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Multicenter Study
. 2023 Jun;109(3):324-334.
doi: 10.1177/03008916221099558. Epub 2022 Jun 8.

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

Caterina Caminiti  1 , Jane Bryce  2 , Silvia Riva  3 , Diane Ng  4 , Francesca Diodati  1 , Elisa Iezzi  1 , Lucia Sparavigna  5 , Silvia Novello  6 , Camillo Porta  7   8 , Lucia Del Mastro  9 , Giuseppe Procopio  10 , Saverio Cinieri  11 , Amalia Falzetta  12 , Fabio Calabrò  13 , Vito Lorusso  14 , Alessio Aligi Cogoni  15 , Giampaolo Tortora  16 , Marco Maruzzo  17 , Rodolfo Passalacqua  18 , Francesco Cognetti  19 , Vincenzo Adamo  20 , Enrica Capelletto  6 , Alessandra Ferrari  7 , Michela Bagnalasta  21 , Maurizio Bassi  21 , Annalisa Nicelli  21 , Davide De Persis  22 , Alessia D'Acunti  23 , Elisabetta Iannelli Patient  22 , Francesco Perrone  5 , Sandra A Mitchell  24
Affiliations
Multicenter Study

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

Caterina Caminiti et al. Tumori. 2023 Jun.

Abstract

Introduction: US National Cancer Institute's (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) is a library of 78 symptom terms and 124 items enabling patient reporting of symptomatic adverse events in cancer trials. This multicenter study used mixed methods to develop an Italian language version of this widely accepted measure, and describe the content validity and reliability in a diverse sample of Italian-speaking patients.

Methods: All 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).

Results: Four 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.

Keywords: Linguistic validation; PRO-CTCAE; cognitive interviewing; patient-reported outcomes; symptomatic adverse events.

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Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article:

SN received payments or honoraria from Eli Lilly, Sanofi, Amgen, Beigene, Roche, Takeda, Pfizer, AstraZeneca, Boeringher Ingelheim, MSD, Novartis.

CP received payments or honoraria from Eisai, MSD, BMS, Astra Zeneca, Pfizer, Novartis, Merck, Janssen, Ipsen, EUSA Pharma, Angelini, General Electric.

LDM received payments or honoraria from Roche, Novartis, Eli Lilly, MSD, Pfizer, Ipsen, Celgene, Genomic Helath, Pierre Fabre, Daiichi Sankyo, Seagen, AstraZeneca, Eisai.

GP received payments or honoraria BMS, MSD, Bayer, Astra Zeneca, Merck, Ipsen, Janssen, Novartis, Pfizer, Sanofi.

SC received payments or honoraria from Eli Lilly.

FCal received payments or honoraria from MSD, BMS, Pfizer, AstraZeneca, Ipsen.

GT received payments or honoraria from BMS, MSD, Servier, Astra Zeneca, Merck.

RP received payments or honoraria from Regeneron, Ipsen, Sanofi-Aventis, Amgen, MSD.

FCog received payments or honoraria from Genomic Helath, Biolitec Pharma, Pfizer, Abbott, Celgene, Glaxo, Roche, Bayer, Novartis, Amgen, Pfizer, AstraZeneca, Eisai, Merck-Serono, Boeringher Ingelheim, MSD, BMS, Takeda, Astella, Eli Lilly, Seagen.

VA received payments or honoraria from Amgen, Astra Zeneca, BMS, Eli Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, Sanofi, Servier, Takeda.

DDP received grants to his institution from Fondazione Smith Kline.

EIan received grants to her institution from Fondazione Smith Kline.

FP received payments or honoraria from Incyte, GSK, Eli Lilly, Ipsen, Astellas, Astra Zeneca, Roche, BMS, Bayer, Clovis, Pierre Fabre; FP also received grants to his institution from Roche, Astra Zeneca, Pfizer, MSD, Bayer, Incyte Taiho, Janssen, Exelixis, Aileron, Daiichi Sankyo.

CC, JB, SR, DN, FD, EIez, LS, AFal, VL, AAC, MM, EC, AFer, MBag, MBas, AN, ADA, SAM did not declare competing interests.

Figures

Figure 1.
Figure 1.
Waterfall plot of rates of comprehension difficulties with PRO-CTCAE-Italian symptom terms across four rounds of interviews (n=96) and the total number of participants debriefed on each item.
Figure 2.
Figure 2.
Test-retest reliability of 49 PRO-CTCAE-Italian Items: Intraclass Correlation Coefficient and 95% CI (n=135). A, Amount; F, Frequency; I, Inference with usual or daily activities; PRO-CTCAE, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events; S, Severity. Note: Rash [Presence] (n=135): Proportion of agreement =84%, Range: 65%-100%; Skin darkening [Presence] (n=134): Proportion of agreement = 86%, Range: 74%-97%.
Figure 3.
Figure 3.
Distribution of PRO-CTCAE Item Scores for Symptomatic Toxicities Prevalent in ⩾10% of Respondents at Visit 1 (n=135). A, Amount; F, Frequency; I, Inference with usual or daily activities; P, Presence; PRO-CTCAE, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events; S, Severity. Response options: Frequency: 0= “Never”, 1= “Rarely”, 2= “Occasionally”, 3= “Frequently”, 4= “Almost constantly”. Severity: 0= “None”, 1= “Mild”, 2= “Moderate”, 3= “Severe”, 4= “Very severe”. Interference: 0= “Not at all ”, 1= “A little bit”, 2= “Somewhat”, 3= “Quite a bit”, 4= “Very much”. Amount: 0= “Not at all ”, 1= “A little bit”, 2= “Somewhat”, 3= “Quite a bit”, 4= “Very much”. Presence/Absence: 0= “No”, 1= “Yes”.
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