title: The REporting of Studies Conducted Using Observational Routinely-Collected Health Data (RECORD) Statement: Methods for Arriving at Consensus and Developing Reporting Guidelines.
abstract: OBJECTIVE
  Routinely collected health data, collected for administrative and clinical purposes, without specific a priori research questions, are increasingly used for observational, comparative effectiveness, health services research, and clinical trials. The rapid evolution and availability of routinely collected data for research has brought to light specific issues not addressed by existing reporting guidelines. The aim of the present project was to determine the priorities of stakeholders in order to guide the development of the REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement.
  
  
  METHODS
  Two modified electronic Delphi surveys were sent to stakeholders. The first determined themes deemed important to include in the RECORD statement, and was analyzed using qualitative methods. The second determined quantitative prioritization of the themes based on categorization of manuscript headings. The surveys were followed by a meeting of RECORD working committee, and re-engagement with stakeholders via an online commentary period.
  
  
  RESULTS
  The qualitative survey (76 responses of 123 surveys sent) generated 10 overarching themes and 13 themes derived from existing STROBE categories. Highest-rated overall items for inclusion were: Disease/exposure identification algorithms; Characteristics of the population included in databases; and Characteristics of the data. In the quantitative survey (71 responses of 135 sent), the importance assigned to each of the compiled themes varied depending on the manuscript section to which they were assigned. Following the working committee meeting, online ranking by stakeholders provided feedback and resulted in revision of the final checklist.
  
  
  CONCLUSIONS
  The RECORD statement incorporated the suggestions provided by a large, diverse group of stakeholders to create a reporting checklist specific to observational research using routinely collected health data. Our findings point to unique aspects of studies conducted with routinely collected health data and the perceived need for better reporting of methodological issues.
authors.affiliation: Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada; Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada.
authors.forename: Stuart G
authors.initials: SG
authors.lastname: Nicholls
authors.affiliation: Institute for Clinical Evaluative Sciences, Toronto, Canada.
authors.forename: Pauline
authors.initials: P
authors.lastname: Quach
authors.affiliation: Cochrane Switzerland, Institute of Social and Preventive Medicine, University of Lausanne, Lausanne, Switzerland.
authors.forename: Erik
authors.initials: E
authors.lastname: von Elm
authors.affiliation: Institute for Clinical Evaluative Sciences, Toronto, Canada; Hospital for Sick Children, Department of Paediatrics and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Canada.
authors.forename: Astrid
authors.initials: A
authors.lastname: Guttmann
authors.affiliation: Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada; Ottawa Hospital Research Institute, Ottawa, Canada.
authors.forename: David
authors.initials: D
authors.lastname: Moher
authors.affiliation: Department of Primary Care and Population Health, University College London, London, United Kingdom.
authors.forename: Irene
authors.initials: I
authors.lastname: Petersen
authors.affiliation: Department of Clinical Epidemiology, Aarhus University, Aarhus, Denmark.
authors.forename: Henrik T
authors.initials: HT
authors.lastname: Sørensen
authors.affiliation: London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Liam
authors.initials: L
authors.lastname: Smeeth
authors.affiliation: London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Sinéad M
authors.initials: SM
authors.lastname: Langan
authors.affiliation: Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada; Children's Hospital of Eastern Ontario Research Institute, Ottawa, Canada; Institute for Clinical Evaluative Sciences, Toronto, Canada; Department of Pediatrics, Children's Hospital of Eastern Ontario, University of Ottawa, Ottawa, Canada.
authors.forename: Eric I
authors.initials: EI
authors.lastname: Benchimol
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D032921:Consensus; D003628:Database Management Systems; D005260:Female; D017408:Guidelines as Topic; D006801:Humans; D008297:Male; D008499:Medical Records / Q000592:standards*; D008875:Middle Aged; D064887:Observational Studies as Topic; D011795:Surveys and Questionnaires