title: Design considerations of a randomized controlled trial of sedation level during hip fracture repair surgery: a strategy to reduce the incidence of postoperative delirium in elderly patients.
abstract: 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 Postoperative Delirium in Elderly Patients" (STRIDE) is to assess the effectiveness of light versus heavy sedation on delirium and other outcomes in elderly patients undergoing hip fracture 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 hip fracture patients; (2) how to implement interventions that involve continuous monitoring and adjustment during the surgery; and (3) how to measure and ascertain the primary outcome, delirium. 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 delirium consisted of standardized interviews of the patient using validated instruments, interviews of those caring for the patient, and review of the medical record. A consensus panel made the final determination of a delirium 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 delirium.
authors.affiliation: 1 Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
authors.forename: Tianjing
authors.initials: T
authors.lastname: Li
authors.affiliation: 2 Center for Integrative Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.
authors.forename: L Susan
authors.initials: LS
authors.lastname: Wieland
authors.affiliation: 3 Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Johns Hopkins Hospital, Baltimore, MD, USA.|4 Division of Geriatric Medicine and Gerontology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
authors.forename: Esther
authors.initials: E
authors.lastname: Oh
authors.affiliation: 3 Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Johns Hopkins Hospital, Baltimore, MD, USA.
authors.forename: Karin J
authors.initials: KJ
authors.lastname: Neufeld
authors.affiliation: 5 Departments of Medicine, Biostatistics, and Epidemiology, Johns Hopkins Medical Institutions, Baltimore, MD, USA.
authors.forename: Nae-Yuh
authors.initials: NY
authors.lastname: Wang
authors.affiliation: 1 Center for Clinical Trials and Evidence Synthesis, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
authors.forename: Kay
authors.initials: K
authors.lastname: Dickersin
authors.affiliation: 6 Johns Hopkins Bayview Medical Center, Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
authors.forename: Frederick E
authors.initials: FE
authors.lastname: Sieber
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000775:Anesthesia, Spinal / Q000009:adverse effects*; D035843:Biomedical Research / Q000379:methods*; D016292:Procedural Sedation / Q000009:adverse effects*; D054810:Deep Sedation / Q000009:adverse effects*; D003693:Delirium / Q000139:chemically induced* / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control; D006620:Hip Fractures / Q000601:surgery*; D006801:Humans; D011183:Postoperative Complications / Q000209:etiology / Q000517:prevention & control; D012307:Risk Factors
keywords: Sedation; delirium; design considerations; hip fracture repair; propofol