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1.  Self-Efficacy Beliefs Are Associated with Visual Height Intolerance: A Cross-Sectional Survey 
PLoS ONE  2014;9(12):e116220.
Responses to height may range from indifference to minor distress to severe symptoms of fear of heights (acrophobia); visual height intolerance (vHI) denotes the whole spectrum of symptoms. Although there are options to manage vHI, only a small part of persons affected by vHI are willing to seek professional help or confront their problem. Purpose of this study was to determine if persons with vHI, specifically those who show avoidant behavior towards heights (avoiders), score lower in their general self-efficacy (GSE) than those who confront vHI (confronters).
Cross-sectional survey in 607 individuals living in the urban region of Munich, Germany, using a mailed questionnaire on presence or absence of vHI, confronting or avoiding behaviour, and GSE.
Of all participants (mean age 53.9, 50.3% female), 407 reported life-time presence of vHI. Participants with vHI had a mean GSE score of 31.8 (SD 4.3) points (participants without vHI: 32.5, SD 4.3, p  = 0.008 for difference). Among individuals with vHI, 23% reported confronting behavior. Confronters were significantly younger (p<.0001, 50.2 vs. 55.7 years), more likely to be female (p  = 0.0039, 64.3% female), and had a higher GSE score (p  = 0.0049, 32.5 vs. 31.1). Associations remained significant after multiple adjustment.
Our study provides evidence for the association of GSE and vHI. These findings may have consequences for strategies of alleviation and therapy of vHI.
PMCID: PMC4280199  PMID: 25548910
2.  Associations between Multiple Accelerometry-Assessed Physical Activity Parameters and Selected Health Outcomes in Elderly People – Results from the KORA-Age Study 
PLoS ONE  2014;9(11):e111206.
Accelerometry is an important method for extending our knowledge about intensity, duration, frequency and patterns of physical activity needed to promote health. This study has used accelerometry to detect associations between intensity levels and related activity patterns with multimorbidity and disability. Moreover, the proportion of people meeting the physical activity recommendations for older people was assessed.
Physical activity was measured in 168 subjects (78 males; 65–89 years of age), using triaxial GT3X accelerometers for ten consecutive days. The associations between physical activity parameters and multimorbidity or disability was examined using multiple logistic regression models, which were adjusted for gender, age, education, smoking, alcohol consumption, lung function, nutrition and multimorbidity or disability.
35.7% of the participants met the physical activity recommendations of at least 150 minutes of moderate to vigorous activity per week. Only 11.9% reached these 150 minutes, when only bouts of at least 10 minutes were counted. Differences in moderate to vigorous activity between people with and without multimorbidity or disability were more obvious when shorter bouts instead of only longer bouts were included. Univariate analyses showed an inverse relationship between physical activity and multimorbidity or disability for light and moderate to vigorous physical activity. A higher proportion of long activity bouts spent sedentarily was associated with higher risk for multimorbidity, whereas a high proportion of long bouts in light activity seemed to prevent disability. After adjustment for covariates, there were no significant associations, anymore.
The accumulated time in moderate to vigorous physical activity seems to have a stronger relationship with health and functioning when shorter activity bouts and not only longer bouts were counted. We could not detect an association of the intensity levels or activity patterns with multimorbidity or disability in elderly people after adjustment for covariates.
PMCID: PMC4220984  PMID: 25372399
3.  Rehabilitation Outcome of Unconscious Traumatic Brain Injury Patients 
Journal of Neurotrauma  2013;30(17):1476-1483.
Outcome prediction of traumatic brain injury (TBI) patients with severe disorders of consciousness (DOC) at the end of their time in an intensive care setting is important for clinical decision making and counseling of relatives, and constitutes a major challenge. Even the question of what constitutes an improved outcome is controversially discussed. We have conducted a retrospective cohort study for the rehabilitation dynamics and outcome of TBI patients with DOC. Out of 188 patients, 37.2% emerged from a minimally conscious state (MCS) and 16.5% achieved at least partial functional independence after a mean observation period of 107 days (range 1–399 days). This reflects that emergence from MCS is much easier to achieve than functional independence. Logistic regression analysis identified age and level of consciousness upon admission to neurorehabilitation as independent prognostic factors for both outcomes. The group who reached at least partial functional independence started to improve significantly more than the corresponding outcome group by post-injury week 7, and the average time to reach this functional status was 18 weeks. In contrast, the group who emerged from MCS started to improve after 6 weeks. The longest delay between brain injury and the beginning of functional improvement (measured by biweekly Functional Independence Measure [FIM] scores) still compatible with reaching at least partial functional independence was 18 weeks. In conclusion, despite a strong negative selection, a substantial proportion of severe TBI patients with DOC achieve functional improvements or at least emerge from MCS within the inpatient rehabilitation phase. In order to avoid self-fulfilling prophecies in decision making, it is important to be aware of the fact that the beginning of clinical improvement may take several months after brain injury. In this study, separation of both of the functional outcome groups started by 7 weeks post-injury.
PMCID: PMC3751265  PMID: 23477301
clinical course; recovery of consciousness; rehabilitation outcome; TBI
4.  Health Outcome after Major Trauma: What Are We Measuring? 
PLoS ONE  2014;9(7):e103082.
Trauma is a global disease and is among the leading causes of disability in the world. The importance of outcome beyond trauma survival has been recognised over the last decade. Despite this there is no internationally agreed approach for assessment of health outcome and rehabilitation of trauma patients.
To systematically examine to what extent outcomes measures evaluate health outcomes in patients with major trauma.
Data Sources
MEDLINE, EMBASE, and CINAHL (from 2006–2012) were searched for studies evaluating health outcome after traumatic injuries.
Study selection and data extraction
Studies of adult patients with injuries involving at least two body areas or organ systems were included. Information on study design, outcome measures used, sample size and outcomes were extracted. The World Health Organisation International Classification of Function, Disability and Health (ICF) were used to evaluate to what extent outcome measures captured health impacts.
34 studies from 755 studies were included in the review. 38 outcome measures were identified. 21 outcome measures were used only once and only five were used in three or more studies. Only 6% of all possible health impacts were captured. Concepts related to activity and participation were the most represented but still only captured 12% of all possible concepts in this domain. Measures performed very poorly in capturing concepts related to body function (5%), functional activities (11%) and environmental factors (2%).
Outcome measures used in major trauma capture only a small proportion of health impacts. There is no inclusive classification for measuring disability or health outcome following trauma. The ICF may provide a useful framework for the development of a comprehensive health outcome measure for trauma care.
PMCID: PMC4106876  PMID: 25051353
5.  Association between anemia and falls in community-dwelling older people: cross-sectional results from the KORA-Age study 
BMC Geriatrics  2014;14:29.
Falls and fractures are among the principal causes of disability, and mortality of older people. Therefore, identifying treatable risk factors for falls in this population is very important. Here we evaluate the association between anemia and falls in community-dwelling people aged 65 years and older.
In 2009 967 community-dwelling people aged 65 years and older were included as part of the KORA-Age study. History of falls was assessed via questions derived from the National Health and Nutrition Examination Survey questionnaire. A non-fasting venous blood sample was obtained from all study participants. Anemia was defined as a hemoglobin level below 12 g/dL in women and below 13 g/dL in men according to the WHO criteria. Different logistic regression models were computed including relevant confounders such as sex, age, and disability to estimate Odds Ratios (OR) for falls.
In the total sample there was no significant association between anemia and falls neither in the unadjusted (OR 1.35; 95% CI 0.87-2.09) nor in the multivariable-adjusted models (OR 1.06; 95% CI 0.66-1.70). The association between continuous hemoglobin levels and falls was significant in the unadjusted model (OR per 1 SD decrease 1.36; 95% CI 1.14-1.64), but after adjustment for age and sex the association was attenuated and lost its significance (OR 1.13; 95% CI 0.92-1.38). In age- and sex-stratified analyses, no significant associations between anemia or hemoglobin levels and falls could be found. However, in joint analysis in the total sample a significantly, more than two-fold increased risk was observed after multivariable adjustment in persons with anemia and disability (OR 2.10; 95% CI 1.12-3.93) in comparison to persons without anemia and disability.
In the present study we have not found an independent association between hemoglobin levels or anemia and falls in older people from the general population. Because there was an additive effect of anemia and disability on the occurrence of falls, blood count should be measured in disabled older men and women to identify persons, who are at particular high risk for falls.
PMCID: PMC3973957  PMID: 24602338
6.  Indicators for Healthy Ageing — A Debate 
Definitions of healthy ageing include survival to a specific age, being free of chronic diseases, autonomy in activities of daily living, wellbeing, good quality of life, high social participation, only mild cognitive or functional impairment, and little or no disability. The working group Epidemiology of Ageing of the German Association of Epidemiology organized a workshop in 2012 with the aim to present different indicators used in German studies and to discuss their impact on health for an ageing middle-European population. Workshop presentations focused on prevalence of chronic diseases and multimorbidity, development of healthy life expectancy at the transition to oldest-age, physical activity, assessment of cognitive capability, and functioning and disability in old age. The communication describes the results regarding specific indicators for Germany, and hereby contributes to the further development of a set of indicators for the assessment of healthy ageing.
PMCID: PMC3881131  PMID: 24317381
old age; health; Germany; methodology
7.  Fear of heights and mild visual height intolerance independent of alcohol consumption 
Brain and Behavior  2013;3(5):596-601.
Background Visual height intolerance occurs when a visual stimulus causes apprehension of losing balance and falling from some height. Affecting one-third of the population, it has a broad spectrum of symptoms, ranging from minor distress to fear of heights, which is defined as a specific phobia. Specific phobias are associated with higher alcohol consumption. This has not been specifically shown for susceptibility to the more general visual height intolerance. Methods Representative case–control study nested within a population-based cross-sectional telephone survey to assess epidemiologically 1253 individuals ≥14 years, using a questionnaire on sociodemographic data, typical symptoms, precipitating visual stimuli, and alcohol drinking patterns (overall frequency of alcohol consumption, the daily quantities, and the motives). Results Individuals susceptible or nonsusceptible to visual height intolerance showed no significant differences in drinking patterns. The daily average alcohol consumption was slightly higher in persons susceptible to visual height intolerance (4.1 g/day vs. 3.7 g/day). Of those consuming alcohol, cases and controls reported on average consuming 2.3 glasses per day. The prevalence of visual height intolerance was insignificantly higher in the small minority of those drinking 2–3 times per week versus teetotalers. Conclusions Our study does not provide evidence that visual height intolerance – contrary to various specific phobias – is significantly associated with individual alcohol consumption patterns.
PMCID: PMC3869986  PMID: 24392279
Acrophobia; alcohol consumption; epidemiology; fear of heights; visual height intolerance
9.  Impact of joint contractures on functioning and social participation in older individuals – development of a standard set (JointConFunctionSet): study protocol 
BMC Geriatrics  2013;13:18.
Joint contractures are frequent in older individuals in geriatric care settings. Even though they are used as indicator of quality of care, there is neither a common standard to describe functioning and disability in patients nor an established standardized assessment to describe and quantify the impact of joint contractures on patients’ functioning. Thus, the aim of our study is (1) to develop a standard set for the assessment of the impact of joint contractures on functioning and social participation in older individuals and (2) to develop and validate a standardized assessment instrument for describing and quantifying the impact of joint contractures on the individuals’ functioning.
The standard set for joint contractures integrate the perspectives of all potentially relevant user groups, from the affected individuals to clinicians and researchers. The development of this set follows the methodology to develop an International Classification of Functioning Disability and Health (ICF) Core Set and involves a formal decision-making and consensus process. Evidence from four preparatory studies will be integrated including qualitative interviews with patients, a systematic review of the literature, a survey with health professionals, and a cross sectional study with patients affected by joint contractures. The assessment instrument will be developed using item-response-theory models. The instrument will be validated.
The standard set for joint contractures will provide a list of aspects of functioning and health most relevant for older individuals in geriatric care settings with joint contractures. This list will describe body functions, body structures, activities and participation and related environmental factors. This standard set will define what aspects of functioning should be assessed in individuals with joint contractures and will be the basis of the new assessment instrument to evaluate the impact of joint contractures on functioning and social participation.
PMCID: PMC3602666  PMID: 23432774
Contracture (MeSH); Aged (MeSH); Aged; 80 and over (MeSH); Disabled persons (MeSH); Outcome assessment (Health care) (MeSH); Geriatric rehabilitation; Home care (MeSH); Nursing homes (MeSH); Acute hospital care
10.  Distribution and determinants of functioning and disability in aged adults - results from the German KORA-Age study 
BMC Public Health  2013;13:137.
Today industrialized countries face a burgeoning aged population. Thus, there is increasing attention on the functioning and disabilities of aged adults as potential determinants of autonomy and independent living. However, there are few representative findings on the prevalence and determinants of disability in aged persons in the German population.
The objective of our study is to examine the frequency, distribution and determinants of functioning and disability in aged persons and to assess the contribution of diseases to the prevalence of disability.
Data originate from the MONICA/KORA study, a population-based epidemiological cohort. Survivors of the original cohorts who were 65 and older were examined by telephone interview in 2009. Disability was assessed with the Health Assessment Questionnaire Disability Index (HAQ-DI). Minimal disability was defined as HAQ-DI > 0. Logistic regression was used to adjust for potential confounders and additive regression to estimate the contribution of diseases to disability prevalence.
We analyzed a total of 4117 persons (51.2% female) with a mean age of 73.6 years (SD = 6.1). Minimal disability was present in 44.7% of all participants. Adjusted for age and diseases, disability was positively associated with female sex, BMI, low income, marital status, physical inactivity and poor nutritional status, but not with smoking and education. Problems with joint functions and eye diseases contributed most to disability prevalence in all age groups.
In conclusion, this study could show that there are vulnerable subgroups of aged adults who should receive increased attention, specifically women, those with low income, those over 80, and persons with joint or eye diseases. Physical activity, obesity and malnutrition were identified as modifiable factors for future targeted interventions.
PMCID: PMC3635873  PMID: 23410010
Aged; Aged, 80 and over; Disability evaluation; Activities of daily living
11.  Identification of aspects of functioning, disability and health relevant to patients experiencing vertigo: a qualitative study using the international classification of functioning, disability and health 
Aims of this study were to identify aspects of functioning and health relevant to patients with vertigo expressed by ICF categories and to explore the potential of the ICF to describe the patient perspective in vertigo.
We conducted a series of qualitative semi-structured face-to-face interviews using a descriptive approach. Data was analyzed using the meaning condensation procedure and then linked to categories of the International Classification of Functioning, Disability and Health (ICF).
From May to July 2010 12 interviews were carried out until saturation was reached. Four hundred and seventy-one single concepts were extracted which were linked to 142 different ICF categories. 40 of those belonged to the component body functions, 62 to the component activity and participation, and 40 to the component environmental factors. Besides the most prominent aspect “dizziness” most participants reported problems within “Emotional functions (b152), problems related to mobility and carrying out the daily routine. Almost all participants reported “Immediate family (e310)” as a relevant modifying environmental factor.
From the patients’ perspective, vertigo has impact on multifaceted aspects of functioning and disability, mainly body functions and activities and participation. Modifying contextual factors have to be taken into account to cover the complex interaction between the health condition of vertigo on the individuals’ daily life. The results of this study will contribute to developing standards for the measurement of functioning, disability and health relevant for patients suffering from vertigo.
PMCID: PMC3464694  PMID: 22738067
Vertigo (MeSH); Outcome assessment (Health Care) (MeSH); Qualitative research (MeSH); Classification (MeSH)
12.  Graphical modeling of binary data using the LASSO: a simulation study 
Graphical models were identified as a promising new approach to modeling high-dimensional clinical data. They provided a probabilistic tool to display, analyze and visualize the net-like dependence structures by drawing a graph describing the conditional dependencies between the variables. Until now, the main focus of research was on building Gaussian graphical models for continuous multivariate data following a multivariate normal distribution. Satisfactory solutions for binary data were missing. We adapted the method of Meinshausen and Bühlmann to binary data and used the LASSO for logistic regression. Objective of this paper was to examine the performance of the Bolasso to the development of graphical models for high dimensional binary data. We hypothesized that the performance of Bolasso is superior to competing LASSO methods to identify graphical models.
We analyzed the Bolasso to derive graphical models in comparison with other LASSO based method. Model performance was assessed in a simulation study with random data generated via symmetric local logistic regression models and Gibbs sampling. Main outcome variables were the Structural Hamming Distance and the Youden Index.
We applied the results of the simulation study to a real-life data with functioning data of patients having head and neck cancer.
Bootstrap aggregating as incorporated in the Bolasso algorithm greatly improved the performance in higher sample sizes. The number of bootstraps did have minimal impact on performance. Bolasso performed reasonable well with a cutpoint of 0.90 and a small penalty term. Optimal prediction for Bolasso leads to very conservative models in comparison with AIC, BIC or cross-validated optimal penalty terms.
Bootstrap aggregating may improve variable selection if the underlying selection process is not too unstable due to small sample size and if one is mainly interested in reducing the false discovery rate. We propose using the Bolasso for graphical modeling in large sample sizes.
PMCID: PMC3305667  PMID: 22353192
13.  Patients' functioning as predictor of nursing workload in acute hospital units providing rehabilitation care: a multi-centre cohort study 
Management decisions regarding quality and quantity of nurse staffing have important consequences for hospital budgets. Furthermore, these management decisions must address the nursing care requirements of the particular patients within an organizational unit. In order to determine optimal nurse staffing needs, the extent of nursing workload must first be known. Nursing workload is largely a function of the composite of the patients' individual health status, particularly with respect to functioning status, individual need for nursing care, and severity of symptoms. The International Classification of Functioning, Disability and Health (ICF) and the derived subsets, the so-called ICF Core Sets, are a standardized approach to describe patients' functioning status. The objectives of this study were to (1) examine the association between patients' functioning, as encoded by categories of the Acute ICF Core Sets, and nursing workload in patients in the acute care situation, (2) compare the variance in nursing workload explained by the ICF Core Set categories and with the Barthel Index, and (3) validate the Acute ICF Core Sets by their ability to predict nursing workload.
Patients' functioning at admission was assessed using the respective Acute ICF Core Set and the Barthel Index, whereas nursing workload data was collected using an established instrument. Associations between dependent and independent variables were modelled using linear regression. Variable selection was carried out using penalized regression.
In patients with neurological and cardiopulmonary conditions, selected ICF categories and the Barthel Index Score explained the same variance in nursing workload (44% in neurological conditions, 35% in cardiopulmonary conditions), whereas ICF was slightly superior to Barthel Index Score for musculoskeletal conditions (20% versus 16%).
A substantial fraction of the variance in nursing workload in patients with rehabilitation needs in the acute hospital could be predicted by selected categories of the Acute ICF Core Sets, or by the Barthel Index score. Incorporating ICF Core Set-based data in nursing management decisions, particularly staffing decisions, may be beneficial.
PMCID: PMC2988780  PMID: 21034438
14.  Functioning and health in patients with cancer on home-parenteral nutrition: a qualitative study 
Malnutrition is a common problem in patients with cancer. One possible strategy to prevent malnutrition and further deterioration is to administer home-parenteral nutrition (HPN). While the effect on survival is still not clear, HPN presumably improves functioning and quality of life. Thus, patients' experiences concerning functioning and quality of life need to be considered when deciding on the provision of HPN. Currently used quality of life measures hardly reflect patients' perspectives and experiences. The objective of our study was to investigate the perspectives of patients with cancer on their experience of functioning and health in relation to HPN in order to get an item pool to develop a comprehensive measure to assess the impact of HPN in this population.
We conducted a series of qualitative semi-structured interviews. The interviews were analysed to identify categories of the International Classification of Functioning, Disability and Health (ICF) addressed by patients' statements. Patients were consecutively included in the study until an additional patient did not yield any new information.
We extracted 94 different ICF-categories from 16 interviews representing patient-relevant aspects of functioning and health (32 categories from the ICF component 'Body Functions', 10 from 'Body Structures', 32 from 'Activities & Participation', 18 from 'Environmental Factors'). About 8% of the concepts derived from the interviews could not be linked to specific ICF categories because they were either too general, disease-specific or pertained to 'Personal Factors'. Patients referred to 22 different aspects of functioning improving due to HPN; mainly activities of daily living, mobility, sleep and emotional functions.
The ICF proved to be a satisfactory framework to standardize the response of patients with cancer on HPN. For most aspects reported by the patients, a matching concept and ICF category could be found. The development of categories of the component 'Personal Factors' should be promoted to close the existing gap when analyzing interviews using the ICF. The identification and standardization of concepts derived from individual interviews was the first step towards creating new measures based on patients' preferences and experiences which both catch the most relevant aspects of functioning and are sensitive enough to monitor change associated to an intervention such as HPN in a vulnerable population with cancer.
PMCID: PMC2862019  PMID: 20398396
15.  Understanding human functioning using graphical models 
Functioning and disability are universal human experiences. However, our current understanding of functioning from a comprehensive perspective is limited. The development of the International Classification of Functioning, Disability and Health (ICF) on the one hand and recent developments in graphical modeling on the other hand might be combined and open the door to a more comprehensive understanding of human functioning. The objective of our paper therefore is to explore how graphical models can be used in the study of ICF data for a range of applications.
We show the applicability of graphical models on ICF data for different tasks: Visualization of the dependence structure of the data set, dimension reduction and comparison of subpopulations. Moreover, we further developed and applied recent findings in causal inference using graphical models to estimate bounds on intervention effects in an observational study with many variables and without knowing the underlying causal structure.
In each field, graphical models could be applied giving results of high face-validity. In particular, graphical models could be used for visualization of functioning in patients with spinal cord injury. The resulting graph consisted of several connected components which can be used for dimension reduction. Moreover, we found that the differences in the dependence structures between subpopulations were relevant and could be systematically analyzed using graphical models. Finally, when estimating bounds on causal effects of ICF categories on general health perceptions among patients with chronic health conditions, we found that the five ICF categories that showed the strongest effect were plausible.
Graphical Models are a flexible tool and lend themselves for a wide range of applications. In particular, studies involving ICF data seem to be suited for analysis using graphical models.
PMCID: PMC2831907  PMID: 20149230
16.  Identification of ICF categories relevant for nursing in the situation of acute and early post-acute rehabilitation 
BMC Nursing  2008;7:3.
The recovery of patients after an acute episode of illness or injury depends both on adequate medical treatment and on the early identification of needs for rehabilitation care. The process of early beginning rehabilitation requires efficient communication both between health professionals and the patient in order to effectively address all rehabilitation goals. The currently used nursing taxonomies, however, are not intended for interdisciplinary use and thus may not contribute to efficient rehabilitation management and an optimal patient outcome. The ICF might be the missing link in this communication process. The objective of this study was to identify the categories of the International Classification of Functioning, Disability and Health (ICF) categories relevant for nursing care in the situation of acute and early post-acute rehabilitation.
First, in a consensus process, "Leistungserfassung in der Pflege" (LEP) nursing interventions relevant for the situation of acute and early post-acute rehabilitation were selected. Second, in an integrated two-step linking process, two nursing experts derived goals of LEP nursing interventions from their practical knowledge and selected corresponding ICF categories most relevant for patients in acute and post-acute rehabilitation (ICF Core Sets).
Eighty-seven percent of ICF Core Set categories could be linked to goals of at least one nursing intervention variable of LEP. The ICF categories most frequently linked with LEP nursing interventions were respiration functions, experience of self and time functions and focusing attention. Thirteen percent of ICF Core Set categories could not be linked with LEP nursing interventions. The LEP nursing interventions which were linked with the highest number of different ICF-categories of all were "therapeutic intervention", "patient-nurse communication/information giving" and "mobilising".
The ICF Core Sets for the acute hospital and early post-acute rehabilitation facilities are highly relevant for rehabilitation nursing. Linking nursing interventions with ICF Core Set categories is a feasible way to analyse nursing. Using the ICF Core Sets to describe goals of nursing interventions both facilitates inter-professional communication and respects patient's needs. The ICF may thus be a useful framework to set nursing intervention goals.
PMCID: PMC2276191  PMID: 18282288
17.  Screening of the hearing of newborns - Update 
Permanent congenital bilateral hearing loss (CHL) of moderate or greater degree (≥40 dB HL) is a rare disease, with a prevalence of about 1 to 3 per 1000 births. However, it is one of the most frequent congenital diseases. Reliance on physician observation and parental recognition has not been successful in the past in detecting significant hearing loss in the first year of life. With this strategy significant hearing losses have been detected in the second year of life. With two objective technologies based on physiologic response to sound, otoacoustic emissions (OAE) and auditory brainstem response (ABR) hearing screening in the first days of life is made possible.
The objective of this health technology assessment report is to update the evaluation on clinical effectiveness and cost-effectiveness of newborn hearing screening programs. Universal newborn hearing screening (UHNS) (i), selective screening of high risk newborns (ii), and the absence of a systematic screening program are compared for age at identification and age at hearing aid fitting of children with hearing loss. Secondly the potential benefits of early intervention are analysed. Costs and cost-effectiveness of newborn hearing screening programs are determined. This report is intended to make a contribution to the decision making whether and under which conditions a newborn hearing screening program should be reimbursed by the statutory sickness funds in Germany.
This health technology assessment report updates a former health technology assessment (Kunze et al. 2004 [1]). A systematic review of the literature was conducted, based on a documented search and selection of the literature using predefined inclusion and exclusion criteria and a documented extraction and appraisal of the included studies. To assess the cost-effectiveness of the different screening strategies in Germany the decision analytic Markov state model which had been developed in our former health technology assessment report was updated.
Universal newborn hearing screening programs are able to substantially reduce the age at identification and the age at intervention of children with CHL to six months of age in the German health care setting. High coverage rates, low fail rates and - if tracking systems are implemented – high follow-up-rates to diagnostic evaluation for test positives were achieved. New publications on potential benefits of early intervention could not be retrieved. For a final assessment of cost-effectiveness of newborn hearing screening evidence based long-term data are lacking. Decision analytic models with lifelong time horizon assuming that early detection results in improved language abilities and lower educational costs and higher life time productivity showed a potential of UNHS for long term cost savings compared to selective screening and no screening. For the short-term cost-effectiveness with a time horizon up to diagnostic evaluation more evidence based data are available. The average costs per case diagnosed range from 16,000 EURO to 33,600 EURO in Germany and hence are comparable to the cost of other implemented newborn screening programs. Empirical data for cost of selective screening in the German health care setting are lacking. Our decision analytic model shows that selective screening is more cost-effective but detects only 50% of all cases of congenital hearing loss.
There is good evidence that UNHS-Programs with appropriate quality management can reduce the age at start of intervention below six months. Up to now there is no indication of considerable negative consequences of screening for children with false positive test results and their parents. However, it is more difficult to prove the efficacy of early intervention to improve long-term outcomes. Randomized clinical trials of the efficacy of early intervention for children with CHL hearing losses are inappropriate because of ethical reasons. Prospective cohort studies with long-term outcomes of rare diseases are costly, take a long time and simultaneously substantial benefits of early intervention for language development seem likely.
A UNHS-Program should be implemented in Germany and be reimbursed by the statutory sickness funds. To achieve high coverage and because of better conditions for obtaining low false positive rates UNHS should be performed in hospital after birth. For outpatient deliveries additionally screening measures in an outpatient setting must be provided.
PMCID: PMC3011344  PMID: 21289971
18.  Neonatal hearing screening: modelling cost and effectiveness of hospital- and community-based screening 
Children with congenital hearing impairment benefit from early detection and management of their hearing loss. These and related considerations led to the recommendation of universal newborn hearing screening. In 2001 the first phase of a national Newborn Hearing Screening Programme (NHSP) was implemented in England. Objective of this study was to assess costs and effectiveness for hospital and community-based newborn hearing screening systems in England based on data from this first phase with regard to the effects of alterations to parameter values.
Design: Clinical effectiveness analysis using a Markov Model. Outcome measure: quality weighted detected child months (QCM).
Both hospital and community programmes yielded 794 QCM at the age of 6 months with total costs of £3,690,000 per 100,000 screened children in hospital and £3,340,000 in community. Simulated costs would be lower in hospital in 48% of the trials. Any statistically significant difference between hospital and community in prevalence, test sensitivity, test specificity and costs would result in significant differences in cost-effectiveness between hospital and community.
This modelling exercise informs decision makers by a quantitative projection of available data and the explicit and transparent statements about assumptions and the degree of uncertainty. Further evaluation of the cost-effectiveness should focus on the potential differences in test parameters and prevalence in these two settings.
PMCID: PMC1402282  PMID: 16504089
19.  Comparing the clinical effectiveness of different new-born hearing screening strategies. A decision analysis 
BMC Public Health  2005;5:12.
Children with congenital hearing impairment benefit from early detection and treatment. At present, no model exists which explicitly quantifies the effectiveness of universal newborn hearing screening (UNHS) versus other programme alternatives in terms of early diagnosis. It has yet to be considered whether early diagnosis (within the first few months) of hearing impairment is of importance with regard to the further development of the child compared with effects resulting from a later diagnosis. The objective was to systematically compare two screening strategies for the early detection of new-born hearing disorders, UNHS and risk factor screening, with no systematic screening regarding their influence on early diagnosis.
Design: Clinical effectiveness analysis using a Markov Model.
Data Sources: Systematic literature review, empirical data survey, and expert opinion. Target Population: All newborn babies.
Time scale: 6, 12 and 120 months.
Perspective: Health care system.
Compared Strategies: UNHS, Risk factor screening (RS), no systematic screening (NS). Outcome Measures: Quality weighted detected child months (QCM).
UNHS detected 644 QCM up until the age of 6 months (72,2%). RS detected 393 child months (44,1%) and no systematic screening 152 child months (17,0%). UNHS detected 74,3% and 86,7% weighted child months at 12 and 120 months, RS 48,4% and 73,3%, NS 23,7% and 60,6%. At the age of 6 months UNHS identified approximately 75% of all children born with hearing impairment, RS 50% and NS 25%. At the time of screening UNHS marked 10% of screened healthy children for further testing (false positives), RS 2%. UNHS demonstrated higher effectiveness even under a wide range of relevant parameters. The model was insensitive to test parameters within the assumed range but results varied along the prevalence of hearing impairment.
We have shown that UNHS is able to detect hearing impairment at an earlier age and more accurately than selective RS. Further research should be carried out to establish the effects of hearing loss on the quality of life of an individual, its influence on school performance and career achievement and the differences made by early fitting of a hearing aid on these factors.
PMCID: PMC549034  PMID: 15679901
20.  Economic evaluation of newborn hearing screening: modelling costs and outcomes 
Objectives: The prevalence of newborn hearing disorders is 1-3 per 1,000. Crucial for later outcome are correct diagnosis and effective treatment as soon as possible. With BERA and TEOAE low-risk techniques for early detection are available. Universal screening is recommended but not realised in most European health care systems.
Aim of the study was to examine the scientific evidence of newborn hearing screening and a comparison of medical outcome and costs of different programmes, differentiated by type of strategy (risk screening, universal screening, no systematical screening).
Methods: In an interdisciplinary health technology assessment project all studies on newborn hearing screening detected in a standardized comprehensive literature search were identified and data on medical outcome, costs, and cost-effectiveness extracted. A Markov model was designed to calculate cost-effectiveness ratios.
Results: Economic data were extracted from 20 relevant publications out of 39 publications found. In the model total costs for screening of 100,000 newborns with a time horizon of ten years were calculated: 2.0 Mio.€ for universal screening (U), 1.0 Mio.€ for risk screening (R), and 0.6 Mio.€ for no screening (N). The costs per child detected: 13,395€ (U) respectively 6,715€ (R), and 4,125€ (N). At 6 months of life the following percentages of cases are detected: U 72%, R 43%, N 13%.
Conclusions: A remarkable small number of economic publications mainly of low methodological quality was found. In our own model we found reasonable cost-effectiveness ratios also for universal screening. Considering the outcome advantages of higher numbers of detected cases a universal newborn hearing screening is recommended.
PMCID: PMC2703224  PMID: 19675707

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