title: Evaluating Data Abstraction Assistant, a novel software application for data abstraction during systematic reviews: protocol for a randomized controlled trial.
abstract: Data abstraction, a critical systematic review step, is time-consuming and prone to errors. Current standards for approaches to data abstraction rest on a weak evidence base. We developed the Data Abstraction Assistant (DAA), a novel software application designed to facilitate the abstraction process by allowing users to (1) view study article PDFs juxtaposed to electronic data abstraction forms linked to a data abstraction system, (2) highlight (or "pin") the location of the text in the PDF, and (3) copy relevant text from the PDF into the form. We describe the design of a randomized controlled trial (RCT) that compares the relative effectiveness of (A) DAA-facilitated single abstraction plus verification by a second person, (B) traditional (non-DAA-facilitated) single abstraction plus verification by a second person, and (C) traditional independent dual abstraction plus adjudication to ascertain the accuracy and efficiency of abstraction.
  
  
  
  This is an online, randomized, three-arm, crossover trial. We will enroll 24 pairs of abstractors (i.e., sample size is 48 participants), each pair comprising one less and one more experienced abstractor. Pairs will be randomized to abstract data from six articles, two under each of the three approaches. Abstractors will complete pre-tested data abstraction forms using the Systematic Review Data Repository (SRDR), an online data abstraction system. The primary outcomes are (1) proportion of data items abstracted that constitute an error (compared with an answer key) and (2) total time taken to complete abstraction (by two abstractors in the pair, including verification and/or adjudication).
  
  
  
  The DAA trial uses a practical design to test a novel software application as a tool to help improve the accuracy and efficiency of the data abstraction process during systematic reviews. Findings from the DAA trial will provide much-needed evidence to strengthen current recommendations for data abstraction approaches.
  
  
  
  The trial is registered at National Information Center on Health Services Research and Health Care Technology (NICHSR) under Registration # HSRP20152269: https://wwwcf.nlm.nih.gov/hsr_project/view_hsrproj_record.cfm?NLMUNIQUE_ID=20152269&SEARCH_FOR=Tianjing%20Li . All items from the World Health Organization Trial Registration Data Set are covered at various locations in this protocol. Protocol version and date: This is version 2.0 of the protocol, dated September 6, 2016. As needed, we will communicate any protocol amendments to the Institutional Review Boards (IRBs) of Johns Hopkins Bloomberg School of Public Health (JHBSPH) and Brown University. We also will make appropriate as-needed modifications to the NICHSR website in a timely fashion.
authors.affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Room W6507-B, Baltimore, MD, 21205, USA. isaldan1@jhmi.edu.
authors.forename: Ian J
authors.initials: IJ
authors.lastname: Saldanha
authors.affiliation: Department of Biostatistics, and Center for Evidence-based Medicine, Brown University School of Public Health, Providence, RI, USA.
authors.forename: Christopher H
authors.initials: CH
authors.lastname: Schmid
authors.affiliation: Department of Health Services, Policy and Practice, and Center for Evidence-based Medicine, Brown University School of Public Health, Providence, RI, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Lau
authors.affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Room W6507-B, Baltimore, MD, 21205, USA.
authors.forename: Kay
authors.initials: K
authors.lastname: Dickersin
authors.affiliation: Epidemiology, Johnson & Johnson, Titusville, NJ, USA.
authors.forename: Jesse A
authors.initials: JA
authors.lastname: Berlin
authors.affiliation: Center for Evidence-based Medicine, Brown University School of Public Health, Providence, RI, USA.
authors.forename: Jens
authors.initials: J
authors.lastname: Jap
authors.affiliation: Center for Evidence-based Medicine, Brown University School of Public Health, Providence, RI, USA.
authors.forename: Bryant T
authors.initials: BT
authors.lastname: Smith
authors.affiliation: Department of Medicine, University of California San Francisco School of Medicine, San Francisco, CA, USA.
authors.forename: Simona
authors.initials: S
authors.lastname: Carini
authors.affiliation: Internal Medicine, Kaiser Permanente Northwest, Portland, OR, USA.
authors.forename: Wiley
authors.initials: W
authors.lastname: Chan
authors.affiliation: National Research Council Information and Communications Technologies Portfolio (NRC-ICT), Ottawa, ON, Canada.
authors.forename: Berry
authors.initials: B
authors.lastname: De Bruijn
authors.affiliation: Northeastern University College of Computer and Information Science, Boston, MA, USA.
authors.forename: Byron C
authors.initials: BC
authors.lastname: Wallace
authors.affiliation: Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD, USA.
authors.forename: Susan M
authors.initials: SM
authors.lastname: Hutfless
authors.affiliation: Department of Medicine, University of California San Francisco School of Medicine, San Francisco, CA, USA.
authors.forename: Ida
authors.initials: I
authors.lastname: Sim
authors.affiliation: College of Medicine, and Evidence-based Practice Center, Mayo Clinic, ᅟRochester, MN, USA.
authors.forename: M Hassan
authors.initials: MH
authors.lastname: Murad
authors.affiliation: California Breast Cancer Organizations, Davis, CA, USA.
authors.forename: Sandra A
authors.initials: SA
authors.lastname: Walsh
authors.affiliation: Cochrane Consumer Network, Fredericton, NB, Canada.
authors.forename: Elizabeth J
authors.initials: EJ
authors.lastname: Whamond
authors.affiliation: Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 615 North Wolfe Street, Room W6507-B, Baltimore, MD, 21205, USA.
authors.forename: Tianjing
authors.initials: T
authors.lastname: Li
mesh_terms: D000043:Abstracting and Indexing; D019317:Evidence-Based Medicine / Q000379:methods; D006801:Humans; D012984:Software; D000078202:Systematic Reviews as Topic
keywords: Data abstraction; Randomized controlled trial; Systematic reviews