title: Characterizing Frailty Status in the Systolic Blood Pressure Intervention Trial.
abstract: BACKGROUND
  The Systolic Blood Pressure Intervention Trial (SPRINT) is testing whether a lower systolic blood pressure (BP) target of 120 mm Hg leads to a reduction in cardiovascular morbidity and mortality among hypertensive, nondiabetic adults. Because there may be detrimental effects of intensive BP control, particularly in older, frail adults, we sought to characterize frailty within SPRINT to address ongoing questions about the ability of large-scale trials to enroll representative samples of noninstitutionalized, community-dwelling, older adults.
  
  
  METHODS
  We constructed a 36-item frailty index (FI) in 9,306 SPRINT participants, classifying participants as fit (FI ≤ 0.10), less fit (0.10 < FI ≤ 0.21), or frail (FI > 0.21). Recurrent event models were used to evaluate the association of the FI with the incidence of self-reported falls, injurious falls, and all-cause hospitalizations.
  
  
  RESULTS
  The distribution of the FI was comparable with what has been observed in population studies, with 2,570 (27.6%) participants classified as frail. The median FI was 0.18 (interquartile range = 0.14 to 0.24) in participants aged 80 years and older (N = 1,159), similar to the median FI of 0.17 reported for participants in the Hypertension in the Very Elderly Trial. In multivariable analyses, a 1% increase in the FI was associated with increased risk for self-reported falls (hazard ratio [HR] = 1.030), injurious falls (HR = 1.035), and all-cause hospitalizations (HR = 1.038) (all p values < .0001).
  
  
  CONCLUSIONS
  Large clinical trials assessing treatments to reduce cardiovascular disease risk, such as SPRINT, can enroll heterogeneous populations of older adults, including the frail elderly, comparable with general population cohorts.
authors.affiliation: Department of Biostatistical Sciences, Division of Public Health Sciences and npajewsk@wakehealth.edu.
authors.forename: Nicholas M
authors.initials: NM
authors.lastname: Pajewski
authors.affiliation: Department of Internal Medicine, Section on Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.
authors.forename: Jeff D
authors.initials: JD
authors.lastname: Williamson
authors.affiliation: Department of Internal Medicine, Section on Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.
authors.forename: William B
authors.initials: WB
authors.lastname: Applegate
authors.affiliation: Bedford Veterans Affairs Hospital, Massachusetts. School of Public Health, Boston University, Massachusetts.
authors.forename: Dan R
authors.initials: DR
authors.lastname: Berlowitz
authors.affiliation: College of Nursing, East Carolina University, Greenville, North Carolina.
authors.forename: Linda P
authors.initials: LP
authors.lastname: Bolin
authors.affiliation: Department of Nephrology, Stanford University School of Medicine, Palo Alto, California.
authors.forename: Glenn M
authors.initials: GM
authors.lastname: Chertow
authors.affiliation: Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana. Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana. Research Division, Ochsner Clinic Foundation, New Orleans, Louisiana.
authors.forename: Marie A
authors.initials: MA
authors.lastname: Krousel-Wood
authors.affiliation: Department of Nephrology, University of Illinois at Chicago.
authors.forename: Nieves
authors.initials: N
authors.lastname: Lopez-Barrera
authors.affiliation: Department of Internal Medicine, Division of General Internal Medicine, East Carolina University, Greenville, North Carolina.
authors.forename: James R
authors.initials: JR
authors.lastname: Powell
authors.affiliation: Veterans Health Administration-Tennessee Valley Healthcare System Geriatric Research Education Clinical Center (GRECC), HSR&D Center, Nashville. Department of Medicine, Vanderbilt University, Nashville, Tennessee.
authors.forename: Christianne L
authors.initials: CL
authors.lastname: Roumie
authors.affiliation: Division of Nephrology and Hypertension, University Hospitals Case Medical Center, Cleveland, Ohio. Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, Ohio.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Still
authors.affiliation: Department of Internal Medicine, Section on Geriatric Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.
authors.forename: Kaycee M
authors.initials: KM
authors.lastname: Sink
authors.affiliation: Department of Surgery, Columbia University, New York.
authors.forename: Rocky
authors.initials: R
authors.lastname: Tang
authors.affiliation: Evelyn F. McKnight Brain Institute, Departments of Neurology and Public Health Sciences, Leonard M. Miller School of Medicine, University of Miami, Florida.
authors.forename: Clinton B
authors.initials: CB
authors.lastname: Wright
authors.affiliation: Division of Geriatrics, School of Medicine, University of Utah, Salt Lake City. Veterans Affairs Salt Lake City, Geriatric Research, Education, and Clinical Center, Utah.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Supiano
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D015331:Cohort Studies; D005260:Female; D016330:Frail Elderly; D015577:Geriatric Assessment; D006304:Health Status; D006305:Health Status Indicators; D006801:Humans; D006973:Hypertension / Q000150:complications* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012044:Regression Analysis; D012307:Risk Factors
chemical_list: D000959:Antihypertensive Agents
keywords: Falls; Frailty; Multimorbidities