First knee for pain and function versus second knee for quality of life.

Aims: The aim of this study was to describe and compare joint-specific and generic health-related quality of life outcomes of the first versus second knee in patients undergoing staged bilateral total knee arthroplasty (BTKA) for osteoarthritis. Methods: This retrospective cohort study used Australian national arthroplasty registry data from January 2013 to January 2021 to identify participants who underwent elective staged BTKA with six to 24 months between procedures. The primary outcome was Oxford Knee Score (OKS) at six months postoperatively for the first TKA compared to the second TKA, adjusted for age and sex. Secondary outcomes compared six-month EuroQol five-dimension five-level (EQ-5D-5L) domain scores, EQ-5D index scores, and the EQ visual analogue scale (EQ-VAS) between knees at six months postoperatively. Results: The cohort included 635 participants (1,270 primary procedures). Preoperative scores were worse in the first knee compared to the second for all instruments; however, comparing the first knee at six months postoperatively with the second knee at six months postoperatively, the mean between-knee difference was minimal for OKS (-0.8 points; 95% confidence interval (CI) -1.4 to -0.2), EQ-VAS (3.3; 95% CI 1.9 to 4.7), and EQ-5D index (0.09 points; 95% CI 0.07 to 0.12). Outcomes for the EQ-5D-5L domains 'mobility', 'usual activities', and 'pain/discomfort' were better following the second TKA. Conclusion: At six months postoperatively, there were no clinically meaningful differences between the first and second TKA in either the joint-specific or overall generic health-related quality of life outcomes. However, individual domain scores assessing mobility, pain, and usual activities were notably higher after the second TKA, likely reflecting the cumulative improvement in quality of life after both knees have been replaced.

Audit of surgeon billing in workers compensation-insured elective spinal surgery in New South Wales, Australia from 2010 to 2018.

BACKGROUND: Medical billing practices have received increasing scrutiny in Australia and worldwide. In 2015, the Australian Government initiated a comprehensive review of the Medicare Benefits Schedule (MBS), including spinal surgery. This study provides a snapshot of five spinal surgeon billing patterns and associated costs in the workers compensation system in New South Wales prior to these changes. METHODS: This retrospective cohort study used workers compensation billing data from the State Insurance Regulatory Authority to capture elective spinal surgeries in New South Wales from 2010 to 2018. The main outcome measures were: proportion of items billed within recommended limits (up to 150% of the listed Australian Medical Association (AMA) fee); surgical billing patterns including repeat billing of items during a single episode of surgery; use of paediatric or scoliosis items; use of surgical items from outside the spinal surgery schedule; co-billing of items not permitted as per the AMA Fees List item descriptions and associated costs. RESULTS: There were 12 622 spinal surgeries in 9520 patients. While only 2.2% of items were billed above the recommended limits, 38% of surgeries included at least one of the five billing patterns. The average cost increase was AU$4700 per surgery, 47% greater than surgeries which did not include the specified billing patterns, for a total additional cost of AU$22.9 M over the 9-year study period. CONCLUSION: Five spinal surgery billing patterns accounted for an additional AU$22.9 million in direct surgical costs from 2010 to 2018.

Elective spinal surgery in New South Wales adults, 2001-20, by procedure funding type: a cross-sectional study.

OBJECTIVE: To investigate elective rates of spinal fusion, decompression, and disc replacement procedures for people with degenerative conditions, by funding type (public, private, workers' compensation). DESIGN, SETTING: Cross-sectional study; analysis of hospitals admissions data extracted from the New South Wales Admitted Patient Data Collection. PARTICIPANTS: All adults who underwent elective spinal surgery (spinal fusion, decompression, disc replacement) in NSW, 1 July 2001 - 30 June 2020. MAIN OUTCOME MEASURES: Crude and age- and sex-adjusted procedure rates, by procedure, funding type, and year; annual change in rates, 2001-20, expressed as incidence rate ratios (IRRs). RESULTS: During 2001-20, 155 088 procedures in 129 525 adults were eligible for our analysis: 53 606 fusion, 100 225 decompression, and 1257 disc replacement procedures. The privately funded fusion procedure rate increased from 26.6 to 109.5 per 100 000 insured adults (per year: IRR, 1.06; 95% confidence interval [CI], 1.05-1.07); the workers' compensation procedure rate increased from 6.1 to 15.8 per 100 000 covered adults (IRR, 1.04; 95% CI, 1.01-1.06); the publicly funded procedure rate increased from 5.6 to 12.4 per 100 000 adults (IRR, 1.03; 95% CI, 1.01-1.06), and from 10.5 to 22.1 per 100 000 adults without hospital cover private health insurance (IRR, 1.03; 95% CI, 1.01-1.05). The privately funded decompression procedure rate increased from 93.4 to 153.6 per 100 000 people (IRR, 1.02; 95% CI, 1.01-1.03); the workers' compensation procedure rate declined from 19.7 to 16.7 per 100 000 people (IRR, 0.98; 95% CI, 0.96-0.99), and the publicly funded procedure rate did not change significantly. The privately funded disc replacement procedure rate increased from 6.2 per million in 2010-11 to 38.4 per million people in 2019-20, but did not significantly change for the other two funding groups. The age- and sex-adjusted rates for privately and publicly funded fusion and decompression procedures were similar to the crude rates. CONCLUSIONS: Privately funded spinal surgery rates continue to be larger than for publicly funded procedures, and they have also increased more rapidly. These differences may indicate that some privately funded procedures are unnecessary, or that the number of publicly funded procedures does not reflect clinical need.

A meta-epidemiological study on the reported treatment effect of pregabalin in neuropathic pain trials over time.

BACKGROUND: Pregabalin is a drug used to treat neuropathic pain, and its use has increased substantially since 2007. Early trials found a strong treatment effect on pain for post-herpetic neuralgia and diabetic neuropathy. However more recent studies have failed to replicate these results. METHODS: This meta-epidemiological study aimed to assess change in the reported effectiveness of pregabalin in neuropathic pain trials over time, and if a change is present, determine any associated factors. DATA SOURCES: We performed electronic searches for published trials in Medline, Embase and Cochrane Central Register of Controlled Trials databases; and unpublished trials on ClinicalTrials.gov, the EU Clinical Trials Register, and the Australia New Zealand Clinical Trials Registry with no restrictions. STUDY SELECTION: We included randomized, placebo-controlled trials of pregabalin for treatment of neuropathic pain in adults. DATA EXTRACTION AND SYNTHESIS: Two authors independently extracted study data: sample size and mean baseline, end-point and change in pain scores with measures of variance, trial end year, publication year, clinical indication, funding source, country of study, treatment duration, treatment dose, mean age and percentage male. PRIMARY OUTCOME MEASURE: We defined treatment effect as the mean difference in pain scores between pregabalin and placebo groups at trial end-point and assessed for change over time using a random-effects meta-regression, adjusted for sample size, indication, treatment duration (weeks) and treatment dose. RESULTS: We included 38 randomized published trials (9038 participants) and found that between 2003 and 2020, the reported treatment effect of pregabalin decreased by 0.4 points (95% CI: 0.3 to 0.6; p<0.001) on an 11-point pain scale per 5-year interval, from 1.3 points (95% CI: 1.0 to 1.5) in trials conducted in 2001-2005, to 0.3 (95% CI: -0.1 to 0.7) in trials conducted in 2016-2020. The reported treatment effect was lower than the minimal clinically important difference (MCID) of 1.7 points across all time periods, doses and most indications and was not found to be associated with study characteristics. CONCLUSIONS: The reported treatment effect or analgesic efficacy of pregabalin from clinical trials has diminished over time. Clinical recommendations may need to be re-evaluated to account for recent evidence and to consider whether pregabalin therapy is indicated.

Dual mobility versus conventional total hip arthroplasty in femoral neck fractures (DISTINCT): protocol for a registry-nested, open-label, cluster-randomised crossover trial.

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 Musculoskeletal Clinical Trials Network. TRIAL REGISTRATION NUMBER: ACTRN12621000069853.

Use of Placebo and Nonoperative Control Groups in Surgical Trials: A Systematic Review and Meta-analysis.

Importance: Nonspecific effects, particularly placebo effects, are thought to contribute significantly to the observed effect in surgical trials. Objective: To estimate the proportion of the observed effect of surgical treatment that is due to nonspecific effects (including the placebo effect). Data Sources: Published Cochrane reviews and updated, extended search of MEDLINE, Embase, and CENTRAL until March 2019. Study Selection: Published randomized placebo-controlled surgical trials and trials comparing the effect of the same surgical interventions with nonoperative controls (ie, no treatment, usual care, or exercise program). Data Extraction and Synthesis: Pairs of authors independently screened the search results, assessed full texts to identify eligible studies and the risk of bias of included studies, and extracted data. The proportion of all nonspecific effects was calculated as the change in the placebo control divided by the change in the active surgery and pooled in a random-effect meta-analysis. To estimate the magnitude of the placebo effect, we pooled the difference in outcome between placebo and nonoperative controls and used metaregression to estimate the association between the type of control group and the treatment effect (difference between the groups), adjusting for risk of bias, sample size, and type of outcome. Main Outcomes and Measures: Between- and within-group effect sizes expressed as Hedges g. Results: In this review, 100 trials were included comprising data from 62 trials with placebo controls (3 also included nonoperative controls), and 38 trials with nonoperative controls (32 interventions; 10 699 participants). Risk of bias across trials was comparable except for performance and detection bias, which was high in trials with nonoperative controls. The mean nonspecific effects accounted for 67% (95% CI, 61% to 73%) of the observed change after surgery; however, this varied widely between different procedures. The estimated surgical placebo effect had a standardized mean difference (SMD) of 0.13 (95% CI, -0.26 to 0.51). Trials with placebo and nonoperative controls found comparable treatment effects (SMD, -0.09 [95% CI, -0.35 to 0.18]; 15 interventions; 73 between-group effects; adjusted analysis: SMD, -0.11 [95% CI, -0.37 to 0.15]). Conclusions and Relevance: In this review, the change in health state after surgery was composed largely of nonspecific effects, but no evidence supported a large placebo effect. Placebo-controlled surgical trials may be redundant when trials with nonoperative controls consistently report no substantial association from surgery compared with nonoperative treatment.

Physical therapy utilization, costs, and return-to-work status following lumbar spine surgery: A retrospective analysis of workers compensation claims in Australia.

BACKGROUND: No study to our knowledge has explored physical therapy utilization following lumbar spine surgery in a workers' compensation setting. OBJECTIVES: Describe physical therapy utilization and costs, and return-to-work status in patients following lumbar spine surgery under a workers' compensation claim. METHODS: Using data from the New South Wales (NSW) State Insurance Regulatory Authority (Australia), we audited physical therapy billing codes for patients who received lumbar spine surgery from 2010 to 2017. We summarised, by fusion versus decompression, the number of physical therapy sessions patients received up to 12 months post-operatively, total cost of physical therapy and time to initiation of physical therapy. Number of physical therapy sessions and physical therapy utilization at 12 months were summarised by return-to-work status at 12 months. RESULTS: We included 3524 patients (1220 had fusion; 2304 decompression). On average, patients received 22 ± 22 physical therapy sessions to 12 months post-operatively (mean cost=AU$1902, US$1217); 24% were receiving physical therapy at 12 months. Most had 9-24 (31%) or 25-50 sessions (25%); 11% had > 50 sessions, whereas 11% had no physical therapy. Patients who had fusion (compared to decompression) had more physical therapy and incurred higher physical therapy costs. Time post-surgery to initiate physical therapy increased from 2010 to 2017. Patients with > 50 sessions and still having physical therapy by 12 months were least likely to be working. CONCLUSIONS: For most patients, physical therapy utilization following lumbar spine surgery aligns with the best available evidence. However, some patients may be receiving too much physical therapy or initiating physical therapy too early.

Physiotherapy utilisation and costs before lumbar spine surgery: a retrospective analysis of workers compensation claims in Australia.

BACKGROUND: Understanding how much physiotherapy people receive before lumbar spine surgery could give insight into what people and clinicians consider an adequate trial of non-operative management. The aim of this study was to investigate physiotherapy utilisation and costs before lumbar spine surgery under a workers' compensation claim in New South Wales (NSW), Australia. METHODS: Using data from the NSW State Insurance Regulatory Authority, we audited physiotherapy billing codes used before surgery for people who received lumbar spine surgery from 2010 to 2018. We summarised, separately for fusion and decompression, the time from initiation of physiotherapy to surgery, number of physiotherapy sessions people received before surgery, total cost of physiotherapy before surgery, and time from injury date to initiation of physiotherapy. All analyses were descriptive. RESULTS: We included 3070 people (800 had fusion, 2270 decompression). Mean age (standard deviation, SD) was similar between those who received fusion and decompression [42.9 (10.4) vs. 41.9 (11.6)]. Compared to people who had fusion, those who had decompression were more likely to not have any physiotherapy before surgery (28.4% vs. 15.4%), received physiotherapy for a shorter duration before surgery [median (interquartile range, IQR): 5 (3 to 11) vs. 15 (4-26) months], were less likely to have physiotherapy for ≥2 years before surgery (5.6% vs. 27.5%), had fewer physiotherapy sessions before surgery [mean (SD): 16 (21) vs. 28 (35) sessions], were less likely to have > 50 physiotherapy sessions before surgery (6.8% vs. 18.1%), and had lower total physiotherapy-related costs [mean (IQR): $1265 ($0-1808) vs. $2357 ($453-2947)]. Time from injury date to first physiotherapy session was similar between people who had fusion and decompression [median (IQR): 23 (9-66) vs.19 (7-53) days]. CONCLUSIONS: There is variation in physiotherapy utilisation and costs before lumbar spine surgery for people funded by NSW Workers' Compensation. Some people may not be receiving an adequate trial of physiotherapy before surgery, particularly before decompression surgery. Others may be receiving an excessive amount of physiotherapy before surgery, particularly before fusion.

Association between pre-operative anxiety and/or depression and outcomes following total hip or knee arthroplasty.

PURPOSE: While elective primary total hip (THA) and knee (TKA) arthroplasty are effective procedures for addressing the symptoms associated with advanced osteoarthritis, there is evidence to suggest that patient anxiety and depression are linked to poorer outcomes following surgery. METHODS: A secondary analysis of prospectively-collected data of people undergoing primary elective THA or TKA for osteoarthritis across 19 hospitals was performed. We assessed outcomes at 1 year post-surgery for people with and without medically treated anxiety and/or depression at the time of surgery (A/D and no-A/D). We used unadjusted and adjusted analyses to compare improvement in Oxford Hip or Knee Scores, the incidences of major post-operative complications, satisfaction and index joint improvement by A/D status. RESULTS: 15.2% (254/1669) of patients were identified with anxiety and/or depression at time of surgery. In the unadjusted analysis, the A/D group had greater mean Oxford score improvement by 2.1 points (95% CI 0.8 to 3.4, p = 0.001), increased major complications (OR 1.39, 95% CI 1.05 to 1.85, p = 0.02), were less likely to report a "much better" global improvement for index joint (OR 0.56, 95% CI 0.38 to 0.83, p = 0.003), and there was no statistically significant difference in the rate of satisfaction with the results of surgery (OR 0.64, 95% CI 0.37 to 1.10, p = 0.10). The adjusted analysis found no significant associations between A/D vs. no-A/D and any of the reported outcomes. CONCLUSION: After adjustment for confounding variables, people with anxiety and/or depression pre-operatively, compared to those without, have similar outcomes following hip or knee arthroplasty.

Volar Locking Plate Fixation Versus Closed Reduction for Distal Radial Fractures in Adults: A Systematic Review and Meta-Analysis.

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 between treatments with respect to patient-reported pain and function at 12 months post-treatment, even though VLP fixation resulted in better fracture alignment than CR. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Complications to 6 months following total hip or knee arthroplasty: observations from an Australian clinical outcomes registry.

BACKGROUND: Total hip and total knee arthroplasty (THA/TKA) are increasing in incidence annually. While these procedures are effective in improving pain and function, there is a risk of complications. METHODS: Using data from an arthroplasty registry, we described complication rates including reasons for reoperation and readmission from the acute period to six months following THA and TKA in an Australian context. Data collection at 6 months was conducted via telephone interview, and included patient-reported complications such as joint stiffness, swelling and paraesthesia. We used logistic regression to identify risk factors for complications. RESULTS: In the 8444 procedures included for analysis, major complications were reported by 9.5 and 14.4% of THA and TKA patients, respectively, whilst minor complications were reported by 34.0 and 46.6% of THA and TKA patients, respectively. Overall complications rates were 39.7 and 53.6% for THA and TKA patients, respectively. In THA patients, factors associated with increased risk for complications included increased BMI, previous THA and bilateral surgery, whereas in TKA patient factors were heart disease, neurological disease, and pre-operative back pain and arthritis in a separate joint. Female gender and previous TKA were identified as protective factors for minor complications in TKA patients. CONCLUSION: We found moderate rates of major and high rates of minor postoperative complications following THA and TKA in Australia and have identified several patient factors associated with these complications. Efforts should be focused on identifying patients with higher risk and optimising pre- and post-operative care to reduce the rates of these complications.

The dangers of ignoring underlying trends in before-and-after studies - A cautionary tale using hip fracture mortality data.

BACKGROUND: Before-and-after studies are a valuable study design in situations where randomization is not feasible. These studies measure an outcome both before and after an intervention and compare the outcome rates in both time periods to determine the effectiveness of the intervention. Before-and-after studies do not involve a contemporaneous control group and must, therefore, take into account any underlying secular trends to separate the effect of the intervention from any pre-existing trend. METHODS: To illustrate the importance of accounting for underlying trends, we performed a before-and-after study assessing 30-day mortality in hip fracture patients without any actual intervention, and instead designated an arbitrarily chosen time point as our 'intervention'. We then analysed the data first disregarding and then incorporating the pre-existing underlying trend. We did this to show that even intervention of nothing may be spuriously interpreted to have an effect if the before-and-after study design is incorrectly analysed. Our study involved a secondary analysis of routinely collected data on 30-day mortality following hip fracture in our institution. RESULTS: We found a secular trend in our data showing improving 30-day mortality in hip fracture patients in our institution. We then demonstrated that disregarding this underlying trend showed that our intervention of nothing 'resulted' in a significant 54% decrease in mortality, from 6.7% in the 'before' period to 3.1% in the 'after' period (p < 0.0008). Though the 30-day mortality rate decreased during the 'after' period, the decrease was not significantly different from the underlying trend in the 'before' period, projected onto the 'after' period. When we accounted for the underlying trend in our analysis, the impact of the intervention (nothing) on 30-day mortality was no longer apparent (incidence rate ratio 0.75, 95% confidence interval 0.32-1.78; p = 0.5). CONCLUSION: Our study highlights the importance of appropriate measurement and consideration of underlying trends when analysing data from before-and-after studies and illustrates what can happen should researchers neglect this important step.

Patient factors associated with weight gain and weight loss after knee or hip arthroplasty.

OBJECTIVES: Following total knee or total hip arthroplasty (TKA, THA), up to 31% of recipients experience significant weight gain while up to 14% experience significant weight loss. Factors associated with significant weight change (≥5% of baseline weight) have not been comprehensively explored. This study aimed to identify pre- and post-surgical (including current) patient factors associated with significant weight change three years after surgery. METHODS: A pre-existing nationally-acquired cohort who underwent TKA or THA for osteoarthritis participated in 3-year telephone follow-up. Updated weight, comorbidity, and complication data were collected along with ongoing index joint problems and other patient-reported outcomes including global improvement. These data, along with body mass index (BMI) pre-surgery and post-surgery rehabilitation received, were incorporated into two multivariable logistic regression models to determine separately the factors associated with ≥5% weight gain and ≥5% loss at 3-years post-surgery. RESULTS: 73.4% (1289/1757) participated in the follow-up; 1191 (n = 663 TKA) provided updated weight data. Patterns of weight change were similar for both surgeries (TKA: 16.1% gained ≥5%, 19.6% lost ≥5%; THA: 15.8% gained ≥5%, 17.8% lost ≥5%). In multivariable modelling, younger age and lower pre-surgery BMI were significantly associated with weight gain; female gender and an absence of ongoing index joint issues were associated with weight loss. CONCLUSION: Different mechanisms are likely associated with significant weight gain or loss at 3-years post-surgery. Cogent weight management entails consideration of both outcomes. Many post-surgical factors appear not to be importantly associated with weight change.

Variation in rehabilitation setting after uncomplicated total knee or hip arthroplasty: a call for evidence-based guidelines.

BACKGROUND: High-level evidence consistently indicates that resource-intensive facility-based rehabilitation does not provide better recovery compared to home programs for uncomplicated knee or hip arthroplasty patients and, therefore, could be reserved for those most impaired. This study aimed to determine if rehabilitation setting aligns with evidence regardless of insurance status. METHODS: Sub-study within a national, prospective study involving 19 Australian high-volume public and private arthroplasty centres. Individuals undergoing primary arthroplasty for osteoarthritis participated. The main outcome was the proportion participating in each rehabilitation setting, obtained via chart review and participant telephone follow-up at 35 and 90 days post-surgery, categorised as 'facility-based' (inpatient rehabilitation and/or ≥ four outpatient-based sessions, including day-hospital) or 'home-based' (domiciliary, monitored or unmonitored home program only). We compared characteristics of the study cohort and rehabilitation setting by insurance status (public or private) using parametric and non-parametric tests, analysing the knee and hip cohorts separately. RESULTS: After excluding ineligible participants (bilateral surgeries, self-funded insurance, participation in a concurrent rehabilitation trial, experience of a major acute complication potentially affecting their rehabilitation pathway), 1334 eligible participants remained. Complete data were available for 1302 (97%) [Knee: n = 610, mean age 68.7 (8.5) yr., 51.1% female; Hip: n = 692, mean age 65.5 (10.4) yr., 48.9% female]; 26% (158/610) of knee and 61% (423/692) of hip participants participated predominantly in home-based programs. A greater proportion of public recipients were obese and had greater pre-operative joint impairment, but participated more commonly in home programs [(Knee: 32.9% (79/240) vs 21.4% (79/370) (P = 0.001); Hip: 71.0% (176/248) vs 55.6% (247/444) (P <  0.001)], less commonly in inpatient rehabilitation [Knee: 7.5% (18/240) vs 56.0% (207/370) P (< 0.001); Hip: 4.4% (11/248) vs 33.1% (147/444) (P <  0.001], and had fewer outpatient treatments [Knee: median (IQR) 6 (3) vs 8 (6) (P < 0.001); Hip: 6 (4) vs 8 (6) (P < 0.001)]. CONCLUSIONS: Facility-based programs remain the norm for most knee and many hip arthroplasty recipients with insurance status being a major determinant of care. Development and implementation of evidence-based guidelines may help resolve the evidence-practice gap, addressing unwarranted practice variation across the insurance sectors.

The Effect of Predialysis Fistula Attempt on Risk of All-Cause and Access-Related Death.

Whether the lower risk of mortality associated with arteriovenous fistula use in hemodialysis patients is due to the avoidance of catheters or if healthier patients are simply more likely to have fistulas placed is unknown. To provide clarification, we determined the proportion of access-related deaths in a retrospective cohort study of patients aged ≥18 years who initiated hemodialysis between 2004 and 2012 at five Canadian dialysis programs. A total of 3168 patients initiated dialysis at the participating centers; 2300 met our inclusion criteria. Two investigators independently adjudicated cause of death using explicit criteria and determined whether a death was access-related. We observed significantly lower mortality in individuals who underwent a predialysis fistula attempt than in those without a predialysis fistula attempt in patients aged <65 years (hazard ratio [HR], 0.49; 95% confidence interval [95% CI], 0.29 to 0.82) and in the first 2 years of follow-up in those aged ≥65 years (HR0-24 months, 0.60; 95% CI, 0.43 to 0.84; HR24+ months, 1.83; 95% CI, 1.25 to 2.67). Sudden deaths that occurred out of hospital accounted for most of the deaths, followed by deaths due to cardiovascular disease and infectious complications. We found only 2.3% of deaths to be access-related. In conclusion, predialysis fistula attempt may associate with a lower risk of mortality. However, the excess mortality observed in patients treated with catheters does not appear to be due to direct, access-related complications but is likely the result of residual confounding, unmeasured comorbidity, or treatment selection bias.

Willingness to participate in a randomized trial comparing catheters to fistulas for vascular access in incident hemodialysis patients: an international survey of nephrologists.

BACKGROUND: Current guidelines favor fistulas over catheters as vascular access. Yet, the observational literature comparing fistulas to catheters has important limitations and biases that may be difficult to overcome in the absence of randomization. However, it is not clear if physicians would be willing to participate in a clinical trial comparing fistulas to catheters. OBJECTIVES: We also sought to elicit participants' opinions on willingness to participate in a future trial regarding catheters and fistulas. DESIGN: We created a three-part survey consisting of 19 questions. We collected demographic information, respondents' knowledge of the vascular access literature, appropriateness of current guideline recommendations, and their willingness to participate in a future trial. SETTING: Participants were recruited from Canada, Europe, Australia, and New Zealand. PARTICIPANTS: Participants include physicians and trainees who are involved in the care of end-stage renal disease patients requiring vascular access. MEASUREMENTS: Descriptive statistics were used to describe baseline characteristics of respondents according to geographic location. We used logistic regression to model willingness to participate in a future trial. METHODS: We surveyed nephrologists from Canada, Europe, Australia, and New Zealand to assess their willingness to participate in a randomized trial comparing fistulas to catheters in incident hemodialysis patients. RESULTS: Our results show that in Canada, 86 % of respondents were willing to participate in a trial (32 % in all patients; 54 % only in patients at high risk of primary failure). In Europe and Australia/New Zealand, the willingness to participate in a trial that included all patients was lower (28 % in Europe; 25 % in Australia/New Zealand), as was a trial that included patients at high risk of primary failure (38 % in Europe; 39 % in Australia/New Zealand). Nephrologists who have been in practice for a few years, saw a larger volume of patients, or self-identified as experts in vascular access literature were more likely to participate in a trial. LIMITATIONS: Survey distribution was limited to vascular access experts in participating European countries and ultimately led to a discrepancy in numbers of European to non-European respondents overall. Canadian views are likely over-represented in the overall outcomes. CONCLUSIONS: Our survey results suggest that nephrologists believe there is equipoise surrounding the optimal vascular access strategy and that a randomized controlled study should be undertaken, but restricted to those individuals with a high risk of primary fistula failure.

MISE EN CONTEXTE: À l'heure actuelle, les lignes directrices en matière d'accès vasculaire préconisent l'usage d'une fistule plutôt que d'un cathéter. Or, en consultant la littérature faisant état des études observationnelles comparant l'usage de ces deux types d'accès vasculaire, on note des limites ou un parti-pris qui sont difficilement évitables en absence de randomisation. Néanmoins, il demeure difficile de prévoir si les médecins traitants seraient enclins à participer à des essais cliniques comparatifs de ces deux méthodes. OBJECTIFS DE L'ÉTUDE: Cette étude avait pour objectif de sonder l'intérêt des participants à prendre part à un essai clinique comparant l'usage des cathéters et des fistules. PARAMÈTRES DE L'ÉTUDE: Pour atteindre cet objectif, nous avons créé un sondage en trois parties constitué de 19 questions. Nous avons colligé les renseignements démographiques des participants, évalué leur connaissance de la littérature et des recommandations actuelles au sujet des accès vasculaires, en plus de sonder leur intérêt à prendre part à un essai clinique à venir. CADRE DE L'ÉTUDE: Les participants ont été recrutés au Canada, en Europe, en Australie et en Nouvelle-Zélande. PARTICIPANTS: Des médecins traitants ainsi que des stagiaires en néphrologie, impliqués auprès de patients atteints d'insuffisance rénale terminale et requérant la mise en place d'un accès vasculaire, ont pris part à cette enquête. MESURES: Des statistiques descriptives ont été utilisées pour définir les caractéristiques démographiques initiales des répondants selon leur situation géographique. Un modèle de régression logistique a été utilisé pour évaluer leur intérêt à participer à un essai clinique. MÉTHODOLOGIE: Des néphrologues canadiens, australiens, néo-zélandais ou provenant de plusieurs pays d'Europe ont été sondés sur leur intérêt à participer à un essai clinique randomisé comparant l'usage d'une fistule ou d'un cathéter comme accès vasculaire chez les patients nouvellement dialysés. RÉSULTATS: Le sondage a démontré qu'au Canada, 86 % des répondants seraient enclins à prendre part à un essai clinique ; 32 % y feraient participer tous leurs patients sous dialyse alors que 54 % ne le feraient que pour ceux présentant un risque élevé de défaillance primaire de la fistule. Pour le reste des participants, l'intérêt en regard d'un essai clinique ouvert à tous les patients sous dialyse s'est avéré moindre (28 % en Europe, 25 % en Australie et Nouvelle-Zélande), tout comme pour l'idée de n'y inclure que les patients présentant un risque élevé de défaillance primaire de la fistule (38 % pour l'Europe et 39 % pour l'Australie et la Nouvelle-Zélande combinées). Les néphrologues qui pratiquaient depuis plusieurs années, qui suivaient un grand nombre de patients ou qui se définissaient comme des experts de la littérature sur les accès vasculaires étaient plus enclins à participer à des essais cliniques à ce sujet. LIMITES DE L'ÉTUDE: La distribution du questionnaire était limitée aux experts de la question de l'accès vasculaire en hémodialyse dans les pays d'Europe participants. Ceci a fait en sorte que le nombre de répondants européens s'est trouvé en déséquilibre en comparaison du nombre de répondants provenant de l'extérieur de l'Europe. De plus, les Canadiens étant surreprésentés parmi les répondants, les résultats obtenus expriment davantage leurs vues que celles des néphrologues provenant d'Australie, de la Nouvelle-Zélande ou des pays d'Europe participants. CONCLUSION: Les résultats du sondage suggèrent qu'en général, les néphrologues croient que les deux méthodes se valent au moment de la mise en place d'un accès vasculaire. La plupart sont également d'avis qu'un essai clinique contrôlé et randomisé pour les comparer devrait être réalisé, mais plusieurs croient que celui-ci ne devrait inclure que les patients présentant un risque élevé de défaillance primaire de la fistule.

Catheter Insertion and Perioperative Practices Within the ISPD North American Research Consortium.

UNLABELLED: ♦ BACKGROUND: In general, efforts to standardize care based on group consensus practice guidelines have resulted in lower morbidity and mortality. Although there are published guidelines regarding insertion and perioperative management of peritoneal dialysis (PD) catheters, variation in practice patterns between centers may exist. The objective of this study is to understand variation in PD catheter insertion practices in preparation for conducting future studies. ♦ METHODS: An electronic survey was developed by the research committee of the International Society for Peritoneal Dialysis - North American Research Consortium (ISPD-NARC) to be completed by physicians and nurses involved in PD programs across North America. It consisted of 45 questions related to 1) organizational characteristics; 2) PD catheter insertion practices; 3) current quality-improvement initiatives; and 4) interest in participation in PD studies. Invitation to participate in the survey was given to nephrologists and nurses in centers across Canada and the United States (US) identified by participation in the inaugural meeting of the ISPD-NARC. Descriptive statistics were applied to analyze the data. ♦ RESULTS: Fifty-one ISPD-NARC sites were identified (45% in Canada and 55% in the US) of which 42 responded (82%). Center size varied significantly, with prevalent PD population ranging from 6 - 300 (median: 60) and incident PD patients in the year prior to survey administration ranging from 3 - 180 (median: 20). The majority of centers placed fewer than 19 PD catheters/year, with a range of 0 - 50. Availability of insertion techniques varied significantly, with 83% of centers employing more than 1 insertion technique. Seventy-one percent performed laparoscopic insertion with advanced techniques (omentectomy, omentopexy, and lysis of adhesions), 62% of sites performed open surgical dissection, 10% performed blind insertion via trocar, and 29% performed blind placement with the Seldinger technique. Use of double-cuff catheters was nearly universal, with a near even distribution of catheters with pre-formed bend versus straight inter-cuff segments. There was also variation in the choice of perioperative antibiotics and perioperative flushing practices. Although 86% of centers had quality-improvement initiatives, there was little consensus as to appropriate targets. ♦ CONCLUSIONS: There is marked variability in PD catheter insertion techniques and perioperative management. Large multicenter studies are needed to determine associations between these practices and catheter and patient outcomes. This research could inform future trials and guidelines and improve practice. The ISPD-NARC is a network of PD units that has been formed to conduct multicenter studies in PD.

Sex-based disparities in cardioprotective medication use in adults with diabetes.

OBJECTIVE: The identification of sex-based disparities in the use of effective medications in high-risk populations can lead to interventions to minimize disparities in health outcomes. The objective of this study was to determine sex-specific rates of cardioprotective medication use in a large population-level administrative-health database from a universal-payer environment. RESEARCH DESIGN AND METHODS: This observational, population-based cohort study used provincial administrative data to compare the utilization of cardioprotective medications between women and men in the first year following a diabetes diagnosis. Competing risks regression was used to calculate crude and adjusted sub-hazard ratios for time-to-first angiotensin-converting-enzyme inhibitor, angiotensin receptor blocker, or statin dispensations. RESULTS: There were 15,120 (45.4%) women and 18,174 (54.6%) men with diabetes in the study cohort. Overall cardioprotective medication use was low for both primary and secondary prevention for both women and men. In the year following a diabetes diagnosis, women were less likely to use a statin relative to men (adjusted sub-hazard ratio [aSHR] 0.90, 95% confidence interval [CI] 0.85 to 0.96), angiotensin-converting-enzyme inhibitors (aSHR 0.90, 95% CI 0.86 to 0.94), or any cardioprotective medication (aSHR 0.93, 95% CI 0.90 to 0.97). CONCLUSIONS: Cardioprotective medication use was not optimal in women or men. We also identified a health care gap with cardioprotective medication use being lower in women with diabetes compared to men. Closing this gap has the potential to reduce the impact of cardiovascular disease in women with diabetes.

Risk of death following kidney allograft failure: a systematic review and meta-analysis of cohort studies.

BACKGROUND: People with kidney allograft failure represent an increasing fraction of all those starting dialysis therapy. We sought to summarize prognosis following kidney allograft failure and identify potentially beneficial interventions or modifiable risk factors. METHODS: We searched MEDLINE and EMBASE (inception to 1 October 2013) and article reference lists without language restriction and selected cohort studies of all-cause mortality and fatal infection-related and cardiovascular events in people starting dialysis following kidney allograft failure. Two reviewers independently extracted data on study design, participant characteristics, dialysis modality, transplant nephrectomy, immunosuppression strategy, transplant-naive comparators and risk of bias. Discrepancies were resolved with a third reviewer. RESULTS: Forty studies comprising 249 716 participants met the inclusion criteria. The first year of dialysis therapy was associated with the highest mortality. By random effects meta-analysis, annual risk of death, from years 1 to 4, was 0.12 [95% confidence interval (95% CI): 0.09-0.15], 0.06 (95% CI: 0.05-0.07), 0.05 (95% CI: 0.04-0.06) and 0.05 (95% CI: 0.04-0.06), respectively. We found high heterogeneity in each meta-analysis, which remained unexplained by prespecified subgroup analyses. We could not find sufficient information to summarize the risk for fatal infection-related and cardiovascular events, or to test the role of transplant nephrectomy or different immunosuppressive strategies. Risk of bias was high, especially participation bias. CONCLUSION: Mortality is higher during the first year of dialysis treatment following kidney allograft failure than in subsequent years. Insufficient data are available to assess factors or interventions potentially impacting prognosis following kidney allograft failure. In a culture promoting transplantation, clinical research of different models of care in this growing high-risk population should be a research priority.

Predictors of treatment with mastectomy, use of sentinel lymph node biopsy and upstaging to invasive cancer in patients diagnosed with breast ductal carcinoma in situ (DCIS) on core biopsy.

BACKGROUND: There are few established indications for sentinel lymph node biopsy (SLNB) in breast ductal carcinoma in situ (DCIS). This study examines factors contributing to the high rate of SLNB in DCIS in Alberta, Canada. METHODS: Patients who underwent definitive surgery from January 2009 to July 2011 for DCIS diagnosed on preoperative core-needle biopsy were identified using a provincial synoptic operative report database (WebSMR). The relationship between baseline patient and tumor characteristics and treatment with total mastectomy (TM), use of SLNB, and upstaging were examined. RESULTS: There were 394 patients identified in the study cohort. Mean age was 57 years, and average preoperative tumor size was 3 cm. Overall, 148 patients (37.6 %) underwent TM; predictors were preoperative tumor size [odds ratio (OR), 1.92 per 1-cm increase in size; 95 % CI 1.65-2.24] and surgeon. Upstaging to invasive cancer at surgery occurred in 23 %, predicted only by preoperative tumor size (OR 1.14 per 1 cm; 95 % CI 1.03-1.27). SLNB was performed in 306 patients overall (77 %) and 140 of those treated with BCS (61 %). Predictors of SLNB were larger preoperative tumor size (OR 1.55 per 1 cm; 95 % CI 1.18-2.04) and the surgeon. In patients treated with BCS, 3 patients who were upstaged had positive SLNs (>0.2 mm), and no patients with DCIS had a positive SLN. CONCLUSIONS: SLNB use is high in patients undergoing BCS for DCIS. Tumor size and the operating surgeon predicted SLNB use. Despite a 23 % upstaging rate, the rate of clinically significant positive SLNs in patients treated with BCS is low, supporting omission of upfront SLNB.