Prostate-specific antigen and health-related quality of life in individuals with advanced prostate cancer treated with apalutamide: a plain language summary of the SPARTAN and TITAN studies.

What Is This Summary About?: This is a summary of a paper that describes the results of the SPARTAN and TITAN studies, which looked at whether a treatment called apalutamide can help treat individuals with advanced prostate cancer.The SPARTAN study included 1207 participants with nonmetastatic castration-resistant prostate cancer (or nmCRPC). The TITAN study included 1052 participants with metastatic castration-sensitive prostate cancer (or mCSPC).

Post Hoc Analysis of Rapid and Deep Prostate-specific Antigen Decline and Patient-reported Health-related Quality of Life in SPARTAN and TITAN Patients with Advanced Prostate Cancer.

Background: Adding apalutamide to androgen-deprivation therapy (ADT) resulted in a rapid (at 3- and 6-mo treatment) and deep prostate-specific antigen (PSA) decline (to ≤0.2 ng/ml or ≥90% from baseline), improved overall survival, reduced risk of disease progression, and prolonged health-related quality of life (HRQoL) in nonmetastatic castration-resistant prostate cancer (nmCRPC) in SPARTAN and metastatic castration-sensitive PC (mCSPC) in TITAN.

Objective: To evaluate the association of a rapid, deep PSA decline at 3 and 6 mo achieved with the addition of apalutamide to ADT with patient-reported outcomes (PROs) in SPARTAN and TITAN.

Apalutamide efficacy, safety and wellbeing in older patients with advanced prostate cancer from Phase 3 randomised clinical studies TITAN and SPARTAN.

Background: Apalutamide plus androgen-deprivation therapy (ADT) improved outcomes in metastatic castration-sensitive prostate cancer (mCSPC) and non-metastatic castration-resistant PC (nmCRPC) in the Phase 3 randomised TITAN and SPARTAN studies, respectively, and maintained health-related quality of life (HRQoL). Apalutamide treatment effect by patient age requires assessment.

Methods: Post-hoc analysis assessed patients receiving 240 mg/day apalutamide (525 TITAN and 806 SPARTAN) or placebo (527 TITAN and 401 SPARTAN) with ongoing ADT, stratified by age groups.

Developmentally specified characterization of the irritability spectrum at early school age: Implications for pragmatic mental health screening.

Objectives: Developmentally specified measures that identify clinically salient irritability are needed for early school-age youth to meaningfully capture this transdiagnostic risk factor for psychopathology. Thus, the current study modeled the normal:abnormal irritability spectrum and generated a clinically optimized screening tool for this population.

Methods: The irritability spectrum was modeled via the youth version of the Multidimensional Assessment Profile Scales-Temper Loss Scale (MAPS-TL-Youth) in children (n = 474; 6.

Health-related quality of life in GALAHAD: A multicenter, open-label, phase 2 study of niraparib for patients with metastatic castration-resistant prostate cancer and DNA-repair gene defects.

Niraparib is a highly selective poly (adenosine diphosphateribose) polymerase-1 and poly (adenosine diphosphate-ribose) polymerase-2 inhibitor indicated for select patients with ovarian, fallopian tube, and primary peritoneal cancer. The phase 2 GALAHAD trial (NCT02854436) demonstrated that niraparib monotherapy is tolerable and efficacious in patients with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations, particularly those with breast cancer gene () alterations who had progressed on prior androgen signaling inhibitor therapy and taxane-based chemotherapy. To report the prespecified patient-reported outcomes analysis from GALAHAD.

Convergent Validity of the Patient Reported Outcome Measurement Information System-Pediatric Physical Activity Instrument (PROMIS-PA) with Wearable Devices in Adolescents.

The study was conducted mainly to examine the convergent validity of the Patient Reported Outcome Measurement Information System-Pediatric Physical Activity instrument (PROMIS-PA) with step counts from wearable devices and another validated self-reported outcome measure. As a secondary aim, we explored the effect of different recall time frames (7-day, end-of-day [EoD], and ecological momentary assessment [EMA] time frames during the day) in terms of their feasibility and associations with each other and with step counts. This was a prospective cohort study that examined the associations between measures of PA in school-age children and adolescents ( = 84, aged 10-20).

Psychometric Evaluation of the Parent Effort Scale.

Objective: The Parent Effort Scale (PES) is a parent report questionnaire designed to quantify the level of effort required of caregivers to assist their children in developmentally appropriate home- and community-based activities. This manuscript describes the psychometric evaluation of the PES.

Method: Data collected from 304 parents of children ages 2-7 years (167 parents of a children with autism spectrum disorder and 137 parents of neurotypical children) were factor analyzed, calibrated using item response theory, and evaluated for construct validity.

Enhancing the Content Validity of Self-Reported Physical Activity Self-Efficacy in Adolescents: A Qualitative Study.

Purpose: This study's primary purpose was to enhance the content validity of a self-reported measure of self-efficacy for physical activity (PA) in adolescents. This was addressed through assessment of younger and older adolescents' understanding of the construct of self-efficacy for PA, coupled with assessment of the content coverage and comprehensibility of items derived from existing measures.

Methods: Participants completed individual semistructured and cognitive debriefing interviews as well as 3 PA self-efficacy questionnaires.

Measuring PROMIS® Well-Being in Early Childhood.

Objective: Expand the current Patient-Reported Outcome Measurement Information System (PROMIS®) well-being measures to early childhood (1-5 years) using best practices from PROMIS and developmental science.

Methods: Qualitative methods included expert input, literature and measure review, and parent interviews to confirm measure frameworks, item understandability, and developmental appropriateness. Quantitative methods included two waves of field testing and item response theory (IRT)-based psychometric evaluation of reliability and validity, as well as IRT centering and item calibration.

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.

Apalutamide plus abiraterone acetate and prednisone versus placebo plus abiraterone and prednisone in metastatic, castration-resistant prostate cancer (ACIS): a randomised, placebo-controlled, double-blind, multinational, phase 3 study.

Background: The majority of patients with metastatic castration-resistant prostate cancer (mCRPC) will have disease progression of a uniformly fatal disease. mCRPC is driven by both activated androgen receptors and elevated intratumoural androgens; however, the current standard of care is therapy that targets a single androgen signalling mechanism. We aimed to investigate the combination treatment using apalutamide plus abiraterone acetate, each of which suppresses the androgen signalling axis in a different way, versus standard care in mCRPC.

Health-related Quality of Life at the SPARTAN Final Analysis of Apalutamide for Nonmetastatic Castration-resistant Prostate Cancer Patients Receiving Androgen Deprivation Therapy.

Background: In SPARTAN, apalutamide improved metastasis-free and overall survival for patients with nonmetastatic castration-resistant prostate cancer (nmCRPC) with a prostate-specific antigen doubling time of ≤10 mo.

Objective: We evaluated health-related quality of life (HRQoL) at the final analysis of the SPARTAN study.

Intervention: Patients received apalutamide (240 mg/d) or placebo in 28-d cycles.

Apalutamide in Patients With Metastatic Castration-Sensitive Prostate Cancer: Final Survival Analysis of the Randomized, Double-Blind, Phase III TITAN Study.

Purpose: The first interim analysis of the phase III, randomized, placebo-controlled TITAN study showed that apalutamide significantly improved overall survival (OS) and radiographic progression-free survival in patients with metastatic castration-sensitive prostate cancer (mCSPC) receiving ongoing androgen deprivation therapy (ADT). Herein, we report final efficacy and safety results after unblinding and placebo-to-apalutamide crossover.

Methods: Patients with mCSPC (N = 1,052) were randomly assigned 1:1 to receive apalutamide (240 mg QD) or placebo plus ADT.

Using nationally representative percentiles to interpret PROMIS pediatric measures.

Purpose: This study's aim was to use a representative sample of the US pediatric population to estimate percentiles for several PROMIS pediatric measures: Anger, Anxiety, Depressive Symptoms, Family Relationships, Fatigue, Global Health, Life Satisfaction, Meaning and Purpose, Pain Behavior, Pain Interference, Physical Activity, Physical Function Mobility, Physical Function Upper Extremity, Physical Stress Experiences, Positive Affect, Psychological Stress Experiences, Sleep Disturbance, Sleep Impairment, and Peer Relationships.

Methods: We used two separate, nationally representative samples of parents and children aged 5-17 years drawn in different years from the GfK Knowledge Panel, a dual-frame online probability panel.

Results: All measures that were developed using a representative sample had a median at or near the expected value of 50.

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.

The Free2B Multi-Media Bullying Prevention Experience: An Exemplar of Scientific Edutainment.

Objective: The objective of the current article is to highlight an example of a new paradigm, . The manuscript describes how educational researchers and technologists worked together to develop a multi-media bullying prevention experience, called Free2B for middle school students paying particular attention to ensure that the programming was not only relevant to all students but also was appealing and responsive to the needs of urban youth. Bullying is the most common form of aggression experienced among school-aged youth, which impairs students' learning and social-emotional functioning and has financial costs to society.

Psychometric Evaluation of the Participation and Sensory Environment Questionnaire-Home Scale (PSEQ-H).

Importance: The impact of sensory processing challenges on occupational participation is underrepresented by existing measurement tools even though these outcomes are highly prioritized by families. The Participation and Sensory Environment Questionnaire-Home Scale (PSEQ-H) is a parent-report assessment designed to evaluate the impact of the sensory environment on young children's participation in home-based activities.

Objective: To describe the psychometric evaluation of the PSEQ-H, including the tool's structural validity; item difficulty, discrimination, and bias; reliability; and construct validity.

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.

Development and Validation of the Pediatric Sleep Practices Questionnaire: A Self-Report Measure for Youth Ages 8-17 Years.

: To develop and evaluate the validity of a self-report measure of sleep practices for youth 8-17 years. : Following recommended guidelines for the development of patient reported outcomes (PROs), sleep practice concepts were identified through expert (n = 8) and child (n = 28) concept elicitation interviews and a systematic literature review. Items were developed based on these concepts and tested in cognitive interviews with children (n = 32).

Investigating child self-report capacity: a systematic review and utility analysis.

Purpose: To identify and evaluate methods for assessing pediatric patient-reported outcome (PRO) data quality at the individual level.

Methods: We conducted a systematic literature review to identify methods for detecting invalid responses to PRO measures. Eight data quality indicators were applied to child-report data collected from 1780 children ages 8-11 years.

Clinical Validity of the PROMIS Pediatric Sleep Measures across Populations of Children with Chronic Illnesses and Neurodevelopment Disorders.

Objective: To examine the clinical validity of the Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Sleep Disturbance (SD) and Sleep-Related Impairment (SRI) short forms.

Methods: Youth (8-17 years) from clinical populations with known SDs (sleep clinic n = 126, autism n = 276, asthma n = 82, asthma + eczema n = 68) and the general population (n = 902) completed the PROMIS Pediatric SD and SRI 8-item short forms, along with established measures of sleep (Children's Report of Sleep Patterns, Sleep Habits Survey), PROMIS Pediatric Fatigue, and parent-reported clinical indicators (does child have sleep problem, use melatonin, use prescription sleep medication).

Results: Confirmatory factor analyses demonstrated factorial invariance for all clinical groups.

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.