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Three-dimensional (3D) right ventricular (RV) strain analysis is not routinely performed perioperatively. Although 3D RV strain adds incrementally to outcome prediction in various cardiac diseases, its role in the perioperative setting is not sufficiently understood. The aim of this study was to investigate the association between 3D RV strain measured on RV meshes created from 3D transesophageal echocardiographic data and short-term outcomes among patients undergoing cardiac surgery.A total of 496 patients undergoing cardiac surgery who underwent intraoperative 3D transesophageal echocardiography (under general anesthesia, before sternotomy) were retrospectively selected, and RV meshes were generated using commercially available speckle-tracking software. Custom-made software automatically quantified longitudinal and circumferential RV strains on the mesh surfaces. Echocardiographic and clinical parameters were entered into logistic regression models to determine their associations with the primary (in-hospital death or need for extracorporeal life support) and secondary (postoperative ventilation48 hours) end points.Mesh-derived RV strain analysis was feasible in 94% of patients and revealed distinct regional patterns with basal-apical gradients for both longitudinal and circumferential strain. Thirty-seven patients (7.6%) reached the primary end point, and 118 patients (23.8%) reached the secondary end point. In a multivariable logistic regression model, serum lactate (P .01), an emergency indication for surgery (P .01), tricuspid regurgitation (P .001), and mesh-derived RV global longitudinal strain (RV-GLS; P .01) were independently associated with the primary end point, while established measures of RV function (3D RV ejection fraction, fractional area change, tricuspid annular plane systolic excursion) and left ventricular (LV) function (3D-derived LV ejection fraction and LV-GLS) were not independently associated. Hematocrit (P .01), serum lactate (P .001), pulmonary hypertension (P = .04), tricuspid regurgitation (P .01), emergency procedures (P = .02), LV-GLS (P = .02), and RV-GLS (P .001) were associated with the secondary end point.RV-GLS measured on RV meshes derived from 3D transesophageal echocardiography was independently associated with short-term outcomes in patients undergoing cardiac surgery and might be helpful for identifying patients at risk for adverse postoperative events.

Background: Acute mesenteric ischemia (AMI) is a life-threatening condition resulting from occlusion of the mesenteric arterial vessels. AMI requires immediate treatment with revascularization of the occluded vessels. Purpose: to evaluate the technical success, clinical outcomes and survival of patients receiving endovascular treatment for AMI followed by surgery. Material and Methods: A search of our institution’s database for AMI revealed 149 potential patients between 08/2016 and 08/2021, of which 91 were excluded due to incomplete clinical data, insufficient imaging or missing follow-up laparoscopy. The final cohort included 58 consecutive patients [(median age 73.5 years [range: 43–96 years], 55% female), median BMI 26.2 kg/m2 (range:16.0–39.2 kg/m2)]. Periinterventional imaging regarding the cause of AMI (acute-embolic or acute-on-chronic) was evaluated by two radiologists in consensus. The extent of AMI and the degree of technical success was graded according to a modified TICI (Thrombolysis in Cerebral Infarction scale) score (TICI-AMI) classification (0: no perfusion; 1: minimal; 2a < 50% filling; 2b > 50%; 2c: near complete or slow; 3: complete). Lab data and clinical data were collected, including the results of follow-up laparoscopy. Non-parametric statistics were used. Results: All interventions were considered technically successful. The most common causes of AMI were emboli (51.7%) and acute-on-chronic thrombotic occlusions (37.9%). Initial imaging showed a TICI-AMI score of 0, 1 or 2a in 87.9% (n = 51) of patients. Post-therapeutic TICI-AMI scores improved significantly with 87.9% of patients grade 2b and better. Median lactate levels reduced from 2.7 (IQR 2.0–3.7) mg/dL (1–18) to 1.45 (IQR 0.99–1.90). Intestinal ischemia was documented in 79.1% of cases with resection of the infarcted intestinal loops. In total, 22/58 (37.9%) patients died during the first 30 days after intervention and surgery. According to CIRSE criteria, we did not observe any SAE scores of grade 2 or higher. Conclusions: AMI is a serious disease with high lethality within the first 30 days despite optimal treatment. However, interventional revascularization before surgery with resection of the infarcted bowel can save two out of three of critically ill patients.

Comfort and recovery are major concerns of patients seeking aesthetic surgery. This study aimed to assess postoperative pain and recovery after outpatient breast surgery under sedation, intercostal block, and local anaesthesia.This prospective cohort study included all consecutive patients who underwent aesthetic breast surgery between April 2021 and August 2022. Epidemiological data, anaesthesia, pain, and patients' satisfaction were systematically assessed with standardized self-assessment questionnaires.Altogether, 48 patients [median (IQR) age: 30 (36-25)] were included. The most frequent surgery was mastopexy. 69% of surgeries involved additional procedures. The mean intercostal block and local anaesthesia time was 15 min. Patients received a median (IQR) of 19 (34-2) mg/kg lidocaine and 2.3 (2.5-2.0) mg/kg ropivacaine. The median (IQR) consumption of propofol and alfentanil was, respectively, 4.89 (5.48-4.26) mg/kg/h and 0.27 (0.39-0.19) µg/kg/min. No conversion to general anaesthesia or unplanned hospital admission occurred. Patients were discharged after a median (IQR) of 2:40 (3:43-1:58) hours. Within the first 24 postoperative hours, 17% required once an antiemetic medication and 38% an opioid. Patients were very satisfied with the anaesthesia and 90% of the patients had not wished more analgesia in the first 24 h.Aesthetic breast surgery under sedation, intercostal block, and tumescent anaesthesia can safely be performed as an ambulatory procedure and is associated with minimal intra- and postoperative opioid consumption and high patient satisfaction. These data may be used to inform patients and clinicians and improve the overall quality of care.This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Breast size alteration is the most common aesthetic surgical procedure worldwide. This study aimed to assess the correlation between breast volume and BMI or age.The analyses were conducted utilizing 400 patients selected by a retrospective review of the archives at our institution. Epidemiological data and medical history were assessed. Adjusting for the age and BMI of patient from previously described cohorts, we calculated mean breast volumes per side and differences from the upper and lower percentiles to the mean volumes.The patients had a median BMI of 23.5 (range: 14.7-45.6) and a median age of 51 (range: 24-82). The average total breast volume increased strongly with BMI (r=0.834, p0.01) and moderately with age (r=0.305, p0.01). Within a BMI range of 18-24, breast volumes in the 8th and 18th percentile differ on average by about 50 ml. One BMI unit increase in women with breast sizes in the 10th percentile accounts for a breast volume difference of about 30 ml.BMI strongly correlates with breast size. To achieve natural results, preoperative consultation and planning of aesthetic and reconstructive breast surgery must recognize BMI as a major determinant of average breast size.This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Background The EQ-5D-5L is a well-established health questionnaire that estimates health utilities by applying preference-based weights. Limited work has been done to examine alternative scoring approaches when utility weights are unavailable or inapplicable. We examined whether the Mokken scaling approach can elucidate 1) if the level summary score is appropriate for the EQ-5D-5L and 2) an interpretation of such a score. Methods The R package “mokken” was used to assess monotonicity (scaling coefficients H, automated item selection procedure) and manifest invariant item ordering (MIIO: paired item response functions [IRF], HT). We used a rich dataset (the Multiple Instrument Comparison, MIC) which includes EQ-5D-5L data from six Western countries. Results While all EQ-5D-5L items demonstrated monotonicity, the anxiety/depression (AD) item had weak scalability (Hi = 0.377). Without AD, scalability improved from Hs = 0.559 to Hs = 0.714. MIIO revealed that the 5 items can be ordered, and the ordering is moderately accurate in the MIC data (HT = 0.463). Excluding AD, HT improves to 0.743. Results were largely consistent across disease and country subgroups. Discussion The 5 items of the EQ-5D-5L form a moderate to strong Mokken scale, enabling persons to be ordered using the level summary score. Item ordering suggests that the lower range of the score represents mainly problems with pain and anxiety/depression, the mid-range indicates additional problems with mobility and usual activities, and middle to higher range of scores reveals additional limitations with self-care. Scalability and item ordering are even stronger when the anxiety/depression item is not included in the scale.

PurposeAlthough the EQ-5D has a long history of use in a wide range of populations, the newer five-level version (EQ-5D-5L) has not yet had such extensive experience. This systematic review summarizes the available published scientific evidence on the psychometric properties of the EQ-5D-5L.MethodsPre-determined key words and exclusion criteria were used to systematically search publications from 2011 to 2019. Information on study characteristics and psychometric properties were extracted: specifically, EQ-5D-5L distribution (including ceiling and floor), missing values, reliability (test–retest), validity (convergent, known-groups, discriminate) and responsiveness (distribution, anchor-based). EQ-5D-5L index value means, ceiling and correlation coefficients (convergent validity) were pooled across the studies using random-effects models.ResultsOf the 889 identified publications, 99 were included for review, representing 32 countries. Musculoskeletal/orthopedic problems and cancer (n = 8 each) were most often studied. Most papers found missing values (17 of 17 papers) and floor effects (43 of 48 papers) to be unproblematic. While the index was found to be reliable (9 of 9 papers), individual dimensions exhibited instability over time. Index values and dimensions demonstrated moderate to strong correlations with global health measures, other multi-attribute utility instruments, physical/functional health, pain, activities of daily living, and clinical/biological measures. The instrument was not correlated with life satisfaction and cognition/communication measures. Responsiveness was addressed by 15 studies, finding moderate effect sizes when confined to studied subgroups with improvements in health.ConclusionsThe EQ-5D-5L exhibits excellent psychometric properties across a broad range of populations, conditions and settings. Rigorous exploration of its responsiveness is needed.

Online activity-based data can be used to aid infectious disease forecasting. Our aim was to exploit the converging nature of the tuberculosis (TB) and diabetes epidemics to forecast TB case numbers. Thus, we extended TB prediction models based on traditional data with diabetes-related Google searches. We obtained data on the weekly case numbers of TB in Germany from June 8(th), 2014, to May 5(th), 2019. Internet search data were obtained from a Google Trends (GTD) search for ‘diabetes’ to the corresponding interval. A seasonal autoregressive moving average (SARIMA) model (0,1,1) (1,0,0) [52] was selected to describe the weekly TB case numbers with and without GTD as an external regressor. We cross-validated the SARIMA models to obtain the root mean squared errors (RMSE). We repeated this procedure with autoregressive feed-forward neural network (NNAR) models using 5-fold cross-validation. To simulate a data-poor surveillance setting, we also tested traditional and GTD-extended models against a hold-out dataset using a decreased 52-week-long period with missing values for training. Cross-validation resulted in an RMSE of 20.83 for the traditional model and 18.56 for the GTD-extended model. Cross-validation of the NNAR models showed a mean RMSE of 19.49 for the traditional model and 18.99 for the GTD-extended model. When we tested the models trained on a decreased dataset with missing values, the GTD-extended models achieved significantly better prediction than the traditional models (p

Purpose Although multiple imputation is the state-of-the-art method for managing missing data, mixed models without multiple imputation may be equally valid for longitudinal data. Additionally, it is not clear whether missing values in multi-item instruments should be imputed at item or score-level. We therefore explored the differences in analyzing the scores of a health-related quality of life questionnaire (EQ-5D-5L) using four approaches in two empirical datasets. Methods We used simulated (GR dataset) and observed missingness patterns (ABCD dataset) in EQ-5D-5L scores to investigate the following approaches: approach-1) mixed models using respondents with complete cases, approach-2) mixed models using all available data, approach-3) mixed models after multiple imputation of the EQ-5D-5L scores, and approach-4) mixed models after multiple imputation of EQ-5D 5L items. Results Approach-1 yielded the highest estimates of all approaches (ABCD, GR), increasingly overestimating the EQ-5D-5L score with higher percentages of missing data (GR). Approach-4 produced the lowest scores at follow-up evaluations (ABCD, GR). Standard errors (0.006–0.008) and mean squared errors (0.032–0.035) increased with increasing percentages of simulated missing GR data. Approaches 2 and 3 showed similar results (both datasets). Conclusion Complete cases analyses overestimated the scores and mixed models after multiple imputation by items yielded the lowest scores. As there was no loss of accuracy, mixed models without multiple imputation, when baseline covariates are complete, might be the most parsimonious choice to deal with missing data. However, multiple imputation may be needed when baseline covariates are missing and/or more than two timepoints are considered.

IntroductionThe actual prevalence of a SARS-CoV-2 infection and the individual assessment of being or having been infected may differ. Facing the great uncertainty—especially at the beginning of the pandemic—and the possibility of asymptomatic or mildly symptomatic, subclinical infections, we evaluate the experience of SARS-CoV-2 antibody screening at a tertiary clinical setting.Methods and analysisAll employees of a tertiary eye centre and a research institute of ophthalmology were offered antibody testing in May 2020, using a sequential combination of different validated assays/antigens and point-of-care (POC) testing for a subset (NCT04446338). Before taking blood, a systematic inquiry into past symptoms, known contacts and a subjective self-assessment was documented. The correlations between serostatus, patient contacts and demographic characteristics were analysed. Different tests were compared by Kappa statistics.ResultsAmong 318 participants, SARS-CoV-2 antibodies were detected in 9 employees. Chemiluminescence assays (chemiluminescence immunoassay and electrochemiluminescence) showed superior specificity and high reproducibility, compared with ELISA and POC results.In contrast to the low seropositivity (2.8%) of healthcare workers, higher than that of the other departments of the hospital, a large proportion mistakenly assumed that they might have already been infected. Antiviral antibody titres increased and remained on a plateau for at least 3 months.ConclusionsThe great demand and acceptance confirmed the benefit of highly sensitive testing methods in the early phase of the pandemic. The coincidence of low seroprevalence and anxious employees may have contributed to internalising the need of hygiene measures.

BackgroundThe translated and culturally adapted German version of the Veterans Rand 36 Items Health Survey (VR-36), and its short form, the VR-12 counterpart, were validated in a German sample of orthopedic (n = 399) and psychosomatic (n = 292) inpatient rehabilitation patients.MethodsThe instruments were analyzed regarding their acceptance, distributional properties, validity, responsiveness and ability to discriminate between groups by age, sex and clinically specific groups. Eligible study participants completed the VR-36 (n = 169) and the VR-12 (n = 177). They also completed validated patient-reported outcome measures (PROs) including the Euroqol-5 Dimensions 5 Level (EQ-5D-5L); Depression, Anxiety and Stress Scale (DASS); Hannover Functional Abilities Questionnaire (HFAQ); and CDC Healthy Days. The VR-12 and the VR-36 were compared to the reference instruments MOS Short Form-12 Items Health Survey (SF-12) version 1.0 and MOS Short Form-36 Items Health Survey (SF-36) version 1.0, using percent of completed items, distributional properties, correlation patterns, distribution measures of known groups validity, and effect size measures.ResultsItem non-response varied between 1.8%/1.1% (SFVR-36/RESF-36) and 6.5%/8.6% (GHVR-36/GHSF-36). PCS was normally distributed (Kolmogorov–Smirnov tests: p > 0.05) with means, standard deviations and ranges very similar between SF-36 (37.5 ± 11.7 [13.8–66.1]) and VR-36 (38.5 ± 10.1 [11.7–67.8]), SF-12 (36.9 ± 10.9 [15.5–61.6]) and VR-12 (36.2 ± 11.5 [12.7–59.3]). MCS was not normally distributed with slightly differing means and ranges between the instruments (MCSVR-36: 36.2 ± 14.2 [12.9–66.6], MCSSF-36: 39.0 ± 15.6 [2.0–73.2], MCSVR-12: 37.2 ± 13.8 [8.4–70.2], MCSSF-12: 39.0 ± 12.3 [17.6–65.4]). Construct validity was established by comparing correlation patterns of the MCSVRand PCSVRwith measures of physical and mental health. For both PCSVRand MCSVRthere were moderate (≥ 0.3) to high (≥ 0.5) correlations with convergent (PCSVR: 0.55–0.76, MCSVR: 0.60–0.78) and small correlations (VR: VR: ConclusionsThe psychometric analysis confirmed that the German VR is a valid and reliable instrument for use in orthopedic and psychosomatic rehabilitation. Yet further research is needed to evaluate its usefulness in other populations.

Background When the EuroQol EQ-5D is applied in settings other than resource allocation, a non–preference-based score may be more appropriate than societal, preference-weighted utility. To develop a psychometric score for the EQ-5D, its structural relationship, ie, how the 5 items/dimensions interrelate, must be understood to inform appropriate methods of summarizing the instrument. Objectives To explore psychometrically derived approaches of elucidating the 5-level EQ-5D (EQ-5D-5L) item structure. Methods Three measurement models were assessed. All 5 items were modeled as reflective indicators using confirmatory factor analysis. EQ-5D-5L items were conceptualized as formative indicators, and other health scales (eg, the short form 36 health survey) were conceptualized as reflective indicators in Multiple Indicators Multiple Causes models (external MIMIC). The EQ-5D-5L items were modeled as a combination of formative and reflective indicators in internal MIMIC models. Results across 9 data sets from various countries and patient groups were examined to determine their robustness. Results All items loaded well (0.63-0.96) in the confirmatory factor analysis except for anxiety/depression (0.20-0.66, excluding 1 outlier). The model fit statistics of the external MIMIC models were poor, and the coefficients of the Self-Care dimension were small. The internal MIMIC model with Mobility, Pain/Discomfort, and Anxiety/Depression as formative indicators and Self-Care and Usual Activities as reflective indicators fit best. The model results of the Spanish valuation data set were outliers. Conclusions Although there were some variations in results across subgroups, the relationship between the items remained robust. The evidence calls for testing of formative/reflective combination approaches to summarize the EQ-5D-5L.

Background The objective of this study was to identify clinical risk factors for COVID-19 in a German outpatient fever clinic that allow distinction of SARS-CoV-2 infected patients from other patients with flu-like symptoms. Methods This is a retrospective, single-centre cohort study. Patients were included visiting the fever clinic from 4th of April 2020 to 15th of May 2020. Symptoms, comorbidities, and socio-demographic factors were recorded in a standardized fashion. Multivariate logistic regression was used to identify risk factors of COVID-19, on the bases of those a model discrimination was assessed using area under the receiver operation curves (AUROC). Results The final analysis included 930 patients, of which 74 (8%) had COVID-19. Anosmia (OR 10.71; CI 6.07–18.9) and ageusia (OR 9.3; CI 5.36–16.12) were strongly associated with COVID-19. High-risk exposure (OR 12.20; CI 6.80–21.90), especially in the same household (OR 4.14; CI 1.28–13.33), was also correlated; the more household members, especially with flu-like symptoms, the higher the risk of COVID-19. Working in an essential workplace was also associated with COVID-19 (OR 2.35; CI 1.40–3.96), whereas smoking was inversely correlated (OR 0.19; CI 0.08–0.44). A model that considered risk factors like anosmia, ageusia, concomitant of symptomatic household members and smoking well discriminated COVID-19 patients from other patients with flu-like symptoms (AUROC 0.84). Conclusions We report a set of four readily available clinical parameters that allow the identification of high-risk individuals of COVID-19. Our study will not replace molecular testing but will help guide containment efforts while waiting for test results.

BackgroundThe translated and culturally adapted German version of the Veterans Rand 36 Items Health Survey (VR-36), and its short form, the VR-12 counterpart, were validated in a German sample of orthopedic (n = 399) and psychosomatic (n = 292) inpatient rehabilitation patients.MethodsThe instruments were analyzed regarding their acceptance, distributional properties, validity, responsiveness and ability to discriminate between groups by age, sex and clinically specific groups. Eligible study participants completed the VR-36 (n = 169) and the VR-12 (n = 177). They also completed validated patient-reported outcome measures (PROs) including the Euroqol-5 Dimensions 5 Level (EQ-5D-5L); Depression, Anxiety and Stress Scale (DASS); Hannover Functional Abilities Questionnaire (HFAQ); and CDC Healthy Days. The VR-12 and the VR-36 were compared to the reference instruments MOS Short Form-12 Items Health Survey (SF-12) version 1.0 and MOS Short Form-36 Items Health Survey (SF-36) version 1.0, using percent of completed items, distributional properties, correlation patterns, distribution measures of known groups validity, confirmatory factor analysis (CFA) and effect size measures.ResultsItem non-response varied between 1.8%/1.1% (SFVR−36/RESF−36) and 6.5%/8.6% (GHVR−36/GHSF−36). PCS was normally distributed (Kolmogorov-Smirnov Tests: p > 0.05) with means, standard deviations and ranges very similar between SF-36 (37.5 ± 11.7[13.8–66.1]) and VR-36 (38.5 ± 10.1[11.7–67.8]), SF-12 (36.9 ± 10.9[15.5–61.6]) and VR-12 (36.2 ± 11.5[12.7–59.3]). MCS was not normally distributed with slightly differing means and ranges between the instruments (MCSVR−36: 36.2 ± 14.2[12.9–66.6], MCSSF−36: 39.0 ± 15.6[2.0-73.2], MCSVR−12: 37.2 ± 13.8[8.4–70.2], MCSSF−12: 39.0 ± 12.3[17.6–65.4]). Construct validity was established by comparing correlation patterns of the MCSVR and PCSVR with measures of physical and mental health. For both PCSVR and MCSVR there were moderate (0.4–0.7) to high (> 0.7) correlations with convergent (PCSVR: 0.55–0.76, MCSVR: 0.60–0.78) and small correlations (VR: VR

Background Since the introduction of the five-level version of the EQ-5D (5L), many studies have comparatively investigated the measurement properties of the original three-level version (3L) with the 5L version. Objective The aim of this study was to consolidate the available evidence on the performance of both instruments. Methods A systematic literature search of studies in the English and German languages was conducted (2007–January 2018) using the PubMed, EMBASE, and PsycINFO (EBSCO) databases, as well as the EuroQol Research Foundation website. Data were extracted and assessed on missing values, distributional properties, informativity indices (Shannon’s H′ and J′), inconsistencies, responsiveness, and test–retest reliability. Results Twenty-four studies were included in the review. Missing values and floor effects (percentage reporting the worst health state) were found to be negligible for both 3L and 5L (

Background Chronic pain and depression are highly comorbid; however, the longitudinal link is only partially understood. This study examined direct and indirect effects of chronic back pain on depression using path analysis in a general population sample, focussing on cognitive mediator variables. Methods Analyses are based on 413 participants (aged 18-75 years) in a population-based postal survey on back pain who reported chronic back pain at baseline. Follow-up data were collected after 1 year. Depression was measured with the Center for Epidemiologic Studies Depression Scale (CES-D). Fear-avoidance-beliefs (FABQ), catastrophizing and helplessness/hopelessness (KRSS) were considered as cognitive mediators. Data were analyzed using path analysis. Results Chronic back pain had no direct effect on depression at follow-up when controlling for cognitive mediators. A mediating effect emerged for helplessness/hopelessness but not for catastrophizing or fear-avoidance beliefs. Conclusions These results support the cognitive mediation hypothesis which assumes that psychological variables mediate the association between pain and depression. The importance of helplessness/hopelessness is of relevance for the treatment of patients with chronic back pain.

Background A five-level version of the EuroQol five-dimensional (EQ-5D) descriptive system (EQ-5D-5L) has been developed, but value sets based on preferences directly elicited from representative general population samples are not yet available. The objective of this study was to develop values sets for the EQ-5D-5L by means of a mapping ("crosswalk") approach to the currently available three-level version of the EQ-5D (EQ-5D-3L) values sets. Methods The EQ-5D-3L and EQ-5D-5L descriptive systems were coadministered to respondents with conditions of varying severity to ensure a broad range of levels of health across EQ-5D questionnaire dimensions. We explored four models to generate value sets for the EQ-5D-5L: linear regression, nonparametric statistics, ordered logistic regression, and item-response theory. Criteria for the preferred model included theoretical background, statistical fit, predictive power, and parsimony. Results A total of 3691 respondents were included. All models had similar fit statistics. Predictive power was slightly better for the nonparametric and ordered logistic regression models. In considering all criteria, the nonparametric model was selected as most suitable for generating values for the EQ-5D-5L. Conclusions The nonparametric model was preferred for its simplicity while performing similarly to the other models. Being independent of the value set that is used, it can be applied to transform any EQ-5D-3L value set into EQ-5D-5L index values. Strengths of this approach include compatibility with three-level value sets. A limitation of any crosswalk is that the range of index values is restricted to the range of the EQ-5D-3L value sets.

Hintergrund Wenig Evidenz besteht in Deutschland fur den differenziellen Einfluss von Sozialschichtindikatoren auf Ruckenschmerzen. Diese Arbeit geht daher der Frage nach, welche Sozialschichtindikatoren bei Berufstatigen mit welchen Ruckenschmerzindikatoren am engsten assoziiert sind.

Objectives The aim of this study was to determine the relationship between iso-body mass index (iso-BMI) and both dental caries status and caries increment among German school children. Methods Six hundred and ninety-four students (age range 9–12 years, mean 10.34 ± 0.56, 48% females) were recruited from the fifth grade of 18 primary schools. Weight, height, and oral health data number of decayed, missing and filled teeth (DMFT) as well as parent/legal guardian questionnaire (measuring SES) were collected during school dental examination at baseline and after one and a half-year follow-up. The body mass index (BMI) was calculated using the international classification system for childhood overweight and obesity (iso-BMI). Statistical analyses were performed using Poisson regression models. Results Iso-BMI was significantly associated with dental caries prevalence and severity in the permanent dentition (P = 0.039). Low-normal weight children had a lower mean DMFT (0.56) than did overweight/obese children (0.70). In addition, a border-line significant association was found between overweight/obese children and caries increment (P = 0.055). Conclusion Although iso-BMI was associated with dental caries prevalence and severity, the association between caries increment and iso-BMI did not reach a statistical significance. Overweight/obese children however acquired more additional carious lesions during the follow-up period than children with low-normal weight.

BACKGROUND: Results from existing studies indicate that different respondent groups' health state valuations in cost-utility analyses are not equivalent.OBJECTIVES: The objectives in our study were to analyse differences in health state valuations among three respondent groups in the context of medical rehabilitation in Germany.METHODS: Using the time trade-off (TTO) technique, valuations of EQ-5D-3L health states were obtained from patients with musculoskeletal diseases, healthy volunteers and health care professionals. We used linear mixed models to predict TTO utilities and specified and tested interaction effects.RESULTS: We identified statistically significant (p < 0.05) differences among the three groups in six out of 42 health states. On average, patients' TTO values were somewhat higher compared with other respondent groups. Most of these differences occurred in severe health states. Mean differences and mean absolute differences were 0.02 and 0.14 for patients vs healthy volunteers and 0.06 and 0.14 for patients vs health care professionals. Furthermore, significant effects among respondents were observed for seven of the 22 possible interactions describing differences between respondent groups. Coefficients associated with significant interaction effects ranged from 0.08 to 0.18 (absolute values).CONCLUSION: The results of our study suggest that TTO valuations of health states differ depending on the specific respondent group from which valuations are obtained. On average, these differences were small. However, researchers and decision makers should remain aware of these differences when interpreting incremental cost-utility assessments.

Background Associations between measures of subjective health and mortality risk have previously been shown. We assessed the impact and comparative predictive performance of a multi-biomarker panel on this association. Methods Data from 4,261 individuals aged 20-79 years recruited for the population-based Study of Health in Pomerania was used. During an average 9.7 year follow-up, 456 deaths (10.7%) occurred. Subjective health was assessed by SF-12 derived physical (PCS-12) and mental component summaries (MCS-12), and a single-item self-rated health (SRH) question. We implemented Cox proportional-hazards regression models to investigate the association of subjective health with mortality and to assess the impact of a combination of 10 biomarkers on this association. Variable selection procedures were used to identify a parsimonious set of subjective health measures and biomarkers, whose predictive ability was compared using receiver operating characteristic (ROC) curves, C-statistics, and reclassification methods. Results In age- and gender-adjusted Cox models, poor SRH (hazard ratio (HR), 2.07; 95% CI, 1.34-3.20) and low PCS-12 scores (lowest vs. highest quartile: HR, 1.75; 95% CI, 1.31-2.33) were significantly associated with increased risk of all-cause mortality; an association independent of various covariates and biomarkers. Furthermore, selected subjective health measures yielded a significantly higher C-statistic (0.883) compared to the selected biomarker panel (0.872), whereas a combined assessment showed the highest C-statistic (0.887) with a highly significant integrated discrimination improvement of 1.5% (p < 0.01). Conclusion Adding biomarker information did not affect the association of subjective health measures with mortality, but significantly improved risk stratification. Thus, a combined assessment of self-reported subjective health and measured biomarkers may be useful to identify high-risk individuals for intensified monitoring.

Background Cachexia, a >10% loss of body-weight, is one factor determining the poor prognosis of pancreatic cancer. Deficiency of L-Carnitine has been proposed to cause cancer cachexia. Findings We screened 152 and enrolled 72 patients suffering from advanced pancreatic cancer in a prospective, multi-centre, placebo-controlled, randomized and double-blinded trial to receive oral L-Carnitine (4 g) or placebo for 12 weeks. At entry patients reported a mean weight loss of 12 ± 2,5 (SEM) kg. During treatment body-mass-index increased by 3,4 ± 1,4% under L-Carnitine and decreased (−1,5 ± 1,4%) in controls (p Conclusion While these data are preliminary and need confirmation they indicate that patients with pancreatic cancer may have a clinically relevant benefit from the inexpensive and well tolerated oral supplementation of L-Carnitine.

Background There are a number of instruments that describe severity and progression of multiple sclerosis and they are increasingly used as endpoints to assess the effectiveness of therapeutic interventions. We examined to what extent the psychometric properties of two accepted instruments – EDSS and MSFC – meet methodological standards and the value they have in clinical trials. Methods We conducted a systematic literature search in relevant databases [MEDLINE (PubMed), ISI Web of Science, EMBASE, PsycINFO & PSYNDEX, CINAHL] yielding 3,860 results. Relevant full-text publications were identified using abstract and then full-text reviews, and the literature was reviewed. Results For evaluation of psychometric properties (validity, reliability, sensitivity of change) of EDSS and MSFC, 120 relevant full-text publications were identified, 54 of them assessed the EDSS, 26 the MSFC and 40 included both instruments. The EDSS has some documented weaknesses in reliability and sensitivity to change. The main limitations of the MSFC are learning effects and the z-scores method used to calculate the total score. However, the methodological criterion of validity applies sufficiently for both instruments. For use in clinical studies, we found the EDSS to be preferred as a primary and secondary outcome measure in recent studies (50 EDSS, 9 MSFC). Conclusions Recognizing their strengths and weaknesses, both EDSS and MSFC are suitable to detect the effectiveness of clinical interventions and to monitor disease progression. Almost all publications identify the EDSS as the most widely used tool to measure disease outcomes in clinical trials. Despite some limitations, both instruments are accepted as endpoints and neither are discussed as surrogate parameters in identified publications. A great advantage of the EDSS is its international acceptance (e.g. by EMA) as a primary endpoint in clinical trials and its broad use in trials, enabling cross-study comparisons.