Surgery (St Vincent's) - Research Publications

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    Prognostic Indicators in Pediatric Clinically Isolated Syndrome
    Iaffaldano, P ; Simone, M ; Lucisano, G ; Ghezzi, A ; Coniglio, G ; Morra, VB ; Salemi, G ; Patti, F ; Lugaresi, A ; Izquierdo, G ; Bergamaschi, R ; Cabrera-Gomez, JA ; Pozzilli, C ; Millefiorini, E ; Alroughani, R ; Boz, C ; Pucci, E ; Zimatore, GB ; Sola, P ; Lus, G ; Maimone, D ; Avolio, C ; Cocco, E ; Sajedi, SA ; Costantino, G ; Duquette, P ; Shaygannejad, V ; Petersen, T ; Fernandez Bolanos, R ; Paolicelli, D ; Tortorella, C ; Spelman, T ; Margari, L ; Amato, MP ; Comi, G ; Butzkueven, H ; Trojano, M (WILEY, 2017-05)
    OBJECTIVE: To assess prognostic factors for a second clinical attack and a first disability-worsening event in pediatric clinically isolated syndrome (pCIS) suggestive of multiple sclerosis (MS) patients. METHODS: A cohort of 770 pCIS patients was followed up for at least 10 years. Cox proportional hazard models and Recursive Partitioning and Amalgamation (RECPAM) tree-regression were used to analyze data. RESULTS: In pCIS, female sex and a multifocal onset were risk factors for a second clinical attack (hazard ratio [HR], 95% confidence interval [CI] = 1.28, 1.06-1.55; 1.42, 1.10-1.84, respectively), whereas disease-modifying drug (DMD) exposure reduced this risk (HR, 95% CI = 0.75, 0.60-0.95). After pediatric onset MS (POMS) diagnosis, age at onset younger than 15 years and DMD exposure decreased the risk of a first Expanded Disability Status Scale (EDSS)-worsening event (HR, 95% CI = 0.59, 0.42-0.83; 0.75, 0.71-0.80, respectively), whereas the occurrence of relapse increased this risk (HR, 95% CI = 5.08, 3.46-7.46). An exploratory RECPAM analysis highlighted a significantly higher incidence of a first EDSS-worsening event in patients with multifocal or isolated spinal cord or optic neuritis involvement at onset in comparison to those with an isolated supratentorial or brainstem syndrome. A Cox regression model including RECPAM classes confirmed DMD exposure as the most protective factor against EDSS-worsening events and relapses as the most important risk factor for attaining EDSS worsening. INTERPRETATION: This work represents a step forward in identifying predictors of unfavorable course in pCIS and POMS and supports a protective effect of early DMD treatment in preventing MS development and disability accumulation in this population. Ann Neurol 2017;81:729-739.
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    Impact of surgical experience on outcomes in total joint arthroplasties
    Wilson, MD ; Dowsey, MM ; Spelman, T ; Choong, PFM (WILEY-BLACKWELL, 2016-12)
    BACKGROUND: Outcomes of primary total hip and knee arthroplasties performed by consultant surgeons were compared with those performed by orthopaedic trainees. Furthermore, outcomes of these procedures performed by senior trainees were compared with those performed by junior trainees. METHODS: Data from the St Vincent's Melbourne Arthroplasty Outcomes Registry and the surgical log kept by trainees were reviewed to investigate if an association exists between surgical experience and clinical outcomes following primary total hip and knee arthroplasties. Multivariate logistic regression analyses were conducted to produce odds ratios with 95% confidence intervals to assess these relationships. RESULTS: Arthroplasties performed by trainees were not significantly different from those performed by consultant surgeons in regards to medical, surgical and wound complications. Trainee-performed primary total hip arthroplasties were associated with a 30% increase in the risk of requiring a transfusion compared with consultant cases. Primary total knee arthroplasties performed by junior trainees were associated with a 50% increase in the risk of developing a wound complication compared with those performed by senior trainees. CONCLUSIONS: Overall, senior orthopaedic trainees working independently and junior orthopaedic trainees under supervision as the primary surgeon have the ability to achieve a level of clinical outcomes similar to a consultant surgeon. Junior trainees with supervision have the ability to achieve a level of clinical outcomes similar to senior trainees. These findings can be used to further improve orthopaedic training to reduce adverse events during supervised surgery.
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    Predictors of Long-Term Disability Accrual in Relapse-Onset Multiple Sclerosis
    Jokubaitis, VG ; Spelman, T ; Kalincik, T ; Lorscheider, J ; Havrdova, E ; Horakova, D ; Duquette, P ; Girard, M ; Prat, A ; Izquierdo, G ; Grammond, P ; Van Pesch, V ; Pucci, E ; Grand'Maison, F ; Hupperts, R ; Granella, F ; Sola, P ; Bergamaschi, R ; Iuliano, G ; Spitaleri, D ; Boz, C ; Hodgkinson, S ; Olascoaga, J ; Verheul, F ; McCombe, P ; Petersen, T ; Rozsa, C ; Lechner-Scott, J ; Laura Saladino, M ; Farina, D ; Iaffaldano, P ; Paolicelli, D ; Butzkueven, H ; Lugaresi, A ; Trojano, M (WILEY, 2016-07)
    OBJECTIVE: To identify predictors of 10-year Expanded Disability Status Scale (EDSS) change after treatment initiation in patients with relapse-onset multiple sclerosis. METHODS: Using data obtained from MSBase, we defined baseline as the date of first injectable therapy initiation. Patients need only have remained on injectable therapy for 1 day and were monitored on any approved disease-modifying therapy, or no therapy thereafter. Median EDSS score changes over a 10-year period were determined. Predictors of EDSS change were then assessed using median quantile regression analysis. Sensitivity analyses were further performed. RESULTS: We identified 2,466 patients followed up for at least 10 years reporting post-baseline disability scores. Patients were treated an average 83% of their follow-up time. EDSS scores increased by a median 1 point (interquartile range = 0-2) at 10 years post-baseline. Annualized relapse rate was highly predictive of increases in median EDSS over 10 years (coeff = 1.14, p = 1.9 × 10(-22) ). On-therapy relapses carried greater burden than off-therapy relapses. Cumulative treatment exposure was independently associated with lower EDSS at 10 years (coeff = -0.86, p = 1.3 × 10(-9) ). Furthermore, pregnancies were also independently associated with lower EDSS scores over the 10-year observation period (coeff = -0.36, p = 0.009). INTERPRETATION: We provide evidence of long-term treatment benefit in a large registry cohort, and provide evidence of long-term protective effects of pregnancy against disability accrual. We demonstrate that high annualized relapse rate, particularly on-treatment relapse, is an indicator of poor prognosis. Ann Neurol 2016;80:89-100.
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    Metastatic bone disease of the pelvis and extremities: rationalizing orthopaedic treatment
    Kirkinis, MN ; Spelman, T ; May, D ; Choong, PFM (WILEY, 2017-11)
    BACKGROUND: Choosing the appropriate treatment for patients presenting with impending or pathological fractures is difficult and understanding the prognosis based on certain characteristics can help inform the decision to treat and construct to use in a palliative setting. We retrospectively analysed patients presenting with metastatic bone disease in the extremities and pelvis. METHODS: Patients presenting with metastatic bone disease to the extremities or pelvis who underwent orthopaedic treatment from 1996 to 2012 were identified. Survival rates were calculated using life table analysis. Univariate and multivariate analysis was achieved with Cox proportional hazards regression. RESULTS: There were a total of 462 patients. An overall 1-, 2- and 5-year survival rate of 45%, 29% and 13% was identified, respectively. In the multivariate analysis, preoperative haemoglobin was found to be an independent predictor of better survival while lung histotype, age, pathological fracture and previous combined therapy were negative predictors of survival. Patients undergoing prosthetic replacement had a significantly longer period of hospitalization in comparison to those undergoing internal fixation. CONCLUSION: This study has contributed to our understanding of the survival rate and survival prognostication for patients presenting for orthopaedic treatment of metastatic bone disease.
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    Risk of early relapse following the switch from injectables to oral agents for multiple sclerosis
    Spelman, T ; Mekhael, L ; Burke, T ; Butzkueven, H ; Hodgkinson, S ; Havrdova, E ; Horakova, D ; Duquette, P ; Izquierdo, G ; Grand'Maison, F ; Grammond, P ; Barnett, M ; Lechner-Scott, J ; Alroughani, R ; Trojano, M ; Lugaresi, A ; Granella, F ; Pucci, E ; Vucic, S (WILEY, 2016-04)
    BACKGROUND AND PURPOSE: Early relapse outcomes in long-term stable patients switching from interferon β/glatiramer acetate (IFNβ/GA) to oral therapy are unknown. OBJECTIVE: The objective of this study was to compare early relapse and progression in multiple sclerosis (MS) patients switching to oral therapy following a period of stable disease on IFNβ/GA, relative to a propensity-matched comparator of patients remaining on IFNβ/GA. METHODS: The MSBase cohort study is a global, longitudinal registry for MS. Time to first 6-month relapse in previously stable MS patients switching from platform injectables ('switchers') to oral agents were compared with propensity-matched patients remaining on IFNβ/GA ('stayers') using a Cox marginal model. RESULTS: Three-hundred and ninety-six switchers were successfully matched to 396 stayers on a 1:1 basis. There was no difference in the proportion of patients recording at least one relapse in the first 1-6 months by treatment arm (7.3% switchers, 6.6% stayers; P = 0.675). The mean annualized relapse rate (P = 0.493) and the rate of first 6-month relapse by treatment arm (hazard ratio 1.22, 95% confidence interval 0.70, 2.11) were also comparable. There was no difference in the rate of disability progression by treatment arm (hazard ratio 1.43, 95% confidence interval 0.63, 3.26). CONCLUSION: This is the first study to compare early relapse switch probability in the period immediately following switch to oral treatment in a population previously stable on injectable therapy. There was no evidence of disease reactivation within the first 6 months of switching to oral therapy.
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    Predicting the prognosis of undifferentiated pleomorphic soft tissue sarcoma: a 20-year experience of 266 cases
    Vodanovich, DA ; Spelman, T ; May, D ; Slavin, J ; Choong, PFM (WILEY, 2019-09)
    BACKGROUND: Undifferentiated pleomorphic sarcoma (UPS) is a rare malignant tumour of mesenchymal origin, which was conceived following re-classification of malignant fibrous histiocytoma (MFH). The objective of this study is to determine prognostic factors for the outcome of UPS, following multi-modal treatment. METHODS: Data of UPS tumours from 1996 to 2016 were collected, totalling 266 unique UPS patients. Median follow-up was 7.8 years. All tumours were retrospectively analysed for prognostic factors of the disease, including local recurrence (LR) and metastatic disease (MD) at diagnosis, tumour size, grade, location and depth, patient age, adjuvant therapy and surgical margin. Overall survival (OS), post-treatment LR and metastatic-free survival were assessed as outcomes. RESULTS: The 5- and 10-year OS rates for all ages were 60% and 48%, respectively, with a median survival time of 10.1 years. Multivariate analysis revealed that the adverse prognostic factors associated with decreased OS were older age (P < 0.001; hazard ratio 1.03) and MD at diagnosis (P = 0.001; 2.89), with upper extremity tumours being favourable (P = 0.043; 2.30). Poor prognosis for post-operative LR was associated with older age (P = 0.046; 1.03) and positive surgical margins (P = 0.028; 2.68). Increased post-treatment MD was seen in patients with large tumours (5-9 cm (P < 0.001; 4.42), ≥10 cm (P < 0.001; 6.80)) and MD at diagnosis (P < 0.001; 3.99), adjuvant therapy was favourable, shown to reduce MD (P < 0.001; 0.34). CONCLUSIONS: UPS is a high-grade soft tissue sarcoma, for which surgery striving for negative margins, with radiotherapy, is the treatment of choice. Older age, lower extremity location, MD at presentation, large size and positive surgical margins, were unfavourable.
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    Congenital heart defect repair with ADAPT tissue engineered pericardium scaffold: An early-stage health economic model
    Velickovic, VM ; Borisenko, O ; Svensson, M ; Spelman, T ; Siebert, U ; Backx, PH (PUBLIC LIBRARY SCIENCE, 2018-09-27)
    OBJECTIVE: The objective of this study was to evaluate the cost effectiveness of tissue engineered bovine tissue pericardium scaffold (CardioCel) for the repair of congenital heart defects in comparison with surgery using xenogeneic, autologous, and synthetic patches over a 40-year time horizon from the perspective of the UK National Health Service. METHODS: A six-state Markov state-transition model to model natural history of disease and difference in the interventional effect of surgeries depending on patch type implanted. Patches differed regarding their probability of re-operation due to patch calcification, based on a systematic literature review. Transition probabilities were based on the published literature, other clinical inputs were based on UK registry data, and cost data were based on UK sources and the published literature. Incremental cost-effectiveness ratio (ICER) was determined as incremental costs per quality adjusted life years (QALY) gained. We used a 40-year analytic time-horizon and adopted the payer perspective. Comprehensive sensitivity analyses were performed. RESULTS: According to the model predictions, CardioCel was associated with reduced incidence of re-operation, increased QALY, and costs savings compared to all other patches. Cost savings were greatest compared to synthetic patches. Estimated cost savings associated with CardioCel were greatest within atrioventricular septal defect repair and lowest for ventricular septal defect repair. Based on our model, CardioCel relative risk for re-operations is 0.938, 0.956and 0.902 relative to xenogeneic, autologous, and synthetic patches, respectively. CONCLUSION: CardioCel was estimated to increase health benefits and save cost when used during surgery for congenital heart defects instead of other patches.
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    Treatment of scabies using a tea tree oil-based gel formulation in Australian Aboriginal children: protocol for a randomised controlled trial
    Thomas, J ; Davey, R ; Peterson, GM ; Carson, C ; Walton, SF ; Spelman, T ; Calma, T ; Dettwiller, P ; Tobin, J ; McMillan, F ; Collis, P ; Naunton, M ; Kosari, S ; Christenson, JK ; Bartholomaeus, A ; McEwen, J ; Fitzpatrick, P ; Baby, KE (BMJ PUBLISHING GROUP, 2018-05)
    INTRODUCTION: In remote Aboriginal communities in Australia, scabies affects 7 out of 10 children before their first birthday. This is more than six times the rate seen in the rest of the developed world. Scabies infestation is frequently complicated by bacterial infection, leading to the development of skin sores and other more serious consequences, such as septicaemia and chronic heart and kidney diseases. Tea tree oil (TTO) has been used as an antimicrobial agent for several decades with proven clinical efficacy. Preclinical investigations have demonstrated superior scabicidal properties of TTO compared with widely used scabicidal agents, such as permethrin 5% cream and ivermectin. However, current data are insufficient to warrant a broad recommendation for its use for the management of scabies because previous studies were small or limited to in vitro observations. METHODS AND ANALYSIS: A pragmatic first trial will examine the clinical efficacy of a simple and low-cost TTO treatment against paediatric scabies and the prevention of associated secondary bacterial infections, with 1:1 randomisation of 200 participants (Aboriginal children, aged 5-16 years and living in remote Australia) into active control (permethrin 5% cream) and treatment (5% TTO gel) groups. The primary outcome for the study is clinical cure (complete resolution). Secondary outcome measures will include relief of symptoms, recurrence rate, adverse effects, adherence to treatment regimen and patient acceptability. ETHICS AND DISSEMINATION: The project has received approvals from the University of Canberra Human Research Ethics Committee (HREC 16-133), Wurli-Wurlinjang Health Service Indigenous subcommittee and the Aboriginal Medical Services Alliance Northern Territory reference group. The results of this study will be published in core scientific publications, with extensive knowledge exchange activities with non-academic audiences throughout the duration of the project. TRIAL REGISTRATION: ACTRN12617000902392; Pre-results.
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    Higher Human T-Lymphotropic Virus Type 1 Subtype C Proviral Loads Are Associated With Bronchiectasis in Indigenous Australians: Results of a Case-Control Study
    Einsiedel, L ; Cassar, O ; Goeman, E ; Spelman, T ; Au, V ; Hatami, S ; Joseph, S ; Gessain, A (OXFORD UNIV PRESS INC, 2014-03)
    BACKGROUND: We previously suggested that infection with the human T-lymphotropic virus type 1 (HTLV-1) subtype C is associated with bronchiectasis among Indigenous Australians. Bronchiectasis might therefore result from an HTLV-1-mediated inflammatory process that is typically associated with a high HTLV-1 proviral load (PVL). Human T-lymphotropic virus type 1 PVL have not been reported for Indigenous Australians. METHODS: Thirty-six Indigenous adults admitted with bronchiectasis from June 1, 2008, to December 31, 2009 were prospectively recruited and matched by age, sex, and ethno-geographic origin to 36 controls. Case notes and chest high-resolution computed tomographs were reviewed, and pulmonary injury scores were calculated. A PVL assay for the HTLV-1c subtype that infects Indigenous Australians was developed and applied to this study. Clinical, radiological, and virological parameters were compared between groups and according to HTLV-1 serostatus. RESULTS: Human T-lymphotropic virus type 1 infection was the main predictor of bronchiectasis in a multivariable model (adjusted risk ratio [aRR], 1.84; 95% confidence interval [CI], 1.19-2.84; P = .006). Moreover, the median HTLV-1c PVL (interquartile range) for cases was >100-fold that of controls (cases, 0.319 [0.007, 0.749]; controls, 0.003 [0.000, 0.051] per 100 peripheral blood lymphocytes; P = .007), and HTLV-1c PVL were closely correlated with radiologically determined pulmonary injury scores (Spearman's rho = 0.7457; P = .0000). Other predictors of bronchiectasis were positive Strongyloides serology (aRR, 1.69; 95% CI, 1.13-2.53) and childhood skin infections (aRR, 1.62; 95% CI, 1.07-2.44). Bronchiectasis was the major predictor of death (aRR, 2.71; 95% CI, 1.36-5.39; P = .004). CONCLUSIONS: These data strongly support an etiological association between HTLV-1 infection and bronchiectasis in a socially disadvantaged population at risk of recurrent lower respiratory tract infections.
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    Predictors of non-cystic fibrosis bronchiectasis in Indigenous adult residents of central Australia: results of a case-control study
    Einsiedel, L ; Pham, H ; Au, V ; Hatami, S ; Wilson, K ; Spelman, T ; Jersmann, H (EUROPEAN RESPIRATORY SOC JOURNALS LTD, 2019-10-01)
    The human T-cell leukaemia virus type 1 (HTLV-1) is associated with pulmonary inflammation. Indigenous Australians in central Australia have a very high prevalence of HTLV-1 infection and we hypothesised that this might contribute to high rates of bronchiectasis in this population. 80 Indigenous adults with confirmed bronchiectasis, each matched by age, sex and language to two controls without bronchiectasis, were recruited. Case notes and chest imaging were reviewed, HTLV-1 serology and the number of peripheral blood leukocytes (PBLs) infected with HTLV-1 (pro-viral load (PVL)) were determined, and radiological abnormality scores were calculated. Participants were followed for a mean±sd of 1.14±0.86 years and causes of death were determined. Median (interquartile range) HTLV-1 PVL for cases was 8-fold higher than controls (cases 213.8 (19.7-3776.3) copies per 105 PBLs versus controls 26.6 (0.9-361) copies per 105 PBLs; p=0.002). Radiological abnormality scores were higher for cases with HTLV-1 PVL ≥1000 copies per 105 PBLs and no cause of bronchiectasis other than HTLV-1 infection. Major predictors of bronchiectasis were prior severe lower respiratory tract infection (adjusted OR (aOR) 17.83, 95% CI 4.51-70.49; p<0.001) and an HTLV-1 PVL ≥1000 copies per 105 PBLs (aOR 12.41, 95% CI 3.84-40.15; p<0.001). Bronchiectasis (aOR 4.27, 95% CI 2.04-8.94; p<0.001) and HTLV-1 PVL ≥1000 copies per 105 PBLs (aOR 3.69, 95% CI 1.11-12.27; p=0.033) predicted death. High HTLV-1 PVLs are associated with bronchiectasis and with more extensive radiological abnormalities, which may result from HTLV-1-mediated airway inflammation.