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Purpose: To assess the equivalence of patient-reported outcome (PRO) survey responses across Web, interactive voice response system (IVRS), and paper modes of administration., Methods: Postoperative colorectal cancer patients with home Web/e-mail and phone were randomly assigned to one of the eight study groups: Groups 1-6 completed the survey via Web, IVRS, and paper, in one of the six possible orders; Groups 7-8 completed the survey twice, either by Web or by IVRS. The 20-item survey, including the MSKCC Bowel Function Instrument (BFI), the LASA Quality of Life (QOL) scale, and the Subjective Significance Questionnaire (SSQ) adapted to bowel function, was completed from home on consecutive days. Mode equivalence was assessed by comparison of mean scores across modes and intraclass correlation coefficients (ICCs) and was compared to the test-retest reliability of Web and IVRS., Results: Of 170 patients, 157 completed at least one survey and were included in analysis. Patients had mean age 56 (SD = 11), 53% were male, 81% white, 53% colon, and 47% rectal cancer; 78% completed all assigned surveys. Mean scores for BFI total score, BFI subscale scores, LASA QOL, and adapted SSQ varied by mode by less than one-third of a score point. ICCs across mode were: BFI total score (Web-paper = 0.96, Web-IVRS = 0.97, paper-IVRS = 0.97); BFI subscales (range = 0.88-0.98); LASA QOL (Web-paper = 0.98, Web-IVRS = 0.78, paper-IVRS = 0.80); and SSQ (Web-paper = 0.92, Web-IVRS = 0.86, paper-IVRS = 0.79)., Conclusions: Mode equivalence was demonstrated for the BFI total score, BFI subscales, LASA QOL, and adapted SSQ, supporting the use of multiple modes of PRO data capture in clinical trials.

Aims: We evaluated pedometry as a novel patient-centered outcome because it enables passive continuous assessment of activity and may provide information about the consequences of symptomatic toxicity complementary to self-report., Methods: Adult patients undergoing hematopoietic cell transplant (HCT) wore pedometers and completed PRO assessments during transplant hospitalization (4 weeks) and 4 weeks post-discharge. Patient reports of symptomatic treatment toxicities (single items from PRO-CTCAE, http://healthcaredelivery.cancer.gov/pro-ctcae ) and symptoms, physical health, mental health, and quality of life (PROMIS(®) Global-10, http://nih.promis.org ), assessed weekly with 7-day recall on Likert scales, were compared individually with pedometry data, summarized as average daily steps per week, using linear mixed models., Results: Thirty-two patients [mean age 55 (SD = 14), 63 % male, 84 % white, 56 % autologous, 43 % allogeneic] completed a mean 4.6 (SD = 1.5, range 1-8) evaluable assessments. Regression model coefficients (β) indicated within-person decrements in average daily steps were associated with increases in pain (β = -852; 852 fewer steps per unit increase in pain score, p < 0.001), fatigue (β = -886, p < 0.001), vomiting (β = -518, p < 0.01), shaking/chills (β = -587, p < 0.01), diarrhea (β = -719, p < 0.001), shortness of breath (β = -1018, p < 0.05), reduction in carrying out social activities (β = 705, p < 0.01) or physical activities (β = 618, p < 0.01), and global physical health (β = 101, p < 0.001), but not global mental health or quality of life., Conclusions: In this small sample of HCT recipients, more severe symptoms, impaired physical health, and restrictions in the performance of usual daily activities were associated with statistically significant decrements in objectively measured daily steps. Pedometry may be a valuable outcome measure and validation anchor in clinical research.

Background: Pelvic radiotherapy with concurrent 5-fluorouracil-based chemotherapy is a component of standard therapy for patients with T3/T4 or node-positive rectal cancer and may be associated with acute gastrointestinal toxicity. In this retrospective study, we sought to compare patient-reported outcomes (PROs) with clinician reports of acute symptoms experienced by rectal cancer patients receiving chemoradiation., Patients and Methods: Charts of 199 patients with rectal cancer who received chemoradiation at some point from November 2006 through February 2011 were reviewed. Clinicians assessed toxicity weekly using Common Terminology for Clinical Adverse Events version 3.0, and, beginning in September 2009, the patients reported symptoms weekly, using the 7-item Bowel Problems Scale. One hundred ninety-seven patients with at least 1 clinician or patient assessment were eligible for the study. We used descriptive statistics to compare patient and clinician assessments in a subgroup of 65 patients (paired group) who had at least 1 patient and clinician assessment on the same day. Cohen's κ coefficient was used to evaluate agreement between the patients and the clinicians., Results: The patients reported diarrhea and proctitis more often than clinicians reported them throughout treatment. Uncorrected agreement for diarrhea and proctitis was 82% and 72%, respectively. Cohen's κ was .64 for diarrhea, indicating moderate agreement, and .22 for proctitis, indicating only slight agreement., Conclusions: Our findings suggest a discrepancy between clinician and PRO reports. Further study may discern potential benefits of collecting PROs in prospective studies and in clinical practice.

Objective: To develop a definition of high-risk asthma that more precisely identifies patients needing case management than the 2006 Healthcare Effectiveness Data and Information Set (HEDIS) definition., Study Design: Two-year claims-based study, with cross-sectional phone survey data, for a sample of 769 youths (age 11-17 years) with asthma., Methods: The 2006 HEDIS measure defines high-risk asthma as meeting any of the following criteria: >1 emergency department (ED) visits, > or =1 hospitalizations for asthma, > or =4 asthma medication prescriptions, or > or =4 ambulatory visits for asthma with > or =2 prescriptions for asthma medication in 1 year. We created a revised definition (> or =1 ED visits or > or =1 hospitalizations for asthma or > or =1 oral steroid prescriptions for asthma) and identified patients with high-risk asthma in year 1 according to each definition. We compared the 2 groups on demographic and clinical characteristics, and healthcare utilization and costs in years 1 and 2., Results: The revised definition identified 29% of the sample as having high-risk asthma, whereas the 2006 definition identified 67%. Compared with the 2006 definition, the revised definition identified patients with significantly greater asthma-related physical health problems and higher medical costs in year 1. In year 2, youths classified as high risk by the revised definition made more ED visits and were more likely to use oral steroids than those classified as high risk by the 2006 definition., Conclusion: The revised high-risk asthma definition identifies half as many individuals and is better able to identify patients with poorly controlled asthma in the subsequent year.