A qualitative analysis and development of a conceptual model assessing financial toxicity in cancer patients accessing t
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ORIGINAL ARTICLE
A qualitative analysis and development of a conceptual model assessing financial toxicity in cancer patients accessing the universal healthcare system Silvia Riva 1,2 & Fabio Efficace 3 & Massimo Di Maio 4 & Jane Bryce 5,6,7 & Laura Del Campo 8 & Francesco De Lorenzo 9,10 & Luciano Frontini 11 & Diana Giannarelli 12 & Lara Gitto 13 & Elisabetta Iannelli 8 & Claudio Jommi 14 & Vincenzo Montesarchio 15 & Francesca Traclò 8 & Concetta Maria Vaccaro 16 & Laura Arenare 5 & Giuliana Canzanella 5 & Anna Gimigliano 5 & Fiorella Romano 5 & Alfonso Savio 5 & Lucia Sparavigna 5 & Maria Carmela Piccirillo 5 & Lorenzo Guizzaro 17 & Ciro Gallo 17 & Francesco Perrone 5 Received: 20 June 2020 / Accepted: 16 October 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract Purpose 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. Methods 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. Results 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. Conclusions 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. Trial registration clinicaltrials.gov NCT03473379 first posted on March 22, 2018. Keywords Financial toxicity . Qualitative research . Conceptual model . Patient experience . Cancer * Francesco Perrone [email protected]
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European Cancer Patient Coalition (ECPC), Brussels, Belgium
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Associazione Italiana Malati di Cancro (AIMAC), Rome, Italy
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St Mary’s University, Twickenham, London, UK
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Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University Hospital of Milan, Milan, Italy
Federation of Italian Cooperative Oncology Groups (FICOG), Milan, Italy
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Unità di Biostatistica, Istituto Nazionale per lo Studio e la Cura dei Tumori Regina Elena, IRCCS, Rome, Italy
3
Fondazione GIMEMA, Health Outcome
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