School of Mathematics and Statistics - Research Publications
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ItemPeri-operative lidocaine infusion for open radical prostatectomy - a reply(WILEY-BLACKWELL, 2016-10)
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ItemPositive airway pressure for sleep-disordered breathing in acute quadriplegia: a randomised controlled trial(BMJ PUBLISHING GROUP, 2019-03)RATIONALE: Highly prevalent and severe sleep-disordered breathing caused by acute cervical spinal cord injury (quadriplegia) is associated with neurocognitive dysfunction and sleepiness and is likely to impair rehabilitation. OBJECTIVE: To determine whether 3 months of autotitrating CPAP would improve neurocognitive function, sleepiness, quality of life, anxiety and depression more than usual care in acute quadriplegia. METHODS AND MEASUREMENTS: Multinational, randomised controlled trial (11 centres) from July 2009 to October 2015. The primary outcome was neurocognitive (attention and information processing as measure with the Paced Auditory Serial Addition Task). Daytime sleepiness (Karolinska Sleepiness Scale) was a priori identified as the most important secondary outcome. MAIN RESULTS: 1810 incident cases were screened. 332 underwent full, portable polysomnography, 273 of whom had an apnoea hypopnoea index greater than 10. 160 tolerated at least 4 hours of CPAP during a 3-day run-in and were randomised. 149 participants (134 men, age 46±34 years, 81±57 days postinjury) completed the trial. CPAP use averaged 2.9±2.3 hours per night with 21% fully 'adherent' (at least 4 hours use on 5 days per week). Intention-to-treat analyses revealed no significant differences between groups in the Paced Auditory Serial Addition Task (mean improvement of 2.28, 95% CI -7.09 to 11.6; p=0.63). Controlling for premorbid intelligence, age and obstructive sleep apnoea severity (group effect -1.15, 95% CI -10 to 7.7) did not alter this finding. Sleepiness was significantly improved by CPAP on intention-to-treat analysis (mean difference -1.26, 95% CI -2.2 to -0.32; p=0.01). CONCLUSION: CPAP did not improve Paced Auditory Serial Addition Task scores but significantly reduced sleepiness after acute quadriplegia. TRIAL REGISTRATION NUMBER: ACTRN12605000799651.
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ItemMultidisciplinary home-based rehabilitation in inoperable lung cancer: a randomised controlled trial(BMJ PUBLISHING GROUP, 2019-08)BACKGROUND: Lung cancer is associated with poor health-related quality of life (HRQoL) and high symptom burden. This trial aimed to assess the efficacy of home-based rehabilitation versus usual care in inoperable lung cancer. METHODS: A parallel-group, assessor-blinded, allocation-concealed, randomised controlled trial. Eligible participants were allocated (1:1) to usual care (UC) plus 8 weeks of aerobic and resistance exercise with behaviour change strategies and symptom support (intervention group (IG)) or UC alone. Assessments occurred at baseline, 9 weeks and 6 months. The primary outcome, change in between-group 6 min walk distance (6MWD), was analysed using intention-to-treat (ITT). Subsequent analyses involved modified ITT (mITT) and included participants with at least one follow-up outcome measure. Secondary outcomes included HRQoL and symptoms. RESULTS: Ninety-two participants were recruited. Characteristics of participants (UC=47, IG=45): mean (SD) age 64 (12) years; men 55%; disease stage n (%) III=35 (38) and IV=48 (52); radical treatment 46%. There were no significant between-group differences for the 6MWD (n=92) at 9 weeks (p=0.308) or 6 months (p=0.979). The mITT analyses of 6MWD between-group differences were again non-significant (mean difference (95% CI): 9 weeks: -25.4 m (-64.0 to 13.3), p=0.198 and 6 months: 41.3 m (-26.7 to 109.4), p=0.232). Significant 6-month differences, favouring the IG, were found for HRQoL (Functional Assessment of Cancer Therapy-Lung: 13.0 (3.9 to 22.1), p=0.005) and symptom severity (MD Anderson Symptom Inventory-Lung Cancer: -2.2 (-3.6 to -0.9), p=0.001). CONCLUSIONS: Home-based rehabilitation did not improve functional exercise capacity but there were improvements in patient-reported exploratory secondary outcomes measures observed at 6 months. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12614001268639).
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ItemBenefits of home-based multidisciplinary exercise and supportive care in inoperable non-small cell lung cancer - protocol for a phase II randomised controlled trial(BMC, 2017-09-29)BACKGROUND: Lung cancer is one of the most commonly diagnosed cancers, and is a leading cause of cancer mortality world-wide. Due to lack of early specific symptoms, the majority of patients present with advanced, inoperable disease and five-year relative survival across all stages of non-small cell lung cancer (NSCLC) is 14%. People with lung cancer also report higher levels of symptom distress than those with other forms of cancer. Several benefits for survival and patient reported outcomes are reported from physical activity and exercise in other tumour groups. We report the protocol for a study investigating the benefits of exercise, behaviour change and symptom self-management for patients with recently diagnosed, inoperable, NSCLC. METHODS: This multi-site, parallel-group, assessor-blinded randomised controlled trial, powered for superiority, aims to assess functional and patient-reported outcomes of a multi-disciplinary, home-based exercise and supportive care program for people commencing treatment. Ninety-two participants are being recruited from three tertiary-care hospitals in Melbourne, Australia. Following baseline testing, participants are randomised using concealed allocation, to receive either: a) 8 weeks of home-based exercise (comprising an individualised endurance and resistance exercise program and behaviour change coaching) and nurse-delivered symptom self-management intervention or b) usual care. The primary outcome is the between-group difference in the change in functional exercise capacity (six-minute walk distance) from baseline to post-program assessment. Secondary outcomes include: objective and self-reported physical activity levels, physical activity self-efficacy, behavioural regulation of motivation to exercise and resilience, muscle strength (quadriceps and grip), health-related quality of life, anxiety and depression and symptom interference. DISCUSSION: There is a lack of evidence regarding the benefit of exercise intervention for people with NSCLC, particularly in those with inoperable disease receiving treatment. This trial will contribute to evidence currently being generated in national and international trials by implementing and evaluating a home-based program including three components not yet combined in previous research, for people with inoperable NSCLC receiving active treatment and involving longer-term follow-up of outcomes. This trial is ongoing and currently recruiting. TRIAL REGISTRATION: This trial was prospectively registered on the Australian New Zealand Clinical Trials Registry ( ACTRN12614001268639 : (4/12/14).
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ItemA randomised controlled trial of peri-operative lidocaine infusions for open radical prostatectomy(WILEY, 2016-04)We allocated 76 men scheduled for radical retropubic prostatectomy to peri-operative lidocaine 2% or saline 0.9%: a pre-operative 0.075 ml.kg(-1) intravenous bolus; an intra-operative intravenous infusion at 0.075 ml.kg(-1) .h(-1) ; and 24 hours' postoperative subcutaneous infusion at 0.075 ml.kg(-1) .h(-1) . Lidocaine reduced the postoperative hospital stay by a mean (95% CI) of 1.3 (0.3-2.4) days, p = 0.017, from a mean (SD) of 4.6 (3.2) days with saline. There were no significant differences in pain at rest or on coughing at 24 h. [corrected]. Lidocaine reduced 24-h morphine consumption by a mean (95% CI) of 13.9 (2.2-25.7) mg, p = 0.021, from a mean (SD) of 52.3 (26.9) mg with saline. There were no differences in other outcomes.
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ItemCohort Profile: Ten to Men ( the Australian Longitudinal Study on Male Health)(OXFORD UNIV PRESS, 2017-06)
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ItemThe Australian longitudinal study on male health-methods(BMC, 2016-10-31)BACKGROUND: The Australian Longitudinal Study on Male Health (Ten to Men) was established in 2011 to build the evidence base on male health to inform policy and program development. METHODS: Ten to Men is a national longitudinal study with a stratified multi-stage cluster random sample design and oversampling in rural and regional areas. Household recruitment was conducted from October 2013 to July 2014. Males who were aged 10 to 55 years residing in private dwellings were eligible to participate. Data were collected via self-completion paper questionnaires (participants aged 15 to 55) and by computer-assisted personal interview (boys aged 10 to 14). Household and proxy health data for boys were collected from a parent via a self-completion paper-based questionnaire. Questions covered socio-demographics, health status, mental health and wellbeing, health behaviours, social determinants, and health knowledge and service use. RESULTS: A cohort of 15,988 males aged between 10 and 55 years was recruited representing a response fraction of 35 %. CONCLUSION: Ten to Men is a unique resource for investigating male health and wellbeing. Wave 1 data are available for approved research projects.
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ItemMinimal important difference of the 6-minute walk distance in lung cancer(SAGE PUBLICATIONS LTD, 2015-05)The 6-minute walk distance (6MWD) is one of the most commonly used measures of functional capacity in lung cancer, however, the minimal important difference (MID) has not been established. The aims of this exploratory study are, in lung cancer, to estimate (1) the MID of the 6MWD and (2) relationship between 6MWD, demographic and disease-related factors. Fifty-six participants with stage I-IV lung cancer completed the 6MWD prior to treatment and 10 weeks later. No exercise intervention occurred. Additional measures included European Organization for Research and Treatment of Cancer questionnaire (EORTC-QLQ-C30) and questionnaires assessing function, physical activity and symptoms. MID was calculated using anchor- and distribution-based methods. The mean 6MWD decline in participants classed as deteriorated was 60 m compared with 16 m in participants classed as not-deteriorated (p = 0.01). The receiver operating curve indicated a cut-off value for clinically relevant change to be 42 m (95% confidence interval (CI) 6-75) (area under curve = 0.66, 95% CI 0.51-0.81) or a 9.5% change. Distribution-based methods indicated an MID between 22 m (95% CI 18-26) and 32 m (95% CI 20-42). Higher 6MWD correlated with better function (r = -0.42, p = 0.001), physical activity (r = 0.56, p < 0.005) and dyspnoea (r = -0.44, p = 0.001). The MID for deterioration of the 6MWD in lung cancer is estimated to be between 22 m and 42 m or a change of 9.5%.
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ItemUltrasonography in the intensive care setting can be used to detect changes in the quality and quantity of muscle and is related to muscle strength and function(W B SAUNDERS CO-ELSEVIER INC, 2015-10)PURPOSE: This study aimed to (1) document patterns of quadriceps muscle wasting in the first 10 days of admission and (2) determine the relationship between muscle ultrasonography and volitional measures. MATERIALS AND METHODS: Twenty-two adults ventilated for more than 48 hours were included. Sequential quadriceps ultrasound images were obtained over the first 10 days and at awakening and intensive care unit (ICU) discharge. Muscle strength and function were assessed at awakening and ICU discharge. RESULTS: A total of 416 images were analyzed. There was a 30% reduction in vastus intermedius (VI) thickness, rectus femoris (RF) thickness, and cross-sectional area within 10 days of admission. Muscle echogenicity scores increased for both RF and VI muscles by +12.7% and +25.5%, respectively (suggesting deterioration in muscle quality). There was a strong association between function and VI thickness (r = 0.82) and echogenicity (r = -0.77). There was a moderate association between function and RF cross-sectional area (r = 0.71). CONCLUSIONS: Muscle wasting occurs rapidly in the ICU setting. Ultrasonography is a useful surrogate measure for identifying future impairment. Vastus intermedius may be an important muscle to monitor in the future because it demonstrated the greatest change in muscle quality and had the strongest relationship to volitional measures.