Joselito® and lowering of LDL-cholesterol concentration, blood pressure, and reduction of coronary heart disease risk: Evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006.

Following an application from Cárnicas Joselito S.A. pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Spain, the Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to 'Joselito ham increases antioxidant substances in the body, reduces blood pressure and plasma triglycerides, decreases oxidative stress and prevents effect in diseases related to the cardiovascular and intestinal systems'. The scope of the application was proposed to fall under a health claim referring to disease risk reduction. The food constituent that is the subject of the health claim is Joselito, an Iberian ham characterised by a high content of oleic acid. The Panel considers that the food is sufficiently characterised. The Panel considers that lowering of LDL-cholesterol concentration and blood pressure is a beneficial effect by decreasing the risk of coronary heart disease. Upon a request from EFSA, the applicant identified one human intervention study as being pertinent to the claim. However, due to methodological limitations, the Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panel notes that no human intervention studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant. The Panel concludes that a cause and effect relationship has not been established between the intake of Joselito® ham and the reduction of LDL-cholesterol concentration or blood pressure.

Development and validation of a claims-based algorithm to identify patients with Neuromyelitis Optica Spectrum disorder.

INTRODUCTION: No validated algorithm exists to identify patients with neuromyelitis optica spectrum disorder (NMOSD) in healthcare claims data. We developed and tested the performance of a healthcare claims-based algorithm to identify patients with NMOSD. METHODS: Using medical record data of 101 adults with NMOSD, multiple sclerosis (MS), or myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), we tested the sensitivity and specificity of claims-based algorithms developed through interviews with neurologists. We tested the best-performing algorithm's face validity using 2016-2019 data from IBM MarketScan Commercial and Medicare Supplemental databases. Demographics and clinical characteristics were reported. RESULTS: Algorithm inclusion criteria were age ≥ 18 years and (≥1 NMO diagnosis [or ≥ 1 transverse myelitis (TM) and ≥ 1 optic neuritis (ON) diagnosis] and ≥ 1 NMOSD drug) or (≥2 NMO diagnoses ≥90 days apart). Exclusion criteria were MS diagnosis or use of MS-specific drug after last NMO diagnosis or NMOSD drug; sarcoidosis diagnosis after last NMO diagnosis; or use of ≥1 immune checkpoint inhibitor. In medical record billing data of 50 patients with NMOSD, 30 with MS, and 21 with MOGAD, the algorithm had 82.0% sensitivity and 70.6% specificity. When applied to healthcare claims data, demographic and clinical features of the identified cohort were similar to known demographics of NMOSD. CONCLUSIONS: This clinically derived algorithm performed well in medical records. When tested in healthcare claims, demographics and clinical characteristics were consistent with previous clinical findings. This algorithm will enable a more accurate estimation of NMOSD disease burden using insurance claims datasets.

A retrospective observational study of ibrutinib in chronic lymphocytic leukaemia in a real-life setting in France using the national claims database (OSIRIS).

BACKGROUND: Ibrutinib is a Bruton's tyrosine kinase inhibitor indicated for the first-line treatment and relapse of chronic lymphocytic leukaemia (CLL), Waldenström's macroglobulinemia (WM) and mantle cell lymphoma (MCL). This study aimed to describe the characteristics of CLL patients treated with ibrutinib and its effectiveness, safety, and treatment pattern in real life. METHODS: All patients covered by the general health scheme (approximately 80% of the French population) with a first ibrutinib dispensation from August 1, 2017 (date of reimbursement in France) to December 31, 2020, were identified in the French National Health Insurance database (SNDS). An algorithm was developed to identify the disease (CLL, MCL or WM) for which ibrutinib was prescribed. This article focused on CLL patients. The time to next treatment (TTNT) was plotted using Kaplan‒Meier curves. RESULTS: During this period, 6,083 patients initiated ibrutinib, among whom 2,771 (45.6%) patients had CLL (mean age of 74 years; 61% of men). At ibrutinib initiation, 46.6% of patients had a cardiovascular comorbidity. Most patients (91.7%) were not hospitalized during the exposure period for one of the cardiovascular or bleeding events studied. Hospitalizations were more frequent in patients with a cardiovascular comorbidity (5.9% versus 11.0%, p-value < 0.0001) and aged over 70 (5.9% versus 9.4%, p-value < 0.0001). The median TTNT was not reached. CONCLUSION: This is one of the largest cohorts of ibrutinib-treated patients in the world. The profile of CLL patients treated with ibrutinib was in accordance with the marketing authorization and reimbursement. This study confirmed effectiveness and safety data.

Long-Term HIV Pre-Exposure Prophylaxis Persistence and Reinitiation in Connecticut from 2012 to 2018.

HIV pre-exposure prophylaxis (PrEP) is a highly effective biomedical prevention for HIV infections. PrEP persistence is critical to achieving optimal protection against HIV infection. However, little is known about PrEP persistence in the United States. This study utilized the Connecticut All-Payer Claims Database (APCD) to identify PrEP persistence among patients who filled their PrEP prescriptions in the state. The authors identified 1,576 PrEP patients who picked up PrEP prescriptions and extracted medical and pharmacy claims to evaluate a longitudinal cohort during 2012-2018 based on the Connecticut APCD. Patients who did not pick up medication for one consecutive month (ie, 30 days) were defined as discontinuing PrEP. Kaplan-Meier Survival Curve and proportional hazard regression were used to describe PrEP persistence. Of the 1,576 patients who picked up PrEP prescriptions, the median age was 32.0 (interquartile range [IQR]: 22.0-44.0). The majority were male individuals (93%). Of 1,040 patients who discontinued PrEP, 702 (67.5%) restarted PrEP at least once. The median time of PrEP persistence was 3 months (IQR: 1-6 months) for initial PrEP use. The median time on PrEP was also around 3 months in the following episodes of PrEP use. Being female, being on parent's insurance, and having high co-pays were associated with shorter periods of PrEP persistence. PrEP persistence was low among patients who picked up PrEP prescriptions. Although many patients restarted PrEP, persistence remained low during follow-up PrEP use and possibly led to periods of increased HIV risk. Effective interventions are needed to improve PrEP persistence and reduce HIV incidence.

Longitudinal changes in a claims-based frailty proxy measure compared to concurrent changes in the Fried frailty phenotype.

BACKGROUND: Frailty is a dynamic aging-related syndrome, but measuring frailty transitions is challenging. The Faurot frailty index is a validated Medicare claims-based frailty proxy based on demographic and billing information. We evaluated whether three-year changes in the Faurot frailty index were consistent with concurrent changes in the frailty phenotype in a cohort of older adults. METHODS: We used longitudinal data from the National Health and Aging Trends (NHATS) study with Medicare claims linkage (2010-2018). We identified older adults (66+ years) in the 2011 and 2015 NHATS cohorts with at least one year of Medicare fee-for-service continuous enrollment (N=6,951). We described annual changes in mean claims-based frailty for up to three-years, based on concurrent transitions in the frailty phenotype. RESULTS: At baseline, 32% were robust, 48% prefrail, and 19% frail based on the frailty phenotype. Mean claims-based frailty for older adults who were robust at baseline and worsened to frail increased over three-years (0.09-0.25). Similarly, those who worsened from prefrail to frail experienced an increase in mean claims-based frailty (0.14-0.26). Improvements in the frailty phenotype did not correspond to decreases in claims-based frailty. Older adults whose frailty phenotype improved over time had a lower baseline claims-based frailty score than those who experienced stable or worsening frailty. CONCLUSIONS: Older adults who experienced a frailty phenotype worsening over three years experienced concurrent increases in the Faurot frailty index. Our results suggest that claims data may be used to identify clinically meaningful worsening in frailty.

High disease burden and healthcare resource usage in patients with acute porphyria-A population-based analysis.

BACKGROUND AND AIMS: Acute porphyria is a chronic recurrent disease with late diagnosis, heterogeneous clinical presentations and potentially devastating complications. The study aimed at providing real-world evidence on the natural course of acute porphyria, patient characteristics, disease burden, and healthcare utilization before diagnosis. METHODS: This observational study used anonymized claims data covering 8 365 867 persons from German statutory health insurance, spanning 6 years (2015-2020). Patients with at least one diagnosis of acute porphyria during the index period (2019-2020) were classified into three groups by attack frequency. These findings were compared with two age- and sex-adjusted reference groups: the general population and fibromyalgia patients. Prevalence over the index period was calculated for all porphyria patients and those with active acute porphyria. RESULTS: We revealed a prevalence of 79.8 per 1 000 000 for acute porphyria, with 12.9 per 1 000 000 being active cases. Acute porphyria patients, particularly with frequent attacks, demonstrated a higher comorbidity burden compared to the general population. Within the year before the recorded diagnosis, patients with acute porphyria required a median of 23.0 physician visits, significantly higher than the general population's 16.0. Additionally, 33.8% were hospitalized at least once during this period, a notably higher proportion than the general population (19.3%). CONCLUSIONS: This study's findings, collected before the introduction of givosiran, as the first approved preventive therapy for acute porphyria in Europe, highlight the need for healthcare strategies and policies tailored to the complex needs of acute porphyria patients. The significant healthcare demands, heightened comorbidity burden, and increased healthcare system utilization emphasize the urgency of developing a comprehensive support infrastructure for these patients. Also, these acute porphyria real-world findings provide additional insights on disease characteristics in Germany.

Getting the right tail right: Modeling tails of health expenditure distributions.

Health expenditure data almost always include extreme values, implying that the underlying distribution has heavy tails. This may result in infinite variances as well as higher-order moments and bias the commonly used least squares methods. To accommodate extreme values, we propose an estimation method that recovers the right tail of health expenditure distributions. It extends the popular two-part model to develop a novel three-part model. We apply the proposed method to claims data from one of the biggest German private health insurers. Our findings show that the estimated age gradient in health care spending differs substantially from the standard least squares method.

Impact of COVID-19 on work loss in the United States- A retrospective database analysis.

OBJECTIVES: This study investigates the utilization of work absence benefits among United States (US) employees diagnosed with COVID-19, examining frequency, duration, cost, and types of work loss benefits used. METHODS: This retrospective analysis of the Workpartners Research Reference Database (RRDb) included employees eligible for short- and long-term disability (STD and LTD employer-sponsored benefits, respectively), and other paid work absence benefits from 2018 to 2022. Workpartners RRDb includes over 3.5 million employees from over 500 self-insured employers across the US. Employees were identified by codes from adjudicated medical and disability claims for COVID-19 (2020-2022) and influenza, as well as prescription claims for COVID-19 treatments. Associated payments were quantified for each absence reason. RESULTS: Approximately 1 million employees were eligible for employer-sponsored paid leave benefits between January 2018 and December 2022. The mean age was 37 years (22% >50 years), and 49.4% were females. COVID-19 was the 2nd most common reason for an STD claim (6.9% of all STD claims) and 13th for an LTD claim (1.7% of all LTD claims) from 2020-2022. The mean duration for COVID-19 STD claims was 24 days (N = 3,731, mean claim=$3,477) versus 10 days for influenza (N = 283, mean claim=$1,721). The mean duration for an LTD claim for COVID-19 was 153 days (N = 11, mean claim=$19,254). Only 21.5% of employees with STD claims in the COVID-19 cohort had prior COVID-19-associated medical or pharmacy claims; over half (range 53%-61%) had documented high risk factors for severe COVID-19. CONCLUSION: COVID-19 and influenza have the potential to cause work loss in otherwise healthy employees. In this analysis, COVID-19 was the second most frequent reason for an STD claim at the start of the pandemic and remained high (ranked 5th) in 2022. These results highlight the impact of COVID-19 on work loss beyond the acute phase. Comprehensively evaluating work loss implications may help employers prioritize strategies, such as vaccinations and timely treatments, to mitigate the impact of COVID-19 on employees and their companies.

COVID-19 results in short- and long-term symptoms that may affect employees' ability to work. Short- and long-term disability (STD and LTD, respectively), other work absences, and medical and pharmacy claims from the Workpartners Research Reference Database were analyzed for US adult (≥18 years) employees. COVID-19 claims were identified using the Center for Disease Control and Prevention recommended International Classification of Diseases codes during the analysis from 2020 to 2022. During 2020 to 2022, COVID-19 ranked as the second most frequent reason for STD claims and 13th most frequent among LTD claims. Influenza ranked 58th overall with no LTD claims (2018­2022). The average COVID-19 STD claim lasted 24 days and cost employers $3,477 per claim, and LTD claims averaged 153 days, costing $19,254. Only 21.5% of employees with STD claims in the COVID-19 cohort had prior COVID-19-associated medical or pharmacy claims, and over half (range 53%­61%) had a documented high-risk factor for severe COVID-19. Our results highlight the ongoing and substantial impact of COVID-19 on work absence benefit utilization beyond the acute phase. This analysis demonstrates the need for employers and researchers to review all available medical, pharmacy, and disability claims to assess the acute and long-term impact of COVID-19 on employees and prioritize mitigation strategies to reduce the burden of the virus to their employees.

Burden of illness in patients with pulmonary hypertension due to interstitial lung disease: a real-world analysis.

BACKGROUND: Pulmonary hypertension due to interstitial lung disease (PH-ILD) is associated with high rates of respiratory failure and death. Healthcare resource utilization (HCRU) and cost data are needed to characterize PH-ILD disease burden. METHODS: A retrospective cohort analysis of the Truven Health MarketScan® Commercial Claims and Encounters Database and Medicare Supplemental Database between June 2015 to June 2019 was conducted. Patients with ILD were identified and indexed based on their first claim with a PH diagnosis. Patients were required to be 18 years of age on the index date and continuously enrolled for 12-months pre- and post-index. Patients were excluded for having a PH diagnosis prior to ILD diagnosis or the presence of other non-ILD, PH-associated conditions. Treatment patterns, HCRU, and healthcare costs were compared between the 12 months pre- versus 12 months post-index date. RESULTS: In total, 122 patients with PH-ILD were included (mean [SD] age, 63.7 [16.6] years; female, 64.8%). The same medication classes were most frequently used both pre- and post-index (corticosteroids: pre-index 43.4%, post-index 53.5%; calcium channel blockers: 25.4%, 36.9%; oxygen: 12.3%, 25.4%). All-cause hospitalizations increased 2-fold, with 29.5% of patients hospitalized pre-index vs. 59.0% post-index (P < 0.0001). Intensive care unit (ICU) utilization increased from 6.6 to 17.2% (P = 0.0433). Mean inpatient visits increased from 0.5 (SD, 0.9) to 1.1 (1.3) (P < 0.0001); length of stay (days) increased from 5.4 (5.9) to 7.5 (11.6) (P < 0.0001); bed days from 2.5 (6.6) to 8.0 (16.3) (P < 0.0001); ICU days from 3.8 (2.3) to 7.0 (13.2) (P = 0.0362); and outpatient visits from 24.5 (16.8) to 32.9 (21.8) (P < 0.0001). Mean (SD) total all-cause healthcare costs increased from $43,201 ($98,604) pre-index to $108,387 ($190,673) post-index (P < 0.0001); this was largely driven by hospitalizations (which increased from a mean [SD] of $13,133 [$28,752] to $63,218 [$75,639] [P < 0.0001]) and outpatient costs ($16,150 [$75,639] to $25,604 [$93,964] [P < 0.0001]). CONCLUSION: PH-ILD contributes to a high HCRU and cost burden. Timely identification, management, and treatment are needed to mitigate the clinical and economic consequences of PH-ILD development and progression.

Health Claims for Sports Drinks-Analytical Assessmentaccording to European Food Safety Authority's Scientific Opinion.

In Europe, sports food supplements (SSFs) are subject to specific laws and regulations. Up to 70% of athletes are highly influenced by the information on the label or the advertisement of the SSF, which often does not correspond to the scientific evidence, such as health claims. The aim is to analyze such claims relating to sports drinks (SDs) in commercial messages. To this end, an observational and cross-sectional study was conducted based on the analysis of the content and degree of adequacy of the health claims indicated on the labelling or technical data sheet of the SDs with those established by the European legislation in force according to the European Food Safety Authority (EFSA). The SSFs were searched for via Amazon and Google Shopping. A total of 114 health claims were evaluated. No claim fully conformed with the recommendations. A total of 14 claims (n = 13 products) almost conformed to the recommendations; they were "Maintain endurance level in exercises requiring prolonged endurance", "Improve water absorption during physical exercise", and "Improved physical performance during high intensity, high duration physical exercise in trained adults", representing 12.3% of the total (n = 114). The vast majority of the claims identified indicated an unproven cause-effect and should be modified or eliminated, which amounts to food fraud towards the consumer.

Spinal fusion surgery use among adults with low back pain enrolled in a digital musculoskeletal program: an observational study.

OBJECTIVES: To compare 12-month spinal fusion surgery rates in the setting of low back pain among digital musculoskeletal (MSK) program participants versus a comparison cohort who only received usual care. STUDY DESIGN: Retrospective cohort study with propensity score matched comparison cohort using commercial medical claims data representing over 100 million commercially insured lives. METHODS: All study subjects experienced low back pain between January 2020 and December 2021. Digital MSK participants enrolled in the digital MSK low back program between January 2020 and December 2021. Non-participants had low back pain related physical therapy (PT) between January 2020 and December 2021. Digital MSK participants were matched to non-participants with similar demographics, comorbidities and baseline MSK-related medical care use. Spinal fusion surgery rates at 12 months post participation were compared. RESULTS: Compared to non-participants, digital MSK participants had lower rates of spinal fusion surgery in the post-period (0.7% versus 1.6%; p < 0.001). Additionally, in the augmented inverse probability weighting (AIPW) model, digital MSK participants were found to have decreased odds of undergoing spinal fusion surgery (adjusted odds ratio: 0.64, 95% CI: 0.51-0.81). CONCLUSIONS: This study provides evidence that participation in a digital MSK program is associated with a lower rate of spinal fusion surgery.

Prevalence of Tendon Rupture and Tendinopathies Among Patients with Atherosclerotic Cardiovascular Disease Derived From United States Administrative Claims Data.

INTRODUCTION: The prevalence of tendon rupture and tendinopathies (TRT) has not been determined in a large population of patients with atherosclerotic cardiovascular disease (ASCVD). We investigated TRT prevalence among patients with ASCVD and in the general population, using data from the Symphony Health Integrated Dataverse, a large US medical and pharmacy claims database. METHODS: This retrospective, observational study included patients aged ≥ 19 years from the claims database during the identification period (January 2019 to December 2020) and 12 months of continuous enrollment. The primary outcome was evidence of TRT in the 12 months following the index date (first ASCVD diagnosis in the ASCVD cohort; first claim in the claims database in the overall population). Diagnostic codes (ICD-10 and/or CPT) were used to define ASCVD and TRT diagnosis. RESULTS: The ASCVD cohort and overall population included 5,589,273 and 61,715,843 patients, respectively. In the ASCVD cohort, use of medications with a potential or known association with TRT was identified in 67.9% (statins), 17.7% (corticosteroids), and 16.7% (fluoroquinolones) of patients. Bempedoic acid use was reported in 1556 (< 0.1%) patients. TRT prevalence during 12-month follow-up was 3.4% (ASCVD cohort) and 1.9% (overall population). Among patients with ASCVD, 83.5% experienced TRT in only one region of the body. Factors most associated with TRT in the ASCVD cohort were increasing age, most notably in those aged 45-|64 years (odds ratio [OR] 2.19; 95% confidence interval [CI] 2.07-2.32), obesity (OR 1.51; 95% CI 1.50-1.53), and rheumatoid arthritis (OR 1.47; 95% CI 1.45-1.79). Use of statins or bempedoic acid was not associated with increased TRT risk. CONCLUSION: Patients with ASCVD may have greater risk of TRT than the general population, which may be driven by an increased prevalence of comorbidities and use of medications with a potential or known association with TRT.

Patients with atherosclerosis, the main cause of heart attacks, strokes, and peripheral vascular disease, typically require several drugs to control the disease. Some of the drugs used to treat atherosclerosis have been linked to a higher occurrence of tendon tears (or ruptures) or swelling/inflammation of the tendons (tendinopathies). However, there may be other factors present in these patients that increase the risk of tendon injuries that are not related to these drugs. This study used the medical records of over 5.5 million patients with atherosclerosis and over 63 million patients reflecting the general population in the United States to determine the prevalence of tendon injury. Additionally, the researchers looked at other factors that might be related to a higher risk of tendon injury in each group. Over a 12-month period, tendon injuries occurred in 3.4% of patients with atherosclerosis and 1.8% of patients in the general population. In patients with atherosclerosis, factors such as being obese, older (45­64 years), or having rheumatoid arthritis were also linked to an increased risk of tendon injuries. There was no association seen between statin or bempedoic acid use and tendon injuries. These results may help healthcare providers to determine the underlying risk of tendon injuries and guide treatment of this patient population.

Evaluation of inpatient and emergency department healthcare resource utilization and costs pre- and post-nusinersen for the treatment of spinal muscular atrophy using United States claims.

Aim: Nusinersen, administered by intrathecal injection at a dose of 12 mg, is indicated across all ages for the treatment of spinal muscular atrophy (SMA). Evidence on real-world healthcare resource use (HRU) and costs among patients taking nusinersen remains limited. This study aimed to evaluate real-world HRU and costs associated with nusinersen use through US claims databases. Patients & methods: Using the Merative™ MarketScan® Research Databases, patients with SMA receiving nusinersen were identified from commercial (January 2017 to June 2020) and Medicaid claims (January 2017 to December 2019). Those likely to have complete information on the date of nusinersen initiation and continuous enrollment 12 months pre- and post-index (first record of nusinersen treatment) were retained. Number and costs (US$ 2020) of inpatient admissions and emergency department (ED) visits, unrelated to nusinersen administration, were evaluated for 12 months pre- and post-nusinersen initiation and stratified by age: pediatric (<18 years) and adult (≥18 years). Results: Overall, 103 individuals treated with nusinersen were retained: 59 were pediatric (mean age [range]: 9 [1-17] years), and 44 were adults (30 [18-63] years). Inpatient admissions decreased by 41% for pediatrics and 67% for adults in the 12 months post-treatment versus the 12 months pre-treatment. Average inpatient admission costs per patient for the pediatric cohort decreased by 63% ($22,903 vs $8466) and by 79% ($13,997 vs $2899) for the adult cohort when comparing the 12 months pre-index with the 12 months post-index period. Total ED visits and ED visit costs decreased by 8% and 35%, respectively, for the overall cohort over the 12-month period pre- and post-index. Conclusion: Using US claims databases, nusinersen treatment in pediatric and adult patients was associated with reductions in HRU and costs over a 12-month period post-treatment initiation relative to the pre-treatment period.

Prevalence and disease burden of chronic cough in nine cities of China: an observational study.

BACKGROUND: Chronic cough (CC) is common in the general population of China, creating a difficult-to-ignore public health burden. However, there is a lack of research on the nationwide prevalence and disease burden of CC in the Chinese population. We aim to use an insurance claims database to assess the prevalence and the corresponding economic burden owing to CC in China. METHODS: This was a retrospective observational study based on an administrative medical insurance database in 2015, 2016 and 2017, from nine cities in North, South, East, South-West, and North-West regions of China. The study population was Chinese adults (≥ 18 years old) who had been identified as CC patients. Descriptive data analyses were used in statistical analysis. RESULTS: A total of 44,472, 55,565, and 56,439 patients with mean ages of 53.2 (16.3) years were identified as patients with CC in 2015, 2016, and 2017, respectively. Of these, 55.24% were women. In addition, 8.90%, 9.46%, and 8.37% of all patients in 2015, 2016, and 2017, who had applied for medical insurance, had CC, respectively, with a three-year average probability of 8.88%. The median number of outpatient visits within a calendar year was 27 per year due to any reason during the period of 2015-2017. The median medical cost of each patient per year increased from 935.30 USD to 1191.47 USD from 2015 to 2017. CONCLUSION: CC is common among medical insurance users, with a substantial utilization of medical resources, highlighting the huge burden of CC in China.

Risk of Urogenital Bacterial Infection with Sodium-Glucose Cotransporter-2 Inhibitors: A Retrospective Cohort Study Using a Claims Database.

INTRODUCTION: The association between sodium-glucose cotransporter-2 (SGLT2) inhibitors and the risk of urogenital infections remains controversial. This study aimed to investigate the association between SGLT2 inhibitors and the incidence of perineal soft tissue infections, including Fournier's gangrene (FG), genital bacterial infections, and urinary tract infections (UTIs), using administrative claims data in Japan. METHODS: In this retrospective cohort study, we utilized the JMDC Claims Database. The study included patients aged 18 years or older diagnosed with type 2 diabetes mellitus, identified by a diagnostic code, who received new prescriptions for SGLT2 inhibitors or dipeptidyl peptidase 4 (DPP-4) inhibitors between April 2014 and August 2020. Using one-to-one propensity score (PS) matching, we compared the incidence of perineal soft tissue infections, including FG, genital bacterial infection, and UTIs between groups treated with SGLT2 and DPP-4 inhibitors. Hazard ratios (HR) and their 95% confidence intervals (CI) were estimated using the Cox proportional hazards model. RESULTS: We identified 34,897 patients in the SGLT2 inhibitor group and 135,311 patients in the DPP-4 inhibitor group. After one-to-one PS matching, 31,665 pairs were generated. The mean age of the patients was 51 years, with approximately 70% being male. The use of SGLT2 inhibitors was associated with a decreased risk of UTI (HR 0.90, 95% CI 0.83-0.98) and an increased risk of genital bacterial infection (HR 1.23, 95% CI 1.03-1.46) compared to DPP-4 inhibitors. However, no significant association was observed with perineal soft tissue infection (HR 1.05, 95% CI 0.61-1.81). CONCLUSIONS: SGLT2 inhibitors were associated with a reduced risk of UTI and an increased risk of genital bacterial infection. They showed no significant association with perineal soft tissue infection when compared to DPP-4 inhibitors. Future research should explore broader demographics, focusing on the elderly and achieving gender balance, to gain a comprehensive understanding of infection risks.

Validation of an algorithm to prioritize patients for comprehensive medication management in primary care settings.

BACKGROUND: Comprehensive medication management (CMM) programs optimize the effectiveness and safety of patients' medication regimens, but CMM may be underutilized. Whether healthcare claims data can identify patients appropriate for CMM is not well-studied. AIM: Determine the face validity of a claims-based algorithm to prioritize patients who likely need CMM. METHOD: We used claims data to construct patient-level markers of "regimen complexity" and "high-risk for adverse effects," which were combined to define four categories of claims-based CMM-need (very likely, likely, unlikely, very unlikely) among 180 patient records. Three clinicians independently reviewed each record to assess CMM need. We assessed concordance between the claims-based and clinician-review CMM need by calculating percent agreement as well as kappa statistic. RESULTS: Most records identified as 'very likely' (90%) by claims-based markers were identified by clinician-reviewers as needing CMM. Few records within the 'very unlikely' group (5%) were identified by clinician-reviewers as needing CMM. Interrater agreement between CMM-based algorithm and clinician review was moderate in strength (kappa = 0.6, p < 0.001). CONCLUSION: Claims-based pharmacy measures may offer a valid approach to prioritize patients into CMM-need groups. Further testing of this algorithm is needed prior to implementation in clinic settings.

Validation of self-reported medical condition in the Taiwan Biobank.

BACKGROUND: This study aimed to validate self-reported medical conditions in the Taiwan Biobank (TWBB), in which participants were inquired about 30 disease conditions, by comparing them with claims records from Taiwan's National Health Insurance (NHI) claims database. METHODS: We identified 30 clinical diagnoses using ICD-CM codes from ambulatory and hospital claims within the NHI claims database, matching diseases included in the TWBB. The concordance between self-reports and claims records was evaluated using tetrachoric correlation to assess the correlation between binary variables. RESULTS: A total of 131,834 participants aged 30-70 years with data from the TWBB and NHI records were included. Concordance analysis revealed tetrachoric correlations ranged from 0.420 (chronic obstructive pulmonary disease) to 0.970 (multiple sclerosis). However, several disorders exhibited lower tetrachoric correlations. The concordance was higher among those with higher education attainment, and lower among married individuals. CONCLUSION: The concordance between self-reports in the TWBB and NHI claims records varied across clinical diagnoses, showing inconsistencies depending on participant characteristics. These findings underscore the need for further investigation, especially when these variables are crucial to research objectives. Integrating complementary databases such as clinical diagnoses, prescription records, and medical procedures can enhance accuracy through customized algorithms based on disease categories and participant characteristics and optimize sensitivity or positive predictive values to align with specific research objectives.

Processing and validation of inpatient Medicare Advantage data for use in hospital outcome measures.

OBJECTIVE: To determine the feasibility of integrating Medicare Advantage (MA) admissions into the Centers for Medicare & Medicaid Services (CMS) hospital outcome measures through combining Medicare Advantage Organization (MAO) encounter- and hospital-submitted inpatient claims. DATA SOURCES AND STUDY SETTING: Beneficiary enrollment data and inpatient claims from the Integrated Data Repository for 2018 Medicare discharges. STUDY DESIGN: We examined timeliness of MA claims, compared diagnosis and procedure codes for admissions with claims submitted both by the hospital and the MAO (overlapping claims), and compared demographic characteristics and principal diagnosis codes for admissions with overlapping claims versus admissions with a single claim. DATA COLLECTION/EXTRACTION METHODS: We combined hospital- and MAO-submitted claims to capture MA admissions from all hospitals and identified overlapping claims. For admissions with only an MAO-submitted claim, we used provider history data to match the National Provider Identifier on the claim to the CMS Certification Number used for reporting purposes in CMS outcome measures. PRINCIPAL FINDINGS: After removing void and duplicate claims, identifying overlapped claims between the hospital- and MAO-submitted datasets, restricting claims to acute care and critical access hospitals, and bundling same admission claims, we identified 5,078,611 MA admissions. Of these, 76.1% were submitted by both the hospital and MAO, 14.2% were submitted only by MAOs, and 9.7% were submitted only by hospitals. Nearly all (96.6%) hospital-submitted claims were submitted within 3 months after a one-year performance period, versus 85.2% of MAO-submitted claims. Among the 3,864,524 admissions with overlapping claims, 98.9% shared the same principal diagnosis code between the two datasets, and 97.5% shared the same first procedure code. CONCLUSIONS: Inpatient MA data are feasible for use in CMS claims-based hospital outcome measures. We recommend prioritizing hospital-submitted over MAO-submitted claims for analyses. Monitoring, data audits, and ongoing policies to improve the quality of MA data are important approaches to address potential missing data and errors.

Clinical and patient-level predictors of procedure and tooth survival after direct pulp capping.

BACKGROUND: Historical reports of unpredictable outcomes associated with vital pulpal therapies, particularly direct pulp capping (DPC), have contributed to clinicians' skepticism of the procedure. Contemporary reports highlight more predictable outcomes of vital pulpal therapies, inclusive of DPC. There is a dearth of reported patient-centered outcomes of these procedures. METHODS: Insurance claims were used in an observational, retrospective cohort study to evaluate outcomes of DPC performed on permanent teeth. Statistical analyses included Kaplan-Meier survival estimates and Cox proportional hazards regression. Log-rank tests were used to evaluate unadjusted differences in survival. Cox proportional hazard regression was used to evaluate the adjusted hazard of adverse event occurrence. RESULTS: The analytic cohort included 4,136 teeth from 3,716 patients. DPC procedures were identified in public-payer (85.5%) and private-payer (13.4%) insurance claims databases. After DPC, procedure survival rate was 83% and tooth survival rate was 93% during a mean follow-up time of 52 months. Molar tooth type, same-day permanent restoration placement, and amalgam restoration type were significant positive predictors of procedure (DPC) survival. Age was not a statistically significant predictor of procedure survival after controlling for tooth type, gender, time to restoration, and restoration type. Nonmolar tooth type and younger age were significant positive predictors of tooth survival after DPC. Failures were most likely to occur within the first year. CONCLUSIONS: DPC has favorable patient-centered outcomes and contributes to long-term tooth survival. PRACTICAL IMPLICATIONS: The favorable patient-centered outcomes of DPC bolster calls to consider cost-effectiveness and access to care for endodontic procedures.

Validation of the International Classification of Diseases, Tenth Revision-Clinical Modification Diagnostic Code for Essential Tremor.

Background: The positive predictive value (PPV) of the International Classification of Diseases, Ninth Revision-Clinical Modification (ICD-9-CM) code for "essential and other specified forms of tremor" in identifying essential tremor (ET) cases was found to be less than 50%. The ability of the ICD-10-CM G25.0 code for "essential tremor" to identify ET has not been determined. The study objective was to determine the PPV of the G25.0 code. Methods: Patients in a tertiary health system with a primary care encounter associated with ICD-10-CM code G25.0 in 2022 underwent medical record review to determine if the consensus criteria from the International Parkinson and Movement Disorder Society for an ET diagnosis were met. Results: 442 patients were included. The PPV of G25.0 in identifying probable ET cases was 74.7% (95% confidence interval (CI) 70.4-78.5%). Among patients prescribed propranolol, the PPV improved to 87.8% (95% CI 78.0-93.6%). Discussion: Compared to the ICD-9-CM code 333.1, G25.0 is superior for identifying ET cases. A potential limitation of this study is that the consensus criteria applied relies on nonspecific physical exam findings which may lead to an overestimation of the PPV of G25.0. Highlights: The ICD-10-CM diagnosis code for essential tremor has not been previously validated. The objective of this study was to determine the PPV of the G25.0 code. The PPV in identifying essential tremor cases was 74.7%. The PPV improved among patients prescribed propranolol.