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1.  USING FORMATIVE RESEARCH TO DEVELOP A CONTEXT-SPECIFIC APPROACH TO INFORMED CONSENT FOR CLINICAL TRIALS 
Participant understanding is of particular concern when obtaining informed consent. Recommendations for improving understanding include disclosing information using culturally appropriate and innovative approaches. To increase the effectiveness of the consent process for a clinical trial in Malawi on interventions to prevent mother-to-child transmission of HIV during breastfeeding, formative research was conducted to explore the community’s understanding of medical research as well as how to explain research through local terms and meanings. Contextual analogies and other approaches were identified to explain consent information. Guided by theory, strategies for developing culturally appropriate interventions, and recommendations from the literature, we demonstrate how the formative data were used to develop culturally appropriate counseling cards specifically for the trial in Malawi. With appropriate contextual modifications, the steps outlined here could be applied in other clinical trials conducted elsewhere, as well as in other types of research.
doi:10.1525/jer.2006.1.4.45
PMCID: PMC3140046  PMID: 19385837
Formative research; informed consent; theory; culturally appropriate; HIV/AIDS
2.  Predicting Minority Student Performance in the First Medical School Year 
Impressions and anecdotal evidence have raised concerns that traditional cognitive measures of past performance may not be predictive of the performance among minority students in medical school. This study assessed the relationship between nine objective measures and actual first year academic performance for cohorts of minority students enrolled in a single medical school between 1973 and 1976.
The findings support previous impressions that objective measures together explain less than half of the variance in academic performance. Furthermore, the cumulative undergraduate college average and the competitiveness of the undergraduate college are consistently the strongest predictors of academic performance among this group.
PMCID: PMC2537291  PMID: 529325

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