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Objectives: To examine the within-trial costs and cost-effectiveness of using PARO, compared with a plush toy and usual care, for reducing agitation and medication use in people with dementia in long-term care., Design: An economic evaluation, nested within a cluster-randomized controlled trial., Setting: Twenty-eight facilities in South-East Queensland, Australia., Participants: A total of 415 residents, all aged 60 years or older, with documented diagnoses of dementia., Intervention: Facilities were randomized to 1 of 3 groups: PARO (individual, nonfacilitated 15-minute sessions, 3 afternoons per week for 10 weeks); plush toy (as per PARO but with artificial intelligence disabled); and usual care., Measurements: The incremental cost per Cohen-Mansfield Agitation Inventory-Short Form (CMAI-SF) point averted from a provider's perspective. Australian New Zealand Clinical Trials Registry (BLINDED FOR REVIEW)., Results: For the within-trial costs, the PARO group was $50.47 more expensive per resident compared with usual care, whereas the plush toy group was $37.26 more expensive than usual care. There were no statistically significant between-group differences in agitation levels after the 10-week intervention. The point estimates of the incremental cost-effectiveness ratios were $13.01 for PARO and $12.85 for plush toy per CMAI-SF point averted relative to usual care., Conclusion: The plush toy used in this study offered marginally greater value for money than PARO in improving agitation. However, these costs are much lower than values estimated for psychosocial group activities and sensory interventions, suggesting that both a plush toy and the PARO are cost-effective psychosocial treatment options for agitation., (Copyright © 2017 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.)

Objectives: The robotic seal, PARO, has been used as an alternative to animal-assisted therapies with residents with dementia in long-term care, yet understanding of its efficacy is limited by a paucity of research. We explored the effects of PARO on motor activity and sleep patterns, as measured by a wearable triaxial accelerometer., Study Design: Cluster-randomised controlled trial, involving 28 facilities in Queensland, Australia. Nine facilities were randomised to the PARO group (individual, non-facilitated, 15-min sessions three afternoons per week for 10 weeks), 10 to a plush toy (PARO with robotic features disabled) and nine to usual care., Main Outcome Measures: Changes in day- and nighttime motor activity and sleep after the 10-week intervention, as measured by SenseWear ® armbands, worn by participants continuously for 24 h at baseline, during two single intervention days in weeks 5 and 10 respectively, and post-intervention (week 15). Analyses followed intention-to-treat, using repeated-measures mixed-effects models., Results: After 10 weeks, the PARO group showed a greater reduction in daytime step count than usual care (p = 0.023), and in nighttime step count (p = 0.028) and daytime physical activity (p = 0.026) compared with the plush toy group. At post-intervention, the PARO group showed a greater reduction in daytime step count than the plush toy group (p = 0.028), and at nighttime compared with both the plush toy group (p = 0.019) and the usual-care group (p = 0.046). The PARO group also had a greater reduction in nighttime physical activity than the usual-care group (p = 0.015)., Conclusions: PARO may have some effect on motor activity of older people with dementia in long-term care, but not on sleep patterns. Australian New Zealand Clinical Trials Registry (ACTRN12614000508673)., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Objectives: To test the effects of individual, nonfacilitated sessions with PARO (version 9), when compared against a look-alike plush toy and usual care, on the emotional and behavioral symptoms of dementia for people living in long-term care facilities., Design: Parallel, 3-group, cluster-randomized controlled trial conducted between June 14, 2014, and May 16, 2015., Setting: Twenty-eight long-term care facilities operated by 20 care organizations located in South-East Queensland, Australia., Participants: Four hundred fifteen participants aged ≥60 years, with a documented diagnosis of dementia., Intervention: Stratified by private/not-for-profit status and randomized using a computer-generated sequence, 9 facilities were randomized to the PARO group (individual, nonfacilitated, 15-minute sessions 3 times per week for 10 weeks); 10 to plush toy (same, but given PARO with robotic features disabled); and 9 to usual care. Treatment allocation was masked to assessors., Measurements: Primary outcomes were changes in levels of engagement, mood states, and agitation after a 10-week intervention, assessed by coded video observations (baseline, weeks 1, 5, 10, and 15) and Cohen-Mansfield Agitation Inventory-Short Form (baseline, weeks 10 and 15). Analyses followed intention-to-treat, using repeated measures mixed effects models. Australian New Zealand Clinical Trials Registry (ACTRN12614000508673)., Results: Video data showed that participants in the PARO group were more verbally [3.61, 95% confidence interval (CI): 6.40-0.81, P = .011] and visually engaged (13.06, 95% CI: 17.05-9.06, P < .0001) than participants in plush toy. Both PARO (-3.09, 95% CI: -0.45 to -5.72, P = .022) and plush toy (-3.58, 95% CI: -1.26 to -5.91, P = .002) had significantly greater reduced neutral affect compared with usual care, whilst PARO was more effective than usual care in improving pleasure (1.12, 95% CI: 1.94-0.29, P = .008). Videos showed that PARO was more effective than usual care in improving agitation (3.33, 95% CI: 5.79-0.86, P = .008). When measured using the CMAI-SF, there was no difference between groups., Conclusions: Although more effective than usual care in improving mood states and agitation, PARO was only more effective than a plush toy in encouraging engagement., (Copyright © 2017 AMDA – The Society for Post-Acute and Long-Term Care Medicine. All rights reserved.)

Background: The use of information technology, including internet- and telephone-based resources, is becoming an alternative and supporting method of providing many forms of services in a healthcare and health management setting. Telephone consultations provide a promising alternative and supporting service for face-to-face general practice care. The aim of this review is to utilize a systematic review to collate evidence on the use of telephone consultation as an alternative to face-to-face general practice visits., Methods: A systematic search of MEDLINE, CINAHL, The Cochrane Library, and the International Clinical Trials Registry Platform was performed using the search terms for the intervention (telephone consultation) and the comparator (general practice). Systematic reviews and randomized control trials that examined telephone consultation compared to normal face-to-face consultation in general practice were included in this review. Papers were reviewed, assessed for quality (Cochrane Collaboration's 'Risk of bias' tool) and data extracted and analysed., Results: Two systematic reviews and one RCT were identified and included in the analysis. The RCT (N = 388) was of patients requesting same-day appointments from two general practices and patients were randomized to a same-day face-to-face appointment or a telephone call back consultation. There was a reduction in the time spent on consultations in the telephone group (1.5 min (0.6 to 2.4)) and patients in the telephone arm had 0.2 (0 to 0.3) more follow-up consultations than the face-to-face group. One systematic review focused on telephone consultation and triage on healthcare use, and included one RCT and one other observational study that examined telephone consultations. The other systematic review focused on patient access and included one RCT and four observational studies that examined telephone consultations. Both systematic reviews provided narrative interpretations of the evidence and concluded that telephone consultations provided an appropriate alternative to telephone consultations and reduced practice work load., Conclusion: There is a lack of high level evidence for telephone consultations in a GP setting; however, current evidence suggests that telephone consultations as an alternative to face-to-face general practice consultations offers an appropriate option in certain settings., Systematic Review Registration: PROSPERO CRD42015025225.

Introduction: Around 30% of peripherally inserted central catheters (PICCs) fail from vascular, infectious or mechanical complications. Patients with cancer are at highest risk, and this increases morbidity, mortality and costs. Effective PICC dressing and securement may prevent PICC failure; however, no large randomised controlled trial (RCT) has compared alternative approaches. We designed this RCT to assess the clinical and cost-effectiveness of dressing and securements to prevent PICC failure., Methods and Analysis: Pragmatic, multicentre, 2×2 factorial, superiority RCT of (1) dressings (chlorhexidine gluconate disc (CHG) vs no disc) and (2) securements (integrated securement dressing (ISD) vs securement device (SED)). A qualitative evaluation using a knowledge translation framework is included. Recruitment of 1240 patients will occur over 3 years with allocation concealment until randomisation by a centralised service. For the dressing hypothesis, we hypothesise CHG discs will reduce catheter-associated bloodstream infection (CABSI) compared with no CHG disc. For the securement hypothesis, we hypothesise that ISD will reduce composite PICC failure (infection (CABSI/local infection), occlusion, dislodgement or thrombosis), compared with SED., Secondary Outcomes: types of PICC failure; safety; costs; dressing/securement failure; dwell time; microbial colonisation; reversible PICC complications and consumer acceptability. Relative incidence rates of CABSI and PICC failure/100 devices and/1000 PICC days (with 95% CIs) will summarise treatment impact. Kaplan-Meier survival curves (and log rank Mantel-Haenszel test) will compare outcomes over time. Secondary end points will be compared between groups using parametric/non-parametric techniques; p values <0.05 will be considered to be statistically significant., Ethics and Dissemination: Ethical approval from Queensland Health (HREC/15/QRCH/241) and Griffith University (Ref. No. 2016/063). Results will be published., Trial Registration: Trial registration number is: ACTRN12616000315415., Competing Interests: Competing interests: CMR’s employer has received on her behalf: unrestricted research and educational grants from: 3M, Adhezion, Angiodynamics, Bard, Baxter, BBraun, BD, Carefusion, Centurion Medical Products, Cook Medical, Entrotech, Flomedical, ICU Medical, Medical Australia, Medtronic, Smiths Medical, Teleflex; consultancies payments for educational lectures from 3M, Bard, BBraun, BD,Carefusion and Mayo, and expert reports from BD, ResQDevices and Smiths Medical. NM’s employer has received on her behalf: consultancy payments for educational lectures based on her research from Hospira and BD, and unrestricted research grants from Adhezion and BD. JW: Nil. NG’s employer has received on her behalf: unrestricted research grants from Baxter. RC’s employer has received on his behalf: unrestricted research and educational grants from: StratPHARMA. ALM: Nil. PM’s employer has received on his behalf: research grants from Celgene, Janssen and Hospira. PM is a member of Advisory Boards for Celgene, Janssen, Amgen and BMS. PM has received consultancy payments from Celgene and Amgen. AU’s employer has received on her behalf: unrestricted research and educational grants from Adhezion, Angiodynamics, 3M, Carefusion, Centurion Medical Products and BBraun; consultancy payments for educational lectures based on her research from 3M and BD. TK’s employer has received on her behalf: unrestricted research and educational grants from 3M, Angiodynamics, Centurion Medical Products and Baxter; consultancy payments for educational lectures from Angiodynamics and BD VC: Nil. LZ’s employer has received on her behalf: an unrestricted research grant from BD. MM: Nil. EL: Nil. MAC: Nil. SK’s employer has on her behalf received consultancy payments for educational lectures and unrestricted research grants from BD. EA’s employer has received on his behalf: unrestricted research and educational grants from: 3M, BD, Carefusion, Cook Medical, Flo Medical. Consultancy payments for educational lectures based on his research and clinical expertise from 3M, BD, Carefusion, Teleflex, Cook Medical and Flo Medical. DM: Nil. MCM: Nil. DP: Nil. MC’s employer has received on her behalf: unrestricted research and educational grants from BD, Baxter, 3M and Entrotech. GRB’s employer has received on her behalf: unrestricted research grants from 3M, BBraun and BD/Carefusion. Consultancy payments for educational lectures based on her research from Becton Dickinson and ResQDevices. MIC: Nil. AH: Nil. AC: Nil. EGP: Nil. No commercial entity had any role in the conception, design or funding of this study, or in the preparation of this manuscript., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Purpose: To evaluate the impact of a person-centred, community rehabilitation service on outcomes for people with a neurological condition, in the first year of service., Method: A prospective, observational, pre-post study was conducted with 206 people who had a neurological condition and attended the rehabilitation service to restore function (e.g., Stroke); maximize recovery in an ongoing situation (e.g., Spina Bifida); or maximize function and independence while preparing for inevitable decline (e.g., Parkinson's Disease). Outcomes were measured via self-report questionnaires, prior to, and following three months of rehabilitation. The primary outcome was achievement of self-identified goals, measured by the Patient-Specific Functional scale. Secondary outcomes included the Lawton Instrumental Activities of Daily Living (IADL) scale, EQ-5D-5L European Quality of Life scale, and ICECAP-O - Index of Capability for Older Adults and health and medical resource use., Results: Participants demonstrated significant goal achievement and a significant reduction in health and medical resource use. There were small positive changes in the Lawton IADL, EQ-5D-5L, and ICECAP-O however these changes were not significant., Conclusions: In the first year of operation, the community rehabilitation service made a significant impact on outcomes for individuals with a neurological condition. Further research is required to identify appropriate measures of activities of daily living and quality of life that reflect person-centred rehabilitation outcomes for restoring function, maximizing function, or preparing for functional decline. Implications for Rehabilitation Self-identified goals are an important guide for achievement of meaningful outcomes for individuals with a neurological condition. Person-centred outcome measures are required to evaluate the benefits of a person-centred community rehabilitation service for individuals with a neurological condition.

Objective: To estimate costs on the Medicare Benefits Schedule (MBS) and the Pharmaceutical Benefits Scheme (PBS) attributable to the diagnosis and treatment of prostate cancer., Methods: We used data from a cohort study of 1064 men with localized prostate cancer recruited between 2005 and 2007 by 24 urologists across 10 sites in Queensland, Australia (ProsCan). We estimated the MBS and PBS costs attributable to prostate cancer from the date of initial appointment to 12 months after diagnosis in 2013 Australian dollars using a comparison group without prostate cancer. We used generalized linear modeling to identify key determinants of higher treatment-related costs., Results: From the date of initial appointment to 12 months postdiagnosis, the average MBS costs attributable to prostate cancer were $9,357 (SD $191) per patient. These MBS costs were most sensitive to having private health insurance and the type of primary treatment received. The PBS costs were higher in the control group than in the ProsCan group ($5,641 vs $1,924)., Conclusions: The costs of treating and managing prostate cancer are high and these result in a substantial financial burden for the Australian MBS. Costs attributable to prostate cancer appear to vary widely based on initial treatment and these are likely to increase with the introduction of more expensive services and pharmaceuticals. There is a pressing need for better prognostic tools to distinguish between indolent and aggressive prostate tumors to reduce potential over treatment and help ease the burden of prostate cancer., (© 2017 John Wiley & Sons Australia, Ltd.)

Objectives: The aim of this study was to examine submissions made to the Pharmaceutical Benefits Advisory Committee (PBAC) and assess whether the predicted financial impact was associated with a recommendation. The second objective was to assess whether the financial and utilization estimates for listing the proposed medicine were reliable., Methods: Data were extracted from public summary documents of major submissions considered by the PBAC from 2012 to 2014. Information collected included whether submissions were accepted, rejected, or deferred; estimated use; and financial impact. For those submissions that were recommended in 2012 and listed on the Pharmaceutical Benefits Scheme (PBS) by January 2014, a comparison was made between predicted and actual use and cost in 2014, based on PBS utilization., Results: In 2012 to 2014, the PBAC considered 142 unique major submissions; of those, 65 were recommended for listing. A higher financial cost to the government was a statistically significant factor in predicting rejection (p = .004 for cost > AUD 30 million Australian dollars [20.7 million Euros] compared with cost-saving). Of the submissions that were recommended in 2012 and listed by 2014, the actual use was higher than predicted for 5/19 medications. The estimated cost was outside the predicted bracket of cost for 10/19 medications, with 8/19 medications having threefold underestimated expenditure, and 2/19 items having lower than predicted expenditure., Conclusions: This study highlights that the predicted financial impact of a medication to the PBS budget is associated with a PBAC recommendation and also highlights that predicted use may not reflect actual prescribing practices.

The purpose of this study was to understand the extent, nature and variability of the current economic burden of prostate cancer among Australian men. An online cross-sectional survey was developed that combined pre-existing economic measures and new questions. With few exceptions, the online survey was viable and acceptable to participants. The main outcomes were self-reported out-of-pocket costs of prostate cancer diagnosis and treatment, changes in employment status and household finances. Men were recruited from prostate cancer support groups throughout Australia. Descriptive statistical analyses were undertaken. A total of 289 men responded to the survey during April and June 2013. Our study found that men recently diagnosed (within 16 months of the survey) (n = 65) reported spending a median AU$8000 (interquartile range AU$14 000) for their cancer treatment while 75% of men spent up to AU$17 000 (2012). Twenty per cent of all men found the cost of treating their prostate cancer caused them 'a great deal' of distress. The findings suggest a large variability in medical costs for prostate cancer treatment with 5% of men spending $250 or less in out-of-pocket expenses and some men facing very high costs. On average, respondents in paid employment at diagnosis stated that they had retired 4-5 years earlier than planned., (© 2015 The Authors. European Journal of Cancer Care Published by John Wiley & Sons Ltd.)

Objectives: Made available since 2002, transcatheter aortic valve implantation (TAVI) is a minimally invasive new intervention which can provide significant survival improvement to patients with aortic stenosis. However, TAVI is expensive and currently not reimbursed by many governments. Some governments and institutions have been conducting health technology assessments (HTAs) to inform their reimbursement decisions. The aim of the present study is to review HTAs that have relied on a cost-effectiveness analysis to inform reimbursement decisions of TAVI., Methods: A systematic literature review was conducted among published literature as well as reports released by HTA agencies. Predetermined inclusion and exclusion criteria, following the Preferred Reporting System for Systematic Reviews and Meta-Analysis guidelines, were used to select relevant HTAs. The selected papers were assessed against the Consolidated Health Economic Evaluation Reporting Standards., Results: HTAs on TAVI from three countries were available for this review: Canada, Belgium, and the United Kingdom. All three HTAs used the Placement of Aortic Transcatheter Valve (PARTNER) trial data with Markov models to estimate the incremental cost effectiveness ratio. The three HTAs recommended conditional reimbursement for TAVI for otherwise inoperable patients. The HTAs did not use clear methods to estimate the health-related utility which ultimately affected their cost-effectiveness results. The UK HTA showed the best value for money (US$20,416 per quality-adjusted life-year)., Conclusion: All studies found TAVI to be more costly and less effective for high-risk patients suitable for surgery, whereas TAVI was consistently found to be cost effective for otherwise inoperable patients.

Background: The use of information technology in healthcare is fast becoming an alternative and supporting method of providing many forms of services in a healthcare and health management setting. Telephone technology is used readily to deliver services such as disease management, consultations and behaviour coaching. Telemedicine provides a promising alternative and supporting service for face-to-face general practice care. The aim of this review is to utilise a systematic review to collate evidence on the use of telemedicine as a lead in and an alternative to general practice visits., Methods/design: A systematic search of MEDLINE, CINAHL, the Cochrane Library and the International Clinical Trials Registry Platform will be performed using the search terms for the intervention (telemedicine) and the comparator (general practice) to search the databases. The systematic review aims to identify randomised control trials; however, if none are identified, an updated search will be conducted to identify lower levels of evidence. Papers will be reviewed and assessed for quality and data extracted using two reviewers; if consensus is required, a third reviewer will be consulted. If applicable, a meta-analysis of relevant outcomes will be conducted. The protocol has been reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses protocols (PRISMA-P) guidelines., Discussion: The intervention and comparator have the potential to provide a vast range of healthcare services to a range of diseases and health conditions. There is likely to be difficulty in identifying relevant clinical outcome measures for the patient population. A range of outcome measures will therefore be collected in the data extraction phase., Systematic Review Registration: PROSPERO CRD42015025225.

The literature has shown strong associations between health, financial and social life events and mental health. However, no studies as yet have looked at the temporal nature of the effects of life events on stated mental health nor have they included the effects of the events befalling partners within a household. This paper looks at the spillover in mental health, measured with the SF-36 scale, from one partner to the other, using life events to identify this relationship. We propose a new model that allows for both a temporal spacing of effects (anticipation and adaptation) as well as a spillover factor, which we define as the degree to which the events that are experienced by the partner affect us in the same way as if these events were to happen to us. We use data from 51,380 person-year observations of the Household, Income and Labour Dynamics in Australia survey (2002-10) which consistently measures nine distinct events, including illnesses, social shocks and financial shocks. We find that the events befalling a partner on average have an effect about 15% as large as the effect of own events. We use the estimates to compute the compensation required to offset own and partner's life events. The methodology in this paper is potentially useful for estimating other spillover parameters such as the effects of others in the family or in the neighbourhood., (Copyright © 2014 Elsevier Ltd. All rights reserved.)