BACKGROUND & AIMS:For the local excision of early rectal tumors (ERTs), the relative effectiveness of endoscopic submucosal dissection (ESD) vs transanal endoscopic microsurgery (TEM) is subject to debate. The comparisons are limited to retrospective, single-center studies lacking a health economic assessment. METHODS:A cost-effectiveness analysis was conducted alongside a nonrandomized, 2-arm, comparative, multicenter study. The main inclusion criterion was an ERT (adenomas, in situ and usT1N0 carcinomas) that could be resected with ESD or TEM, depending on the center. The primary effectiveness criterion was complete resection. A health care system perspective and a 1-year horizon were adopted for the cost evaluation. The results of the analysis were adjusted for baseline covariates: age, sex, body mass index, American Society of Anesthesiologists score, histology, and previous pelvic surgery. RESULTS:A total of 213 ESD and 117 TEM procedures were analyzed. At 1 year and with a willingness to pay of €2500 for complete resection, the incremental net monetary benefit of ESD was significant (€1797; 95% confidence interval, €861-€3,032; P < .001). ESD was more cost-effective for decision thresholds ranging from €0 to €6000. In terms of secondary outcomes, the en bloc excision rate favored ESD (99.0% vs 92.5%, P < .01). There were no significant between-group differences in overall and major morbidity. At 3 years, a cost-utility analysis did not reveal between-group differences in health-related quality of life, and the overall survival rates were similar. However, the disease-free survival rate was higher after ESD (94.3% vs 84.6% for TEM; adjusted hazard ratio, 3.55; 95% confidence interval, 1.64-7.75; P < .001). CONCLUSIONS:For ERT, ESD was more cost-effective and offered higher-quality excision and lower recurrence rates than TEM. (ClinicalTrials.gov, Number: NCT02885142).

Objective This study aimed to evaluate the cost-effectiveness of introducing tofacitinib in second-line therapies after methotrexate failure for rheumatoid arthritis in France. Methods Using a Markov model, we simulated a cohort of 10,000 patients based on literature data to compare various treatment strategies. The reference strategy included the four classes of biologics commonly used in France (TNFi, tocilizumab, abatacept, rituximab). The trial strategies additionally included tofacitinib at different introduction positions. The cycle duration was set at 6 months, and the time horizon was a lifetime. The data for severe adverse effects were sourced from the ORAL Surveillance study. Results Compared to the reference strategy, introducing tofacitinib is a dominant strategy, regardless of its introduction position. Introducing it as the first-line treatment results in the greatest cost savings (1,679 per patient) while increasing quality-adjusted life years (QALYs) by 0.29. According to the one-way sensitivity analysis, the discount rate and the cost of TNFi were the two variables that most influenced costs, while the change in HAQ score and the discount rate were the two variables that most influenced QALYs. Conclusion Our study represents the first assessment of the cost-effectiveness of tofacitinib in France and incorporates the latest adverse effects reported in the literature. It reinforces previously obtained results from other countries. Our study has some limitations, mainly related to the use of data from clinical trials. Our analysis is limited to severe adverse effects, and their cost is extrapolated from the average hospitalisation cost. The estimated costs are therefore underestimated for chronic diseases such as cancer.

Dans le contexte de l’évaluation des technologies de santé tout au long de leur cycle de vie, les données en vie réelle (DVR) occupaient jusqu’à présent une place secondaire par rapport à celles issues des essais cliniques. Avec l’accessibilité à des DVR massives, de meilleure qualité, en particulier avec l’émergence des dispositifs connectés, avec l’amélioration des méthodes de caractérisation des populations, permettant une vision plus représentative des effets de traitement parfois à l’échelle d’un territoire national, le positionnement des DVR est susceptible d’évoluer du point de vue des évaluateurs des technologies de santé, passant de traditionnellement complémentaire, à possiblement substitutif de celles des essais cliniques. C’est à cette question de fond que s’est attachée de répondre la table ronde réunissant des experts des mondes académiques et/ou hospitaliers, institutionnels, et industriels. Ces travaux ont permis dans un premier temps d’établir la place actuelle des DVR dans l’évaluation des technologies de santé, en distinguant les principales finalités des DVR, le moment de l’évaluation par rapport au cycle de vie de la technologie, puis selon l’acteur commanditaire ou destinataire des résultats des études fondées sur des DVR. Dans un deuxième temps, la table ronde a proposé six recommandations générales pouvant permettre un usage plus intensif et décisif des DVR dans le processus d’évaluation et de prise de décision.

Within the life-cycle assessment of health technologies, real-world data (RWD) have until now been of secondary importance to clinical trial data. The availability of massive, better quality RWD, particularly with the emergence of connected devices, the improvement of methods for characterizing populations, make it possible to have a better insight into the effects of treatment, sometimes on a national scale the importance of RWD is likely to progress in the eyes of health technology assessors, going from being traditionally complementary to possibly replacing clinical trial data. This is the fundamental question that the round table, involving experts from the academic and/or hospital, institutional, and industrial worlds, set out to answer. This work served first to establish the current role of RWD in health technology assessment, by distinguishing the main purposes of RWD, the timing of the evaluation in relation to the life cycle of the technology, and then according to the party commissioning or receiving the outcomes of RWD-based studies. Secondly, the round table proposed six general recommendations for more intensive and decisive use of RWD in the assessment and decision-making process.

Background: Respiratory syncytial virus (RSV) causes a considerable disease burden in young children globally, but reliable estimates of RSV-related costs and health-related quality-of-life (HRQoL) are scarce. This study aimed to evaluate the RSV-associated costs and HRQoL effects in infants and their caregivers in four European countries.Methods: Healthy term-born infants were recruited at birth and actively followed up in four European countries. Symptomatic infants were systematically tested for RSV. Caregivers recorded the daily HRQoL of their child and themselves, measured by a modified EQ-5D with Visual Analogue Scale, for 14 consecutive days or until symptoms resolved. At the end of each RSV episode, caregivers reported healthcare resource use and work absenteeism. Direct medical costs per RSV episode were estimated from a healthcare payer's perspective and indirect costs were estimated from a societal perspective. Means and 95% confidence intervals (CI) of direct medical costs, total costs (direct costs + productivity loss) and quality-adjusted life-day (QALD) loss per RSV episode were estimated per RSV episode, as well as per subgroup (medical attendance, country).Results: Our cohort of 1041 infants experienced 265 RSV episodes with a mean symptom duration of 12.5 days. The mean (95% CI) cost per RSV episode was 6399.5 (242.3, 584.2) and 6494.3 (317.7, 696.1) from the healthcare payer's and societal perspective, respectively. The mean QALD loss per RSV episode of 1.9 (1.7, 2.1) was independent of medical attendance (in contrast to costs, which also differed by country). Caregiver and infant HRQoL evolved similarly.Conclusion: This study fills essential gaps for future economic evaluations by prospectively estimating direct and indirect costs and HRQoL effects on healthy term infants and caregivers separately, for both medically attended (MA) and non-MA laboratory-confirmed RSV episodes. We generally observed greater HRQoL losses than in previous studies which used non-community and/or non-prospective designs.(c) 2023 Elsevier Ltd. All rights reserved.

BackgroundIn young children, respiratory syncytial virus (RSV)-related bronchiolitis is typically more severe than other respiratory tract infections, with a greater need for oxygen therapy and respiratory support. Few studies have compared the cost of hospitalization with regard to virological status. The objective of this study was to compare the costs of hospitalization for RSV-positive vs. RSV-negative bronchiolitis in a French university medical center between 2010 and 2015.MethodsThe cost models were compared using conventional goodness-of-fit criteria. Covariates included the characteristics of the patients, pre-existing respiratory and non-respiratory comorbidities, superinfections, medical care provided, and the length of stay.ResultsRSV was detected in 679 (58.3%) of the 1,164 hospital stays by children under 2 years with virological data. Oxygen therapy and respiratory support were twice as frequent for the RSV-positive cases. The median hospitalization cost was estimated at €3,248.4 (interquartile range: €2,572.1). The cost distribution was positively skewed with a variation coefficient (CV = standard deviation/mean) greater than one (mean = €4,212.9, standard deviation = €5,047, CV = 1.2). In univariate analyses, there was no significant cost difference between the RSV-positive and RSV-negative cases. In the best multivariate model, the significant positive effect of RSV positivity on cost waned after the introduction of medical care variables and the length of stay. The results were sensitive to the specification of the model.ConclusionsIt was impossible to firmly conclude that hospitalization costs were higher for the RSV-positive cases.

Abstract Background Since the beginning of the COVID-19 pandemic, many countries, including Canada, have adopted unprecedented physical distancing measures such as closure of schools and non-essential businesses, and restrictions on gatherings and household visits. We described time trends in social contacts for the pre-pandemic and pandemic periods in Quebec, Canada. Methods CONNECT is a population-based study of social contacts conducted shortly before (2018/2019) and during the COVID-19 pandemic (April 2020 – February 2021), using the same methodology for both periods. We recruited participants by random digit dialing and collected data by self-administered web-based questionnaires. Questionnaires documented socio-demographic characteristics and social contacts for two assigned days. A contact was defined as a two-way conversation at a distance ≤ 2 m or as a physical contact, irrespective of masking. We used weighted generalized linear models with a Poisson distribution and robust variance (taking possible overdispersion into account) to compare the mean number of social contacts over time and by socio-demographic characteristics. Results A total of 1291 and 5516 Quebecers completed the study before and during the pandemic, respectively. Contacts significantly decreased from a mean of 8 contacts/day prior to the pandemic to 3 contacts/day during the spring 2020 lockdown. Contacts remained lower than the pre-COVID period thereafter (lowest = 3 contacts/day during the Christmas 2020/2021 holidays, highest = 5 in September 2020). Contacts at work, during leisure activities/in other locations, and at home with visitors showed the greatest decreases since the beginning of the pandemic. All sociodemographic subgroups showed significant decreases of contacts since the beginning of the pandemic. The mixing matrices illustrated the impact of public health measures (e.g. school closure, gathering restrictions) with fewer contacts between children/teenagers and fewer contacts outside of the three main diagonals of contacts between same-age partners/siblings and between children and their parents. Conclusion Physical distancing measures in Quebec significantly decreased social contacts, which most likely mitigated the spread of COVID-19.

Les confinements sont a priori des outils efficaces pour contenir la propagation d'une épidémie, mais il n'y a pas eu d'évaluation à grande échelle en situation réelle jusqu'à présent. A l'occasion de la pandémie de COVID-19 en France, une étude sur les contacts sociaux a permis d'évaluer l'impact du confinement sur les schémas de contact, les comportements et son effet sur l'épidémie. Un sondage en population a été mené sur un échantillon représentatif de la population française durant chacun des trois confinements. Les participants devaient décrire leurs contacts et leurs comportements sur 2 jours consécutifs (un jour de semaine et un jour de week-end). Pendant le 1er, le 2ème et le 3ème confinement, 1087, 1112, et 1019 participants ont respectivement rapporté 2489, 2485 et 3235 contacts. Les participants étaient des femmes pour 51,8 %(563), 51,8 %(576) et 51,3 %(523), avec un âge médian [min-max] de 43 ans, et une taille de foyer de 3 [1-8], 2 [1-10], 2 [1-10]. Mille cinquante-huit (97,3 %), 90,9 %(1011) et 90,5 %(922) ont cessé de faire la bise ou serrer la main hors de leur foyer. Trois cent trente-trois (30,6 %), 81,9 %(911) et 83,9 %(855) ont porté systématiquement un masque contre 17,6 %(191), 9,3 %(103) et 8,2 %(84) occasionnellement. Respectivement 0,9 %(10), 5,9 %(66) et 6,0 %(61) des participants avaient fait un COVID confirmé par une PCR SARS-CoV2 positive. Le nombre médian (min-max) de contact en semaine et en weekend était 1,0 [0,0-12,0] et 0,0 [0,0-10,0], de 0,0 [0,0-24,0] et 0,0 [0,0-14,0] et de 3,0 [2,0-43,0] et 2,0 [2,0-47,0] Le nombre de contact a été influencé par de nombreux facteurs dont l'âge, la taille du foyer, et les modalités d'exercice professionnel. Le télétravail a augmenté à 26,7 %(229/858), 22,6 %(104/460) et 22,9 %(98/428) contre 13 %(59/453) avant confinement. L'alternance (télétravail et travail hors du domicile) s'est aussi développée à 15,4 %(71/460) au 2ème confinement et 22,9 %(98/428) au 3ème. Parmi les personnes interrogées, 19 %(207), 24,2 %(269) et 23,9 %(243) n'ont pas passé le confinement sur leur lieu de vie habituel. En moyenne, un sujet sortait pour réaliser des achats de première nécessité 1,4, 2,2 et 2,3 fois par semaine, pour faire de l'activité physique 2,4, 2,5 et 2,8 fois par semaine, pour raison médicale 0,2, 0,5 et 0,5 fois par semaine et pour raison professionnelle 1,0, 1,9 et 1,9 fois par semaine. L'impact des mesures sanitaires a été important sur le mode de transport des participants qui étaient 4,3 %(47), 14,2 %(158) et 15,1 %(154) à prendre les transports en commun pendant la semaine contre 27,2 %(296/1087) avant le 1er confinement. Ces comportements étaient proportionnels à la rigueur décroissante des confinements selon l'index d'astringence qui était de 88,0, 78,7 et 68,5. Les schémas de contacts et les comportements ont été profondément impactés lors des confinements, et proportionnellement à la rigueur des confinements. Le nombre de contacts était fortement réduit dans notre étude, par rapport au niveau pré-pandémie (Beraud et al, Plos One 2015). Aucun lien d'intérêt

ObjectivesFor medical devices, a usability assessment is mandatory for market access; the objective is to detect potentially harmful use errors that stem from the device’s design. The manufacturer assesses the final version of the device and determines the risk-benefit ratio for remaining errors. Nevertheless, the decision rule currently used to determine the sample size for this testing has statistical limitations and the lack of a clear decision-making perspective.MethodsAs an alternative, we developed a value-of-information analysis from the medical device manufacturer’s perspective. The consequences of use errors not detected during usability testing and the errors’ probability of occurrence were embedded in a loss function. The value of further testing was assessed as a reduction in the expected loss for the manufacturer. The optimal sample size was determined using the expected net benefit of sampling (ENBS) (the difference between the value provided by new participants and the cost of their inclusion).ResultsThe value-of-information approach was applied to a real usability test of a needle-free adrenaline autoinjector. The initial estimate (performed on the first n = 20 participants) gave an optimal sample size of 100 participants and an ENBS of €255 453. This estimation was updated iteratively as new participants were included. After the inclusion of 90 participants, the ENBS was null for any sample size; hence, the cost of adding more participants outweighed the expected value of information, and therefore, the study could be stopped.ConclusionsOn the basis of these results, our method seems to be highly suitable for sample size estimation in the usability testing of medical devices before market access.

La maîtrise des durées de séjour est une composante de la performance hospitalière mesurée par l’IPDMS. Cet indicateur identifie des activités dont la durée est en écart à la moyenne, mais néglige les caractéristiques « patients » et « séjours » et la distribution de durée. L’objectif de l’analyse est de permettre à un établissement de se situer par rapport aux autres en intégrant ces éléments. Sont inclus dans l’analyse les séjours des patients > 17 ans des CHU métropolitains de la base PMSI nationale 2018, correspondant aux racines de GHM représentatives de l’activité du CHU de Lille (≥ 52 séjours par an et/ou part de marché ≥ 3 %). Des régressions non paramétriques sur les déciles de durée sont réalisées. Les variables d’ajustement sont : genre, âge, niveaux de sévérité des diagnostics, score de Charlson, unité à suppléments, nombre de RUM, IGS2, décès, précarité. Les résultats sont restitués sous format graphique représentant en abscisse les déciles et en ordonnée les estimations des effets fixes établissement, déclinés au groupe d’activité (DA), au groupe de planification et racine de GHM. Vingt-huit CHU étaient comparés au CHU de Lille, sur 465 racines de GHM, soient 6 521 480 RSA. À titre d’exemples, pour la DA endocrinologie, l’IPDMS du CHU (1,06) le classe 26e ; son rang ajusté varie entre 1 et 2 selon le décile retenu. L’IPDMS de la racine 08C47-Prothèses de hanche pour traumatismes récents classe le CHU 10e ; après ajustement il est 5e pour les séjours jusqu’au 5e décile (< 8 nuitées ; +2 nuits par rapport au meilleur CHU) et 3e à partir du 6e décile (10 nuitées). Les disciplines en écart selon l’IPDMS ne sont pas nécessairement retrouvées par les régressions. On identifie des situations particulières (ex : nuitée préopératoire) et des établissements de référence. L’ajustement lève les freins habituels aux discussions sur les DMS avec les équipes soignantes. Il est utilisé dans le cadre du plan de modernisation et d’équilibre du CHU.

Social contact data for France, with a total of 1755 participants of which the same participants can be present in 2 waves (≈13%). In each wave, participants reported contacts in two consecutive days.

Background: Postoperative Upper Gastro-Intestinal Fistula (PUGIF) is a devastating complication, leading to a high mortality rate reaching up to 80%, increased length of hospital stay, reduced Health related quality of life (HRQOL) and increased health costs. Nutritional support is a key component of therapy in such cases, related to the high prevalence of malnutrition. In prophylactic setting, enteral nutrition (EN) is associated to shorter hospital stay, lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery. In curative settingafter fistula occurrence, there are very few evidences available. We hypothesise that EN increases 30-day fistula closure rate in PUGIF, allowing better HRQOL without increasing morbi-mortality. Methods/Design: The NUTRILEAK trial is a multicenter, randomized, parallel-group, open label phase III trial to assess the efficacy of EN (experimental group) compared with TPN (control group) in patients with PUGIF. The primary objective of the study is to compare EN versus TPN in the treatment of PUGIF (after oesophago-gastric resection including bariatric surgery, duodeno-jejunal resection or pancreatic resection with digestive tract violation) in terms of 30-day fistula closure rate. Secondary objectives are to evaluate the 6-month post-randomization fistula closure rate, time of first fistula closure (in days), medical and surgical treatment-related complication rate at 6 months after randomization, fistula related complication rate at 6 months after randomization, type and severity of early (30 days after randomization) and late fistula-related complications (over 30 days after randomization), 30-day and 6-month post-randomization mortality rate, nutritional status at day 30, day 60, day 90 and day 180 post randomization, mean length of hospital stay, patient’s Health related quality of life (HRQOL) (self-assessment questionnaire), oral feeding time anddirect costs of treatment. A total of 321 patients will be enrolled. Discussion: The two nutritional supports are already used in daily practice, but most surgeons are reluctant to use the enteral route in case of PUGIF. This study will be the first randomized trial testing the role of EN versus TPN in PUGIF. Trial registration: ClinicalTrials.gov, NCT03742752. Registered on 14 November 2018.

OBJECTIVE:The aim of this study was to compare the efficacy and safety of 12-month implantation of a duodeno-jejunal bypass liner (DJBL) with conventional medical care in patients with metabolic syndrome (MS).SUMMARY BACKGROUND DATA:DJBL is an endoscopic device for treating obesity and related disorders. The persistence of favorable results after 6 months has not been tested in a controlled study.METHODS:We conducted a multicenter randomized controlled trial, stratified by center and diabetes status. The primary endpoint was the remission of MS at 12 months. The secondary endpoints included body mass index (BMI), glucose control, blood pressure, and lipids, assessed at 12 months after implantation, and again, at 12 months after the removal of the DJBL. Up to 174 subjects were planned to be randomized into either the DJBL or the control arm at a 2:1 ratio, respectively. Study enrollment was discontinued by the Scientific Monitoring Committee due to the early termination of the ENDO trial (NCT01728116) by the US Food and Drug Administration. The study was terminated after withdrawal of the device's European Conformity marking by the European Medicines Agency, and an interim analysis was performed.RESULTS:A total of 82 patients were enrolled (67.5% female, 48.8% with diabetes). At 12 months after randomization, the primary endpoint was met in 6 (12%) DJBL patients and 3 (10%) controls (P = 0.72). Patients in the DJBL group experienced greater BMI loss [mean adjusted difference (95% confidence interval, CI) -3.1 kg/m (-4.4 to -1.9) kg/m, P < 0.001] and HbA1c change [mean adjusted difference -0.5% (95% CI -0.9 to -0.2); P < 0.001] than those in the control group. No difference remained statistically significant at 12 months after the removal of the DJBL. In the DJBL group, 39% of patients experienced at least one device-related serious adverse event, which was classified as Grade III Dindo-Clavien in 22%, and required premature device explantation in 16%.CONCLUSIONS:The present study showed a transient clinical benefit of DJBL, which was only apparent at 1 year, when the device was still in situ, and was obtained at the risk of serious device-related adverse events in 39% of patients. These results do not support the routine use of DJBL for weight loss and glucose control in patients with MS.

Background: Endovascular treatment has become the first-line revascularization technique for femoropopliteal lesions. This technique lacks reliable and accurate morphological control of the arterial segment treated. Intraoperative 2-dimensional angiogram consumes iodinated contrast media and increases X-ray exposure; this subsequently provides no 3-dimensional information on the quality of the revascularization completed, what could explain some of the early and late failures of the technique. We evaluated whether intraoperative optical coherence tomography (OCT) control in addition to standard angiogram could improve the primary patency rate at 12 months in comparison to standard angiogram alone in patients with occlusive femoropopliteal lesions. Methods: The tomography by optical coherence in femoral artery trial is a multicentric, prospective, randomized, controlled, and single-blind study including patients with long de novo occlusive femoropopliteal lesions. The randomization will be achieved in 2 balanced groups of patients after crossing successfully the lesion: group 1 with intraoperative OCT control in addition to standard angiogram and group 2 with standard angiogram alone. The randomization will be stratified by center. The protocol has been submitted and approved by a French ethic's committee under reference number CPP2019-12-098. The study has been registered under the reference number NCT04434586 on the Web site of clinicaltrials.gov. Results: The primary outcome of the study is the primary patency at 12 months. The number of patients who need to be treated is 166 (83 in each group) considering 5% of no workable data. Symptoms' improvement, target lesion revascularization, target vessel revascularization, quality-of-life questionnaires, cost utility, and cost effectiveness will be analyzed as secondary end-point variables at 12 months. Conclusions: The present study is to evaluate the potential benefit for patients on the result of endovascular revascularization of long occlusive femoropopliteal lesion at 12 months when using intraoperative OCT control.

Objective: The objective of this study was to evaluate the impact of a rapid diagnostic test for influenza (the Sofia (R) Influenza A+B FIA rapid diagnostic test [RDT]) in a pediatric emergency department (PED). Methods: A retrospective, observational, cross-sectional study was conducted in the PED of the Lille University Hospital between 2013 and 2015. All patients under 18 years of age for whom influenza RDT was administered were included. Clinical data, management, and related hospitalizations were compared between positive and negative RDT groups. The length of stay in the PED (main outcome) and the number of additional tests (biological and radiographic tests) between the two groups were compared. Results: A total of 238 tests were reported: 119 positive, 110 negative, nine invalid. The mean length of stay in the PED was significantly lower in the positive RDT group: 4.0 h vs. 7.4 h (P < 10(-6)). Patients with positive RDT had significantly fewer biological tests (20% vs. 56%; P <10(-7)) and radiographs (23% vs. 52%; P <10(-5)). The prevalence of hospitalizations in a short-stay unit was significantly lower in patients with positive RDT (0.8% vs. 9.1%; P = 0.009). Conclusions: This study showed a significant medical impact of the use of Sofia (R) Influenza RDT A+B FIA in a PED regarding the length of stay and the number of additional explorations. (C) 2018 Elsevier Masson SAS. All rights reserved.

Background Catheter-related bacteremia (CRB) is the most frequent nosocomial infection in neonatal intensive care unit (NICU) patients, especially in very low-birth-weight infants. Administration of injectable drugs in premature newborn infants has many particularities and several types of infusion incidents have been reported. The Edelvaiss® Multiline NEO device is a novel multi-lumen access infusion device adapted to the specificities of infusion in neonatology. This multicenter, randomized, controlled study was therefore designed to determine whether or not Edelvaiss® Multiline NEO reduces the risk of CRB in preterm newborn infants in an NICU. Methods/design This is a multicenter, randomized, controlled trial, using a cluster-randomized crossover design. Four investigator centers (four clusters) will participate in the study and will be randomized into two groups, corresponding to two different sequences (either the Edelvaiss® Multiline NEO or standard infusion system sequence, then vice versa). A total of 280 patients will be recruited. Infants will be enrolled in the study at the time of placing a single-lumen central venous catheter. Three visits recording specific data are planned in the study protocol. The primary outcome measure is the incidence density (ID) of CRB. For each patient, the total number of catheters and CRB incidents as well as the duration of stay in the NICU will be computed and considered for analysis. Discussion The study will provide high-quality evidence to determine whether the Multiline NEO device reduces the risk of CRB in preterm newborns in NICUs or not. Trial registration ClinicalTrials.gov, NCT02633124 . Registered on 7 December 2015.

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. (C) 2018 Elsevier Masson SAS. All rights reserved.

Background and Aims: The potential benefit of the centralization of Bariatric surgery (BS) remains debated. The aim of this study was to evaluate the impact on 90-day mortality of an innovative organization aiming at centralizing the care of severe postoperative complications of BS. Study Design: The centralization of care for postoperative complication after BS was implemented by French Authorities in 2013 in the Nord-Pas-de-Calais Region, France. This unique formalized network (OSEAN), coordinated by 1 tertiary referral center, enrolled all regional institutions performing bariatric surgery. Data were extracted from the medico-administrative database providing information on all patients undergoing BS between 2009 and 2016 in OSEAN (n = 22,928) and in Rest of France (n = 288,942). The primary outcome was the evolution of 90-day mortality before and after the implementation of this policy. Rest of France was used as a control group to adjust the results to improvement with time of BS outcomes. Results: The numbers of primary procedure and reoperations increased similarly before and after 2013 within OSEAN and in Rest of France. The 90-day mortality rate became significantly lower within OSEAN than in the rest of France after 2013 (0.03% vs 0.08%, P < 0.01). This difference was confirmed in multivariate analysis after adjustment to the procedure specific mortality (P < 0.04). The reduction of 90-day mortality was most visible for sleeve gastrectomy. Conclusion: The implementation of centralized care for early postoperative complications after BS in OSEAN was associated with reduced 90-day mortality. Our results indicate that this reduction was not due to a lower incidence of complications but to the improvement of their management.