"Feed-and-wrap" technique versus deep sedation for neonatal magnetic resonance imaging: a retrospective comparative study.

OBJECTIVES: Neonatal MRI is usually performed under deep sedation, which is challenging-especially in low-weight premature patients. In addition, long-term side effects, such as neurotoxicity, are of concern. An alternative to sedation is to induce natural sleep by feeding and immobilising the child, the "feed-and-wrap" technique (FWT). The objective of this study was to evaluate differences in image quality between neonates examined under sedation and by using the FWT during the first four months of life. MATERIALS AND METHODS: We retrospectively assessed image quality (based on a 4-point semiquantitative scale) of all MRI examinations in neonates performed at our institution between July 2009 and August 2022. Differences in image quality between examinations under sedation versus FWT were evaluated. RESULTS: We included 432 consecutive patients, 243 (56%) using sedation and 189 (44%) using the FWT. Corrected age and body weight (mean ± SD: 3.7 ± 1.1 versus 4.5 ± 1.3 kg, p < 0.001) were significantly lower in the FWT group. The overall success rate in the FWT group was 95%. Image quality was slightly lower when using the FWT (mean ± SD: 3.7 ± 0.43 versus 3.96 ± 0.11, p < 0.001). Multivariate analysis showed a higher risk of acquiring sequences with diagnostic limitations in the FWT group (p < 0.001), increasing with corrected age (p = 0.048). CONCLUSION: The FWT is a highly successful method to perform MRI scans in term and preterm neonates. Overall image quality is only slightly lower than under sedation. Especially in immature low-weight preterm patients, the FWT is a reliable option to perform MRI studies without exposing the child to risks associated with sedation. CLINICAL RELEVANCE STATEMENT: The "feed-and-wrap" technique enables high-quality MRI examinations in neonates, including low-weight premature patients. Deep sedation for diagnostic MRI procedures in this age group, which has the risk of short- and long-term complications, can often be avoided. KEY POINTS: Deeply sedating neonates for MR examinations comes with risks. Image quality is only slightly lower when using the "feed-and-wrap" technique. The "feed-and-wrap" technique is feasible even in low-weight premature infants.

Impact of depersonalization on the course of depression: longitudinal observations from the gutenberg health study.

BACKGROUND: Symptoms of depersonalization (DP) and derealization (DR) are a risk factor for more severe impairment, non-response to various treatments, and a chronic course. In this study, we investigated the effects of DP/DR symptoms in patients with clinically significant depressive symptoms on clinical characteristics and various outcomes in a representative population-based sample with a 5-year follow-up. METHODS: The middle-aged sample comprised n = 10,422 persons at baseline, of whom n = 9,301 were free from depressive and DP/DR symptoms. N = 522 persons had clinically significant depression (PHQ-9 ≥ 10) and co-occurring DP/DR symptoms, and n = 599 persons had clinically significant depression (PHQ-9 ≥ 10) without DP/DR symptoms. RESULTS: There were substantial health disparities between persons with and without depression. These disparities concerned a wide range of life domains, including lower quality of the recalled early life experiences with the parents, current socioeconomic status, social integration (partnership, loneliness), current social and interpersonal stressors (family, work), functional bodily complaints (e.g., tinnitus, migraine, chest pain), unhealthy lifestyle, and the prevalence of already developed physical diseases. These disparities persisted to the 5-year follow-up and were exceptionally severe for depressed persons with co-occurring DP/DR symptoms. Among the depressed persons, the co-occurrence of DP/DR symptoms more than doubled the risk for recurrence or persistence of depression. Only 6.9% of depressed persons with DP/DR symptoms achieved remission at the 5-year follow-up (PHQ-9 < 5). Depression with and without co-occurring DP/DR worsened self-rated physical health significantly. The impact of depression with co-occurring DP/DR on the worsening of the self-rated physical health status was stronger than those of age and major medical diseases (e.g., heart failure). However, only depression without DP/DR was associated with mortality in a hazard regression analysis adjusted for age, sex, and lifestyle. CONCLUSIONS: The results demonstrated that DP/DR symptoms represent an important and easily assessable prognostic factor for the course of depression and health outcomes. Given the low remission rates for depression in general and depression with DP/DR in particular, efforts should be made to identify and better support this group, which is disadvantaged in many aspects of life.

Immediate versus delayed implant placement of novel fully tapered tissue-level implants - A retrospective multicenter clinical study.

OBJECTIVES: To compare the clinical and radiological outcomes of novel fully tapered tissue-level implants in immediate implant placement (type 1) versus late implant placement (type 4) for the first time. MATERIALS AND METHODS: For this clinical study, 318 fully tapered tissue-level implants in 65 patients were inserted immediately (n = 68 implants) or late (n = 250 implants) in two different centers. Implant survival and success rates and marginal bone levels were analyzed. RESULTS: After a mean follow-up of 12.0 ± 5 months, implant survival rates were 97.8% for all implants. No statistically significant difference in implant survival rates between type 1 and type 4 could be detected (98.5% vs 97.6%, HR 0.70, 95%-CI 0.084-5.81). Neither for implant length (HR 0.53, 95%-CI 0.055-5.08) nor for implant width (HR 0.27, CI 0.028-2.55), a significant influence on implant survival could be detected. Type of used biomaterial for filling the gap and immediate loading showed no effect on implant survival. Mean marginal bone loss was 0.02 ± 0.05 mm for type 1 and 0.04 ± 0.1 for type 4. CONCLUSIONS: Within the limitations of this retrospective study and the short follow-up, the results demonstrated comparable high survival and success rates and stable marginal bone levels for type 1 and type 4 placement of this novel tissue-level implant (no clinical trial registration as retrospective study design).

Teachers reported that children with special health care needs displayed more attention problems.

AIM: Children with special health care needs (SHCN) perform more poorly at school compared to their classmates. Specific causal pathways have not yet been extensively studied. Therefore, we investigated teacher-rated global attention, an important prerequisite for educational attainment, in children with SHCN. METHODS: Data of a population-based prospective cohort study, which recruited preschool children from the Mainz-Bingen area, Germany, were analysed. Children with SHCN were identified by the Children with Special Health Care Needs screening tool. In 2016, global attention was reported by teachers at the end of first grade (mean age: 7.3 years) on a 5-point rating scale ranging from -2 through +2. Associations between SHCN consequences and teacher-rated attention were estimated by linear mixed models, adjusted for confounding variables. RESULTS: We included 1921 children (51% males); of these, 14% had SHCN. Compared to their classmates, children with SHCN had poorer teacher-rated attention scores (adjusted mean difference: -0.35, 95% CI: -0.52 to -0.17). The effect was strongest among children with treatment or counselling for mental health problems or functional limitations. The effect remained after excluding children with attention deficit hyperactivity disorder from the analysis. CONCLUSION: Children with SHCN showed more teacher-rated attention problems, which could explain their lower educational attainment.

Depressive symptoms predict the incidence of common chronic diseases in women and men in a representative community sample.

BACKGROUND: Depression, the most frequent and harmful mental disorder, has been associated with specific somatic diseases as the leading cause of death. The purposes of this prospective study were to predict incident chronic diseases based on baseline depressive symptoms and to test sex-dependent effects. METHODS: In a representative German community sample of over 12 000 participants, baseline depressive symptoms (assessed using the Patient Health Questionnaire-9) were tested as a predictor of new onset of cardiovascular disease (CVD), chronic obstructive lung disease, diabetes, cancer, and migraine at 5-year follow-up. To study disease incidence, we created subsamples for each chronic disease by excluding participants who already had the respective disease at baseline. Potential confounders were included in logistic regression models and sex-specific analyses were performed. RESULTS: Controlling for demographic characteristics and loneliness, in men and women, baseline depressive symptoms were predictive of CVD, chronic obstructive lung disease, diabetes, and migraine, but not of cancer. When we additionally adjusted for metabolic and lifestyle risk factors, there was an 8% increase of chronic obstructive lung disease and migraine per point of depressive symptoms. There was a trend for CVD (4%; p = 0.053). Sex-sensitive analyses revealed trends for the relevance of depressive symptoms for CVD in men (p = 0.065), and for diabetes in women (p = 0.077). CONCLUSIONS: These findings underscore the need to implement screening for depression in the treatment of major somatic illnesses. At the same time, depressed patients should be screened for metabolic and lifestyle risk factors and for somatic diseases and offered lifestyle interventions.

Value of a web-based pediatric drug information system to prevent serious adverse drug reactions in child and adolescent psychiatry.

Psychotropic drugs are frequently prescribed 'off-label' to children and adolescents and carry the risk of serious adverse drug reactions (sADR). We examined the frequency of sADRs of psychotropic drugs in pediatric inpatients and explored their potential preventability through following the recommendations of a web-based pediatric drug information system (PDIS). The potential socio-economic impacts of using this online system is also addressed. Routine clinical data from all inpatients treated in a child and adolescent psychiatry department between January 2017 and December 2018 were retrospectively examined for the occurrence of sADRs as defined by the European Medicines Agency. The preventability of the sADRs was assessed based on the information of the PDIS. Furthermore, the expected prolongation of the hospital stay due to sADRs was calculated as well as the associated treatment costs. The study was supported by the Innovation Fund of the Joint Federal Committee, grant number 01NVF16021. In total, 1036 patients were screened of whom 658 (63.5%) received psychopharmacological treatment. In 53 (8.1%) of these patients 54 sADRs were documented, of which 37 sADRs were identified as potentially preventable through PDIS. Mitigating sADR through PDIS would likely have prevented prolonged hospital stays and conferred considerable savings for health insurance companies. PDIS provides systematic and evidence-based information about pediatric psychopharmacotherapy and helps to prevent prescribing errors. Therefore, PDIS is a useful tool to increase drug therapy safety in child and adolescent psychiatry. Further prospective studies are needed to confirm the results.

Changes in the probability of hysterectomy in the city of Mainz and Mainz-Bingen region, Germany.

BACKGROUND: To assess the hysterectomy probability by calendar period and age, the overall and the age-specific prevalence of hysterectomy in women aged 30-65 years. METHODS: Baseline data (2005-2007) from the population-based MARZY study conducted in Mainz and Mainz-Bingen, Germany, were analysed. 6429 women aged 30-65 years were asked whether they had undergone a hysterectomy and the date and indication of the procedure. We calculated the 5-year age-specific prevalence of hysterectomy and estimated the probability of undergoing a hysterectomy combining two approaches: 1) Kaplan-Meier and 2) Inverse probability weighting (IPW). We assessed potential changes over calendar periods by simulating survival curves, having hysterectomy as the event, employing a Cox proportional hazard model. RESULTS: Data on hysterectomy were available for 4719 women. Of these, 961 (20.4%) had undergone a hysterectomy between 1960 and 2006. The hysterectomy prevalence was highest among the 60-64 year-olds (40.7%). The IPW-corrected probability of having a hysterectomy up to the age of 65 years was 36.4%. The age-specific probability of hysterectomy increased from 0.1% (20-24 years), peaking at 45-49 years (7.8%) and declining thereafter to less than 5% among women aged 50 and older. Over time, women were hysterectomised at an increasingly older age. Most hysterectomies (86.7%) were done due to benign disease. CONCLUSIONS: A shift to older age at hysterectomy with an advancing calendar period likely reflects changes in clinical practice in Germany. TRIAL REGISTRATION: Landesärztekammer Rheinland-Pfalz: 837.438.03 (4100).

Influence of cluster-period cells in stepped wedge cluster randomized trials.

Stepped wedge cluster randomized trials (SWCRT) are increasingly used for the evaluation of complex interventions in health services research. They randomly allocate treatments to clusters that switch to intervention under investigation at variable time points without returning to control condition. The resulting unbalanced allocation over time periods and the uncertainty about the underlying correlation structures at cluster-level renders designing and analyzing SWCRTs a challenge. Adjusting for time trends is recommended, appropriate parameterizations depend on the particular context. For sample size calculation, the covariance structure and covariance parameters are usually assumed to be known. These assumptions greatly affect the influence single cluster-period cells have on the effect estimate. Thus, it is important to understand how cluster-period cells contribute to the treatment effect estimate. We therefore discuss two measures of cell influence. These are functions of the design characteristics and covariance structure only and can thus be calculated at the planning stage: the coefficient matrix as discussed by Matthews and Forbes and information content (IC) as introduced by Kasza and Forbes. The main result is a new formula for IC that is more general and computationally more efficient. The formula applies to any generalized least squares estimator, especially for any type of time trend adjustment or nonblock diagonal matrices. We further show a functional relationship between IC and the coefficient matrix. We give two examples that tie in with current literature. All discussed tools and methods are implemented in the R package SteppedPower.

A novel point-of-care device accurately measures thyrotropin in whole blood, capillary blood and serum.

OBJECTIVES: Point-of-care (POC) measurement of thyrotropin (TSH) may facilitate prompt diagnosis of thyroid dysfunction. We evaluated the analytical performance of a new POC TSH assay (Wondfo). METHODS: TSH measurements were made from 730 consecutive, unselected subjects in an outpatient setting, using Wondfo in whole blood, capillary blood and serum or automated reference equipment (serum only). RESULTS: TSH measurements were user-independent. Total intra-and inter-assay variation (CV%) was 12.1 and 16.2%, respectively. Total CV% was 10.6-22.6% and 14.5-21.6% in serum and whole blood, respectively. Linearity was very good. Recovery rate was 97-127%. Prolongation of incubation time increased TSH results of 12% (13%) and 33% (35%) after 2 and 5 additional minutes in serum (blood), respectively. When measured simultaneously in two Wondfo devices, the slope of the regression line was 1.03 (serum) and 1.02 (blood), with Spearman's correlation of 0.99 for both. TSH measurements between Wondfo and reference correlated strongly (r=0.93-0.96), though TSH measurements were lower with Wondfo (slopes of plots of measurements made using the two devices were 0.94 [serum vs. serum]; 0.83 [whole blood vs. serum] and 0.64 [capillary blood vs. serum]). Depending on sample material, TSH in capillary blood was lower vs. whole blood (slope: 0.82) and for whole blood vs. serum (Wondfo and reference method; slope: 0.69 and 0.83). Total haemolysis, but not elevated bilirubin or lipemia, disrupted TSH measurement. CONCLUSIONS: The Wondfo system was straightforward to use without need for specialist technicians and demonstrated analytic performance suitable for clinical use for the diagnosis of thyroid dysfunction.

Dental implants in patients with head and neck cancer-A systematic review and meta-analysis of the influence of radiotherapy on implant survival.

PURPOSE: The purpose of this meta-analysis was to compare implant survival in irradiated and non-irradiated bone and to investigate potential risk factors for implant therapy in oral cancer patients. MATERIAL AND METHODS: An extensive search in the electronic databases of the National Library of Medicine was performed. Systematic review and meta-analysis were conducted according to PRISMA statement. The meta-analysis was performed for studies with a mean follow-up of at least three and five years, respectively. RESULTS: The systematic review resulted in a mean overall implant survival of 87.8% (34%-100%). The meta-analysis revealed a significantly higher rate of implant failure in irradiated bone compared to non-irradiated bone (p < .00001, OR 1.97, CI [1.63, 2.37]). The studies also showed that implants placed into irradiated grafted bone were more likely to fail than those in irradiated native bone (p < .0001, OR 2.26, CI [1.50, 3.40]). CONCLUSION: Even though overall implant survival was high, radiotherapy proves to be a significant risk factor for implant loss. Augmentation procedures may also increase the risk of an adverse outcome, especially in combination with radiotherapy. CLINICAL RELEVANCE: The treatment of patients receiving radiotherapy of any form requires precise individual planning and a close aftercare. Implants should be placed in local bone rather than in bone grafts, if possible.

[Chronically ill at School - School Performance in Children with Special Health Care Needs. Results of the Child Health Study ikidS]. / Chronisch krank in der Schule ­ schulische Fähigkeiten von Kindern mit speziellem Versorgungsbedarf. Ergebnisse der Kindergesundheitsstudie ikidS.

BACKGROUND: The association between health status in childhood and later educational achievement is unknown. We describe the association between a chronic health condition (CHC) and school performance at the end of first grade. PATIENTS: As part of the child health survey ikidS, 2,003 preschoolers from the Mainz-Bingen area (Rhineland-Palatinate; Germany) were recruited. METHOD: In a prospective cohort study, children with CHC were identified by the children with special health care needs screener. At the end of first grade, classroom teachers evaluated the child's school performance on a rating scale ranging from - 2 through+2 in 5 domains: numeracy, science, reading, writing, and social competencies. Associations between special health care needs (SHCN) and each domain were assessed by linear mixed regression models adjusted for potential confounders. RESULTS: 1,463 children (51% males) were analyzed. Of these, 15% had SHCN. Compared to their classmates, children with SHCN performed poorer in numeracy (adjusted mean difference: - 0.40; 95% CI[- 0.57; - 0.23]) and writing (- 0.22; 95% CI[- 0.39; - 0.05]). DISCUSSION: For the first time in a German sample, we found an indication which educational competencies might be negatively impacted by SHCN early in school. This could have long-lasting effects on educational attainment and later socio-economic status. CONCLUSION: Our results question the uptake and/or effectiveness of existing medical care as well as educational support concepts for children with a CHC.

Age at school entry and reported symptoms of attention-deficit/hyperactivity in first graders: results of the prospective cohort study ikidS.

Young age at school entry (ASE) is related to attention-deficit/hyperactivity disorder in higher grades. The reason for this association is unclear, but medical oversupply and stress-related factors are discussed. We aimed to investigate whether ASE is associated with reported symptoms of attention-deficit/hyperactivity (ADH) already in first grade. Data of a population-based prospective cohort study (N = 2003; Mainz-Bingen region; Rhineland-Palatinate; Germany) with baseline assessments prior to school entry and two follow-ups during first grade were analysed. ADH symptoms were assessed by parent and teacher versions of the Strengths and Difficulties Questionnaire. Associations between ASE and scores of the hyperactivity/inattention subscale (range 0-10) were investigated by regression analysis and adjusted for potential confounders and baseline symptoms prior to school entry. In total, 1633 children (52% boys, mean ASE 6.5 years) were included. There were no relationships between ASE and parent-reported scores of the hyperactivity/inattention subscale prior to school entry and 3 months thereafter. However, at the end of first grade, ASE was negatively associated with the hyperactivity/inattention subscale in parent (- 0.7 subscale points per year ASE, standard error = 0.16, p < 0.0001) and teacher reports (- 1.2 subscale points per year ASE, standard error = 0.25, p < 0.0001). This ASE effect appeared more pronounced in girls than in boys. Young ASE is related to more reported symptoms of ADH at the end of first grade, but not before. The evolvement of this effect during first grade may be a clue to ASE-related stress factors.

Risk factors, physical and mental health burden of male and female pathological gamblers in the German general population aged 40-80.

BACKGROUND: Gambling Disorder (GD) has been associated with considerable mental and physical health risks in clinical samples. The paper determines risk factors, mental and physical health burden of probable GD for both men and women in the general population. METHODS: In the Gutenberg Health Study, a population-based sample of N = 11,875 aged 40-80 years was analyzed regarding lifetime probable GD prevalence (measured with the Lie/ Bet Questionnaire) and a wide array of health variables including standardized measures of depression, anxiety, and somatic symptoms. RESULTS: Probable GD lifetime prevalence was 2.1%, with higher rates among 1st generation migrants (5.5%; vs. non-migrants 1.6%), men (3.0%; vs. women 1.2%), and the sample's youngest age decade (40-49 y., 3.1%). Lifetime probable GD was associated with current work-related, family and financial stressors as well as unhealthy behavior (smoking, extended screen time), and lifetime legal offenses. In men, but not in women, increased rates of imprisonment, mental and somatic symptoms were found. CONCLUSIONS: GD is a major public health problem with serious social, mental and physical health burden. Epidemiological findings underscore the preponderance of GD among 1st generation migrants and men. Findings are consistent with a vicious cycle of family, work related and financial stress factors, and mental and physical burden, particularly in men. Demographic risk factors may help to target specific prevention and treatment efforts.

Bidimensional structure and measurement equivalence of the Patient Health Questionnaire-9: sex-sensitive assessment of depressive symptoms in three representative German cohort studies.

BACKGROUND: The Patient Health Questionnaire-9 (PHQ-9) has been proposed as a reliable and valid screening instrument for depressive symptoms with one latent factor. However, studies explicitly testing alternative model structures found support for a two-dimensional structure reflecting a somatic and a cognitive-affective dimension. We investigated the bidimensional structure of the PHQ-9, with a somatic (sleeping problems, fatigability, appetitive problems, and psychomotor retardation) and a cognitive-affective dimension (lack of interest, depressed mood, negative feelings about self, concentration problems, and suicidal ideation), and tested for sex- and regional-differences. METHODS: We have included data from the GEnder-Sensitive Analyses of mental health trajectories and implications for prevention: A multi-cohort consortium (GESA). Privacy-preserving analyses to provide information on the overall population and cohort-specific information and analyses of variance to compare depressive, somatic and cognitive-affective symptoms between sexes and cohorts were executed in DataSHIELD. In order to determine the dimensionality and measurement invariance of the PHQ-9 we tested three models (1 factor, 2 correlated factors, and bifactor) via confirmatory analyses and performed multi-group confirmatory factor analysis. RESULTS: Differences between sex and cohorts exist for PHQ-9 and for both of its dimensions. Women reported depressive symptoms in general as well as somatic and cognitive-affective symptoms more frequently. For all tested models an acceptable to excellent fit was found, consistently indicating a better model fit for the two-factor and bifactor model. Scalar measurement invariance was established between women and men, the three cohorts, and their interaction. CONCLUSIONS: The two facets of depression should be taken into account when using PHQ-9, while data also render support to a general factor. Somatic and cognitive-affective symptoms assessed by the PHQ-9 can be considered equivalent across women and men and between different German populations from different regions.

Treatment concepts of horizontally deficient ridges-A retrospective study comparing narrow-diameter implants in pristine bone with standard-diameter implants in augmented bone.

OBJECTIVES: To compare clinical and radiological outcomes of narrow-diameter implants (NDI) placed in pristine bone to standard-diameter implants placed in combination with horizontal bone augmentation procedures (SDI+A) for horizontally deficient alveolar ridges. MATERIAL AND METHODS: For this retrospective study, the outcome of 597 NDI (∅ 3.3 mm, 272 patients), inserted in pristine bone, were compared with 180 SDI (∅ 4.1 mm, 83 patients), inserted in combination with horizontal augmentation procedures. Oral health-related quality of life was assessed in patients available for recall. RESULTS: After a mean follow-up of 37.6 ± 40 months for the NDI and of 42.4 ± 49 months for the SDI+A, survival rates were 96.1% for NDI and 95.6% for SDI+A. Cumulative 5-year and 10-year implant survival rates were 94.3% and 92.2% for the NDI group and 97.0% and 88.3% for the SDI+A group, indicating no significant difference (p = .89). According to the criteria of Buser et al., an implant success rate of 84.3% was obtained for the NDI and an implant success rate of 81.3% for the SDI+A (p = .79). Regarding oral health-related quality of life, a similar and high patient satisfaction could be observed in both groups. CONCLUSIONS: NDI without augmentation procedures showed a similar clinical outcome as SDI in combination with augmentation procedures after a follow-up of more than 3 years. Therefore, NDI might be a reasonable alternative in cases of horizontal bone atrophy (no clinical trial registration as patient inclusion started 2003).

[Evaluation of the Language-related Domain of the Pediatric Developmental Screening Instrument for Preschool Health Examinations (SOPESS): Results from the Prospective Child Health Survey ikidS]. / Evaluation der Sprachaufgaben des sozialpädiatrischen Entwicklungsscreenings für Schuleingangsuntersuchungen (SOPESS): Ergebnisse der prospektiven Kindergesundheitsstudie ikidS.

PURPOSE OF THE STUDY: Developmental delays at school enrollment can affect early educational achievement. Thus, diagnosis and treatment prior to school entry are important. In Germany, SOPESS - a pediatric developmental screening instrument for preschool health examinations (PHE) - was introduced in several federal states. We investigated the relationships between the results of the language-related domain of the SOPESS and later academic language competencies at the end of first grade. PROCEDURES: Data of the population-based cohort study ikidS (Rhineland Palatinate; Germany) and the PHE provided by public health authorities were linked at individual level. The relationship between the SOPESS-language risk score (range: 0 to 6, higher values indicate more developmental delay) and class teacher-based ratings of academic language competencies (range: -4 to+4, higher values indicate better competencies) was investigated with linear regression models and adjusted for several socio-economic and medical language predictors (e. g. age at school entry, gender, parental education, migration background, hearing disorder). The additional benefits of the SOPESS-language risk score was analyzed using analysis of variance. RESULTS: In total, 1357 children (48% girls, age at PHE 4.9-7.2 years) were included. A clear negative relationship between the SOPESS-language risk score and competencies in spoken and written language was found. Mean academic language competencies decreased with increasing SOPESS-language risk level from 0.8 (SD=1.7) at a risk score of 0 to-3.2 (SD=0.9) at a risk score of 6. The relationship persisted after adjusting for other language predictors. Analysis of variance showed significant benefits of the SOPESS-language risk score, even when further language predictors were considered. CONCLUSIONS: There was a clear relationship between results of the SOPESS-language screening and later academic language competencies. Hence, the language-related domain of the SOPESS may be useful for further recommendations of tailored special educational and medical support services, especially if additional socio-economic and medical factors are considered.

Imaging-based target volume reduction in chemoradiotherapy for locally advanced non-small-cell lung cancer (PET-Plan): a multicentre, open-label, randomised, controlled trial.

BACKGROUND: With increasingly precise radiotherapy and advanced medical imaging, the concept of radiotherapy target volume planning might be redefined with the aim of improving outcomes. We aimed to investigate whether target volume reduction is feasible and effective compared with conventional planning in the context of radical chemoradiotherapy for patients with locally advanced non-small-cell lung cancer. METHODS: We did a multicentre, open-label, randomised, controlled trial (PET-Plan; ARO-2009-09) in 24 centres in Austria, Germany, and Switzerland. Previously untreated patients (aged older than 18 years) with inoperable locally advanced non-small-cell lung cancer suitable for chemoradiotherapy and an Eastern Cooperative Oncology Group performance status of less than 3 were included. Undergoing 18F-fluorodeoxyglucose (18F-FDG) PET and CT for treatment planning, patients were randomly assigned (1:1) using a random number generator and block sizes between four and six to target volume delineation informed by 18F-FDG PET and CT plus elective nodal irradiation (conventional target group) or target volumes informed by PET alone (18F-FDG PET-based target group). Randomisation was stratified by centre and Union for International Cancer Control stage. In both groups, dose-escalated radiotherapy (60-74 Gy, 2 Gy per fraction) was planned to the respective target volumes and applied with concurrent platinum-based chemotherapy. The primary endpoint was time to locoregional progression from randomisation with the objective to test non-inferiority of 18F-FDG PET-based planning with a prespecified hazard ratio (HR) margin of 1·25. The per-protocol set was included in the primary analysis. The safety set included all patients receiving any study-specific treatment. Patients and study staff were not masked to treatment assignment. This study is registered with ClinicalTrials.gov, NCT00697333. FINDINGS: From May 13, 2009, to Dec 5, 2016, 205 of 311 recruited patients were randomly assigned to the conventional target group (n=99) or the 18F-FDG PET-based target group (n=106; the intention-to-treat set), and 172 patients were treated per protocol (84 patients in the conventional target group and 88 in the 18F-FDG PET-based target group). At a median follow-up of 29 months (IQR 9-54), the risk of locoregional progression in the 18F-FDG PET-based target group was non-inferior to, and in fact lower than, that in the conventional target group in the per-protocol set (14% [95% CI 5-21] vs 29% [17-38] at 1 year; HR 0·57 [95% CI 0·30-1·06]). The risk of locoregional progression in the 18F-FDG PET-based target group was also non-inferior to that in the conventional target group in the intention-to-treat set (17% [95% CI 9-24] vs 30% [20-39] at 1 year; HR 0·64 [95% CI 0·37-1·10]). The most common acute grade 3 or worse toxicity was oesophagitis or dysphagia (16 [16%] of 99 patients in the conventional target group vs 17 [16%] of 105 patients in the 18F-FDG PET-based target group); the most common late toxicities were lung-related (12 [12%] vs 11 [10%]). 20 deaths potentially related to study treatment were reported (seven vs 13). INTERPRETATION: 18F-FDG PET-based planning could potentially improve local control and does not seem to increase toxicity in patients with chemoradiotherapy-treated locally advanced non-small-cell lung cancer. Imaging-based target volume reduction in this setting is, therefore, feasible, and could potentially be considered standard of care. The procedures established might also support imaging-based target volume reduction concepts for other tumours. FUNDING: German Cancer Aid (Deutsche Krebshilfe).

Acoustic radiation force impulse point shear wave elastography of the liver and spleen in patients with Gaucher disease type 1: Correlations with clinical data and markers of disease severity.

PURPOSE: To evaluate the feasibility of acoustic radiation force impulse point shear wave elastography (ARFI-pSWE) of the liver and spleen in patients with Gaucher disease type 1 (GD1), and to assess correlations between organ stiffness and clinico-radiologic data, particularly the GD1 Severity Scoring System (GD-DS3). MATERIALS AND METHODS: We retrospectively evaluated the results of ARFI-pSWE as measures of liver and spleen stiffness in 57 patients with GD1. The feasibility of the method was assessed. Correlations between elastography data and clinical data related to the metabolic syndrome, laboratory tests, and GD1-related clinico-radiologic data (bone marrow burden score, GD-DS3) were assessed. RESULTS: ARFI-pSWE provided reliable results (i.e. standard deviation <30% of the mean value between the measurements) in 50/57 patients. Significant liver fibrosis was present in 35/50 patients (70%). Liver stiffness significantly correlated with GD-DS3 score (p = .03), and number of fulfilled criteria of metabolic syndrome (p = .03). Spleen stiffness significantly correlated with age (p = .021), body mass index (p = .002), number of fulfilled criteria of metabolic syndrome (p = .02), and several laboratory parameters (alanine aminotransferase, gamma glutamyltranspeptidase, triglycerides, cholesterol), and nearly significantly with GD-DS3 score (p = .059). CONCLUSION: ARFI-pSWE is a useful tool for a more detailed assessment of disease severity in patients with GD1, which adds relevant information to the standard clinical scores. Thus, elastography might allow for extended therapy monitoring, especially in patients with significant liver fibrosis. Spleen elastography showed promising results; thus, its role should be further investigated.

The association between recalled parental rearing behavior and depressiveness: a comparison between 1st immigrants and non-immigrants in the population-based Gutenberg Health Study.

BACKGROUND: Studies in immigrant youth have suggested differences in parenting patterns by immigration status. Knowledge of variation in recalled parenting pattern and its distinctive impact on mental health in adult immigrants, however, is limited. Therefore, the purpose of the current study was to investigate similarities and differences in recalled maternal and paternal rearing behavior and its association with depressiveness in adult 1st generation immigrants compared to non-immigrants. METHODS: Seven hundred and forty-three 1st generation immigrants (M = 57.4, SD = 10.1 years) and 6518 non-immigrants (M = 60.3, SD = 10.7 years) participated in a population-based study. Regarding countries of origin, the largest subgroups were immigrants from Eastern-Europe, Former-SU, and Arabic-Islamic countries. All participants completed the ultra-short version of The Recalled Parental Rearing Behavior-questionnaire and the PHQ-9 assessing depressiveness. Multiple linear regressions with depressiveness as outcome variable were analyzed separately for each facet of parental rearing behavior adjusting for socio-demographic and migration-related variables. RESULTS: In addition to differences in depressiveness and socioeconomic status, 1st generation immigrants recalled both their mothers and fathers as more controlling and overprotecting than non-immigrants. Parental emotional warmth was negatively associated with depressiveness across all groups. The relationship between parental control, respectively parental rejection and depressiveness, however, varied in direction and severity between the groups. CONCLUSION: The results support the notion that parental warmth is a universal protective factor against depressiveness, whereas the impact of parental control on mental health might be more culturally influenced. Analyses point to the importance of considering the unique contribution of fathers' rearing behavior on mental health, particularly in immigrant samples.

Psychological interventions to foster resilience in healthcare students.

BACKGROUND: Resilience can be defined as maintaining or regaining mental health during or after significant adversities such as a potentially traumatising event, challenging life circumstances, a critical life transition or physical illness. Healthcare students, such as medical, nursing, psychology and social work students, are exposed to various study- and work-related stressors, the latter particularly during later phases of health professional education. They are at increased risk of developing symptoms of burnout or mental disorders. This population may benefit from resilience-promoting training programmes. OBJECTIVES: To assess the effects of interventions to foster resilience in healthcare students, that is, students in training for health professions delivering direct medical care (e.g. medical, nursing, midwifery or paramedic students), and those in training for allied health professions, as distinct from medical care (e.g. psychology, physical therapy or social work students). SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, 11 other databases and three trial registries from 1990 to June 2019. We checked reference lists and contacted researchers in the field. We updated this search in four key databases in June 2020, but we have not yet incorporated these results. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing any form of psychological intervention to foster resilience, hardiness or post-traumatic growth versus no intervention, waiting list, usual care, and active or attention control, in adults (18 years and older), who are healthcare students. Primary outcomes were resilience, anxiety, depression, stress or stress perception, and well-being or quality of life. Secondary outcomes were resilience factors. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, extracted data, assessed risks of bias, and rated the certainty of the evidence using the GRADE approach (at post-test only). MAIN RESULTS: We included 30 RCTs, of which 24 were set in high-income countries and six in (upper- to lower-) middle-income countries. Twenty-two studies focused solely on healthcare students (1315 participants; number randomised not specified for two studies), including both students in health professions delivering direct medical care and those in allied health professions, such as psychology and physical therapy. Half of the studies were conducted in a university or school setting, including nursing/midwifery students or medical students. Eight studies investigated mixed samples (1365 participants), with healthcare students and participants outside of a health professional study field. Participants mainly included women (63.3% to 67.3% in mixed samples) from young adulthood (mean age range, if reported: 19.5 to 26.83 years; 19.35 to 38.14 years in mixed samples). Seventeen of the studies investigated group interventions of high training intensity (11 studies; > 12 hours/sessions), that were delivered face-to-face (17 studies). Of the included studies, eight compared a resilience training based on mindfulness versus unspecific comparators (e.g. wait-list). The studies were funded by different sources (e.g. universities, foundations), or a combination of various sources (four studies). Seven studies did not specify a potential funder, and three studies received no funding support. Risk of bias was high or unclear, with main flaws in performance, detection, attrition and reporting bias domains. At post-intervention, very-low certainty evidence indicated that, compared to controls, healthcare students receiving resilience training may report higher levels of resilience (standardised mean difference (SMD) 0.43, 95% confidence interval (CI) 0.07 to 0.78; 9 studies, 561 participants), lower levels of anxiety (SMD -0.45, 95% CI -0.84 to -0.06; 7 studies, 362 participants), and lower levels of stress or stress perception (SMD -0.28, 95% CI -0.48 to -0.09; 7 studies, 420 participants). Effect sizes varied between small and moderate. There was little or no evidence of any effect of resilience training on depression (SMD -0.20, 95% CI -0.52 to 0.11; 6 studies, 332 participants; very-low certainty evidence) or well-being or quality of life (SMD 0.15, 95% CI -0.14 to 0.43; 4 studies, 251 participants; very-low certainty evidence). Adverse effects were measured in four studies, but data were only reported for three of them. None of the three studies reported any adverse events occurring during the study (very-low certainty of evidence). AUTHORS' CONCLUSIONS: For healthcare students, there is very-low certainty evidence for the effect of resilience training on resilience, anxiety, and stress or stress perception at post-intervention. The heterogeneous interventions, the paucity of short-, medium- or long-term data, and the geographical distribution restricted to high-income countries limit the generalisability of results. Conclusions should therefore be drawn cautiously. Since the findings suggest positive effects of resilience training for healthcare students with very-low certainty evidence, high-quality replications and improved study designs (e.g. a consensus on the definition of resilience, the assessment of individual stressor exposure, more attention controls, and longer follow-up periods) are clearly needed.