Symptom-oriented follow-up of early breast cancer is not inferior to conventional control. Results of a prospective multicentre study.

BACKGROUND: The homogeneity of the schemes for follow-up care after curative surgical treatment of early breast cancer is still a matter of debate in Germany. We investigated whether symptom-oriented follow-up is equivalent in terms of survival rates to conventional surveillance based on scheduled tests. PATIENTS AND METHODS: In a prospective, non-randomised, multicentre cohort study carried out between 1995 and 2000, 244 patients underwent a conventional follow-up (scheduled laboratory tests including CEA and CA 15-3, chest X-rays and liver ultrasound). 426 patients were monitored in a symptom-oriented manner (additional tests only in the case of symptoms indicating possible recurrence). Mammography, structured histories and physical examinations were done regularly in both branches. 1,108 patients did not participate in the project. They represent 'real world patients', unaffected by the implications of a study. RESULTS: The symptom-oriented follow- up group produced results not inferior to those of the intensive one (p < 0.05) in terms of overall and relapse-free survival. Furthermore, no difference was indicated in terms of overall survival between study participants and the 'real world patients' (p = 0.316). CONCLUSION: The results confirm that regular imaging and laboratory tests have no relevant effect on overall survival of patients after curative primary therapy of early breast cancer and support the implementation of a symptom-oriented routine follow-up.

[High quality and restricted resources--a contradiction in terms?]. / Hohe Qualität und restriktive Ressourcen--ein Widerspruch?

The aim of quality management is to optimize the quality of care under given circumstances, which include the provided resources. If these resources no longer suffice, a deterioration of the achievable quality will follow. This could be avoided by 1) recognizing and eliminating unnecessary or deficient health services, 2) excluding health services from funding when adequate scientific proof of effectiveness is lacking, and 3) modifying the definition of the level of quality to be achieved. Outcome quality of health care is measured, on the one hand, by prevention of avoidable mortality and morbidity and, on the other hand, by improvement of quality of life and patient satisfaction. Methodologically, it is difficult to determine which part of the quality of life and of patient satisfaction is to be attributed to private life style. Since the evidence for effects on quality of life and patient satisfaction is often worse than for mortality and morbidity, there is the risk that they will become increasingly less relevant when defining the quality that is to be achieved for the community of the insured. In order to prevent this from happening unnoticed, measurements of the outcome quality of care with the indicator group mortality, morbidity, quality of life and patient satisfaction need to be intensified.

[Consensus development in evidence-based guidelines: from myths to rational strategies]. / Konsensusfindung in evidenzbasierten Leitlinien - vom Mythos zur rationalen Strategie.

Guidelines are meant to be decision aids with precise procedural recommendations that are based upon the best knowledge available and thus should contribute to improving healthcare delivery. The achievement of this goal necessitates both a systematic and methodically sound approach in guideline development. Essential elements include the search for and the selection and evaluation of empirical evidence for existing knowledge. In addition, personal experience and subjective judgements will always be part of guideline recommendations, especially when the applicability of the evidence is appraised and health benefits and risks of different management options for the disease or condition are considered. To achieve high-quality results in this process, formal consensus techniques should be employed and potential users and affected patients should be involved. Typical of this technique is the structured interaction that provides the framework in which contributions of individual participants are documented, made transparent and brought together. Quality and acceptance of results are determined by the preparation and practical implementation of these procedures, in which individual- and group-psychological influencing factors play an important role. Along with the methods of evidence synthesis, structured consensus building methodology represents a cornerstone of guideline development.

[Method report 2007 of the Programme for National Disease Management Guidelines--background and content]. / Der Methodenreport 2007 des Nationalen Programms für VersorgungsLeitlinien - Hintergrund und Inhalt.

The Programme for National Disease Management Guidelines (German DM-CPG Programme) was established in 2002 by the German Medical Association (umbrella organisation of the German Chambers of Physicians) and joined by the Association of the Scientific Medical Societies (AWMF)--umbrella organisation of more than 150 professional societies--and by the National Association of Statutory Health Insurance Physicians (NASHIP) in 2003. The programme provides a conceptual basis for disease management, focussing on high priority healthcare topics and aiming at the implementation of best practice recommendations for prevention, acute care, rehabilitation and chronic care. It is organised by the German Agency for Quality in Medicine, a founding member of the Guidelines International Network G-I-N. The main objective of the German DM-CPG Programme is to establish consensus among the medical professions on evidence-based key recommendations covering all sectors of healthcare provision and facilitating the coordination of care for the individual patient through time and across interfaces. Within the last year DM-CPGs have been published for asthma, COPD, type 2 diabetes and coronary heart disease. In addition, experts from national patient self-help groups have been developing patient guidance based upon the recommendations for healthcare providers. The article describes background, methods and tools of the DM-CPG programme using the DM-CPG Method Report 2007.

[Is reaching consensus on the development of guidelines nonsense?]. / Ist Konsens bei der Leitlinienerstellung Nonsens?

Cultural background influences the development of guidelines. In Germany, classifications exist from S1 (low level of evidence, no structured process of consensus finding) up to S3 (high level of evidence, consensus finding by a representative body). Consensus is indispensable in the guideline development process because every step is influenced by preferences and values, from the choice of output and outcome criteria to the role of pathophysiological models in the assessment of new therapies. A structured process of consensus finding increases transparency. Different models of consensus finding are discussed.

[Health services research and guidelines--from the Association of the Scientific Medical Societies' (AWMF) perspective]. / Versorgungsforschung und Leitlinien--die Perspektive der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesell- schaften (AWMF).

The Association of the Scientific Medical Societies (AWMF, Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften) is an umbrella organization. It currently represents 151 scientific societies and thus the majority of medical researchers in Germany. Through the coordination and support of the scientific medical societies, the AWMF significantly contributes to health services research by establishing guidelines that ensure a high quality of healthcare. To this purpose, AWMF founded a guideline committee in 1995, whose objective is to assist AWMF member societies in the establishment of guidelines, the organization of training sessions for AWMF guideline representatives, the hosting of regular guideline conferences and the close cooperation with the German Medical Association (Bundesärztekammer, BAK) and the National Association of Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung, KBV) in the development of national disease management guidelines (Nationale Versorgungs Leitlinien, NVL). Together with the Agency for Quality in Medicine [AQuMed; Arztliches Zentrum für Qualität in der Medizin (AZQ)], AWMF published a 'German Instrument for Methodological Guideline Appraisal' ('Deutsches Instrument zur methodischen Leitlinien-Bewertung', DELBI) in order to assure the quality of the guideline development process. A close cooperation has also developed between AWMF and the German Medical Association within the scope of their program for promoting health services research and with the Board of the German Network for Health Services Research (Deutsches Netzwerk for Versorgungsforschung, DNVF). Furthermore, AMWF has acknowledged a special need for improving the financial and conceptual promotion of a systematic evaluation of guideline development and the implementation and application of guidelines in everyday clinical practice.

[Quality and quality development in medical practices--epidemiological results of the accompanying evaluation of the new KBV quality management system]. / Qualität und Qualitäts- entwicklung in Praxen--epidemiologische Ergebnisse der begleitenden Evaluation des neuen Qualitätsmanagementsystems der KBV.

The motivation for quality management has now reached medical and psychotherapeutic practices. This is partly due to exogenous factors, including regulatory requirements such as Sect. 135a SGB V (German Book of Social Code) demanding the implementation and further development of internal quality management from both out-patient and in-patient healthcare providers. The National Association of SHI-Accredited Physicians in Germany (KBV), along with several regional associations, responded to these internal demands and external requirements by developing the quality management system "Quality and Development in Practices (QEP)". Assisted by an independent institute, 61 selected practices participated in the pilot study. The pilot phase included five interview rounds held between April and November 2004 with 60 practices taking part. The results describe practitioners' expectations for the current state of and the demand for internal quality management. Only one in five practices expects improvements from the implementation of quality management in the area of healthcare processes and management. The improvement of organizational processes, patients' safety and patient outcomes are considered more important. In a self-assessment procedure which included 73 targets with 236 verifications from the quality target catalogue a distinct potential for quality improvement has been revealed. The greatest need for improvement has been identified in cases where quality management defines specific requirements for the practices. These include: treatment pathways, patient information, risk management, case discussions and instruction, quality improvement, regulations and quality measurement. Even practices with advanced quality development activities were able to detect some potential for improvement with the application of the QEP catalogue. In order to attain 15 selected quality targets with 45 verifications, the practices were provided with tools like sample documents and suggestions for internal regulations to be used for quality improvement and requiring relatively small efforts. The effectiveness of implementing a quality management system cannot be adequately demonstrated by an accompanying evaluation. However, established instruments (such as the quality target catalogue and verifications), complemented with suitable outcome indicators, allow the effects of the implementation of internal quality management to be measured in a comparative, or, ideally in a randomized study.

[The German program for disease management guidelines. Background, methods, and development process]. / Nationale Versorgungsleitlinien von BAK, AWMF und KBV : Hintergrund, Methodik und Instrumente.

The Program for National Disease Management Guidelines (German DM-CPG Program) was established in 2002 by the German Medical Association (umbrella organization of the German Chambers of Physicians) and joined by the Association of the Scientific Medical Societies (AWMF; umbrella organization of more than 150 professional societies) and by the National Association of Statutory Health Insurance Physicians (NASHIP) in 2003. The program provides a conceptual basis for disease management, focusing on high-priority health-care topics and aiming at the implementation of best practice recommendations for prevention, acute care, rehabilitation and chronic care. It is organized by the German Agency for Quality in Medicine, a founding member of the Guidelines International Network (G-I-N). The main objective of the German DM-CPG Program is to establish consensus of the medical professions on evidence-based key recommendations covering all sectors of health-care provision and facilitating the coordination of care for the individual patient through time and across interfaces. Within the last year, DM-CPGs have been published for asthma, chronic obstructive pulmonary disease, type 2 diabetes, and coronary heart disease. In addition, experts from national patient self-help groups have been developing patient guidance based upon the recommendations for health-care providers. The article describes background, methods, and tools of the DM-CPG Program, and is the first of a publication series dealing with innovative recommendations and aspects of the program.

Diagnostic accuracy of multidetector computed tomography coronary angiography in patients with angiographically proven coronary artery disease.

OBJECTIVES: The aim of the present study was to evaluate the diagnostic accuracy in detecting high-grade coronary stenoses in patients with known coronary artery disease (CAD) using multidetector computed tomography (MDCT). BACKGROUND: The MDCT systems with electrocardiographic (ECG)-gating permit visualization of the coronary arteries. However, severe calcifications and higher heart rates are known to degrade image quality and limit correct diagnosis. METHODS: Sixty-six patients with proven CAD as assessed by conventional coronary angiography (CCA) were studied by MDCT (mean time 24 months postangiography). Total calcium score and all coronary arteries, including distal segments and side branches, were assessed with respect to evaluability, presence of high-grade coronary artery stenoses (>70%), and correct diagnosis. Results were compared to CCA. RESULTS: A total of 105 lesions were detected by CCA. The MDCT correctly detected 39 lesions (sensitivity 37%, specificity 99%). The correct clinical diagnosis could be obtained in 24 patients (36%). Artifacts due to elevated heart rates or severe coronary artery calcification were the main cause of degraded image quality inhibiting correct diagnosis. In 21/66 patients (32%) all four major coronary vessel segments could be visualized. A threshold for maximum heart rate and a maximum calcification level were established (65 beats/min and an Agatston Score Equivalent of 335, respectively). A second analysis was made using these thresholds. Of all patients studied, 10/11 (91%) were correctly diagnosed when adhering to these thresholds. CONCLUSIONS: When using MDCT as a noninvasive diagnostic modality to assess advanced CAD, it appears to be mandatory to preselect patients in order to achieve reliable results.

[Evaluation of the pilot project for the gradual area-wide outpatient medical care of patients with diabetes mellitus in Southern Wuerttemberg]. / Evaluation des Modellvorhabens Südwürttemberg zur abgestuften, flächendeckenden ambulanten Versorgung von Patienten mit Diabetes mellitus.

The aim of the diabetes pilot project of the AOK Baden-Wuerttemberg and the KV Southern Wuerttemberg was to prevent diabetes-related complications or to delay their progress by attaining predefined, short-term therapy goals (e.g., stabilization of HbA1c and blood pressure levels). Besides the observation of the short-term therapy aims, the scientific monitoring also included the development of the healthcare structure and the changes of the healthcare processes. Measured against the HbA1c value of the 13.902 patients suffering from type-2 diabetes included in the first 6 months of the year 2000, an improvement of the outcome quality (HbA1c < or = 7.5%) could be observed with an increased goal attaihment degree of 66.6% (IV/2002) compared to the initial value of 60.3% (p < 0.001). The predefined blood pressure levels (< or = 140/90 mmHg) were achieved by 55.8% of the patients at the beginning and by 64.6% at the end of the evaluation period (p < 0.001). In terms of healthcare processes, an intensification of the medicinal therapy is remarkable.

[Assessment of methodological quality of clinical performance measures]. / Beurteilung der methodischen Qualität klinischer Messgrössen.

One of the tasks of the federal "Coordinating Committee" within Germany's self-governing health care system is to develop clinical performance measures. Since these performance measures usually exert an enormous influence on health care delivery their methodological quality should meet highest standards. The aim of our study was to develop quality requirements for clinical performance measures to be used in Germany; we did this mainly by compiling internationally published criteria. We present lists of quality requirements for clinical performance measures and performance assessment programs as well as a checklist for documenting and assessing comprehensively the methodological quality of these measures. Developing clinical performance measures by using these criteria could improve their methodological quality and promote the objectivity of performance assessment in medical care.

[Quality of hygiene in endoscope reprocessing--the fundamentals of indicator-assisted quality management in gastroenterology]. / Qualität der Hygiene bei der Endoskop-Aufbereitung--die Grundlage eines indikatorengestützten Qualitätsmanagements in der Gastroenterologie.

High level disinfection and infection control in reprocessing gastrointestinal endoscopes is a critical security factor for patients in gastrointestinal health care. National and international guidelines for an adequate high quality disinfection of gastrointestinal endoscopes have been developed aiming to obtain infection control. The German Medical Association has recently published recommendations on quality assurance in gastrointestinal endoscopy including standardised procedures for disinfection and infection control. A prospective study was carried out in a large urban area in both private practices and hospitals to identify and characterise flaws and limitations in disinfection of gastrointestinal endoscopes by measuring a set of indicators of the quality of structures, processes and outcomes. Moreover, the influence of information and continuous medical education on the quality of disinfection and infection control were to be evaluated. The bacterial contamination of endoscopes after reprocessing was measured as a relevant outcome quality indicator. The results revealed substantial flaws in cleaning and disinfection procedures in gastrointestinal endoscopy under routine clinical conditions. Overall, 49 and 39 percent of all (pre- and post-interventionally, resp.) checked endoscopes were contaminated by one or more bacteria. More often failures were discovered in the optic rinse system than in the cleaning/disinfection and the final rinse and drying process. A substantial failure rate was detected in gastrointestinal endoscope reprocessing under routine conditions according to the reprocessing procedure. Compared to manual and semi-automatic cleaning and disinfection, the full automatic cleaning and disinfection machines (RDG-E) showed the best results. Though their cleaning process remains improveable, it seems advisable to prefer RDG-E-machines for disinfection and infection control in gastrointestinal endoscopy. Continuous quality control of disinfection should be obtained by introducing regular microbiological examinations of the reprocessed endoscopes. Negative microbiological controls of the contamination of endoscopes are suitable quality indicators of a quality management system aiming to improve the quality of structures, processes and outcomes in gastroenterological health care.

[On the attractiveness, implementation and evaluation of guidelines]. / Leitlinien - Attraktivität, Implementierung und Evaluation.

Principles and conditions for guideline implementation and evaluation were the subject of a workshop organised by the German Association of the Scientific Medical Societies (AWMF) and the German Network for Health Services Research (DNVF). This report reflects contents and discussions and suggests possible future activities. The workshop highlighted the need for conceptual frameworks, theory-driven research and concerted strategies. The reinforcement of strategic partnerships within the health care organisations is an indispensable prerequisite for successful guideline implementation and evaluation.(As supplied by author).

[Benchmarking in health care: conclusions and recommendations]. / Benchmarking in der Gesundheitsversorgung: Fazit und Empfehlungen.

The German Health Ministry funded 10 demonstration projects and accompanying research of benchmarking in health care. The accompanying research work aimed to infer generalisable findings and recommendations. We performed a meta-evaluation of the demonstration projects and analysed national and international approaches to benchmarking in health care. It was found that the typical benchmarking sequence is hardly ever realised. Most projects lack a detailed analysis of structures and processes of the best performers as a starting point for the process of learning from and adopting best practice. To tap the full potential of benchmarking in health care, participation in voluntary benchmarking projects should be promoted that have been demonstrated to follow all the typical steps of a benchmarking process.

[Evaluation of benchmarking networks in Germany: background and methodology]. / Evaluation von Benchmarking-Verbünden in Deutschland: Hintergrund und Methode.

Benchmarking as a tool of organisational development is directed towards improvement through learning from others. The German Ministry of Health funded 10 demonstration projects on clinical benchmarking in order to study the prerequisites to and the methods for its dissemination. The evaluation was carried out as an observational study in 2008. The evaluation tools used included a list of criteria to uniformly describe benchmarking networks and a scheme to categorize the realized benchmarking steps.

[Benchmarking projects examining patient care in Germany: methods of analysis, survey results, and best practice]. / Benchmarking-Vorhaben in der Patientenversorgung in Deutschland: Analysemethodik, Erhebungsergebnisse und gute Praxis.

A survey among 232 German health care organisations addressed benchmarking projects in patient care. 53 projects were reported and analysed using a benchmarking development scheme and a list of criteria. None of the projects satisfied all the criteria. Rather, examples of best practice for single aspects have been identified.

[Results of the evaluation of German benchmarking networks funded by the Ministry of Health]. / Ergebnisse der Evaluation der vom Bundesministerium für Gesundheit geförderten Benchmarking-Verbünde in Deutschland.

Nine out of ten demonstration projects on clinical benchmarking funded by the German Ministry of Health were evaluated. Project reports and interviews were uniformly analysed using a list of criteria and a scheme to categorize the realized benchmarking approach. At the end of the funding period four benchmarking networks had implemented all benchmarking steps, and six were continued after funding had expired. The improvement of outcome quality cannot yet be assessed. Factors promoting the introduction of benchmarking networks with regard to organisational and process aspects of benchmarking implementation were derived.