[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.

[Statutory ambulatory medical care through the eyes of the health insurance beneficiaries--methods and results of the 2006 NASHIP Health Insurance Beneficiary survey: care utilisation, primary care, and emergency medical services]. / Die ambulante vertragsärztliche Versorgung aus der Perspektive der Versicherten--Methodik und Ergebnisse der KBV-Versichertenbefragung 2006: Inanspruchnahme, Versorgung beim Hausarzt, Bereitschafts- und Notdienstpraxen.

OBJECTIVE: The aim of this study was to obtain valid information on the delivery of ambulatory medical care from the point of view of the health insurance beneficiaries. The National Association of Statutory Health Insurance Physicians (NASHIP) conducted in 2006 for the first time a nationally representative telephone survey. The survey set out to gather information on health care utilisation, patients' experiences and satisfaction with care delivery, and to provide an indication for the further development of the services offered. METHODS: Between 22 May and 8 June 2006, a random sample of 4 315 inhabitants from 18 to 79 years of age was interviewed using a computer-assisted telephone interview (CATI). The questionnaire included 51 questions relating to six topics, and consisted of a core set of questions and supplementary questions dealing with further details or special issues. One section of the 2006 survey focused on emergency medical services. In the analysis, samples were weighted to reflect the distribution of the population by age and sex. RESULTS: 82% of survey participants have visited a doctor's office in the last 12 months, and 93% indicated to have a regular general practitioner (GP) they consult for medical problems or health advice. Referring to all respondents, the mean number of consultations in a doctor's office was about 5 per year. Over 90% of respondents having a regular GP arrive at the office within 20 min, and for 61% home visits by their regular doctor are very important or important. 90% of respondents having seen the GP during the last 12 months assess the medical care received as very good or good. The places contacted when the regular office is closed are clearly varying by region and respondent's age. Whereas younger people primarily consult the hospital emergency department, the importance of the general practitioner in the case of an emergency increases with age. Overall, 29% preferentially turn to a hospital or hospital emergency department, another 25% to outpatient emergency medical services, and scarcely 16% to their regular GP. 61% of survey participants or their close relatives have already utilised emergency medical services (EMS). Regarding the last case of a medical emergency, in 3 out of 5 cases patients went themselves to the emergency service. A total of 74% of patients assess the care received by the emergency medical service as very good or good. Evaluations are less favourable in the event of prolonged waiting time for the emergency medical doctor at home or in the EMS office. CONCLUSION: The NASHIP health insurance beneficiary survey reflects a broadening patient and service orientation and provides valid information on ambulatory medical care through the eyes of the insurance beneficiaries. The survey depicts high overall satisfaction with primary care, a high degree of trust in the doctor's medical competence, and easily accessible services. Patient evaluations of outpatient emergency medical care are mainly positive, but still show room for improvement.

[The role of university medicine in the development of clinical guidelines]. / Die Rolle der Hochschulmedizin bei der Entwicklung von Leitlinien.

Clinical guidelines are bridges between clinical research and patient care. In Germany, medical societies and university medicine are the main bodies responsible for the development, dissemination, and updating of high quality guidelines. The high demand on these to be based on evidence, clinical judgement, and structured consensus requires considerable resources. Currently, there is an inequality between the resources available to university hospitals and the incentives they receive. Financial and scientific recognition of the professionals, who develop and disseminate these guidelines, should be improved.

[Development and implementation of the guideline "Diagnosis of and Therapy for Carpal Tunnel Syndrome"]. / Zur Entstehung und Implementierung der Leitlinie "Diagnostik und Therapie des Karpaltunnelsyndroms".

In the period from July 2005 through November 2006, the evidence-based guidelines were developed by a steering committee consisting of three members from each of the societies involved (German Society for Hand Surgery, German Society of Neurosurgery, German Society of Neurology and German Society of Orthopaedics), coordinated by one member each from the DGH and the DGNC, under the methodological guidance of Prof. Selbmann of the German Association of the Scientific Medical Societies (AWMF). Six all-day working sessions and one proceeding to build a consensus (modified Delphi process) were held within the seven specialised societies involved. Degrees of recommendation, based upon the degree of evidence of the underlying literature studies, modified, if necessary, by the expert opinion of the steering committee's members and the external evaluators of the Delphi round, were established for the most important diagnostic and therapeutic methods. In addition to the long version, a short version and a patient information bulletin were prepared as well, and the ways, means, and considerations surrounding their realisation and implementation, and other potential developments were also pursued.

[Diagnosis and therapy of carpal tunnel syndrome--guideline of the German Societies of Handsurgery, Neurosurgery, Neurology, Orthopaedics, Clinical Neurophysiology and Functional Imaging, Plastic, Reconstructive and Aesthetic Surgery, and Surgery for Traumatology]. / Diagnostik und Therapie des Karpaltunnelsyndroms--Leitlinie der Deutschen Gesellschaften für Handchirurgie, Neurochirurgie, Neurologie, Orthopädie unter Mitbeteiligung der Gesellschaften für Unfallchirurgie, Klinische Neurophysiologie und Funktionelle Bildgebung sowie Plastiche, Rekonstruktive und Asthetische Chirurgie.

Evidence-based supradisciplinary guideline that deals with the epidemiology, pathogenesis, symptoms, clinical and electrophysiological diagnosis, supplementary imaging investigations, differential diagnosis, conservative and surgical treatments, prognosis and course along with complications and revision surgery. The recommendations on investigation and treatment are based on a comprehensive literature search with critical evaluation and two consensus methods (expert group and Delphi technique) within the participating specialist societies. Besides this long version, a short version and a patient version can be viewed through the AWMF platform. The development of the guideline and the methodological foundations are documented in a method report. MAIN STATEMENTS: Apart from an accurate history and clinical neurological examination (including clinical tests), electrophysiological investigations (distal motor latency and sensory neurography) are particularly important. Radiography, MRI, high-resolution ultrasonography can be regarded as optional supplementary investigations. Among conservative treatment methods, treatment with a nocturnal splint and local infiltration of a corticosteroid preparation are effective. Oral steroids, splinting and ultrasound showed only short-term benefit. Surgical treatment is clearly superior to all other methods. Open and endoscopic procedures (when the endoscopic surgeon has sufficient experience) are equivalent. A routine epineurotomy and interfascicular neurolysis cannot be recommended. Early functional treatment postoperatively is important.

Randomized adjuvant chemotherapy trial in high-risk, lymph node-negative breast cancer patients identified by urokinase-type plasminogen activator and plasminogen activator inhibitor type 1.

BACKGROUND: Most patients with lymph node-negative breast cancer are cured by locoregional treatment; however, about 30% relapse. Because traditional histomorphologic and clinical factors fail to identify the high-risk patients who may benefit from adjuvant chemotherapy, other prognostic factors are needed. In a unicenter study, we have found that levels of urokinase-type plasminogen activator (uPA) and plasminogen activator inhibitor type 1 (PAI-1) in the primary tumor are predictive of disease recurrence. Thus, we designed the Chemo N(0) prospective randomized multicenter therapy trial to investigate further whether uPA and PAI-1 are such prognostic factors and whether high-risk patients identified by these factors benefit from adjuvant chemotherapy. After 4.5 years, we present results of the first interim analysis. METHODS: We studied 556 patients with lymph node-negative breast cancer. The median follow-up was 32 months. All patients with low tumor levels of uPA (< or = 3 ng/mg of protein) and of PAI-1 (< or = 14 ng/mg of protein) were observed. Patients with high tumor levels of uPA (> 3 ng/mg of protein) and/or of PAI-1 (> 14 ng/mg of protein) were randomly assigned to combination chemotherapy or subjected to observation only. All statistical tests were two-sided. RESULTS: A total of 241 patients had low levels of uPA and PAI-1, and 315 had elevated levels of uPA and/or PAI-1. The estimated 3-year recurrence rate for patients with low tumor levels of uPA and PAI-1 (low-risk group) was 6.7% (95% confidence interval [CI] = 2.5% to 10.8%). This rate for patients with high tumor levels of uPA and/or PAI-1 (high-risk group) was 14.7% (95% CI = 8.5% to 20.9%) (P = 0.006). First interim analysis suggests that high-risk patients in the chemotherapy group benefit, with a 43.8% lower estimated probability of disease recurrence at 3 years than high-risk patients in the observation group (intention-to-treat analysis: relative risk = 0.56; 95% CI = 0.25 to 1.28), but further follow-up is needed for confirmation. CONCLUSIONS: Using uPA and PAI-1, we have been able to classify about half of the patients with lymph node-negative breast cancer as low risk, for whom adjuvant chemotherapy may be avoided, and half as high risk, who appear to benefit from adjuvant chemotherapy.

Low molecular weight heparin (reviparin) in percutaneous transluminal coronary angioplasty. Results of a randomized, double-blind, unfractionated heparin and placebo-controlled, multicenter trial (REDUCE trial). Reduction of Restenosis After PTCA, Early Administration of Reviparin in a Double-Blind Unfractionated Heparin and Placebo-Controlled Evaluation.

OBJECTIVES: The specific objective of the REDUCE trial was to evaluate the effect of low molecular weight heparin on the incidence and occurrence of restenosis in patients undergoing percutaneous transluminal coronary angioplasty (PTCA). BACKGROUND: Unfractionated heparin and its low molecular weight fragments possess antiproliferative effects and have been shown to reduce neointimal smooth muscle cell migration and proliferation in response to vascular injury in experimental studies. METHODS: The REDUCE trial is an international prospective, randomized, double-blind, multicenter study. Twenty-six centers in Europe and Canada enrolled 625 patients with single-lesion coronary artery obstructions suitable for PTCA. Three hundred six patients received reviparin as a 7,000-U bolus before PTCA, followed by 10,500 U as an infusion over 24 h and then twice-daily 3,500-U subcutaneous application for 28 days. The 306 patients in the control group received a bolus of 10,000 U of unfractionated heparin followed by an infusion of 24,000 U over 24 h. These patients then underwent 28 days of subcutaneous placebo injections. The primary end points were efficacy (defined as a reduction in the incidence of major adverse events [i.e., death, myocardial infarction, need for reintervention or bypass surgery]), absolute loss of minimal lumen diameter and incidence of restenosis during the observation period of 30 weeks after PTCA. RESULTS: Using the intention to treat analysis for all patients, 102 (33.3%) in the reviparin group and 98 (32%) in the control group have reached a primary clinical end point (relative risk [RR] 1.04, 95% confidence interval [CI] 0.83 to 1.31, p = 0.707). Likewise, no difference in late loss of minimal lumen diameter was evident for both groups. Acute events within 24 h occurred in 12 patients (3.9%) in the reviparin group and 25 (8.2%) in the control group (RR 0.49, 95% CI 0.26 to 0.92, p = 0.027) during or immediately after the initial procedure. In the control group, eight major bleeding complications occurred, and in the reviparin group, seven were observed within 35 days after PTCA. CONCLUSIONS: Reviparin use during and after coronary angioplasty did not reduce the occurrence of major clinical events or the incidence of angiographic restenosis over 30 weeks.

Compliance of German pediatric patients with oral antibiotic therapy: results of a nationwide survey.

BACKGROUND: Noncompliance with a prescribed therapy is a common problem in ambulatory pediatrics. OBJECTIVE: To establish a nationwide status quo of compliance of German ambulatory pediatric patients with oral antibiotics prescribed for various bacterial infections. PATIENTS AND METHODS: In this study, organized and financed by the German Society for Pediatric Infectious Diseases, 42 pediatricians in private practice who were selected to represent the 3 main regions of Germany and residence in large cities or small towns, respectively, enrolled consecutive patients who had bacterial infections that required therapy with oral antibiotics. Choice of agent and duration of treatment were left to the study physicians. Compliance was measured by a standardized telephone interview on the penultimate day and a urine bioassay for antibacterial activity on the last day of the planned treatment period. Parents did not know the true purpose of the study. RESULTS: Five hundred eight-four patients were fully evaluable. The most frequent diagnoses included tonsillopharyngitis (n = 231), otitis media (n = 170) and lower respiratory tract infections (n = 114). Most frequently prescribed antibiotics included amoxicillin (n = 102), potassium penicillin V (n = 81) and clarithromycin (n = 67). Overall compliance (positive urine test) on the last day of therapy was 69.5% (406 of 584 patients). Compliance was not significantly influenced by the region of residence or the underlying bacterial infection. It was significantly associated with the antibiotic used (macrolides, 89.0%; penicillins, 62.2%; cephalosporins, 66.4%; P = 0.0001 for macrolides vs. the others). Best compliance was found with clarithromycin (94.0%) and erythromycin estolate (89.8%). Compliance was also significantly better in patients > or =6 years old (77.7%; P = 0.016); with a treatment duration of < or =7 days (77.6%; P = 0.014); when the drug package contained a dose-taking reminder (79.7%; P = 0.003); and when the pediatrician's behavior toward the patient was assessed by the parents as "very sympathetic" or "sympathetic" (72.6%; P = 0.017). Subjecting all variables to logistic regression analysis, we found 3 variables to be significant predictors of treatment compliance: choice of antibiotic (P = 0.0001); patient age (P = 0.0008); and residence in town or city (P = 0.03). CONCLUSIONS: A noncompliance rate of >30% is unsatisfactory. Whereas some variables significantly associated with compliance cannot be influenced (patient age; place of residence in town or city), others are amenable to modifications. These include the physician-patient interaction and the choice of antibiotic. Agents should be preferred that are well-accepted by patients, that enable short-term therapy with few daily doses and with a package that contains a dose-taking reminder.

Prevention of colonization and respiratory infections in long-term ventilated patients by local antimicrobial prophylaxis.

In a randomized clinical trial the prophylactic effects of locally administered antimicrobials on quantitative colonization and respiratory infections were studied in intubated patients with an expected period of mechanical ventilation of greater than 6 days. Nineteen patients received 50 mg of polymyxin B and 80 mg of gentamicin distributed among nose, oropharynx and stomach at 6-h intervals, as well as 300 mg of amphotericin B in the oropharynx. Twenty untreated patients served as controls. In the control group colonization by respiratory pathogens was more common (oropharynx 19 vs 6 patients (p less than 0.001); trachea 19 vs 11 (p less than 0.01)), and the number as well as the count of the colonizing species was usually higher. Fourteen patients of the control group developed respiratory infections, including nine cases of pneumonia, as compared to four patients with prophylaxis, including one case of pneumonia (p less than 0.01). Pneumonia-associated deaths were prevented with prophylaxis; however, the overall mortality remained unchanged. Respiratory infections in the prophylaxis group were associated with organisms resistant to the agents used, but the overall occurrence of resistance was not increased, as compared to the control group. We conclude that unrestrained upper airway colonization by respiratory pathogens and respiratory tract infection were causally related. Local antimicrobial prophylaxis proved to be a highly effective strategy for the prevention of potentially life-threatening pneumonias in critically ill patients, but in the present study the host setting appeared to be the major determinant of outcome.

Internal and external measures of quality assurance in gynecological surgery.

In the light of exploding costs in health care and increasing demands for public accountability, gynecological surgeons are forced to improve the effectiveness and efficiency of their care in order to increase the satisfaction of their 'clients'. To do so, the implementation of a structured quality management system in gynecological care units is strongly encouraged. Basic requirements for an efficient quality management system comprise developing appropriate structures for the system, training staff in management techniques and using tools to monitor the quality of care. An important part of a quality management system is structured data collection permitting regional benchmarking between hospitals. The study 'Quality assurance in gynecological surgery' of the German Society of Gynecology and Obstetrics is mentioned as an example of such an external measure. Profiles help gynecological care units to recognize problem areas of their care. A list of further structural characteristics of a quality-oriented gynecological care unit, such as second opinion techniques or the application of clinical practice guidelines, is given to enable the evaluation or certification of quality management systems in gynecological departments.

[Sensitivity and specificity of masked field campimetry]. / Sensitivität und Spezifität der Rauschfeldkampimetrie.

Patients with circumscribed visual field defects are able to perceive the scotomata immediately while looking at randomly distributed black and white squares (12' x 12') flickering on a VDU with a high frequency (approximately 30 Hz), resulting in a stimulus field comparable to the white-noise field on a TV screen without reception. In 368 eyes of 368 patients with varying lesions of the visual pathway the results of white-noise field campimetry were compared with those of conventional threshold-related, slightly suprathreshold automated grid perimetry. Rate of detection (sensitivity) was 84.2% in conventional perimetry and 80.7% in white-noise field campimetry, respectively. The results are not significantly different (p > 0.1; McNemar test). Examinations in 198 eyes of 198 persons without any indication of a visual pathway defect allowed a definition of the normal range of white-noise field campimetry to be made. The specificity of this new method was 82.3%. The outcome of this most extensive study on sensitivity and specificity of noise field campimetry is compared with other publications. The results presented emphasize the capabilities of this new method as a screening test. They encourage the initiation of a field study using the noise field stimulus broadcasted to home TV sets.

[New blindness incidents in Württemberg-Hohenzollern]. / Neuerblindungen in Württemberg-Hohenzollern.

UNLABELLED: Blindness causes human suffering and high social costs. Preventive measures are necessary. Virtually all blind people are registered with the social services. Data from these institutions may help in (long-term) planning for blindness prevention. MATERIAL AND METHODS: The present investigation analysed data from the social services of the region Württemberg-Hohenzollern. The files contained information on ocular status, year of birth, district, and sex of newly blind subjects of the year 1994. RESULTS: Two thirds (66.8%) of newly blind subjects are women. About half (47.8%) of all subjects are over 80 years of age. The most frequent causes of blindness are: macular degeneration, 33.7%; diabetic retinopathy, 17.3%; glaucoma, 13.8%; and high myopia, 6.6%. CONCLUSIONS: Blindness is increasingly a problem of high age. Diabetic retinopathy and glaucoma are still major causes of blindness. For these diseases blindness prevention is conceivable. Thus co-ordinated blindness prevention activities should focus on diabetic retinopathy and glaucoma.

[Quality management, possibilities and chances in ophthalmology]. / Qualitätsmanagement, Möglichkeiten und Chancen in der Augenheilkunde.

German legislation introduced in 1988 called for obligatory quality assurance (QA) practice to be initiated by health care providers. In 1992 the scope of the legislation was extended. Opportunities for introducing quality assurance practice in ophthalmology are demonstrated through examples. A necessary preliminary step to QA is to identify priority areas requiring action. A second necessary action entails the definition of quality indicators. Through their monitoring, these quality indicators allow identification of problem areas as reflected in the collected data. The final important phase of QA practice involves development of strategies to counteract identified problems. This process implies one or more cycles of: problem analysis, establishment of rectifying targets, actual intervention and finally evaluation of interventions made. Compulsory inter-hospital comparison of QA data calls for agreed standards within health care fields. In conclusions, QA practices in ophthalmology (with special reference to the pilot project on QA in cataract surgery) suggest that QA measures are well accepted by health care providers in this field.

[Noise field screening. Results of a television field study for detection of visual field defects]. / Rauschfeld-Screening. Ergebnisse einer Fernsehfeldstudie zur Detektion von Gesichtsfelddefekten.

White noise field campimetry is able to transform usually negative scotomas immediately into perceivable visual field defects. As this method needs a monitor, the obvious solution was to evaluate the suitability of the noise field stimulus broadcasted to home TV sets. Therefore, in cooperation with the "Süddeutscher Rundfunk" (SDR) as well as several health insurance companies ("AOK Baden-Württemberg" and other "RVO-Kassen"), approximately 300,000 viewers were invited to take this test after receiving brief information and instruction. There were 531 calls for questionnaires to document the subjects' findings and the results of a subsequent ophthalmological examination. In most cases this clarified the perceived noise field defect. Out of 127 evaluable questionnaires, 78 cases did not show any relevant ophthalmological pathology; this held true especially for lesions of the visual pathway. However, in 49 persons the ophthalmologists detected pathological findings; in 20 of these, the scotomas were previously unknown to the physicians. Glaucomatous optic neuropathy and macular degeneration were most frequently diagnosed as causing the white noise field defects. Finally, some preliminary estimates of the costs and benefit of this study are presented.

Application of neural networks to the ranking of perinatal variables influencing birthweight.

In this paper we compare Multi-Layer Perceptrons (a neural network type) with Multivariate Linear Regression in predicting birthweight from nine perinatal variables which are thought to be related. Results show, that seven of the nine variables, i.e., gestational age, mother's body-mass index (BMI), sex of the baby, mother's height, smoking, parity and gravidity, are related to birthweight. We found no significant relationship between birthweight and each of the two variables, i.e., maternal age and social class.

[What is "quality management"?]. / Was ist "Qualitätsmanagement"?

According to the EN DIN ISO norms measures of quality planning, quality control, quality assurance and quality improvement define a comprehensive quality management. These international norms may solve the recent confusion of terms in Germany. The trend in quality assuring measures clearly shows in the direction of quality audits, but we believe that too much control is contra-productive. Benefits may be expected by the implementation of comprehensive quality management systems, appropriate techniques of benchmarking, practical guidelines and certifications of surgical departments with good quality management systems.