Interobserver agreement on definition of the target volume in stereotactic radiotherapy for pancreatic adenocarcinoma using different imaging modalities.

PURPOSE: The aim of this study was to evaluate interobserver agreement (IOA) on target volume definition for pancreatic cancer (PACA) within the Radiosurgery and Stereotactic Radiotherapy Working Group of the German Society of Radiation Oncology (DEGRO) and to identify the influence of imaging modalities on the definition of the target volumes. METHODS: Two cases of locally advanced PACA and one local recurrence were selected from a large SBRT database. Delineation was based on either a planning 4D CT with or without (w/wo) IV contrast, w/wo PET/CT, and w/wo diagnostic MRI. Novel compared to other studies, a combination of four metrics was used to integrate several aspects of target volume segmentation: the Dice coefficient (DSC), the Hausdorff distance (HD), the probabilistic distance (PBD), and the volumetric similarity (VS). RESULTS: For all three GTVs, the median DSC was 0.75 (range 0.17-0.95), the median HD 15 (range 3.22-67.11) mm, the median PBD 0.33 (range 0.06-4.86), and the median VS was 0.88 (range 0.31-1). For ITVs and PTVs the results were similar. When comparing the imaging modalities for delineation, the best agreement for the GTV was achieved using PET/CT, and for the ITV and PTV using 4D PET/CT, in treatment position with abdominal compression. CONCLUSION: Overall, there was good GTV agreement (DSC). Combined metrics appeared to allow a more valid detection of interobserver variation. For SBRT, either 4D PET/CT or 3D PET/CT in treatment position with abdominal compression leads to better agreement and should be considered as a very useful imaging modality for the definition of treatment volumes in pancreatic SBRT. Contouring does not appear to be the weakest link in the treatment planning chain of SBRT for PACA.

Advances in rectal cancer: Real-world evidence suggests limited gains in prognosis for elderly patients.

BACKGROUND: Rectal cancer treatment has improved considerably due to the introduction of total meso-rectal excision, radio-chemotherapy, and high-resolution imaging. The aim of this observational cohort study was to quantify the effectiveness of these advances using high-quality data from a representative cohort of patients. METHODS: 20 281 non-metastasized cases retrieved from the Munich Cancer Registry database were divided into three time periods corresponding to before (1988-1997), partial (1998-2007), and full implementation (2008-2019) of clinical advances. Early-onset (<50 yrs.), middle-aged, elderly patient subgroups (> 70 yrs.) were compared. The overall effectiveness of evidence-based guideline adherence was also examined. RESULTS: Median survival improved by 1.5 yrs. from the first to the last time period. Relative survival increased from 74.9% (5-yr 95%CI[73.3 - 76.6]) to 79.2% (95%CI[77.8 - 80.5]). The incidence of locoregional recurrences was reduced dramatically by more than half (5-yr 17.7% (95%CI[16.5 - 18.8]); 6.7% (95%CI[6.1 - 7.3])). Gains in 5-yr relative survival were limited to early-onset and middle-aged patients with no significant improvement seen in elderly patients (Female 68.6% [63.9 - 73.3] to 67.6% [64.0 - 71.2]; Male 71.7% [65.9 - 77.4] to 74.0% [70.8 - 77.2]). CONCLUSIONS: Real-world evidence suggests that recent treatment advances have lead to an increase in prognosis for rectal cancer patients. However, more effort should be made to improve the implementation of new developments in elderly patients. Especially considering, that these cases represent a growing majority of diagnosed patients.

[Opioid therapy in patients with back pain. Claims data analysis for patient group characterization, influence on opioid therapy and work disability]. / Opioidtherapie bei Versicherten mit Rückenschmerzen. Sekundärdatenanalyse zur Charakterisierung von Patientengruppen, Einfluss auf Opioidtherapie und Arbeitsunfähigkeit.

This study features an analysis of the analgesic therapy of patients with back pain focusing on opioid administration. Using claims data of a German statutory health insurance fund the analysis focuses on prescription patterns, the association between opioids and antiemetics as well as between opioid therapy and work disability. Based on typical diagnosis patterns three types of back pain could be identified: (other) specific back pain (46.0%), pain due to spinal disc diseases (23.5%) and non-specific back pain. The proportion of patients receiving continuous opioid therapy ranged between 24.3% and 48.8%. The prescription of antiemetics was associated with a higher chance of continuous opioid therapy (odds ratio [OR] 1.93; 95% confidence interval [CI] 1.79-2.08). The chance of continuous opioid therapy was higher in pain patients with spinal disc diseases and patients with (other) specific back pain (OR 1.62 and 1.76, respectively; 95% CI 1.56-1.69 and 1.69-1.83, respectively). Continuous opioid therapy appears to increase the probability of a lower number of days off work due to disability (incidence rate ratio [IRR] 0.76; 95% CI 0.70-0.84). Adequate prospective studies should test if the associations found can be confirmed.

[Pain-specific diagnosis patterns in claims data - Identification by means of classification and regression trees (CART)]. / Schmerztypische Diagnosemuster in Routinedaten - Identifikation mittels Classification and Regression Trees (CART).

The identification of beneficiaries with persistent, recurrent or chronic pain in claims data by means of individual diagnoses or analgesic prescription is not sufficient and reliable. By using CLASSIFICATION AND REGRESSION TREES (CART) it was possible to identify specific diagnosis patterns for patients suffering from pain. Diagnosis patterns are considered as specific if they occur more frequently among beneficiaries with at least two opioid prescriptions within one year compared with beneficiaries who did not receive any analgesic therapy. Diagnosis and prescription data of 2006 were provided by the German sickness fund DAK. As a result, 65 diagnosis patterns occurred more frequently among beneficiaries treated with opioids than among the control group. These 65 patterns can be classified as follows: cancer-related pain (4), specific back pain/osteoporosis (8), spine-related pain (6), arthritis-related pain/rheumatoid arthritis (22), pain after traumatic fractures (5), pain in multimorbid, dependent patients (3), neuropathic pain (7), headache (5), non-specific back pain (5). The derived diagnosis patterns showed high predictive values (sensitivity: 78%, specificity: 66%) and are suitable for the identification of beneficiaries suffering from pain - the first step towards health services research in pain-based on claims data.

[Identification and grouping of pain patients according to claims data]. / Identifikation und Gruppierung von Schmerzpatienten anhand von Routinedaten einer Krankenkasse.

The ICD classification does not provide the opportunity to adequately identify pain patients. Therefore we developed an alternative method for the identification and classification of pain patients which is based on prescription and diagnoses data from the year 2006 of one nationwide sickness fund (DAK) and which is led by two main assumptions: 1. Beneficiaries without prescription of an analgetic drug but with a diagnosis pattern that is characteristic of patients who are treated with opioids are also likely to be pain patients. 2. Each combination of diagnosis groups can be traced back to one primary diagnosis out of a diagnosis group according to the patient classification system CCS (Clinical Classifications Software). The selection of this diagnosis group (CCS) allows for the allocation of the beneficiary to only one pain type. As a result we identified 65 combinations of CCS diagnosis groups--aggregated to nine "CCS pain types"--to which 77.1% of all patients with at least two opioid prescriptions can be allocated: 26.3% to pain due to arthrosis, 18.0% to pain due to intervertebral disc illnesses, 13.1% to other specific back pain, 6.7% to neuropathic pain, 4.5% to unspecific back pain, 4.2% to headache, 2.4% to pain after traumatic fractures, 1.3% to pain of multimorbid, high-maintenance patients, and 0.6% to cancer pain. Based on our method beneficiaries who have a high probability of suffering from moderate to strong pain can be identified and included in further claims data analyses of health care delivery and utilization pattern of pain-related disorders in Germany.

Tumorectomy plus tamoxifen for the treatment of breast cancer in the elderly.

Between 1987 and 1991 a total of 37 breast cancer patients with a mean age of 78.8 (68-89) years underwent local tumor excision and were continuously given 20-30 mg tamoxifen. Thirteen patients presented with clinical stage I, 21 with stage II, two patients with stage III and one woman with stage IV. Surgical complications were minimal and hospital stay 3.5 days. Four patients were lost to follow-up. After a mean observation time of 44.5 months, three of the remaining patients developed local recurrence, which was excised, and 12 patients (32.4%) died. Death, however, was never related to breast cancer. One further patient developed visceral metastases after 46 months of treatment, which responded well to an increase in tamoxifen. The patient with osseous metastases at the time of diagnosis is still alive with stable disease after 75 months. Growing axillary lymph nodes were dissected 16 and 22 months after primary surgery in two patients. It is concluded from this series that limited surgery with hormonal therapy is an effective treatment of breast cancer in elderly patients.

[Myocardial infarct and occupational reintegration in insured patients of a regional sickness fund]. / Myokardinfarkt und berufliche Reintegration bei Versicherten einer regionalen Krankenkasse.

For a region in the Federal Republic of Germany, some important indicators for procedures and outcomes of the care of myocardial infarction patients have been demonstrated. The study was restricted to patients under 65 years of age and was based on routine data from the health insurance fund. Length of stay in the hospital was more than five weeks. Half of the patients who underwent coronary angiography coronary bypass surgery had to wait longer than three or five months, respectively, for the procedure. Half of the patients who were treated in a rehabilitation clinic had to wait more than two weeks elapsed after discharge from the acute care hospital. Utilization of this type of service was about 75% for patients who were employed before the infarction compared to only about 15% for patients who had already been retired from work. Only about half of the men under 60 years returned to work after their infarction. Half of the patients were still disabled after nine months after onset of disease. The study was part of a project for the development of care for patients with myocardial infarction in that region. It turned out that routine data are effective for the description of the situation. Studies of this type can be repeated in other regions with comparable little effort.

[Incidence of appendectomy and length of hospital stay in a region of West Germany]. / Appendektomie-Häufigkeit und Krankenhaus-Verweildauer in einer Region der Bundesrepublik Deutschland.

Based on public health routine data, a study on the incidence of appendectomies was carried out in the Federal Republic of Germany. The result of 130 appendectomies per 100,000 inhabitants per annum comes very close to the findings made in England and Wales though it only represents one fifth of the figure, Lichtner and Pflanz had established for some other region about 20 years ago. Duration of hospitalization averaged 10.6 days, thus showing a reduction of 2 days compared to the earlier study. In England and Wales however, the average length of stay in hospital came up to only 5.6 days. The length of stay, standardized by age and sex, showed differences of more than 4 days on the various wards. The possible influences of institution inherent factors on the frequency of operations and on the duration of hospitalization are discussed.

[Translation and validation initiatives of the German version of the Teenage Inventory of Social Skills]. / Ubersetzungs- und Validierungsansätze der deutschen Version des "Teenage Inventory of Social Skills".

OBJECTIVES: A lot of studies show the close connection between low social competence and psychological disturbances of adolescents. METHODS: To record the social behavior of adolescents among each other the "Teenage Inventory of Social Skills" (TISS) was translated into German and evaluated. RESULTS: The factorial created scales "positive behaviour", and "negative behaviour" show an internal constistuency of alpha = .86 and .85. The 13 to 18 days test-retest reliability amounts to r = .89 for both scales. While there is no substantial correlation between the scale "positive behaviour" and the syndrome scales of the "Youth Self-Report", the scale "negative behaviour" shows the expected correlations with the YSR scales "aggressive behaviour" and "dissocial behaviour". CONCLUSIONS: The "Teenage Inventory of Social Skills--German" (TISS-D) seems to be a self-rated, economical and reliable instrument for the recording of sympathy and antipathy generating behavior of adolescents.

Excess health care costs of obesity in adults with diabetes mellitus: a claims data analysis.

BACKGROUND: Body weight management is a key factor in diabetes mellitus. However, both behavioral and pharmacological innovations to manage obesity may imply additional costs. In order to provide further insights into the role of obesity in diabetes-associated resource consumption, this study aims to estimate incremental costs of concomitant obesity in German adult patients (≥ 18 years) with different types of diabetes. METHODS: Adopting a third-party payer perspective, claims data from a German statutory sickness fund (N=1,094,496) were analyzed for costs of annual drug prescriptions and out- and inpatient care in adult beneficiaries with diabetes in 2004. Using diagnostic information, 37,570 beneficiaries with diabetes were identified. Concomitant obesity was assessed by ICD-10-codes (E66) in the claims data. Adjusting for sex, age, and micro- and macro-vascular complications, one generalized gamma regression model with the log link was performed for type 2 diabetes patients (N=24,562), type 1 diabetes patients (N=5,663), and an unclassified group (N=7,345), respectively. RESULTS: Overall, 33% of the patients with diabetes were identified as obese (type 2 diabetes: 34%, type 1 diabetes: 20%, unclassified: 38%). Affirming descriptive analyses, the generalized gamma regression models revealed that obesity is associated with significant increments in health care costs regardless of type of diabetes (type 2 diabetes: € 454, type 1 diabetes: € 812, unclassified: € 532). The interaction of obesity and macro-vascular complications was numerically stronger in type 1 than in type 2 diabetes but reached statistical significance only in type 2 diabetes (and the unclassified group). Moreover, concurrent macro- and micro-vascular complications were associated with higher incremental costs in all groups. CONCLUSIONS: Concomitant obesity is independently associated with incremental health care costs in adult patients with type 2 diabetes and, even more so, type 1 diabetes. Results are discussed with respect to the fact that in this sample, concurrent micro- and macro-vascular complications were more frequent in type 1 diabetes. At any rate, in light of these health care costs, obesity seems relevant in both types of diabetes. Due to claims data limitations, it was not possible to distinguish obesity classes based on body height and weight information. Further research should identify adiposity thresholds for increased resource consumption using both primary and secondary data.

[Quality of life and treatment satisfaction in patients being treated with long-acting insulin analogues]. / Lebensqualität und Behandlungszufriedenheit unter Therapie mit langwirksamen Analoginsulinen.

BACKGROUND AND OBJECTIVES: The purpose of this study was to review studies reporting on quality of life and treatment satisfaction of patients with diabetes mellitus being treated with long-acting insulin analogues. MATERIAL AND METHODS: A systematic literature search was made of trials published between January 1, 2000 and June 28, 2007. Retrieved studies were analysed, using predefined inclusion criteria as well as methodological and quality aspects. RESULTS: Twelve studies were included, all of them dealing with insulin glargine as the trial drug or for comparison. With regard to treatment satisfaction, insulin glargine was superior in one head-to-head comparison with NPH (neutral protamine Hagedorn) and one head-to-head comparison with NPH as an add-on to oral glimepiride. There was no difference in comparisons with continuous subcutaneous insulin infusion (CSII), insulin aspart or exenatide. Regarding health related quality of life (HRQoL), insulin glargine was shown to be superior to rosiglitazone as an add-on to metformin and sulfonylurea. Again, there were no differences in comparisons with NPH, CSII or exenatide. CONCLUSION: There are only a limited number of high quality studies showing that insulin glargine is superior regarding treatment satisfaction and HRQoL of patients with diabetes mellitus. There are fewer publications with good evidence of patient-reported outcomes than those reporting well-established outcomes using HbA1c levels or the incidence of hypoglycaemia.

[Transdermal and oral opioids for outpatient pain therapy. Comparing patients' characteristics by a claims data analysis]. / Transdermale und orale Opioide in der ambulanten Schmerztherapie. Vergleich von Patientencharakteristika anhand einer GKV-Datenanalyse.

Opioid prescriptions have increased in Germany in recent years. The usage of transdermal therapeutic systems has substantially driven this growth. The analysis was based on claims data of a German statutory health insurance (2001-2003). Statistical analysis applied univariate comparisons (exploratively only) as well as a multivariate logistic regression models. Patients in the transdermal group were older and the percentage of women was higher than in the oral group. Patients in the transdermal group received their opioids significantly more often from a GP. They had significantly less prescriptions for laxatives and antidepressants. The patients in both groups differed significantly with regard to a number of characteristics. The results indicate that GPs prefer transdermal opioids if prescribing strong-acting opioids.

Epidemiology, treatment and costs of osteoporosis in Germany--the BoneEVA Study.

INTRODUCTION: In Germany, accurate data on the prevalence and treatment of osteoporosis, as well as the cost of this illness, are not available. The aim of this study is to give a valid estimation of these items for the year 2003. METHODS: Routine data from a German sickness fund covering 1.5 million beneficiaries and billing data for outpatient visits were used to obtain estimates of prevalence for osteoporosis. Claims data for patients with osteoporosis (M80, M81) or an osteoporosis-related fracture diagnosis (S22, S32, S42, S52, S72, S82) or treatment with anti-osteoporosis drugs were examined. Costs were calculated from the perspective of the German health insurance system and the German nursing care insurance system, respectively. Only direct costs of osteoporosis were considered. RESULTS: In 2003, 7.8 million Germans (6.5 million women) were affected by osteoporosis. Of them, 4.3% experienced at least one clinical fracture. Only 21.7% were treated with an anti-osteoporosis drug. The total direct costs attributable to osteoporosis amounted to euros 5.4 billion. CONCLUSION: This study confirms that osteoporosis is underdiagnosed, undertreated and imposes a considerable economic burden on the health system in Germany. Effective strategies for the prevention and management of this disease are needed.

[Quality circles in rehabilitation clinics. What has been effective in general practice?]. / Qualitätszirkel in Rehabilitationskliniken. Was hat sich in der Praxis bewährt?

Within the framework of their quality assurance programme, the German statutory pension funds in 1994 and 1995 required over 400 rehabilitation hospitals to develop structures permitting to establish comprehensive quality management programmes. In particular, they asked that these hospitals should establish quality circles. Structured information could be gathered from 380 hospitals at the end of a pilot phase. According to this information, 233 hospitals conduct a total of 558 quality circles. However, only 23.5% of these quality circles fulfil the criteria of a well-structured quality circle. Another 34.7% of the reported activities can, in a broader sense, be considered as activities that might be helpful in developing Total Quality Management (TQM) systems, whereas 41.8% account for more routine activities such as floor meetings etc. A detailed analysis of the documented information revealed that a high proportion of quality circle participants are recruited from leadership positions. From a subject matter perspective, quality circles still focus on their conceptualization. Taking into consideration the large number of hospitals, the introduction of quality circles can be considered quite successful.