Evidence map›Paper›PMID 36701073›Full record

ArticleJournal of patient-reported outcomes2023

Development of patient- and observer-reported outcome measures to assess COVID-19 signs and symptoms in children and adolescents.

Carla Romano, Margaret Mayorga, Javier Ruiz-Guiñazú, Géralyn C Trudel, Sheri Fehnel, Kelly McQuarrie, Eric K H Chan, Eva G Katz

Abstract read
In one paragraph

Article in Journal of patient-reported outcomes, 2023. 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
–field-weighted citation impact
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.

  1. "Reading level is just one component": best practices for cognitive debriefing patient-reported outcome instruments with pediatric populations.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2026
    Review
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

8 authors.

Carla RomanoRTI Health Solutions, Research Triangle Park, NC, USA.
Margaret MayorgaRTI Health Solutions, Research Triangle Park, NC, USA.
Javier Ruiz-GuiñazúJanssen Research and Development, Beerse, Belgium.
Géralyn C TrudelJanssen Global Services LLC, Raritan, NJ, USA.
Sheri FehnelRTI Health Solutions, Research Triangle Park, NC, USA.
Kelly McQuarrieJanssen Global Services LLC, Horsham, PA, USA.
Eric K H ChanJanssen Global Services LLC, Raritan, NJ, USA.
Eva G KatzJanssen Global Services LLC, Raritan, NJ, USA. Ekatz1@its.jnj.com.ORCID 0000-0002-6293-1674

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Symptoms of Infection with Coronavirus-19 (SIC) is a 30-item patient-reported outcome measure to evaluate the presence and severity of COVID-19 signs/symptoms in adults. This study expanded the context of use of the adult SIC among adolescents aged 12-17 years and supported a pediatric adaptation (the Pediatric SIC [PedSIC]) for caregiver assessment of signs/symptoms in children aged < 12 years.

methodsDraft versions of the PedSIC and reference materials containing sign/symptom definitions for adolescents, based on an assessment of the reading level of SIC items by a professional linguist, were developed to facilitate accurate completion of the SIC by adolescents and observer-report (PedSIC) by caregivers. For adolescents, reference materials were intended to provide definitions for selected signs/symptoms identified to have a higher reading level. Iterative rounds of cognitive debriefing interviews were conducted from November 2020 to January 2021 to evaluate adolescent understanding of the SIC reference materials and inform refinement of the PedSIC for caregivers of children too young to reliably self-report. Participants were identified via databases of individuals who previously expressed interest in participating in qualitative research and were then screened for eligibility. Recruitment quotas were established to improve sample diversity. Thematic analysis and descriptive statistics were used to assess qualitative and demographic data, respectively.

resultsNine healthy adolescents (mean [SD, range] age, 14 [1.76, 12-17] years, 56% female, 22% non-White; round 1, n = 6; round 2, n = 3) and 17 caregivers (mean [SD, range] age, 34 [6.28, 26-41] years, 59% female, 35% non-White; round 1, n = 9; round 2, n = 8) were interviewed. Adolescents understood the majority of signs/symptoms (22 of the 30 SIC items) without assistance or use of the reference materials during the cognitive debriefing interview. Definitions were added to the reference materials for 5 additional items, and clarifications provided to existing definitions for 3 items. Seven observer-report (PedSIC) items were modified following feedback from caregivers of healthy young children. Reference materials (similar to those for adolescent use) were developed to support caregiver understanding of the intent of the PedSIC items collecting input from children ages ≥ 5- < 12 years.

conclusionsResults support using the SIC, PedSIC, and their associated reference materials to evaluate the presence and severity of COVID-19 signs/symptoms in adolescents and children aged < 12 years via caregiver-supported report, respectively.

Indexed as

COVID-19AdolescentAdultCaregiversChildChild, PreschoolFemaleHumansMalePatient Reported Outcome MeasuresQualitative ResearchSurveys and QuestionnairesAdolescentCaregiverContent validityCOVID-19Observer-reported outcomePatient-reported outcomePediatric

Identifiers

PMID36701073
PMCPMC9879250

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.