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Gabet, Amélie, Valérie Olié, and Yannick Béjot. "Stroke Patients with Atrial Fibrillation Treated with Oral Anticoagulants: Comparison of the Population-Based Stroke Registry of Dijon and the French National Health Databases." Neuroepidemiology 54, no. 6 (2020): 506–12. http://dx.doi.org/10.1159/000511206.
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<b><i>Introduction:</i></b> The objective of this study was to evaluate the complementarity of the French national health database (<i>Système national des données de Santé</i>, SNDS) and the Dijon Stroke Registry for the epidemiology of stroke patients with anticoagulated atrial fibrillation (AF). <b><i>Methods:</i></b> The SNDS collects healthcare prescriptions and procedures reimbursed by the French national health insurance for almost all of the 66 million individuals living in France. A previously published algorithm was used to identify AF newly treated with oral anticoagulants. The Dijon Stroke Registry is a population-based study covering the residents of the city of Dijon since 1985 and records all stroke cases of the area. We compared the proportions of stroke patients with anticoagulated AF in the city of Dijon identified in SNDS databases to those registered in the Dijon Stroke Registry. <b><i>Results:</i></b> For the period 2013–2017 in the city of Dijon, 1,146 strokes were identified in the SNDS and 1,188 in the registry. The proportion of strokes with anticoagulated AF was 13.4% in the SNDS and 20.3% in the Dijon Stroke Registry. Very similar characteristics were found between patients identified through the 2 databases. The overall prevalence of AF in stroke patients could be estimated only in the Dijon stroke registry and was 30.4% for the study period. <b><i>Discussion/Conclusion:</i></b> If administrative health databases can be a useful tool to study the epidemiology of anticoagulated AF in stroke patients, population-based stroke registries as the Dijon Stroke Registry remain essential to fully study the epidemiology of strokes with anticoagulated AF.
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Pol, Stanislas, Ingrid Rodriguez, Olivier Lada, Fayssoil fouad, Magali Lemaitre, and Françoise Roudot-Thoraval. "Patients treated for hepatitis C: an observational study with the French administrative healthcare database (SNDS)." Journal of Hepatology 73 (August 2020): S613. http://dx.doi.org/10.1016/s0168-8278(20)31693-7.
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Meaume, Sylvie, Patricia Senet, Benoît Thomé, Victor-Alexandre Aragno, Bohbot Serge, Sophie Fortin, Isabelle Boucley, Ulrique Michon-Pasturel, and Hester Colboc. "Impact of primary dressings on healing of venous leg ulcers: a French cohort study from the healthcare insurance database." Journal of Wound Care 33, no. 9 (September 2, 2024): 678–86. http://dx.doi.org/10.12968/jowc.2024.0189.
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Objective: Multicomponent bandages (MCBs) are recommended by the French Authority for Health (Haute Autorité de Santé) as first-line treatment for venous leg ulcers (VLUs). A first analysis of the data collected from the French administrative healthcare database (Système National des Données de Santé (SNDS)) on 25,255 patients with a VLU supported superiority of MCBs versus short stretch bandages when considering the healing outcomes and costs associated with closure of these wounds. The aim of this study was to assess how beneficial the primary dressing (technology lipido-colloid nano-oligosaccharide factor (TLC NOSF) or control dressing group (CDG)) could be, when used in combination with MCBs in the treatment of VLUs. Method: Data from the SNDS were collected for patients meeting the following inclusion criteria: treatment for a VLU with MCBs and with the same dressing type (TLC-NOSF or CDG) during the whole treatment period. Healing outcomes were documented on the global cohorts and propensity score-matched cohorts. The mean healthcare cost and the ecological impact were calculated for those patients healed within the study period. Results: In total, 12,507 patients met the criteria for treatment with both MCBs and TLC-NOSF dressings (n=1134) versus MCBs and CDG (n=11,373); with 1134 and 2268 patients per group following propensity score matching. Healing outcomes were favourable for the TLC-NOSF group in the global cohort and were enhanced in the propensity score-matched cohorts. At every point of the analysis, the adjusted healing rates were significantly higher in the TLC-NOSF group than in the CDG group (p<0.001). In the propensity score-matched cohorts (n=3402), the healing rate at three months was 52% in the TLC-NOSF group versus 37% in the CDG group (p<0.001). The median healing time was 87 days versus 125.5 days in the TLC-NOSF and CDG groups, respectively (p<0.0001). TLC-NOSF dressings significantly reduced the average treatment cost per healed ulcer (€2099) by 23.7% compared with dressings without TLC-NOSF (€2751) (p<0.001), as well as the resources used. Conclusion: This SNDS analysis confirms, in the largest real-life study performed in VLU management, the superiority of the TLC-NOSF dressings versus those not impregnated with the NOSF compound. Better clinical outcomes associated with cost savings and a positive ecological impact support the combination of MCBs and TLC-NOSF dressings and should be considered as an optimal standard of care for the global management of VLUs. These outcomes reinforce the current positions of the international guidelines on the use of NOSF impregnated dressings (UrgoStart range; Laboratoires Urgo, France) in this pathology.
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Lartigau, Marion, Martine Barateau, Mathieu Rosé, Nicoleta Petricã, and Nathalie Salles. "Pressure ulcer prevention devices in the management of older patients at risk after hospital discharge: an SNDS study." Journal of Wound Care 32, Sup9a (September 1, 2023): clxxi—clxxx. http://dx.doi.org/10.12968/jowc.2023.32.sup9a.clxxi.
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Objective: Our aim was to measure the effectiveness of home healthcare pressure ulcer (PU) prevention devices (PUPDs) for at-risk patients after hospital discharge in France. Method: We conducted a retrospective analysis of PU-associated hospitalisations based on the French medico-administrative database (Système National des Données de Santé, SNDS), which covers the entire French population. All adults >70 years of age, hospitalised from 1 July to 31 December 2015, and equipped with a medical bed at home, were included. Follow-up was for a maximum of 18 months. Propensity score matching allowed the comparison of PUPD equipped and non-equipped groups (No-PUPD), considering sociodemographic characteristics and other factors. Results: The study included 43,078 patients. Of this population, 54% were PUPD patients and 46% No-PUPD. After matching, PUPD patients had significantly fewer PUs than No-PUPD patients (5.5% versus 8.9%, respectively; p<0.001). The adoption of PUPD reduced by 39% the risk of a PU in hospital. Patients equipped within the first 30 days at home after hospitalisation had fewer PUs than those equipped later (4.8% versus 5.9%, respectively). The estimated PUPD use costs represented 1% of total healthcare expenditure per patient during the study period. Conclusion: The study results demonstrated the effectiveness of the adoption of mattress toppers or prevention mattresses in reducing PU occurrence in patients aged >70 years of age. A short delay in PUPD delivery appeared to have a real impact in the medical setting. Future research on a larger population might provide more evidence on the appropriate support and timeframe to choose based on risk assessment.
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Juge, P. A., L. Wemeau Stervinou, S. Ottaviani, G. Desjeux, J. Zhuo, B. Bregman, V. Vannier-Moreau, R. M. Flipo, B. Crestani, and P. Dieudé. "OP0099 EPIDEMIOLOGY AND MORTALITY OF RA-ASSOCIATED INTERSTITIAL LUNG DISEASE: DATA FROM A FRENCH ADMINISTRATIVE HEALTHCARE DATABASE." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 54.2–55. http://dx.doi.org/10.1136/annrheumdis-2021-eular.871.
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Background:Interstitial lung disease (ILD) is a common extra-articular manifestation of RA and is associated with increased morbidity and mortality.1-3 Studies have shown variability in the prevalence and mortality rate of patients with RA-associated ILD (RA-ILD).4 Further studies are needed to better characterise the epidemiology of RA-ILD.Objectives:To estimate the prevalence and incidence of clinical RA-ILD in France and to compare mortality rates between patients with RA-ILD and patients with RA without clinical ILD (RA-noILD).Methods:A historical cohort study was conducted using data from the French national claims database (SNDS) between 1 January 2013 and 31 December 2018. Adults with an RA diagnosis (International Classification of Diseases, Tenth revision [ICD-10] codes M05, M06.0, M06.8 and M06.9) and ≥2 distinct dates of DMARD delivery were included. Onset of RA was defined as the first date of occurrence between RA codes and the first known DMARD reimbursement. ILD diagnosis was defined as having ICD-10 code J84 and ≥1 computed tomography scan after, but within 1 year of, the first date of ILD occurrence. All patients had ≥6 months’ reimbursement after RA-ILD onset. The prevalence and incidence (2014–2018) of RA-ILD were estimated. The mortality rate was calculated, comparing patients with RA-ILD and patients with RA-noILD, matched 1:1 for age, sex, age at RA-ILD onset, duration of RA and presence of diabetes, arterial disease, dyslipidaemia and cardiac disease. Mortality was compared between patients with RA with and without clinical ILD in the matched population using Cox proportional hazards regression.Results:The prevalence of RA-ILD was 6.52 per 100,000 inhabitants (incidence=1.04 per 100,000 person-years). Of the 173,138 patients with RA included in the overall population, 4330 (2.5%) had clinical ILD. Patients with RA-ILD were older at RA diagnosis (mean [SD] age: 63.3 [13.7] vs 56.9 [15.2] years) and were more likely to be male (39.8% vs 27.0%) compared with patients with RA-noILD. Patients with RA-ILD were more likely to have cardiac disease (84.9% vs 63.1%), arterial disease (38.0% vs 19.3%), diabetes (21.4% vs 12.5%) and dyslipidaemia (44.7% vs 32.9%) compared with those with RA-noILD. The mortality rate in patients with clinical RA-ILD was 1.71 per 100,000 inhabitants. The mortality rate increased according to age (0.28 per 100,000 inhabitants for patients aged <65 years, 4.60 per 100,000 inhabitants for patients aged 65–74 years and 11.4 per 100,000 inhabitants for patients aged ≥75 years). After matching, the adjusted mortality risk was three times higher (HR [95% CI]: 3.1 [3.1, 3.9]) in patients with RA-ILD than in those with RA-noILD (Figure 1).Conclusion:This is the largest epidemiological study of RA-ILD in France. The prevalence of clinical RA-ILD in this population was towards the lower end of previous estimates (1–58%),3 possibly due to under-reporting of claims data. However, the occurrence of clinical ILD was associated with a strong increase in mortality compared with patients with RA-noILD.References:[1]Bodolay E, et al. Rheumatology (Oxford) 2005;44:656–661.[2]Duarte AC, et al. Rheumatology (Oxford) 2019;58:2031–2038.[3]Hyldgaard C, et al. Ann Rheum Dis 2017;76:1700–1706.[4]Spagnolo P, et al. Arthritis Rheumatol 2018;70:1544–1554.Acknowledgements:This study was funded by Bristol Myers Squibb. Claire Line, PhD of Caudex provided medical writing support, funded by Bristol Myers Squibb.Disclosure of Interests:Pierre-Antoine Juge Consultant of: Bristol Myers Squibb, Lidwine Wemeau Stervinou Consultant of: Boehringer Ingelheim, Bristol Myers Squibb, Roche, Sanofi, Sebastien Ottaviani Consultant of: AbbVie, Bristol Myers Squibb, Lilly, Merck Sharp & Dohme, Novartis, Roche-Chugai, SOBI, UCB, Guillaume Desjeux: None declared, Joe Zhuo Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Bruno Bregman Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Virginie Vannier-Moreau Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Rene-Marc Flipo Speakers bureau: AbbVie, Bristol Myers Squibb, Janssen, Lilly, Medac, Merck Sharp & Dohme, Novartis, Pfizer, Roche-Chugai, Grant/research support from: Amgen, Janssen, Novartis, Pfizer, Bruno Crestani: None declared, Philippe Dieudé Consultant of: Boehringer Ingelheim, Bristol Myers Squibb, Chugaï, Lilly, Medac, Novartis, Pfizer, Sanofi, Grant/research support from: Bristol Myers Squibb, GlaxoSmithKline, Pfizer
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Meaume, Sylvie, Patricia Senet, Benoît Thomé, Victor-Alexandre Aragno, Serge Bohbot, Sophie Fortin, Isabelle Boucley, Ulrique Michon-Pasturel, and Hester Colboc. "Aetiological treatment of venous leg ulcers with compression therapy: real-life outcomes with two different procedures." Journal of Wound Care 32, no. 10 (October 2, 2023): 615–23. http://dx.doi.org/10.12968/jowc.2023.32.10.615.
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Objective: To evaluate the healing outcomes and costs associated with the aetiological management of venous leg ulcers (VLUs) treated with recommended multicomponent bandages (MCBs) and short-stretch bandages (SSBs). Method: This observational study is a retrospective comparative study (Level 2b), based on the French administrative healthcare database (Système National des Données de Santé, SNDS). It includes patients treated from onset with reimbursed MCBs and SSBs for a VLU episode, between July 2018 and September 2020. Although other compression systems, such as long-stretch bandages, are commonly used for the treatment of VLUs, they are not recommended by health authorities in France and thus, were not considered for this study. A binomial regression model was performed to estimate the adjusted relative risk of wound closure rates at three months for each group, based on potential confounding factors including, notably, age, sex, key comorbidities, and wound dressing size. The mean healthcare cost was calculated for patients whose VLUs healed within the study period. Results: The reimbursement data (including prescribed compression systems and nursing care) of the 25,255 selected patients were analysed in the study. There were no significant differences between the MCBs and SSBs groups when considering patient characteristics. The healing rates after three months' treatment, were 42% and 35% (p<0.001) in the MCBs and SSBs groups, respectively. When adjusting the statistical model, the chance of healing at three months was still 12% higher with MCBs compared with SSBs (p<0.0001). The median healing time was estimated at 115 (interquartile range (IQR): 60–253) days in the MCB group versus 137 (IQR: 68–300) days in the SSBs group. The average treatment cost per patient with a healed ulcer was €2875±3647 in the MCB group and €3580±5575) in the SSBs group (p=0.0179), due to lower hospital stay and nursing costs in the MCB group. Differences in wound characteristics between the two groups cannot be totally excluded, due to the limited content of the database in terms of clinical data, but should have been addressed, to some extent, through the study selection criteria and the chosen regression model. Conclusion: In this study, this SNDS analysis seemed to confirm that the healing outcomes achieved in real-life with MCBs were in line with those reported in clinical trials, and superior to SSBs, which reinforces the current position from the guidelines.
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Bastard, Léa, Pascal Claudepierre, Laetitia Penso, Emilie Sbidian, and Laura Pina Vegas. "Risk of serious infection associated with different classes of targeted therapies used in psoriatic arthritis: a nationwide cohort study from the French Health Insurance Database (SNDS)." RMD Open 10, no. 1 (March 2024): e003865. http://dx.doi.org/10.1136/rmdopen-2023-003865.
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ObjectiveTo assess the risk of serious infection associated with different targeted therapies for psoriatic arthritis (PsA) in real-world settings.MethodsThis nationwide cohort study used the administrative healthcare database of the French health insurance scheme linked to the hospital discharge database to identify all adults with PsA who were new users of targeted therapies (adalimumab, etanercept, golimumab, certolizumab pegol, infliximab, secukinumab, ixekizumab, ustekinumab, and tofacitinib) from 1 January 2015 to 30 June 2021. The primary outcome was a serious infection (ie, requiring hospitalisation), in a time-to-event analysis using propensity score-weighted Cox models, with adalimumab as the comparator, estimating weighted HRs (wHRs) and their 95% CIs.ResultsA total of 12 071 patients were included (mean age 48.7±12.7 years; 6965 (57.7%) women). We identified 367 serious infections (3.0% of patients), with a crude incidence rate of 17.0 per 1000 person-years (95% CI, 15.2 to 18.7). After inverse propensity score weighting and adjustment for time-dependent covariates and calendar year, risk of serious infection was significantly lower for new users of etanercept (wHR 0.72; 95% CI, 0.53 to 0.97) or ustekinumab (wHR, 0.57; 95% CI, 0.35 to 0.93) than adalimumab new users. This risk was not statistically modified with the other targeted therapies.ConclusionsThe incidence of serious infection was low for PsA patients who were new users of targeted therapies in real-world settings. Relative to adalimumab new users, this risk was lower among new users of etanercept and ustekinumab and unmodified for the other molecules.
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Pol, Stanislas, Fayssoil Fouad, Magali Lemaitre, Ingrid Rodriguez, Olivier Lada, Pascaline Rabiega, Elias Benabadji, and Françoise Roudot-Thoraval. "Impact of extending direct antiviral agents (DAA) availability in France: an observational cohort study (2015-2019) of data from French administrative healthcare databases (SNDS)." Lancet Regional Health - Europe 13 (February 2022): 100281. http://dx.doi.org/10.1016/j.lanepe.2021.100281.
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Pina Vegas, Laura, Léa Hoisnard, Léa Bastard, Emilie Sbidian, and Pascal Claudepierre. "Long-term persistence of second-line biologics in psoriatic arthritis patients with prior TNF inhibitor exposure: a nationwide cohort study from the French health insurance database (SNDS)." RMD Open 8, no. 2 (December 2022): e002681. http://dx.doi.org/10.1136/rmdopen-2022-002681.
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IntroductionTumour necrosis factor inhibitor (TNFi) agents are most often the first-choice biological treatment for patients with psoriatic arthritis (PsA). When their discontinuation is needed, a switch to another TNFi or to another therapeutic class may be considered. However, data supporting one approach over another are lacking.ObjectiveTo compare the long-term persistence of classes of biologics in PsA patients with prior TNFi exposure.MethodsThis nationwide cohort study involved the administrative healthcare database of the French health insurance scheme linked to the hospital discharge database. We included all adults with PsA starting a second-line biological after discontinuing a TNFi during 2015–2020. Persistence was defined as the time from biological initiation to discontinuation and was estimated by the Kaplan-Meier method. Comparison of persistence by biological class was performed with Poisson regression models with time divided into 6-month intervals.ResultsWe included 2975 patients: 1580 (53%) initiating a second TNFi, 426 (14%) an interleukin 12/23 inhibitor (IL-12/23i) and 969 (33%) an IL-17 inhibitor (IL-17i). Overall, 1-year and 3-year persistence rates were 42% and 17%, respectively. After adjustment, persistence was associated with treatment with an IL-17i (adjusted relative risk (RRa) 0.79, 95% CI 0.71 to 0.87) or IL-12/23i (RRa0.69, 95% CI 0.61 to 0.79) vs a TNFi, with no significant difference between IL-12/23 and IL-17 inhibitors (RRa0.88, 95% CI 0.76 to 1.02).ConclusionsOverall, this real-life study shows low persistence for all biologics at 3 years in PsA patients previously exposed to a TNFi. However, persistence was higher with an IL-17i or IL-12/23i than a TNFi.
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Pina Vegas, Laura, Laetitia Penso, Emilie Sbidian, and Pascal Claudepierre. "Influence of sex on the persistence of different classes of targeted therapies for psoriatic arthritis: a cohort study of 14 778 patients from the French health insurance database (SNDS)." RMD Open 9, no. 4 (December 2023): e003570. http://dx.doi.org/10.1136/rmdopen-2023-003570.
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BackgroundSex differences in phenotype presentation, disease trajectory and treatment response in psoriatic arthritis (PsA) have been reported. Nevertheless, whether classes of targeted therapies differentially affect men and women with PsA remains unclear.ObjectivesTo assess the effect of sex on the long-term persistence of each class of targeted therapies in PsA.MethodsThis nationwide cohort study involved the administrative healthcare database of the French health insurance scheme linked to the hospital discharge database. We included all adults with PsA who were new users of targeted therapies (not in the year before the index date) during 2015–2021 and studied all treatment lines during the study period. Persistence was defined as the time from treatment initiation to discontinuation and was estimated by the Kaplan-Meier method. Comparison of persistence by sex involved multivariate frailty models with conventional synthetic disease-modifying antirheumatic drugs and prednisone as time-dependant variables.ResultsWe included 14 778 patients with PsA who were new users of targeted therapies: 8475 (57%) women (mean age 50±13 years; 15 831 lines), 6303 (43%) men (mean age 51±13 years; 10 488 lines). Overall, 1-year persistence was 52% for women and 62% for men and at 3 years it was 27% and 39%, respectively. After adjustments, persistence was lower for women than men for inhibitors of tumour necrosis factor (TNFi) (adjusted HR (HRa) 1.4, 99% CI 1.3 to 1.5) and interleukin 17 inhibitor (IL17i) (HRa1.2, 99% CI 1.1 to 1.3) but not IL12/23i (HRa1.1, 99% CI 0.9 to 1.3), IL23i (HRa1.1, 99% CI 0.7 to 1.5) or Janus kinase inhibitor (JAKi) (HRa1.2, 99% CI 0.9 to 1.6).ConclusionThe treatment persistence was lower for women than men for TNFi and IL17i but not for IL12/23i, IL23i or JAKi.
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Pina Vegas, L., L. Penso, E. Sbidian, and P. Claudepierre. "POS0075 LONG-TERM PERSISTENCE OF FIRST-LINE BIOLOGICS FOR PSORIATIC ARTHRITIS AND PSORIASIS: A COHORT STUDY OF 23,423 PATIENTS FROM THE FRENCH HEALTH INSURANCE DATABASE (SNDS)." Annals of the Rheumatic Diseases 81, Suppl 1 (May 23, 2022): 255–56. http://dx.doi.org/10.1136/annrheumdis-2022-eular.960.
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BackgroundTreatment options for psoriasis (PsO) and psoriatic arthritis (PsA) have evolved significantly since the era of biologics. Clinical trials (mainly placebo-controlled for 12 to 16 weeks) are inadequate to assess the relative long-term efficacy of biologics and are often insufficient regarding safety.ObjectivesTo assess the long-term persistence of different biologic classes to treat PsA and PsO.MethodsThis nationwide cohort study involved the administrative healthcare database of the French health insurance scheme linked to the hospital discharge database. We included, in two sub-cohorts, all adults with PsA and those with PsO, who were new users of biologics (not in the year before the index date) during 2015-2019. We excluded patients hospitalised for PsO in the PsA cohort and for PsA in the PsO cohort in the year before the index date. Persistence was defined as the time from biologic initiation to discontinuation and was estimated by the Kaplan-Meier method. Comparison of persistence by biologic class involved using propensity score-weighted Cox models (IPTW) and adjustment on specific systemic non-biologics (time-dependant variables).ResultsWe included 6,531 patients with PsA (mean age 49±13 years, 45% male): 4,974 (76%) starting a TNFi, 803 (12%) an IL12/23i and 754 (12%) an IL17i. We included 16,892 patients with PsO (mean age 53±17 years, 50% male): 10,199 (60%) starting a TNF inhibitor (TNFi), 3,982 (24%) an IL12/23i, and 2,711 (16%) an IL17i. Overall 3-year persistence rates were 36% and 41% for PsA and PsO (Figure 1). After IPTW and adjustment, IL17i was associated with higher persistence than TNFi for PsA (weighted hazard ratio [HRw] 0.70, 95% confidence interval [95%CI] 0.58-0.85) and PsO (HRw 0.78, 95%CI 0.73-0.83) and than IL12/23i for PsA (HRw 0.69, 95%CI 0.55-0.87). We found no difference between IL17i and IL12/23i for PsO. IL12/23i had better persistence than TNFi for PsO (HRw 0.76, 95%CI 0.72-0.80), with no difference observed for PsA.Figure 1.Kaplan Meier estimates of biologic treatment persistence in psoriasis and psoriatic arthritis cohorts TNFi: tumor necrosis factor inhibitor; ILi: interleukin inhibitor.ConclusionThis real-life study suggests a higher persistence of IL17i than TNFi for PsA and PsO. IL17i also has better persistence than IL12/23i for PsA, with no difference for PsO. However, the persistence rates of all biologics remained globally low at 3 years.Disclosure of InterestsLaura Pina Vegas: None declared, Laetitia Penso: None declared, Emilie Sbidian: None declared, Pascal Claudepierre Speakers bureau: P. Claudepierre has been an investigator for Roche Chugai, Sanofi Aventis, Celgene, Pfizer, MSD, Novartis and BMS., Consultant of: P. Claudepierre has received consulting fees from Abbvie, Amgen, Pfizer, Roche-Chugai, BMS, MSD, UCB, Novartis, Janssen, Lilly, Galapagos, Celgene (less than $10,000 each)
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Arnaud, L., C. Fabry-Vendrand, R. Todea, B. Vidal, C. Juliette, J. Robert, S. Bouée, and G. Thabut. "OP0046 REAL-WORLD ORAL GLUCOCORTICOID USE IN SYSTEMIC LUPUS ERYTHEMATOSUS: A NATION-WIDE POPULATION-BASED STUDY USING THE FRENCH NATIONAL MEDICO-ADMINISTRATIVE DATABASE (LUPIN-F STUDY)." Annals of the Rheumatic Diseases 82, Suppl 1 (May 30, 2023): 30.1–30. http://dx.doi.org/10.1136/annrheumdis-2023-eular.1315.
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BackgroundThe daily dose of oral glucocorticoids (OCS) is associated with damage in Systemic Lupus Erythematosus (SLE), and OCS reduction is a major goal of SLE care. However, evidence regarding the real-world use of OCS in nation-wide populations are currently lacking.ObjectivesThe aim of this study was to analyze the use of OCS in French patients with SLE, at the national level, using medico-administrative data.MethodsThis study used the French health-insurance claims database (SNDS), which contains pseudonymized individual data for over 66 million people. SLE patients were identified with the ICD-10 diagnosis code for SLE (M32), documented as a chronic condition or associated to hospital stay. Included SLE patients were defined as patients alive on January 1st2020 whenever the SLE diagnosis occurred. SLE comorbidities and OCS complications were identified through validated algorithms. Real-world use of treatments was identified through drug deliveries in pharmacies and daily OCS doses (expressed in prednisone-equivalent) were calculated for the year 2019. Comparisons were made to age- and gender-matched controls without SLE from the general population.ResultsA total of 32,173 patients with SLE (mean age 49.9 ± 16.0 years; 86.1% women) were alive on January 1st2020, with a mean disease duration of 7.1 ± 6.2 years.Among these prevalent SLE patients, 48.2% were treated with OCS. The mean daily dose of OCS was below 5 mg/day in 35.7%, between 5 and 7.5 mg/day in 6.4% and above 7.5 mg/day in 6.1%. OCS use was significantly more frequent in women, in patients with CMUc (specific health coverage for low income patients) and decreased with age (p<0.0001, for all). SLE-specific comorbidities, including glomerular disease, skin involvement, polyarthritis, pleurisy, pericarditis, and thrombocytopenia, were significantly increased in patients with higher doses of OCS (p<0.0001, for all). Use of SLE treatments other than OCS was significantly increased in patients with higher doses of OCS (p<0.0001, for all) (Table 1). Strikingly, 14.6% of patients receiving 5 to 7.5 mg of OCS per day and 14.2% of those receiving more than 7.5 mg per day were not treated with antimalarial drugs, immunosuppressives or other biologic treatments for SLE. Complications of OCS, including cardiovascular diseases, infections, osteoporosis, and obesity, were significantly increased in SLE patients receiving ≥ 5 mg per day of OCS (p<0.0001 for all). The overall annual mean cost of healthcare consumptions from a societal perspective in 2019 was 6,048€ for prevalent SLE patients and 2,601€ for matched controls (p<0.0001). Among prevalent SLE patients, the cost increased significantly according to the OCS daily dose: 4,633€ for patients without OCS, 6,383€ (daily dose of 0-5 mg/day), 9,815€ (5-7.5 mg/day) and 13,861€ (above 7.5 mg/day).ConclusionTo the best of our knowledge, this is the first nation-wide study reporting on real-life use of OCS in patients with SLE. The proportion of patients treated with high-dose OCS ≥ 7.5mg/day remains unacceptably high and associated with increased comorbidities, OCS complications and significantly increased healthcare costs. Also, over 14% of patients receiving OCS doses ≥ 5 mg/day were not treated with antimalarial drugs, immunosuppressives or other biologic treatments for SLE. These results highlight the need for tight disease control and implementation of robust OCS-sparing strategies in SLE.Table 1.Proportion of patients treated with SLE treatments other than corticosteroids in 2019No OCSOCS0-5 mg/dayOCS5-7.5 mg/dayOCS≥ 7.5 mg/dayp-valueAntimalarials(Hydroxychloroquine/ Chloroquine)8,826 (53.0%)7,286 (63.5%)1,505 (72.9%)1,416 (71.9%)<0.0001Methotrexate958 (5.7%)1,405 (12.2%)361 (17.5%)358 (18.2%)<0.0001Mycophenolate mofetil337 (2.0%)878 (7.6%)350 (17.0%)496 (25.2%)<0.0001Azathioprine264 (1.6%)549 (4.8%)175 (8.5%)206 (10.5%)<0.0001Cyclophosphamide207 (1.2%)367 (3.2%)147 (7.1%)266 (13.5%)<0.0001REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsLaurent Arnaud Consultant of: Abbvie, Alexion, Alpine, Amgen, AstraZeneca, Biogen, BMS, Boehringer-Ingelheim, GSK, Grifols, Janssen, LFB, Lilly, Kezar, Medac, Novartis, Oséus, Pfizer, Roche-Chugaï, Sêmeia, UCB, Caroline Fabry-Vendrand Employee of: AstraZeneca, Remus Todea Employee of: AstraZeneca, Blandine VIDAL Employee of: AstraZeneca, Cottin Juliette Grant/research support from: I am employed by the company CEMKA who receive grants by pharmaceutical companies to conduct epidemiological and economic studies, Julien Robert Grant/research support from: I am employed by the company CEMKA who receive grants by pharmaceutical companies to conduct epidemiological and economic studies, Stéphane Bouée Grant/research support from: I am employed by the company CEMKA who receive grants by pharmaceutical companies to conduct epidemiological and economic studies, Gabriel Thabut Employee of: AstraZeneca.
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Frenzel, Laurent, Véronique Cahoreau, Nicolas Giraud, Stephanie Delienne, Francis Fagnani, Stéphane Bouée, Juliette Cottin, et al. "Health Care Resource Use, Comorbidities, and Costs of Hemophilia B Patients in France: A Nationwide Claims Database Analysis." Blood 142, Supplement 1 (November 28, 2023): 3982. http://dx.doi.org/10.1182/blood-2023-173445.
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Background and objectives Hemophilia B is an inherited bleeding disorder characterized by a deficiency in blood clotting factor IX (FIX). Its severity varies based on the degree of FIX deficiency, with the most severe cases experiencing frequent spontaneous hemorrhages (FIX levels < 1 IU/dL). Treatment options include on-demand administration following a hemorrhage or prophylaxis to prevent bleeding. A complication is the production of inhibitory antibodies against the coagulation factors in some patients, leading to more aggressive and expensive treatments. The aim of this study was to describe Hemophilia B patients according to severity in France in 2021, including sociodemographic characteristics and comorbidities, current treatments, healthcare resource use and related costs. Methods This study used the French health-insurance claims database (SNDS) containing pseudonymized individual data for over 66 million people. Hemophilia B patients are fully covered in France and might be identified by the ICD-10 code D67. Patients alive on January 1st, 2021, were selected after exclusion of those presenting with Willebrand disease and other rare bleeding disorders. Comorbidities were identified through validated algorithms. An age and gender matched control group without Hemophilia B was randomly selected in the general population: for each HB patient a subject of the same age,gender and region of residence was randomly selected among the overall population of French citizens (excluding HB patients). Sub-group analyses were performed according to the treatment pattern (on demand / in prophylaxis) and the presence of inhibitors (defined with the treatment: high dose of factor IX or bypassing agents). Direct costs were estimated in a societal perspective. Results 1,311 patients with Hemophilia B were identified. Mean age was 36 years and 83.5% were males. Compared to controls, hemophilia patients had significantly (p<0.05) more frequently an HIV infection, hepatitis B or C, and a chronic cardiopathy (Figure 1). There were no significant differences for coronary artery diseases, chronic heart failure, arrhythmia, and hepatic diseases. Respectively 996 (76.0%) and 303 (23.1%) patients were treated on demand and in prophylaxis both without inhibitors. Less than 10 patients were treated either on demand with inhibitors or in prophylaxis with inhibitors. Compared to controls, patients with hemophilia B had more frequent consultations with general practitioners and hospital specialists, visits to emergency unit, with nurses and physiotherapists (Table 1). They also were more frequently treated with analgesics and corticosteroids but less frequently with non-steroid anti-inflammatory drugs. The proportion of hemophilia B patients hospitalized was higher than controls, overall and also for bleeding and for orthopedic surgery. The mean annual direct medical costs (drugs, consultations, hospitalizations, ...) varied strongly according to treatment modalities: €6,506 for patients treated on demand without inhibitors (versus €1,795 for their matched controls)€162,635 for patients treated in prophylaxis without inhibitors (versus €1,071 for their matched controls). The majority of the costs was related to antihemophilic drugs: 33% and 92% respectively for these 2 treatment groups. Conclusion: These results highlight the burden of hemophilia B in terms of comorbidities, healthcare consumptions and cost. The cost of Hemophilia B varied greatly with disease severity and was mostly due to the antihemophilic drugs
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Lebreton, Aurelien, Véronique Cahoreau, Nicolas Giraud, Stephanie Delienne, Francis Fagnani, Stéphane Bouée, Juliette Cottin, et al. "Health Care Resource Use, Comorbidities, and Costs of Hemophilia A Patients in France: A Nationwide Claims Database Analysis." Blood 142, Supplement 1 (November 28, 2023): 1237. http://dx.doi.org/10.1182/blood-2023-173257.
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Background and objectives Hemophilia A is an inherited bleeding disorder characterized by a deficiency in blood clotting factor VIII (FVIII). Its severity varies based on the degree of FVIII deficiency, with the most severe cases experiencing frequent spontaneous hemorrhages (FVIII levels < 1 IU/dL). Treatment options include on-demand administration following a hemorrhage or prophylaxis to prevent bleeding. The most frequent complication is the production of inhibitory antibodies against the coagulation factors, leading to more aggressive and expensive treatments. The aim of this study was to describe Hemophilia A patients according to severity in France in 2021, including sociodemographic characteristics and comorbidities, current treatments, healthcare resource use and related costs. Methods This study used the French health-insurance claims database (SNDS) containing pseudonymized individual data for over 66 million people. Hemophilia A patients are fully covered in France and might be identified by the ICD-10 code D66. Patients alive on January 1st, 2021, were selected after exclusion of those presenting with Willebrand disease and other rare bleeding disorders. Comorbidities were identified through validated algorithms. An age and gender matched control group without Hemophilia A was randomly selected in the general population: for each HA patient a subject of the same age, gender and region of residence was randomly selected among the overall population of French citizens (excluding HA patients). Sub-group analyses were performed according to the treatment pattern (on demand / in prophylaxis) and the presence of inhibitors (defined with the treatment: emicizumab before October 2019, high dose of factor VIII or bypassing agents). Direct costs were estimated in a societal perspective. Results 5,507 patients with Hemophilia A were identified. Mean age was 36 years and 97.3% were males. Compared to controls, hemophilia patients had significantly (p<0.05) more frequently an HIV infection, hepatitis B or C, and a hepatic disease (Figure 1). There were no significant differences for chronic cardiopathy, coronary artery disease, chronic heart failure and arrhythmia. Respectively 4,056 (73.7%), 36 (0.7%), 1,243 (22.6%) and 172 (3.1%) patients were treated on demand without and with inhibitors and in prophylaxis without and with inhibitors. Compared to controls, patients with hemophilia A had more frequent consultations with general practitioners and hospital specialists, visits to emergency unit, with nurses and physiotherapists (Table 1). They also were more frequently treated with analgesics and corticosteroids but less frequently with non-steroid anti-inflammatory drugs. The proportion of hemophilia A patients hospitalized was higher than controls, overall and also for bleeding episodes and for orthopedic surgery. The mean annual direct medical costs (drugs, consultations, hospitalizations, ...) varied strongly according to treatment modalities and presence of inhibitors: €11,471 for patients treated on demand without inhibitors (versus €1,806 for their matched controls)€76,332 for patients treated on demand with inhibitors (versus €2,288 for their matched controls)€247,937 for patients treated in prophylaxis without inhibitors (versus €1,159 for their matched controls)€349,616 for patients treated in prophylaxis with inhibitors (versus €1,342 for their matched controls). The majority of the costs was related to antihemophilic drugs: 64%, 60%, 94% and 93% respectively in the 4 treatment groups. Conclusion: These results highlight the burden of hemophilia A in terms of comorbidities, healthcare consumptions and cost. The cost of Hemophilia A varied greatly with disease severity and presence of inhibitors and was mostly due to the antihemophilic drugs.
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Scailteux, Lucie-Marie, Catherine Droitcourt, Frédéric Balusson, Emmanuel Nowak, Sandrine Kerbrat, Alain Dupuy, Erwan Drezen, André Happe, and Emmanuel Oger. "French administrative health care database (SNDS): The value of its enrichment." Therapies 74, no. 2 (April 2019): 215–23. http://dx.doi.org/10.1016/j.therap.2018.09.072.
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Pol, S., I. Rodriguez, F. Fouad, M. Lemaitre, X. Ansolabehere, O. Lada, and F. Roudot-Thoraval. "PIN151 PATIENTS TREATED FOR HEPATITIS C: AN OBSERVATIONAL STUDY WITH THE FRENCH ADMINISTRATIVE HEALTH CARE DATABASE (SNDS)." Value in Health 22 (November 2019): S663. http://dx.doi.org/10.1016/j.jval.2019.09.1391.
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Quignot, N., B. Amzal, and S. Bakshi. "PNS213 THE FRENCH SNDS NATIONAL DATA PLATFORM: A GOLDMINE FOR EFFECTIVE DECISION-MAKING OR JUST ANOTHER ADMINISTRATIVE DATABASE?" Value in Health 23 (May 2020): S323. http://dx.doi.org/10.1016/j.jval.2020.04.1204.
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Amadou, Coralie, Pierre Denis, Kristel Cosker, and Anne Fagot-Campagna. "Less amputations for diabetic foot ulcer from 2008 to 2014, hospital management improved but substantial progress is still possible: A French nationwide study." PLOS ONE 15, no. 11 (November 30, 2020): e0242524. http://dx.doi.org/10.1371/journal.pone.0242524.
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Objective To assess the improvement in the management of diabetes and its complications based on the evolution of hospitalisation rates for diabetic foot ulcer (DFU) and lower extremity amputation (LEA) in individuals with diabetes in France. Methods Data were provided by the French national health insurance general scheme from 2008 to 2014. Hospitalisations for DFU and LEA were extracted from the SNIIRAM/SNDS French medical and administrative database. Results In 2014, 22,347 hospitalisations for DFU and 8,342 hospitalisations for LEA in patients with diabetes were recorded. Between 2008 and 2014, the standardised rate of hospitalisation for DFU raised from 508 to 701/100,000 patients with diabetes. In the same period, the standardised rate of LEA decreased from 301 to 262/100,000 patients with diabetes. The level of amputation tended to become more distal. The proportion of men (69% versus 73%) and the frequency of revascularization procedures (39% versus 46%) increased. In 2013, the one-year mortality rate was 23% after hospitalisation for DFU and 26% after hospitalisation for LEA. Conclusions For the first time in France, the incidence of a serious complication of diabetes, i.e. amputations, has decreased in relation with a marked improvement in hospital management.
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Blom Fily, Astrid, Laurent Mortier, Isabelle Kachaner, Nicolas Meyer, Mahtab Samimi, Laura Luciani, Capucine Cahuzac, et al. "Avelumab as second-line or later (2L+) treatment in patients (pts) with metastatic Merkel cell carcinoma (mMCC): Analysis of real-world outcomes in France using the CARADERM registry and the French national healthcare database." Journal of Clinical Oncology 41, no. 16_suppl (June 1, 2023): 9537. http://dx.doi.org/10.1200/jco.2023.41.16_suppl.9537.
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9537 Background: Avelumab, an anti–PD-L1 antibody, has been approved in multiple countries for the treatment of mMCC based on the results of the pivotal phase 2 JAVELIN Merkel 200 trial (NCT02155647). In pts who received avelumab as 2L+ treatment in the trial (part A), median overall survival (OS) was 12.6 months and median progression-free survival (PFS) was 2.7 months. The French health technology assessment agency requested the collection of real-world data from pts with mMCC from a comprehensive registry; data are reported here. Methods: This retrospective, noninterventional, real-world study evaluated all pts with mMCC in France using combined data from 2 databases: CARADERM (French national database of rare dermatological cancers) and Système National des Données de Santé (SNDS; national healthcare database). For this analysis, eligible pts were diagnosed with mMCC and initiated 2L+ avelumab outside of a clinical trial between August 2016 and December 2019. Pts were followed for 24 months after initiation of avelumab. Probabilistic linkage was performed to identify pts registered in both databases. OS and PFS were analyzed using Kaplan-Meier methodology. Safety data were not collected. Results: A total of 180 pts who received 2L+ avelumab were identified, data were obtained for 112 pts from the CARADERM database and for 68 additional pts after SNDS linkage. Median age at diagnosis was 74.0 years, 66.7% were male, and 98.3% received chemotherapy as first-line treatment. Median follow-up was 13.1 months. 79.5% of CARADERM database pts had discontinued avelumab; the most common reasons specified were progressive disease (36.4%), complete response (17.0%), and death (13.6%). Median OS was 14.6 months (95% CI, 9.9-21.3 months) overall; in CARADERM database pts, median OS was 15.9 months (95% CI, 8.6-28.3 months) vs 13.3 months (95% CI, 6.7-19.1 months) in non-CARADERM database pts. 12- and 24-month OS rates in the overall population were 53.8% (95% CI, 46.2%-60.8%) and 40.5% (95% CI, 33.2%-47.6%), respectively. In CARADERM database pts (data not available in non-CARADERM database pts), median PFS was 3.6 months (95% CI, 2.7-7.5 months), and the objective response rate was 55.3% (95% CI, 45.3%-65.4%), including complete response in 31.9%. Median duration of response was 39.3 months (95% CI, 24.3 months-not estimable). Conclusions: In this real-world study of national data from France, outcomes with avelumab as 2L+ treatment for mMCC were similar to those observed in part A of the JAVELIN Merkel 200 trial. These findings confirm the effectiveness of avelumab in pts with mMCC that have progressed following first-line systemic treatment in routine clinical practice.
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Thurin, N., R. Lassalle, R. Baulain, J. Jové, D. Sakr, M. Gross-Goupil, M. Rouyer, P. Blin, and C. Droz-Perroteau. "MSR10 Applying Sequence Clustering Methods to Characterize Healthcare Pathways of Patients at Different Prostate Cancer Stages in the French Nationwide Healthcare Database (SNDS)." Value in Health 25, no. 12 (December 2022): S351. http://dx.doi.org/10.1016/j.jval.2022.09.1742.
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Grimaldi, Lamiae, Tom Duchemin, Yann Hamon, Albert Buchard, Jacques Benichou, Lucien Abenhaim, Nathalie Costedoat-Chalumeau, and Yola Moride. "Hydroxychloroquine and Cardiovascular Events in Patients With Systemic Lupus Erythematosus." JAMA Network Open 7, no. 8 (August 30, 2024): e2432190. http://dx.doi.org/10.1001/jamanetworkopen.2024.32190.
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ImportanceSystemic lupus erythematosus (SLE) predisposes individuals to early cardiovascular (CV) events. While hydroxychloroquine is thought to mitigate CV risk factors, its protective role against CV events, particularly arterial ones, remains to be confirmed.ObjectiveTo evaluate the association between hydroxychloroquine and the risk of myocardial infarction (MI), stroke, and other thromboembolic events (OTEs) in patients with SLE.Design, Setting, and ParticipantsThis cohort study using a nested case-control design was conducted within the National French Healthcare Database (SNDS), which represents 99% of the French population, from 2010 to 2020. Participants were the cohort of all patients with SLE recorded in the SNDS. Patients with SLE experiencing CV events during the study period were the case group; those without CV events were controls. The analysis period was from February 2022 to September 2023.ExposuresHydroxychloroquine use within 365 days prior to the index date, defined as current (within 90 days), remote (91-365 days), or no exposure within the previous 365 days.Main Outcomes and MeasuresOutcomes of interest were MI, stroke, and OTE, analyzed individually and as a composite outcome (primary analysis). Controls were matched to patients with CV events by age, sex, time since SLE onset and entry into the SNDS database, index date, prior antithrombotic and CV medication, chronic kidney disease, and hospitalization. Multivariable conditional logistic regression was performed using hydroxychloroquine exposure as the main independent variable.ResultsThe SLE cohort included 52 883 patients (mean [SD] age, 44.23 [16.09] years; 45 255 [86.6%] female; mean [SD] follow-up, 9.01 [2.51] years), including 1981 patients with eligible CV events and 16 892 matched control patients. There were 669 MI events, 916 stroke events, and 696 OTEs in the individual outcome studies. For current exposure to hydroxychloroquine, the adjusted odds were lower for composite CV events (odds ratio [OR], 0.63; 95% CI, 0.57-0.69) as well as for MI (OR, 0.72; 95% CI, 0.60-0.85), stroke (OR, 0.69; 95% CI, 0.60-0.81), and OTEs (OR, 0.58; 95% CI, 0.49-0.69) individually compared with no hydroxychloroquine exposure within 365 days.Conclusions and RelevanceIn this nationwide cohort study of patients with SLE, a protective association was found between the current use of hydroxychloroquine and the occurrence of CV events, but not between remote use of hydroxychloroquine and CV outcomes, highlighting the value of continuous hydroxychloroquine treatment in patients with SLE.
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Leleu, X., B. Gorsh, A. Bessou, P. Paka, J. De Nascimento, X. Colin, S. Landi, and P. F. Wang. "P943: SURVIVAL OUTCOMES OF PATIENTS WITH MULTIPLE MYELOMA IN FRANCE: A COHORT STUDY USING THE FRENCH NATIONAL HEALTHCARE DATABASE (SNDS)." HemaSphere 6 (June 2022): 833–34. http://dx.doi.org/10.1097/01.hs9.0000846640.89066.41.
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Miadi, H., D. Logeart, F. Fagnani, L. Batel, and M. Vittori. "EE625 Economic and Clinical Burden of Worsening Heart Failure Patients With Reduced Ejection Fraction: French National Healthcare Database Analysis (SNDS)." Value in Health 25, no. 12 (December 2022): S179. http://dx.doi.org/10.1016/j.jval.2022.09.864.
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Dumas, Elise, Lucie Laot, Florence Coussy, Beatriz Grandal Rejo, Eric Daoud, Enora Laas, Amyn Kassara, et al. "The French Early Breast Cancer Cohort (FRESH): A Resource for Breast Cancer Research and Evaluations of Oncology Practices Based on the French National Healthcare System Database (SNDS)." Cancers 14, no. 11 (May 27, 2022): 2671. http://dx.doi.org/10.3390/cancers14112671.
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Background: Breast cancer (BC) is the most frequent cancer and the leading cause of cancer-related death in women. The French National Cancer Institute has created a national cancer cohort to promote cancer research and improve our understanding of cancer using the National Health Data System (SNDS) and amalgamating all cancer sites. So far, no detailed separate data are available for early BC. Objectives: To describe the creation of the French Early Breast Cancer Cohort (FRESH). Methods: All French women aged 18 years or over, with early-stage BC newly diagnosed between 1 January 2011 and 31 December 2017, treated by surgery, and registered in the general health insurance coverage plan were included in the cohort. Patients with suspected locoregional or distant metastases at diagnosis were excluded. BC treatments (surgery, chemotherapy, targeted therapy, radiotherapy, and endocrine therapy), and diagnostic procedures (biopsy, cytology, and imaging) were extracted from hospital discharge reports, outpatient care notes, or pharmacy drug delivery data. The BC subtype was inferred from the treatments received. Results: We included 235,368 patients with early BC in the cohort (median age: 60 years). The BC subtype distribution was as follows: luminal (80.2%), triple-negative (TNBC, 9.5%); HER2+ (10.3%), or unidentifiable (n = 44,388, 18.9% of the cohort). Most patients underwent radiotherapy (n = 200,685, 85.3%) and endocrine therapy (n = 165,655, 70.4%), and 38.3% (n = 90,252) received chemotherapy. Treatments and care pathways are described. Conclusions: The FRESH Cohort is an unprecedented population-based resource facilitating future large-scale real-life studies aiming to improve care pathways and quality of care for BC patients.
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Medioni, J., Y. Lopez Marquez, D. Scimeca, E. Leray, M. Dalichampt, and M. Bennani. "POSB397 Benefits of Homeopathic Complementary Treatment in Breast Cancer Patients: A Retrospective Cohort Study Based on the French Nationwide Healthcare Database (SNDS)." Value in Health 25, no. 1 (January 2022): S258. http://dx.doi.org/10.1016/j.jval.2021.11.1260.
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Dziadzko, Mikhail, Manon Belhassen, Eric Van Ganse, Claire Marant-Micallef, Valeria Martinez, and Frederic Aubrun. "Are Healthcare Resource Utilization Patterns for Pain Management Specific to Post-Acute COVID-19 Syndrome? A Study of Survivors from the First French Pandemic Wave." Journal of Clinical Medicine 13, no. 24 (December 17, 2024): 7680. https://doi.org/10.3390/jcm13247680.
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Objectives: Chronic pain is a common symptom in Post-Acute COVID-19 Syndrome (PACS), affecting 11–60% of patients, but the link between COVID-19 and chronic pain remains unclear. This study assesses healthcare resource utilization (HRU) for pain management among French COVID-19 survivors, using the National French Claims Database (SNDS). We analyzed medical consultations, rehabilitation services, diagnostic procedures, and medication dispensing to identify PACS-related pain patterns and their impact on the healthcare system. Methods: The cohort included 68,822 patients hospitalized during the first COVID-19 wave (March–June 2020), with 13,939 ICU survivors. HRU was assessed for six months pre- and post-hospitalization in four areas: (1) medical consultations and rehabilitation; (2) pain-related medication dispensing; (3) neuropathic diagnostic procedures; (4) hospital admissions for chronic pain. A post–pre ratio (PP-Ratio) compared post-COVID to pre-COVID HRU. Results: Significant changes in HRU were observed, particularly for ICU survivors. Neurology consultations (PP-Ratio 1.41) and outpatient physical therapy (PP-Ratio 1.69) increased. Dispensing of strong opioids, antiepileptics, anxiolytics, and hypnotics rose, while NSAID use decreased. Hospitalizations for chronic pain also increased (PP-Ratio 1.52). Similar trends were seen among ICU survivors, with notable increases in opioid and antiepileptic use. No distinct PACS-related pain patterns emerged. Conclusions: Non-specific increases in HRU for pain management were found following COVID-19 hospitalization, likely due to disease severity and ICU care rather than PACS-related chronic pain. Further research is needed to explore long-term pain outcomes in this population.
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Fakih, Olivier, Maxime Desmarets, Bérenger Martin, Clement Prati, Elisabeth Monnet, Frank Verhoeven, and Daniel Wendling. "Difficult-to-treat axial spondyloarthritis is associated with psoriasis, peripheral involvement and comorbidities: results of an observational nationwide study." RMD Open 9, no. 4 (November 2023): e003461. http://dx.doi.org/10.1136/rmdopen-2023-003461.
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ObjectivesTo determine the cumulative incidence and identify the factors associated with difficult-to-treat axial spondyloarthritis (D2T-axSpA) in French patients newly benefiting from the French ‘long-term illness’ (LTI) social security scheme for axial spondyloarthritis (axSpA).MethodsThis national cohort study was based on the French National Medico-Administrative Database, SNDS, which contains data on hospitalisation, LTI and outpatient care consumption. All French patients newly receiving LTI benefits for ankylosing spondylitis (AS) between 2010 and 2013 were included in the study. In France, LTI is required to access biological/targeted synthetic DMARDs (b/tsDMARDs). The follow-up period ended on 31 December 2018. So-called D2T-axSpA was defined as the failure of three b/tsDMARDs or of two b/tsDMARDs with different modes of action. Comorbidities and extra-musculoskeletal manifestations were identified using previously described algorithms. Characteristics were compared between patients with D2T-axSpA and patients with non-D2T-axSpA who had received at least one b/tsDMARD with bivariate and multivariate analysis using logistic regression. Incidence rates of major cardiovascular event (MACE) and death were compared using competitive risk analysis.Results22 932 patients were included. 10 798 (47.08%) patients received at least one bDMARD. None received tsDMARD. During follow-up, 2115 patients were classified as having D2T-axSpA, representing 19.59% of patients who received at least one bDMARD. In multivariate analysis, D2T-axSpA was significantly associated with female gender, peripheral involvement, psoriasis, hypertension and depression (p<0.001 for each case). There was no difference in the incidence of MACE (p=0.92) or death (p=0.87).ConclusionD2T-axSpA affects one in five patients exposed to bDMARDs in this national cohort. D2T-axSpA is more common in women and patients with peripheral involvement and/or comorbidities.
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Thurin, Nicolas H., Régis Lassalle, Martijn Schuemie, Marine Pénichon, Joshua J. Gagne, Jeremy A. Rassen, Jacques Benichou, et al. "Empirical assessment of case‐based methods for identification of drugs associated with upper gastrointestinal bleeding in the French National Healthcare System database ( SNDS )." Pharmacoepidemiology and Drug Safety 29, no. 8 (June 10, 2020): 890–903. http://dx.doi.org/10.1002/pds.5038.
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Bretin, O., E. Casarotto, A. Bessou, F. Maurel, P. Serusclat, M. Joubert, G. Fagherazzi, C. Berteau, and A. Pouyet. "MSR2 Development of an Algorithm to Identify the Type of Diabetes in the French Administrative Health Care Database “Système National Des Données De Santé” (SNDS)." Value in Health 26, no. 12 (December 2023): S393. http://dx.doi.org/10.1016/j.jval.2023.09.2061.
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Touzeau, Cyrille, Nadia Quignot, Jie Meng, Heng Jiang, Artak Khachatryan, Moushmi Singh, Vanessa Taieb, Jean-Vannak Chauny, and Gaëlle Désaméricq. "Survival and treatment patterns of patients with relapsed or refractory multiple myeloma in France — a cohort study using the French National Healthcare database (SNDS)." Annals of Hematology 100, no. 7 (April 21, 2021): 1825–36. http://dx.doi.org/10.1007/s00277-021-04522-y.
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AbstractOver the past decade, several drugs have been approved for the treatment of relapsed or refractory multiple myeloma (RRMM). This retrospective study, using the French National Healthcare database (SNDS), describes the treatment patterns and outcomes of patients with RRMM treated in real-world clinical practice in France. Patients were adults, with a diagnosis of multiple myeloma, who initiated second-line (2L) treatment approved for use in France between 2014 and 2018; this included bortezomib, carfilzomib, daratumumab, ixazomib, lenalidomide, or pomalidomide. Data were analyzed overall, by first-line (1L) autologous stem cell transplant (ASCT) status and by lenalidomide treatment status at 2L. In total, 12987 patients with RRMM were included in the study (mean age 69.5 years); 27% received an ASCT at 1L, and 30% received a lenalidomide-sparing regimen at 2L. Overall, and among the ASCT and non-ASCT subgroups, most patients received a bortezomib-based regimen at 1L, whereas lenalidomide-based regimens were most common at 2L. Among patients who received a lenalidomide-sparing regimen at 2L, this was most often a proteasome inhibitor-based regimen. Mortality rate was 26.1/100 person-years, and median (95% confidence interval) survival from 2L initiation was 32.4 (31.2–33.6) months. Survival differed by various factors, shorter survival was reported in the non-ASCT group, those receiving a lenalidomide-sparing regimen at 2L, older patients (≥ 70 years), and those with multiple comorbidities. This analysis provides insight into the real-world use of approved novel MM treatments and highlights an ongoing unmet need to improve outcomes, particularly for selected patient groups.
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Thurin, Nicolas H., Régis Lassalle, Martijn Schuemie, Marine Pénichon, Joshua J. Gagne, Jeremy A. Rassen, Jacques Benichou, et al. "Empirical assessment of case‐based methods for drug safety alert identification in the French National Healthcare System database (SNDS): Methodology of the ALCAPONE project." Pharmacoepidemiology and Drug Safety 29, no. 9 (March 4, 2020): 993–1000. http://dx.doi.org/10.1002/pds.4983.
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Fakih, O., M. Desmarets, B. Martin, C. Prati, D. Wendling, E. Monnet, and F. Verhoeven. "POS0301 IMPACT OF NSAIDS ON 8-YEAR INCIDENCE OF MAJOR CARDIOVASCULAR EVENTS IN PATIENTS WITH ANKYLOSING SPONDYLITIS." Annals of the Rheumatic Diseases 82, Suppl 1 (May 30, 2023): 393.1–393. http://dx.doi.org/10.1136/annrheumdis-2023-eular.2177.
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BackgroundAnkylosing spondylitis (AS) is a chronic inflammatory rheumatic disease associated with the occurrence of major cardiovascular events (MACEs). The effect of AS treatments on the occurrence of MACEs is poorly studied, especially for non-steroidal anti-inflammatory drugs (NSAIDs), whose cardiovascular risk remains debated in this disease.ObjectivesTo determine the incidence of MACEs in patients newly benefiting from long-term illness (LTI) for AS and to study the relationship between AS treatments and MACEs.MethodsThis national cohort study was based on the national health data system Système National des Données de Santé (SNDS), a French national medico-administrative database containing data containing administrative data, data on LTIs, outpatient care and medication consumption, and hospitalizations of all beneficiaries of the French health insurance system. All patients newly benefiting from the LTI #27 “severe spondyloarthritis”, with associated diagnostic code M45 (AS), between 2010 and 2013, were included. The use of LTI allowed us to build a cohort of patients with a supposedly active disease, the SNDS, being a medico-administrative database, having no data on the activity of the disease. All patients with active SpA despite NSAID treatment, and therefore requiring disease-modifying anti-rheumatic drugs (DMARDs), were theoretically newly enrolled in the LTI scheme. The end date of follow-up was 31 December 2018. The occurrence of MACEs (stroke and myocardial infarction [MI]) and comorbidities (diabetes, hypertension, dyslipidemia, smoking, obesity, chronic kidney disease, atherosclerosis, and depression) were identified using algorithms previously described in the literature.An analysis taking into account the competitive risk of death and an inverse propensity score weighting (determining the likelihood of NSAID treatment) was performed to compute cumulative incidence functions and determine the subhazard ratios (SHRs) for the occurrence of MACEs for the different treatments of interest.ResultsBetween 2010 and 2013, 22929 patients were included (mean age 43.0 (SD 13.9) years, 44.9% male). During follow-up, 344 MACEs (195 strokes, 152 MI) and 415 deaths were identified. The cumulative 8-year incidences of MACE, stroke and MI were 1.81% [1.61-2.05], 0.97% [0.83-1.14] and 0.85% [0.71-1.04] respectively. The occurrence of MACE was associated in univariate analysis with age (SHR: 1.07 [1.06-1.07]), male sex (SHR: 1.61 [1.31-2.00]), diabetes (SHR: 2.21 [1.63-3.00]), dyslipidaemia (SHR: 3.67 [2.96-4.57]), and hypertension (SHR: 3.74 [2.87-7.49]) (p<0.001 in all cases). After inverse propensity score weighting, NSAIDs (SHR: 0.40 [0.32-0.49], p<0.001) and anti-TNFs (SHR: 0.61 [0.47-0.81], p<0.001) were associated with a lower risk of MACE occurrence, which was not the case for conventional synthetic DMARDs (SHR: 0.89 [0.63-1.24]) and anti-IL17 (SHR: 2.06 [0.78-5.44]). Similar results for DMARDs were found when stratifying the analysis on the presence or absence of NSAID treatment (Table 1).ConclusionThe incidence of MACEs at eight years is low in patients newly benefiting from LTI for AS. Our results support the hypothesis of a protective role of NSAIDs and anti-TNF drugs on cardiovascular risk in these patients.Table 1.Inverse Probability Treatment Analysis with stabilized weighted subhazard ratio (wSHR) and its 95% confidence interval [95% CI] stratified by non-steroidal anti-inflammatory drugs (NSAIDs) treatment.wSHR [95% CI] globalwSHR [95% CI] in patients treated with NSAIDswSHR [95% CI] in patients NOT treated with NSAIDsNSAIDs0.39*** [0.32-0.50]N/AN/AcsDMARDs0.89 [0.63-1.24]0.91 [0.58-1.43]1.02 [0.61-1.71]Anti-TNF0.61*** [0.46-0.80]0.68* [0.47-0.99]0.57** [0.38-0.85]Anti-IL172.10 [0.79-5.57]2.88 [0.73-11.3]1.90 [0.47-7.72]* p<0.05, ** p<0.01, *** p<0.001, otherwise non-significantREFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsNone declared.
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Juge, Pierre-Antoine, Lidwine Wemeau, Sebastien Ottaviani, Guillaume Desjeux, Joe Zhuo, Virginie Vannier-Moreau, René-Marc Flipo, Bruno Crestani, and Philippe Dieudé. "Increased mortality in patients with RA-associated interstitial lung disease: data from a French administrative healthcare database." RMD Open 9, no. 4 (December 2023): e003491. http://dx.doi.org/10.1136/rmdopen-2023-003491.
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ObjectivesInterstitial lung disease (ILD) is a severe extra-articular manifestation of rheumatoid arthritis (RA). The objectives of this study were to estimate mortality rate in patients with RA-ILD and identify factors affecting mortality.MethodsData from a French national claims database (Système National des Données de Santé) from 2013 to 2018 were analysed. Adults with an RA diagnosis (International Classification of Diseases (ICD)-10 codes M05, M06.0, M06.8 and M06.9) were included. ILD diagnosis was defined with ICD-10 code J84. Mortality rates were compared between patients with RA with and without ILD, using Cox proportional hazards regression, after matching 1:1 for age, sex, age at RA-ILD onset and RA duration.ResultsAmong 173 132 patients with RA, 4330 (3%) also had ILD (RA-ILD). After matching, RA-ILD was associated with an increased mortality rate (HR 3.4, 95% CI 3.1 to 3.9). The HR for mortality was greater for: patients aged <75 years (HR 4.8, 95% CI 3.9 to 5.9) versus ≥75 years (HR 3.0, 95% CI 2.6 to 3.5); patients with ILD onset occurring before RA onset (HR 8.4, 95% CI 5.5 to 13.0) versus ILD onset occurring after RA onset (HR 2.9, 95% CI 2.6 to 3.3); and men (HR 5.2, 95% CI 4.4 to 6.2) versus women (HR 3.6, 95% CI 3.0 to 4.2).ConclusionIn this nationwide cohort study, RA-ILD was associated with increased mortality rate (vs in patients with RA without ILD), notably for those aged <75 years, those whose ILD preceded RA onset and men.
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Borget, I., A. Urtizberea, A. S. Lot, S. Affinito, H. Denis, G. Leiba, A. Schmidt, A. Panes, S. Quijano-Roy, and I. Desguerre. "RWD134 Healthcare Pathways and Therapeutic Outcomes of Patients With Spinal Muscular Atrophy: Results From the 12-Year Real-World Study EPI-SMA Based on the French National Healthcare Database (SNDS)." Value in Health 27, no. 12 (December 2024): S599. https://doi.org/10.1016/j.jval.2024.10.3692.
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Mathurin, Philippe, Marie De Zelicourt, Nadia Kelkouli, and Jean-frederic Blanc. "Risk factors, treatment patterns and survival of patients with incident hepatocellular carcinoma in France: A retrospective data analysis." Journal of Clinical Oncology 39, no. 3_suppl (January 20, 2021): 284. http://dx.doi.org/10.1200/jco.2021.39.3_suppl.284.
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284 Background: Despite the screening of patients at risk, hepatocellular carcinoma (HCC) is often diagnosed at an advanced stage disease, with a very poor prognosis. Aim: To describe risk factors, treatment patterns and survival of patients with newly diagnosed HCC in France over the period 2015-2017 using SNDS, the national administrative healthcare database covering around 99% of the population. Methods: The database was searched for patients with a diagnosis of HCC (ICD-10: C220) from 1 January 2015–31 December 2017. Disease stage (Barcelona Clinic Liver Cancer B, C or D classification) was defined by the identification of treatment: transcatheter arterial chemoembolization (TACE) or radioembolization (TARE), HCC systemic therapy and/or best Supportive Care (BSC). Patients were followed up for a maximum of 2 years. Results: 21,071 patients were identified, mean age 69.2 years (SD: 11.1), 82.2% were male. Liver disease or diabetes was identified in 86.4% of patients. The most frequent risk factors were alcohol liver disease (42.7%), viral hepatitis and alcohol liver disease (7.2%), viral hepatitis alone (12.6%), NASH/NAFLD or diabetes (17.7%). At diagnosis, 6,571 (31.2%) received a curative HCC treatment. Within the total population, 8,616 patients (40.9%) were only managed by BSC, 6,571 (31.2%) received a treatment therapy, of which 3,184 (15.1%) had a TACE or TARE and 2 700 (12.8%) sorafenib. The 1-year survival rates by initial treatment were: curative (88.7%), TACE or TARE (70%), systemic therapy (32.2%) and only 17.8% with BSC. Conclusions: These results show the high burden of HCC, with more than two thirds of patients not receiving active treatment.
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Fautrel, B., A. Saraux, I. Idier, G. Bizouard, H. Bonnabau, D. Pau, and B. Combe. "RWD166 Matching 3 Observational Studies With the French National Healthcare Database (SNDS) to Assess the Long-Term Management of Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab." Value in Health 27, no. 12 (December 2024): S606. https://doi.org/10.1016/j.jval.2024.10.3723.
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Rinder, Pierre, Théo Marcille, Paul Sinel–Boucher, Pierre Hornus, Pierre E. Heudel, Chantal Bernard-Marty, Christelle Levy, Luis Teixeira, and Dorra Kanoun. "Abstract P6-03-03: Persistence and compliance of the French metastatic breast cancer population." Cancer Research 83, no. 5_Supplement (March 1, 2023): P6–03–03—P6–03–03. http://dx.doi.org/10.1158/1538-7445.sabcs22-p6-03-03.
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Abstract Keywords Metastatic breast cancer, Endocrine therapy, Targeted therapy, Oral chemotherapy, French population Context Oral anti-cancer treatments have been shown to be effective when followed carefully. Tamoxifen, for example, reduces the risk of relapse by half within 10 years of the diagnosis [1]. However, these treatments are frequently poorly adhered to. To determine the categories of patients at risk and the appropriate moment to contact them, we developed predictive models trained on anonymised reimbursement data extracted from the French Health Insurance database. Objective The primary objective is to model a metastatic breast cancer patient’s persistence and compliance to the treatment. We aim at detecting unwanted episodes (non persistence and non compliance) six months before they happen. The oncologist may then follow the patient more closely. Methods Patients data is extracted from the SNDS database, one of the largest structured databases of health data in the world. It contains reimbursement data of the French Health System, covering 98% of the French population (66 million persons). Useful data are, for example, hospitalisations, drug purchases or the patient’s age and city of residence. From this database, patients were selected on the basis of a diagnosis of metastatic breast cancer (if hospital stay) or on the basis of specific treatments for metastatic breast cancer. Men and patients under 18 are excluded from the study. We consider that a patient has a non persistent event if she has no treatment stock for 2 months (during a phase of targeted therapy or oral chemotherapy) or 3 months (during a phase of endocrine therapy) and if no change in treatment, palliative care entry or death is observed. The compliance is labelled through the MPR (Medical Possession Ratio): a patient is considered non-compliant if the MPR of her 3 nexts purchases is below 80%. The proposed models are trained to detect non-persistence and non-compliance events in the next 180 days. We created several groups of features describing the patient and her healthcare pathway. Results 250 000 patients were spotted with a breast cancer in the SNDS database. Amongst these, around 40 000 were spotted for a metastatic breast cancer between 2013 and 2018. 14% of the patients had at least one non persistence episode and 46% had at least one non compliance episode. For the persistence study, we used a logistic regression with a feature selection. This model has a Gini coefficient of 0.35. For the compliance study, we used a deep learning model based on a GRU model. This model has a Gini coefficient of 0.37. A multivariate analysis shows that the following features had a significative impact on both predicted risks (persistence and compliance) : age, previous compliance, type of oral treatment(s) currently followed (endocrine therapy, targeted therapy, or oral chemoterapy), number of different oral treatments followed in the past year. In both models, if the patient’s age is between 50 and 70 years it does not correlate with an increased risk. On the other hand, the more they deviate from this interval, the more likely they are to be non-compliant. Conclusion Both studies have models with quite the same interpretation. Patients younger than 50 or older than 70 are more likely to be non-persistent and non-prevalent. The past compliance is highly correlated to the future events. The consumption of oral chemotherapy in comparison to oral endocrine and targeted therapy is linked to an increased risk in both studies. Bibliographie [1]: E. Ekinci, S. Nathoo, T. Korattyil et al. (2018) Interventions to improve endocrine therapy adherence in breast cancer survivors: what is the evidence? J Cancer Surviv 12:348-356 Citation Format: Pierre Rinder, Théo Marcille, Paul Sinel–Boucher, Pierre Hornus, Pierre E. Heudel, Chantal Bernard-Marty, Christelle Levy, Luis Teixeira, Dorra Kanoun. Persistence and compliance of the French metastatic breast cancer population [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-03-03.
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Quijano-Roy, S., I. Bourget, A. Lot, I. Desguerre, J. Urtizberea, A. de Chasteigner, G. Leiba, et al. "114P Epidemiology and therapeutic outcomes of patients with spinal muscular atrophy: results from a 12-year real-world study based on the French National Healthcare database (SNDS)." Neuromuscular Disorders 43 (October 2024): 104441.12. http://dx.doi.org/10.1016/j.nmd.2024.07.021.
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Baudrier, Cyril, Yohann Tran, Nicolas Delanoy, Sandrine Katsahian, Brigitte Sabatier, and Germain Perrin. "Identifying homogeneous healthcare use profiles and treatment sequences by combining sequence pattern mining with care trajectory clustering in kidney cancer patients on oral anticancer drugs: A case study." Health Informatics Journal 28, no. 2 (January 2022): 146045822211015. http://dx.doi.org/10.1177/14604582221101526.
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Objective We evaluated the ability of a coupled pattern-mining and clustering method to identify homogeneous groups of subjects in terms of healthcare resource use, prognosis and treatment sequences, in renal cancer patients beginning oral anticancer treatment. Methods Data were retrieved from the permanent sample of the French medico-administrative database. We applied the CP-SPAM algorithm for pattern mining to healthcare use sequences, followed by hierarchical clustering on principal components (HCPC). Results and conclusion We identified 127 individuals with renal cancer with a first reimbursement of an oral anticancer drug between 2010 and 2017. Clustering identified three groups of subjects, and discrimination between these groups was good. These clusters differed significantly in terms of mortality at six and 12 months, and medical follow-up profile (predominantly outpatient or inpatient care, biological monitoring, reimbursement of supportive care drugs). This case study highlights the potential utility of applying sequence-mining algorithms to a large range of healthcare reimbursement data, to identify groups of subjects homogeneous in terms of their care pathways and medical behaviors.
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Gross-Goupil, Marine, Nicolas H. Thurin, Magali Rouyer, Jérémy Jové, Thibaud Haaser, Xavier Rebillard, Michel Soulie, et al. "Survival outcome in patients with metastatic castration-resistant prostate cancer according to first-line treatment." Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020): 5570. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.5570.
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5570 Background: Therapeutic strategy in metastatic castration-resistant prostate cancer (mCRPC) has evolved significantly with the introduction of abiraterone acetate in association with prednisone/prednisolone in first-line treatment in December 2012. This work aimed to compare the effectiveness of abiraterone acetate and docetaxel as first-line treatments for mCRPC, in real-life setting. Methods: Patients with mCRPC were identified in the main scheme of the National Healthcare System database (SNDS), which covers about 86% of the French population, and capturing all reimbursed healthcare expenditures and hospital discharge summaries. Those initiating docetaxel or abiraterone acetate in 1st line in 2014 were included and 1:1 matched on the previous prostate cancer stage before mCRPC status, the delay from the date of initial diagnosis and a high-dimensional propensity score. The 36-month overall survival and the 36-month discontinuation-free survival (i.e. survival time until treatment switch or death) were compared using Cox proportional hazards risk model. Results: In 2014, out of the 12,951 patients with prevalent mCRPC, 1,214 initiated docetaxel in 1st line and 2 444 initiated abiraterone. A total of 716 patients per group were matched with good comparability (C-statistic = 0.6). The median duration of docetaxel–defined as the time between the first and the last infusion–was 7.3 months with a median of 6 infusions. The median duration of abiraterone acetate–corresponding to the period covered by the dispensed drug–was 9.1 months. Near 70% of the docetaxel and 62% of the abiraterone acetate patients received a 2nd line of treatment. Results related to the main survival outcomes are presented in the table below. Conclusions: First-line treatment with abiraterone acetate in mCRPC patients results in a better 36-month overall survival and discontinuation-free survival compared to docetaxel in real-life setting. [Table: see text]
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Naim, I., F. Tubach, S. Guillo, A. Ajrouche, Y. De Rycke, and F. Kaguelidou. "P47 Prevalence, incidence and patterns of antiasthma medication use in children: a nationwide prescription study in France." Archives of Disease in Childhood 104, no. 6 (May 17, 2019): e36.2-e36. http://dx.doi.org/10.1136/archdischild-2019-esdppp.85.
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BackgroundUse of antiasthmatic medications has increased over the years worldwide. The aim of this study was to describe the use of antiasthmatic drugs in children in France.MethodsData were retrieved from the permanent sample (1/97th) of the French national healthcare database - the Système National des Données de Santé (SNDS) for all individuals aged from 5 to 18 years old (n=143,909) from 1 January 2011 to 31 December 2017. Prevalence and incidence rate of antiasthmatic dispensing were calculated. All analyses were stratified by calendar year, age (5–11, 12–18 years) and gender. Users were classified as occasional if they had only one dispensing of antiasthmatic drugs over the year, moderate and high if they had antiasthmatic drug dispensing at two distinct occasions or at three or more occasions, respectively.ResultsThe annual prevalence of antiasthmatic drug use varied between 12 (2011) and 11 (2017) per 100 persons and incidence varied between 4.3 (2013) and 3.8 (2017) per 100 PYs. Prevalence and incidence of use were higher in children aged between 5–11 years compared to adolescents and in boys compared to girls. Most users were occasional (52%) and only one third redeemed prescriptions on a regular basis (high users: 30%). No trend was observed regarding these percentages over time or with gender and age group.ConclusionsUse of antiasthmatic drugs in France is higher than previously described in other European countries. Prevalence of use is also higher than the prevalence of asthma as assessed in epidemiological national studies suggesting that these drugs are over-prescribed.Disclosure(s)Nothing to disclose
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Champeaux-Depond, Charles, Nicolas Penet, Joconde Weller, Jean-Charles Le Huec, and Vincent Jecko. "Functional Outcome After Spinal Meningioma Surgery. A Nationwide Population-Based Study." Neurospine 19, no. 1 (March 31, 2022): 96–107. http://dx.doi.org/10.14245/ns.2143186.593.
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Objective: To describe and analysed the functional outcome (FO) after spinal meningioma (SM) surgery.Methods: We processed the système national des données de santé (SNDS) i.e. , the French national administrative medical database to retrieve appropriate cases. We analysed the International Classification of Diseases 10 codes to assess the FO. Logistic models were implemented to search for variables associated with a favourable FO i.e. , a patient being independent at home without disabling symptom.Results: A total of 2,844 patients were identified of which 79.1% were female. Median age at surgery was 66 years, interquartile range (IQR) (56–75). Ninety-five point nine percent of the SMs were removed through a posterior ± lateral approach and 0.7% need an associated stabilisation. Benign meningioma represented 92.9% and malignant 2.1%. Median follow-up was 5.5 years, IQR (2.1–8), and at data collection 9% had died. The FO was good and increased along the follow-up: 84.3% of the patients were alive and had not associated symptoms at one year, 85.9% at 2 and 86.8% at 3 years. Nonetheless, 3 years after the surgery 9.8% of the alive patients still presented at least one disabling symptom of which 2.7% motor deficit, 3.3% bladder control problem, and 2.5% gait disturbance. One point seven percent were care-provider dependent and 2.1% chair or bedfast. In the multivariable logistic regression an older age at surgery (odds ratio [OR], 0.37; 95% confidence interval [CI], 0.29–0.47, p < 0.001), a high level of comorbidities (OR, 0.71; 95% CI, 0.66–0.75, p < 0.001), and an aggressive tumor (OR, 0.49; 95% CI, 0.33–0.73; p < 0.001) were associated with a worse FO.Conclusion: FO after meningioma surgery is favourable but, may be impaired for older patients with a high level of comorbidities and aggressive tumor.
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Pina Vegas, Laura, Siham Iggui, Emilie Sbidian, and Pascal Claudepierre. "Impact of initiation of targeted therapy on the use of psoriatic arthritis-related treatments and healthcare consumption: a cohort study of 9793 patients from the French health insurance database (SNDS)." RMD Open 10, no. 3 (August 2024): e004631. http://dx.doi.org/10.1136/rmdopen-2024-004631.
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ObjectivesTo assess the potential impact of targeted therapies for psoriatic arthritis (PsA) on symptomatic treatments (non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, opioid analgesics), methotrexate and mood disorder treatments and on hospitalisation and sick leave.MethodsUsing the French health insurance database, this nationwide cohort study included adults with PsA who were new users (not in the year before the index date) of targeted therapies for ≥9 months during 2015–2021. Main endpoints were difference in proportion of users of associated treatments, hospitalisations and sick leaves between 3 and 9 months after and 6 months before targeted therapy initiation. Logistic regression models adjusted for sex, age, psoriasis, inflammatory bowel disease and Charlson Comorbidity Index compared the impact of biologics initiation (tumour necrosis factor inhibitor (TNFi)/interleukin 17 inhibitor (IL17i)/IL12/23i) on associated treatment discontinuation.ResultsAmong 9793 patients initiating targeted therapy for PsA (mean age: 51±13 years, 47% men), 62% initiated TNFi, 14% IL17i, 10% IL12/23i, 1% Janus kinase inhibitor, 12% phosphodiesterase-4 inhibitor. After treatment initiation, the proportion of treatment users was significantly reduced for NSAIDs (−15%), opioid analgesics (−9%), prednisone (−9%), methotrexate (−15%) and mood disorder treatments (−2%), along with decreased hospitalisations (−12%) and sick leaves (−4%). TNFi had a greater sparing effect on NSAIDs and prednisone use than IL17i (ORa=1.04, 95% CI=1.01 to 1.07; 1.04, 1.02 to 1.06) and IL12/23i (1.07, 1.04 to 1.10; 1.06, 1.04 to 1.09). Odds of methotrexate discontinuation was reduced with TNFi versus IL17i (0.96, 0.94 to 0.98) and IL12/23i (0.94, 0.92 to 0.97).ConclusionsTargeted therapy initiation for PsA reduced the use of associated treatment and healthcare, with TNFi having a slightly greater effect than IL17i and IL12/23i, except for methotrexate discontinuation.
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Pandolfi, Fanny, Didier Guillemot, Laurence Watier, and Christian Brun-Buisson. "Trends in bacterial sepsis incidence and mortality in France between 2015 and 2019 based on National Health Data System (Système National des données de Santé (SNDS)): a retrospective observational study." BMJ Open 12, no. 5 (May 2022): e058205. http://dx.doi.org/10.1136/bmjopen-2021-058205.
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ObjectiveThis study aims to provide a case definition of sepsis of presumed bacterial aetiology based on 10th revision of the International Classification of Diseases (ICD-10) codes, to assess trends in sepsis incidence and mortality between 2015 and 2019 in France, and to describe the characteristics of affected patients and hospital stays.DesignNationwide, population-based, retrospective observational study.SettingMetropolitan France between 2015 and 2019.ParticipantsBetween 2015 and 2019, 1 224 433 patients with sepsis of presumed bacterial aetiology were selected from the French National Hospital Discharge Database (Programme de Médicalisation des Systèmes d’Information) and were identified from corresponding ICD-10 codes for explicit sepsis or implicit sepsis.Main outcomes measuresAnnual overall and age-specific and gender-specific incidence and 95% CI, as well as trends in sepsis incidence and mortality, were estimated. Comorbidities, length of hospital stay and outcomes were described.ResultsThe sex-standardised and age-standardised incidence per 100 000 (95% CI) increased from 357 (356.0 to 359.0) in 2015 to 403 (401.9 to 405.0) in 2019 and remained higher for males compared with females. Children under 1 year and patients over 75 years consistently had the highest incidence. The most common comorbidities were cancer and chronic heart failure. The median hospital length of stay was 12 days. Most patients came from home, but only half returned home after their hospital stay and approximately 15% were discharged to long-term care. In-hospital mortality was about 25% and declined along the study period.ConclusionsMedico-administrative databases can be used to provide nationwide estimates of the in-hospital burden of bacterial sepsis. The results confirm the high burden of sepsis in France. These data should be complemented by estimating the additional burden associated with fungal and viral infections during the COVID-19 pandemic.
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Moltó, A., A. Ajrouche, D. Tran, B. Roux, N. Costedoat-Chalumeau, E. Elefant, V. Tsatsaris, et al. "POS1405 LESS THAN 50% FEMALES WITH CHRONIC RHEUMATIC INFLAMMATORY DISEASES CONTINUE A DMARD DURING PREGNANCY: A DESCRIPTIVE ANALYSIS OF THE NATIONAL FRENCH SOCIAL SECURITY DATABASE." Annals of the Rheumatic Diseases 81, Suppl 1 (May 23, 2022): 1043.1–1044. http://dx.doi.org/10.1136/annrheumdis-2022-eular.1334.
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BackgroundTreatment of patients with chronic rheumatic inflammatory diseases (CRID) during pregnancy has changed in the last decade, namely due to the availability of new DMARDs labelled to be used during pregnancy.ObjectivesTo describe the anti-rheumatic drug use during pregnancy in women with CRID (i.e. rheumatoid arthritis (RA) or spondyloarthritis (SpA)) in France over the past decade.MethodsThis is a retrospective cohort study within the French Healthcare database (SNDS), which covers 98% of the French population. Adult women were included if they had RA or SpA according to CIM-10 codes, had started a singleton pregnancy between 2008 and 2017 (index date), and were continuously covered by this health insurance from 1-year before pregnancy onset to 1-year after end of the pregnancy or death (whichever comes first). The treatment exposures of interest were: NSAIDs, oral corticosteroids, csDMARD (methotrexate, leflunomide, sulfasalazine, azathioprine, hydroxychloroquine), biologics (anti-TNF, rituximab, abatacept, tocilizumab, ustekinumab, anakinra). Exposure during pregnancy was defined as at least one drug reimbursement from the 6 months before the last menstrual period (LMP) to the end of pregnancy period.ResultsAmong the 35,737 adult women with a CIRD (40.7% with RA and 59.3% with SpA) who had a past history of DMARD reimbursement, 11,274 (41.7%) started a singleton pregnancy during the study period. In total, during preconception and pregnancy, 4,773 (42.3%) women were not delivered any DMARD nor corticosteroids, 769 (6.8%) were delivered corticosteroids alone, 3,639 (32.2%) a csDMARD alone and 2,862 (25.4%) a biologic (among whom 33.1% associated a csDMARD). Biologics delivered during pregnancy were mainly anti-TNFs (92.1%).Exposure to NSAIDs was more frequent during the first trimester (30% patients) of pregnancy but occurred all along the pregnancy (6% and 2% in the second and third trimesters, respectively). Conversely, exposure to oral corticosteroids was stable during the pregnancy (33% to 27%); however, more than half of the prescriptions corresponded to doses higher than 10mg. Exposure to DMARDs including bDMARDs during pregnancy was more frequent during the first trimester, compared to the rest of the pregnancy (see graph).ConclusionOverall, less than 50% of women with a CRID who received a DMARD prior to the pregnancy continued to retrieve such treatment during pregnancy, and overall less than 20% were delivered biologics during pregnancy. Whether the withdrawal of DMARDs led to unfavorable maternal and pregnancy outcomes needs to be evaluated.AcknowledgementsThis study was conducted thanks to a grant from the French Ministry of Health - Programme Hospitalier de Recherche CliniqueDisclosure of InterestsAnna Moltó Consultant of: UCB, Abbvie, Lilly, Pfizer, BMS, MSD, Novartis, Biogen, Janssen, Grant/research support from: UCB, Aya Ajrouche: None declared, Diep Tran: None declared, Barbara Roux: None declared, Nathalie Costedoat-Chalumeau Grant/research support from: UCB, Elisabeth Elefant: None declared, Vassilis Tsatsaris: None declared, Jeanne Fresson: None declared, Brigitte Bader-Meunier: None declared, Bruno Fautrel: None declared, Florence Tubach: None declared
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Foulon, Stephanie, Pascale Cony-Makhoul, Agnes Guerci-Bresler, Marc Delord, Eric Solary, Alain Monnereau, Julia Bonastre, and Pascale Tubert Bitter. "Using Healthcare Claims Data to Analyze the Prevalence of Chronic Myeloid Leukemia in France: A Nationwide Population-Based Study." Blood 132, Supplement 1 (November 29, 2018): 3015. http://dx.doi.org/10.1182/blood-2018-99-111489.
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Abstract Background: In France, as in many other countries, nationwide data on prevalence are rarely available and recent prevalence estimates of Chronic Myeloid Leukemia (CML) are scarce. Improved overall survival following the introduction of tyrosine kinase inhibitors (TKIs) is expected to have increased the prevalence of CML in Western countries. Aim: We sought to estimate and analyze the prevalence of CML in France for the year 2014 using a large health care claim-based dataset. Methods: Using the French national health insurance database that covers 98.8% of the French population (66 million people) we implemented a 3-step approach. First, focusing on the 2006-2014 period, we selected: 1) all patients treated with a TKI (ie, imatinib, dasatinib, nilotinib, bosutinib or ponatinib) and/or 2) identified by the ICD-10 diagnosis code C92.1 (Chronic Myeloid Leukemia, BCR/ABL-positive) among hospital discharge diagnoses and/or 3) identified by the ICD-10 diagnosis code C92 (myeloid leukemia) for coinsurance exemption. Then, we developed a claim-based algorithm to identify CML cases. Case definition was based on 1) identifying any TKI reimbursement lasting ≥ 2 months and 2) excluding patients receiving TKIs for diseases other than CML including Phi+ Acute Lymphoblastic Leukemia, Gastrointestinal Stromal Tumor, Stromal or other connective tissue tumor, and hypereosinophilic disease. Finally, prevalent CML cases were those identified by the algorithm above and having ≥ 1 healthcare reimbursement during the year 2014 and still alive on December, 31st 2014. The internal validity of the algorithm was tested on a random sample of 100 potential CML cases fulfilling ≥ 1/3 selection criteria in step 1 by comparing the results of the algorithm with the opinion of two hematologists (gold standard). For each individual, hematologists reviewed patient demographics and the sequence of care from 2006 to 2014 including healthcare resource utilization (ie, all hospitalizations and ICD-10 diagnosis codes, all medication use, all specialist consultations with date and specialist type). In addition, we assessed the external validity of the algorithm by comparing the number of incident CML patients in 2014 as identified in the French national health insurance database with the number of incident CML cases recorded in the French cancer registries for respective departments (i.e. ~ 20% of the French territory). Results: There were 10,789 prevalent CML cases in 2014 out of 68,067 individuals from the French national health insurance database who fulfilled the selection criteria for the overall 2006-2014 period. Eighty-nine percent of the prevalent CML cases were identified by at least two out of three selection criteria (TKI, ICD-10 code C92.1 among hospital discharge diagnoses, ICD-10 code C92 for coinsurance exemption). There was a 96% concordance rate (internal validity) between the algorithm and the opinion of the hematologists. For the year 2014, 162 and 150 incident CML patients were identified by the algorithm and the French cancer registries, respectively (high external validity). Median age [Inter-Quartile Range] of the prevalent population of CML patients was 63 years [51-73], with slightly more males affected (55%). On December, 31st 2014, the crude prevalence of CML was estimated at 16.3 per 100,000 inhabitants [95% confidence interval (CI) 16.0-16.6]. The crude prevalence of CML was 18.5 per 100,000 in men (95% CI 18.0-19.0) and 14.2 per 100,000 in women (95% CI 13.8-14.6). The crude prevalence of CML was less than 1.6 per 100,000 (95% CI 1.2-2.0) before 20 years of age, progressively increasing to 19.4 per 100,000 (95% CI 18.1-20.7) among those with 50-54 and reaching a peak of 48.2 per 100,000 (95% CI 45.3-51.1) at 75-79 years. There was a male preponderance in CML prevalence in all age groups. The crude prevalence of CML varied in a ratio of one to two throughout the French territory (from 10.2 to 23.8 per 100,000 inhabitants). Conclusion: Healthcare claims data are increasingly used to estimate epidemiological parameters worldwide. This approach is particularly relevant for rare diseases and administrative databases with high population coverage. Countries without national cohorts or cancer registries could easily use our algorithm to estimate their prevalence of CML. Disclosures Cony-Makhoul: Pfizer: Consultancy; BMS: Consultancy, Speakers Bureau; Incyte: Other: Travels for attending to Congress; Novartis: Consultancy, Other: Writing support, Travels for attending to Congress. Guerci-Bresler:Pfizer: Other: Fees for symposiums and boards; Novartis: Consultancy, Other: Fees for symposiums and boards; Incyte: Other: Fees for symposiums and boards; BMS: Other: Fees for symposiums and boards; Pfizer: Other: Travel fees for Congress. Delord:Incyte: Consultancy.
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Jubinville, Maripier, Eric Nguemeleu Tchouaket, and Caroline Longpré. "Scoping review protocol examining charge nurse skills: requirement for the development of training." BMJ Open 13, no. 2 (February 2023): e067307. http://dx.doi.org/10.1136/bmjopen-2022-067307.
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IntroductionThe charge nurse (CN) holds a position in clinical-administrative management and is essential for improving the quality and safety of care in healthcare institutions. The position requires five essential skills: leadership; interpersonal communication; clinical-administrative caring; problem solving; and knowledge and understanding of the work environment. The scientific literature has not widely examined the importance of providing these skills as part of initial training, nor when CNs begin their duties. This study aims to fill this gap through an exhaustive review of the literature with the aim of developing standardised training for the CN when they start in their position.Methods and analysisA scoping review using the Joanna Briggs Institute framework will be conducted. The CINAHL, MEDLINE, Science Direct and Cairn, databases as well as grey literature from ProQuest dissertations and thesis global database, Google Scholar and the website of the Order of Nurses of Quebec will be queried using keywords. Relevant literature in French and English, published between 2000 and 2022 will be retained. The CN is the target population. Outcomes address at least one of the five CN skills, describe how they are operationalised and what their impact is on the organisation of work and quality of care. This analysis will identify essential and relevant elements for the development of standardised, up-to-date and appropriate training for the position of CN.Ethics and disseminationEthical approval is not required, as data does not include individual patient data. The results will be published in peer-reviewed journals, presented at conferences and presented to nursing managers and directors.Scoping review registrationResearch Registry ID: researchregistry7030.
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Logeart, Damien, Maxime Doublet, Margaux Gouysse, Thibaud Damy, Richard Isnard, and François Roubille. "Development and validation of algorithms to predict left ventricular ejection fraction class from healthcare claims data." ESC Heart Failure, March 4, 2024. http://dx.doi.org/10.1002/ehf2.14725.
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AbstractAimsThe use of large medical or healthcare claims databases is very useful for population‐based studies on the burden of heart failure (HF). Clinical characteristics and management of HF patients differ according to categories of left ventricular ejection fraction (LVEF), but this information is often missing in such databases. We aimed to develop and validate algorithms to identify LVEF in healthcare databases where the information is lacking.Methods and resultsAlgorithms were built by machine learning with a random forest approach. Algorithms were trained and reinforced using the French national claims database [Système National des Données de Santé (SNDS)] and a French HF registry. Variables were age, gender, and comorbidities, which could be identified by medico‐administrative code‐based proxies, Anatomical Therapeutic Chemical codes for drug delivery, International Classification of Diseases (Tenth Revision) coding for hospitalizations, and administrative codes for any other type of reimbursed care. The algorithms were validated by cross‐validation and against a subset of the SNDS that includes LVEF information. The areas under the receiver operating characteristic curve were 0.84 for the algorithm identifying LVEF ≤ 40% and 0.79 for the algorithms identifying LVEF < 50% and ≥50%. For LVEF ≤ 40%, the reinforced algorithm identified 50% of patients in the validation dataset with a positive predictive value of 0.88 and a specificity of 0.96. The most important predictive variables were delivery of HF medication, sex, age, hospitalization, and testing for natriuretic peptides with different orders of positive or negative importance according to the LVEF category.ConclusionsThe algorithms identify reduced or preserved LVEF in HF patients within a nationwide healthcare claims database with high positive predictive value and low rates of false positives.
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Cottin, Vincent, Sophie Larrieu, Loic Boussel, Salim Si-Mohamed, Fabienne Bazin, Sébastien Marque, Jacques Massol, et al. "Epidemiology, Mortality and Healthcare Resource Utilization Associated With Systemic Sclerosis-Associated Interstitial Lung Disease in France." Frontiers in Medicine 8 (August 30, 2021). http://dx.doi.org/10.3389/fmed.2021.699532.
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Objectives: To investigate the clinical characteristics, epidemiology, survival estimates and healthcare resource utilization and associated costs in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) in France.Methods: The French national administrative healthcare database, the Système National des Données de Santé (SNDS), includes data on 98.8% of the French population, including data relating to ambulatory care, hospitalizations and death. In our study, claims data from the SNDS were used to identify adult patients with SSc-ILD between 2010 and 2017. We collected data on clinical features, incidence, prevalence, survival estimates, healthcare resource use and costs.Results: In total, 3,333 patients with SSc-ILD were identified, 76% of whom were female. Patients had a mean age [standard deviation (SD)] of 60.6 (14.4) years and a mean (SD) individual study duration of 3.9 (2.7) years. In 2016, the estimated overall incidence and prevalence were 0.69/100,000 individuals and 5.70/100,000 individuals, respectively. The overall survival estimates of patients using Kaplan–Meier estimation were 93, 82, and 55% at 1, 3, and 8 years, respectively. During the study, 98.7% of patients had ≥1 hospitalization and 22.3% of patients were hospitalized in an intensive care unit. The total annual mean healthcare cost per patient with SSc-ILD was €25,753, of which €21,539 was related to hospitalizations.Conclusions: This large, real-world longitudinal study provides important insights into the epidemiology of SSc-ILD in France and shows that the disease is associated with high mortality, healthcare resource utilization and costs. SSc-ILD represents a high burden on both patients and healthcare services.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT03858842.
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Haneef, Romana, Sofiane Kab, Rok Hrzic, Sonsoles Fuentes, Sandrine Fosse-Edorh, Emmanuel Cosson, and Anne Gallay. "Use of artificial intelligence for public health surveillance: a case study to develop a machine Learning-algorithm to estimate the incidence of diabetes mellitus in France." Archives of Public Health 79, no. 1 (September 22, 2021). http://dx.doi.org/10.1186/s13690-021-00687-0.
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Abstract Background The use of machine learning techniques is increasing in healthcare which allows to estimate and predict health outcomes from large administrative data sets more efficiently. The main objective of this study was to develop a generic machine learning (ML) algorithm to estimate the incidence of diabetes based on the number of reimbursements over the last 2 years. Methods We selected a final data set from a population-based epidemiological cohort (i.e., CONSTANCES) linked with French National Health Database (i.e., SNDS). To develop this algorithm, we adopted a supervised ML approach. Following steps were performed: i. selection of final data set, ii. target definition, iii. Coding variables for a given window of time, iv. split final data into training and test data sets, v. variables selection, vi. training model, vii. Validation of model with test data set and viii. Selection of the model. We used the area under the receiver operating characteristic curve (AUC) to select the best algorithm. Results The final data set used to develop the algorithm included 44,659 participants from CONSTANCES. Out of 3468 variables from SNDS linked to CONSTANCES cohort were coded, 23 variables were selected to train different algorithms. The final algorithm to estimate the incidence of diabetes was a Linear Discriminant Analysis model based on number of reimbursements of selected variables related to biological tests, drugs, medical acts and hospitalization without a procedure over the last 2 years. This algorithm has a sensitivity of 62%, a specificity of 67% and an accuracy of 67% [95% CI: 0.66–0.68]. Conclusions Supervised ML is an innovative tool for the development of new methods to exploit large health administrative databases. In context of InfAct project, we have developed and applied the first time a generic ML-algorithm to estimate the incidence of diabetes for public health surveillance. The ML-algorithm we have developed, has a moderate performance. The next step is to apply this algorithm on SNDS to estimate the incidence of type 2 diabetes cases. More research is needed to apply various MLTs to estimate the incidence of various health conditions.