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.

It's OK to move! Effect of a brief video on community confidence in activity despite back pain: A randomised trial.

OBJECTIVE: To estimate the difference in confidence to become active despite low back pain in people who were exposed to one of two video interventions delivered on social media, compared to no intervention. DESIGN: A proof of concept three group randomised controlled trial, in a 1:1:1 ratio. METHODS: Participants aged 18 years and over, with and without low back pain, were recruited via the social media channel Facebook, to view either a humorous video, a neutral video or to no intervention. The videos were delivered online, explained evidence-based management for low back pain, and were designed to "go viral". The primary outcome was confidence in becoming active despite pain, measured using the Pain Self Efficacy Questionnaire(Item 10) [range from 0 (not at all confident) to 6 (completely confident)] immediately after watching the video. We aimed to capture the real-time impact and immediate reactions that contributed to the content's reach. RESULTS: Among 1933 randomized participants (mean [SD] age 58.9 [14.0] years, 1285 [75%] women) 1232 [70%] had low back pain and 88.8% completed the primary outcome. 1264 participants were randomised to receive a video intervention, and 633 participants did not receive a video. On a 6-point scale, individuals exposed to either video (n=1088) showed a mean confidence level 0.3 points higher (95% CI 0.1 to 0.6) compared with no video (n=630). CONCLUSION: Participants who viewed a brief video intervention reported a very small difference in confidence to become active despite low back pain, compared with no intervention. The difference may lack clinical relevance.

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.

Hip-specific and generic patient-reported outcome measure scores after primary hip replacement are associated with early revision surgery: a national registry study.

BACKGROUND: The ability to efficiently identify patients at higher risk of poor outcomes after joint replacement would enable limited resources for post-operative follow-up to be directed to those with the greatest clinical need. This is particularly important as joint replacement rates continue to grow internationally, stretching health system capabilities. Patient-reported outcome measures (PROMs) are routinely administered in many settings and offer an opportunity to detect suboptimal patient outcomes early. This study aimed to determine whether hip-specific and generic PROM scores are associated with early revision hip replacement within six to 24 months after the primary procedure. METHODS: Pre-operative and six-month post-operative PROM scores for patients undergoing primary total hip replacement (THR) were obtained from the Australian Orthopaedic Association National Joint Replacement Registry and Arthroplasty Clinical Outcomes Registry National and linked to revision surgery data. Clinically important improvement was defined using anchor-based thresholds. Associations between PROM scores (hip pain, Oxford Hip Score, HOOS-12, EQ-5D-5L, EQ VAS, patient-perceived change, satisfaction) and revision surgery were evaluated using t-tests, chi-square tests and regression models. RESULTS: Data were analysed for 21,236 primary THR procedures between 2013 and 2022. Eighty-eight revision procedures were performed at six to 24 months. Patients who were revised had more back pain and worse HOOS-12 scores pre-operatively but between-group differences were small. Worse post-operative PROM scores (hip pain, Oxford, HOOS-12, EQ-5D-5L, EQ VAS) were associated with early revision, after adjusting for age and sex (p < 0.001 for all analyses). Patient dissatisfaction (relative risk (RR) 10.18, 95%CI 6.01-17.25) and patient-perceived worsening (RR 19.62, 95%CI 11.33-33.98) were also associated with a higher likelihood of revision. Patients who did not achieve clinically important improvement in hip pain, function, or quality of life had a higher revision risk (RRs 2.54-5.64), compared with those who did (reference). CONCLUSION: Six-month hip-specific and generic PROM scores can identify patients at higher risk of early revision surgery. Our data highlight the utility of routine post-operative PROM assessment for signaling suboptimal surgical outcomes.

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.

Behavioural 'nudging' interventions to reduce low-value care for low back pain in the emergency department (NUDG-ED): protocol for a 2×2 factorial, before-after, cluster randomised trial.

INTRODUCTION: Opioids and imaging are considered low-value care for most people with low back pain. Yet around one in three people presenting to the emergency department (ED) will receive imaging, and two in three will receive an opioid. NUDG-ED aims to determine the effectiveness of two different behavioural 'nudge' interventions on low-value care for ED patients with low back pain. METHODS AND ANALYSIS: NUDG-ED is a 2×2 factorial, open-label, before-after, cluster randomised controlled trial. The trial includes 8 ED sites in Sydney, Australia. Participants will be ED clinicians who manage back pain, and patients who are 18 years or over presenting to ED with musculoskeletal back pain. EDs will be randomly assigned to receive (i) patient nudges, (ii) clinician nudges, (iii) both interventions or (iv) no nudge control. The primary outcome will be the proportion of encounters in ED for musculoskeletal back pain where a person received a non-indicated lumbar imaging test, an opioid at discharge or both. We will require 2416 encounters over a 9-month study period (3-month before period and 6-month after period) to detect an absolute difference of 10% in use of low-value care due to either nudge, with 80% power, alpha set at 0.05 and assuming an intra-class correlation coefficient of 0.10, and an intraperiod correlation of 0.09. Patient-reported outcome measures will be collected in a subsample of patients (n≥456) 1 week after their initial ED visit. To estimate effects, we will use a multilevel regression model, with a random effect for cluster and patient, a fixed effect indicating the group assignment of each cluster and a fixed effect of time. ETHICS AND DISSEMINATION: This study has ethical approval from Southwestern Sydney Local Health District Human Research Ethics Committee (2023/ETH00472). We will disseminate the results of this trial via media, presenting at conferences and scientific publications. TRIAL REGISTRATION NUMBER: ACTRN12623001000695.

Variation in care and outcomes for people after hip fracture with and without cognitive impairment; results from the Australian and New Zealand Hip Fracture Registry.

BACKGROUND: People with dementia have poorer outcomes after hip fracture and this may be due in part to variation in care. We aimed to compare care and outcomes for people with and without cognitive impairment after hip fracture. METHODS: Retrospective cohort study using Australian and New Zealand Hip Fracture Registry data for people ≥50 years of age who underwent hip fracture surgery (n = 49,063). Cognitive impairment or known dementia and cognitively healthy groups were defined using preadmission cognitive status. Descriptive statistics and multivariable mixed effects models were used to compare groups. RESULTS: In general, cognitively impaired people had worse care and outcomes compared to cognitively healthy older people. A lower proportion of the cognitively impaired group had timely pain assessment (≤30 min of presentation: 61% vs 68%; p < 0.0001), were given the opportunity to mobilise (89% vs 93%; p < 0.0001) and achieved day-1 mobility (34% vs 58%; p < 0.0001) than the cognitively healthy group. A higher proportion of the cognitively impaired group had delayed pain management (>30 mins of presentation: 26% vs 20%; p < 0.0001), were malnourished (27% vs 15%; p < 0.0001), had delirium (44% vs 13%; p < 0.0001) and developed a new pressure injury (4% vs 3%; p < 0.0001) than the cognitively healthy group. Fewer of the cognitively impaired group received rehabilitation (35% vs 64%; p < 0.0001), particularly patients from RACFs (16% vs 39%; p < 0.0001) and were prescribed bone protection medication on discharge (24% vs 27%; p < 0.0001). Significantly more of the cognitively impaired group had a new transfer to residential care (46% vs 11% from private residence; p < 0.0001) and died at 30-days (7% vs 3% from private residence; 15% vs 10% from RACF; both p < 0.0001). In multivariable models adjusting for covariates with facility as the random effect, the cognitively impaired group had a greater odds of being malnourished, not achieving day-1 walking, having delirium in the week after surgery, dying within 30 days, and in those from private residences, having a new transfer to a residential care facility than the cognitively healthy group. CONCLUSIONS: We have identified several aspects of care that could be improved for patients with cognitive impairment - management of pain, mobility, nutrition and bone health, as well as delirium assessment, prevention and management strategies and access to rehabilitation. Further research is needed to determine whether improvements in care will reduce hospital complications and improve outcomes for people with dementia after hip fracture.

Improving hip fracture care: A five-year review of the early contributors to the Australian and New Zealand Hip Fracture Registry.

OBJECTIVE: The aim of this study was to examine temporal trends (2016-2020) in hip fracture care in Australian and New Zealand (ANZ) hospitals that started providing patient-level data to the ANZ Hip Fracture Registry (ANZHFR) on/before 1 January 2016 (early contributors). METHODS: Retrospective cohort study of early contributor hospitals (n = 24) to the ANZHFR. The study cohort included patients aged ≥50 years admitted with a low trauma hip fracture between 1 January 2016 and 31 December 2020 (n = 26,937). Annual performance against 11 quality indicators and 30- and 365-day mortality were examined. RESULTS: Compared to 2016/2017, year-on-year improvements were demonstrated for preoperative cognitive assessment (2020: OR 3.57, 95% confidence interval [95% CI] 3.29-3.87) and nerve block use prior to surgery (2020: OR 4.62, 95% CI 4.17-5.11). Less consistent improvements over time from 2016/2017 were demonstrated for emergency department (ED) stay of <4 h (2017; 2020), pain assessment ≤30 min of ED presentation (2020), surgery ≤48 h (2020) and bone protection medication prescribed on discharge (2017-2020; 2020 OR 2.22, 95% CI 2.03-2.42). The odds of sustaining a hospital-acquired pressure injury increased in 2019-2020 compared to 2016. The odds of receiving an orthogeriatric model of care and being offered the opportunity to mobilise on Day 1 following surgery fluctuated. There was a reduction in 365-day mortality in 2020 compared to 2016 (OR 0.86, 95% CI 0.74-0.98), whereas 30-day mortality did not change. CONCLUSIONS: Several quality indicators improved over time in early contributor hospitals. Indicators that did not improve may be targets for future care improvement activities, including considering incentivised hip fracture care, which has previously been shown to improve care/outcomes. COVID-19 and reporting practices may have impacted the study findings.

Transitivity, coherence, and reliability of network meta-analyses comparing proximal humerus fracture treatments: a meta-epidemiological study.

BACKGROUND: Network meta-analyses can be valuable for decision-makers in guiding clinical practice. However, for network meta-analysis results to be reliable, the assumptions of both transitivity and coherence must be met, and the methodology should adhere to current best practices. We aimed to assess whether network meta-analyses of randomized controlled trials (RCTs) comparing interventions for proximal humerus fractures provide reliable estimates of intervention effects. METHODS: We searched PubMed, EMBASE, The Cochrane Library, and Web of Science for network meta-analyses comparing interventions for proximal humerus fractures. We critically assessed the methodology regarding the development of a protocol, search strategy, trial inclusion, outcome extraction, and the methods used to conduct the network meta-analyses. We assessed the transitivity and coherence of the network graphs for the Constant score (CS), Disabilities of the Arm, Shoulder, and Hand score (DASH), and additional surgery. Transitivity was assessed by comparing probable effect modifiers (age, gender, fracture morphology, and comorbidities) across intervention comparisons. Coherence was assessed using Separating Indirect from Direct Evidence (SIDE) (Separating Indirect from Direct Evidence) and the design-by-treatment interaction test. We used CINeMA (Confidence in Network Meta-analyses) to assess the confidence in the results. RESULTS: None of the three included network meta-analyses had a publicly available protocol or data-analysis plan, and they all had methodological flaws that could threaten the validity of their results. Although we did not detect incoherence for most comparisons, the transitivity assumption was violated for CS, DASH, and additional surgery in all three network meta-analyses. Additionally, the confidence in the results was 'very low' primarily due to within-study bias, reporting bias, intransitivity, imprecision, and heterogeneity. CONCLUSIONS: Current network meta-analyses of RCTs comparing interventions for proximal humerus fractures do not provide reliable estimates of intervention effects. We advise caution in using these network meta-analyses to guide clinical practice. To improve the utility of network meta-analyses to guide clinical practice, journal editors should require that network meta-analyses are done according to a predefined analysis plan in a publicly available protocol and that both coherence and transitivity have been adequately assessed and reported.

Utilizing Stems in Primary Total Knee Arthroplasty: Analysis of the Australian Orthopaedic Association National Joint Replacement Registry Data.

BACKGROUND: We compared revision rates and reasons for revision for primary total knee arthroplasty (TKA) performed for osteoarthritis with and without tibial stem extensions. METHODS: Data from the Australian Orthopaedic Association National Joint Replacement Registry were used to compare all-cause revision, reason, and type of revision between primary TKA using stemmed tibial prostheses and non-stemmed prostheses. RESULTS: All-cause revision for TKA with stem extension was higher for the first 6 months (hazard ratio [HR] 1.47; 95% confidence interval [CI]1.19 to 1.82; P < .001); while after 1.5 years TKA with stem extension had a lower rate of revision (HR 0.84; 95% CI 0.73 to 0.97; P = .01). Stemmed components were more likely to be revised for infection between 3 months and 1.5 years after surgery (HR 1.39; 95% CI 1.05 to 1.83; P = .02). The revision rate for aseptic loosening was lower in the stemmed group beyond 2 years (HR = 0.45; 95% CI 0.31 to 0.63; P < .001). Insert-only revision was higher in the stemmed group at all times (HR = 1.42; 95% CI 1.21 to 1.66, P < .001). Isolated tibial component revision was lower in the stemmed group at all times (HR 0.47; 95% CI 0.29 to 0.74; P = .001). Aseptic loosening for tibial component-only revision was significantly lower in the stemmed group at all times (HR 0.23; 95% CI 0.11 to 0.50; P < .001). CONCLUSIONS: Patients undergoing primary stemmed TKA have lower rates of all-cause revision beyond 1.5 years and tibial component-only revision at all times. Further investigation is required to preoperatively select patients that benefit from augmentation with stems.

Measurement Properties of the Oxford Shoulder Score and Minimal Clinically Important Changes After Primary Total Shoulder Replacement Surgery.

OBJECTIVE: We evaluated the measurement properties of the Oxford Shoulder Score (OSS) and estimated the minimal clinically important change (MCIC) in patients undergoing primary total shoulder replacement in Australia. METHODS: Deidentified data from the Australian Orthopaedic Association National Joint Replacement Registry were used for this analysis. Pre- and 6-month postoperative OSS scores were used, with the 5-level EuroQoL quality of life instrument and shoulder pain scores used as comparators. Floor and ceiling effects, internal consistency reliability, construct validity, and responsiveness to change were evaluated using standard psychometric methods. Mean change and predictive modeling approaches (with and without adjustment for the proportion of improved patients) were used to calculate MCIC thresholds, with patient-perceived improvement after surgery as the anchor. RESULTS: Preoperative OSS data were available for 1,117 patients (59% female; 90% aged ≥60 years) undergoing primary total shoulder replacement. No floor or ceiling effects were observed pre- or postoperatively. The OSS showed high internal consistency reliability (Cronbach alpha >0.89), good construct validity, and high responsiveness to change (effect size 1.88). The MCIC derived from the mean change method was 6.50 points (95% confidence interval [95% CI] 4.41-8.61). The predictive modeling approach produced an MCIC estimate of 8.42 points (95% CI 5.68-12.23) after adjustment. CONCLUSION: The OSS has good measurement properties to capture pain and function outcomes after shoulder replacement procedures and is highly responsive to change. Based on robust methods, an increase in OSS scores of at least eight points can be considered as meaningful improvement after surgery from the patient's perspective.

Development of the Reporting Infographics and Visual Abstracts of Comparative studies (RIVA-C) checklist and guide.

People often use infographics (also called visual or graphical abstracts) as a substitute for reading the full text of an article. This is a concern because most infographics do not present sufficient information to interpret the research appropriately and guide wise health decisions. The Reporting Infographics and Visual Abstracts of Comparative studies (RIVA-C) checklist and guide aims to improve the completeness with which research findings of comparative studies are communicated and avoid research findings being misinterpreted if readers do not refer to the full text. The primary audience for the RIVA-C checklist and guide is developers of infographics that summarise comparative studies of health and medical interventions. The need for the RIVA-C checklist and guide was identified by a survey of how people use infographics. Possible checklist items were informed by a systematic review of how infographics report research. We then conducted a two-round, modified Delphi survey of 92 infographic developers/designers, researchers, health professionals and other key stakeholders. The final checklist includes 10 items. Accompanying explanation and both text and graphical examples linked to the items were developed and pilot tested over a 6-month period. The RIVA-C checklist and guide was designed to facilitate the creation of clear, transparent and sufficiently detailed infographics which summarise comparative studies of health and medical interventions. Accurate infographics can ensure research findings are communicated appropriately and not misinterpreted. By capturing the perspectives of a wide range of end users (eg, authors, informatics editors, journal editors, consumers), we are hopeful of rapid endorsement and implementation of RIVA-C.

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.

Stemmed Tibial Fixation for Primary Total Knee Arthroplasty in Obese Patients-A National Registry Study.

BACKGROUND: We investigated if the use of augmented tibial fixation with stems in primary total knee arthroplasty (TKA) in obese patients was associated with a difference in reason for revision, type of revision, or overall revision rate. METHODS: Data from the Australian Orthopaedic Association National Joint Replacement Registry compared reason for revision, rate, and type of revision between primary TKA using stemmed tibial prostheses to nonstemmed prostheses, stratified by body mass index (BMI) and obesity. The cumulative percent revision was obtained using the Kaplan-Meier method, and Cox proportional hazards models estimated hazard ratios (HRs) adjusted for age and sex with 95% confidence intervals (CIs). All tests were 2-tailed at 5% statistical significance (P < .05). There were 66,508 procedures available for analyses. RESULTS: Obese class 2 (BMI 35 to 39.99) had higher rates of revision in the stemmed group compared to the nonstemmed group (HR 1.44, 95% CI 1.00, 2.05, P = .047). There was no significant difference in revision rates between stemmed and nonstemmed tibial prostheses in any other BMI group. Primary TKA in obese patients (BMI ≥30) with a stem extension had a significantly higher rate of minor revisions compared to no stem extension (HR 1.31, 95% CI 1.03, 1.66, P = .025). There was no significant difference between stemmed and nonstemmed groups for major revision in obese patients and for minor or major revision in nonobese patients. CONCLUSION: Using a tibial stem during primary TKA in obese patients is not associated with a lower rate of revision.

Stakeholder perspectives on short-stay joint replacement programs: results from a national cross-sectional study.

BACKGROUND: The capacity to meet anticipated growth in joint replacement demand requires safe, efficient models of care. While short-stay joint replacement programs are being used internationally, they have not been widely implemented in many countries. Importantly, the critical challenges that need to be addressed ahead of large-scale program implementation remain unclear. This study aimed to investigate stakeholder perspectives on short-stay joint replacement programs, including perceived barriers and enablers to implementation and sustainability, and understand current practices in Australia. METHODS: Four key stakeholder groups were invited to participate in this national study: (1) health professionals who provide joint replacement care; (2) hospital administrators involved in joint replacement provision; (3) patients with recent joint replacement; and (4) carers of people with recent joint replacement. Data on perceived feasibility (0 (not at all feasible) - 10 (highly feasible), appeal (0 (not at all appealing) - 10 (highly appealing), current practices, and barriers and enablers were collected using visual analogue scales, multiple response option and open-ended questions, via an online platform. Descriptive analysis and free-text content analysis was undertaken. RESULTS: Data were available from 1,445 participants including 360 health professionals, 20 hospital administrators, 1,034 patients, and 31 carers. Short-stay program implementation was considered moderately feasible by health professionals (median 6, interquartile range (IQR) 3-8) and hospital administrators (median 5, IQR 5-6). Short-stay programs were moderately appealing to patients (median 7, IQR 2-9) but of little appeal to carers (median 3, IQR 1-7). Prominent implementation barriers included perceived limited appropriateness of short-stay programs, inadequate home supports, and issues around reimbursement models or program funding. Not having daily physiotherapy access and concerns about pain and mobility at home were common barriers for patients. Concern about patients' ability to manage daily activities was the most common barrier for carers. Access to post-discharge services, better funding models, improved staffing, and consistent protocols and national care standards were prominent enablers. CONCLUSIONS: This national study has uniquely captured multiple stakeholder perspectives on short-stay joint replacement programs. The findings can guide future quality improvement and implementation initiatives and the development of resources to best support patients, carers, clinicians, and hospitals.

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.

Patients' experiences of subacute pain management following total hip or knee arthroplasty: A qualitative study.

BACKGROUND: Total hip and knee arthroplasties are common surgeries performed worldwide, but the management of pain during the subacute period (defined as hospital discharge to 3 months postoperatively) is poorly understood. This study aimed to determine patients' experiences, facilitators and barriers to subacute pain management following total hip or knee arthroplasty. METHODS: Semi-structured interviews with a purposive sample of patients following total hip or knee arthroplasty were conducted between June and August 2022. Participants were recruited from two tertiary metropolitan hospitals. Interviews were audio-recorded and transcribed verbatim. Data were analysed using an inductive thematic approach to identify common themes. RESULTS: In total, 30 interviews were conducted with patients following hip or knee arthroplasty. Four main themes were identified: (i) Physical constitution before surgery (joint condition, analgesic use, age, and hearing); (ii) Attitude and knowledge (motivation, outlook on life, attitude towards taking medications, individual benchmarking, and knowledge); (iii) Socio-ethno-cultural factors (family and community connection, language, and religion), and (iv) Health-system support (health-professional delivered education, medications, services, staff, and costs). CONCLUSIONS: Participants' experiences of subacute pain following hip or knee arthroplasty were shaped by multidimensional factors. Strategies to empower patients through increased education and support during postoperative opioid tapering as well as a shift to a biopsychosocial approach to pain management during the subacute period may improve patient and health-system outcomes.

Do we understand each other when we develop and implement hip fracture models of care? A systematic review with narrative synthesis.

BACKGROUND: A hip fracture in an older person is a devastating injury. It impacts functional mobility, independence and survival. Models of care may provide a means for delivering integrated hip fracture care in less well-resourced settings. The aim of this review was to determine the elements of hip fracture models of care to inform the development of an adaptable model of care for low and middle-income countries (LMICs). METHODS: Multiple databases were searched for papers reporting a hip fracture model of care for any part of the patient pathway from injury to rehabilitation. Results were limited to publications from 2000. Titles, abstracts and full texts were screened based on eligibility criteria. Papers were evaluated with an equity lens against eight conceptual criteria adapted from an existing description of a model of care. RESULTS: 82 papers were included, half of which were published since 2015. Only two papers were from middle-income countries and only two papers were evaluated as reporting all conceptual criteria from the existing description. The most identified criterion was an evidence-informed intervention and the least identified was the inclusion of patient stakeholders. CONCLUSION: Interventions described as models of care for hip fracture are unlikely to include previously described conceptual criteria. They are most likely to be orthogeriatric approaches to service delivery, which is a barrier to their implementation in resource-limited settings. In LMICs, the provision of orthogeriatric competencies by other team members is an area for further investigation.

The effect of body mass index and preoperative weight loss in people with obesity on postoperative outcomes to 6 months following total hip or knee arthroplasty: a retrospective study.

BACKGROUND: Few studies have investigated the association between obesity, preoperative weight loss and postoperative outcomes beyond 30- and 90-days post-arthroplasty. This study investigated whether body mass index (BMI) and preoperative weight loss in people with obesity predict postoperative complications and patient-reported outcomes 6 months following total knee or hip arthroplasty. METHODS: Two independent, prospectively collected datasets of people undergoing primary total knee or hip arthroplasty for osteoarthritis between January 2013 and June 2018 at two public hospitals were merged. First, the sample was grouped into BMI categories, < 35 kg/m2 and ≥ 35 kg/m2. Subgroup analysis was completed separately for hips and knees. Second, a sample of people with BMI ≥ 30 kg/m2 was stratified into participants who did or did not lose ≥ 5% of their baseline weight preoperatively. The presence of postoperative complications, Oxford Hip Score, Oxford Knee Score, EuroQol Visual Analogue Scale and patient-rated improvement 6 months post-surgery were compared using unadjusted and adjusted techniques. RESULTS: From 3,552 and 9,562 patients identified from the datasets, 1,337 were included in the analysis after merging. After adjustment for covariates, there was no difference in postoperative complication rate to 6 months post-surgery according to BMI category (OR 1.0, 95%CI 0.8-1.4, P = 0.8) or preoperative weight loss (OR 1.1, 95%CI 0.7-1.8, P = 0.7). There was no between-group difference according to BMI or preoperative weight change for any patient-reported outcomes 6 months post-surgery. CONCLUSION: Preoperative BMI or a 5% reduction in preoperative BMI in people with obesity was not associated with postoperative outcomes to 6 months following total knee or hip arthroplasty.