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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. [ABSTRACT FROM AUTHOR]

We analyzed symptoms and comorbidities as predictors of hospitalization in 710 outpatients in North-East Germany with PCR-confirmed SARS-CoV-2 infection. During the first 3 days of infection, commonly reported symptoms were fatigue (71.8%), arthralgia/myalgia (56.8%), headache (55.1%), and dry cough (51.8%). Loss of smell (anosmia), loss of taste (ageusia), dyspnea, and productive cough were reported with an onset of 4 days. Anosmia or ageusia were reported by only 18% of the participants at day one, but up to 49% between days 7 and 9. Not all participants who reported ageusia also reported anosmia. Individuals suffering from ageusia without anosmia were at highest risk of hospitalization (OR 6.8, 95% CI 2.5–18.1). They also experienced more commonly dyspnea and nausea (OR of 3.0, 2.9, respectively) suggesting pathophysiological connections between these symptoms. Other symptoms significantly associated with increased risk of hospitalization were dyspnea, vomiting, and fever. Among basic parameters and comorbidities, age > 60 years, COPD, prior stroke, diabetes, kidney and cardiac diseases were also associated with increased risk of hospitalization. In conclusion, due to the delayed onset, ageusia and anosmia may be of limited use in differential diagnosis of SARS-CoV-2. However, differentiation between ageusia and anosmia may be useful for evaluating risk for hospitalization. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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Objective: The aim of this study was to compare online, unsupervised and face-to-face (F2F), supervised valuation of EQ-5D-5L health states using composite time trade-off (cTTO) tasks.Methods: The official EuroQol experimental design and valuation protocol for the EQ-5D-5L of 86 health states were implemented in interviewer-assisted, F2F and unsupervised, online studies. Validity of preferences was assessed using prevalence of inconsistent valuations and expected patterns of TTO values. Respondent task engagement was measured using number of trade-offs and time per task. Trading patterns such as better-than-dead only was compared between modes. Value sets were generated using linear regression with a random intercept (RILR). Value set characteristics such as range of scale and dimension ranking were evaluated between modes.Results: Five hundred one online and 1,134 F2F respondents completed the surveys. Mean elicited TTO values were higher online than F2F when compared by health state severity. Compared to F2F, a larger proportion of online respondents did not assign the poorest EQ-5D-5L health state (i.e., 55555) the lowest TTO value ([Online] 41.3% [F2F] 12.2%) (p < 0.001). A higher percentage of online cTTO tasks were completed in 3 trade-offs or fewer ([Online] 15.8% [F2F] 3.7%), (p < 0.001). When modeled using the RILR, the F2F range of scale was larger than online ([Online] 0.600 [F2F] 1.307) and the respective dimension rankings differed.Conclusions: Compared to F2F data, TTO tasks conducted online had more inconsistencies and decreased engagement, which contributed to compromised data quality. This study illustrates the challenges of conducting online valuation studies using the TTO approach. [ABSTRACT FROM AUTHOR]

Background Web-based surveys are increasingly utilized for health valuation studies but may be more prone to lack of engagement and, therefore, poor data validity. The objective of this study was to evaluate the effect of imposed engagement (i.e., at least three trade-offs) in the composite time trade-off (cTTO) task. Methods The EQ-5D-5L valuation study protocol and study design were adapted for online, unsupervised completion in two arms: base case and engagement. Validity of preferences was assessed using the prevalence of inconsistent valuations and expected patterns of TTO values. Respondent task engagement was measured using time per task. Value sets were generated using linear regression with a random intercept (RILR). Results The base case (n = 501) and engagement arms (n = 504) clustered at different TTO values: [base case] 0, 1; [engagement] -0.5, 0.45, 0.6. Mean TTO values were lower for the engagement arm. Engagement respondents did not spend more time per TTO task: [base case] 63.3 s (SD 77.9 s); [engagement] 64.7 s (SD 73.3 s); p = 0.36. No significant difference was found between arms for prevalence of respondents with at least one inconsistent TTO value: [base case] 61.1%; [engagement] 63.5%; p = 0.43. Both value sets had significant intercepts far from 1: [base case] 0.846; [engagement] 0.783. The relative importance of the EQ-5D dimensions also differed between arms. Conclusions Both online arms had poor quality data. A minimum trade-off threshold did not improve engagement nor face validity of the data, indicating that modifications to the number of iterations are insufficient alone to improve data quality/ validity of online TTO studies. [ABSTRACT FROM AUTHOR]

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Background: This study aimed to prospectively investigate patients' satisfaction with briefings before computed tomography (CT) examinations, determine feasibility, and identify factors influencing patient satisfaction independent of patient and physician characteristics. Methods: One hundred sixty patients received information by a radiologist prior to contrast-enhanced CT examinations in an open, prospective, two-center, cross-sectional study (including the introduction of the radiologist, procedure, radiation exposure, possible side effects, and alternatives). Afterwards, patients and radiologists evaluated the briefing using a standardized questionnaire. Additionally, factors such as age, socioeconomic status, inpatient/outpatient status, length of the radiologist's professional experience, duration of the briefing, clarity of the radiologist's explanations as perceived by patients, and the duration of communication were obtained in this questionnaire. Subsequently, three classes of influencing factors were defined and entered stepwise into a hierarchical regression. Results: Patient satisfaction ratings differed significantly by type of hospitalization, perceived type of communication, and patient gender. Hierarchical regression analysis revealed that perceived clarity was the strongest predictor of patients' satisfaction when controlling for the patient and physician characteristics. Conclusions: Patients appeared to be satisfied with the briefing prior to CT examination. The mean briefing time (2 min 35 s) seemed feasible. Patients' demographics influenced satisfaction. To improve patients' satisfaction with briefings before contrast-enhanced CT, radiologists should aim to clarify their communication. [ABSTRACT FROM AUTHOR]

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 (< 5%). From 18 studies, inconsistencies ranged from 0 to 10.6%, although they were generally well below 5%, with 9 studies reporting the most inconsistencies for Usual Activities (mean percentage 4.1%). Shannon's indices were always higher for 5L than for 3L, and all but three studies reported lower ceiling effects ('11111') for 5L than for 3L. There is mixed and insufficient evidence on responsiveness and test-retest reliability, although results on index values showed better performance for 5L on test-retest reliability.Conclusion: Overall, studies showed similar or better measurement properties of the 5L compared with the 3L, and evidence indicated moderately better distributional parameters and substantial improvement in informativity for the 5L compared with the 3L. Insufficient evidence on responsiveness and test-retest reliability implies further research is needed. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate a visual acuity test (VAT) with unexpected optotypes to detect malingering. Methods: We tested two groups. Group 1 consisted of 20 individuals with normal best corrected visual acuity (BCVA). Group 2 included participants with ocular diseases and reduced BCVA. All subjects underwent a VAT proposed by Gräf and Roesen to assess suspected malingering. This test used 36 charts with one Landolt-C per page. The first 20 optotypes were Landolt-Cs, while at positions 21, 26, 30, and 34 closed rings were presented. The testing distance was adapted to 50% of the test person's visual acuity. The test person was requested to name the gap direction of the Landolt-C within 3 s. The complete testing conversation was recorded digitally to determine response latency for each optotype from the audio tracks. Results: The average response time was 0.46 s in group 1 and 0.45 s in group 2 for the first 20 Landolt-Cs. In both groups the response time was significantly extended ( p < 0.05) for the first closed ring compared to the mean of the first 20 Landolt-Cs, (group 1: 2.9 s; group 2: 2.3 s). The following three closed rings had also longer response times. However, these differences were not significant. Conclusions: Our results suggest that the proposed test may be helpful to evaluate ocular malingering. The testing procedure appeared to be feasible and showed good repeatability. The fast training effect may be a limitation for malingering detection. [ABSTRACT FROM AUTHOR]

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Since the introduction of new oral anticoagulants (NOACs), besides vitamin-K antagonists, an additional option for stroke prevention of patients with atrial fibrillation (AF) is available. The objective of this study was to assess AF patients' preferences with regard to the attributes of these different treatment options. We conducted a multicenter study among randomly selected physicians. Preferences were assessed by computer-assisted telephone interviews. We used a discrete-choice-experiment (DCE) with four convenience-related treatment dependent attributes (need of bridging: yes/no, interactions with food/nutrition: yes/no, need of INR controls/dose adjustment: yes/no; frequency of intake: once/twice daily) and one comparator attribute (distance to practitioner: <1 km/>15 km). Preferences measured in the interviews were analyzed descriptively and based on a conditional logit regression model. A total of 486 AF patients (age: 73.9 ± 8.2 years; 43.2 % female; mean CHA2DS2-VASc: 3.7 ± 1.6; current medication: 48.1 % rivaroxaban, 51.9 % VKA) could be interviewed. Regardless of type of medication, patients significantly preferred the attribute levels (in order of patients' importance) 'once daily intake' (Level: once = 1 vs. twice = 0; Coefficient = 0.615; p < 0.001), 'bridging necessary' (yes = 1 vs. no = 0; −0.558; p < 0.001), 'distance to practitioner of ≤1 km (>15 km = 0 vs. ≤1 km = 1; 0.494; p < 0.001), 'interactions with food/nutrition' (yes = 1 vs. no = 0; −0.332; p < 0.001) and 'need of INR controls/dose adjustment' (yes = 1 vs. no = 0; −0.127; p < 0.001). In our analyses, 'once daily frequency of intake' was the most important OAC-attribute for patients' choice followed by 'no bridging necessary' and 'no interactions with food/nutrition'. Thus, patients with AF seem to prefer treatment options which are easier to administer. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to identify, document, and weight attributes of a pain medication that are relevant from the perspective of patients with chronic pain. Within the sub-population of patients suffering from 'chronic neuropathic pain', three groups were analyzed in depth: patients with neuropathic back pain, patients with painful diabetic polyneuropathy, and patients suffering from pain due to post-herpetic neuralgia. The central question was: 'On which features do patients base their assessment of pain medications and which features are most useful in the process of evaluating and selecting possible therapies?' Methods: A detailed literature review, focus groups with patients, and face-to-face interviews with widely recognized experts for pain treatment were conducted to identify relevant treatment attributes of a pain medication. A pre-test was conducted to verify the structure of relevant and dominant attributes using factor analyses by evaluating the most frequently mentioned representatives of each factor. The Discrete-Choice Experiment (DCE) used a survey based on self-reported patient data including socio-demographics and specific parameters concerning pain treatment. Furthermore, the neuropathic pain component was determined in all patients based on their scoring in the painDETECT questionnaire. For statistical data analysis of the DCE, a random effect logit model was used and coefficients were presented. Results: A total of 1,324 German patients participated in the survey, of whom 44 % suffered from neuropathic back pain (including mixed pain syndrome), 10 % complained about diabetic polyneuropathy, and 4 % reported pain due to post-herpetic neuralgia. A total of 36 single quality aspects of pain treatment, detected in the qualitative survey, were grouped in 7 dimensions by factor analysis. These 7 dimensions were used as attributes for the DCE. The DCE model resulted in the following ranking of relevant attributes for treatment decision: 'no character change', 'less nausea and vomiting', 'pain reduction' (coefficient: >0.9 for all attributes, 'high impact'), 'rapid effect', 'low risk of addiction' (coefficient ~0.5, 'middle impact'), 'applicability with comorbidity' (coefficient ~0.3), and 'improvement of quality of sleep' (coefficient ~0.25). All attributes were highly significant ( p < 0.001). Conclusions: The results were intended to enable early selection of an individualized pain medication. The results of the study showed that DCE is an appropriate means for the identification of patient preferences when being treated with specific pain medications. Due to the fact that pain perception is subjective in nature, the identification of patients´ preferences will enable therapists to better develop and implement patient-oriented treatment of chronic pain. It is therefore essential to improve the therapists´ understanding of patient preferences in order to make decisions concerning pain treatment. DCE and direct assessment should become valid instruments to elicit treatment preferences in chronic pain. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Purpose: The health state classifier EQ-5D of the EuroQoL group has been expanded to a 5-level instrument (EQ-5D-5L), but studies on psychometric properties of this new instrument, applied to the general population, are rare. Methods: A sample of 2,469 subjects, representatively selected from the German general population, was asked to fill in the EQ-5D-5L and several other questionnaires. Crude sum scores of the EQ-5D-5L were calculated and compared with scores derived from two sets of utilities, one from a German and one from a UK sample. Results: The mean sum score (0-100 scale) was 91.5. Males reported better health states than females, and there was a nearly linear age trend. The list of the 45 most frequent health patterns (those with at least 0.2 % of the respondents) showed that almost half of the participants (47.5 %) responded being in the optimal health state, indicating a ceiling effect. Correlations between EQ-5D-5L scores and other questionnaires were very similar for all three scoring systems of the EQ-5D-5L. Finally, normative scores are given on the basis of sum scores. Conclusions: The applicability of the EQ-5D-5L in the general population is limited because of the skewness. Sum scores are useful because of their simplicity, international generalizability, and construct validity. [ABSTRACT FROM AUTHOR]

Objectives: Little is known about the psychosocial impact and subjective interpretation of communicated incide ntal findings from whole-body magnetic resonance imaging (wb-MRI). This was addressed with this general population study.Methods: Data was based on the Study of Health in Pomerania (SHIP), Germany. SHIP comprised a 1.5-T wb-MRI examination. A postal survey was conducted among the first 471 participants, aged 23-84 years, who received a notification about incidental findings (response 86.0 %, n = 405). The severity of incidental findings was assessed from the participants' and radiologists' perspective.Results: In total, 394 participants (97.3 %) wanted to learn about their health by undergoing wb-MRI. Strong distress while waiting for a potential notification of an incidental finding was reported by 40 participants (9.9 %), whereas 116 (28.6 %) reported moderate to severe psychological distress thereafter. Strong disagreement was noted between the subjective and radiological evaluation of the findings' severity (kappa = 0.02). Almost all participants (n = 389, 96.0 %) were very satisfied with their examination.Conclusions: Despite the high satisfaction of most participants, there were numerous adverse consequences concerning the communication of incidental findings and false expectations about the likely potential benefits of whole-body-MRI.Key Points: • Disclosed incidental findings from MRI may lead to substantial psychosocial distress. • Subjective and radiological evaluations of incidental findings' severity differ strongly. • Disclosing incidental findings is strongly endorsed by study volunteers. • Study volunteers tend to have false expectations about potential benefits from MRI. • Minimizing stress in study volunteers should be a key aim in MRI research. [ABSTRACT FROM AUTHOR]

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EQ-5D, HUI II and SF-6D often produce very different valuations for the same health state. This paper aims at clarifying to what extent this might be caused by differences between the multi-attribute classification systems belonging to these instruments. Subjects were 264 patients of rehabilitation clinics in Mecklenburg-Western Pomerania (44.3% female; mean age 49.1) who completed the EQ-5D, the HUI II and the SF-36 (the basis of the SF-6D). After scaling with principal component analyses for categorical data, each attribute of each classification system was regressed on the classification systems of the other two instruments, and all attributes together were subjected to ordinary principal component analysis with varimax rotation. Adjusted multiple R2 for regression analyses ranged from 0.01 to 0.57. The HUI II attribute ‘sensation’ and the SF-6D attribute ‘role limitation’ are virtually unrelated to the remainder. All other attributes of all three instruments can be predicted by each other. EQ-5D and HUI II focus distinctly more on physical functioning than SF-6D. Although all three classification systems have a lot in common, they differ so much that EQ-5D, HUI II and SF-6D would produce different valuations even if these valuations were determined according to the same principle. [ABSTRACT FROM AUTHOR]

To compare the EQ-5D, 15D, HUI 2, HUI 3, SF-6D, and QWB-SA in terms of their descriptive statistics, score distribution, agreement and responsiveness in a sample of German rehabilitation inpatients. Patients with musculoskeletal ( N = 106), cardiovascular ( N = 88), and psychosomatic ( N = 70) disorders completed questionnaires at the beginning (baseline) and end (follow-up) of their inpatient treatment. Comparisons addressed the proportion of missing data, distributional properties, agreement, and responsiveness. Intraclass correlation coefficients (ICC), paired t-tests, and standardized response means (SRM) were computed. Mean index scores at baseline ranged from 0.48 (HUI 3; psychosomatic) to 0.86 (15D; cardiovascular). At baseline, ceiling effects across all patient groups ranged from zero (SF-6D; cardiovascular and psychosomatic) to 21.6% (EQ-5D; cardiovascular). ICCs ranged from 0.26 (EQ-5D–QWB-SA; cardiovascular) to 0.80 (HUI 2–HUI 3; musculoskeletal). Substantial differences in responsiveness were observed between measures. Results obtained with different preference-based quality-of-life measures in a sample of patients with mild to moderate disease severity are not equivalent. As differences between measures may have considerable effects in health economic evaluation studies, careful selection of instruments for a given study is essential. [ABSTRACT FROM AUTHOR]

Monitoring the health status of patients has become a major activity in rehabilitation research in recent years. As a result, various self-assessment instruments have been developed, adapted or improved with the aim of measuring patient-reported outcomes and predictors. Among these are international instruments, such as the NHP or the SF-36, as well as those developed in Germany, such as the IRES, the FREM-17 or the SPE-scale. Some of the widely used international instruments, such as the NHP and SF-36, have been translated into German for application in Germany. All of these instruments have been thoroughly tested and validated in several studies. Current trends in statistical methods (e.g. responsiveness, Rasch scaling) as well as classical test-theoretical standards were taken into consideration in the development of these instruments. In this article, we provide a comprehensive review of five important assessment fields of rehabilitation research in Germany: health-related quality of life (generic, disease-specific, children and adolescents, preference-based), evaluation of specific therapy and education programs, motivation, screening for vocational problems and screening for comorbid disorders. The questionnaires are critically discussed, and perspectives for further research are specified. Although assessment instruments as the IRES or the SF-36 are well-established in rehabilitation research studies, there is still a need for further research to determine the best choice of instruments for a given purpose. The limitations of the questionnaires with respect to health care studies are also discussed. [ABSTRACT FROM AUTHOR]

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Copyright of Social & Preventive Medicine is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Objective: The international development of the Parents' Index of Quality of Life in Atopic Dermatitis (PIQoL-AD), a quality of life (QoL) instrument specific to parents of children with atopic dermatitis (AD) is described.Method: The instrument was developed simultaneously in several countries. Its content was derived from 65 qualitative interviews with parents in the UK, Netherlands and Italy. The measure was then produced for the UK, Netherlands, Italy, Germany, France, US and Spain. Field-test interviews were conducted with approximately 20 patients in each country to assess face and content validity. A two time-point survey was conducted with between 45 and 328 parents in each country to finalise the instrument through application of the Rasch model and to evaluate the psychometric properties of the final instrument.Results: Application of the Rasch model to the survey data identified the final 28-item version. All language versions had good item fit, test-retest reliability (above 0.85), internal consistency and promising validity.Conclusions: The PIQoL-AD is a valuable instrument for inclusion in clinical trials and routine clinical practice. It provides distinct and complementary information to that of existing dermatology-specific measures and has been shown to be responsive to changes in QoL in clinical trials. [ABSTRACT FROM AUTHOR]

Several studies have shown that growth hormone deficiency in adults leads to poor well-being and other clinical consequences, and that these improve when the hormone is replaced. However, the studies employed generic measures of health status that miss important aspects of the patients' experience and that have inadequate reliability and responsiveness. This paper describes the European development and testing of the Quality of Life-Assessment of Growth Hormone Deficiency in Adults (QoL-AGHDA), a condition-specific quality of life measure for use in clinical trials and for the routine monitoring of patients. The instrument was produced in five languages; English, Swedish, Italian, German and Spanish. Each language version is shown to have good reliability, internal consistency and construct validity. The QoL-AGHDA is currently included in an international database monitoring the long-term efficacy and safety of growth hormone replacement therapy and in clinical trials in a number of countries. [ABSTRACT FROM AUTHOR]

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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. [ABSTRACT FROM AUTHOR]

Background: To extend the benefits of minimally invasive surgery, an increasing enthusiasm has emerged for the laparo-endoscopic single-site surgery (LESS). The idea of LESS is to allow inserting multiple laparoscopic instruments through only one umbilical incision instead of multiple abdominal incisions. Methods: Sixty patients from three different centers in Germany were randomized (1:1) to conventional laparoscopic hysterectomy (n = 31) or LESS hysterectomy (n = 29). The study focused in particular on the safety and efficacy of both techniques. Results: The mean operative time was comparable in both groups (68.2 vs 73.6 min., p = 0.409; 95% CI − 18.69–7.12). No differences were seen regarding estimated blood loss (p = 0.915; 95% CI − 21.02–18.88), intra- and postoperative complications (p = 0.944), and wound infection rates (p = 0.944). Patients within the LESS group experienced significantly less pain in the first 24 h postoperatively (p = 0.006); the pain scores at 3, 5, 7 days and 2 months postoperatively were comparable. Conclusion: LESS hysterectomy is a reliable and safe option in gynecologic surgery. Compared to conventional laparoscopic hysterectomy, LESS surgery demonstrated comparable surgical properties in regard to blood loss, duration of surgery, and intra-/postoperative complications. Notably, patients undergoing LESS hysterectomy experienced some less pain postoperatively. [ABSTRACT FROM AUTHOR]

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