Mapping research activity on mental health disorders in Europe: study protocol for the Mapping_NCD project

Background: Mental health disorders (MHDs) constitute a large and growing disease burden in Europe, although they typically receive less attention and research funding than other non-communicable diseases (NCDs). This study protocol describes a methodology for the mapping of MHD research in Europe as part of Mapping_NCD, a 2-year project funded by the European Commission which seeks to map European research funding and impact for five NCDs in order to identify potential gaps, overlaps, synergies and opportunities, and to develop evidence-based policies for future research. Methods: The project aims to develop a multi-focal view of the MHD research landscape across the 28 European Union Member States, plus Iceland, Norway and Switzerland, through a survey of European funding entities, analysis of research initiatives undertaken in the public, voluntary/not-for-profit and commercial sectors, and expert interviews to contextualize the gathered data. The impact of MHD research will be explored using bibliometric analyses of scientific publications, clinical guidelines and newspaper stories reporting on research initiatives. Finally, these research inputs and outputs will be considered in light of various metrics that have been proposed to inform priorities for the allocation of research funds, including burden of disease, treatment gaps and cost of illness. Discussion: Given the growing burden of MHDs, a clear and broad view of the current state of MHD research is needed to ensure that limited resources are directed to evidence-based priority areas. MHDs pose a particular challenge in mapping the research landscape due to their complex nature, high co-morbidity and varying diagnostic criteria. Undertaking such an effort across 31 countries is further challenged by differences in data collection, healthcare systems, reimbursement rates and clinical practices, as well as cultural and socioeconomic diversity. Using multiple methods to explore the spectrum of MHD research funding activity across Europe, this project aims to develop a broad, high-level perspective to inform priority setting for future research

Decrementally cost-effective health technologies in non-inferiority studies: A systematic review

Background: HTA guidance has generally been driven by situations where innovative and usually more expensive technologies are compared to the prevailing standards of care. Cheaper and less efficacious interventions have received scarce attention, although strategies with minimal individual efficacy losses might produce collective health gains when savings are redistributed.Purpose: This systematic review of health economic evaluations identified interventions that are both cost and outcome reducing to procure a list of candidate decrementally cost-effective technologies.Data Sources: English language searches were performed in PubMed, EMBASE and ClinicalTrials.gov covering 2005 to September 2021.Study Selection: Full economic evaluations reporting in English decrementally cost-effective health technologies based on RCT data, modelling or mixed methods.Data Synthesis: After filtering 4,975 studies found through the systematic database search, 107 decrementally cost-effective health technologies (HTs) were identified. Nearly a third were services (n = 29) and similarly for drugs (n = 31). For over half of the studies (n = 54) health outcomes were measured in QALYs and the cost-utility ratios varied from €140 to €5 million saved per QALY lost, albeit with time horizons varying from 4 days of follow-up to lifetime extrapolations. Less than a quarter of the studies were carried out from the societal perspective.Limitations: Despite including ClinicalTrials.gov as data source, unpublished studies may have been missed.Conclusions: Our results show a growth in recent years in the number of economic publications demonstrating decrementally cost-effective HTs. Economic tools are needed to facilitate the adoption of such HTs by policy-makers at the national level to maximise health outcomes at the population level.Systematic Review Registration:https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=95504, identifier CRD42018095504

How to perform a cost-effectiveness analysis with surrogate endpoint: renal denervation in patients with resistant hypertension (DENERHTN) trial as an example

<p>Whilst much uncertainty exists as to the efficacy of renal denervation (RDN), the positive results of the DENERHTN study in France confirmed the interest of an economic evaluation in order to assess efficiency of RDN and inform local decision makers about the costs and benefits of this intervention. The uncertainty surrounding both the outcomes and the costs can be described using health economic methods such as the non-parametric bootstrap. Internationally, numerous health economic studies using a cost-effectiveness model to assess the impact of RDN in terms of cost and effectiveness compared to antihypertensive medical treatment have been conducted. The DENERHTN cost-effectiveness study was the first health economic evaluation specifically designed to assess the cost-effectiveness of RDN using individual data. Using the DENERHTN results as an example, we provide here a summary of the principle methods used to perform a cost-effectiveness analysis.</p

DataSheet3_Decrementally cost-effective health technologies in non-inferiority studies: A systematic review.docx

Background: HTA guidance has generally been driven by situations where innovative and usually more expensive technologies are compared to the prevailing standards of care. Cheaper and less efficacious interventions have received scarce attention, although strategies with minimal individual efficacy losses might produce collective health gains when savings are redistributed.Purpose: This systematic review of health economic evaluations identified interventions that are both cost and outcome reducing to procure a list of candidate decrementally cost-effective technologies.Data Sources: English language searches were performed in PubMed, EMBASE and ClinicalTrials.gov covering 2005 to September 2021.Study Selection: Full economic evaluations reporting in English decrementally cost-effective health technologies based on RCT data, modelling or mixed methods.Data Synthesis: After filtering 4,975 studies found through the systematic database search, 107 decrementally cost-effective health technologies (HTs) were identified. Nearly a third were services (n = 29) and similarly for drugs (n = 31). For over half of the studies (n = 54) health outcomes were measured in QALYs and the cost-utility ratios varied from €140 to €5 million saved per QALY lost, albeit with time horizons varying from 4 days of follow-up to lifetime extrapolations. Less than a quarter of the studies were carried out from the societal perspective.Limitations: Despite including ClinicalTrials.gov as data source, unpublished studies may have been missed.Conclusions: Our results show a growth in recent years in the number of economic publications demonstrating decrementally cost-effective HTs. Economic tools are needed to facilitate the adoption of such HTs by policy-makers at the national level to maximise health outcomes at the population level.Systematic Review Registration:https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=95504, identifier CRD42018095504.</p

Table2_Decrementally cost-effective health technologies in non-inferiority studies: A systematic review.DOCX

Background: HTA guidance has generally been driven by situations where innovative and usually more expensive technologies are compared to the prevailing standards of care. Cheaper and less efficacious interventions have received scarce attention, although strategies with minimal individual efficacy losses might produce collective health gains when savings are redistributed.Purpose: This systematic review of health economic evaluations identified interventions that are both cost and outcome reducing to procure a list of candidate decrementally cost-effective technologies.Data Sources: English language searches were performed in PubMed, EMBASE and ClinicalTrials.gov covering 2005 to September 2021.Study Selection: Full economic evaluations reporting in English decrementally cost-effective health technologies based on RCT data, modelling or mixed methods.Data Synthesis: After filtering 4,975 studies found through the systematic database search, 107 decrementally cost-effective health technologies (HTs) were identified. Nearly a third were services (n = 29) and similarly for drugs (n = 31). For over half of the studies (n = 54) health outcomes were measured in QALYs and the cost-utility ratios varied from €140 to €5 million saved per QALY lost, albeit with time horizons varying from 4 days of follow-up to lifetime extrapolations. Less than a quarter of the studies were carried out from the societal perspective.Limitations: Despite including ClinicalTrials.gov as data source, unpublished studies may have been missed.Conclusions: Our results show a growth in recent years in the number of economic publications demonstrating decrementally cost-effective HTs. Economic tools are needed to facilitate the adoption of such HTs by policy-makers at the national level to maximise health outcomes at the population level.Systematic Review Registration:https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=95504, identifier CRD42018095504.</p

Table1_Decrementally cost-effective health technologies in non-inferiority studies: A systematic review.xlsx

Background: HTA guidance has generally been driven by situations where innovative and usually more expensive technologies are compared to the prevailing standards of care. Cheaper and less efficacious interventions have received scarce attention, although strategies with minimal individual efficacy losses might produce collective health gains when savings are redistributed.Purpose: This systematic review of health economic evaluations identified interventions that are both cost and outcome reducing to procure a list of candidate decrementally cost-effective technologies.Data Sources: English language searches were performed in PubMed, EMBASE and ClinicalTrials.gov covering 2005 to September 2021.Study Selection: Full economic evaluations reporting in English decrementally cost-effective health technologies based on RCT data, modelling or mixed methods.Data Synthesis: After filtering 4,975 studies found through the systematic database search, 107 decrementally cost-effective health technologies (HTs) were identified. Nearly a third were services (n = 29) and similarly for drugs (n = 31). For over half of the studies (n = 54) health outcomes were measured in QALYs and the cost-utility ratios varied from €140 to €5 million saved per QALY lost, albeit with time horizons varying from 4 days of follow-up to lifetime extrapolations. Less than a quarter of the studies were carried out from the societal perspective.Limitations: Despite including ClinicalTrials.gov as data source, unpublished studies may have been missed.Conclusions: Our results show a growth in recent years in the number of economic publications demonstrating decrementally cost-effective HTs. Economic tools are needed to facilitate the adoption of such HTs by policy-makers at the national level to maximise health outcomes at the population level.Systematic Review Registration:https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=95504, identifier CRD42018095504.</p

DataSheet1_Decrementally cost-effective health technologies in non-inferiority studies: A systematic review.docx

Background: HTA guidance has generally been driven by situations where innovative and usually more expensive technologies are compared to the prevailing standards of care. Cheaper and less efficacious interventions have received scarce attention, although strategies with minimal individual efficacy losses might produce collective health gains when savings are redistributed.Purpose: This systematic review of health economic evaluations identified interventions that are both cost and outcome reducing to procure a list of candidate decrementally cost-effective technologies.Data Sources: English language searches were performed in PubMed, EMBASE and ClinicalTrials.gov covering 2005 to September 2021.Study Selection: Full economic evaluations reporting in English decrementally cost-effective health technologies based on RCT data, modelling or mixed methods.Data Synthesis: After filtering 4,975 studies found through the systematic database search, 107 decrementally cost-effective health technologies (HTs) were identified. Nearly a third were services (n = 29) and similarly for drugs (n = 31). For over half of the studies (n = 54) health outcomes were measured in QALYs and the cost-utility ratios varied from €140 to €5 million saved per QALY lost, albeit with time horizons varying from 4 days of follow-up to lifetime extrapolations. Less than a quarter of the studies were carried out from the societal perspective.Limitations: Despite including ClinicalTrials.gov as data source, unpublished studies may have been missed.Conclusions: Our results show a growth in recent years in the number of economic publications demonstrating decrementally cost-effective HTs. Economic tools are needed to facilitate the adoption of such HTs by policy-makers at the national level to maximise health outcomes at the population level.Systematic Review Registration:https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=95504, identifier CRD42018095504.</p

DataSheet2_Decrementally cost-effective health technologies in non-inferiority studies: A systematic review.docx

Background: HTA guidance has generally been driven by situations where innovative and usually more expensive technologies are compared to the prevailing standards of care. Cheaper and less efficacious interventions have received scarce attention, although strategies with minimal individual efficacy losses might produce collective health gains when savings are redistributed.Purpose: This systematic review of health economic evaluations identified interventions that are both cost and outcome reducing to procure a list of candidate decrementally cost-effective technologies.Data Sources: English language searches were performed in PubMed, EMBASE and ClinicalTrials.gov covering 2005 to September 2021.Study Selection: Full economic evaluations reporting in English decrementally cost-effective health technologies based on RCT data, modelling or mixed methods.Data Synthesis: After filtering 4,975 studies found through the systematic database search, 107 decrementally cost-effective health technologies (HTs) were identified. Nearly a third were services (n = 29) and similarly for drugs (n = 31). For over half of the studies (n = 54) health outcomes were measured in QALYs and the cost-utility ratios varied from €140 to €5 million saved per QALY lost, albeit with time horizons varying from 4 days of follow-up to lifetime extrapolations. Less than a quarter of the studies were carried out from the societal perspective.Limitations: Despite including ClinicalTrials.gov as data source, unpublished studies may have been missed.Conclusions: Our results show a growth in recent years in the number of economic publications demonstrating decrementally cost-effective HTs. Economic tools are needed to facilitate the adoption of such HTs by policy-makers at the national level to maximise health outcomes at the population level.Systematic Review Registration:https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=95504, identifier CRD42018095504.</p

Impact of Next Generation Sequencing on Clinical Practice in Oncology in France: Better Genetic Profiles for Patients Improve Access to Experimental Treatments

International audienceObjectives: We evaluated how next generation sequencing (NGS) can modify care pathways in an observational impact study in France.Methods: All patients with lung cancer, colorectal cancer, or melanoma who had NGS analyses of somatic genomic alterations done in 1 of 7 biomolecular platforms certified by the French National Cancer Institute (INCa) between 2013 and 2016 were eligible. We compared patients' pathways before and after their NGS results. Endpoints consisted of the turnaround time in obtaining results, the number of patients with at least 1 genomic alteration identified, the number of actionable alterations, the impact of the genomic multidisciplinary tumor board on care pathways, the number of changes in the treatment plan, and the survival outcome up to 1 year after NGS analyses.Results: 1213 patients with a request for NGS analysis were included. NGS was performed for 1155 patients, identified at least 1 genomic alteration for 867 (75%), and provided an actionable alteration for 614 (53%). Turnaround time between analyses and results was on average 8 days (Min: 0; Max: 95) for all cancer types. Before NGS analysis, 33 of 614 patients (5%) were prescribed a targeted therapy compared with 54 of 614 patients (8%) after NGS analysis. Proposition of inclusion in clinical trials with experimental treatments increased from 5% (n = 31 of 614) before to 28% (n = 178 of 614) after NGS analysis. Patients who benefited from a genotype matched treatment after NGS analysis tended to have a better survival outcome at 1 year than patients with nonmatched treatment: 258 days (±107) compared with 234 days (±106), (P = .41).Conclusions: NGS analyses resulted in a change in patients' care pathways for 20% of patients (n = 232 of 1155)