VersKiK: Study protocol of an observational registry-based study on the current state of follow-up care and adherence to follow-up guidelines after cancer in childhood or adolescence.

BACKGROUND: This article describes the study design of the quantitative part of the VersKiK study, The primary objectives of this study are to examine the occurrence of late effects in survivors of childhood or adolescent cancer (module 1), investigate health-related vulnerabilities and medical service utilization within this survivor group (modules 1 and 3), and assess the alignment between documented follow-up care for cardiological and audiological late effects with guideline recommendations, along with evaluating the extent of adherence among paediatric cancer survivors (module 3). METHODS: This is a non-interventional retrospective observational cohort study. It is based on stochastically linked insurance claims data from approximately 150,000 statutory insured persons with information concerning around 25,000-30,000 cancer survivors recorded in the German Childhood Cancer Register (GCCR). To explore adherence to selected follow-up guidelines, intention to treat treatment data from clinical study groups for particular diagnostic entities will be additionally included. DISCUSSION: The growing group of survivors after cancer in childhood and adolescence is representing a special population with an increasing demand for life-long healthcare services through relative high probability of late effects. Currently, there is a limited evidence in Germany on utilization of corresponding medical services and adherence to follow-up guidelines. With this study design, we are aiming to address these gaps and, consequently, suggest improvements to existing follow-up guidelines and follow-up care provision in Germany.

Long-term care, care needs and wellbeing of individuals after cancer in childhood or adolescence (VersKiK): study protocol of a large scale multi-methods non-interventional study.

BACKGROUND: It has been shown previously that a relevant proportion of childhood cancer survivors suffers from late effects, which are often directly related to the cancer itself or its therapy, resulting in particular follow-up needs, additionally burdening healthcare systems. Being diagnosed with cancer at a vulnerable stage of development, this group of cancer survivors is at comparatively higher risk of relapse or subsequent cancer. Although national and international follow-up guidelines based on treatment modalities have been developed, their implementation seems to leave room for improvement. Additionally, they lack a sufficient consideration of the survivors' psychosocial needs, affecting their adherence to them. The aim of the VersKiK study is to provide representative information on late effects in childhood and adolescence cancer survivors in Germany. The main research objectives are: (1) to describe the state of follow-up care among survivors after a cancer diagnosis in childhood or adolescence; (2) to quantify the occurrence of late effects among this group of survivors; (3) to examine the adherence to selected audiological and cardiological follow-up guidelines and to identify factors affecting it; (4) to explore actual follow-up needs of paediatric cancer survivors; (5) to review selected follow-up guidelines with the aim to improve and expand them. METHODS: VersKiK is designed as a mixed-methods non-interventional study. We will use claims data from statutory health insurance companies in combination with individually linked population-based registry data from the German Childhood Cancer Registry (GCCR). This data base will permit us to quantify diagnoses and procedures in comparison to the general population as well as the adherence to existing follow-up guidelines. Additional information will be obtained through interviews with childhood and adolescence cancer survivors and their informal caregivers, as well as in focus groups with healthcare professionals. DISCUSSION: The present study aims to research the actual needs of individuals after cancer diagnosis and treatment in childhood or adolescence - physical, psychological and organisational - in order to improve existing follow-up guidelines. These improvements might further positively affect not only actual care provided to paediatric cancer survivors, but also benefit healthcare systems in general while decreasing consequent medical visits in this group of patients. TRIAL REGISTRATION: Registered at German Clinical Trial Register (ID: DRKS00025960 and DRKS00026092).

Prescription of analgesics in patients with rheumatic diseases in Germany : A claims data analysis.

OBJECTIVE: To investigate the prescription frequency of analgesics in persons diagnosed with rheumatoid arthritis (RA), axial spondylarthritis (axSpA), psoriatic arthritis (PsA) and systemic lupus erythematosus (SLE) in 2019 using claims data. METHODS: Persons ≥ 18 years insured in 2019 with a diagnosis of RA (M05, M06), axSpA (M45), PsA (M07.0-3) or SLE (M32.1,8,9) were included. Analgesics were identified by the anatomic therapeutic classification (ATC) system. Reported is the percentage of individuals with ≥ 1 analgesics prescription for the respective rheumatic diagnosis in 2019 and for opioids age-standardized in each of the years 2005-2019. In addition, the proportion of long-term opioid use (prescriptions in ≥ 3 consecutive quarter years) in 2006 and 2019 is compared. RESULTS: Metamizole (29-33%) was the most commonly prescribed analgesic. Nonsteroidal anti-inflammatory drugs (NSAID)/coxibs were prescribed from 35% (SLE) to 50% (axSpA). Of the patients 11-13% were prescribed weak and 6-8% strong opioids. From 2005 to 2019, the proportion of persons with an opioid prescription remained stable, with similar or slightly decreasing proportions of weak opioids and more frequent prescriptions of strong opioids. The proportion of long-term opioid prescriptions increased from 2006 to 2019 from 8.9% to 11.0% (RA), from 6.9% to 9.1% (axSPA), from 7.8% to 9.5% (PsA), and from 7.5% to 8.8% (SLE), corresponding to a 17-24% increase. CONCLUSION: The prescription of opioids for persons with inflammatory rheumatic diagnoses is not as high in Germany as in other countries; however, the proportion of long-term prescriptions has considerably increased. The frequent prescription of metamizole is conspicuous.

[Prescription of analgesics in patients with rheumatic diseases in Germany : A claims data analysis. German version]. / Verordnung von Schmerzmitteln bei Patienten mit rheumatischen Erkrankungen in Deutschland : Eine Analyse von Abrechnungsdaten.

OBJECTIVE: To investigate the prescription frequency of analgesics in persons diagnosed with rheumatoid arthritis (RA), axial spondylarthritis (axSpA), psoriatic arthritis (PsA) and systemic lupus erythematosus (SLE) in 2019 using claims data. METHODS: Persons ≥ 18 years insured in 2019 with a diagnosis of RA (M05, M06), axSpA (M45), PsA (M07.0-3) or SLE (M32.1,8,9) were included. Analgesics were identified by the anatomic therapeutic classification (ATC) system. Reported is the percentage of individuals with ≥ 1 analgesics prescription for the respective rheumatic diagnosis in 2019 and for opioids age-standardized in each of the years 2005-2019. In addition, the proportion of long-term opioid use (prescriptions in ≥ 3 consecutive quarter years) in 2006 and 2019 is compared. RESULTS: Metamizole (29-33%) was the most commonly prescribed analgesic. Nonsteroidal anti-inflammatory drugs (NSAID)/coxibs were prescribed from 35% (SLE) to 50% (axSpA). Of the patients 11-13% were prescribed weak and 6-8% strong opioids. From 2005 to 2019, the proportion of persons with an opioid prescription remained stable, with similar or slightly decreasing proportions of weak opioids and more frequent prescriptions of strong opioids. The proportion of long-term opioid prescriptions increased from 2006 to 2019 from 8.9% to 11.0% (RA), from 6.9% to 9.1% (axSPA), from 7.8% to 9.5% (PsA), and from 7.5% to 8.8% (SLE), corresponding to a 17-24% increase. CONCLUSION: The prescription of opioids for persons with inflammatory rheumatic diagnoses is not as high in Germany as in other countries; however, the proportion of long-term prescriptions has considerably increased. The frequent prescription of metamizole is conspicuous.

[Various scenarios for billing and remuneration of preoperative management of iron deficiency anemia in the German healthcare system]. / Verschiedene Szenarien zu Abrechnung und Kostenerstattung eines präoperativen Managements der Eisenmangelanämie im deutschen Gesundheitssystem.

More than 30% of all patients undergoing surgery suffer from preoperative anemia. Iron deficiency anemia is the most common type of anemia. The diagnostics and treatment of iron deficiency anemia can be carried out before patients undergo surgery as an alternative to blood transfusion and is an interdisciplinary task. This article gives an overview of various billing modalities and payment arrangements for management of preoperative anemia in the German healthcare system.

[Health care and disease burden in persons with axial spondyloarthritis in Germany]. / Gesundheitsversorgung und Krankheitslast bei Personen mit axialer Spondyloarthritis in Deutschland.

BACKGROUND: Only very few data are available on the comprehensive care in patients with axial spondylarthritis (axSpA), one of the most frequent inflammatory rheumatic disease. OBJECTIVE: Description of the comprehensive care and common prescription patterns of medications and other therapies in patients with axSpA depending on the type of medical care by rheumatologists or nonrheumatologists. METHODS: A cross-sectional analysis was performed based on claims data of the BARMER health insurance company (in 2015) and a questionnaire, which was sent to a representative sample of patients with axSpA (International Classification of Diseases, 10th revision, German modification, ICD-10-GM, code M45) aged 18-79 years. A stratified sample of 5000 patients was used. The patients received a postal questionnaire including questions regarding the disease, health-related and psychological parameters and socioeconomic factors. Claims data consisted of demographic factors, medicinal and nonmedicinal treatment and the extra-articular manifestations inflammatory bowel disease, psoriasis and uveitis. RESULTS: A total of 1741 patients (mean age 55.9 years, female 46.4%, 86.2% Human Leucocyte Antigen[HLA]-B27 positive) confirmed the diagnosis and answered the questionnaire. The mean Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was 4.5 and the mean Bath Ankylosing Spondylitis Functional Index (BASFI) 4.1. Of the patients 46% were treated by rheumatologists. There was a substantial difference between patients in rheumatological care and those who were not in rheumatological care regarding prescriptions for drug treatment of axSpA (91.8% versus 66.4%). This difference was especially prominent for prescriptions of biologic disease-modifying antirheumatic drugs: 34.1% of patients in rheumatological care versus 3.1% of patients treated by nonrheumatologists (p < 0.0001), despite similar disease activity in both groups. CONCLUSION: The data show that the majority of patients diagnosed with axSpA did not receive regular care from rheumatologists. This seemed to be associated with insufficient medicinal care at least in some of these patients.

Which Back Pain Patients Benefit From Multidisciplinary Pain Management? A Comparative Cost Analysis Using Claims Data of Statutory Health Insurance.

Aim: Multidisciplinary pain therapy (MPT) is considered as best practice for treating patients with chronical back pain. Several studies showed the cost effectiveness of interdisciplinary treatment. The aim of the present study is to identify patient characteristics that, under condition of MMT, can be associated with favourable cost trajectories after intervention. We assume that an improved health status leads to less health care utilisation. Furthermore, we aim at identifying those patients with back pain without MPT for whom we can expect favourable cost trajectories. Methods: On the basis of pseudonymised claims data of a nationwide health insurance, we identified MMT back pain patients as well as a control group of back pain patients without MMT. Using comparative cost analysis (costs insensitive to indication), we determined those MMT patients for whom the cumulated total costs per patient for the two postinterventional years were lower than the mean cumulated total costs of the control group. By means of a CART analysis, we identified statistically significant characteristics (profiles) associated with these favourable cost trajectories. Additionally, we quantified control group patients with the same profiles. Results: The study population comprised 1 252 patients with specific back pain and 767 patients with pain due to spinal disc conditions who received MPT. Compared to the control group, total post-therapy costs (insensitive to indication) of MPT patients were higher. For roughly half of MPT patients per pain type, we could identify favourable cost trajectories as per definition. These patients mainly displayed lower levels of pain intensity, no pain-related hospitalisation, and less (mental) co-morbidity in the year preceding the intervention. These profiles concerned to 58-65% of back pain patients without MPT. Conclusion: The developed methodology enables identification of back pain patients likely to benefit from MPT. The study points out the need for patient individual pain management and underlines the importance of early-stage integration of patients into multidisciplinary pain management programmes.

Long-term opioid therapy for chronic non-cancer pain in Germany.

BACKGROUND: No data are available on the prevalence and predictors of (high-dose) long-term opioid therapy (LTOT) and on abuse/addiction of prescribed opioids by patients with chronic non-cancer pain (CNCP) outside North America and Scandinavia. METHODS: We analysed randomly selected claims records of 870,000 persons (10% of insureds) in a large German medical health insurance organization during the fiscal year 2012. RESULTS: The prevalence of LTOT prescriptions (defined by at least one opioid prescription per quarter for at least three consecutive quarters) for CNCP was 1.3% of all insureds. The mean daily dosage of LTOT was 58 (SD 79; minimum 0.3, maximum 2010) mg morphine equivalent/day. The percentage of insureds with high-dose opioid prescriptions (≥100 mg morphine equivalent/day) among LTOT insureds was 15.5%. High-dose LTOT (compared to traditional dose) prescription was associated with younger age, male gender, diagnoses of chronic pain disease, somatoform pain disorder, depression and prescription of anticonvulsants. The pooled 1­year prevalence of abuse/addiction of prescribed opioids (defined by hospital stays because of mental and behavioural disorders due to alcohol, opioids, tranquilizers, multiple substances and intoxications by narcotic agents) was 0.56%. Abuse/addiction of prescribed opioids was associated with younger age, diagnoses of somatoform pain disorder, depression and prescription of tranquilizers. CONCLUSIONS: The study found no signals of an 'opioid epidemic' in Germany. However, careful selection of patients with CNCP considered for LTOT and continuous evaluation during LTOT are warranted.

[Administrative prevalence, treatment and costs of somatoform pain disorder. Analysis of data of the BARMER GEK for the years 2008-2010]. / Administrative Prävalenz, Behandlung und Krankheitskosten der somatoformen Schmerzstörung. Analyse von Daten der BARMER GEK für die Jahre 2008-2010.

INTRODUCTION: Data on administrative prevalence, types of treatment and disease costs of patients diagnosed with somatoform pain disorder (according to ICD 10) in Germany were not previously available. MATERIALS AND METHODS: We analysed health insurance data from 2008-2010 of 8.5 million people of the German statutory health insurance company BARMER GEK on administrative prevalence of insurants with at least one billing code F 45.4x in 2009 and at least one second billing code F 45.4x in the time period 2008-2010 stratified by age and gender, different professions being involved in treatment, diagnostics and treatment methods applied. The types and costs of out-patient treatment and of in-patient treatment in case of any discharge with diagnosis of F45.4 were analysed. RESULTS: The administrative prevalence doubled from 2008 to 2010 after the separation of the previous code F45.4 into F45.40 and F45.41. In 2009, 0.5 % of the insurants were diagnosed with F 45.4, whereby F 45.4 was diagnosed 2.3-fold more often in women than in men. Family practitioners (41 %) and anaesthesiologists (28 %) were the leading specialties in the care of chronic patients. In 2009, 54 % of patients underwent x-ray examination, 25 % magnetic resonance imaging and 11 % computed tomography. In all, 66 % of the chronic patients received basic psychosomatic care, 38 % were prescribed opioids, 12 % underwent spinal nerve anaesthesia and 14 % received psychotherapy. In 2009, the average direct and indirect treatment costs per patient with somatoform pain disorder were 5500 . CONCLUSION: Insurants diagnosed with somatoform pain disorder were probably overtreated with radiology and invasive procedures and with opioids.

[Treatment and healthcare costs of fibromyalgia syndrome in Germany: analysis of the data of the Barmer health insurance (BEK) from 2008-2009]. / Behandlung und Krankheitskosten des Fibromyalgiesyndroms in Deutschland: Eine Analyse der Daten der Barmer Ersatzkasse des Jahres 2008-2009.

BACKGROUND: The data available on the types of treatment delivered and healthcare costs of fibromyalgia syndrome (FMS) patients in Germany are currently not representative. MATERIAL AND METHODS: The data from all 6,897,846 insured persons of the German statutory health insurance company Barmer Ersatzkasse (BEK) before the fusion with the Gmünder Ersatzkasse (GEK) were analyzed if more than 2 billing cases with the diagnosis M79.7 were found (FMS cases) in the 8 consecutive quarter years of 2007-2008. In these cases the types and costs of out-patient treatment as well as the operation and procedure key (OPS) classification of in-patient treatment in cases of any discharge diagnosis of FMS were analyzed. RESULTS: A diagnosis of FMS was recorded in 14,870 insured persons in out-patient care and in 6130 in-patients from 1(st) January 2008 to 31(st) December 2009. The 1-year prevalence of FMS diagnosis was 19,592 of the patients (0.3%). Non-steroidal agents were prescribed in 48%, weak opioids in 21% and strong opioids in 11% of the out-patients with FMS. Out-patient psychotherapy was conducted in 8% of the FMS cases. In 31% of the cases hospital treatment was carried out of which 14% received multicomponent therapy. The average healthcare costs were 4,331  per year. CONCLUSION: The data of the BEK document high healthcare costs and treatment which is mainly not in line with the recommendations of the German guidelines on the management of FMS.

[Health services research project "action alliance pain-free city Münster" : Objectives and methods]. / Versorgungsforschungsprojekt "aktionsbündnis schmerzfreie stadt Münster" : zielsetzung und methodik.

Inadequate pain care in health care facilities is still a major concern. Due to structural and organizational shortcomings the potential of modern analgesia is far from being exhausted. The project "Action Alliance Pain-free City Münster" is designed to analyze the multiprofessional pain management in health care facilities in the model City of Münster in an epidemiologic study and aims to optimize pain management in accordance with nursing standards and medical guidelines. Hospitals, nursing homes, outpatient nursing services, hospices and pain care centers will be examined. After an analysis of the current state on the basis of a pre-test, the necessary optimization measures will be developed and implemented. Subsequently, the pain management will be reevaluated in a post-test. In partly still unexplored health care areas of Germany, epidemiologic data will be generated, barriers to the implementation of standards and guidelines revealed and measures of improvements developed and tested. In addition, interface problems between the evaluated sectors will be identified. In this article the objective and the methods of the project are described.

In liver transplantation, T tube bile represents total bile flow: physiological and scintigraphic studies on biliary secretion of organic anions.

The present study was performed to clarify the recovery of hepatocellular uptake and the biliary secretion of bile acids during the first 14 days after orthotopic liver transplantation (OLT) and to determine the fraction of bile flow appearing outside through the T tube and entering the duodenum. Therefore, we determined primary and secondary bile acids in bile samples obtained from the T tube at day 5 after OLT, while the T tube was permanently open, and at days 10 and 14 after OLT, i.e., 4 and 9 days after closure of the T tube, respectively, thus restoring enterohepatic bile acid circulation. In addition, we performed hepatobiliary scintigraphy using technetium 99m-labeled [2,4,6 trimethyl-3-bromo]imino-diacetic acid (technetium 99m-BRIDA) in 12 patients between days 4 and 17 after OLT. Chromatographic analyses of biliary bile acids showed no secondary bile acids during the first 5 days after OLT, as opposed to 10 and 14 days after OLT when enterohepatic circulation was restored. Eleven patients with an uncomplicated postoperative course after OLT showed a significantly reduced hepatic uptake and biliary secretion of 99mTc-BRIDA during the first days after OLT with progressive recovery. One patient with an acute allograft rejection episode showed almost no uptake and only minimal secretion. The bile fraction appearing outside through the inserted T tube represented 94.6% +/- 6.2% of the injected 99mTc-BRIDA. We conclude that OLT results in markedly impaired hepatocellular uptake and biliary secretion of organic anions. Simultaneously, bile acid synthesis is significantly reduced, which, in addition, diminishes bile secretion of the graft. We show that T tube bile is a valid tool for bile physiological studies in patients in whom transplantation was successfully performed.