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.

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.