title: Side effects are incompletely reported among systematic reviews in gastroenterology.
abstract: OBJECTIVE
  Systematic reviews are an integral component of evidence-based health care. However, little is known on how well they report the potential harms of interventions. We assessed the reporting of harms in recently published systematic reviews of interventions relevant to clinical gastroenterology.
  
  
  METHODS
  We identified all systematic reviews of randomized trials of gastroenterology interventions published from 2008 to 2012 in highly cited gastroenterology and general medical journals. We adapted the Consolidated Standards of Reporting Trials guidelines for harms and assessed qualitative and quantitative parameters of harms reporting. Regression analyses determined predictors of more comprehensive harms reporting.
  
  
  RESULTS
  In total, 78 systematic reviews were identified, with 72 published in gastroenterology journals and six in general medical journals. Overall, one in three systematic reviews (26/78, 33%) did not refer to harms of the intervention anywhere in the article. Less than half of the studies included adverse events as an outcome measure, and data on absolute rates of adverse events were only provided in 28%. Most (65%) did not include any figures or tables on adverse event; however, all included these on efficacy outcomes (mean, 3 and range, 1-7). Regression analyses indicated that the use of reporting guidelines was significantly associated with better harms reporting (P = 0.04).
  
  
  CONCLUSIONS
  The reporting of harms in gastroenterology systematic reviews is largely inadequate and highly asymmetrical compared with the reporting of benefits. We suggest that review authors routinely assess both efficacy and harms outcomes of an intervention and that reporting guidelines specifically targeting harms reporting be developed.
authors.affiliation: School of Public Health, University of Sydney, Sydney, Australia; Storr Liver Unit, Westmead Millennium Institute, Westmead Hospital and University of Sydney, NSW, Australia. Electronic address: suzanne.mahady@sydney.edu.au.
authors.forename: Suzanne E
authors.initials: SE
authors.lastname: Mahady
authors.affiliation: School of Public Health, University of Sydney, Sydney, Australia.
authors.forename: Timothy
authors.initials: T
authors.lastname: Schlub
authors.affiliation: Department of Clinical Pharmacy and Institute for Health Policy Studies, University of California, San Francisco, CA, USA.
authors.forename: Lisa
authors.initials: L
authors.lastname: Bero
authors.affiliation: Clinical Epidemiology Program, Ottawa Hospital Research Institute, Faculty of Medicine, University of Ottawa, Ottawa, Canada.
authors.forename: David
authors.initials: D
authors.lastname: Moher
authors.affiliation: Cochrane Editorial Unit, 11-13 Cavendish Square, London W1G 0AN, United Kingdom.
authors.forename: David
authors.initials: D
authors.lastname: Tovey
authors.affiliation: Storr Liver Unit, Westmead Millennium Institute, Westmead Hospital and University of Sydney, NSW, Australia.
authors.forename: Jacob
authors.initials: J
authors.lastname: George
authors.affiliation: School of Public Health, University of Sydney, Sydney, Australia; Centre for Kidney Research, Kids Research Institute, The Children's Hospital at Westmead, NSW, Australia.
authors.forename: Jonathan C
authors.initials: JC
authors.lastname: Craig
mesh_terms: D064420:Drug-Related Side Effects and Adverse Reactions; D005762:Gastroenterology; D006801:Humans; D010506:Periodicals as Topic / Q000592:standards*; D011643:Publishing / Q000592:standards*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design / Q000592:standards*; D012196:Review Literature as Topic
keywords: Adverse events; Gastroenterology; Harms; Meta-analyses; Outcomes reporting bias; Systematic reviews