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.

School absenteeism in children with special health care needs. Results from the prospective cohort study ikidS.

OBJECTIVE: Children with special health care needs (SHCN) due to a chronic health condition perform more poorly at school compared to their classmates. There is still little knowledge on the causal pathways and which factors could be targeted by interventions. We, therefore, investigated school absenteeism in children with SHCN compared to their peers. METHODS: This study was based on data from the German population-based prospective cohort study ikidS (German for: I will start school). Children with SHCN were identified by the Children with Special Health Care Needs screener that captures five consequences of physical or mental chronic health conditions: (1) use or need of prescription medication, (2) above average use or need of medical, mental health, or educational services, (3) functional limitations compared with others of the same age, (4) use or need of specialized therapies, and (5) treatment or counseling for emotional, behavioral, or developmental problems. School absenteeism was defined as days absent from school due to illness during first grade and was reported by classroom teachers. Associations between SHCN consequences and school absenteeism were investigated by negative binomial regression models. Effect estimates were adjusted for confounding variables identified by a causal framework and directed acyclic graphs. RESULTS: 1,921 children (mean age at follow-up 7.3 years, standard deviation 0.3; 49% females) were included; of these, 14% had SHCN. Compared to their classmates, children with SHCN had more days absent (adjusted rate ratio: 1.37; 95% confidence interval 1.16, 1.62). The effect was strongest among children with i) functional limitations, ii) treatment or counseling for emotional, behavioral, or developmental problems, and iii) those who experienced two or more SHCN consequences. CONCLUSIONS: Children with SHCN have higher school absenteeism, which could-at least partly-explain their poorer school performance and lower educational attainment. SHCN-specific targeted interventions may reduce the adverse effects of SHCN on educational outcomes in children.

[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.

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.

Multiphoton microscopy in the diagnostic assessment of pediatric solid tissue in comparison to conventional histopathology: results of the first international online interobserver trial.

Purpose: Clear resection margins are paramount for good outcome in children undergoing solid tumor resections. Multiphoton microscopy (MPM) can provide high-resolution, real-time, intraoperative microscopic images of tumor tissue. Objective: This prospective international multicenter study evaluates the diagnostic accuracy, feasibility, and interobserver congruence of MPM in diagnosing solid pediatric tissue and tumors for the first time. Material and methods: Representative fresh sections from six different neonatal solid tissues (liver, lung, kidney, adrenal gland, heart muscle, testicle) and two types of typical pediatric solid tumors (neuroblastoma, rhabdomyosarcoma) with adjacent nonneoplastic tissue were imaged with MPM and then presented online with corresponding H&E stained slides of the exact same tissue region. Both image sets of each tissue type were interpreted by 38 randomly selected international attending pediatric pathologists via an online evaluation software. Results: The quality of MPM was sufficient to make the diagnosis of all normal tissue types except cardiac muscle in >94% of assessors with high interobserver congruence and 95% sensitivity. Heart muscle was interpreted as skeletal muscle in 55% of cases. Based on MPM imaging, participating pathologists diagnosed the presented pediatric neoplasms with 100% specificity, although the sensitivity reached only about 50%. Conclusion: Even without prior training, pathologists are able to diagnose normal pediatric tissues with valuable accuracy using MPM. While current MPM imaging protocols are not yet sensitive enough to reliably rule out neuroblastoma or rhabdomyosarcoma, they seem to be specific and therefore useful to confirm a diagnosis intraoperatively. We are confident that improved algorithms, specific training, and more experience with the method will make MPM a valuable future alternative to frozen section analysis. Registration: The trial was registered at www.researchregistry.com, registration number 2967.

Is assessment of depression equivalent for migrants of different cultural backgrounds? Results from the German population-based Gutenberg Health Study (GHS).

BACKGROUND: Bearing in mind the multicultural background of a national population, little is known about the measurement invariance across different cultures or ethnicities of frequently used screeners for depression. For this reason, the main objective of the current study is to assess the measurement invariance of the Patient Health Questionnaire (PHQ-9) across groups with different migration backgrounds. METHODS: We provided psychometric analyses (descriptive statistics at item and scale level, reliability analysis, exploratory [EFA] and confirmatory factor analyses [CFA]) comparing a native population with first- and second-generation migrants of the German population-based Gutenberg Health Study with N = 13,973 participants completing the PHQ-9. Furthermore, we conducted measurement invariance analyses among different groups of first-generation migrants. RESULTS: Comparing the native population with first- and second-generation migrants, a higher prevalence for mental distress was found for first generation. Although mean score patterns were similar for all groups, analyses of item loadings among first-generation migrants yielded some variance in patterns pointing out that certain items have a distinct impact on depression for specific groups. With regard to the factorial validity for all groups, EFA and CFA provided evidence for the proposed one latent factor structure of the PHQ-9. Depression assessed by the PHQ-9 turned out to be equivalent from a psychometric perspective across different groups stratified by their migration background. CONCLUSIONS: Overall, results of thorough scale and item analyses, especially multigroup confirmatory analyses, provided support that depression, assessed by the PHQ-9, can be considered as psychometrically equivalent across all analyzed groups.

Chronic health conditions and school performance in first graders: A prospective cohort study.

OBJECTIVE: Children with chronic health conditions may perform poorer at school. Associations may be confounded by numerous social factors. We aimed to estimate the effects of a chronic health condition on overall school performance in first graders with an emphasis on rigorous adjustment for potential confounders. METHODS: A population-based cohort study was performed in the area of Mainz-Bingen (Germany). In 2015 all preschoolers were approached and the presence of a chronic health condition was assessed by parental questionnaires and preschool health examination data. The identification of a chronic health condition was based on special health care needs and presence of a doctor's diagnosis out of 24 school-relevant diseases. At the end of the first school year, overall school performance was assessed by teachers and rated on a 5-item scale ranging from -10 to +10. RESULTS: Of 3683 children approached, 2003 were enrolled. Overall school performance was available for 1462 children (51% boys). Of these, 52% suffered from a chronic health condition. Compared to children without a chronic health condition, children with special health care needs (15%) performed worse at school (adjusted mean difference: -0.95, 95% CI: [-1.55; -0.35], P = 0.002). Children with a doctor's diagnosis but without special health care needs (37%) did not perform worse at school. The effect was further analysed considering the extent of special health care needed. CONCLUSIONS: Chronic health conditions affect overall school performance early in primary school. To identify academically at-risk children, a chronic health condition identification based on special health care needs may be used.

A weighted combined effect measure for the analysis of a composite time-to-first-event endpoint with components of different clinical relevance.

Composite endpoints combine several events within a single variable, which increases the number of expected events and is thereby meant to increase the power. However, the interpretation of results can be difficult as the observed effect for the composite does not necessarily reflect the effects for the components, which may be of different magnitude or even point in adverse directions. Moreover, in clinical applications, the event types are often of different clinical relevance, which also complicates the interpretation of the composite effect. The common effect measure for composite endpoints is the all-cause hazard ratio, which gives equal weight to all events irrespective of their type and clinical relevance. Thereby, the all-cause hazard within each group is given by the sum of the cause-specific hazards corresponding to the individual components. A natural extension of the standard all-cause hazard ratio can be defined by a "weighted all-cause hazard ratio" where the individual hazards for each component are multiplied with predefined relevance weighting factors. For the special case of equal weights across the components, the weighted all-cause hazard ratio then corresponds to the standard all-cause hazard ratio. To identify the cause-specific hazard of the individual components, any parametric survival model might be applied. The new weighted effect measure can be tested for deviations from the null hypothesis by means of a permutation test. In this work, we systematically compare the new weighted approach to the standard all-cause hazard ratio by theoretical considerations, Monte-Carlo simulations, and by means of a real clinical trial example.

Factors associated with supportive care needs in glioma patients in the neuro-oncological outpatient setting.

Objective of this study aimed at assessing glioma patients' supportive care needs in a neurosurgical outpatient setting and identifying factors that are associated with needs for support. In three neuro-oncological outpatient departments, glioma patients were assessed for their psychosocial needs using the Supportive Care Needs Survey short-form (SCNS-SF34-G). Associations between clinical, sociodemographic, treatment related factors as well as distress (measured with the distress thermometer) and supportive care needs were explored using multivariable general linear models. One-hundred and seventy three of 244 eligible glioma patients participated, most of them with primary diagnoses of a high-grade glioma (81%). Highest need for support was observed in 'psychological needs' (median 17.5, range 5-45) followed by 'physical and daily living needs' (median 12.5, range 0-25) and 'health system and information needs' (median 11.3, range 0-36). Needs in the psychological area were associated with distress (R2 = 0.36) but not with age, sex, Karnofsky performance status (KPS), extend of resection, currently undergoing chemotherapy and whether guidance during assessment was offered. Regarding 'health system and information needs', we observed associations with distress, age, currently undergoing chemotherapy and guidance (R2 = 0.31). In the domain 'physical and daily living needs' we found associations with KPS, residual tumor, as well as with distress (R2 = 0.37). Glioma patients in neuro-oncological departments report unmet supportive care needs, especially in the psychological domain. Distress is the factor most consistently associated with unmet needs requiring support and could serve as indicator for clinical neuro-oncologists to initiate support.

Evaluating patients for psychosocial distress and supportive care needs based on health-related quality of life in primary brain tumors: a prospective multicenter analysis of patients with gliomas in an outpatient setting.

The association between health-related quality of life (HRQoL), psychosocial distress, and supportive care is in the focus of patient-centered neuro-oncology. We investigated the relationship between the aforementioned in glioma-patients to evaluate the association of these instruments and determine cut-off values for suitable HRQoL scales indicating a potential need for intervention. In an observational multi-center study, outpatients completed the Distress Thermometer (DT), EORTC Quality of Life Questionnaire (EORTC-QLQ-C30/BN20, HRQoL), and Supportive-Care-Needs-Survey-SF34-G (SCNS). Based on nine EORTC-function and selected -symptom scales items of the questionnaires were matched. Convergent validity of related single items and scores across the instruments was estimated. EORTC cut-off values were calculated. Data of 167 patients were analyzed. The strongest correlation of EORTC-QLQ-C30 and DT was found for cognitive function (cogf), global health status (GHS), emotional (emof), role function (rolef), future uncertainty (FU), fatigue, and between EORTC-QLQ-C30 and SCNS for FU, emof, rolef (r = |0.4-0.7|; p < 0.01). EORTC cut-off values of <54.2 (GHS/QoL) and <62.5 (emof) predicted a DT ≥ 6 (AUC 0.79, 0.85, p < 0.01). EORTC cut-off values of <70.8 (emof) and <52.8 (FU) predicted the need for supportive care (AUC 0.78, 0.85; p < 0.01). Worse EORTC-C30 scores correlate with higher DT and SCNS scores. With this exploratory assessment, cut-off values for EORTC-C30 subscores to predict distress and pathological SCNS-scores could be determined, which could influence patients' referral to further treatment. However, further prospective clinical trials are needed to confirm the clinical relevance of these cut-off values.

[Patient attitudes and expectations towards conflicts of interest of attending physicians]. / Einstellungen und Erwartungen von Patienten in Bezug auf Interessenkonflikte ihrer behandelnden Ärzte.

BACKGROUND: Patients can truly expect to be treated by their physicians without undue influences of secondary interests. It is not known what patients in Germany know about relationships between physicians and the pharmaceutical industry and if and how they want to be informed about these relationships. METHOD: An information sheet explaining conflicts of interest and a 19-item questionnaire were distributed to 765 patients at various medical offices and hospitals in two German cities. 80 % (n=612) of the patients completed and returned the questionnaires anonymously. RESULTS: 65 % of the patients did not know of conflicts of interest (COI) doctors may have with the pharmaceutical industry. 74 % of the patients would like to know if their doctor had obtained any benefits through contacts with the pharmaceutical industry. 71 % agreed that a disclosure would increase their confidence, and 74 % wanted their physicians to declare COI verbally to them during a consultation. 40 % would prefer a doctor who is not receiving any benefits from the pharmaceutical industry. The desire for disclosure was significantly higher in patients who had an awareness of the problems of COI (OR 4.95; 95 % CI 3.33 - 7.35). However, 35 % of the patients trusted their attending physicians anyway and did not see a need for disclosure of any COI. CONCLUSION: The majority of patients, but not all patients want to be informed about COI of their physicians. The best way to do this has yet to be determined.

Cost-effectiveness of depression case management in small practices.

BACKGROUND: Case management undertaken by healthcare assistants in small primary care practices is effective in improving depression symptoms and adherence in patients with major depression. AIMS: To evaluate the cost-effectiveness of depression case management by healthcare assistants in small primary care practices. METHOD: Cost-effectiveness analysis on the basis of a pragmatic randomised controlled trial (2005-2008): practice-based healthcare assistants in 74 practices provided case management to 562 patients with major depression over 1 year. Our primary outcome was the incremental cost-effectiveness ratio (ICER) calculated as the ratio of differences in mean costs and mean number of quality-adjusted life-years (QALYs). Our secondary outcome was the mean depression-free days (DFDs) between the intervention and control group at 24-month follow-up. The study was registered at the International Standard Randomised Controlled Trial Number Registry: ISRCTN66386086. RESULTS: Intervention v. control group: no significant difference in QALYs; significantly more DFDs (mean: 373 v. 311, P<0.01); no significant difference in mean direct healthcare costs (€4495 v. €3506, P = 0.16); considerably lower mean indirect costs (€5228 v. €7539, P = 0.06), resulting in lower total costs (€9723 v. €11 045, P = 0.41). The point estimate for the cost-utility ratio was €38 429 per QALY gained if only direct costs were considered, and 'dominance' of the intervention if total costs were considered. Yet, regardless of decision makers' willingness to pay per QALY, the probability of the intervention being cost-effective was never above 90%. CONCLUSIONS: In small primary care practices, 1 year of case management did not increase the number of QALYs but it did increase the number of DFDs. The intervention was likely to be cost-effective.

Evaluation of health information systems-problems and challenges.

OBJECTIVES: Information technology (IT) is emerging in health care. A rigorous evaluation of this technology is recommended and of high importance for decision makers and users. However, many authors report problems during the evaluation of information technology in health care. In this paper, we discuss some of these problems, and propose possible solutions for these problems. METHODS: Based on own experience and backed up by a literature review, some important problems during IT evaluation in health care together with their reasons, consequences and possible solutions are presented and structured. RESULTS AND CONCLUSIONS: We define three main problem areas-the complexity of the evaluation object, the complexity of an evaluation project, and the motivation for evaluation. Many evaluation problems can be subsumed under those three problem areas. A broadly accepted framework for evaluation of IT in healthcare seems desirable to address those problems. Such a framework should help to formulate relevant questions, to find adequate methods and tools, and to apply them in a sensible way.