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

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e031485 ◽  
Author(s):  
Silvia Riva ◽  
Jane Bryce ◽  
Francesco De Lorenzo ◽  
Laura Del Campo ◽  
Massimo Di Maio ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Financial Burden ◽  
External Validation ◽  
Patient Reported Outcome ◽  
Health Coverage ◽  
Financial Toxicity ◽  
Internal Validation ◽  
Concept Elicitation ◽  
Research Guidelines ◽  
Patient Reported

IntroductionFinancial 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 analysisOur 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 disseminationThe 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 numberNCT03473379.

scholarly journals Identifying missing links in the conceptualization of financial toxicity: a qualitative study

2021 ◽  
Author(s):  
Sara L. Lueckmann ◽  
Nadine Schumann ◽  
Christoph Kowalski ◽  
Matthias Richter
Keyword(s):  
Financial Distress ◽  
Financial Burden ◽  
Subjective Evaluation ◽  
Subjective Assessment ◽  
Patient Reported Outcome ◽  
Financial Toxicity ◽  
Perceived Burden ◽  
Conceptual Clarity ◽  
Patient Reported ◽  
The Impact

Abstract Purpose Financial toxicity can have a major impact on the quality of life of cancer survivors but lacks conceptual clarity and understanding of the interrelationships of the various aspects that constitute financial toxicity. This study aims to extract major drivers and mediators along the pathway from cancer-related costs to subjective financial distress from the patients’ experiences to establish a better understanding of financial toxicity as a patient-reported outcome. Methods Qualitative semistructured interviews with 39 cancer patients were conducted in Germany and addressed patient experiences with cancer-related financial burden and distress in a country with a statutory health care system. Transcripts were analyzed using content analysis. Results Several aspects of financial burden need to be considered to understand financial toxicity. The assessment of the ability to make ends meet now or in the future and the subjective evaluation of financial adjustments—namely, the burden of applied financial adjustments and the availability of financial adjustment options—mediate the connection between higher costs and subjective financial distress. Moreover, bureaucracy can influence financial distress through a feeling of helplessness during interactions with authorities because of high effort, non-traceable decisions, or one’s own lack of knowledge. Conclusion We identified four factors that mediate the impact of higher costs on financial distress that should be addressed in further studies and targeted by changes in policies and support measures. Financial toxicity is more complex than previously thought and should be conceptualized and understood more comprehensively in measurements, including the subjective assessment of available adjustment options and perceived burden of financial adjustments.

Patient-reported benefit from proposed interventions to reduce financial hardship during cancer treatment.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 7080-7080
Author(s):  
Emeline Aviki ◽  
Fumiko Chino ◽  
Julia Ramirez ◽  
Victoria Susana Blinder ◽  
Jennifer Jean Mueller ◽  
...  
Keyword(s):  
Cancer Treatment ◽  
Cancer Patients ◽  
Financial Burden ◽  
Gynecologic Cancer ◽  
Financial Hardship ◽  
Care Providers ◽  
Financial Toxicity ◽  
The Past ◽  
Patient Reported ◽  
The Impact

7080 Background: Awareness of cancer patients’ financial toxicity (FT) has increased substantially over the past decade; however, interventions to minimize financial burden remain underdeveloped and understudied. This survey-based study explores patient beliefs on which potential mitigating strategies could improve their financial hardship during cancer treatment. Methods: Interviewer-administered surveys were conducted with consecutive patients in an outpatient, urban, private academic Gynecologic Cancer clinic waiting room for 2 weeks in August 2019. The survey items included patient demographics, disease characteristics, the Comprehensive Score for Financial Toxicity (COST) tool (validated measure of FT with score 0-44; lower scores indicate worse FT), assessment of cost-coping strategies, and patient-reported anticipated benefit from described potential interventions (items that were feasible and relevant to implement in clinic). Results: Of 101 patients who initiated the survey, 87 (86%) completed it and were included in this analysis. The median age was 66 (range, 32-87). Thirty-eight patients (44%) had ovarian, 29 (33%) uterine, 5 (6%) cervical, and 15 (17%) an “other” gynecologic cancer. The median COST score was 32 (range, 6-44). Twenty-nine patients (33%) had COST scores ≤25 and 16 (18%) had COST scores ≤18. The most frequent cost-coping strategy reported was reducing leisure activities (n = 36, 41%) and using savings to pay for medical bills (n = 34, 39%). Six patients (7%) reported not taking a prescribed medication in the past 12 months due to the inability to pay and 0 reported skipping a recommended imaging study. When it came to interventions patients anticipated would improve their current financial hardships, 34 (39%) indicated access to transportation assistance to and from appointments, 31 (36%) said “knowing up front how much I’m going to have to pay for my healthcare”, 29 (33%) indicated “minimizing wait time associated with appointments, which keeps me away from work”, and 22 (25%) indicated “access to free food during/around appointments and treatments”. Only 26 (30%) noted they were not experiencing financial hardship. Conclusions: For an outpatient population of gynecologic cancer patients, several focused, feasible interventions could be implemented to potentially decrease patient FT. Our study can help health care providers in the design of interventions to create meaningful improvements in patient financial burden. Next steps should assess the impact of targeted interventions on patient outcomes.

Measuring financial toxicity of cancer in the Italian health care system: Initial results of the patient reported outcome for fighting financial toxicity of cancer project (proFFiT).

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 91-91
Author(s):  
Jane Bryce ◽  
Silvia Riva ◽  
Massimo Di Maio ◽  
Fabio Efficace ◽  
Luciano Frontini ◽  
...  
Keyword(s):  
Health Care ◽  
Cancer Patients ◽  
Health Care System ◽  
The United States ◽  
Financial Toxicity ◽  
Concept Elicitation ◽  
Patient Reported ◽  
Importance Analysis ◽  
Material Conditions ◽  
Care System

91 Background: Financial toxicity in cancer patients has been initially reported in the United States and subsequently in other countries, including Italy, despite its health care system is grounded on universal coverage. Considering that the way healthcare and welfare systems are shaped does impact on financial problems faced by cancer patients, we are developing an instrument for evaluating occurrence, gravity, and consequences of financial toxicity in Italy, and hopefully for fighting it. Methods: Concept elicitation, item generation and qualitative analyses represented the initial tasks of the project. Literature review, focus groups with 34 cancer patients or caregivers in three regions located in nothern, central, and southern Italy, and semi-structured interviews with 97 oncologists were conducted for concept elicitation. A recursive process was used to identify themes in the data to inform instrument until saturation was reached. Importance analysis questionnaires were administered to further 44 cancer patients to evaluate and revise the draft item pool. A multi-disciplinary committee (including oncologists, psychologists, statisticians, patient association’s representatives, nurses, social science researchers and economists) oversights the project. Results: Overall, 156 concepts were distributed among 10 themes (bureaucracy, medical care, domestic economy, emotion, family, job, health workers, welfare state, free time, transportation). After controlling for redundancy, 55 candidate items were generated and 30 items, with at least one per each theme, remained after importance analysis. Out of the 30 items, 23 (77%) refer to material conditions, 4 (13%) to psychological response and 3 (10%) to coping behaviors. Conclusions: The first results of the proFFiT project show that most of the items selected by patients are related to material conditions that cause, or derive from, financial hardship. The final questionnaire will be ready by the end of 2019. Supported by Fondazione AIRC IG grant 2017-20402. Clinical trial information: NCT03473379 .

scholarly journals Development of a patient-reported outcome measure for neck pain in military aircrew: qualitative interviews to inform design and content

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e039488
Author(s):  
Anna Dowling ◽  
Ellen Slungaard ◽  
Nicola R Heneghan
Keyword(s):  
Neck Pain ◽  
Outcome Measure ◽  
Physical Symptoms ◽  
Patient Reported Outcome ◽  
Direct Access ◽  
Specific Patient ◽  
Concept Elicitation ◽  
Patient Reported Outcome Measure ◽  
Patient Reported ◽  
The Impact

IntroductionThe prevalence of flight-related neck pain is 70% in UK fast jet pilots; much higher than the general population. The Aircrew Conditioning Programme and direct access physiotherapy exist to minimise the impact on military capability, but a population specific patient-reported outcome measure (PROM) is required to investigate the effectiveness of these. We aimed to explore the experiences of flight-related neck pain to inform the content validity and development of a population specific PROM.MethodsQualitative semistructured interviews combining phenomenological and grounded theory methods, reported using Consolidated criteria for Reporting Qualitative research guidelines. A purposive sample of 10 fast jet pilots with neck pain was recruited. Concept elicitation interviews were audio recorded, transcribed verbatim along with field notes. Data analysis involved subject and methodological expertise used a concept elicitation approach.ResultsParticipants included 10 male fast jet pilots, age 34.7 years. Identified themes included: (1) physical symptoms associated with flying activities; (2) occupational effects revealed modifications of flying, or ‘suboptimal’ performance owing to neck pain; (3) psychological effects revealed feelings or worry and (4) social and activity effects showed impact on out of work time.ConclusionPopulation-specific occupational, psychological and social factors should be considered alongside physical symptoms when managing neck pain in military aircrew. Findings support the development of a PROM specifically designed for military aircrew with neck pain.

Which electronic patient’s reported outcome should I choose for remote monitoring of my cancer patients? (Preprint)

2021 ◽  
Author(s):  
Fabrice Denis
Keyword(s):  
Cancer Patients ◽  
Remote Monitoring ◽  
Survival Benefit ◽  
Patient Reported Outcome ◽  
Controlled Trials ◽  
Symptom Monitoring ◽  
Best Value ◽  
Patient Reported ◽  
Oncology Practice

UNSTRUCTURED Abstract Digital electronic patient reported outcome (ePRO) systems for symptom monitoring in cancer patients demonstrated evidence of quality of life and survival benefit in controlled trials. They are beginning to be used in routine oncology practice. Many software editors provide solutions to clinicians but how can clinician choose it? We propose a synthesis of the main questions about effectiveness, safety and functionality of ePRO system that may ask clinician to software providers to be helped in selecting a software in order to obtain the best value of these tools for their patients and their practice.

scholarly journals Comparison of Chief Complaints and Patient-Reported Symptoms of Treatment-Naive Lung Cancer Patients Before Surgery

2021 ◽  
Author(s):  
Yaqian Feng ◽  
Wei Dai ◽  
Yaqin Wang ◽  
Jia Liao ◽  
Xing Wei ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Physical Examination ◽  
Cancer Patients ◽  
Patient Reported Outcome ◽  
Prospective Longitudinal Study ◽  
Lung Cancer Patients ◽  
Outcome Instrument ◽  
Patient Reported ◽  
Chief Complaints ◽  
Prospective Longitudinal

Abstract BackgroundLung cancer patients without chief complaints have been increasingly identified by physical examination. This study aimed to profile and compare chief complaints with patient-reported symptoms of lung cancer patients before surgery.MethodsData was extracted from a multicenter, prospective longitudinal study (CN-PRO-Lung 1) in China from November 2017 and January 2020. A comparison between chief complaints and patient-reported symptoms was analyzed using the Chi-squared test.ResultsA total of 201 (50.8%) lung cancer patients without chief complaints were found by physical examination at admission, and 195(49.2%) patients had chief complaints. The top 5 chief complaints were coughing (38.1%), expectoration (25.5%), chest pain (13.6%), hemoptysis (10.6%), and shortness of breath (5.1%). There were significantly more patients with chief complaints of coughing (38.1% vs. 15.0 %, P <0.001) and pain (20.5% vs. 6.9%, P<0.001) than those with the same symptoms rated ≥4 via MDASI-LC. There were less patients with chief complaints of fatigue (1.8% vs. 10.9%, P<0.001), nausea (0.3% vs. 2.5%, P=0.006), and vomiting (0.3% vs. 1.8%, p=0.032) than those with the same symptoms rated ≥4 via MDASI-LC. In patients without chief complaints, the five most common moderate to severe patient-reported symptoms were disturbed sleep (19.5%), distress (13.5%), dry mouth (13%), sadness (12%), and difficulty remembering (11.1%).ConclusionsSymptoms of lung cancer patients not included in the chief complaint could be identified via a patient-reported outcome instrument, suggesting the necessity of implementing the patient-reported outcome assessment before lung cancer surgery for better patient care.

Creation of a Tool to Evaluate Supportive Care: Experiences from Socioesthetics

2021 ◽  
Author(s):  
Damien Giacchero ◽  
Guillaume Buiret ◽  
Cecile Grosjean ◽  
CHARLES TAIEB ◽  
Mahasti Saghatchian ◽  
...  
Keyword(s):  
Supportive Care ◽  
External Validation ◽  
Care Patient ◽  
Patient Reported Outcome ◽  
Measurement Properties ◽  
Research Teams ◽  
Patient Reported ◽  
The Impact ◽  
Published Research

Abstract The absence of a specific tool to evaluate the impact of Supportive care in general and socioesthetics in particular as a rendered medical service is undoubtedly at the origin of the lack of published research based on scientific standards.In this context, we developed one supportive-care patient-reported outcome [PRO] using the multistep methods following COSMIN recommendations. Its construction followed all recommended steps: elaboration of the questionnaire, measurement properties of the questionnaire, internal and external validation, test-retest validation and translation, cross-cultural adaptation and cognitive debriefing. In total, our questionnaire includes11 items. It is scored by adding each VAS, making it range from 0 to 110, with a higher benefit when the score is higher. The Cronbach’s α coefficient is 0.88 for the entire questionnaire. The questionnaire thus constructed is a reflection of the patient's feelings, and it is quite natural that the name The “patient centricity questionnaire” (PCQ) was retained and validated by the Scientific Committee. The PCQ correlated negatively and moderately with the PSS, positively and moderately with the mental dimension of the and poorly with the WB12, the physical dimension of the SF-12 and the satisfaction EVA. Constructed according to the recommendations, the PCQ meets the prerequisite for this type of questionnaire. Its short format (11 questions) and simplicity of use allow it to be used by a large number of people and provides an pragmatic answer by making available to research teams a simple, reliable, easy-to-use and validated tool. It makes possible randomized studies to prove the impact on quality of life of the Supportive care in general and socioesthetics" in particular.

scholarly journals Colon Interposition for Esophageal Reconstruction in Cancer Patients

2018 ◽  
Vol 103 (5-6) ◽  
pp. 238-247
Author(s):  
Martin H. Hangaard ◽  
Michael B. Mortensen
Keyword(s):  
Cancer Patients ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Colon Interposition ◽  
Esophageal Reconstruction ◽  
Low Grade ◽  
Extensive Review ◽  
First Choice ◽  
Patient Reported ◽  
Esophagectomy For Cancer

Objective: The aim of this study was to report our experience with colon interposition (COI) and to compare the results with an extensive review of the COI literature. Summary of Background Data: The stomach is the first choice as an esophageal substitute following esophagectomy in cancer patients, while COI is reserved for patients where the stomach is not available or must be included in the resection due to cancer. Methods: We retrospectively reviewed the records of cancer patients undergoing colon interposition from 2006 to 2017. Outcomes were compared with an extensive review of the literature published between 2000 and 2017. Results: A total of 13 patients underwent planned COI. Mortality was zero and overall morbidity was 53%; 4 patients suffered from leakage and 2 patients from strictures. None of the patients suffered from necrosis of the interponat and there was no need for subsequent redundancy operations. The extensive review identified 23 publications. Overall study grading was low (grade C). Only 3 studies were prospective, no randomized studies were found, and many outcomes were poorly defined. The rates for 30-day and in-hospital mortality were 1% and 2%, respectively. Overall morbidity was 43%. The reported number of leakages, strictures, necrosis of the interponat, and redundancy operations varied between 0% and 50%, 0% and 21%, 0% and 9%, and 0% and 2%, respectively. Conclusions: COI is a complex technique that is necessary in a relatively small group of selected patients after esophagectomy for cancer. Prospective and comparative studies with strict outcome definitions, long-term follow up, and patient reported outcome measures are lacking.

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