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Empirical analysis shows reduced cost data collection may be an efficient method in economic clinical trials
Seidl Hildegard,Meisinger Christa,Wende Rupert,Holle Rolf
BMC Health Services Research , 2012, DOI: 10.1186/1472-6963-12-318
Abstract: Background Data collection for economic evaluation alongside clinical trials is burdensome and cost-intensive. Limiting both the frequency of data collection and recall periods can solve the problem. As a consequence, gaps in survey periods arise and must be filled appropriately. The aims of our study are to assess the validity of incomplete cost data collection and define suitable resource categories. Methods In the randomised KORINNA study, cost data from 234 elderly patients were collected quarterly over a 1-year period. Different strategies for incomplete data collection were compared with complete data collection. The sample size calculation was modified in response to elasticity of variance. Results Resource categories suitable for incomplete data collection were physiotherapy, ambulatory clinic in hospital, medication, consultations, outpatient nursing service and paid household help. Cost estimation from complete and incomplete data collection showed no difference when omitting information from one quarter. When omitting information from two quarters, costs were underestimated by 3.9% to 4.6%. With respect to the observed increased standard deviation, a larger sample size would be required, increased by 3%. Nevertheless, more time was saved than extra time would be required for additional patients. Conclusion Cost data can be collected efficiently by reducing the frequency of data collection. This can be achieved by incomplete data collection for shortened periods or complete data collection by extending recall windows. In our analysis, cost estimates per year for ambulatory healthcare and non-healthcare services in terms of three data collections was as valid and accurate as a four complete data collections. In contrast, data on hospitalisation, rehabilitation stays and care insurance benefits should be collected for the entire target period, using extended recall windows. When applying the method of incomplete data collection, sample size calculation has to be modified because of the increased standard deviation. This approach is suitable to enable economic evaluation with lower costs to both study participants and investigators. Trial registration The trial registration number is ISRCTN02893746
Uric Acid Is More Strongly Associated with Impaired Glucose Regulation in Women than in Men from the General Population: The KORA F4-Study
Christa Meisinger, Angela D?ring, Doris St?ckl, Barbara Thorand, Bernd Kowall, Wolfgang Rathmann
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0037180
Abstract: Objective High serum uric acid (UA) levels are associated with the metabolic syndrome, type 2 diabetes and cardiovascular disease. It is largely unknown whether there are gender-specific differences regarding the association between UA and prediabetic states. We examined the possible association between UA levels and known as well as newly diagnosed diabetes (NDD), isolated impaired fasting glucose (i-IFG), isolated impaired glucose tolerance (i-IGT), and combined IFG/IGT in a population-based sample of 32-to-81-year-old men and women. Research Design and Methods An oral glucose tolerance test was carried out in all 2,740 participants without known diabetes of the Cooperative Health Research in the Region of Augsburg (KORA) F4 Study conducted between 2006 and 2008 in Southern Germany. Serum UA was analysed by the uricase method. Results In women after multivariable adjustment the associations between UA and i-IFG (OR 1.57, 95% CI 1.15–2.14), IFG/IGT (OR 1.52, 1.07–2.16), NDD (OR 1.67, 95% CI 1.28–2.17), and known diabetes (OR 1.47, 95% CI 1.18–1.82) remained significant, but the association with i-IGT (OR 1.14, 95% CI 0.95–1.36) lost significance. In contrast in men, after multivariable adjustment there was only a significant association between UA levels and i-IFG (OR 1.49, 95% CI 1.21–1.84), all other associations were non-significant (i-IGT: OR 1.09, IFG/IGT: OR 1.06, NDD: OR 0.91, known diabetes: OR 1.04; all p-values>0.05). Conclusions Serum UA concentrations were associated with different categories of impaired glucose regulation in individuals from the general population, particularly in women. Further studies investigating the role of UA in the development of derangements in glucose metabolism are needed.
Reproductive Factors and Serum Uric Acid Levels in Females from the General Population: The KORA F4 Study
Doris St?ckl, Angela D?ring, Barbara Thorand, Margit Heier, Petra Belcredi, Christa Meisinger
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0032668
Abstract: Objective Hyperuricemia is associated with an increased risk of metabolic and cardiovascular diseases. There are pronounced sex differences in the levels of uric acid. It is largely unknown whether or not reproductive parameters which induce hormonal changes are responsible for this. We examined if there are associations between reproductive parameters and uric acid levels in a female population-based sample. Methods In this cross-sectional analysis, data of 1530 women aged 32 to 81 years participating in the KORA F4 study, conducted between 2006 and 2008 in Southern Germany were used. Reproductive parameters were obtained by standardized interviews. Uric acid levels were tested by the uricase method. The whole study sample and stratified in pre- and postmenopausal women was analyzed. Results Menopausal status and earlier age at menarche were associated with higher serum uric acid levels (age-adjusted: p-values 0.003, <0.001 respectively; after multivariable adjustment, including BMI: p-values 0.002, 0.036). A history of oral contraceptive use showed an association with uric acid levels only after multivariable adjustment (p-value 0.009). Hot flushes showed an association with uric acid levels only after age-adjustment (p-value 0.038), but lost significance after adding other confounders. Other reproductive factors, including parity, current or ever use of hormone replacement therapy, current use of oral contraceptives, hysterectomy, bilateral oophorectomy, or depressive mood related to menopausal transition were not associated with uric acid levels. Conclusions Postmenopausal status, earlier age at menarche and a history of oral contraceptive use were independently associated with higher serum uric acid concentrations in women from the general population. Further studies, especially longitudinal population-based studies investigating the relationship of female reproductive parameters with uric acid levels are necessary to confirm our findings.
Socio-economic differences in life expectancy among persons with diabetes mellitus or myocardial infarction: results from the German MONICA/KORA study
Laura Perna, Uta Thien-Seitz, Karl-Heinz Ladwig, Christa Meisinger, Andreas Mielck
BMC Public Health , 2010, DOI: 10.1186/1471-2458-10-135
Abstract: The dataset consists of 13,427 participants (6,725 men, 6,702 women) aged 25-74 years, recruited in the region of Augsburg in Germany through three independent cross-sectional representative surveys conducted in 1984/85, 1989/90, 1994/95, with a mortality follow up in 1998 and 2002. We use a parametric model for the survival function based on the Weibull distribution, in which the hazard function is described in terms of two parameters. We estimate these parameters with a maximum likelihood method that takes into account censoring and data truncation.The difference in LE between the lowest and the highest socio-economic group is estimated to be 3.79 years for men and 4.10 years for women. Diabetes mellitus reduces LE of men from the upper three income quartiles by 4.88 years, and LE of men belonging to the lowest income quartile by 7.97 years. For women, the corresponding figures are 5.79 and 5.72 years. Myocardial infarction reduces LE of men and women from the upper three income quartiles by 3.65 and 3.75 years, respectively, and LE of men and women belonging to the lowest income quartile by 5.11 and 10.95 years, respectively.This study shows that in Germany the differences in LE by socio-economic status are comparable to those found in other European countries, and that these differences seem to increase when diabetes mellitus or myocardial infarction is present. The statistical method used allows estimates of LE with relatively small datasets.Life expectancy (LE) is an estimate of the average number of years that a person can expect to live. It can be defined both at birth and at any later age. It reflects the mortality rates of a population as a function of age for the year for which it is calculated. As such, it is only dependent on the observed average age-specific death rates and it should not be viewed as a reflection of future mortality rates [1].From a public health perspective, LE at birth represents a fundamental measure of a population's state of gener
Living alone is a risk factor for mortality in men but not women from the general population: a prospective cohort study
Ulla Kandler, Christa Meisinger, Jens Baumert, Hannelore L?wel, the KORA Study Group
BMC Public Health , 2007, DOI: 10.1186/1471-2458-7-335
Abstract: We analysed data from the population-based MONICA/KORA cohort study including 3596 men and 3420 women of at least one of three surveys carried out between 1984 and 1995 in the region of Augsburg, Germany. They were between 45 and 74 years old and were followed-up until 31 December 2002. During follow-up 811 men and 388 women died. Cox proportional hazards analysis was used to examine the association between living alone and mortality.Altogether 260 men (7%) and 620 women (18%) were living alone at baseline. Men, who lived alone, were less well educated, had fewer children and friends, and they smoked significantly more than other men. Women, living alone, were also significantly more often current smokers and had less children and friends, but they were more often better educated than cohabitating women. The latter group showed a higher proportion of obese and hypertensive women. Men living alone had a twofold risk to die after multivariable adjustment (hazard ratio = 1.96; p < 0.0001; 95% confidence interval 1.56–2.46). This was not the case for women.Living alone is an independent risk factor for mortality in men. It is unclear whether living alone causes an increased mortality or whether predisposition for increased mortality is responsible for men living alone.According to the German micro-census 2004, almost 40 percent of the households are so-called "single-person households" (Statistisches Bundesamt 2005). They are defined as households in which one person is living alone. Living alone is often equated with social isolation, which is supposed to be associated with an increased risk of mortality [1-7]. Recently, Schmaltz et al. used living alone as a proxy for social isolation and found an increased post-acute myocardial infarction mortality for persons who live alone. Kharicha et al. reported a significant association between living alone and the risk of social isolation, when they examined the clinical significance of living alone [8]. Routasalo et al invest
Nurse-based case management for aged patients with myocardial infarction: study protocol of a randomized controlled trial
Inge Kirchberger, Christa Meisinger, Hildegard Seidl, Rupert Wende, Bernhard Kuch, Rolf Holle
BMC Geriatrics , 2010, DOI: 10.1186/1471-2318-10-29
Abstract: The KORINNA (Koronarinfarkt Nachbehandlung im Alter) study is designed as a single-center randomized two-armed parallel group trial. KORINNA is conducted in the framework of KORA (Cooperative Health Research in the Region of Augsburg). Patients assigned to the intervention group receive a nurse-based follow-up for one year including home visits and telephone calls. Key elements of the intervention are to detect problems or risks, to give advice regarding a broad range of aspects of disease management and to refer to the general practitioner, if necessary. The control group receives usual care. Twelve months after the index hospitalization all patients are re-assessed. The study has started in September 2008. According to sample size estimation a total number of 338 patients will be recruited. The primary endpoint of the study is time to first readmission to hospital or out of hospital death. Secondary endpoints are functional status, participation, quality of life, compliance, and cost-effectiveness of the intervention. For the economic evaluation cost data is retrospectively assessed by the patients. The incremental cost-effectiveness ratio (ICER) will be calculated.The KORINNA study will contribute to the evidence regarding the effectiveness of case management programmes in aged people with MI. The results can be an important basis for clinicians, administrators and health policy makers to decide on the provision of high-quality care to older patients with CHD.ISRCTN02893746The aging of the population and the increasing prevalence of chronic diseases imply great challenges to the health systems of developed countries. CHD is the leading cause of mortality and morbidity in the industrialized world. The treatment of acute myocardial infarction (MI) has improved dramatically over the last 10 to 20 years and nowadays, aged patients with an acute MI are receiving treatment that had been limited to mainly younger patients about a decade ago [1]. Subsequently, the number
Albuminuria, cardiovascular risk factors and disease management in subjects with type 2 diabetes: a cross sectional study
Christa Meisinger, Margit Heier, Rüdiger Landgraf, Michael Happich, H-Erich Wichmann, Wolfgang Piehlmeier
BMC Health Services Research , 2008, DOI: 10.1186/1472-6963-8-226
Abstract: The presented data were derived from the 'KORA Augsburg Diabetes Family Study', conducted between October 2001 and September 2002. Participants were adults aged 29 years and older with previously diagnosed type 2 diabetes (n = 581). Microalbuminuria was defined as an albumin-creatinine ratio of 30 to 300 mg/g, and macroalbuminuria as an albumin-creatinine ratio of more than 300 mg/g.Microalbuminuria was revealed in 27.2% and macroalbuminuria in 9.0% of the 581 included diabetic persons. Multivariable regression analysis identified HBA1c, duration of diabetes, systolic blood pressure, serum creatinine, smoking and waist circumference as independent risk factors associated with albuminuria (micro- or macroalbuminuria). Relatively few persons with type 2 diabetes achieved treatment targets of HbA1c < 7% (46.6%), total cholesterol < 200 mg/dl (44.1%), and LDL cholesterol < 100 mg/dl (16.0%). Optimal HDL cholesterol values (> 45 mg/dl in men, > 55 mg/dl in women) were found in 55.8%, and blood pressure values < 130 and < 85 mmHg in 31.3% of the personsAlbuminuria is common among German persons with known type 2 diabetes. Despite evidence-based guidelines, only a small proportion of type 2 diabetic persons achieved the recommended levels of glycemic control and control of cardiovascular risk factors.Throughout the world, the number of people developing type 2 diabetes mellitus is increasing dramatically. At the present time the disease affecting around 171 million people worldwide and the World Health Organization predicts that this number will rise to 366 million by 2030 [1]. Consequently, the number of people developing diabetes-related complications will increase. Microalbuminuria is a common complication of diabetes and appears to be a strong predictor of subsequent development of overt diabetic nephropathy [2], which is the leading cause of end-stage renal disease in the western world [3,4]. Without any intervention, among type 2 diabetic patients about 20–40% with m
Associations between Blood Glucose and Carotid Intima-Media Thickness Disappear after Adjustment for Shared Risk Factors: The KORA F4 Study
Bernd Kowall, Nina Ebert, Cornelia Then, Joachim Thiery, Wolfgang Koenig, Christa Meisinger, Wolfgang Rathmann, Jochen Seissler
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0052590
Abstract: Objective The association between blood glucose and carotid intima-media thickness (CIMT) is considered to be established knowledge. We aimed to assess whether associations between different measures of glycaemia and CIMT are actually independent of anthropometric variables and metabolic risk factors. Moreover, we checked published studies for the adjustment for shared risk factors of blood glucose and CIMT. Methods Fasting glucose, 2-hour glucose, HbA1c, and CIMT were measured in 31-81-years-old participants of the population-based Cooperative Health Research in the Region of Augsburg (KORA) F4 study in Southern Germany (n = 2,663). CIMT was assessed according to the Rotterdam protocol. Linear and logistic regression models with adjustment for age, sex, anthropometric measures, hypertension, and dyslipidaemia were fitted to assess the association between continuous measures of glycaemia, and categories of glucose regulation, respectively, with CIMT. Results We found a 0.10 mm increase (95%-confidence interval: 0.08–0.12) in CIMT in subjects with compared to subjects without diabetes in crude analysis. This increase was not significant in age-sex adjusted models (p = 0.17). Likewise, neither impaired fasting glucose (p = 0.22) nor impaired glucose tolerance (p = 0.93) were associated with CIMT after adjustment for age, sex, and waist circumference. In multivariable adjusted models, age, sex, hypertension, waist circumference, HDL and LDL cholesterol, but neither fasting glucose nor 2-hour glucose nor HbA1c were associated with elevated CIMT. Literature findings are inconclusive regarding an independent association of glucose levels and CIMT. Conclusion CIMT is highly dependent on traditional cardiovascular risk factors, but no relationships between blood glucose and CIMT were found after adjustment for age, sex, and anthropometric variables.
Association between Markers of Fatty Liver Disease and Impaired Glucose Regulation in Men and Women from the General Population: The KORA-F4-Study
Ina-Maria Rückert,Margit Heier,Wolfgang Rathmann,Sebastian E. Baumeister,Angela D?ring,Christa Meisinger
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0022932
Abstract: To investigate whether the elevated liver enzymes gamma-glutamyltransferase (GGT), glutamate-pyruvate transaminase (GPT), glutamate-oxalacetate transaminase (GOT) and alkaline phosphatase (AP) and non-alcoholic fatty liver disease (NAFLD) respectively are independently associated with pre-diabetic states, namely impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) or known and newly diagnosed diabetes (NDD), in men and women from the general German population.
Association of daily tar and nicotine intake with incident myocardial infarction: Results from the population-based MONICA/KORA Augsburg Cohort Study 1984 - 2002
Qiu-Li Zhang, Jens Baumert, Karl-Heinz Ladwig, H-Erich Wichmann, Christa Meisinger, Angela D?ring
BMC Public Health , 2011, DOI: 10.1186/1471-2458-11-273
Abstract: The study was based on 4,099 men and 4,197 women participating in two population-based MONICA Augsburg surveys between 1984 and 1990 and followed up within the KORA framework until 2002. During a mean follow-up of 13.3 years, a number of 307 men and 80 women developed an incident MI event. Relative risks were calculated as hazard ratios (HRs) estimated by Cox proportional hazards models adjusted for cardiovascular risk factors.In the present study, male regular smokers consumed on average more cigarettes per day than female regular smokers (20 versus 15) and had a higher tar and nicotine intake per day. In men, the MI risk compared to never-smokers increased with higher tar intake: HRs were 2.24 (95% CI 1.40-3.56) for 1-129 mg/day, 2.12 (95% CI 1.37-3.29) for 130-259 mg/day and 3.01 (95% CI 2.08-4.36) for ≥ 260 mg/day. In women, the corresponding associations were comparable but more pronounced for high tar intake (HR 4.67, 95% CI 1.76-12.40). Similar associations were observed for nicotine intake.The present study based on a large population-based sample adds important evidence of cumulative effects of tar and nicotine intake on the risk of incident MI. Even low or medium tar and nicotine intake revealed substantial risk increases as compared to never-smokers. Therefore, reduction of tar and nicotine contents in cigarettes cannot be seen as a suitable public health policy in preventing myocardial infarction.Cigarette smoking is a central issue in public health policy as it has been shown to be associated with an elevated risk of various cardiovascular diseases and types of cancer [1,2]. Smoking has been determined as one of the most important risk factors for myocardial infarction (MI) [3-5], but it was shown that smoking cessation can reduce this risk [6]. Many countries and international agencies have made great efforts to change smoking behaviour and to encourage smokers to quit smoking, e.g. by preventing initiation of tobacco use, promoting cessation among ado
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