[Predictors of cognitive outcome in ventilated early rehabilitation patients]. / Prädiktoren des kognitiven Outcomes beatmeter Frührehabilitationspatienten.

BACKGROUND: After weaning failure, patients who are transferred from intensive care units to early rehabilitation centers (ERC) not only suffer from motor deficits but also from cognitive deficits. It is still uncertain which patient factors have an impact on cognitive outcome at the end of early rehabilitation. OBJECTIVE: Investigation of predictors of cognitive performance for initially ventilated early rehabilitation patients. METHODS: A total of 301 patients (mean age 68.3 ± 11.4 years, 67% male) were consecutively enrolled in an ERC for a prospective observational study between January 2014 and December 2015. To investigate influencing factors on cognitive outcome operationalized by the neuromental index (NMI), we collected sociodemographic data, parameters about the critical illness, comorbidities, weaning and decannulation as well as different functional scores at admission and discharge and carried out multivariate analyses by ANCOVA. RESULTS: Of the patients 248 (82%) were successfully weaned, 155 (52%) decannulated and 75 patients (25%) died of whom 39 (13%) were under palliative treatment. For the survivors (n = 226) we could identify independent predictors of the NMI at discharge from the ERC in the final sex and age-adjusted statistical model: alertness and decannulation were positively associated with the NMI whereas hypoxia, cerebral infarction and traumatic brain injury had a negative impact on cognitive ability. The model justifies 57% of the variance of the NMI (R2 = 0.568) and therefore has a high quality of explanation. CONCLUSION: Because of increased risk of cognitive deficits at discharge of ERC, all patients who suffered from hypoxia, cerebral infarction or traumatic brain injury should be intensively treated by neuropsychologists. Since decannulation is also associated with positive cognitive outcome, a rapid decannulation procedure should also be an important therapeutic target, especially in alert patients.

[Subjective Aspects of Return to Work and Social Reintegration in Patients with Extensive Work-related Problems in Cardiac Rehabilitation - Results of a Qualitative Investigation]. / Aspekte beruflicher und sozialer Wiedereingliederung aus Sicht kardiovaskulär erkrankter Rehabilitanden in besonderen beruflichen Problemlagen ­ Ergebnisse einer qualitativen Erhebung.

This study investigated subjective biopsychosocial effects of coronary heart disease (CHD), coping strategies and social support in patients undergoing cardiac rehabilitation (CR) and having extensive work-related problems. A qualitative investigation was performed in 17 patients (48.9±7.0 y, 13 male) with extensive work-related problems (SIMBO-C>30). All patients were interviewed with structured surveys. Data analysis was performed using a software that is based on the content analysis approach of Mayring. In regard to effects of disease, patients indicated social aspects including occupational aspects (62%) more often than physical or mental factors (9 or 29%). Applied coping strategies and support services are mainly focused on physical impairments (70 or 45%). The development of appropriate coping strategies was insufficient although social effects of disease were subjectively meaningful for patients in CR.

[Outcome based center comparisons in inpatient cardiac rehabilitation - results from the EVA-Reha® Cardiology project]. / Outcome-basierte Einrichtungsvergleiche in der stationären kardiologischen Rehabilitation - Ergebnisse aus dem Projekt EVA-Reha® Kardiologie.

BACKGROUND: So far, for center comparisons in inpatient cardiac rehabilitation (CR), the objective outcome quality was neglected because of challenges in quantifying the overall success of CR. In this article, a multifactorial benchmark model measuring the individual rehabilitation success is presented. METHODS: In 21 rehabilitation centers, 5123 patients were consecutively enrolled between 01/2010 and 12/2012 in the prospective multicenter registry EVA-Reha (®) Cardiology. Changes in 13 indicators in the areas cardiovascular risk factors, physical performance and subjective health during rehabilitation were evaluated according to levels of severity. Changes were only rated for patients who needed a medical intervention. Additionally, the changes had to be clinically relevant. Therefore Minimal Important Differences (MID) were predefined. Ratings were combined to a single score, the multiple outcome criterion (MEK). RESULTS: The MEK was determined for all patients (71.7 ± 7.4 years, 76.9% men) and consisted of an average of 5.6 indicators. After risk adjustment for sociodemographic and clinical baseline parameters, MEK was used for center ranking. In addition, individual results of indicators were compared with means of all study sites. CONCLUSION: With the method presented here, the outcome quality can be quantified and outcome-based comparisons of providers can be made.

Target organ damage and control of cardiovascular risk factors in hypertensive patients. Evidence from the multicenter ESTher registry.

AIMS: This study investigated the incidence of hypertensive target organ damage (TOD), control of cardiovascular risk factors, and the short-term prognosis in hypertensive patients under contemporary guideline-oriented therapy. PATIENTS AND METHODS: A total of 1,377 consecutive patients (mean age 58.2 ± 9.9 years, 82.2 % male) with arterial hypertension were included in the ESTher (Endorganschäden, Therapie und Verlauf - target organ damage, therapy, and course) registry at 15 rehabilitation clinics within the framework of the National Genome Research Network. Cardiovascular risk factors, medication, comorbidities, and glomerular filtration rate (GFR) were assessed. Left ventricular hypertrophy (LVH), left ventricular mass (LVM), left ventricular mass index (LVMI), and left ventricular ejection fraction (LVEF) were determined by two-dimensional echocardiography. The mean follow-up was 513 ± 159 days. Changes in continuous parameters were tested by the t test, changes in discrete characteristics are presented by means of transition tables and tested with the McNemar test. RESULTS: The mean LVEF was 59.3 ± 9.9 %, both mean LVM (238.6 ± 101.5 g) and LVMI (54.0 ± 23.6 g/m(2.7)) were increased while relative wall thickness (RWT, 0.46 ± 0.18) indicated the presence of concentric LVH. Of the patients, 10.2 % displayed renal dysfunction (estimated GFR < 60 ml/min/1.73 m(2)). The 1.5-year overall mortality was 1.2 %. Compared with discharge, at follow-up the proportion of patients with blood pressure (BP) values < 140/90 mmHg decreased from 68.7 % to 55.0 % (p < 0.001) and with low-density lipoprotein (LDL) values < 100 mg/dl from 62.6 % to 38.1 % (p < 0.001). At follow-up significantly more patients displayed a GFR value of < 60 ml/min/1.73 m(2) (10.2 % vs. 16.0 %, p < 0.001). CONCLUSION: A significant proportion of hypertensive rehabilitation participants displayed TOD including LVH and renal dysfunction. Even after stringent BP reduction, a considerable increase in nephropathy could be found after 18 months.

[Oral feeding of long-term ventilated patients with a tracheotomy tube. Underestimated danger of dysphagia]. / Oralisierung langzeitbeatmeter Patienten mit Trachealkanüle. Unterschätzte Gefahr von Dysphagien.

BACKGROUND: In long-term mechanically ventilated patients, dysphagia is a common and potentially life-threatening complication, which can lead to aspiration and pneumonia. Nevertheless, many intensive care unit (ICU) patients are fed by mouth without evaluation of their deglutition capability. OBJECTIVE: The goal of this work was to evaluate the prevalence of aspiration due to swallowing disorders in long-term ventilated patients who were fed orally in the ICU while having a blocked tracheotomy tube. METHODS: In all, 43 patients participated-each underwent a fiberoptic investigation of deglutition on the day of admission to the rehabilitation clinic. RESULTS: A total of 65 % of the patients aspirated, 71 % of these silently. There were no associations between aspiration and any of the following: gender, indication for mechanical ventilation (underlying disease) or the duration of intubation and ventilation by tracheotomy tube. However, the association between aspiration and age was statistically significant (p = 0.041). Aspirating patients were older (arithmetic mean = 70 years, median = 74 years) than patients who did not aspirate (arithmetic mean = 66 years, median = 67 years). CONCLUSION: Intubation and add-on tracheotomies can lead to potentially life-threatening swallowing disorders that cause aspiration, independent of the underlying disease. Before feeding long-term mechanically ventilated patients by mouth, their ability to swallow needs to be investigated using fiberoptic endoscopic evaluation of swallowing (FEES) or a saliva dye test, if a cuff deflation and the use of a speaking valve are possible during spontaneous respiration.

[Predictors of exercise capacity improvement in patients after an acute coronary event during inpatient rehabilitation]. / Prädiktoren zur Förderung der körperlichen Leistungs-fähigkeit bei Patienten mit akutem koronarem Ereignis in der kardiologischen Rehabilitation.

UNLABELLED: Objective Patients who suffered from an acute coronary syndrome (ACS) boast a low exercise capacity (EC). To enhance EC is a core component of cardiac rehabilitation (CR). The aim of the study was to investigate predictors of exercise capacity to optimize the rehabilitation process in untrained subgroups. METHOD: 47 286 patients (mean age 64±11.62, 74.5% male) were enclosed in the TROL registry. All patients underwent a bicycle stress test at admission and discharge. The dependent variable for the univariate analysis and multivariate logistic regression was the increase of EC during CR, with a cutoff of 15 Watts (pre/post design). Furthermore comorbidities and physical activity before the index event were analyzed. RESULTS: Exercise capacity enhancement differs between active and inactive patients significantly (21.84 Watt vs. 16.35 Watt; p<0.001). While a male gender (OR 1.62 [95% CI: 1.51-1.74]) and physical activity before rehabilitation (OR 1.85 [95% CI: 1.75-1.97]) were positive, comorbidities and age (OR 0.82 [95% CI: 0.74-0.90]) were negative predictors. CONCLUSION: In cardiac rehabilitation settings special exercise training programs for elderly and comorbid patients are needed, to enhance their exercise capacity sufficiently.

[Computer aided dosage management of phenprocoumon anticoagulation therapy. Clinical validation]. / Rechnergestützte Dosierung in der Antikoagulationstherapie mit Phenprocoumon. Validierung für den klinischen Einsatz.

UNLABELLED: A recently developed multiparameter computer-aided expert system (TheMa) for guiding anticoagulation with phenprocoumon (PPC) was validated by a prospective investigation in 22 patients. The PPC-INR-response curve resulting from physician guided dosage was compared to INR values calculated by "twin calculation" from TheMa recommended dosage. Additionally, TheMa was used to predict the optimal time to perform surgery or invasive procedures after interruption of anticogulation therapy. RESULTS: Comparison of physician and TheMa guided anticoagulation showed almost identical accuracy by three quantitative measures: Polygon integration method (area around INR target) 616.17 vs. 607.86, INR hits in the target range 166 vs. 161, and TTR (time in therapeutic range) 63.91 vs. 62.40 %. After discontinuation of anticoagulation therapy, calculating the INR phase-out curve with TheMa INR prognosis of 1.8 was possible with a standard deviation of 0.50 ± 0.59 days. CONCLUSION: Guiding anticoagulation with TheMa was as accurate as Physician guided therapy. After interruption of anticoagulant therapy, TheMa may be used for calculating the optimal time performing operations or initiating bridging therapy.

[Method of the assessment of patients outcome in cardiac rehabilitation by means of quality indicators--a description of the method]. / Ergebnismessung und -bewertung kardiologischer Rehabilitation anhand von Qualitätsindikatoren--eine Methodenbeschreibung.

INTRODUCTION: Cardiac rehabilitation is designed for patients suffering from cardiovascular diseases or functional disabilities. The aim of a cardiac rehabilitation is to improve overall physical health, psychological well-being, physical function, the ability to participate in social life and help patients to change their habits. Regarding the heterogeneity of these aims measuring of the effect of cardiac rehabilitation is still a challenge. This study recommends a concept to assess the effects of cardiac rehabilitation regarding the individual change of relevant quality indicators. METHODS: With "EVA-Reha; cardiac rehabilitation" the Medical Advisory Service of Statutory Health Insurance Funds in Rhineland-Palatinate, Alzey (MDK Rheinland-Pfalz) developed a software to collect data set including sociodemographic and diagnostic data and also the results of specific assessments. The project was funded by the Techniker Krankenkasse, Hamburg, and supported by participating rehabilitation centers. From 01. July 2010 to 30. June 2011 1309 patients (age 71.5 years, 76.1% men) from 13 rehabilitation centers were consecutively enrolled. 13 quality indicators in 3 scales were developed for evaluation of cardiac rehabilitation: 1) cardiovascular risk factors (blood pressure, LDL cholesterol, triglycerides), 2) exercise capacity (resting heart rate, maximal exercise capacity, maximal walking distance, heart failure [NYHA classification], and angina pectoris [CCS classification]) and 3) subjective health (IRES-24: pain, somatic health, psychological wellbeing and depression as well as anxiety on the HADS). The study was prospective; data of patients were assessed at entry and discharge of rehabilitation. To measure the success of rehabilitation each parameter was graded in severity classes at entry and discharge. For each of the 13 quality indicators changes of severity class were rated in a rating matrix. For indicators without a requirement for medical care neither at entry nor at discharge no rating was performed. RESULTS: The grading into severity classes as well as the minimal important differences were given for the 13 quality indicators. The result of rehabilitation can be demonstrated in suitable form by means of rating of the 13 quality indicators according to a clinical population. The rating model differs well between clinically changed and unchanged patients for the quality indicators. CONCLUSION: The result of cardiac rehabilitation can be assessed with 13 quality indicators measured at entry and dis­charge of the rehabilitation program. If a change into a more ­favorable category at the end of rehabilitation could be achieved it was counted as a success. The 13 quality indicators can be used to assess the individual result as well as the result of a population--e. g. all patients of a clinic in a specific time period. In addition, the assessment and rating of relevant quality indicators can be used for comparisons of rehabilitation centers.

Comparable short-term prognosis in diabetic and non-diabetic patients with acute coronary syndrome after cardiac rehabilitation.

BACKGROUND: Patients with pathological glucometabolism are at increased risk of recurrent cardiovascular events after acute coronary syndrome (ACS). The goal of this study was to investigate the association of glucometabolism and the one-year outcome of cardiac rehabilitation patients. DESIGN: Prospective multicentre registry from four German rehabilitation clinics. METHODS: During 2005-2006, 1614 consecutive patients (85.9% male, mean age 55 ± 10.3 years) were included after the first ACS (mean 18.9 days) and classified into group 1 (apparent diabetes mellitus, n = 268), group 2 (no diabetes, impaired oral glucose tolerance [OGT], n = 185), and group 3 (normal fasting glucose and normal OGT, n = 1161). The mean follow-up was 13.4 months and the follow-up events were analysed by multivariate logistic regression models with backward elimination. RESULTS: The overall mortality was 1.3% (group 1: 1.2%; group 2: 1.8%; group 3: 1.5%; p(Trend) = NS). The target blood pressure values at discharge (<140/90 mmHg) were achieved by 88.7%, 89.1% and 90.8% of patients in groups 1, 2 and 3, respectively (p(Trend) = NS). The target value for LDL cholesterol (<100 mg/dl) was attained by 87.0%, 80.8% and 81.5% of the patients in groups 1, 2 and 3, respectively (p(Trend) = NS). There was a trend of a lower proportion of patients reaching the target values for HDL-C of 46.1%, 51.4% and 60.8% (p(Trend) < 0.001) and triglycerides of 65.1%, 79.9% and 74.6% (p(Trend) = 0.004) for groups 1, 2 and 3, respectively. The strongest multivariate predictors for overall mortality were patients experiencing a previous stroke (OR, 6.29 [95% CI: 1.06-37.19]; p = 0.042) and, with a trend, peripheral arterial disease (OR, 3.60 [95% CI: 0.95-13.68]; p = 0.061). In the multivariate analysis, the diabetic state had no association with poor outcomes (i.e. death or rehospitalization). CONCLUSION: The short-term prognosis for both diabetic and non-diabetic patients was good and was determined by end organ damage rather than by glucometabolic status. Diabetic patients received comparable (and not more aggressive) pharmacotherapy and therefore achieved target values for cardiovascular risk factors to a lesser extent than the non-diabetic and pre-diabetic patients.

Computer-aided dosage in oral anticoagulation therapy using phenprocoumon. Problems and approaches.

Oral anticoagulation using vitamin K antagonists has been established for over 50 years. Although it is highly effective in preventing thromboembolic incidents, its therapeutic control still remains problematic. Therefore, a computer-aided approach is recommended for deriving dosages. Up to now, the dosage is often based on the visual inspection of previous INR measurements, average weekly doses, and the INR target range. Statistical variations of measurement results and time-delayed effects of dosages, however, frequently result in the misinterpretation of data and suggest pseudo-trends. Treating physicians are not only responsible for determining the patient-specific maintenance dose, but must also respond to deviating INR values, overdosage or underdosage, initiate the oral anticoagulation therapy, and control the INR level in case of a new target range (bridging). Instructive examples are provided to illustrate the described difficulties. A computer-aided expert system is currently developed to ensure the therapeutic safety under the specified conditions. We present preliminary results from a study designed to validate mathematical models underlying such expert systems.

[Methods of health economic evaluation for health services research]. / Methoden der gesundheitsökonomischen Evaluation in der Versorgungsforschung.

On August 30, 2010, the German Network for Health Services Research [Deutsches Netzwerk Versorgungsforschung e. V. (DNVF e. V.)] approved the Memorandum III "Methods for Health Services Research", supported by the member societies mentioned as authors and published in this Journal [Gesundheitswesen 2010; 72: 739-748]. The present paper focuses on methodological issues of economic evaluation of health care technologies. It complements the Memorandum III "Methods for Health Services Research", part 2. First, general methodological principles of the economic evaluations of health care technologies are outlined. In order to adequately reflect costs and outcomes of health care interventions in the routine health care, data from different sources are required (e. g., comparative efficacy or effectiveness studies, registers, administrative data, etc.). Therefore, various data sources, which might be used for economic evaluations, are presented, and their strengths and limitations are stated. Finally, the need for methodological advancement with regard to data collection and analysis and issues pertaining to communication and dissemination of results of health economic evaluations are discussed.

[New oral anticoagulants: better than vitamin K antagonists?]. / Neue orale Antikoagulanzien: Werden sie die Vitamin-K-Antagonisten verdrängen?

Many years of practical use and intensive scientific research have allowed vitamin K antagonists to become a cornerstone of treatment of internal diseases. Nevertheless, limitations in pharmacokinetics and -dynamics of vitamin K antagonists and the availability of new drugs in regard to a targeted anticoagulation therapy ask for a new review of the situation. Proof of effectiveness for the perioperative prophylaxis of venous thrombosis after hip and knee replacement has already been achieved for the direct thrombin inhibitor dabigatran etexilate as well as for the factor Xa inhibitors rivaroxaban und apixaban compared to low molecular weight heparins. These new drugs are now also investigated in patients with internal diseases. For the long-term application (6 or 12 months) concerning the treatment of venous thrombosis and/or stroke prophylaxis in patients with atrial fibrillation data is already available for the direct thrombin inhibitor dabigatran etexilate. Depending on its dosage its effectiveness in comparison with vitamin K antagonists is equal or even better without disadvantages in safety. However, vitamin K antagonists will remain the standard oral anticoagulation until open questions regarding e.g. insufficient therapy adherence (with termination rates up to 20%) or problems with drug interactions of the new competitive products have been completely answered.

[Anticoagulation in the elderly]. / Antikoagulation im Alter.

The recommendations for anticoagulation in over 80 years old patients are based on the thromboembolic/bleeding risk relation. They add to the published recommendations for the specific indications. Low-molecular-weight heparin (LMWH) is used to prevent thromboembolism postoperatively. Compression stockings and/or intermittent pneumatic compression are used if bleeding risk is very high. The dose is increased starting at day two if the thromboembolic risk is very high. Bleeding and thromboembolic risks are re-evaluted daily. The antithrombotic therapy is adjusted accordingly. Prophylaxis of thromboembolism in patients with acute illnesses and bedrest is performed according postoperative care. Two-thirds of therapeutic doses of low-molecular-weight heparin are used to treat acute venous thromboembolism. Reduced renal function (creatinine clearance <30 ml/ min for most LMWHs or <20 ml/min for tinzaparin) should result in a further reduction of dose. Intensity and duration of prophylaxis of recurrent events with vitamin K antagonist or LMWH in malignancy follow current or herein described recommendations. Patients with atrial fibrillation are treated with vitamin K antagonists adjusted to an INR of 2-3 for prophylaxis of embolism. Further details of anticoagulant therapy should be in agreement with the national or international recommendations.

[Determinants of health care expenses during cardiac rehabilitation]. / Versorgungsaufwand und Kosten während der kardiologischen Rehabilitation.

BACKGROUND AND OBJECTIVES: Diagnosis-related systems (ICD-10, OPS, PCCL) are used in acute medical care as part of the multidisciplinary classification of overall care and related costs. In contrast, such systems, reflecting therapeutic requirements and distinguishing between patients according to the level of effort and costs incurred, are still not available for use in clinical rehabilitation units. METHODS: 215 consecutive patients (aged 63.8 +/- 11.1 years; 68.2% males ) were included in a single-center prospective registry during inpatient cardiac rehabilitation (CR). The following data were included: clinical condition, diagnosis of diseases, length of acute hospitalization and various parameters of physical and psychological state (Karnofsky performance score, Hospital Anxiety and Depression Scale [HADS]). Efforts out of normal care by nurses. doctors and laboratories were measured in minutes and divided into quartiles. Logistic regression models were used to estimate the odds for predictive parameters for patients requiring care and efforts above the highest quartile. RESULTS: Mean acute in-hospital stay was 14.7 +/- 14.5 days, duration of CR 21.8 +/- 3.5 days. Mean duration of nursing efforts was 221 +/- 170 min, of medical staff efforts 5564 min, of physiotherapy 174 +/- 281 min. In the multivariate model five determinants were significantly associated with increased care provision during CR: duration of hospitalization, diabetes, arterial hypertension, low exercise capacity and anxiety as measured by HADS. Increased laboratory testing was predominantly the result of diabetes mellitus and an increased Karnofsky score. CONCLUSION: Prolonged acute hospitalization, anxiety and diabetes mellitus were associated with increased nursing/medical/phyisiotherapeutic care during CR. These factors should be taken into account in any cost classification system that needs to be developed for use in rehabilitation clinics so as to provide better transparency in cost assessment.

[Rehabilitation of patients with cardiac pacemakers and implanted cardioverter-defibrillators: recommendations for training, physiotherapeutic procedures and re-employment]. / Rehabilitation von Patienten mit Herzschrittmachern und Kardioverter-Defibrillatoren: Empfehlungen zu Training, Physiotherapie und beruflicher Wiedereingliederung.

Rehabilitation of patients with cardiac pacemakers (CP) or implantable cardioverter defibrillators (ICD) comprises secondary prevention of underlying cardiac disease, conditioning training activities and psychological education and includes furthermore the assessment of aggregate function, detection of any device malfunction as well as the return to work efforts. The extent to which the physical activities can be permitted is determined by both cardiopulmonary capacity and the primary arrhythmic indication. Under consideration of upper frequency limit, left ventricular dysfunction and the avoidance of mechanical exposure on device can and leads, an individually designed training programme is acceptable even on a high load level. Likewise, electrotherapeutic procedures due to musculoskeletal pain syndrome are not generally contraindicated, if differentiated limitations are respected. Beside the assessment of aggregate function and, if necessary, parameter optimization, psychologic intervention programs play an important role particularly in ICD-patients and can be utilized as an additive therapeutic module. Personalized recommendations for driving with an ICD are determined by the time interval since idex arrhythmia and the rhythmological risk profile as well as by the motor vehicle class. The return to work rate of CP and ICD patients is resumably influenced by the underlying cardiac disease and to a lesser extend by the implanted device. Except industrial jobs the risk of electromagnetic interference during the working process is low and can be objected by working place analysis including noise field measurement. Thus cardiac of CP and ICD patients should be used to a large extend for the recovery of individual physical and psychological integrity as well as for the organisation of reemployment.