Prevalence of vestibular disease in France: analysis of prescription data from a national health insurance database.

Vestibular problems are frequent reasons for primary care consultations. However, there is considerable uncertainty about the prevalence and cost of vestibular disorders. Despite ambiguous effectiveness data, the histamine analogue betahistine is widely and almost exclusively used for treatment of vertigo. Prescription of betahistine can, therefore, be used as a proxy estimate for prevalence. We used openly available claims data from the French health insurance data warehouse, defining annual prevalence of vestibular disease as the number of people who received at least one betahistine prescription that year. Dosage and pack size of each prescribed formulation were extracted to calculate the sum of betahistine in mg and the Defined Daily Dose (DDD) for age and sex strata and in total. To estimate the relative impact of one landmark trial, the BEMED study, we compared prescriptions from the years 2014/2015 to prescriptions in 2019/2022. A total of 735,121 (2014), 694,705 (2015), 614,431 (2019), and 562,476 (2022) persons filled in a prescription of betahistine. Patients were predominantly older and female. Average amount dispensed per year and per person increased from 4422.54 mg during the pre-BEMED period to 4736.90 mg during the post-BEMED period. DDD decreased from 130 Mio per year in 2014/2015 to 116 Mio per year in 2019/2022. Total costs for betahistine decreased by 42% from 21,615,037 Euro in 2014 to 12,894,249 Euro in 2022. Vestibular disease is frequent in France and has a relevant impact on population health. Despite conflicting clinical evidence, betahistine continues to be prescribed widely in medical practice.

Effects of medical interventions on health-related quality of life in chronic disease - systematic review and meta-analysis of the 19 most common diagnoses.

Introduction: The demographic shift leads to a tremendous increase in age-related diseases, which are often chronic. Therefore, a focus of chronic disease management should be set on the maintenance or even improvement of the patients' quality of life (QoL). One indicator to objectively measure QoL is the EQ-5D questionnaire, which was validated in a disease- and world region-specific manner. The aim of this study was to conduct a systematic literature review and meta-analysis on the QoL across the most frequent chronic diseases that utilized the EQ-5D and performed a disease-specific meta-analysis for treatment-dependent QoL improvement. Materials and methods: The most common chronic disease in Germany were identified by their ICD-10 codes, followed by a systematic literature review of these ICD-10 codes and the EQ-5D index values. Finally, out of 10,016 independently -screened studies by two persons, 538 studies were included in the systematic review and 216 studies in the meta-analysis, respectively. Results: We found significant medium to large effect sizes of treatment effects, i.e., effect size >0.5, in musculoskeletal conditions with the exception of fractures, for chronic depression and for stroke. The effect size did not differ significantly from zero for breast and lung cancer and were significantly negative for fractures. Conclusion: Our analysis showed a large variation between baseline and post-treatment scores on the EQ-5D health index, depending on the health condition. We found large gains in health-related quality of life mainly for interventions for musculoskeletal disease. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020150936, PROSPERO identifier CRD42020150936.

Second opinion and time to knee arthroplasty: a prospective cohort study of 142 patients.

OBJECTIVE: The objective of this study was to determine the impact of obtaining a second opinion consultation on time to knee arthroplasty (KA). We further examined the frequency of KA and the determinants of KA following the second opinion. DESIGN: Prospective cohort study. SETTING: The second opinion programme was implemented at the Ludwig Maximilian University Hospital in Munich. PARTICIPANTS: Participants comprised patients with knee osteoarthritis who were insured with one of the largest statutory health insurance Allgemeine Ortskrankenkasse Bayern (mean age 64.3±9.6 years). Patients participated in a second-opinion programme and completed questionnaires on site before and after personal presentation for the second opinion consultation. Follow-up questionnaires were delivered by post at 3 and 12 months after the second opinion consultation. Of the 142 patients included in the study, 47 (33.1%) underwent KA within 12 months after obtaining the second opinion. PRIMARY OUTCOME MEASURES: Primary outcome measure was time until patients received KA. Cox proportional hazard modelling was used to calculate the associations between the selected predictors and time that elapsed between receipt of the second opinion to KA. RESULTS: Mean time until KA was 17 weeks. Kaplan-Meier curves showed significant differences in time to KA according to the recommendation given at second opinion consultation, knee-related quality of life and Kellgren-Lawrence grade. In multivariate Cox proportional hazard modelling, second opinion recommendation (HR 5.33, 95% CI 1.16, 24.41) and knee-related quality of life (HR 1.03, 95% CI 1.01, 1.06) were significant predictors of time from second opinion to KA. CONCLUSIONS: Obtaining a second opinion had significant impact on time to knee replacement. Those who were recommended immediate surgery also underwent surgery more quickly after the second opinion. The effect of knee-related quality of life supports the importance of patient-reported outcome measures in the decision for or against KA.

Association of physical activity with utilization of long-term care in community-dwelling older adults in Germany: results from the population-based KORA-Age observational study.

BACKGROUND: Physical activity (PA) is a proven strategy to prevent chronic diseases and reduce falls. Furthermore, it improves or at least maintains performance of activities of daily living, and thus fosters an independent lifestyle in older adults. However, evidence on the association of PA with relevant subgroups, such as older adults with utilization of long-term care (LTC), is sparse. This knowledge would be essential for establishing effective, need-based strategies to minimize the burden on healthcare systems due to the increasing need for LTC in old age. METHODS: Data originate from the 2011/12 (t1) baseline assessment and 2016 (t2) follow-up of the population-based Cooperative Health Research in the Region of Augsburg (KORA-)Age study in southern Germany. In 4812 observations of individuals ≥65 years, the association between various types of PA (walking, exercise (i. e., subcategory of PA with the objective to improve or maintain one or more components of physical fitness), walking+exercise) and utilization of LTC (yes/no) was analyzed using generalized estimating equation logistic models. Corresponding models stratified by sex (females: 2499 observations; males: 2313 observations) examined sex-specific associations. Descriptive analyses assessed the proportion of individuals meeting the suggested minimum values in the German National Physical Activity Recommendations for older adults (GNPAR). RESULTS: All types of PA showed a statistically significant association with non-utilization of LTC in the entire cohort. "Walking+exercise" had the strongest association with non-utilization of LTC in the entire cohort (odds ratio (OR): 0.52, 95% confidence interval (CI): 0.39-0.70) and in males (OR: 0.41, CI: 0.26-0.65), whereas in females it was "exercise" (OR: 0.58; CI: 0.35-0.94). The proportion of individuals meeting the GNPAR was higher among those without utilization of LTC (32.7%) than among those with LTC (11.7%) and group differences were statistically significant (p ≤ 0.05). CONCLUSIONS: The GNPAR are rarely met by older adults. However, doing any type of PA is associated with non-utilization of LTC in community-dwelling older adults. Therefore, older adults should be encouraged to walk or exercise regularly. Furthermore, future PA programs should consider target-groups' particularities to reach individuals with the highest needs for support.

Feasibility of the MELD score as a screening tool for pharmacists to identify patients with impaired hepatic function at hospital admission.

WHAT IS KNOWN AND OBJECTIVE: Hepatic impairment (HI) is a known risk factor for drug safety. The MELD score (Model-for-endstage-liver-disease), calculated from serum creatinine, bilirubin and International Normalized Ratio (INR), is a promising screening tool corresponding to Child-Pugh Score (CPS) for drug adjustment. We tested the feasibility of MELD as an automatic screening tool accounting for correct calculation, interfering factors (IF) and detection of patients corresponding to CPS-B/C potentially requiring drug adjustment. METHODS: We retrospectively calculated MELD for a 3-month cohort of surgical patients and assessed need for adjustment of MELD parameters to standard values. IF for INR (oral anticoagulants) and serum creatinine (renal insufficiency (RI; eGFR<60 ml/min/1.73m²); as well as drugs elevating creatinine levels (DECL)) and the number of patients with MELD scores corresponding to CPS-B/C were analysed. For MELD ≥7.5, liver and bile diagnoses were recorded. RESULTS AND DISCUSSION: Of 1183 patients, MELD was calculable for 761 (64%; median 7.5, range 6.4-36.8). Parameters had to be adjusted for 690 (91%) patients. IF of parameters were RI in 172 (23%), INR-elevating drugs in 105 (14%) and DECL in 33 (4%) patients. Of 335 (44%) patients with MELD ≥7.5, 122 (36%) had documented liver or bile diagnoses. MELD 10-<15 (corresponding to CPS-B) was found for 105 (14%), MELD ≥15 (corresponding to CPS-C) for 66 (9%) of the 761 patients with a calculated MELD. Referred to all patients, drug adjustments due to possible HI were recommendable for 14% of patients with suspected CPS-B/C. WHAT IS NEW AND CONCLUSION: MELD is a feasible screening tool for HI as a risk factor for drug safety at hospital admission when appropriately considering correct parameter adjustment and RI and INR-elevating drugs as IF. Further evaluation of sensitivity and specificity is needed.

Effects of a medical second opinion programme on patients' decision for or against knee arthroplasty and their satisfaction with the programme.

BACKGROUND: German social legislation gives patients the right to obtain a second opinion before elective surgery and defines quality criteria for reimbursement by statutory health insurances. However, the effects of second opinions before elective surgery are largely unknown. The aim of this study was to evaluate the effects of a second opinion programme in patients recommended for knee arthroplasty. METHODS: The largest statutory health insurance funds in Bavaria offered patients who had been recommended to have knee arthroplasty the opportunity to partake in a second opinion programme which consisted of an in person presentation to an experienced knee surgeon. In this cohort study, consecutive patients from this second opinion programme who signed informed consent were included from 07/10/2016 to 14/02/2020. Data were collected before and after the second opinion visit. RESULTS: A total of 141 (66%) of 215 patients who presented for a second opinion participated in the evaluation study. The second opinion physician recommended knee arthroplasty to 40% of the patients, later knee arthroplasty if the conditions worsened to 40%, and no knee arthroplasty to 20%. After receiving the second opinion 28 of 56 (41%) undecided patients preferred knee arthroplasty, 14 no knee arthroplasty, 14 remained undecided. Four of 46 patients with a preference for "arthroplasty" changed their decision to "no arthroplasty", five of 35 patients from "no arthroplasty" to "arthroplasty". The patients were more confident in their decision according to the decision confidence scale (before: 5.4 ± 3.0; after: 7.8 ± 2.5; p < 0.001). They rated their satisfaction with the second opinion programme with a mean grade of 1.35 (± 0.60) (best:1; worst:6). Logistic regression analyses showed that the recommendation of the second opinion physician for joint arthroplasty was associated with the guideline criteria radiological severity of osteoarthritis (p = 0.001) and knee-joint-specific quality of life (p = 0.041). CONCLUSION: The second opinion of an experienced knee surgeon frequently deviates from the initial recommendation for knee arthroplasty. The association of guideline criteria to the second recommendation suggests a high quality of the second opinion. From the patient perspective, the second opinion reduces uncertainties in their treatment decision.

The times we are born into and our lifestyle choices determine our health trajectories in older age - Results from the KORA-Age study.

Health projections often extrapolate from observations in current ageing cohorts, but health in older age may depend not only on individual characteristics but also on a person's historical context. Our objective was to investigate how health deficit accumulation trajectories after age 65 differed in five adjacent birth cohorts and according to individual life course characteristics. Data originate from the 2008/09 KORA (Cooperative Health Research in the Region of Augsburg)-Age cohort study from Southern Germany and their 2012 and 2016 follow-ups. Deficit accumulation was assessed using a Frailty Index. The effects of birth cohort membership and individual life course characteristics on deficit accumulation trajectories were analyzed using generalized linear mixed models. Out of 2701 participants (49% male) from five birth cohorts (1919-23, 1924-28, 1929-33, 1934-38, 1939-43), we included 2512 individuals with 5560 observations. Frailty Index levels were higher for women, smokers, alcohol abstainers, obese participants and persons with a sedentary lifestyle or living below the poverty threshold. We found higher age-specific Frailty Index levels for the two most recent birth cohorts (e.g. 61%, CI: [13%; 130%] for the 1934-38 as compared to the 1919-23 cohort), but the rate of deficit accumulation with age (7% per life year, (CI: [5%, 9%]) was cohort-independent. Results indicate that the historical context (birth cohort membership) may influence the number of accumulated health deficits after age 65 in addition to poverty and other individual life course characteristics, but BMI, physical activity and smoking remain the modifiable risk factors offering the highest prevention potential.

Effects of Whole Body Vibration Therapy and Classic Physiotherapy on Postural Stability in People With Back Pain: A Randomized Trial.

STUDY DESIGN: This 2-step prospective randomized parallel trial evaluated postural stability in 65 back pain participants (61.6±7.9 y) and 50 nonback pain participants (61.2±8.6 y) in a first step using the MFT-S3-Check. In a second step, postural stability and questionnaires were evaluated in back pain participants before and after therapy with either whole body vibration therapy or classic physiotherapy. OBJECTIVE: The first aim was to investigate whether the MFT-S3-Check is suitable to evaluate differences in postural stability in back pain and nonback pain participants. The second aim was to evaluate the effect of whole body vibration therapy and classic physiotherapy on postural stability and the influence of depressive symptoms and pain. SUMMARY OF BACKGROUND DATA: Objective bodily measurement values in chronic back pain are rare; therefore, the evaluation of effectiveness of different therapies is difficult. METHODS: Postural stability was investigated using stability-, sensorimotor-, and symmetry indexes, in standing and seated positions with the MFT-S3-Check. The following standard questionnaires were used to investigate pain and depressive symptoms: HADS, ODI, NASS, SF-36. RESULTS: No significant difference in postural stability was found between back pain participants and the nonback pain group. None of the two training concepts in back pain participants was superior, concerning postural stability and pain. Both treatments showed positive effects, with significant improvements in postural stability in the classic physiotherapy group. Depressive symptoms had a significant correlation with pain intensity in back pain participants. CONCLUSIONS: The MFT-S3-Check could not find a significant difference in postural stability between the back pain and nonback pain group in the study setting. Postural stability improved after treatment.

Anticholinergic and sedative medications and the risk of vertigo or dizziness in the German primary care setting-A matched case-control study from the CONTENT registry.

PURPOSE: To date, there is little information on the utilization of anticholinergic and sedative (AS) medications to vertigo or dizziness (VoD) patients in the German primary care setting. The objective of this study was to evaluate AS medication use and its association with VoD within the German primary care setting. METHODS: Cases with VoD from the CONTENT (CONTinuous morbidity registration Epidemiologic NeTwork) database were 1:1 matched to controls on age, sex, and comorbidities by propensity score matching. AS medication was defined using the fourth level of Anatomical Therapeutic Chemical Classification (ATC) Codes. A prescription of AS medication any time within the study period formed the primary exposure. Multivariable conditional logistic regression examined the association between AS use and VoD. RESULTS: Of a total of N = 151 446 patients, 6971 (4.6%) cases and 6971 corresponding controls were analyzed (mean age (sd): 59.9 years (20.9), 64.2% female). Dizziness and giddiness (ICD-10 Code R42) were diagnosed most prominently (87.2%). AS medication was prescribed on 1072 of 10 552 (10.2%) consultation days with VoD diagnoses. After adjusting for covariates, AS use was significantly and independently associated with VoD, adjusted odds ratio (1.37; 95% CI: 1.18-1.58), compared with no AS use. CONCLUSION: Primary care practitioners should consider AS medication as a risk factor for VoD and avoid prescribing AS medications after a VoD diagnosis. Caution should also be taken when prescribing AS medications to older adults (≥65 years). Systematical calculations of AS medication burden for patients could help acknowledge this issue and raise awareness for prescription habits in primary care.

Interventions for the prevention and treatment of disability due to acquired joint contractures in older people: a systematic review.

Background: acquired joint contractures have significant effects on quality of life and functioning. Objective: to determine the effects of interventions to prevent and treat disabilities in older people with acquired joint contractures. Methods: systematic search (last 8/2016) via Cochrane Library, PubMed, EMBASE, PEDro, CINAHL, trial registries, reference lists of retrieved articles and scientific congress pamphlets. Controlled and randomised controlled trials in English or German comparing an intervention with another intervention or standard care were included. Two independent researchers performed the selection of publications, data extraction and critical appraisal. Results: seventeen studies with 992 participants met the inclusion criteria: 16 randomised controlled trials and 1 controlled trial (nursing homes = 4, community settings = 13). The methodological quality of the studies varied. Splints were examined in four studies, stretching exercises in nine studies, and ultrasound, passive movement therapy, bed-positioning and group exercise were each examined in one study. Studies on splints revealed inconclusive results regarding joint mobility or spasticity. Five of seven studies that assessed active stretching programmes for healthy older people reported statistically significant effects on joint mobility in favour of the intervention. Pain, quality of life, activity limitations and participation restrictions were rarely assessed. Conclusion: the evidence for the effectiveness of interventions to prevent and treat disability due to joint contractures is weak, particularly for established nursing interventions such as positioning and passive movement. Better understanding is required regarding the delivery of interventions, such as their intensity and duration. In addition to functional issues, activities and social participation should also be studied as outcomes.

Common eye diseases in older adults of southern Germany: results from the KORA-Age study.

Purpose: a population-based study in the region of Augsburg (Germany, KORA) was used to identify the prevalence of eye diseases and their risk factors in a sample of aged individuals. Methods: data originated from the KORA-Age study collected in 2012 and 822 participants (49.6% women, 50.4% men, aged 68-96 years) were asked standardised questions about eye diseases. Positive answers were validated and specified by treating ophthalmologists. Additional information came from laboratory data. Polymorphic markers were tested for candidate genes. Results: we received validations and specifications for 339 participants. The most frequent eye diseases were cataracts (299 cases, 36%), dry eyes (120 cases, 15%), glaucoma (72 cases, 9%) and age-related macular degeneration (AMD) (68 cases, 8%). Almost all participants suffering from glaucoma or from AMD also had cataracts. Cataract surgery was associated with diabetes (in men; OR = 2.24; 95% confidence interval [CI] 1.11-4.53; P = 0.025) and smoking (in women; OR = 6.77; CI 1.62-28.35; P = 0.009). In men, treatments in airway diseases was associated with cataracts (glucocorticoids: OR = 5.29, CI 1.20-23.37; P = 0.028; sympathomimetics: OR = 4.57, CI 1.39-15.00; P = 0.012). Polymorphisms in two genes were associated with AMD (ARMS2: OR = 2.28, CI 1.48-3.51; P = 0.005; CFH: OR = 2.03, CI 1.35-3.06; P = 0.010). Conclusion: combinations of eye diseases were frequent at old age. The importance of classical risk factors like diabetes, hypertension and airway diseases decreased either due to a survivor bias leaving healthier survivors in the older age group, or due to an increased influence of other up to now unknown risk factors.

[Frailty in Germany: status and perspectives : Results from a workshop of the German Society for Epidemiology]. / Frailty in Deutschland: Stand und Perspektiven : Ergebnisse eines Workshops der Deutschen Gesellschaft für Epidemiologie.

BACKGROUND: A standardized, valid and comparable operationalization and assessment of frailty in population-based studies is essential in order to describe the prevalence and determinants of frailty in the population. AIM: After an introduction to the subject the main goal of a workshop at the 9th annual meeting of the German Society for Epidemiology (DGEpi) was to present approaches and results from four different studies in Germany. MATERIAL AND METHODS: The following four population-based studies were used to describe frailty in Germany: the German health interview and examination survey for adults (DEGS1), the epidemiological study on the chances of prevention, early recognition and optimized treatment of chronic diseases in the older population (ESTHER), the cooperative health research in the region Augsburg (KORA Age) study and the longitudinal urban cohort ageing study (LUCAS) in Hamburg. RESULTS: The four studies consistently showed that frailty is widespread in older and oldest-old persons in Germany. It is obvious that frailty represents a relevant concept in Germany even if there is currently no uniform basis for operationalization. CONCLUSION: Concepts and instruments for the collation of frailty should be included in future population-based studies in order to make a better assessment of older people's health situation and to describe the unused potential for prevention in an aging society.

Associations between multiple accelerometry-assessed physical activity parameters and selected health outcomes in elderly people--results from the KORA-age study.

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Rehabilitation outcome of anoxic-ischaemic encephalopathy survivors with prolonged disorders of consciousness.

OBJECTIVES: To examine the natural clinical course of patients admitted to inpatient neurorehabilitation in a coma, vegetative state (VS), or minimally conscious state (MCS) after anoxic-ischaemic encephalopathy (AIE). METHODS: This is a retrospective cohort study of 113 consecutive patients admitted to a German inpatient neurorehabilitation centre with severe disorders of consciousness (DOC) following AIE due to cardiac arrest over a 6-year period. Functional independence was measured with the Glasgow Outcome Scale (GOS) and recovery of consciousness with the Coma Remission Scale (CRS). Separate binary logistic regression models were used to identify independent predictors for functional and behavioural outcomes. RESULTS: Seven patients (6.2%) achieved a good functional outcome (GOS 4-5). Five of these showed significant functional improvement within the first 8 weeks. 22 patients (19.5%) recovered consciousness; the last patient began to make significant improvement between weeks 10 and 12. Logistic regression showed that both increasing age and lower admission CRS predicted unfavourable functional outcome and persistent DOC. A longer stay in the ICU also predicted persistent DOC at the end of neurorehabilitation. However, neither malignant somatosensory evoked potential (SEP) test results nor hypothermia treatment on the ICU were outcome predictors in either outcome category. CONCLUSION: Even among severely affected AIE patients arriving at a neurological rehabilitation centre in a DOC, there remains potential for functional and behavioural improvement. However, significant improvements may not begin for up to 3 months post-injury. This study suggests that recovery of consciousness and even a good neurological outcome are possible despite malignant SEP test results.

Distribution and determinants of functioning and disability in aged adults--results from the German KORA-Age study.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Graphical modeling of binary data using the LASSO: a simulation study.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Effects of pharmaceutical counselling on antimicrobial use in surgical wards: intervention study with historical control group.

PURPOSE: The objective of this study was to assess the impact of pharmaceutical consulting on the quality of antimicrobial use in a surgical hospital department in a prospective controlled intervention study. METHODS: Patients receiving pharmaceutical intervention (intervention group, IG, n = 317) were compared with a historical control group (control group, CG, n = 321). During the control period, antimicrobial use was monitored without intervention. During the subsequent intervention period, a clinical pharmacist reviewed the prescriptions and gave advice on medication. RESULTS: Intervention reduced the length of antimicrobial courses (IG = 10 days, CG = 11 days, incidence rate ratio for i.v. versus o.p. = 0.88, 95% confidence interval 0.84 to 0.93) and shortened i.v. administration (IG = 8 days, CG = 10 days, hazard rate = 1.76 in favour of switch from i.v. to p.o., 95% confidence interval 1.23 to 2.52). Intervention also helped to avoid useless combination therapy and reduced total costs for antimicrobials. CONCLUSIONS: A clinical pharmacist who reviews prescriptions can promote an increase in efficiency, for example, by shortening the course of treatment. Counselling by ward-based clinical pharmacists was shown to be effective to streamline antimicrobial therapy in surgical units and to increase drug safety.

Graphical modeling can be used to illustrate associations between variables describing functioning in head and neck cancer patients.

OBJECTIVE: To examine the associations between variables of functioning measured by the International Classification of Functioning, Disability and Health (ICF) in head and neck cancer (HNC) patients by means of graphical modeling. STUDY DESIGN AND SETTING: Graphical modeling was used on a data set of a cross-sectional multicentric study of 145 patients with HNC. Functioning was qualified using the extended ICF checklist. Multiple imputation was used to handle missing data. The least absolute shrinkage and selection operator for generalized linear models was used to identify conditional associations between the ICF categories. Bootstrap aggregating was used to enhance the accuracy and validity of model selection. RESULTS: The resulting graph shows largely meaningful associations between the ICF categories. One central point could be visualized consisting of a circular path of d330 Speaking, d350 Conversation, b510 Ingestion functions, s320 Structure of mouth, and b310 Voice functions. Another important structure in the graph were the bow-shaped associations beginning with d335 Producing nonverbal messages to b130 Energy and drive functions. CONCLUSION: Graphical modeling can be used to describe associations between different areas of functioning in HNC patients. They found associations can be the basis for improved rehabilitation and gives a deeper understanding of functioning in HNC patients.

Functioning and health in patients with cancer on home-parenteral nutrition: a qualitative study.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.