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Karl Wegscheider

Publications and source records attributed to Karl Wegscheider.

30 records · Page 2Linked to original sources
PubMed2004

Prevalence of thyroid disorders in the working population of Germany: ultrasonography screening in 96,278 unselected employees.

Germany continues to be iodine deficient despite considerable improvement in the past years. To assess the current prevalence of diffuse and/or nodular thyroid disorders, a cross-sectional observational study in a nonrandom sample of the working population was carried out throughout Germany in 2001 and 2002. A total of 96,278 employees 18-65 years of age from 214 companies or other private or public institutions voluntarily underwent ultrasonographic examinations by 230 experienced investigators. To compare the prevalence of different abnormal findings in relation to age and gender, descriptive statistics and the Kruskal-Wallis test were used. Data from volunteers with previous thyroid treatment (13.0% of total sample) were not included in the analysis. Abnormal findings (goiter and/or nodules > 0.5 cm) were observed in 33.1% (men, 32.0%; women, 34.2%) of the examined patient population, an enlarged thyroid without nodules in 9.7% (men, 11.9%; women, 7.6%), nodules only without enlargement of the thyroid in 14.3% (men, 11.5%; women, 17.0%), and nodular goiter in 9.1% (men, 8.6%; women, 9.6%). Nodules (with or without goiter) between 0.5 and up to 1.0 cm were found in 10.0%, and nodules above 1.0 cm in 11.9% of the population. Rates of abnormal findings increased with age in both genders. Goiter was more common in men, nodules in women. In light of these findings, the prevalence of thyroid disorders in Germany continues to be high. Although the study may slightly overestimate the prevalence, about one third of the working population is affected and remains unaware of this condition. These results emphasize the importance of effective sonographic screening to detect early thyroid abnomalities in order to initiate preventive and therapeutic measures to prevent the onset or progression of disease and its sequels.

Adult↗
PubMed2004

Self management of oral anticoagulation with the IN Ratio system: impact of a structured teaching program on patient's knowledge of medical background and procedures.

BACKGROUND: Self management of oral anticoagulation (OAC) decreases complication rates and improves quality of life. Manual and cognitive abilities of patients and patient training in a structured format are a precondition for this concept. Up to now, there is no evidence about knowledge increase from teaching programs. METHODS: Seventy-six patients (mean age, 57.4 years, 71% male) who started long-term OAC were included in the prospective multi-center study at three teaching centers representing different populations of anticoagulation patients: a department of cardiovascular surgery, an inpatient rehabilitation center and an anticoagulation clinic. The patients were trained in a structured education program for two days. For the evaluation, the patients performed standardized tests including 16 questions prior to start (T0), after each training unit (T1/T2) and 6 weeks later (T3). The primary endpoint was the percentage of > or =75% of patients who could answer > or =50% of questions correctly at T3. Secondary endpoints were the overall and item-specific percentages of correct answers at the end of each training unit (T1, T2) and at T3. In addition, the teaching program was rated by the patients on a six-point rating scale. RESULTS: Seventy-four out of 76 patients gave at least 50% correct answers at T3 (97.4%; 95% confidence interval, 90.8-99.7%). The average rates of correct answers developed from 40% (T0), 86% (T1), 94% (T2) to 96% (T3). The greatest increase of knowledge was observed with blood components, interpretation of International Normalized Ratio (INR) value, and the interaction of anticoagulation with other variables (e.g. drugs or infection). Patients rated the teaching program between 1 (best rating) and 2 at all time points. At T3, the patients reported less fear of complications and less limitations in their daily life than in earlier evaluations. CONCLUSION: The structured training program INRatio appears to be an appropriate instrument for instruction of INR self management. In comparison with baseline knowledge, the percentage of correctly answered questions was twice as high directly after the end of training and remained at a high level of >90% for at least 6 weeks.

Administration, Oral↗
PubMed2004

Assessment of levothyroxine sodium bioavailability: recommendations for an improved methodology based on the pooled analysis of eight identically designed trials with 396 drug exposures.

BACKGROUND: Assessment of dosage form performance in delivering endogenous compounds, such as hormones, in vivo requires a specific approach. OBJECTIVES: Assessment of relative bioavailability of levothyroxine sodium (L-T4) from eight solid preparations, compared with a liquid formulation, by using pharmacological doses, and critical evaluation of trial methodology based on the pooled analysis of individual data. DESIGN: Eight open-label, randomised, single-dose, crossover phase I studies using eight solid L-T4 dosage forms (25, 50, 75, 100, 125, 150, 175, 200 microg per tablet; administered total doses 600, 625 or 700 microg) and a liquid formulation; assessment of relative bioavailability by 90% confidence intervals for the relative area under the concentration-time curve (AUC) of total thyroxine (TT4), i.e. protein-bound plus free thyroxine, calculated by using the recommended log AUC four-way analysis of variance models for crossover designs. For the pooled analysis, general linear models were applied to assess the validity of model assumptions, to identify potential sources of effect modification, to discuss alternative modelling approaches with respect to endogenous hormone secretion and to give recommendations for future designs and sample sizes. PARTICIPANTS: One hundred and sixty-nine healthy males; 29 of these individuals participating in two studies. INTERVENTIONS: Single oral doses of L-T4 tablets and the liquid formulation administered after fasting, separated by at least 6 weeks; a total of 396 drug exposures. MAIN OUTCOME MEASURES: TT4 AUC from 0 to 48 hours and peak plasma concentration with and without baseline correction. RESULTS: Each study demonstrated equivalence of the tablets to the drinking solution, independent of the chosen analysis model. Sequence effects that could devalidate the chosen crossover approach were not found. Period effects with changing directions that could best be explained by seasonal variation were detected. While the pre-specified method of baseline correction of simply subtracting individual time-zero TT4 values was disadvantageous, the analysis of total AUC could be improved considerably by covariate adjustment for baseline TT4. With this approach, sample sizes could have been substantially reduced or, alternatively, the recommended equivalence ranges could be reduced to +/-6%. CONCLUSION: Using a single pharmacological dose of L-T4 in two-period crossover designs is a safe and reliable procedure to assess L-T4 dosage form performance. With an adequate statistical modelling approach, the design is efficient and allows general conclusions with moderate sample sizes.

Area Under Curve↗
PubMed2004

Results of intracoronary beta-brachytherapy administered by 60 mm transfer device/radiation source train: a subgroup analysis from the RENO registry.

UNLABELLED: To investigate the safety and efficacy of a 60 mm transfer device, delivering 60 mm radiation source train, in the treatment of coronary lesions by b-brachytherapy employing the BetaCath system (Novoste, Norcross, Georgia). METHODS AND RESULTS: As part of the REgistry NOvoste (RENO), the first large-scale registry of intracoronary beta-radiation applied in routine clinical practice, 46 centers registered 1,098 consecutive patients undergoing brachytherapy with the BetaCath system. Of these, 49 patients with 56 lesions were treated with a 60 mm transfer device/radiation source train (TD/RST) in at least 1 vessel, constituting the study population. With 75.4% in-stent restenosis (ISR), 3.6% graft lesions, long lesions (30.9 +/- 14.7 mm) and 19% diabetes, the cohort had a high-risk for recurrence. The in-hospital major adverse cardiac event (MACE) rate was 4.1%. The 6-month follow-up revealed 2.0% death, 4.1% myocardial infarction, 8.2% target vessel revascularization, 12.2% MACE, 82.6% improved angina, 16.7% binary restenosis and 4.1% late thrombosis. The results were comparable to all other patients in the registry treated with standard source lengths of 30 mm and 40 mm, although much longer lesions were treated by the 60 mm device (18.4 +/- 11.3 mm versus 30.9 +/- 14.7 mm; p < 0.0001). In the ISR subgroup (mean lesion length, 32.03 +/- 14.99 mm), the 6-month MACE rate was 12.8%, while the angiographic restenosis rate was 16.0% and the late thrombosis rate was 2.6%. CONCLUSION: Beta-brachytherapy with 60 mm TD/RST was safe, feasible and effective in this broad population of high-risk patients presenting in day-to-day practice. Its efficacy in long-segment ISR, where conventional interventional strategies have poor outcome rates, is particularly noteworthy.

Angioplasty, Balloon, Coronary↗
PubMed2004

[Methodological requirements for center comparisons (profiling) in healthcare].

Quantitative comparisons of health institutions (e.g. hospitals, rehabilitation centers, or disease management programs) have become increasingly common in Germany, focused at assuring and improving the quality of the healthcare system. For evaluation, frequently only raw center means of one specific outcome are calculated and ranked. This evaluation method is insufficient because it does not reflect the multidimensional profiles of the institutions or their development in the time domain. Also, the observed means are not corrected for random effects and thus suggest larger differences among institutions than actually exist. Additionally, raw means do not allow fair comparisons since they do not take into account baseline differences among institutions. Instead of presenting raw means, multilevel statistical models with institutions as random effects and carefully selected potential confounders as fixed effects should be applied and used for the estimation of center effects. For presentation of the results, profiles plots and control charts should be preferred to the widely used rankings and league tables.

Delivery of Health Care↗
PubMed2003

Magnetic resonance perfusion measurements for the noninvasive detection of coronary artery disease.

BACKGROUND: With MRI, an index of myocardial perfusion reserve (MPRI) can be determined. We assessed the value of this technique for the noninvasive detection of coronary artery disease (CAD) in patients with suspected CAD. METHODS AND RESULTS: Eighty-four patients referred for a primary diagnostic coronary angiography were examined with a 1.5 T MRI tomograph (Philips-ACS). For each heartbeat, 5 slices were acquired during the first pass of 0.025 mmol gadolinium-diethylenetriamine pentaacetic acid/kg body weight before and during adenosine vasodilation by using a turbo-gradient echo/echo-planar imaging-hybrid sequence. MPRI was determined from the alteration of the upslope of the myocardial signal intensity curves for 6 equiangular segments per slice. Receiver operating characteristics were performed for different criteria to differentiate ischemic and nonischemic segments. Prevalence of CAD was 51%. Best results were achieved when only the 3 inner slices were assessed and a threshold value of 1.1 was used for the second smallest value as a marker for significant CAD. This approach yielded a sensitivity of 88%, specificity of 90%, and accuracy of 89%. CONCLUSIONS: The determination of MPRI with MRI yields a high diagnostic accuracy in patients with suspected CAD.

Coronary Angiography↗
PubMed2003

Intracoronary beta-brachytherapy in chronic total occlusions: a subgroup analysis from the RENO registry.

Conventional interventional therapy has been less rewarding in chronic total occlusion (CTO). Brachytherapy by its antiproliferative and positive remodeling effect may be more efficacious. Forty-six centers registered 1,098 consecutive patients undergoing brachytherapy with the BetaCath system. Of these, 78 patients had 82 lesions (CTO) at presentation-the study population. With 67% in-stent CTO, 8% graft CTO, 4% recurrent CTO, long lesions (27.6 +/- 20.9 mm), and 31% diabetes, the cohort had high risk for recurrence. The in-hospital event rate was 1.3%. Six-month follow-up revealed 1.3% death, 5.1% myocardial infarction, 21.8% target vessel revascularization, 77.8% improved angina, 34.5% binary restenosis, 12.7% reocclusion, and 10.3% late thrombosis. The results were comparable to all other patients in the registry, although late thrombosis rate was higher in the CTO group (10.3% vs. 5.0%; P = 0.047). In the in-stent CTO subgroup (n = 52; 66.7%), there was no in-hospital event, no follow-up death or myocardial infarction, restenosis in 35.1%, and reocclusion in 10.8% of patients. In comparison, death or myocardial infarction was significantly higher in de novo CTO subgroup (P = 0.005). Compared to all other in-stent restenosis patients in the registry, the patients with in-stent CTO had similar clinical and angiographic event rate. Thus, beta-brachytherapy was safe, feasible, and effective in this broad population of high-risk patients with CTO presenting in day-to-day practice. It was particularly effective in in-stent CTO, where conventional interventional strategies are disappointing.

Aged↗
PubMed2003

Annual distribution of ventricular tachycardias and ventricular fibrillation.

BACKGROUND: Ischemic events and coronary deaths show seasonal variability with a peak during December and January. It remains unclear whether ventricular tachycardias (VT) and ventricular fibrillation (VF) follow a similar pattern. The purpose of this study was to investigate the annual distribution of malignant ventricular arrhythmias. METHODS: Over a period of 11 years, all appropriate shock episodes (SE) after VT and VF in patients with an implantable cardioverter defibrillator (lCD) were analyzed with respect to the month of occurrence. An appropriate SE was defined as out-of-hospital VT/VF terminated by lCD shocks. Multiple shocks within 1 week were defined as 1 SE. RESULTS: Two hundred and thirty-three of 308 patients with an lCD had appropriate SE during follow-up. In these patients the seasonal variation of 753 SE was calculated. Most SE occurred during January (93 SE), and the fewest SE occurred during June (39 SE). The seasonal pattern was statistically significant with a peak during winter (P =.001). The seasonal pattern did not differ between patients with an ischemic and those with a nonischemic underlying cardiac disease. CONCLUSION: Appropriate shock episodes due to out-of-hospital VT/VF in patients with an lCD show seasonal variation with a significant peak during winter. The pattern is similar in patients with ischemic and nonischemic cardiac disease.

Circadian Rhythm↗
PubMed2003

Analgesic efficacy of flupirtine in primary care of patients with osteoporosis related pain. A multivariate analysis.

OBJECTIVE: Although chronic pain in elderly patients with osteoporosis is extremely common it has rarely been addressed in pharmacotherapy studies. The efficacy and tolerability of flupirtine (CAS 56995-20-1, Trancopal Dolo) up to 600 mg/day was investigated under daily practice conditions. DESIGN: This was an open-label, multicentre, prospective, observational phase IV study on 869 patients performed in 290 practices (mainly orthopedists) throughout Germany. MAIN OUTCOME MEASURE: Decrease in pain scores on a visual analogue scale (VAS, from 0 = none to 10 = maximum) after an average 3-week therapy, and evaluation of adverse events. Multivariate analyses were performed to identify factors associated with the efficacy of pain reduction. RESULTS: 81% of patients were female; the mean age of all patients was 67 years, and the mean body mass index was 25.7 kg/m2. 81% of patients had reduced bone density, 30% had a family history of osteoporosis, and 32% had previous bone fractures. The mean daily flupirtine dose was 270 +/- 12 mg. The mean baseline pain VAS scores were 7.1 (low back pain), 5.8 (neck pain), 5.6 (shoulder-arm pain), and 6.6 (other pain). Mean pain reduction at the end of flupirtine treatment was 43% for low back pain, 44% for neck pain, 40% for shoulder-arm pain, and 40% for other pain (all reductions p < 0.05 vs. baseline). Rates of pain reduction at the various sites were closely correlated, and the efficacy of pain reduction was independent of age. The pain reduction was more pronounced in patients with recent onset of pain and with higher pain intensity at entry. Tolerability of treatment was excellent with only 2.4% of patients reporting adverse events and only 12 patients (1.4%) withdrawing from the trial. CONCLUSION: This trial performed under daily practice conditions in a large unselected sample of patients confirms the efficacy and safety of flupirtine in the treatment of chronic pain in patients with osteoporosis, independent of the age of the patient.

Aged↗
PubMed2003

Clinical outcome following combination of cutting balloon angioplasty and coronary beta-radiation for in-stent restenosis: a report from the RENO registry.

At present, vascular brachytherapy is the only efficient therapy for in-stent restenosis. Nevertheless, edge restenosis often related to geographical miss has been identified as a major limitation of the technique. The non-slippery cutting balloon has the potential to limit vascular barotraumas, which, together with low-dose irradiation at both ends of the radioactive source, are the prerequisite for geographical miss. This prospective study aimed to examine the efficacy of combining cutting balloon angioplasty and brachytherapy for in-stent restenosis. The Radiation in Europe NOvoste (RENO) registry prospectively tracked all patients who had been treated by coronary beta-radiation with the Beta-Cath System (Novoste Corporation, Brussels, Belgium) but were not included in a randomized radiation trial. A subgroup of patients with in-stent restenosis treated by cutting balloon angioplasty and coronary beta-radiation (group 1, n = 166) was prospectively defined, and clinical outcomes of patients at 6 months were compared with those of patients treated by conventional angioplasty and coronary beta-radiation (group 2, n = 712). At 6-month follow-up, there was a significant difference between groups 1 and 2 in target vessel revascularization (10.2% versus 16.6% respectively; p = 0.04) and in the incidence of major adverse clinical events (MACE) including death, myocardial infarction, and revascularization (10.8% versus 19.2%; p = 0.01). This observation was confirmed by a multivariate analysis indicating a lower risk for MACE at 6 months (odds ratio: 0.49; confidence intervals: 0.27 0.88; p = 0.02). Compared to conventional angioplasty, cutting balloon angioplasty prior to coronary beta-radiation with the Beta-Cath System seems to improve the 6-month clinical outcome in patients with in-stent restenosis.

Aged↗
PubMed2002

Comparison of cardiac output and circulatory blood volumes by transpulmonary thermo-dye dilution and transcutaneous indocyanine green measurement in critically ill patients.

OBJECTIVE: We prospectively studied the agreement between transpulmonary aortic fiberoptic-based and pulse dye densitometry (PDD) measurements of cardiac output and circulatory blood volumes. DESIGN: Prospective clinical study. SETTING: Operative ICU of a university hospital. PATIENTS: Sixteen critically ill, deeply sedated patients receiving mechanical ventilation with ARDS (n = 8), sepsis/septic shock (n = 6), subarachnoid hemorrhage (n = 1), and severe head injury (n = 1). MEASUREMENTS AND RESULTS: Each patient received a 4F aortic catheter with an integrated fiberoptic and thermistor that was connected to a computer system for automatic calculation of the transpulmonary indicator dilution (TPID) technique for the measurement of cardiac output (COTPID), intrathoracic blood volume (ITBV), and total blood volume measured by TPID technique (TBVTPID). In each patient, an indocyanine green sensor was attached to one nasal wing and connected to an analyzer for the PDD measurement of cardiac output (COPDD), central blood volume (CBV), and TBV measured by PDD (TBVPDD). For all first measurements, linear regression analysis between COTPID and COPDD revealed that COPDD = 0.63 x COTPID + 3.69 (L/min) [r = 0.64, p = 0.008]. Mean bias between both techniques was - 0.8 L/min (SD, 1.7 L/min). Correlations between ITBV/CBV (r = 0.52) and TBVTPID/TBVPDD were only moderate: TBVPDD = 0.74 x TBVTPID + 2,362 (mL) [r = 0.60, p = 0.015; mean bias, - 999 mL; SD, 1,353 mL]. Over all 55 measurements, TPID measurements were on average 11.5% (cardiac output) and 17.6% (TBV) higher than PDD measurements. The differences between both measurements ranged from - 58 to 81% (cardiac output) and from - 47 to 82% (TBV; 95% reference ranges). The main source of variation were the intraindividual differences, resulting in different peaks and trends in the patients time courses depending on which measurement method was used. CONCLUSION: PDD measurement of cardiac output and circulatory blood volumes agrees moderately with transpulmonary thermo-dye dilution technique in critically ill patients.

Adolescent↗