Scoring the EQ-HWB-S: can we do it without value sets? A non-parametric item response theory analysis.

BACKGROUND: Only one pilot value set (UK) is currently available for the EQ Health and Wellbeing Instrument short version (EQ-HWB-S). As an alternative to preference-weighted scoring, we examined whether a level summary score (LSS) is appropriate for the EQ-HWB-S using Mokken scaling analyses. METHODS: Data from patients, carers and the general population collected during the developmental phase of the EQ-HWB-S in Australia, US and UK were used, noting 3 of 9 items have since undergone revision. EQ-HWB-S data fit was examined using R package Mokken scaling's monotone homogeneity model, utilizing the automated item selection procedure (AISP) as well as Loevinger's scaling coefficients for items and the scale (HS). Manifest monotonicity was assessed by examining whether the cumulative probability for responses at or above each response level did not decrease across the summary score. RESULTS: EQ-HWB-S data were available for 3340 respondents: US = 903, Australia = 514 and UK = 1923. Mean age was 50 ± 18 and 1841 (55%) were female. AISP placed all 9 items of the EQ-HWB-S on a single scale when the lower bound was set to < 0.448. Strong scalability (HS = 0.561) was found for the EQ-HWB-S as a single scale. Stronger scales were formed by separating the psychosocial items (n = 6, HS = 0.683) and physical sensation items (n = 3, HS = 0.713). No violations of monotonicity were found except for the items mobility and daily activities for the subgroups with long-term conditions and UK subjects, respectively. DISCUSSION: As EQ-HWB-S items formed a strong scale and subscales based on Mokken analysis, LSS is a promising weighting-free approach to scoring.

Enhanced Recovery After Surgery (ERAS) Pathways for Aesthetic Breast Surgery: A Prospective Cohort Study on Patient-Reported Outcomes.

BACKGROUND: Patients' expectations of an anticipated timeline of recovery and fear of anesthesia in aesthetic breast surgery have not been studied. OBJECTIVE: This study aims to assess patient anxiety, expectations, and satisfaction after Enhanced Recovery after Surgery (ERAS) pathways for aesthetic breast surgery and the progress of postoperative recovery. MATERIALS AND METHODS: All consecutive patients who underwent aesthetic breast surgery between April 2021 and August 2022 were included in this single-center prospective cohort study. The ERAS protocol consists of more than 20 individual measures in the pre-, intra-, and postoperative period. Epidemiological data, expectations, and recovery were systematically assessed with standardized self-assessment questionnaires, including the International Pain Outcome Questionnaire (IPO), the BREAST-Q or BODY-Q, and data collection forms. RESULTS: In total, 48 patients with a median of 30 years of age were included. Patients returned to most daily activities within 5 days. Eighty-eight percent of patients were able to accomplish daily activities sooner than expected. The time of return to normal daily activities was similar across all procedure types. There was no statistically significant difference regarding postoperative satisfaction between patients who recovered slower (12%) and patients who recovered as fast or faster (88%) than anticipated (p=0.180). Patients reporting fear of anesthesia in the form of conscious sedation significantly diminished from 17 to 4% postoperatively (p<0.001). CONCLUSION: Enhanced Recovery after Surgery (ERAS) pathways for aesthetic breast surgery are associated with rapid recovery and high patient satisfaction. This survey study provides valuable insight into patients' concerns and perspectives that may be implemented in patient education and consultations to improve patient satisfaction following aesthetic treatments. LEVEL OF EVIDENCE IV: 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 .

Danger Zones of the Gluteal Anatomy: Improving the Safety Profile of the Gluteal Fat Grafting.

INTRODUCTION: Knowledge of the vascular anatomy is critical to performing safe gluteal surgery. To date, only the course of the main blood vessels within the muscles has been outlined. These findings are based on MRI and CTA images that do not conform to a topographically standardized and normalized probability distribution. OBJECTIVES: The aim of this study was to develop a three-dimensional mapping of the gluteal zones of high vascular density in relation to anatomical landmarks. MATERIALS AND METHODS: This single-center retrospective cohort analysis comprised all consecutive patients who underwent cone-beam computed tomography (CBCT) scans between January 2016 and October 2021. The location of blood vessels in the gluteal region was allometrically normalized in relation to anatomical landmarks. Moreover, the caliber and area of the blood vessels were assessed. RESULTS: CBCT scans of 32 patients with an average age of 64 ± 12 years (range 34-87 years) were included. Fifty-three percent were female. The median [IQR] caliber of the intramuscular gluteal vessels was 1.47 [1.15-1.88] mm, significantly greater than that of the subcutaneous vessels 1.09 [0.72-1.44] mm (p < 0.001). Vascular density was higher intramuscularly, as 4.5% of the area of the muscle was occupied by blood vessels, as opposed to 0.3% in the adipose tissue. CONCLUSION: The analysis of the CBCT scans showed a higher vascular density and larger vessels intramuscularly. We, therefore, recommend the injection of autologous fat merely to the subcutaneous plane. LEVEL OF EVIDENCE II: 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 .

Predicting complicated appendicitis is possible without the use of sectional imaging-presenting the NoCtApp score.

PURPOSE: Appendicitis is among the most common acute conditions treated by general surgery. While uncomplicated appendicitis (UA) can be treated delayed or even non-operatively, complicated appendicitis (CA) is a serious condition with possible long-term morbidity that should be managed with urgent appendectomy. Distinguishing both conditions is usually done with computed tomography. The goal of this study was to develop a model to reliably predict CA with widespread available clinical and laboratory parameters and without the use of sectional imaging. METHODS: Data from 1132 consecutive patients treated for appendicitis between 2014 and 2021 at a tertiary care hospital were used for analyses. Based on year of treatment, the data was divided into training (n = 696) and validation (n = 436) samples. Using the development sample, candidate predictors for CA-patient age, gender, body mass index (BMI), American Society of Anesthesiologist (ASA) score, duration of symptoms, white blood count (WBC), total bilirubin and C-reactive protein (CRP) on admission and free fluid on ultrasound-were first investigated using univariate logistic regression models and then included in a multivariate model. The final development model was tested on the validation sample. RESULTS: In the univariate analysis age, BMI, ASA score, symptom duration, WBC, bilirubin, CRP, and free fluid each were statistically significant predictors of CA (each p < 0.001) while gender was not (p = 0.199). In the multivariate analysis BMI and bilirubin were not predictive and therefore not included in the final development model which was built from 696 patients. The final development model was significant (x2 = 304.075, p < 0.001) with a sensitivity of 61.7% and a specificity of 92.1%. The positive predictive value (PPV) was 80.4% with a negative predictive value (NPV) of 82.0%. The receiver operator characteristic of the final model had an area under the curve of 0.861 (95% confidence interval 0.830-0.891, p < 0.001. We simplified this model to create the NoCtApp score. Patients with a point value of ≤ 2 had a NPV 95.8% for correctly ruling out CA. CONCLUSIONS: Correctly identifying CA is helpful for optimizing patient treatment when they are diagnosed with appendicitis. Our logistic regression model can aid in correctly distinguishing UA and CA even without utilizing computed tomography.

Enhanced Recovery After Aesthetic Breast Surgery Under Sedation, Intercostal Block and Tumescent Anaesthesia: A Prospective Cohort Study of the Early Postoperative Phase.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. LEVEL OF EVIDENCE IV: 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 .

Definitions of Abnormal Breast Size and Asymmetry: A Cohort Study of 400 Women.

BACKGROUND: Macromastia, micromastia and breast asymmetry have an impact on health and quality of life. However, there is scarce information addressing breast size and asymmetry frequency distribution in reference populations. OBJECTIVE: The current study aims to identify factors that influence breast size and symmetry and classifies abnormal breast sizes and breast asymmetries in an adult German population. METHODS: Breast base dimensions, breast volume, symmetry, and other breast anthropometric parameters of 400 German female patients were determined in a retrospective review of the MRI archives at our institution. Professional medical MRI-segmentation software was used for volume measurement. RESULTS: A total of 400 Patients were retrospectively enrolled. The patients had a mean age of 50 ± 12 years (min: 24; max: 82), mean BMI of 25.0 ± 5.0 (min: 14.7, max: 45.6), and a mean total breast volume of 976 ml (right: 973 ml, min: 64, max: 4777; left: 979 ml, min: 55, max: 4670). The strongest correlation of breast volume was observed with BMI (r = 0.834, p < 0.001), followed by breast base width (r = 0.799, p < 0.001). Smaller breasts have higher breast volume asymmetry ratios (r = - 0.124, p < 0.014). For a BMI between 18.5 and 24.9 kg/m2, micromastia is defined by breast volumes below 250 ml (5th percentile) and macromastia by volumes above 1250 ml (95th percentile). Abnormal breast volume asymmetry (< 5th and > 95th percentile) is equivalent to an absolute difference of approximately 25% relative to the smallest side (bidirectional asymmetry ratio 5th percentile - 19%; 95th percentile 26%). CONCLUSION: This study provides normative data of German women, as well as selected size-for-BMI percentiles and asymmetry ratio percentiles. The normative data may help to establish transparent and objective coverage criteria for health insurances. LEVEL OF EVIDENCE IV: 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 .

Quantification of Breast Volume According to age and BMI: A Three-Dimensional MRI Analysis of 400 Women.

OBJECTIVE: 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. MATERIALS AND METHODS: 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. RESULTS: 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, p<0.01) and moderately with age (r=0.305, p<0.01). 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. CONCLUSION: 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. LEVEL OF EVIDENCE IV: 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 .

Combining EQ-5D-5L items into a level summary score: demonstrating feasibility using non-parametric item response theory using an international dataset.

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.

What difference does multiple imputation make in longitudinal modeling of EQ-5D-5L data? Empirical analyses of simulated and observed missing data patterns.

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.

Translation and adaptation of the German version of the Veterans Rand-36/12 Item Health Survey.

BACKGROUND: The 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. METHODS: The 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. RESULTS: Item 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 (≥ 0.3) to high (≥ 0.5) correlations with convergent (PCSVR: 0.55-0.76, MCSVR: 0.60-0.78) and small correlations (< 0.1) with divergent (PCSVR: < 0.12, MCSVR: < 0.16) self-report measures. Known-groups validity was demonstrated for both VR-12 and VR-36 (MCS and PCS) via comparisons of distribution parameters with significant higher mean PCS and MCS scores in both VR instruments found in younger patients with fewer sick days in the last year and a shorter duration of rehabilitation. CONCLUSIONS: The 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.

Psychometric properties of the EQ-5D-5L: a systematic review of the literature.

PURPOSE: Although 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. METHODS: Pre-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. RESULTS: Of 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. CONCLUSIONS: The EQ-5D-5L exhibits excellent psychometric properties across a broad range of populations, conditions and settings. Rigorous exploration of its responsiveness is needed.

Exploring the Internal Structure of the EQ-5D Using Non-Preference-Based Methods.

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.

Measuring changes in health over time using the EQ-5D 3L and 5L: a head-to-head comparison of measurement properties and sensitivity to change in a German inpatient rehabilitation sample.

PURPOSE: To compare measurement properties and sensitivity to change of the standard version of the EQ-5D (3L) with a newly developed 5-level version (5L) in a multicenter sample of German rehabilitation inpatients (n = 230). METHODS: Rehabilitation patients (n = 114 orthopedic, n = 54 psychosomatic, n = 62 rheumatic) were asked to complete both versions of the EQ-5D and several other questionnaires at the beginning of, the end of and 3 month after inpatient rehabilitation. 3L and 5L were compared regarding missing values, ceiling effects, redistribution properties, informativity and sensitivity to change. RESULTS: There were nearly no missing values in both questionnaires. Ceiling effects were 1.6 % points to 16.4 % points lower on average for the 5L. For psychosomatic patients, ceiling effects for 5L were as high as in the general German population. Absolute informativity (mean 5L: 1.76, 3L: 1.06) and relative informativity (5L: 0.76, 3L: 0.67) were both higher for 5L. 5L could better detect both positive and negative health changes in most dimensions and patient samples. Overall, patients made better use of the response levels of the 5L. Average proportion of inconsistent responses between 3L and 5L was 6.1 %. CONCLUSIONS: Cross-sectionally and longitudinally, 5L was associated with an improved ability to detect health changes over time, reduced ceiling effects, and improved discriminatory power. Overall, these findings were in line with previous study outcomes, although differing in magnitude. Since the sample size is moderate and generalizability of the reported results is unclear, further comparisons in other patient populations will be informative and should be encouraged.

Overweight and dental caries: the association among German children.

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.

Systematic literature review and validity evaluation of the Expanded Disability Status Scale (EDSS) and the Multiple Sclerosis Functional Composite (MSFC) in patients with multiple sclerosis.

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.

Occupational health literacy and work ability: a moderation analysis including interpersonal and organizational factors in healthy organizations.

Introduction: Healthy organizations approach to occupational safety and health should holistically include individual, interpersonal, and organizational levels. There is an empirical research gap in considering different levels in organizations for health promotion in the context of maximizing work ability. This study aims to investigate the association of (1) occupational health literacy (on an individual level), (2) health-oriented leadership (interpersonal level), (3) participation possibilities in health, and (4) values of health in companies (both organizational levels) on work ability. Additionally, we examined the potentially moderating role of health-oriented leadership, participation possibilities in health, and values of health between occupational health literacy and work ability. Methods: Cross-sectional data were obtained from 828 employers and employees in small and medium-sized enterprises. Self-report measures included occupational health literacy, health-oriented leadership, work ability, participation possibilities in health at work, and values of health in the company. Occupational health literacy comprises two factors: a knowledge-/skill-based approach to occupational health and a willingness/responsibility for occupational health. Participation possibilities in health are measured regarding participatory opportunities and co-creation of health at work. Values of health in the company capture the importance of health in the workplace and the scope for improving employees' health. Data were analyzed using latent regression and latent moderation analyses controlling for age, gender, and educational level. Results: Occupational health literacy (knowledge-/skill-based), health-oriented leadership, participation possibilities in health, and values of health in companies showed positive associations with work ability. Health-oriented leadership on an interpersonal level was found to moderate the positive relationship between (knowledge-/skill-based) occupational health literacy and work ability. Participation possibilities in health on an organizational level acted as a moderator on the relationship between both occupational health literacy factors and work ability. Discussion: Individual, interpersonal, and organizational factors play important roles in maintaining work ability in healthy organizations. This study highlights the importance of promoting occupational health literacy among employees and leaders, creating a healthy workplace through health-oriented leadership, and providing participatory opportunities for co-creation in health promotion at work. Future research should further explore these factors' roles in different industries and contexts and how they may be addressed effectively in tailored workplace interventions.

Prospective study of complications and sequelae of glucocorticoid therapy in ANCA-associated vasculitis.

OBJECTIVE: Glucocorticoids (GC) are a cornerstone in treating antineutrophil cytoplasmic antibodies-associated vasculitides (AAV), however, they add to morbidity and mortality. To date, GC toxicity in AAV has rarely been systematically investigated. METHODS: Patients with a confirmed AAV were included in this monocentric prospective study. GC toxicity was assessed by structured interviews, clinical examination and electronic medical record analysis. The Glucocorticoid Toxicity Index (GTI) consisting of the Aggregate Improvement Score (GTI-AIS) and the Cumulative Worsening Score (GTI-CWS) was assessed at two time points (t1 baseline, t2 6 months later). We used regression analyses to assess the relationship between GTI and GC exposure, toxicity, and disease activity, and a receiver operating characteristic analysis to calculate a GC threshold dose beyond which toxicity is expected to occur. RESULTS: We included 138 patients with AAV. The median cumulative GC dose was 9014.0 mg. The most frequent adverse events were skin atrophy, osteoporosis and myopathy. GC exposure and toxicity were significantly correlated (p<0.001). GTI-AIS was significantly higher in active disease compared with patients in remission (p<0.001). GTI-CWS scored significantly higher in long-standing diseases (p=0.013) with high cumulative GC doses (p=0.003). Patients with a cumulative GC dose of 935 mg or more showed an 80% likelihood for a clinically meaningful change in GTI scoring. CONCLUSION: The GTI is capable of capturing GC toxicity in AAV and identifies patients at increased risk for GC side effects. Our data support efforts to limit GC exposure in patients with AAV.

Fast 5-minute shoulder MRI protocol with accelerated TSE-sequences and deep learning image reconstruction for the assessment of shoulder pain at 1.5 and 3 Tesla.

Purpose: The objective of this study was to implement a 5-minute MRI protocol for the shoulder in routine clinical practice consisting of accelerated 2D turbo spin echo (TSE) sequences with deep learning (DL) reconstruction at 1.5 and 3 Tesla, and to compare the image quality and diagnostic performance to that of a standard 2D TSE protocol. Methods: Patients undergoing shoulder MRI between October 2020 and June 2021 were prospectively enrolled. Each patient underwent two MRI examinations: first a standard, fully sampled TSE (TSES) protocol reconstructed with a standard reconstruction followed by a second fast, prospectively undersampled TSE protocol with a conventional parallel imaging undersampling pattern reconstructed with a DL reconstruction (TSEDL). Image quality and visualization of anatomic structures as well as diagnostic performance with respect to shoulder lesions were assessed using a 5-point Likert-scale (5 = best). Interchangeability analysis, Wilcoxon signed-rank test and kappa statistics were performed to compare the two protocols. Results: A total of 30 participants was included (mean age 50±15 years; 15 men). Overall image quality was evaluated to be superior in TSEDL versus TSES (p<0.001). Noise and edge sharpness were evaluated to be significantly superior in TSEDL versus TSES (noise: p<0.001, edge sharpness: p<0.05). No difference was found concerning qualitative diagnostic confidence, assessability of anatomical structures (p>0.05), and quantitative diagnostic performance for shoulder lesions when comparing the two sequences. Conclusions: A fast 5-minute TSEDL MRI protocol of the shoulder is feasible in routine clinical practice at 1.5 and 3 T, with interchangeable results concerning the diagnostic performance, allowing a reduction in scan time of more than 50% compared to the standard TSES protocol.

Pulmonary function in patients with ANCA-associated vasculitis.

BACKGROUND AND AIM: Although pulmonary manifestations occur frequently in ANCA-associated vasculitis (AAV), empirical evidence of their impact on pulmonary function is scarce. This study analyzed pulmonary function test (PFT) data from a large cohort of patients with AVV. Results were correlated with findings from diagnostic imaging and disease activity. METHODS: Data from AAV patients with PFTs performed between 2008 and 2018 were extracted retrospectively from the database of a tertiary vasculitis center. Demographic and disease characteristics, imaging data and follow-up results were assessed and compared to PFT results. RESULTS: The final analysis encompassed 147 patients. The mean time between first PFT and follow-up was 7.0 ± 11.0 months. In Granulomatosis with Polyangiitis (GPA), forced expiratory vital capacity (FVCex, p<0.001), residual volume (RV, p<0.001) and the diffusion capacity of carbon oxide (TLCO, p=0.003) were significantly reduced compared to the reference value of 100% predicted. There was no significant difference between patients with or without pulmonary manifestations. In Microscopic Polyangiitis (MPA), reductions of FVCex (p<0.001), TLC (p=0.005), and TLCO (p=0.003) were observed. In Eosinophilic Granulomatosis with Polyangiitis (EGPA), total airway resistance (RAWtot, p=0.024) and RV (p=0.009) were significantly elevated and TLCO was reduced (p=0.014). Interstitial lung disease (ILD) is associated with a decline of FVCex (-15.7%, p=0.0028), TLC (-26.5%, p<0.001), RV (-38.9%, p=0.023) and TLCO (-29.1%, p=0.007). Significant differences were neither detected between first PFT and follow-up examination, nor between patients with active versus inactive disease. CONCLUSIONS: AAV patients presented with characteristic alterations in PFTs according to their respective pulmonary and/or airway manifestations. These results did not change over time and were independent from vasculitis activity.

Quantification of Facial Fat Compartment Variations: A Three-Dimensional Morphometric Analysis of the Cheek.

BACKGROUND: Cheek contour is a main determinant of facial attractiveness. The aim of this study was to evaluate the relationship between age, sex, and body mass index (BMI) and cheek fat volume in a large cohort to better understand and treat facial aging. METHODS: The authors performed a retrospective review of the archives of the Department of Diagnostic and Interventional Radiology, University Hospital of Tübingen. Epidemiologic data and medical history were assessed. Cheek superficial and deep fat compartment volumes were measured on magnetic resonance images. Statistical analyses were performed using SPSS and SAS statistical software. RESULTS: A total of 87 patients with a mean age of 46 years (range, 18 to 81 years) were included. The superficial and deep fat compartment volumes of the cheek increased with BMI ( P < 0.001 and P = 0.005), but there was no significant relationship between age and volume. The ratio of superficial versus deep fat did not change with age. No significant difference of the superficial or deep fat compartments was found between men and women in a regression analysis ( P = 0.931 and P = 0.057). CONCLUSIONS: Cheek fat volume measurements on magnetic resonance imaging scans using reconstruction software suggest that the fat volume of the cheek increases with BMI but does not change significantly with age. Further studies are needed to elucidate the role of age-related changes of bone structures or sagging of the fat compartments.