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To assess the psychometric properties of the disease-specific Hypoparathyroidism Symptom Diary (HypoPT-SD) patient-reported outcome (PRO) tool, which consists of a 7-item symptom subscale, a 4-item impact subscale, a single item for anxiety, and a single item for sadness or depression, using data from the BALANCE randomized, placebo-controlled Phase 3b/4 study (NCT03324880). Eligible patients had symptomatic hypoparathyroidism (HypoPT) at baseline and were aged 18-85 years (inclusive). Patients received recombinant human parathyroid hormone (1-84) or placebo. The HypoPT-SD was filled in daily; data recorded at baseline and Weeks 4, 12, and 26 (end of treatment [EOT]) were included in this analysis. Inter-item and item-total correlations were used to assess HypoPT-SD structure; Cronbach's coefficient α was used to analyze the internal consistency and reliability, and intraclass correlations were used to measure test-retest reliability. Construct validity was determined using correlational analyses between HypoPT-SD scores and scores from other conceptually similar PRO tools. Ability to detect change was assessed and thresholds for meaningful within-patient change were established. The psychometric analysis population (N=93) was predominantly female (88.2%) and white (96.8%), with a mean age of 48.5 years. Inter-item correlations ranged from 0.35 to 0.85 at baseline and from 0.49 to 0.93 at EOT. Item-total correlations ranged from 0.57 to 0.83 at baseline and from 0.69 to 0.88 at EOT. Cronbach's α values at baseline were 0.90 (symptom subscale) and 0.88 (impact subscale). Intraclass correlation coefficients for both subscales in stable patients exceeded 0.70. Significant cross-sectional correlations were observed with most of the conceptually linked PRO tools analyzed, and HypoPT-SD scores were responsive to change. Potential changes of 1.5 (symptom subscale) and 0.8 (impact subscale) were determined as meaningful change thresholds for within-patient improvements. The HypoPT-SD is a reliable measure of key symptoms and impacts of HypoPT.

Background The Symptoms of Infection with Coronavirus-19 (SIC) is a 30-item patient-reported outcome (PRO) measure scored by body system composites to assess signs/symptoms of coronavirus disease 2019 (COVID-19). In addition to cross-sectional and longitudinal psychometric evaluations, qualitative exit interviews were conducted to support the content validity of the SIC. Methods In a cross-sectional study, adults diagnosed with COVID-19 in the United States completed the web-based SIC and additional PRO measures. A subset was invited to participate in phone-based exit interviews. Longitudinal psychometric properties were assessed in ENSEMBLE2, a multinational, randomized, double-blind, placebo-controlled, phase 3 trial of the Ad26.COV2.S COVID-19 vaccine. Psychometric properties evaluated included structure, scoring, reliability, construct validity, discriminating ability, responsiveness, and meaningful change thresholds of SIC items and composite scores. Results In the cross-sectional study, 152 participants completed the SIC (mean age, 51.0 ± 18.6 years) and 20 completed follow-up interviews. Fatigue (77.6%), feeling unwell (65.8%), and cough (60.5%) were symptoms most frequently reported. SIC inter-item correlations were all positive and mostly moderate (r ≥ 0.3) and statistically significant. SIC items and Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) scores correlated as hypothesized (all r ≥ 0.32). Internal consistency reliabilities of all SIC composite scores were satisfactory (Cronbach’s alpha, 0.69–0.91). SIC composite scores correlated moderately (r = 0.30–0.49) to strongly (r ≥ 0.50) with PROMIS-29 scores and Patient Global Impression of Severity (PGIS) ratings (all P  < 0.01). A variety of signs/symptoms were cited in exit interviews, and participants considered the SIC straightforward, comprehensive, and easy to use. From ENSEMBLE2, 183 participants with laboratory-confirmed moderate to severe/critical COVID-19 were included (51.5 ± 14.8 years). Strong test-retest reliabilities were observed for most SIC composite scores (intraclass correlations ≥ 0.60). Statistically significant differences across PGIS severity levels were found for all but 1 composite score, supporting known-groups validity. All SIC composite scores demonstrated responsiveness based on changes in PGIS. Conclusions The psychometric evaluations provided strong evidence for the reliability and validity of the SIC for measuring COVID-19 symptoms, supporting its use in vaccine and treatment trials. In exit interviews, participants described a broad range of signs/symptoms consistent with previous research, further supporting the content validity and format of the SIC. Plain english summary Coronavirus disease 2019 (COVID-19) is a serious disease that continues to evolve globally. Researchers developed the Symptoms of Infection with Coronavirus-19 (SIC), a 30-item questionnaire designed for patients to report signs and symptoms of COVID-19. In this study, the researchers formally analyzed how well the SIC measures the patient experience with COVID-19, using survey and clinical trial data as well as telephone interviews. Adults with COVID-19 and at least 2 bothersome symptoms completed the web-based survey, and some of these individuals also participated in in-depth interviews. Participants in a clinical trial for a COVID-19 vaccine also completed the SIC measure. The SIC was compared with other commonly used questionnaires that evaluate patient experience. The most commonly reported symptoms of COVID-19 were fatigue, feeling unwell, cough, weakness, and headache. The items for individual symptoms (e.g., “cough”) and combined scores for body systems (e.g., “respiratory system”) performed well in statistical analyses. Participants found the SIC to be straightforward, comprehensive, and easy to use. The SIC may prove useful in the future for vaccine and treatment trials for COVID-19.

Study Objectives: The Nocturia Sleep Quality Scale (NSQS), a novel patient-reported outcomes measure, was developed to assess the impact of sleep disturbance from nocturia. The objective of this study was to assess the psychometric properties of the NSQS, including its structure, reliability, and validity. Methods: Data were collected in the context of a web-based, prospective, longitudinal, observational study. Participants with nocturia were randomized 1:1 to either a group that received sleep hygiene instructions, including instructions to limit liquids at nighttime and empty bladder prior to bedtime, or one that did not receive sleep instructions. All participants were asked to provide responses to the web-based questionnaires from day 1 to day 10. Psychometric analyses, aligned with current regulatory guidance, were conducted to evaluate the daily scores and 3-day average scores of NSQS items and potential composites. Item-level analyses were conducted first, followed by composite-level analyses. Results: The NSQS items and supporting measures demonstrated very slight improvement in patient-perceived sleep disturbance from nocturia over the course of the study. NSQS test-retest reliabilities were generally satisfactory. Correlations between NSQS items and related patient-reported measures tended to support the construct validity of the NSQS, and the known-groups analyses supplied evidence of its discriminating ability. NSQS responsiveness statistics were small. Conclusions: The NSQS is a reliable and valid measure of the impact of nocturia on patients’ sleep. The present analyses lay the psychometric groundwork for the use of the NSQS in future clinical trials to support product approval and labeling claims. Citation: Williams V, Qin S, Romano CD, et al. Psychometric evaluation of the Nocturia Sleep Quality Scale based on data from a prospective observational study. J Clin Sleep Med . 2021;17(4):691–701.