Study protocol for The GOAL Trial: comprehensive geriatric assessment for frail older people with chronic kidney disease to increase attainment of patient-identified goals-a cluster randomised controlled trial.

BACKGROUND: An increasing number of older people are living with chronic kidney disease (CKD). Many have complex healthcare needs and are at risk of deteriorating health and functional status, which can adversely affect their quality of life. Comprehensive geriatric assessment (CGA) is an effective intervention to improve survival and independence of older people, but its clinical utility and cost-effectiveness in frail older people living with CKD is unknown. METHODS: The GOAL Trial is a pragmatic, multi-centre, open-label, superiority, cluster randomised controlled trial developed by consumers, clinicians, and researchers. It has a two-arm design, CGA compared with standard care, with 1:1 allocation of a total of 16 clusters. Within each cluster, study participants ≥ 65 years of age (or ≥ 55 years if Aboriginal or Torres Strait Islander (First Nations Australians)) with CKD stage 3-5/5D who are frail, measured by a Frailty Index (FI) of > 0.25, are recruited. Participants in intervention clusters receive a CGA by a geriatrician to identify medical, social, and functional needs, optimise medication prescribing, and arrange multidisciplinary referral if required. Those in standard care clusters receive usual care. The primary outcome is attainment of self-identified goals assessed by standardised Goal Attainment Scaling (GAS) at 3 months. Secondary outcomes include GAS at 6 and 12 months, quality of life (EQ-5D-5L), frailty (Frailty Index - Short Form), transfer to residential aged care facilities, cost-effectiveness, and safety (cause-specific hospitalisations, mortality). A process evaluation will be conducted in parallel with the trial including whether the intervention was delivered as intended, any issue or local barriers to intervention delivery, and perceptions of the intervention by participants. The trial has 90% power to detect a clinically meaningful mean difference in GAS of 10 units. DISCUSSION: This trial addresses patient-prioritised outcomes. It will be conducted, disseminated and implemented by clinicians and researchers in partnership with consumers. If CGA is found to have clinical and cost-effectiveness for frail older people with CKD, the intervention framework could be embedded into routine clinical practice. The implementation of the trial's findings will be supported by presentations at conferences and forums with clinicians and consumers at specifically convened workshops, to enable rapid adoption into practice and policy for both nephrology and geriatric disciplines. It has potential to materially advance patient-centred care and improve clinical and patient-reported outcomes (including quality of life) for frail older people living with CKD. TRIAL REGISTRATION: ClinicalTrials.gov NCT04538157. Registered on 3 September 2020.

Intergenerational care: an exploration of consumer preferences and willingness to pay for care.

OBJECTIVES: To identify feasible models of intergenerational care programmes, that is, care of children and older people in a shared setting, to determine consumer preferences and willingness to pay. METHOD: Feasible models were constructed in extensive consultations with a panel of experts using a Delphi technique (n = 23) and were considered based on their practical implementation within an Australian setting. This informed a survey tool that captured the preferences and willingness to pay for these models by potential consumers, when compared to the status quo. Information collected from the surveys (n = 816) was analysed using regression analysis to identify fundamental drivers of preferences and the prices consumers were willing to pay for intergenerational care programmes. RESULTS: The shared campus and visiting models were identified as feasible intergenerational care models. Key attributes of these models included respite day care; a common educational pedagogy across generations; screening; monitoring; and evaluation of participant outcomes. Although parents were more likely to take up intergenerational care compared to the status quo, adult carers reported a higher willingness to pay for these services. Educational attainment also influenced the likely uptake of intergenerational care. CONCLUSIONS: The results of this study show that there is demand for the shared campus and the visiting campus models among the Australian community. The findings support moves towards consumer-centric models of care, in line with national and international best practice. This consumer-centric approach is encapsulated in the intergenerational care model and enables greater choice of care to match different consumer demands.

An empirical comparison of Markov cohort modeling and discrete event simulation in a capacity-constrained health care setting.

OBJECTIVES: To empirically compare Markov cohort modeling (MM) and discrete event simulation (DES) with and without dynamic queuing (DQ) for cost-effectiveness (CE) analysis of a novel method of health services delivery where capacity constraints predominate. METHODS: A common data-set comparing usual orthopedic care (UC) to an orthopedic physiotherapy screening clinic and multidisciplinary treatment service (OPSC) was used to develop a MM and a DES without (DES-no-DQ) and with DQ (DES-DQ). Model results were then compared in detail. RESULTS: The MM predicted an incremental CE ratio (ICER) of $495 per additional quality-adjusted life-year (QALY) for OPSC over UC. The DES-no-DQ showed OPSC dominating UC; the DES-DQ generated an ICER of $2342 per QALY. CONCLUSIONS: The MM and DES-no-DQ ICER estimates differed due to the MM having implicit delays built into its structure as a result of having fixed cycle lengths, which are not a feature of DES. The non-DQ models assume that queues are at a steady state. Conversely, queues in the DES-DQ develop flexibly with supply and demand for resources, in this case, leading to different estimates of resource use and CE. The choice of MM or DES (with or without DQ) would not alter the reimbursement of OPSC as it was highly cost-effective compared to UC in all analyses. However, the modeling method may influence decisions where ICERs are closer to the CE acceptability threshold, or where capacity constraints and DQ are important features of the system. In these cases, DES-DQ would be the preferred modeling technique to avoid incorrect resource allocation decisions.

The Efficiency of Increasing the Capacity of Physiotherapy Screening Clinics or Traditional Medical Services to Address Unmet Demand in Orthopaedic Outpatients: A Practical Application of Discrete Event Simulation with Dynamic Queuing.

BACKGROUND: Hospital outpatient orthopaedic services traditionally rely on medical specialists to assess all new patients to determine appropriate care. This has resulted in significant delays in service provision. In response, Orthopaedic Physiotherapy Screening Clinics and Multidisciplinary Services (OPSC) have been introduced to assess and co-ordinate care for semi- and non-urgent patients. OBJECTIVES: To compare the efficiency of delivering increased semi- and non-urgent orthopaedic outpatient services through: (1) additional OPSC services; (2) additional traditional orthopaedic medical services with added surgical resources (TOMS + Surg); or (3) additional TOMS without added surgical resources (TOMS - Surg). METHODS: A cost-utility analysis using discrete event simulation (DES) with dynamic queuing (DQ) was used to predict the cost effectiveness, throughput, queuing times, and resource utilisation, associated with introducing additional OPSC or TOMS ± Surg versus usual care. RESULTS: The introduction of additional OPSC or TOMS (±surgery) would be considered cost effective in Australia. However, OPSC was the most cost-effective option. Increasing the capacity of current OPSC services is an efficient way to improve patient throughput and waiting times without exceeding current surgical resources. An OPSC capacity increase of ~100 patients per month appears cost effective (A$8546 per quality-adjusted life-year) and results in a high level of OPSC utilisation (98 %). CONCLUSION: Increasing OPSC capacity to manage semi- and non-urgent patients would be cost effective, improve throughput, and reduce waiting times without exceeding current surgical resources. Unlike Markov cohort modelling, microsimulation, or DES without DQ, employing DES-DQ in situations where capacity constraints predominate provides valuable additional information beyond cost effectiveness to guide resource allocation decisions.

A workplace exercise versus health promotion intervention to prevent and reduce the economic and personal burden of non-specific neck pain in office personnel: protocol of a cluster-randomised controlled trial.

INTRODUCTION: Non-specific neck pain is a major burden to industry, yet the impact of introducing a workplace ergonomics and exercise intervention on work productivity and severity of neck pain in a population of office personnel is unknown. RESEARCH QUESTION: Does a combined workplace-based best practice ergonomic and neck exercise program reduce productivity losses and risk of developing neck pain in asymptomatic workers, or decrease severity of neck pain in symptomatic workers, compared to a best practice ergonomic and general health promotion program? DESIGN: Prospective cluster randomised controlled trial. PARTICIPANTS AND SETTING: Office personnel aged over 18 years, and who work>30 hours/week. INTERVENTION: Individualised best practice ergonomic intervention plus 3×20 minute weekly, progressive neck/shoulder girdle exercise group sessions for 12 weeks. CONTROL: Individualised best practice ergonomic intervention plus 1-hour weekly health information sessions for 12 weeks. MEASUREMENTS: Primary (productivity loss) and secondary (neck pain and disability, muscle performance, and quality of life) outcome measures will be collected using validated scales at baseline, immediate post-intervention and 12 months after commencement. PROCEDURE: 640 volunteering office personnel will be randomly allocated to either an intervention or control arm in work group clusters. ANALYSIS: Analysis will be on an 'intent-to-treat' basis and per protocol. Multilevel, generalised linear models will be used to examine the effect of the intervention on reducing the productivity loss in dollar units (AUD), and severity of neck pain and disability. DISCUSSION: The findings of this study will have a direct impact on policies that underpin the prevention and management of neck pain in office personnel.

Can post-acute care programmes for older people reduce overall costs in the health system? A case study using the Australian Transition Care Programme.

There is an increasing demand for acute care services due in part to rising proportions of older people and increasing rates of chronic diseases. To reduce pressure and costs in the hospital system, community-based post-acute care discharge services for older people have evolved as one method of reducing length of stay in hospital and preventing readmissions. However, it is unclear whether they reduce overall episode cost or expenditure in the health system at a more general level. In this paper, we review the current evidence on the likely costs and benefits of these services and consider whether they are potentially cost-effective from a health services perspective, using the Australian Transition Care Programme as a case study. Evaluations of community-based post-acute services have demonstrated that they reduce length of stay, prevent some re-hospitalisations and defer nursing home placement. There is also evidence that they convey some additional health benefits to older people. An economic model was developed to identify the maximum potential benefits and the likely cost savings from reduced use of health services from earlier discharge from hospital, accelerated recovery, reduced likelihood of readmission to hospital and delayed entry into permanent institutional care for participants of the Transition Care Programme. Assuming the best case scenario, the Transition Care Programme is still unlikely to be cost saving to a healthcare system. Hence for this service to be justified, additional health benefits such as quality of life improvements need to be taken into account. If it can be demonstrated that this service also conveys additional quality of life improvements, community-based programmes such as Transition Care could be considered to be cost-effective when compared with other healthcare programmes.

Guidelines for conducting and reporting economic evaluation of fall prevention strategies.

UNLABELLED: Falls in older people result in substantial health burden. Compelling evidence indicates that falls can be prevented. We developed comprehensive guidelines for economic evaluations of fall prevention interventions to facilitate publication of high-quality economic evaluations of the effective strategies and aid decision making. INTRODUCTION: The importance of economics applied to falls and fall prevention in older people has largely been overlooked. The use of different methodologies to assess the costs and health benefits of the interventions and their comparators and the inconsistent reporting in the studies limits the usefulness of these economic evaluations for decision making. We developed guidelines to encourage and facilitate completion of high-quality economic evaluations of effective fall prevention strategies. METHODS: We used a generic checklist for economic evaluations as a platform to develop comprehensive guidelines for conducting and reporting economic evaluations of fall prevention strategies. We considered the many challenges involved, particularly in identifying, measuring, and valuing the relevant cost items. RESULTS: We recommend researchers include cost outcomes and report incremental cost-effectiveness ratios in terms of falls prevented and quality adjusted life years in all clinical trials of fall prevention interventions. Studies should include the following cost categories: (1) implementing the intervention, (2) delivering the comparator group intervention, (3) total health care costs, (4) costs of fall-related health care resource use, and (5) personal and informal carer opportunity costs. CONCLUSIONS: This paper provides a timely benchmark to promote comparability and consistency for conducting and reporting economic evaluations of fall prevention strategies.

Removal of human immunodeficiency virus by an 0.04-micron membrane filter.

We tested the ability of a 0.04-micron nylon membrane filter to remove human immunodeficiency virus (HIV) from tissue culture media containing 10% fetal calf serum. Endpoint titrations of infectious virus (ID50) were performed on lymphocyte cultures. The presence of virus in the cultures was determined using an enzyme-linked immunoabsorbant assay (ELISA) of the HIV-1 P24 core antigen. In repeated experiments, filtration of the virus suspension resulted in the removal of HIV below detectable limits. The titer reduction was estimated to be greater than 8.5 x 10(2). These results suggest that this filter is effective in removing HIV from fluids containing serum or serum products.