BACKGROUND: The need for evidence about the effectiveness of therapeutics and other medical practices has triggered new interest in methods for comparative effectiveness research. OBJECTIVE: Describe an approach to comparative effectiveness research involving cluster randomized trials in networks of hospitals, health plans, or medical practices with centralized administrative and informatics capabilities. RESEARCH DESIGN: We discuss the example of an ongoing cluster randomized trial to prevent methicillin-resistant Staphylococcus aureus (MRSA) infection in intensive care units (ICUs). The trial randomizes 45 hospitals to: (a) screening cultures of ICU admissions, followed by Contact Precautions if MRSA-positive, (b) screening cultures of ICU admissions followed by decolonization if MRSA-positive, or (c) universal decolonization of ICU admissions without screening. SUBJECTS: All admissions to adult ICUs. MEASURES: The primary outcome is MRSA-positive clinical cultures occurring >or=2 days following ICU admission. Secondary outcomes include blood and urine infection caused by MRSA (and, separately, all pathogens), as well as the development of resistance to decolonizing agents. RESULTS: Recruitment of hospitals is complete. Data collection will end in Summer 2011. CONCLUSIONS: This trial takes advantage of existing personnel, procedures, infrastructure, and information systems in a large integrated hospital network to conduct a low-cost evaluation of prevention strategies under usual practice conditions. This approach is applicable to many comparative effectiveness topics in both inpatient and ambulatory settings.
RCT Entities:
BACKGROUND: The need for evidence about the effectiveness of therapeutics and other medical practices has triggered new interest in methods for comparative effectiveness research. OBJECTIVE: Describe an approach to comparative effectiveness research involving cluster randomized trials in networks of hospitals, health plans, or medical practices with centralized administrative and informatics capabilities. RESEARCH DESIGN: We discuss the example of an ongoing cluster randomized trial to prevent methicillin-resistant Staphylococcus aureus (MRSA) infection in intensive care units (ICUs). The trial randomizes 45 hospitals to: (a) screening cultures of ICU admissions, followed by Contact Precautions if MRSA-positive, (b) screening cultures of ICU admissions followed by decolonization if MRSA-positive, or (c) universal decolonization of ICU admissions without screening. SUBJECTS: All admissions to adult ICUs. MEASURES: The primary outcome is MRSA-positive clinical cultures occurring >or=2 days following ICU admission. Secondary outcomes include blood and urine infection caused by MRSA (and, separately, all pathogens), as well as the development of resistance to decolonizing agents. RESULTS: Recruitment of hospitals is complete. Data collection will end in Summer 2011. CONCLUSIONS: This trial takes advantage of existing personnel, procedures, infrastructure, and information systems in a large integrated hospital network to conduct a low-cost evaluation of prevention strategies under usual practice conditions. This approach is applicable to many comparative effectiveness topics in both inpatient and ambulatory settings.
Authors: J Stephen Mikita; Jules Mitchel; Nicolle M Gatto; John Laschinger; James E Tcheng; Emily P Zeitler; Arlene S Swern; E Dawn Flick; Christopher Dowd; Theodore Lystig; Sara B Calvert Journal: Ther Innov Regul Sci Date: 2020-06-22 Impact factor: 1.778
Authors: Nasia Safdar; Deverick J Anderson; Barbara I Braun; Philip Carling; Stuart Cohen; Curtis Donskey; Marci Drees; Anthony Harris; David K Henderson; Susan S Huang; Manisha Juthani-Mehta; Ebbing Lautenbach; Darren R Linkin; Jennifer Meddings; Loren G Miller; Aaron Milstone; Daniel Morgan; Sharmila Sengupta; Meera Varman; Deborah Yokoe; Danielle M Zerr Journal: Infect Control Hosp Epidemiol Date: 2014-05 Impact factor: 3.254