Should the Preference-based Index Set of Values Be Country- or Disease-specific? An Analysis Using Data From Women With Symptoms of Overactive Bladder

Background: Overactive bladder (OAB) and urinary incontinence (UI) are common conditions among women. However, no studies have evaluated the utility value of this population using different country-specific value sets. We aimed to 1) verify the difference between the preference-based index extracted from the Short Form six dimensions (SF-6Dv1) questionnaire in women with OAB using different country-specific value sets; 2) translate and cross-culturally adapt the King's Health Questionnaire Five Dimension (KHQ-5D) into Brazilian Portuguese; and 3) examine the association between utility index obtained by the SF-6Dv1 and KHQ-5D. Methods: This cross-sectional study included 387 women over 18 years of age with OAB symptoms, divided into groups with and without UI. All participants answered the sociodemographic questionnaire, KHQ, KHQ-5D, and SF-6Dv1. To the statistical analysis a two-way mixed ANOVA was applied to verify the interaction between the presence of UI and utility index obtained from different country-specific value sets. Post-hoc multiple comparisons were applied following the main analysis. Spearman’s test was applied to verify the correlation between the utility values of SF-6Dv1 and KHQ-5D. The significance level was set at 5%. Results: We evaluated 298 women classified according to the presence of UI (119 without UI vs. 179 with UI). The main analysis showed a statistically significant interaction between the presence of UI and the utility index obtained from the different countries (p = 0.005, Cohen’s d= 0.02). The post-hoc analyses showed that there was a statistically significant main effect of the utility index obtained from different countries (p <0.001, d = 0.63) and in the presence of UI (p = 0.012, d = 0.02). The correlations between the utility indices obtained from different countries using the SF-6Dv1 and KHQ-5D were significant, positive, and small. Conclusions: The differences between the indices obtained in different countries and groups with and without UI, assessed using the SF-6Dv1, are shown. The correlation between general and specifics preference-based measures was small; therefore, the SF-6Dv1 should be used with caution in cost-utility studies for this population. We recommend that in women with OAB, the value set for GPBM be obtained in countries where cost utility is applied.

Adding Rituximab to Chemotherapy for Diffuse Large B-Cell Lymphoma Patients in Indonesia: A Cost Utility and Budget Impact Analysis

Background This study aims to estimate the cost-effectiveness and budget impact of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) compared to CHOP for the treatment of patients with diffuse large B-cell lymphoma (DLBCL) in Indonesia. Methods We conducted a cost utility analysis using Markov model over a lifetime horizon, from a societal perspective. Clinical evidence was derived from published clinical trials. Direct medical costs were gathered from hospital data. Direct non-medical costs, indirect costs, and utility data were primarily gathered by interviewing the patients. We applied 3% discount rate for both costs and effect. All monetary data are converted into USD (1 USD = IDR 14,000, 2019). Probabilistic sensitivity analysis was performed. In addition, from a payer perspective, budget impact analysis was estimated using price reduction scenarios. Results The incremental cost-effectiveness ratio (ICER) of R-CHOP was USD 4,674/LYG and 9,280/QALY. If we refer to the threshold three times the GDP per capita (USD 11,538), R-CHOP could thus be determined as a cost-effective therapy. Its significant health benefit has contributed to the considerable ICER result. Although the R-CHOP has been considered a cost-effective intervention, the financial consequence of R-CHOP if remain in benefit package under National Health Insurance (NHI) system in Indonesia is considerably substantial, approximately USD 66 million with 75% price reduction scenario. Conclusions As a favorable treatment for DLBCL, R-CHOP ensures value for money in Indonesia. Budget impact analysis provides results which can be used as further consideration for decision-makers in matters related to benefit packages.

Meta-analysis of health state utility values measured by EuroQol 5-dimensions (EQ5D) questionnaire in Chinese women with breast cancer

Background To synthesise EQ5D health state utility values in Chinese women with breast cancer for parameterising a cost utility model. Methods Eligible studies had to report health state utility values measured by EQ-5D in Chinese women diagnosed with breast cancer. Risk of bias was assessed using the Newcastle Ottawa Scale (NOS). Data from single arm studies was pooled using meta-analysis of single proportions to provide overall point estimates and 95% confidence intervals for fixed and random effects models using the inverse variance and Der Simonian-Laird methods respectively. Heterogeneity was evaluated using the I2 statistic and sensitivity analysis and meta-regression were conducted. Results Five papers were included, when all studies were combined (n = 4,100) the mean utility (95% confidence interval) for random effects model was 0.83 (0.78, 0.89); for TNM 0-1 0.85 (0.75, 0.95); for TNM II 0.85 (0.78, 0.93); for TNM III 0.83 (0.77, 0.90) and for TNM IV 0.73 (0.63, 0.82).The utility of patients in State P (first year after primary breast cancer) 0.84 (0.80, 0.88); in State R (first year after recurrence) 0.73 (0.69, 0.76), in State S (second and following years after primary breast cancer or recurrence) 0.88 (0.83, 0.92); and in State M (metastatic disease) 0.78 (0.74, 0.82). Mean utility for duration since diagnosis 13 to 36 months was 0.88 (0.80, 0.96, I2 =95%); for 37 to 60 months 0.89 (0.82, 0.96, I2 =90%); for more than 60 months 0.86 (0.76, 0.96, I2 =90%). Mean utility for chemotherapy was 0.86 (0.79, 0.92, I2 =97%); for radiotherapy 0.83 (0.69, 0.96, I2 =97%); surgery 0.80 (0.69, 0.91, I2 =98%); concurrent chemo-radiation 0.70 (0.60, 0.81, I2 =86%) and endocrine therapy 0.90 (0.83, 0.97, I2 =91%). Conclusion: This study synthesises the evidence for health state utility values for Chinese women with breast cancer which is useful to inform cost utility models.

Cost-Utility of an Online Education Platform and Diabetes Personal Health Record: Analysis Over Ten Years

Background and Aims: My Diabetes My Way (MDMW) is Scotland’s interactive website and mobile app for people with diabetes and their caregivers. It contains multimedia resources for diabetes education and offers access to electronic personal health records. This study aims to assess the cost-utility of MDMW compared with routine diabetes care in people with type 2 diabetes who do not use insulin. Materials and Methods: Analysis used the United Kingdom Prospective Diabetes Study (UKPDS) Outcomes Model 2. Clinical parameters of MDMW users (n = 2576) were compared with a matched cohort of individuals receiving routine care alone (n = 11 628). Matching criteria: age, diabetes duration, sex, and socioeconomic status. Impact on life expectancy, quality-adjusted life years (QALYs), and costs of treatment and complications were simulated over ten years, including a 10% sensitivity analysis. Results: MDMW cohort: 1670 (64.8%) men; average age 64.3 years; duration of diabetes 5.5 years. 906 (35.2%) women: average age 61.6 years; duration 4.7 years. The cumulative mean QALY (95% CI) gain: 0.054 (0.044-0.062) years. Mean difference in cost: –£118.72 (–£150.16 to –£54.16) over ten years. Increasing MDMW costs (10%): –£50.49 (–£82.24-£14.14). Decreasing MDMW costs (10%): –£186.95 (–£218.53 to –£122.51). Conclusions: MDMW is “dominant” over usual care (cost-saving and life improving) in supporting self-management in people with type 2 diabetes not treated with insulin. Wider use may result in significant cost savings through delay or reduction of long-term complications and improved QALYs in Scotland and other countries. MDMW may be among the most cost-effective interventions currently available to support diabetes.

Study protocol for a randomised, double-blinded, placebo-controlled phase III trial examining the add-on efficacy, cost–utility and neurobiological effects of low-dose naltrexone (LDN) in patients with fibromyalgia (INNOVA study)

IntroductionThere is evidence that low-dose naltrexone (LDN; <5.0 mg/day) reduces pain and improves the quality of life of people with fibromyalgia syndrome (FMS). However, no randomised controlled trials with long-term follow-ups have been carried out. The INNOVA study will evaluate the add-on efficacy, safety, cost–utility and neurobiological effects of LDN for reducing pain in patients with FMS, with a 1-year follow-up.Methods and analysisA single-site, prospective, randomised, double-blinded, placebo-controlled, parallel design phase III trial will be performed. Eligibility criteria include being adult, having a diagnosis of FMS and experiencing pain of 4 or higher on a 10-point numerical rating scale. Participants will be randomised to a LDN intervention group (4.5 mg/day) or to a placebo control group. Clinical assessments will be performed at baseline (T0), 3 months (T1), 6 months (T2) and 12 months (T3). The primary endpoint will be pain intensity. A sample size of 60 patients per study arm (120 in total), as calculated prior to recruitment for sufficient power, will be monitored between January 2022 and August 2024. Assessment will also include daily ecological momentary evaluations of FMS-related symptoms (eg, pain intensity, fatigue and sleep disturbance), and side effects via ecological momentary assessment through the Pain Monitor app during the first 3 months. Costs and quality-adjusted life years will be also calculated. Half of the participants in each arm will be scanned with MRI at T0 and T1 for changes in brain metabolites related to neuroinflammation and central sensitisation. Inflammatory biomarkers in serum will also be measured.Ethics and disseminationThis study has been approved by the Ethics Committee of the Fundació Sant Joan de Déu. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and community engagement activities.Trial registration numberNCT04739995.

Economic Effects of Occupational Therapy Services for Adults in Acute and Subacute Care Settings: A Systematic Review

Importance: Research supports the clinical effectiveness of hospital-based occupational therapy to improve functional outcomes, but no synthesis of economic evaluations of occupational therapy services provided in these settings has been published. Objective: To determine the economic value of occupational therapy services in acute and subacute care settings. Data Sources: MEDLINE, CINAHL, CENTRAL, EconLit, Embase, National Health Services Economic Evaluation Database, PsycINFO, ProQuest (Health and Medicine and Social Science subsets only), OTseeker, and gray literature. Study Selection and Data Collection: Eligible studies used trial-based or modeled economic analyses and included an adult population (ages ≥18 yr) and occupational therapy assessments or interventions provided in acute and subacute care. Two authors independently assessed abstracts and then full text. Articles were then appraised using the Evers Consensus on Health Economic Criteria. Findings: The authors identified 13,176 unique abstracts and assessed 190 full-text articles for eligibility. Ten studies were included in the systematic review; they varied in their primary objectives, methodology, costs, and outcomes. Studies examined the cost–benefit, cost-effectiveness, cost–utility, or cost minimization of a range of occupational therapy services. Five studies suggested that occupational therapy services offer value for money (lower cost, higher benefit); 4 suggested that they offer higher cost and benefits. One study that investigated upper limb rehabilitation did not indicate value for money. Conclusions and Relevance: The findings suggest that occupational therapy for adults poststroke and post–traumatic brain injury, acute discharge planning, and pre– and post–hip replacement is cost-effective, but further research is needed to substantiate these findings. What This Article Adds: The findings provide preliminary evidence of the economic effectiveness of occupational therapy in acute and subacute care.