Belgian medication exposure during pregnancy (BeMeP), a new nationwide linked database: Linkage methods and prevalence of medication use.

PURPOSE: This study aimed to describe the implementation of a new retrospective Belgian national cohort of pregnant women, the Belgian Medication Exposure during Pregnancy (BeMeP). METHODS: We linked the national dispensing data to birth and death certificates and hospital stay data for a 7-year period between 2010 and 2016 for the first time in Belgium. We presented the characteristics of pregnancy events associated with the mothers enrolled in the linkage study. Next, we constructed a cohort of pregnancies and compared some characteristics computed using the BeMeP database with the national statistics. Finally, we described the use of medications during pregnancy based on the first level of the Anatomical Therapeutic Chemical (ATC) classification. RESULTS: We included 630 457 pregnant women with 900 024 pregnancy-related events (843 780 livebirths, 1937 stillbirths, 6402 ectopic events, and 47 905 abortions) linked to medication exposure information. Overall, 96.3% of live births and 83.5% of stillbirths (national statistics as reference) were captured from the BeMeP. During pregnancy, excluding the week of birth, 78.9% of live birth pregnancies and 79.6% of stillbirth pregnancies were exposed to at least one medication. The most frequently dispensed medications were anti-infectives (ATC code J = 50.2%) for live births and for stillbirths (44.0%). CONCLUSION: We linked information on pregnancies, all reimbursed medications dispensed by community pharmacists, all medications dispensed during hospitalization, sociodemographic status, and infant health to create the BeMeP database. The database represents a valuable potential resource for studying exposure-outcome associations for medication use during pregnancy.

Nationwide epidemiology and health resource use among children with COVID-19 in Japan.

BACKGROUND: The COVID-19 pandemic posed substantial challenges to healthcare systems. Understanding the responses of pediatric health services is crucial for future pandemic planning and preparedness, yet such data remains limited. METHODS: In this retrospective cohort study, we analyzed data from administrative databases developed by Japan Medical Data Center and DeSC Healthcare Inc. The dataset comprised records of 2,612,511 children, totaling 60,224,888 person-months, from January 2020 to May 2022. Multivariate generalized estimation equations were used to examine the incidence rates of COVID-19 and associated health resource use. RESULTS: Our analysis revealed that the incidence rates of COVID-19 gradually increased from Wave I (2.2 cases per 100,000 person-months) to Wave V (177.8cases per 100,000 person-months), with a notable elevation during Wave VI (2367.7 cases per 100,000 person-months). While nucleic acid amplification tests were primarily used during Waves I-V, the use of rapid antigen tests markedly increased in Wave VI. The hospitalization rates increased gradually from 0.2 in Wave I to 10.2 events per 100,000 person-months in Wave VI, and the case-hospitalization risk decreased from 14.9% in Wave II to 0.7% in Wave VI. Additionally, we observed decreasing trends in the use of antibiotics (Wave I, 31.8%; Wave VI, 9.0%), whereas antipyretic use rose from Wave I (56.1%) to Wave VI (86.6%). CONCLUSIONS: Our study highlighted essential changes in the nationwide pediatric healthcare system's response to the COVID-19 pandemic. These findings provide valuable insights into the future pandemic planning and preparedness.

Risk of anastomotic leakage with two-row versus three-row manual circular staplers in colorectal anastomosis: a U.S. cohort study.

PURPOSES: To compare the risk of anastomotic leak (AL) between Ethicon manual circular staplers (two-row) versus Medtronic EEA™ circular stapler with Tri-Staple™ technology (three-row) and between Medtronic EEA™ circular stapler with DST™ Series technology (two-row) versus Tri-Staple™ technology. METHODS: A retrospective cohort study was conducted in adult patients who underwent a left-sided colorectal surgery 2019-2022 in U.S. Premier Healthcare Database to assess the risk of AL within 30 days post-index procedure. The study devices were Ethicon manual circular staplers, Medtronic EEA™ circular stapler with DST™ technology, and Medtronic EEA™ circular stapler with Tri-Staple™ technology. RESULTS: Across 447 hospitals, the cumulative incidences (95% confidence intervals [CI]) of AL within 30 days post-index procedure were 7.78% (6.91-8.74%) among 8337 patients in the Ethicon manual circular stapler cohort, 7.54% (6.87-8.27%) among 7928 patients in the Medtronic EEA™ circular stapler with DST™ technology cohort, and 8.19% (6.57-10.07%) among 1306 patients in the Medtronic EEA™ circular stapler with Tri-Staple™ technology cohort. Comparative analyses revealed no difference comparing Ethicon manual circular staplers with Medtronic EEA™ circular staplers with Tri-Staple™ technology (risk ratio [RR], 0.72; 95% CI, 0.52-1.01) or comparing Medtronic EEA™ circular staplers with DST™ technology to Tri-Staple™ technology (RR, 0.75; 95% CI, 0.53-1.06). CONCLUSION: In this analysis of a large cohort of patients undergoing a left-sided colorectal surgery from a U.S. hospital database, the risk of AL observed with manual two-row circular staplers was similar to that seen with three-row devices. This study affirms the safety of manual two-row circular staplers in colorectal anastomosis.

Trends and regional variations in prescriptions dispensed to stimulate uterine contractions at the end of pregnancy in Belgium: A community-based study from 2003 to 2018.

PURPOSE: To investigate trends and regional variations in uterotonics dispensed around birth between 2003 and 2018 in Belgium. METHODS: Data, including outpatient and inpatient prescriptions were extracted from a nationally representative prescription database. The prevalence of uterotonics dispensed during a period including the 7 days before birth, the delivery day and the 7 days after birth was computed over three 4-year-long study periods from 2003 to 2018. The trends between periods and associations between the use of at least one uterotonic and maternal age, region of residence, delivery type and social status were assessed using logistic regression. RESULTS: In total, 31 675 pregnancies were included in the study. The proportion of pregnancies exposed to at least one uterotonic decreased significantly from 92.9% (95%CI, 92.3-93.4) in 2003-2006 to 91.4% (95%CI, 90.7-92.0) in 2015-2018 for vaginal births and from 95.5% (95%CI, 94.5-96.4) to 93.7% (95%CI, 92.6-94.7) for caesarean sections. However, for vaginal births, the proportion of oxytocin increased from 84.5% (95%CI, 83.7-85.2) to 89% (95%CI 88.3-89.7). A significant association was found between uterotonic agent use and maternal age, region of residence, and delivery type. The dispensation of some uterotonic agents differed significantly between the regions. CONCLUSIONS: The proportion of pregnancies exposed to at least one uterotonic was high across the study period but decreased slightly between 2003 and 2018. Important variations in uterotonic use between regions highlight the need for improved national guidance.

Validation of diagnosis codes in healthcare databases in Taiwan, a literature review.

PURPOSE: To compile validation findings of diagnosis codes and related algorithms for health outcomes of interest from National Health Insurance (NHI) or electronic medical records in Taiwan. METHODS: We carried out a literature review of English articles in PubMed® and Embase from 2000 through July 2022 with appropriate search terms. Potentially relevant articles were identified through review of article titles and abstracts, full text search of methodology terms "validation", "positive predictive value", and "algorithm" in Subjects & Methods (or Methods) and Results sections of articles, followed by full text review of potentially eligible articles. RESULTS: We identified 50 published reports with validation findings of diagnosis codes and related algorithms for a wide range of health outcomes of interest in Taiwan, including cardiovascular diseases, stroke, renal impairment, malignancy, diabetes, mental health diseases, respiratory diseases, viral (B and C) hepatitis, and tuberculosis. Most of the reported PPVs were in the 80% ~ 99% range. Assessment of algorithms based on ICD-10 systems were reported in 8 articles, all published in 2020 or later. CONCLUSIONS: Investigators have published validation reports that may serve as empirical evidence to evaluate the utility of secondary health data environment in Taiwan for research and regulatory purpose.

A methodology to assess the population size and estimate the needed resources for new licensed medications by combining clinical and administrative databases: The example of glycated haemoglobin in type 2 diabetes.

PURPOSE: To develop and validate a model to estimate glycated haemoglobin (HbA1c) values in patients with type 2 diabetes mellitus (T2DM) using a clinical data source, with the aim to apply this equation to administrative databases. METHODS: Using a primary care and administrative Italian databases, namely the Health Search database (HSD) and the ReS (Ricerca e Salute) database, we selected all patients aged 18 years or older on 31 December 2018 being diagnosed with T2DM and without prior prescription of sodium-glucose cotransporter-2 (SGLT-2) inhibitors. We included patients prescribed with and adherent to metformin. HSD was used to develop and test (using 2019 data as well) the algorithm imputing HbA1c values ≥7% according to a series of covariates. The algorithm was gathered by combining beta-coefficients being estimated by logistic regression models using complete case (excluding missing values) and imputed (after multiple imputation) dataset. The final algorithm was applied to ReS database using the same covariates. RESULTS: The tested algorithms were able to explain 17%-18% variation in assessing HbA1c values. Good discrimination (70%) and calibration were obtained as well. The best algorithm (three) cut-offs, namely those providing correct classifications ranging 66%-70% was therefore calculated and applied to ReS database. By doing so, from 52 999 (27.9, 95% CI: 27.7%-28.1%) to 74 250 (40.1%, 95% CI: 38.9%-39.3%) patients were estimated with HbA1c ≥7%. CONCLUSION: Through this methodology, healthcare authorities should be able to quantify the population eligible to a new licensed medication, such as SGLT-2 inhibitors, and to simulate scenarios to assess reimbursement criteria according to precise estimates.

Validation Study of Diabetes Definitions Using Japanese Diagnosis Procedure Combination Data Among Hospitalized Patients.

BACKGROUND: Validation studies of diabetes definitions using nationwide healthcare databases are scarce. We evaluated the validity of diabetes definitions using disease codes and antidiabetic drug prescriptions in the Japanese Diagnosis Procedure Combination (DPC) data via medical chart review. METHODS: We randomly selected 500 records among 15,334 patients who participated in the Japan Public Health Center-Based Prospective Study for the Next Generation in Yokote City and who had visited a general hospital in Akita between October 2011 and August 2018. Of the 500 patients, 98 were linked to DPC data; however, only 72 had sufficient information in the medical chart. Gold standard confirmation was performed by board-certified diabetologists. DPC-based diabetes definitions were based on the International Classification of Diseases, 10th Revision codes and antidiabetic prescriptions. Sensitivity, specificity, and the positive and negative predictive values (PPV and NPV, respectively) of DPC-based diabetes definitions were evaluated. RESULTS: Of 72 patients, 23 were diagnosed with diabetes using chart review; 19 had a diabetes code, and 13 had both a diabetes code and antidiabetic prescriptions. The sensitivity, specificity, PPV, and NPV were 89.5% (95% confidence interval [CI], 66.9-98.7%), 96.2% (95% CI, 87.0-99.5%), 89.5% (95% CI, 66.9-98.7%), and 96.2% (95% CI, 87.0-99.5%), respectively, for (i) diabetes codes alone; 89.5% (95% CI, 66.9-98.7%), 94.3% (95% CI, 84.3-98.8%), 85.0% (95% CI, 62.1-96.8%), and 96.2% (95% CI, 86.8-99.5%) for (ii) diabetes codes and/or prescriptions; 68.4% (95% CI, 43.4-87.4%), 100% (95% CI, 93.3-100%), 100% (95% CI, 75.3-100%), and 89.8% (95% CI, 79.2-96.2%) for (iii) both diabetes codes and prescriptions. CONCLUSION: Our results suggest that DPC data can accurately identify diabetes among inpatients using (i) diabetes codes alone or (ii) diabetes codes and/or prescriptions.

Immeasurable Time Bias in Self-controlled Designs: Case-crossover, Case-time-control, and Case-case-time-control Analyses.

BACKGROUND: Impact of immeasurable time bias (IMTB) is yet to be examined in self-controlled designs. METHODS: We conducted case-crossover, case-time-control, and case-case-time-control analyses using Korea's healthcare database. Two empirical examples among elderly patients were used: 1) benzodiazepines-hip fracture; 2) benzodiazepines-mortality. For cases, the date of hip fracture diagnosis or death was defined as the index date, and the inherited date of their matched cases for controls or future cases. Exposure was assessed in the 1-30 day (hazard) and 61-90 day (control) windows preceding the index date. A non-missing exposure setting included in- and outpatient prescriptions and the pseudo-outpatient setting included only the outpatients. Conditional logistic regression was done to estimate odds ratios (ORs) with 95% confidence intervals (CIs), where the relative difference in OR among the two settings was calculated to quantify the IMTB. RESULTS: The IMTB had negligible impacts in the hip fracture example in the case-crossover (non-missing exposure setting OR 1.27; 95% CI, 1.12-1.44; pseudo-outpatient setting OR 1.21; 95% CI, 1.06-1.39; magnitude 0.05), case-time-control (OR 1.18; 95% CI, 0.98-1.44; OR 1.13; 95% CI, 0.92-1.38; 0.04, respectively), and case-case-time-control analyses (OR 0.99; 95% CI, 0.80-1.23; OR 0.94; 95% CI, 0.75-1.18; 0.05, respectively). In the mortality example, IMTB had significant impacts in the case-crossover (non-missing exposure setting OR 1.44; 95% CI, 1.36-1.52; pseudo-outpatient setting OR 0.72; 95% CI, 0.67-0.78; magnitude 1.00), case-time-control (OR 1.38; 95% CI, 1.26-1.51; OR 0.68; 95% CI, 0.61-0.76; 1.03, respectively), and case-case-time-control analyses (OR 1.27; 95% CI, 1.15-1.40; OR 0.62; 95% CI, 0.55-0.69; 1.05, respectively). CONCLUSION: Although IMTB had negligible impacts on the drug's effect on acute events, as these are unlikely to be accompanied with hospitalizations, it negatively biased the drug's effect on mortality, an outcome with prodromal phases, in the three self-controlled designs.

Association between thromboembolic events and COVID-19 infection within 30 days: a case-control study among a large sample of adult hospitalized patients in the United States, March 2020-June 2021.

The association between thromboembolic events (TE) and COVID-19 infection is not completely understood at the population level in the United States. We examined their association using a large US healthcare database. We analyzed data from the Premier Healthcare Database Special COVID-19 Release and conducted a case-control study. The study population consisted of men and non-pregnant women aged ≥ 18 years with (cases) or without (controls) an inpatient ICD-10-CM diagnosis of TE between 3/1/2020 and 6/30/2021. Using multivariable logistic regression, we assessed the association between TE occurrence and COVID-19 diagnosis, adjusting for demographic factors and comorbidities. Among 227,343 cases, 15.2% had a concurrent or prior COVID-19 diagnosis within 30 days of their index TE. Multivariable regression analysis showed a statistically significant association between a COVID-19 diagnosis and TE among cases when compared to controls (adjusted odds ratio [aOR] 1.75, 95% CI 1.72-1.78). The association was more substantial if a COVID-19 diagnosis occurred 1-30 days prior to index hospitalization (aOR 3.00, 95% CI 2.88-3.13) compared to the same encounter as the index hospitalization. Our findings suggest an increased risk of TE among persons within 30 days of being diagnosed COVID-19, highlighting the need for careful consideration of the thrombotic risk among COVID-19 patients, particularly during the first month following diagnosis.

Trends in use, outcomes, and revision procedures of anterior cervical disc replacement in the United States: a premiere database analysis from 2006-2019.

PURPOSE: We sought to characterize trends in demographics, comorbidities, and postoperative complications among patients undergoing primary and revision cervical disc replacement (pCDR/rCDR) procedures. METHODS: In this retrospective database study, the Premier Healthcare database was queried from 2006 to 2019. Annual proportions or medians were calculated for patient and hospital characteristics, comorbidities, and postoperative complications associated with CDR surgery. Trends were assessed using linear regression analyses with year of service as the sole predictor. RESULTS: A total of 16,178 pCDR and 758 rCDR cases were identified, with a median (IQR) age of 46 (39; 53) and 51 (43; 60) years among patients, respectively. The annual number of both procedures increased between 2006 and 2019, from 135 to 2220 for pCDR (p < 0.001), and from 17 to 49 for rCDR procedures (p < 0.001), with radiculopathy being the main indication for surgery in both groups. Mechanical failure was identified as a major indication for rCDR procedures with an increase over time (p = 0.002). Baseline patient comorbidity burden (p = 0.045) and complication rates (p < 0.001) showed an increase. For both procedures, an increase in outpatient surgeries and procedures performed in rural hospitals was seen (pCDR: p = 0.045; p = 0.006; rCDR: p = 0.028; p = 0.034). CONCLUSION: PCDR and rCDR procedures significantly increased from 2006 to 2019. At the same time, comorbidity burden and complication rates increased, while procedures were more often performed in an outpatient and rural setting. The identification of these trends can help guide future practice and lead to further areas of research.

Record linkage of claims and cancer registries data-Evaluation of a deterministic linkage approach based on indirect personal identifiers.

PURPOSE: In Germany, record linkage of claims and cancer registry data is cost- and time-consuming, since up until recently no unique personal identifier was available in both data sources. The aim of this study was to evaluate the feasibility and performance of a deterministic linkage procedure based on indirect personal identifiers included in the data sources. METHODS: We identified users of glucose-lowering drugs with residence in four federal states in Northern and Southern Germany (Bavaria, Bremen, Hamburg, Lower Saxony) in the German Pharmacoepidemiological Research Database (GePaRD) and assessed colorectal and thyroid cancer cases. Cancer registries of the federal states selected all colorectal and thyroid cancer cases between 2004 and 2015. A deterministic linkage approach was performed based on indirect personal identifiers such as year of birth, sex, area of residence, type of cancer and an absolute difference between the dates of cancer diagnosis in both data sources of at most 90 days. Results were compared to a probabilistic linkage using "direct" personal identifiers (gold standard). RESULTS: The deterministic linkage procedure yielded a sensitivity of 71.8% for colorectal cancer and 66.6% for thyroid cancer. For thyroid cancer, the sensitivity improved when using only inpatient diagnosis to define cancer in GePaRD (71.4%). Specificity was always above 99%. Using the probabilistic linkage to define cancer cases, the risk for colorectal cancer was estimated 10 percentage points lower than when using the deterministic approach. CONCLUSIONS: Sensitivity of the deterministic linkage approach appears to be too low to be considered as reasonable alternative to the probabilistic linkage procedure.

Relative survival after meningioma surgery. A French nationwide population-based cohort study.

BACKGROUND: Survival after meningioma surgery is often reported with inadequate allowance for competing causes of death. METHODS: We processed the Système National des Données de Santé, the French administrative medical database to retrieve appropriate patients' case of surgically treated meningiomas. The Pohar Perme relative survival (RS) method was implement. RESULTS: A total of 28,778 patients were identified between 2007 and 2017 of which 75% were female. Median age at surgery 59 years. Cranial convexity was the most common (24.7%) location and, benign meningioma represented 91.5% of all meningioma. Median follow-up was 3.5 years interquartile range [3.4-3.5]. At data collection, 2,232 patients were dead. The five-year survival relative to the expected survival of an age- and gender-matched French standard population was 96.2% 95% confidence interval (CI)[95.7-96.8]. Meningioma absolute excess risk of death was 973/100,000 person-years 95%CI[887-1068] (p< .001). The related standardised mortality ratio was 1.8 95%CI[1.7-1.9] (p< .001). In the adjusted model, male gender (hazard ratio [HR] =1.39, 95%CI[1.27-1.54], p< .001), age at surgery (HR=0.97, 95%CI[0.97-0.97], p < .001), type 2 neurofibromatosis (HR=2.95, 95%CI[1.95-4.46], p < .001), comorbidities HR=1.39, 95%CI[1.36-1.42], p < .001), location (HR=0.8, 95%CI[0.67-0.95], p= .0111), pre-operative embolization, (HR=1.3, 95%CI[1.08-1.56], p= .00507), cerebro-spinal fluid shunt, (HR=2.48, 95%CI[2.04-3.01], p < .001), atypical (HR=1.3, 95%CI [1.09-1.54], p= .00307) or malignant histology (HR=1.86, 95%CI[1.56-2.22], p< .001), redo surgery (HR=1.19, 95%CI[1.04-1.36], p= .0122) and radiotherapy (HR=1.43, 95%CI[1.26-1.62], p < .001) were established as independent predictors of RS. CONCLUSION: This unique study highlights the excess mortality associated with meningioma disease. Many factors such as gender, age, location, histopathological grading, redo surgery influence the RS.

Intravenous immunoglobulin and the current risk of moderate and severe anaphylactic events, a cohort study.

This large cohort study from the US Premier Healthcare Database evaluated the risk and predictors of anaphylaxis in association with intravenous immunoglobulin (IvIg) therapy in the inpatient and outpatient setting. Data were collected retrospectively (January 2009-December 2018) from 24 919 patients administered IgPro10 IvIg, median age 54 years. Immunoglobulins of interest were IgPro10 and other IvIg given before or after IgPro10. Moderate and severe anaphylaxis was identified from same-day parenteral epinephrine and IvIg use and reviews of patient record summaries. Predictors for first anaphylactic reactions associated with IvIg administration were derived from adjusted incidence rate ratios (IRR) using Poisson regression. Moderate anaphylaxis in IvIg use was rare and severe anaphylaxis very rare based on a total of 124 moderate and four non-fatal severe first anaphylactic events, incidence rate of 7.11 and 0.23/10 000 IvIg administrations, respectively. Age under 18 years was an independent predictor of moderate or severe anaphylactic events [adjusted incidence rate ratio = 2.94, 0.95 confidence interval  = 1.91-4.52] compared with those aged 18 years and older. First IvIg administration was a strong predictor of anaphylaxis. The IRR in those with a subsequent IvIg administration in the preceding 42 days decreased to 0.27 (0.17-0.42) and in those effectively IvIg-naive (no IvIg for > 42 days) to 0.76 (0.44-1.32) compared with first IvIg use. The key conclusions from this study are that the risk of anaphylaxis has progressively reduced over the last decade, from 14.87 of 10 000 in 2009-10 to 4.39 of 10 000 IvIg administrations in 2017-18 and is rare overall, and that the risk of anaphylaxis is increased in those aged under 18 years.

Quantifying the risk-adjusted hospital costs of postoperative complications after lower extremity bypass in patients with claudication.

OBJECTIVE: Increasing evidence has shown that the risks associated with surgical revascularization for intermittent claudication outweigh the benefits. The aim of our study was to quantify the cost of care associated with perioperative complications after elective lower extremity bypass (LEB) in patients presenting with intermittent claudication. METHODS: All patients undergoing first-time LEB for claudication in the Healthcare Database (2009-2015) were included. The primary outcome was in-hospital postoperative complications, including major adverse limb events (MALE), major adverse cardiac events (MACE), acute kidney injury, and wound complications. The overall crude hospital costs are reported, and a generalized linear model with log link and inverse Gaussian distribution was used to calculate the predicted hospital costs for specific complications. RESULTS: Overall, 7154 patients had undergone elective LEB for claudication during the study period. The median age was 66 years (interquartile range, 59-73 years), 67.5% were male, and 75.3% were white. Two thirds of patients (61.2%) had Medicare insurance, followed by private insurance (26.9%), Medicaid (7.7%), and other insurance (4.2%). In-hospital complications occurred in 8.5% of patients, including acute kidney injury in 3.0%, MALE in 2.8%, wound complications in 2.3%, and MACE in 1.0%. The overall median crude hospital cost was $11,783 (interquartile range, $8911-$15,767) per patient. The incremental increase in cost associated with a postoperative complication was significant, ranging from $6183 (95% confidence interval, $4604-$7762) for MALE to $10,485 (95% confidence interval, $6529-$14,441) for MACE after risk adjustment. CONCLUSIONS: Postoperative complications after elective LEB for claudication are not uncommon and increase the in-hospital costs by 46% to 78% depending on the complication. Surgical revascularization for claudication should be used sparingly in carefully selected patients.

Using administrative healthcare database records to study trends in prescribed medication dispensed during pregnancy in Belgium from 2003 to 2017.

PURPOSE: The aim of this study was to describe trends in medication prescriptions dispensed during pregnancy in Belgium using administrative healthcare database records from a representative sample of the Belgian population. METHODS: Pregnant women were identified with reimbursement codes associated with the delivery of a baby. Data were extracted for three study periods, each over 3 years: 2003-2005, 2009-2011, and 2015-2017. The age-standardized prevalence of dispensed medications during pregnancy were computed and logistic regression models were used to evaluate the trends in prevalence across the study periods. The most frequently dispensed medications were listed for each study period. RESULTS: The study included 23 912 pregnancies. The age-standardized prevalence of pregnant women with at least one dispensed medication increased across the three study periods from 81.8.% to 89.3%. The median number and interquartile range of the different medications dispensed during pregnancy rose from 2 (1-6) to 3 (1-7) between the first and last study periods. In the 2015-2017 period, the most frequently dispensed medications during pregnancy included progesterone (25.5%), paracetamol (17.8%), and amoxicillin (17.1%). The data also showed an increasing trend for the dispensation of ibuprofen and ketorolac during pregnancy across the three study periods. CONCLUSIONS: The prevalence of prescribed medications dispensed during pregnancy increased in Belgium from 2003 to 2017 with high proportion for Progesterone and Antibiotics. Utilization of certain nonsteroidal anti-inflammatory drugs (NSAIDs) increased between 2003 and 2017, despite recommendations to avoid them.

Suitability of databases in the Asia-Pacific for collaborative monitoring of vaccine safety.

INTRODUCTION: Information regarding availability of electronic healthcare databases in the Asia-Pacific region is critical for planning vaccine safety assessments particularly, as COVID-19 vaccines are introduced. This study aimed to identify data sources in the region, potentially suitable for vaccine safety surveillance. This manuscript is endorsed by the International Society for Pharmacoepidemiology (ISPE). METHODS: Nineteen countries targeted for database reporting were identified using published country lists and review articles. Surveillance capacity was assessed using two surveys: a 9-item introductory survey and a 51-item full survey. Survey questions related to database characteristics, covariate and health outcome variables, vaccine exposure characteristics, access and governance, and dataset linkage capability. Other questions collated research/regulatory applications of the data and local publications detailing database use for research. RESULTS: Eleven databases containing vaccine-specific information were identified across 8 countries. Databases were largely national in coverage (8/11, 73%), encompassed all ages (9/11, 82%) with population size from 1.4 to 52 million persons. Vaccine exposure information varied particularly for standardized vaccine codes (5/11, 46%), brand (7/11, 64%) and manufacturer (5/11, 46%). Outcome data were integrated with vaccine data in 6 (55%) databases and available via linkage in 5 (46%) databases. Data approval processes varied, impacting on timeliness of data access. CONCLUSIONS: Variation in vaccine data availability, complexities in data access including, governance and data release approval procedures, together with requirement for data linkage for outcome information, all contribute to the challenges in building a distributed network for vaccine safety assessment in the Asia-Pacific and globally. Common data models (CDMs) may help expedite vaccine safety research across the region.

Real-world reproducibility study characterizing patients newly diagnosed with multiple myeloma using Clinical Practice Research Datalink, a UK-based electronic health records database.

PURPOSE: We evaluated the reproducibility of a study characterizing newly-diagnosed multiple myeloma (MM) patients within an electronic health records (EHR) database using different analytic tools. METHODS: We reproduced the findings of a descriptive cohort study using an iterative two-phase approach. In Phase I, a common protocol and statistical analysis plan (SAP) were implemented by independent investigators using the Aetion Evidence Platform® (AEP), a rapid-cycle analytics tool, and SAS statistical software as a gold standard for statistical analyses. Using the UK Clinical Practice Research Datalink (CPRD) dataset, the study included patients newly diagnosed with MM within primary care setting and assessed baseline demographics, conditions, drug exposure, and laboratory procedures. Phase II incorporated analysis revisions based on our initial comparison of the Phase I findings. Reproducibility of findings was evaluate by calculating the match rate and absolute difference in prevalence between the SAS and AEP study results. RESULTS: Phase I yielded slightly discrepant results, prompting amendments to SAP to add more clarity to operational decisions. After detailed specification of data and operational choices, exact concordance was achieved for the number of eligible patients (N = 2646), demographics, comorbidities (i.e., osteopenia, osteoporosis, cardiovascular disease [CVD], and hypertension), bone pain, skeletal-related events, drug exposure, and laboratory investigations in the Phase II analyses. CONCLUSIONS: In this reproducibility study, a rapid-cycle analytics tool and traditional statistical software achieved near-exact findings after detailed specification of data and operational choices. Transparency and communication of the study design, operational and analytical choices between independent investigators were critical to achieve this reproducibility.

Practice patterns of vasal reconstruction in a large United States cohort.

We aimed to characterise diverse practice patterns for vasal reconstruction and to determine whether surgeon volume is associated with vasoepididymostomy performance at the time of reconstruction. We identified adult men who underwent vasal reconstruction from 2000 to 2020 in Premier Healthcare Database and determined patient, surgeon, cost and hospital characteristics for each procedure. We identified 3,494 men who underwent either vasovasostomy-alone (N = 2,595, 74.3%) or any-vasoepididymostomy (N = 899, 25.7%). The majority of providers (N = 487, 88.1%) performed only-vasovasostomy, 10 (1.8%) providers performed only-vasoepididymostomy and 56 (10.1%) providers performed both. Median total hospital charge of vasoepididymostomy was significantly higher than vasovasostomy ($39,163, interquartile range [IQR]$11,854-53,614 and $17,201, IQR$10,904-29,986, respectively). On multivariable regression, men who underwent procedures at nonacademic centres (OR 2.71, 95% CI 2.12-3.49) with higher volume surgeons (OR 11.60, 95% CI 8.65-16.00) were more likely to undergo vasoepididymostomy. Furthermore, men who underwent vasoepididymostomy were more likely to self-pay (OR 2.35, 95% CI 1.83-3.04, p < .001) and more likely had procedures in the Midwest or West region (OR 2.22, 95% CI 1.66-2.96 and OR 2.11, 95% CI 1.61-2.76, respectively; p < .001). High-volume providers have increased odds of performing vasoepididymostomy at the time of reconstruction but at a significantly higher cost. These data suggest possibly centralising reconstructive procedures among high-volume providers.

Consequences of the new zolpidem prescription regulations: a cohort study from the French national healthcare database.

PURPOSE: To determine changes in the prevalence of zolpidem consumption since the change in the regulations of prescription. Formulations containing zolpidem were subject to the regulations of narcotics by the French decree of April 7, 2017. METHODS: Longitudinal cohort study using data from the representative French healthcare database. The main outcome was the prevalence of oral hypnotic drug reimbursement before and after April 2017. The secondary outcome was the change in prescription habits for zolpidem since the decree in long-term users and excessive users. RESULTS: A total of 81,174 individuals had at least one hypnotic drug reimbursement; among, whom 2143 had at least one reimbursement of zolpidem. Before the decree, 26% had at least one reimbursement of zolpidem, whereas it dropped to 18.4% after the decree. Among the 545 long-term users, the reimbursement of zolpidem was discontinued after the decree for 60.4% and 24.2% retained zolpidem as a treatment. The main replacement drug was zopiclone for 6.4% of them. Among the 1598 excessive users, the reimbursement of zolpidem was stopped after the decree for 16.5% and 56.3% retained zolpidem as a treatment. The main replacement drug was zopiclone for 12.1% of them. CONCLUSIONS: The French decree had a major impact on the reimbursement of oral zolpidem. Indeed, prescription of the hypnotic was discontinued for half of the long-term users of zolpidem, and just over one-sixth of the excessive users discontinued the prescription of zolpidem after the decree.

Trajectories of Antipsychotic Drug Use Over 10 Years in a French Community-Based Sample of Persons Aged 50 and Older.

OBJECTIVE: To identify the temporal prescribing patterns of antipsychotics among persons aged 50 and older and to explore the demographic and clinical characteristics associated with each trajectory of antipsychotic drug use. METHODS: This was a historical fixed cohort study on a community-based sample of persons affiliated with the French Insurance Healthcare system. Data from community drug reimbursement claims were collected by the French Insurance Healthcare system over the period 2006-2015. The study included 160,853 persons aged 50 and older. Trajectories of antipsychotic drug use were identified by examining the distribution of antipsychotic use within consecutive 3-month periods over the entire follow-up period. Latent class analyses were used to identify distinct trajectories. Multivariate polynomial logistic regression models were used to explore the characteristics independently associated with trajectories. RESULTS: Five trajectories of antipsychotic use were identified: null or very low use (93.8%), occasional use (2%), decreasing use (1.6%), chronic use (1.5%), and increasing use (1.1%). Occasional users were older and had a lower use of other psychotropic drugs and a high use of health resources. Chronic users had the highest frequency of chronic psychiatric diseases and were less likely to present with dementia or Parkinson disease. Persons with increasing use of antipsychotics were more frequently males and had a high frequency of dementia; half of them died over the follow-up period compared with 20% in the total sample. CONCLUSION: Further studies should explore whether the benefit-risk ratio of antipsychotic drugs in older adults differs according to trajectories of use.