Cross-sectional study to develop and describe psychometric characteristics of a patient-reported instrument (PROFFIT) for measuring financial toxicity of cancer within a public healthcare system

Silvia Riva, Laura Arenare, Massimo Di Maio, Fabio Efficace, Vincenzo Montesarchio, Luciano Frontini, Diana Giannarelli, Jane Bryce, Laura Del Campo, Francesco De Lorenzo, Elisabetta Iannelli, Francesca Traclò, Lara Gitto, Claudio Jommi, Concetta Maria Vaccaro, Daniela Barberio, Saverio Cinieri, Camillo Porta, Lucia Del Mastro, Vittorina Zagonel, Alessio Aligi Cogoni, Roberto Bordonaro, Anna Gimigliano, Maria Carmela Piccirillo, Lorenzo Guizzaro, Ciro Gallo, Francesco Perrone, Silvia Riva, Laura Arenare, Massimo Di Maio, Fabio Efficace, Vincenzo Montesarchio, Luciano Frontini, Diana Giannarelli, Jane Bryce, Laura Del Campo, Francesco De Lorenzo, Elisabetta Iannelli, Francesca Traclò, Lara Gitto, Claudio Jommi, Concetta Maria Vaccaro, Daniela Barberio, Saverio Cinieri, Camillo Porta, Lucia Del Mastro, Vittorina Zagonel, Alessio Aligi Cogoni, Roberto Bordonaro, Anna Gimigliano, Maria Carmela Piccirillo, Lorenzo Guizzaro, Ciro Gallo, Francesco Perrone

Abstract

Objectives: To measure and explain financial toxicity (FT) of cancer in Italy, where a public healthcare system exists and patients with cancer are not expected (or only marginally) to pay out-of-pocket for healthcare.

Setting: Ten clinical oncological centres, distributed across Italian macroregions (North, Centre, South and Islands), including hospitals, university hospitals and national research institutes.

Participants: From 8 October 2019 to 11 December 2019, 184 patients, aged 18 or more, who were receiving or had received within the previous 3 months active anticancer treatment were enrolled, 108 (59%) females and 76 (41%) males.

Intervention: A 30-item prefinal questionnaire, previously developed within the qualitative tasks of the project, was administered, either electronically (n=115) or by paper sheet (n=69).

Primary and secondary outcome measures: According to the protocol and the International Society for Pharmacoeconomics and Outcomes Research methodology, the final questionnaire was developed by mean of explanatory factor analysis and tested for reliability, internal consistency (Cronbach's α test and item-total correlation) and stability of measurements over time (test-retest reliability by intraclass correlation coefficient and weighted Cohen's kappa coefficient).

Results: After exploratory factor analysis, a score measuring FT (FT score) was identified, made by seven items dealing with outcomes of FT. The Cronbach's alpha coefficient for the FT score was 0.87 and the item-total correlation coefficients ranged from 0.53 to 0.74. Further, nine single items representing possible determinants of FT were also retained in the final instrument. Test-retest analysis revealed a good internal validity of the FT score and of the 16 items retained in the final questionnaire.

Conclusions: The Patient-Reported Outcome for Fighting FInancial Toxicity (PROFFIT) instrument consists of 16 items and is the first reported instrument to assess FT of cancer developed in a country with a fully public healthcare system.

Trial registration number: NCT03473379.

Keywords: health economics; oncology; qualitative research; quality in health care.

Conflict of interest statement

Competing interests: SR has received personal fees from CSL-Behring and GlaxoSmithKline Foundation. MDM has received personal fees from Bristol Myers Squibb, Merck Sharp & Dohme, Astra Zeneca, Janssen, Astellas, Pfizer, Eisai, Takeda. FE has received personal fees from AbbVie, BMS, Amgen, Orsenix, Takeda and research grant (Institution) from Amgen. VM has received personal fees from Bristol Myers Squibb and Italfarmaco; a member of his family is employee in Bayer. CJ has received personal fees from Amgen, Astra Zeneca, Biogen, Boehringer Ingelheim, Celgene, Gilead, GSK, Ipsen, Janssen-Cilag, Takeda and Sanofi. CMV has received personal fees from from Baxter, MSD, Novartis, Sanofi, Sanofi Genzyme. CP acted as a Speaker and/or Consultant for MSD, BMS, AstraZeneca, Ipsen, Pfizer, Eisai, EUSA, Novartis, Merck, General Electrics and Angelini; furthermore, was an Expert Testimony for Pfizer and EUSA. LDM has received personal fees from Eli Lilly, Roche, MSD, Novartis, Genomic Health, Pierre Fabre, Pfizer, Seattle Genetics, Daiichi Sankyo, Astra Zeneca, Ipsen, Eisai. VZ has received personal fees from BMS, MSD, Eisai, Italfarmaco, Roche, Astellas Pharma, Servier, Astra Zeneca, MSD, Janssen, Ipsen and research grant (Institution) from Bayer, Roche, Eli Lilly, Astra Zeneca, BMS, Ipsen, Astellas. RB reports personal fees from Bayer, Astra Zeneca, Sanofi, Novartis, Amgen, Hoffmann La Roche, Pfizer, Janssen Cilag, Bristol Myers Squibb, Merck. MCP reports personal fees from Daichii Sankyo, personal fees from GSK, personal fees from MSD, grants from Roche, grants and personal fees from AstraZeneca, non-financial support from Bayer. FP has received personal fees from Bayer, Ipsen, Astra Zeneca, Bristol Myers Squibb, Sandoz, Incyte, Celgene, Pierre Fabre, Janssen-Cilag and research grants (Institution) from Astra Zeneca, Bayer, Roche, Merck, Pfizer, Incyte, Sanofi, BioClin, Tesaro. All the above disclosures are outside the submitted work. The other Authors have no conflict to disclose.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Postulated causal structure for PROFFIT tool. PROFIT, Patient-Reported Outcome for Fighting FInancial Toxicity.

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