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\begin{document}

\title{Recommended Scoring Approach for the Pediatric Patient-Reported Outcomes
version of the Common Terminology Criteria for Adverse Events}



\author[1]{Pamela Hinds}%
\author[2]{Laura Pinheiro}%
\author[3]{Molly McFatrich}%
\author[4]{Mia Waldron}%
\author[5]{Justin Baker}%
\author[1]{Catriona Mowbray}%
\author[6]{Scott Maurer}%
\author[1]{Yao Cheng}%
\author[3]{Bryce Reeve}%
\author[1]{Jichuan Wang }%
\affil[1]{Children's National Medical Center}%
\affil[2]{Well Cornell Medicine}%
\affil[3]{Duke University School of Medicine}%
\affil[4]{Children\'s National Health System}%
\affil[5]{St. Jude Children's Research Hospital}%
\affil[6]{Children's Hospital of Pittsburgh of UPMC}%


\vspace{-1em}



  
  \date{June 13, 2024}


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\selectlanguage{english}
\begin{abstract}
Background Collecting 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. Methods Scoring
approaches compared were 1) at the AE attribute (frequency, severity,
interference) using ordinal and dichotomous measures, 2) a weighted
composite AE item score by AE attribute (0.5 - frequency; 1.0 -
severity; 1.5 - interference), and 3) overall number of AEs endorsed.
Associations of each AE attribute, AE item score and overall AE score
with the PROMIS\selectlanguage{ngerman}® Pediatric measures of anxiety, depressive symptoms, and
fatigue 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. Results The 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). Conclusions
Although 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 clinical care and research.%
\end{abstract}\selectlanguage{ngerman}%



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\textbf{Hosted file}

\verb`Scoring Manuscript-09-02-21.docx`  available at \url{https://authorea.com/users/437388/articles/539057-recommended-scoring-approach-for-the-pediatric-patient-reported-outcomes-version-of-the-common-terminology-criteria-for-adverse-events}

\textbf{Hosted file}

\verb`Scoring Manuscript Table 1 Sample Characteristics.docx`  available at \url{https://authorea.com/users/437388/articles/539057-recommended-scoring-approach-for-the-pediatric-patient-reported-outcomes-version-of-the-common-terminology-criteria-for-adverse-events}

\textbf{Hosted file}

\verb`Scoring Manuscript Table 2 Polyserial Correlations of Ped-PRO-CTCAE Symptomatic AEs wtih PROMIS Pediatric Measures.docx`  available at \url{https://authorea.com/users/437388/articles/539057-recommended-scoring-approach-for-the-pediatric-patient-reported-outcomes-version-of-the-common-terminology-criteria-for-adverse-events}

\textbf{Hosted file}

\verb`Scoring Manuscript Table 3 Biserial Correlations of Ped-PRO-CTCAE Symptomatic AE Dichotomous Items with PROMIS Pediatric Measures .docx`  available at \url{https://authorea.com/users/437388/articles/539057-recommended-scoring-approach-for-the-pediatric-patient-reported-outcomes-version-of-the-common-terminology-criteria-for-adverse-events}

\textbf{Hosted file}

\verb`Scoring Manuscript Table 4 Spearman Correlations of Weighted AE Scores with PROMIS Pediatric Measures .docx`  available at \url{https://authorea.com/users/437388/articles/539057-recommended-scoring-approach-for-the-pediatric-patient-reported-outcomes-version-of-the-common-terminology-criteria-for-adverse-events}

\textbf{Hosted file}

\verb`Scoring Manuscript Table 5 Cut-off Point for the Ped-PRO-CTCAE Overall Scores to Predict PROMIS Pediatric Measure T-scores using ROC Analysis .docx`  available at \url{https://authorea.com/users/437388/articles/539057-recommended-scoring-approach-for-the-pediatric-patient-reported-outcomes-version-of-the-common-terminology-criteria-for-adverse-events}

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