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Biomedical subjects

Gary Cutter

Publications and source records attributed to Gary Cutter.

21 records · Page 2Linked to original sources

Sample size estimates for determining treatment effects in high-risk patients with early relapsing-remitting multiple sclerosis.

BACKGROUND: Risk factors for short-term progression in early relapsing remitting MS have been identified recently. Previously we determined potential risk factors for rapid progression of early relapsing remitting MS and identified three groups of high-risk patients. These non-mutually exclusive groups of patients were drawn from a consecutively studied sample of 98 patients with newly diagnosed MS. High-risk patients had a history of either poor recovery from initial attacks, more than two attacks in the first two years of disease, or a combination of at least four other risk factors. OBJECTIVE: To determine differences in sample sizes required to show a meaningful treatment effect when using a high-risk sample versus a random sample of patients. METHODS: Power analyses were used to calculate the different sample sizes needed for hypothetical treatment trials. RESULTS: We found that substantially smaller numbers of patients should be needed to show a significant treatment effect by employing these high-risk groups of patients as compared to a random population of MS patients (e.g., 58% reduction in sample size in one model). CONCLUSION: The use of patients at higher risk of progression to perform drug treatment trials can be considered as a means to reduce the number of patients needed to show a significant treatment effect for patients with very early MS.

Aged↗

Detection of ductal carcinoma in situ in women undergoing screening mammography.

BACKGROUND: With the large number of women having mammography-an estimated 28.4 million U.S. women aged 40 years and older in 1998-the percentage of cancers detected as ductal carcinoma in situ (DCIS), which has an uncertain prognosis, has increased. We pooled data from seven regional mammography registries to determine the percentage of mammographically detected cancers that are DCIS and the rate of DCIS per 1000 mammograms. METHODS: We analyzed data on 653 833 mammograms from 540 738 women between 40 and 84 years of age who underwent screening mammography at facilities participating in the National Cancer Institute's Breast Cancer Surveillance Consortium (BCSC) throughout 1996 and 1997. Mammography results were linked to population-based cancer and pathology registries. We calculated the percentage of screen-detected breast cancers that were DCIS, the rate of screen-detected DCIS per 1000 mammograms by age and by previous mammography status, and the sensitivity of screening mammography. Statistical tests were two-sided. RESULTS: A total of 3266 cases of breast cancer were identified, 591 DCIS and 2675 invasive breast cancer. The percentage of screen-detected breast cancers that were DCIS decreased with age (from 28.2% [95% confidence interval (CI) = 23.9% to 32.5%] for women aged 40-49 years to 16.0% [95% CI = 13.3% to 18.7%] for women aged 70-84 years). However, the rate of screen-detected DCIS cases per 1000 mammograms increased with age (from 0.56 [95% CI = 0.41 to 0.70] for women aged 40-49 years to 1.07 [95% CI = 0.87 to 1.27] for women aged 70-84 years). Sensitivity of screening mammography in all age groups combined was higher for detecting DCIS (86.0% [95% CI = 83.2% to 88.8%]) than it was for detecting invasive breast cancer (75.1% [95% CI = 73.5% to 76.8%]). CONCLUSIONS: Overall, approximately 1 in every 1300 screening mammography examinations leads to a diagnosis of DCIS. Given uncertainty about the natural history of DCIS, the clinical significance of screen-detected DCIS needs further investigation.

Adult↗

Mammography screening and differences in stage of disease by race/ethnicity.

OBJECTIVES: We examined the effect of routine screening on breast cancer staging by race/ethnicity. METHODS: We used a 1990 to 1998 mammography database (N = 5182) of metropolitan Denver, Colo, women to examine each racial/ethnic cohort's incident cancer cases (n = 1902) and tumor stage distribution given similar patterns of routine screening use. RESULTS: Regardless of race/ethnicity, women participating in routine screenings had earlier-stage disease by 5 to 13 percentage points. After control for possible confounding factors, White women were more likely to have early-stage disease compared with Black and Hispanic women. CONCLUSIONS: Lack of screening coverage in certain racial/ethnic populations has often been cited as a reason for tumor stage differences at detection. In this study, correcting for screening did not completely reduce stage differentials among Black and Hispanic women.

Adult↗