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

Abstract

ObjectivesTo 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.SettingTen clinical oncological centres, distributed across Italian macroregions (North, Centre, South and Islands), including hospitals, university hospitals and national research institutes.ParticipantsFrom 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.InterventionA 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 measuresAccording 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).ResultsAfter 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.ConclusionsThe 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 numberNCT03473379.

Psychometric properties of self-reported financial toxicity measures in cancer survivors: a systematic review

“…After duplications were removed, a total of 11 731 articles were retained, 11 669 articles were deleted after reading the title and abstract, and 39 were deleted after full-text reading. Finally, a total of 23 articles (21 PROMs) were eligible for inclusion in this study 12 14 16 23–42…”

“…All included studies were published from 2005 to 2022. Eight studies were conducted in the USA,12 14 23 27 30 37 39 41 four in the UK,16 29 35 38 two in Canada31 36 and two in China (mainland and Hong Kong),25 39 India26 34 and Italy 33 42. One study was conducted in 12 countries in Europe and North America 22 23.…”

Patient-reported financial toxicity within the Italian public healthcare system: a single center cross-sectional analysis in patients with cancer

“…The PROFFIT questionnaire has been developed in Italy, so in this analysis it was used within the specific context which led to its development and validation (12)(13)(14). This is particularly important for an instrument for action, both at a local and a national level.…”

“…PROFFIT results are reported as a FT-score (including items #1 to #7) and 9 separate items for FT determinants. According to the methodology previously described, all the scores are normalised to 0-100%, where 100 indicates the highest toxicity (14). For calculation of the FT-score, including items #1 to #7, the following steps should be followed: (1) reverse the score for Item #1 according to the following formula: where X 1 is the response given to item #1; (2) calculate the FT-score according to the following formula: statement "I have reduced my spending on leisure activities such as holidays, restaurants or entertainment in order to cope with expenses related to my illness", 12.0% for the statement "I have reduced spending on essential goods (e.g., food) in order to cope with expenses related to my illness" and 30.5% for the statement "I am worried that I will not be able to work due to my illness".…”

“…ening global quality of life (QoL) during the treatment, and that patients, who developed financial toxicity during treatment, had a statistically significant shorter survival (1). Therefore, in 2018, in order to develop an instrument for measuring and understanding the determinants of FT in patients with cancer, sensitive to dimensions of a universal healthcare system, the multicentre PROFFIT (Patient Reported Outcome for Fighting FInancial Toxicity of cancer) project was started (12)(13)(14). That project led to the production of the PROFFIT questionnaire which is, to the best of our knowledge, the first instrument for FT fully published from a European country.…”