Medical Claims Database Research Articles

The Impact of Comorbid Sleep-Disordered Breathing on Hospitalization Risk Related to Diabetes and Atherosclerotic Disease: A Retrospective Cohort Analysis

Objective: To determine the relationship between comorbid sleep-disordered breathing (SDB) and hospitalization rates related to diabetes mellitus (DM) and atherosclerotic disease (AD). Methods: This study used a retrospective cohort design from a large medical claims database with 5 years of data between 2018 and 2022. The presences of SDB, DM, and AD were identified using International Classification of Diseases (ICD-10) and relevant Current Procedural Terminology (CPT) codes. Hospitalizations related to DM and AD were identified primarily using Place of Service (POS) code 21. Propensity-score matching was first used on data from the entire 5-year period to select matched controls (unadjusted n = 883,910, adjusted n = 888,619) compared to those diagnosed with SDB (n = 519,818) on hospitalization rates during the concurrent 5-year period. A second analysis used propensity-score matching on data from year 1 only to select matched controls (unadjusted n = 248,848, adjusted n = 260,298) compared to those diagnosed with SDB in year 1 (n = 193,671) on hospitalization outcomes in the subsequent 4-year period. Results: Odds ratios (ORs) revealed a significant association between SDB diagnosis and hospitalizations related to DM (OR 1.23–1.71), AD (OR: 1.08–1.34), and either condition (OR 1.17–1.49) in both analyses. Post hoc analysis revealed sex differences in the relationship between SDB and future hospitalizations, with females showing a pattern of significantly elevated risk across all future hospitalization outcomes (OR: 1.25–1.44), whereas males were found to have a significant relationship between SDB diagnosis and future DM hospitalization only (OR 1.10). Conclusions: These findings provide real-world evidence that comorbid SDB increases the risk for hospitalizations related to chronic cardiometabolic conditions. Sex is a potential moderator of this relationship and should be further explored.

Association between alpha blocker use and the risk of fractures in patients with chronic kidney disease: a cohort study

BackgroundAlpha blockers (ABs) are frequently prescribed to patients with chronic kidney disease (CKD), which is often complicated by refractory hypertension (HT). Although there have been several reports on the association between AB use and the risk of fractures, their conclusions have not yet been drawn. Therefore, this study aimed to investigate the association between AB use and the risk of fractures in patients with CKD.MethodThis population-based cohort study used patient data obtained between April 2008 and August 2021 from a large-scale Japanese medical claims database. Consecutive patients with CKD who were newly prescribed ABs or non-AB antihypertensive drugs were included; males and females were analysed separately. The AB group was then divided into AB for HT and voiding dysfunction (VD) groups according to the drug approval in Japan. The primary outcome was the first hospitalisation due to fracture, and the variables were evaluated with weighted Cox proportional hazard model using overlap weights.ResultsA total of 65,012, 4,723, and 10,958 males constituted the non-AB, AB for HT (doxazosin), and AB for VD (naftopidil, silodosin, tamsulosin, or urapidil) groups, respectively. A total of 31,887, 2,409, and 965 females constituted the non-AB, AB for HT (doxazosin or guanabenz), and AB for VD (urapidil) groups, respectively. In males, hazard ratio (HR) for primary outcome was not increased in the non-AB and AB for VD groups compared with the AB for HT group (HR, 0.70; 95% confidence interval [CI], 0.38–1.28 and HR, 1.33; 95% CI, 0.67–2.66, in the non-AB and AB for VD groups, respectively). Whereas, in females, although HR for the primary outcome was not increased in the non-AB group (HR, 1.06; 95% CI, 0.56–1.99), it was significantly increased in the AB for VD group (HR, 2.28; 95% CI, 1.01–5.16) compared with the AB for HT group.ConclusionAB use in patients with CKD did not increase the risk of fractures when used for the treatment of HT; however, it increased the risk of fractures when used for the treatment of VD in females. These results suggest that ABs should be used with caution in these patients.

Nationwide database study of postoperative sequelae and in-hospital mortality in super-elderly hip fracture patients.

The risk of postoperative sequelae and in-hospital mortality in Japanese patients aged 90years and older with hip fractures is unexplored. This study aims to use a comprehensive medical claims database in Japan to compare super-elderly patients aged 90years and older with elderly aged 65-89 and clarify the risk of sequelae and in-hospital mortality in super-elderly patients. We retrospectively analyzed the Diagnosis Procedure Combination (DPC) database for all of Japan from April 2016 to March 2022. Medical records from approximately 1100 DPC-related hospitals were provided with consistent consent during this period. In this study, we focused on super-elderly patients and examined the association with the risk of postoperative pneumonia, pulmonary embolism, myocardial infarction, urinary tract infection, acute renal dysfunction, subsequent cognitive dysfunction, and in-hospital mortality after one-to-one propensity score matching. After performing propensity score matching based on sex and comorbidities, 129,953 pairs of patients were identified. These pairs were compared to elderly and super-elderly patients. The results of this study showed that compared with hip fractures in the elderly, hip fractures in the super-elderly were associated with an increased risk of pneumonia, urinary tract infection, acute renal dysfunction, subsequent cognitive dysfunction, and in-hospital mortality after adjustment for confounders. The odds ratio of in-hospital mortality was 2.190 (95% CI 2.062-2.325). As it has been shown that super-elderly patients with hip fractures are at greater risk of respiratory and urinary tract infections and increased in-hospital mortality, careful attention should be required for perioperative management.

Trends in Ulnar Collateral Ligament Injuries and Surgery From 2010 to 2019: An Analysis of a National Medical Claims Database.

Ulnar collateral ligament (UCL) injuries have been on the rise for the past 3 decades. Current epidemiological studies on the incidence of UCL injuries have been limited to state or regional data. To utilize a large national claims database to determine the rates of UCL injuries and UCL surgical procedures over the past decade (2010-2019) and whether there has been a change in UCL surgical procedure patterns in the United States. Descriptive epidemiology study. The PearlDiver patient claims database was used to identify UCL injuries occurring from 2010 and 2019 that were sustained by male patients between 10 and 34 years of age. The study cohort was divided into 5 age groups (10-14, 15-19, 20-24, 25-29, and 30-34 years). Primary outcomes included the number of patients in each age group who sustained a UCL injury, the number of patients in each age group who underwent surgery, and the mean time from injury to surgery. A total of 19,348 UCL injuries occurred between 2010 and 2019, and 13% required a surgical intervention. Most of the injuries (54%) occurred in the 15- to 19-year group. Patients in the 20- to 24-year group were more likely to undergo surgery versus the 15- to 19-year group. Results demonstrated a trend toward delayed surgical interventions in patients in the 20- to 24-year group in the latter part of the decade. Data suggested that male patients <20 years account for the majority of UCL injuries, while male patients aged between 20 and 24 years are most likely to undergo surgery. Despite a number of targeted injury-prevention strategies and rule changes in sports, the UCL injury rate remained high. Therefore, there is a clear and present need to continue to develop UCL injury-prevention strategies for the younger population.

Patient journey from the appearance of red flags to the diagnosis of transthyretin cardiac amyloidosis (ATTR-CM) in Japan: a nationwide retrospective study using a medical claims database

Abstract Introduction Transthyretin amyloid cardiomyopathy (ATTR-CM) is an under-recognized cause of common cardiovascular conditions in the elderly, with relatively high rates among patients diagnosed with heart failure (HF) with preserved ejection fraction. In addition to cardiac symptoms such as HF, extracardiac symptoms such as carpal tunnel syndrome (CTS) and lumbar spinal stenosis (LSS) are also red flags for ATTR-CM. Tafamidis is currently the only disease-modifying therapy approved for the treatment of patients with ATTR-CM and is likely to be more effective in the earlier stage. Patients with ATTR-CM often undergo a long and difficult diagnostic journey because of the nonspecificity of clinical manifestations, resulting in delays in establishing the correct diagnosis. Purpose To identify the timing of appearance of comorbidities in patients with ATTR-CM during diagnosis. Methods In this retrospective, non-interventional, observational study using a claims database (dataset period: April 1, 2014–August 31, 2021), adult patients with a diagnosis of ATTR-CM or prescription for tafamidis 80 mg were included. The index date was defined as the first date of recording ATTR-CM diagnosis or the prescription of tafamidis 80 mg, whichever was earlier. The baseline period was defined as the period between the index date and 6 months before the index date. The onset date was defined as the first date of recording diagnosis of the first red-flags that was suspicious for ATTR-CM. Results Of 11,101,578 patients in the database, 246 patients with ATTR-CM met the inclusion criteria. A total of 239 patients were included, of whom 139 had received tafamidis 80 mg. The median (range) age at the index date was 79.0 (46.0–95.0) years, and 79.9% (191/239) were male. The most frequently reported comorbidity defined as onset of ATTR-CM was conduction disorders (88.7%) followed by atrial fibrillation/atrial flutter (50.6%), hypertensive heart disease (19.7%), aortic stenosis (15.9%), and hypertrophic cardiomyopathy (11.7%), with the median (interquartile range [IQR]) time to the index date being 15.5 (5.0–24.5), 14.0 (5.0–22.0), 9.0 (2.0–18.0), 5.0 (2.0–16.0), and 12.0 (6.5–21.5) months, respectively (Fig. 1). LSS (23.9%), neuropathy (13.0%), and CTS (7.5%) were frequently observed as extracardiac symptoms at baseline, and the median (IQR) time from appearance to the index date was 19 (9.0–28.0), 5.0 (1.0–16.0), and 18.0 (14.0–25.0) months, respectively (Fig. 2). Conclusions This study elucidated the time lag between the appearance of cardiac and extracardiac complications of ATTR-CM and its diagnosis in real-world clinical settings. These novel findings highlight the potential for earlier detection of ATTR-CM.

Cardiodiabesity: Epidemiology, resource and economic impact

ObjectiveTo assess i) the epidemiology of cardiodiabesity, ii) its association with healthcare resource utilization and cost of care, as well as iii) provide recommendations for its management. MethodsA cohort study of insured adults with early-stage and/or active cardiodiabesity from January 2019 to December 2021 identified through a longitudinal, and de-identified medical and pharmacy claims database was conducted. All patients were followed for one year through December 2022. Conditions include cardiovascular disease, prediabetes, Type 2 diabetes (T2D), chronic kidney disease (CKD), overweight and/or obesity. Rates of progression from early-stage cardiodiabesity to active cardiodiabesity and/or advanced cardiodiabesity with complications; frequency of emergency department, inpatient and outpatient visits; as well as total cost of care over one year were analyzed. ResultsA total of 3,273,813 and 1,628,407 patients had at least one of the comorbid conditions for early-stage and active cardiodiabesity, respectively. Among those with all early-stage cardiodiabesity conditions, 27.4 % progressed to active cardiodiabesity, while 88.4 % of those with all active cardiodiabesity conditions progressed to complications within one year. Predictors of progression from early-stage to active cardiodiabesity were hypertension (OR: 2.31, 95 % CI: 2.29–2.33, p < 0.001), hyperlipidemia (OR: 1.77, 95 % CI: 1.76–1.79, p < 0.001), CKD stages 1 and 2 (OR: 1.74, 95 % CI: 1.69–1.79, p < 0.001), prediabetes (OR: 1.64, 95 % CI: 1.63–1.66, p < 0.001) and living in areas with very high social needs (OR: 1.25, 95 % CI: 1.23–1.26, p < 0.001). Significant predictors of progression from active cardiodiabesity to complications were T2D (OR: 1.88, 95 % CI: 1.81–1.96, p < 0.001), CVD (OR: 1.47, 95 % CI: 1.44–1.51, p < 0.001), CKD stages 3 and 4 (OR: 1.37, 95 % CI: 1.34–1.41, p < 0.001) and obesity (OR: 1.29, 95 % CI: 1.26–1.32, p < 0.001). Average total cost of care increased significantly among those who progressed from one disease phase to the next (p < 0.05). ConclusionsCardiodiabesity is deadly and rapidly progressive with substantial economic burden on the healthcare system. However, it is preventable. Innovative approaches to better understand the holistic impact of cardiodiabesity on total cost of care, early intervention or management to halt disease progression and promote equity, as well as decrease resource utilization are needed.

Effects of SGLT2 inhibitors on the onset of esophageal varices and extrahepatic cancer in type 2 diabetic patients with suspected MASLD: a nationwide database study in Japan

Background & aimSGLT2 inhibitors (SGLT2i) improve hepatic steatosis in patients with type 2 diabetes mellitus (T2DM) and MASLD. We aimed to investigate the impact of SGLT2i on the incidence of liver-related events and extrahepatic cancer compared to DPP4 inhibitors (DPP4i) in patients with T2DM and suspected MASLD using a medical claims database in Japan.MethodsWe conducted a retrospective study using a Japanese medical claims database. Among patients with T2DM who were prescribed SGLT2i or DPP4i (n = 1,628,656), patients with suspected MASLD were classified into SGLT2i (n = 4204) and DPP4i (n = 4204) groups. Effects of SGLT2i on the following outcomes were compared to DPP4i: (1) changes in HbA1c and ALT levels after 6 months, (2) changes in hepatic fibrosis index, and (3) the incidence of liver-related events/extrahepatic cancer over 12 months.ResultsAfter 6 months, DPP4i significantly decreased HbA1c levels compared to SGLT2i. In contrast, SGLT2i significantly decreased ALT levels compared to DPP4i. SGLT2i significantly decreased FIB-4 index compared to DPP4i over 12 months. Although no significant difference was observed in the incidence of overall liver-related events between the two groups, SGLT2i significantly reduced the incidence of esophageal varices (HR 0.12, 95%CI 0.01–0.95, P = 0.044). Moreover, SGLT2i significantly suppressed the incidence of extrahepatic cancer (HR 0.50, 95%CI 0.30–0.84, P = 0.009) compared to DPP4i.ConclusionSGLT2i was more beneficial than DPP4i in improving the hepatic inflammation and fibrosis indices. Moreover, SGLT2i suppressed the incidence of esophageal varices and extrahepatic cancer compared to DPP4i. SGLT2i may suppress life-threatening events in patients with T2DM and suspected MASLD.

6374 Prevalence and risk factor of complications in patients with adult growth hormone deficiency: A retrospective database study

Abstract Disclosure: H. Fukuoka: None. S. Fujio: None. T. Endo: Employee; Self; Novo Nordisk. Stock Owner; Self; Novo Nordisk. S. Tsuboi: Employee; Self; Novo Nordisk. Stock Owner; Self; Novo Nordisk. Though adult growth hormone deficiency (AGHD) is known to lead to increased prevalence of complications, large database studies on AGHD have not been conducted. We investigated the clinical characteristics and prevalence of AGHD-related complications in Japanese patients. We identified 8,809 GH-untreated patients with AGHD from Medical Data Vision claims database between April 2008 and September 2022. In 2020, 3,420 AGHD patients were identified, and their prevalence of complications adjusted for sex and age was higher than that of Japanese general population, 9.3% vs 3.6% for diabetes mellitus (DM), 4.8% vs 1.3% for osteoporosis, and especially 22.0% vs 3.9% for dyslipidemia. We explored the risk factors for the onset of complications using Cox proportional hazard model. Age was significant risk factor for most complications and being female was significant risk factor for osteoporosis. DM was a significant risk factor for dyslipidemia, ischemic heart disease, cerebrovascular disease, and all cause death. AGHD increases the overall risk of metabolic complications, risk factors of these complications were similar to those in general population. Comprehensive treatment approach needs to be considered to alleviate the risk of complications. Presentation: 6/3/2024

Serum Lipoprotein(a) Levels and Their Association with Atherosclerotic Cardiovascular Disease in Japan.

To investigate the distribution of lipoprotein(a) (Lp(a)) and its association with atherosclerotic cardiovascular disease (ASCVD) in Japanese patients at high risk for ASCVD using a health insurance database. Between July 2013 and June 2021, patients eligible for ASCVD prevention according to the 2017 Japan Atherosclerosis Society (JAS) guidelines with documented Lp(a) test results were extracted from the Medical Data Vision claims database and divided into three groups: primary prevention high-risk (Group I), secondary prevention (Group II) and secondary prevention high-risk (Group III). Data on lipid levels, cardiovascular morbidity risk factors and lipid-lowering treatments were extracted. Of 700,580 patients with documented low-density lipoprotein cholesterol (LDL-C), 2,967 (0.42%) were tested for Lp(a). In 2,170 eligible patients, the median [interquartile range] serum concentration of Lp(a) was 13.9 [7.5-24.6] mg/dL, with 151 patients (7.0%) above the recommended risk threshold of ≥ 50 mg/dL. Lp(a) levels increased with risk across all prevention groups. Being in the highest Lp(a) quintile (Q5) was associated with an increased frequency of ASCVD (28.9% versus 18.9% in the lowest quintile (Q1) for unstable angina; 18.7% versus 10.1% for myocardial infarction; 27.9% versus 17.0% for ischemic stroke). In the secondary prevention groups, the proportion of patients meeting an LDL-C target of ＜70 mg/dL decreased from 30.2% in Q1 to 19.0% in Q5 for Group II and from 32.9% to 16.3% for Group III. Despite a high prevalence of Lp(a) ≥ 50mg/dL in Japanese patients at high risk for ASCVD, it found that the Lp(a) testing rate was very low.

A nationwide survey of changes in nutritional management after gastrointestinal cancer surgery over a 12-year period using medical claims database

A nationwide survey of changes in nutritional management after gastrointestinal cancer surgery over a 12-year period using medical claims database

Optimal Pediatric Outpatient Antibiotic Prescribing

In the US, 50% of all pediatric outpatient antibiotics prescribed are unnecessary or inappropriate. Less is known about the appropriateness of pediatric outpatient antibiotic prescribing. To identify the overall percentage of outpatient antibiotic prescriptions that are optimal according to guideline recommendations for first-line antibiotic choice and duration. This cross-sectional study obtained data on any clinical encounter for a patient younger than 20 years with at least 1 outpatient oral antibiotic, intramuscular ceftriaxone, or penicillin prescription filled in the state of Tennessee from January 1 to December 31, 2022, from IQVIA's Longitudinal Prescription Claims and Medical Claims databases. Each clinical encounter was assigned a single diagnosis corresponding to the lowest applicable tier in a 3-tier antibiotic tier system. Antibiotics prescribed for tier 1 (nearly always required) or tier 2 (sometimes required) diagnoses were compared with published national guidelines. Antibiotics prescribed for tier 3 (rarely ever required) diagnoses were considered to be suboptimal for both choice and duration. Primary outcome was the percentage of optimal antibiotic prescriptions consistent with guideline recommendations for first-line antibiotic choice and duration. Secondary outcomes were the associations of optimal prescribing by diagnosis, suboptimal antibiotic choice, and patient- and clinician-level factors (ie, age and Social Vulnerability Index) with optimal antibiotic choice, which were measured by odds ratios (ORs) and 95% CIs calculated using a multivariable logistic regression model. A total of 506 633 antibiotics were prescribed in 488 818 clinical encounters (for 247 843 females [50.7%]; mean [SD] age, 8.36 [5.5] years). Of these antibiotics, 21 055 (4.2%) were for tier 1 diagnoses, 288 044 (56.9%) for tier 2 diagnoses, and 197 660 (39.0%) for tier 3 diagnoses. Additionally, 194 906 antibiotics (38.5%) were optimal for antibiotic choice, 259 786 (51.3%) for duration, and 159 050 (31.4%) for both choice and duration. Acute otitis media (AOM) and pharyngitis were the most common indications, with 85 635 of 127 312 (67.3%) clinical encounters for AOM and 42 969 of 76 865 (55.9%) clinical encounters for pharyngitis being optimal for antibiotic choice. Only 257 of 4472 (5.7%) antibiotics prescribed for community-acquired pneumonia had a 5-day duration. Optimal antibiotic choice was more likely in patients who were younger (OR, 0.98; 95% CI, 0.98-0.98) and were less socially vulnerable (OR, 0.84; 95% CI, 0.82-0.86). This cross-sectional study found that less than one-third of antibiotics prescribed to pediatric outpatients in Tennessee were optimal for choice and duration. Four stewardship interventions may be targeted: (1) reduce the number of prescriptions for tier 3 diagnoses, (2) increase optimal prescribing for AOM and pharyngitis, (3) provide clinician education on shorter antibiotic treatment courses for community-acquired pneumonia, and (4) promote optimal antibiotic prescribing in resource-limited settings.

Estimation of the Eligible Population For Resmetirom Among Adults in the United States for Treatment of Non-Cirrhotic NASH with Moderate-to-Advanced Liver Fibrosis.

As of March 2024, resmetirom is the first and only therapy approved in the United States (US) for the treatment of adults with non-cirrhotic nonalcoholic steatohepatitis (NASH) with moderate-to-advanced liver fibrosis (MALF) consistent with stages F2/F3 fibrosis. Estimates of the diagnosed, treatment-eligible NASH population are poorly understood due to diagnostic variability. This study provides a contemporary estimate of the size of the US resmetirom treatment-eligible population. A dynamic population calculator was developed combining literature, screening guidelines, resmetirom study criteria, and analyses of the NHANES 2017-March 2020 cycle. It computes NASH prevalence, proportion non-cirrhotic NASH with MALF, Year 1 diagnosis, and new diagnoses in Years 2 and 3. NASH prevalence was estimated by applying the American Association of Clinical Endocrinology screening algorithm and recommended NIT cut-offs in the NHANES dataset. The proportion of non-cirrhotic NASH with MALF was informed by analyses of the Forian US integrated medical claims database using NASH and cirrhosis-specific ICD-10-CM codes and FIB-4 scores. NASH diagnosis rates were obtained from published estimates and NHANES responses. Treatment-eligible population growth was projected using published incidence data. Estimates were compared to a NASH budget-impact-analysis (BIA) from the Institute for Clinical and Economic Review (ICER). In the base case, a NASH prevalence of 4.6% was modeled (range 1.3-14.2%). This value was multiplied by the proportion estimated to have non-cirrhotic MALF (i.e., 35%). Published analyses suggest a diagnosis rate of~10% (range 3.3-14.3%) and~16% year-over-year growth in the treatment-eligible population. Assuming a 1-million commercial-member population, the resmetirom treatment-eligible population was estimated as 1255-1699 in Years 1-3 following approval. Sensitivity analyses were conducted and comparison to the ICER BIA was influenced by different diagnosis rates. Estimation of the treatment-eligible population for resmetirom depends importantly on NASH diagnosis rates, which are predicted to be<15% in the 3years after drug approval. Nonalcoholic steatohepatitis (NASH) is an advanced form of nonalcoholic fatty liver disease. Previously there were no treatments for NASH in the United States (US), but as of March 2024, the US Food and Drug Administration (FDA) approved resmetirom (REZDIFFRA™), a once-daily, oral therapy, in conjunction with diet and exercise, under accelerated approval for the treatment of adults (aged 18years or older) with non-cirrhotic NASH with moderate-to-advanced liver fibrosis (MALF), consistent with stages F2-F3. It is not well understood how many diagnosed patients with NASH would be eligible for treatment with resmetirom; thus, this study aimed to estimate the size of the US resmetirom treatment-eligible population. To do so, we created a flexible population calculator that considers how many people have NASH, what proportion would be eligible for resmetirom treatment-i.e., have non-cirrhotic NASH with MALF-and of those how many people would be diagnosed. We used published literature, screening guidelines, resmetirom study criteria, and analyses of national surveys to inform our range of estimates. In the main analysis, we modeled a NASH prevalence of 4.6% (range 1.3-14.2%), which was then limited to the proportion estimated to have non-cirrhotic NASH with MALF (i.e., 35%) and diagnosed (i.e., 10%, range 3.3-14.3%). A year-over-year growth of approximately 16% in the treatment-eligible population was modeled in years following approval. Assuming a population of 1million commercial insurance enrollees, the resmetirom treatment-eligible population was estimated to be 1255-1699 in Years 1-3 following approval. We assessed alternative scenarios and have compared our results to existing models.

Immediate Breast Reconstruction After Mastectomy for Cancer Among US Military Health System Beneficiaries.

In the Military Health System (MHS), women with breast cancer may undergo surgical treatment in military hospitals (direct care) or in the civilian setting via the insurance benefit (private sector care). We conducted this study to determine immediate breast reconstruction rates among women undergoing mastectomy for cancer in the MHS by setting of care. Using the linked Department of Defense's Central Cancer Registry and MHS Data Repository, the Department of Defense's medical claims database, we identified adult women who underwent mastectomy for breast cancer from 1998 to 2014. Patients were then subgrouped by setting of care (direct vs private sector care). The primary outcome was the rate and type of immediate breast reconstruction. Regression models were constructed to determine factors associated with receipt of immediate breast reconstruction. The final sample included 3251 women who underwent mastectomy for cancer in the direct (67.0%) or private sector care (32.6%) settings. The overall rate of immediate breast reconstruction was 29.9% with an upward trend noted throughout the study (P < 0.001). Overall, implant-based reconstruction (81.4%) was more common than tissue-based reconstruction (18.6%). Compared with direct care, the immediate breast reconstruction rate was significantly higher in the private sector care setting (49.3% vs 20.5%, P < 0.001) despite accounting for differences in clinical characteristics (adjusted odds ratio = 4.51, 95% confidence interval [3.72-5.46]). Immediate breast reconstruction in the direct care setting lags that in the civilian community during the study time period. Further research is needed to ascertain current immediate reconstruction rates and understand factors contributing to any differences in rates between care settings.

Characteristics and real-world medication persistence of people living with HIV treated with DTG/3TC or BIC/FTC/TAF: a hospital claims database study in Japan.

As the life expectancy of people living with human immunodeficiency virus (HIV) (PLWH) has improved, chronic disease burden and polypharmacy have increased in PLWH. Simplification of the antiretroviral therapy (ART) regimen for PLWH has become crucial. The real-world treatment patterns and medication persistence of the 2-drug single-tablet regimen (STR), dolutegravir/lamivudine (DTG/3TC), compared to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) prescribed were investigated. This retrospective, database study extracted data from a hospital-based medical claims database in Japan. The changes in ART distributions by year during the identification period between January 1, 2018 and December 31, 2021 were observed. Patients with disease record of HIV-1 infection and prescribed DTG/3TC or BIC/FTC/TAF as the first prescription of STR during the identification period were divided into two cohorts; DTG/3TC cohort and BIC/FTC/TAF cohort, respectively. Patient without medication records more than 3 months and no future data more than 6 months were excluded. Patients' characteristics were compared between the DTG/3TC cohort and the BIC/FTC/TAF cohort by Mantel-Haenszel test to adjust for age. Medication persistence was compared between the two cohorts by evaluating the continuation rates using Kaplan-Meier methods, using the log-rank test to assess the difference between the Kaplan-Meier curves. The median time-to-first prescription was compared between the two cohorts by Kaplan-Meier methods. Prescriptions of DTG/3TC and BIC/FTC/TAF increased steadily from 2019 to 2021 after the release year of each STR. There was no significant difference in the time-to-first prescription (p = 0.3). A total of 959 patients were included, with 120 patients and 839 patients on DTG/3TC and BIC/FTC/TAF, respectively. The proportion of dyslipidemia at baseline was significantly higher in the DTG/3TC cohort than in the BIC/FTC/TAF cohort after adjusting for mean age (p = 0.002). There was no significant difference in medication persistence between the two cohorts (p = 0.91). This study showed that DTG/3TC was likely to be selected for elderly patients and those with chronic disease in real-world clinical practice, which seems in accordance with the treatment strategy recommended by guidelines. Comparable medication persistence was observed with both regimens, aligning with findings from other countries. The 2-drug single-tablet regimen DTG/3TC may be an important ART regimen for PLWH with multiple morbidities and polypharmacy in an aging society. Due to the limitations of the database, further research to assess viral loads, emergence of resistance and adverse events will be encouraged.

Changes in use of acute and preventive medications for migraine after erenumab initiation over 12 months: A United States retrospective cohort study.

To assess changes in real-world use of acute and preventive medications for migraine over a 12-month follow-up period in the United States following initiation of the anti-calcitonin gene-related peptide (CGRP) pathway monoclonal antibody (mAb) erenumab. Early assessments of real-world use of acute and preventive medications for migraine after initiation of erenumab have been limited to 6 months of follow-up. This retrospective cohort study used data from the IQVIA open-source longitudinal prescription (LRx) and medical (Dx) claims databases. Adult patients with an initial claim (index date) for erenumab between May 2018 and April 2020 were identified. Among 201,176 patients who met inclusion criteria, the mean (standard deviation [SD]) age was 47.5 (13.8) years and 85.6% (n = 172,153) were female. Most patients used one or more acute (88.4%; n = 177,795) and one or more traditional preventive (86.1%; n = 173,225) medications during the 12-month pre-index period. Adherence to erenumab (proportion of days covered [PDC] ≥0.80) was 40.2% (n = 80,927) with an overall mean (SD) PDC of 0.60 (0.34). Among all patients, 70.0% (n = 140,809) discontinued erenumab. After accounting for 24.7% (n = 49,720) of patients who restarted erenumab, discontinuation without reinitiation was observed in 45.3% (n = 91,089) of total patients. Switching to a different anti-CGRP pathway mAb was observed in 13.1% (n = 26,446) of total patients. Among 177,795 patients with pre-index use of one or more acute migraine medication class, 86.5% (n = 153,788) had post-index use of the same class, and 56.7% (87,134/153,788) of them discontinued one or more class of acute medication in the 12-month follow-up period. Similarly, among 173,225 patients with pre-index use of one or more traditional migraine preventive medication class, 67.7% (n = 117,274) had post-index use of the same class, and 46.7% (54,790/117,274) of them discontinued one or more class of traditional preventive medication in the 12-month follow-up period. In this long-term study, we observed the discontinuation of both acute and preventive medications for migraine post-erenumab initiation.

Tuberculosis risk in patients with Crohn's disease on biologics: a retrospective analysis of the Japanese Medical Claims Database.

Treatment using tumor necrosis factor-α (TNF-α) inhibitors is one of the risk factors for active tuberculosis (TB) in patients with Crohn's disease (CD). Biologics, such as ustekinumab (UST) and vedolizumab (VDZ), are less likely to cause opportunistic infections. However, large-scale studies for active TB and biologics other than TNF-α inhibitors are limited. We aimed to investigate the association between biologics and active TB utilizing a Japanese medical claims database. We analyzed retrospectively the association of the risk of active TB development with treatment using TNF-α inhibitors and other biologics (UST and VDZ) in patients with CD using the Japanese Medical Data Vision (MDV) database between April 2008 and June 2022. The durations of each biologic and biologic-free treatment were calculated for each patient. Univariate and multivariate analyses were performed using the Cox proportional hazards model, with the utilization of biologics considered as time-dependent covariates. We included 28,811 patients with CD in MDV database. Finally, 17,169 patients were analyzed. In total, 7,064 patients were categorized as biologic-naïve, while 10,105 were classified as biologic-experienced. Seventeen patients developed active TB, including 7 on infliximab, 5 on adalimumab, and 5 on no biologics. None of the patients treated with UST and VDZ developed active TB. Multivariate analysis suggested that TNF-α inhibitors were the risk factors for active TB (hazard ratio, 3.66; P= 0.020). TNF-α inhibitors, but not UST or VDZ, are risk factors for active TB in Japanese patients with CD.

Bridging Real-World Data Gaps: Connecting Dots Across 10 Asian Countries.

The economic trend and the health care landscape are rapidly evolving across Asia. Effective real-world data (RWD) for regulatory and clinical decision-making is a crucial milestone associated with this evolution. This necessitates a critical evaluation of RWD generation within distinct nations for the use of various RWD warehouses in the generation of real-world evidence (RWE). In this article, we outline the RWD generation trends for 2 contrasting nation archetypes: "Solo Scholars"-nations with relatively self-sufficient RWD research systems-and "Global Collaborators"-countries largely reliant on international infrastructures for RWD generation. The key trends and patterns in RWD generation, country-specific insights into the predominant databases used in each country to produce RWE, and insights into the broader landscape of RWD database use across these countries are discussed. Conclusively, the data point out the heterogeneous nature of RWD generation practices across 10 different Asian nations and advocate for strategic enhancements in data harmonization. The evidence highlights the imperative for improved database integration and the establishment of standardized protocols and infrastructure for leveraging electronic medical records (EMR) in streamlining RWD acquisition. The clinical data analysis and reporting system of Hong Kong is an excellent example of a successful EMR system that showcases the capacity of integrated robust EMR platforms to consolidate and produce diverse RWE. This, in turn, can potentially reduce the necessity for reliance on numerous condition-specific local and global registries or limited and largely unavailable medical insurance or claims databases in most Asian nations. Linking health technology assessment processes with open data initiatives such as the Observational Medical Outcomes Partnership Common Data Model and the Observational Health Data Sciences and Informatics could enable the leveraging of global data resources to inform local decision-making. Advancing such initiatives is crucial for reinforcing health care frameworks in resource-limited settings and advancing toward cohesive, evidence-driven health care policy and improved patient outcomes in the region.

Generalizability of Heat-related Health Risk Associations Observed in a Large Healthcare Claims Database of Patients with Commercial Health Insurance.

Extreme ambient heat is unambiguously associated with a higher risk of illness and death. The Optum Labs Data Warehouse (OLDW), a database of medical claims from US-based patients with commercial or Medicare Advantage health insurance, has been used to quantify heat-related health impacts. Whether results for the insured subpopulation are generalizable to the broader population has, to our knowledge, not been documented. We sought to address this question, for the US population in California from 2012 to 2019. We examined changes in daily rates of emergency department encounters and in-patient hospitalization encounters for all-causes, heat-related outcomes, renal disease, mental/behavioral disorders, cardiovascular disease, and respiratory disease. OLDW was the source of health data for insured individuals in California, and health data for the broader population were gathered from the California Department of Health Care Access and Information. We defined extreme heat exposure as any day in a group of 2 or more days with maximum temperatures exceeding the county-specific 97.5th percentile and used a space-time-stratified case-crossover design to assess and compare the impacts of heat on health. Average incidence rates of medical encounters differed by dataset. However, rate ratios for emergency department encounters were similar across datasets for all causes [ratio of incidence rate ratios (rIRR) = 0.989; 95% confidence interval (CI) = 0.969, 1.009], heat-related causes (rIRR = 1.080; 95% CI = 0.999, 1.168), renal disease (rIRR = 0.963; 95% CI = 0.718, 1.292), and mental health disorders (rIRR = 1.098; 95% CI = 1.004, 1.201). Rate ratios for inpatient encounters were also similar. This work presents evidence that OLDW can continue to be a resource for estimating the health impacts of extreme heat.

Do Orally Disintegrating Tablets Facilitate Medical Adherence and Clinical Outcomes in Patients with Post-stroke Dysphagia?

Orally disintegrating tablets (ODTs) dissolve rapidly in contact with saliva and have been reported to facilitate oral administration of medications in swallowing difficulties. However, their clinical benefits remain unclear because no previous studies have examined whether ODTs facilitate medication adherence and clinical outcomes in patients with post-stroke dysphagia. This study evaluated the association between ODT prescriptions and clinical benefits using high-dimensional propensity score (hd-PS) matching to adjust for confounding factors. Using a large Japanese commercial medical and dental claims database, we identified patients aged ≥ 65years with post-stroke dysphagia between April 2014 and March 2021. To compare 1-year outcomes of medication adherence, cardiovascular events, and aspiration pneumonia between patients taking ODTs and non-ODTs, we performed hd-PS matching. We identified 11,813 patients without ODTs and 3178 patients with ODTs. After hd-PS matching, 2246 pairs were generated. Medication adherence for 1year, based on the proportion of days covered, was not significantly different between the non-ODT and ODT groups before (0.887 vs. 0.900, P = 0.999) and after hd-PS matching (0.889 vs. 0.902, P = 0.977). The proportion of cardiovascular events (0.898 vs. 0.893, P = 0.591) and aspiration pneumonia (0.380 vs. 0.372, P = 0.558) were also not significantly different between the groups. This study found no significant differences in medication adherence, cardiovascular diseases, or aspiration pneumonia between the non-ODT and ODT groups in patients with post-stroke dysphagia. Both groups achieved a proportion of days covered exceeding 80%. Clinicians may consider prescribing ODTs or non-ODTs based on patient preferences rather than solely on post-stroke conditions.

Endophthalmitis Rates and Types of Treatments After Intraocular Procedures

Long-term trend analyses of overall endophthalmitis rates and treatment patterns are scarce. It is also unknown if the deviation from the recommendations of the Endophthalmitis Vitrectomy Study toward decreased utilization of vitrectomy is associated with different vision outcomes. To determine whether the rate of endophthalmitis after intraocular procedures or the primary treatment (prompt vitrectomy vs tap and inject) for endophthalmitis has changed over the past 20 years. This cohort study examined data for cohorts created by querying for different intraocular procedures, including intravitreal injections and surgeries for cataract removal, glaucoma, retinal conditions, and corneal transplants from 2000 to 2022. The data source was a US administrative medical claims database comprising commercial and Medicare Advantage insurance plans. Any intraocular procedure with at least 6 months of data available before and 6 weeks after the procedure was eligible. Exclusion criteria consisted of any previous diagnosis of endophthalmitis or another intraocular procedure during the follow-up period. The main outcomes were rate of postprocedure endophthalmitis and relative rate of prompt vitrectomy (vs tap and inject) as the primary method of treatment. Among 2 124 964 patients, the mean (SD) age was 71.4 (10.2) years; 1 230 320 were female and 894 414 male. Over 22 years, 5 827 809 intraocular procedures were analyzed with 4305 cases of endophthalmitis found for an overall endophthalmitis rate of 0.07%. The yearly rate of endophthalmitis varied but generally declined from a high of 7 cases per 3502 procedures (0.20%) in 2000 to a low of 163 cases per 332 159 procedures (0.05%) in 2022. The percentage of cases treated with prompt vitrectomy also varied but generally declined over time with a high of 17 of 35 (48.6%) in 2003 and a low of 60 of 515 (11.6%) in 2021. Multivariable analysis of the endophthalmitis incidence rate ratio (IRR) showed a per-year decrease of 2.7% (IRR, 0.97; 95% CI, 0.97-0.98; P < .001) over the study period. A similar analysis also showed that the incidence rate of prompt surgical treatment decreased by 3.8% per year throughout the study period (IRR, 0.96; 95% CI, 0.95-0.97; P < .001). This study found that the incidence of endophthalmitis following intraocular procedures appears to have decreased substantially over the past 20 years while prompt vitrectomy is being used less frequently as primary treatment than in the past.