Economic evaluation of germline genetic testing for breast cancer in low- and middle-income countries: a systematic review.

BACKGROUND: Breast cancer (BC) is the most common cancer affecting women globally. Genetic testing serves as a prevention and treatment strategy for managing BC. This study aims to systematically review economic evaluations and the quality of selected studies involving genetic screening strategies for BC in low and middle-income countries (LMICs). METHODS: A search was performed to identify related articles that were published up to April 2023 on PubMed, Embase, CINAHL, Web of Science, and the Centre for Reviews and Dissemination. Only English-language LMIC studies were included. Synthesis of studies characteristics, methodological and data input variations, incremental cost-effectiveness ratios (ICERs), and reporting quality (Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 checklist) were performed. RESULTS: This review found five pertinent studies, mainly focusing on economic evaluations of germline genetic testing in upper-middle-income countries (Upper MICs) like Malaysia, China, and Brazil. Only one study covered multiple countries with varying incomes, including lower-middle-income nations (Lower MICs) like India. The ICERs values in various screening scenarios for early-stage BC, HER2 negative BC patients, and healthy women with clinical or family history criteria were ranging from USD 2214/QALY to USD 36,342/QALY. Multigene testing for all breast cancer patients with cascade testing was at USD 7729/QALY compared to BRCA alone. Most studies adhered to the CHEERS 2022 criteria, signifying high methodological quality. CONCLUSIONS: Germline testing could be considered as cost-effective compared to no testing in Upper MICs (e.g., Malaysia, China, Brazil) but not in Lower MICs (e.g., India) based on the willingness-to-pay (WTP) threshold set by each respective study. Limitations prevent a definite conclusion about cost-effectiveness across LMICs. More high-quality studies are crucial for informed decision-making and improved healthcare practices in these regions.

Direct and Indirect Mapping of Assessment of Quality of Life - 6 Dimensions (AQoL-6D) Onto EQ-5D-5L Utilities Using Data From a Multicenter, Cross-Sectional Study of Malaysians With Chronic Heart Failure.

OBJECTIVES: The Assessment of Quality of Life - 6 Dimensions (AQoL-6D), a generic preference-based measure, is an appealing alternative to EQ-5D-5L for assessing health status in patients with chronic heart failure (HF), given its expanded scope. However, without a Malaysian value set, the AQoL-6D cannot generate health state utility values (HSUVs) to support local economic evaluations. This study intended to develop algorithms for predicting EQ-5D-5L HSUVs from AQoL-6D in an HF population. METHODS: Cross-sectional data from a multicenter cohort of 419 HF outpatients were used. Both direct and indirect mapping approaches were attempted using 5 sets of explanatory variables and 8 models (ordinary least squares, Tobit, censored least absolute deviations, generalized linear model, 2-part model [TPM], beta regression-based model, adjusted limited dependent variable mixture model, and multinomial ordinal regression [MLOGIT]). The models' predictive performance was assessed through 10-fold cross-validated mean absolute error [MAE] and root mean squared error [RMSE]). Potential prediction bias was also examined graphically. The best-performing models, with the lowest RMSE and no bias, were then identified. RESULTS: Among the models evaluated, TPM, which included age, sex, and 5 AQoL-6D dimension scores as predictors, appears to be the best-performing model for directly predicting EQ-5D-5L HSUVs from AQoL-6D. TPM yielded the lowest MAE (0.0802) and RMSE (0.1116), and demonstrated predictive accuracy for HSUVs >0.2 without significant bias. A MLOGIT model developed for response mapping had suboptimal predictive accuracy. CONCLUSIONS: This study developed potentially useful mapping algorithms for generating Malaysian EQ-5D-5L HSUVs from AQoL-6D responses among patients with HF when direct EQ-5D-5L data are unavailable.

Examining health-related quality of life in ambulatory adult patients with chronic heart failure: insights from Malaysia using EQ-5D-5L.

PURPOSE: Health-related quality-of-life (HRQoL) data for the chronic heart failure (HF) population in Malaysia are lacking. Using EQ-5D-5L, this study intended to describe their HRQoL, identify predictors of worse HRQoL, and derive EQ-5D-5L index scores for use in economic evaluations. METHODS: A cross-sectional survey was conducted between April and September 2023 to collect EQ-5D-5L, sociodemographic, and clinical data from outpatients with HF across seven public specialist hospitals in Malaysia. Multivariable logistic and linear regression models were used to identify independent predictors of reported problems in the EQ-5D-5L dimensions, and predictors of index scores and EQ-VAS, respectively. RESULTS: EQ-5D-5L data from 424 outpatients of multi-ethnic background (mean age: 57.1 years, 23.8% female, mean left ventricular ejection fraction: 35.7%, 89.7% NYHA class I-II) were collected using either Malay, English, or Chinese, achieving a 99.8% completion rate. Nearly half of the respondents reported issues in the Mobility, Usual Activities, and Pain/Discomfort dimensions. Mean EQ-5D-5L index was 0.820, lower than the general population, and significantly lower with NYHA class III-IV (0.747) versus NYHA class I (0.846) and NYHA class II (0.805). Besides NYHA class, independent predictors of worse HRQoL included Indian ethnicity, living alone, lower education, unemployment due to ill-health, and proxy-reported HRQoL, largely aligning with existing literature. CONCLUSION: Community-dwelling Malaysians with HF reported poorer HRQoL compared to the general population. The observed disparities in HRQoL among HF patients may be linked to specific patient characteristics, suggesting potential areas for targeted interventions. HRQoL assessment using EQ-5D-5L proves feasible and should be considered for routine implementation in local clinics.

Cost-effectiveness analysis of sorafenib, lenvatinib, atezolizumab plus bevacizumab and sintilimab plus bevacizumab for the treatment of advanced hepatocellular carcinoma in China.

BACKGROUND AND OBJECTIVE: Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related death worldwide, especially in China. According to the 2021 Chinese Society of Clinical Oncology guidelines, sorafenib, lenvatinib, atezolizumab combined with bevacizumab, and sintilimab combined with bevacizumab are recommended as first-line treatment options for advanced HCC. This study provides a cost-effectiveness analysis of these treatments from the patient perspective. METHODS: A partitioned survival model was established using the TreeAge 2019 software to evaluate the cost-effectiveness. The model includes three states, namely progression-free survival, progressive disease, and death. Clinical data were derived from three randomized controlled studies involving patients with advanced HCC who received the following treatment: sorafenib and lenvatinib (NCT01761266); atezolizumab in combination with bevacizumab (NCT03434379); and sintilimab in combination with bevacizumab (NCT03794440). Cost and clinical preference data were obtained from the literature and interviews with clinicians. RESULTS: All compared with sorafenib therapy, lenvatinib had an incremental cost-effectiveness ratio (ICER) of US$188,625.25 per quality-adjusted life year (QALY) gained; sintilimab plus bevacizumab had an ICER of US$75,150.32 per QALY gained; and atezolizumab plus bevacizumab had an ICER of US$144,513.71 per QALY gained. The probabilistic sensitivity analysis indicated that treatment with sorafenib achieved a 100% probability of cost-effectiveness at a threshold of US$36,600/QALY. One-way sensitivity analysis revealed that the results were most sensitive to the medical insurance reimbursement ratio and drug prices. CONCLUSIONS: In this economic evaluation, therapy with lenvatinib, sintilimab plus bevacizumab, and atezolizumab plus bevacizumab generated incremental QALYs compared with sorafenib; however, these regimens were not cost-effective at a willingness-to-pay threshold of US$36,600 per QALY. Therefore, some patients may achieve preferred economic outcomes from these three therapies by tailoring the regimen based on individual patient factors.

Quantifying health-related quality of life in Malaysian type 2 diabetes: focusing on complication types and severity.

PURPOSE: There is a knowledge gap of health utility values for Type 2 Diabetes Mellitus (T2DM) complications in Malaysia. This study aimed to estimate EQ-5D-5L utility values and evaluate health-related quality of life (HRQoL) for Malaysian T2DM associated with complications and clinical characteristics. METHODS: A cross-sectional study was conducted on T2DM patients at a tertiary hospital outpatient using the Malay and English version of the EQ-5D-5L questionnaire. Health utility values were derived using the Malaysian EQ-5D-5L value set. Ordinary least squares (OLS) multivariable regression model was used to estimate the health utility decrements associated with T2DM-related complications and clinical characteristics. RESULTS: A total of 513 T2DM patients were recruited. Overall, pain was the most affected of all five EQ-5D-5L dimensions. Patients with foot ulcer, amputation, severe heart failure and frequent hypoglycemia reported more problems collectively in all EQ-5D-5L dimensions. Older age, lower education level, longer duration of T2DM, urine protein creatine index (UPCI) > 0.02 g/mmol, and injection therapy were significantly associated with lower EQ-5D-5L utility values (p < 0.004, Bonferroni adjusted). The lowest unadjusted utility values were reported for severe heart failure 0.65 (interquartile range, IQR 0.50), frequent hypoglycemia 0.74 (0.22) and being amputated 0.78 (0.47). In the multivariable regression model after controlling for sociodemographic and clinical characteristics, the largest utility value decrement was observed for amputation (- 0.158, SE 0.087, p = 0.05), frequent hypoglycemia (- 0.101, SE 0.030, p = 0.001), myocardial infarction (-0.050, SE 0.022, p = 0.022) and obesity (-0.034, SE 0.016, p = 0.029). CONCLUSION: Larger utility value decrements were found for severe stages of complications. These findings suggest the value of defining severity of complications in utility elicitation studies. The utility decrement quantified for different T2DM complication severity will be useful for economic evaluations within diabetic-related fields.

Evaluation of the tolerability and effectiveness of Tenecteplase in patients with ST-Segment-Elevation Myocardial Infarction in a Secondary Hospital in Malaysia: A Retrospective Case Series.

BACKGROUND: In Malaysia, knowledge regarding the clinical efficacy of tenecteplase (TNK), a fibrin-specific tissue-plasminogen activator, is limited. OBJECTIVES: To evaluate the effectiveness and tolerability of TNK in patients with ST-segment-elevation myocardial infarction in a secondary referral Malaysian hospital. METHODS: This was a single-center retrospective case series based on the medical records of patients with ST-segment-elevation myocardial infarction admitted to the cardiac care unit between January 2016 and May 2019. Data regarding the mortality status and date of death were collected from the database of the National Registration Department of Malaysia. RESULTS: Data for 30 patients with ST-segment-elevation myocardial infarction, who received weight-adjusted doses of TNK, were analyzed. The patients' mean (SD) age was 62 (14) years, and 77% were men. The median time to treatment was 265 minutes (interquartile range = 228-660 minutes), and the clinical success rate of thrombolysis was 79%. The overall all-cause in-hospital mortality rate was 33%. The 1-year survival rates were higher in patients achieving a time to treatment ≤360 minutes (P = 0.03), with a trend toward greater survival in this group at 30 days. Similarly, a trend toward lower in-hospital all-cause mortality was observed in this group (21% vs 50%; P = 0.12). Only 1 patient (3%), who had a HAS-BLED score based on hypertension, abnormal liver/renal function, stroke history, bleeding history or predisposition, labile international normalized ratio, old age, drug/alcohol use of 5, developed major bleeding that required blood transfusion. No cases of ischemic stroke, nonmajor bleeding, in-hospital reinfarction, or TNK-induced allergic reaction were identified. CONCLUSIONS: We hypothesized that the mortality-related outcomes of TNK in patients with ST-segment-elevation myocardial infarction were influenced by TTT, with TTT ≤360 minutes indicating a better prognosis than TTT >360 minutes. TNK-induced bleeding-related complications were minimal in low-risk patients. Further local studies are needed to compare TNK's profile with that of streptokinase, which is a common agent currently used in clinical practice in Malaysian public hospitals. (Curr Ther Res Clin Exp. 2021; 82:XXX-XXX).

Assessment of the public perception of the hospital pharmacist and their satisfaction level with the pharmacy services provided in a developing country: a cross-sectional survey in Malaysia.

OBJECTIVE: To assess the public perception of the role of hospital pharmacists, their satisfaction with the pharmacy service provided, and the factors associated with their perception and satisfaction. METHODS: A cross-sectional, questionnaire survey was conducted on adults older than 18 years who utilized public pharmacy services. A self-developed, validated questionnaire consisting of three parts was used, i.e., demographic data, perception, and satisfaction. The questionnaire was tested in a pilot study of 50 study participants and demonstrated good reliability results of 0.900 for the perception section and 0.836 for the satisfaction section. Therefore, all items were used in the final questionnaire. KEY FINDINGS: Four hundred and seventy-nine completed questionnaires were collected with a response rate of 91.6%. The Cronbach's α for perception and satisfaction scores were 0.938 and 0.841, respectively. The median total score for public perception was 83 (interquartile range [IQR]: 15), whereas the median total score for public satisfaction was 38 (IQR: 33). The level of public perception was significantly associated with the age groups (P = .009), ethnic groups (P < .001), respondents' locality groups (P < .001), the level of education achieved group (P = .017), and the income groups (P = .006). Satisfaction was not significantly associated with any sociodemographic factors. CONCLUSIONS: This study has found that the general public had a favorable perception of the role of hospital pharmacists, and they were generally satisfied with the pharmacy service provided.

Cost-effectiveness of empagliflozin in the treatment of Malaysian patients with chronic heart failure and preserved or mildly reduced ejection fraction.

INTRODUCTION: Empagliflozin demonstrates promising clinical benefits in patients with heart failure (HF). While an early study demonstrates that empagliflozin is cost-effective for treating HF patients with reduced ejection fraction (HFrEF) in Malaysia, its cost-effectiveness for HF with ejection fraction (EF)>40% remains unclear. Therefore, the current study aimed to assess the cost-effectiveness of adding empagliflozin to the standard of care (SoC) for HF patients with EF>40% from the perspective of Malaysian healthcare system. Subsequently, the results were consolidated with the findings for HFrEF to evaluate the cost-effectiveness of empagliflozin when used for all HF patients in Malaysia, irrespective of EF. METHODS: A cost-utility analysis was performed using a validated Markov model, which modelled a cohort of adult patients through health states related to symptom severity and functional impairment, to estimate costs and quality-adjusted life-years (QALYs). The influence of model inputs and assumptions, sensitivity, scenario, and subgroup analyses were explored. All costs were expressed in 2022 Malaysian ringgits (RM). Costs and QALYs were discounted at an annual rate of 3.0% as per local pharmacoeconomic guideline. RESULTS: The base-case incremental cost-effectiveness ratio (ICER) for HF patients with EF>40% was RM 40,454 per QALY gained. At a cost-effectiveness threshold of RM 47,439/QALY gained, empagliflozin was cost-effective in 57% of replications. The model outcomes were sensitive to inputs related to the treatment effect of empagliflozin in reducing HF-related hospitalisation and cardiovascular mortality, and empagliflozin cost. For the overall HF population, the ICER was RM 29,463/QALY gained. CONCLUSION: The findings suggest that empagliflozin is a cost-effective treatment option for the Malaysian HF population, including those with EF>40%. As such, the intervention warrants consideration by the Malaysian healthcare provider to mitigate the burden of HF and address the unmet needs of the EF>40% population.

Budget Impact Analysis of Dapagliflozin in Treating Patients With Heart Failure With Reduced Ejection Fraction From the Perspective of Malaysian Public Healthcare System.

PURPOSE: This is a budget impact analysis that compared the scenario of treating heart failure with reduced ejection fraction (HFrEF) using dapagliflozin plus standard of care (SoC) versus a scenario without dapagliflozin, from the perspective of Ministry of Health (MOH) Malaysia over a 5-year time horizon. METHODS: A Microsoft Excel-based cost calculator was developed for such comparison. The estimated size of eligible population, uptake rates for dapagliflozin, as well as costs related to drugs, clinical events, and adverse events were based on published data, official tariffs, and databases, and expert opinion. Clinical data from the DAPA-HF trial were used to inform efficacy and safety inputs (i.e., hospitalization for heart failure (hHF), cardiovascular death, and adverse events). Results were reported as total annual and cumulative costs (in 2023 Malaysian Ringgits [RM], United States Dollars [USD], and European Union Euros, [EUR]; with exchange rates of 1 USD = RM 4.40 and 1 EUR = RM 4.90]), as well as the number of clinical events. Sensitivity and scenario analyses were also conducted. FINDINGS: The base-case analysis estimated that over a five-year period, the adoption of dapagliflozin for HFrEF treatment would result in a cumulative cost-saving of RM 2.6 million (USD 0.6 million/EUR 0.5 million), representing a 0.3% reduction in costs, driven primarily by reduced expenditure on hHF. Moreover, dapagliflozin treatment would lead to 731 fewer hHF and 366 fewer cardiovascular deaths. Sensitivity and scenario analyses revealed that the results were most sensitive to assumptions regarding loop diuretic requirements and the cost of dapagliflozin. Although cost savings or a net-zero balance were projected for the first four years, an anticipated 2.5% annual increase in dapagliflozin uptake in the longer term would lead to additional costs for the MOH, starting from the fifth year. IMPLICATIONS: Incorporating dapagliflozin into the SoC can improve health outcomes for HFrEF patients and may generate cost savings, potentially easing the economic strain of HFrEF management on Malaysia's public healthcare system in the short term. Nonetheless, a modest increase in budget should be anticipated as more patients gain access to the treatment over time.

Cost of illness of breast cancer in low- and middle-income countries: a systematic review.

This systematic review explores the cost of illness (COI) studies on breast cancer in low- to middle-income countries (LMICs). Studies in Cochrane, Proquest Thesis, PubMed and Scopus were considered. The reporting criteria were evaluated using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 statement. Studies must (1) be peer-reviewed, (2) report cost data, and (3) be full-text articles. Non-English articles were excluded. Twelve studies were included. The identified costs were made constant to 2022 USD values for reporting and comparison across studies. Annual costs per patient varied from $195 to $11,866 direct medical costs, $201 to $2233 direct non-medical costs and $332 to $26,390 productivity losses were reported. Cost differences were due to the cost types and components in each study. Only three COI studies reported sensitivity analysis and discount rates. Hence, it is recommended that future COI studies include an analysis of correlation between cost components and other variables.

Economic Burden of Alzheimer's Disease: A Systematic Review.

OBJECTIVES: Alzheimer's disease (AD) has become one of the most prevalent neurodegenerative disorders among the elderly. The global cost of dementia is expected to reach US $2 trillion in 2030. In this systematic review, existing evidence on the cost of dementia specific to AD is appraised. METHODS: A comprehensive search was done on 3 databases, namely PubMed, ScienceDirect, and Web of Science, to identify original cost-of-illness studies that only evaluate the economic burden of AD up to August 2022. The risk of bias in the studies was assessed using Consolidated Health Economic Evaluation Reporting Standards 2022 criteria. Cost articles without specifying etiology of AD or those in non-English were excluded. RESULTS: Twelve of 5536 studies met the inclusion criteria. The total annual cost of AD per capita ranged from US $468.28 in mild AD to US $171 283.80 in severe AD. The cost of care raised nonlinearly with disease severity. Indirect caregiving cost represented the main contributor to societal cost in community-dwelling patients. When special caregiving accommodation was opted in daily care, it results in cost shifting from indirect cost to direct nonmedical cost. Formal caregiving accommodation caused increase in direct cost up to 67.3% of overall economic burden of the disease. CONCLUSIONS: AD exerts a huge economic burden on patients and caregivers. Overall rise of each cost component could be anticipated with disease deterioration. Choice of special caregiving accommodation could reduce caregiver's productivity loss but increase the direct nonmedical expenditure of the disease from societal perspective.

Health state utility values ranges across varying stages and severity of type 2 diabetes-related complications: A systematic review.

INTRODUCTION: Health state utility values (HSUV) for Type 2 diabetes mellitus (T2DM) complications are useful in economic evaluations to determine cost effectiveness of an intervention. However, there is a lack of reference ranges for different severity and stages of individual complications. This study aimed to provide an overview of HSUV decrement ranges for common T2DM complications focusing on different severity and stages of complications. METHOD: A systematic search was conducted in MEDLINE, SCOPUS, WEB OF SCIENCE. (Jan 2000 to April 2022). Included studies for HSUV estimates were from outpatient setting, regardless of treatment types, complication stages, regions and HRQoL instruments. Health Related Quality of Life (HRQoL) outcomes was to be presented as HSUV decrement values, adjusted according to social demographics and comorbidities. Adjusted HSUV decrements were extracted and compiled according to individual complications. After which, subsequently grouped into mild or severe category for comparison. RESULTS: Searches identified 35 studies. The size of the study population ranged from 160 to 14,826. The HSUV decrement range was widest for cerebrovascular disease (stroke): -0.0060 to -0.0780 for mild stroke and -0.035 to -0.266 for severe stroke; retinopathy: mild (-0.005 to -0.0862), moderate (-0.0030 to -0.1845) and severe retinopathy (-0.023 to -0.2434); amputation: (-0.1050 to -0.2880). Different nature of complication severity defined in studies could be categorized into: those with acute nature, chronic with lasting effects, those with symptoms at early stage or those with repetitive frequency or episodes. DISCUSSION: Overview of HSUV decrement ranges across different stages of each T2DM diabetes-related complications shows that chronic complications with lasting impact such as amputation, severe stroke with sequelae and severe retinopathy with blindness were generally associated with larger HSUV decrement range. Considerable heterogeneities exist across the studies. Promoting standardized complication definitions and identifying the most influential health state stages on HSUV decrements may assist researchers for future cost-effectiveness studies.

Cost-effectiveness of immune checkpoint inhibitors as a first-line therapy for advanced hepatocellular carcinoma: a systematic review.

Since 2017, immune checkpoint inhibitors (ICIs) have been available for the treatment of advanced hepatocellular carcinoma (HCC) or unresectable HCC, but their adoption into national medical insurance programs is still limited. Cost-effectiveness evidence can help to inform treatment decisions. This systematic review aimed to provide a critical summary of economic evaluations of ICIs as a treatment for advanced HCC and identify key drivers (PROSPERO 2023: CRD42023417391). The databases used included Scopus, Web of Science, PubMed, Embase, and Cochrane Central. Economic evaluations of ICIs for the treatment of advanced HCC were included. Studies were screened by two people. Of the 898 records identified, 17 articles were included. The current evidence showed that ICIs, including atezolizumab plus bevacizumab, sintilimab plus bevacizumab/bevacizumab biosimilar, nivolumab, camrelizumab plus rivoceranib, pembrolizumab plus lenvatinib, tislelizumab, durvalumab, and cabozantinib plus atezolizumab, are probably not cost-effective in comparison with tyrosine kinase inhibitors or other ICIs. The most influential parameters were price of anticancer drugs, hazard ratios for progression-free survival and overall survival, and utility for health statest. Our review demonstrated that ICIs were not a cost-effective intervention in advanced HCC. Although ICIs can significantly enhance the survival of patients with advanced HCC, decision-makers should consider the findings of economic evaluations and affordability before adoption of new therapies.

A qualitative study exploring community pharmacists' awareness, attitudes and perceptions about drive-thru community pharmacy service in Malaysia during COVID-19.

Introduction: Drive-thru services are not given sufficient focus in the community pharmacy setting which was highlighted during COVID-19, particularly in Malaysia. This study aimed to explore the community pharmacists' perspectives regarding drive-thru community pharmacy service during COVID-19 in Malaysia. Methods: In-depth online semi-structured individual interviews were conducted among 25 community pharmacists working in Malaysia. All interviews were conducted between March 2022 and May 2022 and were audio-recorded and transcribed verbatim, and then analysed by thematic analysis. Results: Thematic analysis yielded seven major themes, 1-familiarity with drive-thru community pharmacy service during COVID-19, 2-willingness toward this service during COVID-19, 3-perceived benefits toward drive-thru community pharmacy service during COVID-19, 4-perceived disadvantages toward this service, 5-barriers toward drive-thru community pharmacy service, 6-factors affecting the preference toward this service, and 7-facilitators to drive-thru community pharmacy service. Enhancing social distancing and preventing the spread of COVID-19 were the major perceived benefits of this service during COVID-19 as reported by participants. Conclusion: Overall, community pharmacists reported positive attitudes toward drive-thru community pharmacy service during COVID-19. However, concerns about poor communication between the pharmacist and the patient, limited counselling, and dispensing errors were acknowledged. These concerns would need to be addressed to improve the provision of drive-thru community pharmacy service.

Development and validation of the mobile adherence satisfaction scale (MASS) for medication adherence apps.

OBJECTIVE: To develop and validate the Mobile Adherence Satisfaction Scale (MASS) for assessing user satisfaction with mobile health applications aimed to improve medication adherence. METHODS: The study involved patients over 18 with asthma, hypertension, heart failure, or diabetes, who used the CareAide® app for six months. Scale development included a literature review, expert consultations, and patient interviews, initially identifying 129 items. These were refined to 27 using a two-round Delphi technique and grouped into six dimensions: user interface, perceived usability, system quality, service quality, feature satisfaction, and general satisfaction. A pilot study with 30 participants further refined the model, which was then validated with 135 participants using exploratory and confirmatory factor analyses in SPSS 29 and SmartPLS 4. Data were collected via self-administered questionnaires. RESULTS: A total of 135 complete questionnaires were analysed. Respondents had an average age of 66.7 years (SD = 11.6) with 42.2 % male (n = 57) and 57.8 % female (n = 78). After removal of an item due to cross loading, exploratory factor analysis resulted six dimensions and 26 items with Kaiser-Meyer-Olkin measure of 0.837 and Bartlett's Test of Sphericity (χ2(n = 325) = 2085.673, P < 0.001). The confirmatory factor analysis confirmed high reliability and validity: Cronbach's alpha values > 0.70 for each dimension and an overall alpha of 0.89, with Composite Reliability and Average Variance Extracted both >0.70 and >0.50, respectively, for each dimension. Structural model indicated a significant positive impact of user interface (ß = 0.226, P = 0.006) and feature satisfaction (ß = 0.230, P = 0.002) on general satisfaction, explaining 23.1 % of the variance (R2 = 0.231). CONCLUSION: The study developed and validated the MASS, a reliable tool for assessing user satisfaction with mHealth apps. User interface design and feature satisfaction are key for long-term engagement and consistent medication adherence.

A systematic review of the economic burden of diabetes mellitus: contrasting perspectives from high and low middle-income countries.

Introduction: Diabetes increases preventative sickness and costs healthcare and productivity. Type 2 diabetes and macrovascular disease consequences cause most diabetes-related costs. Type 2 diabetes greatly costs healthcare institutions, reducing economic productivity and efficiency. This cost of illness (COI) analysis examines the direct and indirect costs of treating and managing type 1 and type 2 diabetes mellitus. Methodology: According to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, Cochrane, PubMed, Embase, CINAHL, Scopus, Medline Plus, and CENTRAL were searched for relevant articles on type 1 and type 2 diabetes illness costs. The inquiry returned 873 2011-2023 academic articles. The study included 42 papers after an abstract evaluation of 547 papers. Results: Most articles originated in Asia and Europe, primarily on type 2 diabetes. The annual cost per patient ranged from USD87 to USD9,581. Prevalence-based cost estimates ranged from less than USD470 to more than USD3475, whereas annual pharmaceutical prices ranged from USD40 to more than USD450, with insulin exhibiting the greatest disparity. Care for complications was generally costly, although costs varied significantly by country and problem type. Discussion: This study revealed substantial heterogeneity in diabetes treatment costs; some could be reduced by improving data collection, analysis, and reporting procedures. Diabetes is an expensive disease to treat in low- and middle-income countries, and attaining Universal Health Coverage should be a priority for the global health community.

Direct healthcare expenditure on Alzheimer's disease from healthcare providers' perspective in Malaysia: a micro-costing approach.

Alzheimer's disease (AD) is an important geriatric disease that creates challenges in health policy planning. There is no previous attempt to quantify the actual direct healthcare cost of AD among older adults in Malaysia. This retrospective observational study with bottom-up micro-costing approach aimed to evaluate the direct healthcare expenditure on AD along with its potential predictors from healthcare providers' perspective, conducted across six tertiary hospitals in Malaysia. AD patients aged 65 and above who received AD treatment between 1 January 2016 and 31 December 2021 were included. Direct healthcare cost (DHC) of AD was estimated by extracting one-year follow-up information from patient medical records. As a result, 333 AD patients were included in the study. The mean DHC of AD was estimated RM2641.30 (USD 572.45) per patient per year (PPPY) from the healthcare payer's perspective. Laboratory investigations accounted for 37.2% of total DHC, followed by clinic care (31.5%) and prescription medicine (24.9%). As disease severity increases, annual DHC increases from RM2459.04 (mild), RM 2642.27 (moderate), to RM3087.61 (severe) PPPY. Patients aged 81 and above recorded significantly higher annual DHC (p = 0.003). Such real-world estimates are important in assisting the process of formulating healthcare policies in geriatric care.

Translation, cross-cultural adaptation, and psychometric validation of the Malay version of the Assessment of Quality of Life-6 Dimensions (Malay-AQoL-6D) instrument among Malaysians living with chronic heart failure.

BACKGROUND: This study aimed to translate and culturally adapt the Assessment of Quality of Life (AQoL)-6D into Malay (Malay-AQoL-6D), and assesses the instrument's acceptability, reliability, and validity among Malaysians living with chronic heart failure (HF). METHODS: The translation and cross-cultural adaptation process adhered to international guidelines. The Malay-AQoL-6D underwent content and face validity assessments via expert review, and pretesting among healthy individuals and patients with chronic conditions. Subsequent psychometric validation utilised clinico-sociodemographic data and paired AQoL-6D and EQ-5D-5L data from a health-related quality-of-life (HRQoL) survey involving Malay-speaking patients with HF, which encompassed assessments of Malay-AQoL-6D acceptability, internal consistency and test-retest reliability, as well as its construct, concurrent, convergent and divergent, and known-group validity. RESULTS: The Malay-AQoL-6D was deemed acceptable among clinicians and local patients, achieving a 90.8% completion rate among 314 patients surveyed. The instrument demonstrated strong content validity (item-level content validity index [CVI]: 0.83-1.00, average CVI: 0.98), internal consistency (Cronbach's alpha: 0.72-0.89; MacDonald's omega: 0.82-0.90, excluding the Senses dimension), and test-retest reliability (average intraclass correlation coefficients: 0.79-0.95). Confirmatory factor analysis confirmed the instrument's two-level, six-factor structure (Satorra-Bentler [SB]-scaled χ2(df: 164): 283.67, p-value < 0.001; root mean square error of approximation [RMSEA]: 0.051; comparative fix index [CFI]: 0.945, Tucker-Lewis index [TLI]: 0.937; standardised root mean-squared error [SRMR]: 0.058). The Malay-AQoL-6D's concurrent validity was evident through its good agreement with EQ-5D-5L. Multiple hypothesis tests further affirmed its construct and known-group validity. The Malay-AQoL-6D's psychometric properties remained consistent across different missing data techniques. CONCLUSION: The findings suggest that Malay-AQoL-6D could be a culturally acceptable, reliable, and valid HRQoL measure for quantifying HRQoL among the local HF population. Future studies are necessary to further validate the instrument against other measures and confirm the instrument's test-retest reliability and responsiveness, which are possible with the availability of the Malay-AQoL-6D.

Financial burden of heart failure in Malaysia: A perspective from the public healthcare system.

BACKGROUND: Estimating and evaluating the economic burden of HF and its impact on the public healthcare system is necessary for devising improved treatment plans in the future. The present study aimed to determine the economic impact of HF on the public healthcare system. METHOD: The annual cost of HF per patient was estimated using unweighted average and inverse probability weighting (IPW). Unweight average estimated the annual cost by considering all observed cases regardless of the availability of all the cost data, while IPW calculated the cost by weighting against inverse probability. The economic burden of HF was estimated for different HF phenotypes and age categories at the population level from the public healthcare system perspective. RESULTS: The mean (standard deviation) annual costs per patient calculated using unweighted average and IPW were USD 5,123 (USD 3,262) and USD 5,217 (USD 3,317), respectively. The cost of HF estimated using two different approaches did not differ significantly (p = 0.865). The estimated cost burden of HF in Malaysia was USD 481.9 million (range: USD 31.7 million- 1,213.2 million) per year, which accounts for 1.05% (range: 0.07%-2.66%) of total health expenditure in 2021. The cost of managing patients with heart failure with reduced ejection fraction (HFrEF) accounted for 61.1% of the total financial burden of HF in Malaysia. The annual cost burden increased from USD 2.8 million for patients aged 20-29 to USD 142.1 million for those aged 60-69. The cost of managing HF in patients aged 50-79 years contributed 74.1% of the total financial burden of HF in Malaysia. CONCLUSION: A large portion of the financial burden of HF in Malaysia is driven by inpatient costs and HFrEF patients. Long-term survival of HF patients leads to an increase in the prevalence of HF, inevitably increasing the financial burden of HF.

Is Using Sodium-Glucose Cotransporter-2 Inhibitors to Treat Adults with Chronic Heart Failure Cost-Effective? A Systematic Review of Cost-Effectiveness Studies.

OBJECTIVE: This systematic review aimed to summarise the outcomes of economic evaluations that evaluated sodium-glucose cotransporter-2 inhibitors (SGLT2i) in combination with standard of care compared to standard of care alone for patients with chronic heart failure. METHODS: This systematic review searched MEDLINE, CINAHL+, Econlit, Scopus, the Cochrane Library, the National Health Service Economic Evaluation Database and the Cost-Effectiveness Analysis Registry from inception to 31 December, 2022, for relevant economic evaluations, which were critically appraised using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) and Bias in Economic Evaluation (ECOBIAS) criteria. The costs, quality-adjusted life-years, incremental cost-effectiveness ratios and cost-effectiveness thresholds were qualitatively analysed. Net monetary benefits at different decision thresholds were also computed. Subgroup analyses addressing the heterogeneity of economic outcomes were conducted. All costs were adjusted to 2023 international dollar (US$) values using the CCEMG-EPPI-Centre cost converter. RESULTS: Thirty-nine economic evaluations that evaluated dapagliflozin and empagliflozin in patients with heart failure were found: 32 for the left ventricular ejection fraction (LVEF) ≤ 40% and seven for LVEF > 40%. Sodium-glucose cotransporter-2 inhibitors were cost-effective in all but two economic evaluations for LVEF > 40%. Economic outcomes varied widely, but favoured SGLT2i use in LVEF ≤ 40% over LVEF > 40% and upper-middle income over high-income countries. At a threshold of US$30,000/quality-adjusted life-year, ~ 90% of high to upper-middle income countries would consider SGLT2i cost-effective for heart failure treatment. The generalisability of study findings to low- and low-middle income countries is limited because of insufficient evidence. CONCLUSIONS: Using SGLT2i to treat heart failure is cost-effective, with more certainty in LVEF ≤ 40% compared to LVEF > 40%. Policymakers in jurisdictions where economic evaluations are not available could potentially use this study's findings to make informed decisions about treatment adoption. SYSTEMATIC REVIEW PROTOCOL REGISTRATION: This study protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO; CRD42023388701).