Evidence map›Paper›PMID 27260018›Full record

SynthesisSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2016

The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review.

Thomas M Atkinson, Sean J Ryan, Antonia V Bennett, Angela M Stover, Rebecca M Saracino, Lauren J Rogak, Sarah T Jewell, Konstantina Matsoukas, Yuelin Li, Ethan Basch

Registry-linked trialAbstract readSystematic Review
In one paragraph

Synthesis in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04456920 (Pain Monitoring After Breast Biopsy), which is not on this map. Cited by 202 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
202citing papers in PubMed, 7 pooled it
–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.

NCT04456920 nacompletednot on this mapstarted 2021, after this paper: background citation

Pain Monitoring After Breast Biopsy: Benefit of E-health

TypeinterventionalSponsorInstitut du Cancer de Montpellier - Val d'AurelleRan2021 to 2024Enrolled193ConditionsBreast Cancer, Biopsy WoundArmsphone consultation, e-PRO self-completed via connected objects (tablet/phone), visit
3 · Its place in the literature

Who cites it

202 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. Pooled it
  2. Associations of frailty with symptoms, and HRQOL in older cancer survivors after cancer treatments: a systematic review and meta-analyses.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2024
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  6. Information visualizations of symptom information for patients and providers: a systematic review.Journal of the American Medical Informatics Association : JAMIA · 2019
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  17. Effects of a Geriatric Assessment Intervention on Patient-Reported Symptomatic Toxicity in Older Adults With Advanced Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
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142 more citing papers are in PubMed but not listed here.

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.

Thomas M AtkinsonDepartment of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA. atkinsot@mskcc.org.
Sean J RyanDepartment of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA.
Antonia V BennettUniversity of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Angela M StoverUniversity of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
Rebecca M SaracinoDepartment of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA.
Lauren J RogakDepartment of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA.
Sarah T JewellRutgers, The State University of New Jersey, Newark, NJ, USA.
Konstantina MatsoukasDepartment of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA.
Yuelin LiDepartment of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA.
Ethan BaschDepartment of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Psychosocial Palliative & Community Research in CancerT32CA009461 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI JENNIFER L HAY, Jamie S. Ostroff · 1985 to 2026
$10.1M
Cancer Training GrantR25CA116339 · NCI · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BASCH, ETHAN M., REEVE, BRYCE B · 2008 to 2017
$4.0M
NCI NIH HHS P30 CA008748NCI NIH HHS R25 CA116339NCI NIH HHS T32 CA009461
6 · The paper itself

Abstract

purposeSymptomatic adverse events (AEs) are monitored by clinicians as part of all US-based clinical trials in cancer via the U.S. National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) for the purposes of ensuring patient safety. Recently, there has been a charge toward capturing the patient perspective for those AEs amenable to patient self-reporting via patient-reported outcomes (PRO). The aim of this review was to summarize the empirically reported association between analogous CTCAE and PRO ratings.

methodsA systematic literature search was conducted using PubMed, EMBASE, Web of Science, and Cochrane databases through July 2015. From a total of 5658 articles retrieved, 28 studies met the inclusion criteria.

resultsAcross studies, patients were of mixed cancer types, including anal, breast, cervical, chronic myeloid leukemia, endometrial, hematological, lung, ovarian, pelvic, pharyngeal, prostate, and rectal. Given this mixture, the AEs captured were variable, with many common across studies (e.g., dyspnea, fatigue, nausea, neuropathy, pain, vomiting), as well as several that were disease-specific (e.g., erectile dysfunction, hemoptysis). Overall, the quantified association between CTCAE and PRO ratings fell in the fair to moderate range and had a large variation across the majority of studies (n = 21).

conclusionsThe range of measures used and symptoms captured varied greatly across the reviewed studies. Regardless of concordance metric employed, reported agreement between CTCAE and PRO ratings was moderate at best. To assist with reconciliation and interpretation of these differences toward ultimately improving patient care, an important next step is to explore approaches to integrate PROs with clinician reporting of AEs.

Indexed as

Patient Reported Outcome MeasuresAdverse Drug Reaction Reporting SystemsAntineoplastic AgentsDrug MonitoringFemaleHumansSelf ReportAntineoplastic AgentsDrug monitoringDrug-related side effects and adverse reactionsLiterature reviewNeoplasmsSelf reportToxicity

Identifiers

PMID27260018
PMCPMC4919215

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Registered trials

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.