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Purpose: We conducted a cost-effectiveness analysis in which we compared a preoperative [18F]Fluorocholine PET/CT-based one-stop-shop imaging strategy with current best practice in which [18F]Fluorocholine PET/CT is only recommended after negative or inconclusive [99mTc]Tc-methoxy isobutyl isonitrile SPECT/CT for patients suffering from primary hyperparathyroidism. We investigated whether the one-stop-shop strategy performs as well as current best practice but at lower costs. Methods: We developed a cohort-level state transition model to evaluate both imaging strategies respecting an intraoperative parathyroid hormone monitored treatment setting as well as a traditional treatment setting. The model reflects patients' hospital journeys after biochemically diagnosed primary hyperparathyroidism. A cycle length of twelve months and a lifetime horizon were used. We conducted probabilistic analyses simulating 50,000 cohorts to assess joint parameter uncertainty. The incremental net monetary benefit and cost for each quality-adjusted life year were estimated. Furthermore, threshold analyses regarding the tariff of [18F]Fluorocholine PET/CT and the sensitivity of [99mTc]Tc-methoxy isobutyl isonitrile SPECT/CT were performed. Results: The simulated long-term health effects and costs were similar for both imaging strategies. Accordingly, there was no incremental net monetary benefit and the one-stop-shop strategy did not result in lower costs. These results applied to both treatment settings. The threshold analysis indicated that a tariff of €885 for [18F]Fluorocholine PET/CT was required to be cost-effective compared to current best practice. Conclusion: Both preoperative imaging strategies can be used interchangeably. Daily clinical practice grounds such as available local resources and patient preferences should inform policy-making on whether a hospital should implement the one-stop-shop imaging strategy. [ABSTRACT FROM AUTHOR]

Importance: The effects of altered neural processing, defined as altering neural networks responsible for perceptions of pain and function, on chronic pain remains unclear.Objective: To estimate the effect of a graded sensorimotor retraining intervention (RESOLVE) on pain intensity in people with chronic low back pain.Design, Setting, and Participants: This parallel, 2-group, randomized clinical trial recruited participants with chronic (>3 months) nonspecific low back pain from primary care and community settings. A total of 276 adults were randomized (in a 1:1 ratio) to the intervention or sham procedure and attention control groups delivered by clinicians at a medical research institute in Sydney, Australia. The first participant was randomized on December 10, 2015, and the last was randomized on July 25, 2019. Follow-up was completed on February 3, 2020.Interventions: Participants randomized to the intervention group (n = 138) were asked to participate in 12 weekly clinical sessions and home training designed to educate them about and assist them with movement and physical activity while experiencing lower back pain. Participants randomized to the control group (n = 138) were asked to participate in 12 weekly clinical sessions and home training that required similar time as the intervention but did not focus on education, movement, and physical activity. The control group included sham laser and shortwave diathermy applied to the back and sham noninvasive brain stimulation.Main Outcomes and Measures: The primary outcome was pain intensity at 18 weeks, measured on an 11-point numerical rating scale (range, 0 [no pain] to 10 [worst pain imaginable]) for which the between-group minimum clinically important difference is 1.0 point.Results: Among 276 randomized patients (mean [SD] age, 46 [14.3] years; 138 [50%] women), 261 (95%) completed follow-up at 18 weeks. The mean pain intensity was 5.6 at baseline and 3.1 at 18 weeks in the intervention group and 5.8 at baseline and 4.0 at 18 weeks in the control group, with an estimated between-group mean difference at 18 weeks of -1.0 point ([95% CI, -1.5 to -0.4]; P = .001), favoring the intervention group.Conclusions and Relevance: In this randomized clinical trial conducted at a single center among patients with chronic low back pain, graded sensorimotor retraining, compared with a sham procedure and attention control, significantly improved pain intensity at 18 weeks. The improvements in pain intensity were small, and further research is needed to understand the generalizability of the findings.Trial Registration: ANZCTR Identifier: ACTRN12615000610538. [ABSTRACT FROM AUTHOR]

Objective: To estimate the cost-effectiveness of a strength and balance exercise programme (SUNBEAM) which has been shown to be clinically effective in reducing the rate of falls in residents of aged care facilities. Design: An economic evaluation was conducted alongside a pragmatic cluster randomized controlled trial that included 16 residential care facilities and 221 participants. Mean participant age was 86 years, 65% were female and 78% relied on a mobility aide. A cost-effectiveness analysis examined the costs of providing the exercise programme and costs of health service use arising from falls in each arm (intervention and usual care) over 12 months. Main measures: Incremental cost-effectiveness ratios were calculated for the cost per fall avoided. Costs were bootstrapped to obtain adjusted confidence intervals for the incremental cost-effectiveness ratios. Results: Of 63 facilities contacted, 16 met the eligibility criteria and were randomized to the intervention or usual care (1:1). There were 142 falls in the intervention group and 277 in the usual care group. 72 injurious falls occurred in the intervention group versus 157 with usual care. Delivery of the SUNBEAM programme cost $463 per participant. The mean total cost of each fall (regardless of group) was $400.09 and the mean cost of each injurious fall was $708.27. The incremental cost-effectiveness ratio was $22 per fall per person avoided with the mean bootstrapped incremental cost-effectiveness ratio $18 per fall avoided (95% CI: −$380.34 to $417.85). Conclusion: The SUNBEAM programme can be considered cost-effective, relative to other fall-prevention interventions in older adults. [ABSTRACT FROM AUTHOR]

Background: This study aimed to determine the cost‐effectiveness of contrast‐enhanced magnetic resonance imaging (CE‐MRI) compared with multiphase CE computed tomography (CE‐CT) scan to characterize suspected liver lesions in patients with known colorectal carcinoma. Methods: A decision analytic model linking diagnostic accuracy to health outcomes in patients with colorectal carcinoma was constructed. The model assumed that CE‐MRI has superior sensitivity and equivalent specificity to CE‐CT, and patients with a colorectal liver metastasis could be eligible for curative surgery or chemotherapy and palliation. Delayed diagnosis or misdiagnosis was associated with worse health outcomes (disutility). Cost‐effectiveness was calculated as the incremental cost relative to the incremental benefit, the benefit was estimated using quality‐adjusted life years. Sensitivity analyses were conducted to test the robustness of the results. Results: The clinical evidence supports increased sensitivity of CE‐MRI compared with CE‐CT (0.943 versus 0.768). CE‐MRI was more effective and more costly than CE‐CT. The incremental cost‐effectiveness ratio was estimated to be $40 548 per quality‐adjusted life year gained. The model is most sensitive to the cost of MRI, cost of palliative treatment and the disutility associated with delayed palliative care. The results were also sensitive to the assumptions made about the clinical algorithm. Conclusion: The results provide evidence of the potential cost‐effectiveness associated with CE‐MRI for the diagnosis of liver metastases in patients with identified colorectal carcinoma. CE‐MRI can be recommended as cost‐effective provided it replaces CE‐CT and that improved diagnostic accuracy results in earlier, curative, disease management. [ABSTRACT FROM AUTHOR]

Statistical analysis plans describe the planned data management and analysis for clinical trials. This supports transparent reporting and interpretation of clinical trial results. This paper reports the statistical analysis plan for the RESOLVE clinical trial. The RESOLVE trial assigned participants with chronic low back pain to graded sensory-motor precision training or sham-control. We report the planned data management and analysis for the primary and secondary outcomes. The primary outcome is pain intensity at 18-weeks post randomization. We will use mixed-effects models to analyze the primary and secondary outcomes by intention-to-treat. We will report adverse effects in full. We also describe analyses if there is non-adherence to the interventions, data management procedures, and our planned reporting of results. This statistical analysis plan will minimize the potential for bias in the analysis and reporting of results from the RESOLVE trial. ACTRN12615000610538 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368619). [ABSTRACT FROM AUTHOR]

Background: Up to 50% of heart transplant candidates require bridging with left ventricular assist devices (VAD). This study describes hospital activity and cost 1 year preceding and 1 year following VAD implant (pre-VAD) and for the year before transplant (pre-HTX). The sample comprises an Australian cohort and is the first study to investigate costs using both institutional and linked administrative data.Methods: Institutional activity was established for 77 consecutive patients actively listed for transplant between 2009 and 2012. Costs were sourced from the institution or Australian refined diagnosis groups (arDRGs) and the National Efficient Price for admissions to other public and private institutions. Data from 25/77 VAD recipients were analysed and compared with data from 52/77 pre-transplant patients. Total and per day at risk costs were assessed, as well as totals per resource.Results: Fifty per cent (50%) of the hospital costs in the pre-VAD year occurred during admission of VAD implant. Sixty-four per cent (64%) of costs in the pre-HTX and 38% in the pre-VAD period occurred outside the implanting centre. Costs in the year prior to VAD, $97,565 (IQR $86,907-$153,916), were significantly higher than costs accrued in the year prior to transplant, $40,250 ($13,493-$81,260), p < 0.0001. Once discharged, costs per day at risk for post-VAD patients approximated those from the pre-admission period, p = 0.16 and in the more clinically stable pre-HTX cohort, p = 0.08.Conclusion: Compared with the year prior, VAD implant stabilised hospital cost in patients discharged home. A high proportion of the hospital costs in the pre-implant year occur outside the implanting centre and should be considered in economic models assessing the impact of VAD implant. [ABSTRACT FROM AUTHOR]