UNASSIGNED: Background Delirium is an acute change in mental status characterized by sudden onset, fluctuating course, inattention, disorganized thinking, and abnormal level of consciousness. The objective of the randomized controlled trial "A STrategy to Reduce the Incidence of @entity260 in Elderly @entity1 " (STRIDE) is to assess the effectiveness of light versus heavy sedation on @entity933 and other outcomes in elderly @entity1 undergoing @entity173 repair surgery. Our goal is to describe the design considerations and lessons learned in planning and implementing the STRIDE trial. Methods Discussed are challenges encountered including (1) how to ensure that we quickly identify, assess the eligibility of, and randomize traumatic @entity173 @entity1 ; (2) how to implement interventions that involve continuous monitoring and adjustment during the surgery; and (3) how to measure and ascertain the primary outcome, @entity933 . Results To address the first challenge, we monitored the operating room schedule more actively than anticipated. We constructed and organized eligibility assessment data collection forms by purpose and by source of information needed to complete them. We decided that randomization needs to take place in the operating room. To address the second challenge, we designed and implemented a treatment protocol and covered the bispectral index monitor to prevent the Anesthesiologist/Anesthetist from being influenced by the bispectral index reading while administering the intervention. Finally, clinical assessment of @entity933 consisted of standardized interviews of the @entity1 using validated instruments, interviews of those caring for the @entity1 , and review of the medical record. A consensus panel made the final determination of a @entity933 diagnosis. We note that STRIDE is a single-center trial. The decisions we took may have different implications for multi-center trials. Conclusions Lessons learned are likely to provide useful information to others designing trials in emergency and surgical setting and for those who are interested in unbiased assessment of @entity933 .

Design considerations of a randomized controlled trial of sedation level during XXXX repair surgery: a strategy to reduce the incidence of @entity260 in elderly @entity1 .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity173 :: ('MESH:D006620', 'Disease') :: ['hip fracture'] @entity933 :: ('MESH:D003693', 'Disease') :: ['delirium'] @entity260 :: ('MESH:D011183', 'Disease') :: ['Postoperative Delirium']
@entity173 :: (MESH:D006620,Disease) :: ['hip fracture']
