Dataset Information

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:

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.

SUBMITTER: Riva S

PROVIDER: S-EPMC8529986 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

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Publications

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.

Riva Silvia S Arenare Laura L Di Maio Massimo M Efficace Fabio F Montesarchio Vincenzo V Frontini Luciano L Giannarelli Diana D Bryce Jane J Del Campo Laura L De Lorenzo Francesco F Iannelli Elisabetta E Traclò Francesca F Gitto Lara L Jommi Claudio C Vaccaro Concetta Maria CM Barberio Daniela D Cinieri Saverio S Porta Camillo C Del Mastro Lucia L Zagonel Vittorina V Cogoni Alessio Aligi AA Bordonaro Roberto R Gimigliano Anna A Piccirillo Maria Carmela MC Guizzaro Lorenzo L Gallo Ciro C Perrone Francesco F

BMJ open 20211020 10

<h4>Objectives</h4>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.<h4>Setting</h4>Ten clinical oncological centres, distributed across Italian macroregions (North, Centre, South and Islands), including hospitals, university hospitals and national research institutes.<h4>Participants</h4>From 8 October 2019 to 11 December 2019, 184 patients ...[more]

PMID: 34670762

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Project description:ObjectiveThe aim of this systematic review was to summarise the psychometric properties of patient-reported outcome measures (PROMs) measuring financial toxicity (FT) in cancer survivors.DesignThis systematic review was conducted according to the guidance of the Consensus-Based Standards for the Selection of Health Measurement Instruments (COSMIN) methodology.Data sourcesComprehensive searches were performed in PubMed, MEDLINE, Embase, CINAHL, PsycINFO, Web of Science, ProQuest and Cochrane Library from database inception to February 2022.Eligibility criteria for selecting studiesWe included studies that reported any PROMs for measuring FT in cancer survivors who were ≥18 years old. FT was defined as perceived subjective financial distress resulting from objective financial burden. Studies that were not validation studies and that used a PROM only as an outcome measurement were excluded.Data extraction and synthesisTwo reviewers independently extracted data from the included papers. We used the COSMIN criteria to summarise and evaluate the psychometric properties of each study regarding structural validity, internal consistency, reliability, measurement error, hypothesis testing for construct validity, cross-cultural validity/measurement invariance, criterion validity and responsiveness.ResultsA total of 23 articles (21 PROMs) were eligible for inclusion in this study. The findings highlighted that the Comprehensive Score for Financial Toxicity (COST) had an adequate development process and showed better psychometric properties than other PROMs, especially in internal consistency (Cronbach's α=0.92), reliability (intraclass correlation coefficient=0.80) and hypothesis testing (r=0.42-0.20).ConclusionsFrom a psychometric property perspective, the COST could be recommended as the most suitable worldwide available measure for use in research and clinical practice across different contexts. We suggest that PROMs should be selected only after careful consideration of the local socioeconomic context. Future studies are warranted to develop various FT PROMs based on different social and cultural backgrounds and to clarify the theoretical grounds for assessing FT.

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Dataset Information

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.

Objectives

Setting

Participants

Intervention

Primary and secondary outcome measures

Results

Conclusions

Trial registration number

Publications

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.

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