Biomedical subjects

Karl Wegscheider

Publications and source records attributed to Karl Wegscheider.

At least 19 recordsLinked to original sources

PubMed2006

Management of high-risk patients with hypertension and left ventricular hypertrophy in Germany: differences between cardiac specialists in the inpatient and outpatient setting.

BACKGROUND: Among patients with hypertension, those with established left ventricular hypertrophy (LVH) represent a high risk cohort with poor prognosis. We aimed to investigate differences in characteristics and health care management of such patients treated as inpatients or outpatients by cardiac specialists. METHODS: Prospective cross-sectional study in patients with hypertension and LVH who were referred to either inpatient care (rehabilitation hospitals) or to outpatient care (cardiology practices). RESULTS: A total of 6358 inpatients (59.6% males; mean age 66.6 years) and 2246 outpatients (59.5% males; mean age 63.2 years) were followed up for a mean of 23 vs. 52 days, respectively. Inpatients compared to outpatients had a significantly higher prevalence of coronary heart disease, history of stroke, renal failure or diabetes. Mean blood pressure of inpatients compared to outpatients was significantly lower both at entry (150/84 vs. 161/93 mmHg) and at end of follow-up (129/75 vs. 139/83 mmHg). After adjustment for baseline blood pressure and a propensity score, differences between out- and inpatients at end of follow-up were 8.0/5.1 mmHg in favour of inpatients. Blood pressure goals as specified by guidelines were not met by 32% of inpatients and 55% of outpatients. CONCLUSION: Inpatients had a higher rate of comorbidities and more advanced atherosclerotic disease than outpatients. Control of hypertension of inpatients was already better on admission than in outpatients, and treatment intensity in this group was also higher during the observation period. While blood pressure lowering was substantial in both groups, there were still a high proportion of patients who did not achieve treatment goals at discharge.

Adult↗

PubMed2006

Pragmatic randomized trial evaluating the clinical and economic effectiveness of acupuncture for chronic low back pain.

In a randomized controlled trial plus a nonrandomized cohort, the authors investigated the effectiveness and costs of acupuncture in addition to routine care in the treatment of chronic low back pain and assessed whether the effects of acupuncture differed in randomized and nonrandomized patients. In 2001, German patients with chronic low back pain were allocated to an acupuncture group or a no-acupuncture control group. Persons who did not consent to randomization were included in a nonrandomized acupuncture group. All patients were allowed to receive routine medical care in addition to study treatment. Back function (Hannover Functional Ability Questionnaire), pain, and quality of life were assessed at baseline and after 3 and 6 months, and cost-effectiveness was analyzed. Of 11,630 patients (mean age=52.9 years (standard deviation, 13.7); 59% female), 1,549 were randomized to the acupuncture group and 1,544 to the control group; 8,537 were included in the nonrandomized acupuncture group. At 3 months, back function improved by 12.1 (standard error (SE), 0.4) to 74.5 (SE, 0.4) points in the acupuncture group and by 2.7 (SE, 0.4) to 65.1 (SE, 0.4) points among controls (difference=9.4 points (95% confidence interval 8.3, 10.5); p<0.001). Nonrandomized patients had more severe symptoms at baseline and showed improvements in back function similar to those seen in randomized patients. The incremental cost-effectiveness ratio was euro10,526 (euros) per quality-adjusted life year. Acupuncture plus routine care was associated with marked clinical improvements in these patients and was relatively cost-effective.

Acupuncture↗

PubMed2006

Acupuncture for patients with chronic neck pain.

Acupuncture is widely used by patients with neck pain, but there is a lack of information about its effectiveness in routine medical care. The aim was to investigate the effectiveness of acupuncture in addition to routine care in patients with chronic neck pain compared to treatment with routine care alone. We performed a randomized controlled multicentre trial plus non-randomized cohort in general practices in Germany. 14,161 patients with chronic neck pain (duration >6 months). Patients were randomly allocated to an acupuncture group or a control group receiving no acupuncture. Patients in the acupuncture group received up to 15 acupuncture sessions over three months. Patients who did not consent to randomization received acupuncture treatment. All subjects were allowed to receive usual medical care in addition to study treatment. Neck pain and disability (NPAD Scale by Wheeler) after three months. Of 14,161 patients (mean age 50.9+/-13.1 years, 68% female) 1880 were randomized to acupuncture and 1886 to control, and 10,395 included into the non-randomized acupuncture group. At three months, neck pain and disability improved by 16.2 (SE: 0.4) to 38.3 (SE: 0.4); and by 3.9 (SE: 0.4) to 50.5 (SE: 0.4), difference 12.3 (p<0.001) in the acupuncture and control group, respectively. Treatment success was essentially maintained through six months. Non-randomized patients had more severe symptoms at baseline and showed higher neck pain and disability improvement compared to randomized patients. Treatment with acupuncture added to routine care in patients with chronic neck pain was associated with improvements in neck pain and disability compared to treatment with routine care alone.

Activities of Daily Living↗

PubMed2006

Determination of interobserver variability for identifying inducible left ventricular wall motion abnormalities during dobutamine stress magnetic resonance imaging.

AIMS: To determine the interobserver variability for identifying inducible left ventricular (LV) wall motion abnormalities during high-dose dobutamine/atropine stress cardiovascular magnetic resonance (DSMR). METHODS AND RESULTS: Four readers from various institutions were supplied with the image data from 150 consecutive DSMR examinations and asked to grade wall motion and image quality throughout graded doses of dobutamine infusion administered to achieve 85% of the maximum age-predicted heart rate. Inducible ischaemia was identified if more than one segment demonstrated a new or worsening LV wall motion abnormality, and significant stenosis was defined as > or =50% luminal diameter reduction by quantitative contrast coronary angiography. Seventy-seven patients (51%) had luminal narrowings > or =50%. Diagnostic performance (sensitivity, specificity, diagnostic accuracy) of all readers was 78.2, 87.0 and 82.5%. Disagreement between two readers occurred in every seventh examination. Agreement on the presence or absence of inducible wall motion abnormalities was moderate (mean kappa value 0.59, range 0.52-0.76). Diagnostic performance and disagreement were independent of the presence of luminal narrowings > or =50% or the number of diseased coronary vessels. Image quality was regarded excellent in 89.3% of standard views. CONCLUSION: In the setting of multiple observers from different institutions performing a diagnostic reading of DSMR examinations carried out at a single centre, the interobserver variability was low for identifying inducible LV wall motion abnormalities indicative of coronary arterial luminal narrowings > or =50%.

Cardiotonic Agents↗

PubMed2006

Acupuncture in patients with osteoarthritis of the knee or hip: a randomized, controlled trial with an additional nonrandomized arm.

OBJECTIVE: To investigate the effectiveness of acupuncture in addition to routine care, compared with routine care alone, in the treatment of patients with chronic pain due to osteoarthritis (OA) of the knee or hip. METHODS: In a randomized, controlled trial, patients with chronic pain due to OA of the knee or hip were randomly allocated to undergo up to 15 sessions of acupuncture in a 3-month period or to a control group receiving no acupuncture. Another group of patients who did not consent to randomization underwent acupuncture treatment. All patients were allowed to receive usual medical care in addition to the study treatment. Clinical OA severity (Western Ontario and McMaster Universities Osteoarthritis Index [WOMAC]) and health-related quality of life (Short Form 36) were assessed at baseline and after 3 months and 6 months. RESULTS: Of 3,633 patients (mean +/- SD age 61.8 +/- 10.8 years; 61% female), 357 were randomized to the acupuncture group and 355 to the control group, and 2,921 were included in the nonrandomized acupuncture group. At 3 months, the WOMAC had improved by a mean +/- SEM of 17.6 +/- 1.0 in the acupuncture group and 0.9 +/- 1.0 in the control group (3-month scores 30.5 +/- 1.0 and 47.3 +/- 1.0, respectively [difference in improvement 16.7 +/- 1.4; P < 0.001]). Similarly, quality of life improvements were more pronounced in the acupuncture group versus the control group (P < 0.001). Treatment success was maintained through 6 months. The changes in outcome in nonrandomized patients were comparable with those in randomized patients who received acupuncture. CONCLUSION: These results indicate that acupuncture plus routine care is associated with marked clinical improvement in patients with chronic OA-associated pain of the knee or hip.

Acupuncture↗

PubMed2006

Drug utilization of ezetimibe in rehabilitation centres: registry analysis of factors influencing prescription and effectiveness of treatment.

BACKGROUND: While randomized controlled trials (RCTs) generate informative data about clinical outcomes, by their nature they cannot provide information about drug utilization and factors influencing prescribing decisions. In the secondary prevention of patients with cardiac events, lipid lowering therapy with statins and other agents, such as cholesterol absorption inhibitors (CAI, e.g. ezetimibe) plays a pivotal role and is often initiated or modified in rehabilitation centres. The aims of the present study were to analyse factors that influence the prescribing decisions of physicians, and to investigate success rates of lipid lowering therapy with ezetimibe after adjustment for covariates. METHODS: Ninety-three rehabilitation centres throughout Germany documented a total of 17029 patients in cardiac rehabilitation, of which 6976 (41.6%) were prescribed a CAI. A logistic regression model with forward selection based on 31 potential regressors for ezetimibe prescription (demographics, diagnosis, risk factors etc.) was used to construct a propensity score, which reflects the inclination of physicians to prescribe CAI. This score was subsequently used for bias reduction in the comparison of co-medications and success rates. RESULTS: Nineteen variables were associated with ezetimibe prescriptions, the most important ones being total cholesterol, level of education, unstable angina pectoris and arterial hypertension. Ezetimibe was more frequently prescribed together with simvastatin and pravastatin than with other statins, and frequently together with aspirin or beta blockers, respectively. After adjustment for baseline lipid values and covariates, the probability of target level achievement appears to be substantially higher for patients on ezetimibe than for those without ezetimibe. CONCLUSIONS: Other factors than conventional risk factors contribute to the CAI prescription habits of physicians. Additional lipid level reductions due to ezetimibe are seen in routine health care corresponding to findings from randomized studies.

Aged↗

PubMed2006

Gender-specific determinants of goiter.

Despite the strong implications of differences between females and males in the risk of goiter, gender-specific issues have not been extensively addressed in investigations of goiter prevalence. The objective of our analysis was to investigate the gender-specific determinants of goiter. Between April 2001 and April 2002. A total of 853 healthy employees from 4 institutions in the western part of Germany between 18 and 68 yr of age were examined by ultrasound of the neck to determine the thyroid volume. Information on sex, age, daily use of iodized salt, the history of goiter in the first-degree relatives, type and amount of smoking, oral contraceptives, and number of pregnancies were assessed by standardized questionnaires. Gender-specific predictors of goiter prevalence were assessed by multivariate logistic regression. The overall prevalence of goiter among study subjects was 204/853 (23.9%). Goiter was present in 80 out of 370 females (21.6%) vs 124/483 (25.7%) in males. In general, smoking (p < 0.0001), increasing age (p < 0.0001), and lack of daily intake of iodized salt (p = 0.004) were associated with goiter prevalence, but not sex (p = 0.39) and family history of goiter (p = 0.16). In 370 females, parity (p = 0.004) and lack of daily intake of iodized salt (p = 0.01) were the major determinants for goiter, whereas age (p = 0.18), oral contraceptives (p = 0.82), family history of goiter (p = 0.33), and smoking (p = 0.09) did not affect goiter prevalence. In 483 males, smoking (p < 0.0001) and age (p < 0.001) affected goiter prevalence, but not family history of goiter (p = 0.39), and the iodine status failed just to reach the significant level (p = 0.08) in this analysis. Gender-specific determinants of goiter are parity and iodine status in females and smoking and increasing age in males.

Adolescent↗

PubMed2005

Noise burden and the risk of myocardial infarction.

AIMS: Chronic noise exposure is associated with adverse pathophysiological effects and may contribute to the progression of cardiovascular disease. We, therefore, determined the risk of noise for the incidence of myocardial infarction. METHODS AND RESULTS: In a case-control study, 4115 patients (3054 men, 56+/-9 years; 1061 women, 58+/-9 years) consecutively admitted to all 32 major hospitals in Berlin with confirmed diagnosis of acute myocardial infarction were enrolled from 1998 to 2001 in the Noise and Risk of Myocardial Infarction (NaRoMI) study. Controls were matched for gender, age, and hospital. In standardized interviews, information was obtained on environmental and work noise annoyance. The sound levels of environmental and work noise were assessed using traffic noise maps as proxy and international standards for workplaces, respectively. In multivariate logistic regression models, the adjusted odds ratios of noise variables were determined. There was a marginally increased risk of myocardial infarction associated with annoyance by environmental noise in women (adjusted odds ratio 1.47, 95% confidence interval 0.95-2.25, P=0.081) but not in men, and not associated with annoyance by work noise. Environmental sound levels were associated with increased risk in men and women (odds ratios 1.46, 1.02-2.09, P=0.040 and 3.36, 1.40-8.06, P=0.007) and work sound levels in men only (1.31, 1.01-1.70, P=0.045). CONCLUSION: Chronic noise burden is associated with the risk of myocardial infarction. The risk increase appears more closely associated with sound levels than with subjective annoyance. Further investigation of the gender-related risk of noise exposure may aid in improving prevention.

Case-Control Studies↗

PubMed2005

[The LISA trial-a- randomized, double-blind, placebo-controlled four-arm study of 1,000 patients with nodular goiter in Germany. Study Design and first results of feasibility].

BACKGROUND: Although levothyroxine is the mostly prescribed medicament in Germany, its therapeutic effectiveness in nodular goiter was never studied in a randomized, double-blind trial with sufficient power. Thus, in May 2004 a TSH-adapted (TSH: thyroid-stimulating hormone), randomized, doubleblind, placebo-controlled four-arm (placebo [P] vs. levothyroxine [T] vs. iodine [I] vs. levothyroxine + iodine [TI]) multicenter study was started in Germany (LISA study). PATIENTS AND METHODS: Based on former retrospective and prospective studies, it was calculated that a sufficient statistical power (> 80%) would be achieved with 250 patients in each arm. The primary endpoint of the trial is the 1-year change of ultrasonographically measured total volume of all nodules. Secondary criteria are volume of goiter, number of nodules, and echogenic structure of nodules. While the study is kept strictly double-blind, the dose of levothyroxine in the T and TI groups is adapted once according to 3-month TSH measurements (target range 0.2-0.8 mU/l). RESULTS: Up to now (1 year after beginning), 305 patients have been included. TSH adaptation could be performed without compromising the double-blind character of the study with good results: about 90% of the patients reached the TSH target range. CONCLUSION: Unblinded results are to be expected in 2007.

Adolescent↗

PubMed2005

ST resolution in a single electrocardiographic lead: a simple and accurate predictor of cardiac mortality in patients with fibrinolytic therapy for acute ST-elevation myocardial infarction.

BACKGROUND: The extent of ST-segment resolution in the 12-lead electrocardiograph (ECG) obtained early after reperfusion therapy in patients with ST-elevation myocardial infarction (MI) has been shown to predict short- and long-term mortalities. To improve the ease of this method in clinical practice, we sought to evaluate the optimal cutoffs and the prognostic value of ST resolution (STR) measured in a single ECG lead. METHODS: In conjunction with the Intravenous nPA for the Treatment of Infarcting Myocardium Early (InTIME)-2 study, in which patients with an ST-elevation MI of <6 hours' duration were treated with alteplase or lanoteplase, 12-lead ECGs were obtained at baseline and 90 minutes after the start of fibrinolytic therapy in 3030 patients. RESULTS: There was a close correlation between the extent of the sum STR and single-lead ST-elevation resolution ( r = 0.94). The optimal cutoffs for definition of single-lead complete, partial, and no-STR groups were 70% and 50% for anterior infarcts and 70% and 20% for inferior infarcts. The cardiac 30-day mortality rates for the 2 sets of risk groups by sum or single-lead STR were as follows: no resolution, 9.5% vs 10.3%; partial resolution, 5.0% vs 3.6%; complete resolution, 2.0% vs 1.2%. The predictive power was significantly better for single-lead STR. CONCLUSIONS: ST resolution obtained in a single lead is an easy and accurate prognosticator of cardiac 30-day mortality in patients with ST-elevation MI. It is therefore useful for early identification of low- and high-risk subgroups after fibrinolysis and as a surrogate end point in clinical trials.

Aged↗

PubMed2005

Outcome and costs of homoeopathic and conventional treatment strategies: a comparative cohort study in patients with chronic disorders.

OBJECTIVES: To evaluate the effectiveness of homoeopathy versus conventional treatment in routine care. DESIGN: Comparative cohort study. SETTING: Patients with selected chronic diagnoses were enrolled in medical practice. INTERVENTIONS: Conventional treatment or homeopathy. OUTCOME MEASURES: Severity of symptoms assessed by patients and physicians (visual rating scale, 0-10) at baseline, 6 and 12 months and costs. RESULTS: The analyses of 493 patients (315 adults, 178 children) indicated greater improvement in patients' assessments after homoeopathic versus conventional treatment (adults: homeopathy from 5.7 to 3.2; conventional, 5.9-4.4; p=0.002; children from 5.1 to 2.6 and from 4.5 to 3.2). Physician assessments were also more favourable for children who had received homoeopathic treatment (4.6-2.0 and 3.9-2.7; p<0.001). Overall costs showed no significant differences between both treatment groups (adults, 2155 versus 2013, p=0.856; children, 1471 versus 786, p=0.137). CONCLUSION: Patients seeking homoeopathic treatment had a better outcome overall compared with patients on conventional treatment, whereas total costs in both groups were similar.

Adolescent↗

PubMed2005

Increased use of hip protectors in nursing homes: economic analysis of a cluster randomized, controlled trial.

OBJECTIVES: To assess the cost-efficacy of an intervention program aimed at reducing hip fractures. DESIGN: Economic evaluation within an 18-month cluster randomized trial. SETTING: Forty-nine nursing homes in Hamburg, Germany. PARTICIPANTS: Residents with a high risk of falling (intervention group (IG), n=459; control group (CG), n=483). INTERVENTION: Education session for nurses, who subsequently educated residents, and provision of three hip protectors per resident. CG care was optimized by providing brief information to nurses about hip protectors and providing two protectors per nursing home for demonstration purposes. MEASUREMENTS: Main outcomes were hip fractures, costs, and incremental cost-effectiveness ratio (ICER). RESULTS: The intervention was effective in reducing hip fractures (21 in the IG vs 42 in the CG) and resulted in a cost difference of 51 dollars per participant in favor of the CG (95% confidence interval covering cost saving of 242 dollars to cost expense of 325 dollars). Costs per additional hip fracture avoided were 1,234 dollars. Sensitivity analyses aimed at investigating robustness of the results to a real practice implementation scenario resulted in ICERs varying from 439 dollars to 1,693 dollars. Taking into account lower hip protector reimbursement levels, the intervention program would be cost saving (break-even point within the base case analysis=22 dollars per hip protector). CONCLUSION: A program consisting of education and provision of hip protectors might produce a slight increase in costs or might even be cost saving if the price of the hip protector could be decreased.

Aged↗

PubMed2005

Differential outcome after intracoronary radiation therapy is related to a simple classification based on lesion length and reference diameter.

OBJECTIVE: We sought to develop a prognostic lesion classification based on simple angiographic parameters, lesion length and reference diameter that predicts differential outcome in patients undergoing intracoronary radiation. METHODS AND RESULTS: Three types of lesions were identified: Type A characterized by lesion length less than or equal to 30 mm, reference diameter > 2.5 mm to less than or equal to 4.0 mm (short lesion: normal diameter), Type B by lesion length less than or equal to 30 mm, reference diameter less than or equal to 2.5 mm or > 4 mm (short lesion: extreme diameter), and Type C by lesion length > 30 mm (long lesion). A total of 1,151 lesions (77.7% in-stent restenosis) in 1,098 consecutive patients undergoing brachytherapy were classified into these 3 lesion types. Overall, 79.9%, 10.3% and 9.8% patients met the criteria for Type A, B and C lesions. While the in-hospital major adverse cardiac event (MACE) rate was 1.4%, 3.6% and 3.8% (p = 0.026), the 6-month MACE rate was 16.1%, 22.5% and 32.1% (p < 0.001), the angiographic restenosis rate was 21.3%, 32.4% and 42.4% (p < 0.001), and the late thrombosis rate was 4.1%, 9.0% and 11.3%, (p < 0.001) in Type A, B and C lesions, respectively. Consequently, with increasing lesion severity, 3 risk groups with low, medium and high risk were defined. Multivariate analysis showed that Type B and C lesions were independent predictors of 6-month MACE (OR, 1.5 and 1.9, respectively). CONCLUSION: The proposed novel and easily applicable lesion classification effectively predicts early and medium term outcome, and may be used for appropriate therapeutic decision making in patients undergoing brachytherapy.

Aged↗

PubMed2005

[Which therapy comparisons are fair?].

Two approaches to treatment comparison are discussed: According to the principles of evidence-based medicine (EBM), methods of comparison are graded on a study-type scale, with randomised controlled trials and meta-analyses of randomised trials ranking at the highest levels. In contrast, cognition-based medicine (CBM) is based on the physician's recognition of causality of a treatment in the individual patient. A careful examination of potential sources of misinterpretation reveals that none of these approaches enforces fairness of comparisons: Randomised controlled trials often cannot be generalised, meta-analyses are based on retrospectively-selected studies and exposed to the ecological fallacy, and CBM approaches are not sufficiently controlled. Thus, fairness does not result from the choice of a perfect method or from the tailoring of the evaluation method to the therapy under examination. Rather, a complementary approach of different evaluation methods with all treatments to be compared should be used, with open discussion of strengths and weaknesses of the approaches applied in each particular case.

Clinical Medicine↗

PubMed2004

[Bioequivalence of L-thyroxine tablets and a liquid L-thyroxine solution in the treatment of hypothyroid patients].

BACKGROUND AND PURPOSE: The therapeutic equivalence of L-thyroxine (T(4)) tablets and a new liquid T(4) solution was investigated in patients with hypothyroidism. PATIENTS AND METHODS: The study was unblinded, multicentric and prospective: 136 patients (with autoimmune thyroiditis, after thyroid surgery and/or after therapy with radioiodine), who had been treated with T(4) tablets, were switched to a treatment with a liquid T(4) solution (containing 5 microg T(4) per drop) in the same dosage. Thyrotropin (TSH) was measured after 1, 2, 3, and 6 months; the dose of the T4 solution was adapted to obtain a midnormal TSH level. RESULTS: The T(4) dose remained constant during the 6 months. Dose adaptations were necessary in 19-23% of patients at the different timepoints, with dose reductions and increases, respectively, becoming equally frequently necessary. The mean TSH level was 0.79 mU/l at the beginning and 0.81 mU/l after 6 months; similarly, the mean levels of free triiodothyronine (fT(3)) and free thyroxine (fT(4)) were equivalent. The liquid T(4) solution was well tolerated: adverse events were noted in three patients (1.8%); one serious adverse event (thyroid carcinoma) showed no correlation to the treatment. CONCLUSION: T(4) tablets and liquid T(4) solution have been proven to be therapeutically equivalent; the use of liquid T(4) solutions will have advantages in the treatment of hypothyroid infants or elderly patients with disturbed swallowing, patients who need a differentiated titration of the T(4) dose, as well as patients with an allergy against inactive ingredients of L-thyroxine tablets.

Adolescent↗

PubMed2004

Intracoronary brachytherapy, a promising treatment option for diabetic patients: Results from a European multicenter registry (RENO).

Despite advances in the interventional treatment of coronary disease, diabetics still have double the case fatality rate as nondiabetics. The purpose of this analysis from the Radiation in Europe With Novoste (RENO) registry was to assess the clinical and angiographic 6-month outcome of diabetic patients in comparison to nondiabetic patients after localized beta-radiation. A total of 1,098 patients (83.8% with in-stent restenosis) treated with the Novoste Beta-Cath system in Europe were enrolled in the RENO registry. Diabetes was, irrespective of the type of lesion treated, no significant risk factor for major adverse cardiac events or target vessel revascularization. Individuals with diabetes (n = 256) and without diabetes (n = 833) displayed no significant differences concerning clinical or angiographic endpoints. Vascular brachytherapy appears to be the first technique to even out the increased risk of diabetic patients undergoing percutaneous coronary interventions in the routine clinical setting. Thus, intracoronary brachytherapy represents a promising treatment option for diabetic patients.

Brachytherapy↗

PubMed2004

Economic evaluation of a compliance-enhancing intervention in patients with hypercholesterolemia: design and baseline results of the Open Label Primary Care Study: Rosuvastatin Based Compliance Initiatives To Achievements of LDL Goals (ORBITAL) study.

BACKGROUND: Previous studies investigating the effectiveness of compliance programs in patients with cardiovascular risk factors have been inconclusive and have not included economic analyses. The primary aim of this Open Label Primary Care Study: Rosuvastatin Based Compliance Initiatives To Achievements of LDL Goals (ORBITAL) study is to determine the long-term cost-effectiveness of a compliance-enhancing intervention in patients with hypercholesterolemia (HC). Secondary objectives include the assessment of compliance, cardiovascular events, and health-related quality of life. STUDY DESIGN: A total of 7598 patients (56% men, age 60 +/- 10 years, and 44% women, 64 +/- 10 years) with HC requiring statin therapy according to the Second Joint European Guidelines were recruited at presentation to 1961 primary care physicians in Germany. Patients were randomized to rosuvastatin therapy with or without a compliance-enhancing program (including standardized contacts between the study center and patients, 9 mailings, 6 telephone calls, and access to a Web page and hotline) for 12 months. Following the intervention phase, there will be a 24-month observational period with patients receiving usual care. Baseline and 6-monthly follow-up assessments are to be obtained from patients and their physicians using standardized questionnaires to evaluate medical and economic parameters. Cumulative direct and indirect disease-related costs (including resource utilization for ambulatory, hospital, rehabilitative, and nursing care, medication, physiotherapy, and transportation, and loss of productivity) will be compared applying a societal perspective. CONCLUSIONS: The results of this ORBITAL study will provide a basis to develop cost-effective compliance strategies and eventually improve medical care for patients with HC.

Aged↗

PubMed2004

Out-of-hospital delays in patients with acute stroke.

STUDY OBJECTIVE: We determine the interval between stroke symptom onset and time to emergency department (ED) arrival and factors associated with delays in presentation. METHODS: All patients with acute stroke presenting at 4 hospitals in a metropolitan area and consenting to an interview were prospectively included over a 12-month period, excluding patients with presentation greater than 7 days after onset of symptoms and discharge or death within 24 hours after ED arrival. Initially, National Institutes of Health Stroke Scale and times of symptom onset and of ED arrival were registered by a neurologist. Sociodemographic factors and data about the course of events were obtained by standardized interview conducted with patients or proxies. In a multivariable analysis, an extended Cox proportional hazards model was used, and hazard ratios were determined. RESULTS: Primary analyses were performed for 558 interviewed patients (mean age 66.8+/-13.5 years, 45% female patients) with confirmed stroke; 452 (81%) patients had a known onset of symptoms. Median interval between symptom onset and ED arrival was 151 minutes (range 5 to 9,590 minutes). Transport by emergency medical services (adjusted hazard ratio 0.28 [95% confidence interval (CI) 0.19 to 0.41]), increasing age (hazard ratio 0.99 [95% CI 0.98 to 0.99]), greater stroke severity (National Institutes of Health Stroke Scale score; hazard ratio 0.93 [95% CI 0.90 to 0.96]), having transient ischemic attack rather than persistent symptoms (hazard ratio 0.32 [95% CI 0.22 to 0.46]) and symptoms considered urgent (hazard ratio 0.68 [95% CI 0.55 to 0.84]) were the factors most strongly associated with a shorter out-of-hospital interval. CONCLUSION: There are considerable delays between stroke symptom onset and ED arrival. Programs to improve awareness of patients with stroke to seek medical help immediately may reduce unnecessary delays to ED arrival.

Aged↗