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Additional file 3. UAB IRB Stamped Consent Form for the Patient Interview – This file contains the IRB approved consent form that patients will review and sign if they agree to participate in the patient interview.

Additional file 1. Provider Semi-structured Interview Guide – This file contains the interview guide that will used for each of the Provider interviews that will be conducted.

Additional file 2. ePRO Patient Interview Guide – This file contains the interview guide that will be used for each of the patient interviews that will be conducted.

Supplemental material, sj-pdf-1-ctj-10.1177_1740774520975120 for Composite grading algorithm for the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) by Ethan Basch, Claus Becker, Lauren J Rogak, Deborah Schrag, Bryce B Reeve, Patricia Spears, Mary Lou Smith, Mrinal M Gounder, Michelle R Mahoney, Gary K Schwartz, Antonia V Bennett, Tito R Mendoza, Charles S Cleeland, Jeff A Sloan, Deborah Watkins Bruner, Gisela Schwab, Thomas M Atkinson, Gita Thanarajasingam, Monica M Bertagnolli and Amylou C Dueck in Clinical Trials

Aims���The U.S. National Cancer Institute recently developed the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). PRO-CTCAE is a library of questions for clinical trial participants to self-report symptomatic adverse events (e.g., nausea). The objective of this study is to inform evidence-based selection of a recall period when PRO-CTCAE is included in a trial. We evaluated differences between 1-week, 2-week, 3-week, and 4-week recall periods, using daily reporting as the reference. Methods���English-speaking patients with cancer receiving chemotherapy and/or radiotherapy were enrolled at four U.S. cancer centers and affiliated community clinics. Participants completed 27 PRO-CTCAE items electronically daily for 28 days, and then weekly over 4 weeks, using 1-week, 2-week, 3-week, and 4-week recall periods. For each recall period, mean differences, effect sizes, and intraclass correlation coefficients were calculated to evaluate agreement between the maximum of daily ratings and the corresponding ratings obtained using longer recall periods (e.g., maximum of daily scores over 7 days vs. 1-week recall). Analyses were repeated using the average of daily scores within each recall period rather than the maximum of daily scores. Results���127 subjects completed questionnaires (57% male; median age 57). The median of the 27 mean differences in scores on the PRO-CTCAE 5-point response scale comparing the maximum daily versus the longer recall period (and corresponding effect size), was ���0.20 (���0.20) for 1-week recall; ���0.36 (���0.31) for 2-week recall; ���0.45 (���0.39) for 3-week recall; and ���0.47 (���0.40) for 4-week recall. The median intraclass correlation across 27 items between the maximum of daily ratings and the corresponding longer recall ratings for 1-week recall was 0.70 (range: 0.54���0.82); 2-week recall: 0.74 (range: 0.58���0.83); 3-week recall: 0.72 (range: 0.61���0.84); and 4-week recall: 0.72 (range: 0.64���0.86). Similar results were observed for all analyses using the average of daily scores rather than the maximum of daily scores. Conclusions���1-week recall corresponds best to daily reporting. Although intraclass correlations remain stable over time, there are small but progressively larger differences between daily and longer recall periods at 2, 3, and 4 weeks, respectively. The preferred recall period for the PRO-CTCAE is the past 7 days, although investigators may opt for recall periods of 2, 3, or 4 weeks with an understanding that there may be some information loss.

Contains fulltext : 118780.pdf (Publisher’s version ) (Closed access) BACKGROUND: Abiraterone acetate, an androgen biosynthesis inhibitor, improves overall survival in patients with metastatic castration-resistant prostate cancer after chemotherapy. We evaluated this agent in patients who had not received previous chemotherapy. METHODS: In this double-blind study, we randomly assigned 1088 patients to receive abiraterone acetate (1000 mg) plus prednisone (5 mg twice daily) or placebo plus prednisone. The coprimary end points were radiographic progression-free survival and overall survival. RESULTS: The study was unblinded after a planned interim analysis that was performed after 43% of the expected deaths had occurred. The median radiographic progression-free survival was 16.5 months with abiraterone-prednisone and 8.3 months with prednisone alone (hazard ratio for abiraterone-prednisone vs. prednisone alone, 0.53; 95% confidence interval [CI], 0.45 to 0.62; P

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 PROCTCAE, 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 (��) indicated within-person decrements in average daily steps were associated with increases in pain (�� = -852; 852 fewer steps per unit increase in pain score, p