[Complication rates and secondary interventions after coronary procedures in clinical routine: 1-year follow-up based on routine data of a German health insurance company]. / Komplikationen und Folgeeingriffe nach koronaren Prozeduren in der klinischen Routine.

BACKGROUND: Data on 1-year complication and follow-up intervention rates after coronary angiography (CA) and percutaneous coronary intervention (PCI) in German clinical routine are sparse. This analysis aims to determine these rates. METHODS: The analysis uses 2009 AOK claims data. Patients were divided into 3 groups (CA, without cardiac surgery and without acute myocardial infarction (AMI) n=116.071; PCI with stenting, without AMI: n=36.685; PCI with stenting and with AMI: n=32.707). The frequency of the endpoints MACCE (mortality, AMI, stroke, TIA), CABG, PCI and CA was recorded for up to one year. RESULTS: 1-year MACCE rates were 8.1 % (CA), 9.9 % (PCI without AMI) and 17.9 % (PCI with AMI). Quality-relevant follow-up intervention rates in the CA group were 2.5 % for CABG (after 31-365 days), 1.7 % for PCI within 90 days and 3.5 % for follow-up CA within 1 year. In the PCI groups, the frequencies were 1.6 % (without AMI) and 2.7 % (with AMI) for CABG (after 31-365 days), and 10.2 % (without AMI) and 10.1 % (with AMI) for PCI after 91-365 days. CONCLUSION: This is the first cross-sectoral routine analysis of cardiac catheters and sequential events up to one year in Germany. The actual medical care situation revealed information particularly with regard to the second and follow-up inventions, which cannot be derived directly from medical guidelines. Beyond clinical trials, knowledge can be gained which is important both for medicine as well as the politics of health services.

[Decision criteria for the appropriateness of inpatient treatment in patients with peripheral angiopathy]. / MDK - Prüfungen zur primären und sekundären Fehlbelegung am Beispiel der Angiologie.

In various medical subspecialties like angiology, invasive diagnostic procedures and elective therapy, which under certain conditions may be carried out on outpatients, represent a large proportion of all inpatient medical treatment. As regulations for the statutory health insurance in Germany demand that medical procedures should be preferentially carried out in outpatient facilities, there is a high potential for conflicting views with respect to the question whether hospitalisation of an individual patient is mandatory for medical reasons. Explicit criteria may be useful to prevent conflicting views and to increase truth and fairness in the proceedings of hospitals on one hand and the medical service of the statutory health insurance on the other hand. With respect to this problem we present decision criteria which were compiled by a hospital (Hochrhein-Eggberg-Klinik Bad Säckingen) and the medical service of the statutory health insurance in the state of Baden-Württemberg (MDK-Baden-Württemberg). Our model has proven to be of value in our practical experience. It seems to be transferable to medical subspecialties with similar problems.

[Elzach concept and intervention catalogue of nursing therapy in postacute neurological rehabilitation within the German DRG System]. / Elzacher Konzept und Leistungskatalog der therapeutischen Pflege in der neurologischen Frührehabilitation (Phase B).

The German DRG system defines specialized treatments through a set of minimal requirements, the documentation of which and its assessment by external specialists of the medical service of the statutory health insurance causing frictions between rehabilitation hospitals and the medical service. It is especially problematic to make a clear distinction between nursing care and treatment. To reduce frictions and interface problems, a catalogue of acts of therapy performed by nurses was agreed for neurological early rehabilitation in Baden-Württemberg. This Elzach concept and catalogue describe therapeutic nursing in neurological rehabilitation and increase transparency and accountability both for providers and cost carriers.

[Case payments in hospital psychiatry in the USA. The Inpatient Psychiatric Facility Prospective Payment System (IPF PPS)]. / Fallpauschalen in der Krankenhaus-Psychiatrie der USA. Das Inpatient Psychiatric Facility Prospective Payment System (IPF PPS).

OBJECTIVE: In Germany the introduction of a prospective payment system (PPS) is intended for inpatients hospitalised in psychiatric facilities. We investigate the various elements of the Prospective Payment System for Inpatient Psychiatric Facilities (IFP PPS) which was established in the USA in 2005 with respect to their potential to be incorporated into a german PPS. RESULTS: The most important elements of IFP PPS (impact of diagnosis, comorbidity, patient age, per diem adjustment for length of stay, various other adjustment factors like facility characteristics and geographical factors) are presented. The IFP PPS was especially designed for the requirements of psychiatric inpatient facilities in the USA. Complexity of the individual elements of the PPS appears to be manageable. However, various elements, e. g. the facility based adjustments including wage index or rural location and cost of living adjustments will not be applicable to countries other than the US. The 15 diagnosis related groups of the IFP PPS system refer to ICD-9 which is less differentiated than the ICD-10 which is in use in Germany, thus these psychiatric DRG will not be compatible under conditions of a german PPS. The per diem adjustment for length of stay is the predominating element of the IFP PPS, relation to effort/performance is insufficiently represented. CONCLUSION: Some elements of the IFP PPS may be applicable to a german prospective payment system for psychiatric inpatient facilities, especially with respect to the rules for per diem adjustment for length of stay and for handling of cases with frequent discharge and readmission of patients. Altogether a stronger representation of elements of performance of inpatient facilities seems to be desirable.

[Integrated case fees in cardiosurgery--a pilot project for fast-track rehabilitation]. / Komplexfallpauschalen in der Herzchirurgie--ein Modellprojekt zur Frührehabilitation.

BACKGROUND: Lengthy recovery and treatment times following cardiosurgical interventions were the motivation for introducing a pilot procedure to integrate acute and rehabilitative treatment structures. The advantage of such a pilot procedure is the medico-economic link between direct transition from acute care to rehabilitation treatment and cutting average case costs. With this in mind, shared case fees for patients following cardiosurgery are being agreed in a pilot project between health insurance companies, acute-care hospitals and rehabilitation clinics. The aim of this study was thus to investigate whether rehabilitation directly after cardiosurgery without prior transferral to an acute-care hospital is comparable with the conventional procedure involving acute care. METHODS: A total of 221 patients were included in the investigation. The pilot project group comprised 159 patients (mean age 70 +/- 6 yrs, 117 men and 42 women) who were transferred directly to rehabilitation following cardiosurgery. The control group, comprising 62 patients (mean age = 71 +/- 6 yrs, 42 men and 20 women), was transferred to an acute-care hospital following cardiosurgery before commencing rehabilitation. Sociodemographic and clinical data were comparable between the two groups. RESULTS: At the end of rehabilitation, the mean maximum ergometric performance in the pilot group was 96 +/- 33 W, significantly higher than the control group's performance of 81 +/- 31 W. One difference between the two groups related to complications. During rehabilitation, complications occurred more frequently within the pilot group. In the pilot group, compared to the control group, postcardiotomy syndrome occurred in 45.3 versus 25.8% and impaired wound healing in 10.1 versus 4.8% of cases. Despite these results, the pilot group demonstrated a significantly shorter overall hospital stay of 39.5 +/- 7.5 days compared to the control group stay of 45.7 +/- 9.7 days. CONCLUSION: Compared to the control group, the pilot group was at no disadvantage with regard to clinical or performance data by the end of rehabilitation. Cardiac complications occur more often during rehabilitation taking place directly after cardiosurgery than with the conventional procedure. These can be viewed, however, as complications occurring directly in temporal conjunction with the operation and as to be expected. Complications attributed directly to fast-track rehabilitation can be excluded. In the pilot group the overall hospital stay was thus shortened. In an environment of legislative restructuring within the healthcare sector, this shows that adequate treatment of cardiosurgical patients is still guaranteed with fast-track rehabilitation.

[DRG evaluation results--state comparisons: MDK Baden-Württemberg versus MDK Westfalen-Lippe]. / DRG-Prüfergebnisse im Ländervergleich: MDK Baden-Württemberg und MDK Westfalen-Lippe.

We report on the first detailed comparison of evaluation results regarding the correct billing in the G-DRG (German diagnosis-related group) system. For two Medical Review Boards of the Statutory Health Insurance Funds of comparable size (MDK Baden-Württemberg and MDK Westfalen-Lippe), we analysed consecutive expertises regarding correct billing according to section sign 275 SGB V, and the results were compared in terms of the frequency of DRG-relevant error codes, their relevance to revenue, and the question of error clustering (specific DRGs, primary diagnoses, etc.). The analysis comprised 51,010 individual expertises pertaining to billings of the year 2005 (admittance to hospital from January 1 to December 31, 2005). The proportion of disapproved cases was 38.5% in Baden-Württemberg and 44.6% in Westfalen-Lippe. Among these, errors to the disadvantage of the Health Insurance (incorrectly high) were 33.9% and 39.3%, respectively, and errors to the disadvantage of the hospitals (incorrectly low) were 4.6% and 5.3%, respectively. The resulting ratio (incorrectly high vs. low) was an identical 7.4 in both cases. Not only the most commonly rejected DRGs but also the primary and secondary diagnoses were similar in both cases, while the disapproved procedure codes showed a significant variability (analysis based on the respective 10 most common objections). We discuss the similarities and differences in these results and their possible causes, and demonstrate the cost relevance of this audit segment. Result comparisons of this type can yield insights into streamlining of the review practice of Medical Review Boards, as well as increase the efficiency and effectiveness of the selection of cases.

[Neonatal septicemia in the G-DRG system]. / Die Neugeborenensepsis in DRG-System.

INTRODUCTION: The introduction of Diagnosis Related Groups in Germany (G-DRG) has brought forward the obligation for physicians to take into account an intricate system of medical, economical and legal implementations. Mistakes in the process of encoding the principal diagnosis or procedures may have financial consequences. Problems to determine the correct ICD-code will be most prominent for diseases with poorly defined or even inconsistent diagnostic criteria as is the case for neonatal septicemia. We decided to evaluate whether the introduction of G-DRG resulted in a change of frequency of the diagnosis "neonatal septicemia". METHODS: We analysed data derived from the quality assurance program "Neonatalerhebung" in the state of Baden-Württemberg during the years of 2001 through 2004, i. e., 2 years before and 2 years during the introduction of G-DRG. During this period an annual number of 12,316 up to 13,172 newborns were admitted to the participating hospitals. RESULTS: The mean number of diagnoses per patient increased from 2.2 to 3.8. The frequency of the diagnosis of septicemia remained constant. The percentage of newborns receiving antibiotic therapy did not change. The ratio of cases with "septicemia yes" over "antibiotics yes" did not change. Although it is difficult to determine the diagnosis of neonatal septicemia and in spite of the economic implications of this diagnosis, no change in the frequency of this diagnosis occurred during the introduction of DRG. CONCLUSIONS: Assuming that the participating hospitals used an identical database for the quality assurance program "Neonatalerhebung" and for accounting, we conclude that the DRG system is stable with respect to neonatal septicemia.

mdclust--exploratory microarray analysis by multidimensional clustering.

MOTIVATION: Unsupervised clustering of microarray data may detect potentially important, but not obvious characteristics of samples, for instance subgroups of diagnoses with distinct gene profiles or systematic errors in experimentation. RESULTS: Multidimensional clustering (mdclust) is a method, which identifies sets of sample clusters and associated genes. It applies iteratively two-means clustering and score-based gene selection. For any phenotype variable best matching sets of clusters can be selected. This provides a method to identify gene-phenotype associations, suited even for settings with a large number of phenotype variables. An optional model based discriminant step may reduce further the number of selected genes.

Determinants and prognoses of locoregional and distant progression in breast cancer.

PURPOSE: To describe locoregional and distant progression in a population-based breast cancer sample. METHODS AND MATERIALS: Between 1978 and 1998, the Munich Cancer Registry evaluated 14,429 patients. The mean follow-up of survivors was 8.3 years. Metastases (MET), local recurrence (LR), and lymph node recurrence (LNR) were considered as outcome measures. The prognostic factor for, and effects of, LR and MET were assessed multivariately by the Cox and dynamic Aalen models. RESULTS: The LR and MET rate increased with increasing tumor size, with the latter described by pT category. Distant MET occurred earlier than local progression. MET was recorded even earlier for MET alone. The mean time from diagnosis to MET for MET and LR was 54.9, 43.4, 29.4, and 24.7 months and for MET only was 36.5, 31.0, 22.6, and 12.9 months for pT1, pT2, pT3, and pT4, respectively. After MET, survival varied only slightly by pT stage; after LR, a more favorable prognosis, especially for pT1 and pT2, was evident. The prognosis after MET depended mainly on the MET location; 50% of patients with cerebral or nervous system MET survived <1 year and 50% of those with skeletal MET survived >2 years. In the Cox model, the relative risk of LR for MET was 3.0. In the Aalen model, after 30 months, when the hazard rates of MET began to decline, there was still an excess risk of MET after LR. CONCLUSION: This disease description highlights the importance of long-term observational studies. Empiric evidence that LR is both an indicator for, and in part a cause of, MET has been provided. In the future, the MET location should be reported. Variations in guidelines or health care systems that influence the time to MET and survival after MET through different diagnostic procedures should also be considered.

[Model project on coding accuracy]. / Modellprojekt Kodierqualität.

First experiences with the external evaluation of coding accuracy in view of the German DRG-System are reported. 387 randomised inpatient cases of three departments of a municipal hospital were evaluated. 1.648 diagnosis codes and 946 procedure codes were evaluated with complete clinical data. Before and after correction by the reviewers the cases were grouped (AR-DRG 4.1) and the casemix index of the sample was calculated. 45.9% to 56.7% of primary diagnosis in the department samples were rated as correct. 25.2% to 37.5% of secondary diagnosis were rated as correct, 8.3% to 14.2% were corrected and 49.2% to 60.5% were rated as not relevant with regard to the German coding standards. 7.2% to 22.7% of secondary diagnosis had to be completed in the data. Evaluation of procedure codes resulted in 54.2% to 65.7% accepted codes, 5.9% to 12.1% corrected codes and 23.1% to 39.9% not accepted with regard to the German coding standards. 30.8% to 37.0% of procedure codes had to be completed in the data. After review, remarkable shift in DRGs was seen and casemix index increased 6.9% in average (0.25-12.1%). General and department-specific implications for improvement of coding accuracy could be evaluated. Consequences of potential coding errors in a prospective payment system on DRG basis were seen under conditions of daily hospital practice. External evaluation of coding accuracy used in this study could be the methodological basis for further investigations on this topic.

[Quality project in invasive/interventional cardiology]. / Qualitätsprojekt Invasive/Interventionelle Kardiologie.

With installing a new catheterization laboratory, a quality project with focus on indications for invasive/interventional procedures was implemented. Health insurance companies as budget holders were involved in the project, external control is accomplished by their medical service (MDK). The focus on indications is new, since most approaches in this area deal with structure and/or process quality. The actual concept of this quality project makes medical performance transparent with regard to adequate indication as the first and important step to excellent quality of results. Further, the concept contains a rational approach to the controversial discussion about the increasing frequency of catheter-based coronary interventions.

Altered genotoxicity in mucosal cells of head and neck cancer patients due to environmental pollutants.

The complexity of carcinogenesis in squamous cell cancer (SCC) of the upper aerodigestive tract requires examining environmental risk factors, including mutagen sensitivities to xenobiotics. Three environmental, occupational, and habitual pollutants - dibutylphthalate (DBP), diisobutylphthalate (DiBP), and N'nitrosodiethylamine (NDELA) - were submitted to genotoxicity testing on mucosal biopsy specimens of tumor and nontumor patients in vitro. The single-cell microgel electrophoresis (Comet) assay was applied to detect DNA strand breaks in human epithelial cells of the pharynx and larynx from nontumor patients, patients with SCC of the oropharynx and patients with SCC of the larynx. Genotoxicity was found for DBP, DiBP, and NDELA in cells derived from nontumor and tumor patients. With respect to phthalates, Olive tail moment (OTM) levels were higher in patients with SCC of the oropharynx and SCC of the larynx (P < 0.01), the latter showing even more pronounced genotoxicity for DiBP. Testing epithelial cells of the patients with either oropharyngeal or laryngeal SCC for NDELA demonstrated results similar to the nontumor patients. Present findings indicate heterogeneous mutagen sensitivities to some but not all xenobiotics.

Procalcitonin for differential diagnosis of graft rejection and infection in patients with heart and/or lung grafts.

OBJECTIVES: Investigation of the reliability of Procalcitonin (PCT) for differential diagnosis of acute rejections and non-viral infections in heart and lung transplanted patients. DESIGN: Retrospective study. SETTING: Transplant intensive care unit (ICU) at a university hospital. PATIENTS: 57 heart, 18 lung and 3 heart-lung transplant patients. MEASUREMENTS: PCT was measured in plasma samples of heart and lung transplanted patients using a commercial immuno-luminescence assay and was compared with values of C-reactive protein (CRP) and leukocytes (WBC). RESULTS: PCT was elevated in patients suffering from bacterial and fungal infections. The magnitude of values was clearly associated with the severity of the infection. Rejections and viral infections did not interfere with the PCT release. CONCLUSION: PCT is a reliable predictor with discriminating power for non-viral systemic infections in patients after heart and/or lung transplantation. PCT allows an early differential diagnosis between rejection (AR) and bacterial/fungal infection (IF) and thus a rapid and focused therapeutic intervention. It avoids unnecessary antibiotic treatment which could be toxic for the graft itself in patients with rejection only. PCT provides vital information early to clinicians and allows them to improve the management of bacterial/fungal infections in immunocompromized transplant patients. PCT thus facilitates and improves the outcome of survival rate and the quality of life in the postoperative period of patients with heart and/or lung grafts.

Analysis of time-dependent covariates in failure time data.

In failure time analyses, time-dependent covariates are only rarely used. In some clinical studies, however, consideration of available covariate information over time could be relevant to understanding complex disease processes. We propose the time-dependent Cox model and the linear model of Aalen as two possible approaches for such time-dependent survival analyses. The approaches are illustrated with the data of the Stanford Heart Transplantation Study and a study of malignant glioma. Differences between these models and the baseline analysis are discussed.

Procalcitonin: a new marker for diagnosis of acute rejection and bacterial infection in patients after heart and lung transplantation.

UNLABELLED: The aim of the study was to investigate the reliability of procalcitonin (PCT), a new potential marker for detection of bacterial, fungal and protozoal infections, in order to differentiate these from viral infections and early rejections in heart, heart-lung and lung transplanted patients. PCT is a propeptide of calcitonin with unknown origin which is not detectable in plasma of healthy subjects. It increases rapidly and significantly under severe microbial infections. METHODS: PCT plasma levels were measured using an immuno-luminescence assay. C-reactive protein and white blood cells were quantified to validate the PCT values. RESULTS: Increased levels of PCT were found in all transplant patients with bacterial, fungal and protozoal infections. The magnitude of the values were clearly associated with the severity of the infection. Trauma of operation or inflammatory events such as viral infections and rejections did not trigger PCT-production. The release of PCT did not depend on the type of pathogens even though Aspergillum resulted in the highest levels measured. Sensitivity, specificity and prognostic value of PCT for systemic infections were higher than of the other parameters investigated. CONCLUSION: PCT is a highly specific analyte which shows significant diagnostic validities when nonviral infections are compared with rejection episodes. PCT discriminates between inflammatory events such as rejection or viral infections and nonviral-infections including bacterial, fungal and protozoal infections. The half-life of PCT is 24 h indicating clearly a competent antibiotic treatment. Unnecessary antibiotic therapy can be avoided due to the early exclusion of bacterial and fungal infections.

Maternal smoking during pregnancy and lactation increases the risk for atopic eczema in the offspring.

BACKGROUND: Maternal smoking during pregnancy has been shown to lead to immunologic changes in the offspring. However, little is known about the influence of this exposure on atopic manifestations. OBJECTIVE: Our purpose was to investigate the influence of air pollutants on manifestations of atopy in preschool children. METHODS: Unselected cohorts of a total of 678 5- to 6-year-old preschool children (350 boys, 328 girls) were investigated in areas with different degrees of air pollution in Bavaria. Data on the history of atopic diseases and other relevant factors were obtained by questionnaire. A skin-prick test was performed with common aeroallergens. Manifestation of atopy was defined as personal history of atopic disease or positive prick test to either grass pollen, house dust mite, or cat and analyzed multivariately. RESULTS: Of all children, 38.9% exhibited at least one manifestation of atopy. Atopic eczema was reported in 7.9% to 15.5%, hayfever in 4.1% to 25.6%, and asthma in 3.0% to 8.1%. Of the mothers, 12.6% smoked during pregnancy or lactation or both. Analysis of the manifestation of atopy including sex, location, nitrogen oxide and sulfur dioxide exposure and maternal smoking as covariates revealed an influence of the maternal smoking during pregnancy/lactation. Of children whose mothers had smoked during pregnancy/lactation, 52.2% exhibited manifestations of atopy in contrast to 35.7% of children of nonsmoking mothers (p < 0.044). A history of atopic eczema was the only component of the variable "manifestation of atopy" that was significantly associated with maternal smoking during pregnancy and lactation. A causal interpretation of this finding, however, was not supported by a follow-up study. CONCLUSION: Maternal smoking during pregnancy or lactation or both might play a role in the development of atopic eczema and should be avoided.

[Validity of telephone ECG multichannel transmission]. / Zur Validität der telefonischen EKG-Mehrkanal-Ubertragung.

Transtelephonic ECG transmission is an established monitoring system for cardiac patients in many countries around the world with the exception of Germany. This study reports first experiences with a multichannel ECG system using nine leads. This system allows to analyze ECG for ischemic events in addition to cardiac arrhythmias. In this study the reliability of a modified lead registration procedure of the telephonic ECG system David 9 (MAP, München) was compared to conventional 12-lead ECG recording (Mingograph 7, Siemens) in 225 consecutive patients. Comparison was performed using the arm electrodes of the telephonic ECG system (Tel. ECG) within the armpit (group I) or at the wrists (group II). Placing the electrodes at the wrists improved sensitivity and specificity of electrocardiograpic abnormalities to conventional 12 lead ECG (Conv. ECG). Specificity for detection of anterior myocardial infarction was 0.95 (Tel. ECG vs. Conv. ECG), specificity was 1.0. For infero-posterior infarction these relations were 0.94 and 1.0 respectively. ST-segment changes have been detected in the Tel. ECG with 0.93 and 0.89 for specificity and sensitivity. The numbers of arrhythmia analysis were 1.0 and 0.7 for all rhythm disturbances. Detection of atrial fibrillation was less reliable due to short recording time and low amplitude of the transmitted signal. Specificity and sensitivity for detection of ventricular arrhythmias were 1.0 and 0.89. Optimizing the placement of arm electrodes to the wrist instead of armpits as done up to now improved the reliability of the telephonic transmitted ECG. This telephonic ECG system then enables a reliable registration of ischemic and arrhythmic events.