title: Patient-Reported Safety Events in Chronic Kidney Disease Recorded With an Interactive Voice-Inquiry Dial-Response System: Monthly Report Analysis.
abstract: BACKGROUND
  Monitoring patient-reported outcomes (PROs) may improve safety of chronic kidney disease (CKD) patients.
  
  
  OBJECTIVE
  Evaluate the performance of an interactive voice-inquiry dial-response system (IVRDS) in detecting CKD-pertinent adverse safety events outside of the clinical environment and compare the incidence of events using the IVDRS to that detected by paper diary.
  
  
  METHODS
  This was a 6-month study of Stage III-V CKD patients in the Safe Kidney Care (SKC) study. Participants crossed over from a paper diary to the IVDRS for recording patient-reported safety events defined as symptoms or events attributable to medications or care. The IVDRS was adapted from the SKC paper diary to record event frequency and remediation. Participants were auto-called weekly and permitted to self-initiate calls. Monthly reports were reviewed by two physician adjudicators for their clinical significance.
  
  
  RESULTS
  52 participants were followed over a total of 1384 weeks. 28 out of 52 participants (54%) reported events using the IVDRS versus 8 out of 52 (15%) with the paper diary; hypoglycemia was the most common event for both methods. All IVDRS menu options were selected at least once except for confusion and rash. Events were reported on 121 calls, with 8 calls reporting event remediation by ambulance or emergency room (ER) visit. The event rate with the IVDRS and paper diary, with and without hypoglycemia, was 26.7 versus 4.7 and 18.3 versus 0.8 per 100 person weeks, respectively (P=.002 and P<.001). The frequent users (ie, >10 events) largely differed by method, and event rates excluding the most frequent user of each were 16.9 versus 2.5 per 100 person weeks, respectively (P<.001). Adjudicators found approximately half the 80 reports clinically significant, with about a quarter judged as actionable. Hypoglycemia was often associated with additional reports of fatigue and falling. Participants expressed favorable satisfaction with the IVDRS.
  
  
  CONCLUSIONS
  Use of the IVDRS among CKD patients reveals a high frequency of clinically significant safety events and has the potential to be used as an important supplement to clinical care for improving patient safety.
authors.affiliation: University of Maryland School of Medicine, Department of Medicine, Baltimore, MD, United States. jfink@medicine.umaryland.edu.
authors.forename: Jeffrey C
authors.identifier: http://orcid.org/0000-0002-5622-5052
authors.initials: JC
authors.lastname: Fink
authors.forename: Rebecca M
authors.identifier: http://orcid.org/0000-0001-8142-0610
authors.initials: RM
authors.lastname: Doerfler
authors.forename: Marni R
authors.identifier: http://orcid.org/0000-0002-8860-0742
authors.initials: MR
authors.lastname: Yoffe
authors.forename: Clarissa J
authors.identifier: http://orcid.org/0000-0001-8212-6288
authors.initials: CJ
authors.lastname: Diamantidis
authors.forename: Jacob B
authors.identifier: http://orcid.org/0000-0002-4193-1536
authors.initials: JB
authors.lastname: Blumenthal
authors.forename: Tariq
authors.identifier: http://orcid.org/0000-0001-8818-6388
authors.initials: T
authors.lastname: Siddiqui
authors.forename: James F
authors.identifier: http://orcid.org/0000-0002-8185-7238
authors.initials: JF
authors.lastname: Gardner
authors.forename: Soren
authors.identifier: http://orcid.org/0000-0001-8313-6701
authors.initials: S
authors.lastname: Snitker
authors.forename: Min
authors.identifier: http://orcid.org/0000-0002-3776-7884
authors.initials: M
authors.lastname: Zhan
mesh_terms: D000328:Adult; D000368:Aged; D015331:Cohort Studies; D005260:Female; D006801:Humans; D008875:Middle Aged; D061214:Patient Safety / Q000706:statistics & numerical data*; D051436:Renal Insufficiency, Chronic / Q000453:epidemiology*; D057566:Self Report
keywords: CKD; interactive voice-response system; patient safety; patient-reported outcomes