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BACKGROUND The informed consent of participants is ethically and legally required for most research involving human subjects. However, standardized methods for assessing the adequacy of informed consent to research are lacking. METHODS AND RESULTS We designed a brief questionnaire, the Quality of Informed Consent (QuIC), to measure subjects' actual(More)
BACKGROUND Investigators have to obtain informed consent before enrolling participants in clinical trials. We wanted to measure the quality of understanding among participants in clinical trials of cancer therapies, to identify correlates of increased understanding, and to assess providers' beliefs about clinical research. We also sought evidence of(More)
BACKGROUND Many oncologists believe that patients with cancer who enroll in clinical trials have better outcomes than those who do not enroll. We aimed to assess the empirical evidence that such a trial effect exists. METHODS We developed a conceptual framework for comparison of trial and non-trial patients. We then did a comprehensive literature search(More)
BACKGROUND High-quality care must be not only appropriate but also timely. We assessed time to initiation of adjuvant chemotherapy for breast cancer as well as factors associated with delay to help identify targets for future efforts to reduce unnecessary delays. METHODS Using data from the National Comprehensive Cancer Network (NCCN) Outcomes Database,(More)
BACKGROUND Chemotherapy for metastatic lung or colorectal cancer can prolong life by weeks or months and may provide palliation, but it is not curative. METHODS We studied 1193 patients participating in the Cancer Care Outcomes Research and Surveillance (CanCORS) study (a national, prospective, observational cohort study) who were alive 4 months after(More)
CONTEXT Laparoscopic-assisted colectomy (LAC) has emerged as the preferred minimally invasive surgical strategy for diseases of the colon. The safety and efficacy of LAC for colon cancer are unknown, and the nature and magnitude of any quality-of-life (QOL) benefit resulting from LAC for colon cancer is also unknown. OBJECTIVE To compare short-term QOL(More)
In gene expression experiments, hormone receptor (HR)-positive/human epidermal growth factor-2 (HER2)-positive tumors generally cluster within the luminal B subset; whereas HR-negative/HER2-positive tumors reside in the HER2-enriched subset. We investigated whether the clinical behavior of HER2-positive tumors differs by HR status. We evaluated 3,394(More)
OBJECTIVE To evaluate measures that could use existing administrative data to assess the intensity of end-of-life cancer care. METHODS Benchmarking standards and statistical variation were evaluated using Medicare claims of 48,906 patients who died from cancer from 1991 through 1996 in 11 regions of the United States. We assessed accuracy by comparing(More)