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Background Studies of the hospital volume-outcome relationship have highlighted that a greater volume activity improves patient outcomes. While this finding has been known for years, most studies to date have failed to delve into what underlies this relationship. Objective This study aimed to shed light on the basis of the hospital volume effect on patient outcomes by comparing treatment modalities for epithelial ovarian carcinoma patients. Data An exhaustive dataset of 355 patients in first-line treatment for Epithelial Ovarian Carcinoma (EOC) in 2012 in three regions of France was used. These regions account for 15% of the metropolitan French population. Methods In the presence of endogeneity induced by a reverse causality between hospital volume and patient outcomes, we used an instrumental variable approach. Hospital volume of activity was instrumented by the distance from patients’ homes to their hospital, the population density, and the median net income of patient municipalities. Results Based on our parameter estimates, we found that the rate of complete tumor resection would increase by 15.5 percentage points with centralized care, and by 8.3 percentage points if treatment decisions were coordinated by high-volume centers compared to decentralized care. Conclusion As volume alone is an imperfect correlate of quality, policy-makers need to know what volume is a proxy for in order to devise volume-based policies.

Background Germ cell tumors and sex cord stromal tumors are rare cancers of the ovary. They mainly affect young women and are associated with a high survival rate. The standard treatment mainly involves conservative surgery combined with chemotherapy [bleomycin, etoposide and cisplatin (BEP)] depending on the stage and the prognostic factors, as for testicular cancers. As reported in testicular cancer survivors, chemotherapy may induce sequelae impacting quality of life, which has not yet been evaluated in survivors of germ cell tumors and sex cord stromal tumors. The GINECO-VIVROVAIRE-Rare tumor study is a two-step investigation aiming to assess i) chronic fatigue and quality of life and ii) long-term side-effects of chemotherapy with a focus on cardiovascular and pulmonary disorders. Methods Using self-reported questionnaires, chronic fatigue and quality of life are compared between 134 ovarian cancer survivors (cancer-free ≥2 years after treatment) treated with surgery and chemotherapy and 2 control groups (67 ovarian cancer survivors treated with surgery alone and 67 age-matched healthy women). Medical data are collected from patient records. In the second step evaluating the long-term side-effects of chemotherapy, a subgroup of 90 patients treated with chemotherapy and 45 controls undergo the following work-up: cardiovascular evaluation (clinical examination, non-invasive cardiovascular tests to explore heart disease, blood tests), pulmonary function testing, audiogram, metabolic and hormonal blood tests. Costs of sequelae will be also assessed. Patients are selected from the registry of the INCa French Network for Rare Malignant Ovarian Tumors, and healthy women by the ‘Seintinelles’ connected network (collaborative research platform). Discussion This study will provide important data on the potential long-term physical side-effects of chemotherapy in survivors of Germ Cell Tumors (GCT) and Sex Cord Stromal Tumors (SCST), especially cardiovascular and pulmonary disorders, and neurotoxicity. The identification of long-term side-effects can contribute to adjusting the treatment of ovarian GCT or SCST patients and to managing follow-up with adapted recommendations regarding practices and chemotherapy regimens, in order to reduce toxicity while maintaining efficacy. Based on the results, intervention strategies could be proposed to improve the management of these patients during their treatment and in the long term. Trial registration This trial was registered at clinicaltrials.gov: 03418844, on 1 February 2018. This trial was registered on 25 October 2017 under the unique European identification number (ID-RCB): 2017-A03028–45. Recruitment Status: Recruiting. Protocol version Version n° 4.2 dated from Feb 19, 2021. Trial sponsor Centre François Baclesse, 3 avenue du Général Harris, F-14076 Caen cedex 05, France.

Background The demographic and social changes associated with population aging and the increasing incidence of chronic diseases underscore the importance of the role of informal carers. The number of informal carers is increasing and negative consequences associated with providing care, such as burnout, are known. However the influence of socioeconomic and psychological factors on the need for respite have not been well characterized to date. Informal care represents an essential component of health care systems and long-term care. The purpose of this study was to shed light on how the characteristics of informal carers affect the need for respite. Methods We used data from a nationally representative survey, Capacités Aides et Resources des Seniors (CARE - ménage), collected in 2015 by the National Institute for Statistics and Economic Studies (INSEE) and the Directorate for Research, Studies, Assessment and Statistics (DREES). The determinants of the need for respite among the characteristics of informal caregivers were explored using a probit model. To handle missing data, sensitivity analyses were performed using multiple imputations. Results Our study included N = 4033 dyads of informal carers and care recipients. The mean age was 61 for carers. The majority of carers were female, married, the child of the care recipient. Almost 27% reported a need for respite. A worse health status, feeling of loneliness, having a lack of time for oneself and needing to provide more than 30 h of care per month very significantly increased the need for respite irrespective of whether or not the carer lived with the care recipient (p p p p Conclusions These findings provide useful information for policymakers, physicians and other health professionals for reducing carers’ risk of exhaustion and burnout and for referring carers to the relevant service, e.g. psychological intervention, respite care support, training support and education support.

Background Stereotactic Body Radiation Therapy (SBRT) is an innovative modality based on high precision planning and delivery. Cancer with bone metastases and oligometastases are associated with an intermediate or good prognosis. We assume that prolonged survival rates would be achieved if both the primary tumor and metastases are controlled by local treatment. Our purpose is to demonstrate, via a multicenter randomized phase III trial, that local treatment of metastatic sites with curative intent with SBRT associated of systemic standard of care treatment would improve the progression-free survival in patients with solid tumor (breast, prostate and non-small cell lung cancer) with up to 3 bone-only metastases compared to patients who received systemic standard of care treatment alone. Methods This is an open-labeled randomized superiority multicenter phase III trial. Patients with up to 3 bone-only metastases will be randomized in a 1:1 ratio.between Arm A (Experimental group): Standard care of treatment & SBRT to all bone metastases, and Arm B (Control group): standard care of treatment. For patients receiving SBRT, radiotherapy dose and fractionation depends on the site of the bone metastasis and the proximity to critical normal structures. This study aims to accrue a total of 196 patients within 4 years. The primary endpoint is progression-free survival at 1 year, and secondary endpoints include Bone progression-free survival; Local control; Cancer-specific survival; Overall survival; Toxicity; Quality of life; Pain score analysis, Cost-utility analysis; Cost-effectiveness analysis and Budget impact analysis. Discussion The expected benefit for the patient in the experimental arm is a longer expectancy of life without skeletal recurrence and the discomfort, pain and drastic reduction of mobility and handicap that the lack of local control of bone metastases eventually inflicts. Trials registration ClinicalTrials.gov NCT03143322 Registered on May 8th 2017. Ongoing study

IntroductionEnd-stage renal disease (ESRD) affects 84 000 persons in France and costs an estimated €4.2 billion. Education about their disease empowers patients and allows improved management of their disease and better health outcomes. This study aims to explore whether the addition of an interactive web-based platform to patient education is effective and cost-effective and additionally whether complementing the platform with social functions and features improves its performance.Methods and analysisPatients with severe, ESRD or post-transplant will be randomised 1:1:1 to either standard therapeutic education; or education using a specific application; or the enhanced interactive app with social features. The total follow-up duration is 18 months. Primary endpoint is the cost utility of using app-based therapeutic intervention; secondary endpoints are: compliance with treatment guidelines, app use (professionals and patients), patients’ satisfaction, budget impact analysis.Ethics and disseminationThe findings will inform the deployment and reimbursement of the application. The study has ethical approval by the Ile de France ethics committee. Dissemination of the results will be presented at conferences and in peer-reviewed publications.Trial registration numberNCT03090828.

Summary Since 2013, the process of pricing of innovative drugs by the French National Health Insurance has considered both cost-effectiveness and budget impact. CAR-T cell therapies were first subject to economic evaluation from 2019 in France. We aim to describe the process and results of the economic evaluation of tisagenlecleucel and axicabtagene ciloleucel as well as the challenges these evaluations raised. Evaluations submitted by the firms were reviewed by HAS and submitted to the Committee of Economic Evaluation and Public Health (CEESP). The CEESP issued opinions related to: (1) the methodological quality of economic evidence and, (2) the cost-effectiveness and budget impact of the drugs. The CEESP invalidated the estimated incremental cost-utility ratios (ICUR) of tisagenlecleucel due to the insufficient clinical evidence and methodological quality to extrapolate the long-term progression of the disease after treatment and compare tisagenlecleucel with alternatives. The CEESP concluded that tisagenlecleucel was not proven cost-effective. The estimated ICUR of axicabtagene ciloleucel at €114,509/QALY vs. chemotherapies was associated with an acceptable level of methodological quality despite being based on a weak indirect comparison and limited data on quality of life. The CEESP considered axicabtagene ciloleucel ICUR to be “very high” and questioned the societal/community willingness-to-pay of the claimed price. The primary source of uncertainty surrounding the ICUR estimates of both drugs was the lack of hindsight on effectiveness. The economic evaluation of CAR-T cell therapies highlights the risk of inefficient resource allocation driven by limited clinical data. It calls for payment schemes accounting for this risk and effective collection of post-marketing data.

Introduction Despite safety and benefits of physical activity during treatment of localised breast cancer, successful exercise strategies remain to be determined. The primary objective of the ‘dispositif connecté’, that is, connected device in English trial is to evaluate the efficacy of two 6-month exercise interventions, either single or combined, concomitant to adjuvant treatments, on the physical activity level of patients with breast cancer, compared with usual care: an exercise programme using a connected device (activity tracker, smartphone application, website) and a therapeutic patient education intervention. Secondary objectives are to evaluate adherence to interventions, their impact at 6 and 12 months, representations and acceptability of interventions, and to assess the cost-effectiveness of the interventions using quality-adjusted life-years. Methods and analysis This is a 2×2 factorial, multicentre, phase III randomised controlled trial. The study population (with written informed consent) will consist of 432 women diagnosed with primary localised invasive breast carcinoma and eligible for adjuvant chemotherapy, hormonotherapy and/or radiotherapy. They will be randomly allocated between one of four arms: (1) web-based connected device (evolving target number of daily steps and an individualised, semisupervised, adaptive programme of two walking and one muscle strengthening sessions per week in autonomy), (2) therapeutic patient education (one educational diagnosis, two collective educational sessions, one evaluation), (3) combination of both interventions and (4) control. All participants will receive the international physical activity recommendations. Assessments (baseline, 6 and 12 months) will include physical fitness tests, anthropometrics measures, body composition (CT scan, bioelectrical impedance), self-administered questionnaires (physical activity profile (Recent Physical Activity Questionnaire), quality of life (European Organization for Research and Treatment of Cancer Quality-Of-Life Questionnaire-30, EQ-5D-5L), fatigue (Piper Fatigue Scale-12), social deprivation (Evaluation of Deprivation and Inequalities in Health Examination Centres), lifestyle, physical activity barriers, occupational status) and biological parameters (blood draw). Ethics and dissemination This study was reviewed and approved by the French Ethics Committee. The findings will be disseminated to the scientific and medical community via publications in peer-reviewed journals and conference presentations. Trial registration number NCT03529383; Pre-results.

Chimeric antigen receptor T-cells (CAR-T cells) have the potential to be a major innovation as a new type of cancer treatment, but are associated with extremely high prices and a high level of uncertainty. This study aims to assess the cost of the hospital stay for the administration of anti-CD19 CAR-T cells in France. Data were collected from the French Medical Information Systems Program (PMSI) and all hospital stays associated with an administrated drug encoded 9439938 (tisagenlecleucel, Kymriah®) or 9440456 (axicabtagene ciloleucel, Yescarta®) between January 2019 and December 2020 were included. 485 hospital stays associated with an injection of anti-CD19 CAR-T cells were identified, of which 44 (9%), 139 (28.7%), and 302 (62.3%) were for tisagenlecleucel in acute lymphoblastic leukaemia (ALL), tisagenlecleucel in diffuse large B-cell lymphoma (DLBCL), and axicabtagene ciloleucel respectively. The lengths of the stays were 37.9, 23.8, and 25.9 days for tisagenlecleucel in ALL, tisagenlecleucel in DLBCL, and axicabtagene ciloleucel, respectively. The mean costs per hospital stay were € 372,400 for a tisagenlecleucel in ALL, € 342,903 for tisagenlecleucel in DLBCL, and € 366,562 for axicabtagene ciloleucel. CAR T-cells represented more than 80% of these costs. n=13 hospitals performed CAR-T cell injections, with two hospitals accounting for more than 50% of the total number of injections. This study provides original data in a context of limited information regarding the costs of hospitalization for patients undergoing CAR-T cell treatments. In addition to the financial burden, distance may also be an important barrier for accessing CAR T-cell treatment.

BACKGROUND In recent years, the rapid development of information and communications technology enabled by innovations in videoconferencing solutions and the emergence of connected medical devices has contributed to expanding the scope of application and expediting the development of telemedicine. OBJECTIVE This study evaluates the use of teleconsultations (TCs) for specialist consultations at hospitals in terms of costs, resource consumption, and patient travel time. The key feature of our evaluation framework is the combination of an economic evaluation through a cost analysis and a performance evaluation through a discrete-event simulation (DES) approach. METHODS Three data sets were used to obtain detailed information on the characteristics of patients, characteristics of patients’ residential locations, and usage of telehealth stations. A total of 532 patients who received at least one TC and 18,559 patients who received solely physical consultations (CSs) were included in the initial sample. The TC patients were recruited during a 7-month period (ie, 2020 data) versus 19 months for the CS patients (ie, 2019 and 2020 data). A propensity score matching procedure was applied in the economic evaluation. To identify the best scenarios for reaping the full benefits of TCs, various scenarios depicting different population types and deployment strategies were explored in the DES model. Associated break-even levels were calculated. RESULTS The results of the cost evaluation reveal a higher cost for the TC group, mainly induced by higher volumes of (tele)consultations per patient and the substantial initial investment required for TC equipment. On average, the total cost per patient over 298 days of follow-up was €356.37 (US $392) per TC patient and €305.18 (US $336) per CS patient. However, the incremental cost of TCs was not statistically significant: €356.37 – €305.18 = €51.19 or US $392 – US $336 = US $56 (95% CI –35.99 to 114.25; P=.18). Sensitivity analysis suggested heterogeneous economic profitability levels within subpopulations and based on the intensity of use of TC solutions. In fact, the DES model results show that TCs could be a cost-saving strategy in some cases, depending on population characteristics, the amortization speed of telehealth equipment, and the locations of telehealth stations. CONCLUSIONS The use of TCs has the potential to lead to a major organizational change in the health care system in the near future. Nevertheless, TC performance is strongly related to the context and deployment strategy involved.

International audience; Le séquençage du génome est aujourd’hui accessible à la population mais il n’existe que peu de preuves de son utilité comme outil diagnostique, thérapeutique et pronostique. En France, le plan France médecine génomique 2025 a été lancé en 2015 avec pour objectif d’intégrer les analyses génomiques dans la pratique clinique pour des indications validées et de développer une filière nationale de la médecine génomique incluant des partenariats industriels. Une réflexion sur les applications scientifiques et les enjeux opérationnels et sociétaux est nécessaire afin de formuler des recommandations pour permettre de mieux associer la génomique et la médecine de demain. Dans la perspective d’une médecine factuelle personnalisée, il convient de promouvoir des études avec un niveau d’exigence méthodologique approprié et d’approfondir la définition du niveau de preuve. Les nombreux enjeux opérationnels nécessitent de mettre en place des organisations et des moyens afin de fluidifier le circuit de rendu des résultats ainsi que des adaptations réglementaires sur les statuts des professions impliquées, la gestion des données générées et le consentement des patients. En parallèle des actions de formation en génétique à destination des professionnels de santé et des actions de sensibilisation sur les tests génétiques vis-à-vis du grand public doivent être envisagées. Les enjeux éthiques doivent également être pris en compte, notamment sur la participation du patient aux décisions le concernant en fonction de ses attentes et en intégrant la notion d’incertitude dans l’information délivrée. Les effets sociologiques sur le vécu et les attentes des patients et de la population générale vis-à-vis de la médecine génomique doivent également être évalués pour améliorer l’information, la prévention et l’accompagnement des personnes. Enfin, des études médicoéconomiques doivent être conduites pour éclairer les décideurs sur le caractère coût-efficace du séquençage complet du génome pour la santé des populations.

IntroductionSince 2013, the coverage of innovative and expensive drugs by the French National Health Insurance considers cost-effectiveness and budget impact, as assessed by the National Authority for Health (HAS) on the basis of an evaluation submitted by the firm. First CAR-T cell therapies were subject to economic evaluation in 2019 in France. We aim at describing the process and results of the economic evaluation of tisagenlecleucel and axicabtagene ciloleucel and the challenges these evaluations raised.MethodsPrimary evaluations were submitted by the firms to be reviewed by HAS. The final analyses were submitted to the Committee of Economic Evaluation and Public Health (CEESP), composed of independent economists, clinicians and patients’ representatives. The CEESP issued Opinions related to i) the methodological quality of economic evidence and ii) the cost-effectiveness and budget impact of the drugs under review.ResultsThe estimated incremental cost-utility ratio (ICUR) of tisagenlecleucel were rejected, being based on insufficient clinical evidence to estimate and extrapolate the long-term progression and to compare tisagenlecleucel with alternatives. Thus, the CEESP concluded that tisagenlecleucel was not proved cost-effective. The estimated ICUR of axicabtagene ciloleucel at 114,509EUR/QALY vs. chemotherapies was associated with an acceptable level of evidence despite being based on a frail indirect comparison and limited data on quality of life. In a context where France has no official cost-effectiveness threshold, the CEESP considered axicabtagene ciloleucel ICUR to be “very high” and questioned the collective acceptability of the claimed price.The CEESP stressed that the main source of uncertainty surrounding the ICUR estimates of both drugs was related to the lack of hindsight on effectiveness, especially in terms of overall survival and safety.ConclusionsThe economic evaluation of CAR-T cell therapies highlights the sources of uncertainty underlying the decision and the risk of inefficient resource allocation driven by limited clinical data. It calls for payment schemes accounting for the uncertainty, and effective collection of relevant post-marketing data.

Background: There is no evidence to support surgery or radiotherapy as the best treatment for resectable oropharyngeal cancers with a negative HPV status. Predictive algorithms may help to decide which strategy to choose, but they will only be accepted by caregivers and European authorities if they are interpretable. As a proof of concept, we developed a predictive and interpretable algorithm to predict locoregional relapse at 18 months for oropharyngeal cancers as a first step towards that goal. Methods: The model was based on clinical and Pyradiomics features extracted from the dosimetric CT scan. Intraclass correlation was used to filter out features dependant on delineation. Correlated redundant features were also removed. An XGBoost model was cross-validated and optimised on the HN1 cohort (79 patients), and performances were assessed on the ART ORL cohort (45 patients). The Shapley Values were used to provide an overall and local explanation of the model. Results: On the ART ORL cohort, the model trained on HN1 yielded a precision&mdash, or predictive positive value&mdash, of 0.92, a recall of 0.42, an area under the curve of the receiver operating characteristic of 0.68 and an accuracy of 0.64. The most contributory features were shape Voxel Volume, grey level size zone matrix Small Area Emphasis (glszmSAE), gldm Dependence Non Uniformity Normalized (gldmDNUN), Sex and Age. Conclusions: We developed an interpretable and generalizable model that could yield a good precision&mdash, positive predictive value&mdash, for relapse at 18 months on a different test cohort.

Resume Introduction Avec l’amelioration des traitements du cancer du sein et du pronostic de la maladie, la prevention tertiaire, a travers l’education therapeutique du patient (ETP), fait partie integrante de l’accompagnement des patientes. Cette etude pilote avait pour objectif d’evaluer les couts d’un programme d’ETP nutritionnel et d’activite physique dont le but etait d’aider les patientes atteintes d’un cancer du sein infiltrant localise a gerer leur poids. Methodes La description des couts s’appuie sur une approche de type micro-costing. L’horizon temporel comprend l’ensemble des etapes du programme d’ETP composees de quatre a cinq seances individuelles d’une heure environ. Ces dernieres sont menees en ambulatoire au Centre Leon Berard a Lyon, France, avec l’implication d’une dieteticienne et d’un enseignant en activite physique adaptee. Les couts directs ont ete estimes en euros 2016 selon la perspective hospitaliere. Des analyses de sensibilite deterministes et probabilistes ont ete conduites. Resultats Soixante-cinq patientes (âge moyen 52 ans) ont participe au programme en 2014 et 2015. La majorite d’entre elles etait en arret maladie (65 %) et avait subi une chirurgie (95 %) et une chimiotherapie adjuvante (71 %). Le cout total moyen par patiente du programme s’elevait a 541,04 € (ecart-type 88,44 € ; intervalle de confiance a 95 % [520,06–562,03]) hors charges indirectes, soit 687,13 € charges indirectes incluses. La variation du cout unitaire d'une dieteticienne impactait le plus le cout total du programme. Conclusion Cette etude de couts permet d’eclairer le decideur sur les modalites de tarifications et les changements a apporter pour optimiser l’organisation d’un programme d’ETP.

Since the life expectancy of women with breast cancer has increased, tertiary prevention, through the Therapeutic Patient Education (TPE), is now a part of patient support. The main objective of this pilot study is to evaluate the cost of a nutrition and physical activity TPE program intended to help women with breast cancer in the management of their weight.This study is a description of costs, based on the micro-costing method, of the first two years of the program, conducted on an outpatient basis, at the Cancer Center Leon Berard, Lyon, France, with the involvement of a dietician and a physical activity trainer. Only the direct costs were taken into account, from the hospital's perspective, in Euro 2016. Sensitivity analyses were also conducted.Sixty-five patients were included in the study in 2014/2015. Their mean age was 52 years, the majority of them were in sick leave (65 %). In most cases, they had undergone surgery (95 %) and chemotherapy (71 %). The average cost per patient of the program was 541.04€ (SD 88.44€; 95 % IC [520.06-562.03]) excluding overhead costs, i.e. 687.13€ overhead costs included. The unit cost of the dietician was the most sensitive parameters.This cost study, an accurate estimate of the production costs, allows to inform the decision-maker in term of pricing of such a program and to make the necessary adjustments in order to optimize the organization of this activity.

We undertook a cost-effectiveness analysis (CEA) to compare an exercise and nutritional program with the usual nutritional care concomitant to adjuvant chemotherapy in localized breast cancer patients. The CEA was designed as part of the interventional, controlled, randomized, single-center, open-label PASAPAS study. Breast cancer patients receiving first-line adjuvant chemotherapy at a French Comprehensive Cancer Center were randomized 2:1 to a 6-month exercise program of supervised indoor and outdoor group sessions in addition to usual nutritional care (exercise arm) or a usual nutritional care group receiving dietary and physical activity counseling (control arm). Costs were assessed from the French national insurance perspective (in Euros, 2012). Incremental cost-effectiveness ratios (ICERs) were calculated for four criteria: body mass index, waist circumference, body fat percentage, and estimated aerobic capacity. Uncertainty around the ICERs was captured by a probabilistic analysis using a non-parametric bootstrap method. The analysis was based on 60 patients enrolled between 2011 and 2013. Average intervention costs per participant were €412 in the exercise arm (n = 41) and €117 (n = 19) in the control arm. Total mean costs were €17,344 (standard deviation 9,928) and €20,615 (standard deviation 14,904), respectively, did not differ significantly (p = 0.51). The 6-month exercise program was deemed to be cost-effective compared with usual care for the estimated aerobic capacity. Multicenter randomized studies with long-term costs and outcomes should be done to provide additional evidence. Clinical trial: The PASAPAS study is registered under ClinicalTrials.gov. Trial registration ID: NCT01331772.

Objectives: This prospective, observational, non-randomized multicentric study was conducted to compare efficiency and toxicity using different modalities of stereotactic body radiation therapy (SBRT) in early-stage peripheral non-small cell lung cancer (NSCLC). Methods: From 9 April to 11 December, 106 patients were treated according to the local equipment availability for peripheral NSCLC with SBRT: 68 by linear accelerator equipped for SBRT and 38 by Cyberknife®. Multivariate analysis and propensity score analysis using Inverse Probability Treatment Weighting (IPTW) were undertaken in an effort to adjust for potential bias due to non-randomization. Results: 2-year local control rates were 97.0% (95% CI: [90.6%; 99.4%]) with SBRT by Linac vs 100% (95% CI: ([100%; 100%]) with Cyberknife® (p = 0.2839). 2-year PFS and 2-year OS rates were 52.7% (95% CI [39.9%;64.0%]) versus 54.1% (95% CI [36.8; 68.6%]) (p = 0.8582) and 65.1% (95% CI: [51.9%; 75.5%] versus 83.9% (95% CI: [67.5%; 92.4%] (p = 0.0831) using Linac and Cyberknife® respectively. Multivariate regression analysis indicates no significant effect of SBRT treatment type on PFS or OS. Local relapse could not be modeled due to the small number of events (n = 2). Acute and late toxicity rates were not significantly different. After IPTW adjustment, results were unchanged. Conclusions: No difference in efficiency or toxicity was shown after SBRT of peripheral NSCLC treatment using Linac or Cyberknife®. Advances in knowledge: This is the first large prospective non-randomized study focusing on peripheral localized NSCLC comparing SBRT using an appropriately equipped linac with Cyberknife®. No significant difference in efficiency or toxicity was shown in this situation.

Demographic and epidemiological changes place an increasing reliance on informal carers. Some support programmes exist, but funding is often limited. There is a need for economic evaluation of interventions for carers to assist policymakers in prioritizing carer support. Our aim was to systematically review and critically appraise cost–utility analyses of interventions for informal carers, in order to assess the methods employed and the quality of the reporting. A systematic review of databases was conducted using MEDLINE, Embase, PsycINFO, and EconLit of items published between 1950 and February 2019. Published studies were selected if they involved a cost–utility analysis of an intervention mainly or jointly targeting informal carers. The reporting quality of economic analyses was evaluated using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. An initial set of 1364 potentially relevant studies was identified. The titles and the abstracts were then screened, resulting in the identification of 62 full-text articles that warranted further assessment of their eligibility. Of these, 20 economic evaluations of informal carer interventions met the inclusion criteria. The main geographical area was the UK (n = 11). These studies were conducted in mental and/or behavioural (n = 15), cardiovascular (n = 3) or cancer (n = 2) clinical fields. These cost–utility analyses were based on randomized clinical trials (n = 16) and on observational studies (n = 4), of which only one presented a Markov model-based economic evaluation. Four of the six psychological interventions were deemed to be cost effective versus two of the four education/support interventions, and four of the nine training/support interventions. Two articles achieved a CHEERS score of 100% and nine of the economic evaluations achieved a score of 85% in terms of the CHEERS criteria for high-quality economic studies. Our critical review highlights the lack of cost–utility analyses of interventions to support informal carers. However, it also shows the relative prominence of good reporting practices in these analyses that other studies might be able to build on.

International audience; 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 (±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).

This work addresses the analysis of individual cost data in the setting of interventional or observational studies using statistical analysis software once the costs per patient have been estimated. It is in fact necessary to be able to present and describe data in an appropriate manner in each of the studied health strategies and to test whether the difference in costs observed between treatment groups is due to chance or not. Furthermore, cost analysis differs from conventional statistical analysis in that cost data have a certain number of specific properties, including their use by health decision-makers. This work also addresses the difficulties that generally arise in regard to the distribution of cost; it explains why the mathematical average constitutes the only relevant measure for economists; and it outlines which analyses are required for inter-strategy cost comparisons. It also covers the issue of missing or censored data, features that are inherent to information collected regarding costs and to sensitivity analyses., Ce travail traite de l’analyse des données de coût individuelles dans le cadre d’études interventionnelles ou observationnelles à l’aide de logiciels d’analyse de données et de traitement statistique dès lors que les coûts par patient ont été estimés. Il est, en effet, nécessaire de pouvoir les présenter et les décrire de façon appropriée dans chacune des stratégies de santé étudiées et de tester si la différence de coût observée entre les groupes de traitement est due au hasard ou non. De plus, l’analyse des données de coût se distingue des analyses statistiques « classiques » par un certain nombre de caractéristiques propres à ces données ainsi qu’à leur utilisation par les décideurs de santé. Ce travail présente également les difficultés que posent généralement les distributions de coût, explique pourquoi la moyenne arithmétique constitue la seule mesure pertinente pour les économistes, et décrit quelles analyses sont nécessaires pour la comparaison des coûts entre les stratégies. Il s’intéresse aussi à la question des données manquantes ou censurées, spécificités souvent inhérentes aux informations collectées sur les coûts et aux analyses de sensibilité.

Quality of life is a major issue for good prognostic prostate cancer, for which brachytherapy is one of the reference treatments. Stereotactic Body Radiotherapy (SBRT) is a recent alternative however not yet validated as a standard treatment. This review of the literature reports and compares the toxicities and the quality of life, either after exclusive brachytherapy with iodine 125 or after SBRT. The comparison is made with the limitations of the absence of randomized trial comparing the two treatment techniques. Acute toxicity appears to be lower after SBRT compared to brachytherapy (from 10 to 40 % versus 30 to 40 %, respectively). Conversely, acute and late gastrointestinal toxicity (from 0 to 21 % and from 0 to 10 % of grade 2, respectively) appears more frequent with SBRT. Late urinary toxicity seems identical between both techniques (from 20 to 30 % of grade 2), with a possible urinary flare syndrome. Both treatments have an impact on erectile dysfunction, although it is not possible to conclude that a technique is superior because of the limited data on SBRT. SBRT has better bowel and urinary (irritation or obstruction) quality of life scores than brachytherapy; while sexual and urinary incontinence remain the same. The absence of randomized trial comparing SBRT with brachytherapy for prostate cancers does not allow to conclude on the superiority of one technique over another, thus justifying a phase III medicoeconomic evaluation.

International audience; Ten to 29% of lung cancers might be linked to occupational factors but 60% of them are not compensated. The PROPOUMON project aimed to improve the identification, recognition and compensation of occupational lung cancer as occupational disease using a self-administered questionnaire (AQREP). One objective was to assess the AQREP, comparing it with the questionnaire drawn up by the French Language Pneumology Society (Q-SPLF). From March 2014 to September 2015, 90 lung cancer patients treated at the Centre Léon-Bérard responded to the AQREP and Q-SPLF. The two physicians in charge of the consultation assessed independently whether or not a consultation was indicated. A certificate for the compensation process was proposed when a suspicion of high or average imputability was identified. Analysis of the questionnaires was concordant for 73% of the patients. The AQREP has a sensitivity of 72% and a specificity of 73%. Its positive and negative predictive values were 62 and 82%. The information provided by 24 patients were discordant between questionnaires. In two patients with discordant evaluation (AQREP+/Q-SPLF-; AQREP-/Q-SPLF+), one Initial Medical Certificate (IMC) was written. This study made it possible to conclude that AQREP is relevant for the identification of potentially occupational lung cancers. Collegial discussion of complex cases might be considered. The project is currently been extended to other centers and to lymphoma.; Dix à 29 % des cancers bronchopulmonaires seraient d’origine professionnelle dont 60 % ne seraient pas indemnisés. Le projet Propoumon vise à améliorer le repérage, la reconnaissance et l’indemnisation des cancers bronchopulmonaires d’origine professionnelle en maladie professionnelle à partir d’un auto-questionnaire (AQREP). Un des objectifs était d’évaluer sa capacité à détecter les patients pouvant bénéficier d’une consultation « cancers professionnels », en le comparant avec le questionnaire de la Société de pneumologie de langue française (Q-SPLF). De mars 2014 à septembre 2015, 90 patients suivis au centre Léon-Bérard pour un cancer bronchopulmonaire ont répondu aux deux questionnaires. Les deux médecins responsables de la consultation évaluaient de façon indépendante, sur la base de l’AQREP ou du Q-SPLF, l’indication d’une consultation. Si à l’issue de la consultation des arguments en faveur d’une origine professionnelle étaient réunis, une démarche de déclaration était proposée. L’analyse des questionnaires par les médecins était concordante à 73 %. L’AQREP a une sensibilité de 72 % et une spécificité de 73 %. Ses valeurs prédictives positive et négative sont de 62 et 82 %. Les informations renseignées par 24 patients étaient discordantes entre les questionnaires. Pour deux patients ayant une évaluation discordante (AQREP+/Q-SPLF- ; AQREP-/Q-SPLF+), un « Certificat médical initial » a été rédigé. Le premier a été refusé par l’Assurance maladie, le second est en cours d’instruction. Cette étude a permis de conclure en la capacité de l’AQREP à repérer les cancers bronchopulmonaires potentiellement d’origine professionnelle. Une réunion de concertation pour discuter des cas complexes pourrait être envisagée. Le projet s’élargit actuellement à d’autres centres et aux lymphomes.

Background: The Health Economics in Radiation Oncology (ESTRO-HERO) project aims to provide a knowledge base for health economics in European radiotherapy. A cost-accounting model, providing data on national resource requirements and costs of external beam radiotherapy (EBRT), was developed.Materials and methods: Time-driven activity-based costing (TD-ABC) was applied from the healthcare provider perspective at national level. TD-ABC allocates resource costs to treatment courses through the activities performed, based on time estimates.Results: The model is structured in three layers. The central layer, EBRT-Core, accounts for EBRT care-pathway activities and follows TD-ABC allocation principles. Activities supporting radiation oncology (RO) (RO-Support) and multidisciplinary oncology (Beyond-EBRT) follow standard allocation principles.To demonstrate the model's capabilities, a dataset was constructed for the hypothetical country Europalia, based on published evidence on resources and treatments, whereas time estimates were expert opinions. Applying the TD-ABC model to this example, treatment delivery activities represent 68.4% of the costs; treatment preparation 31.6%. The cost per course shows large variation for different indications, techniques, and fractionation schedules, ranging between (sic)838 and (sic)7193. Resource utilization was estimated to be within the available capacity. Scenario analyses on changes in fractionation and treatment complexity are presented.The ESTRO-HERO TD-ABC tool can model EBRT costs and resource requirements. While the Europalia example illustrates its potential, the results cannot be generalized nor used as a proxy for national evidence. Only real-world data, tailored to the specificities of individual countries, will support National Radiation Oncology Societies with investment planning and access to innovative radiotherapy. (C) 2019 Elsevier B.V. All rights reserved.

BACKGROUND Breast cancer is the most frequent cancer in women in industrialized countries. Lifestyle and environmental factors, particularly endocrine-disrupting pollutants, have been suggested to play a role in breast cancer risk. Current epidemiological studies, although not fully consistent, suggest a positive association of breast cancer risk with exposure to several International Agency for Research on Cancer Group 1 air-pollutant carcinogens, such as particulate matter, polychlorinated biphenyls (PCB), dioxins, Benzo[a]pyrene (BaP), and cadmium. However, epidemiological studies remain scarce and inconsistent. It has been proposed that the menopausal status could modify the relationship between pollutants and breast cancer and that the association varies with hormone receptor status. OBJECTIVE The XENAIR project will investigate the association of breast cancer risk (overall and by hormone receptor status) with chronic exposure to selected air pollutants, including particulate matter, nitrogen dioxide (NO2), ozone (O3), BaP, dioxins, PCB-153, and cadmium. METHODS Our research is based on a case-control study nested within the French national E3N cohort of 5222 invasive breast cancer cases identified during follow-up from 1990 to 2011, and 5222 matched controls. A questionnaire was sent to all participants to collect their lifetime residential addresses and information on indoor pollution. We will assess these exposures using complementary models of land-use regression, atmospheric dispersion, and regional chemistry-transport (CHIMERE) models, via a Geographic Information System. Associations with breast cancer risk will be modeled using conditional logistic regression models. We will also study the impact of exposure on DNA methylation and interactions with genetic polymorphisms. Appropriate statistical methods, including Bayesian modeling, principal component analysis, and cluster analysis, will be used to assess the impact of multipollutant exposure. The fraction of breast cancer cases attributable to air pollution will be estimated. RESULTS The XENAIR project will contribute to current knowledge on the health effects of air pollution and identify and understand environmental modifiable risk factors related to breast cancer risk. CONCLUSIONS The results will provide relevant evidence to governments and policy-makers to improve effective public health prevention strategies on air pollution. The XENAIR dataset can be used in future efforts to study the effects of exposure to air pollution associated with other chronic conditions. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/15167

International audience; Fifteen years after the completion of first human genome sequencing, the technique is almost a commodity but there is still little evidence of its usefulness as a diagnostic, prognostic or therapeutic tool. In France, the France genomics plan 2025 was launched in 2015 with the goal of integrating genomic tests into clinical practice and developing a National genomics network including industrial partnerships. Reflection on scientific applications and operational or societal issues is needed to make recommendations to help better associate Genomics and the medicine of tomorrow. In the perspective of personalized Evidence-based Medicine, studies with an appropriate methodological level to improve the definition of evidence should be promoted. The many operational challenges require the implementation of organisations and means to streamline the process of results reporting, and regulatory adaptations concerning the status of professions involved, the management of data generated, and the consent of patients. In parallel, genetic training for healthcare professionals and raising awareness on genetic tests for the public should be considered. The ethical stake should also be taken into account, especially on the participation of the patient in decisions concerning them and integrating the notion of uncertainty into the information given. The sociological effects on the experience and expectations of patients and the general population towards genomic medicine should also be evaluated to improve information, prevention and support for people. Finally, medico-economic studies must be conducted to inform policy-makers on the cost-effectiveness of complete genome sequencing for population health.

Purpose Intensity-modulated radiation therapy (IMRT) has shown its interest for head and neck cancer treatment. In parallel, cetuximab has demonstrated its superiority against exclusive radiotherapy. The objective of this study was to assess the acute toxicity, local control and overall survival of cetuximab associated with different IMRT modalities compared to platinum-based chemotherapy and IMRT in the ARTORL study ( NCT02024035 ). Patients and method This prospective, multicenter study included patients with epidermoid or undifferentiated nasopharyngeal carcinoma, epidermoid carcinoma of oropharynx and oral cavity (T1–T4, M0, N0–N3). Acute toxicity, local control and overall survival were compared between groups (patients receiving cetuximab or not). Propensity score analysis at the ratio 1:1 was undertaken in an effort to adjust for potential bias between groups due to non-randomization. Results From the 180 patients included in the ARTORL study, 29 patients receiving cetuximab and 29 patients treated without cetuximab were matched for the analysis. Ten patients (34.5%) reported acute dermal toxicity of grade 3 in the cetuximab group versus three (10.3%) in the non-cetuximab group obtained after matching ( P = 0.0275). Cetuximab was not significantly associated with more grade 3 mucositis ( P = 0.2563). There were no significant differences in cutaneous or oral toxicity for patients treated with cetuximab between the different IMRT modalities ( P = 1.000 and P = 0.5731, respectively). There was no significant difference in local relapse-free survival ( P = 0.0920) or overall survival ( P = 0.4575) between patients treated with or without cetuximab. Conclusion Patients treated with cetuximab had more cutaneous toxicities, but oral toxicity was similar between groups. The different IMRT modalities did not induce different toxicity profiles.

Objectives: Untreated obstructive sleep apnea-hypopnea syndrome (OSAHS) is associated with excessive daytime sleepiness, increased risk of cardiovascular (CV) disease, and road traffic accidents (RTAs), which impact survival and health-related quality of life. This study, funded by the French National Authority for Health (HAS), aimed to assess the cost-effectiveness of different treatments (i.e., continuous positive airway pressure [CPAP], dental devices, lifestyle advice, and no treatment) in patients with mild-to-moderate OSAHS in France.Methods: A Markov model was developed to simulate the progression of two cohorts, stratified by CV risk, over a lifetime horizon. Daytime sleepiness and RTAs were taken into account for all patients while CV events were only considered for patients with high CV risk.Results: For patients with low CV risk, incremental cost-effectiveness ratio (ICER) of dental devices versus no treatment varied between 32,976 EUR (moderate OSAHS) and 45,579 EUR (mild OSAHS) per quality-adjusted life-year (QALY), and CPAP versus dental devices, above 256,000 EUR/QALY. For patients with high CV risk, CPAP was associated with a gain of 0.62 QALY compared with no treatment, resulting in an ICER of 10,128 EUR/QALY.Conclusion: The analysis suggests that it is efficient to treat all OSAHS patients with high CV risk with CPAP and that dental devices are more efficient than CPAP for mild-to-moderate OSAHS with low CV risk. However, out-of-pocket costs are currently much higher for dental devices than for CPAP (i.e., 3,326 EUR versus 2,430 EUR) as orthodontic treatment is mainly non-refundable in France.

International audience; PURPOSE: Lack of physical activity (PA), weight gain, and overweight have been associated with increased risk of recurrence and mortality after breast cancer diagnosis. We evaluated the feasibility of implementing an individualized exercise program and nutritional counseling during adjuvant treatment of localized invasive breast cancer. METHODS: Sixty-one patients eligible for adjuvant chemotherapy were randomized 2:1 to receive a 6-month program of weekly aerobic exercises associated with nutritional counseling (n = 41) or usual care with nutritional counseling (n = 20, one withdrawal). The primary endpoints were the proportion of patients compliant with two weekly supervised sessions and their overall adherence (i.e., proportion of supervised and unsupervised sessions completed versus planned sessions). RESULTS: Ten percent of patients in the intervention group were compliant with the two weekly supervised sessions for 6 months, but the overall median adherence rate was 85% of supervised and non-supervised sessions completed. Non-adherence was mainly due to intrinsic reasons (medical, organizational, psychological barriers). Adherence was positively associated with education and baseline PA level and inversely associated with baseline weight and tumor grade. No statistically significant benefits were observed in the intervention group, even if overall PA level and body composition improved and anthropometrics were maintained over time (p \textless 0.05). CONCLUSIONS: Overall, there was good adherence with the 6-month exercise program during adjuvant treatment for breast cancer, despite poor compliance to twice-weekly supervised sessions. This study highlights the need for flexible exercise modalities and innovative experimental design to reach patients who would most adhere and benefit from intervention. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01331772. Registered 8 April 2011, https://clinicaltrials.gov/ct2/show/NCT01331772?term=pasapas&rank=1.

It is currently unclear if next-generation sequencing (NGS) technologies can be implemented in the diagnosis setting at an affordable cost. The aim of this study was to measure the total cost of performing NGS in clinical practice in France, in both germline and somatic cancer genetics. The study was performed on 15 French representative cancer molecular genetics laboratories performing NGS panels’ tests. The production cost was estimated using a micro-costing method with resources consumed collected in situ in each laboratory from a healthcare provider perspective. In addition, we used a top–down methodology for specific post-sequencing steps including bioinformatics, technical validation, and biological validation. Additional non-specific costs were also included. Costs were detailed per step of the process (from the pre-analytical phase to delivery of results), and per cost driver (consumables, staff, equipment, maintenance, overheads). Sensitivity analyses were performed. The mean total cost of NGS for targeted gene panels was estimated to 607€ (±207) in somatic genetics and 550€ (±140) in germline oncogenetic analysis. Consumables were the highest cost driver of the sequencing process. The sensitivity analysis showed that a 25% reduction of consumables resulted in a 15% decrease in total NGS cost in somatic genetics, and 13% in germline analysis. Additional costs accounted for 30–32% of the total NGS costs. Beyond cost assessment considerations, the diffusion of NGS technologies will raise questions about their efficiency when compared to more targeted approaches, and their added value in a context of routine diagnosis.

Background To investigate the relationship between hospital volume activities and the survival for Epithelial Ovarian Carcinoma (EOC) patients in France. Methods This retrospective study using prospectively implemented databases was conducted on an exhaustive cohort of 267 patients undergoing first-line therapy during 2012 in the Rhone-Alpes Region of France. We compared Progression-Free Survival for Epithelial Ovarian Carcinoma patients receiving first-line therapy in high- (i.e. ≥ 12 cases/year) vs. low-volume hospitals. To control for selection bias, multivariate analysis and propensity scores were used. An adjusted Kaplan-Meier estimator and a univariate Cox model weighted by the propensity score were applied. Results Patients treated in the low-volume hospitals had a probability of relapse (including death) that was almost two times (i.e. 1.94) higher than for patients treated in the high-volume hospitals (p

Occupational lung cancers are under-reported and under-compensated worldwide. We assessed systematic screening for occupational exposure to carcinogens combining a self-administered questionnaire and an occupational consultation to improve the detection of occupational lung cancers and their compensation. Social deprivation and the costs of this investigation were estimated. Patients with lung cancer received a self-administered questionnaire to collect their job history, potential exposure to carcinogens and deprivation. A physician assessed the questionnaire and recommended an occupational consultation if necessary. During the consultation, a physician assessed if the lung cancer was work-related and, if it was, delivered a medical certificate to claim for compensation. Over 18 months, 440 patients received the self-administered questionnaire: 234 returned a completed questionnaire and a consultation was required for 120 patients. Compensation was judged possible for 41 patients. Among the 35 medical certificates delivered, 19 patients received compensation. Nearly half the patients (46%) were assessed as socially deprived and these patients took significantly longer to return the questionnaire compared with those who were not deprived. The mean cost of the process was €62.65 per patient. Our results showed a systematic self-administered questionnaire can be used to identify patients potentially exposed to carcinogens and to improve compensation.

International audience; It is currently unclear if next-generation sequencing (NGS) technologies can be implemented in the diagnosis setting at an affordable cost. The aim of this study was to measure the total cost of performing NGS in clinical practice in France, in both germline and somatic cancer genetics.The study was performed on 15 French representative cancer molecular genetics laboratories performing NGS panels' tests. The production cost was estimated using a micro-costing method with resources consumed collected in situ in each laboratory from a healthcare provider perspective. In addition, we used a top-down methodology for specific post-sequencing steps including bioinformatics, technical validation, and biological validation. Additional non-specific costs were also included. Costs were detailed per step of the process (from the pre-analytical phase to delivery of results), and per cost driver (consumables, staff, equipment, maintenance, overheads). Sensitivity analyses were performed.The mean total cost of NGS for targeted gene panels was estimated to 607€ (±207) in somatic genetics and 550€ (±140) in germline oncogenetic analysis. Consumables were the highest cost driver of the sequencing process. The sensitivity analysis showed that a 25% reduction of consumables resulted in a 15% decrease in total NGS cost in somatic genetics, and 13% in germline analysis. Additional costs accounted for 30-32% of the total NGS costs.Beyond cost assessment considerations, the diffusion of NGS technologies will raise questions about their efficiency when compared to more targeted approaches, and their added value in a context of routine diagnosis.

Management of adolescents and young adults (AYAs) differs between adult and pediatric units, especially regarding febrile neutropenia (FN). In our previous study, we found that AYAs treated in adult units were significantly less hospitalized for FN than in pediatric units, without difference in morbimortality. The objective of this work was to assess the economic impact of these practices.This study retrospectively collected data from the medical records of AYAs treated at the Comprehensive Cancer Center Léon Bérard, Lyon, France, in the Euro-E-W-I-N-G99 protocol between September 1, 2000 and May 31, 2013. We focused on FN occurring after VIDE (vincristine, ifosfamide, doxorubicin, etoposide) courses. Costs were calculated using a micro-costing technique from the hospital's perspective (in 2014-Euro); the time horizon was the induction period. Multivariate analyses were performed on the total cost and cost of FN. Uncertainty was captured by sensitivity analyses.Forty-four AYAs (18 in the adult sector, 26 in the pediatric sector) received 260 courses of VIDE. Mean cost of care was €37,544 in the pediatric sector, including €11,948 (32%) for FN (€11,851 in hospitalization), versus €34,677 in the adult sector, including €6,143 (18%) for FN (€5,789 in hospitalization). Cost for FN was significantly higher in pediatric units (difference in mean cost of €5,830 per patient, 95% bootstrapped confidence interval [1,939.1; 10,028.9]). In multivariate analysis, the only factor significantly influencing this cost difference was the sector of care. The most sensitive parameter was the unit cost of conventional hospitalization.These results support the adult sector strategy, in agreement with the results of our first work showing comparable effectiveness.

International audience; BACKGROUND:The International organization for standardization (ISO) is the world leader in providing industrial and commercial standards and certifications. Beyond medical devices, four French clinical research and innovation departments have received an ISO 9001 certification (the standard for quality management). Simultaneously, medico-economic studies have become increasingly important in the public decision process. Using the clinical research and innovation department from the Léon-Bérard Cancer Center as an example, the purpose of this article is to show how the scope of the ISO 9001 certification has been extended to cover medico-economic studies.METHOD:All of the processes, procedures, operating modes, documents, and indicators used by the clinical research and innovation department of the Léon-Bérard center were investigated. Literature searches were conducted using Medline keywords. The recommendations from the French national authority for health and other organizations, such as the International society for pharmacoeconomics and outcomes research (ISPOR), were also considered, as well as the recommendations of the General inspectorate of social affairs.RESULTS:In accordance with the national and international recommendations, two procedures were created and four procedures were revised at this center. Five indicators of quality and an evaluation chart were developed.CONCLUSION:By adopting the ISO 9001 certification into its medico-economic studies, the clinical research and innovation department of the Léon-Bérard center has used an innovative approach in the context of the growing importance of economic studies in decision-making.Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Background Electronic health records (EHR) are increasingly being adopted by healthcare systems worldwide. In France, the “Hopital numerique 2012–2017” program was implemented as part of a strategic plan to modernize health information technology (HIT), including promotion of widespread EHR use. With significant upfront investment costs as well as ongoing operational expenses, it is important to assess this system in terms of its ability to result in improvements in hospital performances. The aim of this study was to evaluate the impact of EHR use on the organizational performances of acute care hospital surgical units throughout France. Methods This retrospective study was based on data derived from three national databases for year the 2012: IPAQSS (Indicators of improvement in the quality and the management of healthcare, “IPAQSS”), Hospi-Diag (French hospital performance indicators), and the national accreditation database. National data and methodological support were provided by the French Ministry of Health (DGOS) and the French National Authority for Health (HAS). Multivariate linear models were used to assess four organizational performance indicators: the occupancy rate of surgical inpatient beds, operating room utilization, the activity per surgeon, and the activity per both nurse anesthetist and anesthesiologist which were dependent variables. Several independent variables were taken into account, including the degree of EHR use. Results The models revealed a significant positive impact of EHR use on operating room utilization and bed occupancy rates for surgical inpatient units. No significant association was found between the activity per surgeon or the activity per nurse anesthetist and anesthesiologist with EHR use. All four organizational performance indicators were impacted by the type of hospital, the geographical region, and the severity of the pathologies. Conclusion We were able to verify the purported potential benefits of EHR use on the organizational performances of surgical units in French hospitals.