Zhaohui Su

Impact of symptom burden on work-related abilities in patients with locally recurrent or metastatic breast cancer: Results from a substudy of the VIRGO observational cohort study.

Limited data exist on the association of symptom burden, daily activity impairment, and work productivity (WP) in patients with advanced breast cancer. This cross-sectional analysis evaluated baseline patient-reported outcomes (PROs) in patients with locally recurrent or metastatic breast cancer (MBC) receiving first-line hormonal therapy or chemotherapy and/or targeted therapy in the VIRGO observational study. The primary PRO study endpoint, symptom severity and interference score, was measured using the MD Anderson Symptom Inventory (MDASI). Secondary endpoints included Activity Level Scale (ALS), health-related quality of life (HRQOL), and Work Productivity and Activity Impairment Questionnaire (WPAI:SHP) scores. Overall, 152 patients (chemotherapy cohort, 104; hormonal therapy cohort, 48) answered questionnaires. Fatigue, decreased sexual interest, disturbed sleep, emotional distress, and drowsiness were the most common severe symptoms, and were of moderate-to-severe intensity in 38.8%-52.0% of patients. Mean percent daily activity impairment was 30% for study patients, and WP impairment ranged from 20% to 40% across indices in employed patients (n, 58). Significant positive correlations existed for MDASI severity and interference scores with activity impairment and WP indices (Pearson correlation coefficients [R] = 0.47-0.82; p < 0.0001). ALS and overall HRQOL correlated negatively with these indices (R = -0.41 to -0.60; p ≤ 0.001). After adjustment for potential confounders, MDASI symptom interference and ALS were significant predictors of activity and WP impairment. Our results indicate patients receiving treatment for MBC are symptomatic with significant daily activity and/or WP impairment. Symptom severity and interference, functional status, and overall HRQOL were moderately correlated with perceived work-related ability.

Characterization of Missing Data in Clinical Registry Studies

Patterns of missing data are seldom well-characterized in observational research. This study examined the magnitude of, and factors associated with, missing data across multiple observational studies. Missingness was evaluated for demographic, clinical, and patient-reported outcome (PRO) data from a procedure registry (TOPS), a rare disease (cystic fibrosis) registry (Port-CF), and a comparative effectiveness registry (glaucoma, RiGOR). Generalized linear mixed effects models were fit to assess whether patient characteristics or follow-up methods predicted missingness. Data from 156,707 surgical procedures, 32,118 cystic fibrosis patients, and 2373 glaucoma patients were analyzed. Data were rarely missing for demographics, treatments, and outcomes. Missingness for clinical variables varied by registry and measure and depended on whether a variable was required. Within RiGOR, PRO forms were missing more often when collected by e-mail compared with office-based paper data collection. In Port-CF, missingness varied based on insurance status and sex. Strategic consideration of operational approaches affecting missing data should be performed prior to data collection and assessed periodically during study conduct.

Practice patterns and treatment changes for open-angle glaucoma: the RiGOR study

AIMS The RiGOR study provides a current picture of the types of glaucoma treatment over 12 months. METHODS Patients were identified and enrolled at the time of decision to proceed with laser surgery procedure or other procedure such as incisional surgery or drainage device implantation, or initiation of a new or additional course of therapy with medication for glaucoma treatment. RESULTS The most frequent type of treatments were prostaglandin analogues (60%) among patients with additional medication, selective laser trabeculoplasty (87%) among patients with laser surgery and trabeculectomy (57%) among patients with incisional surgery. CONCLUSION For 36% of patients, a treatment cascade involves two or more therapies over a year. This demonstrates the complex nature of open-angle glaucoma treatment.

Patient-reported outcomes (PRO) in patients with metastatic breast cancer (MBC) from the VIRGO observational cohort study (OCS).

111 Background: Limited data exist on patient (pt) experience and work productivity (WP) in MBC. VIRGO is a prospective OCS following >1,200 pts with locally advanced or MBC receiving 1st-line hormonal therapy (HT) or chemotherapy (CT) in a real-world setting. We report baseline characteristics of 277 pts from the VIRGO PRO substudy and correlations between health-related quality of life (HRQoL), symptoms, activities of daily living, and WP. METHODS Symptom severity and interference (M.D. Anderson Symptom Inventory [MDASI]), functional status (Activity Level Scale [ALS] from the Rotterdam Symptom Checklist) and WP (Work Productivity and Activity Impairment Questionnaire) were assessed. Pts rated their HRQoL during the past week on a scale of 0-10. RESULTS See table. The five most severe symptoms at baseline were fatigue, decreased sexual interest, disturbed sleep, drowsiness, and emotional distress; these were reported with less severity in the HT cohort (24%-37% vs 42%-59%). Overall MDASI severity and interference correlated with WP measures in the CT (R=0.46 to 0.78) and HT cohorts (0.36 to 0.94). Mean of the 5 most severe symptoms also significantly correlated with WP indices (R=0.47 to 0.66). HRQoL correlated (p<0.05) with all WP measures (R=-0.46 to -0.56) in the CT cohort and with % impairment while working (R=-0.65) and % overall work impairment (R=-0.71) in the HT cohort. In univariate regression analysis, MDASI symptom interference score was the best predictor of reduced WP (R2=0.52 while working; R2=0.48 for non-work activities). CONCLUSIONS MBC pts receiving CT and HT report significant work impairment. Results indicate moderate correlations between WP indices, HRQoL and symptom burden. [Table: see text].

RiGOR: a prospective observational study comparing the effectiveness of treatment strategies for open-angle glaucoma

AIMS The RigOR study was designed to assess comparative effectiveness of medications, laser trabeculoplasty and incisional surgery in patients with open-angle glaucoma (OAG) in the community initiating a new or additional course of therapy as judged necessary by their ophthalmologist. This paper focuses specifically on demographic and clinical characteristics of OAG patients at enrollment. PATIENTS & METHODS A total of 2597 with OAG already on medical therapy were enrolled from 45 community and academic practices throughout the USA. RESULTS Overall, 784 (30%) patients were treated with laser surgery, 436 with other surgical procedures (17%), and 1377 with additional medication (53%). Patients had mild (35%) or moderate (31%) glaucoma, with 28% with severe glaucoma. CONCLUSION The RiGOR study enrolled a diverse population and will provide valuable information regarding visual function and treatment patterns among different racial/ethnic populations. African-American and Hispanic patients entered the study with poorer visual acuity and more severe glaucoma.

Impact of treatment strategies for open angle glaucoma on intraocular pressure: the RiGOR study

AIMS The RiGOR studys primary outcome measure was a 15% reduction in intraocular pressure (IOP) for patients with open-angle glaucoma at 1 year. METHODS Patients received treatment according to the ophthalmologists usual practice. RESULTS A higher proportion of patients in the incisional and other surgery group achieved a 15% reduction in IOP than in the laser surgery or additional medication groups (82, 57, and 57% respectively). In multivariate regression analyses, incisional surgery patients were 2.7-times as likely as patients treated with additional medication to achieve a 15% reduction in IOP (odds ratio: 2.67; 95% CI: 2.01-3.57). CONCLUSION Incisional and other surgical procedures are effective treatments. There were no differences in treatment response by race or ethnicity.

Comparison of Resource Utilization and Clinical Outcomes Following Screening with Digital Breast Tomosynthesis Versus Digital Mammography: Findings From a Learning Health System

RATIONALE AND OBJECTIVES To compare outcomes associated with breast cancer screening with digital mammography (DM) alone versus in combination with digital breast tomosynthesis (DBT) in a large representative cohort. MATERIALS AND METHODS A total of 325,729 screening mammograms from 247,431 women were analyzed, across two healthcare systems, from June 2015 to September 2017. Patient level demographic, calculated risk levels, and clinical outcomes were extracted from radiology information system and electronic medical records. Multivariable regression modeling adjusting for institution, age, breast density, and first exam was conducted to compare patient characteristics, recall rates, time to biopsy and final diagnosis, clinical outcomes, and diagnostic performance. Participating institutions and the Coordinating Center received Institutional Review Board approval for a waiver of consent to collect and link data and perform analysis. RESULTS A total of 194,437 (59.7%) screens were DBT versus 131,292 (40.3%) with DM. Women with dense breasts and higher calculated risk were more likely to be screened with DBT. Recall rates were lower for DBT overall (8.83% DBT vs 10.98% DM, adjusted odds ratio, 95% confidence interval = 0.85, 0.83-0.87) and across all age groups, races, and breast densities, and at facilities that used predominantly DBT (8.05%) versus predominantly DM (11.22%), or a combination (10.73%). The most common diagnostic pathway after recall was mammography and ultrasound. Women recalled from DBT were more likely to proceed directly to ultrasound. The median time to biopsy (18 vs 22 days) and final diagnosis (10 vs 13 days) was shorter for DBT. The adjusted cancer rate, cancer detection rate, and specificity were higher for DBT. CONCLUSION DBT demonstrated a more efficient screening pathway and improved quality measures with lower recall rates in all patient types, reduced diagnostic mammography and shorter time to biopsy and final diagnosis.

Quality of life and visual acuity outcomes in the Registry in Glaucoma Outcomes Research study

AIMS The RiGOR study evaluated the association of treatment and patient-reported outcomes for open-angle glaucoma patients. METHODS The Glaucoma Symptom Scale (National Eye Institute-Visual Function Questionnaire (NEI-VFQ) and visual acuity (VA) were collected as quality of life measures. RESULTS The proportion of patients with improvement of at least two lines of vision was highest in the incisional surgery group (14.2% compared with 9.9% for laser surgery and 10.9% for additional medication). CONCLUSION No clinically relevant differences were seen in benefit for the laser surgery or incisional surgery groups compared with additional medications for the Glaucoma Symptom Scale or NEI-VFQ measures or subscales. Differences in quality of life by race need to be explored in further studies.