title: Evaluating iatrogenic prescribing: development of an oncology-focused trigger tool.
abstract: BACKGROUND
  Drug-related iatrogenic effects are common in oncology because chemotherapy is toxic. The evaluation of the application of the guidelines may be a way to understand the occurrence of adverse drug-related event (ADE). There is no specific method for identifying ADEs and measuring harm to patients in oncology.
  
  
  OBJECTIVE
  Our objective was to develop and test an Oncology Trigger Tool (OTT) for ADEs and to describe ADE characteristics and incidence.
  
  
  METHODS
  A clinical advisory panel identified situations at high risk of ADE occurrence and built 22 triggers with, in each case, an analysis flowchart to confirm or refute occurrence. The OTT was used to review 288 random admissions (Oct. 2010-Sept. 2011) and measure ADE incidence and severity (CTCAE 4.03 - Common Terminology Criteria for Adverse Events). Tool feasibility (time required), inter-rater (IR) reproducibility and positive predictive value (PPV) were measured.
  
  
  RESULTS
  Overall, 884 triggers were detected and 122 ADEs, with 42.4 ADEs/100 admissions or 46.0 ADEs/1000 patient-days, and a 31.1% rate of severe ADEs. The most common ADEs were hyperglycaemia (14.5%), unplanned drug-related admission within 30 days (13.7%) and opiate-induced constipation (12.1%). Unplanned drug-related admission was the most serious (82.4% incidence of severe harm). Mean time for OTT implementation was 21.8 min; IR reproducibility was high (κ=0.965 (trigger); κ=0.935 (ADE); κ=0.853 (harm)); PPV 22-trigger version was 20.7%.
  
  
  CONCLUSIONS
  ADE analysis flowcharts coupled with standardised grading of harm considerably reduced IR variability, thus providing a robust oncology-focused trigger tool for use in ADE audits and hospital comparisons. The involvement of a clinical advisory panel in tool development should help drive changes for improving practice. Further research on the OTT is warranted.
authors.affiliation: Gustave Roussy, Projet CAPRI, Villejuif F-94805, France; Equipe d'accueil "Management des organisations de santé", Ecoles de Hautes Etudes en Santé Publique, Rennes F-35000, France. Electronic address: guillaume.hebert@gustaveroussy.fr.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Hébert
authors.affiliation: Gustave Roussy, Département de Pharmacie Clinique, Villejuif F-94805, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Netzer
authors.affiliation: Gustave Roussy, Projet CAPRI, Villejuif F-94805, France; Equipe d'accueil "Management des organisations de santé", Ecoles de Hautes Etudes en Santé Publique, Rennes F-35000, France.
authors.forename: Marie
authors.initials: M
authors.lastname: Ferrua
authors.affiliation: Gustave Roussy, Département d'Oncologie Médicale, Villejuif F-94805, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Ducreux
authors.affiliation: Gustave Roussy, Département de Pharmacie Clinique, Villejuif F-94805, France; Département de pharmacie clinique, PRES Sorbonne Paris-Cité, Paris F-75006, France.
authors.forename: François
authors.initials: F
authors.lastname: Lemare
authors.affiliation: Gustave Roussy, Projet CAPRI, Villejuif F-94805, France; Equipe d'accueil "Management des organisations de santé", Ecoles de Hautes Etudes en Santé Publique, Rennes F-35000, France.
authors.forename: Etienne
authors.initials: E
authors.lastname: Minvielle
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D016903:Drug Monitoring / Q000379:methods*; D011307:Drug Prescriptions / Q000706:statistics & numerical data*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis* / Q000453:epidemiology*; D005260:Female; D019983:Guideline Adherence / Q000706:statistics & numerical data; D006801:Humans; D007049:Iatrogenic Disease / Q000453:epidemiology*; D015994:Incidence; D007223:Infant; D007231:Infant, Newborn; D007902:Length of Stay / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents
keywords: Anticancer drug; Medical audit; Medical errors; Medication errors; Oncology; Retrospective studies; Safety management; adverse effects; methods; statistics & numerical data