Recruitment strategy cost and impact on minority accrual to a breast cancer prevention trial.

BACKGROUND: Recruitment of minorities to cancer prevention trials is difficult and costly. Early-phase cancer prevention trials have fewer resources to promote recruitment. Identifying cost-effective strategies that can replace or supplement traditional recruitment methods and improve minority accrual to small, early-phase cancer prevention trials are of critical importance. PURPOSE: To compare the costs of accrual strategies used in a small breast cancer prevention trial and assess their impact on recruitment and minority accrual. METHODS: A total of 1196 potential subjects with a known recruitment source contacted study coordinators about the SOY study, a breast cancer prevention trial. Recruitment strategies for this study included recruitment from within the Northwestern University network (internal strategy), advertisements placed on public transportation (Chicago Transit Authority (CTA)), health-related events, media (print/radio/television), and direct mail. Total recruitment strategy cost included the cost of study personnel and material costs calculated from itemized receipts. Incremental cost-effectiveness ratios (ICERs) were calculated to compare the relative cost-effectiveness of each recruitment strategy. If a strategy was more costly and less effective than its comparator, then that strategy was considered dominated. Scenarios that were not dominated were compared. The primary effectiveness measure was the number of consents. Separate ICERs were calculated using the number of minority consents as the effectiveness measure. RESULTS: The total cost of SOY study recruitment was US$164,585, which included the cost of materials (US$26,133) and personnel (US$138,452). The internal referral strategy was the largest source of trial contacts (748/1196; 63%), consents (107/150; 71%), and minority consents (17/34; 50%) and was the most expensive strategy (US$139,033). CTA ads generated the second largest number of trial contacts (326/1196; 27%), the most minority contacts (184/321; 57%), and 16 minority consents (16/34; 47%), at a total cost of US$15,562. The other three strategies yielded many fewer contacts and consents. The methods of health events, CTA ads, and the internal strategy showed some evidence of cost-effectiveness (ICER: US$581, US$717, and US$1524, respectively). The CTA strategy was the most cost-effective strategy for minority accrual (ICER: US$908). LIMITATIONS: Recall bias may have limited the accuracy of estimated time spent on recruitment by study personnel. Also, costs spent specifically on minority accrual were unobtainable; results may not be generalizable to other settings; and cost-effectiveness data for the methods of media, health events, and direct mail should be interpreted with caution since these methods generated few consents. CONCLUSIONS: Public transportation ads have the potential to generate numerous minority contacts and consents at a reasonable cost within an urban setting. Combined with traditional methods of recruitment, this method can lead to timelier study completion and increased minority accrual. Future research should prospectively track recruitment and costs in order to better assess the cost-effectiveness of recruitment methods used to target minority populations.

Evaluación del aprendizaje en la educación médica / Learning assessment in medical education

El propósito de este artículo es proporcionar un panorama general de la evaluación educativa en el contexto de las ciencias de la salud, específicamente en el campo de la Medicina. Para ello, se realizó una revisión del estado del arte de la evaluación, enfatizando los conceptos fundamentales en el desarrollo teórico y metodológico, así como los alcances de la evaluación educativa en la educación superior. Se enfatiza la necesidad de desarrollar instrumentos de evaluación congruentes con los perfiles de egreso de los planes y programas de estudio de la carrera de medicina y se pone en perspectiva la evaluación de la competencia médica a través de instrumentos como el Examen Clínico Objetivo Estructurado (ECOE), que por sus características es considerado como una herramienta útil en el ámbito de la evaluación de la competencia medica a nivel internacional.

The purpose of this article is to provide an overview of educational evaluation in the context of health sciences, specifically in the field of medicine. To do this, a review of the state of the art of evaluation was performed, emphasizing the fundamental concepts in theoretical and methodological development and the scope of educational evaluation in higher education. The need to develop evaluation instruments consistent with the graduate profiles according to the syllabus of medicine is highlighted, and the evaluation of medical competence through instruments such as the Objective Structured Clinical Examination (OSCE), which by its characteristics is considered as a useful tool in the field of assessment of medical competency in the international context, is also assessed.

Soy isoflavone supplementation for breast cancer risk reduction: a randomized phase II trial.

Soy isoflavone consumption may protect against breast cancer development. We conducted a phase IIB trial of soy isoflavone supplementation to examine its effect on breast epithelial proliferation and other biomarkers in the healthy high-risk breast. One hundred and twenty-six consented women underwent a random fine-needle aspiration (rFNA); those with 4,000 or more epithelial cells were randomized to a double-blind 6-month intervention of mixed soy isoflavones (PTIG-2535) or placebo, followed by repeat rFNA. Cells were examined for Ki-67 labeling index and atypia. Expression of 28 genes related to proliferation, apoptosis, and estrogenic effect was measured using quantitative reverse transcriptase PCR. Hormone and protein levels were measured in nipple aspirate fluid (NAF). All statistical tests were two-sided. Ninety-eight women were evaluable for Ki-67 labeling index. In 49 treated women, the median Ki-67 labeling index was 1.18 at entry and 1.12 post intervention, whereas in 49 placebo subjects, it was 0.97 and 0.92 (P for between-group change: 0.32). Menopausal stratification yielded similar results between groups, but within premenopausal soy-treated women, Ki-67 labeling index increased from 1.71 to 2.18 (P = 0.04). We saw no treatment effect on cytologic atypia or NAF parameters. There were significant increases in the expression of 14 of 28 genes within the soy, but not the control group, without significant between-group differences. Plasma genistein values showed excellent compliance. A 6-month intervention of mixed soy isoflavones in healthy, high-risk adult Western women did not reduce breast epithelial proliferation, suggesting a lack of efficacy for breast cancer prevention and a possible adverse effect in premenopausal women.

Conversion from delayed-release sodium valproate to extended-release sodium valproate: initial results and long-term follow-up.

OBJECTIVE: The goal of our study was to evaluate clinical and serum valproic acid concentration changes in patients following overnight conversion from delayed-release sodium valproate (VPA-DR) to the same daily dosage of extended-release sodium valproate (VPA-ER). METHODS: Epilepsy patients on VPA-DR were offered the chance to convert to VPA-ER. Thirty patients were converted to twice-daily dosing and 11 were converted to once-daily dosing. Trough levels of valproic acid were measured prior to the change and 2 weeks after conversion. Short-term and long-term clinical data were evaluated. RESULTS: Patients successfully converted from VPA DR to VPA-ER. No significant difference in percentage change in serum trough valproic acid level was observed when comparing dosing frequency of VPA-DR, total daily dosage of VPA, conversion to once-daily versus twice-daily VPA-ER, or presence of enzyme-inducing agents. Mean seizure count per month prior to conversion was 3.35 versus 3.29 following conversion. Improvements in tremor, weight gain, and nausea/vomiting were noted. CONCLUSIONS: Overnight conversion to VPA-ER was well tolerated by all patients. Long-term results were favorable, with 77.5% of patients remaining on drug. Seizure counts and adverse events remained the same or were improved in both short-term and long-term evaluations. Dosing of VPA-ER either once-daily or twice-daily is acceptable.