Application of research design of randomized controlled trial in clinical research related to hospital-acquired infections and standards for reporting results

OBJECTIVE To explore the application of randomized controlled trial (RCT) in clinical research related to hospital-associated infections (HAIs) so as to provide methodological references for clinical research. METHODS With taking into account the particularities of research on HAIs, the applicability of general principles for design of RCT in this field was explored, the key elements for the design of RCT were elaborated in detail, and the standards for reporting the RCT results based on clinical problems about HAIs were systematically sorted out. RESULTS The design principles for RCT in clinical research relating to HAIs (random allocation, allocation concealment, blinding, sample size calculation, confounder control) and implementation methods (data management, follow-up procedure, standards for reporting results) were outlined in the article. The reporting paradigm for such research results were made standardized, and the importance of following the standards for improving the quality of research and pushing forward the prevention and control of HAIs was stressed on. CONCLUSION The clear and definite key points for design of RCT, accurate implementation and analysis of procedures and standardized result reporting may remarkably improve the scientificity, feasibility and quality of RCT clinical research relating to HAIs so as to provide powerful scientific bases for prevention and control of HAIs.