Objective-To evaluate the effectiveness of methods that control for confounding by indication, we compared breast cancer recurrence rates among women receiving adjuvant chemotherapy versus those who did not.Study Design and Setting-In a medical record review-based study of breast cancer treatment in older women (n=1798) diagnosed 1990-1994, our crude analysis suggested adjuvant Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. Conclusion-Conventional methods do not control for unmeasured factors, which often remain important when addressing confounding by indication. PS and IV analysis methods can be useful under specific situations, but neither method adequately controlled confounding by indication in this study. NIH Public AccessAuthor Manuscript J Clin Epidemiol. Author manuscript; available in PMC 2011 January 1.

OBJECTIVE The purpose of this trial was to compare usual patient education plus the Internet-based, Personal Patient Profile-Prostate, versus usual education alone, on conflict associated with decision making, plus explore time-to-treatment and treatment choice. METHODS A randomized, multi-center clinical trial was conducted with measures at baseline, one and six months. Men with newly diagnosed localized prostate cancer who sought consultation at urology, radiation oncology or multi-disciplinary clinics in four geographically-distinct American cities were recruited. Intervention group participants used the Personal Patient Profile-Prostate, a decision support system comprised of customized text and video coaching regarding potential outcomes, influential factors, and communication with care providers. The primary outcome, patient-reported decisional conflict, was evaluated over time using Generalized Estimating Equations to fit generalized linear models. Additional outcomes, time-to-treatment, treatment choice and program acceptability/usefulness, were explored. RESULTS A total of 494 eligible men were randomized (266 intervention; 228 control). The intervention reduced adjusted decisional conflict over time as compared with the control group, for the uncertainty score (estimate −3.61; (confidence interval, −7.01,−0.22) and values clarity (estimate −3.57; confidence interval (−5.85,−1.30) Borderline effect was seen for the total decisional conflict score (estimate −1.75; confidence interval (−3.61,0.11). Time-to-treatment was comparable between groups, while undecided men in the intervention group chose brachytherapy more often than in the control group. Acceptability and usefulness were highly rated. CONCLUSION The Personal Patient Profile-Prostate is the first intervention to significantly reduce decisional conflict in a multi-center trial of American men with newly diagnosed localized prostate cancer. Our findings support efficacy of P3P for addressing decision uncertainty and facilitating patient selection of a prostate cancer treatment that is consistent with the patient values and preferences.

Background: Preliminary evidence suggests that metformin may decrease breast cancer risk by decreasing insulin levels and reducing cell proliferation. We evaluated the effect of metformin medication on the risk of incident breast cancer among peri-and postmenopausal women.Methods: We used Danish medical registries to conduct a nested case-control study among type 2 diabetic women 50 years or older who resided in northern Denmark from 1989 to 2008 (n ¼ 4,323). We identified 393 diabetic cases and used risk-set sampling to select 10 diabetic controls per case (n ¼ 3,930) matched on county of residence. Odds ratios (OR) and 95% CIs were estimated by conditional logistic regression associating metformin use with breast cancer occurrence.Results: Ninety-six cases (24%) and 1,154 controls (29%) used metformin for at least 1-year duration. Cases were slightly older on average than controls, but they were similar in distribution for parity, use of hormone replacement therapy, and history of diabetes complications. Metformin users were less likely with a diagnosis of breast cancer (OR ¼ 0.77; 95% CI ¼ 0.61-0.99) than nonmetformin users. Adjustment for diabetes complications, clinically diagnosed obesity, and important predictors of breast cancer did not substantially alter the association (OR ¼ 0.81; 95% CI ¼ 0.63-0.96).Conclusion: Our results suggest that metformin may protect against breast cancer in type 2 diabetic peri-or postmenopausal women.Impact: This study supports the growing evidence of a role for metformin in breast cancer chemoprevention. Cancer Epidemiol Biomarkers Prev; 20(1); 101-11. Ó2011 AACR.

PURPOSE To evaluate use of specific antiepileptic drugs (AEDs) in pregnancy in relation to specific birth defects. METHODS Using data from the National Birth Defects Prevention Study, we assessed use of AEDs and the risk of neural tube defects (NTDs), oral clefts (OCs), heart defects (HDs), hypospadias, and other major birth defects, taking specific agent, timing, and indication into consideration. RESULTS Drug-specific increased risks were observed for valproic acid in relation to NTDs [adjusted odds ratio (aOR), 9.7;, 95% confidence interval (CI), 3.4–27.5], OCs (aOR, 4.4; 95% CI, 1.6–12.2), HDs (aOR, 2.0; 95% CI, 0.78–5.3), and hypospadias (aOR. 2.4; 95% CI, 0.62–9.0), and for carbamazapine in relation to NTDs (aOR, 5.0; 95% CI, 1.9–12.7). Epilepsy history without AED use did not seem to increase risk. CONCLUSIONS Valproic acid, which current guidelines suggest should be avoided in pregnancy, was most notable in terms of strength and breadth of its associations. Carbamazapine was associated with NTDs, even after controlling for folic acid use. Sample sizes were still too small to adequately assess risks of less commonly used AEDs, but our findings support further study to identify lower risk options for pregnant women.