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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. [ABSTRACT FROM AUTHOR]

Abstract In Israel there is no registry of multiple sclerosis (MS), thus the prevalence of MS is unknown. Clalit Health Services (CHS) is Israel’s largest health care organization. We have developed an algorithm to identify people with MS (PwMS) using CHS database and validated it against a gold-standard diagnosis by expert neurologists. People with a possible diagnosis of MS were identified in CHS database according to ICD-9 code or dispense of MS specific disease modifying treatment (DMT). The electronic medical records (EMRs) of a random sample of 25% of this population, stratified by age and sex were examined to determine positive predictive value (PPV). Another age- and sex- stratified random sample of 15% of pwMS under our care were searched in CHS database to determine database sensitivity (Sn). Finally, a random sample of 40% of people without MS were searched in CHS database to evaluate database specificity (Sp). The best case definition to retrieve pwMS was ICD-9 code 340 as an established diagnosis or at least one dispense of a DMT (PPV = 87%, Sn = 92%, Sp = 90%). Using this definition the prevalence of MS in Israel was 68, 82 and 95 per 100,000 population by the end of 2011, 2016 and 2021, respectively. The prevalence of MS in Israel is rising, in line with the worldwide trend.

Although drugs for osteoporosis have been demonstrated to be effective in reducing fracture risk in placebo‐controlled clinical trials, data on effectiveness in real‐world practice is limited. Data from the French national health insurance claims database (SNDS) were used to follow five cohorts of women aged ≥55 years after initiating treatment for ≥6 months with either denosumab, zoledronic acid, oral bisphosphonates, raloxifene, or teriparatide in 2014–2016. Fracture incidence was compared within each cohort between the 3 months following initiation (baseline fracture risk) and the 12month, 18month, and 24 month postinitiation periods. Data are presented as incidence rate ratios (IRRs) with their 95% confidence intervals (CIs)s. Overall, 67,046 women were included in the denosumab cohort, 52,914 in the oral bisphosphonate cohort, 41,700 in the zoledronic acid cohort, 11,600 in the raloxifene cohort, and 7510 in the teriparatide cohort. The baseline vertebral fracture rate ranged from 1.74 per 1000 person years (‰PY) in the raloxifene cohort to 34.75‰PY in the teriparatide cohort, and the baseline hip fracture rate from 0.70‰PY in the raloxifene cohort to 10.52‰PY in the zoledronic acid cohort. Compared with the baseline fracture rate, vertebral fractures involving hospitalization were significantly reduced in the 3–24–month postinitiation period with denosumab (IRR 0.6; 95% CI, 0.5–0.7), zoledronic acid (IRR 0.4; 95% CI, 0.3–0.4), teriparatide (IRR 0.3; 95% CI, 0.2–0.5), and oral bisphosphonates (IRR 0.6; 95% CI, 0.4–0.8). Hip fracture incidence was reduced with denosumab (IRR 0.8; 95% CI, 0.6–0.9), but higher for oral bisphosphonates (IRR 1.7; 95% CI, 1.2–2.3); no significant change in hip fracture rate was observed for zoledronic acid, teriparatide, or raloxifene. A reduction in nonvertebral, non‐hip fracture incidence was observed only in the denosumab cohort (IRR 0.8; 95% CI, 0.7–0.9). These findings indicate that treatment with osteoporosis drugs is effective in the real‐world setting. © 2023 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research. [ABSTRACT FROM AUTHOR]

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.

Ylenia Ingrasciotta,1,2 Valentina Isgrò,1 Saveria Serena Foti,2 Valentina Ientile,3 Andrea Fontana,4 Luca L’Abbate,3 Roberto Benoni,1 Elena Sofia Fiore,1 Michele Tari,5 Angela Alibrandi,6 Gianluca Trifirò1,2 1Department of Diagnostics and Public Health, University of Verona, Verona, Italy; 2Academic Spin-off “INSPIRE – Innovative Solutions for Medical Prediction and Big Data Integration in Real World Setting” – Azienda Ospedaliera Universitaria “G. Martino”, Messina, Italy; 3Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy; 4Unit of Biostatistics, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni, Rotondo, Italy; 5Caserta-1 Local Health Service, Caserta, Italy; 6Department of Economics, University of Messina, Messina, ItalyCorrespondence: Ylenia Ingrasciotta, Department of Diagnostics and Public Health, University of Verona, P. le L.A. Scuro 10, Verona, 37134, Italy, Tel +39 045 802 7679, Email ylenia.ingrasciotta@univr.itBackground: Inflammatory bowel diseases (IBDs), Crohn’s disease (CD) and ulcerative colitis (UC), are chronic diseases that have been increasingly treated with biological drugs in recent years. Newly developed coding algorithms for IBD identification using claims databases are needed to improve post-marketing surveillance of biological drugs.Objective: To test algorithms to identify CD and UC, as indication for use of biological drugs approved for IBD treatment, using a claims database.Methods: Data were extracted from the Caserta Local Health Unit database between 2015 and 2018. CD/UC diagnoses reported by specialists in electronic therapeutic plans (ETPs) were considered as gold standard. Five algorithms were developed based on ICD-9-CM codes as primary cause of hospital admissions, exemption from healthcare service co-payment codes and drugs dispensing with only indication for CD/UC. The accuracy was assessed by sensitivity (Se), specificity (Sp), positive (PPV) and negative predicted values (NPV) along with computation of the Youden Index and F-score.Results: In the study period, 1205 subjects received at least one biological drug dispensing approved for IBD and 134 (11.1%) received ≥ 1 ETP with IBD as use indication. Patients with CD and CU were 83 (61.9%) and 51 (38.1%), respectively. Sensitivity of the different algorithms ranged from 71.1% (95% CI: 60.1– 80.5) to 98.8 (95% CI: 93.5– 100.0) for CD and from 64.7% (95% CI: 50.1– 77.6) to 94.1 (95% CI: 83.8– 98.8) for UC, while specificity was always higher than 91%. The best CD algorithm was “Algorithm 3”, based on hospital CD diagnosis code OR CD exemption code OR [IBD exemption code AND dispensing of non-biological drugs with only CD indication] (Se: 98.8%; Sp: 97.2%; PPV: 84.5%, NPV: 99.8%), achieving the highest diagnostic accuracy (Youden Index=0.960). The best UC algorithm was “Algorithm 3”, based on specific hospital UC diagnosis code OR UC exemption code OR [IBD exemption code AND golimumab dispensing] OR dispensing of non-biological drugs with only UC indication (Se: 94.1%; Sp: 91.6%; PPV: 50.0%; NPV: 99.4%), and achieving the highest diagnostic accuracy (Youden Index=0.857).Conclusion: In a population-based claims database, newly coding algorithms including diagnostic and exemption codes plus specific drug dispensing yielded highly accurate identification of CD and UC as distinct indication for biological drug use.Keywords: biological drugs, algorithm, healthcare database, ulcerative colitis, Crohn’s disease

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.

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. [ABSTRACT FROM AUTHOR]

ABSTRACT Although drugs for osteoporosis have been demonstrated to be effective in reducing fracture risk in placebo‐controlled clinical trials, data on effectiveness in real‐world practice is limited. Data from the French national health insurance claims database (SNDS) were used to follow five cohorts of women aged ≥55 years after initiating treatment for ≥6 months with either denosumab, zoledronic acid, oral bisphosphonates, raloxifene, or teriparatide in 2014–2016. Fracture incidence was compared within each cohort between the 3 months following initiation (baseline fracture risk) and the 12month, 18month, and 24 month postinitiation periods. Data are presented as incidence rate ratios (IRRs) with their 95% confidence intervals (CIs)s. Overall, 67,046 women were included in the denosumab cohort, 52,914 in the oral bisphosphonate cohort, 41,700 in the zoledronic acid cohort, 11,600 in the raloxifene cohort, and 7510 in the teriparatide cohort. The baseline vertebral fracture rate ranged from 1.74 per 1000 person years (‰PY) in the raloxifene cohort to 34.75‰PY in the teriparatide cohort, and the baseline hip fracture rate from 0.70‰PY in the raloxifene cohort to 10.52‰PY in the zoledronic acid cohort. Compared with the baseline fracture rate, vertebral fractures involving hospitalization were significantly reduced in the 3–24–month postinitiation period with denosumab (IRR 0.6; 95% CI, 0.5–0.7), zoledronic acid (IRR 0.4; 95% CI, 0.3–0.4), teriparatide (IRR 0.3; 95% CI, 0.2–0.5), and oral bisphosphonates (IRR 0.6; 95% CI, 0.4–0.8). Hip fracture incidence was reduced with denosumab (IRR 0.8; 95% CI, 0.6–0.9), but higher for oral bisphosphonates (IRR 1.7; 95% CI, 1.2–2.3); no significant change in hip fracture rate was observed for zoledronic acid, teriparatide, or raloxifene. A reduction in nonvertebral, non‐hip fracture incidence was observed only in the denosumab cohort (IRR 0.8; 95% CI, 0.7–0.9). These findings indicate that treatment with osteoporosis drugs is effective in the real‐world setting. © 2023 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

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

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. [ABSTRACT FROM AUTHOR]

Background: National health monitoring agencies have reported the alternative use of morphine sulfate painkiller for maintenance treatment of opioid use disorder (OUD), associated with a potential increase in overdose risk. Objectives: This study sought to assess the prevalence of regular and occasional legally prescribed morphine use in patients treated for OUD and compare their characteristics to those of patients receiving conventional opioid maintenance treatment (OMT), buprenorphine or methadone. Then, we assessed the factors associated with opioid overdose risk. Methods: Data were extracted from the French national healthcare system database, covering the entire population in 2015. Diagnosis associated with hospital discharge and long-term disease codes were extracted to select the population and identify outcomes and covariates. OUD non-chronic pain patients were divided into regular (=35 days between dispensing and =3 months of continuous treatment duration) morphine users, and occasional users. Their sociodemographic and health characteristics were compared to OMT controls. A multivariate logistic regression model was performed to determine factors associated with opioid overdose. Results: In patients treated for OUD, 2,237 (2.2%) morphine users (1,288 regular and 949 occasional), 64,578 (63.7%) buprenorphine and 34,638 (34.1%) methadone controls were included. The prevalence of regular morphine use among patients treated for OUD regularly receiving an opioid was 1.3%. Compared to users who receive morphine regularly, occasional users had an increased risk of overdose [OR = 2.2 (1.5-3.3)], while the risk was reduced in the buprenorphine group [OR = 0.5 (0.4-0.7)] and not significantly different for methadone [OR = 1.0 (0.7-1.4)]. Other overdose risk factors were low-income, comorbidity, i.e., psychiatric conditions, alcohol use disorder or complications related to intravenous drug use, and coprescription with benzodiazepines or pregabalin. These factors were more frequent in morphine groups. Conclusions: Patients that were prescribed oral morphine represented a small minority of the treated for OUD. The poorer health condition affected by numerous comorbidities and higher risk of opioid overdose in patients treated with oral morphine compared with OMT controls points toward the need to better supervise the practices of these patients, to strengthen multidisciplinary care and risk reduction measures. [ABSTRACT FROM AUTHOR]

Context: The abuse of opioids and opioid-related harms, including deaths, in the United States are well documented. In the European Union, opioid use has also been increasing, particularly of fentanyl.Objective: We assessed the prevalence of off-label prescribing of transmucosal immediate-release fentanyl (TIRF), in France, in 2019. We looked at the patients' and prescribers' characteristics and compared the population of patients who received TIRF in off-label prescriptions with those taking it on-label. We also examined the differences between the patients with and without cancer in the off-label use population.Methods: This was a population-based cross-sectional study conducted in 2019, using the French national insurance claims database Système National d'Informations Inter-Régimes de l'Assurance Maladie, covering 98.8% of the French population, or 66 million people.Results: We selected 224,000 patients with fentanyl prescriptions. Among them, 23,209 had at least one TIRF delivered. The median age was 71 years (59-85) and most patients were female (55.8%). The prevalence of off-label prescribing of TIRF was 51.8% (n = 12,031), corresponding to 9827 patients not diagnosed with cancer. The three main pharmaceutical TIRF specialties prescribed in two groups were Abstral, Pecfent, and Instanyl. Overall, TIRF was mainly prescribed by private general practitioners (64.8%).Conclusion: The prevalence of off-label prescribing of TIRF in France is extremely high. A field survey is now needed 1) to better understand why TIRF is used in conditions not indicated in its marketing authorization, and in what clinical situations, and 2) to determine whether the benefit/risk ratio of such use is favorable. [ABSTRACT FROM AUTHOR]

BackgroundNational health monitoring agencies have reported the alternative use of morphine sulfate painkiller for maintenance treatment of opioid use disorder (OUD), associated with a potential increase in overdose risk.ObjectivesThis study sought to assess the prevalence of regular and occasional legally prescribed morphine use in patients treated for OUD and compare their characteristics to those of patients receiving conventional opioid maintenance treatment (OMT), buprenorphine or methadone. Then, we assessed the factors associated with opioid overdose risk.MethodsData were extracted from the French national healthcare system database, covering the entire population in 2015. Diagnosis associated with hospital discharge and long-term disease codes were extracted to select the population and identify outcomes and covariates. OUD non-chronic pain patients were divided into regular (≤35 days between dispensing and ≥3 months of continuous treatment duration) morphine users, and occasional users. Their sociodemographic and health characteristics were compared to OMT controls. A multivariate logistic regression model was performed to determine factors associated with opioid overdose.ResultsIn patients treated for OUD, 2,237 (2.2%) morphine users (1,288 regular and 949 occasional), 64,578 (63.7%) buprenorphine and 34,638 (34.1%) methadone controls were included. The prevalence of regular morphine use among patients treated for OUD regularly receiving an opioid was 1.3%. Compared to users who receive morphine regularly, occasional users had an increased risk of overdose [OR = 2.2 (1.5–3.3)], while the risk was reduced in the buprenorphine group [OR = 0.5 (0.4–0.7)] and not significantly different for methadone [OR = 1.0 (0.7–1.4)]. Other overdose risk factors were low-income, comorbidity, i.e., psychiatric conditions, alcohol use disorder or complications related to intravenous drug use, and coprescription with benzodiazepines or pregabalin. These factors were more frequent in morphine groups.ConclusionsPatients that were prescribed oral morphine represented a small minority of the treated for OUD. The poorer health condition affected by numerous comorbidities and higher risk of opioid overdose in patients treated with oral morphine compared with OMT controls points toward the need to better supervise the practices of these patients, to strengthen multidisciplinary care and risk reduction measures.

Abstract Background To study patient physiology throughout a period of acute hospitalization, we sought to create accessible, standardized nationwide data at the level of the individual patient-facility-day. This methodology paper summarizes the development, organization, and characteristics of the Veterans Affairs Patient Database 2014–2017 (VAPD 2014–2017). The VAPD 2014–2017 contains acute hospitalizations from all parts of the nationwide VA healthcare system with daily physiology including clinical data (labs, vitals, medications, risk scores, etc.), intensive care unit (ICU) indicators, facility, patient, and hospitalization characteristics. Methods The VA data structure and database organization represents a complex multi-hospital system. We define a single-site hospitalization as one or more consecutive stays with an acute treating specialty at a single facility. The VAPD 2014–2017 is structured at the patient-facility-day level, where every patient-day in a hospital is a row with separate identification variables for facility, patient, and hospitalization. The VAPD 2014–2017 includes daily laboratory, vital signs, and inpatient medication. Such data were validated and verified through lab value range and comparison with patient charts. Sepsis, risk scores, and organ dysfunction definitions were standardized and calculated. Results We identified 565,242 single-site hospitalizations (SSHs) in 2014; 558,060 SSHs in 2015; 553,961 SSHs in 2016; and 550,236 SSHs in 2017 at 141 VA hospitals. The average length of stay was four days for all study years. In-hospital mortality decreased from 2014 to 2017 (1.7 to 1.4%), 30-day readmission rates increased from 15.3% in 2014 to 15.6% in 2017; 30-day mortality also decreased from 4.4% in 2014 to 4.1% in 2017. From 2014 to 2017, there were 107,512 (4.8%) of SSHs that met the Center for Disease Control and Prevention’s Electronic Health Record-based retrospective definition of sepsis. Conclusion The VAPD 2014–2017 represents a large, standardized collection of granular data from a heterogeneous nationwide healthcare system. It is also a direct resource for studying the evolution of inpatient physiology during both acute and critical illness.

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: Neuromuscular blockade (NMB) agents are a critical component of balanced anesthesia. NMB reversal methods can include spontaneous reversal, sugammadex, or neostigmine and the choice of reversal strategy can depend on various factors. Unanticipated changes to clinical practice emerged due to the COVID-19 pandemic, and a better understanding of how NMB reversal trends were affected by the pandemic may help provide insight into how providers view the tradeoffs in the choice of NMB reversal agents., Objective: We aim to analyze NMB reversal agent use patterns for US adult inpatient surgeries before and after the COVID-19 outbreak to determine whether pandemic-related practice changes affected use trends., Methods: A retrospective longitudinal analysis of a large all-payer national electronic US health care database (PINC AI Healthcare Database) was conducted to identify the use patterns of NMB reversal during early, middle, and late COVID-19 (EC, MC, and LC, respectively) time periods. Factors associated with NMB reversal choices in inpatient surgeries were assessed before and after the COVID-19 pandemic reached the United States. Multivariate logistic regression assessed the impact of the pandemic on NMB reversal, accounting for patient, clinical, procedural, and site characteristics. A counterfactual framework was used to understand if patient characteristics affected how COVID-19-era patients would have been treated before the pandemic., Results: More than 3.2 million inpatients experiencing over 3.6 million surgical procedures across 931 sites that met all inclusion criteria were identified between March 1, 2017, and December 31, 2021. NMB reversal trends showed a steady increase in reversal with sugammadex over time, with the trend from January 2018 onwards being linear with time (R 2 >0.99). Multivariate analysis showed that the post-COVID-19 time periods had a small but statistically significant effect on the trend, as measured by the interaction terms of the COVID-19 time periods and the time trend in NMB reversal. A slight increase in the likelihood of sugammadex reversal was observed during EC relative to the pre-COVID-19 trend (odds ratio [OR] 1.008, 95% CI 1.003-1.014; P=.003), followed by negation of that increase during MC (OR 0.992, 95% CI 0.987-0.997; P<.001), and no significant interaction identified during LC (OR 1.001, 95% CI 0.996-1.005; P=.81). Conversely, active reversal (using either sugammadex or neostigmine) did not show a significant association relative to spontaneous reversal, or a change in trend, during EC or MC (P>.05), though a slight decrease in the active reversal trend was observed during LC (OR 0.987, 95% CI 0.983-0.992; P<.001)., Conclusions: We observed a steady increase in NMB active reversal overall, and specifically with sugammadex compared to neostigmine, during periods before and after the COVID-19 outbreak. Small, transitory alterations in the NMB reversal trends were observed during the height of the COVID-19 pandemic, though these alterations were independent of the underlying NMB reversal time trends., (©Vladimir Turzhitsky, Lori D Bash, Richard D Urman, Michael Kattan, Ira Hofer. Originally published in JMIR Perioperative Medicine (http://periop.jmir.org), 22.07.2024.)

Our study assessed the trends and patterns of tramadol prescriptions and possible correlations of a person being prescribed tramadol using the Korean National Health Insurance Service Sample Cohort from 2003 to 2013. The study population consisted of patients who were prescribed tramadol, opioids, or nonsteroidal anti-inflammatory drugs (NSAIDs) in an outpatient setting. From 2003 to 2013, the number of tramadol users increased from 2,476 (19.9% of the study population in 2003) to 124,592 (33.3% of the 2013 study population). The absolute change in the proportion of study patients prescribed tramadol (%) was +13.4%, a relative change (%) of +67.3%. In contrast, absolute changes in the number of opioid and NSAID users were -4.78% and -8.65%, respectively, which were relative changes of -73.5% and -11.8%, respectively. Of the studied pain types, arthritis and back pain were the most prominent diagnoses in tramadol users. Notable correlations for tramadol prescriptions, when compared with NSAIDs, were rural area (adjusted odds ratio (aOR): 1.64; 95% CI 1.61-1.66), co-prescription of a benzodiazepine (aOR 2.01; 95% CI 1.97-2.05), and tertiary hospital (aOR: 3.08, 95% CI 3.00-3.17). [ABSTRACT FROM AUTHOR]

Abstract Background Orthopedic surgeries of lower extremities such as total knee arthroplasty (TKA), total hip arthroplasty (THA), and hip fracture surgery (HFS) are widely considered to carry a high risk of developing deep venous thrombosis (DVT) and pulmonary thromboembolism (PTE). Growing attention to epidemiological studies using a healthcare database led us to quantify the risks using a Japanese database to reveal recent medical care for such events. Methods The study comprised 36,947 patients who had undergone orthopedic surgeries of the lower extremities and whose medical information from April 2008 to September 2013 was available. The source population of the database was derived from 100 acute-care hospitals with Diagnosis Procedure Combination. The events were defined by diagnosis, medication, imaging, and laboratory tests. Results A breakdown of patients who underwent orthopedic surgeries by type of surgery showed 13.6% for TKA, 10.4% for THA, 56.8% for HFS, 1.5% for rupture of Achilles tendon, and 18.0% for simple fracture of lower extremities. The incidence for DVT, PTE, and bleeding events by type of surgery was 1.3, 0.2, and 1.0% for TKA; 0.9, 0.2, and 1.1% for THA; and 0.4, 0.1, and 1.8% for HFS, respectively. The population for risk factor analysis consisted of patients with similar background factors who underwent TKA, THA, or HFS. The statistically significant risk factors for PTE analyzed by the backward elimination procedure in a multivariate model were female sex, history of venous thromboembolism (VTE), thrombophilia, and varicose veins of lower extremity. Conclusions The incidence of DVT, PTE, and bleeding events and the risk factors for DVT and PTE in patients by type of orthopedic surgeries of lower extremities found in our study are considered to be rational as they reflect evidence from real-world cases. Trial registration University Hospital Medical Information Network Clinical Trials Registry UMIN000012667

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. [ABSTRACT FROM AUTHOR]

Objective: To explore the temporal dynamic of antidepressant and antipsychotic co‐prescribing in real‐life conditions. Methods: The study was performed using reimbursement data from the French Insurance Healthcare system in a cohort of 118 454 persons with at least one dispensing of antidepressants and/or antipsychotics over the period 2006–2016. Latent class analyses were used to identify homogeneous groups of persons following similar multi‐trajectories of antidepressant and/or antipsychotic dispensing. Multivariate polynomial logistic regression models were used to explore the characteristics independently associated with distinct trajectories. Results: Five multi‐trajectories of antidepressant and/or antipsychotic dispensing were identified: more than half of the sample (58%) had very low antidepressant and antipsychotic use; two groups had chronic (12%) or decreasing (11%) antidepressant use with very low antipsychotic use; two groups used both antidepressants and antipsychotics simultaneously either in an increasing (12%) or chronic (7%) way. Persons with chronic antidepressant–antipsychotic use presented with markers of poor social and mental health conditions. Conclusions: Most persons using antipsychotics over the follow‐up also used antidepressants over the same period. The benefit/risk ratio of these prescribing practices should be further explored as the long‐term efficacy of antidepressant–antipsychotic polypharmacy is poorly documented, while this combination increases the risk of adverse effects. [ABSTRACT FROM AUTHOR]

Abstract Although age- and season-specific effects on fracture risk have been reported, the effects of seasonality across different age groups and for different fracture sites have not yet been clarified. Therefore, our study aimed to comprehensively investigate the effects of seasonality on fracture risk across age and fracture sites using a large-scale population database of fracture incidence. Fracture data were accumulated over a 3-year period in the region of Tokyo and in surrounding areas, which accounts for a total population of 42 million. Information on fracture occurrence, fracture site, and patient demographics were obtained from the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB). Over the study period, 508,051 fractures were identified across the following five age groups: 0–19, 20–39, 40–64, 65–79, and 80+ years. The incidence rate for fractures in 10 site groups was calculated. Fracture risk was the highest in the spring and autumn for children aged 0–19 years and was the highest in the winter for elderly individuals (65–79 and 80+ years). Toe fractures, which occurred more frequently in the summer, were the most notable exception. The risk of fracture of the distal radius and hip was associated with daily temperature and rainfall and was elevated on days with a mean temperature higher than that of the previous day. Fracture risk exhibited seasonal variations that differed between children and elderly individuals and between toe fractures and fractures at other sites. These findings can help us understand the epidemiology of fractures and develop preventive strategies, as well as aid in the allocation of healthcare resources. Highlights • Fracture risk of most bones of arms and legs is highest in spring/autumn (children) and winter (elderly). • For young adults, distal radius fractures are more common in winter, but leg fractures were not. • After 40 years of age, the seasonal pattern of fracture risk is similar to that of elderly individuals. • Unlike other fractures, toe fractures occur the most frequently in summer. • A decrease in mean temperature on successive days lowers the risk of fractures. [ABSTRACT FROM AUTHOR]

Objectives: Abuse of zolpidem has sporadically been reported and little is known regarding nationwide patterns of zolpidem use in Korea. This study investigates the extent of zolpidem usage exceeding the recommended duration and the predictors.Methods: We conducted a drug utilization study using the national sample cohort database of the Korea National Health Insurance Corporation between 2002 and 2013. The study subjects were patients treated with zolpidem in the outpatient setting. An episode was defined as a period of continuous zolpidem therapy. The provider-based episode allowed for a gap of up to 3 days between two consecutive prescriptions from the same institution. The person-based episode allowed for a gap of up to 3 days, regardless of institution. We calculated the proportion of zolpidem use for periods over 30 days and conducted logistic regression analyses to investigate the relevant predictors. An adjusted odds ratio (aOR) with a 95% confidence interval (CI) was estimated for each predictor.Results: The usage of zolpidem is dramatically increased by approximately 18 times since zolpidem was authorized in the market (1181 in 2002 vs. 21,399 in 2013). The treatment duration in 8.3% of episodes exceeded 30 days out of 75,087 zolpidem users. The odds of zolpidem prescription exceeding 30 days were highest in patients aged 65 years and older (aOR = 2.13, 95% CI 1.78-2.53) and at tertiary hospitals (aOR = 2.14, 95% CI 1.68-2.72). Women were more likely than men to be treated with zolpidem for over 30 days.Conclusion: We found dramatic increase of zolpidem use from 2002 to 2013. In 8.3% of the prescribed episodes of zolpidem, the recommended duration was exceeded. Efforts are required to reduce prescriptions that are inconsistent with the recommended guidelines for older patients, women, and in tertiary hospitals. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: To understand the reality of patients who experienced a cardioembolic stroke (CES) is important because of the high incidence of recurrent stroke and the need to account for bleeding risk in relation to the need for anticoagulation treatment. We elucidated the current real-world medical care in patients who had a CES and identified the risk factors for recurrent stroke.Methods and Results: The study comprised 9804 patients who were diagnosed with CES between April 2008 and September 2013 as identified in a healthcare database used by acute-care institutions in Japan. We analyzed the incidence and risk factors of stroke and bleeding events in CES patients. The incidence of stroke was 10.3% during the median observation period of 68 days, mainly consisting of recurrent CES (8.5%). The incidence of bleeding events and intracranial bleeding was 10.3% and 7.0%, respectively. The recurrence of ischemic stroke was significantly lower, and brain hemorrhage was significantly higher in the anticoagulation treatment group. The factors related to an increased risk of stroke were a history of cerebral infarction or transient ischemic attack, diabetes, and increase of CHA2DS2-VASc and CHADS2 scores. The risk factors for bleeding events were hypertension, renal dysfunction, and use of proton pump inhibitors (PPIs).Conclusions: The patients who experienced CES had a high rate of recurrent stroke or CES, mainly consisting of recurrent CES. Although anticoagulation may be beneficial for reducing recurrence of ischemic stroke, careful management is required given consideration of increased risk of brain hemorrhage during anticoagulation treatment, especially for patients with hypertension, renal dysfunction, and use of PPIs. [ABSTRACT FROM AUTHOR]

Background Big data are gaining attention as a valuable resource for providing insights into a range of issues and questions in healthcare. We evaluated the capacity of a Japanese healthcare database to conduct epidemiological research in non-valvular atrial fibrillation (NVAF). Methods and results We examined data collected between April 2008 and September 2013 in a Japanese healthcare database. Prior to the risk factor analysis, we validated the criteria for defining the occurrence of a stroke, systemic embolic event (SEE), and intracranial bleeding event during the study period. The validity was considered appropriate based on the resulting high positive predictive values. The data of 18,998 NVAF patients demonstrated that the incidence rates of stroke, SEE, and any bleeding events were 2.2, 0.08, and 2.4 per 100 patient-years, respectively. In patients who had not been treated with an anticoagulant, incidence of stroke significantly increased in higher CHADS 2 or CHA 2 DS 2 -VASc score, 1.7 and 1.5 fold by 1 point increase, respectively. The use of a proton pump inhibitor (PPI) was also identified as an independent risk factor for stroke. In patients who had been treated with an anticoagulant, the independent risk factors for any bleeding events were hypertension, renal dysfunction, hepatic failure, medical history of stroke, older age (≥65 years), use of nonsteroidal anti-inflammatory drug, and PPIs. Conclusion The data obtained in this study were comparable with results obtained in prospective cohort studies conducted in Japan. [ABSTRACT FROM AUTHOR]

Background Treatment to prevent the recurrence of venous thromboembolism (VTE) and prevent bleeding events should be given to patients with VTE in an appropriate balance in relation to relevant predictors. We elucidated the current medical care in a real world setting and quantified predictors using a Japanese healthcare database. Methods The study included 3578 patients who were diagnosed with VTE between April 2008 and September 2013 at a Japanese acute-care hospital and included in the hospital database. Twenty-four patients who had a VTE event during the 180-day period after enrollment were excluded. We analyzed the incidence of recurrent VTE, incidence of bleeding events, and predictors in VTE patients. Events were defined by disease, medication, imaging, and laboratory testing, among other factors. Results The rate of recurrence of VTE events was 7.2 per 100 patient-years. The incidence rate of bleeding events was 8.3 per 100 patient-years. The presence of malignant disease, antipsychotic drugs, and nonsteroidal anti-inflammatory drugs increased the risk for recurrent VTE. The predictors for bleeding events were malignant disease, central venous catheterization, cancer chemotherapy, stroke, and diabetes. Conclusions These findings obtained from healthcare database suggest predictors either for recurrent VTE and bleeding that should be considered when selecting treatment to reduce the risk of recurrent VTE and mitigate bleeding. [ABSTRACT FROM AUTHOR]

The Bayesian network is a useful method for modeling healthcare issues since it can graphically represent causal relationships among variables and provide probabilistic information. We apply this method to conduct hypertension and hypertension complications incidence analyses using the National Health Insurance Corporation (NHIC) sample cohort database from 2002 to 2010, which contains more than a million prescribers' information, including socio-demographic information, health check-up records, and other information related to medical treatments and medical expenses in South Korea. We select significant factors that affect hypertension and its complications incidence using Cox regression, and perform Bayesian network analysis with respect to those factors. We investigate the causality for hypertension and its complications incidence, and then calculate the conditional probabilities about nodes of interest. In addition, we evaluate performance to predict the incidence of hypertension and its complications. We conclude that the Bayesian network method has several notable advantages. Firstly, it can demonstrate which factors affect hypertension and its complications incidence and how they are related to each other. Secondly, it can calculate conditional probability; thus, we can perform qualitative and quantitative analyses at the same time. [ABSTRACT FROM PUBLISHER]

Objectives: To study risk for cardiovascular disease (CVD) in Japanese patients with rheumatoid arthritis (RA). Methods: We used a Medical Data Vision database mainly composed of health insurance claim data and diagnosis-procedure combination data from Japan. Patients with RA diagnosed from April 2011 to March 2014 at 71 hospitals were identified with the International Classification of Diseases 10th revision (ICD-10) and history of anti-RA drug prescription. Hospitalizations for CVD including ischemic heart disease, heart failure, and stroke were identified by a combination of diagnosis (ICD-10) and diagnostic procedures. CVD incidence rate ratio (IRR) for RA versus osteoarthritis was calculated. Risk factors were analyzed using univariate and multivariate Cox proportional hazard models with baseline C-reactive protein (CRP) and traditional risk factors as covariates. Results: We identified 8658 patients with RA. The age-sex adjusted IRR for RA versus osteoarthritis was high for total CVD [2.12; 95 % confidence interval (CI) 1.93-2.32], ischemic heart disease (2.16; 95 % CI 1.86-2.50), heart failure (2.34; 95 % CI 2.07-2.65), and stroke (1.68; 95 % CI 1.41-2.00). Risk factor analysis showed a tendency for cardiovascular risk to increase with higher baseline CRP, although the difference was not statistically significant (hazard ratio 1.43; 95 % CI 0.99-2.07). Conclusion: Our study indicates an increased risk for CVD and an association between systemic inflammation and CVD in Japanese RA patients. [ABSTRACT FROM AUTHOR]

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