Surgery (St Vincent's) - Research Publications
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ItemAssessing the Mortality Rate After Primary Total Knee Arthroplasty: An Observational Study to Inform Future Economic Analysis(CHURCHILL LIVINGSTONE INC MEDICAL PUBLISHERS, 2023-11)BACKGROUND: Previous research has focused on the perioperative or short-term (<1 year) mortality rate of total knee arthroplasty (TKA), leaving the long-term (>1 year) mortality rate unresolved. In this study, we calculated the mortality rate up to 15 years after primary TKA. METHODS: Data from the New Zealand Joint Registry from April 1998 to December 2021 were analyzed. Patients aged 45 years or older who underwent TKA for osteoarthritis were included. Mortality data were linked with national records from births, deaths, and marriages. To determine the expected mortality rates in the general population, age-sex-specific life tables from statistics New Zealand were used. Mortality rate was presented as standardized mortality ratios (SMRs) - a comparison of relative mortality rate between the TKA and general populations. In total, 98,156 patients with a median follow-up of 7.25 years (range, 0.00 to 23.74) were included. RESULTS: Over the entire follow-up period, 22,938 patients (23.4%) had died. The overall SMR for the TKA cohort was 1.08 (95% confidence interval (CI): 1.06 to 1.09), suggesting that TKA patients have an 8% higher mortality rate compared to the general population. However, a reduction in short-term mortality rate was observed for TKA patients up to 5 years post TKA (SMR 5 years post TKA; 0.59 95% CI: 0.57 to 0.60]). On the contrary, a significantly increased long-term mortality rate was observed in TKA patients with greater than 11 years of follow-up, particularly in men over the age of 75 years (SMR 11 to 15 years post TKA for males ≥ 75 years; 3.13 [95% CI: 2.95 to 3.31]). CONCLUSION: The results suggest a reduction in short-term mortality rate for patients who undergo primary TKA. However, there is an increased long-term mortality rate particularly in men over the age of 75 years. Importantly, the mortality rates observed in this study cannot be causally attributed to TKA alone.
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ItemDifferences in Outcomes Between Initial Responders and Subsequent Responders to Health Questionnaires for Total Hip and Knee Arthroplasty: An Australian Tertiary Institutional Registry Study(CHURCHILL LIVINGSTONE INC MEDICAL PUBLISHERS, 2023-12)BACKGROUND: Patient-reported outcome measure (PROM) questionnaires in national arthroplasty registries often have low response rates leading to questions about data reliability. In Australia, the SMART (St. Vincent's Melbourne Arthroplasty Outcomes) registry captures all elective total hip (THA) and total knee (TKA) arthroplasty patients with an approximate 98% response rate for preoperative and 12-month PROM scores. This high response rate is due to dedicated registry staff following up patients who do not initially respond (subsequent responders). This study compared initial responders to subsequent responders to find differences in 12-month PROM outcomes for THA and TKA. METHODS: All elective THA and TKA patients for osteoarthritis from 2012 to 2021 captured by the SMART registry were included. In total, 1,333 THA and 1,340 TKA patients were included. The PROM scores were assessed using the Veterans-RAND 12 (VR12) and Western Ontario and McMasters Universities Arthritis Index (WOMAC) questionnaires. The primary outcome was differences in mean 12-month PROM scores between initial and subsequent responders. RESULTS: Baseline characteristics and PROM scores were similar between initial and subsequent responders. However, 12-month PROM scores varied significantly. The adjusted mean difference showed that for the WOMAC pain score, subsequent responders scored 3.4 points higher in the THA cohort and 7.4 points higher in the TKA cohort compared to initial responders. Significant differences were also found in other WOMAC and VR12 scores for both THA and TKA cohorts at the 12-month timepoint. CONCLUSION: This study found that significant differences in PROM outcomes postsurgery occurred in THA and TKA patients based on response to PROM questionnaires, suggesting that loss to follow-up in PROM outcomes should not be treated as missing completely at random (MCAR).
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ItemNo Preview AvailableSMART choice (knee) tool: a patient-focused predictive model to predict improvement in health-related quality of life after total knee arthroplasty(WILEY, 2023-01)BACKGROUND: Current predictive tools for TKA focus on clinicians rather than patients as the intended user. The purpose of this study was to develop a patient-focused model to predict health-related quality of life outcomes at 1-year post-TKA. METHODS: Patients who underwent primary TKA for osteoarthritis from a tertiary institutional registry after January 2006 were analysed. The primary outcome was improvement after TKA defined by the minimal clinically important difference in utility score at 1-year post-surgery. Potential predictors included demographic information, comorbidities, lifestyle factors, and patient-reported outcome measures. Four models were developed, including both conventional statistics and machine learning (artificial intelligence) methods: logistic regression, classification tree, extreme gradient boosted trees, and random forest models. Models were evaluated using discrimination and calibration metrics. RESULTS: A total of 3755 patients were included in the study. The logistic regression model performed the best with respect to both discrimination (AUC = 0.712) and calibration (intercept = -0.083, slope = 1.123, Brier score = 0.202). Less than 2% (n = 52) of the data were missing and therefore removed for complete case analysis. The final model used age (categorical), sex, baseline utility score, and baseline Veterans-RAND 12 responses as predictors. CONCLUSION: The logistic regression model performed better than machine learning algorithms with respect to AUC and calibration plot. The logistic regression model was well calibrated enough to stratify patients into risk deciles based on their likelihood of improvement after surgery. Further research is required to evaluate the performance of predictive tools through pragmatic clinical trials. LEVEL OF EVIDENCE: Level II, decision analysis.
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ItemAn Economic Model for Estimating Trial Costs with an Application to Placebo Surgery Trials(SPRINGER INT PUBL AG, 2023-03)BACKGROUND AND OBJECTIVE: Waste in clinical trials remains rife. We developed an economic model to predict the cost of trials based on input costs, duration, power, number of sites, recruitment eligibility and consenting rates. METHODS: We parameterised the model for three proxy placebo-controlled surgical trials using data from a systematic review, a bespoke cost survey, and from the literature. We used the model to compare target and actual trial performance for (i) a trial that was completed on time but with more sites, (ii) a trial that completed after a time extension, and (iii) an incomplete trial. RESULTS: Successful trials more accurately anticipated the true recruitment rate that they achieved and those that overestimated this were most likely to fail. The costs of overestimating recruitment rates were dramatic: all proxy trials had significantly higher costs than planned, with additional funding of at least AUD$600,000 (50% above budget) required for trials that completed after adding more sites or more time, and over AUD$2 million (260% above budget) for incomplete trials. CONCLUSIONS: This model shows the trade-offs between time and cost, or both, when recruitment is lower than anticipated. Greater consideration is needed to improve trial planning, reviewing, and funding of these trials to avoid costly overruns and incomplete trials.
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ItemNo Preview AvailableImplementing predictive tools in surgery: A narrative review in the context of orthopaedic surgery(WILEY, 2022-12)Clinical predictive tools are a topic gaining interest. Many tools are developed each year to predict various outcomes in medicine and surgery. However, the proportion of predictive tools that are implemented in clinical practice is small in comparison to the total number of tools developed. This narrative review presents key principles to guide the translation of predictive tools from academic bodies of work into useful tools that complement clinical practice. Our review identified the following principles: (1) identifying a clinical gap, (2) selecting a target user or population, (3) optimizing predictive tool performance, (4) externally validating predictive tools, (5) marketing and disseminating the tool, (6) navigating the challenges of integrating a tool into existing healthcare systems, and (7) developing an ongoing monitoring and evaluation strategy. Although the review focuses on examples in orthopaedic surgery, the principles can be applied to other disciplines in medicine and surgery.
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ItemNo Preview AvailableAnalysis of Rates of Completion, Delays, and Participant Recruitment in Randomized Clinical Trials in Surgery(JAMA Network, 2023-01-17)IMPORTANCE: Discontinuation and nonpublication are established sources of avoidable waste among surgical trials, but rates of delayed completion and recruiting shortfalls remain unclear. OBJECTIVES: To examine the rate of delayed completion, incomplete enrollment, and discontinuation among randomized clinical trials in surgical populations and the duration of delays and extent of recruiting shortfalls among these trials. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study examined randomized clinical trials in surgical populations registered on ClinicalTrials.gov between January 1, 2010, and December 31, 2014. Analysis was conducted between October 27, 2021, and June 30, 2022. MAIN OUTCOMES AND MEASURES: The main outcomes were the percentages of trials completed on time or with full enrollment. Delays and recruiting shortfalls were identified by comparing projected enrollment and study timeframes prespecified at the time of registration with the actual study duration and enrollment reported on completion or discontinuation. Absolute and relative differences between planned and actual trial conduct were presented for discontinued trials and those completed with delays or recruiting shortfalls. RESULTS: In total, 2542 randomized clinical trials in surgical populations were included in the study sample, of which 370 (14.6%; 95% CI, 13.2%-15.9%) were completed both on time and with full enrollment. Approximately 1 in 5 trials (20.4%; 95% CI, 18.9%-22.0%) were completed within their planned timeframe, and 1166 trials (45.9%; 95% CI, 43.9%-47.8%) met their prespecified enrollment target. The median delay among completed trials was 12.2 months (IQR, 5.1-24.3 months) or 66.7% (IQR, 30.1%-135.8%) longer than planned. Among completed trials that did not meet their prespecified enrollment target, the median recruiting shortfall was equivalent to 31.0% (IQR, 12.7%-55.5%) of the planned study sample. A total of 546 trials (21.5%; 95% CI, 19.9%-23.1%) were discontinued. The median time to discontinuation was 26.4 months (IQR, 15.2-45.7 months), and the median recruiting shortfall among discontinued trials was equivalent to 92.7% (IQR, 65.0%-100.0%) of the trial's prespecified enrollment target. CONCLUSIONS AND RELEVANCE: This cross-sectional study found that delayed completion, recruiting shortfalls, and untimely discontinuation were common among surgical trials. These findings highlight the importance of ensuring that investigators and funders do not overestimate the feasibility of planned trials.
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ItemThe Impact of Enhanced Recovery After Surgery on Total Joint Arthroplasty: Protocol for a Systematic Review and Meta-analysis(JMIR PUBLICATIONS, INC, 2021-03)BACKGROUND: The number of total joint arthroplasties (TJAs) being performed is increasing worldwide. To match this increasing demand, there has been focus on hastening patients' recovery of function. This effort has culminated in the formulation of enhanced recovery after surgery (ERAS) strategies. However, with evolving ERAS programs and new recommendations, a review of current evidence is required to provide clinicians with up-to-date information about its effect on outcomes for TJA. OBJECTIVE: The objective of this study is to assess the utility of ERAS programs on patient, health service, and economic outcomes for primary, elective total hip arthroplasty (THA) and total knee arthroplasty (TKA). METHODS: A systematic search will be conducted in Medline (Ovid), EMCARE (Ovid), EMBASE (Ovid), Web of Science, CINAHL, National Health Service Economic Evaluations Database, and the Cochrane Library. Analytical, observational, and experimental designs will be included in this systematic review. Only studies including patients undergoing primary TKA and THA comparing ERAS programs with conventional surgery and postoperative care will be included. Data related to patient outcomes, health service outcomes, safety, and economic evaluation will be extracted. RESULTS: The search terms and primary database searches have been finalized. Findings will be reported in narrative and tabular form. Where appropriate, random effects meta-analyses will be conducted for each outcome, and heterogeneity quantified with Cochran Q test and I2 statistic. Measures of effect or mean differences will be reported with 95% confidence intervals. The results of this systematic review will be disseminated in a peer-reviewed journal. CONCLUSIONS: This protocol will guide a systematic review assessing outcomes associated with ERAS surgery in primary THA and TKA. TRIAL REGISTRATION: Open Science Framework osf.io/y4bhs; https://osf.io/y4bhs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/25581.
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ItemEvaluating willingness for surgery using the SMART Choice (Knee) patient prognostic tool for total knee arthroplasty: study protocol for a pragmatic randomised controlled trial(BMC, 2022-02-24)BACKGROUND: Approximately 1 in 5 patients feel unsatisfied after total knee arthroplasty (TKA). Prognostic tools may aid in the patient selection process and reduce the proportion of patients who experience unsatisfactory surgery. This study uses the prognostic tool SMART Choice (Patient Prognostic Tool for Total Knee Arthroplasty) to predict patient improvement after TKA. The tool aims to be used by the patient without clinician input and does not require clinical data such as X-ray findings or blood results. The objective of this study is to evaluate the SMART Choice tool on patient decision making, particularly willingness for surgery. We hypothesise that the use of the SMART Choice tool will influence willingness to undergo surgery, especially when used earlier in the patient TKA journey. METHODS: This is a multicentred, pragmatic, randomised controlled trial conducted in Melbourne, Australia. Participants will be recruited from the St. Vincent's Hospital, Melbourne (SVHM) Orthopaedic Clinic, and the client base of HCF, Australia (private health insurance company). Patients over 45 years of age who have been diagnosed with knee osteoarthritis and considering TKA are eligible for participation. Participants will be randomised to either use the SMART Choice tool or treatment as usual. The SMART Choice tool provides users with a prediction for improvement or deterioration / no change after surgery based on utility score change calculated from the Veterans-RAND 12 (VR-12) survey. The primary outcome of the study is patient willingness for TKA surgery. The secondary outcomes include evaluating the optimal timing for tool use and using decision quality questionnaires to understand the patient experience when using the tool. Participants will be followed up for 6 months from the time of recruitment. DISCUSSION: The SMART Choice tool has the potential to improve patient decision making for TKA. Although many prognostic tools have been developed for other areas of surgery, most are confined within academic bodies of work. This study will be one of the first to evaluate the impact of a prognostic tool on patient decision making using a prospective clinical trial, an important step in transitioning the tool for use in clinical practice. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12622000072718 . Prospectively registered - 21 January 2022.
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ItemPlacebo Surgery Controlled Trials Do They Achieve What They Set Out To Do? A Systematic Review(LIPPINCOTT WILLIAMS & WILKINS, 2021-06)OBJECTIVE: To explore whether placebo surgery controlled trials achieve what they set out to do by investigating discrepancy between projected and actual design aspects of trials identified through systematic review methods. SUMMARY BACKGROUND: Interest in placebo surgery controlled trials is growing in response to concerns regarding unnecessary surgery and the societal cost of low-value healthcare. As questions about the justifiability of using placebo controls in surgery have been addressed, attention is now being paid to more practical concerns. METHODS: Six databases were searched from inception - May 2020 (MEDLINE, Embase, Emcare, APA PsycInfo, CINAHL, Cochrane Library). Placebo surgery controlled trials with a published protocol were included. Three authors extracted "projected" design aspects from protocols and "actual" design aspects from main findings papers. Absolute and relative difference between projected and actual design aspects were presented for each trial. Trials were grouped according to whether they met their target sample size ("completed") and were concluded in a timely fashion. Pairs of authors assessed risk of bias. RESULTS: Of 24 trials with data available to analyse; 3 were completed and concluded within target timeframe; 10 were completed and concluded outside the target timeline; 4 were completed without clear target timeframes; 2 were incomplete and concluded within the target framework; 5 were incomplete and concluded outside the target timeline. Trials which reached the recruitment target underestimated trial duration by 88% and number of recruitment sites by 87%. CONCLUSIONS: Trialists need to factor additional time and sites into future placebo surgery controlled trials. A robust reporting framework of projected and actual trial design is imperative for trialists to learn from their predecessors. REVIEW REGISTRATION: PROSPERO (CRD42019133296).
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ItemFactors Underlying Patient and Surgeon Willingness to Participate in a Placebo Surgery Controlled trial: A Qualitative Investigation.(Ovid Technologies (Wolters Kluwer Health), 2021-12)OBJECTIVE: To investigate the factors underlying willingness to participate in a hypothetical trial among patients and surgeons, to inform the design of future placebo surgery controlled trials. BACKGROUND: Placebo surgery controlled trials are the gold standard for testing the efficacy of surgical procedures. However, these trials commonly fail to meet the target sample size and terminate underpowered. METHODS: From October 2019 to July 2020, eligible patients were identified from the orthopedic waiting list at a single tertiary hospital and surgeons were identified from orthopedic clinics at three tertiary hospitals in Australia. Qualitative interviews explored factors underlying willingness to participate in a hypothetical trial, including understanding of trial concepts; attitudes; and trial design preferences. Data collection and analysis were conducted in parallel. Recruitment ceased when no new concepts emerged. Interview data were analyzed using reflexive thematic analysis. RESULTS: The majority of surgeons and only a few patients indicated a willingness to participate in a placebo surgery controlled trial. Factors underlying willingness were captured in four themes: (1) Understanding and attitudes toward placebo; (2) Attitudes towards randomization/perception of equipoise; (3) Perception of risk; and (4) Ethical concerns. CONCLUSIONS: To optimize recruitment in the future, trialists may consider embedding strategies into the recruitment process that validate patients' symptoms, encourage an altruistic mindset, address surgeon biases, and involve surgeons in explaining trial concepts to patients. Trialists may also consider designing three arm trials that meet surgeons' preferences for a "low" and "high" fidelity placebo.