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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]

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]

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]

The present study aimed to evaluate the invariance of the factor structure of the Drinking Motives Questionnaire Revised (DMQ-R) between Portuguese and US university students. Following tests of factor model invariance we further evaluated cross-cultural differences in (1) mean levels of the four motives, and (2) the association of the four motives with weekly drinking, peak drinking, and binge drinking among college students from the United States and Portugal. Participants were 983 undergraduate students (67% female) from the US (N=515) and Portugal (N=468). Participants completed a confidential online (US) or paper and pencil (Portugal) survey. Results of a CFA demonstrated that the four-factor model of the DMQ-R was invariant with respect to factor loadings, factor variances, and factor covariances across the two countries. Mean differences in ratings of drinking motives were found, with US students ranking all motives higher than Portuguese students. However, rank order of motives (social>enhancement>coping>conformity) were equivalent across countries. Support for convergent validity was demonstrated by significant associations between drinking motives and alcohol consumption for men and women of both samples. Results support the factorial invariance and convergent validity of the DMQ-R across US and Portuguese college students, making it a trustworthy means of assessing college students' drinking motives, and a useful instrument for clinical and research purposes, both within and across cultures. [ABSTRACT FROM AUTHOR]

Objective: Health-related websites have developed to be much more than information sites: they are used to exchange experiences and find support as well as information and advice. This paper documents the development of a tool to compare the potential consequences and experiences a person may encounter when using health-related websites.Methods: Questionnaire items were developed following a review of relevant literature and qualitative secondary analysis of interviews relating to experiences of health. Item reduction steps were performed on pilot survey data (n=167). Tests of validity and reliability were subsequently performed (n=170) to determine the psychometric properties of the questionnaire.Results: Two independent item pools entered psychometric testing: (1) Items relating to general views of using the internet in relation to health and, (2) Items relating to the consequences of using a specific health-related website. Identified sub-scales were found to have high construct validity, internal consistency and test-retest reliability.Conclusion: Analyses confirmed good psychometric properties in the eHIQ-Part 1 (11 items) and the eHIQ-Part 2 (26 items).Practice Implications: This tool will facilitate the measurement of the potential consequences of using websites containing different types of material (scientific facts and figures, blogs, experiences, images) across a range of health conditions. [ABSTRACT FROM AUTHOR]

Older people have different eating patterns than their younger counterparts, although in most nutritional studies of older populations, food frequency questionnaires (FFQ) that were developed and validated for the general adult population are used. In this paper, we present the advantages of developing an FFQ for an older population based on a population survey. A random sample of the Negev's (Southern Israel) Jewish population > or = 35 y old was recruited and interviewed for their dietary intake using 24-h recalls. Foods eaten were aggregated into conceptually similar groups and entered into stepwise regression models to predict variation in nutrient intake. We interviewed 796 people age 35-64 y and 377 people > or = 65 y old for the study. Significantly more items were required to reach 80% between-person variability for zinc, magnesium, vitamin E and protein for the elderly compared with the younger age group. Portion sizes of most items consumed by the elderly were smaller compared with the Israeli Ministry of Health portion sizes booklet and the younger age group's intake estimates. The nutrient values assigned for each line based on a weighted mean of the intake of the elderly were different from those using the most frequently used item. The above findings highlight some of the advantages of developing an FFQ for an older population based on a population survey. Further studies are required to compare the validity of existing tools adapted for the elderly to those developed on the basis of population surveys. [ABSTRACT FROM AUTHOR]