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Morton SC, Costlow MR, Graff JS, et al. Standards and guidelines for observational studies: quality is in the eye of the beholder. J Clin Epidemiol. 2015;71:3-10doi: 10.1016/j.jclinepi.2015.10.014.
Morton, S. C., Costlow, M. R., Graff, J. S., & Dubois, R. W. (2016). Standards and guidelines for observational studies: quality is in the eye of the beholder. Journal of clinical epidemiology, 713-10. https://doi.org/10.1016/j.jclinepi.2015.10.014
Morton, Sally C, et al. "Standards and guidelines for observational studies: quality is in the eye of the beholder." Journal of clinical epidemiology vol. 71 (2016): 3-10. doi: https://doi.org/10.1016/j.jclinepi.2015.10.014
Morton SC, Costlow MR, Graff JS, Dubois RW. Standards and guidelines for observational studies: quality is in the eye of the beholder. J Clin Epidemiol. 2016 Mar;71:3-10. doi: 10.1016/j.jclinepi.2015.10.014. Epub 2015 Nov 05. PMID: 26548541.
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J Clin Epidemiol. 2016 Mar;71:3-10. doi: 10.1016/j.jclinepi.2015.10.014. Epub 2015 Nov 05.

Standards and guidelines for observational studies: quality is in the eye of the beholder.

Journal of clinical epidemiology

Sally C Morton, Monica R Costlow, Jennifer S Graff, Robert W Dubois

Affiliations

  1. Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, 130 DeSoto Street, Pittsburgh, PA 15261, USA. Electronic address: [email protected].
  2. Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, 130 DeSoto Street, Pittsburgh, PA 15261, USA.
  3. National Pharmaceutical Council, 1717 Pennsylvania Avenue, NW, Suite 800, Washington, DC 20006, USA.

PMID: 26548541 DOI: 10.1016/j.jclinepi.2015.10.014

Abstract

OBJECTIVES: Patient care decisions demand high-quality research. To assist those decisions, numerous observational studies are being performed. Are the standards and guidelines to assess observational studies consistent and actionable? What policy considerations should be considered to ensure decision makers can determine if an observational study is of high-quality and valid to inform treatment decisions?

STUDY DESIGN AND SETTING: Based on a literature review and input from six experts, we compared and contrasted nine standards/guidelines using 23 methodological elements involved in observational studies (e.g., study protocol, data analysis, and so forth).

RESULTS: Fourteen elements (61%) were addressed by at least seven standards/guidelines; 12 of these elements disagreed in the approach. Nine elements (39%) were addressed by six or fewer standards/guidelines. Ten elements (43%) were not actionable in at least one standard/guideline that addressed the element.

CONCLUSION: The lack of observational study standard/guideline agreement may contribute to variation in study conduct; disparities in what is considered credible research; and ultimately, what evidence is adopted. A common set of agreed on standards/guidelines for conducting observational studies will benefit funders, researchers, journal editors, and decision makers.

Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Keywords: Comparative effectiveness research; Observational studies; Standards

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