Cost-effectiveness of pessary therapy versus surgery for symptomatic pelvic organ prolapse: an economic evaluation alongside a randomised non-inferiority controlled trial.

OBJECTIVE: To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective. DESIGN: Economic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up. SETTING: 21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022. PARTICIPANTS: 1605 women referred to secondary care with symptomatic prolapse stage ≥2 were requested to participate. Of them, 440 women gave informed consent and were randomised to pessary therapy (n=218) or to surgery (n=222) in a 1:1 ratio stratified by hospital. INTERVENTIONS: Pessary therapy and surgery. PRIMARY AND SECONDARY OUTCOME MEASURES: The Patient Global Impression of Improvement (PGI-I), a 7-point scale dichotomised into successful versus unsuccessful, with a non-inferiority margin of -10%; quality-adjusted life-years (QALYs) measured by the EQ-5D-3L; healthcare and societal costs were based on medical records and the institute for Medical Technology Assessment questionnaires. RESULTS: For the PGI-I, the mean difference between pessary therapy and surgery was -0.05 (95% CI -0.14; 0.03) and -0.03 (95% CI -0.07; 0.002) for QALYs. In total, 54.1% women randomised to pessary therapy crossed over to surgery, and 3.6% underwent recurrent surgery. Healthcare and societal costs were significantly lower in the pessary therapy (mean difference=-€1807, 95% CI -€2172; -€1446 and mean difference=-€1850, 95% CI -€2349; -€1341, respectively). The probability that pessary therapy is cost-effective compared with surgery was 1 at willingness-to-pay thresholds between €0 and €20 000/QALY gained from both perspectives. CONCLUSIONS: Non-inferiority of pessary therapy regarding the PGI-I could not be shown and no statistically significant differences in QALYs between interventions were found. Due to significantly lower costs, pessary therapy is likely to be cost-effective compared with surgery as an initial treatment option for women with symptomatic POP treated in secondary care. TRIAL REGISTRATION NUMBER: NTR4883.

Predicting direct healthcare costs of general practitioner-guided care in patients with musculoskeletal complaints.

ABSTRACT: Information on healthcare utilization and costs of general practitioner (GP)-guided care in patients with musculoskeletal complaints is important for keeping healthcare affordable and accessible. A registry-based study was performed to describe healthcare utilization and costs of GP-guided care in patients with musculoskeletal complaints and to predict having higher direct healthcare costs. Healthcare costs of GP-guided care included all healthcare resources used by patients due to a musculoskeletal condition in 2018. Data were extracted from the database with a 1-year follow-up and descriptively analyzed. A general linear model was developed to predict having higher direct healthcare costs. In total, 403,719 patients were included, of whom 92% only received a single consultation. The number of referrals varied across the different types of complaints. Total annual direct healthcare costs amounted to €39,180,531, of which a key cost driver was referrals. Primary care consultations accounted for the largest part of referral-related costs. For all musculoskeletal conditions combined, the mean annual direct healthcare cost per patient was €97 (SEM = €0.18). Older age, being a woman, low socioeconomic status, spine complaints, high number of musculoskeletal diagnoses, and a high comorbidity score were predictive of having higher direct healthcare costs and explained 0.7% of the variance. This study showed that mean annual direct healthcare costs of GP-guided care in patients with musculoskeletal conditions were relatively low and did not differ considerably across conditions. The predictive model explained a negligible part of the variance in costs. Thus, it is unclear which factors do predict high direct healthcare costs in this population.

Can EQ-5D-3L utility values of low back pain patients be validly predicted by the Oswestry Disability Index for use in cost-effectiveness analyses?

PURPOSE: To assess whether regression modeling can be used to predict EQ-5D-3L utility values from the Oswestry Disability Index (ODI) in low back pain (LBP) patients for use in cost-effectiveness analysis. METHODS: EQ-5D-3L utility values of LBP patients were estimated using their ODI scores as independent variables using regression analyses, while adjusting for case-mix variables. Six different models were estimated: (1) Ordinary Least Squares (OLS) regression, with total ODI score, (2) OLS, with ODI item scores as continuous variables, (3) OLS, with ODI item scores as ordinal variables, (4) Tobit model, with total ODI score, (5) Tobit model, with ODI item scores as continuous variables, and (6) Tobit model, with ODI item scores as ordinal variables. The models' performance was assessed using explained variance (R2) and root mean squared error (RMSE). The potential impact of using predicted instead of observed EQ-5D-3L utility values on cost-effectiveness outcomes was evaluated in two empirical cost-effectiveness analysis. RESULTS: Complete individual patient data of 18,692 low back pain patients were analyzed. All models had a more or less similar R2 (range 45-52%) and RMSE (range 0.21-0.22). The two best performing models produced similar probabilities of cost-effectiveness for a range of willingness-to-pay (WTP) values compared to those based on the observed EQ-5D-3L values. For example, the difference in probabilities ranged from 2 to 5% at a WTP of 50,000 €/QALY gained. CONCLUSION: Results suggest that the ODI can be validly used to predict low back pain patients' EQ-5D-3L utility values and QALYs for use in cost-effectiveness analyses.

Cost-effectiveness of single-layer versus double-layer uterine closure during caesarean section on postmenstrual spotting: economic evaluation alongside a randomised controlled trial.

OBJECTIVE: To evaluate the cost-effectiveness of double-layer compared with single-layer uterine closure after a first caesarean section (CS) from a societal and healthcare perspective. DESIGN: Economic evaluation alongside a multicentre, double-blind, randomised controlled trial. SETTING: 32 hospitals in the Netherlands, 2016-2018. PARTICIPANTS: 2292 women ≥18 years undergoing a first CS were randomly assigned (1:1). Exclusion criteria were: inability for counselling, previous uterine surgery, known menstrual disorder, placenta increta or percreta, pregnant with three or more fetuses. 1144 women were assigned to single-layer and 1148 to double-layer closure. We included 1620 women with a menstrual cycle in the main analysis. INTERVENTIONS: Single-layer unlocked uterine closure and double-layer unlocked uterine closure with the second layer imbricating the first. MAIN OUTCOME MEASURES: Spotting days, quality-adjusted life-years (QALYs), and societal costs at 9 months of follow-up. Missing data were imputed using multiple imputation. RESULTS: No significant differences were found between single-layer versus double-layer closure in mean spotting days (1.44 and 1.39 days; mean difference (md) -0.056, 95% CI -0.374 to 0.263), QALYs (0.663 and 0.658; md -0.005, 95% CI -0.015 to 0.005), total healthcare costs (€744 and €727; md €-17, 95% CI -273 to 143), and total societal costs (€5689 and €5927; md €238, 95% CI -624 to 1108). The probability of the intervention being cost-effective at willingness-to-pay of €0, €10 000 and €20 000/QALY gained was 0.30, 0.27 and 0.25, respectively, (societal perspective), and 0.55, 0.41 and 0.32, respectively, (healthcare perspective). CONCLUSION: Double-layer uterine closure is not cost-effective compared with single-layer uterine closure from both perspectives. If this is confirmed by our long-term reproductive follow-up, we suggest to adjust uterine closure technique guidelines. TRIAL REGISTRATION NUMBER: NTR5480/NL5380.

Cost-Effectiveness and Return-on-Investment of the Dynamic Work Intervention Compared With Usual Practice to Reduce Sedentary Behavior.

OBJECTIVE: To assess the cost-effectiveness and return-on-investment (ROI) of the Dynamic Work (DW) Intervention, a worksite intervention aimed at reducing sitting time among office workers. METHODS: In total, 244 workers were randomized to the intervention or control group. Overall sitting time, standing time, step counts, quality-adjusted life years (QALYs), and costs were measured over 12 months. The cost-effectiveness analysis was performed from the societal perspective and the ROI analysis from the employers' perspective. RESULTS: No significant differences in effects and societal costs were observed between groups. Presenteeism costs were significantly lower in the intervention group. The probability of the intervention being cost-effective was 0.90 at a willingness-to-pay of 20,000&OV0556;/QALY. The probability of financial savings was 0.86. CONCLUSION: The intervention may be considered cost-effective from the societal perspective depending on the willingness-to-pay. From the employer perspective, the intervention seems cost-beneficial.

Cost-utility Analysis of Opportunistic and Systematic Diabetic Retinopathy Screening Strategies from the Perspective of the Brazilian Public Healthcare System.

OBJECTIVE: To perform a cost-utility analysis of diabetic retinopathy (DR) screening strategies from the perspective of the Brazilian Public Healthcare System. METHODS: A model-based economic evaluation was performed to estimate the incremental costs per quality-adjusted life-year (QALY) gained between three DR screening strategies: (1) the opportunistic ophthalmology referral-based (usual practice), (2) the systematic ophthalmology referral-based, and (3) the systematic teleophthalmology-based. The target population included individuals with type 2 diabetes (T2D) aged 40 years, without retinopathy, followed over a 40-year time horizon. A Markov model was developed with five health states and a 1-year cycle. Model parameters were based on literature and country databases. One-way and probabilistic sensitivity analyses were performed to assess model parameters' uncertainty. WHO willingness-to-pay (WHO-WTP) thresholds were used as reference (i.e. one and three times the Brazilian per capita Gross Domestic Product of R$32747 in 2018). RESULTS: Compared to usual practice, the systematic teleophthalmology-based screening was associated with an incremental cost of R$21445/QALY gained ($9792/QALY gained). The systematic ophthalmology referral-based screening was more expensive (incremental costs = R$4) and less effective (incremental QALY = -0.012) compared to the systematic teleophthalmology-based screening. The probability of systematic teleophthalmology-based screening being cost-effective compared to usual practice was 0.46 and 0.67 at the minimum and the maximum WHO-WTP thresholds, respectively. CONCLUSION: Systematic teleophthalmology-based DR screening for the Brazilian population with T2D would be considered very cost effective compared to the opportunistic ophthalmology referral-based screening according to the WHO-WTP threshold. However, there is still a considerable amount of uncertainty around the results.

Diagnostic performance of retinal digital photography for diabetic retinopathy screening in primary care.

Introduction: We must study alternatives to structure an effective diabetic retinopathy screening program for Brazilian public health system. Objectives: Evaluate the diagnostic performance of retinal digital photography for diabetic retinopathy screening in primary care, accuracy of the family physician in diabetic retinopathy identification compared to the ophthalmologist, and the need for dilation. Methodology: In a primary care service were performed retinal photographs with non-mydriatic Retinal Camera in 219 type 2 diabetic patients with and without medication mydriasis. We evaluated the performance of the diagnostic of the photos graded by three family physicians with training compared to two ophthalmologists (gold standard), and explore related factors with the need for mydriasis pharmacologically. Results: The prevalence of diabetic retinopathy and proliferative diabetic retinopathy was 19.2% and 1.5%, respectively. The sensitivity of family physicians to evaluate diabetic retinopathy averaged 82.9% (66.7-94.8%); specificity, 92% (90.2-93.3%); the accuracy, 90.3% (88.2-93%) and positive predictive value, 71.2% (68-75.5%). The agreement calculated using the kappa adjusted coefficient was from 0.74 to 0.8 for retinopathy and 0.88 to 0.92 for macular edema. Without drug mydriasis the photos were unreadable by 14.8%, when using mydriatic collyrium this number decreased to 8.7% (McNemar test, P < 0.005). Patients with more than 65 years old has more readability after drug mydriasis (McNemar test, P = 0.011). Conclusion: Trained family physician reached a good performance for evaluation of retinography for diabetic retinopathy. There was improvement in readability with pupil dilation in older patients.