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Biomedical subjects

I Kopp

Publications and source records attributed to I Kopp.

At least 19 recordsLinked to original sources

[Clinical pathways in psychiatry and psychotherapy].

BACKGROUND: Implementing evidence-based clinical guidelines by means of clinical pathways is one of the key elements of continuous quality management at the University Hospital of Marburg. This paper explains how clinical pathways for suicidal ideation and suicide attempts were developed. METHODS: Based upon a review of existing guidelines and literature, optimal standards of care were defined. Step-by-step analysis of the process of care and results of a questionnaire were used to describe the actual processes. A problem-orientated comparison of the actual and the optimal process of care was the basis for developing these pathways. A consensus was achieved with all persons involved in the respective process of care taking into consideration local resources as well as barriers. The most important decisions and interventions were defined and presented as a patient-oriented process. RESULTS: The lack of explicit "how to do it"-recommendations of the guidelines for the entire care processes required specific, locally tailored adaptations. Potentials for improvement were identified in the following areas: transfer of patients, consultation, information and coordination within the team, and diagnosis of suicide risk. The pathways include care-oriented algorithms, checklists and assignments of responsibility. CONCLUSIONS: The development of clinical pathways as part of quality management and transsectoral integrated care in psychiatry and psychotherapy is feasible. The concept presented incorporates the potential of increasing transparency, efficiency and efficacy of care, and of improving satisfaction of those involved. It offers psychiatric hospitals the chance to guarantee optimal quality of care in face of increasing workload and costs.

Critical Pathways↗

Computerized visualization of quality of life data of individual cancer patients--the QoL-Profiler.

OBJECTIVE: Quality of life (QoL) is increasingly considered as an important endpoint in clinical studies but difficult to use in clinical practice. For daily clinical practice, we developed a computer program that is able to calculate and draw QoL profiles for individual cancer patients. METHODS: The computer program was developed in several steps during the course of studies with different patient populations (prospective cohort study, randomised surgical trial, breast cancer patients, all tumour patients of a clinic) and using different software packages. RESULTS: The current version is based on Microsoft ACCESS and combines QoL data and medical data. Automated QoL profile output comprises 10 scores that are of clinical relevance. Scores range from 0 (worst) to 100 (best), with 50 considered as the threshold for intervention. CONCLUSIONS: Practitioners found QoL-profiles comprehensible and clinically useful. QoL profiles are the crucial link between the QoL concept and QoL enhancing treatment decisions.

Aged↗

Understanding quality of life in patients with colorectal cancer: comparison of data from a randomised controlled trial, a population based cohort study and the norm reference population.

BACKGROUND AND AIMS: Quality of life (QoL) is an important outcome measure in clinical studies. However, there is little experience with the interpretation of QoL results. METHODS: To guide interpretation of QoL results from a randomised controlled trial (RCT) targeting the effectiveness of the immune modulator G-CSF on postoperative recovery in high risk (ASA III/IV) colorectal cancer patients, we compared RCT data with data from a population based cohort study and norm reference data. QoL was assessed using the European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 and CR38 questionnaires. QoL results were analysed on discharge from hospital and six months postoperatively. RESULTS: Colorectal cancer patients (both from the RCT and the cohort study) showed the greatest differences in QoL scores compared to norm reference data at discharge from hospital. Six months postoperatively, global quality of life and pain approximated norm reference values indicating optimal recovery. However, deficits still appeared in scores for role functioning, physical functioning, social functioning and fatigue. The best improvements (discharge from hospital to six months postoperatively) were seen with respect to physical functioning, fatigue and pain. CONCLUSIONS: For further analysis of RCT data, physical functioning and fatigue scores may be more sensitive than global quality of life to detect differences in treatment effects.

Adult↗

[The Guideline Clearing Project COPD. Recommendations for a National Guideline].

In order to promote the care of patients with COPD in Germany a national guideline clearing project was initiated jointly by autonomous corporate bodies of the German health care system. Following a systematic search of literature data bases between 1992 and 2002, 20 guidelines were identified that met the inclusion criteria and were evaluated with the German Checklist for Methodological Guideline Appraisal. Following this, a multidisciplinary expert group appointed by the German Guideline Clearinghouse (Leitlinien-Clearingstelle im Arztlichen Zentrum fur Qualitat in der Medizin, AZQ) reviewed the suitability of these guidelines for the use in the German health care system. Referring to methodological aspects, criteria were best met by the guideline of the Veteran's Health Administration/Department of Defense (US), followed by the one of the Deutsche Atemwegsliga and the Deutsche Gesellschaft fur Pneumologie. Aiming at the production respectivly a revision of a German national guideline for COPD the expert group agreed on recommendations organized in 19 chapters. Among others these strengthened the role of a precise definition of COPD based primarily on the pathogenesis, of a subtle description of all diagnostic and therapeutic tools and of a detailed description of quality assurance and quality management. The feasability of recommendations were demonstrated by examples chosen from the evaluated guidelines. Additionally the presented findings may be used as steering tools in the German Health care system.

Delivery of Health Care↗

[From clinical guidelines to clinical pathways: development of a management-oriented algorithm for the treatment of polytraumatized patients in the acute period].

INTRODUCTION: The treatment of polytraumatized patients in the acute period is an exemplary model of multidisciplinary cooperation in a very critical timeframe. Implementing standards formulated in the clinical guidelines of the German Association of Traumatology requires a detailed description of "how to do it." METHODS: Based on the guidelines and validated quality indictors, the optimal standard of care as the goal was defined. A clinical algorithm was developed and personal responsibilities and time limits were clearly assigned to each decision step and action. Checklists, documentation charts, and a full text supplement the algorithm. The complete pathway was adopted by representatives of all occupational groups involved in early trauma care in a consensus process. RESULTS: Improvement potentials were identified in those areas for which the guidelines did not provide explicit recommendations. These represent the key elements of the algorithm. Pathway-specific review criteria (quality indicators) were defined for scheduled reevaluation. CONCLUSIONS: Implementing clinical guidelines at the local level requires a problem-oriented and management-oriented elaboration towards a clinical pathway as the basis for a quantitative process and cost analysis.

Algorithms↗

[A guideline for guidelines--methodological report and use of the guideline women's information].

UNLABELLED: Information and education is needed to empower autonomy and self-determination of patients (informed consent). Furthermore reliable and accurate medical information is necessary for patients who want to take an active part in medical decision-making. The aim of this work is to define the requirements helping to assure the development of good qualified information material relevant for women and female patients as "a guideline on women information". An example of its use is given by embeding this guideline in the guideline for early detection of breast cancer in Germany by defining the specific elements required for developing qualified information on this issue for women. METHODS: A systematic, stepwise methodological process according to a level two guideline of the German Association of the Scientific Medical Societies (AWMF) and the Agency for Quality in Medicine (AZQ) was performed with the following elements: 1. Establishing an expert panel, 2. Generating the guideline statements by a formal, consensus based nominal group process, 3. External review process and finding supportive partners for the guideline on women information, 4. Using the guideline for guidelines: implementing the concept in the guideline of early detection of breast cancer in Germany. RESULTS: The "guideline women information" comprises nine elements of quality assuring requirements for the development of gender-specific information material and eleven specific elements which directly relate to the guideline statements on early detection of breast cancer. After external review 30 organisations gave their written support for future implementation of the guideline. The "guideline women information" was integrated as a tool for quality assurance of lay information into the "guideline for early detection of breast cancer in Germany". CONCLUSION: The "guideline women information" is a systematically developed, consensus-based recommendation to improve the development of qualified lay information at the point of its process by defining gender-specific aspects required for good lay information and its evaluation. As a guideline for guidelines its use is demonstrated by integrating this guideline into the "guideline for early detection of breast cancer in Germany" to ensure the development of qualified guideline compliant information.

Breast Neoplasms↗

Quality of life profile: from measurement to clinical application.

Quality of life (QoL) can be assessed in an accurate, valid and reliable way by means of standardized QoL questionnaires and is an important endpoint in clinical trials today. The aim of this study is to implement quality of life as a diagnostic tool for problem-oriented follow-up care of cancer patients. This is done in the framework of an intervention study in the area of regional health care research using qualitative analysis and the methodological concept of barrier analysis. We developed the diagnostic tool by generating individual, graphic QoL profiles based on patients' responses to the EORTC QLQ-C30 and the corresponding disease-specific modules BR23 for breast cancer and CR38 for rectal cancer. The clinical application is investigated by assessing physicians' responses. The QoL profile is judged as a useful diagnostic tool by all participating physicians. It enables physicians to assess the QoL of the patient and incorporate the knowledge they gain in their daily practice. Especially in breast cancer follow-up care QoL profiles give added value to both patients and doctors. The next implementation steps have to extend the concept of QoL to larger groups of patients and physicians by overcoming the restraining factors as identified in the barrier analysis.

Journal Article↗

[Surgical therapy of rectal carcinoma. Portrayal of the current health care status within the scope of a district quality assurance study].

UNLABELLED: In an era of economic pressure, patient's participation in decision-making and evidence-based medicine, the need for quality assurance of medical processes in daily routine becomes increasingly important. The aim of this quality assessment study is to demonstrate the real state of surgical care of patients with rectal carcinoma in the context of a field study on quality management in oncology. METHODS: Prolective cohort-study, small-area-analysis. Between 01.01.1997 and 31.12.1998, all patients with newly diagnosed rectal carcinoma and treatment in the county of Marburg-Biedenkopf (252.975 inhabitants, 3 hospitals) were included in the study. Documentation included all variables (n = 82) relevant for primary surgical therapy according to guidelines and standards. RESULTS: 146 consecutive patients fulfilled the inclusion criteria. 93% underwent resection of the tumor. In 6.6% of these cases rigid rectoscopy for determination of the tumor's distance from the anal verge was not performed. In 16.9% the colon was not examined completely. In 98.5% the state of distant metastases was documented preoperatively. 93% of the patients with tumors in the upper/middle third of the rectum and curative-intent surgery (n = 68) received a sphincter-saving operation. For all curative-intent procedures negative resection margins were confirmed histologically. Complication rates were 31.6% for anterior resection and 46.9% for abdominoperineal extirpation. CONCLUSIONS: Comparative analysis of quality indicators revealed a predominantly good quality of care. Improving efforts can now be concentrated on few areas of suboptimal quality in the setting of internal quality management. Critical results require detailed analysis of the single cases. Thus, conditions requiring deviation from guidelines become apparent.

Adult↗

Predictive genetic screening and clinical findings in multiple endocrine neoplasia type I families.

Germline mutations of the MEN1 gene have been identified as the causative genetic defect of multiple endocrine neoplasia type I (MEN-I), an autosomal dominantly inherited condition. To establish the basis for predictive family screening we evaluated the spectrum of MEN1 gene mutations in MEN-I patients treated at our institution. Relatives at risk were subjected to predictive genetic screening after genetic counseling. Gene carriers were subjected to extensive clinical screening for MEN-I, including biochemical tests for basal hormone concentrations in blood and urine, a standardized meal stimulation test and imaging procedures (ultrasonography, computed tomography, magnetic resonance imaging). Among index patients of 15 independent MEN-I kindreds, 14 heterozygous MEN1 germline mutations were identified by single-strand conformational variant analysis (SSCV) and direct DNA sequence analysis. Of 51 individuals at risk, 26 predictively tested relatives with the wild-type MEN1 gene could be excluded from further screening procedures because they had not inherited the disease. In all previously presumed unaffected relatives with the mutant gene, our extensive clinical screening program revealed at least one manifestation of MEN-I. Furthermore, 22 additional diagnoses could be established in identified MEN-I patients. We show that mutation analysis enables predictive genetic screening for MEN-I families, providing a valuable tool for genetic counseling and clinical management. An extensive clinical screening program focusing on genetically proven individuals at risk allows detection of MEN-I manifestations at an early, asymptomatic stage of the disease. Controlled, prospective studies are now required to prove whether timely appropriate treatment on the basis of predictive screening might help improve disease-related quality of life and prolong life expectancy in MEN-I kindreds.

DNA Mutational Analysis↗

Prospective controlled trial of a standardized meal stimulation test in the detection of pancreaticoduodenal endocrine tumours in patients with multiple endocrine neoplasia type 1.

BACKGROUND: Use of a standardized meal stimulation test has been recommended for the early diagnosis of pancreaticoduodenal endocrine tumours (PETs) in patients with multiple endocrine neoplasia type 1 (MEN 1). The diagnostic value of this test was re-evaluated. METHODS: In a prospective, controlled trial 58 standardized meal stimulation tests (563 kcal) were performed in 12 patients with MEN 1 and histologically, biochemically and/or radiologically confirmed PETs (group 1), 11 carriers of an MEN 1 mutation with no evidence of PETs (group 2) and in 27 healthy controls (group 3). Serum pancreatic polypeptide (PP) and gastrin concentrations were measured before and during the test meal. RESULTS: Patients in group 1 had significantly higher mean basal serum PP and gastrin concentrations than patients in group 2 and controls (P < 0.05). In all three groups an increase in serum PP was observed after meal stimulation, but there was no significant difference between the groups. No increase in gastrin level was found in any of the groups after meal stimulation. CONCLUSION: The standardized meal stimulation test does not reliably indicate the presence of PETs in patients with MEN 1, whereas raised basal serum PP and gastrin levels do. The expensive and time-consuming meal test can be excluded from MEN 1 screening programmes.

Adult↗

[Evaluation of therapy of patients with rectal carcinoma. Goals of healing (outcome) and implementation of the quality of life concept in total medical care].

Quality of life (QL) assessment by means of standardised scales allows a valid representation of an individual's subjective sense of well-being in three dimensions: somatic (intensity and frequency of symptoms), psychological (anxiety, depression) and social (family life, employment, sexuality). The question, however, whether routine measurement, documentation and analysis of QL-data could lead to an improvement of patient care is still unsolved. Studies with a clearly defined practical goal in collaboration with physicians and patients should help to resolve this issue. The introduction of the QL concept into everyday clinical practice first requires that this tool is understandable and valuable to the clinician. In this respect, we propose to integrate the factor QL into a broader outcome-concept in parallel to the classical quality indicators (outcome-criteria), to demonstrate individual patient's clinical and therapeutical course in the form of QL-profiles and to correlate the patient's actual clinical and psychosocial situation with the results of QL measurement. We illustrate the feasibility of a stepwise concept of implementation of the QL concept by demonstrating interim results of our field trial on regional management and care of patients with rectal carcinoma in the county of Marburg-Biedenkopf.

Germany↗

Magnetic resonance colonography and virtual magnetic resonance colonoscopy with the 1.0-T system: a feasibility study.

RATIONALE AND OBJECTIVES: An ex vivo study and a clinical, prospective, patient study were undertaken to evaluate the feasibility of magnetic resonance (MR) colonography with a 1.0-T system. METHODS: An ex vivo colon model was scanned. A cleaned pig colon was prepared with six simulated sessile polyps (diameters of 4-12 mm) and one simulated pedunculated polyp (diameter of 5 mm). Subsequently, five patients (aged 39-81 years; four women, one man) were examined with MR colonography, immediately followed by endoscopic colonoscopy. After preparation for colonoscopy, the colon was filled with a Gd-DTPA/water solution (1:100). A breath-hold 3D gradient-echo sequence was acquired in both the prone and supine positions and after intravenous Gd-DTPA administration. Images were analyzed interactively by using multiplanar projections, maximum-intensity projection, and a virtual endoscopic view. The MR results were compared with the findings of the fiberoptic endoscopy. RESULTS: All seven simulated lesions of the colon model could be detected by MR imaging. In one patient, an advanced colon cancer as well as an additional small polyp was depicted. In the other four patients, single polyps with a diameter of 1 to 2.5 cm and a large adenoma were visualized by MR colonography. Contrast enhancement of the polyps was noted only after subtraction. CONCLUSIONS: The 1.0-T system is feasible for MR colonography. Reduced requirements for hardware could contribute to establish the novel technique as a screening method for colorectal polyps.

Adenoma↗

[Germline mutations in the MEN1 gene: basis for predictive genetic screening and clinical management of multiple endocrine neoplasia type 1 (MEN1) families].

BACKGROUND AND OBJECTIVE: Mutations in the MEN 1 gene were recently discovered as the causative genetic defect of the autosomal dominantly inherited multiple endocrine neoplasia type 1. It was the aim of this study to evaluate the spectrum of MEN 1 mutations in our own series of patients in order to obtain a basis for predictive family screening. PATIENTS AND METHODS: Genomic DNA from peripheral blood of 21 patients with MEN 1, members of 14 non-related MEN 1 families, was examined for MEN 1 germ-line mutations by means of single-strand conformation variant analysis (SSCP) and direct DNA sequencing. In addition, blood from 20 asymptomatic family members of five families was tested for its predictive value. RESULTS: Eleven different heterozygotic germ-line mutations, among them eight frameshift, two missense and one nonsense mutations, were identified. In four of the 20 asymptomatic members from five MEN 1 families who had been tested after appropriate genetic counselling, the MEN 1 mutation characteristic for the particular family was found. Clinical screening programme in three mutation carriers revealed abnormal findings in all three: one primary hyperparathyroidism, one prolactinoma and one nonfunctioning pancreatic tumour each. The 16 family members without MEN 1 mutation were spared further unnecessary screening investigations. CONCLUSION: Although the function of the MEN 1 gene is not yet known, molecular genetic tests provide a basis for genetic counselling, predictive genetic screening and clinical management of MEN 1 families.

Adult↗

Localization of the peritoneal reflection in the pelvis by endorectal ultrasound.

BACKGROUND: Large adenomas and low-risk rectal carcinomas (T1) that are localized distal of the pelvic peritoneal reflection (PPR) are treated by transanal excision. However, the location of the PPR varies widely and cannot be detected reliably by preoperative methods. Therefore, we evaluated the value of endorectal ultrasound (EUS) for the prediction of an intraperitoneal location of rectal tumors. METHODS: Fourteen patients with rectal tumors measuring </=15 cm from the anal verge were examined by EUS. If peristalsis beyond the rectal wall or any intraperitoneal fluid was seen at the proximal tumor edge, the lesion was classified as localized above or in the level of the PPR. During the operation, the surgeon determined whether the upper end of the tumor reached the PPR. RESULTS: In each of our 14 patients, the prediction by EUS was correct. In two patients, a small rectal tumor was excised with an electric sling during rectoscopy, but the polyp bases were not free of dysplastic epithelial tissue. The point where these two polyps were removed could be visualized by endoscopy but not by EUS. Once the relevant area was marked with a titanic endoclip, EUS was able to predict the resection place in relation to the PPR in these two patients as well. CONCLUSIONS: Although this knowledge would be very important for the therapeutic strategy of small rectal tumors, it is impossible to determine the location of a rectal tumor with regard to the PPR either clinically or by endoscopy. EUS provides this information with high reliability. Thus, we recommend EUS as the method of choice for predicting the location of the PPR.

Adenocarcinoma↗

MEN1 gene mutations in 12 MEN1 families and their associated tumors.

Multiple endocrine neoplasia type 1 (MEN1) is an autosomal dominant inherited tumor syndrome characterized by the development of multiple endocrine tumors. The gene responsible for the disease, termed MEN1 gene. has recently been isolated and germline mutations have been described in affected MEN1 individuals. Twelve unrelated (German MEN1 families and their associated tumors (5 parathyroid tumors, 1 vipoma, 1 gastrinoma, 1 insulinoma) were characterized for MEN1 gene mutations by single-strand conformational variant (SSCV) analysis and DNA sequence analysis as well as for loss of heterozygosity on chromosome 11q13. We identified nine different heterozygous germline mutations (6 frameshift, 2 missense, 1 nonsense), eight of them were novel. Four of five informative MEN1-associated tumors revealed deletion of the second MEN1 allele, supporting the concept of a tumor suppressor gene. Furthermore. SSCV analysis proved an effective and sensitive method for the detection of menin mutations providing a reliable genetic screening approach supporting genetic counseling and clinical management of MEN1 family members.

Adenoma↗