Participant recruitment and attrition in surgical randomised trials with placebo controls versus non-operative controls: a meta-epidemiological study and meta-analysis.

OBJECTIVE: To compare differences in recruitment and attrition between placebo control randomised trials of surgery, and trials of the same surgical interventions and conditions that used non-operative (non-placebo) controls. DESIGN: Meta-epidemiological study. DATA SOURCES: Randomised controlled trials were identified from an electronic search of MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials from their inception date to 21 November 2018. STUDY SELECTION: Placebo control trials evaluating efficacy of any surgical intervention and non-operative control trials of the same surgical intervention were included in this study. 25 730 records were retrieved from our systemic search, identifying 61 placebo control and 38 non-operative control trials for inclusion in analysis. OUTCOME MEASURES: Primary outcome measures were recruitment and attrition. These were assessed in terms of recruitment rate (number of participants enrolled, as a proportion of those eligible) and overall attrition rate (composite of dropout, loss to follow-up and cross-overs, expressed as proportion of total sample size). Secondary outcome measures included participant cross-over rate, dropout and loss to follow-up. RESULTS: Unadjusted pooled recruitment and attrition rates were similar between placebo and non-operative control trials. Study characteristics were not significantly different apart from time to primary timepoint which was shorter in studies with placebo controls (365 vs 274 days, p=0.006). After adjusting for covariates (follow-up duration and number of timepoints), the attrition rate of placebo control trials was almost twice as high compared with non-operative controlled-trials (incident rate ratio (IRR) (95% CI) 1.8 (1.1 to 3.0), p=0.032). The incorporation of one additional follow-up timepoint (regardless of follow-up duration) was associated with reduced attrition in placebo control surgical trials (IRR (95% CI) 0.64 (0.52 to 0.79), p<0.001). CONCLUSIONS: Placebo control trials of surgery have similar recruitment issues but higher attrition compared with non-operative (non-placebo) control trials. Study design should incorporate strategies such as increased timepoints for given follow-up duration to mitigate losses to follow-up and dropout. PROSPERO REGISTRATION NUMBER: CRD42019117364.

Compliance with Australian Orthopaedic Association guidelines does not reduce the risk of venous thromboembolism after total hip and knee arthroplasty.

Preventing avoidable venous-thrombo-embolism (VTE) is a priority to improve patient and service outcomes after total hip and total knee arthroplasty (THA, TKA), but compliance with relevant clinical guidelines varies. This study aims to determine the degree to which prophylaxis was compliant with Australian Orthopaedic Association (AOA) VTE prophylaxis guidelines and whether non-compliance is associated with increased risk of VTE. A prospective multi-centre cohort study of adults with osteoarthritis undergoing primary TKA/THA was completed at 19 high-volume public and private hospitals. Data were collected prior to surgery and for one-year post-surgery. Logistic regression was undertaken to explore associations between non-compliance with AOA VTE prophylaxis guidelines and symptomatic 90-day VTE outcomes. Data were analysed for 1838 participants from 19 sites. The rate of non-compliance with all clinical guideline recommendations was 20.1% (N = 369), with 14.1% (N = 259) non-compliance for risk-stratified prophylaxis, 35.8% (N = 658) for duration, and 67.8% (N = 1246) for other general recommendations. Symptomatic VTE was experienced up to 90-days post-surgery by 48 people (2.6%). Overall guideline non-compliance (AOR = 0.93, 95%CI = 0.4 to 1.3, p = 0.86) was not associated with a lower risk of symptomatic 90-day VTE. Results were consistent when people with high bleeding risk were excluded (AOR = 0.94, 95%CI = 0.44 to 2.34, p = 0.89). Non-compliance with the AOA VTE prophylaxis guidelines was not associated with risk of 90-day VTE after arthroplasty. This counterintuitive finding is concerning and necessitates a rigorous review of the AOA VTE prevention clinical guideline.

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.

Does preoperative opioid use predict outcomes to 6 months following primary unilateral knee or hip arthroplasty for osteoarthritis? A data-linked retrospective study.

BACKGROUND: Few Australian studies have examined the incidence of prescribed opioid use prior to primary total knee or total hip arthroplasty (TKA, THA) and whether it predicts post-surgery outcomes. A recent Australian study demonstrated that the prevalence of pre-arthroplasty opioid use was approximately 16%. In the United States, approximately 24% of people undergoing TKA or THA are chronic opioid users preoperatively. PURPOSE: This study aimed to determine (i) the proportion of TKA and THA patients who use prescribed opioids regularly (daily) before surgery (i.e., opioid use reported between the time of waitlisting and any time up to 3 months before surgery), (ii) if opioid use before surgery predicts (a) complication/readmission rates to 6-months post-surgery, and (b) patient-reported outcomes to 6-months post-surgery. METHODS: A retrospective cohort study of patients who underwent TKA or THA between January 2013 and June 2018 from two Australian public hospitals was undertaken utilizing linked individual patient-level data from two prospectively collected independent databases comprising approximately 3,500 and 9,500 people (database contained known opioid usage data within the 5-year time frame). Inclusion criteria included (i) primary diagnosis of osteoarthritis of the index joint, (ii) primary elective THA or TKA, and (iii) age ≥ 18 years. Exclusion criteria included (i) revision arthroplasty, (ii) non-elective arthroplasty, (iii) hip hemiarthroplasty, (iv) uni-compartmental knee arthroplasty, and (v) previous unilateral high tibial osteotomy. RESULTS: Analysis was completed on 1,187 study participants (64% female, 69% TKA, mean (SD) age 67 [9.9]). 30% were using regular opioids preoperatively. Adjusted regression analyses controlling for multiple co-variates indicated no significant association between preoperative opioid use and complications/readmission rates or patient-reported outcomes to 6 months post-surgery. Model diagnostics produced poor discrimination for area under the curves and non-significant goodness of fit tests. Pre-arthroplasty opioid use was associated with lower health-related quality of life (EuroQol-Visual Analogue Scale) compared to non-opioid users undergoing primary THA (mean difference -5.04 [-9.87, -0.22], P = 0.04, Adjusted R2 = 0.06) CONCLUSION: In this study, 30% of patients were using prescribed opioids daily prior to primary TKA or THA. Pre-arthroplasty opioid use was not associated with postoperative adverse events or patient-reported pain, function, or global perceived improvement up to six months post-surgery.

HIP fracture Supplemental Therapy to Enhance Recovery (HIPSTER): a protocol for a randomised controlled trial.

INTRODUCTION: Hip fractures result in substantial health impacts for patients and costs to health systems. Many patients require prolonged hospital stays and up to 60% do not regain their prefracture level of mobility within 1 year. Physical rehabilitation plays a key role in regaining physical function and independence; however, there are no recommendations regarding the optimal intensity. This study aims to compare the clinical efficacy and cost-effectiveness of early intensive in-hospital physiotherapy compared with usual care in patients who have had surgery following a hip fracture. METHODS AND ANALYSIS: This two-arm randomised, controlled, assessor-blinded trial will recruit 620 participants who have had surgery following a hip fracture from eight hospitals. Participants will be randomised 1:1 to receive usual care (physiotherapy according to usual practice at the site) or intensive physiotherapy in the hospital over the first 7 days following surgery (two additional sessions per day, one delivered by a physiotherapist and the other by an allied health assistant). The primary outcome is the total hospital length of stay, measured from the date of hospital admission to the date of hospital discharge, including both acute and subacute hospital days. Secondary outcomes are functional mobility, health-related quality of life, concerns about falling, discharge destination, proportion of patients remaining in hospital at 30 days, return to preadmission mobility and residence at 120 days and adverse events. Twelve months of follow-up will capture data on healthcare utilisation. A cost-effectiveness evaluation will be undertaken, and a process evaluation will document barriers and facilitators to implementation. ETHICS AND DISSEMINATION: The Alfred Hospital Ethics Committee has approved this protocol. The trial findings will be published in peer-reviewed journals, submitted for presentation at conferences and disseminated to patients and carers. TRIAL REGISTRATION NUMBER: ACTRN12622001442796.

Tapentadol Versus Oxycodone for Opioid-Related Adverse Drug Events and Clinical Outcomes After Inpatient Surgery.

Oxycodone is a commonly prescribed opioid for postoperative pain. However, there has been a marked increase in the use of tapentadol over the previous decade due to a perceived superior safety profile of tapentadol compared to oxycodone. There is limited real-world evidence on the safety of tapentadol compared to oxycodone after surgery. The primary objective was to examine the impact of tapentadol compared to oxycodone use on the incidence of opioid-related adverse drug events after surgery. Data for adult surgical patients receiving tapentadol or oxycodone during hospitalization between January 1, 2018, and December 31, 2021, were collected from electronic medical records of 3 tertiary metropolitan hospitals in Australia. The primary outcome was the incidence of opioid-related adverse events. Patients receiving tapentadol or oxycodone were matched using nearest-neighbour propensity score matching. In the matched cohorts (n = 1,530 vs n = 2,775; mean [standard deviation] age 62.3 [17.0] years vs 61.9 [standard deviation 17.9] years; 43% vs 45% male for the tapentadol vs oxycodone groups, respectively), patients given tapentadol experienced a similar incidence of adverse events overall (14.4%, 220/1,530 vs 12.6%, 349/2,775; P = .100; 95% CI -.35% to 3.95%). Secondary outcomes included an increased risk of delirium (2.7%, 41/1,530 vs 1.3%, 37/2,775), arrhythmias (3.4%, 52/1,530 vs 2.2%, 62/2,775), and length of hospital stay (5 [range 1-201] vs 4 [range 1-226] days) compared with oxycodone use. Further real-world studies are warranted to determine the impact of tapentadol use on a broad range of patient outcomes. PERSPECTIVE: This study provides an early signal that tapentadol use may be associated with an increased risk of some adverse events and a longer length of stay. Further research is needed to examine the impact of tapentadol use on a broad range of patient outcomes in clinical practice settings.

A systematic review and meta-analysis of short-stay programmes for total hip and knee replacement, focusing on safety and optimal patient selection.

BACKGROUND: Short-stay joint replacement programmes are used in many countries but there has been little scrutiny of safety outcomes in the literature. We aimed to systematically review evidence on the safety of short-stay programmes versus usual care for total hip (THR) and knee replacement (KR), and optimal patient selection. METHODS: A systematic review and meta-analysis. Randomised controlled trials (RCTs) and quasi-experimental studies including a comparator group reporting on 14 safety outcomes (hospital readmissions, reoperations, blood loss, emergency department visits, infection, mortality, neurovascular injury, other complications, periprosthetic fractures, postoperative falls, venous thromboembolism, wound complications, dislocation, stiffness) within 90 days postoperatively in adults ≥ 18 years undergoing primary THR or KR were included. Secondary outcomes were associations between patient demographics or clinical characteristics and patient outcomes. Four databases were searched between January 2000 and May 2023. Risk of bias and certainty of the evidence were assessed. RESULTS: Forty-nine studies were included. Based upon low certainty RCT evidence, short-stay programmes may not reduce readmission (OR 0.95, 95% CI 0.12-7.43); blood transfusion requirements (OR 1.75, 95% CI 0.27-11.36); neurovascular injury (OR 0.31, 95% CI 0.01-7.92); other complications (OR 0.63, 95% CI 0.26-1.53); or stiffness (OR 1.04, 95% CI 0.53-2.05). For registry studies, there was no difference in readmission, infection, neurovascular injury, other complications, venous thromboembolism, or wound complications but there were reductions in mortality and dislocations. For interrupted time series studies, there was no difference in readmissions, reoperations, blood loss volume, emergency department visits, infection, mortality, or neurovascular injury; reduced odds of blood transfusion and other complications, but increased odds of periprosthetic fracture. For other observational studies, there was an increased risk of readmission, no difference in blood loss volume, infection, other complications, or wound complications, reduced odds of requiring blood transfusion, reduced mortality, and reduced venous thromboembolism. One study examined an outcome relevant to optimal patient selection; it reported comparable blood loss for short-stay male and female participants (p = 0.814). CONCLUSIONS: There is low certainty evidence that short-stay programmes for THR and KR may have non-inferior 90-day safety outcomes. There is little evidence on factors informing optimal patient selection; this remains an important knowledge gap.

Comparison of short-term outcomes between people with and without a pre-morbid mental health diagnosis following surgery for traumatic hand injury: a prospective longitudinal study of a multicultural cohort.

BACKGROUND: Following traumatic hand injury, few studies have compared outcomes between people with and without a pre-morbid mental health diagnosis. This study aimed to compare sub-acute outcomes in a multicultural patient cohort with surgically managed traumatic hand injury with and without a pre-morbid mental health diagnosis. METHODS: A prospective, observational cohort study of people with traumatic hand injury presenting pre- surgically to a high-volume hand injury centre in a region of cultural and language diversity was conducted. Participants were assessed face-to-face (baseline) then via telephone (3-months post-surgery) and categorized according to a pre-morbid medically diagnosed mental health diagnosis. Baseline and follow-up assessments included global mental health, and the EuroQol (EQ) 'Health Today' analogue scale (0-100) and health domains. Return-to-work status, complications/symptomatic complaints, and hand function (QuickDASH) were also collected at follow-up. Adjusted analyses-accounting for covariates including cultural identity-were conducted to determine whether 3-month outcomes were associated with a pre-morbid mental health diagnosis. RESULTS: From 405 eligible patients, 386 were enrolled (76% male, mean age 38.9 (standard deviation 15.6)); 57% self-identified as Australian and 22% had a pre-morbid mental health diagnosis. Common injuries regardless of pre-morbid mental health diagnosis were skin (40%), tendon (17%) and bone (17%) injuries. None were complex mutilating injuries. Seventy-eight per cent of the cohort was followed-up. In adjusted analyses, a pre-morbid mental health diagnosis was associated with lower odds for reporting 'good or better' global mental health (Odds Ratio (OR) 0.23 (95% Confidence Interval (CI) 0.18, 0.47), p < 0.001), 'no' anxiety or depression (OR 0.21 (0.11, 0.40), p < 0.001) and no pain (OR 0.56 (0.31, 0.98), p = 0.04)(EQ domains), and worse EQ 'Health Today' (10 points on average (95%CI -14.9, -5.1, p < 0.001). QuickDASH scores, rates of complications/symptomatic complaints and return-to-work profiles were similar. CONCLUSIONS: Despite reporting worse mental and health-related quality-of-life outcomes post-surgery, people with a pre-morbid mental health diagnosis regardless of cultural identity experienced similar clinical and return-to-work outcomes. Future research assessing the value of screening for pre-morbid mental health conditions on post-surgical outcomes is required and should include people with more complex hand injuries.

Prevalence and predictors of long-term opioid use following orthopaedic surgery in an Australian setting: A multicentre, prospective cohort study.

Opioid analgesics prescribed for the management of acute pain following orthopaedic surgery may lead to unintended long-term opioid use and associated patient harms. This study aimed to examine the prevalence of opioid use at 90 days after elective orthopaedic surgery across major city, regional and rural locations in New South Wales, Australia. We conducted a prospective, observational cohort study of patients undergoing elective orthopaedic surgery at five hospitals from major city, regional, rural, public and private settings between April 2017 and February 2020. Data were collected by patient questionnaire at the pre-admission clinic 2-6 weeks before surgery and by telephone call after 90 days following surgery. Of the 361 participants recruited, 54% (195/361) were women and the mean age was 67.7 years (standard deviation 10.1 years). Opioid use at 90 or more days after orthopaedic surgery was reported by 15.8% (57/361; 95% confidence interval (CI) 12.2-20%) of all participants and ranged from 3.5% (2/57) at a major city location to 37.8% (14/37) at an inner regional location. Predictors of long-term postoperative opioid use in the multivariable analysis were surgery performed at an inner regional location (adjusted odds ratio 12.26; 95% CI 2.2-68.24) and outer regional location (adjusted odds ratio 5.46; 95% CI 1.09-27.50) after adjusting for known covariates. Long-term opioid use was reported in over 15% of patients following orthopaedic surgery and appears to be more prevalent in regional locations in Australia.

A mixed methods approach to investigating physical activity in people with obesity participating in a chronic care programme awaiting total knee or hip arthroplasty.

AIMS: To describe patient-reported physical activity and step count trajectory and explore perceived barriers and enablers to physical activity amongst people with obesity participating in a chronic care programme whilst awaiting arthroplasty. DESIGN: Convergent parallel mixed-method study. METHOD: A patient cohort derived from a longitudinal sample of adults with end-stage osteoarthritis and obesity from a chronic care programme whilst awaiting primary total knee or hip arthroplasty (n = 97) was studied. Physical activity was measured at baseline (entry to the wait list) and before surgery (9-12 months waiting time) using the Lower Extremity Activity Scale (LEAS) and activity monitors (activPAL™). A subset of participants completed in-depth semi-structured interviews 6 months after being waitlisted to explore perceived barriers and enablers to physical activity. Themes were inductively derived and then interpreted through the COM-B model. RESULTS: Baseline LEAS and activPAL™ data were available from 97 and 63 participants, respectively. The proportion of community ambulant individuals reduced from 43% (95% CI 33%-53%) at baseline to 17% (95% CI 9%-28%) pre-surgery. Paired activPAL™ data (n = 31) for step count, upright time, and stepping time remained unchanged. Twenty-five participants were interviewed. Five themes underpinning physical activity were mapped to the COM-B model components of capability (physical capability), opportunity (accessibility and social norms), and motivation (self-efficacy and beliefs and physical activity). CONCLUSIONS: Participation in a chronic care programme did not improve physical activity levels for people with obesity awaiting arthroplasty. Programs cognisant of the COM-B model components may be required to address the natural trajectory of declining physical activity levels while awaiting arthroplasty.

Safer medicines To reduce falls and refractures for OsteoPorosis (#STOP): a study protocol for a randomised controlled trial of medical specialist-initiated pharmacist-led medication management reviews in primary care.

INTRODUCTION: Minimal trauma fractures (MTFs) often occur in older patients with osteoporosis and may be precipitated by falls risk-increasing drugs. One category of falls risk-increasing drugs of concern are those with sedative/anticholinergic properties. Collaborative medication management services such as Australia's Home Medicine Review (HMR) can reduce patients' intake of sedative/anticholinergics and improve continuity of care. This paper describes a protocol for an randomised controlled trial to determine the efficacy of an HMR service for patients who have sustained MTF. METHOD AND ANALYSIS: Eligible participants are as follows: ≥65 years of age, using ≥5 medicines including at least one falls risk-increasing drug, who have sustained an MTF and under treatment in one of eight Osteoporosis Refracture Prevention clinics in Australia. Consenting participants will be randomised to control (standard care) or intervention groups. For the intervention group, medical specialists will refer to a pharmacist for HMR focused on reducing falls risk predominately through making recommendations to reduce falls risk medicines, and adherence to antiosteoporosis medicines. Twelve months from treatment allocation, comparisons between groups will be made. The main outcome measure is participants' cumulative exposure to sedative and anticholinergics, using the Drug Burden Index. Secondary outcomes include medication adherence, emergency department visits, hospitalisations, falls and mortality. Economic evaluation will compare the intervention strategy with standard care. ETHICS AND DISSEMINATION: Approval was obtained via the New South Wales Research Ethics and Governance Information System (approval number: 2021/ETH12003) with site-specific approvals granted through Human Research Ethics Committees for each research site. Study outcomes will be published in peer-reviewed journals. It will provide robust insight into effectiveness of a pharmacist-based intervention on medicine-related falls risk for patients with osteoporosis. We anticipate that this study will take 2 years to fully accrue including follow-up. TRIAL REGISTRATION NUMBER: ACTRN12622000261718.

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.

Taking the first step: protocol for a cluster randomised implementation trial comparing strategies on access to exercise programmes for people with knee osteoarthritis.

INTRODUCTION: This cluster randomised implementation trial will assess the effect of two behavioural change interventions on the proportion of people with structural knee osteoarthritis (OA) referred and attending exercise-based professionals (physiotherapists and exercise physiologists). The interventions are designed to increase awareness of guidelines, benefits and access pathways for exercise therapy. We hypothesise either strategy will result in more people with knee OA being referred and attending physiotherapy/exercise physiology than current standard of care. METHODS AND ANALYSIS: We will recruit 30 radiology clinics. 10 clinics will be randomly assigned to each trial arm with 1020 people with knee OA consecutively recruited (102 people per practice) into each arm. Intervention arm 1 is an educational reminder message targeted at primary care practitioners with a hyperlink to national guidelines regarding knee OA clinical management. It will be included in the reporting template of a plain knee X-ray. Intervention arm 2 is the reminder message and a patient-facing infographic explaining the benefits and access pathways for exercise. Both interventions will be delivered once, by the radiology clinics, when a person undergoes plain X-ray for non-traumatic knee pain/dysfunction. The primary outcome is referral to physiotherapist/exercise physiology. The secondary outcome is attendance to that appointment. Both outcomes are self-reported via an online survey administered 4 weeks after the X-ray. Additional survey questions explore facilitators and barriers to appointment attendance and acceptability of the interventions. A subsample of the intervention groups will be recruited for semistructured telephone-based interviews to further explore these latter outcomes. ETHICS AND DISSEMINATION: The study protocol was approved by Macquarie University Human Research Ethics Committee (#520221190343842) and prospectively registered with the Australian New Zealand Clinical Trials Registry. The findings of the trial will be disseminated through peer-reviewed scientific journals and conferences. We will engage with Australian physician colleges and main-stream media to distribute findings. TRIAL REGISTRATION NUMBER: ACTRN12622001414707p.

Knee osteoarthritis patient perspectives of their care in an australian private physiotherapy setting: a qualitative exploratory interview study.

PURPOSE: This study aimed to understand perceptions that knee osteoarthritis patients have regarding their experiences of guideline-based recommendations within their care received from physiotherapists in private practice. METHODS: A qualitative semi-structured interview study nested within a larger trial auditing care provided by physiotherapists. Recruited adults ≥ 45 years with knee osteoarthritis across nine primary care physiotherapy practices. Interview questions were anchored around the core elements recommended in guidelines for the management of knee osteoarthritis and patient perceptions of these were analysed using both content and thematic qualitative analysis approaches. Patient satisfaction with care received was asked at the time of interview. RESULTS: Twenty-six patients volunteered for the study (mean 60 years, 58% female). Analysis identified that physiotherapists focused on treating symptoms through quadriceps strengthening exercises, which patients found to be effective, though focussed less on other aspects of evidenced-based care. Patient's perceived treatment to be effective in relieving pain and enabling them to stay active and they appreciated the positive role that their physiotherapist provided in alleviating their concerns. Overall, patients were satisfied with their physiotherapy care but would have liked more specific osteoarthritis education and longer-term management. CONCLUSION: The description of the physiotherapy-related care received by people with knee osteoarthritis aligns with guideline recommendations, though mainly for strength-related exercise prescription. Despite some perceived shortfalls in care, patients do appear to be satisfied. However, improvements in patient outcomes may be possible if more elements of guideline-base care are regularly provided, including enhancing osteoarthritis education and fostering behaviour change. TRIAL REGISTRATION: ACTRN12620000188932.

Prevalence and predictors of opioid use before orthopaedic surgery in an Australian setting: A multicentre, cross-sectional, observational study.

Opioid analgesics are commonly used by patients awaiting orthopaedic surgery, and preoperative opioid use is associated with a greater burden of postoperative pain, suboptimal surgical outcomes and higher healthcare costs. This study aimed to examine the prevalence of total opioid use before elective orthopaedic surgery with a focus on regional and rural hospitals in New South Wales, Australia. This was a cross-sectional, observational study of patients undergoing orthopaedic surgery conducted between April 2017 and November 2019 across five hospitals that included a mix of metropolitan, regional, rural, private and public settings. Preoperative patient demographics, pain scores and analgesic use were collected during pre-admission clinic visits, held between two and six weeks before surgery. Of the 430 patients included, 229 (53.3%) were women and the mean age was 67.5 (standard deviation 10.1) years. The overall prevalence of total preoperative opioid use was 37.7% (162/430). Rates of preoperative opioid use ranged from 20.6% (13/63) at a metropolitan hospital to 48.8% (21/43) at an inner regional hospital. Multivariable logistic regression showed that the inner regional setting was a significant predictor of opioid use before orthopaedic surgery (adjusted odds ratio 2.6; 95% confidence interval 1.0 to 6.7) after adjusting for covariates. Opioid use prior to orthopaedic surgery is common and appears to vary by geographical location.

Preliminary insights into patient preparedness for knee or hip arthroplasty: a descriptive survey study.

OBJECTIVE: Knowledge-based preparedness for surgery is achieved through education. It is unclear which of brief or extended education programs prior to knee or hip arthroplasty provides better patient preparedness. Using the Patient Preparedness for Surgery survey, we investigated whether people awaiting arthroplasty attending a hospital that provided education over multiple visits via a pre-surgery management program ('Extended') report superior preparedness compared to those attending a hospital in the same health district that only provides education at the pre-admission clinic assessment ('Brief'). RESULTS: A consecutive sample of 128 people (n = 101, 'Extended', n = 27 'Brief') completed the anonymized survey. COVID-19 related service disruptions undermined the sample size, reducing statistical power. The pre-specified superiority of the Extended program (a relative 20% more reporting 'agree'/'strongly agree') was not observed for 'Overall preparedness' [95% (Extended) vs. 89% (Brief), p = 0.36]. Between-group differences exceeding 20% relative superiority were observed for three preparedness sub-domains ['Alternatives explained' (52 vs. 33%, p = 0.09); 'Prepared for home' (85 vs. 57%, p < 0.01); 'Recall of complications' (42 vs 26%, p = 0.14)]. The preliminary findings suggest an extended education program potentially yields better patient-reported preparedness in some preparedness sub-domains, but not all.

The Natural Helper approach to culturally responsive disease management: protocol for a type 1 effectiveness-implementation cluster randomised controlled trial of a cultural mentor programme.

INTRODUCTION: Chronic disease is a leading cause of death and disability that disproportionately burdens culturally and linguistically diverse (CALD) communities. Self-management is a cornerstone of effective chronic disease management. However, research suggests that patients from CALD communities may be less likely to engage with self-management approaches. The Natural Helper Programme aims to facilitate patient engagement with self-management approaches (ie, 'activation') by embedding cultural mentors with lived experience of chronic disease into chronic disease clinics/programmes. The Natural Helper Trial will explore the effect of cultural mentors on patient activation, health self-efficacy, coping efforts and health-related quality of life (HRQoL) while also evaluating the implementation strategy. METHODS AND ANALYSIS: A hybrid type-1 effectiveness-implementation cluster-randomised controlled trial (phase one) and a mixed-method controlled before-and-after cohort extension of the trial (phase 2). Hospital clinics in highly multicultural regions in Australia that provide healthcare for patients with chronic and/or complex conditions, will participate. A minimum of 16 chronic disease clinics (clusters) will be randomised to immediate (active arm) or delayed implementation (control arm). In phase 1, the active arm will receive a multifaceted strategy supporting them to embed cultural mentors in their services while the control arm continues with usual care. Each cluster will recruit an average of 15 patients, assessed at baseline and 6 months (n=240). In phase 2, clusters in the control arm will receive the implementation strategy and evaluate the intervention on an additional 15 patients per cluster, while sustainability in active arm clusters will be assessed qualitatively. Change in activation over 6 months, measured using the Patient Activation Measure will be the primary effectiveness outcome, while secondary effectiveness outcomes will explore changes in chronic disease self-efficacy, coping strategies and HRQoL. Secondary implementation outcomes will be collected from patient-participants, mentors and healthcare providers using validated questionnaires, customised surveys and interviews aligning with the Reach, Effectiveness, Adoption, Implementation, Maintenance framework to evaluate acceptability, reach, dose delivered, sustainability, cost-utility and healthcare provider determinants. ETHICS AND DISSEMINATION: This trial has full ethical approval (2021/ETH12279). The results from this hybrid trial will be presented at scientific meetings and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12622000697785.

Post-discharge patient-reported non-adherence to aspirin compared to enoxaparin for venous thromboembolism prophylaxis after hip or knee arthroplasty.

BACKGROUND: Aspirin and enoxaparin are commonly used for venous thromboembolism (VTE) prophylaxis following total hip arthroplasty (THA) or total knee arthroplasty (TKA). The purpose of this study was to compare non-adherence after discharge to aspirin or enoxaparin following THA or TKA. METHODS: A subset of participants in the CRISTAL study were selected for participation. Additional inclusion criteria were no preoperative anticoagulant use and discharge from hospital before the prophylaxis period ended. The first four consecutive patients from each arm at each participating hospital were planned to be recruited (planned sample size n = 248). A patient-reported adherence questionnaire was completed by telephone at 36-41 days after THA and at 15-20 days after TKA. The primary outcome was non-adherence. Secondary outcomes were number of missed doses and the reasons for non-adherence. RESULTS: There were 178 participants included from 15 sites, less than planned explained by early stopping of trial recruitment. There was no significant between-group difference in patient-reported non-adherence: 24% (17/71) for aspirin, 30% (32/107) for enoxaparin, odds ratio = 1.4 (95% CI 0.7-2.9). The mean number of missed doses was 2.5 for aspirin and 3.4 for enoxaparin (mean difference = 0.9 doses, 95% CI -1.2 to 3.1). For aspirin, the most commonly reported reason for non-adherence was forgotten doses and for enoxaparin it was clinician-recommended change. CONCLUSIONS: Rates of non-adherence and the number of missing doses were similar for patients regardless of drug prescribed. The most common reasons for non-adherence were unrelated to the mode of administration.

Discharge to inpatient rehabilitation following arthroplasty is a strong predictor of persistent opioid use 90 days after surgery: a prospective, observational study.

BACKGROUND: Total knee and hip arthroplasty are considered a clinically and cost-effective intervention, however, persistent pain post-surgery can occur, and some continue to take opioid medications long-term. One factor which has infrequently been included in prediction modelling is rehabilitation pathway, in particular, one which includes inpatient rehabilitation. As discharge to inpatient rehabilitation post-arthroplasty is common practice, we aimed to identify whether rehabilitation pathway (discharge to in-patient rehabilitation or not) predicts continued use of opioids at 3 months (90 days) post- total knee arthroplasty (TKA) and total hip arthroplasty (THA) whilst controlling for other covariates. METHODS: The study was nested within a prospective observational study capturing pre-operative, acute care and longer-term data from 1900 osteoarthritis (OA) patients who underwent primary TKA or THA. The larger study involved a part-random, part-convenience sample of 19 high-volume hospitals across Australia. Records with complete pre-and post-operative analgesic (35 days and 90 days) use were identified [1771 records (93% of sample)] and included in logistic regression analyses. RESULTS: Three hundred and thirteen people (17.8%) reported ongoing opioid use at 90 days post-operatively. In the adjusted model, admission to inpatient rehabilitation after surgery was identified as an independent and significant predictor of opioid use at 90-days. Inpatient rehabilitation was associated with almost twice the odds of persistent opioid use at 90-days compared to discharge directly home (OR = 1.9 (1.4, 2.5), p < .001). CONCLUSION: The inpatient rehabilitation pathway is a strong predictor of longer-term opioid use (90 days) post-arthroplasty, accounting for many known and possible confounders of use including sex, age, insurance status, major complications, smoking status and baseline body pain levels. TRIAL REGISTRATION: The study was nested within a prospective cohort observational study capturing pre-operative, acute-care and longer-term data from patients undergoing primary TKA or THA for osteoarthritis (ClinicalTrials.gov NCT01899443).

Is Enoxaparin Associated With a Higher Risk of Persistent Wound Drainage Than Aspirin? A Secondary Analysis of Data From the CRISTAL Randomized Trial.

BACKGROUND: Owing to its association with prosthetic joint infection, persistent wound drainage has become an important clinical entity after THA or TKA. The association between venous thromboembolism (VTE) prophylaxis and persistent wound drainage has not been extensively reported before but has potentially important clinical implications. QUESTIONS/PURPOSES: (1) Is the type of VTE prophylaxis (enoxaparin or aspirin) used after hip arthroplasty or knee arthroplasty associated with a higher risk of persistent wound drainage? (2) In patients who experience persistent wound drainage, is the type of VTE prophylaxis associated with a longer time taken to achieve a dry wound? (3) Is type of VTE prophylaxis associated with a higher risk of joint-related reoperation within 6 months? METHODS: This was a secondary analysis of data from an earlier cluster-randomized trial conducted through the Australian Orthopaedic Association National Joint Replacement Registry; data were drawn from two participating hospitals from that study. According to the trial's allocation sequence, the two participating hospitals were randomized to administer aspirin (100 mg daily) or enoxaparin (40 mg daily) as VTE prophylaxis to all patients undergoing hip arthroplasty for 35 days after the procedure and for all patients undergoing knee arthroplasty for 14 days afterwards. Crossover to the alternate prophylaxis group occurred after the patient enrollment target had been met for the first arm. Between April 2019 and December 2020, 1339 of 1679 eligible patients were included in this study; 82% (707 of 861) of eligible patients were allocated to the enoxaparin group and 77% (632 of 818) of eligible patients we allocated to the aspirin group. The mean age in both groups was 67 ± 10 years and the mean BMI was 32 ± 7 kg/m 2 . There was a higher proportion of male patients (43% [302 of 707] versus 36% [227 of 632]; p = 0.01), hip arthroplasties (36% [254 of 707] versus 29% [182 of 632]; p = 0.006), and patients receiving subcuticular closure (62% [441 of 707] versus 33% [208 of 631]; p < 0.001) in the enoxaparin group than in the aspirin group. Patients were monitored for wound drainage on each postoperative day until discharge, and this was recorded in the medical record once per day. Assessors were not blinded to the type of prophylaxis each patient received. Persistent wound drainage was defined as any wound drainage beyond Postoperative Day 3. For patients who experienced persistent wound drainage, the time taken to achieve a dry wound was defined as the number of days beyond Postoperative Day 3 for the wound to become dry. Logistic regression was used to determine whether the prophylaxis type was associated with persistent wound drainage. For patients with persistent wound drainage, the median time of drainage was compared between groups using the Kruskal-Wallis test. The number of patients undergoing a joint-related reoperation within 6 months was identified through data linkage to the Australian Orthopaedic Association National Joint Replacement Registry and electronic record review, and was compared using a Fisher exact test. RESULTS: We found no difference between the enoxaparin and aspirin groups in terms of the percentage of patients who had persistent wound drainage (9% [65 of 707] versus 8% [49 of 632], odds ratio 1.2 [95% confidence interval 0.8 to 1.8]; p = 0.40). For patients receiving subcuticular closure, after controlling for other potentially confounding variables, including age, sex, BMI, preoperative anticoagulant use, and type of arthroplasty, enoxaparin was associated with a higher risk of persistent wound drainage than aspirin (OR 3.6 [95% CI 1.5 to 10.6]; p = 0.009). For patients receiving a skin staple closure, after controlling for the same variables above, we found enoxaparin was not associated with a higher risk of persistent wound drainage (OR 1.1 [95% CI 0.7 to 1.9]; p = 0.66). For patients who experienced persistent wound drainage patients (114: 65 in the enoxaparin group and 49 in the aspirin group), there was no difference in the median (interquartile range) time taken to achieve a dry wound (enoxaparin: 1 day [IQR 1 to 2 days], aspirin: 1 day [IQR 1 to 3 days]; p = 0.22). There was no difference in the risk of joint-related reoperation within 6 months between enoxaparin (2.4% [17 of 707]) and aspirin (2.2% [14 of 632], OR 1.1 [95% CI 0.5 to 2.4]; p = 0.86). CONCLUSION: Enoxaparin was not associated with an increased risk of persistent wound drainage compared with aspirin for all patients included in this study. Enoxaparin may be associated with a higher risk of drainage for patients receiving subcuticular closure. However, this finding should be interpreted cautiously, given the small sample size in this analysis. The duration of drainage was short regardless of the prophylaxis used, and enoxaparin was not associated with an increased risk of joint-related reoperation. These findings should not deter clinicians from using enoxaparin for VTE prophylaxis after hip or knee arthroplasty. LEVEL OF EVIDENCE: Level III, therapeutic study.