Surgery (St Vincent's) - Research Publications
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ItemLaying the foundations of community engagement in Aboriginal health research: establishing a community reference group and terms of reference in a novel research field.(Springer Science and Business Media LLC, 2022-08-04)BACKGROUND: Community engagement or community involvement in Aboriginal health research is a process that involves partnering, collaborating and involving Aboriginal and Torres Strait Islander people or potential research participants to empower them to have a say in how research with Aboriginal communities is conducted. In the context of Aboriginal health, this is particularly important so that researchers can respond to the priorities of the community under study and conduct research in a way that is respectful of Aboriginal cultural values and beliefs. One approach to incorporating the principals of community engagement and to ensure cultural oversight and guidance to projects is to engage a community reference group. The aim of this study was to describe the process of establishing an Aboriginal community reference group and terms of reference. The community reference group was established to guide the research activities of a newly formed research collaboration aiming to to develop osteoarthritis care that meets the needs of Aboriginal and Torres Strait Islander people in Australia. METHODS: Adopting a Participatory Action Research approach, this two-phase study was conducted in Victoria, Australia. In phase one, semi-structured research yarns (a cultural form of conversation used as a data gathering tool) were conducted collaboratively by Aboriginal and non-Aboriginal co-investigators to explore Aboriginal health stakeholder perspectives on establishing a community reference group and terms of reference. In phase two, recommendations in phase one were identified to invite members to participate in the community reference group and to ratify the terms of reference through a focus group. Data were analyzed using a framework analysis approach. RESULTS: Thirteen people (eight female, four male) participated in phase one. Participants represented diverse professional backgrounds including physiotherapy, nursing, general practice, health services management, hospital liaison, cultural safety education, health research and the arts. Three themes were identified in phase one; Recruitment and Representation (trust and relationships, in-house call-outs, broad-spectrum expertise and Aboriginal majority); Purpose (community engagement, research steering, knowledge dissemination and advocacy) and; Function and Logistics (frequency and format of meetings, size of group, roles and responsibilities, authority, communication and dissemination). In phase two, six Aboriginal people were invited to become members of the community reference group who recommended changes which were incorporated into the seven domains of the terms of reference. CONCLUSION: The findings of this study are captured in a 10-step framework which describes practical strategies for establishing a community reference group and terms of reference in Aboriginal health research.
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ItemPatient and clinician characteristics and preferences for increasing participation in placebo surgery trials: a scoping review of attributes to inform a discrete choice experiment(BMC, 2022-04-12)BACKGROUND: Orthopaedic surgeries include some of the highest volume surgical interventions globally; however, studies have shown that a significant proportion of patients report no clinically meaningful improvement in pain or function after certain procedures. As a result, there is increasing interest in conducting randomised placebo-controlled trials in orthopaedic surgery. However, these frequently fail to reach recruitment targets suggesting a need to improve trial design to encourage participation. The objective of this study was to systematically scope the available evidence on patient and clinician values and preferences which may influence the decision to participate in placebo surgery trial. METHODS: A systematic review was conducted via a literature search in the MEDLINE, Embase, PsycInfo, CINAHL, and EconLit databases as of 19 July 2021, for studies of any design (except commentaries or opinion pieces) based on two key concepts: patient and clinician characteristics, values and preferences, and placebo surgery trials. RESULTS: Of 3424 initial articles, we retained 18 eligible studies. Characteristics, preferences, values, and attitudes of patients (including levels of pain/function, risk/benefit perception, and altruism) and of clinicians (including concerns regarding patient deception associated with placebo, and experience/training in research) influenced their decisions to participate in placebo-controlled trials. Furthermore, some aspects of trial design, including randomisation procedures, availability of the procedure outside of the trial, and the information and consent procedures used, also influenced decisions to participate. CONCLUSION: Participant recruitment is a significant challenge in placebo surgery trials, and individual decisions to participate appear to be sensitive to preferences around treatment. Understanding and quantifying the role patient and clinician preferences may play in surgical trials may contribute to the optimisation of the design and implementation of clinical trials in surgery.
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ItemEffect of Bariatric Surgery on Risk of Complications After Total Knee Arthroplasty: A Randomized Clinical Trial(American Medical Association, 2022-04-14)Importance: People with severe obesity who undergo a total knee arthroplasty (TKA) for osteoarthritis (OA) are at higher risk of short-term and long-term complications compared with people with reference (<30) body mass index (BMI; weight in kilograms divided by height in meters squared). It is not known whether weight loss before TKA modifies this risk. Objective: To determine whether outcomes are improved by undergoing bariatric surgery before TKA in people with BMI greater than or equal to 35 and end-stage OA. Design, Setting, and Participants: This parallel-group, assessor-blinded, randomized clinical trial was conducted between May 2012 and June 2020 with a minimum follow-up of 12 months after TKA. TKA was performed at a tertiary referral university-affiliated public hospital, and bariatric surgery was performed at a private hospital facility and a university-affiliated private practice. Data analysis was performed from February to July 2021. Interventions: Bariatric surgery compared with usual weight management advice (treatment as usual [TAU]) in people scheduled for TKA. Main Outcomes and Measures: The primary outcome was complications of TKA measured by a composite of death from any cause, perioperative or postoperative complications resulting in a discharge delay, unplanned procedure, or readmission for at least 12 months after TKA. Secondary outcomes included hospital bed day utilization, anthropomorphic measures, and patient-reported outcomes. Results: Eighty-two patients waiting for TKA were randomized to undergo bariatric surgery (41 patients) or TAU (41 patients). Of the 82 participants, 66 (80.5%) were women, the mean (SD) age was 57.8 (4.9) years, and the mean (SD) BMI was 43.8 (5.5). Thirty-nine participants (95.1%) in the intervention group underwent laparoscopic adjustable gastric banding, and 29 (70.7%) subsequently underwent TKA. Thirty-nine patients (95.1%) in the TAU group underwent TKA. Six patients (14.6%) in the intervention group incurred the primary outcome (median follow-up, 24 months), compared with 15 (36.6%) in the TAU group (median follow-up, 27 months) (difference, 22.0%; 95% CI, 3.7% to 40.3%; P = .02). The between-group difference in BMI at 12 months was -6.32 (95% CI, -7.90 to -4.50; P < .001) in favor of the intervention group. TKA was declined by 12 participants (29.3%) in the intervention group because of symptom improvement, whereas 2 participants (4.9%) in the TAU group declined TKA (difference, 24.4%; 95% CI, 9.0% to 39.8%; P = .003). Conclusions and Relevance: Weight loss following bariatric surgery reduced the risk of complications of TKA in people with BMI greater than or equal to 35. Significantly fewer participants required TKA following weight loss, contributing to this finding. Trial Registration: Australian New Zealand Clinical Trials Registry Number: ACTRN12611001178932.
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ItemResponse to Letter to the Editor on "A Randomized Controlled Trial Comparing a Medial Stabilized Total Knee Prosthesis to a Cruciate Retaining and Posterior Stabilized Design: A Report of the Clinical and Functional Outcomes Following Total Knee Replacement"(CHURCHILL LIVINGSTONE INC MEDICAL PUBLISHERS, 2020-11-01)
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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, 2021-03-01)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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ItemA Nomogram for Predicting Non-Response to Surgery One Year after Elective Total Hip Replacement(MDPI, 2022-03-01)BACKGROUND: Total hip replacement (THR) is a common and cost-effective procedure for end-stage osteoarthritis, but inappropriate utilization may be devaluing its true impact. The purpose of this study was to develop and test the internal validity of a prognostic algorithm for predicting the probability of non-response to THR surgery at 1 year. METHODS: Analysis of outcome data extracted from an institutional registry of individuals (N = 2177) following elective THR performed between January 2012 and December 2019. OMERACT-OARSI responder criteria were applied to Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain and function scores at pre- and 1 year post-THR, to determine non-response to surgery. Independent prognostic correlates of post-operative non-response observed in adjusted modelling were then used to develop a nomogram. RESULTS: A total of 194 (8.9%) cases were deemed non-responders to THR. The degree of contribution (OR, 95% CI) of each explanatory factor to non-response on the nomogram was, morbid obesity (1.88, 1.16, 3.05), Kellgren-Lawrence grade <4 (1.89, 1.39, 2.56), WOMAC Global rating per 10 units (0.86, 0.79, 0.94) and the following co-morbidities: cerebrovascular disease (2.39, 1.33, 4.30), chronic pulmonary disease (1.64; 1.00, 2.71), connective tissue disease (1.99, 1.17, 3.39), diabetes (1.86, 1.26, 2.75) and liver disease (2.28, 0.99, 5.27). The concordance index for the nomogram was 0.70. CONCLUSION: We have developed a prognostic nomogram to calculate the probability of non-response to THR surgery. In doing so, we determined that both the probability of and predictive prognostic factors for non-response to THR differed from a previously developed nomogram for total knee replacement (TKR), confirming the benefit of designing decision support tools that are both condition and surgery site specific. Future external validation of the nomogram is required to confirm its generalisability.
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ItemAddressing surgical inequity for Aboriginal and Torres Strait Islander people in Australia's universal health care system: a call to action(WILEY, 2021-01-28)Aboriginal and Torres Strait Islander people continue to experience health inequity within the Australian health care system. Little research has examined how disparities in surgical care access and outcomes contribute to Aboriginal health. In this narrative review and call to action, we discuss five care points along the journey to high-quality surgical care: health care seeking, primary health care services, specialist services, surgery and surgical outcomes. We highlight barriers and disparities that exist along this journey, drawing examples from the field of joint replacement surgery. Finally, we present opportunities for change at the health system, health service and clinician level, calling upon researchers, clinicians and policy makers to confront the surgical disparities experienced by Aboriginal and Torres Strait Islander people.
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ItemSham surgery: justified but practical? A systematic review of sham surgery trials in orthopaedics(Academy of Science of South Africa, 2018)BACKGROUND: An increasing trend for sham surgery trials in minor orthopaedic procedures has been observed. Trial outcomes have changed the practice landscape of these procedures. However, there has been no sham surgery trial in a major orthopaedic procedure. The aims of this systematic review were to consider the ethics of sham surgery trials; to describe orthopaedic sham surgery trials conducted to date; and to consider the challenges that will need to be overcome in order to conduct sham surgery trials for major orthopaedic procedures in the future. METHODS: A systematic review of the literature and clinical trial registries was undertaken. Trials with a published main findings paper underwent a risk of bias assessment using the Cochrane Collaboration risk of bias tool, in addition to an ethical assessment based on the work of Horng and Miller. RESULTS: We identified 22 sham surgery trials for minor orthopaedic procedures that have been completed, terminated, or are currently in process. Among the ten trials with a published main findings paper, only one was free from risk of bias; all others were at risk of bias. According to the ethical assessment, the benefits of a sham control were outweighed by the risks in all but two of the ten trials. Across the 22 trials with published and unpublished main findings, participant recruitment within reasonable timeframes, as well as the low threshold for crossover from the sham were recurring challenges. CONCLUSIONS: Researchers are obliged to carefully consider the feasibility of conducting a sham surgery trial in a major orthopaedic procedure, before drawing on limited research funds. Exploring the conditions under which patients and surgeons would find participation in a sham surgery trial acceptable, and simulating trial costs based on patient and surgeon preferences may assist funders, assessors and ethics boards to determine whether to support the conducting of future sham surgery trials in major orthopaedic procedures.
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ItemMisconceptions and the Acceptance of Evidence-based Nonsurgical Interventions for Knee Osteoarthritis. A Qualitative Study(LIPPINCOTT WILLIAMS & WILKINS, 2019-09-01)BACKGROUND: In contrast to best practice guidelines for knee osteoarthritis (OA), findings from several different healthcare settings have identified that nonsurgical treatments are underused and TKA is overused. Empirical evidence and qualitative observations suggest that patients' willingness to accept nonsurgical interventions for knee OA is low. A qualitative investigation of why patients may feel that such interventions are of little value may be an important step toward increasing their use in the treatment of knee OA QUESTIONS/PURPOSES: This qualitative study was embedded in a larger study investigating patient-related factors (beliefs/attitudes toward knee OA and its treatment) and health-system related factors (access, referral pathways) known to influence patients' decisions to seek medical care. In this paper we focus on the patient-related factors with the aim of exploring why patients may feel that nonsurgical interventions are of little value in the treatment of knee OA. METHODS: A cross-sectional qualitative study was conducted in a single tertiary hospital in Australia. Patients with endstage knee OA on the waiting list for TKA were approached during their preadmission appointment and invited to participate in one-to-one interviews. As prescribed by the qualitative approach, data collection and data analysis were performed in parallel and recruitment continued until the authors agreed that the themes identified would not change through interviews with subsequent participants, at which point, recruitment stopped. Thirty-seven patients were approached and 27 participated. Participants were 48% female; mean age was 67 years. Participants' beliefs about knee OA and its treatment were identified in the interview transcripts. Beliefs were grouped into five belief dimensions: identity beliefs (what knee OA is), causal beliefs (what causes knee OA), consequence beliefs (what the consequences of knee OA are), timeline beliefs (how long knee OA lasts) and treatment beliefs (how knee OA can be controlled). RESULTS: All participants believed that their knee OA was "bone on bone" (identity beliefs) and most (> 14 participants) believed it was caused by "wear and tear" (causal beliefs). Most (> 14 participants) believed that loading the knee could further damage their "vulnerable" joint (consequence beliefs) and all believed that their pain would deteriorate over time (timeline beliefs). Many (>20 participants) believed that physiotherapy and exercise interventions would increase pain and could not replace lost knee cartilage. They preferred experimental and surgical treatments which they believed would replace lost cartilage and cure their knee pain (treatment beliefs). CONCLUSIONS: Common misconceptions about knee OA appear to influence patients' acceptance of nonsurgical, evidence-based treatments such as exercise and weight loss. Once the participants in this study had been "diagnosed" with "bone-on-bone" changes, many disregarded exercise-based interventions which they believed would damage their joint, in favor of alternative and experimental treatments, which they believed would regenerate lost knee cartilage. Future research involving larger, more representative samples are needed to understand how widespread these beliefs are and if/how they influence treatment decisions. In the meantime, clinicians seeking to encourage acceptance of nonsurgical interventions may consider exploring and targeting misconceptions that patients hold about the identity, causes, consequences, timeline, and treatment of knee OA. LEVEL OF EVIDENCE: Level II, prognostic study.