Setting the RECORD straight: developing a guideline for the REporting of studies Conducted using Observational Routinely collected Data

Setting the RECORD straight: developing a guideline for the REporting of studies Conducted using Observational Routinely collected Data Sinéad M Langan,1 Eric I Benchimol,2,3 Astrid Guttmann,2 David Moher,4 Irene Petersen,5 Liam Smeeth,1 Henrik Toft Sørensen,6 Fiona Stanley,7 Erik Von Elm81Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom; 2Institute for Clinical Evaluative Sciences, University of Toronto, Toronto, Canada; 3Department of Pediatrics and Epidemiology and Community Medicine University of Ottawa, Ottawa, Canada; 4Ottawa Hospital Research Institute, Ottawa, Canada; 5Department of Primary Care and Population Health, University College London, London, United Kingdom; 6Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus University, Aarhus, Denmark; 7Telethon Department of Child Health, University of Western Australia, Perth, Australia; 8Institut Universitaire de Médecine Sociale et Préventive, University of Lausanne, Switzerland Recent technological developments in recording health care delivery have led to major research opportunities for epidemiologists and others. There has been a dramatic increase in the availability of "routine data" for research purposes, including data from electronic medical records, administrative data for billing purposes, disease registries, and sources of sociodemographic data. Examples of routine data include data from medical records in the UK in the Clinical Practice Research Database, administrative data from Surveillance, Epidemiology and End Results Medicare, and registry data from the Danish National Registry of Patients. The key aspect that differentiates routine data from other research data sources is the reasons for which the data were collected, since routine data are not specifically collected for research purposes. These data are increasingly available from various health care settings and geographic locations. They present innovative, efficient, and cost-effective prospects with which to answer key research questions. However, use of these data for research leads to specific challenges for researchers and for policymakers and clinicians in using studies based on such data.