Surgery (St Vincent's) - Research Publications
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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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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.
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ItemPopulation growth, ageing and obesity do not sufficiently explain the increased utilization of total knee replacement in Australia(WILEY, 2020-07)BACKGROUND: The utilization of total knee replacement (TKR) has increased significantly. The objective of this study was to assess the impact of changes in population demography (population growth, ageing and gender) and body mass indices (BMIs) on the additional volume of knee replacement surgery undertaken in Australia. METHODS: Using national data, we compared estimates based on changes in population demography and BMIs to the reported increase in TKR between 2007 and 2017. The costs of additional surgery were estimated using the National Hospital Cost Data Collection. RESULTS: An additional 25 814 TKRs were performed in 2017 compared to 2007. Contributions from population growth, ageing and changing BMIs were 27.1%, 10.4%, and 6.3%-15.3%, respectively. Other drivers contributed between 47.2% and 56.2%, representing 12 176-14 506 TKRs at a financial cost of A$320.9 million to A$382.3 million per year in 2017. CONCLUSION: The volume of additional surgery being performed considerably exceeded estimates based on changing population demography and rising rates of obesity. The other drivers of additional TKR utilization will likely have significant implications for the health budget and warrant further investigation. This may involve an examination of the current indications for surgery and the cost-effectiveness of TKR in various settings, reviewing patient expectations and preferences, and assessing the impact of policies which relate to the funding and provision of TKR.
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ItemThe cost-effectiveness of computer navigation in primary total knee replacement: a scoping review(The British Editorial Society of Bone and Joint Surgery, 2021-03-01)Despite additional costs associated with the use of computer navigation technology in total knee replacement (TKR), its impact on quality-adjusted life years following surgery has not been demonstrated. Cost-effectiveness evaluations require a balanced assessment of both quality and cost metrics.This review sought to evaluate the cost-effectiveness of computer navigation, identify barriers to translation, and suggest directions for further investigation. A systematic search of the Cost-Effectiveness Analysis Registry, PubMed, and Embase was undertaken.Cost-effectiveness analyses of computer navigation in primary total knee replacement were identified. Only primary studies of cost-effectiveness analyses published in the English language from the year 2000 onwards were included. Studies that reported secondary data were excluded from the analysis. Four publications met the inclusion criteria.Estimated gains in quality-adjusted life years attributed to reductions in revision surgery were 0.0148 to 0.0164 over 10 years, and 0.0192 (95% CI -0.002 to 0.0473) over 15 years. Cost estimates ranged from 952 kr (US $90, 2020) per case at 250 TKRs/year, to $1,920 US per case at 25 TKRs/year.The estimated probability of meeting local cost-effectiveness thresholds was 54% in the United States and 92% in the United Kingdom. These data were not available for Norway.The cost-effectiveness of computer navigation in current practice settings remains uncertain, with the use of this technology associated with marginal increased quality-adjusted life years (QALYs) at additional cost. Existing analyses demonstrated a number of limitations which restrict the potential for translation to practice and policy settings. Further research evaluating the impact of computer navigation on QALYs following primary TKR is required to inform contemporary cost-effectiveness evaluations. Cite this article: EFORT Open Rev 2021;6:173-180. DOI: 10.1302/2058-5241.6.200073.
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ItemCohort profile: the St Vincent's Melbourne Arthroplasty Outcomes (SMART) Registry, a pragmatic prospective database defining outcomes in total hip and knee replacement patients(BMJ PUBLISHING GROUP, 2021)PURPOSE: The St Vincent's Melbourne Arthroplasty Outcomes (SMART) Registry is an institutional clinical registry housed at a tertiary referral hospital in Australia. The SMART Registry is a pragmatic prospective database, which was established to capture a broad range of longitudinal clinical and patient-reported outcome data to facilitate collaborative research that will improve policy and practice relevant to arthroplasty surgery for people with advanced arthritis of the hip or knee. The purpose of this cohort profile paper is to describe the rationale for the SMART Registry's creation, its methods, baseline data and future plans for the Registry. A full compilation of the data is provided as a reference point for future collaborators. PARTICIPANTS: The SMART Registry cohort comprises over 13 000 consecutive arthroplasty procedures in more than 10 000 patients who underwent their procedure at St Vincent's Hospital Melbourne, since January 1998. Participant recruitment, data collection and follow-up is ongoing and currently includes up to 20 years follow-up data. FINDINGS TO DATE: SMART Registry data are used for clinical audit and feedback, as well as for a broad range of research including epidemiological studies, predictive statistical modelling and health economic evaluations. At the time of writing, there were 46 publications from SMART Registry data, with contributions from more than 67 coauthors. FUTURE PLANS: With the recent linking of the SMART Registry with Medicare Benefits Schedule and Pharmaceutical Benefits Scheme data through the Australian Institute of Health and Welfare, research into prescribing patterns and health system utilisation is currently underway. The SMART Registry is also being updated with the Clavien-Dindo classification of surgical complications.
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ItemPatient-Reported Outcomes Following Total Knee Replacement in Patients < 65 Years of Age-A Systematic Review and Meta-Analysis(MDPI, 2020-10-01)An increasing number of total knee replacements (TKRs) are being performed in response to the growing burden of osteoarthritis. Patients <65 years of age represent the fastest growing group of TKR recipients and are expected to account for an increasing number of primary and revision procedures. Concerns have been raised about the outcomes that can be expected by this age demographic who are more active, physically demanding, and have longer life expectancies compared to older TKR recipients. This systematic review and meta-analysis evaluated the effectiveness of TKR for osteoarthritis in patients <65 years of age, compared to older individuals. A systematic search of Embase and Medline was conducted to identify studies which examined patient-reported outcomes measured using disease-specific and generic health-related quality of life instruments. Ten studies met our inclusion criteria and were included in this review. These studies comprised 1747 TKRs performed between 1977 and 2014. In the meta-analysis of two prospective studies (288 TKRs), patients <65 years of age were able to attain large and clinically meaningful improvements in pain, function, and quality of life. One of these studies (61 TKRs) suggested that patients <55 years of age attained a larger degree of improvement compared to older individuals. Results into the second postoperative decade were less certain, with some data suggesting a high prevalence of pain and patterns of functional decline. Further research is required to investigate longer-term outcomes following TKR for osteoarthritis in younger patients.
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ItemPreoperative opioid use and complications following total joint replacement: a protocol for a systematic review and meta-analysis.(BMJ Journals, 2020-06-16)INTRODUCTION: Mounting evidence now indicates that preoperative opioid use is associated with an array of complications following total joint replacement (TJR). However, evidence of these risks remains fragmented. A comprehensive and well-integrated understanding of this body of evidence is necessary to appropriately inform treatment decisions, the allocation of limited healthcare resources, and the direction of future clinical research. The proposed systematic review and meta-analysis aims to identify and synthesise the available evidence of an association between opioid use prior to TJR and postoperative complications, categorised by complication type. METHODS AND ANALYSIS: We will search MEDLINE, EMBASE, CINAHL, PsycINFO, and Web of Science from inception to April 2020. Observational and experimental studies that compare preoperative opioid users who have undergone elective TJR to opioid naïve TJR patients will be included. The primary outcomes will be postoperative complications, which will be categorised as either mortality, morbidity, or joint-related complications. The secondary outcomes will be persistent postoperative opioid use, readmission, and length of stay. Individual study quality will be assessed using the relevant NIH-NHLBI study quality assessment tools. Findings will be reported in narrative and tabular form, and, where possible, odds ratios (dichotomous outcomes) or standardised mean differences (continuous outcomes) will be reported with 95% confidence intervals. Where appropriate, random effect meta-analyses will be conducted for each outcome, and heterogeneity will be quantified using the I2 statistic and Cochran's Q test. This study will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Meta-analyses Of Observational Studies in Epidemiology (MOOSE) guidelines. ETHICS AND DISSEMINATION: Ethics approval will not be required as no primary or private data are being collected. Findings will be disseminated through peer-reviewed publication and presentation at academic conferences. PROSPERO REGISTRATION NUMBER: CRD42020153047.