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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: 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. Ten clinical oncological centres, distributed across Italian macroregions (North, Centre, South and Islands), including hospitals, university hospitals and national research institutes. 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. 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). 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). 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. 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. NCT03473379.

SUBMITTER: Riva S

PROVIDER: S-EPMC8529986 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundCancer and its treatment lead to increased financial distress for patients. To the authors' knowledge, to date, no standardized patient-reported outcome measure has been validated to assess this distress.MethodsPatients with AJCC Stage IV solid tumors receiving chemotherapy for at least 2 months were recruited. Financial toxicity was measured by the COmprehensive Score for financial Toxicity (COST) measure. The authors collected data regarding patient characteristics, clinical trial participation, health care use, willingness to discuss costs, psychological distress (Brief Profile of Mood States [POMS]), and health-related quality of life (HRQOL) as measured by the Functional Assessment of Cancer Therapy: General (FACT-G) and the European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaires. Test-retest reliability, internal consistency, and validity of the COST measure were assessed using standard-scale construction techniques. Associations between the resulting factors and other variables were assessed using multivariable analyses.ResultsA total of 375 patients with advanced cancer were approached, 233 of whom (62.1%) agreed to participate. The COST measure demonstrated high internal consistency and test-retest reliability. Factor analyses revealed a coherent, single, latent variable (financial toxicity). COST values were found to be correlated with income (correlation coefficient [r]?=?0.28; P<.001), psychosocial distress (r?=?-0.26; P<.001), and HRQOL, as measured by the FACT-G (r?=?0.42; P<.001) and by the EORTC QOL instruments (r?=?0.33; P<.001). Independent factors found to be associated with financial toxicity were race (P?=?.04), employment status (P<.001), income (P?=?.003), number of inpatient admissions (P?=?.01), and psychological distress (P?=?.003). Willingness to discuss costs was not found to be associated with the degree of financial distress (P?=?.49).ConclusionsThe COST measure demonstrated reliability and validity in measuring financial toxicity. Its correlation with HRQOL indicates that financial toxicity is a clinically relevant patient-centered outcome. Cancer 2017;123:476-484. © 2016 American Cancer Society.

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.

Project description:BackgroundWomen diagnosed with early stage (I or II) breast cancer face a highly challenging decision - whether or not to undergo adjuvant chemotherapy. We developed a decision quality instrument for chemotherapy for early stage breast cancer and sought to evaluate its performance.MethodsCross-sectional, mailed survey of recent breast cancer survivors, providers, and healthy controls and a retest survey of survivors. The decision quality instrument includes questions on knowledge and personal goals. It results in a knowledge score and concordance score, which reflects the percentage of patients who received treatments that match their goals. Hypotheses related to acceptability, feasibility, validity, and reliability of the survey instrument were examined.ResultsResponses were received from 352 patients, 89 providers and 35 healthy controls. The decision quality instrument was feasible to implement with few missing data. The knowledge scores had good retest reliability (intraclass correlation coefficient (ICC) =0.75). Knowledge scores discriminated between providers and patients (mean difference 31.1%, 95% CI 26.9, 35.3) and between patients and healthy controls (mean difference 11.2, 95% CI 5.4, 17.1). Most providers reported that the knowledge items covered essential content. Two of the five goal items had a ceiling effect, and one goal had low content validity. The goal items had moderate retest reliability (ICC's 0.57 to 0.78). In the multivariable model of treatment, none of the patient goals was associated with receipt of chemotherapy. Age and hormone receptor status were the only variables independently associated with chemotherapy. Most patients (77.6%) had treatment concordant with that predicted by the model. Patients who had concordant treatment had similar levels of confidence and regret as those who did not.ConclusionsThe Decision Quality Instrument is a reliable and valid measure of patient knowledge about chemotherapy, but its ability to measure concordance with patient goals is limited. In this sample, patient goals were not associated with treatment, and most patients reported they were not asked their preference, suggesting that goals were not adequately considered in decision making.

Project description:Background:Immersion is important for simulation-based education; however, questionnaire-based instruments to measure immersion have some limitations. The aim of the present work is to develop a new instrument to measure immersion among participants in healthcare simulation scenarios. Methods:The instrument was developed in four phases: trigger identification, content validity scores, inter-rater reliability analysis and comparison with an existing immersion measure instrument. A modified Delphi process was used to develop the instrument and to establish validity and reliability. The expert panel consisted of 10 researchers. All the researchers in the team had previous experience of simulation in the health and/or fire and rescue services as researchers and/or educators and simulation designers. To identify triggers, the panel members independently screened video recordings from simulation scenarios. Here, a trigger is an event in a simulation that is considered a sign of reduced or enhanced immersion among simulation participants. Results:The result consists of the Immersion Score Rating Instrument (ISRI). It contains 10 triggers, of which seven indicate reduced and three enhanced immersion. When using ISRI, a rater identifies trigger occurrences and assigns them strength between 1 and 3. The content validity analysis shows that all the 10 triggers meet an acceptable content validity index for items (I-CVI) standard. The inter-rater reliability (IRR) among raters was assessed using a two-way mixed, consistency, average-measures intra-class correlation (ICC). The ICC for the difference between weighted positive and negative triggers was 0.92, which indicates that the raters are in agreement. Comparison with results from an immersion questionnaire mirrors the ISRI results. Conclusions:In conclusion, we present a novel and non-intrusive instrument for identifying and rating the level of immersion among participants in healthcare simulation scenarios.

Project description:OBJECTIVE:Measuring the quality of care as experienced by patients is increasingly recognised as a way of improving healthcare services. However, disease-specific measures that take the patient journey into account are needed. This paper presents the development of such a measure for patients with heart disease and details the psychometric evaluation. DESIGN:The questionnaire was developed based on a literature review, qualitative interviews and a pilot-test. The psychometric evaluation of the measure was assessed using exploratory factor analysis (EFA) and confirmatory factor analysis (CFA), Cronbach's alpha coefficient and differential item functioning analysis with data from a population-based survey. SETTING:Denmark in 2013-2014. STUDY PARTICIPANTS:Nineteen heart patients, four relatives and eight health professionals participated in qualitative interviews in the development phase, and 15 patients participated in the pilot-test. The questionnaire was subsequently sent to a random sample of 5000 heart patients who were diagnosed in 2013. RESULTS:The comprehensive development phase and pilot-testing contributed to high content validity of the questionnaire. Eligible questionnaire responses were received from 2496 patients. EFA indicated a nine-factor model: communication at the hospital, communication with the general practitioner, information on disease and treatment, information on psychosocial aspects, rehabilitation/support, organisation, medication, involvement of relatives and consideration of comorbidity. CFA confirmed the proposed factor structure (eg, goodness-of-fit index=0.88, adjusted goodness-of-fit index=0.86, root mean square error of approximation=0.05), and Cronbach's alpha coefficient revealed good internal consistency of the factors (range: 0.69-0.93). CONCLUSIONS:The results suggest that this disease-specific patient-reported experience measure is of good quality when measuring the quality of care among heart patients. The inclusion of patients in the development phase contributed to high content validity, and subsequent psychometric evaluation found high construct validity and internal consistency. This measure may be especially relevant when seeking information about which aspects of care require improvement and the impact on health outcomes.

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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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