Biomedical subjects
Publications and source records attributed to H K Selbmann.
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The methods and processes of a guideline development programme including a structured consensus conference for the employment of Diagnostic Imaging in Trauma Surgery are presented and critically reviewed. International standards and methodical concepts described in the Guideline Manual by the Agency for Quality in Medicine (AQuMed) and the Association of the Scientific Medical Societies in Germany (AWMF) have been implemented. Experiences with this project reveal that even a small multidisciplinary panel group is potentially able to cope with the comprehensive panel work if they are methodologically supported. The establishment of an internal quality management proved to be a useful tool for the production of high-quality results in the face of limited project resources. As expected, for most sub-questions knowledge of evidence and medical experience correlated well. However, the lack of a method for ensuring that consensus recommendations finally obtained by panel work and discussions during the conference were always based on evidence was the weak spot of this evidence-based consensus conference.
AIM: Despite of asthma guidelines existing for years, secondary data analysis shows insufficient medical care of asthmatics in Germany. The aim of the present study was to improve asthma guideline adherence by promoting guidelines implementation. METHOD: We analyzed prospectively pre- and post-interventional medical care of a sample of 127 asthmatics who were recruited by physicians working in ambulatory care and in hospitals of the Region Neckar-Alb, Germany. Data came primarily from patient interviews by phone. Our intervention to promote guidelines implementation consisted of following methods: 1. analyzing regional asthma care followed by a feedback performance report to physicians; 2. delivering asthma patient diaries and peak flow meters to study patients; 3. developing and adapting regionally asthma guidelines for adult asthmatics in the Region of Neckar-Alb; 4. promoting guidelines utilization by publishing the adapted guidelines in a scientific journal, direct mailing of a short version to the practitioners, and boosting the guidelines at regional CE meetings; 5. reanalyzing asthma care of the study cohort and the implementation of the guidelines 13 months after the beginning of the intervention. We studied the effect of the intervention using a qualitative model comprising 18 quality indicators measuring the proportion of patients who were treated in accordance to the guidelines. To compare pre- and post-interventional proportions we used the McNemar test for statistical analysis. RESULTS: The proportion of asthmatics treated in accordance to the guidelines improved significantly from 48 % to 57 %. The increase was mainly due to an improvement of guidelines adherence within the field of promoting asthma self-management and continuous monitoring of patients (42 % pre- and 57 % post-intervention), whereas guidelines adherence in pharmacotherapy improved only from 53 % to 56 %. CONCLUSION: The proportion of asthmatics treated in accordance to guidelines can be improved by using a multifaceted regional approach to promote guidelines implementation.
BACKGROUND: The so-called "external quality assurance" allows the comparison of hospitals using selected quality indicators for process and outcome of care. The methods were developed in early projects of perinatologists and surgeons in the mid 70s. The comparative statistics inform hospitals about their strengths and deficiencies compared to other hospitals. STATE OF THE ART: Since 2001 the Federal Committee on Quality Assurance (Bundeskuratorium Qualitätssicherung) requests the realization of external quality assurance measures for 27 diseases and procedures in all German hospitals based on the 5th Social Law. If hospitals refuse participation or participate incompletely, they have to expect financial sanctions. The comparative statistics enable first assessments of the quality of hospital care. However, the methods have to be improved if they will be used to demonstrate quality of hospital care to people outside the hospitals.
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.
The reliable noninvasive assessment of coronary artery disease would constitute an important step forward in clinical cardiology. The aim of the New Age pilot trial was to evaluate the diagnostic accuracy of multislice computed tomography (MSCT) in determining coronary lesions. As a gold standard for in vivo plaque detection, intracoronary ultrasound (ICUS) was used. Forty plaques were detected by ICUS in 15 target vessels (LAD, n = 8; RCA, n = 7) in patients assigned for ICUS-guided PTCA. Preinterventional MSCT was performed in all patients and the results were compared to ICUS with regard to lesion detection and quantification. According to ICUS results, the 40 plaques were divided into three groups: group I, mild lesions < 50% (n = 14; 44.36% +/- 5.77%); group II, intermediate lesions 50%-75% (n = 12; 59.18% +/- 9.39%); and group III, severe lesions > 75% (n = 14; 91.47% +/- 3.68%). All MSCT scans showed sufficient image quality for analysis. Thirty of 40 (75%) plaques were detected by MSCT in a first blinded session. After unblinding the ICUS results, the remaining 10 (25%) plaques could be identified. Lesion severity was classified correctly in 34 of 40 (85%) plaques. Plaque calcifications were diagnosed correctly in 16 of 19 (84.2%) plaques. Quantification of vessel size revealed a good correlation to the ICUS results (r(2) 0.68; P = 0.004). Noninvasive MSCT angiography showed good diagnostic accuracy with regard to lesion detection and quantification of vessel size. The overall good image quality, makes this new technology a promising modality, which might become an alternative diagnostic approach in patients with known or suspected coronary artery disease. Cathet Cardiovasc Intervent 2001;53:352-358.
This study assessed the clinical efficacy of a chemically standardized willow bark extract in the treatment of osteoarthritis. Willow bark extract, in a dose corresponding to 240 mg salicin/day, was compared with placebo in a 2-week, double-blind, randomized controlled trial. The primary outcome measure was the pain dimension of the WOMAC Osteoarthritis Index. Secondary outcome measures included the stiffness and physical function dimensions of the WOMAC, daily visual analogue scales (VAS) on pain and physical function, and final overall assessments by both patients and investigators. A total of 78 patients (39 willow bark extract, 39 placebo) participated in the trial. A statistically significant difference between the active treatment and the placebo group was observed in the WOMAC pain dimension (d = 6.5 mm, 95% C.I. = 0.2-12.7 mm, p = 0.047); the WOMAC pain score was reduced by 14% from the baseline level after 2 weeks of active treatment, compared with an increase of 2% in the placebo group. The patient diary VAS confirmed this result, and likewise the final overall assessments showed superiority of the willow bark extract over the placebo (patients' assessment, p = 0.0002; investigators' assessment, p = 0.0073). It is concluded that the willow bark extract showed a moderate analgesic effect in osteoarthritis and appeared to be well tolerated.
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OBJECTIVE: To assess the clinical efficacy of a chemically standardized willow bark extract in the treatment of osteoarthritis. METHODS: Willow bark extract, in a dose corresponding to 240 mg salicin/day, was compared to placebo in a 2-week, double-blind, randomized controlled trial. The primary outcome measure was the pain dimension of the WOMAC Osteoarthritis Index. Secondary outcome measures included the stiffness and physical function dimensions of the WOMAC, daily visual analogue scales (VAS) on pain and physical function, and final overall assessment by both patients and investigators. RESULTS: 78 patients (39 willow bark extract, 39 placebo) participated in the trial. A statistically significant difference between active treatment and placebo group was observed in the WOMAC pain dimension (d = 6.5 mm, 95% C.I. = 0.2-12.7 mm, p = 0.047); the WOMAC pain score was reduced by 14% from baseline level after two weeks of active treatment, compared to an increase of 2% in the placebo group. Patient diary VAS confirmed this result, and likewise the final overall assessments showed superiority of willow bark extract over placebo (patients assessment, p = 0.0002; investigators assessment, p = 0.0073). CONCLUSION: Willow bark extract shows a moderate analgesic effect in osteoarthritis.
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Quality of care and cost considerations are becoming increasingly intertwined. While costs were an insignificant factor in quality management 30 years ago, today the consumption of resources is a measure of the quality of outcome. Newly developed clinical guidelines are intended to reduce the cost of care in the future. However, they entail a significant potential for abuse that can compromise quality. Guidelines are necessary to demonstrate the cost effectiveness of quality control and quality assurance measures. Excessive emphasis on quality assurance may increase the overall consumption of resources. In a managed care setting with budgetary constraints, this can reduce the quality of care.
Frequently, there is a gap between publication and implementation of guidelines into clinical practice. To improve adherence with guidelines, experts recommend among other things local adaptation of guidelines. The goal of the present study was to conceptualize and test such an adaptation in the region of Neckar-Alb in Germany by using asthma guidelines as an example. We conceptualized a three-step approach for regional guideline adaptation: 1) Compilation of existing national and international asthma guidelines by regional experts to develop a draft for regional asthma guideline; 2) regional consensus conference to discuss the draft with local physicians; 3) modified Delphi procedure using regional physicians as "experts" to get consent for the regional asthma guideline. We defined consensus as reaching at least a 2/3 consent for each of the statements. As starting point for the process of guideline adaptation, the regional experts developed a first draft of the regional asthma guideline including 132 recommendations. 60 out of 500 regional general practitioners (GP), internists and asthma specialists participated in the consensus process. After the preparations of the regional experts and the regional consensus conference, only four recommendations had to be changed considerably during the Delphi procedure to reach the consensus criterion. If the recommendations remained unchanged, the whole guideline might be disapproved because they were considered to affect the role of GPs by shifting responsibilities from GPs to asthma specialists. As the result of the adaptation, the first regionally adapted asthma guideline for the Neckar-Alb region fosters the principal responsibility of regional GPs in asthma care, thereby surmounting resistance for implementation that former specialist-centered guidelines provoked. Hence, the new guideline meets the requirements for successfully implementing the recommendations into clinical practice.
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In a number of anglophone countries in parallel to the industrial trend accreditation systems have been developed for health care organizations and specially for hospitals. These systems were introduced and instituted as a part of the health care system in the countries. Central elements and central procedures of these genuine-medical accreditation systems for hospitals in the United States, in Australia, Canada, France and in Great Britain are mostly identical. They focus primarily on the patient and his way from access to post discharge in a hospital. Core of the systems is a catalogue with standards, which in a systematic and comprehensive way gives ideas of good professional performance in hospitals. The catalogues can be used internally to develop and improve quality and quality management in a hospital. Primarily, however, the accreditation systems are designed to provide most objective measures for external evaluation of quality and quality management.