Confirmatory and bi-factor analysis of the Short Form Health Survey 8 (SF-8) scale structure in a German general population sample.

BACKGROUND: The SF-8 is a short form of the SF-36 Health Survey, which is used for generic assessment of physical and mental aspects of health-related quality of life (HRQoL). Each of the 8 dimensions of the SF-36 is covered by a single item in the SF-8. The aim of the study was to examine the latent model structure of the SF-8. METHOD: One-, two- and three dimensional as well as bi-factor structural models were defined and estimated adopting the ML- as well as the WLSMV-algorithm for ordinal data. The data were collected in a German general population sample (N = 2545 persons). RESULTS: A two- (physical and mental health) and a three-dimensional CFA structure (in addition overall health) represent the empirical data information adequately [CFI = .987/.995; SRMR = .024/.014]. If a general factor is added, the resulting bi-factor models provide a further improvement in data fit [CFI = .999/.998; SRMR = .001]. The individual items are much more highly associated with the general HRQoL factor (loadings: .698 to .908) than with the factors physical, mental, and overall health (loadings: -.206 to .566). CONCLUSIONS: In the SF-8, each item reflects mainly general HRQoL (general factor) as well as one of the three components physical, mental, and overall health. The findings suggest in particular that the evaluation of the information of the SF-8 items can be validly supplemented by a general value HRQoL.

Viscoelastic haemostatic assay augmented protocols for major trauma haemorrhage (ITACTIC): a randomized, controlled trial.

PURPOSE: Contemporary trauma resuscitation prioritizes control of bleeding and uses major haemorrhage protocols (MHPs) to prevent and treat coagulopathy. We aimed to determine whether augmenting MHPs with Viscoelastic Haemostatic Assays (VHA) would improve outcomes compared to Conventional Coagulation Tests (CCTs). METHODS: This was a multi-centre, randomized controlled trial comparing outcomes in trauma patients who received empiric MHPs, augmented by either VHA or CCT-guided interventions. Primary outcome was the proportion of subjects who, at 24 h after injury, were alive and free of massive transfusion (10 or more red cell transfusions). Secondary outcomes included 28-day mortality. Pre-specified subgroups included patients with severe traumatic brain injury (TBI). RESULTS: Of 396 patients in the intention to treat analysis, 201 were allocated to VHA and 195 to CCT-guided therapy. At 24 h, there was no difference in the proportion of patients who were alive and free of massive transfusion (VHA: 67%, CCT: 64%, OR 1.15, 95% CI 0.76-1.73). 28-day mortality was not different overall (VHA: 25%, CCT: 28%, OR 0.84, 95% CI 0.54-1.31), nor were there differences in other secondary outcomes or serious adverse events. In pre-specified subgroups, there were no differences in primary outcomes. In the pre-specified subgroup of 74 patients with TBI, 64% were alive and free of massive transfusion at 24 h compared to 46% in the CCT arm (OR 2.12, 95% CI 0.84-5.34). CONCLUSION: There was no difference in overall outcomes between VHA- and CCT-augmented-major haemorrhage protocols.

The German Aerospace Center M-42 radiation detector-A new development for applications in mixed radiation fields.

In the last few years, the Biophysics Working Group of the Institute of Aerospace Medicine of the German Aerospace Center (DLR) started the development of a small low power consumption radiation detector system for the measurement of the absorbed dose to be applied in various environments, such as onboard aircraft, in space, and also as a demonstration tool for students. These so called DLR M-42 detectors are based on an electronics design, which can easily be adjusted to the user- and mission-requirements. M-42 systems were already applied for measurements in airplanes, during two MAPHEUS (Materialphysikalische Experimente unter Schwerelosigkeit) rocket missions, and are currently prepared for long term balloon experiments. In addition, they will be part of the dosimetry suite of the upcoming Matroshka AstroRad Radiation Experiment on the NASA Artemis I mission. This paper gives an overview of the design and the testing of the DLR M-42 systems and provides highlighted results from the MAPHEUS campaigns where the detectors were tested for the first time under space flight conditions. Results clearly show that the system design enables independent measurements starting upon rocket launch due to the built-in accelerometer sensors and provides data for the relevant 6 min of µ-gravity as given for the MAPHEUS missions. These 6 min of the µ-gravity environment at altitudes between 100 and 240 km lead to a total absorbed dose of 1.21 ± 0.15 µGy being equivalent to half a day of radiation background measured with the M-42 in the laboratory at DLR, Cologne, Germany.

The Arabidopsis THADA homologue modulates TOR activity and cold acclimation.

Low temperature is one of the most important environmental factors that affect global survival of humans and animals and equally importantly the distribution of plants and crop productivity. Survival of metazoan cells under cold stress requires regulation of the sensor-kinase Target Of Rapamycin (TOR). TOR controls growth of eukaryotic cells by adjusting anabolic and catabolic metabolism. Previous studies identified the Thyroid Adenoma Associated (THADA) gene as the major effect locus by positive selection in the evolution of modern human adapted to cold. Here we investigate the role of THADA in TOR signaling and cold acclimation of plants. We applied BLAST searches and homology modeling to identify the AtTHADA (AT3G55160) in Arabidopsis thaliana as the highly probable orthologue protein. Reverse genetics approaches were combined with immunological detection of TOR activity and metabolite profiling to address the role of the TOR and THADA for growth regulation and cold acclimation. Depletion of the AtTHADA gene caused complete or partial loss of full-length mRNA, respectively, and significant retardation of growth under non-stressed conditions. Furthermore, depletion of AtTHADA caused hypersensitivity towards low-temperatures. Atthada displayed a lowered energy charge. This went along with decreased TOR activity, which offers a molecular explanation for the slow growth phenotype of Atthada. Finally, we used TOR RNAi lines to identify the de-regulation of TOR activity as one determinant for sensitivity towards low-temperatures. Taken together our results provide evidence for a conserved function of THADA in cold acclimation of eukaryotes and suggest that cold acclimation in plants requires regulation of TOR.

Predictors of Incomplete Occlusion following Pipeline Embolization of Intracranial Aneurysms: Is It Less Effective in Older Patients?

BACKGROUND AND PURPOSE: Flow diversion with the Pipeline Embolization Device (PED) for the treatment of intracranial aneurysms is associated with a high rate of aneurysm occlusion. However, clinical and radiographic predictors of incomplete aneurysm occlusion are poorly defined. In this study, predictors of incomplete occlusion at last angiographic follow-up after PED treatment were assessed. MATERIALS AND METHODS: A retrospective analysis of consecutive aneurysms treated with the PED between 2009 and 2016, at 3 academic institutions in the United States, was performed. Cases with angiographic follow-up were selected to evaluate factors predictive of incomplete aneurysm occlusion at last follow-up. RESULTS: We identified 465 aneurysms treated with the PED; 380 (81.7%) aneurysms (329 procedures; median age, 58 years; female/male ratio, 4.8:1) had angiographic follow-up, and were included. Complete occlusion (100%) was achieved in 78.2% of aneurysms. Near-complete (90%-99%) and partial (<90%) occlusion were collectively achieved in 21.8% of aneurysms and defined as incomplete occlusion. Of aneurysms followed for at least 12 months (211 of 380), complete occlusion was achieved in 83.9%. Older age (older than 70 years), nonsmoking status, aneurysm location within the posterior communicating artery or posterior circulation, greater aneurysm maximal diameter (≥21 mm), and shorter follow-up time (<12 months) were significantly associated with incomplete aneurysm occlusion at last angiographic follow-up on univariable analysis. However, on multivariable logistic regression, only age, smoking status, and duration of follow-up were independently associated with occlusion status. CONCLUSIONS: Complete occlusion following PED treatment of intracranial aneurysms can be influenced by several factors related to the patient, aneurysm, and treatment. Of these factors, older age (older than 70 years) and nonsmoking status were independent predictors of incomplete occlusion. While the physiologic explanation for these findings remains unknown, identification of factors predictive of incomplete aneurysm occlusion following PED placement can assist in patient selection and counseling and might provide insight into the biologic factors affecting endothelialization.

Recovery assessment scale: Examining the factor structure of the German version (RAS-G) in people with schizophrenia spectrum disorders.

BACKGROUND: The recovery framework has found its way into local and national mental health services and policies around the world, especially in English speaking countries. To promote this process, it is necessary to assess personal recovery validly and reliably. The Recovery Assessment Scale (RAS) is the most established measure in recovery research. The aim of the current study is to examine the factor structure of the German version of the RAS (RAS-G). METHODS: One hundred and fifty-six German-speaking clients with schizophrenia or schizoaffective disorder from a community mental health service completed the RAS-G plus measures of recovery attitudes, self-stigma, psychotic symptoms, depression, and functioning. A confirmatory factor analysis of the original 24-item RAS version was conducted to examine its factor structure, followed by reliability and validity testing of the extracted factors. RESULTS: The CFA yielded five factors capturing 14 items which showed a substantial overlap with the original subscales Personal Confidence and Hope, Goal and Success Orientation, Willingness to Ask for Help, Reliance on Others, and No Domination by Symptoms. The factors demonstrated mean to excellent reliability (0.59-0.89) and satisfactory criterial validity by positive correlations with measures of recovery attitudes and functioning, and negative correlations with measures of self-stigma, and psychotic and depressive symptoms. CONCLUSIONS: The study results are discussed in the light of other studies examining the factor structure of the RAS. Overall, they support the use of the RAS-G as a means to promote recovery oriented services, policies, and research in German-speaking countries.

[Application and Integration of Qualitative and Quantitative Research Methods in Intervention Studies in Rehabilitation Research]. / Anwendung und Integration qualitativer und quantitativer Forschungsmethoden in der rehabilitationswissenschaftlichen Interventionsforschung.

In order to develop and evaluate interventions in rehabilitation research a wide range of empirical research methods may be adopted. Qualitative research methods emphasize the relevance of an open research focus and a natural proximity to research objects. Accordingly, using qualitative methods special benefits may arise if researchers strive to identify and organize unknown information aspects (inductive purpose). Particularly, quantitative research methods require a high degree of standardization and transparency of the research process. Furthermore, a clear definition of efficacy and effectiveness exists (deductive purpose). These paradigmatic approaches are characterized by almost opposite key characteristics, application standards, purposes and quality criteria. Hence, specific aspects have to be regarded if researchers aim to select or combine those approaches in order to ensure an optimal gain in knowledge.

[Costello syndrome. A rare RASopathy with cutaneous symptoms]. / Costello-Syndrom. Eine seltene RASopathie mit kutanen Symptomen.

An 18-year-old female with palmoplantar keratoderma, hyperhidrosis, facial verruciform papillomatosis, coarse face, growth retardation and developmental delay presented to our outpatient clinic. A diagnosis of Costello syndrome was made, and genetic counseling and a molecular genetic analysis were initiated. By this means, a heterozygous missense mutation in exon 2 of the HRAS gene, designated c.34G > A (p.Gly12Ser), was detected, confirming the clinical diagnosis. Costello syndrome belongs to the group of clinically and genetically heterogeneous RASopathies with cutaneous symptoms. Collectively, the RASopathies are caused by mutations in different genes, which lead to dysregulation of the RAS/MAPK (mitogen-activated protein kinase) signaling pathway. This signaling route regulates the delicate balance between cell proliferation and differentiation, and plays an important role in embryogenesis and carcinogenesis. In the RASopathies with cutaneous symptoms, overlapping clinical findings may hamper making an accurate diagnosis. Therefore, a molecular genetic analysis may be useful, as in the patient described here.

The minimum detectable difference (MDD) and the interpretation of treatment-related effects of pesticides in experimental ecosystems.

In the European registration procedure for pesticides, microcosm and mesocosm studies are the highest aquatic experimental tier to assess their environmental effects. Evaluations of microcosm/mesocosm studies rely heavily on no observed effect concentrations (NOECs) calculated for different population-level endpoints. Ideally, a power analysis should be reported for the concentration-response relationships underlying these NOECs, as well as for measurement endpoints for which significant effects cannot be demonstrated. An indication of this statistical power can be provided a posteriori by calculated minimum detectable differences (MDDs). The MDD defines the difference between the means of a treatment and the control that must exist to detect a statistically significant effect. The aim of this paper is to expand on the Aquatic Guidance Document recently published by the European Food Safety Authority (EFSA) and to propose a procedure to report and evaluate NOECs and related MDDs in a harmonised way. In addition, decision schemes are provided on how MDDs can be used to assess the reliability of microcosm/mesocosm studies and for the derivation of effect classes used to derive regulatory acceptable concentrations. Furthermore, examples are presented to show how MDDs can be reduced by optimising experimental design and sampling techniques.

[Turnover of Non-medical Staff in Outpatient Oncology Practices: Is Building Social Capital a Solution?]. / Fluktuation bei nicht-ärztlichem Personal in onkologischen Schwerpunktpraxen: Sozialkapitalaufbau als Lösungsansatz?

STUDY AIM: While a lot is known about potential and actual turnover of non-medical hospital staff, only few data exist for the outpatient setting. In addition, little is known about actual instruments which leaders can use to influence staff turnover in physician practices. In the literature, the social capital of an organisation, which means the amount of trust, common values and reciprocal behaviour in the organisation, has been discussed as a possible field of action. In the present study, staff turnover as perceived by outpatient haematologists and oncologists is presented and analysed as to whether social capital is associated with that staff turnover. In conclusion, measures to increase the social capital of a practice are presented. METHODS: The present study is based on data gathered in a questionnaire-based survey with members of the Professional Organisation of -Office-Based Haematologists and Oncologists (N=551). The social capital of the practice was captured from the haematologists and oncologists using an existing and validated scale. To analyse the impact of the practice's social capital on staff turnover, as perceived by the physicians, bivariate correlations and linear regression analyses were calculated. RESULTS: In total, 152 haematologists and oncologists participated in the study which represents a response rate of 28%. In the regression analyses, social capital appears as a significant and strong predictor of staff turnover (beta=-0.34; p<0.001). CONCLUSIONS: Building social capital within the practice may be an important contribution to reducing staff turnover although the underlying study design does not allow for drawing causal conclusions regarding this relationship. To create social capital in their practice, outpatient physicians may apply measures that facilitate social interaction among staff, foster trust and facilitate cooperation. Such measures may already be applied when hiring and training new staff, but also continuously when leading employees and when organising work tasks, e.g., by establishing regular team meetings.

[Keep an eye on the side effects]. / Nebenwirkungen im Auge behalten.

A 52-year-old man presented with a progressive grey-black pigmentation of facial skin, sclera and teeth. The cause was long-term ingestion of minocycline, as confirmed by history and skin biopsy. Minocycline-induced hyperpigmentation can be divided into four main patterns based on clinical appearance, distribution, light- and electron microscopic characteristics. Some patterns can manifest within weeks of initiating therapy. One must be alert to the early signs and warn the patient about the often cosmetically disturbing and persistent minocycline-induced hyperpigmentation.

[Validation of the computerized adaptive assessment procedure RehaCAT related to functional and mental strain in a sample of rehabilitation patient suffering from musculoskeletal diseases]. / Validierung der computeradaptiven Assessmentprozedur RehaCAT hinsichtlich funktionaler und psychischer Belastungen bei Rehabilitanden mit muskuloskelettalen Erkrankungen.

The Rasch-based, computerized adaptive assessment procedure RehaCAT allows to assess the ICF-oriented dimensions "activities in daily living", "functionality upper extremities" and "functionality lower extremities" as well as "depression" economically and reliably in orthopaedic rehabilitation patients. This validation study aimed at analyzing the multivariate association of the RehaCAT dimensions with the commonly applied ODI, SF-12 and HADS-D assessment scales in a sample of rehabilitation patient suffering from musculoskeletal diseases (spine disease: 58,7%). By means of structural equation modeling high convergent and divergent validity of the RehaCAT dimensions could be proven in a sample of N=184 rehabilitation patients (71,2% inpatient and 28,8% outpatient). In the resulting model between 41% (functionality upper extremities) and 76% (activities in daily living) of the RehaCAT dimensions could be explained mainly by the theoretical assumed predictor constructs. Because of its psychometric foundation, economy and validity, the RehaCAT provides an optimal basis to assess central ICF-oriented constructs in orthopaedic rehabilitation.

Can a stressed oncologist be good in a consultation? A qualitative study on the oncologists' perception.

The aim of this exploratory study was to examine how the working conditions and job stress of private practice oncologists (PPOs) affect their interaction with patients. Data for the study were collected through semi-structured interviews with PPOs selected based on purposeful sampling criteria. The data were evaluated using content analysis. Factors perceived by PPOs to influence their level of stress and patient care were some of their own personal characteristics as well as working conditions both within and outside their practices. Apart from being able to name specific stressors (e.g., dysfunctional organisational workflow and interruptions during medical encounters), the oncologists also mentioned individual and organisational resources (e.g., professional experience, well-educated nurses and good work organisation) for coping with job stress and improving interaction with patients. Within this study, we identified some obstacles on the individual and organisational level for good patient care, as working conditions which might lead to time pressure and stress, which subsequently have an impact on quality in patient care (e.g., less time for personal issues during patient consultations). Future stress research should conduct a more in-depth investigation of these and other interventions at both the individual and organisational levels in order to improve patient care.

[Granulomatous mycosis fungoides: combination therapy with bexarotene and PUVA]. / Granulomatöse Mycosis fungoides : Kombinationstherapie mit Bexaroten und PUVA.

A 74-year-old male with granulomatous mycosis fungoides presented with multiple, red-brown macules and plaques up to 8 cm in diameter, just as in classical mycosis fungoides. Dermatohistopathologic findings showed extensive granulomatous infiltrates, in which clonality could be detected in various locations via T cell receptor rearrangement. Granulomatous mycosis fungoides is a very rare form of mycosis fungoides with histological resemblance to granulomatous slack skin. It shows a rather aggressive course and can be challenging to diagnose. In our case, combination treatment with bexarotene and bath PUVA, as recommended in guidelines, resulted in an impressive improvement of the skin lesions within ten weeks.

[Validity and responsiveness of the Scales for the Assessment of Functioning at Work]. / Validität und Änderungssensitivität der Skalen zur Erfassung der Funktionsfähigkeit im Beruf (SE-FFB).

The Scales for the Assessment of Functioning at Work (SE-FFB) allow for an ICF-oriented assessment of patient reported work performance and symptoms at work. The aim of the study is to test convergent end discriminate validity through correlations with measures that are typically applied in rehabilitation and responsiveness by means of description of the change in the course of rehabilitation (t0=beginning of the rehabilitation, t1=3 months after rehabilitation). The sample comprises 249 rehabilitation patients with musculoskeletal diseases. The correlations of the SE-FFB with the criteria of convergent and discriminate validity are in accordance with the expectations. For women medium effects were found, indicating better work performance and fewer symptoms 3 months after rehabilitation, for men the effects were small. The SE-FFB allows for a reliable, valid and responsive assessment of the working situation.

[Resources and self-management skills in multiple sclerosis patients - can the scale structure of the questionnaire FERUS be replicated?]. / Ressourcen und Selbstmanagementfähigkeiten bei Multiple-Sklerose-Erkrankten - Lässt sich die Skalenstruktur des Fragebogens FERUS replizieren?

BACKGROUND: To assess resources and self-management skills the generic questionnaire FERUS was developed by Jack (2007) and validated and standardized in a sample of psychosomatic patients and of healthy people. The aim of this study was the psychometric review of the FERUS with a sample of patients with Multiple Sclerosis (MS). METHODS: The dimensional structure identified by Jack was replicated in an exploratory factor analyses as well as tested in a confirmatory factor analyses and the discrimination ability of the scales was examined. RESULTS: Jack's results of the exploratory factor analyses and scale analyses were replicated essentially. After elimination of non-theory-compliant items, differentiation of the construct "motivation for change" and insertion of a second-order construct "self-management skills" a good confirmatorical model fit could be achieved. CONCLUSION: The FERUS can be used for MS patients. The consideration of optimization proposals allows higher construct validity and a more economical use of FERUS.