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Introduction: We developed low-cost, portable paper-based diagnostic devices for detection of human immunoglobulin M (IgM) and immunoglobulin G (IgG) in serum without any sample preparation. These devices can be used to help identify presence of diseases, used to provide rapid results (<5 minutes), readily used by untrained personnel, employed in austere environments, configured to obtain multiplexed assays, and easily disposed of.Materials and Methods: We successfully accomplished colorimetric detection of human IgG and human IgM using a sandwich-style assay within the microfluidic paper device via vertical flow immunoassay configuration. The reaction zone in the wax printed paper layer is a small circular pattern. Gold nanoparticles conjugated with anti-human IgG and IgM antibodies have been used for colorimetric detection of IgG or IgM by naked eye. Colorimetric signal can be precisely quantified through implementation of image analysis software which can be developed as an app for a smartphone. The size of the device is 2 cm × 2 cm × 1 mm.Results: Colorimetric detection of human IgG was accomplished at 100 fg/mL concentration using a gold nanoparticle-conjugated anti-human IgG antibody. The developed platform has a dynamic range of IgM and IgG concentrations between 0.1 pg/mL and 100 μg/mL. These devices provided a color readout in <5 minutes using 20 µL of serum. We also demonstrated that the devices show a significant degree of ruggedness and temperature stability as they were able to provide satisfactory results (detection of 0.1 pg/mL IgG) after 14 days of long stability and shelf-life experiment at an elevated temperature of at least 50 ˚C-the shelf life can be as long as 180 days under ambient conditions for detection of 100 µg/mL IgG.Conclusions: Because of the inherent simplicity of the device operation and their ease of use, there is no variation between samples and users of the device. This low-cost approach enables multiplexing with >1 measurement performed in parallel at the same time. We anticipate that because of the sensitivity, specificity, ease of use, and overall reliability, this approach will become a standard for diagnosis of diseases and health conditions. [ABSTRACT FROM AUTHOR]

Objectives: A new patient-reported outcome (PRO) instrument to measure fatigue symptoms and impacts in relapsing multiple sclerosis (RMS) was developed in a qualitative stage, followed by psychometric validation and migration from paper to an electronic format.Methods: Adult patients with relapsing-remitting multiple sclerosis (RRMS) were interviewed to elicit fatigue-related symptoms and impacts. A draft questionnaire was debriefed in cognitive interviews with further RRMS patients, and revised. Content confirmation interviews were conducted with patients with progressive-relapsing multiple sclerosis (PRMS) and relapsing secondary-progressive multiple sclerosis (RSPMS). Psychometric analyses used data from adult patients with different RMS subtypes and matched non-RMS controls in a multicenter, observational study. After item reduction, the final instrument was migrated to a smartphone (eDiary) and usability was confirmed in interviews with additional adult RMS patients.Results: The qualitative stage included 37 RRMS, 5 PRMS, and 5 RSPMS patients. Saturation of concepts was reached during concept elicitation. Cognitive interviews confirmed that participants understood the instructions, items, and response options of the instrument-named FSIQ-RMS-as intended. Psychometric validation included 164 RMS and 74 control patients. Internal consistency and test-retest reliability were demonstrated. The symptoms domain discriminated along the RMS symptom-severity continuum and between patients and controls. Patients were able to attribute fatigue-related symptoms to RMS. Usability and conceptual equivalence of the eDiary were confirmed (n = 10 participants).Conclusions: With 7 symptom items and 13 impact items (in 3 impacts subdomains: physical, cognitive and emotional, and coping) after item reduction, the FSIQ-RMS is a comprehensive, valid, and reliable measure of fatigue-related symptoms and impacts in RMS patients. [ABSTRACT FROM AUTHOR]

Integration of e-Health technologies for purposes of both assessment and intervention has recently become an interest area in pediatric psychology. The purpose of this study is to present psychometric characteristics of a technology-based (i.e., tablet administration) approach for measuring quality of life (QOL) in children. Eighty children (8-12 years) completed the Quality of Life Systemic Inventory for Children (QLSI-C) twice over a 2-week delay, in a crossover design that used paper and tablet-based modes of administration. Equivalence of scores across methods was examined using intraclass correlation coefficients (ICC), augmented by paired t test and Pearson's correlations. Test-retest reliability was assessed using paired t test and Pearson's correlations while internal consistency was assessed using Cronbach's coefficient. Results showed a good concordance across methods of administration (ICCs = .72 to .91; r = .56 to .83). Paired t test showed no significant differences between the tablet and paper version of the QLSI-C. Internal consistency reliability yielded acceptable Cronbach's alphas for all QLSI-C scores, with all α > .70. Test-retest reliability for the tablet-administered QLSI-C was good (r = .66 to .90). Paired t test showed no significant difference between Time 1 and 2 for the QLSI-C scores, except for the state score. Findings established the reliability of the tablet-administered QLSI-C scores. This technology approach to assessment is more attractive for children, decreases time for administration, and enhances the ease of scoring. These advantages might encourage both clinicians and researchers to consider using e-Health developments in assessment in pediatric psychology. (PsycINFO Database Record [ABSTRACT FROM AUTHOR]

Objectives: To compare data based on computerized and paper versions of health status questionnaires (HSQs) for sampling patient-reported outcomes (PROs) in patients with fibromyalgia (FM). In addition, to examine associations between patient characteristics (age, education, computer experience) and differences between versions. Finally, to evaluate the acceptability of computer-based questionnaires among patients with FM.Method: The study population comprised female patients diagnosed with FM. All patients completed six HSQs: the Fibromyalgia Impact Questionnaire (FIQ), the Major Depression Inventory (MDI), the 36-item Short Form Health Survey (SF-36), the painDETECT questionnaire (PDQ), the Coping Strategies Questionnaire (CSQ), and the Generalized Anxiety Disorder Self-Assessment Questionnaire (GAD-10), both on paper and using a touch screen. One HSQ was tested at a time in a repeated randomized cross-over design. The two versions were completed with a 5-min interval and between each HSQ the participants had a 5-min break. Means, mean differences with 95% confidence intervals (CIs), medians, median differences, and intraclass correlation coefficients (ICCs) were calculated for all HSQs, including relevant subscales. Associations between patient characteristics and differences between versions were explored using Spearman's correlation coefficients.Results: Twenty women, mean age 48.4 years, participated in the study. Except for one item, ICCs between touch-screen and paper versions of the HSQs examined indicated acceptable agreement (ICC = 0.71-0.99). Overall, mean and median differences revealed no differences between versions. No significant associations were observed for patient characteristics. None of the participants preferred paper questionnaires over computerized versions.Conclusions: The computerized HSQs using a touch screen gave comparable results to answers given on paper and were generally preferred by the participants. [ABSTRACT FROM AUTHOR]

Mobile devices are increasingly used to administer self-report measures of mental health symptoms. There are significant differences, however, in the way that information is presented on mobile devices compared to the traditional paper forms that were used to administer such measures. Such differences may systematically alter responses. The present study evaluated if and how responses differed for a self-report measure, the PTSD Checklist (PCL), administered via mobile device relative to paper and pencil. Participants were 153 trauma-exposed individuals who completed counterbalanced administrations of the PCL on a mobile device and on paper. PCL total scores (d = 0.07) and item responses did not meaningfully or significantly differ across administrations. Power was sufficient to detect a difference in total score between administrations determined by prior work of 3.46 with a d = 0.23. The magnitude of differences between administration formats was unrelated to prior use of mobile devices or participant age. These findings suggest that responses to self-report measures administered via mobile device are equivalent to those obtained via paper and they can be used with experienced as well as naïve users of mobile devices. [ABSTRACT FROM AUTHOR]

Most Human African Trypanosomiasis (HAT) control programmes in areas endemic for Trypanosoma brucei gambiense rely on a strategy of active mass screening with the Card Agglutination Test for Trypanosomiasis (CATT)/T. b. gambiense. We evaluated the performance, stability and reproducibility of the CATT/T. b. gambiense on blood-impregnated filter papers (CATT-FP) in Kajo-Keji County, South-Sudan, where some areas are inaccessible to mobile teams. The CATT-FP was performed with a group of 100 people with a positive CATT on whole blood including 17 confirmed HAT patients and the results were compared with the CATT on plasma (CATT-P). The CATT-FP was repeated on impregnated filter papers stored at ambient and refrigerated temperature for 1, 3, 7 and 14 days. Another 82 patients with HAT, including 78 with a positive parasitology, were tested with the CATT-FP and duplicate filter paper samples were sent to a reference laboratory to assess reproducibility. The CATT-FP was positive in 90 of 99 patients with HAT (sensitivity: 91%). It was less sensitive than the CATT-P (mean dilution difference: -2.5). There was no significant loss of sensitivity after storage for up to 14 days both at ambient and cool temperature. Reproducibility of the CATT-FP was found to be excellent (kappa: 0.84). The CATT-FP can therefore be recommended as a screening test for HAT in areas where the use of CATT-P is not possible. Further studies on larger population samples in different endemic foci are still needed before the CATT-FP can be recommended for universal use. [ABSTRACT FROM AUTHOR]

Cysticercosis is an infestation of Cysticercus cellulosae. When it occurs in the brain, chronic neurological complications can ensue, most commonly seizures. Neurocysticercosis is usually diagnosed by neuroimaging, a technique not available in most endemic countries. Hence immunological tests are valuable for diagnosis and epidemiological surveys. We evaluated the suitability of paper for storing blood and cerebrospinal fluid (CSF) until subsequent testing by enzyme-linked immunosorbent assay (ELISA), by testing whole blood samples on filter paper from 305 patients and CSF samples from 117 patients stored on ordinary white typing paper and on filter paper. Optimal preservation of biological samples is achieved when whole blood is stored on filter paper, CSF on white paper, and when samples are frozen within 1 week after collection. Our results could improve diagnostic capabilities and facilitate epidemiological surveys in endemic countries where immunodiagnostic tests cannot be rapidly performed because of inadequate laboratory infrastructure. [ABSTRACT FROM AUTHOR]

Background: The motion capture has been used as the usual method for measuring movement parameters of human, and most of the measuring data are obtained by partial manual process based on commercial software. An automatic kinematics data process was developed by programming on MATLAB software in this paper.Methods: The motion capture measurement of healthy volunteers was carried out and the MATLAB program was used for data process. Firstly, the coordinate data of markers and anatomical points on human lower limb measured by motion capture system were read and repaired through the usual and the patch program. Meantime, the local coordinate systems of human femur and tibia were established with anatomical points. Then flexion/extension, abduction/adduction and internal/external rotation of human knee tibiofemoral joint were obtained by special coordinate transformation program.Results: Using the above methods, motion capture measurements and batch data processing were carried out on squatting and climbing stairs of 29 healthy volunteers. And the motion characteristics (flexion/extension, internal/external rotation and adduction/abduction) of the knee joint were obtained. For example, the maximum internal/external rotation in squatting and climbing stairs were respectively was 30.5 degrees and 14 degrees, etc. Meantime, the results of this paper also were respectively compared with the results processed by other research methods, and the results were basically consistent, thus the reliability of our research method was verified. After calibration processing, the compiled MATLAB program of this paper can directly be used for efficient batch processing and avoiding manual modeling one by one.Conclusion: A novel Patch Program of this paper has been developed, which can make reasonable compensation for missing and noise signals to obtain more complete motion data. At the same time, a universal data processing program has also been developed for obtaining the relative movement of various components of the human body, and the program can be modified for detail special analysis. These motion capture technologies can be used to judge whether the human body functions are abnormal, provide a reference for rehabilitation treatment and design of rehabilitation equipment, and evaluate the effectiveness before and after surgery. [ABSTRACT FROM AUTHOR]

Background: Accurately identifying patients at an elevated risk of suicide in minimal time is an important mental health issue. Therefore, we developed the Ultra Brief Checklist for Suicidality (UBCS) and reported its psychometric properties.Methods: We studied 544 participants who had completed the UBCS, other self-report measures, and structured clinical interviews by trained interviewers. We explored the psychometric properties of the UBCS's paper-based and online versions by identifying optimal cutoff points, sensitivity, specificity, etc. of all participants.Results: The mean score of the UBCS (paper-pencil version) in the no-suicide-risk group was 0.23 (SD = 0.73), while in the Risk-Positive (RP) and the High-Risk (HR) groups it was 3.54 (SD = 3.22) and 6.31 (SD = 3.97), respectively. Optimal cutoff points for the RP and HR groups were 1 (AUC = 0.914) and 3 (AUC = 0.928), respectively.Limitations: The current findings apply only to adults, not to children or adolescents. The original MINI was used as the assessment instrument's reference standard rather than MINI 7.0.2 of DSM-5. Predictive validity was not addressed as this was not a longitudinal cohort study.Conclusions: The UBCS was rigorously tested and validated. More than half the participants completed the UBCS within a minute. It possesses adequate psychometric properties and can be easily administered with minimal clinician time and effort, via paper or Internet. We believe it can contribute to suicide risk identification and timely interventions. [ABSTRACT FROM AUTHOR]

Aim: To validate the paper grip test for assessing plantar flexion strength of the hallux.Methods: Plantar flexor strength for 69 people with diabetic neuropathy was assessed: (a) using the paper grip test while simultaneously a plantar pressure platform quantified the force under the hallux, and (b) using a hand-held dynamometer. Following testing, participants were divided into groups: (1) passed vs. failed paper grip test (2) males vs. females. Statistical analyses determined if differences were evident between the groups and assessed the relationship between the paper grip test and the hand-held dynamometer. The discrimination ability, sensitivity, specificity, and reproducibility of the paper grip test was established.Results: Participants who passed the paper grip test demonstrated greater grip force at the hallux than those who failed, and they also exhibited greater isometric maximum force during the hand-held dynamometry test (p ≤ 0.05). Grip force for males was significantly higher than for females. A moderate positive correlation between the paper grip test and the hand-held dynamometer was evident.Conclusions: In the population examined the paper grip test was found to be a valid clinical tool; it offers a non-invasive, inexpensive, and quick method to assess plantar flexion strength of the hallux. [ABSTRACT FROM AUTHOR]

Late-onset toxicities often occur in phase I trials investigating novel immunotherapy and molecular targeted therapies. For trials with cohort based designs (such as modified toxicity probability interval, Bayesian optimal interval, and i3+3), patients are often turned away since the current cohort are still being followed without definite dose-limiting toxicities, which results in prolonged trial duration and waste of patient resources. In this paper, we incorporate a probability-of-decision framework into the i3+3 design and allow real-time dosing inference when the next patient becomes available. Both follow-up time for the pending patients and time to dose-limiting toxicities for the observed patients are used in calculating the posterior probability of each possible dosing decision. An intensive simulation study is conducted to evaluate the operating characteristics of the newly proposed probability-of-decision-i3+3 design under various dosing scenarios and patient accrual settings. Results show that the probability-of-decision-i3+3 design achieves comparable safety and reliability performances but much shorter trial duration compared to the complete designs. [ABSTRACT FROM AUTHOR]

Background: The classification of patients with primary progressive aphasia (PPA) into variants is time-consuming, costly, and requires combined expertise by clinical neurologists, neuropsychologists, speech pathologists, and radiologists.Objective: The aim of the present study is to determine whether acoustic and linguistic variables provide accurate classification of PPA patients into one of three variants: nonfluent PPA, semantic PPA, and logopenic PPA.Methods: In this paper, we present a machine learning model based on deep neural networks (DNN) for the subtyping of patients with PPA into three main variants, using combined acoustic and linguistic information elicited automatically via acoustic and linguistic analysis. The performance of the DNN was compared to the classification accuracy of Random Forests, Support Vector Machines, and Decision Trees, as well as to expert clinicians' classifications.Results: The DNN model outperformed the other machine learning models as well as expert clinicians' classifications with 80% classification accuracy. Importantly, 90% of patients with nfvPPA and 95% of patients with lvPPA was identified correctly, providing reliable subtyping of these patients into their corresponding PPA variants.Conclusion: We show that the combined speech and language markers from connected speech productions can inform variant subtyping in patients with PPA. The end-to-end automated machine learning approach we present can enable clinicians and researchers to provide an easy, quick, and inexpensive classification of patients with PPA. [ABSTRACT FROM AUTHOR]

Background: Even though investigating predictors of intervention success (e.g Cognitive Training, CT) is gaining more and more interest in the light of an individualized medicine, results on specific predictors of intervention success in the overall field are mixed and inconsistent due to different and sometimes inappropriate statistical methods used. Therefore, the present paper gives a guidance on the appropriate use of multiple regression analyses to identify predictors of CT and similar non-pharmacological interventions.Methods: We simulated data based on a predefined true model and ran a series of different analyses to evaluate their performance in retrieving the true model coefficients. The true model consisted of a 2 (between: experimental vs. control group) × 2 (within: pre- vs. post-treatment) design with two continuous predictors, one of which predicted the success in the intervention group and the other did not. In analyzing the data, we considered four commonly used dependent variables (post-test score, absolute change score, relative change score, residual score), five regression models, eight sample sizes, and four levels of reliability.Results: Our results indicated that a regression model including the investigated predictor, Group (experimental vs. control), pre-test score, and the interaction between the investigated predictor and the Group as predictors, and the absolute change score as the dependent variable seemed most convenient for the given experimental design. Although the pre-test score should be included as a predictor in the regression model for reasons of statistical power, its coefficient should not be interpreted because even if there is no true relationship, a negative and statistically significant regression coefficient commonly emerges.Conclusion: Employing simulation methods, theoretical reasoning, and mathematical derivations, we were able to derive recommendations regarding the analysis of data in one of the most prevalent experimental designs in research on CT and external predictors of CT success. These insights can contribute to the application of considered data analyses in future studies and facilitate cumulative knowledge gain. [ABSTRACT FROM AUTHOR]

Objectives: Qigong has been shown to effectively reduce depressive symptoms in older adults with chronic physical illness. Here, we sought to evaluate the effects of qigong on serotonin, cortisol, and Brain-derived Neurotropic Factors (BDNF) levels and test their roles as potential mediators of the effects of qigong on depressive symptoms.Methods: Thirty older adults with chronic physical illness participated in a randomized clinical trial. They were randomly assigned to a qigong group (n = 14) or a control group for cognitive training of executive function and memory (n = 16). The participants provided blood and saliva samples at baseline and post-intervention. Levels of cortisol were measured from the salvia samples, and serotonin and BDNF were measured from the blood samples.Results: Consistent with the study findings presented in the primary outcome paper, a significant Group × Time interaction effect emerged on depressive symptoms, explained by greater reductions in the qigong group than the control group. Qigong participants had significantly larger increases in serotonin and BDNF, and decreases in cortisol levels, compared with control group participants. Moreover, treatment-related changes in cortisol levels (but not serotonin or BDNF) fully mediated the beneficial effects of qigong on depressive symptoms.Conclusion: The findings provide preliminary evidence that treatment-related changes in cortisol may mediate the benefits of qigong on depressive symptoms. Given the limitation of small sample size of the present study, future studies with larger sample sizes and more extended follow-up assessment are warranted to determine the reliability of these findings. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the properties of the Infant Motor Activity Log (IMAL), a caregiver-report for frequency and quality of use of more affected upper extremity in infants with neurological and functional impairments.Method: This was a prospective cohort study of 66 children (34 females, 32 males) aged 6 to 24 months (mean age [SD] 13.7mo [5.3]) with neurological and functional impairments and a confirmed cerebral palsy diagnoses after 2 years, and 51 age-matched typically developing children. The IMAL was administered at baseline and 4 weeks later. Typically developing infants were tested with randomly assigned 'more affected' upper extremity. Psychometric properties were evaluated using Spearman's correlation coefficient, Cronbach's alpha, and Jonckheere-Terpstra tests.Results: In the children with impairments, the IMAL showed internal consistency (alpha≥0.88) for the How Well Scale (HWS) and How Often Scale (HOS). Test-retest reliability was 0.64 (HOS) and 0.70 (HWS), demonstrating stability over time. Correlation with Bayley Scales of Infant and Toddler Development, Third Edition more affected arm raw scores were 0.70 (HOS) and 0.72 (HWS) (p<0.001) demonstrating construct validity. Both scale scores decreased with increasing Gross Motor Function Classification System and Mini-Manual Ability Classification System (p<0.001) levels, supporting discriminative validity. Discrimination between typically developing infants and infants with impairments was high (HWS: area under the receiver operating characteristic curve [AUC] 0.96, 95% confidence interval [CI] 0.94-0.99 and HOS AUC=0.95, CI 0.92-0.99).Interpretation: The IMAL is a valid and reliable discriminative caregiver measure of upper limb performance and may complement measures of capacity in infants with neurological and functional impairments.What This Paper Adds: The Infant Motor Activity Log (IMAL) is a valid and reliable measure of caregiver perception of upper limb function. The IMAL fills a measurement gap for infant motor performance in children with impairments. The IMAL discriminates among motor function levels. [ABSTRACT FROM AUTHOR]

This study aimed to evaluate the accuracy of three measurement systems estimating gait speed during a loaded military march over graded terrain. Systems developed by the Swiss and Netherlands Armed Forces and a commercial wrist-based device were evaluated in comparison to a Global Positioning System. The first part of the paper focuses on the development of the Dutch system, where speed is estimated from a chest worn accelerometer and body measurements. For this validation study 36 subjects were walking or running 13 laps of 200 m at different speeds. Results showed that walking and running speed can be estimated with a R2adj of 0.968 and 0.740, respectively. In the second part of this paper, data from 64 soldiers performing a 35 km march were used to evaluate the accuracy of three measurement systems in estimating speed. Data showed that estimating gait speed with a single accelerometer can be accurate for military activity, even without prior individual calibration measurements. However, predictions should be corrected for confounders such as body size and shoe type to be accurate. Both, downhill and uphill walking led to changes in gait characteristics and to an overestimation of speed by up to 10%. Correcting for slope or gradient using altimetry in future algorithms/experiments could improve the estimation of gait speed. [ABSTRACT FROM AUTHOR]

Background: To validate the reliability and validity of the Chinese version of the THINC-it tool in adults with major depressive disorder (MDD).Methods: Subjects aged 18 to 65 years (n=117) with MDD were evaluated and compared to age- and sex-matched healthy controls (n=124). Subjects completed the THINC-it, four criteria-related objective cognitive subtests, and the paper version of Perceived Deficits Questionnaire for Depression-5-item (PDQ-5-D).Results: There were significant differences in Spotter [Mean difference (MD) Standard errors (SE)=-0.40 (0.17), P=0.018; 95% Confidence intervals (CI) (-0.73 to -0.07)]; Codebreaker [MD (SE)=-0.39 (0.14), P=0.006; 95% CI(-0.67 to -0.11)]; and the overall performance of four objective tests (including variants of IDN, OBK, DSST, and TMT-B) [MD (SE)=-0.30 (0.12), P=0.013; 95% CI (-0.53 to -0.06]) between the two groups. In the HC group, PDQ-5-D retest reliability was good (ICC = 0.841), and the test-retest reliability of the objective cognitive test was relatively low (ICC ranging from 0.123 to 0.545). In the MDD group: Cronbach's α of PDQ-5-D=0.704; all the THINC-it subtests had good concurrent validity (r ranging from 0.343 to 0.835, all P<0.01).Limitation: The test-retest sample size was relatively small, the educational level and IQ of the control and MDD groups were not completely matched.Conclusion: The Chinese version of the THINC-it tool exhibits good reliability and validity in adults with MDD. There is a need to incorporate cognitive assessment of adults with MDD broadly. The THINC-it tool is the first tool validated to assess cognition of MDD in a Chinese population. [ABSTRACT FROM AUTHOR]

Aim: To assess the reliability and predictive validity of the developmental and socio-emotional scales of the Standardized Infant NeuroDevelopmental Assessment (SINDA).Method: To assess reliability, two sets of three assessors forming eight assessor-pairs independently rated the developmental and socio-emotional scales of 60 infants. To evaluate predictive validity, 223 infants (gestational age 30wks [range 23-41wks]; 117 males, 106 females) attending a non-academic outpatient clinic were assessed by different assessors with SINDA's neurological, developmental, and socio-emotional scales. Atypical neurodevelopmental outcome at a corrected age of 24 months or older implied a Bayley Mental or Psychomotor Developmental Index score of less than 70 or neurological disorder (including cerebral palsy). Behavioural and emotional disorders were classified according to the International Classification of Diseases, 10th Revision. Predictive values were calculated from SINDA (2-12mo corrected age, median 7mo) and typical versus atypical outcome, and for intellectual disability only (Mental Developmental Index <70).Results: Assessors highly agreed on the developmental and socio-emotional assessments (developmental scores: Spearman's rank correlation coefficient ρ=0.972; single socio-emotional behaviour items: Cohen's κ=0.783-0.896). At 24 months or older, 65 children had atypical outcome. Atypical neurological scores predicted atypical outcome (sensitivity 83%, specificity 96%); atypical developmental scores predicted intellectual disability (sensitivity 77%, specificity 92%). Atypical emotionality and atypical self-regulation were associated with behavioural and emotional disorders.Interpretation: SINDA's three scales are reliable, and have a satisfactory predictive validity for atypical developmental outcome at 24 months or older in a non-academic outpatient setting. SINDA's developmental scale has promising predictive validity for intellectual disability. SINDA's socio-emotional scale is a tool for caregiver counselling.What This Paper Adds: Standardized Infant NeuroDevelopmental Assessment (SINDA)'s developmental and socio-emotional scales have excellent interrater reliability. Replication of the satisfactory validity of SINDA's neurological scale for atypical outcome. [ABSTRACT FROM AUTHOR]

Aims: The TTM2-trial is a multi-centre randomised clinical trial where targeted temperature management (TTM) at 33 °C will be compared with normothermia and early treatment of fever (≥37.8 °C) after Out-of-Hospital Cardiac Arrest (OHCA). This paper presents the design and rationale of the TTM2-trial follow-up, where information on secondary and exploratory outcomes will be collected. We also present the explorative outcome analyses which will focus on neurocognitive function and societal participation in OHCA-survivors.Methods: Blinded outcome-assessors will perform follow-up at 30-days after the OHCA with a telephone interview, including the modified Rankin Scale (mRS) and the Glasgow Outcome Scale Extended (GOSE). Face-to-face meetings will be performed at 6 and 24-months, and include reports on outcome from several sources of information: clinician-reported: mRS, GOSE; patient-reported: EuroQol-5 Dimensions-5 Level responses version (EQ-5D-5L), Life satisfaction, Two Simple Questions; observer-reported: Informant Questionnaire on Cognitive Decline in the Elderly-Cardiac Arrest version (IQCODE-CA) and neurocognitive performance measures: Montreal Cognitive Assessment, (MoCA), Symbol Digit Modalities Test (SDMT). Exploratory analyses will be performed with an emphasis on brain injury in the survivors, where the two intervention groups will be compared for potential differences in neuro-cognitive function (MoCA, SDMT) and societal participation (GOSE). Strategies to increase inter-rater reliability and decrease missing data are described.Discussion: The TTM2-trial follow-up is a pragmatic yet detailed pre-planned and standardised assessment of patient's outcome designed to ensure data-quality, decrease missing data and provide optimal conditions to investigate clinically relevant effects of TTM, including OHCA-survivors' neurocognitive function and societal participation. [ABSTRACT FROM AUTHOR]

Background: Free and Cued Selective Reminding Test (FCSRT) is a reliable cognitive marker for Alzheimer's disease (AD), and the identification of neuropsychological tests sensitive to the early signs of AD pathology is crucial both in research and clinical practice.Objective: The study aimed to ascertain the ability of FCSRT in predicting the amyloid load as determined from amyloid PET imaging (Amy-PET) in patients with cognitive disorders.Methods: For our purpose, 79 patients (71 MCI, 8 mild dementia) underwent a complete workup for dementia, including the FCSRT assessment and a [18F]florbetaben PET scan. FCSRT subitem scores were used as predictors in different binomial regression models.Results: Immediate free recall and delayed free recall were the best predictors overall in the whole sample; whereas in patients <76 years, all models further improved with immediate total recall (ITR) and Index of Sensitivity of Cueing (ISC) resulting the most accurate in anticipating Amy-PET results, with a likelihood of being Amy-PET positive greater than 85% for ITR and ISC scores of less than 25 and 0.5, respectively.Conclusion: FCSRT proved itself to be a valid tool in dementia diagnosis, also being able to correlate with amyloid pathology. The possibility to predict Amy-PET results through a simple and reliable neuropsychological test might be helpful for clinicians in the dementia field, adding value to a paper and pencil tool compared to most costly biomarkers. [ABSTRACT FROM AUTHOR]

Objective: To present initial validity data on three web-based computerized versions of the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-COMP).Method: The sample for evaluating the validity of the clinician-administered KSADS-COMP included 511 youths 6-18 years of age who were participants in the Child Mind Institute Healthy Brain Network. The sample for evaluating the parent and youth self-administered versions of the KSADS-COMP included 158 youths 11-17 years of age recruited from three academic institutions.Results: Average administration time for completing the combined parent and youth clinician-administered KSADS-COMP was less time than previously reported for completing the paper-and-pencil K-SADS with only one informant (91.9 ± 50.1 minutes). Average administration times for the youth and parent self-administered KSADS-COMP were 50.9 ± 28.0 minutes and 63.2 ± 38.3 minutes, respectively, and youths and parents rated their experience using the web-based self-administered KSADS-COMP versions very positively. Diagnoses generated with all three KSADS-COMP versions demonstrated good convergent validity against established clinical rating scales and dimensional diagnostic-specific ratings derived from the KSADS-COMP. When parent and youth self-administered KSADS-COMP data were integrated, good to excellent concordance was also achieved between diagnoses derived using the self-administered and clinician-administered KSADS-COMP versions (area under the curve = 0.89-1.00).Conclusion: The three versions of the KSADS-COMP demonstrate promising psychometric properties, while offering efficiency in administration and scoring. The clinician-administered KSADS-COMP shows utility not only for research, but also for implementation in clinical practice, with self-report preinterview ratings that streamline administration. The self-administered KSADS-COMP versions have numerous potential research and clinical applications, including in large-scale epidemiological studies, in schools, in emergency departments, and in telehealth to address the critical shortage of child and adolescent mental health specialists.Clinical Trial Registration Information: Computerized Screening for Comorbidity in Adolescents With Substance or Psychiatric Disorders; https://clinicaltrials.gov/; NCT01866956. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the reliability and validity of the Children's Visual Impairment Test for 3- to 6-year-olds (CVIT 3-6).Method: Reliability was assessed via test-retest correlation and intraclass correlation coefficient (ICC) in typically developing children, children with cerebral visual impairment (CVI), intellectual impairment, and simulated impaired vision (validation groups n=59, mean developmental age=4y 10mo, 27 females, 32 males). Internal validity was evaluated with a confirmatory factor analysis on the normative sample (n=301, median age=4y 8mo, SD=9.7mo, 148 females, 153 males). External validity was assessed by correlating performance on CVIT 3-6 with L94, the Beery-Buktenica Developmental Test of Visuo-Motor Integration (Beery-VMI), the Freiburg Vision Test, the revised Snijders-Oomen Nonverbal Intelligence Test for children between 2 years 6 months and 7-years-old (SON-R 2.5-7), and the Social Responsiveness Scale (SRS) questionnaire and by comparing performance between validation groups.Results: We observed very good test-retest reliability (r=0.82, p<0.001, ICC=0.80) and confirmed the hypothesized factor structure (comparative fit index=1; Tucker-Lewis index=1.045). We found high correlations with tests with a strong visual perception component (L94: r=0.74, p<0.001; SON-R 2.5-7: r=0.37, p=0.01) and low correlations with other tests (Beery-VMI: r=0.25, p=0.09; SRS: r=0-0.26, p=0.09). Lowest scores were observed for children with CVI compared to the other validation groups (F[3,44]=5.1, p=0.003).Interpretation: CVIT 3-6 is grounded in knowledge of visual perception. The tool specifically measures CVI-related visual perception deficits and is not mediated by intellectual abilities or low visual acuity.What the Paper Adds: Evidence for good test-retest reliability of the Children's Visual Impairment Test for 3- to 6-year-olds (CVIT 3-6). Factor structure of normative data reflects CVIT 3-6's foundations in vision science. CVIT 3-6 specifically measures visual perception impairments. CVIT 3-6 performance is not influenced by intelligence or low visual acuity. [ABSTRACT FROM AUTHOR]

Background: With the advent of new high-throughput electron microscopy techniques such as serial block-face scanning electron microscopy (SBF-SEM) and focused ion-beam scanning electron microscopy (FIB-SEM) biomedical scientists can study sub-cellular structural mechanisms of heart disease at high resolution and high volume. Among several key components that determine healthy contractile function in cardiomyocytes are Z-disks or Z-lines, which are located at the lateral borders of the sarcomere, the fundamental unit of striated muscle. Z-disks play the important role of anchoring contractile proteins within the cell that make the heartbeat. Changes to their organization can affect the force with which the cardiomyocyte contracts and may also affect signaling pathways that regulate cardiomyocyte health and function. Compared to other components in the cell, such as mitochondria, Z-disks appear as very thin linear structures in microscopy data with limited difference in contrast to the remaining components of the cell.Methods: In this paper, we propose to generate a 3D model of Z-disks within single adult cardiac cells from an automated segmentation of a large serial-block-face scanning electron microscopy (SBF-SEM) dataset. The proposed fully automated segmentation scheme is comprised of three main modules including "pre-processing", "segmentation" and "refinement". We represent a simple, yet effective model to perform segmentation and refinement steps. Contrast stretching, and Gaussian kernels are used to pre-process the dataset, and well-known "Sobel operators" are used in the segmentation module.Results: We have validated our model by comparing segmentation results with ground-truth annotated Z-disks in terms of pixel-wise accuracy. The results show that our model correctly detects Z-disks with 90.56% accuracy. We also compare and contrast the accuracy of the proposed algorithm in segmenting a FIB-SEM dataset against the accuracy of segmentations from a machine learning program called Ilastik and discuss the advantages and disadvantages that these two approaches have.Conclusions: Our validation results demonstrate the robustness and reliability of our algorithm and model both in terms of validation metrics and in terms of a comparison with a 3D visualisation of Z-disks obtained using immunofluorescence based confocal imaging. [ABSTRACT FROM AUTHOR]

Agreement studies are of paramount importance in various scientific domains. When several observers classify objects on categorical scales, agreement can be quantified through multirater kappa coefficients. In most statistical packages, the standard error of these coefficients is only available under the null hypothesis that the coefficient is equal to zero, preventing the construction of confidence intervals in the general case. The aim of this paper is triple. First, simple analytic formulae for the standard error of multirater kappa coefficients will be given in the general case. Second, these formulae will be extended to the case of multilevel data structures. The formulae are based on simple matrix algebra and are implemented in the R package "multiagree". Third, guidelines on the choice between the different mulitrater kappa coefficients will be provided. [ABSTRACT FROM AUTHOR]

Aim: To assess the reliability and to evaluate the responsiveness of both the Jebsen-Taylor Test of Hand Function (JTTHF) and the Box and Block Test (BBT) in children with cerebral palsy (CP).Method: In this retrospective study, the reliability analyses were conducted with paired t-tests considering a short (mean 14d) and a long (mean 120d) time in between two assessment periods. In addition, an intraclass correlation coefficient (ICC) was used to assess the level of congruency. The responsiveness to therapy was conducted with a paired t-test in the whole sample regarding the age, the manual ability level as classified with the Manual Ability Classification System (MACS), and the topography.Results: Our main results confirmed the tests' reliability in a short time period for the JTTHF in both hands and for the BBT on the less affected hand. These results were consistent with the ICC. The responsiveness was confirmed, except on the less affected hand for the JTTHF, with similar results for age, MACS, and topography approach.Interpretation: This study supports the use of the JTTHF and the BBT to examine changes after short-term interventions for children with CP. These results should be interpreted with association to normative values or with a control group when used over long assessment periods.What This Paper Adds: The Box and Block Test (BBT) is reliable in a brief period of assessment in children with cerebral palsy (CP). The Jebsen-Taylor Test of Hand Function (JTTHF) is reliable in a brief period of assessment in children with CP. The JTTHF and BBT are responsive to changes in a brief period of intensive therapy in children with CP. The reliability and responsiveness of the JTTHF and BBT are weak over long assessment periods. [ABSTRACT FROM AUTHOR]

Aim: To create a classification system for severe, rare, and progressive genetic conditions for use in research reporting.Method: A modified Delphi consensus technique was used to create and reach agreement on a new system of condition categories. Interrater reliability was tested via two rounds of an online survey whereby physicians classified a subset of conditions using our novel system. Overall percentage agreement and agreement above chance were calculated using Fleiss' kappa (κ).Results: Eleven physicians completed the first Delphi, with an overall agreement of 76.4%, the κ value was 0.57 (95% confidence interval 0.51-0.63), indicating moderate agreement (0.41-0.60) above chance. Based on the first survey several categories were described in more detail. The second survey confirmed a classification system with 12 categories, with an overall percentage agreement among the participants of 82.6%. The overall mean κ value was 0.71 (95% confidence interval 0.65-0.77), indicating substantial agreement (0.61-0.80).Interpretation: Our new system was useful in categorizing a broad range of rare childhood diseases and may be applicable to other rare disease studies; further validation in larger cohorts is required.What This Paper Adds: This novel 12-category classification system can be used in research reporting in rare and progressive genetic conditions. [ABSTRACT FROM AUTHOR]

Background: Recent findings indicate that impairments in functional performance do occur among individuals diagnosed with mild cognitive impairment (MCI). Most assessment strategies for everyday competence are associated with challenges with reliability, are typically in paper and pencil format, or require in-person administration by a trained professional.Objective: This paper reports on a novel technology-based assessment battery of everyday competence that includes ecologically valid simulations of daily activities important to independence.Methods: The sample included 85 non-cognitively impaired older adults aged 65+ and 62 older adults diagnosed with amnestic MCI (aMCI). Participants completed standard measures of cognitive abilities and the computerized battery of everyday tasks, which included simulations of a doctor's visit; and medication and financial management tasks.Results: The older adults with aMCI performed significantly poorer on all three tasks in the everyday task battery. Performance on these measures were also moderately correlated with standard measures of cognitive abilities and showed good test-retest reliability.Conclusions: The results show that it is feasible to use a technology-based assessment battery of everyday tasks with both non-cognitively impaired older adults and older adults with MCI. The use of this type of battery can overcome many of the logistic constraints associated with current functional assessment protocols. [ABSTRACT FROM AUTHOR]

Computerized tests benefit from automated scoring procedures and standardized administration instructions. These methods can reduce the potential for rater error. However, especially in patients with severe mental illnesses, the equivalency of traditional and tablet-based tests cannot be assumed. The Brief Assessment of Cognition in Schizophrenia (BACS) is a pen-and-paper cognitive assessment tool that has been used in hundreds of research studies and clinical trials, and has normative data available for generating age- and gender-corrected standardized scores. A tablet-based version of the BACS called the BAC App has been developed. This study compared performance on the BACS and the BAC App in patients with schizophrenia and healthy controls. Test equivalency was assessed, and the applicability of paper-based normative data was evaluated. Results demonstrated the distributions of standardized composite scores for the tablet-based BAC App and the pen-and-paper BACS were indistinguishable, and the between-methods mean differences were not statistically significant. The discrimination between patients and controls was similarly robust. The between-methods correlations for individual measures in patients were r>0.70 for most subtests. When data from the Token Motor Test was omitted, the between-methods correlation of composite scores was r=0.88 (df=48; p<0.001) in healthy controls and r=0.89 (df=46; p<0.001) in patients, consistent with the test-retest reliability of each measure. Taken together, results indicate that the tablet-based BAC App generates results consistent with the traditional pen-and-paper BACS, and support the notion that the BAC App is appropriate for use in clinical trials and clinical practice. [ABSTRACT FROM AUTHOR]

Aim: To examine the stability over time of the Manual Ability Classification System (MACS) levels in children with cerebral palsy (CP) aged 18 to 60 months.Method: This was a prospective longitudinal population-based study of 252 Australian children (160 males [63%] 92 females [37%]; mean age [SD] 41.7mo [14], range 17.2mo-69.2mo) with CP. Children were classified at 18 months (n=70), 24 months (n=131), 30 months (n=173), 36 months (n=209), 48 months (n=226), and 60 months (n=221) of age. Stability of the MACS was examined using the proportion of specific positive agreement and transition proportions, which are measures of agreement.Results: There were 1030 unique observations, with each of the 252 participants seen between two and six occasions (median=4). Average specific positive agreement over the study period was 76% for MACS level I, 67% for level II, 50% for level III, 51% for level IV, and 83% for level V. MACS levels I and V have the highest degree of stability, while levels III and IV have the lowest. We show how this may be explained by the proportion of children in each MACS level.Interpretation: Using measures of agreement rather than measures of reliability provides accurate information when measuring stability over time of an ordinal classification system. The relative stability of MACS levels can be explained by the proportion of children in each level.What This Paper Adds: Children classified in Manual Ability Classification System (MACS) levels III and IV change levels at next assessment about 50% of the time. Children should be assessed with the MACS regularly, particularly those in levels III and IV. Stability within ordinal classification level categories can be predicted using a measurement error model. Transition proportions or specific agreement is recommended for reporting stability of ordinal classification systems. [ABSTRACT FROM AUTHOR]

Objective: The eButton takes frontal images at 4s intervals throughout the day. A three-dimensional manually administered wire mesh procedure has been developed to quantify portion sizes from the two-dimensional images. The present paper reports a test of the inter-rater reliability and validity of use of the wire mesh procedure.Design: Seventeen foods of diverse shapes and sizes served on plates, bowls and cups were selected to rigorously test the portion assessment procedure. A dietitian not involved in inter-rater reliability assessment used standard cups to independently measure the quantities of foods to generate the 'true' value for a total of seventy-five 'served' and seventy-five smaller 'left' images with diverse portion sizes.Setting: The images appeared on the computer to which the digital wire meshes were applied.Subjects: Two dietitians and three engineers independently estimated portion size of the larger ('served') and smaller ('left') images for the same foods.Results: The engineers had higher reliability and validity than the dietitians. The dietitians had lower reliabilities and validities for the smaller more irregular images, but the engineers did not, suggesting training could overcome this limitation. The lower reliabilities and validities for foods served in bowls, compared with plates, suggest difficulties with the curved nature of the bowls.Conclusions: The wire mesh procedure is an important step forward in quantifying portion size, which has been subject to substantial self-report error. Improved training procedures are needed to overcome the identified problems. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the psychometric properties of the Child and Adolescent Intellectual Disability Screening Questionnaire (CAIDS-Q) in paediatric neurodevelopment clinics.Method: Participants were 181 children (aged 6-18y) attending paediatric services in Scotland, divided into three age groups according to previous CAIDS-Q standardization cut-off scores. Fifty-four children (37 males, 17 females; mean age 117mo [SD 29.9mo]) met the criteria for intellectual disability and 127 did not (88 males, 39 females; mean age 120.1mo [SD 32.7mo]). A number of psychometric properties of the CAIDS-Q were evaluated, including test-retest and interrater reliability, convergent validity, sensitivity, specificity, and positive and negative predictive values based on existing cut-off scores.Results: Significant positive relationships were found for all three age groups between CAIDS-Q scores and measures of intellectual and adaptive functioning. Test-retest reliability ranged from 'moderate' to 'almost perfect', whereas interrater reliability ranged from 'fair' to 'almost perfect'. Sensitivity and positive predictive value were 100% for all groups and specificity was between 83% and 94%, depending on age. Negative predictive values ranged from 75% to 91%.Interpretation: The CAIDS-Q appears to show psychometric properties that support its use as a screen for intellectual disability in paediatric neurodevelopmental settings.What This Paper Adds: The Child and Adolescent Intellectual Disability Screening Questionnaire showed good psychometric properties. It identified all participating children who met the criteria for intellectual disability. Between 83% and 94% of children without intellectual disability were also correctly identified. [ABSTRACT FROM AUTHOR]

TiO2 scaffolds have previously shown to have promising osteoconductive properties in previous in vivo experiments. Appropriate mechanical stimuli can further promote this osteoconductive behaviour. However, the complex mechanical environment and the mechanical stimuli enhancing bone regeneration for porous bioceramics have not yet been fully elucidated. This paper aims to compare and evaluate mechanical environment of TiO2 scaffold with three commercial CaP biomaterials, i.e. Bio-Oss, Cerabone and Maxresorb under simulated perfusion culture conditions. The solid phase and fluid phase were modelled as linear elastic material and Newtonian fluid, respectively. The mechanical stimulus was analysed within these porous scaffolds quantitatively. The results showed that the TiO2 had nearly heterogeneous stress distributions, however lower effective Young's modulus than Cerabone and Maxresorb. The permeability and wall shear stress (WSS) for the TiO2 scaffold was significantly higher than other commercial bone substitute materials. Maxresorb and Bio-Oss showed lowest permeability and local areas of very high WSS. The detailed description of the mechanical performance of these scaffolds could help researchers to predict cell behaviour and to select the most appropriate scaffold for different in vitro and in vivo performances. Graphical abstract Schematic representation of the establishment procedure. Take the establishment process of Cerabone as an example. Left shows a slice of micro-CT image from Cerabone, and 1.5 mm × 1.5 mm region of interest was shown in the red box. A 1.5-mm3 cube was cut out by Boolean operation in Mimics (Materialise, Belgium), and the cubic model was remeshed in 3-Matic 6.0 (Materialise, Belgium). The cubic model is shown in blue, and the empty space in red. [ABSTRACT FROM AUTHOR]

Aim: People with cerebral palsy (CP) are often unable to express pain owing to cognitive or speech impairments. Reports that rely on observation can be inaccurate, because behaviours such as grimacing, common in people with spastic CP, resemble pain expressions. We examined preliminary validity and reliability of the revised Face, Legs, Activity, Cry, and Consolability (r-FLACC) scale in people with spastic CP.Method: Forty-eight young people and adults (35 females, 13 males; mean [SD] age 29y 2mo [13y]) were video-recorded during a standard examination, rating their pain (0-10) afterwards. Two raters completed the r-FLACC using the video recordings. Interrater reliability was assessed with an unconditional cross-classified random-effects model and item response theory approach; Pearson correlations measured agreement between raters and participants.Results: Mean (SD) participant (n=48) pain scores were 2.48 (2.5) and mean (SD) r-FLACC scores were 1.46 (1.68). There was moderate agreement between raters (intraclass coefficient 0.41 and 0.57 respectively) but low agreement between participants and raters (r=0.26). There were no significant effects for raters (lay observers, nurses, physicians, and inexperienced raters).Interpretation: Results provide mixed support for the interrater reliability of the r-FLACC in people with spastic CP.What This Paper Adds: The revised Face, Legs, Activity, Cry, and Consolability (r-FLACC) scale can be reliably used by experts and lay raters for people with spastic cerebral palsy (CP). Support is mixed for interrater reliability of the r-FLACC scale used with people with spastic CP. [ABSTRACT FROM AUTHOR]

The present paper has three objectives. First, methods for comparing alternative tests for the purpose of replacement of one test with a second presumably superior test are described. Second, problems in the interpretation of the relevance of different diagnostic thresholds (thresholds of positivity) that define who is and who is not a disordered gambler are examined and a potential solution offered in the form of a common quantitative measure of the risk of being a disordered gambler. Third, alternative methodologies are described as potential solutions to the lack of a gold or reference standard in the evaluation of new tests. [ABSTRACT FROM AUTHOR]

Purpose: Imaging phantoms can be cost prohibitive, therefore a need exists to produce low cost alternatives which are fit for purpose. This paper describes the development and validation of a low cost paediatric pelvis phantom based on the anatomy of a 5-year-old child.Methods: Tissue equivalent materials representing paediatric bone (Plaster of Paris; PoP) and soft tissue (Poly methyl methacrylate; PMMA) were used. PMMA was machined to match the bony anatomy identified from a CT scan of a 5-year-old child and cavities were created for infusing the PoP. Phantom validation comprised physical and visual measures. Physical included CT density comparison between a CT scan of a 5-year old child and the phantom and Signal to Noise Ratio (SNR) comparative analysis of anteroposterior phantom X-ray images against a commercial anthropomorphic phantom. Visual analysis using a psychometric image quality scale (face validity).Results: CT density, the percentage difference between cortical bone, soft tissue and their equivalent tissue substitutes were -4.7 to -4.1% and -23.4%, respectively. For SNR, (mAs response) there was a strong positive correlation between the two phantoms (r > 0.95 for all kVps). For kVp response, there was a strong positive correlation between 1 and 8 mAs (r = 0.85), this then decreased as mAs increased (r = -0.21 at 20 mAs). Psychometric scale results produced a Cronbach's Alpha of almost 0.8.Conclusions: Physical and visual measures suggest our low-cost phantom has suitable anatomical characteristics for X-ray imaging. Our phantom could have utility in dose and image quality optimisation studies. [ABSTRACT FROM AUTHOR]

In vivo dosimetry (IVD) is the last step of a radiotherapy quality control program aimed to ensure that the dose delivered is in agreement with that prescribed. IVD procedures based on single detectors are time-consuming and impossible to use for the modern radiotherapy techniques, based on static or kinetic beams (modulated in intensity fluence); this means that more efficient and practical methods are highly recommended. The practical method SOFTDISO, based on the use of electronic portal image device (EPID), provides two tests (i) the R ratio between the reconstructed and the planned isocenter doses to verify an agreement within 5% and (ii) the γ-analysis of the EPID images, to verify γ% ≥ 90% and γmean ≤ 0.4. This paper reports the results of 11,357 IVD tests carried out for 823 patients treated by three-dimensional conformal radiation therapy and volumetric modulated arc therapy techniques. In particular, the dose disagreements are reported distinguishing two kinds of causes, those of (i) class 1 that includes the errors due to inadequate quality controls and (ii) the class 2, due to patient morphological changes. About the tests out of tolerance, 6% were by VMAT and 21% by 3DCRT, but taking into account the only class 1 of errors, i.e., removing the causes of class 2, only 7% of patients examined presented at least one of the three mean indexes out of tolerance. The workload for IVD on 9 patients/day per linac is about 52 min/day but recently, a new automated SOFTDISO version has been implemented to reduce the time to about 34 min/day. [ABSTRACT FROM AUTHOR]

Aim: To determine the stability of the Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), and Communication Function Classification System (CFCS) over 1-year and 2-year intervals using a process for consensus classification between parents and therapists.Method: Participants were 664 children with cerebral palsy (CP), 18 months to 12 years of age, one of their parents, and 90 therapists. Consensus between parents and therapists on level of function was ≥92% for the GMFCS, MACS, and CFCS. A linearly weighted kappa coefficient of ≥0.75 was the criterion for stability.Results: Kappa coefficients varied from 0.76 to 0.88 for the GMFCS, 0.59 to 0.73 for the MACS, and 0.57 to 0.77 for the CFCS. For children younger than 4 years of age, level of function did not change for 58.2% on the GMFCS, 30.3% on the MACS, and 39.3% on the CFCS. For children 4 years of age or older, level of function did not change for 72.3% on the GMFCS, 49.1% on the MACS, and 55% on the CFCS.Interpretation: The findings support repeated classification of children over time. The kappa coefficients for the GMFCS are attributed to descriptions of levels for each age band. Consensus classification facilitates discussion between parents and professionals that has implications for shared decision-making.What This Paper Adds: The findings support repeated classification of children over time. Stability was higher for the Gross Motor Function Classification System than the Manual Ability Classification System and Communication Function Classification System. The function of younger children was more likely to be reclassified. Percentage agreement between parents and therapists using consensus classification varied from 92% to 97%. The intraclass correlation coefficient overestimated stability compared with the weighted kappa coefficient. [ABSTRACT FROM AUTHOR]

Obsessive-compulsive disorder (OCD) includes many symptom presentations, which creates unique diagnostic challenges. Fears surrounding one's sexual orientation are common within OCD (also called SO-OCD), but SO-OCD is consistently misdiagnosed by physicians and psychologists. To address this issue, we describe the development of a self-report measure for assessing SO-OCD to help distinguish OCD from distress caused by a sexual orientation identity crisis. The current paper details two studies that established the psychometric properties and clinical utility of this measure. In Study 1, the factor structure, validity, and reliability were examined for the measure's 12 items in a sample of 1,673 university students. The results revealed a two-factor solution for the measure (Factor 1: Transformation Fears; Factor 2: Somatic Checking) and preliminary evidence of validity and reliability. In Study 2, the measure was tested with LGBTQ and heterosexual community samples and clinical samples of individuals with SO-OCD and other types of OCD. The two-factor solution and evidence of validity and reliability were supported in these samples. Cut-off points were established to distinguish between community members and SO-OCD sufferers, as well as between those experiencing SO-OCD and other types of OCD. Limitations and future directions are discussed. [ABSTRACT FROM AUTHOR]

Background: The Youth Anxiety Measure-I for DSM-5 has recently been developed to assess youth's anxiety symptomatology. As social anxiety is one of the most common disorders in adolescence, this scale includes a subscale measuring social anxiety. However, psychometric properties of the YAM-5-I social anxiety subscale (YAM-5-I-SAD) in clinical samples are lacking. This paper aims to bridge the gap.Methods: The sample comprised 24 clinically diagnosed and 24 healthy control Spanish-speaking adolescents aged 14-17 years.Results: Data revealed that the YAM-5- I-SAD yielded excellent sensitivity, which makes it particularly useful as a screening tool to early detect socially anxious adolescents. In addition, the YAM-5-I-SAD evidenced good internal consistency and construct validity.Limitations: Data are limited to the social anxiety subscale.Conclusions: The YAM-5-I-SAD is a sensitive and specific measure to screen for adolescents with social anxiety. [ABSTRACT FROM AUTHOR]

Aim: The aim of this cross-sectional study was to provide normative data for motor proficiency (motor performance and contralateral associated movements [CAMs]) in typically developing children between 3 years and 18 years of age using an updated version of the Zurich Neuromotor Assessment (ZNA-2).Method: Six-hundred and sixteen typically developing children between 3 years and 18 years of age were enrolled from day-care centres, kindergartens, and schools, and were tested using the ZNA-2 with improved items of the original battery. Motor proficiency was assessed on five components (fine motor tasks, pure motor tasks, static balance, dynamic balance, and CAMs) as a function of age and sex to determine centile curves for each task. Intraobserver, interobserver, and test-retest reliabilities were evaluated.Results: Most ZNA-2 tasks featured a marked developmental trend and substantial interindividual variability. Test-retest reliability was generally high (e.g. static balance 0.67; CAMs 0.81; and total scores 0.84).Interpretation: The ZNA-2 is a reliable and updated test instrument to measure motor proficiency in children from 3 to 18 years with improved properties for assessing motor performance. It allows continuous measurement without changing items for the entire age range; this feature of the ZNA-2 is unique and makes the instrument suitable for clinical purposes. The reduction of CAMs scoring simplifies the clinical procedure and increases its reliability.What This Paper Adds: The Zurich Neuromotor Assessment, Second Edition (ZNA-2) provides new norms for motor proficiency in children between 3 years and 18 years. High reliabilities suggest that the revised test battery is a useful tool for assessing neuromotor development. Integration of a 'not able to perform' category makes the ZNA-2 suitable for clinical purposes. [ABSTRACT FROM AUTHOR]

Background: Several indirect comparison methods, including network meta-analyses (NMAs), using individual patient data (IPD) have been developed to synthesize evidence from a network of trials. Although IPD indirect comparisons are published with increasing frequency in health care literature, there is no guidance on selecting the appropriate methodology and on reporting the methods and results.Methods: In this paper we examine the methods and reporting of indirect comparison methods using IPD. We searched MEDLINE, Embase, the Cochrane Library, and CINAHL from inception until October 2014. We included published and unpublished studies reporting a method, application, or review of indirect comparisons using IPD and at least three interventions.Results: We identified 37 papers, including a total of 33 empirical networks. Of these, only 9 (27 %) IPD-NMAs reported the existence of a study protocol, whereas 3 (9 %) studies mentioned that protocols existed without providing a reference. The 33 empirical networks included 24 (73 %) IPD-NMAs and 9 (27 %) matching adjusted indirect comparisons (MAICs). Of the 21 (64 %) networks with at least one closed loop, 19 (90 %) were IPD-NMAs, 13 (68 %) of which evaluated the prerequisite consistency assumption, and only 5 (38 %) of the 13 IPD-NMAs used statistical approaches. The median number of trials included per network was 10 (IQR 4-19) (IPD-NMA: 15 [IQR 8-20]; MAIC: 2 [IQR 3-5]), and the median number of IPD trials included in a network was 3 (IQR 1-9) (IPD-NMA: 6 [IQR 2-11]; MAIC: 2 [IQR 1-2]). Half of the networks (17; 52 %) applied Bayesian hierarchical models (14 one-stage, 1 two-stage, 1 used IPD as an informative prior, 1 unclear-stage), including either IPD alone or with aggregated data (AD). Models for dichotomous and continuous outcomes were available (IPD alone or combined with AD), as were models for time-to-event data (IPD combined with AD).Conclusions: One in three indirect comparison methods modeling IPD adjusted results from different trials to estimate effects as if they had come from the same, randomized, population. Key methodological and reporting elements (e.g., evaluation of consistency, existence of study protocol) were often missing from an indirect comparison paper. [ABSTRACT FROM AUTHOR]

Purpose: Assessment of patient-reported outcomes (PROs), such as health-related quality of life, has become an important component of healthcare that measures the impact of disease and medical treatment on patient health. Collecting PROs during point-of-care assessments and integrating them into the clinical setting, however, remains challenging. The objective of this pilot study was to evaluate the reliability, usability, and acceptability of point-of-care electronic PRO assessments implemented in a prostate cancer clinic.Methods: Fifty subjects completed paper-pencil and computerized formats of the Expanded Prostate Cancer Index Composite (EPIC), a validated, condition-specific QOL instrument, at separate times before treatment. Parallel-forms reliability was evaluated by comparing mean scores, variations in response distribution, and correlations between administration formats. Correlation coefficients of at least 0.70 were used for reliability testing. Differences between administration forms, indicating potential bias, were compared using the signed-rank test. A 6-item acceptability scale was also used to evaluate patient acceptability and satisfaction with the electronic format.Results: Mean scores and standard deviations were similar between the paper-pencil and electronic forms across all EPIC instrument domains, and no assessment bias was found. Each EPIC domain demonstrated a high reliability between administration formats (correlation coefficients: 0.70-0.98). The majority (>90 %) of respondents found that the computerized QOL format was user friendly and simple to use.Conclusions: Point-of-care computerized QOL assessments were reliable and acceptable to patients in this study, supporting the feasibility of PRO integration at the point-of-care in clinical settings. [ABSTRACT FROM AUTHOR]

Introduction: The PROMIS Smoking Initiative has developed six item banks for assessment related to cigarette smoking among adult smokers (Nicotine Dependence, Coping Expectancies, Emotional and Sensory Expectancies, Health Expectancies, Psychosocial Expectancies, and Social Motivations). This article evaluates the psychometric performance of the banks when administered via short form (SF), computer adaptive test (CAT), and by mode of administration (computer vs. paper-and-pencil).Methods: Data are from two sources: an internet sample (N = 491) of daily and nondaily smokers who completed both SFs and CATs via the web and a community sample (N = 369) that completed either paper-and-pencil or computer administration of the SFs at two time points. First a CAT version of the PROMIS Smoking Assessment Toolkit was evaluated by comparing item administration rates and scores to the SF administration. Next, we considered the effect of computer versus paper-and-pencil administration on scoring and test-retest reliability.Results: Across the domains approximately 5.4 to 10.3 items were administered on average for the CAT. SF and CAT item response theory-scores were correlated from 0.82 to 0.92 across the domains. Cronbach's alpha for the four- to eight-item SFs among daily smokers ranged from .80 to .91 and .82 to .91 for paper-and-pencil and computer administrations, respectively. Test-retest reliability of the SFs ranged from 0.79 to 0.89 across mode of administration.Conclusions: Results indicate that the SF and CAT and computer and paper-and-pencil administrations provide highly comparable scores for daily and nondaily smokers, but preference for SF or CAT administration may vary by smoking domain. [ABSTRACT FROM AUTHOR]

Craniofacial reconstruction recreates a facial outlook from the cranium based on the relationship between the face and the skull to assist identification. But craniofacial structures are very complex, and this relationship is not the same in different craniofacial regions. Several regional methods have recently been proposed, these methods segmented the face and skull into regions, and the relationship of each region is then learned independently, after that, facial regions for a given skull are estimated and finally glued together to generate a face. Most of these regional methods use vertex coordinates to represent the regions, and they define a uniform coordinate system for all of the regions. Consequently, the inconsistence in the positions of regions between different individuals is not eliminated before learning the relationships between the face and skull regions, and this reduces the accuracy of the craniofacial reconstruction. In order to solve this problem, an improved regional method is proposed in this paper involving two types of coordinate adjustments. One is the global coordinate adjustment performed on the skulls and faces with the purpose to eliminate the inconsistence of position and pose of the heads; the other is the local coordinate adjustment performed on the skull and face regions with the purpose to eliminate the inconsistence of position of these regions. After these two coordinate adjustments, partial least squares regression (PLSR) is used to estimate the relationship between the face region and the skull region. In order to obtain a more accurate reconstruction, a new fusion strategy is also proposed in the paper to maintain the reconstructed feature regions when gluing the facial regions together. This is based on the observation that the feature regions usually have less reconstruction errors compared to rest of the face. The results demonstrate that the coordinate adjustments and the new fusion strategy can significantly improve the craniofacial reconstructions. [ABSTRACT FROM AUTHOR]

Background: Interest in collecting Patient Reported Outcomes using electronic methods such as mobile phones has increased in recent years. However there is debate about the level of measurement equivalence between the traditional paper and newer electronic modes. Information about the acceptability of the electronic versions to respondents is also required. The aim of this study is to compare the equivalence of delivering a widely used generic measure of health status (EQ-5D-5L) across two administration modes (paper and mobile phone).Methods: Respondents from a research cohort of people in South Yorkshire were identified, and randomly allocated to one of two administration modes (paper vs. mobile phone) based on stratifications for age and gender (and across a range of self-reported health conditions). A parallel group design was used where each respondent only completed EQ-5D-5L using one of the modes. In total, 70 respondents completed the measure in the mobile phone arm, and 66 completed the standard paper version. Follow up usability questions were also included to assess the acceptability of the mobile version of EQ-5D-5L. Measurement equivalence was compared at the dimension, utility score and visual analogue scale level using chi square analysis and ANOVA, and by comparing mean differences to an estimated minimally important difference value.Results: Response rates were higher in the mobile arm. The mean EQ-5D-5L utility and VAS scores, and the frequency of respondents endorsing individual EQ-5D-5L dimension response levels did not significantly differ across the administration modes. The majority of the mobile arm agreed that the mobile version of EQ-5D-5L was easy to complete, and that the phone was easy to use, and that they would complete mobile health measures again.Conclusions: Completing health status measures such as EQ-5D using mobile phones produces equivalent results to more traditional methods, but with added benefits (for example lessening the burden of data entry). Respondents are positive towards completing questionnaires using these methods. The results provide evidence that electronic measures are valid for use to collect data in a range of settings including clinical trials, routine care, and in health diary settings. [ABSTRACT FROM AUTHOR]

Background: The No Germs on Me (NGoM) Social Marketing Campaign to promote handwashing with soap to reduce high rates of infection among children living in remote Australian Aboriginal communities has been ongoing since 2007. Recently three new television commercials were developed as an extension of the NGoM program. This paper reports on the mass media component of this program, trialling an evaluation design informed by the Theory of Planned Behaviour (TPB).Methods: A survey questionnaire taking an ecological approach and based on the principals and constructs of the TPB was developed. Surveys were completed in six discrete Aboriginal communities immediately before and on completion of four weeks intensive televising of the three new commercials.Results: Across the six communities access in the home to a television that worked ranged from 49 to 83 % (n = 415). Seventy-seven per cent (n = 319) of participants reported having seen one or more of the new commercials. Levels of acceptability and comprehension of the content of the commercials was high (97 % n = 308). Seventy-five per cent (n = 651) of participants reported they would buy more soap, toilet paper and facial tissues if these were not so expensive in their communities. For TPB constructs demonstrated to have good internal reliability the findings were mixed and these need to be interpreted with caution due to limitations in the study design.Conclusions: Cultural, social-economic and physical barriers in remote communities make it challenging to promote adults and children wash their hands with soap and maintain clean faces such that these behaviours become habit. Low levels of access to a television in the home illustrate the extreme level of disadvantage experienced in these communities. Highlighting that social marketing programs have the potential to increase disadvantage if expensive items such as television sets are needed to gain access to information. This trial of a theory informed evaluation design allowed for new and rich information to be obtained about community members' beliefs, attitudes and intentions towards teaching and assisting children so safe hygiene behaviours become habit. Findings will support an evidence-based approach is taken to plan future NGoM program activities. [ABSTRACT FROM AUTHOR]

Accurate psychiatric diagnosis is critical for both sound clinical interventions and valid research methodology. Over the years, attempts to improve diagnostic reliability and accuracy led to the development of more explicit operationalized diagnostic criteria, starting with DSM-III, and subsequently fully structured and semistructured diagnostic interviews.1 As diagnostic assessment changed and with advances in technology, the use of computers soon developed in parallel to improve the reliability and validity of psychiatric diagnosis. As far back as 1968, computers were used to help clinicians formulate psychiatric diagnoses, by helping them process clinical information according to diagnostic algorithms.2 Since that time, there has been an exponential rise in the use of technology in clinical research and practice. Indeed, computers have been used both to transition diagnostic interviews from paper-and-pencil format to instruments that are clinician-administered via an electronic platform and to create self-report versions of clinician-administered diagnostic interviews. We will discuss each of these in turn. [ABSTRACT FROM AUTHOR]

The brain connections in the different regions demonstrate the characteristics of brain activities. In addition, in various conditions and with neuropsychological disorders, the brain has special patterns in different regions. This paper presents a model to show and compare the connection patterns in different brain regions of children with autism (53 boys and 36 girls) and control children (61 boys and 33 girls). The model is designed by cellular neural networks and it uses the proper features of electroencephalography. The results show that there are significant differences and abnormalities in the left hemisphere, (p < 0.05) at the electrodes AF3, F3, P7, T7, and O1 in the children with autism compared with the control group. Also, the evaluation of the obtained connections values between brain regions demonstrated that there are more abnormalities in the connectivity of frontal and parietal lobes and the relations of the neighboring regions in children with autism. It is observed that the proposed model is able to distinguish the autistic children from the control subjects with an accuracy rate of 95.1% based on the obtained values of CNN using the SVM method. [ABSTRACT FROM AUTHOR]

This paper reports on the cross validation of the Gambling Problem Severity Subscale of the Canadian Adolescent Gambling Index (CAGI/GPSS). The CAGI/GPSS was included in a large school based drug use and health survey conducted in 2015. Data from students in grades 9-12 (ages 13-20 years) derived from the (N = 3369 students). The CAGI/GPSS produced an alpha of 0.789. A principle component analysis revealed two eigenvalues greater than one. An oblique rotation revealed these components to represent consequences and over involvement. The CAGI/GPSS indicated that 1% of the students fell into the "red" category indicating a severe problem and an additional 3.3% scored in the "yellow" category indicating low to moderate problems. The CAGI/GPSS was shown to be significantly correlated with gambling frequency (r = 0.36), largest expenditure (r = 0.37), sex (more likely to be male) (r = -0.19), lower school marks (r = -0.07), hazardous drinking, (r = 0.16), problem video game play (r = 0.16), as well as substance abuse. The CAGI/GPSS was cross validated using a shorted version of the short SOGS, r = 0.48. In addition the CAGI/GPSS and short SOGS produced very similar patterns of correlations results. The results support the validity and reliability of the CAGI/GPSS as a measure of gambling problems among adolescents. [ABSTRACT FROM AUTHOR]

Diagnostic information regarding the health status of the corneal endothelium may be obtained by analyzing the size and the shape of the endothelial cells in specular microscopy images. Prior to the analysis, the endothelial cells need to be extracted from the image. Up to today, this has been performed manually or semi-automatically. Several approaches to automatic segmentation of endothelial cells exist; however, none of them is perfect. Therefore this paper proposes to perform cell segmentation using a U-Net-based convolutional neural network. Particularly, the network is trained to discriminate pixels located at the borders between cells. The edge probability map outputted by the network is next binarized and skeletonized in order to obtain one-pixel wide edges. The proposed solution was tested on a dataset consisting of 30 corneal endothelial images presenting cells of different sizes, achieving an AUROC level of 0.92. The resulting DICE is on average equal to 0.86, which is a good result, regarding the thickness of the compared edges. The corresponding mean absolute percentage error of cell number is at the level of 4.5% which confirms the high accuracy of the proposed approach. The resulting cell edges are well aligned to the ground truths and require a limited number of manual corrections. This also results in accurate values of the cell morphometric parameters. The corresponding errors range from 5.2% for endothelial cell density, through 6.2% for cell hexagonality to 11.93% for the coefficient of variation of the cell size. [ABSTRACT FROM AUTHOR]