Improvements in Patient-Reported Outcomes After Treatment With Deucravacitinib in Patients With Psoriatic Arthritis: Results From a Randomized Phase 2 Trial.

OBJECTIVE: Deucravacitinib, a tyrosine kinase 2 inhibitor, was assessed in a phase 2 trial in patients with active psoriatic arthritis (PsA). Here, we report effects of deucravacitinib from the patient perspective. METHODS: This phase 2, double-blind trial (NCT03881059) randomized patients with active PsA 1:1:1 to deucravacitinib 6 mg once daily (QD), 12 mg QD, or placebo, for 16 weeks. Key secondary end points were changes from baseline (CFBs) at week 16 in Health Assessment Questionnaire-Disability Index (HAQ-DI) and 36-item Short-Form Health Survey (SF-36) physical component summary (PCS) scores. Additional patient-reported outcomes (PROs) assessed disease impact, including fatigue, pain, and mental health. The mean CFBs in PROs and percentages of patients reporting improvements with minimum clinically important differences (MCIDs) or scores of greater than normal values were also assessed. RESULTS: This study comprised 203 patients (51.2% female; mean ± SD age, 49.8 ± 13.5 years). At week 16, the adjusted mean difference (95% confidence interval) versus placebo in HAQ-DI and SF-36 PCS CFB was significant for each deucravacitinib group (HAQ-DI 6 mg, -0.26 [-0.42 to -0.10], P = 0.0020; HAQ-DI 12 mg, -0.28 [-0.45 to -0.12], P = 0.0008; SF-36 PCS 6 mg, 3.3 [0.9 to 5.7], P = 0.0062; SF-36 PCS 12 mg, 3.5 [1.1 to 5.9], P = 0.0042). MCID at week 16 were reported for all PROs with either dose of deucravacitinib. Improvements of MCID or to normative values were reported by more patients receiving deucravacitinib than placebo. CONCLUSION: Deucravacitinib groups demonstrate significant and clinically meaningful improvements in PROs versus placebo in patients with active PsA, which warrants further study.

Meaningful Change Thresholds for the Psoriasis Symptoms and Signs Diary: A Secondary Analysis of a Randomized Clinical Trial.

Importance: Change from baseline score on the validated Psoriasis Symptoms and Signs Diary (PSSD) is a widely used, patient-reported end point in clinical trials for psoriasis. Meaningful score change thresholds anchored to patient-reported assessments have not been established in a clinical trial setting. Objective: To evaluate meaningful within-patient score change thresholds for the PSSD using data from the phase 3 Program to Evaluate the Efficacy and Safety of Deucravacitinib, a Selective TYK2 Inhibitor (POETYK), PSO-1 clinical trial, which compared the efficacy and safety of deucravacitinib vs placebo and apremilast among adults with moderate to severe plaque psoriasis. Design, Setting, and Participants: In this predefined analysis using data from the POETYK PSO-1 multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trial, conducted from August 7, 2018, to September 2, 2020, 666 adults with moderate to severe plaque psoriasis completed the PSSD daily throughout the trial. Meaningful change thresholds were derived by anchoring mean PSSD score change from baseline to week 16 to category improvements on the Patient Global Impression of Change (PGI-C) and the Patient Global Impression of Severity (PGI-S). Interventions: Deucravacitinib, 6 mg, once daily; placebo; or apremilast, 30 mg, twice daily. Main Outcome and Measures: The main outcome was score change from baseline to week 16 on the PSSD, anchored to the PGI-C and PGI-S. Results: The trial included 666 patients (mean [SD] age, 46.1 [13.4] years; 453 men [68.0%]). Three thresholds were identified using an analysis set of 609 patients. Score improvement of at least 15 points from baseline reflected meaningful within-patient change anchored to the PGI-C. Score improvements of 25 points were supported by both the PGI-C and the PGI-S, while a 30-point score change identified patients with greater improvements in their psoriasis symptoms and signs. Conclusions and Relevance: This analysis suggests that PSSD score improvements of 15, 25, or 30 points represent increasing improvements in disease burden that are meaningful to patients with psoriasis.

Development, psychometric evaluation and cognitive debriefing of the rheumatoid arthritis symptom and impact questionnaire (RASIQ).

BACKGROUND: Rheumatoid arthritis (RA) is a chronic inflammatory disease often associated with persistent pain. There is a need for a patient-reported outcome measure (PROM) that is rooted in the patient experience and psychometrically validated. We describe the development of the Rheumatoid Arthritis Symptom and Impact Questionnaire (RASIQ), a novel PROM with potential to record key symptoms and impacts of RA with a 24-h recall period. RESULTS: A literature review identified RA concepts that patients considered most important to their disease experience, including pain, fatigue, joint swelling and stiffness. From this, an initial item pool (33 items; 27 related to symptoms, 6 related to impacts) was developed with a recall period of 24 h. Two rheumatologists evaluated each item's relevance, and the second version of the RASIQ was refined (29 items; 21 related to symptoms, 8 related to impacts). Next, three rounds of cognitive debriefing interviews were conducted with patients with RA (n = 15 overall). The RASIQ was revised to remove items deemed irrelevant or redundant, leaving 16 items measuring symptoms (joint pain, energy/tiredness, joint stiffness) and impacts (rest, sleep). A parallel series of semi-structured concept elicitation interviews (n = 30) facilitated the design of a conceptual model of RA symptoms, impacts and treatment experiences. Post-hoc comparison of the model with RASIQ revealed that all items selected were among the most important and relevant symptoms and impacts for patients. A final round of cognitive debriefing interviews (n = 12) confirmed that the final 16-item RASIQ was relevant and easy to understand, with no further changes recommended. Psychometric evaluation using data from two Phase II RA clinical trials confirmed a 3-factor structure, as well as the reliability and validity of the scale scores, and the ability of RASIQ to detect changes in symptoms and impacts when administered at specific study timepoints, using a 24-h recall period. CONCLUSIONS: RASIQ is a novel, 16-item PROM developed with substantial patient input. Results from concept elicitation, cognitive debriefing, and psychometric evaluation confirmed the validity of the instrument, which has the potential to measure symptoms and impacts through a 24-h recall period and complement existing disease activity instruments with longer recall periods.

Development and equivalence of new faces for inclusion in the Childhood Asthma Control Test (C-ACT) response scale.

BACKGROUND: Accurate symptom monitoring is vital when managing pediatric asthma, providing an opportunity to improve control and relieve associated burden. The CHILDHOOD ASTHMA CONTROL TEST (C-ACT) has been validated for asthma control assessment in children; however, there are concerns that response option images used in the C-ACT are not culturally universal and could be misinterpreted. This cross-sectional, qualitative study developed and evaluated alternative response option images using interviews with children with asthma aged 4-11 years (and their parents/caregivers) in the United States, Spain, Poland, and Argentina. Interviews were conducted in two stages (with expert input) to evaluate the appropriateness, understanding and qualitative equivalence of the alternative images (both on paper and electronically). This included comparing the new images with the original C-ACT response scale, to provide context for equivalence results. RESULTS: Alternative response option images included scale A (simple faces), scale B (circles of decreasing size), and scale C (squares of decreasing quantity). In Stage 1, most children logically ranked images using scales A, B and C (66.7%, 79.0% and 70.6%, respectively). However, some children ranked the images in scales B (26.7%) and C (58.3%) in reverse order. Slightly more children could interpret the images within the context of their asthma in scale B (68.4%) than A (55.6%) and C (47.5%). Based on Stage 1 results, experts recommended scales A (with slight modifications) and B be investigated further. In Stage 2, similar proportions of children logically ranked the images used in modified scales A (69.7%) and B (75.7%). However, a majority of children ranked the images in scale B in the reverse order (60.0%). Slightly more children were able to interpret the images in the context of their asthma using scale B (57.6%) than modified scale A (48.5%). Children and parents/caregivers preferred modified scale A over scale B (78.8% and 90.9%, respectively). Compared with the original C-ACT, most children selected the same response option on items using both scales, supporting equivalency. Following review of Stage 2 results, all five experts agreed modified scale A was the optimal response scale. CONCLUSIONS: This study developed alternative response option images for use in the C-ACT and provides qualitative evidence of the equivalency of these response options to the originals.

Accurate monitoring of the symptoms associated with pediatric asthma is important when managing the condition. The CHILDHOOD ASTHMA CONTROL TEST (C-ACT) is a questionnaire widely used to measure asthma severity in young children (aged 4­11 years). Each question answered by the child in the C-ACT has four possible answer choices. To help children answer, each choice is presented alongside an image of a male child's face ranging from sad to happy. However, there are concerns that the images used are not culturally universal and could be misinterpreted­due to difficulties translating to electronic formats and a lack of differentiation between the images used. Through interviewing children with asthma, we aimed to address these concerns by developing and testing new images. Alternative image options developed included simpler faces, circles of decreasing size and squares of decreasing quantity. Children aged 4­11 years old were interviewed to test whether they understood the response scale using the new images and if they answered in the same way as with the original images. Interviews were conducted in two stages, with expert guidance at key stages. Results showed that children can interpret and understand the newly developed images and that they answer the questions the same as they would using the original images. These new images have the advantages of being culturally neutral and easier to implement on an electronic device.

Qualitative and psychometric approaches to evaluate the PROMIS pain interference and sleep disturbance item banks for use in patients with rheumatoid arthritis.

BACKGROUND: Patients with rheumatoid arthritis (RA) commonly experience pain despite the availability of disease-modifying treatments. Sleep disturbances are frequently reported in RA, with pain often a contributing factor. The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference and Sleep Disturbance item banks were initially developed to provide insights into the patient experience of pain and sleep, respectively, though they were not specifically intended for use in RA populations. This study evaluated the content validity of the PROMIS Pain Interference and Sleep Disturbance item banks in RA and identified relevant content for short forms for patients with RA that achieved high measurement precision across a broad range of health. METHODS: A qualitative approach consisting of hybrid concept elicitation and cognitive debriefing interviews was used to evaluate the content validity of the item banks in RA. Interviews were semi-structured and open-ended, allowing a range of concepts and responses to be captured. Findings from the qualitative interviews were used to select the most relevant items for the short forms, and psychometric evaluation, using existing item-response theory (IRT) item parameters, was used to evaluate the marginal reliability and measurement precision of the short forms across the range of the latent variables (i.e. pain interference and sleep disturbance). RESULTS: Thirty-two participants were interviewed. Participants reported that RA-related pain and sleep disturbances have substantial impacts on their daily lives, particularly with physical functioning. The PROMIS Pain Interference and Sleep Disturbance item banks were easy to understand and mostly relevant to their RA experiences, and the 7-day recall period was deemed appropriate. Qualitative and IRT-based approaches identified short forms for Pain Interference (11 items) and Sleep Disturbance (7 items) that had high relevance and measurement precision, with good coverage of the concepts identified by participants during concept elicitation. CONCLUSION: Pain and sleep disturbances affect many aspects of daily life in patients with RA and should be considered when novel treatments are developed. This study supports the use of the PROMIS Pain Interference and Sleep Disturbance item banks in RA, and the short forms developed herein have the potential to be used in clinical studies of RA.

Development of patient-reported outcome measures of children's oral health aesthetics.

OBJECTIVES: To develop and evaluate the psychometric properties of child- and parent-proxy measures of oral health aesthetics. METHODS: Items that describe children's perceptions of their oral attractiveness and its impact on social, emotional, and behavioural functioning were developed based on a systematic review of existing measures, clinician feedback (n = 13) and child semi-structured interviews (n = 27). The tools' content validity was assessed in cognitive interviews with 21 children. Items were administered to socio-demographically diverse samples of 998 children aged 8-17 years and 626 parents of children aged 5-17 years. Psychometric methods were used to finalize and calibrate item banks, generate short questionnaire forms, and evaluate the tools' reliability, precision and validity. RESULTS: The item banks and their short forms provide precise measurement across a wide range of oral health aesthetic states. They measure relevant and meaningful positive and negative experiences using terminology that most children as young as 8 years of age can understand. Known-group comparisons and convergence with existing measures of oral health-related quality of life, global health and body image provide evidence of construct validity. The scores are interpretable relative to the US general population. CONCLUSIONS: The oral health aesthetic item banks and short forms provide precise and valid assessments of children's satisfaction with their oral appearance. They may be useful for targeting and evaluating paediatric dental and orthodontic care in clinical practice and research settings.

Development of the PROMIS Pediatric Physical Activity Item Banks.

OBJECTIVE: The purpose of this study was to develop self-report and parent-proxy measures of children's physical activity for clinical research and practice and to demonstrate a valid and reliable instrument of children's lived experience of physical activity as reported by the children themselves or their parent proxies. METHODS: This study involved qualitative development of item pools followed by 2 cross-sectional validity and reliability studies. The National Institutes of Health Patient Reported Outcome Measurement Information System (PROMIS) instrument development standards were applied to create child self-report and parent-proxy physical activity instruments from previously developed, content-valid pools of physical activity items. Each item used a 7-day recall period and had 5 response options. Item bank calibration was based on national samples totaling 3033 children aged 8 to 17 years and 2336 parents of children aged 5 to 17 years. Quantitative analyses included reliability assessments, factor analyses, item response theory calibration, differential item functioning, and construct validation. RESULTS: The final item banks comprised 10 items each. The items were selected based on content and psychometric properties. The item banks appeared to be unidimensional and free from differential item functioning. They showed excellent reliability and a high degree of precision across the range of the latent variable. Child-report and parent-proxy 4- and 8-item fixed-length instruments were specified. The instruments showed moderate correlation with existing self-report measures of physical activity. CONCLUSION: The PROMIS Pediatric Physical Activity instruments provide precise and valid measurement of children's lived experiences of physical activity. IMPACT: The availability of the PROMIS Pediatric Physical Activity instruments will support advances in clinical practice and research that require measurement of pediatric physical activity by self- and parent-proxy report.

Efficacy, patient-reported outcomes, and safety of the anti-granulocyte macrophage colony-stimulating factor antibody otilimab (GSK3196165) in patients with rheumatoid arthritis: a randomised, phase 2b, dose-ranging study.

BACKGROUND: The human monoclonal antibody otilimab inhibits granulocyte-macrophage colony-stimulating factor (GM-CSF), a key driver in immune-mediated inflammatory conditions. We aimed to evaluate the efficacy, safety, and key patient-reported outcomes related to pain in patients with active rheumatoid arthritis receiving otilimab. METHODS: This phase 2b, dose-ranging, multicentre, placebo-controlled study was done at 64 sites across 14 countries. Patients aged 18 years or older with rheumatoid arthritis who were receiving stable methotrexate were randomly assigned (1:1:1:1:1:1) to subcutaneous placebo or otilimab 22·5 mg, 45 mg, 90 mg, 135 mg, or 180 mg, plus methotrexate, once weekly for 5 weeks, then every other week until week 50. The randomisation schedule was generated by the sponsor, and patients were assigned to treatment by interactive response technology. Randomisation was blocked (block size of six) but was not stratified. Investigators, patients, and the sponsor were blinded to treatment. An unblinded administrator prepared and administered the study drug. The primary endpoint was the proportion of patients who achieved disease activity score for 28 joints with C-reactive protein (DAS28-CRP) <2·6 at week 24. Patients who were not in the otilimab 180 mg group, without a good or moderate European League Against Rheumatism response (week 12) or with DAS28-CRP >3·2 (week 24) escaped to otilimab 180 mg. Patients who escaped were treated as non-responders in their original assigned group. Safety endpoints were incidence of adverse events and serious adverse events, infections, and pulmonary events. Efficacy and safety outcomes were assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02504671. FINDINGS: Between July 23, 2015, and Dec 29, 2017, 222 patients were randomly assigned (37 to each group). 86 (49%) of 175 escaped to otilimab 180 mg at week 12 and 57 (69%) of 83 at week 24. At week 24, the proportion of patients with DAS28-CRP <2·6 was two (5%) of 37 in the otilimab 22·5 mg group, six (16%) of 37 in the 45 mg group, seven (19%) of 37 in the 90 mg group, five (14%) of 37 in the 135 mg group, five (14%) of 37 in the 180 mg, and one (3%) of 37 in the placebo group. The largest difference was achieved with otilimab 90 mg (16·2%; odds ratio [OR] 8·39, 95% CI 0·98-72·14; p=0·053). Adverse events were reported pre-escape in 19-24 (51-65%) patients and post escape in 10-17 (40-61%) patients across otilimab dose groups and in 18 (49%) of 37 and 22 (67%) of 33 in the placebo group. The most common adverse event was nasopharyngitis: 3-9 (8-24%) in otilimab groups and one (3%) in the placebo group pre-escape and 1-3 (4-10%) in otilimab groups and seven (21%) in the placebo group post escape. Pre-escape serious adverse events were foot fracture (otilimab 45 mg); arthralgia, myocardial infarction, dizziness (otilimab 90 mg); oesophageal spasm, acute pyelonephritis (otilimab 22·5 mg), and uterine leiomyoma (otilimab 135 mg). Post-escape serious adverse events were ankle fracture (placebo) and rheumatoid arthritis (otilimab 135 mg). There were no deaths or pulmonary events of clinical concern, and rates of serious infection were low. INTERPRETATION: Otilimab plus methotrexate was well tolerated and, despite not achieving the primary endpoint of DAS28-CRP remission, there were improvements compared with placebo in disease activity scores. Of note, patients reported significant improvement in pain and physical function, supporting further clinical development of otilimab in rheumatoid arthritis. FUNDING: GlaxoSmithKline.

Assessing Children's Eudaimonic Well-Being: The PROMIS Pediatric Meaning and Purpose Item Banks.

OBJECTIVE: To describe the development of the Patient-Reported Outcome Measurement Information System (PROMIS) Pediatric Meaning and Purpose item banks, child-report and parent-proxy editions. METHODS: Data were collected from two samples. The first comprised 1,895 children (8-17 years old) and 927 parents of children 5-17 years old recruited from an Internet panel, medical clinics, and schools. The second comprised a nationally representative sample of 990 children 8-17 years old and 1,292 parents of children 5-17 years old recruited from a different Internet panel. Item pool evaluation was done with Sample 1 and analyses were used to support decisions about item retention. The combined sample was used for item response theory (IRT) calibration of the item bank. Both samples were used in validation studies. RESULTS: Eleven items were deleted from the item pool because of poor psychometric performance. The final versions of the scales showed excellent reliability (>0.90). Short form scales (4 or 8 items) had a high degree of precision across over 4 SD units of the latent variable. The item bank positively correlated with extant measures of positive psychological functioning, and negatively correlated with measures of emotional distress, pessimism, and pain. Lower meaning and purpose scores were associated with adolescence and presence of a special healthcare need. CONCLUSION: The PROMIS Pediatric Meaning and Purpose item banks and their short forms are ready for use in clinical research and practice. They are measures of children's eudaimonic well-being and indicative of children's hopefulness, optimism, goal-directedness, and feelings that life is worth living.

Evaluation of the PROMIS pediatric global health scale (PGH-7) in children with asthma.

OBJECTIVE: To evaluate the reliability and validity of the PROMIS Pediatric Global Health scale, a 7-item measure of perceived physical, mental, and social health, in children with asthma. METHODS: From February 2014 to February 2015, convenience samples of 8-17 year-old children (n = 182) and parents of 5-17 year-old children (n = 328) visiting an emergency department for treatment of asthma were enrolled. The Asthma Control Test was used to characterize children as controlled versus not controlled, and the PROMIS Asthma Impact Scale was used to assess asthma symptoms' impact on functional status. We conducted longitudinal analyses among 92 children and 218 parents at 3 weeks, and 74 children and 171 parents at 8 weeks after enrollment. RESULTS: The PGH-7 reliability ranged from 0.66 to 0.81 for child-report and 0.76 to 0.82 for parent-proxy. In cross-sectional analyses, children with controlled asthma had PGH-7 scores 0.40-0.95 standard deviation units higher than those who were uncontrolled. The PGH-7 was responsive to changes in overall general health between time points, with moderate effect sizes (0.5-0.6 standard deviation units). In longitudinal analyses, PGH-7 scores were no different between those who stayed uncontrolled versus became controlled at 3 weeks of follow-up; however, by 8 weeks of follow-up, the differences between these groups were 0.7-0.8 standard deviation units, indicative of large effects. CONCLUSIONS: The PGH-7 is a reliable and valid patient-reported outcome for assessing general health among children with asthma. It is a useful complement to other asthma-specific outcome measures.

Development and Evaluation of the PROMIS® Pediatric Positive Affect Item Bank, Child-Report and Parent-Proxy Editions.

OBJECTIVE: The purpose of this study is to describe the psychometric evaluation and item response theory calibration of the PROMIS Pediatric Positive Affect item bank, child-report and parent-proxy editions. METHODS: The initial item pool comprising 53 items, previously developed using qualitative methods, was administered to 1,874 children 8-17 years old and 909 parents of children 5-17 years old. Analyses included descriptive statistics, reliability, factor analysis, differential item functioning, and construct validity. A total of 14 items were deleted, because of poor psychometric performance, and an 8-item short form constructed from the remaining 39 items was administered to a national sample of 1,004 children 8-17 years old, and 1,306 parents of children 5-17 years old. The combined sample was used in item response theory (IRT) calibration analyses. RESULTS: The final item bank appeared unidimensional, the items appeared locally independent, and the items were free from differential item functioning. The scales showed excellent reliability and convergent and discriminant validity. Positive affect decreased with children's age and was lower for those with a special health care need. After IRT calibration, we found that 4 and 8 item short forms had a high degree of precision (reliability) across a wide range of the latent trait (>4 SD units). CONCLUSION: The PROMIS Pediatric Positive Affect item bank and its short forms provide an efficient, precise, and valid assessment of positive affect in children and youth.

Development and validation of the PROMIS Pediatric Sleep Disturbance and Sleep-Related Impairment item banks.

Study Objectives: To develop and evaluate the measurement properties of child-report and parent-proxy versions of the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep Disturbance and Sleep-Related Impairment item banks. Methods: A national sample of 1104 children (8-17 years old) and 1477 parents of children 5-17 years old was recruited from an internet panel to evaluate the psychometric properties of 43 sleep health items. A convenience sample of children and parents recruited from a pediatric sleep clinic was obtained to provide evidence of the measures' validity; polysomnography data were collected from a subgroup of these children. Results: Factor analyses suggested two dimensions: sleep disturbance and daytime sleep-related impairment. The final item banks included 15 items for Sleep Disturbance and 13 for Sleep-Related Impairment. Items were calibrated using the graded response model from item-response theory. Of the 28 items, 16 are included in the parallel PROMIS adult sleep health measures. Reliability of the measures exceeded 0.90. Validity was supported by correlations with existing measures of pediatric sleep health and higher sleep disturbance and sleep-related impairment scores for children with sleep problems and those with chronic and neurodevelopmental disorders. The sleep health measures were not correlated with results from polysomnography. Conclusions: The PROMIS Pediatric Sleep Disturbance and Sleep-Related Impairment item banks provide subjective assessments of child's difficulty falling and staying asleep as well as daytime sleepiness and its impact on functioning. They may prove useful in the future for clinical research and practice. Future research should evaluate their responsiveness to clinical change in diverse patient populations.

Psychometric Evaluation of the PROMIS® Pediatric Psychological and Physical Stress Experiences Measures.

Objective: To provide psychometric evaluation of the PROMIS® Pediatric Psychological and Physical Stress Experiences measures. Methods: Across two studies, Psychological and Physical Stress Experiences items were administered to 2,875 children aged 8-17 years and 2,212 parents of children aged 5-17 years. Analyses included descriptive statistics, reliability, factor analysis, differential item functioning (DIF), and assessment of construct validity. Items were calibrated using item response theory to estimate item parameters representative of the United States. Recommended eight- and four-item short forms were constructed for child- and parent-report versions of the Psychological and Physical Stress Experiences item banks. Results: Final item banks were unidimensional and items were locally independent and free from impactful DIF. Psychological Stress banks include 19 child-report and 12 parent-proxy items. Physical Stress banks include 26 child-report and 26 parent-proxy items. All instruments have strong internal consistency and retest-reliability, and provide precise estimates of varying stress levels. The instruments' construct validity was evidenced by known-group comparisons and convergence with legacy measures. Conclusions: The Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Psychological and Physical Stress item banks and short forms provide efficient, precise, and valid assessments of children's stress experiences.

Development and psychometric evaluation of the PROMIS Pediatric Life Satisfaction item banks, child-report, and parent-proxy editions.

PURPOSE: To describe the psychometric evaluation and item response theory calibration of the PROMIS Pediatric Life Satisfaction item banks, child-report, and parent-proxy editions. METHODS: A pool of 55 life satisfaction items was administered to 1992 children 8-17 years old and 964 parents of children 5-17 years old. Analyses included descriptive statistics, reliability, factor analysis, differential item functioning, and assessment of construct validity. Thirteen items were deleted because of poor psychometric performance. An 8-item short form was administered to a national sample of 996 children 8-17 years old, and 1294 parents of children 5-17 years old. The combined sample (2988 children and 2258 parents) was used in item response theory (IRT) calibration analyses. RESULTS: The final item banks were unidimensional, the items were locally independent, and the items were free from impactful differential item functioning. The 8-item and 4-item short form scales showed excellent reliability, convergent validity, and discriminant validity. Life satisfaction decreased with declining socio-economic status, presence of a special health care need, and increasing age for girls, but not boys. After IRT calibration, we found that 4- and 8-item short forms had a high degree of precision (reliability) across a wide range (>4 SD units) of the latent variable. CONCLUSIONS: The PROMIS Pediatric Life Satisfaction item banks and their short forms provide efficient, precise, and valid assessments of life satisfaction in children and youth.

Teachers' dispositional mindfulness and the quality of their relationships with children in Head Start classrooms.

The quality of teachers' relationships with children is a key predictor of children's later social emotional competence and academic achievement. Interventions to increase mindfulness among teachers have focused primarily on the impacts on teachers' subjective well-being, but not on the quality of their relationships with children. Furthermore, none of these interventions have involved preschool teachers. To consider the potential of mindfulness-based interventions to improve the quality of teachers' relationships with preschool-aged children, we examined data from an online survey of 1001 classroom teachers in 37 Pennsylvania Head Start Programs. Using path analysis we investigated the association between teachers' dispositional mindfulness and the quality of their relationships with children (conflict and closeness). We further examined whether this association was mediated by teacher depressive symptoms and moderated by perceived workplace stress. Higher levels of dispositional mindfulness among teachers were associated with higher quality relationships with children (less conflict and greater closeness). The association between greater dispositional mindfulness and less conflict was partially mediated by lower depressive symptoms, and the conditional direct effect of mindfulness on conflict was stronger when perceived workplace stress was lower. These findings suggest that preschool teachers who have higher levels of dispositional mindfulness may experience higher quality relationships with children in their classrooms. Interventions to increase levels of dispositional mindfulness among early childhood educators may improve their well-being along with the quality of their relationships with children, potentially impacting children's educational outcomes. The potential impacts of such interventions may be even stronger if structural and systemic changes are also made to reduce workplace stress.

Children's family experiences: development of the PROMIS® pediatric family relationships measures.

PURPOSE: To describe the development of pediatric family relationships measures, with versions for child self-report (8-17 years) and parent-report for children 5-17 years old. Measures were created for integration into the Patient Reported Outcomes Measurement Information System (PROMIS®). METHODS: Semi-structured interviews with 10 experts, 24 children, and 8 parents were conducted to elicit and clarify essential elements of family relationships. A systematic literature review was conducted to identify item concepts representative of each element. The concepts were transformed into items that were iteratively revised based on cognitive interviews (n = 43 children) and item translatability review. Psychometric studies involving 2846 children and 2262 parents were conducted to further refine and validate the instruments. RESULTS: Qualitative procedures supported the development of content valid Family Relationships item banks. Final child- and parent-report item banks each contain 47 items. Unidimensional item banks were calibrated using IRT-modeling to estimate item parameters representative of the US population and to enable computerized adaptive test administration. Four- and eight-item short forms were constructed for standard fixed format administration. All instruments have strong internal consistency, retest-reliability, and provide precise estimates of various levels of family relationship quality. Preliminary evidence of the instruments' validity was provided by known-group comparisons and convergence with legacy measures. CONCLUSION: The PROMIS pediatric Family Relationships measures can be applied in research focused on determinants, outcomes, and the protective effects of children's subjective family relationship experiences.

Patient-Reported Outcomes Measurement Information System Tools for Collecting Patient-Reported Outcomes in Children With Juvenile Arthritis.

OBJECTIVE: To evaluate the precision and construct validity of pediatric Patient-Reported Outcomes Measurement Information System (PROMIS) instruments in a population of juvenile idiopathic arthritis (JIA) patients and parent proxies. METHODS: A convenience sample of JIA patients and parents of JIA patients completed PROMIS instruments for 8 domains: anger, anxiety, depressive symptoms, fatigue, mobility, pain interference, peer relationships, and upper-extremity function. Short form and computerized adaptive test (CAT) scores were derived from item bank responses. Raw scores were translated to standardized T scores with corresponding SEs. Discrimination between inactive versus active disease was evaluated as an indicator of each measure's construct validity. SEs were plotted to evaluate each instrument's relative precision. Patient-parent concordance was assessed using intraclass correlations (ICCs). RESULTS: A total of 228 patients and 223 parents participated, providing 71-78 responses per domain. Patient- and parent-reported anger, fatigue, mobility, and pain interference scores significantly differed between those with inactive and active disease. Anxiety, depressive symptoms, and peer relationships differed by disease activity levels for parent-report only. Short forms and CATs provided comparable reliability to the full item banks across the full range of each outcome. Patient-parent agreement ranged from ICC 0.3 to 0.8. CATs did not reduce the number of items for any domain compared to the short form. CONCLUSION: Precision and discriminatory abilities of PROMIS instruments depend on health domain and report type (self-report versus parent proxy-report) for children with JIA. Varying levels of patient-parent concordance reinforces the importance of considering both perspectives in comprehensive health outcomes assessments.

Development and Evaluation of a Short Adverse Childhood Experiences Measure.

INTRODUCTION: Clinicians require tools to rapidly identify individuals with significant childhood adversity as part of routine primary care. The goal of this study was to shorten the 11-item Behavioral Risk Factor Surveillance System Adverse Childhood Experiences (ACEs) measure and evaluate the feasibility and validity of this shortened measure as a screener to identify adults who have experienced significant childhood adversity. METHODS: Statistical analysis was conducted in 2015. ACE item responses obtained from 2011-2012 Behavioral Risk Factor Surveillance System data were combined to form a sample of 71,413 adults aged ≥18 years. The 11-item Behavioral Risk Factor Surveillance System ACE measure was subsequently reduced to a two-item screener by maintaining the two dimensions of abuse and household stressors and selecting the most prevalent item within each dimension. RESULTS: The screener included household alcohol and childhood emotional abuse items. Overall, 42% of respondents and at least 75% of the individuals with four or more ACEs endorsed one or both of these experiences. Using the 11-item ACE measure as the standard, a cut off of one or more ACEs yielded a sensitivity of 99%, but specificity was low (66%). Specificity improved to 94% when using a cut off of two ACEs, but sensitivity diminished (70%). There was no substantive difference between the 11-and two-item ACE measures in their strength of association with an array of health outcomes. CONCLUSIONS: A two-item ACE screener appropriate for rapid identification of adults who have experienced significant childhood adversity was developed.

Concurrent validity of the PROMIS® pediatric global health measure.

PURPOSE: To evaluate the concurrent validity of the PROMIS Pediatric Global Health measure (PGH-7), child-report and parent-proxy versions. METHODS: Surveys were administered via home computer on two separate occasions (December, 2011 and August/September, 2012) to a convenience sample of 4636 children 8-17 years old and 2609 parents who participated in a national Internet panel. Data analysis included: (1) evaluations of differences in PGH-7 scores between groups defined by sociodemographics, clinical characteristics, and access to health care; (2) associations with 15 PROMIS pediatric measures; and (3) correlations with two health-related quality-of-life instruments, the KIDSCREEN-10 and PedsQL-15. RESULTS: PGH-7 scores were lower for children with chronic conditions, Hispanic ethnicity, low socioeconomic status, and barriers to accessing health care. The PGH-7 showed excellent convergent and discriminant validity with PROMIS pediatric measures of physical, mental, and social health. The PGH-7 was strongly correlated with the KIDSCREEN-10, which assesses positive health, and moderately correlated with the PedsQL-15, which assesses problems with a child's health. CONCLUSIONS: The PGH-7 measures global health, summarizing a child's physical, mental, and social health into a single score. These properties make it a useful clinical, population health, and research tool for applications that require an efficient, precise, and valid summary measure of a children's self-reported health status. Future research should prospectively evaluate the PGH-7's capacity to detect change that results from alterations in clinical status, transformations of the healthcare delivery system, and children's health development.

Adverse childhood experiences, dispositional mindfulness, and adult health.

OBJECTIVE: To determine whether greater dispositional mindfulness is associated with better adult health across a range of exposures to adverse childhood experiences (ACEs). METHODS: In 2012, a web-based survey of 2160 Pennsylvania Head Start staff was conducted. We assessed ACE score (count of eight categories of childhood adversity), dispositional mindfulness (Cognitive and Affective Mindfulness Scale-Revised), and the prevalence of three outcomes: multiple health conditions (≥ 3 of 7 conditions), poor health behavior (≥ 2 of 5 behaviors), and poor health-related quality of life (HRQOL) (≥ 2 of 5 indicators). RESULTS: Respondents were 97% females, and 23% reported ≥ 3 ACEs. The prevalences of multiple health conditions, poor health behavior, and poor HRQOL were 29%, 21%, and 13%, respectively. At each level of ACE exposure, health outcomes were better in those with greater mindfulness. For example, among persons reporting ≥ 3 ACEs, those in the highest quartile of mindfulness had a prevalence of multiple health conditions two-thirds that of those in the lowest quartile (adjusted prevalence ratio (95% confidence interval)=0.66 (0.51, 0.86)); for those reporting no ACEs, the ratio was 0.62 (0.41, 0.94). CONCLUSION: Across a range of exposures to ACEs, greater dispositional mindfulness was associated with fewer health conditions, better health behavior, and better HRQOL.