Evidence map›Paper›PMID 34866311›Full record

ArticlePediatric blood & cancer2022

Recommended scoring approach for the pediatric patient-reported outcomes version of the Common Terminology Criteria for Adverse Events.

Pamela S Hinds, Laura C Pinheiro, Molly McFatrich, Mia Waldron, Justin N Baker, Catriona Mowbray, Scott H Maurer, Yao Cheng, Bryce B Reeve, Jichuan Wang

Open access · greenAbstract read
In one paragraph

Article in Pediatric blood & cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.7field-weighted citation impact, top 10% 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

10 citing papers in PubMed, 15 citations in OpenAlex.

  1. Patient-reported symptom assessments and early chemotherapy discontinuation in routine gastrointestinal cancer care.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Combination Early-Phase Trials of Anticancer Agents in Children and Adolescents.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Review
  9. Article
  10. Pain Assessment Tools for Infants, Children, and Adolescents With Cancer: A Scoping Review.Pediatrics international : official journal of the Japan Pediatric Society
    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

10 authors at 5 institutions in 1 country.

Pamela S HindsChildren's National Health System, Washington, District of Columbia, USA.ORCID 0000-0001-6491-6649
Laura C PinheiroWeill Cornell Medicine, New York, New York, USA.ORCID 0000-0002-6920-8526
Molly McFatrichDuke University School of Medicine, Durham, North Carolina, USA.
Mia WaldronChildren's National Health System, Washington, District of Columbia, USA.
Justin N BakerSt. Jude Children's Research Hospital, Memphis, Tennessee, USA.
Catriona MowbrayChildren's National Health System, Washington, District of Columbia, USA.
Scott H MaurerUniversity of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
Yao ChengChildren's National Health System, Washington, District of Columbia, USA.
Bryce B ReeveDuke University School of Medicine, Durham, North Carolina, USA.ORCID 0000-0002-6709-8714
Jichuan WangChildren's National Health System, Washington, District of Columbia, USA.
Children's National · USDuke University · USCornell University · USSt. Jude Children's Research Hospital · USUniversity of Pittsburgh · US

Funding

Creating and Validating Child Adverse Event Reporting in Oncology TrialsR01CA175759 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI REEVE, BRYCE B · 2013 to 2018
$3.4M
NCI NIH HHS R01 CA175759
6 · The paper itself

Abstract

backgroundCollecting symptom, function, and adverse event (AE) data directly from children and adolescents undergoing cancer care is more comprehensive and accurate than relying solely on their caregivers or clinicians for their interpretations. We developed the pediatric patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE) measurement system with input from children, parents, and clinicians. Here, we report how we determined the recommended Ped-PRO-CTCAE item scoring approach.

methodsData from 271 patients were analyzed using three scoring approaches: (a) at the AE attribute (frequency, severity, interference) using ordinal and dichotomous measures; (b) a weighted composite AE item score by AE attribute (0.5 - frequency; 1.0 - severity; 1.5 - interference); and (c) overall number of AEs endorsed. Associations of each AE attribute, AE item score, and overall AE score with the Patient-Reported Outcome Measurement Information System (PROMIS) Pediatric measures were examined. The ability of the overall Ped-PRO-CTCAE AE score to identify patients with PROMIS symptom T-scores worse than reference population scores was assessed. Clinician preference for score information display was elicited through interviews with five pediatric oncology clinical trialists.

resultsThe diverse scoring approaches yielded similar outcomes, including positive correlations of the Ped-PRO-CTCAE attributes, AE item score, and the overall AEs score with the PROMIS Pediatric measures. Clinicians preferred the most granular display of scoring information (actual score reported by the child and corresponding descriptive term).

conclusionsAlthough three scoring approaches yielded similar results, we recommend the AE attribute level of one score per Ped-PRO-CTCAE AE attribute for its simplicity of use in care and research.

Indexed as

NeoplasmsAdolescentCaregiversChildHumansMedical OncologyParentsPatient Reported Outcome Measuresadverse eventscancerpatient-reported outcomespediatricsscoring

Identifiers

PMID34866311
PMCPMC9038621
OpenAlexW4200222294

What OpenQuestion holds

Textmetadata
LicenceTDM
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.