Change in intraindividual ICHD-II headache diagnosis over time: A follow-up of the DMKG headache study

Background: Change in headache diagnoses over time within the same individual is not well studied in the adult population. In this study, we prospectively examined the individual variation of migraine and tension-type headache (TTH) diagnoses over time. Methods: As part of the epidemiological Deutsche Migrane und Kopfschmerzgesellschaft (DMKG) headache study, 1312 participants were personally interviewed and 1122 responded to a second mailed questionnaire 2.2 years later. Headaches were assigned to migraine or TTH at two different points in time using the International Headache Classification, ICHD-II. We used broad (definite and probable subtypes) and strict (only definite type) definitions of migraine and TTH. Results: Using the broad definition increased the reproducibility of migraine diagnosis from 48.0% to 62.0% and of TTH from 59.0% to 65.0%. A constant TTH diagnosis was related to a higher social status (OR 2.81; 95% CI 1.43-5.53) a higher level of education (OR 1.96; 95% CI 1.00-3.85) and physical inactivity (OR 2.28; 95% CI 1.16-4.49). A constant diagnosis of definite migraine was associated with severe headache (OR 2.64; 95% CI 0.97-7.21) and frequent use of headache medication (OR 4.73; 95% CI 0.95-23.60). The result that coexisting TTH decreased the likelihood of a constant migraine (OR 0.29; 95% CI 0.10-0.85) is assumed to indicate response variability. Conclusions: In epidemiological studies, definite and probable subtypes should be included in the diagnosis to increase the diagnostic accuracy

Change in intraindividual ICHD-II headache diagnosis over time: A follow-up of the DMKG headache study

Background: Change in headache diagnoses over time within the same individual is not well studied in the adult population. In this study, we prospectively examined the individual variation of migraine and tension-type headache (TTH) diagnoses over time. Methods: As part of the epidemiological Deutsche Migrane und Kopfschmerzgesellschaft (DMKG) headache study, 1312 participants were personally interviewed and 1122 responded to a second mailed questionnaire 2.2 years later. Headaches were assigned to migraine or TTH at two different points in time using the International Headache Classification, ICHD-II. We used broad (definite and probable subtypes) and strict (only definite type) definitions of migraine and TTH. Results: Using the broad definition increased the reproducibility of migraine diagnosis from 48.0% to 62.0% and of TTH from 59.0% to 65.0%. A constant TTH diagnosis was related to a higher social status (OR 2.81; 95% CI 1.43-5.53) a higher level of education (OR 1.96; 95% CI 1.00-3.85) and physical inactivity (OR 2.28; 95% CI 1.16-4.49). A constant diagnosis of definite migraine was associated with severe headache (OR 2.64; 95% CI 0.97-7.21) and frequent use of headache medication (OR 4.73; 95% CI 0.95-23.60). The result that coexisting TTH decreased the likelihood of a constant migraine (OR 0.29; 95% CI 0.10-0.85) is assumed to indicate response variability. Conclusions: In epidemiological studies, definite and probable subtypes should be included in the diagnosis to increase the diagnostic accuracy

Incidence of Multiple Sclerosis in Germany: A Cohort Study Applying Different Case Definitions Based on Claims Data

BACKGROUND: Data on the incidence of multiple sclerosis (MS) on the national level is scarce. We aimed to estimate the incidence of MS in Germany and to compare different MS case definitions based on claims data. METHODS: We conducted a cohort study with the German Pharmacoepidemiological Research Database in 2012 and calculated age- and gender-standardized incidence rates (sIRs) for 3 case definitions. In addition, the effect of stepwise reduction of the look-back period without MS diagnosis on the incidence rate was evaluated. RESULTS: Our cohort comprised 4,175,877 individuals. The first case definition based on ICD-10 diagnoses yielded an sIR of 21.8 (95% CI 20.2–23.5) per 100,000 person years, whereas the second and third case definitions with additional requirements for drug treatment and diagnostic tests resulted in lower sIRs of 10.1 (9.1–11.3) and 6.6 (5.8–7.6) respectively. We observed a higher incidence for shorter look-back periods. CONCLUSION: The incidence of MS in Germany might be substantially higher than suggested in earlier studies. In addition, our study highlights the importance of a look-back period of at least 36 months to identify incident MS cases based on claims data

Drug-use patterns and severe adverse events with disease-modifying drugs in patients with multiple sclerosis: a cohort study based on German claims data

PURPOSE: To describe drug-use patterns in patients with multiple sclerosis (MS) using disease-modifying drugs (DMDs) and to estimate the incidence of severe adverse events (SAEs) of treatment. METHODS: We conducted a cohort study within the German Pharmacoepidemiological Research Database between January 1, 2006 and December 31, 2013. MS patients on DMDs were described in terms of clinical characteristics and drug-use patterns. Next, we assessed the incidence of AEs in new users of fingolimod, natalizumab, glatiramer acetate, and IFNβ1a. RESULTS: Among approximately 11 million insured members of German Statutory Health Insurance, the DMD-user cohort comprised 15,377 patients with MS, with a mean age of 39.6 years and 68% females. Nearly half of all DMD users had a diagnosis of depression, with prevalence ranging from 40.1% for IFNβ1a to 62.3% for immunoglobulins. The overall rate of MS relapses per patient and year was 0.34 (95% CI 0.33–0.34). During an average follow-up of 1,650 days, the majority (42.4%) of MS patients were adherent to DMD treatment (“continuous single users”), followed by patients interrupting treatment (39.5%, “interrupters”). Switch of DMD treatment (11.9%) was less frequent, and only 5.6% discontinued treatment. Treatment discontinuation was most common in users of natalizumab (7.5%) and IFNβ1b (7.0%). The most frequent SAE was hospitalization for depression, followed by any infectious disease and any malignancy. The incidence rate of all adverse events did not significantly differ across different DMDs. CONCLUSION: Treatment discontinuation with DMDs and treatment switch were rare. Causes of rather frequent DMD-treatment interruption have to be evaluated in further studies based on primary data collection. Active safety monitoring of new DMDs based on claims data requires large data sets to detect rare AEs and availability of up-to-date data

Survival of patients with chronic lymphocytic leukemia before and after the introduction of chemoimmunotherapy in Germany

Chronic lymphocytic leukemia (CLL) is the most common leukemia of adults in western countries. Therapy is indicated in symptomatic and advanced stages and has changed fundamentally since 2010 when rituximab, an anti-CD20 antibody, has been approved for treatment of CLL. Until then therapy had been based on chemotherapy drugs. This study investigates whether survival in CLL patients improved at the population level after the introduction of combined chemoimmunotherapy. Data from the cancer registry North-Rhine Westphalia was used to calculate relative survival (RS) by applying period analyses. Age-standardized 5-year RS increased from 79% in 1998-2002 (75% in 2003-2007) to 81% in the calendar period 2008-2012 and 88% in 2013-2016 for men and continuously from 71% in 1998-2002 to 92% in 2013-2016 for women. In CLL patients aged 15-69 years 5-year RS increased from 83% to 90% for men and from 82% to 94% for women after adding an anti-CD20-antibody to chemotherapy while in the older age group of 70-79-year-old CLL patients an increase by 20 percentage points was observed. These findings show marked improvements in the survival of CLL patients at the population level subsequently to the approval of anti-CD 20 antibodies like rituximab, ofatumumab or obinutuzumab for CLL treatment

Breast cancer incidence and mammography screening among resettlers in Germany

Kaucher S, Khil L, Kajüter H, et al. Breast cancer incidence and mammography screening among resettlers in Germany. BMC Public Health. 2020;20(1): 417

Chances and Challenges of Registry-Based Pharmacovigilance in Multiple Sclerosis: Lessons Learnt from the Implementation of the Multicenter REGIMS Registry

The long-term and potential rare side effects of new immunomodulating drugs for the treatment of multiple sclerosis (MS) are often not well known. Spontaneous case report systems of adverse drug effects are a valuable source in pharmacovigilance, but have several limitations. Primary data collections within registries allow a comprehensive analysis of potential side effects, but face several challenges. This article will outline the chances and challenges of registry-based adverse event reporting, using the example of the German immunotherapeutic registry REGIMS. REGIMS is an observational, clinical multicenter registry that aims to assess the incidence, type, and consequences of side effects of MS immunotherapies. Patients treated with an approved MS medication are recruited by their physicians during routine visits in hospitals, outpatient clinics, and MS-specialized practices. REGIMS incorporates an electronic physician-based documentation in each center and a paper-based patient documentation, both at baseline and regular follow-up visits. By the end of 2019, 43 REGIMS centers were actively recruiting patients and performing follow-up documentations. The majority of the first 1000 REGIMS patients were female (69.3%), had relapse-remitting MS (89.8%), and were treated with a second-line therapy. During the implementation of REGIMS, several logistic and procedural challenges had to be overcome, which are outlined in this paper. Pharmacovigilance registries such as REGIMS provide high-quality primary data from a specific patient population in a real-world care setting and enable pharmacovigilance research that cannot be carried out using secondary data. Despite the logistic and procedural challenges in establishing a multicenter pharmacovigilance registry in Germany, the advantages outweigh the drawbacks