The Clinical and Cost-Effectiveness of an Individualized Nutritional CAre (INCA) Bundle versus Standard Care for Adults with Pressure Injuries Receiving Home Nursing Services: A Protocol for a Cluster Randomized and Pragmatic Clinical Trial with an Economic Evaluation.

BACKGROUND: Pressure injuries (PIs) represent a significant healthcare challenge in Singapore among the aging population. These injuries contribute to increased morbidity, mortality, and healthcare expenditure. Existing research predominantly explores single-component interventions in hospital environments, often yielding limited success. The INCA Trial aims to address this research gap by conducting a comprehensive, cluster randomized controlled trial that integrates education, individualized nutritional support, and community nursing care. This study is designed to evaluate clinical and cost-effectiveness outcomes, focusing on PI wound area reduction and incremental costs associated with the intervention. METHODS: The INCA Trial employs a two-group, non-blinded, cluster randomized, and pragmatic clinical trial design, recruiting 380 adult individuals (age ≥ 21 years) living in the community with stage II, III, IV, and unstageable PI(s) who are receiving home nursing service in Singapore. Cluster randomization is stratified by postal codes to minimize treatment contamination. The intervention arm will receive an individualized nutrition and nursing care bundle (dietary education with nutritional supplementation), while the control arm will receive standard care. The 90-day intervention will be followed by outcome assessments extending over one year. Primary outcomes include changes in PI wound area and the proportion of participants achieving a ≥40% area reduction. Secondary outcomes include health-related quality of life (HRQOL), nutritional status, and hospitalization rates. Data analysis will be conducted on an intention-to-treat (ITT) basis, supplemented by interim analyses for efficacy and futility and pre-specified sensitivity and subgroup analyses. The primary outcome for the cost-effectiveness analysis will be based on the change to total costs compared to the change to health benefits, as measured by quality-adjusted life years (QALYs). DISCUSSION: The INCA Trial serves as a pioneering effort in its approach to PI management in community settings. This study uniquely emphasizes both clinical and economic outcomes and melds education, intensive dietetic support, and community nursing care for a holistic approach to enhancing PI management.

Spillover Effects of COVID-19 on Essential Chronic Care and Ways to Foster Health System Resilience to Support Vulnerable Non-COVID Patients: A Multistakeholder Study.

OBJECTIVES: Little empirical research exists on how key stakeholders involved in the provision of care for chronic conditions and policy planning perceive the indirect or "spillover" effects of the COVID-19 on non-COVID patients. This study aims to explore stakeholder experiences and perspectives of the impact of COVID-19 on the provision of care for chronic conditions, evolving modalities of care, and stakeholder suggestions for improving health system resilience to prepare for future pandemics. DESIGN: Qualitative study design. SETTING AND PARTICIPANTS: This study was conducted during and after the COVID-19 lockdown period in Singapore. We recruited a purposive sample of 51 stakeholders involved in care of non-COVID patients and/or policy planning for chronic disease management. They included health care professionals (micro-level), hospital management officers (meso-level), and government officials (macro-level). METHODS: In-depth semi-structured interviews were conducted. All interviews were digitally recorded, transcribed verbatim, and thematically analyzed. RESULTS: Optimal provision of care for chronic diseases may be compromised through the following processes: lack of "direct" communication between colleagues on clinical cases resulting in rescheduling of patient visits; uncertainty in diagnostic decisions due to protocol revision and lab closure; and limited preparedness to handle non-COVID patients' emotional reactions. Although various digital innovations enhanced access to care, a digital divide exists due to uneven digital literacy and perceived data security risks, thereby hampering wider implementation. To build health system resilience, stakeholders suggested the need to integrate digital care into the information technology ecosystem, develop strategic public-private partnerships for chronic disease management, and give equal attention to the provision of holistic psychosocial and community support for vulnerable non-COVID patients. CONCLUSIONS AND IMPLICATIONS: Findings highlight that strategies to deliver quality chronic care for non-COVID patients in times of public health crisis should include innovative care practices and institutional reconfiguration within the broader health system context.

Development and pilot of a multicriteria decision analysis (MCDA) tool for health services administrators.

INTRODUCTION: Health administration is complex and serves many masters. Value, quality, infrastructure and reimbursement are just a sample of the competing interests influencing executive decision-making. This creates a need for decision processes that are rational and holistic. METHODS: We created a multicriteria decision analysis tool to evaluate six fields of healthcare provision: return on investment, capacity, outcomes, safety, training and risk. The tool was designed for prospective use, at the beginning of each funding round for competing projects. Administrators were asked to rank their criteria in order of preference. Each field was assigned a representative weight determined from the rankings. Project data were then entered into the tool for each of the six fields. The score for each field was scaled as a proportion of the highest scoring project, then weighted by preference. We then plotted findings on a cost-effectiveness plane. The project was piloted and developed over successive uses by the hospital's executive board. RESULTS: Twelve projects competing for funding at the Royal Brisbane and Women's Hospital were scored by the tool. It created a priority ranking for each initiative based on the weights assigned to each field by the executive board. Projects were plotted on a cost-effectiveness plane with score as the x-axis and cost of implementation as the y-axis. Projects to the bottom right were considered dominant over projects above and to the left, indicating that they provided greater benefit at a lower cost. Projects below the x-axis were cost-saving and recommended provided they did not harm patients. All remaining projects above the x-axis were then recommended in order of lowest to highest cost-per-point scored. CONCLUSION: This tool provides a transparent, objective method of decision analysis using accessible software. It would serve health services delivery organisations that seek to achieve value in healthcare.

Review of methods and study designs of evaluations related to clinical pathways.

Objective The HealthPathways program is an online information portal that helps clinicians provide consistent and integrated patient care within a local health system through localised pathways for diagnosis, treatment and management of various health conditions. These pathways are consistent with the definition of clinical pathways. Evaluations of HealthPathways programs have thus far focused primarily on website utilisation and clinical users' experience and satisfaction, with limited evidence on changes to patient outcomes. This lack motivated a literature review of the effects of clinical pathways on patient and economic outcomes to inform a subsequent HealthPathways evaluation. Methods A systematic review was performed to summarise the analytical methods, study designs and results of studies evaluating clinical pathways with an economic outcome component published between 1 January 2000 and 31 August 2017 in four academic literature databases. Results Fifty-five relevant articles were identified for inclusion in this review. The practical pre-post study design with retrospective baseline data extraction and prospective intervention data collection was most commonly used in the evaluations identified. Straightforward statistical methods for comparing outcomes, such as the t-test or χ2 test, were frequently used. Only four of the 55 articles performed a cost-effectiveness analysis. Clinical pathways were generally associated with improved patient outcomes and positive economic outcomes in hospital settings. Conclusions Clinical pathways evaluations commonly use pragmatic study designs, straightforward statistical tests and cost-consequence analyses. More HealthPathways program evaluations focused on patient and economic outcomes, clinical pathway evaluations in a primary care setting and cost-effectiveness analyses of clinical pathways are needed. What is known about the topic? HealthPathways is a web-based program that originated from Canterbury, New Zealand, and has seen uptake elsewhere in New Zealand, Australia and the UK. The HealthPathways program aims to assist the provision of consistent and integrated health services through dedicated, localised pathways for various health conditions specific to the health region. Evaluations of HealthPathways program focused on patient and economic outcomes have been limited. What does this paper add? This review synthesises the academic literature of clinical pathways evaluations in order to inform a subsequent HealthPathways evaluation. The focus of the synthesis was on the analytical methods and study designs used in the previous evaluations. The previous clinical pathway evaluations have been pragmatic in nature with relatively straightforward study designs and analysis. What are the implications for practitioners? There is a need for more economic and patient outcome evaluations for HealthPathways programs. More sophisticated statistical analyses and economic evaluations could add value to these evaluations, where appropriate and taking into consideration the data limitations.

Economic evaluation of St. John's wort (Hypericum perforatum) for the treatment of mild to moderate depression.

BACKGROUND: The burden of rising health care expenditures has created a demand for information regarding the clinical and economic outcomes associated with Complementary and Alternative Medicines. Clinical controlled trials have found St. John's wort to be as effective as antidepressants in the treatment of mild to moderate depression. The objective of this study was to develop a model to assess the cost-effectiveness of St. John's wort based on this evidence. METHODS: A Markov model was constructed to estimate health and economic impacts of St. John's wort versus antidepressants. Outcomes were treatment costs, quality-adjusted life years (QALYs) and Net Monetary Benefits (NMB). Probabilistic analyses were conducted on key model parameters. RESULTS: The average NMB across 5000 simulations identified St. John's wort as the strategy with the highest net benefit. The total cost savings for SJW were $359.66 and $202.56 per individual for venlafaxine and sertraline respectively, with a gain of 0.08 to 0.12 QALYs over the 72 weeks of the model. LIMITATIONS: A lack of direct comparative clinical trial data comparing SJW to venlafaxine and limited data with sertraline as a comparator was a major limitation. CONCLUSIONS: In this model, St. John's wort was shown to be a cost-effective alternative to generic antidepressants. Patients are more likely to receive treatment for a duration consistent with professional guidelines for treatment of major depression due to reduced incidence of adverse effects, improving outcomes. This represents an important option in the treatment of Major Depressive Disorder.

Development of an economic model to assess the cost-effectiveness of hawthorn extract as an adjunct treatment for heart failure in Australia.

OBJECTIVE: An economic model was developed to evaluate the cost-effectiveness of hawthorn extract as an adjunctive treatment for heart failure in Australia. METHODS: A Markov model of chronic heart failure was developed to compare the costs and outcomes of standard treatment and standard treatment with hawthorn extract. Health states were defined by the New York Heart Association (NYHA) classification system and death. For any given cycle, patients could remain in the same NYHA class, experience an improvement or deterioration in NYHA class, be hospitalised or die. Model inputs were derived from the published medical literature, and the output was quality-adjusted life years (QALYs). Probabilistic sensitivity analysis was conducted. The expected value of perfect information (EVPI) and the expected value of partial perfect information (EVPPI) were conducted to establish the value of further research and the ideal target for such research. RESULTS: Hawthorn extract increased costs by $1866.78 and resulted in a gain of 0.02 QALYs. The incremental cost-effectiveness ratio was $85 160.33 per QALY. The cost-effectiveness acceptability curve indicated that at a threshold of $40 000 the new treatment had a 0.29 probability of being cost-effective. The average incremental net monetary benefit (NMB) was -$1791.64, the average NMB for the standard treatment was $92 067.49, and for hawthorn extract $90 275.84. Additional research is potentially cost-effective if research is not proposed to cost more than $325 million. Utilities form the most important target parameter group for further research. CONCLUSIONS: Hawthorn extract is not currently considered to be cost-effective in as an adjunctive treatment for heart failure in Australia. Further research in the area of utilities is warranted.

Productivity and time use during occupational therapy and nutrition/dietetics clinical education: a cohort study.

BACKGROUND: Currently in the Australian higher education sector higher productivity from allied health clinical education placements is a contested issue. This paper will report results of a study that investigated output changes associated with occupational therapy and nutrition/dietetics clinical education placements in Queensland, Australia. Supervisors' and students' time use during placements and how this changes for supervisors compared to when students are not present in the workplace is also presented. METHODOLOGY/PRINCIPAL FINDINGS: A cohort design was used with students from four Queensland universities, and their supervisors employed by Queensland Health. There was an increasing trend in the number of occasions of service delivered when the students were present, and a statistically significant increase in the daily mean length of occasions of service delivered during the placement compared to pre-placement levels. CONCLUSIONS/SIGNIFICANCE: A novel method for estimating productivity and time use changes during clinical education programs for allied health disciplines has been applied. During clinical education placements there was a net increase in outputs, suggesting supervisors engage in longer consultations with patients for the purpose of training students, while maintaining patient numbers. Other activities were reduced. This paper is the first time these data have been shown in Australia and form a sound basis for future assessments of the economic impact of student placements for allied health disciplines.

Potential of St John's Wort for the treatment of depression: the economic perspective.

The burden of rising health care expenditures has created a demand for information regarding the clinical and economic outcomes associated with complementary and alternative medicines. Meta-analyses of randomized controlled trials have found Hypericum perforatum preparations to be superior to placebo and similarly effective as standard antidepressants in the acute treatment of mild to moderate depression. A clear advantage over antidepressants has been demonstrated in terms of the reduced frequency of adverse effects and lower treatment withdrawal rates, low rates of side effects and good compliance, key variables affecting the cost-effectiveness of a given form of therapy. The most important risk associated with use is potential interactions with other drugs, but this may be mitigated by using extracts with low hyperforin content. As the indirect costs of depression are greater than five times direct treatment costs, given the rising cost of pharmaceutical antidepressants, the comparatively low cost of Hypericum perforatum extract makes it worthy of consideration in the economic evaluation of mild to moderate depression treatments.

The use of economic evaluation in CAM: an introductory framework.

BACKGROUND: For CAM to feature prominently in health care decision-making there is a need to expand the evidence-base and to further incorporate economic evaluation into research priorities.In a world of scarce health care resources and an emphasis on efficiency and clinical efficacy, CAM, as indeed do all other treatments, requires rigorous evaluation to be considered in budget decision-making. METHODS: Economic evaluation provides the tools to measure the costs and health consequences of CAM interventions and thereby inform decision making. This article offers CAM researchers an introductory framework for understanding, undertaking and disseminating economic evaluation. The types of economic evaluation available for the study of CAM are discussed, and decision modelling is introduced as a method for economic evaluation with much potential for use in CAM. Two types of decision models are introduced, decision trees and Markov models, along with a worked example of how each method is used to examine costs and health consequences. This is followed by a discussion of how this information is used by decision makers. CONCLUSIONS: Undoubtedly, economic evaluation methods form an important part of health care decision making. Without formal training it can seem a daunting task to consider economic evaluation, however, multidisciplinary teams provide an opportunity for health economists, CAM practitioners and other interested researchers, to work together to further develop the economic evaluation of CAM.

Re-interpreting the data on the cost and effectiveness of population screening for colorectal cancer in Australia.

Three studies report estimates of the cost and effectiveness of alternate strategies for screening the average-risk Australian population for colorectal cancer. The options considered are faecal occult blood testing, double contrast barium enema, sigmoidoscopy and colonoscopy. At present, there is no consensus over which screening method is optimal by the economic criterion. Also, the existing studies report a mixture of average and incremental cost-effectiveness ratios derived from data collected between 1994 and 2002. We suggest average cost-effectiveness ratios are not useful for decision-making and illustrate how they differ from the preferred incremental cost-effectiveness ratio. We then update the cost data reported in the three studies to 2002 prices and calculate incremental cost-effectiveness ratios where not previously available. Our re-analysis of one study contradicts the conclusions drawn by the authors, who had only calculated average cost-effectiveness ratios. In particular, we find their recommendation of population screening with colonoscopy would cause, annually, between 33 and 1,322 years of life to be lost and between M17 dollars and M87 dollars to be wasted. Based on updated cost data and the incremental analysis, our findings indicate that population screening using biennial faecal occult blood testing (39,459 dollars per life-year gained), annual faecal occult blood testing (30,556 dollars per life-year gained) and colonoscopy (26,587 dollars per life-year gained) are cost-effective. Hence, the decision over which method of screening is optimal remains ambiguous across the three studies. We recommend policy-makers choose the study they believe produces the most accurate estimates of cost and health effect, identify their willingness to pay for health benefits and consider other issues relevant to the decision.