Guidelines versus reality: is coronary stent application in three-vessel disease standard or the exception?

The national guidelines for treatment of chronic coronary heart disease (CHD) recommend surgical coronary aortic bypass grafting (CABG) rather than percutaneous coronary intervention (PCI) for patients with a coronary three-vessel disease. The epidemiology of three-vessel CHD and data about the application of different revascularisation strategies raise suspicion of deviation from the guidelines in the treatment of those patients. Claims data containing records of almost 10 million patients of the largest German statutory health insurance fund (Techniker Krankenkasse) were utilised to measure adherence to the guidelines for treatment of groups of patients with one-, two-, and three-vessel CHD, respectively. The impact of age, sex, and comorbidity on each patient's revascularisation procedure was investigated as well. There was no significant difference in the rate of PCI between the groups. In conclusion, the hypothesis that patients with a coronary three-vessel disease are not always treated according to the recommendations of the national guidelines could not be disproved by this study. Finally, the results of this study suggest that the best revascularisation strategy for each patient with two- and three-vessel disease should be decided upon by an interdisciplinary discussion between both cardiologists and cardiac surgeons.

[Quality Assurance using routine data: Overdiagnosis by radiological imaging for back pain]. / Überdiagnostik mit Bildgebung bei Rückenschmerzen.

UNLABELLED: Background and Problem: Acute nonspecific back pain disorders are typically self-limiting. According to the national guideline low back pain, only in case of clinical suspicion of a serious course radiological imaging should take place immediately. Otherwise, the guideline recommends waiting at least six weeks. PATIENTS AND METHODOLOGY: Using Statutory Health Insurance (SHI) routine data of the Techniker Krankenkasse we analyzed how many of the insured persons suffering from acute back pain for the first time with no indication of a serious outcome received a non-indicated diagnostic imaging. RESULTS: In about 10 % diagnostic imaging is conducted after initial diagnosis. If an imaging is carried out, roughly one third of these cases takes place ahead of time or is completely unnecessary. Methodically this is a very conservative estimation, thus it seems likely that the extent of overdiagnosis in actual medical care situation is even larger. CONCLUSIONS: Every third patient who received radiological diagnostics due to first acute nonspecific back pain underwent the procedure more quickly than recommended (less than six weeks). Overdiagnosis is not only economically problematic but also with respect to patient orientation and patient safety. It may cause substantial damage to patients - either by the use of diagnostics itself or by means of therapies initiated after diagnostics.

[Brachytherapy for Prostate Cancer: Potentials and Limitations of Social Health Insurance Data for Benefit Assessment]. / Brachytherapie beim Prostata-Ca: Möglichkeiten und Limitationen von GKV-Routinedaten für eine Nutzenbewertung.

BACKGROUND: Due to the insufficient data base the Federal Joint Committee (G-BA) had in 2009 after 7 years of deliberation decided to initiate consultation regarding ambulatory brachytherapy for localised prostate cancer for 10 years from social health insurance (SHI) benefits. The aim is to gain more findings by means of comparative studies. PROBLEM: Based on the non-availability of clinical primary data of a methodologically acceptable level, it was analysed to what extent secondary data of the SHI may be used in order to arrive at valid conclusions for benefit aspects. METHODS: As base approx. 8 million insured of TK with their data of cost reimbursement between 2006 and 2011 were considered. In SHI secondary data no clinical information regarding tumour stage and other prognostic factors are available. Therefore, a novel method with therapy-specific multisectoral inclusion and exclusion criteria, respectively, was developed in order to differentiate between localised and advanced tumours of the prostate. Overall survival, relapse-free survival, event-free survival and side-effects associated to prostate cancer were analysed. RESULTS: Out of 87 822 insured persons with the diagnosis prostate cancer, 795 with PBT, 10 936 with RP and 1 925 with EBRT were investigated in detail. The 4-year event-free survival rate was 73% for RP, 77% for PBT and 71% for EBRT. Many prostate cancer-specific side effects appeared already before intervention. Side effects of the intestinal tract (23.8%) and sexual impairments (26.5%) were more frequent for EBRT than for RP (17.1%/14.8%) and PBT (16.4%/13.2%). CONCLUSION: By means of SHI secondary data and adequate operationalisation important findings regarding relevant aspects of prostate cancer in healthcare research can be generated. However, these hold methodological limitations and are not suited to draw valid conclusions for benefit assessment. Based solely on SHI routine data valid statements regarding comparative benefit assessment are limited. Limitations could be reduced by applying a record linkage with clinical data. Such primary data should include information on tumour stages as well as therapy assignment and observation of survival time.

[Age- and Gender-specific Costs as Well as Drug Therapies of ADHD Patients]. / Alters- und geschlechtsspezifische Kosten sowie die Versorgung mit medikamentösen Therapien von ADHS-Patienten.

UNLABELLED: Backround and Objectives: Attention deficit hyperactivity disorder (ADHD) is one of the most commonly diagnosed mental disorders in children and adolescents. The rate of persistence into adulthood varies up to 60% and shows the importance of the disease. Here we present age-stratified cost information on adult patients, as well as data on occupational therapy, medication and multimodal treatment. Furthermore, we also investigated retrospectively if methylphenidate was prescribed for adults already before its approval in 2011. METHODS: Claims data of a major German insurance fund (Techniker Krankenkasse) was available. Inclusion criteria were patients with ADHD diagnosis, either hospitalized or treated on an outpatient basis in 2006, 2007 and 2008 and insured over this period. This enabled identifying this disease as chronic. The data were analyzed as part of a control group design (1:3). Cost differences were examined as also the odds ratios for the burden of comorbidities and use of atomoxetine and methylphenidate. RESULTS: 77.9% of the identified ADHD patients were male (mean age: 16.5 years ±11.1). The mean total costs of patient treatment were € 2,032 (±4,112). The odds ratio was highest for the indication developmental disorders of scholastic skills (15.4) and differed between the sexes (female: 24.0 vs. male: 14.2). Drug prescription was higher in male than in female patients (atomoxetine: 7.2 vs. 5.9% and methylphenidate 59.1 vs. 48.4%). CONCLUSIONS: This study provides important insights into the importance of the adult ADHD collective. There were increasing resource consumption identified in adult ADHD patients. In addition, methylphenidate was used off-label for treating adults already before 2011 and its approval in 2011 provided increased certainty for physicians regarding prescription of this drug.

[Disease management programs: Difficulties in the analysis of benefit]. / Disease-Management-Programme : Schwierigkeiten bei der Nutzenbewertung.

After an introduction to the theme with an overview of the implementation of the Disease Management Programs (DMP), accompanying documentation, present utilization and costs of the programs, the present article is primarily devoted to the issue of the analysis of the benefits of DMP. Following an assessment of the legally specified evaluation requirements, in the absence of a prospective, randomized, controlled trial (RCT), the results of three studies are first summarized, which, with the application of propensity score matching, utilize the routine data of the statutory health insurance schemes to form a control group. The overview concludes with a look at the planned changes in evaluation and the intended expansion of the DMP to programs for other chronic illnesses.

Economic burden of neural tube defects in Germany.

OBJECTIVE: Failure of closure of the neural tube often leads to serious malformations, including spina bifida, anencephaly and encephalocoele. Despite improvements in medical and surgical treatment, the burden associated with spina bifida is substantial but country-specific data are lacking outside North America. This study aims to improve understanding of the economic implications and burden associated with the morbidity of children and adults with neural tube defects (NTDs) in Germany. STUDY DESIGN: Retrospective data analysis. METHODS: 2006-2009 German health insurance data of persons with NTDs (spina bifida and encephalocoele) were analysed to determine the economic burden of illness associated with NTDs in Germany. Cases were identified using ICD-10 codes; data included outpatient and inpatient care, rehabilitation, remedies and medical aids, pharmacotherapy use, long-term care and information on sick leave. The analysis was stratified by age group to provide a burden estimate specific to a person's age. To obtain an indicator of incremental burden to the Statutory Health Insurance (SHI), results were compared to the standardized healthcare expenditures according to the German Risk Compensation Scheme (RSA). RESULTS: Overall, 4141 persons with an ICD code related to NTDs were identified (out of a population of 7.28 million persons screened). The administrative prevalence ranged from 0.54 to 0.58 per 1000 enrollees. Of those, 3952 (95.4%) were diagnosed with spina bifida. The average annual mean healthcare expenditure of persons with spina bifida was €4532 (95% CI = 4375-4689, SD = 9590, Median = 1000), with inpatient care contributing €1358 (30.0%), outpatient care €644 (14.2%), rehabilitation €29 (0.6%), pharmacotherapy €562 (12.4%), and remedies and medical aids €1939 (42.8%). The incremental cost due to spina bifida was substantially higher than the standardized SHI expenditures for all age groups. The difference was highest for persons ≤ 10 years old (€10,971 vs €2360 for the age group ≤ 1, €8599 vs €833 for the age group 2-5 years and €10,601 vs €863 for the age group 6-10 years). The difference was smallest for the age group 41-50 years (€2524 vs €1101) and for 71 years and over (€5278 vs €4389). CONCLUSION: Expenditures of persons with spina bifida exceeded the standardized SHI expenditures, indicating a considerable economic burden. The economic burden is continuous throughout the person's life, with high monetary impact and exposure to the healthcare system (especially in early years of life). Efforts should be devoted to improve the prevention of NTDs and provide appropriate support for persons with NTDs, parents, and caregivers--especially in early years.

[Calculation of disease-related costs in claims data analyses with the example of attention-deficit hyperactivity disorder. Comparison of methods]. / Die Berechnung indikationsspezifischer Kosten bei GKV-Routinedatenanalysen am Beispiel von ADHS. Ein Methodenvergleich.

Claims data have proven useful for carrying out cost-of-illness studies. To avoid overestimating disease-related costs, only those costs that are related to a specific disease should be considered. The present study demonstrates two basic approaches for identifying disease-related costs. Using the example of attention-deficit hyperactivity disorder (ADHD), the advantages and drawbacks of expert-based approaches and those based on control groups are compared. Anonymized data from the "Techniker Krankenkasse" for 2008 were available for the study. The study population encompassed all ADHD patients and a control group that was five times bigger. Additionally, a systematic literature review was carried out on 65 relevant studies. Compared with the control group, disease-related costs were EUR 2,902 per ADHD patient on average. However, using the expert-based approach, costs were established to be EUR 923 lower. This is mainly because a comparison with an appropriate control group incorporates all costs for possible comorbidities and concomitant diseases. Both approaches have specific advantages and drawbacks, and when planning studies the respective limitations need to be considered.

[The future issues of health services research: what do experts say?]. / Zukunftsthemen der Versorgungsforschung - Was meinen die Experten?

BACKGROUND: The expectations of health services research are growing with its recognition and acceptance as an independent field within health research. What are the issues that health services research should deal with in future to perform the tasks it will be confronted with? Different health-care players like physicians, scientists, sponsors, and third-party payers were invited to give answers to these questions which was the aim of the workshop held in Cologne on the 8th November 2010. The IMVR (Institute for Medical Sociology, Health Services Research, and Rehabilitation Science, University of Cologne) and WINEG (Scientific Institute of TechnikerKrankenkasse for the Benefit and Efficiency in Health Care) jointly hosted the 'Expert Workshop - Future Issues of Health Services Research' in order to get closer to meeting this goal. METHODS: Experts met in 4 focus groups to identify the future issues of health services research in the one-day workshop in Cologne in November 2010. The participants discussed their proposed issues in a moderated session and decided on the key future issues of health services research in a double voting procedure. RESULTS: 36 experts accepted the invitation. Of these 6 were experts of the medical profession, 4 of the group of sponsors, 13 scientific experts and 13 experts of the groups of third-party payers. According to their rating, "intersectoral networking", "patients' preferences", and "the evaluation of innovations, processes, and methods" are the 3 key future issues of health services research. CONCLUSIONS: The experts developed the key future issues for health services research according to their opinion. They answered the question on the issues, health services research should be occupied with in future, i.e. a broad range of topics. To a certain extent, they returned to former issues and problems for which satisfactory solutions have not yet been found.