A comparison of the responsiveness of EQ-5D-5L and the QOLIE-31P and mapping of QOLIE-31P to EQ-5D-5L in epilepsy

Objective: To investigate the responsiveness of and correlation between the EQ-5D-5L and the QOLIE-31P in patients with epilepsy, and develop a mapping function to predict EQ-5D-5L values based on the QOLIE-31P for use in economic evaluations. Methods: The dataset was derived from two clinical trials, the ZMILE study in the Netherlands and the SMILE study in the UK. In both studies, patients’ quality of life using the EQ-5D-5L and QOLIE-31P was measured at baseline and 12 months follow-up. Spearman’s correlations, effect sizes (EF) and standardized response means (SRM) were calculated for both the EQ-5D-5L and QOLIE-31P domains and sub scores. Mapping functions were derived using ordinary least square (OLS) and censored least absolute deviations models. Results: A total of 509 patients were included in this study. Low to moderately strong significant correlations were found between both instruments. The EQ-5D-5L showed high ceiling effects and small EFs and SRMs, whereas the QOLIE-31P did not show ceiling effects and also showed small to moderate EFs and SRMs. Results of the different mapping functions indicate that the highest adjusted R2 we were able to regress was 0.265 using an OLS model with squared terms, leading to a mean absolute error of 0.103. Conclusions: Results presented in this study emphasize the shortcomings of the EQ-5D-5L in epilepsy and the importance of the development of condition-specific preference-based instruments which can be used within the QALY framework. In addition, the usefulness of the constructed mapping function in economic evaluations is questionable

Risk stratification for treating people at ultra-high risk for psychosis:A cost-effectiveness analysis

People who are at ultra-high risk (UHR) for psychosis receive clinical care with the aim to prevent first-episode psychosis (FEP), regardless of the risk of conversion to psychosis. An economic model from the Canadian health system perspective was developed to evaluate the cost-effectiveness of treating all with UHR compared to risk stratification over a 15-year time horizon, based on conversion probability, expected quality-of-life and costs. The analysis used a decision tree followed by a Markov model. Health states included: Not UHR, UHR with <20 % risk of conversion to FEP (based on the North American Prodrome Longitudinal Study risk calculator), UHR with =20 % risk, FEP, Remission, Post-FEP, and Death. The analysis found that: risk stratification (i.e., only treating those with =20 % risk) had lower costs ($1398) and quality-adjusted life-years (0.055 QALYs) per person compared to treating all. The incremental cost-effectiveness ratio for ‘treat all’ was$25,448/QALY, and suggests treating all may be cost-effective. The model was sensitive to changes to the probability of conversion

The cost-effectiveness of the Dutch clinical practice guidelines for anxiety disorders

Background: To examine whether adhering to the Dutch clinical practice guidelines for anxiety disorders is associated with a higher efficiency of care (i.e. cost-effective) compared to guideline-non-adherence. Methods: After the Dutch practice guidelines for anxiety disorders were implemented, adult patients diagnosed with anxiety disorder or hypochondria were approached for participation. Using medical files patients’ treatment was classified as guideline-adherent (N=81) or guideline-non-adherent (N=56). Patients completed questionnaires about severity of symptoms (SCL-90-R) and quality of life (WHOQOL-Bref) before the start of treatment and again one year later. Medical costs and productivity losses were assessed at one-year follow-up. Results: Data of 139 patients for whom the guidelines were applicable were analyzed. From a health care perspective, the guideline-adherent treatment group had lower costs (incremental costs: -€292) and higher effect on the SCL-90-R (incremental effect: 26.17), and therefore dominated guideline-non-adherent treatment on average. There was a 68% likelihood that guideline-adherent treatment was associated with more effects and lower costs. Furthermore, guideline-adherent treatment was associated with an additional 0.09 QALY, indicating that on average more QALYs were generated for fewer costs. Limitations: This study employed an uncontrolled design. Caution should be taken when making causal inferences. Conclusions: Patients who received guideline-adherent treatment are more likely to experience larger symptom reduction and fewer costs during follow-up than patients who do not receive guideline-adherent treatment. The results justify further investigation of the effectiveness of implementing multidisciplinary guidelines

Towards community-based and recovery-oriented care for severe mental disorders in Southern and Eastern Europe: Aims and design of a multi-country implementation and evaluation study (RECOVER-E)

Background: Substantial strides have been made around the world in reforming mental health systems by shifting away from institutional care towards community-based services. Despite an extensive evidence base on what constitutes effective care for people with severe mental ill-health, many people in Europe do not have access to optimal mental health care. In an effort to consolidate previous efforts to improve community mental health care and support the complex transition from hospital-based to community-based care delivery, the RECOVER-E (LaRge-scalE implementation of COmmunity based mental health care for people with seVere and Enduring mental ill health in EuRopE) project aims to implement and evaluate multidisciplinary community mental health teams in five countries in Central and Eastern Europe. This paper provides a brief overview of the RECOVER-E project and its methods. Methods: Five implementation sites were selected (Sofia, Bulgaria; Zagreb, Croatia; Skopje, North Macedonia; Kotor, Montenegro; Siret-Suceava, Romania) where hospital-based mental health services are available (care as usual, CAU) for patients with severe mental disorders (severe depression, bipolar disorder, schizophrenia). The intervention consists of the introduction of a new service delivery model in each site, consisting of community-based recovery-oriented care delivered by trained multidisciplinary community mental health teams (including a peer worker with lived experience of a severe mental disorder). The implementation outcomes of the teams and the effect of the team's approach on patient and service utilisation outcomes will be evaluated using a mix of research methods. The study includes five planned hybrid implementation-effectiveness trials (1 per site) with patient-level randomization (n = 180, with patients randomised to either care as usual or intervention condition). Effectiveness is evaluated using a pragmatic non-blinded design with patients randomised into two parallel groups: receiving new community-based care or receiving usual care in the form of institutional, hospital-based mental health care. Trial-based health economic evaluation will be conducted; implementation outcomes will be evaluated, with data aligned with dimensions from the RE-AIM framework. Pathways to sustaining project results will be developed through policy dialogue sessions, which will be carried out in each country and through ongoing policy engagement activities at the European level. Discussion: The RECOVER-E project has been developed and conducted to demonstrate the impact of implementing an evidence-based service delivery model for people with severe mental illness in different contexts in middle-income countries in Central and Eastern Europe. It is expected that the results will contribute to the growing evidence-base on the health and economic benefits of recovery-oriented and community-based service models for health systems in transition. Trial registration Each trial was registered before participant enrolment in the clinicaltrials.gov database: Site - Croatia, Zagreb (Trial Reg. No. NCT03862209); Montenegro, Kotor (Trial Reg. No. NCT03837340); Romania, Suceava (Trial Reg. No. NCT03884933); Macedonia, Skopje (Trial Reg. No. NCT03892473); Bulgaria, Sofia (Trial Reg. No. NCT03922425