The study of pathogen resistance and antimicrobial use in dementia: study design and methodology.

Advanced dementia is characterized by the onset of infections and antimicrobial use is extensive. The extent to which this antimicrobial use is appropriate and contributes to the emergence of antimicrobial resistant bacteria is not known. The object of this report is to present the methodology established in the Study of Pathogen Resistance and Exposure to Antimicrobials in Dementia (SPREAD), and describe how challenges specific to this research were met. SPREAD is an ongoing, federally funded, 5-year prospective cohort study initiated in September 2009. Subjects include nursing home residents with advanced dementia and their proxies recruited from 31 Boston-area facilities. The recruitment and data collection protocols are described. Characteristics of participant facilities are presented and compared to those nationwide. To date, 295 resident/proxy dyads have been recruited. Baseline and selected follow-up data demonstrate successful recruitment of subjects and repeated collection of complex data documenting infections, decision-making for these infections, and antimicrobial bacteria resistance among the residents. SPREAD integrates methods in dementia, palliative care and infectious diseases research. Its successful implementation further establishes the feasibility of conducting rigorous, multi-site NH research in advanced dementia, and the described methodology serves as a detailed reference for subsequent publications emanating from the study.