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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.

Purpose\ud This paper illustrates a conceptual model for a new patient-reported outcome measure (PROM) aimed at measuring financial toxicity (FT) in oncological setting in Italy, where citizens are provided universal healthcare coverage.\ud \ud Methods\ud Focus groups with overall 34 patients/caregivers in three different Italian centers (from Northern, Centre, and Southern Italy) and an open-ended survey with 97 medical oncologists were undertaken. Transcripts from focus groups and the open-ended survey were analyzed to identify themes and links between themes. Themes from the qualitative research were supplemented with those reported in the literature; concepts identified formed the basis for item development that were then tested through the importance analysis (with 45 patients) and the cognitive debriefing (with other 45 patients) to test relevance and comprehension of the first draft PRO instrument.\ud \ud Results\ud Ten domains were extracted by analyzing 156 concepts generated from focus groups and the open-ended survey. After controlling for redundancy, 55 items were generated and tested through the importance analysis. After controlling comprehension and feasibility through cognitive debriefing interviews, a first version of the questionnaire consisting of 30 items was devised.\ud \ud Conclusions\ud This qualitative study represents the first part of a study conducted to develop a new PROM to assess FT in Italy, by using a bottom-up approach that makes the most of patients’ experiences and the health system analysis.\ud \ud Trial registration\ud clinicaltrials.gov NCT03473379 first posted on March 22, 2018.

Background Financial toxicity in cancer patients has been initially reported in the United States and subsequently in other countries, including Italy, despite a health care system grounded on universal coverage. Considering that the way healthcare and welfare systems are shaped does impact on financial problems faced by cancer patients, we are developing an instrument for evaluating occurrence, gravity, and consequences of financial toxicity in Italy, and hopefully for fighting it. Methods Concept elicitation, item generation and qualitative analyses represented the initial tasks of the project. Literature review, focus groups with 34 cancer patients or caregivers in three regions located in North, Central, and South Italy, and semi-structured interviews with 97 oncologists were conducted for concept elicitation. A recursive process was used to identify themes in the data to inform the instrument until saturation was reached. Importance analysis questionnaires were administered to a further 44 cancer patients to evaluate and revise the draft item pool. A multi-disciplinary committee (including oncologists, psychologists, statisticians, patient association’s representatives, nurses, social science researchers and economists) oversaw the project. Results Overall, 156 concepts were distributed among 10 themes (bureaucracy, medical care, domestic economy, emotion, family, job, health workers, welfare state, free time, transportation). After controlling for redundancy, 55 candidate items were generated and 30 items, with at least one per each theme, remained after importance analysis. Out of the 30 items, 23 (77%) refer to material conditions, 4 (13%) to psychological response, and 3 (10%) to coping behaviors. Conclusions The first results of the proFFiT project show that most of the items selected by patients are related to material conditions that cause, or derive from, financial hardship. The final questionnaire will be ready by the end of 2019. Supported by Fondazione AIRC IG grant 2017-20402. Clinical trial identification NCT03473379. Legal entity responsible for the study Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione Pascale IRCCS, Naples, Italy. Funding Fondazione AIRC IG grant 2017-20402. Disclosure S. Riva: Honoraria (self): CSL-Behring; Honoraria (self): GlaxoSmithLine Foundation. M. Di Maio: Honoraria (self): BMS; Honoraria (self): MSD; Honoraria (self): Roche; Honoraria (self): AstraZeneca; Honoraria (self): Janssen. F. Efficace: Honoraria (self): BMS; Honoraria (self): Incyte; Honoraria (self): Orsenix; Honoraria (self): Amgen. V. Montesarchio: Honoraria (self): BMS; Honoraria (self): Italfarmaco; Spouse / Financial dependant: Bayer. F. Perrone: Honoraria (self): AstraZeneca; Honoraria (self): Bayer; Honoraria (self): Celgene; Honoraria (self): Incyte; Honoraria (self): Janssen-Cilag; Honoraria (self): Pierre Fabre; Honoraria (self): Sandoz. All other authors have declared no conflicts of interest.