A qualitative analysis and development of a conceptual model assessing financial toxicity in cancer patients accessing the universal healthcare system.

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.

What women think about menopause: An Italian survey.

INTRODUCTION: Menopause is a critical period for most women who experience associated symptoms while they are still socially and individually active. OBJECTIVES: The objective of this study is to report how Italian women perceive and approach menopause. MATERIALS AND METHODS: A survey of 1028 Italian women aged 45-65 years was conducted by the Italian Center for Studies of Social Investments (CENSIS) through anonymous interviews using two methods: CATI (Computer Assisted Telephone Interviewing) and CAWI (Computer Assisted Web Interviewing). PRINCIPAL OUTCOME MEASURES: Principal outcome measures were women's perceptions and experiences of menopause and its treatments. RESULTS: The global consciousness and understanding of menopause was common (82.8 %) among Italian women and it was usually considered a physiological condition (77 %). Overall, 74.6 % of the sample were postmenopausal. Hot flushes were reported to be the most frequent (37.9 %) and bothersome symptoms (43.1 %) while 12.9 % of the women were asymptomatic. As for menopausal therapies, 24.5 % were on treatment; herbal medications were the most common remedy (63.3 %) whereas 7.6 % of the women took hormone replacement therapy (HRT). About half of the sample (50.4 %) had not sought help from the Italian National Health System (INHS). Medical expertise in the field of menopause was thought to be moderately satisfactory by 54.5 % of the sample. CONCLUSIONS: Italian women consider menopause a physiological condition. Most postmenopausal women had experienced symptoms but relied on non-hormonal treatments. The median women's satisfaction with the role of the INHS and medical competence suggests the need to improve current knowledge and awareness concerning menopause.

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: 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.

Value based healthcare for rare diseases: efficiency, efficacy, equity.

The paper reviews the literature available on value based health care and relates it to rare diseases. Starting from the economic definition of value and healthcare evaluation, efficacy and efficiency, it includes the equity dimension to define value-based healthcare. It embraces also the cultural framework associated to the concepts of health and disease, normal and pathological, right or wrong for the patient. The paper highlights that a prevention and recovery view and global evaluation of costs/benefits ratio for rare diseases make difficult and limited the applicability of the value-based approach to rare diseases. Since epidemiology of rare diseases identified a series of difficulties in applying value-based public health strategies to rare diseases, the paper underlines the necessity of new culture of health and well-being, radically re-examining how to organise the delivery of prevention, and healthcare services, and finding alternative ways of empowering and giving voice to vulnerable and marginalised groups.

Development and validation of a patient-reported outcome tool to assess cancer-related financial toxicity in Italy: a protocol.

INTRODUCTION: Financial toxicity (FT) is a well-recognised problem in oncology. US-based studies have shown that: (a) cancer patients have a 2.7 times risk of bankruptcy; (b) patients who declare bankruptcy have a 79% greater hazard of death; (c) financial burden significantly impairs quality of life (QoL) and (d) reduces compliance and adherence to treatment prescriptions. The aim of the project is to develop and validate a patient-reported-outcome (PRO) measure to assess FT of cancer patients in Italy, where, despite the universal health coverage provided by the National Health Service, FT is an emerging issue. METHODS AND ANALYSIS: Our hypothesis is that a specific FT measure, which considers the relevant sociocultural context and healthcare system, would allow us to understand the main determinants of cancer-related FT in Italy, in order to address and reduce these factors. According to the International Society for Pharmaco-economics and Outcomes Research guidelines on PROs, the project will include the following steps: (1) concept elicitation (from focus groups with patients and caregivers; literature; oncologists; nurses) and analysis, creating a coding library; (2) item generation (using a format that includes a question and a response on a 4-point Likert scale) and analysis through patients' cognitive interviews of item importance within different coding categories to produce the draft instrument; (3) factor analysis and internal validation (with Cronbach's alpha and test-retest for reliability) to produce the final instrument; (4) external validation with QoL anchors and depression scales. The use of the FT measure in prospective trials is also planned. ETHICS AND DISSEMINATION: The protocol is approved by the ethical committees of all the participating centres. The project will tentatively produce a validated tool by the spring 2021. The project might also represent a model and the basis for future cooperation with other European countries, with different healthcare systems and socioeconomic conditions. TRIAL REGISTRATION NUMBER: NCT03473379.

A comparison between the costs of dialysis treatments in Marche Region, Italy: Macerata and Tolentino hospitals.

BACKGROUNDS: The main aim of this study was to estimate the costs of different dialysis modalities through the analysis of administrative databases in the Macerata and Tolentino hospitals, in Italy. METHODS: We retrospectively analyzed two main categories: medical direct costs (all the monetary costs whose consumption is wholly referable to dialysis treatment) and non-medical direct costs (all the costs that make treatment possible but that are outside the medical care sector), related to 2013. Attention was focused on the analysis of the extracorporeal dialysis methods (HD, HDF/AFB, HDF/MID/HFR) and the peritoneal dialysis (APD, CAPD). RESULTS: An analysis overall of economic costs (direct costs + indirect costs) for dialysis treatment, shows that the cost per week for Continuous Ambulatory Peritoneal Dialysis (CAPD) technique is less expensive for health-care budgets, followed by Automated Peritoneal Dialysis (APD). Regarding the extracorporeal dialysis methods, the treatment more affordable is HD. CONCLUSIONS: Results obtained confirm that peritoneal dialysis technique is more convenient for health-care budget than extracorporeal dialysis. Furthermore, this study allowed to develop a methodology that could be a reference for similar studies.

[A Censis survey on atrial fibrillation awareness in the general population and among general practitioners and affected patients in Italy]. / Indagine Censis sulla conoscenza in Italia della fibrillazione atriale a livello dei cittadini, dei medici di medicina generale e dei pazienti.

BACKGROUND: Atrial fibrillation (AF) is the most common arrhythmia in clinical practice, particularly in the elderly. AF is considered an independent predictor of mortality and risk factor for stroke. AF-related stroke is usually severe and associated with a high rate of mortality and disability. Despite its prevalence, AF is a poorly known disease and it is underestimated by the general population. The aim of the Censis survey was to analyze the levels of AF knowledge and information in the Italian population and the level of AF risk awareness by general practitioners and AF patients. METHODS: The survey included structured interviews with a sample of 1000 Italian citizens aged ≥18 years, 300 general practitioners, and 1200 AF patients. RESULTS: The analysis confirmed low levels of knowledge of AF. In particular, the results showed that only one third of Italians know AF that is however perceived as a severe disease. In this subgroup, the risk of stroke associated with AF is known by 65%, but it is also widespread the wrong concept that AF is associated with an increased risk of myocardial infarction. The lack of knowledge of AF and its complications by the Italian population is due to educational gaps of general practitioners. In particular, only 50% of the Italian general practitioners perceive the thromboembolic risk of paroxysmal AF as comparable to that of permanent AF. In addition, there is an underuse of the scores for thromboembolic and hemorrhagic risk stratification recommended by current guidelines and a frequent use of antiplatelet therapy rather than oral anticoagulant therapy. There is also a low level of knowledge and awareness of the disease among AF patients. However, the majority of AF patients are aware of the importance of antithrombotic prophylaxis for stroke prevention. CONCLUSIONS: This study demonstrates limited knowledge and awareness of AF in the general population and also among general practitioners and affected patients.