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Research Methods & Reporting

The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE)

BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k3532 (Published 14 November 2018) Cite this as: BMJ 2018;363:k3532
  1. Sinéad M Langan, associate professor1,
  2. Sigrún AJ Schmidt, registrar2,
  3. Kevin Wing, assistant professor1,
  4. Vera Ehrenstein, professor2,
  5. Stuart G Nicholls, postdoctoral fellow3 4,
  6. Kristian B Filion, assistant professor5 6,
  7. Olaf Klungel, professor7,
  8. Irene Petersen, professor2 8,
  9. Henrik T Sorensen, professor2,
  10. William G Dixon, professor9,
  11. Astrid Guttmann, senior scientist10 11,
  12. Katie Harron, associate professor12,
  13. Lars G Hemkens, senior scientist13,
  14. David Moher, professor3,
  15. Sebastian Schneeweiss, professor14,
  16. Liam Smeeth, professor1,
  17. Miriam Sturkenboom, associate professor15,
  18. Erik von Elm, codirector16,
  19. Shirley V Wang, assistant professor14,
  20. Eric I Benchimol, associate professor and senior scientist10 17 18
  1. 1Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK
  2. 2Department of Clinical Epidemiology, Aarhus University, Aarhus, Denmark
  3. 3Ottawa Hospital Research Institute, Ottawa, ON, Canada;
  4. 4School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada
  5. 5Departments of Medicine and of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, QC, Canada
  6. 6Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal, QC, Canada
  7. 7Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands
  8. 8Department of Primary Care and Population Health, University College London, London, UK
  9. 9Arthritis Research UK Centre for Epidemiology, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK
  10. 10Institute for Clinical Evaluative Sciences, Toronto, ON, Canada
  11. 11Hospital for Sick Children, Department of Paediatrics, University of Toronto, Toronto, ON, Canada
  12. 12ICH Population, Policy, and Practice Programme, University College London, Great Ormond Street Institute of Child Health, London, UK
  13. 13Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland
  14. 14Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA
  15. 15Julius Global Health, University Medical Center Utrecht, Utrecht, Netherlands
  16. 16Cochrane Switzerland, Institute of Social and Preventive Medicine, University of Lausanne, Lausanne, Switzerland
  17. 17Department of Pediatrics and School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada
  18. 18Children’s Hospital of Eastern Ontario Research Institute, Ottawa, ON, Canada
  1. Correspondence to: S M Langan sinead.langan{at}lshtm.ac.uk
  • Accepted 30 July 2018

In pharmacoepidemiology, routinely collected data from electronic health records (including primary care databases, registries, and administrative healthcare claims) are a resource for research evaluating the real world effectiveness and safety of medicines. Currently available guidelines for the reporting of research using non-randomised, routinely collected data—specifically the REporting of studies Conducted using Observational Routinely collected health Data (RECORD) and the Strengthening the Reporting of OBservational studies in Epidemiology (STROBE) statements—do not capture the complexity of pharmacoepidemiological research. We have therefore extended the RECORD statement to include reporting guidelines specific to pharmacoepidemiological research (RECORD-PE). This article includes the RECORD-PE checklist (also available on www.record-statement.org) and explains each checklist item with examples of good reporting. We anticipate that increasing use of the RECORD-PE guidelines by researchers and endorsement and adherence by journal editors will improve the standards of reporting of pharmacoepidemiological research undertaken using routinely collected data. This improved transparency will benefit the research community, patient care, and ultimately improve public health.

Routinely collected health data are a by-product of the daily operations of healthcare systems, collected independently of specific a priori research questions.12 A broad range of sources (eg, disease registries, health administrative data, quality/safety surveillance databases, electronic health records, and pharmacy data) contain routinely collected data and have both drug exposure and clinical outcomes that are of potential use in pharmacoepidemiology.34

In pharmacoepidemiology, routinely collected health data are a broadly accepted, necessary, and cost effective resource widely used for evaluating the real world effectiveness and safety of medicines. Studies conducted with routinely collected data are necessary for many reasons. Clinical trials might not be available, or ethical, and could have limitations owing to restrictive inclusion and exclusion criteria. Primary data collection could be costly or infeasible, have limited statistical power to detect safety events, or have durations …

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