title: Lack of concordance between empirical scores and physician assessments of stroke and bleeding risk in atrial fibrillation: results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry.
abstract: BACKGROUND
  Physicians treating patients with atrial fibrillation (AF) must weigh the benefits of anticoagulation in preventing stroke versus the risk of bleeding. Although empirical models have been developed to predict such risks, the degree to which these coincide with clinicians' estimates is unclear.
  
  
  RESULTS
  We examined 10 094 AF patients enrolled in the Outcomes Registry for Better Informed Treatment of AF (ORBIT-AF) registry between June 2010 and August 2011. Empirical stroke and bleeding risks were assessed by using the congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, and previous stroke or transient ischemic attack (CHADS2) and Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) scores, respectively. Separately, physicians were asked to categorize their patients' stroke and bleeding risks: low risk (<3%); intermediate risk (3%-6%); and high risk (>6%). Overall, 72% (n=7251) in ORBIT-AF had high-risk CHADS2 scores (≥2). However, only 16% were assessed as high stroke risk by physicians. Although 17% (n=1749) had high ATRIA bleeding risk (score ≥5), only 7% (n=719) were considered so by physicians. The associations between empirical and physician-estimated stroke and bleeding risks were low (weighted Kappa 0.1 and 0.11, respectively). Physicians weighed hypertension, heart failure, and diabetes mellitus less significantly than empirical models in estimating stroke risk; physicians weighted anemia and dialysis less significantly than empirical models when estimating bleeding risks. Anticoagulation use was highest among patients with high stroke risk, assessed by either empirical model or physician estimates. In contrast, physician and empirical estimates of bleeding had limited impact on treatment choice.
  
  
  CONCLUSIONS
  There is little agreement between provider-assessed risk and empirical scores in AF. These differences may explain, in part, the current divergence of anticoagulation treatment decisions from guideline recommendations.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov. Unique identifier: NCT01165710.
authors.affiliation: From the Duke University Medical Center, Durham, NC (B.A.S., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (B.A.S., S.K., L.T., J.P.P., E.D.P.); UCLA School of Medicine, Los Angeles, CA (G.C.F.); Boston University School of Medicine, Boston, MA (E.H.); New York University School of Medicine, Lenox Hill Hospital, New York, NY (J.A.); Kaiser Permanente, Oakland, CA (A.S.G.); Janssen Pharmaceuticals, Inc., Raritan, NJ (P.C.); Lankenau Institute for Medical Research, Wynnewood, PA (P.K.); Mayo Clinic, Rochester, MN (B.J.G.); Stanford University School of Medicine, Palo Alto, CA (K.W.M.); and Harvard Medical School and Massachusetts General Hospital, Boston, MA (D.E.S.). benjamin.steinberg@duke.edu.
authors.forename: Benjamin A
authors.initials: BA
authors.lastname: Steinberg
authors.affiliation: From the Duke University Medical Center, Durham, NC (B.A.S., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (B.A.S., S.K., L.T., J.P.P., E.D.P.); UCLA School of Medicine, Los Angeles, CA (G.C.F.); Boston University School of Medicine, Boston, MA (E.H.); New York University School of Medicine, Lenox Hill Hospital, New York, NY (J.A.); Kaiser Permanente, Oakland, CA (A.S.G.); Janssen Pharmaceuticals, Inc., Raritan, NJ (P.C.); Lankenau Institute for Medical Research, Wynnewood, PA (P.K.); Mayo Clinic, Rochester, MN (B.J.G.); Stanford University School of Medicine, Palo Alto, CA (K.W.M.); and Harvard Medical School and Massachusetts General Hospital, Boston, MA (D.E.S.).
authors.forename: Sunghee
authors.initials: S
authors.lastname: Kim
authors.affiliation: From the Duke University Medical Center, Durham, NC (B.A.S., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (B.A.S., S.K., L.T., J.P.P., E.D.P.); UCLA School of Medicine, Los Angeles, CA (G.C.F.); Boston University School of Medicine, Boston, MA (E.H.); New York University School of Medicine, Lenox Hill Hospital, New York, NY (J.A.); Kaiser Permanente, Oakland, CA (A.S.G.); Janssen Pharmaceuticals, Inc., Raritan, NJ (P.C.); Lankenau Institute for Medical Research, Wynnewood, PA (P.K.); Mayo Clinic, Rochester, MN (B.J.G.); Stanford University School of Medicine, Palo Alto, CA (K.W.M.); and Harvard Medical School and Massachusetts General Hospital, Boston, MA (D.E.S.).
authors.forename: Laine
authors.initials: L
authors.lastname: Thomas
authors.affiliation: From the Duke University Medical Center, Durham, NC (B.A.S., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (B.A.S., S.K., L.T., J.P.P., E.D.P.); UCLA School of Medicine, Los Angeles, CA (G.C.F.); Boston University School of Medicine, Boston, MA (E.H.); New York University School of Medicine, Lenox Hill Hospital, New York, NY (J.A.); Kaiser Permanente, Oakland, CA (A.S.G.); Janssen Pharmaceuticals, Inc., Raritan, NJ (P.C.); Lankenau Institute for Medical Research, Wynnewood, PA (P.K.); Mayo Clinic, Rochester, MN (B.J.G.); Stanford University School of Medicine, Palo Alto, CA (K.W.M.); and Harvard Medical School and Massachusetts General Hospital, Boston, MA (D.E.S.).
authors.forename: Gregg C
authors.initials: GC
authors.lastname: Fonarow
authors.affiliation: From the Duke University Medical Center, Durham, NC (B.A.S., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (B.A.S., S.K., L.T., J.P.P., E.D.P.); UCLA School of Medicine, Los Angeles, CA (G.C.F.); Boston University School of Medicine, Boston, MA (E.H.); New York University School of Medicine, Lenox Hill Hospital, New York, NY (J.A.); Kaiser Permanente, Oakland, CA (A.S.G.); Janssen Pharmaceuticals, Inc., Raritan, NJ (P.C.); Lankenau Institute for Medical Research, Wynnewood, PA (P.K.); Mayo Clinic, Rochester, MN (B.J.G.); Stanford University School of Medicine, Palo Alto, CA (K.W.M.); and Harvard Medical School and Massachusetts General Hospital, Boston, MA (D.E.S.).
authors.forename: Elaine
authors.initials: E
authors.lastname: Hylek
authors.affiliation: From the Duke University Medical Center, Durham, NC (B.A.S., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (B.A.S., S.K., L.T., J.P.P., E.D.P.); UCLA School of Medicine, Los Angeles, CA (G.C.F.); Boston University School of Medicine, Boston, MA (E.H.); New York University School of Medicine, Lenox Hill Hospital, New York, NY (J.A.); Kaiser Permanente, Oakland, CA (A.S.G.); Janssen Pharmaceuticals, Inc., Raritan, NJ (P.C.); Lankenau Institute for Medical Research, Wynnewood, PA (P.K.); Mayo Clinic, Rochester, MN (B.J.G.); Stanford University School of Medicine, Palo Alto, CA (K.W.M.); and Harvard Medical School and Massachusetts General Hospital, Boston, MA (D.E.S.).
authors.forename: Jack
authors.initials: J
authors.lastname: Ansell
authors.affiliation: From the Duke University Medical Center, Durham, NC (B.A.S., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (B.A.S., S.K., L.T., J.P.P., E.D.P.); UCLA School of Medicine, Los Angeles, CA (G.C.F.); Boston University School of Medicine, Boston, MA (E.H.); New York University School of Medicine, Lenox Hill Hospital, New York, NY (J.A.); Kaiser Permanente, Oakland, CA (A.S.G.); Janssen Pharmaceuticals, Inc., Raritan, NJ (P.C.); Lankenau Institute for Medical Research, Wynnewood, PA (P.K.); Mayo Clinic, Rochester, MN (B.J.G.); Stanford University School of Medicine, Palo Alto, CA (K.W.M.); and Harvard Medical School and Massachusetts General Hospital, Boston, MA (D.E.S.).
authors.forename: Alan S
authors.initials: AS
authors.lastname: Go
authors.affiliation: From the Duke University Medical Center, Durham, NC (B.A.S., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (B.A.S., S.K., L.T., J.P.P., E.D.P.); UCLA School of Medicine, Los Angeles, CA (G.C.F.); Boston University School of Medicine, Boston, MA (E.H.); New York University School of Medicine, Lenox Hill Hospital, New York, NY (J.A.); Kaiser Permanente, Oakland, CA (A.S.G.); Janssen Pharmaceuticals, Inc., Raritan, NJ (P.C.); Lankenau Institute for Medical Research, Wynnewood, PA (P.K.); Mayo Clinic, Rochester, MN (B.J.G.); Stanford University School of Medicine, Palo Alto, CA (K.W.M.); and Harvard Medical School and Massachusetts General Hospital, Boston, MA (D.E.S.).
authors.forename: Paul
authors.initials: P
authors.lastname: Chang
authors.affiliation: From the Duke University Medical Center, Durham, NC (B.A.S., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (B.A.S., S.K., L.T., J.P.P., E.D.P.); UCLA School of Medicine, Los Angeles, CA (G.C.F.); Boston University School of Medicine, Boston, MA (E.H.); New York University School of Medicine, Lenox Hill Hospital, New York, NY (J.A.); Kaiser Permanente, Oakland, CA (A.S.G.); Janssen Pharmaceuticals, Inc., Raritan, NJ (P.C.); Lankenau Institute for Medical Research, Wynnewood, PA (P.K.); Mayo Clinic, Rochester, MN (B.J.G.); Stanford University School of Medicine, Palo Alto, CA (K.W.M.); and Harvard Medical School and Massachusetts General Hospital, Boston, MA (D.E.S.).
authors.forename: Peter
authors.initials: P
authors.lastname: Kowey
authors.affiliation: From the Duke University Medical Center, Durham, NC (B.A.S., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (B.A.S., S.K., L.T., J.P.P., E.D.P.); UCLA School of Medicine, Los Angeles, CA (G.C.F.); Boston University School of Medicine, Boston, MA (E.H.); New York University School of Medicine, Lenox Hill Hospital, New York, NY (J.A.); Kaiser Permanente, Oakland, CA (A.S.G.); Janssen Pharmaceuticals, Inc., Raritan, NJ (P.C.); Lankenau Institute for Medical Research, Wynnewood, PA (P.K.); Mayo Clinic, Rochester, MN (B.J.G.); Stanford University School of Medicine, Palo Alto, CA (K.W.M.); and Harvard Medical School and Massachusetts General Hospital, Boston, MA (D.E.S.).
authors.forename: Bernard J
authors.initials: BJ
authors.lastname: Gersh
authors.affiliation: From the Duke University Medical Center, Durham, NC (B.A.S., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (B.A.S., S.K., L.T., J.P.P., E.D.P.); UCLA School of Medicine, Los Angeles, CA (G.C.F.); Boston University School of Medicine, Boston, MA (E.H.); New York University School of Medicine, Lenox Hill Hospital, New York, NY (J.A.); Kaiser Permanente, Oakland, CA (A.S.G.); Janssen Pharmaceuticals, Inc., Raritan, NJ (P.C.); Lankenau Institute for Medical Research, Wynnewood, PA (P.K.); Mayo Clinic, Rochester, MN (B.J.G.); Stanford University School of Medicine, Palo Alto, CA (K.W.M.); and Harvard Medical School and Massachusetts General Hospital, Boston, MA (D.E.S.).
authors.forename: Kenneth W
authors.initials: KW
authors.lastname: Mahaffey
authors.affiliation: From the Duke University Medical Center, Durham, NC (B.A.S., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (B.A.S., S.K., L.T., J.P.P., E.D.P.); UCLA School of Medicine, Los Angeles, CA (G.C.F.); Boston University School of Medicine, Boston, MA (E.H.); New York University School of Medicine, Lenox Hill Hospital, New York, NY (J.A.); Kaiser Permanente, Oakland, CA (A.S.G.); Janssen Pharmaceuticals, Inc., Raritan, NJ (P.C.); Lankenau Institute for Medical Research, Wynnewood, PA (P.K.); Mayo Clinic, Rochester, MN (B.J.G.); Stanford University School of Medicine, Palo Alto, CA (K.W.M.); and Harvard Medical School and Massachusetts General Hospital, Boston, MA (D.E.S.).
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Singer
authors.affiliation: From the Duke University Medical Center, Durham, NC (B.A.S., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (B.A.S., S.K., L.T., J.P.P., E.D.P.); UCLA School of Medicine, Los Angeles, CA (G.C.F.); Boston University School of Medicine, Boston, MA (E.H.); New York University School of Medicine, Lenox Hill Hospital, New York, NY (J.A.); Kaiser Permanente, Oakland, CA (A.S.G.); Janssen Pharmaceuticals, Inc., Raritan, NJ (P.C.); Lankenau Institute for Medical Research, Wynnewood, PA (P.K.); Mayo Clinic, Rochester, MN (B.J.G.); Stanford University School of Medicine, Palo Alto, CA (K.W.M.); and Harvard Medical School and Massachusetts General Hospital, Boston, MA (D.E.S.).
authors.forename: Jonathan P
authors.initials: JP
authors.lastname: Piccini
authors.affiliation: From the Duke University Medical Center, Durham, NC (B.A.S., J.P.P., E.D.P.); Duke Clinical Research Institute, Durham, NC (B.A.S., S.K., L.T., J.P.P., E.D.P.); UCLA School of Medicine, Los Angeles, CA (G.C.F.); Boston University School of Medicine, Boston, MA (E.H.); New York University School of Medicine, Lenox Hill Hospital, New York, NY (J.A.); Kaiser Permanente, Oakland, CA (A.S.G.); Janssen Pharmaceuticals, Inc., Raritan, NJ (P.C.); Lankenau Institute for Medical Research, Wynnewood, PA (P.K.); Mayo Clinic, Rochester, MN (B.J.G.); Stanford University School of Medicine, Palo Alto, CA (K.W.M.); and Harvard Medical School and Massachusetts General Hospital, Boston, MA (D.E.S.).
authors.forename: Eric D
authors.initials: ED
authors.lastname: Peterson
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage; D001281:Atrial Fibrillation / Q000188:drug therapy / Q000453:epidemiology*; D002545:Brain Ischemia / Q000453:epidemiology; D002543:Cerebral Hemorrhage / Q000453:epidemiology*; D015897:Comorbidity; D003324:Coronary Artery Disease / Q000453:epidemiology; D005260:Female; D006470:Hemorrhage / Q000453:epidemiology*; D006801:Humans; D002546:Ischemic Attack, Transient / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012042:Registries / Q000706:statistics & numerical data*; D018570:Risk Assessment; D012307:Risk Factors; D020521:Stroke / Q000453:epidemiology*; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants
keywords: atrial fibrillation; hemorrhage; risk assessment; stroke