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Health-related quality of life in patients with severe COPD hospitalized for exacerbations - comparing EQ-5D, SF-12 and SGRQ
Petra Menn, Norbert Weber, Rolf Holle
Health and Quality of Life Outcomes , 2010, DOI: 10.1186/1477-7525-8-39
Abstract: EQ-5D, SF-12 and SGRQ were obtained from COPD patients with GOLD stage III and IV hospitalized for an acute exacerbation both at admission and discharge. To assess the instruments' properties, utility values were calculated for EQ-5D and SF-12, and a total score was derived from the SGRQ.Mean utilities ranged from 0.54 (SF-12, stage IV) to 0.62 (EQ-5D, stage III) at admission, and from 0.58 (SF-12, stage IV) to 0.84 (EQ-5D, stage III) at discharge. Completeness was best for EQ-5D and SGRQ, while no utility value for the SF-12 could be calculated for more than 30%. For SGRQ subscales, the minimal score occurred in up to 11% at admission, while full health was observed for the EQ-5D at discharge in 13%. Sensitivity to change was generally good, whereas discrimination between COPD stages was low for the EQ-5D.Acute exacerbations seriously impair health status and quality of life. The EQ-5D is generally suitable to measure HrQoL in exacerbations of severe COPD, although the high proportion of patients reporting full health at discharge poses a problem. The main issue with the SF-12 is the high proportion of missing values in a self-assessed setting. Properties of the SGRQ were satisfactory. However, since no utility values can be derived from this disease-specific instrument, it is not suitable for cost-utility analyses in health-economic evaluations.Chronic obstructive pulmonary disease (COPD) is a common chronic condition that severely affects patients' health-related quality of life (HrQoL). With a prevalence of more than 13% in those aged 40 years and older in Germany, COPD is one of the most frequent causes of morbidity and mortality [1]. Exacerbations, acute worsenings of symptoms, have serious health consequences and are associated with an increased decline in lung function, hospitalization and even death [2]. It has been shown that on average, patients with severe or very severe COPD experience about 2.7 exacerbations per year, more than 10% of which require hos
Specific guidelines for assessing and improving the methodological quality of economic evaluations of newborn screening
Langer Astrid,Holle Rolf,John Jürgen
BMC Health Services Research , 2012, DOI: 10.1186/1472-6963-12-300
Abstract: Background Economic evaluation of newborn screening poses specific methodological challenges. Amongst others, these challenges refer to the use of quality adjusted life years (QALYs) in newborns, and which costs and outcomes need to be considered in a full evaluation of newborn screening programmes. Because of the increasing scale and scope of such programmes, a better understanding of the methods of high-quality economic evaluations may be crucial for both producers/authors and consumers/reviewers of newborn screening-related economic evaluations. The aim of this study was therefore to develop specific guidelines designed to assess and improve the methodological quality of economic evaluations in newborn screening. Methods To develop the guidelines, existing guidelines for assessing the quality of economic evaluations were identified through a literature search, and were reviewed and consolidated using a deductive iterative approach. In a subsequent test phase, these guidelines were applied to various economic evaluations which acted as case studies. Results The guidelines for assessing and improving the methodological quality of economic evaluations in newborn screening are organized into 11 categories: “bibliographic details”, “study question and design”, “modelling”, “health outcomes”, “costs”, “discounting”, “presentation of results”, “sensitivity analyses”, “discussion”, “conclusions”, and “commentary”. Conclusions The application of the guidelines highlights important issues regarding newborn screening-related economic evaluations, and underscores the need for such issues to be afforded greater consideration in future economic evaluations. The variety in methodological quality detected by this study reveals the need for specific guidelines on the appropriate methods for conducting sound economic evaluations in newborn screening.
Longitudinal beta regression models for analyzing health-related quality of life scores over time
Hunger Matthias,D?ring Angela,Holle Rolf
BMC Medical Research Methodology , 2012, DOI: 10.1186/1471-2288-12-144
Abstract: Background Health-related quality of life (HRQL) has become an increasingly important outcome parameter in clinical trials and epidemiological research. HRQL scores are typically bounded at both ends of the scale and often highly skewed. Several regression techniques have been proposed to model such data in cross-sectional studies, however, methods applicable in longitudinal research are less well researched. This study examined the use of beta regression models for analyzing longitudinal HRQL data using two empirical examples with distributional features typically encountered in practice. Methods We used SF-6D utility data from a German older age cohort study and stroke-specific HRQL data from a randomized controlled trial. We described the conceptual differences between mixed and marginal beta regression models and compared both models to the commonly used linear mixed model in terms of overall fit and predictive accuracy. Results At any measurement time, the beta distribution fitted the SF-6D utility data and stroke-specific HRQL data better than the normal distribution. The mixed beta model showed better likelihood-based fit statistics than the linear mixed model and respected the boundedness of the outcome variable. However, it tended to underestimate the true mean at the upper part of the distribution. Adjusted group means from marginal beta model and linear mixed model were nearly identical but differences could be observed with respect to standard errors. Conclusions Understanding the conceptual differences between mixed and marginal beta regression models is important for their proper use in the analysis of longitudinal HRQL data. Beta regression fits the typical distribution of HRQL data better than linear mixed models, however, if focus is on estimating group mean scores rather than making individual predictions, the two methods might not differ substantially.
Body weight changes and outpatient medical care utilisation: Results of the MONICA/KORA cohorts S3/F3 and S4/F4 [Ver nderungen des K rpergewichts und Inanspruchnahme ambulanter medizinischer Versorgung: Ergebnisse der MONICA/KORA-Kohorten S3/F3 und S4/F4]
Wolfenstetter, Silke B.,Menn, Petra,Holle, Rolf,Mielck, Andreas
GMS Psycho-Social-Medicine , 2012, DOI: 10.3205/psm000087
Abstract: [english] Objectives: To test the effects of body weight maintenance, gain, and loss on health care utilisation in terms of outpatient visits to different kinds of physicians in the general adult population.Methods: Self-reported utilisation data were collected within two population-based cohorts (baseline surveys: MONICA-S3 1994/95 and KORA-S4 1999/2001; follow-ups: KORA-F3 2004/05 and KORA-F4 2006/08) in the region of Augsburg, Germany, and were pooled for present purposes. N=5,147 adults (complete cases) aged 25 to 64 years at baseline participated. Number of visits to general practitioners (GPs), internists, and other specialists as well as the total number of physician visits at follow-up were compared across 10 groups defined by body mass index (BMI) category maintenance or change. Body weight and height were measured anthropometrically. Hierarchical generalized linear regression analyses with negative binomial distribution adjusted for sex, age, seconomic status (SES), survey, and the need factors incident diabetes and first cancer between baseline and follow-up were conducted.Results: In fully adjusted models, compared to the group of participants that maintained normal weight from baseline to follow-up, the following groups had significantly higher GP utilisation rates: weight gain from normal weight (+36%), weight loss from preobesity (+39%), maintained preobesity (+34%), weight gain after preobesity (+43%), maintained moderate obesity (+48%), weight gain from moderate obesity (+107%), weight loss from severe obesity (+114%), and maintained severe obesity (+83%). Regarding internists, those maintaining moderate obesity reported +107% more visits; those with weight gain from moderate obesity reported +91%. The latter group also had +41% more consultations with other physicians. Across all physicians, mean number of visits were estimated at 7.8 per year for maintained normal weight, 9 for maintained preobesity, 11 for maintained moderate obesity, and 12 for maintained severe obesity. Among those with weight loss, the mean number of visits were 8.7, 10.6 and 10.8 for baseline preobesity, moderate obesity, and severe obesity, respectively. Finally, those with weight gain from normal weight and preobesity reported 9.4 and 9.3 visits, respectively, and those with baseline moderate and follow-up severe obesity reported 13.1 visits (the most overall). Women reported higher GP and other physician utilisation. While all utilisation rates increased with age, GP utilisation was lower in middle to high SES groups.Conclusion: Compared to maintained normal we
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
Multimorbidity and health-related quality of life in the older population: results from the German KORA-Age study
Matthias Hunger, Barbara Thorand, Michaela Schunk, Angela D?ring, Petra Menn, Annette Peters, Rolf Holle
Health and Quality of Life Outcomes , 2011, DOI: 10.1186/1477-7525-9-53
Abstract: The EQ-5D was administered in the population-based KORA-Age study of 4,565 Germans aged 65 years or older. A generalised additive regression model was used to assess the effects of chronic conditions on HRQL and to account for the nonlinear associations with age and body mass index (BMI). Disease interactions were identified by a forward variable selection method.The conditions with the greatest negative impact on the EQ-5D index were the history of a stroke (regression coefficient -11.3, p < 0.0001) and chronic bronchitis (regression coefficient -8.1, p < 0.0001). Patients with both diabetes and coronary disorders showed more impaired HRQL than could be expected from their separate effects (coefficient of interaction term -8.1, p < 0.0001). A synergistic effect on HRQL was also found for the combination of coronary disorders and stroke. The effect of BMI on the mean EQ-5D index was inverse U-shaped with a maximum at around 24.8 kg/m2.There are important interactions between coronary problems, diabetes mellitus, and the history of a stroke that negatively affect HRQL in the older German population. Not only high but also low BMI is associated with impairments in health status.Multimorbidity, defined as the coexistence of two or more chronic conditions, is a common phenomenon among the older population worldwide: two recent population-based studies indicated that the prevalence of multimorbidity ranges between 40% and 56% in the general population aged 65 years and older [1,2]. Multimorbidity is known to negatively affect health outcomes including mortality, hospitalisation, and readmission [3].Health-related quality of life (HRQL) is a health outcome measure which is increasingly used to assess the medical effectiveness of interventions and to support allocation decisions in the health care sector. Generic HRQL instruments like the EQ-5D are appropriate for non-disease-specific analyses and allow comparisons between patient groups with different medical conditions [
Excess costs of dementia disorders and the role of age and gender - an analysis of German health and long-term care insurance claims data
Larissa Schwarzkopf, Petra Menn, Reiner Leidl, Sonja Wunder, Hilmar Mehlig, Peter Marx, Elmar Graessel, Rolf Holle
BMC Health Services Research , 2012, DOI: 10.1186/1472-6963-12-165
Abstract: The analyses used 2006 claims data from the AOK Bavaria Statutory Health Insurance fund of 9,147 dementia patients and 29,741 age- and gender-matched control subjects. Cost predictions based on two-part regression models adjusted for age and gender and excess costs of dementia care refer to the difference in model-estimated means between both groups. Corresponding analyses were performed stratified for gender. Finally, a potentially non-linear association between age and costs was investigated within a generalized additive model.Yearly spending within the social security system was circa €12,300 per dementia patient and circa €4,000 per non-demented control subject. About two-thirds of the additional expenditure for dementia patients occurred in the long-term care sector. Within our study sample, male and female dementia patients incurred comparable total costs. However, women accounted for significantly lower health and significantly higher long-term care expenditures. Long-term care spending increased in older age, whereupon health care spending decreased. Thus, at more advanced ages, women incurred greater costs than men of the same age.Dementia poses a substantial additional burden to the German social security system, with the long-term care sector being more seriously challenged than the health care sector. Our results suggest that female dementia patients need to be seen as a key target group for health services research in an ageing society. It seems clear that strategies enabling community-based care for this vulnerable population might contribute to lowering the financial burden caused by dementia. This would allow for the sustaining of comprehensive dementia care within the social security system.
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
Do diabetes and depressed mood affect associations between obesity and quality of life in postmenopause? Results of the KORA-F3 Augsburg population study
Daniela A Heidelberg, Rolf Holle, Maria E Lacruz, Karl-Heinz Ladwig, Thomas von Lengerke
Health and Quality of Life Outcomes , 2011, DOI: 10.1186/1477-7525-9-97
Abstract: Survey of 983 postmenopausal women aged 35-74, general population, Augsburg region/Germany, 2004/2005. Body weight/height and waist/hip circumference were assessed anthropometrically and classified via BMI ≥ 30 as obese, and WHR ≥ 0.85 as abdominally obese (vs. not). Depressed mood was assessed by the Depression and Exhaustion-(DEEX-)scale, diabetes and postmenopausal status by self-report/medication, and HRQL by the SF-12.General linear models revealed negative associations of obesity and abdominal obesity with physical but not mental HRQL. Both forms of excess weight were associated with diabetes but not depressed mood. Moderation depended on the HRQL-domain in question. In non-diabetic women, depressed mood was found to amplify obesity-associated impairment in physical HRQL (mean "obese"-"non-obese" difference given depressed mood: -6.4, p < .001; among those without depressed mood: -2.5, p = .003). Reduced mental HRQL tended to be associated with obesity in diabetic women (mean "obese"-"non-obese" difference: -4.5, p = .073), independent of depressed mood. No interactions pertained to abdominal obesity.In postmenopausal women, depressed mood may amplify the negative impact of obesity on physical HRQL, while diabetes may be a precondition for some degree of obesity-related impairments in mental HRQL.While the evidence on the effects of the menopausal transition on health-related quality of life (HRQL) is inconclusive [1], it is rather clear regarding effects of menopausal symptoms [2]. Avis et al. [3] found that the menopausal transition showed little impact on physical HRQL when adjusted for symptoms, medical conditions, and stress. Williams et al. [4] revealed that postmenopausal women with severe vasomotor symptoms felt more impaired in their daily activities than those with moderate or mild symptoms. Timur and Sahin [5] showed that menopause-specific quality of life was impaired in menopausal women with sleep disturbances. Finally, van Dole et al. [6] found t
Area Level Deprivation Is an Independent Determinant of Prevalent Type 2 Diabetes and Obesity at the National Level in Germany. Results from the National Telephone Health Interview Surveys ‘German Health Update’ GEDA 2009 and 2010
Werner Maier, Christa Scheidt-Nave, Rolf Holle, Lars E. Kroll, Thomas Lampert, Yong Du, Christin Heidemann, Andreas Mielck
PLOS ONE , 2014, DOI: 10.1371/journal.pone.0089661
Abstract: Objective There is increasing evidence that prevention programmes for type 2 diabetes mellitus (T2DM) and obesity need to consider individual and regional risk factors. Our objective is to assess the independent association of area level deprivation with T2DM and obesity controlling for individual risk factors in a large study covering the whole of Germany. Methods We combined data from two consecutive waves of the national health interview survey ‘GEDA’ conducted by the Robert Koch Institute in 2009 and 2010. Data collection was based on computer-assisted telephone interviews. After exclusion of participants <30 years of age and those with missing responses, we included n = 33,690 participants in our analyses. The outcome variables were the 12-month prevalence of known T2DM and the prevalence of obesity (BMI ≥30 kg/m2). We also controlled for age, sex, BMI, smoking, sport, living with a partner and education. Area level deprivation of the districts was defined by the German Index of Multiple Deprivation. Logistic multilevel regression models were performed using the software SAS 9.2. Results Of all men and women living in the most deprived areas, 8.6% had T2DM and 16.9% were obese (least deprived areas: 5.8% for T2DM and 13.7% for obesity). For women, higher area level deprivation and lower educational level were both independently associated with higher T2DM and obesity prevalence [highest area level deprivation: OR 1.28 (95% CI: 1.05–1.55) for T2DM and OR 1.28 (95% CI: 1.10–1.49) for obesity]. For men, a similar association was only found for obesity [OR 1.20 (95% CI: 1.02–1.41)], but not for T2DM. Conclusion Area level deprivation is an independent, important determinant of T2DM and obesity prevalence in Germany. Identifying and targeting specific area-based risk factors should be considered an essential public health issue relevant to increasing the effectiveness of diabetes and obesity prevention.
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