Evidence map›Paper›PMID 37419999›Full record

ArticleBritish journal of cancer2023

A tailored phase I-specific patient-reported outcome (PRO) survey to capture the patient experience of symptomatic adverse events.

Helena J Janse van Rensburg, Zhihui Liu, Geoffrey A Watson, Zachary W Veitch, Daniel Shepshelovich, Anna Spreafico, Albiruni R Abdul Razak, Philippe L Bedard, Lillian L Siu, Lori Minasian and 1 more

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In one paragraph

Article in British journal of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
5.1field-weighted citation impact, top 4% 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

5 citing papers in PubMed, 15 citations in OpenAlex.

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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

11 authors at 2 institutions in 4 countries.

Helena J Janse van RensburgDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.ORCID 0000-0002-4066-7489
Zhihui LiuDepartment of Biostatistics, Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Geoffrey A WatsonDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.ORCID 0000-0003-1962-7893
Zachary W VeitchDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Daniel ShepshelovichDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Anna SpreaficoDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.ORCID 0000-0002-3034-3042
Albiruni R Abdul RazakDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Philippe L BedardDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.
Lillian L SiuDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada.ORCID 0000-0002-3500-0540
Lori MinasianNational Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Aaron R HansenDivision of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto, ON, Canada. aaron.r.hansen@health.qld.gov.au.ORCID 0000-0002-2363-8707
University Health Network · CANational Institutes of Health · US

Funding

Princess Margaret Phase I Consorium (PMP1C)UM1CA186644 · NCI · UNIVERSITY HEALTH NETWORK · PI Philippe Bedard, Kevin D Courtney · 2014 to 2026
$16.6M
NCI NIH HHS UM1 CA186644
6 · The paper itself

Abstract

backgroundPatient perspectives are fundamental to defining tolerability of investigational anti-neoplastic therapies in clinical trials. Phase I trials present a unique challenge in designing tools for efficiently collecting patient-reported outcomes (PROs) given the difficulty of anticipating adverse events of relevance. However, phase I trials also offer an opportunity for investigators to optimize drug dosing based on tolerability for future larger-scale trials and in eventual clinical practice. Existing tools for comprehensively capturing PROs are generally cumbersome and are not routinely used in phase I trials.

methodsHere, we describe the creation of a tailored survey based on the National Cancer Institute's PRO-CTCAE for collecting patients' perspectives on symptomatic adverse events in phase I trials in oncology.

resultsWe describe our stepwise approach to condensing the original 78-symptom library into a modified 30 term core list of symptoms which can be efficiently applied. We further show that our tailored survey aligns with phase I trialists' perspectives on symptoms of relevance.

conclusionsThis tailored survey represents the first PRO tool developed specifically for assessing tolerability in the phase I oncology population. We provide recommendations for future work aimed at integrating this survey into clinical practice.

Indexed as

Antineoplastic AgentsNeoplasmsClinical Trials, Phase I as TopicHumansMedical OncologyPatient Reported Outcome MeasuresSurveys and QuestionnairesAntineoplastic Agents

Identifiers

PMID37419999
PMCPMC10421959
OpenAlexW4383551038

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.