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.

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.

[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.

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.

[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.

[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.

[A validated questionnaire for measuring patient satisfaction in general and specialist ambulatory medical care: the Qualiskope-A]. / Ein valides Instrument zur Messung der Patientenzufriedenheit in ambulanter haus- und fachärztlicher Behandlung: das Qualiskope-A.

PURPOSE: To develop a reliable and valid questionnaire to measure patient satisfaction in ambulatory care, enabling a detailed analysis of the determinants of patient satisfaction that is applicable in GP and specialist outpatient care. DESIGN: Questionnaire with 27 single items subdivided into four categories: "professional competence", "physician-patient interaction", "information", and "practice organisation". Survey of 3,487 patients in 123 medical practices. 1,151 patients were in specialist care and 2,336 patients in general medical care. RESULTS: Qualiskope-A is a reliable and valid instrument for measuring patient satisfaction in ambulatory care. All item-total correlations for single items were greater than r = 0.40. Coefficients for Cronbach's alpha for the four dimensions ranged between 0.87 and 0.94. CONCLUSIONS: The increasing political importance of patients' attitudes and satisfaction for the development of policy measures to ensure and improve the quality of care is beyond doubt. To make sure that the measurement of patient satisfaction does not only serve to meet regulatory requirements but helps to improve the quality of care and provides reliable data for health services research, a high standard is required for the questionnaires to be used. The Qualiskope-A and only few other instruments meet this high standard.

[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.

Spina bifida as an independent risk factor for sensitization to latex.

PURPOSE: Patients with spina bifida are at a high risk for having an immediate type allergy to latex products. The number of surgical interventions, atopy and catheterization are well known responsible factors, whereas the condition of spina bifida per se has not been established as an independent risk factor. MATERIALS AND METHODS: A total of 131 patients with a shunted hydrocephalus (48 with spina bifida and 83 of other origin) were investigated for sensitization to latex by skin prick tests and determination of specific IgE. We hypothesized that the diagnosis of spina bifida will increase the risk for latex sensitization while considering potential confounding factors. Thus, we performed a multiple logistic regression analysis to determine independent risk factors. RESULTS: Whereas 56.3% (27/48) of children with spina bifida proved sensitized against latex, this result was the case in only 16.9% (14/83) with another cause of hydrocephalus (p <0.001). The mean number of surgical interventions was 6.2 for patients with no latex sensitization and 9.3 for those with sensitization (p = 0.02). Of patient sensitized to latex 43.9% had a history of atopy compared to 15.5% of those not sensitized (p = 0.02). Sensitized and nonsensitized patients were comparable regarding gender and catheterization. In a multiple logistic regression analysis the cause of the hydrocephalus (odds ratio 6.76 for spina bifida), atopy (odds ratio 3.37) and the number of surgical interventions (odds ratio 1.14 per operation) were identified as independent risk factors. CONCLUSIONS: The increased risk of latex sensitization in patients with spina bifida seems to be disease associated. Possible explanations for this finding may be genetic, antigen mediated, early latex exposure and immunological reasons.

Comparison of ropivacaine 0.1% and 0.2% with bupivacaine 0.2% for single-shot caudal anaesthesia in children.

We compared analgesic efficacy and degree of motor block induced by ropivacaine 0.1% (R 0.1) and 0.2% (R 0.2) vs. bupivacaine 0.2% (B 0. 2) after caudal anaesthesia in children. Total and free plasma concentrations were measured after caudal injection. Duration of caudal analgesia (median/range) was significantly shorter in group R 0.1 (1.7 h/0.2-6 h) than in group R 0.2 (4.5 h/1.7-6 h) or group B 0. 2 (4 h/1-6 h) (P<0.05). Motor block in the first 2 h postoperatively was significantly less for both ropivacaine groups compared with bupivacaine (P<0.05). Peak plasma concentrations after ropivacaine 0.2% were higher and protein binding lower than after bupivacaine 0.2% (P<0.05). We conclude that caudal analgesia with ropivacaine 0.1% is less effective and of shorter duration than that of ropivacaine 0.2%, whereas ropivacaine 0.2% provides pain relief similar to bupivacaine 0.2%. Motor block in the early postoperative period is less with ropivacaine than with bupivacaine.

[Utilization of services at the Berlin Center of Ambulatory Rehabilitation]. / Inanspruchnahme von Leistungen im Berliner Zentrum für ambulante Rehabilitation.

The Center for Ambulatory Rehabilitation (ZaR) in Berlin provides rehabilitative services for orthopedic and neurological patient problems offering a rehabilitation program that is flexible, individually adapted and close to the patient's home. This paper analyzes the development of utilization of the ZaR using patient application, admission and discharge data for a one year period (April 1997 to March 1998). Treatment was started for 1,009 patients (mean age 51.1 years; 55% female). While mean duration of a treatment period was 28.5 days, overall utilization of the ZaR was 49%, being higher for the neurological department than for the orthopedic department (74% and 40%, respectively). The variety of patient problems treated was fairly small: more than two thirds of the cases treated were patients after stroke (ICD 430-438) in the neurological department and patients with back problems (ICD 721-724) in the orthopedic department, respectively. Acute care hospitals still play a minor role in referring patients to the ZaR. Referrals of many office-based physicians suggest that the ZaR will achieve its intention to provide rehabilitative services close to the patient's home.