Dataset Information

Testing and Psychometric Validation of a Pediatric Instrument to Self-Assess Symptoms of the Common Cold.

ABSTRACT:

Objectives

Given the lack of validated patient-reported outcomes (PRO) instruments assessing cold symptoms, a new pediatric PRO instrument was developed to assess multiple cold symptoms: the Child Cold Symptom Questionnaire (CCSQ). The objective of this research was to evaluate the measurement properties of the CCSQ.

Methods

This observational study involved daily completion of the self-report CCSQ by children aged 6-11 years in their home for 7 days. These data were used to develop a scoring algorithm and item-scale structure and evaluate the psychometric properties of the resulting scores. Analyses included evaluation of item and dimensionality performance (item response distributions and confirmatory factor analysis) and assessment of test-retest reliability in stable patients, construct validity (convergent and known groups validity), and preliminary responsiveness. Qualitative exit interviews in a subgroup of the children with colds and their parents were conducted.

Results

More than 90% of children had no missing data during the testing period, reflecting an excellent completion rate. For most items, responses were distributed across the options, with approximately normal distributions. Test-retest reliability was adequate, with intra-class correlation coefficients ranging from 0.63 to 0.83. A logical pattern of correlations with the validated Strep-PRO instrument provided evidence supporting convergent validity. Single- and multi-item symptom scores distinguished between children who differed in their cold severity based on global ratings, providing evidence of known groups validity. Preliminary evidence indicates the CCSQ is responsive to changes over time.

Conclusions

The findings demonstrate that the CCSQ items and multi-item scores provide valid and reliable patient-reported measures of cold symptoms in children aged 6-11 years. They provide strong evidence supporting the validity of these items and multi-item scores for inclusion as endpoints in clinical trials to evaluate the efficacy of cold medicines.

SUBMITTER: Arbuckle R

PROVIDER: S-EPMC7794207 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Testing and Psychometric Validation of a Pediatric Instrument to Self-Assess Symptoms of the Common Cold.

Arbuckle Rob R Halstead Patricia P Marshall Chris C Zimmerman Brenda B Bolton Kate K Regnault Antoine A Gelotte Cathy C

The patient 20201111 1

<h4>Objectives</h4>Given the lack of validated patient-reported outcomes (PRO) instruments assessing cold symptoms, a new pediatric PRO instrument was developed to assess multiple cold symptoms: the Child Cold Symptom Questionnaire (CCSQ). The objective of this research was to evaluate the measurement properties of the CCSQ.<h4>Methods</h4>This observational study involved daily completion of the self-report CCSQ by children aged 6-11 years in their home for 7 days. These data were used to devel ...[more]

PMID: 33174079

Similar Datasets

Project description:Nighttime symptoms can negatively impact the quality of life of patients with chronic obstructive pulmonary disease (COPD). The Nighttime Symptoms of COPD Instrument (NiSCI) was designed to measure the occurrence and severity of nighttime symptoms in patients with COPD, the impact of symptoms on nighttime awakenings, and rescue medication use. The objective of this study was to explore item reduction, inform scoring recommendations, and evaluate the psychometric properties of the NiSCI.COPD patients participating in a Phase III clinical trial completed the NiSCI daily. Item analyses were conducted using weekly mean and single day scores. Descriptive statistics (including percentage of respondents at floor/ceiling and inter-item correlations), factor analyses, and Rasch model analyses were conducted to examine item performance and scoring. Test-retest reliability was assessed for the final instrument using the intraclass correlation coefficient (ICC). Correlations with assessments conducted during study visits were used to evaluate convergent and known-groups validity.Data from 1,663 COPD patients aged 40-93 years were analyzed. Item analyses supported the generation of four scores. A one-factor structure was confirmed with factor analysis and Rasch analysis for the symptom severity score. Test-retest reliability was confirmed for the six-item symptom severity (ICC, 0.85), number of nighttime awakenings (ICC, 0.82), and rescue medication (ICC, 0.68) scores. Convergent validity was supported by significant correlations between the NiSCI, St George's Respiratory Questionnaire, and Exacerbations of Chronic Obstructive Pulmonary Disease Tool-Respiratory Symptoms scores.The results suggest that the NiSCI can be used to determine the severity of nighttime COPD symptoms, the number of nighttime awakenings due to COPD symptoms, and the nighttime use of rescue medication. The NiSCI is a reliable and valid instrument to evaluate these concepts in COPD patients in clinical trials and clinical practice. Scoring recommendations and steps for further research are discussed.

Project description:Background:Early morning respiratory symptoms impact quality of life and are often the most troublesome for patients with COPD. Reduction in symptoms and their impact are important treatment outcomes for COPD. The Early Morning Symptoms of COPD Instrument (EMSCI) is a daily diary designed to collect patients' report of the occurrence, severity, and impact of morning COPD symptoms. Methods:To assess the psychometric properties of the EMSCI, a split-half sample of data from a COPD clinical trial where participants completed the EMSCI daily was used for conducting descriptive statistics, factor analyses, and Rasch model analyses to examine item performance and inform scoring. Once the final scoring algorithm was determined, data from the second split-half sample were used to examine the properties of the EMSCI. Test-retest reliability was assessed using intraclass correlation coefficient (ICC). Correlations with other study assessments were used to evaluate convergent and known-groups validity. Results:Data from 1,663 patients with COPD aged 40-93 years were analyzed. Factor analysis and Rasch analysis confirmed a one-factor structure for the 6 individual symptom items. Item analyses supported the generation of 4 scores. All scores demonstrated good test-retest reliability: 6-item symptom severity (ICC, 0.84); overall morning symptom severity (ICC, 0.84); activity limitation (ICC, 0.85); and rescue medication (ICC, 0.62). Significant correlations between EMSCI scores, St George's Respiratory Questionnaire scores, and EXAcerbations of Chronic pulmonary disease Tool (EXACT)-Respiratory Symptoms scores supported the tool's convergent validity. Significant differences (p<0.0001) in all EMSCI domain scores were found between known-groups based on median split St George's Respiratory Questionnaire and EXACT-Respiratory Symptoms scores. Conclusion:The EMSCI consists of 4 scores: 6-item symptom severity, overall symptom severity, activity limitation, and rescue medication. The EMSCI is a reliable and valid instrument for evaluating patients' experience of early morning COPD symptoms.

Project description:BackgroundCultural competence of healthcare professionals (HCPs) is recognized as a strategy to reduce cultural disparities in healthcare. However, standardised, valid and reliable instruments to assess HCPs' cultural competence are notably lacking. The present study aims to 1) identify the core components of cultural competence from a healthcare perspective, 2) to develop a self-report instrument to assess cultural competence of HCPs and 3) to evaluate the psychometric properties of the new instrument.MethodsThe conceptual model and initial item pool, which were applied to the cross-cultural competence instrument for the healthcare profession (CCCHP), were derived from an expert survey (n = 23), interviews with HCPs (n = 12), and a broad narrative review on assessment instruments and conceptual models of cultural competence. The item pool was reduced systematically, which resulted in a 59-item instrument. A sample of 336 psychologists, in advanced psychotherapeutic training, and 409 medical students participated, in order to evaluate the construct validity and reliability of the CCCHP.ResultsConstruct validity was supported by principal component analysis, which led to a 32-item six-component solution with 50% of the total variance explained. The different dimensions of HCPs' cultural competence are: Cross-Cultural Motivation/Curiosity, Cross-Cultural Attitudes, Cross-Cultural Skills, Cross-Cultural Knowledge/Awareness and Cross-Cultural Emotions/Empathy. For the total instrument, the internal consistency reliability was .87 and the dimension's Cronbach's α ranged from .54 to .84. The discriminating power of the CCCHP was indicated by statistically significant mean differences in CCCHP subscale scores between predefined groups.ConclusionsThe 32-item CCCHP exhibits acceptable psychometric properties, particularly content and construct validity to examine HCPs' cultural competence. The CCCHP with its five dimensions offers a comprehensive assessment of HCPs' cultural competence, and has the ability to distinguish between groups that are expected to differ in cultural competence. This instrument can foster professional development through systematic self-assessment and thus contributes to improve the quality of patient care.

Project description:BackgroundA high quality treatment decision means patients are informed and receive treatment that matches their goals. This research examined the reliability and validity of the Depression Decision Quality Instrument (DQI), a survey to measure the extent to which patients are informed and received preferred treatment for depression.MethodsParticipants were aged 18 and older from 17 US cities who discussed medication or counseling with a physician in the past year, and physicians who treated patients with depression who practiced in the same cities. Participants were mailed a survey that included the Depression-DQI, a tool with 10 knowledge and 7 goal and concern items. Patients were randomly assigned to either receive a patient decision aid (DA) on treatment of depression or no DA. A matching score was created by comparing the patient's preferred treatment to their self-reported treatment received. Concordant scores were considered matched, discordant were not. We examined the reliability and known group validity of the Depression-DQI.ResultsMost patients 405/504 (80%) responded, 79% (320/405) returned the retest survey, and 60% (114/187) of physicians returned the survey. Patients' knowledge scores on the 10-item scale ranged from 14.6 to 100% with no evidence of floor or ceiling effects. Retest reliability for knowledge was moderate and for goals and concerns ranged from moderate to good. Mean knowledge scores differentiated between patients and physicians (M = 63 [SD = 15] vs. M = 81 [SD = 11], p < 0.001), and between patients who did and didn't receive a DA (M = 64 [SD = 16] vs. M = 61 [SD = 14], p = 0.041). 60.5% of participants received treatment that matched their preference. Based on the multivariate logistic regression, 'avoiding taking anti-depressants' was the only goal that was predictive of taking mediation (OR = 0.73 [0.66, 0.80], p < 0.01). Shared Decision Making Process scores were similar for those who matched their preference and those who didn't (M = 2.18 [SD = 0.97] vs. M = 2.06 [SD = 1.07]; t(320) = - 1.06, p = 0.29). Those who matched had lower regret scores (matched M = 1.72 [SD = 0.74] vs. unmatched M = 2.32 [SD = 0.8]; t(301) = - 6.6, p < .001).ConclusionsThe Depression DQI demonstrated modest reliability and validity. More work is needed to establish validity of the method to determine concordance.Trial registrationNCT01152307.

Project description:BackgroundConfirmed COVID-19 cases have been registered in more than 200 countries, and as of July 28, 2020, over 16 million cases have been reported to the World Health Organization. This study was conducted during the epidemic peak of COVID-19 in Italy. The early identification of individuals with suspected COVID-19 is critical in immediately quarantining such individuals. Although surveys are widely used for identifying COVID-19 cases, outcomes, and associated risks, no validated epidemiological tool exists for surveying SARS-CoV-2 infection in the general population.ObjectiveWe evaluated the capability of self-reported symptoms in discriminating COVID-19 to identify individuals who need to undergo instrumental measurements. We defined and validated a method for identifying a cutoff score.MethodsOur study is phase II of the EPICOVID19 Italian national survey, which launched in April 2020 and included a convenience sample of 201,121 adults who completed the EPICOVID19 questionnaire. The Phase II questionnaire, which focused on the results of nasopharyngeal swab (NPS) and serological tests, was mailed to all subjects who previously underwent NPS tests.ResultsOf 2703 subjects who completed the Phase II questionnaire, 694 (25.7%) were NPS positive. Of the 472 subjects who underwent the immunoglobulin G (IgG) test and 421 who underwent the immunoglobulin M test, 22.9% (108/472) and 11.6% (49/421) tested positive, respectively. Compared to NPS-negative subjects, NPS-positive subjects had a higher incidence of fever (421/694, 60.7% vs 391/2009, 19.5%; P<.001), loss of taste and smell (365/694, 52.6% vs 239/2009, 11.9%; P<.001), and cough (352/694, 50.7% vs 580/2009, 28.9%; P<.001). With regard to subjects who underwent serological tests, IgG-positive subjects had a higher incidence of fever (65/108, 60.2% vs 43/364, 11.8%; P<.001) and pain in muscles/bones/joints (73/108, 67.6% vs 71/364, 19.5%; P<.001) than IgG-negative subjects. An analysis of self-reported COVID-19 symptom items revealed a 1-factor solution, the EPICOVID19 diagnostic scale. The following optimal scores were identified: 1.03 for respiratory problems, 1.07 for chest pain, 0.97 for loss of taste and smell 0.97, and 1.05 for tachycardia (ie, heart palpitations). These were the most important symptoms. For adults aged 18-84 years, the cutoff score was 2.56 (sensitivity: 76.56%; specificity: 68.24%) for NPS-positive subjects and 2.59 (sensitivity: 80.37%; specificity: 80.17%) for IgG-positive subjects. For subjects aged ≥60 years, the cutoff score was 1.28, and accuracy based on the presence of IgG antibodies improved (sensitivity: 88.00%; specificity: 89.58%).ConclusionsWe developed a short diagnostic scale to detect subjects with symptoms that were potentially associated with COVID-19 from a wide population. Our results support the potential of self-reported symptoms in identifying individuals who require immediate clinical evaluations. Although these results come from the Italian pandemic period, this short diagnostic scale could be optimized and tested as a screening tool for future similar pandemics.

Dataset Information

Testing and Psychometric Validation of a Pediatric Instrument to Self-Assess Symptoms of the Common Cold.

Objectives

Methods

Results

Conclusions

Publications

Testing and Psychometric Validation of a Pediatric Instrument to Self-Assess Symptoms of the Common Cold.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets