A case study of the development of a valid and pragmatic implementation science measure: the Barriers and Facilitators in Implementation of Task-Sharing Mental Health interventions (BeFITS-MH) measure.

BACKGROUND: Few implementation science (IS) measures have been evaluated for validity, reliability and utility - the latter referring to whether a measure captures meaningful aspects of implementation contexts. We present a real-world case study of rigorous measure development in IS that assesses Barriers and Facilitators in Implementation of Task-Sharing in Mental Health services (BeFITS-MH), with the objective of offering lessons-learned and a framework to enhance measurement utility. METHODS: We summarize conceptual and empirical work that informed the development of the BeFITS-MH measure, including a description of the Delphi process, detailed translation and local adaptation procedures, and concurrent pilot testing. As validity and reliability are key aspects of measure development, we also report on our process of assessing the measure's construct validity and utility for the implementation outcomes of acceptability, appropriateness, and feasibility. RESULTS: Continuous stakeholder involvement and concurrent pilot testing resulted in several adaptations of the BeFITS-MH measure's structure, scaling, and format to enhance contextual relevance and utility. Adaptations of broad terms such as "program," "provider type," and "type of service" were necessary due to the heterogeneous nature of interventions, type of task-sharing providers employed, and clients served across the three global sites. Item selection benefited from the iterative process, enabling identification of relevance of key aspects of identified barriers and facilitators, and what aspects were common across sites. Program implementers' conceptions of utility regarding the measure's acceptability, appropriateness, and feasibility clustered across several common categories. CONCLUSIONS: This case study provides a rigorous, multi-step process for developing a pragmatic IS measure. The process and lessons learned will aid in the teaching, practice and research of IS measurement development. The importance of including experiences and knowledge from different types of stakeholders in different global settings was reinforced and resulted in a more globally useful measure while allowing for locally-relevant adaptation. To increase the relevance of the measure it is important to target actionable domains that predict markers of utility (e.g., successful uptake) per program implementers' preferences. With this case study, we provide a detailed roadmap for others seeking to develop and validate IS measures that maximize local utility and impact.

Systematic review of applications and properties of the NoMAD instrument for assessing implementation outcomes: Study protocol.

Background: Implementation outcomes measures can be used to assess the implementation of complex health and social care interventions, but evidence for the use of these measures, and their psychometric properties, remains limited. The NoMAD ( Normalisation Me asure Development) survey, based on Normalisation Process Theory, was developed to assess, monitor, or measure factors likely to affect normalisation of a new practice from the perspective of participants who are engaged in an implementation process. Since publication in 2015, NoMAD has been translated into several languages and is increasingly being used in health and care research. This systematic review will identify, appraise, and synthesise the existing literature on the use of NoMAD as an implementation outcome measure, focusing on use and application across different studies and settings, and on its properties as a measurement tool. Methods: We will systematically search the bibliographic databases Web of Science, Scopus and PubMed for articles reporting empirical data in peer-reviewed journals. A citation search will also be undertaken in Google Scholar for primary NoMAD publications. Studies will be eligible for inclusion if they: (a) specify using NoMAD as a method and report results from using it, and/or (b) report a translation and/or validation study of NoMAD's measurement properties. Screening of abstracts and full text articles will be done independently by two researchers. Data extraction will be structured to allow collection and descriptive synthesis of data on study characteristics, use of NoMAD, psychometric results, and authors' reflections and recommendations. Conclusions: This review will provide the first synthesis of how NoMAD has been applied in health and care research, and evidence on its properties as an outcome measure since its publication. This will be used to update existing freely accessible guidance for researchers and other users, and disseminated through peer-reviewed publications, and engagement activities with researchers and practitioners.

Background: Implementation outcome measures are survey tools that have been developed to assess the success of implementation of health and social care interventions. Using theory, the NoMAD ( Normalisation Me asure Development) survey was developed to assess implementation processes, by asking structured questions of persons who are involved in a specific implementation. Once measures like NoMAD are used enough over time, and in a range of studies of different kinds of interventions in different settings, we can collate evidence from those studies to decide (1) how useful they are, and (2) how scientifically robust they are for making assessments in research. In this review, we will search the published literature for papers that report data from studies using NoMAD and summarise their characteristics and results to provide recommendations about how useful and scientifically robust NoMAD is at this time. Methods:We will search databases (Web of Science, Scopus and PubMed), and a google search engine for published studies. We will include papers if they have used the NoMAD survey in their research and report results in their paper or have translated it into another language and tested it scientifically. Decisions about whether to include a paper will be made independently by two researchers, compared, and then agreed. A structured form will be used to capture the same information from each paper. We will summarise information on the studies, how they used NoMAD, what scientific evidence they provide about it, and what authors thought about using it. Conclusions: This will be the first review of studies using the NoMAD survey since it was published in 2015. The results will be used to update publicly available guidance for researchers and other users. We will also share our findings directly through engagement activities with researchers and practitioners and will publish them in scientific journals.

A mixed-methods approach to assessing implementers' readiness to adopt digital health interventions (RADHI).

BACKGROUND: Despite being the primary setting for HIV prevention among men who have sex with men (MSM) since the start of the epidemic, community-based organizations (CBOs) struggle to reach this historically stigmatized and largely hidden population with face-to-face interventions. HIV researchers have readily turned to the internet to deliver critical HIV education to this group, with evidence of high effectiveness and acceptability across studies. However, implementation outside of research contexts has been limited and not well studied. We aimed to assess HIV CBOs' readiness to adopt digital health interventions and identify contextual factors that may contribute to differing levels of readiness. METHODS: We recruited 22 CBOs across the US through a pragmatic request-for-proposals process to deliver Keep It Up! (KIU!), an evidence-based eHealth HIV prevention program. We used mixed methods to examine CBO readiness to adopt digital health interventions (RADHI). Before implementation, CBO staff completed a 5-item RADHI scale (scored 0-4) that demonstrated concurrent and predictive validity. We interviewed CBO staff using semi-structured questions guided by the Consolidated Framework for Implementation Research and compared RADHI score groups on determinants identified from the interviews. RESULTS: Eighty-five staff (range = 1-10 per CBO) completed the RADHI. On average, CBOs reported moderate-to-great readiness (2.74) to adopt KIU!. High RADHI CBOs thought KIU! was a top priority and an innovative program complementary to their existing approaches for their clients. Low RADHI CBOs expressed concerns that KIU! could be a cultural mismatch for their clients, was lower priority than existing programs and services, relied on clients' own motivation, and might not be suitable for clients with disabilities. Value, appeal, and limitations did not differ by RADHI group. CONCLUSIONS: While HIV CBOs are excited for the opportunities and advantages of digital interventions, additional pre-implementation and implementation support may be needed to increase perceived value and usability for different client populations. Addressing these limitations is critical to effective digital prevention interventions for HIV and other domains such as mental health, chronic disease management, and transitions in care. Future research can utilize our novel, validated measure of CBOs' readiness to adopt digital health interventions. TRIAL REGISTRATION: NCT03896776, clinicaltrials.gov, 1 April 2019.

Psychometric adaptation of the Spanish version of the Brief Pittsburgh Sleep Quality Index in adolescents.

OBJECTIVE: Good sleep quality is essential for adolescent health, yet sleep difficulties persist in this age group. The 6-item Brief Pittsburgh Sleep Quality Index (B-PSQI) was recently developed to improve sleep quality assessment, however, its validity in adolescents remains unexplored. This study examined the B-PSQI's psychometric properties in Spanish adolescents and adapted the scoring method to age-specific sleep recommendations. METHODS: A cross-sectional study involving 1,065 adolescents (15-17 years; 56.8% female) was conducted in public high schools. Sleep quality was measured using the B-PSQI, the Insomnia Severity Index (ISI), the short Patient-Reported Outcomes Measurement Information System (PROMIS), and the Epworth Sleepiness Scale (ESS). Additionally, depression and anxiety were assessed using the Depression, Anxiety, and Stress Scales. Reliability, validity, and measurement invariance were analyzed. RESULTS: The B-PSQI global scores were 4.5 (SD = 1.9) for the original scoring method and 5.4 (SD = 2.8) for the age-adjusted. The age-adjusted B-PSQI showed satisfactory reliability (ω = 0.84) and concurrent, convergent, and discriminant validity (ISI rS = 0.67; PROMIS rS = 0.71; anxiety rS = 0.40; depression rS = 0.42; ESS rS = 0.29). Adequacy for one-factor structure (χ2(4) = 53.9; CFI = 0.97; TLI = 0.92; RMSEA = 0.108; SRMR = 0.05) and invariance across sexes were supported. Both B-PSQI scoring methods showed similar psychometric properties, but the original yielded a higher percentage of poor sleepers (43.1%; cutoff ≥5) than the age-adjusted version (41.9%; cutoff ≥6). CONCLUSIONS: Findings suggest that the B-PSQI is a valid and reliable measure to assess adolescent sleep quality. Its scoring can be adjusted to provide age-specific criteria for good sleep. The B-PSQI has potential utility for screening sleep problems and facilitating overall health promotion in adolescents.

Validity, reliability and responsiveness of a French translation of the Western Ontario Osteoarthritis of the Shoulder index (WOOS).

INTRODUCTION: While several general questionnaires can be used to evaluate shoulder conditions, very few tools specifically evaluate the impact of shoulder osteoarthritis. The Western Ontario Osteoarthritis of the Shoulder index (WOOS) is a patient-reported outcome measure with excellent psychometric properties intended for patients suffering from shoulder osteoarthritis. Unfortunately, there is no validated French version of this questionnaire. OBJECTIVE: Produce a validated French version of the WOOS that is suitable for the Francophone populations of Europe and North America. MATERIAL AND METHODS: A validated protocol was used to create a French version of the WOOS (WOOS-Fr). Included were patients whose first language was French, who could read French and who had shoulder osteoarthritis destined for treatment (surgical treatment=arthroplasty). The WOOS-Fr was compared to the Disability of the Arm, Shoulder and Hand-French translation (F-QuickDASH-D/S) to assess its validity. Reliability and responsiveness were also analyzed. RESULTS: A French version of the WOOS (WOOS-Fr) was accepted by a multinational committee. The WOOS-Fr was validated in 71 French-speaking subjects. A strong positive correlation was found between the WOOS-Fr and the F-QuickDASH-D/S during the initial evaluation. The intra-class correlation (ICC) of the total WOOS-Fr score indicated good reliability between the initial WOOS and the 1-week WOOS (ICC: 0.84; 95% CI: [0.767; 0.896]; p-value: <0.001) in 57 patients. The responsiveness between the initial WOOS-Fr and at 1 year postoperative was high in the 36 operated patients (standardized mean response of 1.95). DISCUSSION: A French translation of the WOOS questionnaire was created and validated for use in French-speaking populations. This questionnaire will make it easier to evaluate the psychometric results of patients with shoulder osteoarthritis in Francophone countries. LEVEL OF EVIDENCE: III; multicenter cohort study.

Trauma History Questionnaire: validation with novel samples of incarcerated women and perinatal women.

Trauma exposure is associated with numerous negative outcomes, many of which are amplified within at-risk populations. Two under-researched and at-risk populations, incarcerated women and perinatal women, both report high rates of trauma, psychopathology, and PTSD compared to the general population. One common measure of trauma exposure in various populations, including incarcerated women and perinatal women, is the Trauma History Questionnaire (THQ). However, no known studies have validated the THQ within these two unique, understudied populations. Using data from two studies of incarcerated women and one study of perinatal women, researchers explored indices of THQ construct, predictive, and convergent validity. The study also included between-sample comparisons, highlighting differences in trauma incidence between the included samples. Analyses supported statistically significant relations between THQ scores and Severity of Violence Against Women Scale (SVAWS), depressive symptoms, PTSD, and psychological distress. Prenatal women's THQ scores were also predictive of later postpartum depressive symptoms. Significantly higher THQ scores were found within the incarcerated samples compared to the perinatal sample. The study results provide further information about trauma within incarcerated and perinatal populations, as well as increase understanding of the utility of trauma assessments within these vulnerable groups.

Psychometric Properties of the PANS 31-Item Symptom Rating Scale.

Objectives: Pediatric acute-onset neuropsychiatric syndrome (PANS) is characterized by sudden onset of obsessive-compulsive disorder and/or eating restriction with associated neuropsychiatric symptoms from at least two of seven categories. The PANS 31-Item Symptom Rating Scale (PANS Rating Scale) was developed to identify and measure the severity of PANS symptoms. The objective of this study was to define the psychometric properties of the PANS Rating Scale. Methods: Children with PANS (N = 135) and their parents participated. Parents completed the PANS Rating Scale and other scales on Research Electronic Data Capture. The PANS Rating Scale includes 31 items that are rated on a Likert scale from 0 = none to 4 = extreme. Pearson's correlations were run between the PANS Total score and scores on the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), Yale Global Tic Severity Scale (YGTSS), Modified Overt Aggression Scale (MOAS), Columbia Impairment Scale (CIS), PANS Global Impairment Score (GIS), and Children's Global Assessment Scale (CGAS). Results: Convergent validity was supported by significant correlations between the PANS Total and scores on the CY-BOCS, YGTSS, MOAS, CIS, GIS, and CGAS. The largest correlations were with measures of functional impairment: PANS Total and CIS (r = 0.81) and PANS Total and GIS (r = 0.74). Cronbach's alpha was 0.89 which demonstrates strong internal consistency of the 31 items. PANS Total score was significantly higher in children in a flare of their neuropsychiatric symptoms compared to children who were not in a flare. Conclusions: This study provides preliminary support for the PANS Rating Scale as a valid research instrument with good internal consistency. The PANS Rating Scale appears to be a useful measure for assessing children with PANS.

A Case Study of the Development of a Valid and Pragmatic Implementation Science Measure: The Barriers and Facilitators in Implementation of Task-Sharing Mental Health Interventions (BeFITS-MH) Measure.

Background: Few implementation science (IS) measures have been evaluated for validity, reliability and utility - the latter referring to whether a measure captures meaningful aspects of implementation contexts. In this case study, we describe the process of developing an IS measure that aims to assess Barriers and Facilitators in Implementation of Task-Sharing in Mental Health services (BeFITS-MH), and the procedures we implemented to enhance its utility. Methods: We summarize conceptual and empirical work that informed the development of the BeFITS-MH measure, including a description of the Delphi process, detailed translation and local adaptation procedures, and concurrent pilot testing. As validity and reliability are key aspects of measure development, we also report on our process of assessing the measure's construct validity and utility for the implementation outcomes of acceptability, appropriateness, and feasibility. Results: Continuous stakeholder involvement and concurrent pilot testing resulted in several adaptations of the BeFITS-MH measure's structure, scaling, and format to enhance contextual relevance and utility. Adaptations of broad terms such as "program," "provider type," and "type of service" were necessary due to the heterogeneous nature of interventions, type of task-sharing providers employed, and clients served across the three global sites. Item selection benefited from the iterative process, enabling identification of relevance of key aspects of identified barriers and facilitators, and what aspects were common across sites. Program implementers' conceptions of utility regarding the measure's acceptability, appropriateness, and feasibility were seen to cluster across several common categories. Conclusions: This case study provides a rigorous, multi-step process for developing a pragmatic IS measure. The process and lessons learned will aid in the teaching, practice and research of IS measurement development. The importance of including experiences and knowledge from different types of stakeholders in different global settings was reinforced and resulted in a more globally useful measure while allowing for locally-relevant adaptation. To increase the relevance of the measure it is important to target actionable domains that predict markers of utility (e.g., successful uptake) per program implementers' preferences. With this case study, we provide a detailed roadmap for others seeking to develop and validate IS measures that maximize local utility and impact.

Validity, reliability and responsiveness of the French translation of the Patient-Rated Wrist Evaluation Questionnaire (PRWE).

INTRODUCTION: The patient-rated wrist evaluation questionnaire (PRWE) is a specific wrist questionnaire, developed in Canada that has been validated and proved reliable and sensitive. It assesses pain and function. Unfortunately, there was no validated French-language version. It is important that a translation should be methodologically rigorous, as both linguistic and cultural factors come into play. OBJECTIVE: To produce a French-language version of the PRWE, culturally adapted to the French-speaking populations of Europe and North America. MATERIALS AND METHODS: A validated protocol was used to produce a French-language version of the PRWE (PRWE-Fr) that would be culturally acceptable for the French-speaking populations of Europe and North America. Reliability and responsiveness analyses were performed and PRWE-Fr scores were compared to F-QuickDASH-D/S (French translation of short-form Disabilities of the Arm, Shoulder and Hand-Disability/Symptoms) scores to assess validity. RESULTS: A French-language version of the PRWE (PRWE-Fr) was accepted by a multinational committee, then validated in 65 French-speaking subjects, divided into 2 groups for analyses. A strong positive correlation was found between PRWE-Fr and F-QuickDASH-D/S scores. Comparison of results between two PRWE-Fr sessions at a 1-week interval found a very strong correlation (ρ=0.93; r2=0.868; p<0.001). The intraclass correlation coefficient for total PRWE-Fr score demonstrated excellent reliability (ICC: 0.93; 95% CI: [0.859; 0.969]; p<0.001). Responsiveness analysis revealed greater sensitivity to change than for the F-QuickDASH-D/S (standardized response mean [SRM], 1.14 versus 1.04 respectively). DISCUSSION: A French-language version of the PRWE was produced and validated for use in French-speaking populations. It should facilitate evaluation of results in French-speaking settings, collaboration in multinational studies and comparison between studies performed in different countries. LEVEL OF EVIDENCE: II; Multicenter cohort study.

A Cross-sectional Conceptual Replication and Longitudinal Evaluation of the PANSS-Autism-Severity-Score Measure Suggests it Does Not Capture Autistic Traits in Individuals With Psychosis.

BACKGROUND: Autism and psychosis co-occur at elevated rates, with implications for clinical outcomes, functioning, and suicidality. The PANSS-Autism-Severity-Score (PAUSS) is a measure of autism trait severity which has not yet been validated externally or longitudinally. STUDY DESIGN: Participants were derived from the GROUP and SCOPE datasets. Participants included 1448 adults with schizophrenia spectrum disorder (SSD), 800 SSD-siblings, 103 adults diagnosed with an autistic spectrum condition (ASC), and 409 typically-developing controls (TC). Analyses from the original validation study were conducted with SSD participants, and extended into ASC, SSD-sibling, and TC participants. Test-retest reliability of the PAUSS at 2-weeks and long-term stability 3 and 6-years was also examined. STUDY RESULTS: Results differed in important ways from the original validation. SSD participants reported higher PAUSS scores than other groups, with only a fraction of ASC participants scoring as "PAUSS-Autistic." Cronbach's alpha was acceptable for the SSD cohort only. Two-week stability of the PAUSS was fair to good for all PAUSS scores. Long-term stability was poor for most PAUSS items but fair for total PAUSS score. CONCLUSIONS: Results suggest that the PAUSS does not appear appropriate for assessing autism, with the low rate of PAUSS-Autistic in the ASC population suggesting the PAUSS may not accurately reflect characteristics of autism. The relative lack of long-term stability is cause for concern and suggestive that the PAUSS is capturing features of psychosis rather than autism traits.

Applying Rasch analysis in refinement and validation of interpersonal skills measure for gifted children.

Background: Interpersonal characteristics of gifted adolescents is important because of the potential influence on individuals' psychological health and future professional success. Understanding the interpersonal characteristics requires valid and reliable measures. This study attempted to explicitly describe the application of Rasch analysis in the validation and development process of an existing measure of interpersonal skills among gifted adolescent in Ohio. Methods: We extensively evaluated the psychometric properties of the 40-item scale measuring the interpersonal competence of adolescents among the gifted population in Ohio (N = 127) using Rasch analysis. Multiple aspects of reliability and validity were tested including dimensionality, rating scale functioning, and fit statistics. Results: The internal consistency reliability of the scale was confirmed with an adequate fit to the Rasch model. However, the scale demonstrates relatively poor performance in terms of unidimensionality with our sample. Also, the rating scale categories were confusing given that our sample could not effectively distinguish some adjacent categories. Corresponding refinements have been made and the revised scale formed a meaningful linear progression with improved performance on unidimensionality, rating scale functioning, and fit statistics. Conclusion: The study provided evidence that the construct of interpersonal skills is measurable. Based upon the original Interpersonal Competence Questionnaires consists of 40 items, the author extracted and piloted a refined measure consisting of 31 items that performed a meaningful, theoretically consistent linear progression measure that could be used to measure the level of interpersonal skills of gifted children.

A Measure of Caregivers' Distress-Promoting Behaviors During Toddler Vaccination: Validation of the OUCHIE-RV.

OBJECTIVE: The current study discusses the development and preliminary validation of an observational measure of caregivers' distress-promoting behavior (OUCHIE-RV) in the context of toddler routine vaccination. METHODS: Measure validation was based on a sample of caregiver-toddler dyads (N = 223) from a longitudinal cohort-sequential study who were observed during toddlers' 12-, 18-, or 24-month routine vaccinations. Validity was assessed using correlations and cross-lagged path analysis and associations were tested between OUCHIE-RV composite scores and toddlers' pain-related distress as well as caregivers' state anxiety, soothing behaviors, heart rate, and heart rate variability. Interrater reliability was examined using intraclass correlations (ICC) and kappa coefficients. RESULTS: Results of a cross-lagged path analysis indicated positive concurrent (ß = .27 to ß = .37) and cross-lagged predictive associations (ß = .01 to ß = .34) between OUCHIE-RV composite scores (reflecting the frequency and intensity of caregivers' distress-promoting behavior) and toddlers' pain-related distress. OUCHIE-RV composite scores were negatively associated with caregivers' concurrent use of physical comfort (r = -.34 to -.24) and rocking (r = -.36 to -.19) and showed minimal associations with caregivers' use of verbal reassurance (r = .06 to .12), state anxiety (r = -.02 to r = .09), heart rate (r = -.15 to r = .05), and heart rate variability (r = -.04 to r = .13). Interrater reliability was strong (Cohen's k = .86 to .97, ICC = .77 to .85). CONCLUSIONS: Findings provide support for the validity and reliability of the OUCHIE-RV as a research tool for measuring caregiver behaviors that promote toddlers' pain-related distress during routine vaccinations and contribute to a better understanding of the dynamics of caregiver-toddler interaction in acute pain contexts.

Creation and Validation of a New Socio-built Environment Index Measure of Opioid Overdose Risk for Use in Both Non-urban and Urban Settings.

A great deal of literature has examined features of the physical built environment as predictors of opioid overdose and other substance use-related outcomes. Other literature suggests that social characteristics of settings are important predictors of substance use outcomes. However, there is a dearth of literature simultaneously measuring both physical and social characteristics of settings in an effort to better predict opioid overdose. There is also a dearth of literature examining built environment as a predictor of overdose in non-urban settings. The present study presents a novel socio-built environment index measure of opioid overdose risk comprised of indicators measuring both social and physical characteristics of settings - and developed for use in both urban and non-urban settings - and assesses its validity among 565 urban, suburban, and rural New Jersey municipalities. We found that this novel measure had good convergent validity, based on significant positive associations with a social vulnerability index and crime rates, and significant negative associations with a municipal revitalization index and high school graduation rates. The index measure had good discriminant validity, based on lack of association with three different racial isolation indices. Finally, our index measure had good health outcome-based criterion validity, based on significant positive associations with recent overdose mortality. There were no major differences between rural, suburban, and urban municipalities in validity analysis findings. This promising new socio-built environment risk index measure could improve ability to target and allocate resources to settings with the greatest risk, in order to improve their impact on overdose outcomes.

The Development and Initial Validation of Items to Assess Parent Fear of Nighttime Hypoglycemia.

OBJECTIVE: Parents of youth with type 1 diabetes (T1D) are fearful their children will experience nighttime hypoglycemia. Currently, the Hypoglycemia Fear Survey for Parents (HFS-P) lacks items that specifically assess parents' nighttime fear. This study aimed to fill this gap by rigorously identifying new items to specifically assess parent fear of nighttime hypoglycemia and then examine the psychometric properties of the revised Hypoglycemia Fear Survey for Parents including Nighttime Fear (HFS-P-NF). METHODS: For Phase 1, we recruited 10 pediatric diabetes providers and 15 parents/caregivers of youth with T1D to generate items related to fear of nighttime hypoglycemia. For Phase 2, we recruited an additional 20 parents/caregivers to pilot-test the newly generated items. For Phase 3, we recruited another 165 parents/caregivers to evaluate structural validity via confirmatory factor analyses, reliability, and content validity of the revised HFS-P-NF. RESULTS: In Phase 1, we generated 54 items. In Phase 2, we removed 34 items due to violations of distributional normality and nonsignificant correlations. In Phase 3, a four-factor model reflecting behaviors maintaining high glucose, helplessness, negative social consequences, and nighttime worries was the best fitting model for the HFS-P-NF. The new items demonstrated strong internal consistency (α = 0.96) and strong to moderate relationships with criterion and content validity measures. CONCLUSION: The current study provides initial evidence of validity and reliability for new items on the HFS-P-NF that broadened the conceptualization of parent fear of nighttime hypoglycemia. These findings are important to clinicians who may consider screening for parent fear of nighttime hypoglycemia more comprehensively.

Validation of the parent-proxy pediatric Charcot-Marie-Tooth disease quality of life outcome measure.

Charcot-Marie-Tooth disease (CMT) reduces health-related quality of life (QOL) in children. We have previously developed and validated the English and Italian versions of the pediatric CMT-specific QOL outcome measure (pCMT-QOL) for children aged 8 to 18. There is currently no parent-proxy CMT QOL outcome measure for use in clinical trials, which could provide complementary information in these children and adolescents. This study describes the validation studies conducted to develop the parent-proxy version of the pCMT-QOL outcome measure for children aged 8 to 18 years old. Development and validation of the parent-proxy version of the pCMT-QOL outcome measure for children aged 8 to 18 years old was iterative, involving identifying relevant domains, item pool generation, prospective pilot testing and clinical assessments, structured focus-group interviews, and psychometric testing, conducted on parents of children with CMT seen at participating sites from the USA, United Kingdom, and Australia. We utilized previously described methods to develop a working parent-proxy version of the pCMT-QOL measure. From 2010 to 2016, the parent-proxy pCMT-QOL working version was administered to 358 parents of children with CMT aged 8 to 18, seen at the participating study sites of the Inherited Neuropathies Consortium. The resulting data underwent rigorous psychometric analysis, including factor analysis, test-retest reliability, internal consistency, convergent validity, IRT analysis, and longitudinal analysis, to develop the final parent-proxy version of the pCMT-QOL outcome measure for children aged 8 to 18 years old. The parent-proxy version of the pCMT-QOL outcome measure is a reliable, valid, and sensitive proxy measure of health-related QOL for children aged 8 to 18 with CMT.

Factor analysis of the stigma scale-child in pediatric inflammatory bowel disease.

OBJECTIVE: Illness stigma, or perceived stigma related to a chronic health condition, is pervasive among youth with inflammatory bowel disease (IBD). However, no studies exist examining the psychometric properties of illness stigma measures in this population. Using a modified version of the Child Stigma Scale originally developed for youth with epilepsy, the current study investigated the factor structure and validity of this adapted measure (i.e., Stigma Scale - Child; SS-C) in youth with IBD. METHODS: Factor analyses were conducted to determine the most parsimonious factor structure for the adapted 8-item Stigma Scale - Child in a sample of 180 youth with IBD. Correlations were conducted to assess convergent validity, and a multiple regression was conducted to further evaluate the measure's predictive validity of child depressive symptoms. RESULTS: The most parsimonious model for the SS-C is a one-factor solution with an error covariance between the two items assessing concealment/disclosure of IBD diagnosis. CONCLUSIONS: The SS-C is a psychometrically sound illness stigma measure in pediatric IBD that demonstrates strong convergent validity with psychosocial adjustment factors such as thwarted belongingness, illness uncertainty, and illness intrusiveness, as well as strong predictive validity with youth depressive symptoms. The SS-C is a viable option for use as a brief screener in youth with IBD across clinical and research settings.

Development and validation of an individual job performance questionnaire (IJPQ).

BACKGROUND: Developing reliable tools to tap into all the behavioral dimensions of individual job performance and identifying the right sub-dimensions is necessary for both research and practice. OBJECTIVE: This study aimed at developing and validating an IJPQ that addresses shortcomings of existing questionnaires. METHODS: After a comprehensive systematic literature review, a framework consisting of four dimensions, including task performance (TP), contextual performance (CP), counterproductive work behavior (CWB), and adaptive performance (AP) was structured for measuring IJP. As well, 45 sub-dimensions were identified for measuring IJP's dimensions. Content and face validity were evaluated, and item impact score (IS), content validity index (CVI), Kappa, and content validity ratio (CVR) were calculated. For reliability and confirmatory factor analysis (CFA), 525 workers completed the validated questionnaire and Cronbach alpha and goodness of fit indexes were determined, respectively. RESULTS: Of the 62 items generated to measure dimensions, 53 were approved. Based on item-level CVI, of the 53 items, only 45 items were accepted. Finally, the results of item level CVR led to the extraction of 27 questions to evaluate IJP. The obtained scale level CVI and scale level CVR were 0.91 and 0.68, respectively. Based on the results obtained from 525 Iranian workers, values of Cronbach's Alpha, X2/df, RMSEA, and P-value were in the acceptable range. CONCLUSIONS: Conclusively, a questionnaire containing 20 items was developed and validated for measuring IJP of Iranian worker's culture. The four dimensions of TP, CO, CWB, and AP consisted of 6, 5, 5, and 4 items each, respectively. Overall, IJPQ is a theory-based, reliable, and valid instrument for assessing job performance.

Assessing Aspects of Social Relationships in Youth Across Middle Childhood and Adolescence: The NIH Toolbox Pediatric Social Relationship Scales.

OBJECTIVE: Social relationships are a critical context for children's socioemotional development and their quality is closely linked with concurrent and future physical and emotional wellbeing. However, brief self-report measures of social relationship quality that translate across middle childhood, adolescence, and adulthood are lacking, limiting the ability to assess the impact of social relationships on health outcomes over time. To address this gap, this article describes the development and testing of the National Institutes of Health (NIH) Toolbox Pediatric Social Relationship Scales, which were developed in parallel with the previously-reported Adult Social Relationship Scales. METHODS: Item sets were selected from the NIH Toolbox adult self-report item banks in the domains of social support, companionship, and social distress, and adapted for use in preadolescent (ages 8-11 years) and adolescent (ages 12-18 years) cohorts. Items were tested across a U.S. community sample of 1,038 youth ages 8-18 years. Classical test and item response theory approaches were used to identify items for inclusion in brief unidimensional scales. Concurrent validity was assessed by comparing resultant scales to established pediatric social relationship instruments. RESULTS: Internal reliability and concurrent validity were established for five unique scales, with 5-7 items each: Emotional Support, Friendship, Loneliness, Perceived Rejection, and Perceived Hostility. CONCLUSIONS: These brief scales represent developmentally appropriate and valid instruments for assessing the quality of youth social relationships across childhood and adolescence. In conjunction with previously published adult scales, they provide an opportunity for prospective assessment of social relationships across the developmental spectrum.

Measuring PROMIS® Social Relationships in Early Childhood.

OBJECTIVE: Apply the Patient-Reported Outcome Measurement Information System (PROMIS®) mixed-methods approach to develop and validate new parent-report measures of young children's (1-5 years) family and peer relationships that conceptually align to those for 5-17 year olds. METHODS: Expert input, parent interviews, and reviews of theoretical and empirical literature were used to develop draft item pools, which were administered in two waves of panel surveys (N = 1,750). Psychometric evaluation was conducted using item response theory-based methods. Scores were normed to the general U.S. population. Initial validation analyses were conducted using Pearson's correlations and analysis of variance to examine known-group differences between children with various health conditions. RESULTS: Experts and parents confirmed the content validity of existing PROMIS family and peer relationships domain frameworks and suggested adding child-caregiver interactions and empathic behaviors, respectively. Bi-factor model analysis supported sufficient unidimensionality where family and peer relationships were modeled as distinct subdomains of a broader concept, Social Relationships. The new measure was robust in discriminating young children with poor social relationships. Correlational and known-group analyses revealed positive associations with general health and well-being and negative associations with emotional and physical distress. CONCLUSIONS: The PROMIS Early Childhood Parent-Report Social Relationships item bank enables clinicians and researchers a brief, efficient, and precise way to evaluate early relational health. Subdomain short forms also offer the ability to assess specific components (i.e., child-caregiver, family, and peer) for more targeted interventions and analyses.

Bringing PROMIS to Early Childhood: Introduction and Qualitative Methods for the Development of Early Childhood Parent Report Instruments.

OBJECTIVE: Provide an overview of the Patient-Reported Outcomes Measurement Information System (PROMIS®) Early Childhood Parent Report measurement development project and describe its qualitative methods. METHODS: The PROMIS Early Childhood (PROMIS EC) initiative used the PROMIS mixed-methods approach to patient-reported outcome development, with insight from the developmental specification framework to create parent report measures appropriate for assessing young children's health-related quality of life. Qualitative methods to develop these instruments included expert input, literature and measure review, and parent concept elicitation and cognitive interviews to confirm the measure frameworks, item understandability, and developmental appropriateness. RESULTS: Twelve measures resulted from the PROMIS EC initiative. These parent report instruments cover young children's physical, mental, and social health. CONCLUSIONS: The new PROMIS EC Parent Report instruments offer clinicians and researchers brief and psychometrically robust tools to evaluate young children's physical, mental, and social health outcomes. Aligned with the PROMIS Pediatric instruments, the early childhood versions enable coherent lifespan measurement starting at age 1 while maintaining developmental sensitivity.