BackgroundMolecular monitoring of chronic myeloid leukemia patients treated with tyrosine kinase inhibitors is essential for therapeutic stratification. Inter-laboratory reproducibility is, therefore, a crucial issue which requires standardization and strict alignment of BCR-ABL1 values to the international scale. An automated cartridge-based assay (Xpert BCR-ABL Monitor TM , Cepheid) had been proposed as a robust alternative to non-automated assays. This study aimed to compare inter-laboratory reproducibility of automated and non-automated quantification, the possibility of converting automated results to the international scale, and the potential economic impact of automation. Design and MethodsOne hundred and eighteen blood samples from chronic myeloid leukemia patients treated with tyrosine kinase inhibitors were prospectively analyzed in two laboratories using both automated and non-automated assays. The economic evaluation involved a micro-costing study and average costs were assessed as a function of sample throughput. ResultsAutomated assays achieved similar inter-laboratory reproducibility to highly standardized nonautomated assays and a short delay (≤6 h) between sampling and blood lysis had a positive impact on inter-laboratory reproducibility. Reporting automated BCR-ABL1 ratios on the international scale was possible using a specific conversion factor which may vary with batches. Cost assessment showed that automated assays could be relevant for annual activity levels below 300 since average costs were lower than those of the non-automated assays. ConclusionsThe Xpert BCR-ABL Monitor TM assay could be appropriately used in a near-patient setting for routine quantification of e13/e14-a2 transcripts, preferably in partnership with a regional reference laboratory. However, its prognostic impact relative to non-automated quantification remains to be tested prospectively within appropriate clinical trials.

BackgroundThe burden of mental health disorders in Europe is well above the world average and has increased from 11.5% to 13.9% of the total disease burden in 2000 and 2015. That from dementia has increased rapidly, and overtaken that from depression as the leading component. There have been no analyses of the research activity in Europe to combat this burden.MethodologyWe identified research papers in the Web of Science (WoS) with a complex mental health disorders filter based on title words and journal names in the years 2001-18, and downloaded their details for analysis.ResultsEuropean mental health disorders research represented less than 6% of the total biomedical research. We estimate that research expenditure in Europe on mental health disorders amounted to about €5.4 billion in 2018. The Scandinavian countries, with Croatia and Estonia, published the most relative to their wealth, but the outputs of France and Romania were less than half the amounts expected.Discussion and conclusionsThe burden from mental health disorders is increasing rapidly in Europe, but research was only half what would have been proportional. Suicide & self-harm, and alcohol misuse, were also neglected by researchers, particularly since the latter also causes many physical burdens, such as foetal alcohol syndrome, interpersonal violence, and road traffic accidents. Other relatively neglected subjects are sexual disorders, obsessive compulsive disorder, post-traumatic stress disorder, attention-deficit hyperactivity and sleep disorders. There is an increasing volume of research on alternative (non-drug) therapies, particularly for post-traumatic stress and eating disorders, notably in Germany.

A strategy of CTCA triage in the intermediate-risk group, no imaging test in the low-risk group, and CA in the high-risk group, has good diagnostic accuracy and could significantly cut costs. Medium-term and long-term outcomes need to be evaluated in patients with coronary stenosis potentially misclassified by CTCA due to false negative examinations.

BackgroundThe determination of foetal Rhesus D (RHD) status allows appropriate use of IgRh prophylaxis by restricting its use to cases of RHD feto-maternal incompatibilities. There is a degree of uncertainty about the cost-effectiveness of foetal RHD determination, yet screening programs are being introduced into clinical practice in many countries.This paper evaluates the impact of non-invasive foetal Rhesus D (RHD) status determination on the costs of managing RHD-negative pregnant women and on the appropriate use of anti-D prophylaxis in a large sample of RHD-negative pregnant women using individual prospectively collected clinical and economic data.MethodsA prospective two-armed trial of RHD negative pregnant women was performed in 11 French Obstetric Departments. Non-invasive foetal RHD genotyping was performed before 26 weeks' gestation in the experimental arm whereas the control arm participants received usual care. The costs associated with patient management in relation to their RHD negative status (biological tests, anti-D prophylaxis and visits) were calculated from inclusion to the end of the postpartum period. The costs of hospital admissions during pregnancy and delivery were also determined.ResultsA total of 949 patients were included by 11 centres between 2009 and 2012, and 850 completed follow-up, including medical and biological monitoring. Patients were separated into two groups: the genotyping group (n=515) and the control group (n=335). The cost of the genotyping was estimated at 140 euros per test. The total mean cost per patient was estimated at €3,259 (SD ± 1,120) and €3,004 (SD ± 1,004) in the genotyping and control groups respectively. The cost of delivery represented three quarters of the total cost in both groups. The performance of managing appropriately RHD negative anti-D prophylaxis was 88% in the genotyping group, versus 65% in the control group. Using the costs related to RHD status (biological tests, anti-D immunoglobulin injections and visits) the incremental cost-effectiveness ratio (ICER) was calculated to be €578 for each percentage gain in women receiving appropriate management.ConclusionEarly knowledge of the RHD status of the foetus using non-invasive foetal RHD genotyping significantly improved the management of RHD negative pregnancies with a small increase in cost.Trial registrationClinical trials registry-NCT00832962–13 January 2009 - retrospectively registered.Electronic supplementary materialThe online version of this article (10.1186/s12884-018-2114-5) contains supplementary material, which is available to authorized users.

Objectives: 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 (6107) compared with 234 days (6106), (P = .41).Conclusions: NGS analyses resulted in a change in patients' care pathways for 20% of patients (n = 232 of 1155).