A flexible approach to measure care coordination based on patient-sharing networks.

BACKGROUND: Effective care coordination may increase clinical efficiency, but its measurement remains difficult. The established metric "care density" (CD) measures care coordination based on patient-sharing among physicians, but it may be too rigid to generalize across disorders and countries. Therefore, we propose an extension called fragmented care density (FCD), which allows varying weights for connections between different types of providers. We compare both metrics in their ability to predict hospitalizations due to schizophrenia. METHODS: We conducted a longitudinal cohort study based on German claims data from 2014 through 2017 to predict quarterly hospital admissions. 21,016 patients with schizophrenia from the federal state Baden-Württemberg were included. CD and FCD were calculated based on patient-sharing networks. The weights of FCD were optimized to predict hospital admissions during the first year of a 24-month follow-up. Subsequently, we employed likelihood ratio tests to assess whether adding either CD or FCD improved a baseline model with control variables for the second follow-up year. RESULTS: The inclusion of FCD significantly improved the baseline model, Χ2(1) = 53.30, p < 0.001. We found that patients with lower percentiles in FCD had an up to 21% lower hospitalization risk than those with median or higher values, whereas CD did not affect the risk. CONCLUSIONS: FCD is an adaptive metric that can weight provider relationships based on their relevance for predicting any outcome. We used it to better understand which medical specialties need to be involved to reduce hospitalization risk for patients with schizophrenia. As FCD can be modified for different health conditions and systems, it is broadly applicable and might help to identify barriers and promoting factors for effective collaboration.

The impact of Germany's human papillomavirus immunization program on HPV-related anogenital diseases: a retrospective analysis of claims data from statutory health insurances.

PURPOSE: Human papillomavirus (HPV) is the most common sexually transmitted infection, responsible for multiple HPV-related diseases, including almost all cervical cancers. The highly effective HPV vaccination has been recommended under the German HPV national immunization program (NIP) since 2007 and is reimbursed by health insurances. Vaccination uptake rates, however, remain suboptimal and data on the real-world impact of HPV vaccination in Germany are lacking. This study aims to demonstrate the population-level impact of Germany's NIP on HPV-related anogenital diseases among young women. METHODS: Retrospective claims data analysis using a classic impact study design comparing disease prevalence among 28- to 33-year-old women before and after introduction of the HPV-immunization program in Germany. Claims data representing approximately two thirds of German health insurances were used. HPV-related disease outcomes included cervical cancer and high grade precancers (cervical intraepithelial neoplasia (CIN) 2+), anogenital warts, as well as vulvar, vaginal, and anal precancer/cancer. RESULTS: Significant declines were seen for CIN2+, anogenital warts, and vaginal precancer/cancer. Prevalence of CIN2+ declined 51.1% from 0.92% (95% CI = 0.78%, 1.08%) to 0.45% (95% CI = 0.38%, 0.53%). There was a 38.6% decline in anogenital warts prevalence from 0.44% (95% CI = 0.36%, 0.54%) to 0.27% (95% CI = 0.22%, 0.32%) and 75.0% decline in vaginal precancer/cancer prevalence from 0.04% (95% CI = 0.02%, 0.07%) to 0.01% (95% CI = 0.00%, 0.02%). CONCLUSION: The German HPV-immunization program has led to significant declines in female anogenital disease among young women in Germany, highlighting the importance of the vaccination. Moreover, the data suggest that increasing vaccination coverage in Germany could further strengthen the public-health impact of its HPV-immunization program.

Epidemiology of Tumor-Induced Osteomalacia in Germany Based on Real World Data.

Tumor-induced osteomalacia (TIO) is an ultra-rare disease caused mostly by benign tumors that secrete fibroblast growth factor-23. Because of nonspecific symptoms, the diagnostic delay is long, and therapy can be challenging. Moreover, epidemiological data on TIO are scarce owing to its rarity. Therefore, this study aimed to quantify TIO's incidence rates and prevalence in Germany. Retrospective longitudinal and cross-sectional analyses were conducted using anonymized German claims data from the statutory health insurance (SHI) database. This database, which comprises the data of approximately 5 million insurants, is a representative sample of the German population and supports national projections. As there is no unique International Statistical Classification of Diseases and Related Health Problems (ICD) code for TIO, operational categories based on different surrogates were defined to determine the prevalence and incidence rates of TIO among probable patients. This study showed that TIO has a prevalence of (documented code, advanced imaging, medication, or tumor removal) 0.187 per 100,000 persons and an incidence rate of ≤ 0.094 per 100,000 person years. This analysis provides the first epidemiological insight into German patients with TIO. Despite the general limitations associated with the analysis of SHI claims data of ultra-rare diseases, we believe that this analysis provides a sound basis for further analysis, particularly with regard to the care situation of patients with TIO.

Incidence, Prevalence, Hospitalization Rates, and Treatment Patterns in Myasthenia Gravis: A 10-Year Real-World Data Analysis of German Claims Data.

BACKGROUND: Myasthenia gravis (MG) is a rare chronic autoimmune disease caused by autoantibodies directed against postsynaptic antigens of the neuromuscular junction. Over the last decades, increasing incidence and prevalence rates have been reported. Epidemiological data on prevalence and incidence in Germany are lacking. Furthermore, the MG treatment landscape is rapidly changing due to the continued approval of novel monoclonal antibodies. METHOD: This is a retrospective study assessing incidence, prevalence, and hospitalization rates of MG as well as treatment patterns in Germany over 10 years based on medical claims data covering 6.1 million insured persons. RESULTS: Between 2011 and 2020, the prevalence rate of MG increased from 15.7 to 28.2 per 100,000 person-years. The age-adjusted incidence rate was 2.8 per 100,000 person-years within the study period (95% confidence interval, 2.43-3.22) and decreased dramatically in 2020, the year of the COVID-19 pandemic. Similarly, the hospitalization rate fluctuated within the study period but reached an overall low of 8.3% in 2020 (mean hospitalization rate 11.5%). Treatment patterns showed that most MG patients are treated with base therapy. However, crisis intervention is necessary for 2-5% of MG patients, and therapeutic monoclonal antibodies, including rituximab and eculizumab, are increasingly used. CONCLUSION: This is the first study on MG prevalence and incidence rates in Germany. Data show an increase in prevalence by 1.8-fold over 10 years. Decreasing incidence and hospitalization rates in 2020 hint at the impact of the COVID-19 pandemic. Treatment patterns in MG are changing with the advent of therapeutic monoclonal antibodies in this indication.

Need for nursing care after laparoscopic and open colorectal cancer surgery: a claims data analysis in German primary care.

PURPOSE: Our study analyzes the influence of minimally invasive vs. open surgery on the postoperative need for nursing care in patients with colorectal carcinoma. Colorectal cancer is an age-related disease, and oncologic surgery is increasingly performed in elderly patients. Long-term effects of the procedural choice on patients' self-sufficiency and autonomy have not been scientifically addressed so far. METHODS: Multivariable logistic regression models based on claims data from a statutory health insurer (AOK, Baden-Württemberg, Germany) were applied to assess potential risk factors for assignment patients to a nursing care level, a German scale to categorize individual need for nursing care, at 12 and 36 months after colorectal cancer surgery. RESULTS: A total of 3996 patients were eligible to be included in the analysis. At 36 months postoperatively, 44 of 427 (10.3%) patients after minimally invasive colon cancer surgery and 231 of 1287 (17.9%) patients after open procedure were newly graded into a nursing care level (OR = 0.62, 95%CI = 0.44-0.90, p = 0.010). Thirty-four of 251 (13.5%) patients receiving minimally invasive rectal cancer surgery compared to 142 of 602 (23.6%) patients after open approach were newly assigned to a nursing care level (OR = 0.53, 95%CI = 0.34-0.81, p = 0.003). CONCLUSIONS: Laparoscopically assisted resection of colorectal cancer seems to be superior in preserving physical autonomy of elderly patients with colorectal cancer.

Impact of initiation of amikacin liposome inhalation suspension on hospitalizations and other healthcare resource utilization measures: a retrospective cohort study in real-world settings.

BACKGROUND: Mycobacterium avium complex lung disease (MAC-LD) is an infection that is increasing in frequency, associated with substantial disease burden, and often refractory to treatment. Amikacin liposome inhalation suspension (ALIS) is the first therapy approved for refractory MAC-LD. In the CONVERT study of adult patients with refractory MAC-LD, adding ALIS to a multidrug background regimen showed evidence of MAC infection elimination in sputum by month 6, which was maintained in most patients through the end of treatment (≤ 12 months post-conversion). This study assessed changes in healthcare resource utilization (HCRU) among patients initiating ALIS in real-world settings. METHODS: This retrospective cohort study of the All-Payer Claims Database (October 2018-April 2020) included patients aged ≥ 18 years with ≥ 1 pharmacy claim for ALIS and ≥ 12 months of continuous health plan enrollment pre- and post-ALIS initiation. Respiratory disease-related (and all-cause) HCRU (hospitalizations, length of stay [LOS], emergency department [ED] visits, and outpatient office visits) were compared 12 months pre- and post-ALIS initiation. Outcomes were reported at 6-month intervals; 0-6 months pre-ALIS initiation was the reference period for statistical comparisons. RESULTS: A total of 331 patients received ALIS, with HCRU highest in the 6 months pre-ALIS initiation. Compared with 26.9% during the reference period, respiratory-related hospitalizations decreased to 19.3% (P < 0.01) and 15.4% (P < 0.0001) during 0-6 and 7-12 months post-ALIS initiation, respectively. Mean number of respiratory disease-related hospitalizations per patient/6-month period decreased from 1.0 (reference period) to 0.6 (P < 0.0005) at both timepoints post-ALIS initiation. A similar pattern was observed for all-cause hospitalizations and hospitalizations per patient/6-month period (both P < 0.005). Reductions in all-cause and respiratory disease-related LOS post-ALIS initiation were significant (both P < 0.05). ED visits were few and unchanged during the study. Significant reductions per patient/6-month period in all-cause and respiratory-related outpatient office visits were observed post-ALIS initiation (all P < 0.01). CONCLUSIONS: In this first real-world study of ALIS, respiratory disease-related (and all-cause) hospitalizations and outpatient visits were reduced in the 12 months following ALIS initiation. The results of this study provide HCRU-related information to better understand the impact of initiating ALIS treatment. TRIAL REGISTRATION: Not appliable.

Trends and patterns in the practice of pediatric sedation for magnetic resonance imaging in Japan: A longitudinal descriptive study from 2012 to 2019.

BACKGROUND: Worldwide, pediatric sedation for magnetic resonance imaging is a standard practice; however, there are few studies on its trends and patterns. AIMS: This study aimed to investigate the trends and patterns of pediatric sedation for magnetic resonance imaging in Japan and determine the incidence of and risk factors for adverse events/interventions. METHODS: This longitudinal descriptive study assessed children (age < 15 years) who underwent sedation for magnetic resonance imaging between April 2012 and December 2019 in Japan using a nationwide claims database. We assessed the patients' demographic characteristics, time trends in sedatives, sedative patterns by age, and adverse events/interventions within two post-sedation days. Further, we used multivariable logistic regression models to explore factors related to the incidence of adverse events/interventions. RESULTS: We identified 29 187 cases (median age, 2.0 years; 55.2% males). The most common sedative was triclofos sodium (n = 18 812, 51.7%). There was an increasing trend in barbiturate use (17.0% [2012] to 25.0% [2019]) and decreasing trends in the use of triclofos sodium (56.4% [2012] to 47.7% [2019]) and chloral hydrate (15.6% [2012] to 10.8% [2019]). We identified 534 adverse events/interventions in 460 cases (1.5%). Multivariable logistic regression analyses revealed that the incidence of adverse events/interventions mainly increased with the number of sedatives (≥3; adjusted odds ratio, 5.10; 95% confidence interval, 3.67-7.10) and unscheduled setting (adjusted odds ratio, 6.28; 95% confidence interval, 4.85-8.61); further, it decreased with high hospital procedure volume (adjusted odds ratio, 0.62; 95% confidence interval, 0.49-0.78). CONCLUSIONS: Based on a Japanese real-world setting, there is an increasing trend in barbiturate use and decreasing trends in the use of triclofos sodium and chloral hydrate in pediatric sedation for magnetic resonance imaging. Low hospital procedure volumes were associated with an increased risk of adverse events/interventions.

Burden of CIN2+ diagnoses and conizations in women aged 18-45 years-a retrospective secondary data analysis of German statutory health insurance claims data.

PURPOSE: High grade cervical intraepithelial neoplasia (CIN2+) may progress to cervical cancer. They may be detected by screening and are usually treated by conization. This study aimed at assessing annual proportions of screening, prevalent and incident CIN2+ diagnoses, as well as proportions of (re-)conizations during 24 months follow-up after conization in Germany. METHODS: A descriptive retrospective claims data analysis of the years 2013-2018 was conducted using the InGef Research Database. Women aged 18-45 years with CIN2+ diagnoses were identified by ICD-10-GM codes (N87.1, N87.2, D06.-, and C53.-). Cervical conizations were identified by OPS codes (5-671.0* or 5-671.1*). Screening participation was identified by EBM codes (01730, 01733, 32819 or 32820). Annual proportions were calculated as women with the respective documented codes divided by all women in the respective age group per calendar year. RESULTS: Overall annual proportions of screened women spanned from 60.01 to 61.33% between 2013 and 2018. The overall annual prevalence of CIN2+ diagnoses (regardless of screening participation) ranged from 0.72 to 0.84% between 2013 and 2018, with highest proportions observed in women aged 27-45 years. Also, CIN2+ incidence was highest in women 27-45 years. Annual proportion of women undergoing conization was 0.24% in 2013 and 0.21% in 2018. During a 24-month follow-up period after conization, 2.91% of women underwent a re-conization 3 months or later after the initial conization. CONCLUSION: This analysis demonstrates a considerable burden of CIN2+, conizations and re-conizations in Germany, especially in women aged 27-45 years. This highlights the need for intensified prevention efforts such as expanding human papillomavirus (HPV) vaccination.

[Epidemiology and treatment of adult patients with atopic dermatitis : Analysis of longitudinal data of the statutory health insurance scheme]. / Epidemiologie und Therapie von erwachsenen Patienten mit atopischer Dermatitis : Analyse von Längsschnittdaten der gesetzlichen Krankenversicherung.

BACKGROUND: The goal was to report incidence, prevalence, and treatment patterns in adult atopic dermatitis (AD) patients in the German statutory health insurance system. PATIENT AND METHODS: Anonymized claims data were evaluated at patient level for 3.3 million persons insured by six different statutory health insurance companies (SHI). Patients for whom the ICD-10 diagnosis code L20 (AD) was applied at least twice were analyzed and data on prescription patterns for AD were reported for the years 2011-2015. RESULTS: AD prevalence in adults was 1.6-1.9% in 2012-2015. Annual incidence was 0.28%. In Q3/Q4 2015, 44.2% of the adult population with AD diagnosis by a dermatologist received prescriptions for AD medications: 1.6% low-potency topical glucocorticoids (without previous prescription of systemic drugs), 46.9% moderate or high-potency topical glucocorticoids or topical calcineurin inhibitors, 23.9% current systemic therapy (systemic glucocorticoids, ciclosporin, methotrexate, azathioprine, mycophenolate mofetil) and 27.6% systemic therapy in the past. CONCLUSIONS: The AD prevalence estimate was in the range of previous reports (1.35-4%) that used different methodologies. Based on treatment proxy, it appeared that almost more than half of AD patients treated with prescription ready-to-use drugs had a severe form of AD which required treatment with systemic drugs.

Association between cytomegalovirus end-organ diseases and moderate-to-severe dementia: a population-based cohort study.

BACKGROUND: The association between cytomegalovirus (CMV) and dementia remains controversial. Previous studies have suggested that CMV serostatus, as assessed by serum immunoglobulin G, plays a role in neurodegeneration with cognitive impairment. We aimed to evaluate the association between CMV tissue-invasive end-organ diseases and moderate-to-severe dementia. METHODS: The ICD 10th revision codes from the National Health Insurance Database covering the entire population of the Republic of Korea were used to classify patients into exposed (n = 687, age ≥ 40 years, with CMV disease) and unexposed (n = 3435, without CMV disease) groups, matched by age and sex at a 1:5 ratio of exposed: unexposed. All non-HIV-1-infected subjects selected during 2010-2014 with a washout period of the previous 4 years were followed up until December 2016 to identify newly diagnosed cases of moderate-to-severe dementia. RESULTS: Multivariate regression model (M3) adjusted for age, sex, low income, body mass index, transplantation status, malignant neoplasms, end-stage renal disease on dialysis, type 2 diabetes mellitus, hypertension, and dyslipidaemia showed a significantly higher incidence of dementia (odds ratio: 1.9; 95% confidence interval: 1.2-2.8) in the exposed group than that in the unexposed group. The risk of vascular dementia (2.9, 1.1-7.5) was higher than that of Alzheimer's disease (1.6, 1.0-2.6) in the exposed group in M3. In M3, patients aged 40-59 years with CMV diseases had a significantly higher risk of all kinds of dementia than those aged 60-79 and ≥ 80 years (11.7, 2.5-49.4 vs. 1.8, 1.1-3.2 vs. 1.3, 0.5-2.8; P = 0.025). CONCLUSIONS: CMV diseases may be associated with the risk of moderate-to-severe dementia.

The burden of hyperkalemia in Germany - a real world evidence study assessing the treatment and costs of hyperkalemia.

BACKGROUND: Hyperkalemia (HK) can affect health outcomes and quality of life, as it is referred to as a potentially life-threatening condition caused by an increased serum potassium concentration in the blood. Patients suffering from heart failure or chronic kidney diseases are at a higher risk of HK, which can further be amplified by the treatment received. To date, data on HK prevalence is lacking for Germany and the aims of this study were to assess HK and compare health-relevant outcomes and healthcare costs between HK patients and non-HK patients. METHODS: The InGef research database containing healthcare claims of over 4 million individuals in Germany was utilized for this retrospective, matched cohort analysis. Patients with non-acute outpatient treated and a subgroup of patients with chronic HK, were identified in 2015 with an individual 1 year pre- and post-index period, taking the first observable HK diagnosis/treatment in 2015 into account as the index event. To identify non-acute outpatient treated HK patients, at least two ICD-10-GM diagnosis codes E87.5 "Hyperkalemia" and/or prescriptions of polystyrene sulfonate were required. Chronic HK patients had additional diagnoses and/or prescriptions in all quarters following the first observable HK diagnosis. Patients without HK were matched 1:1 to the respective HK cohorts. RESULTS: In the year 2015, 3333 patients with non-acute outpatient treated HK were identified of which 1693 were patients with chronic HK. After matching, 3191 and 1664 HK patients and controls were available for analysis. A significantly higher number of hospitalizations was observed for both HK cohorts in comparison to their matched controls. Dialysis initiation as well as the healthcare costs were higher for both HK cohorts when compared to their matched counterparts. CONCLUSIONS: The disease burden was higher for patients with HK, based on a higher proportion of patients with dialysis initiation and higher healthcare costs.

Comorbidities associated with nontuberculous mycobacterial disease in Japanese adults: a claims-data analysis.

BACKGROUND: Nontuberculous mycobacterial (NTM) lung disease is one of a growing number of chronic health problems that is difficult to cure in aging societies. While it is important to be vigilant about associated comorbidities in order to provide better patient care, data on the prevalence of comorbidities stratified by country or region are scarce. We aimed to elucidate the comorbidities associated with NTM disease based on Japanese health insurance claims data. METHODS: Cross-sectional analyses were performed using the claims data for 2014 provided by the Japan Medical Data Center Co., Ltd. Patients aged 20-75 years with ≥3 claims associated with NTM disease were identified and matched to 10 sex-and-age-matched controls that had never made a claim for NTM disease. Thirty-one comorbidities previously suspected to be associated with NTM disease were selected, and the prevalence of these comorbidities compared between cases and controls. RESULT: Overall, 419 NTM patients (134 males and 285 females) and 4190 non-NTM controls were identified from the JMDC database. Aspergillosis, asthma, chronic heart failure, diffuse panbronchiolitis, gastroesophageal reflux, interstitial pneumonia, lung cancer, cancer other than breast, lung, ovary, or prostate cancer, and rheumatoid arthritis were associated with NTM disease in both males and females. Chronic obstructive pulmonary disease was associated with NTM in males while chronic kidney disease, osteoporosis, and Sjögren syndrome were associated with NTM in females. CONCLUSION: NTM disease was associated with multiple comorbidities that should be considered when providing medical care to individuals with NTM disease.

Impact of Buprenorphine Dosage on the Occurrence of Relapses in Patients with Opioid Dependence.

OBJECTIVES: Buprenorphine (BUP) is used in opioid maintenance treatment (OMT) for opioid-dependent patients. Previous real-world evidence suggests that many patients receive lower BUP dosage than recommended, with 38% of patients receiving <6 mg BUP per day. The goal of this research is to evaluate the impact of BUP dosage on the risk of relapses in the real world. METHODS: This study was based on German claims data of 4 million patients. Patients identified by International Classification of Diseases, 10th Edition F11.2 (opioid dependence) between 2011 and 2012 and at least one BUP prescription were selected for this study (n = 364) and followed up over 4 years. Patients were assigned to 6 dosage groups, with <6 mg/day serving as low dosage/reference category. The impact of dosage on the occurrence of relapses (indicated by treatment interruption of >3 months without OMT prescription or hospital admissions) was examined using multivariate logistic regression. Age, gender, comorbidities, fixed/variable dosing, and up-dosing were used as covariates. RESULTS: Results showed a protective effect of higher BUP as higher BUP dosages were significantly associated with a lower risk of relapse. Using low dosage (<6 mg/day) as the reference category, ORs were 0.40 (95% CI 0.19-0.87) at 6-<8 mg/day, 0.28 (0.15-0.56) at 8-<10 mg/day, 0.26 (0.10-0.67) at 10-<12 mg/day, 0.40 (0.18-0.92) at 12-<16 mg/day, and 0.18 (0.09-0.37) at ≥16 mg/day. No covariate showed a significant effect on the probability of relapse. CONCLUSIONS: The present study used a large German health claims dataset to confirm that higher BUP dosages are a protective factor for avoiding relapses in opioid-dependent patients, thus highlighting the importance of adequate BUP dosing in relapse prevention.

Epidemiology and health care utilization of patients suffering from Huntington's disease in Germany: real world evidence based on German claims data.

BACKGROUND: Huntington's disease (HD) is a rare, genetic, neurodegenerative and ultimately fatal disease with no cure or progression-delaying treatment currently available. HD is characterized by a triad of cognitive, behavioural and motor symptoms. Evidence on epidemiology and management of HD is limited, especially for Germany. This study aims to estimate the incidence and prevalence of HD and analyze the current routine care based on German claims data. METHODS: The source of data was a sample of the Institute for Applied Health Research Berlin (InGef) Research Database, comprising data of approximately four million insured persons from approximately 70 German statutory health insurances. The study was conducted in a retrospective cross-sectional design using 2015 and 2016 as a two-year observation period. At least two outpatient or inpatient ICD-10 codes for HD (ICD-10: G10) during the study period were required for case identification. Patients were considered incident if no HD diagnoses in the 4 years prior to the year of case identification were documented. Information on outpatient drug dispensations, medical aids and remedies were considered to describe the current treatment situation of HD patients. RESULTS: A 2-year incidence of 1.8 per 100,000 persons (95%-Confidence interval (CI): 1.4-2.4) and a 2-year period prevalence of 9.3 per 100,000 persons (95%-CI: 8.3-10.4) was observed. The prevalence of HD increased with advancing age, peaking at 60-69 years (16.8 per 100,000 persons; 95%-CI: 13.4-21.0) and decreasing afterwards. The most frequently observed comorbidities and disease-associated symptoms in HD patients were depression (42.9%), dementia (37.7%), urinary incontinence (32.5%), extrapyramidal and movement disorders (30.5%), dysphagia (28.6%) and disorders of the lipoprotein metabolism (28.2%). The most common medications in HD patients were antipsychotics (66.9%), followed by antidepressants (45.1%). Anticonvulsants (16.6%), opioids (14.6%) and hypnotics (9.7%) were observed less frequently. Physical therapy was the most often used medical aid in HD patients (46.4%). Nursing services and speech therapy were used by 27.9 and 22.7% of HD patients, respectively, whereas use of psychotherapy was rare (3.2%). CONCLUSIONS: Based on a representative sample, this study provides new insights into the epidemiology and routine care of HD patients in Germany, and thus, may serve as a starting point for further research.

Primary data, claims data, and linked data in observational research: the case of COPD in Germany.

BACKGROUND: Real-world evidence (RWE) can inform patient management decisions, but RWE studies are associated with limitations. Linkage of different RWE data types could address such limitations by enriching data and improving scientific quality. Using the example of chronic obstructive pulmonary disease (COPD) in Germany, this study assessed the value of data linkage between primary and secondary data sources for RWE. METHODS: Post hoc analysis of data from an observational RWE study, which used prospectively collected data and data from an insurance claims database to assess treatment adherence and persistence in patients with COPD in Germany. Patient-level primary data were collected from the prospective observational study (primary dataset, N = 636), and claims data from the sickness fund AOK Nordost (claims dataset, N = 74,916). Primary and claims data were linked at a patient level using insurance numbers (linked dataset). Patients in the linked dataset were indexed at date of study inclusion for primary data and matched calendar date for claims data. Agreement between primary and claims data was examined for patients in the linked dataset based on comparisons between recorded sociodemographic data at index, comorbidities (primary: any recorded; claims: pre-index), prescriptions for COPD therapies (type and date) and exacerbations in the 12-month post-index period. RESULTS: The linked dataset included primary and claims data for 536 patients. Fewer comorbid patients were reported in primary data compared with claims data (p < 0.001), with overall agreement between 63.6% (hypertension) and 90.5% (osteoporosis). Number of prescriptions for COPD therapies per patient was lower in primary versus claims data (3.7 vs 10.3 prescriptions, respectively), with only 24.5% of prescriptions recorded in both datasets. Only 11.5% of exacerbations (moderate or severe) were recorded in both datasets, with 15.5% recorded only in primary data and 73.0% recorded only in claims data. CONCLUSION: Our study highlighted discrepancies between primary and claims data capture for this population of German patients with COPD, with lower reporting of comorbidities, COPD therapy prescriptions and exacerbations in primary versus claims data. Study findings suggest that data linkage of primary and claims data could provide enrichment and be useful in fully describing COPD endpoints.

The prevalence of diagnosed opioid abuse in commercial and Medicare managed care populations.

PURPOSE: To measure the prevalence of diagnosed opioid abuse and prescription opioid use in a multistate managed care organization. METHODS: This retrospective claims data analysis reviewed the prevalence of diagnosed opioid abuse and the parallel prevalence of prescription opioid use in half-year intervals for commercial and Medicare members enrolled with Humana Inc., from January 1, 2008 to June 30, 2010. Diagnosis of opioid abuse was defined by ≥ 1 medical claim with any of the following ICD-9-CM codes: 304.0 ×, 304.7 ×, 305.5 ×, 965.0 ×, excluding 965.01, and opioid use was defined by ≥ 1 filled prescription for an opioid. The prevalence of opioid abuse was defined by the number of members with an opioid abuse diagnosis, divided by the number of members enrolled in each 6-month interval. RESULTS: The 6-month prevalence of diagnosed opioid abuse increased from 0.84 to 1.15 among commercial and from 3.17 to 6.35 among Medicare members, per 1,000. In contrast, there was no marked increase in prescription opioid use during the same time period (118.0 to 114.8 for commercial members, 240.6 to 256.9 for Medicare members, per 1,000). The prevalence of diagnosed opioid abuse was highest among members younger than 65 years for both genders in commercial (18- to 34-year-olds) and Medicare (35- to 54-year-olds) populations. CONCLUSIONS: Despite a stable rate of prescription opioid use among the observed population, the prevalence of diagnosed opioid abuse is increasing, particularly in the Medicare population.

Treatment Discontinuation in Patients with Psoriasis Treated with Biologics: A Retrospective Analysis of German Health Claims Data.

INTRODUCTION: Plaque psoriasis is a common, often debilitating, chronic autoimmune inflammatory skin disease. Moderate-to-severe forms of psoriasis can be treated with biologics such as anti-interleukin and anti-tumor necrosis factor antibodies. We aimed to investigate treatment discontinuation among patients with psoriasis who initiated biologic treatment. METHODS: We conducted a retrospective, non-interventional cohort study based on anonymized claims data from the German statutory health insurance which covered the years from 2016 to 2021. We included adult patients with psoriasis who initiated biologic treatment in drug-specific cohorts. Over a 365-day follow-up period, we assessed the frequencies and the time until treatment discontinuation for different biologics. Differences in discontinuation rates were compared using a multivariate Cox proportional hazards model. RESULTS: A total of 2565 patients with psoriasis who initiated treatment with secukinumab (n = 612), adalimumab (n = 454), guselkumab (n = 354), ixekizumab (n = 259), ustekinumab (n = 241), tildrakizumab (n = 205), brodalumab (n = 166), risankizumab (n = 145), etanercept (n = 91), certolizumab (n = 29), and infliximab (n = 9) were included. A total of 1290 patients (50.29%) discontinued treatment during the follow-up period, ranging from 30.34% (risankizumab) to 69.23% (etanercept). Median time until discontinuation of treatment ranged from 102 days (etanercept) to 208 days (risankizumab). Once the biologic treatment was discontinued, 45.05% of patients restarted the treatment with the same agent, 23.10% of patients switched to another biologic, and 31.86% received no further biologic agent. Compared to patients treated with risankizumab, the treatment discontinuation rate was significantly higher (p < 0.05) in patients treated with the other biologics except ustekinumab (p = 0.12). CONCLUSIONS: Further research should explore reasons leading to treatment discontinuation in order to support treatment choices for patients with moderate-to-severe psoriasis.

A decade of chronic lymphocytic leukaemia therapy in Germany: Real-world treatment patterns and outcomes (2010-2022).

Pharmacotherapy options for chronic lymphocytic leukaemia (CLL) have expanded significantly in recent years. These options include chemotherapy, chemoimmunotherapy and signalling pathway inhibitors. A notable shift in the treatment landscape began with the widespread adoption of ibrutinib in 2016. This analysis of claims data focuses on understanding how the use of novel therapies has evolved in clinical practice over the past decade in Germany. Anonymized claims data (2010-2022) from German statutory health insurance was used, covering patient demographics, treatments, and prescriptions. The study population included patients with two confirmed CLL diagnoses. Treatment patterns were analysed, and survival outcomes were compared using time-to-event analyses. In the analysed cohort of 2983 incident CLL patients, 1041 started first-line therapy between 2011 and 2022, with a median duration of 18 months from diagnosis to the first prescription. Chemoimmunotherapy, the predominant 1L therapy until 2019, decreased significantly, while targeted therapy usage increased from 3% in 2015 to 77% in 2022. Targeted therapies became dominant in patients receiving treatment for relapsed or refractory disease after 2016. Median treatment durations were: 122 days for chemo, 176 days for chemo-immuno, and 373 days for targeted therapy. The overall survival for patients diagnosed in or after 2016 was significantly better (hazard ratio 0.56, 95% confidence interval, 0.44-0.69)). The adoption of targeted therapies like ibrutinib and venetoclax has transformed CLL treatment in Germany, leading to improved patient outcomes. Additionally, we demonstrate successful adherence to evolving clinical guidelines.

COVID-19 related decline in cancer screenings most pronounced for elderly patients and women in Germany: a claims data analysis.

PURPOSE: This study aimed to analyze the utilization of cancer screenings in Germany before and during the COVID-19 pandemic in 2020. The objective of the analysis was to identify the population at particular risk and to derive recommendations for the future use of resources to prevent long-term deteriorations in health outcomes. METHODS: The analysis was conducted based on claims data of all preventive health services for 15,833,662 patients from the largest statutory health insurance fund in Germany. Utilization of general female cancer screening, general male cancer screening, general health checkup, colorectal cancer screening stool test, colorectal cancer screening consultation, colonoscopy, skin cancer screening, and mammography screening was compared before (2017-2019) and during (2020) the pandemic. RESULTS: Data of a total of 42,046,078 observed screenings showed that the utilization of the individual screenings developed differently, but that the overall utilization decreased significantly by 21.46% during the COVID-19 pandemic (p < 0.001). At the same time, no catch-up effects were detected for total screenings throughout the entire year 2020. The highest decline in screenings was found for the elderly (p < 0.001) and women (p < 0.001). CONCLUSION: Because the elderly are at higher risk for cancer, the omission of early detection might lead to higher treatment costs, reduced quality of life, and higher mortality. In addition, women's medical care in particular has been negatively affected, for example, by the interruption of mammography screenings and the lack of catch-up effects. Therefore, resources must be targeted to reduce burdens on health outcomes and public health in the long term.

Did the change of the vaccination schedule effect pneumococcal conjugate vaccination compliance and adherence of premature and mature born infants in Germany? Answers from a claims database analysis.

BACKGROUND: In August 2015, the German Standing Committee on Vaccination (STIKO) changed the pneumococcal conjugate vaccination (PCV) schedule for mature infants from a 3+1 to a 2+1scheme. For premature infants, the 3+1schedule remained unchanged. Aim was to assess vaccination rates, completeness, and timeliness for PCV stratified by premature and mature infants before and after the recommendation change based on real-world data. METHODS: Retrospective claims data analyses were conducted using a comprehensive research database. The study population consisted of all mature and premature infants born in 2013, 2016, or 2018 with an individual follow-up of 24 months using ICD-10-GM codes P07.2 and P07.3 for premature infants. Hexavalent (HEXA) combination vaccination with a consistent 3+1recommendation for premature and mature infants was analyzed as a reference. RESULTS: After follow-up of 24 months, rates of premature and mature infants receiving ≥1PCV and HEXA vaccination steadily increased since the change of STIKO's recommendation. However, in 2018 (2016/2013), only 47 % (41 %/65 %) of premature but 74 % (72 %/68 %) of mature infants obtained the recommended 3+1 respectively 2+1 PCV doses. At the same age, a consistent increase in complete HEXA vaccination with 3+1 doses was observed over time in premature (2013/2016/2018: 66 %/68 %/70 %) and mature (2013/2016/2018: 69 %/72 %/73 %) infants. Timeliness of PCV and HEXA booster administration remained stable with âˆ¼50 % of all premature and mature infants receiving the booster according to recommended timelines. CONCLUSION: There is no proven evidence that the reduced PCV schedule for mature infants induced a higher acceptance of vaccination. The rate of unvaccinated infants remained at a considerable level and vaccinations were often delayed. Although the STIKO still recommends a 3+1 PCV schedule for premature infants in Germany, less than half of children showed a completed vaccination series. To protect these vulnerable groups, efforts are needed to increase adherence to the STIKO recommendation especially for premature infants.