Evidence map›Paper›PMID 33174079›Full record

Observational studyThe patient2021

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

Rob Arbuckle, Patricia Halstead, Chris Marshall, Brenda Zimmerman, Kate Bolton, Antoine Regnault, Cathy Gelotte

Open access · hybridAbstract readObservational Study
In one paragraph

Observational study in The patient, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 6 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 2 countries.

Rob ArbuckleAdelphi Values, Adelphi Mill, Grimshaw Lane, Bollington, SK10 5JB, CH, UK. rob.arbuckle@adelphivalues.com.ORCID 0000-0003-0345-2523
Patricia HalsteadMcNeil Consumer Healthcare, a Division of Johnson and Johnson Consumer Inc., 7050 Camp Hill Rd, Fort, Washington, PA, 19034, USA.
Chris MarshallAdelphi Values, Adelphi Mill, Grimshaw Lane, Bollington, SK10 5JB, CH, UK.
Brenda ZimmermanMcNeil Consumer Healthcare, a Division of Johnson and Johnson Consumer Inc., 7050 Camp Hill Rd, Fort, Washington, PA, 19034, USA.
Kate BoltonAdelphi Values, Adelphi Mill, Grimshaw Lane, Bollington, SK10 5JB, CH, UK.
Antoine RegnaultModus Outcomes, 61 Cours de La Liberté, 69003, Lyon, France.
Cathy GelotteMcNeil Consumer Healthcare, a Division of Johnson and Johnson Consumer Inc., 7050 Camp Hill Rd, Fort, Washington, PA, 19034, USA.
Adelphi Group (United Kingdom) · GBJohnson & Johnson (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesGiven 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.

methodsThis 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.

resultsMore 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.

conclusionsThe 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.

Indexed as

Common ColdChildFactor Analysis, StatisticalHumansPsychometricsReproducibility of ResultsSurveys and Questionnaires

Identifiers

PMID33174079
PMCPMC7794207
OpenAlexW3100248628

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.