Evidence map›Paper›PMID 37407982›Full record

ArticleBMC cancer2023

Developing tumor-specific PRO-CTCAE item sets: analysis of a cross-sectional survey in three German outpatient cancer centers.

Maximilian Günther, Leopold Hentschel, Markus Schuler, Theresa Müller, Katharina Schütte, Yon-Dschun Ko, Ingo Schmidt-Wolf, Ulrich Jaehde

Open access · goldAbstract read
In one paragraph

Article in BMC cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 18% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Symptom experience of patients undergoing treatment for multiple myeloma: a longitudinal real-world electronic patient-reported outcomes study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Article
  6. 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 at 5 institutions in 1 country.

Maximilian GüntherInstitute of Pharmacy, Department of Clinical Pharmacy, University of Bonn, An der Immenburg 4, 53121, Bonn, Germany.
Leopold HentschelNational Center for Tumor Diseases (NCT/UCC), University Hospital Carl Gustav Carus, Dresden, Germany.
Markus SchulerClinic and Polyclinic for Internal Medicine, University Hospital Carl Gustav Carus, Technical University Dresden, Dresden, Germany.
Theresa MüllerNational Center for Tumor Diseases (NCT/UCC), University Hospital Carl Gustav Carus, Dresden, Germany.
Katharina SchütteNational Center for Tumor Diseases (NCT/UCC), University Hospital Carl Gustav Carus, Dresden, Germany.
Yon-Dschun KoDepartment of Internal Medicine, Johanniter Hospital, Bonn, Germany.
Ingo Schmidt-WolfDepartment of Integrated Oncology, CIO Bonn, University Hospital, Bonn, Germany.
Ulrich JaehdeInstitute of Pharmacy, Department of Clinical Pharmacy, University of Bonn, An der Immenburg 4, 53121, Bonn, Germany. u.jaehde@uni-bonn.de.ORCID http://orcid.org/0000-0002-2493-7370
National Center for Tumor Diseases · DEUniversity of Bonn · DEJohanniter-Krankenhaus Bonn · DEUniversity Hospital Bonn · DEUniversity Hospital Carl Gustav Carus · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo include the patient perspective in the assessment of adverse events in oncology, a patient-reported outcomes (PRO) version of the Common Terminology Criteria for Adverse Events (CTCAE) was developed by the US National Cancer Institute, the so called PRO-CTCAE. The objective of this study was the development of disease-specific PRO-CTCAE item sets for patients with breast cancer (BC), multiple myeloma (MM), and prostate cancer (PC).

methodsThe cross-sectional survey was conducted at three German outpatient cancer centers. Prevalence and importance of the 78 PRO-CTCAE symptoms were assessed using a patient questionnaire. To select the most relevant PRO-CTCAE items for each tumor entity, symptoms were ranked based on patient answers.

results101 patients with BC, 107 with MM, and 66 with PC participated. The final item sets contained 21 symptoms (BC) or 19 symptoms (MM and PC), respectively. Eight symptoms (fatigue, muscle pain, insomnia, joint pain, general pain, dizziness, shortness of breath, and swelling) were represented in all three item sets. Fatigue was the symptom with the highest ranking across item sets followed by insomnia. Symptoms with the highest rankings represented in only one item set were symptoms affecting the urogenital system in the PC item set, blurred vision in the BC item set, and decreased appetite in the MM item set.

conclusionsIndividual PRO-CTCAE item sets for a German patient population were developed for the three tumor entities on the basis of patients' differences in symptom profiles and perceptions. The quality and psychometric criteria of the newly compiled item sets should be evaluated in validation studies.

Indexed as

Breast NeoplasmsMultiple MyelomaNeoplasmsProstatic NeoplasmsSleep Initiation and Maintenance DisordersCross-Sectional StudiesHumansMaleOutpatientsPainPatient Reported Outcome MeasuresBreast cancerMultiple myelomaPatient-reported outcomesPRO-CTCAEProstate cancerSymptom burden

Identifiers

PMID37407982
PMCPMC10320985
OpenAlexW4383263583

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.