National Health Information System Research Articles

Survival and Prognostic Factors after Adrenalectomy for Secondary Malignancy: A Combined Analysis of a French University Center Registry (Eurocrine ®) of 307 Patients and a French Nationwide Study of 2,515 Patients.

To provide a nationwide description of postoperative outcomes and analysis of prognostic factors following adrenalectomy for metastases. Adrenal glands are a common site of metastases in many malignancies. Diagnosisof adrenal metastases is on the rise, leading to an increasing number of patient candidates for surgery without consensual management. We conducted a population-based study between January 2012 and December 2022 using the French national health data system (SNDS) and the Eurocrine® registry (NCT03410394). The first database exhaustively covers all procedures carried out in France, while the second provides more clinical information on procedures and tumor characteristics, based on the experience of 11 specialized centers. From the SNDS, we extracted 2,515 patients who underwent adrenalectomy for secondary malignancy and 307 from the Eurocrine® database. The most common primary malignancies were lung cancer (n=1,203, 47.8%) and renal cancer (n=555, 22.1%). One-year survival was 84.3% (n=2,120). Thirty-day mortality and morbidity rates were, respectively, 1.3% (n=32) and 29.9% (n=753, including planned ICU stays). Radiotherapy within the year before adrenalectomy was significantly associated with higher 30-day major complication rates (P=0.039). In the Eurocrine® database, the proportion of laparoscopic procedures reached 85.3% without impairing resection completeness (R0: 92.9%). Factors associated with poor overall survival were presence of extra-adrenal metastases (HR=0.64; P=0.031) and incomplete resection (≥R1; HR=0.41; P=0.015). The number of patients who can receive local treatment for adrenal metastases is rising, and adrenalectomy is more often minimally invasive and has a low morbidity rate. Subsequent research should evaluate which patients would benefit from adrenal surgery.

Assessing the integration of refugee health data into national health information systems in Jordan, Lebanon, and Uganda

BackgroundWith the increasing number of protracted refugee crises globally, it is essential to ensure strong national health information systems (HIS) in displacement settings that include refugee-sensitive data and disaggregation by refugee status. This multi-country study aims to assess the degree of integration of refugee health data into national HIS in Jordan, Lebanon, and Uganda and identify the strengths and weaknesses of their national HIS in terms of collecting and reporting on refugee-related health indicators.MethodsThe study employs a comparative country analysis approach using a three-phase framework. The first phase involved reviewing 4120 indicators compiled from global health organizations, followed by a multi-stage refinement process, resulting in 45 indicators distributed across five themes. The second phase consisted of selecting relevant criteria from the literature, including data sources, annual reporting, disaggregation by refugee status, refugee population adjustments, accuracy, and consistency. The third phase involved assessing data availability and quality of the selected indicators against these criteria.ResultsOur analysis uncovered significant challenges in assessing the health status of refugees in Jordan, Lebanon, and Uganda, primarily stemming from limitations in the available health data and indicators. Specifically, we identified significant issues including incomplete local data collection with reliance on international data sources, fragmented data collection from various entities leading to discrepancies, and a lack of distinction between refugees and host populations in most indicators. These limitations hinder accurate comparisons and analyses. In light of these findings, a set of actionable recommendations was proposed to guide policymakers in the three countries to improve the integration of refugee health data into their national HIS ultimately enhancing refugees’ well-being and access to healthcare services.ConclusionThe current status of refugee-related health data in Jordan, Lebanon, and Uganda indicates the need for improved data collection and reporting practices, disaggregation by refugee status and better integration of refugee health data into national HIS to capture the health status and needs of refugees in host countries. Key improvement strategies include establishing a centralized authority for consistent and efficient data management, fostering transparent and inclusive data governance, and strengthening workforce capacity to manage refugee health data effectively.

Congenital and acquired hypothyroidism: Temporal and spatial trends in France from 2014 to 2019

PurposeTo assess the incidence of congenital hypothyroidism (CH) and acquired hypothyroidism (AH) between 2014 and 2019 in continental France. MethodsNew cases of CH and AH were identified using the French National Health Data System (Système Nationale des Données de Santé, SNDS). Temporal trends were studied using linear regression models. Spatial distributions were studied using Moran's global index (I) and the statistical method and local indicators of spatial association. ResultsThe incidence of permanent CH in females increased by 8.9 % per year (2014: 36.9 [31.1–43.7] per 100,000 birth-years vs. 2019: 51 [43.9–59.3] per 100,000 birth-years, p < 0.01). The incidence of AH decreased between 2014 and 2019 for both females (2014: 535.7 [533.2–538.2] per 100,000 person-years vs 2019: 335.5 [333.6–337.4] per 100,000 person-years, p < 0.01) and males (2014: 197.5 [195.9–199] per 100,000 person-years vs 2019: 141.7 [140.4–142.9] per 100,000 person-years, p < 0.01). The incidence of hypothyroidism was high in the Nord-Pas-De-Calais and Lorraine regions (CH and AH). ConclusionsThe incidence of permanent CH in females has increased over time. AH incidence decreased. It seems necessary to investigate environmental factors in the disparity of incidence distribution.

Clinical burden and healthcare resource utilization associated with managing transfusion-dependent β-thalassemia in France

Objective To describe the clinical burden and healthcare resource utilization associated with managing transfusion-dependent β-thalassemia (TDT) in France. Methods We used the French National Health Data System (système national des données de santé) to identify eligible patients from January 1, 2012, to March 1, 2019. Inclusion criteria were a diagnosis of β-thalassemia, ≥8 red blood cell (RBC) transfusion episodes per year in ≥2 consecutive years following the diagnosis, and ≥1 year of follow-up data. Patients were excluded if medical records showed evidence of sickle cell disease, α-thalassemia, hereditary persistence of fetal hemoglobin, or hematopoietic stem cell transplant. Clinical complications, mortality, treatment use, and healthcare resource utilization were evaluated. Results Overall, 331 eligible patients with TDT were identified. Mean age was 26.1 (standard deviation [SD]: 18.0) years, and 50.5% were male. Common clinical complications were endocrine (26.0%), hepatobiliary (22.7%), and cardiopulmonary (18.7%). Fifteen (4.5%) patients died during follow-up, with a mortality rate of 1.16 deaths per 100 person-years (mean age of death: 52.5 years [SD: 22]). Patients had a mean of 13.5 (SD: 5.2) RBC transfusion episodes and 11.2 (SD: 5.3) iron chelation therapy treatments per year. Healthcare resource utilization was substantial, with a mean of 14.8 inpatient hospitalizations (including 13.8 mean inpatient day cases) and 16.9 outpatient prescriptions per patient per year. Conclusions Patients with TDT in France experience significant clinical complications, elevated mortality, and substantial healthcare resource utilization driven by frequent RBC transfusion episodes and inpatient hospitalizations. These results reinforce the need for disease-modifying therapies for this patient population.

A reference architecture for personal health data spaces using decentralized content-addressable storage networks.

This paper addresses the dilemmas of accessibility, comprehensiveness, and ownership related to health data. To resolve these dilemmas, we propose and justify a novel, globally scalable reference architecture for a Personal Health Data Space (PHDS). This architecture leverages decentralized content-addressable storage (DCAS) networks, ensuring that the data subject retains complete control and ownership of their personal health data. In today's globalized world, where people are increasingly mobile for work and leisure, healthcare is transitioning from episodic symptom-based treatment toward continuity of care. The main aims of this are patient engagement, illness prevention, and active and healthy longevity. This shift, along with the secondary use of health data for societal benefit, has intensified the challenges associated with health data accessibility, comprehensiveness, and ownership. The study is structured around four health data use case scenarios from the Estonian National Health Information System (EHIS): primary medical use, medical emergency use, secondary use, and personal use. We analyze these use cases from the perspectives of accessibility, comprehensiveness, and ownership. Additionally, we examine the security, privacy, and interoperability aspects of health data. The proposed architectural solution allows individuals to consolidate all their health data into a unified Personal Health Record (PHR). This data can come from various healthcare institutions, mobile applications, medical devices for home use, and personal health notes. The comprehensive PHR can then be shared with healthcare providers in a semantically interoperable manner, regardless of their location or the information systems they use. Furthermore, individuals maintain the autonomy to share, sell, or donate their anonymous or pseudonymous health data for secondary use with different systems worldwide. The proposed reference architecture aligns with the principles of the European Health Data Space (EHDS) initiative, enhancing health data management by providing a secure, cost-effective, and sustainable solution.

O-092 Prevalence of multiple gestation births and perinatal outcomes in pregnancies secondary to clomiphene citrate treatment: a nationwide cohort study

Abstract Study question Is the incidence of multiple gestation births higher in pregnancies obtained after clomiphene citrate (CC) treatment compared to spontaneous pregnancies? Summary answer The rate of multiple gestation births in pregnancies obtained after CC treatment is significantly increased compared to spontaneous pregnancies. What is known already CC is a selective estrogen modulator frequently used to induce ovulation in infertile women. Data regarding the prevalence of multiple gestation births and adverse perinatal outcomes after CC are contradicting and based on meta-analysis of small sample size studies. Multiple gestations are frequently associated with complications such as preeclampsia, premature labor, and growth restriction, which contribute to higher mortality and morbidity rates. Study design, size, duration Using the French National Health Data System (SNDS) spanning 2013 to 2019, we conducted a nationwide cohort study including all pregnancies lasting more than 22 weeks of gestation, in women aged between 18-43 years. Participants/materials, setting, methods For each women, the first pregnancy during study was included. Women with the dispensing of IVF/ICSI treatment and/or gonadotrophins were excluded. Pregnancies exposed to CC (during the period [-60days,-11days] before the beginning of the pregnancy) were 1:10 matched to unexposed pregnancies. Pregnancies exposed to CC between 12 to 2months or less than 11 days before the beginning of the pregnancy were excluded to mitigate misclassification bias. The primary outcome was the multiple gestation birth rate. Main results and the role of chance Of 3,173,013 pregnancies, 32,010 (10 ‰) occurred in women exposed to clomiphene. The multiple pregnancy rate was significantly higher in pregnant women exposed with CC compared to matched controls (odd ratio 4.1, 95% CI [3.9-4.3]) such as twin pregnancies (OR 4.1, 95% CI [3.9-4.3]) and triple or more pregnancies (OR 5.1, 95% CI [3.8-7.2]). Women exposed to CC presented significantly more adverse obstetrical and perinatal outcomes, including stillbirths, premature delivery threats, premature rupture of membranes, gestational diabetes, placenta previa, gravid hypertension, pre-eclampsia, preterm birth, small for gestational age (SGA), C-section rate, and major birth defect rate. After stratification on multiple pregnancy and adjustment on confounders (history of psychiatric disease, diabetes, arterial hypertension, obesity and embryo reduction during pregnancy), women exposed to CC had a significantly higher risk of stillbirth, gestational diabetes, placenta previa, pre-eclampsia, preterm delivery and SGA in case of singleton pregnancies. Additionally, in the case of multiple pregnancies, they had a higher risk of placenta previa, preterm delivery, and SGA compared to non-exposed women. Limitations, reasons for caution The use of filled prescriptions as a measure of drug exposure could be subject to bias such as misclassification bias, although we attempt to mitigate it. Wider implications of the findings Clomiphene use is strongly associated with multiple gestation births and with adverse obstetrical and perinatal outcomes even in singleton pregnancies. These findings should provide awareness of practitioners and patients about its use. It underscore the importance of attentively monitoring follicular growth during the treatment process to avoid multiple pregnancies. Trial registration number NA

P-729 Contribution of medical-administrative databases to health monitoring: example of ovarian hyperstimulation syndrome (OHSS)

Abstract Study question Can we monitor post-oocyte retrieval ovarian hyperstimulation syndrome (OHSS) in the French national health data system to complement the French ART vigilance system? Summary answer Medico-administrative databases offer a more comprehensive view of post-oocyte retrieval complications and can be used to detect abnormal increases in frequency and outlier ART centers. What is known already Assisted reproductive technology (ART), widely used in Europe, accounts for about 3% of births in France. The various studies of ART complications are reassuring, showing relatively low overall complication rates. Nonetheless, the European Union has established a vigilance system to monitor these complications. However, this system is not an exhaustive source of information and does not provide a complete overview of post-ART complications. Study design, size, duration The study population was identified from the comprehensive French National Hospital discharge database and included 53,490 women under 46 years old who underwent 65,924 oocyte retrievals in 2022. Women were classified into three population subgroups according to the indication of oocyte retrieval: infertility (IF), fertility preservation (FP), and oocyte donation (OD). Participants/materials, setting, methods Hospital stays for OHSS within two months post-retrieval were analyzed and characterized according to various characteristics (age, comorbidities, indication of oocyte retrieval, type of hospital stay, length of hospital stay...). Multivariate analysis was performed to determine the relation between the occurrence of OHSS and women’s characteristics, and results are expressed as odds ratios (ORs) and 95% CI. A funnel plot was used to compare the OHSS rate per center with the national average. Main results and the role of chance Hospitalized OHSS accounted for 1.1% of retrievals in 2022 (n = 718). The mean age of the women was 31.6 years (SD 4.5). Women with Polycystic Ovary Syndrome (PCOS) accounted for about 4% of the women with OHSS. More than half of OHSS hospital stays lasted less than two days (54%). Of these stays, 2% of women were in intensive care. Multivariate analysis showed a significantly higher OHSS risk in women under 30 and those with PCOS. Other risk factors are currently introduced into the model, such as a history of OHSS or pregnancy. Funnel plot analysis showed that one ART center has an OHSS rate significantly higher than the national average. In the centers that stand out from all the others, the objective is to return to these centers to understand the possible reasons for this observed rate and to implement corrective measures. Limitations, reasons for caution Despite all its advantages, the French national health data system presents some limitations, such as the risk of inappropriate coding. Moreover, the unavailability of personal or clinical information prevented us from considering certain risk factors. Wider implications of the findings Despite the limits of using medico-administrative databases, this approach provides a better representation of post-ART complications and is a promising way to complement the ART vigilance reporting system. This concept will also be generalized to other complications with regular feedback to professionals. Trial registration number not applicable

Long-Term Safety of Teriflunomide in Multiple Sclerosis Patients: Results of Prospective Comparative Studies in Three European Countries.

Teriflunomide is a disease-modifying therapy (DMT) for multiple sclerosis (MS). This post authorisation safety study assessed risks of adverse events of special interest (AESI) associated with teriflunomide use. Secondary use of individual data from the Danish MS Registry (DMSR), the French National Health Data System (SNDS), the Belgian national database of health care claims (AIM-IMA) and the Belgian Treatments in MS Registry (Beltrims). We included patients treated with a DMT at the date of teriflunomide reimbursement or initiating another DMT. Adjusted hazard rates (aHR) and 95% confidence intervals were derived from Cox models with time-dependent exposure comparing teriflunomide treatment with another DMT. Of 81 620 patients (72% women) included in the cohort, 22 324 (27%) were treated with teriflunomide. After a median follow-up of 4 years, teriflunomide use compared to other DMT was not associated with a risk of all-cause mortality, severe infection, pneumoniae, herpes zoster reactivation, pancreatitis, cardiovascular condition and cancers. For opportunistic infections, aHR for teriflunomide versus other DMT was 2.4 (1.2-4.8) in SNDS, which was not bound to a particular opportunistic agent. The aHR was 2.0 (1.1-3.7) for renal failures in the SNDS, but no association was found in other data sources. A total of 187 SNDS patients had a history of renal failure prior to cohort entry. None of these patients (0%) had a renal failure recurrence when treated with teriflunomide for 19 (13%) recurrences reported for patients on another DMT. We found no evidence that teriflunomide use would be associated with an increased risk of AESI. Trial Registration EUPAS register: EU PAS 19610.

Mind the data gaps: Comparing the quality of data sources for maternal health services in Cameroon

BackgroundNumerous sources of routine data exist but there is limited information on how they relate or complement each other to improve data availability and the quality of data collected. This paper compares data coverage and completeness on selected maternal health service indicators between (1) a performance-based financing(PBF) database, (2) the national health information system, and (3) health facility registers in selected districts in Cameroon. MethodData on antenatal care, skilled birth delivery and family planning were collected from 2010 to 2020 in three purposively selected districts (Buea, Limbe and Tiko) in the southwest region of Cameroon. The coverage and completeness of data from the performance-based financing database, the district health information system (dhis2, a national system) and health facility registers were compared. Data sources for the performance-based financing database and the district health information system are based on data generated from health facilities. ResultsAmong the 90 health facilities in the three districts, 13 (14.5 %) facilities could not be accessed due to ongoing political conflict. Therefore, data were collected from 77 health facilities. Of the 77 facilities, half were public, a third private, and the remainder para-public (13 %) or confessional (5 %). Approximately seven registers at each health facility included data on maternal and child health. Problems of these data included incomplete coverage, misplacement of records, and incomplete data in the records identified. There was inconsistency across all sources. dhis2 collected antenatal care only for the first and fourth visits and PBF collected data for any antenatal care visits without specifying the visit number and health facility collected data for all antenatal care visits. ConclusionThe introduction of dhis2 and PBF programs has strengthened the availability of data in electronic format. Generally, we noted important gaps and heterogeneity in data reporting as well as incomplete data across health sectors and districts. There is need to transform the way data are collected at health facilities and there is also need for capacity building and better data governance to improve data quality and use. This will ensure that reliable, consistent, accurate, and actionable data are available to inform policy towards achieving Universal Health Coverage.

Current status of digital health interventions in the health system in Burkina Faso

BackgroundDigital health is being used as an accelerator to improve the traditional healthcare system, aiding countries in achieving their sustainable development goals. Burkina Faso aims to harmonize its digital health interventions to guide its digital health strategy for the coming years. The current assessment represents upstream work to steer the development of this strategic plan.MethodsThis was a quantitative, descriptive study conducted between September 2022 and April 2023. It involved a two-part survey: a self-administered questionnaire distributed to healthcare information managers in facilities, and direct interviews conducted with software developers. This was complemented by a documentary review of the country’s strategic and standards documents on digital transformation.ResultsBurkina Faso possesses a relatively comprehensive collection of governance documents pertaining to digital transformation. The study identified a total of 35 digital health interventions. Analysis showed that 89% of funding originated from technical and financial partners as well as the private sector. While the use of open-source technologies for the development of the applications, software, or platforms used to implement these digital health interventions is well established (77%), there remains a deficiency in the integration of data from different platforms. Furthermore, the classification of digital health interventions revealed an uneven distribution between the different elements across domains: the health system, the classification of digital health interventions (DHI), and the subsystems of the National Health Information System (NHIS). Most digital health intervention projects are still in the pilot phase (66%), with isolated electronic patient record initiatives remaining incomplete. Within the public sector, these records typically take the form of electronic registers or isolated specialty records in a hospital. Within the private sector, tool implementation varies based on expressed needs. Challenges persist in adhering to interoperability norms and standards during tool design, with minimal utilization of the data generated by the implemented tools.ConclusionThis study provides an insightful overview of the digital health environment in Burkina Faso and highlights significant challenges regarding intervention strategies. The findings serve as a foundational resource for developing the digital health strategic plan. By addressing the identified shortcomings, this plan will provide a framework for guiding future digital health initiatives effectively.

Linking an early access program (EAP) to the National Health Data System (NHDS) in France and assessing its performances and potential biases.

11137 Background: Early access programs (EAP) are a unique opportunity to document first use of innovative treatments in real-world settings. The French HTA body requires mandatory patients’ clinical data collection for EAP and since July 2021, has recommended anticipating linkage EAP to the National Health Data System (NHDS). Prior to drug initiation, the collected data is almost complete contrary to follow-up data. To the best of our knowledge, no other study has proposed a methodology to link EAP to the French Cancer cohort (FCC), an extract of the NHDS of over 8 million persons diagnosed or at high risk of cancer, and to assess its assets and downsides. Methods: This cohort study has reused data of informed French EAP patients treated with durvalumab from October 1st, 2017 to December 31st, 2018 (n=457) in locally advanced unresectable NSCLC and of patients who received durvalumab at the time of the EAP in the FCC (n=666). The linkage methodology consists in harmonizing available data across sources, defining matching, control and study variables, testing several indirect deterministic linkage algorithms and assessing their performances. Consistency and differences between data sources were described for the best performing algorithm. Results: Proposed linkage algorithms required matches on a combination of data among sex, birth year and month, treating hospital ID and department. Performance started at 80.9% (370/457) patients from the EAP cohort linked to eligible patients from FCC up to 85.3% (390/457) for the best performing algorithm. The consistency of linkage variables between the two sources was substantial (Cohen’s kappa &gt; 0.8) or excellent (intraclass correlation &gt; 0.9). It was the same for control variables. Comparisons between linked patients and unlinked patients from the EAP cohort showed no statistically significant difference on matching and control variables, except for few cases on history of chemotherapy and history of radiation therapy prior to durvalumab. Similarly, no statistically significant difference was found on matching and control variables between linked patients and unlinked patients from FCC, except for history of radiation therapy and treating hospital department. Median of time difference between foreseen date of first durvalumab administration in EAP versus the effective date in FCC was -1 (IQR = [-9 ; 0]) day. Lack of reported diagnosis related to prior radiation therapy administration in out-of-hospital settings refrained from using them as matching or control variables. Conclusions: The study illustrates the feasibility of matching EAP patients to the French NDHS with indirect deterministic linkage. Additional EAP linkages will be required to ensure the validation and reproducibility of such methodology. Further works in progress will document the adequacy of French NHDS data to address effectiveness.

Évaluation médicoéconomique du PRADO-BPCO, programme d’accompagnement post-exacerbation

The "Programme d'Accompagnement du retour à Domicile" (PRADO) COPD is a home discharge support program dedicated to organizing care pathways following hospitalization for COPD exacerbation. This study aimed at assessing its medico-economic impact. This was a retrospective database study of patients included in the PRADO BPCO between 2017 and 2019. Data were extracted from the National Health Data System. A control group was built using propensity score matching. Morbi-mortality and costs (national health insurance perspective) were measured during the year following hospitalization. While the proportion of patients with a care pathway complying with recommendations from the National Health Authority was higher in the PRADO group, there was no significant effect on mortality and 12-month rehospitalization. In the PRADO group, the rehospitalization rate was lower when the care pathway was optimal. Healthcare costs per patient were 670 € higher in the PRADO group. The PRADO COPD improves quality of care but without decreasing rehospitalizations and mortality, although rehospitalizations did decrease among PRADO group patients benefiting from an optimal care pathway.

Risk of Gastrointestinal Perforation in Patients With Rheumatic Diseases Exposed to Janus Kinase Inhibitors Versus Adalimumab: A Nationwide Cohort Study.

To compare the risk of gastrointestinal perforation (GIP), a rare but serious adverse event, in patients who a JAK inhibitor (JAKi; tofacitinib, baricitinib, upadacitinib, or filgotinib) versus adalimumab (tumor necrosis factor inhibitor) among a comprehensive real-world population of patients with rheumatic diseases. We conducted a nationwide population-based cohort study of the French national health data system, the exposed group that received a JAKi and the comparison group adalimumab. We included all individuals with a rheumatic disease who had their first dispensation of these treatments from July 2017 to December 2021. The primary endpoint was the occurrence of GIP (end of follow-up May 2022). Weighted hazard ratios (wHRs) were estimated with the inverse probability of treatment weighting method to account for confounding factors. Concomitant administration of systemic glucocorticoids, nonsteroidal anti-inflammatory drugs, and proton-pump inhibitors were time-varying variables. The cohort included 39,758 patients: 12,335 and 27,423 in the groups that received a JAKi and adalimumab (mean age 58.2 and 47.3 years; female 76% and 58%; rheumatoid arthritis 85.3% and 27.3%, and psoriatic arthritis/axial spondyloarthritis 14.7% and 72.7%), respectively. During follow-up, 38 and 42 GIPs occurred in the groups that received a JAKi and adalimumab groups; incidence rates were 2.1 (95% confidence interval [CI] 1.5-2.8) and 1.1 (95% CI 0.8-1.5) per 1,000 person-years, respectively. Rates of GIP did not differ between the groups that received a JAKi and adalimumab: wHR 1.1 (95% CI 0.7-1.9; P = 0.65). Despite the lack of power in some subgroup analyses, results were consistent whatever the subgroup of a type of JAKi received or subgroup with a type of rheumatic disease. In this nationwide cohort study, the rates of GIPs did not differ between groups of patients who received JAKi and adalimumab treatment. These results need to be confirmed in other observational studies.

Sex differences in hospitalization for ventricular arrhythmia after a first myocardial infarction in patients without indication for implantable cardioverter-defibrillator implantation

Abstract Background Ventricular arrhythmias (VAs) represent a serious complication of myocardial infarction (MI). Incidence rate of VAs and sudden cardiac death is commonly reported to be lower in women than in men after MI (1,2). While data regarding SCD and VAs after MI in patients with implantable cardioverter defibrillator (ICD) are well described, data regarding the incidence of readmissions for VA in patients without ICD implantation criteria after a first MI are scarce, as well as the impact of sex on their occurrence. Objective This study aims to investigate the impact of sex on VA occurrences in post-MI patients without ICD implantation criteria. Methods This study was conducted using the French national health data system using electronic codes for procedures (CCAM) and hospitalizations data (PMSI). The study population consisted of patients discharged after a first MI and without criteria for ICD implantation. Results Between January 2014 and January 2015, 137,736 patients were hospitalized in France with a diagnosis of first MI and were followed using CCAM and PMSI codes. Among the 112,465 alive at discharge, 6838 patients were excluded due to criteria for the implantation of an ICD for primary or secondary prevention. Of the remaining 105,629 patients, 1600 (1.51%) were rehospitalized for VA with a median delay of 505 days (IQR 110-1208). Men had almost twice the risk of VA than women after initial discharge for MI (OR 1.88, 95% CI 1.65-2.14; p&amp;lt;0.0001). Among the 72,103 men included, 1240 (1.72%) were rehospitalized for VA with a median delay of 514 days (IQR 107-1212). Factors independently associated with VA in men were previous atrial fibrillation (OR 1.91, 95% CI 1.66 - 2.21, p&amp;lt;0.0001), previous vascular disease (OR 1.28, 95% CI 1.10 - 1.50, p=0.002), absence of coronary angioplasty (OR 1.28, 95% CI 1.10 - 1.50, p=0.002), previous diabetes (OR 1.19, 95% CI 1.04 - 1.36, p=0.012), previous hypertension (OR 1.19, 95% CI 1.05 - 1.34, p=0.007), previous or in-hospital congestive heart failure (OR 1.47, 95% CI 1.03-2.08, p=0.032 and OR 1.65, 95% CI 1.32-2.07, p&amp;lt;0.0001), and age (patients between 60 and 79 yo being at the higher risk of VA compared to &amp;lt;60 and &amp;gt;80yo patients, p=0.002 and &amp;lt;0.0001 respectively). Among the 33,526 women included, 360 (1.07%) were rehospitalized for VA with a median (IQR) delay of 461 days (116-1159) after MI. Factors independently associated with VA were previous atrial fibrillation (OR 1.68, 95% CI 1.30 - 2.18, p&amp;lt;0.0001), previous vascular disease (OR 1.37, 95% CI 1.01 - 1.84, p=0.041), and age (patients between 60 and 79 yo being at the higher risk of VA compared to &amp;gt;80yo patients, p=0.001). Conclusion The risk of readmission for VAs after a first MI is significantly lower in women compared to men, with distinct predictive factors. These findings suggest that sex-specific VA risk stratification and management strategies may be warranted after an initial MI.Sexe influence on post-MI VAs occurence

#1111 The impact of the Covid-19 pandemic on mortality: a study based on the National Health Data System (SNDS)

Abstract Background and Aims The Covid-19 pandemic had a major impact on healthcare systems, challenging the continuity of chronic disease management. Patients with Chronic Kidney Disease (CKD) were identified as particularly at risk. The aim of this study was to measure the impact of the Covid-19 pandemic on their mortality using the French National Health Data System (SNDS). Method The SNDS contains the outpatient and inpatient care of all the French population. We applied an algorithm to identify individuals with CKD based on the healthcare consumption available in the SNDS. We identified two cohorts: individuals identified with CKD in 2016 and in 2019. These two cohorts were followed for one year after the year of identification. Patients’ characteristics were extracted from the SNDS and compared between the two cohorts. The event of interest was death documented in the SNDS with death certificates. The follow-up year was divided into periods according to the chronology of the epidemic: pre-epidemic, first lockdown, post-lockdown and second lockdown. Results The 2016 and 2019 cohorts included 570,701 and 674,008 individuals respectively. The two cohorts didn't differ in terms of age and sex or comorbidities (median age = 76 years old, 51% female). At 31/12 of the year following identification, 10.90% (n = 62,234) of the 2016 cohort had died, compared with 10.94% (n = 76,756) of the 2019 cohort. Among the 60-year-old and less, mortality in the 2019 cohort was lower than the mortality in the 2016 cohort in all periods of the follow-up year. This remained true among those aged ≥60 years old during the pre-epidemic period (Week 1-Week 10). During the first week of the first lockdown, the instantaneous risk of death for the 2019 cohort reached 5.42 individuals per 1000 in the ≥75-year-old group, compared with 3.12 in the equivalent period for the 2016 cohort (+68%). Conclusion All results suggest overall lower mortality in the 2019 cohort of CKD. However, an increase in mortality was observed during strong epidemic periods in the age group of those over 75. These results will be completed with the analyses of the healthcare consumption in the two cohorts describe above.

Impact of Public Policy and COVID-19 Pandemic on Hepatitis C Testing and Treatment in France, 2014–2021

Given the World Health Organization’s target to eliminate the hepatitis C virus (HCV) by 2030, we assessed the impact of French public policies and the COVID-19 pandemic on HCV testing and initiation of direct-antiviral agents (DAAs). Using the French National Health Data System, we identified individuals living in metropolitan France with at least one reimbursement for an anti-HCV test and those with a first delivery of DAAs between 1 January 2014 and 31 December 2021. During this period, the annual number of people tested increased each year between 3.3 (in 2015) and 9.3% (in 2021), except in 2020, with a drop of 8.3%, particularly marked in April (−55.0% compared to February 2020). A return to pre-pandemic testing levels was observed in 2021. The quarterly number of patients initiating DAAs presented an upward trend from Q1-2014 until mid-2017, with greater increases in Q1-2015, and Q1- and Q2-2017, concomitant with DAA access policies and availability of new therapies. Then, quarterly numbers decreased. A 65.5% drop occurred in April compared to February 2020. The declining DAA initiations since mid-2017, despite new measures improving access and screening efforts, could be due to the shrinking pool of patients requiring treatment and a need to increase awareness among undiagnosed infected people. Further action is needed to eliminate HCV in France.

Risk factors for COVID-19 hospitalisation after booster vaccination during the Omicron period: A French nationwide cohort study

BackgroundIn spite of major effectiveness, a residual risk after COVID-19 primary vaccination was identified, in particular, for vulnerable individuals of advanced age or with comorbidities. Less is known about the Omicron period in people protected by a booster dose. We aimed to identify the characteristics associated with severe COVID-19 during the Omicron period in a population that had received a booster dose in France and to compare differences with the previous periods of the pandemic. MethodsThis study was carried out using the French national COVID-19 vaccination database (VAC-SI) coupled with the National Health Data System (SNDS). Individuals aged 12 years or over who received at least one booster dose were identified. Associations between socio-demographic and clinical characteristics and the risk of COVID-19 hospitalisation occurring at least 14 days after receiving a third dose of vaccine during the period of Omicron predominance, i.e., from 1 January 2022 to 10 November 2022, were assessed using Cox proportional hazard models adjusted for age, sex, time since booster dose and vaccination schedule. Analyses were performed overall and by sub-period of circulation of the strains BA.1, BA.2, and BA.4/BA.5, defined as periods where the main sub-variant accounted for more than 80 % of genotyped samples. FindingsIn total, 35,640,387 individuals received a booster dose (mean follow-up of 291 days) and 73,989 were hospitalised for COVID-19 during the total period. Older age (aHR 20.5 95 % CI [19.6–21.5] for 90 years of age or older versus 45–54 years of age), being male (aHR 1.52 [1.50–1.55]), and social deprivation (aHR 1.33 [1.30–1.37] for the most deprived areas versus the least deprived) were associated with an increased risk of hospitalisation for COVID-19. Most of the chronic diseases considered were also positively associated with a residual risk, in particular, cystic fibrosis (aHR 9.83 [7.68–12.56]), active lung cancer (aHR 3.26 [3.06–3.47]), chronic dialysis (aHR 3.79 [3.49–4.11]), psychological and neurodegenerative diseases (more markedly than during the periods of circulation of the alpha and delta variants), and organ transplantation. The use of immunosuppressants was also associated with an increased risk (aHR 2.24 [2.14–2.35], including oral corticosteroids aHR (2.58 [2.50–2.67]). ConclusionDespite an effective booster and a generally less virulent circulating variant, a residual risk of severe COVID-19 still exists in vulnerable populations, especially those with neurological disorders.

IT-Related Barriers and Facilitators to the Implementation of a New European eHealth Solution, the Digital Survivorship Passport (SurPass Version 2.0): Semistructured Digital Survey.

To overcome knowledge gaps and optimize long-term follow-up (LTFU) care for childhood cancer survivors, the concept of the Survivorship Passport (SurPass) has been invented. Within the European PanCareSurPass project, the semiautomated and interoperable SurPass (version 2.0) will be optimized, implemented, and evaluated at 6 LTFU care centers representing 6 European countries and 3 distinct health system scenarios: (1) national electronic health information systems (EHISs) in Austria and Lithuania, (2) regional or local EHISs in Italy and Spain, and (3) cancer registries or hospital-based EHISs in Belgium and Germany. We aimed to identify and describe barriers and facilitators for SurPass (version 2.0) implementation concerning semiautomation of data input, interoperability, data protection, privacy, and cybersecurity. IT specialists from the 6 LTFU care centers participated in a semistructured digital survey focusing on IT-related barriers and facilitators to SurPass (version 2.0) implementation. We used the fit-viability model to assess the compatibility and feasibility of integrating SurPass into existing EHISs. In total, 13/20 (65%) invited IT specialists participated. The main barriers and facilitators in all 3 health system scenarios related to semiautomated data input and interoperability included unaligned EHIS infrastructure and the use of interoperability frameworks and international coding systems. The main barriers and facilitators related to data protection or privacy and cybersecurity included pseudonymization of personal health data and data retention. According to the fit-viability model, the first health system scenario provides the best fit for SurPass implementation, followed by the second and third scenarios. This study provides essential insights into the information and IT-related influencing factors that need to be considered when implementing the SurPass (version 2.0) in clinical practice. We recommend the adoption of Health Level Seven Fast Healthcare Interoperability Resources and data security measures such as encryption, pseudonymization, and multifactor authentication to protect personal health data where applicable. In sum, this study offers practical insights into integrating digital health solutions into existing EHISs.

Medically Assisted Reproduction and Risk of Cancer Among Offspring

Cancer is a leading cause of death among children worldwide. Treatments used for medically assisted reproduction (MAR) are suspected risk factors because of their potential for epigenetic disturbance and associated congenital malformations. To assess the risk of cancer, overall and by cancer type, among children born after MAR compared with children conceived naturally. For this cohort study, the French National Mother-Child Register (EPI-MERES) was searched for all live births that occurred in France between January 1, 2010, and December 31, 2021 (and followed up until June 30, 2022). The EPI-MERES was built from comprehensive data of the French National Health Data System. Data analysis was performed from December 1, 2021, to June 30, 2023. Use of assisted reproduction technologies (ART), such as fresh embryo transfer (ET) or frozen ET (FET), and artificial insemination (AI). The risk of cancer was compared, overall and by cancer type, among children born after fresh ET, FET, or AI and children conceived naturally, using Cox proportional hazards regression models adjusted for maternal and child characteristics at birth. This study included 8 526 306 children with a mean (SD) age of 6.4 (3.4) years; 51.2% were boys, 96.4% were singletons, 12.1% were small for gestational age at birth, and 3.1% had a congenital malformation. There were 260 236 children (3.1%) born after MAR, including 133 965 (1.6%) after fresh ET, 66 165 (0.8%) after FET, and 60 106 (0.7%) after AI. A total of 9256 case patients with cancer were identified over a median follow-up of 6.7 (IQR, 3.7-9.6) years; 165, 57, and 70 were born after fresh ET, FET, and AI, respectively. The overall risk of cancer did not differ between children conceived naturally and those born after fresh ET (hazard ratio [HR], 1.12 [95% CI, 0.96 to 1.31]), FET (HR, 1.02 [95% CI, 0.78 to 1.32]), or AI (HR, 1.09 [95% CI, 0.86 to 1.38]). However, the risk of acute lymphoblastic leukemia was higher among children born after FET (20 case patients; HR 1.61 [95% CI, 1.04 to 2.50]; risk difference [RD], 23.2 [95% CI, 1.5 to 57.0] per million person-years) compared with children conceived naturally. Moreover, among children born between 2010 and 2015, the risk of leukemia was higher among children born after fresh ET (45 case patients; HR, 1.42 [95% CI, 1.06 to 1.92]; adjusted RD, 19.7 [95% CI, 2.8 to 43.2] per million person-years). The findings of this cohort study suggest that children born after FET or fresh ET had an increased risk of leukemia compared with children conceived naturally. This risk, although resulting in a limited number of cases, needs to be monitored in view of the continuous increase in the use of ART.

Pregnancy Among Women Receiving Chronic Dialysis in France (2006–2020)

In women receiving chronic dialysis, fertility is impaired. The objectives of this study were to estimate the incidence rate of pregnancies among women of childbearing age (15-50 years) receiving chronic dialysis from 2006 to 2020 in France, to describe the pregnancy outcomes and renal management during pregnancy. This national observational, retrospective study was based on data from the French REIN registry matched with the National Health Data System. Over the period 2006 to 2020 in France, 348 pregnancies were identified in 240 women receiving chronic dialysis. The overall incidence of pregnancy was 11.1, 95% confidence interval (CI) (9.9-12.3) cases per 1000 person-years. Hemodialysis was the predominant modality during pregnancy. Main maternal complications were preeclampsia (n= 19) and gestational diabetes (n= 11). The most obstetric complications were premature rupture of membranes (n= 14) and polyhydramnios (n= 5). These pregnancies resulted in 174 (50%) abortions (<22 weeks), including 104 elective abortions (29.9%), 44 miscarriages (12.6%), 17 therapeutic abortions (4.9%), 5 ectopic pregnancies (1.4%), and 4 hydatidiform moles (1.2%). The remaining 174 (50%) pregnancies with deliveries (≥22 weeks) resulted in 166 live births (70 full-term [42.2%], 96 preterm births [57.8%]), and 8 stillbirths. Median gestational age was 36 weeks (32-38) for 174 deliveries. There have been improvements in maternal and fetal outcomes regarding pregnancy on chronic dialysis. However, our study shows a significant proportion of elective abortions. Better fertility management of women receiving chronic dialysis is advised by contraception or by pregnancy planning and early multidisciplinary follow-up.