title: Measurement of patient safety: a systematic review of the reliability and validity of adverse event detection with record review.
abstract: Record review is the most used method to quantify patient safety. We systematically reviewed the reliability and validity of adverse event detection with record review.
  
  
  
  A systematic review of the literature.
  
  
  
  We searched PubMed, EMBASE, CINAHL, PsycINFO and the Cochrane Library and from their inception through February 2015. We included all studies that aimed to describe the reliability and/or validity of record review. Two reviewers conducted data extraction. We pooled κ values (κ) and analysed the differences in subgroups according to number of reviewers, reviewer experience and training level, adjusted for the prevalence of adverse events.
  
  
  
  In 25 studies, the psychometric data of the Global Trigger Tool (GTT) and the Harvard Medical Practice Study (HMPS) were reported and 24 studies were included for statistical pooling. The inter-rater reliability of the GTT and HMPS showed a pooled κ of 0.65 and 0.55, respectively. The inter-rater agreement was statistically significantly higher when the group of reviewers within a study consisted of a maximum five reviewers. We found no studies reporting on the validity of the GTT and HMPS.
  
  
  
  The reliability of record review is moderate to substantial and improved when a small group of reviewers carried out record review. The validity of the record review method has never been evaluated, while clinical data registries, autopsy or direct observations of patient care are potential reference methods that can be used to test concurrent validity.
authors.affiliation: Radboud University Medical Center, Institute of Quality Assurance and Patient Safety, Nijmegen, The Netherlands.
authors.forename: Mirelle
authors.initials: M
authors.lastname: Hanskamp-Sebregts
authors.affiliation: Radboud University Medical Center, Radboud Institute for Health Sciences, IQ healthcare, Nijmegen, The Netherlands.
authors.forename: Marieke
authors.initials: M
authors.lastname: Zegers
authors.affiliation: Department of Experimental Psychology, University of Oxford, Oxford, UK.
authors.forename: Charles
authors.initials: C
authors.lastname: Vincent
authors.affiliation: Radboud University Medical Center, Institute of Quality Assurance and Patient Safety, Nijmegen, The Netherlands.
authors.forename: Petra J
authors.initials: PJ
authors.lastname: van Gurp
authors.affiliation: Department of Experimental Psychology, University of Oxford, Oxford, UK Department of Epidemiology and Biostatistics, EMGO Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Henrica C W
authors.initials: HC
authors.lastname: de Vet
authors.affiliation: Radboud University Medical Center, Radboud Institute for Health Sciences, IQ healthcare, Nijmegen, The Netherlands.
authors.forename: Hub
authors.initials: H
authors.lastname: Wollersheim
mesh_terms: D000704:Analysis of Variance; D006801:Humans; D019300:Medical Errors / Q000517:prevention & control* / Q000706:statistics & numerical data; D008499:Medical Records; D015588:Observer Variation; D061214:Patient Safety; D017751:Safety Management / Q000379:methods