Understanding Patient Experience in Biliary Tract Cancer: A Qualitative Patient Interview Study

Cáncer del tracto biliar; Estudio de entrevista; Investigación cualitativaCàncer del tracte biliar; Estudi d'entrevista; Recerca qualitativaBiliary tract cancer; Interview study; Qualitative researchIntroduction Patients living with biliary tract cancer (BTC) experience a decline in health-related quality of life (HRQoL). This study aimed to obtain a comprehensive understanding of the patient experience of BTC-related signs/symptoms and the impacts of these on daily functioning and HRQoL. Methods Patients with BTC participated in qualitative semi-structured concept elicitation interviews. Signs/symptoms and impacts of BTC were initially explored by targeted literature searches and interviews with five clinicians. Patient interviews were transcribed and coded using qualitative research software. Concept saturation was assessed over five interview waves. A sign/symptom or impact was defined as “salient” if mentioned by ≥ 50% of patients, with a mean disturbance rating of ≥ 5 (0–10 scale). A conceptual model of the patient experience of BTC-related signs/symptoms and impacts was produced. Results Twenty-three patients from the USA (78% women; median age: 54 years), diagnosed as having early (n = 3), locally advanced (n = 11) or metastatic (n = 9) disease, were interviewed. Sixty-six signs/symptoms and 12 impacts were identified. Of these, 46 signs/symptoms and 8 impacts were not identified from the targeted literature or clinician interviews. Concept saturation was reached by the fourth of five interview waves. Fourteen disease-related signs/symptoms (including fatigue/lack of energy, abdominal pain, lack of appetite, insomnia and diarrhoea) and three impacts (physical, emotional and cognitive impacts) were deemed “salient”. The conceptual model included 50 signs/symptoms and 12 impacts. Conclusion Patients with BTC reported a range of signs/symptoms and impacts that negatively affect daily functioning and HRQoL.This project was funded by AstraZeneca, Gaithersburg, MD, USA. Research and publication fees are funded by the study sponsor

Understanding the patient experience in hepatocellular carcinoma: a qualitative patient interview study

Hepatocellular carcinoma; Quality of life; SymptomsCarcinoma hepatocelular; Calidad de vida; SíntomasCarcinoma hepatocel·lular; Qualitat de vida; SímptomesPurpose This study aimed to elucidate the patient experience of hepatocellular carcinoma (HCC) to guide patient-centered outcome measurement in drug development. Methods Patients with HCC participated in qualitative interviews to elicit disease-related signs/symptoms and impacts, using discussion guides developed from literature searches and discussions with oncologists. Interview participants rated the disturbance of their experiences (0–10 scale). A conceptual model was developed and mapped against patient-reported outcome (PRO) instruments identified from database reviews. Results Interviews were conducted with 25 individuals with HCC (68% were men; median age: 63 years; 12% Barcelona clinic liver cancer (BCLC) stage A; 32% stage B; and 56% stage C) in the USA. Fifty-one HCC-related concepts were identified from the interviews and were grouped into eight sign/symptom categories (eating behavior/weight changes; extremities [arms, legs]; fatigue and strength; gastrointestinal; pain; sensory; skin; other) and four impact categories (emotional; physical; cognitive function; other) for the conceptual model. The most prevalent and disturbing experiences across the disease stages were fatigue/lack of energy and emotional impacts such as frustration, fear, and depression. Abdominal pain and skin-related issues were particularly common and disturbing in individuals with HCC stage C. The EORTC QLQ-C30 and HCC18 were identified as commonly used PRO instruments in HCC studies and captured the relevant signs/symptoms associated with the patient experience. Conclusion Patients with HCC reported a range of signs/symptoms and impacts that negatively affect daily functioning and quality of life. Including PRO measures in HCC clinical trials can provide meaningful patient perspectives during drug development.This qualitative study was funded by AstraZeneca

A Prospective Study to Validate the Functional Assessment of Cancer Therapy (FACT) for Epidermal Growth Factor Receptor Inhibitor (EGFRI)-induced Dermatologic Toxicities FACT-EGFRI 18 Questionnaire: SWOG S1013

Background Papulopustular rash is a common class effect of epidermal growth factor receptor inhibitors (EGFRI) that can affect patients’ health-related quality of life and cause disruptions to treatment. SWOG S1013 (NCT01416688) is a multi-center study designed to validate the Functional Assessment of Cancer Therapy EGFRI 18 (FACT-EGFRI 18) using 7-items from the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 to assess EGFRI-induced skin-related toxicities and their impact on functional status. Methods Patients with a diagnosis of colorectal or lung cancer to receive EGFRI therapies for at least 6 weeks were enrolled. Patient self-assessments using the FACT-EGFRI 18 were completed prior to undergoing CTCAE assessment by trained clinicians at baseline, weekly × 6, and then monthly × 3. The psychometric properties of the FACT-EGFRI 14 (skin toxicity items only) and 18 (plus 2 nail and 2 hair items) were established based on criterion validity, known groups validity, internal consistency reliability, and responsiveness to change. Results Of the 146 registered patients, 124 were evaluable. High Cronbach’s alpha (\u3e 0.70) for both FACT-EGFRI 14 and FACT-EGFRI 18 scores across assessment times were observed. Although agreement (i.e. criterion validity) between individual and summary scales of the FACT-EGFRI 18 for assessing skin toxicity was good, agreement with the clinician-reported CTCAE was only fair. The minimal important difference was determined to be 3 points. The results also demonstrated responsiveness to symptom change. Discussion Based on the results of this multi-center validation study, the FACT-EGFRI 18 patient-reported outcome instrument provided data from the patient’s perspective yielding unique information as well as complementing clinician-rated CTCAE grades, especially for the symptoms of pain, pruritus, and paronychia. Conclusions Good to excellent psychometric properties for the FACT-EGFRI 18 were demonstrated, supporting further use of this patient-reported outcomes measure. Additional validation with a more diverse group of patients should be conducted

Quality in healthcare organizations: Its meaning and measurement

This dissertation explores two important aspects of quality in healthcare: its meaning and its measurement. For a better understanding of what quality means, the history of quality in the manufacturing and service industries is reviewed. Concepts that are similar are pointed out as are concepts that are different. The definition introduced by the Institute of Medicine (IOM) for quality in healthcare and the six IOM aims of safety, timeliness, patient-centeredness, effectiveness, efficiency, and equitableness for a high quality healthcare system are adopted. The current activities by various organizations that proclaim improvement in quality or measurement of quality as their goal are reviewed. This is followed by examining what is offered by these organizations in terms of how many of IOM aims they address. This dissertation ends by offering a quality measurement framework that satisfies all IOM aims. Operational aspects of the measurement framework are discussed. Future areas of research are also discussed

Etiology and Outcomes of Hepatocellular Carcinoma in an Ethnically Diverse Population: The Multiethnic Cohort

Backgrounds: HCC incidence varies by race/ethnicity. We characterized racial differences in underlying etiology, presentation, and survival in the linkage of Multiethnic Cohort Study with SEER and Medicare claims. Methods: HCC characteristics, treatment, and underlying etiology in participants were obtained. Deaths were ascertained using state death certificates and the National Death Index. Risk factors were collected via questionnaires. Cox models were used to calculate hazard ratios (HR) and 95% confidence intervals (CI) for death. Results: Among 359 cases, the average age at diagnosis was 75.1. The most common etiology was hepatitis C (HCV) (33%), followed by nonalcoholic fatty liver disease (NAFLD) (31%), and different by ethnicity (p < 0.0001). African Americans (AA) (59.5%) and Latinos (40.6%) were more likely to be diagnosed with HCV-related HCC. In Japanese Americans (33.1%), Native Hawaiians (39.1%), and whites (34.8%), NAFLD was the most common etiology. Receipt of treatment varied across ethnic groups (p = 0.0005); AA had the highest proportion of no treatment (50.0%), followed by Latinos (45.3%), vs. whites (15.2%). HCC (72.2%) was the most common cause of death. In a multivariate analysis, AA (HR = 1.87; 95% CI: 1.06–3.28) had significantly higher mortality compared to whites. Conclusions: We found significant ethnic differences in HCC underlying etiology, receipt of treatment, and outcome. The findings are important for reducing disparities

Impact of drug substitution on cost of care: an example of economic analysis of cetuximab versus panitumumab

Abstract Background The alarming increase in the cost of cancer care is forcing all stakeholders to re-evaluate their approach to treatment. Drugs are the main contributor to the cost. To evaluate the significance of drug substitution on the cost of care we assessed the economic value of panitumumab vs. cetuximab in chemo-refractory metastatic CRC (mCRC) with wild-type KRAS from a US societal perspective. Methods We developed a Markov model with three health states: progression-free, progressive, and death. We calculated the transition probabilities between states using the ASPECCT trial report and US life tables. Costs of drug and administration were based on the Medicare reimbursement rates. Published data were used for cost of toxicities and utilities. All costs were converted to 2017 US dollars. The model used quality-adjusted life-years (QALYs) to measure health outcomes for each treatment option. Results Panitumumab and cetuximab produced 0.45 QALYs at a per patient cost of $66,006 and$71,956, respectively. The incremental net monetary benefit of panitumumab compared to cetuximab is $5237 under a societal willingness-to-pay threshold of$150,000. The model showed robustness to one-way sensitivity analyses and various alternative scenarios and was found to be most sensitive to the cost of cetuximab. Conclusions Panitumumab can lower the cost of care without impacting outcomes in chemo-refractory mCRC settings. This finding provides a strong argument to consider panitumumab in lieu of cetuximab in these patients