-based MIDs, and their credibility, for knee symptoms and health-related quality of life (HRQoL). Data sources: MEDLINE, EMBASE and PsycINFO. Eligibility criteria: We included original studies documenting the development of anchor-based MIDs for patient-reported outcomes (PROs) reported in randomised controlled trials included in the linked systematic review and meta-analysis and judged by the parallel BMJ Rapid Recommendations panel as critically important for informing their recommendation: measures of pain, function and HRQoL. Results: 13 studies reported 95 empirically estimated anchor-based MIDs for 8 PRO instruments and/or their subdomains that measure knee pain, function or HRQoL. All studies used a transition rating (global rating of change) as the anchor to ascertain the MID. Among PROs with more than 1 estimated MID, we found wide variation in MID values. Many studies suffered from serious methodological limitations. We identified the following most credible MIDs: Western Ontario and McMaster University Osteoarthritis Index (WOMAC; pain: 12, function: 13), Knee injury and Osteoarthritis Outcome Score (KOOS; pain: 12, activities of daily living: 8) and EuroQol five dimensions Questionnaire (EQ-5D; 0.15). Conclusions: We were able to distinguish between more and less credible MID estimates and provide best estimates for key instruments that informed evidence presentation in the associated systematic review and judgements made by the Rapid Recommendation panel. Trial registration number: CRD42016047912.

Background: Compensation related factors have been repeatedly associated with poor recovery following orthopaedic trauma. There is limited research into the factors associated with seeking financial compensation. Further understanding of these factors could facilitate injury recovery by purposeful compensation scheme design. The aim of this study was to investigate the predictors of seeking financial compensation, namely making a claim and seeking legal representation, following motor vehicle related orthopaedic trauma. The study was conducted in New South Wales (NSW), Australia, in motor vehicle crash and workers’ compensation schemes. Methods: Participants were patients admitted with upper or lower extremity factures following a motor vehicle crash to two trauma hospitals. Data were collected at baseline within two weeks of injury. Participants were followed up at six months. Analysis involved: descriptive statistics for baseline characteristics; comparison of compensable and non-compensable participants with Analysis of Variance (ANOVA) and chi-squared tests; and logistic regression for predictor models. Results: The cohort consisted of 452 participants with a mean age 40 years; 75% male; 74% working pre-injury; 30% in excellent pre-injury health; 56% sustained serious injuries with an Injury Severity Score (ISS) 9-15; 61% had a low-middle range household income; and 35% self-reported at fault in the crash. There was no significant difference in pre-injury/baseline health between compensable and non-compensable participants. Follow up data was available for 301 (67%) participants. The significant predictor of claiming compensation in the adjusted analysis was higher body mass index (BMI) (overweight Odds Ratio [OR] 3.05, 95% Confidence Interval [CI] 1.63-5.68; obese OR 1.63, 95% CI 0.83-3.20). Participants less likely to claim were: involved in a motorcycle crash (OR 0.47, 95% CI 0.28-0.82); socioeconomically less disadvantaged (OR 0.37, 95% CI 0.17-0.82) or leas

© 2017 The Author(s). Background: To understand private consumer and clinician preferences towards different rehabilitation modes following knee or hip arthroplasty, and identify factors which influence the chosen rehabilitation pathway. Methods: Mixed methods cross-sectional study involving 95 semi-structured interviews of consumers (patients and carers) and clinicians (arthroplasty surgeons, physiotherapists and rehabilitation physicians) in Sydney, Australia, during 2014-2015. Participants were asked about the acceptability of different modes of rehabilitation provision, and factors influencing their chosen rehabilitation pathway. Interviews were in person or via the telephone. Qualitative analysis software was used to electronically manage qualitative data. An analytical approach guided data analysis. Results: Pre-operative preferences strongly influenced the type of rehabilitation chosen by consumers. Key factors that influenced this were both intrinsic and extrinsic, including; the previous experience of self or known others, the perceived benefits of the chosen mode, a sense of entitlement, the role of orthopaedic surgeons and influence of patient preference, a patient's clinical status post-surgery, the private hospital business model and insurance provider involvement. The acceptability of rehabilitation modes varied between clinician groups. Conclusions: No one rehabilitation mode provided following arthroplasty is singularly preferred by stakeholders. Factors other than the belief that a particular mode was more effective than another appear to dominate the pathway followed by private arthroplasty consumers, indicating evidence-based policies around rehabilitation provision may have limited appeal in the private sector.

Background: Isolated type B ankle fractures with no injury to the medial side are the most common type of ankle fracture. Objective: This study aimed to determine if surgery is superior to non-surgical management for the treatment of these fractures. Methods: A pragmatic, multicentre, single-blinded, combined randomised controlled trial and observational study. Setting Participants between 18 and 65 years with a type B ankle fracture and minimal talar shift were recruited from 22 hospitals in Australia and New Zealand. Participants willing to be randomised were randomly allocated to undergo surgical fixation followed by mobilisation in a walking boot for 6 weeks. Those treated non-surgically were managed in a walking boot for 6 weeks. Participants not willing to be randomised formed the observational cohort. Randomisation stratified by site and using permuted variable blocks was administered centrally. Outcome assessors were blinded for the primary outcomes. Primary outcomes Patient-reported ankle function using the American Academy of Orthopaedic Surgeons Foot and Ankle Outcomes Questionnaire (FAOQ) and the physical component score (PCS) of the SF-12v2 General Health Survey at 12 months postinjury. Primary analysis was intention to treat; the randomised and observational cohorts were analysed separately. Results: From August 2010 to October 2013, 160 people were randomised (80 surgical and 80 non-surgical); 139 (71 surgical and 68 non-surgical) were analysed as intention to treat. 276 formed the observational cohort (19 surgical and 257 non-surgical); 220 (18 surgical and 202 non-surgical) were analysed. The randomised cohort demonstrated that surgery was not superior to non-surgery for the FAOQ (49.8 vs 53.0; mean difference 3.2 (95% CI 0.4 to 5.9), p=0.028), or the PCS (53.7 vs 53.2; mean difference 0.6 (-2.9 to 1.8), p=0.63). 23 (32%) and 10 (14%) participants had an adverse event in the surgical and non-surgical groups, respectively. Similar results were found

© 2017 The Author(s). Background: To determine if the EuroQol Health Related Quality of Life survey produces equivalent results when administered by phone interview or patient-completed forms. Methods: People awaiting hip or knee arthroplasty at a major metropolitan hospital participated. They were randomly assigned to receive the EuroQol Health Related Quality of Life survey via telephone, followed by a patient completed form 1 week later, or vice versa. Equivalence was determined using two one-sided tests (TOST) based on minimal clinically-important differences for the visual analogue scale (VAS) and the summary Utility Index. Cohen's Kappa scores were computed to determine agreement for the individual EuroQoL Likert scale items. Results: Seventy-six from 90 (84%) participants completed the survey twice. Based on limits set at ±7 and ±0.11 for the VAS and Utility Index, respectively, equivalence was established between the two methods of administration for both the VAS (mean difference 0.05 [90% CI -3.76-3.67]) and the Utility Index (mean difference 0.06 [90% CI 0.02-0.11]). Varying levels of agreement, ranging from slight to substantial (Κ = 0.17-0.67), were demonstrated for the individual health domains. The order of telephone and patient-completed survey administration had no significant effect on results. Conclusions: Equivalent results are obtained between telephone and patient-completed administration for the VAS and Utility Index of the EuroQol Survey in people with advanced hip or knee osteoarthritis. The limits of agreement for the individual health domains vary which prevents the accurate interpretation of real change in these items across modes.

© Journal of Orthopaedic Surgery 2017. Purpose: To assess the accuracy of total knee replacements (TKRs) performed using CT-based patient-specific instrumentation by postoperative CT scan. Method: Approval from the Ethics Committee was granted prior to commencement of this study. Fifty prospective and consecutive patients who had undergone TKR (Evolis, Medacta International) using CT-based patient-specific instrumentation (MY KNEE, Medacta International) were assessed postoperatively using a CT scan and the validated Perth protocol measurement technique. The hip-knee-ankle (HKA) angle of the lower limb in the coronal plane; the coronal, sagittal, and rotational orientation of the femoral component; and the coronal and sagittal orientation of the tibial component were measured. These results were then compared to each patient’s preoperative planning. The percentage of patients found to be less than or equal to 3° of planned alignment was calculated. One patient was excluded as the femoral cutting block did not fit the femur as predicted by planning and therefore underwent a conventional TKR. Results: Ninety-eight percent of patients were within 3° of planned alignment in the coronal plane reproducing the predicted HKA angle. Predicted coronal plane orientation of the tibial and femoral component was achieved in 100% and 96% of patients, respectively. The sagittal orientation of the femoral component was within 3 in 98% of patients. The planned sagittal positioning of the tibial component was achieved in 92% of patients. Furthermore, 90% of patients were found to have a femoral rotation within 3° of planning. Eighty-six percent of patients achieved goodto-excellent outcome at 12 months (Oxford Knee Score ≥ 34). Conclusion: We have found that TKR using this patientspecific instrumentation accurately reproduces preoperative planning in all six of the parameters measured in this study.

© 2017 The Author(s). Objectives: Ankle fractures are common and can be treated with or without surgery. The aim of the present study was to compare patient reported outcomes between patients who sustained an Orthopaedic Trauma Association type 44-B1 ankle fracture who had either surgical or non-surgical fixation. Results: Forty-six people were recruited; 38 were treated non-surgically and 8 were treated surgically. Mean follow-up time was 24 and 25 months for surgical and non-surgical groups respectively. Baseline characteristics were similar between the two groups. On unadjusted analysis, there was no significant difference between the two groups with respect to any outcome. After adjusting for age and gender, the surgical group had a significantly lower outcome score with respect to the FAOQ. Surgical management was associated with a significantly lower patient-reported ankle function compared to non-surgical management for the treatment of patients with type 44-B1 ankle fracture after adjusting for age and gender. However, there was no significant difference between the two groups with respect to the general health outcomes or adverse events. Higher-level evidence is required to inform optimal practice for this common fracture.

Fractures of the distal radius are common and occur in all age groups. The incidence is high in older populations due to osteoporosis and increased falls risk. Considerable practice variation exists in the management of distal radius fractures in older patients ranging from closed reduction with cast immobilisation to open reduction with plate fixation. Plating is currently the most common surgical treatment. While there is evidence showing no significant advantage for some forms of surgical fixation over conservative treatment, and no difference between different surgical techniques, there is a lack of evidence comparing two of the most common treatments used: closed reduction and casting versus plating. Surgical management involves significant costs and risks compared with conservative management. High-level evidence is required to address practice variation, justify costs and to provide the best clinical outcomes for patients. Methods and analysis This pragmatic, multicentre randomised comparative effectiveness trial aims to determine whether plating leads to better pain and function and is more cost-effective than closed reduction and casting of displaced distal radius fractures in adults aged 60 years and older. The trial will compare the two techniques but will also follow consenting patients who are unwilling to be randomised in a separate, observational cohort. Inclusion of non-randomised patients addresses selection bias, provides practice and outcome insights about standard care, and improves the generalisability of the results from the randomised trial. Ethics and dissemination CROSSFIRE(Combined Randomised and Observational Study of Surgery for Fractures In the distal Radius in the Elderly) was reviewed and approved by The Hunter New England HREC (HNEHREC Reference No: 16/02/17/3.04). The results of the trial will be published in a peer-reviewed journal and will be disseminated via various forms of media. Results will be incorporated in clinical recommen