Evidence map›Paper›PMID 35674125›Full record

ArticleTumori2023

Cultural adaptation of the Italian version of the Patient-Reported Outcomes Common Terminology Criteria for Adverse Event (PRO-CTCAE®).

Caterina Caminiti, Jane Bryce, Silvia Riva, Diane Ng, Francesca Diodati, Elisa Iezzi, Lucia Sparavigna, Silvia Novello, Camillo Porta, Lucia Del Mastro and 21 more

Abstract readMulticenter Study
In one paragraph

Article in Tumori, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

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

2 citing papers in PubMed.

  1. Article
  2. 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

31 authors.

Caterina CaminitiResearch and Innovation Unit, University Hospital of Parma, Parma, Italy.ORCID 0000-0002-3196-2435
Jane BryceAscension St. John Clinical Research Institute, Tulsa, Oklahoma, USA.
Silvia RivaDepartment of Psychology, St Mary's University, London, UK.
Diane NgWestat Inc, Rockville, Maryland, USA.
Francesca DiodatiResearch and Innovation Unit, University Hospital of Parma, Parma, Italy.
Elisa IezziResearch and Innovation Unit, University Hospital of Parma, Parma, Italy.
Lucia SparavignaIstituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Napoli, Italy.
Silvia NovelloDepartment of Oncology, Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Orbassano, Italy.
Camillo PortaDivision of Medical Oncology, IRCCS San Matteo University Hospital Foundation, Pavia, Italy.ORCID 0000-0003-2412-1563
Lucia Del MastroDepartment of Medical Oncology, IRCCS Azienda Ospedaliera Universitaria San Martino-IST, Genoa, Italy.
Giuseppe ProcopioFondazione IRCCS, Istituto Nazionale dei Tumori, Oncology Unit 1, Milan, Italy.ORCID 0000-0002-2498-402X
Saverio CinieriMedical Oncology & Breast Unit, Antonio Perrino Hospital, Brindisi, Italy.
Amalia FalzettaOspedale della Val d'Elsa Senese, Poggibonsi, Italy.
Fabio CalabròDepartment of Oncology, San Camillo Forlanini Hospital, Rome, Italy.
Vito LorussoMedical Oncology, Istituto di Ricovero e Cura a Carattere Scientifico Ospedale Oncologico, Bari, Italy.
Alessio Aligi CogoniOspedale Civile SS. Annunziata, Sassari, Italy.
Giampaolo TortoraDepartment of Oncology, G.B. Rossi Hospital, University of Verona, Verona, Italy.
Marco MaruzzoOncology Unit 1, Istituto Oncologico Veneto IRCCS, Padova, Italy.
Rodolfo PassalacquaDivision of Medical Oncology, Hospital of Cremona, Cremona, Italy.
Francesco CognettiDepartment of Clinical and Molecular Medicine, Università La Sapienza di Roma, Roma, Italy.
Vincenzo AdamoMedical Oncology Unit, A.O. Papardo & Department of Human Pathology University of Messina, Messina, Italy.
Enrica CapellettoDepartment of Oncology, Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Orbassano, Italy.
Alessandra FerrariDivision of Medical Oncology, IRCCS San Matteo University Hospital Foundation, Pavia, Italy.
Michela BagnalastaFondazione Smith Kline, Verona, Italy.
Maurizio BassiFondazione Smith Kline, Verona, Italy.
Annalisa NicelliFondazione Smith Kline, Verona, Italy.
Davide De PersisFederazione Italiana delle Associazioni di Volontariato in Oncologia - F.A.V.O., Rome, Italy.
Alessia D'AcuntiAssociazione Italiana Malati di Cancro, parenti ed amici - AIMaC, Rome Italy.
Elisabetta Iannelli PatientFederazione Italiana delle Associazioni di Volontariato in Oncologia - F.A.V.O., Rome, Italy.
Francesco PerroneIstituto Nazionale Tumori, IRCCS, Fondazione G. Pascale, Napoli, Italy.ORCID 0000-0002-9738-0526
Sandra A MitchellDivision of Cancer Control and Population Sciences, Outcomes Research Branch, National Cancer Institute, Rockville, Maryland, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionUS National Cancer Institute's (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE

methodsAll PRO-CTCAE items were translated in accordance with international guidelines. Subsequently, the content validity of the PRO-CTCAE-Italian was explored and iteratively refined through cognitive debriefing interviews. Participants (n=96; 52% male; median age 64 years; 26% older adults; 18% lower educational attainment) completed a PRO-CTCAE survey and participated in a semi-structured interview to determine if the translation captured the concepts of the original English language PRO-CTCAE, and to evaluate comprehension, clarity and ease of judgement. Test-retest reliability of the finalized measure was explored in a second sample (n=135).

resultsFour rounds of cognitive debriefing interviews were conducted. The majority of PRO-CTCAE symptom terms, attributes and associated response choices were well-understood, and respondents found the items easy to judge. To improve comprehension and clarity, the symptom terms for nausea and pain were rephrased and retested in subsequent interview rounds. Test-retest reliability was excellent for 41/49 items (84%); the median intraclass correlation coefficient was 0.83 (range 0.64-0.94). DISCUSSION: Results support the semantic, conceptual and pragmatic equivalence of PRO-CTCAE-Italian to the original English version, and provide preliminary descriptive evidence of content validity and reliability.

Indexed as

NeoplasmsAgedFemaleHumansMaleMiddle AgedNational Cancer Institute (U.S.)Patient Reported Outcome MeasuresReproducibility of ResultsSelf ReportSemanticsSurveys and QuestionnairesUnited Statescognitive interviewingLinguistic validationpatient-reported outcomesPRO-CTCAEsymptomatic adverse events

Identifiers

PMID35674125
PMCPMC10248298

What OpenQuestion holds

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LicenceCC BY-NC
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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.