Cross-cultural adaptation of the awareness and beliefs about cancer measure for Hispanics/Latinos living in the United States.

Introduction: The purpose of this study is to culturally adapt the Awareness and Beliefs about Cancer (ABC) measure for use in the Hispanic/Latino population living in the United States (US). Methods: In accordance with Patient Reported Outcomes (PRO) Consortium guidelines for cross-cultural adaptation of measures for content and linguistic validity, we conducted: two forward-translations, reconciliation, two back-translations, revision and harmonization, six cognitive interviews, revision, external expert review, and finalization of the version. We used a mixed methods approach, conducting cognitive interviews with Hispanic/Latino community members while also convening an expert panel of six clinicians, health professionals, and community representatives and including the in the entire process. After cross-culturally adapting the ABC measure, we assessed the psychometric properties of the instrument using item response theory analysis. Item parameters, discrimination and category thresholds, and standard errors were calculated. For each of the adapted subdomains, we used item information curves to report the graphical profile of item effectiveness. Results: Twenty-two Hispanic/Latino community members were enrolled in cognitive interviews, and Hispanics/Latinos fluent in Spanish completed the measure to assess its psychometric properties. Cognitive interviews revealed opportunities to improve items. Key changes from the original measure include the inclusion of gender inclusive language and an inquiry into e-cigarette use on items related to smoking habits. Psychometric property analyses revealed that the anticipated delay in seeking medical help, general cancer beliefs, and cancer screening beliefs and behaviors subdomains had some slope parameters that were < 1; this implies that those items were not able to adequately discriminate the latent trait and had poor performance. Discussion: The adapted ABC measure for US Hispanics/Latinos meets content and linguistic validity standards, with construct validity confirmed for cancer symptom recognition and barriers to symptomatic presentation subdomains, but revisions are necessary for others, highlighting the need for ongoing refinement to ensure the cultural appropriateness of instruments.

Methodological Comparison of Mapping the Expanded Prostate Cancer Index Composite to EuroQoL-5D-3L Using Cross-Sectional and Longitudinal Data: Secondary Analysis of NRG/RTOG 0415.

PURPOSE: To compare the predictive ability of mapping algorithms derived using cross-sectional and longitudinal data. METHODS: This methodological assessment used data from a randomized controlled noninferiority trial of patients with low-risk prostate cancer, conducted by NRG Oncology (ClinicalTrials.gov identifier: NCT00331773), which examined the efficacy of conventional schedule versus hypofractionated radiation therapy (three-dimensional conformal external beam radiation therapy/IMRT). Health-related quality-of-life data were collected using the Expanded Prostate Cancer Index Composite (EPIC), and health utilities were obtained using EuroQOL-5D-3L (EQ-5D) at baseline and 6, 12, 24, and 60 months postintervention. Mapping algorithms were estimated using ordinary least squares regression models through five-fold cross-validation in baseline cross-sectional data and combined longitudinal data from all assessment periods; random effects specifications were also estimated in longitudinal data. Predictive performance was compared using root mean square error. Longitudinal predictive ability of models obtained using baseline data was examined using mean absolute differences in the reported and predicted utilities. RESULTS: A total of 267 (and 199) patients in the estimation sample had complete EQ-5D and EPIC domain (and subdomain) data at baseline and at all subsequent assessments. Ordinary least squares models using combined data showed better predictive ability (lowest root mean square error) in the validation phase for algorithms with EPIC domain/subdomain data alone, whereas models using baseline data outperformed other specifications in the validation phase when patient covariates were also modeled. The mean absolute differences were lower for models using EPIC subdomain data compared with EPIC domain data and generally decreased as the time of assessment increased. CONCLUSION: Overall, mapping algorithms obtained using baseline cross-sectional data showed the best predictive performance. Furthermore, these models demonstrated satisfactory longitudinal predictive ability.

Economic burden of comorbidities among COPD Patients hospitalized for acute exacerbations: an analysis of a commercially insured population.

INTRODUCTION: This study quantifies costs associated with comorbid conditions among adults diagnosed with chronic obstructive pulmonary disease (COPD) who experience acute exacerbations (AECOPD) needing inpatient hospitalization. METHODS: This retrospective cohort study used 2006-2015 IQVIA PharMetrics® Plus data, a health plan claims database. Patients aged 40-64 years, with AECOPD, defined as an inpatient hospitalization for a COPD-related diagnosis were included. The impact of comorbidities on AECOPD costs (costs of the COPD-related inpatient stay plus healthcare services used 30 days post-discharge) was determined using multivariable regression. The models adjusted for clinical complications, previous utilization, age, sex, region, year, length of hospitalization, and season of admission. RESULTS: Among these COPD patients, 89.5% had at least 1 comorbidity. The mean cost for AECOPD was 2015 US $19,687 (SD: 27,035, median: 11,539). Congestive heart failure, lipid disorders, cancer, and presence of any of the 10 most frequent comorbidities were associated with $1,921 (95% confidence interval (CI): 977-2,866), $1,619 (95% CI: 967-2,272), $8,347 (95% CI: 7,236-9,458), and $4,433 (95% CI: 3,598-5,268) higher costs, respectively than corresponding individuals without these comorbid conditions. Patients with depressive disorders were associated with $1,592 (95% CI: 828-2,355) lower costs compared to those without depressive disorders. CONCLUSION: COPD comorbidity imposes a significant economic burden on AECOPD.

Patient-reported outcomes in breast cancer FDA drug labels and review documents.

BACKGROUND: Patient-reported outcomes (PROs) can provide valuable information about drug benefit-risk tradeoffs from the patient perspective and are particularly important to patients with breast cancer due to its symptoms and adverse events from breast cancer treatments. The United States Food and Drug Administration (U.S. FDA) has acknowledged PROs as important approval endpoints used in clinical trials of cancer drugs. However, previous studies found that PROs are rarely mentioned in cancer drug labels, a widely used and trusted source of information about drugs. Our objectives were to compare PRO data reported in FDA labeling versus FDA medical review documents for breast cancer drugs approved in the U.S. between 2000 and 2019 to identify possible causes for PRO-data labeling exclusions. METHODS: We included new molecular entities (NMEs) and biologic license applications (BLAs) initially approved for breast cancer treatment by the FDA between 1/1/2000 and 12/31/2019. Product labeling and FDA medical review documents were collected from the FDA-Approved Drugs database (Drugs@FDA). From these resources, details on PRO measures used in trials, design of trials using PRO measures, PRO-endpoint status, analytical methods, and FDA reviewer comments regarding PRO measurement were extracted. RESULTS: Of 633 FDA-approved drugs, 13 were indicated for breast cancer treatment; none of their prescribing information contained information about PROs. However, 11 of 13 (85%) included PRO measures and endpoint information in FDA medical review documents. PRO measures were used in 14 different clinical trials, and FDA reviewers' comments regarding PRO measurement were related to lack of meaningfulness and clinical significance, lack of content validity, and inadequate analytical methods. CONCLUSIONS: Despite the importance of PROs to patients with breast cancer, PRO measures were only described in FDA medical review documents of breast cancer drugs, but not in drug product labeling. Therefore, it appears that PRO data are often collected in breast cancer trials, but have not been methodologically acceptable to FDA reviewers. Collaborative efforts between the FDA and industry are warranted to increase the number of breast cancer drug applications with appropriate use of PRO measures and endpoints.

Mapping expanded prostate cancer index composite to EQ5D utilities to inform economic evaluations in prostate cancer: Secondary analysis of NRG/RTOG 0415.

PURPOSE: The Expanded Prostate Cancer Index Composite (EPIC) is the most commonly used patient reported outcome (PRO) tool in prostate cancer (PC) clinical trials, but health utilities associated with the different health states assessed with this tool are unknown, limiting our ability to perform cost-utility analyses. This study aimed to map EPIC tool to EuroQoL-5D-3L (EQ5D) to generate EQ5D health utilities. METHODS AND MATERIALS: This is a secondary analysis of a prospective, randomized non-inferiority clinical trial, conducted between 04/2006 and 12/2009 at cancer centers across the United States, Canada, and Switzerland. Eligible patients included men >18 years with a known diagnosis of low-risk PC. Patient HRQoL data were collected using EPIC and health utilities were obtained using EQ5D. Data were divided into an estimation sample (n = 765, 70%) and a validation sample (n = 327, 30%). The mapping algorithms that capture the relationship between the instruments were estimated using ordinary least squares (OLS), Tobit, and two-part models. Five-fold cross-validation (in-sample) was used to compare the predictive performance of the estimated models. Final models were selected based on root mean square error (RMSE). RESULTS: A total of 565 patients in the estimation sample had complete information on both EPIC and EQ5D questionnaires at baseline. Mean observed EQ5D utility was 0.90±0.13 (range: 0.28-1) with 55% of patients in full health. OLS models outperformed their counterpart Tobit and two-part models for all pre-determined model specifications. The best model fit was: "EQ5D utility = 0.248541 + 0.000748*(Urinary Function) + 0.001134*(Urinary Bother) + 0.000968*(Hormonal Function) + 0.004404*(Hormonal Bother)- 0.376487*(Zubrod) + 0.003562*(Urinary Function*Zubrod)"; RMSE was 0.10462. CONCLUSIONS: This is the first study to identify a comprehensive set of mapping algorithms to generate EQ5D utilities from EPIC domain/ sub-domain scores. The study results will help estimate quality-adjusted life-years in PC economic evaluations.

Chronic non-cancer pain and its association with healthcare use and costs among individuals with obstructive sleep apnea.

Aim: To evaluate the impact of chronic non-cancer pain (CNCP) on healthcare use and costs among individuals diagnosed with obstructive sleep apnea (OSA). Materials & methods: Using the IQVIA PharMetrics® Plus database, we identified individuals (18-64 years old) during 2007-2014, divided into two groups: OSA + CNCP versus OSA-only. Generalized linear models were used to analyze binary and count outcomes. Results: Relative to OSA-only controls, OSA + CNCP cases had increased odds for inpatient and emergency department visits and higher rates for physician office visits, non-physician outpatient visits, and prescription drug fills. Relative to controls, direct healthcare costs for cases were higher, primarily driven by inpatient and non-physician outpatient visit costs. Conclusion: Relative to OSA-only controls, OSA + CNCP cases displayed increased healthcare use and costs across all points of service.

Changes in Opioid Utilization Following Tumor Necrosis Factor Inhibitor Initiation in Patients with Rheumatoid Arthritis.

INTRODUCTION: Pain control is one of the most important aspects of rheumatoid arthritis (RA) management from the patient's perspective. Newer generations of RA treatment including tumor necrosis factor inhibitor (TNFi) have the potential to alleviate pain and thus reduce opioid utilization. However, patterns of opioid utilization before and after TNFi initiation have not been well characterized. This study aims to examine multiple measures of change in opioid utilization after the initiation of TNFi. METHODS: Patients aged ≥ 18 years with RA and 24 months continuous enrollment between January 2007 and December 2015 who newly initiated a TNFi in IQVIA™ Health Plan Claims Data were included in our study. Opioid utilization at baseline and during follow-up were identified and compared. RESULTS: Of 2330 patients with RA that were included in the study, 38.8% of patients used opioids in both baseline and follow-up periods. From pre-index to post-index, the proportion of patients receiving any opioid decreased from 54.0 to 51.0%. In addition, the proportion of those who received ≥ 50 mg median daily MED decreased from 12.6 to 10.6% during pre-post periods. CONCLUSIONS: This real-world study of commercially insured patients with RA suggests that opioid use among these patients is prevalent. There was a small decrease in overall opioid utilization after TNFi initiation.