Strengthening the reliability and credibility of observational epidemiology studies by creating an Observational Studies Register

• Published in: Journal of clinical epidemiology Vol. 64; no. 5; pp. 481 - 486
• Main Authors: Swaen, Gerard M.H, Carmichael, Neil, Doe, John
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01-05-2011; Elsevier; Elsevier Limited
• Subjects: Biological and medical sciences; Clinical trials; Clinical Trials as Topic - standards; Credibility; Data collection; Epidemiologic Research Design; Epidemiologic Studies; Epidemiology; Ethics; Funding; General aspects; Humans; Hypotheses; Initiatives; Internal Medicine; Medical sciences; Methods; Miscellaneous; Observation; Observational studies; Public health. Hygiene; Public health. Hygiene-occupational medicine; Publication Bias; Register; Registries; Review boards; Risk assessment; Risk Factors; Statistical analysis; Systematic review; Transparency; Publication bias; Transparency; Register; Epidemiology; Methods; Risk factors; Observational study; Methodology; Method; Risk factor; Published document; Methodological bias; Reliability; Public health
• ISSN: 0895-4356; 1878-5921
• DOI: 10.1016/j.jclinepi.2010.04.009

Abstract Objective To evaluate the need for the creation of a system in which observational epidemiology studies are registered; an Observational Studies Register (OSR). Study Design and Setting The current scientific process for observational epidemiology studies is described. Next, a parallel is made with the clinical trials area, where the creation of clinical trial registers has greatly restored and improved their credibility and reliability. Next, the advantages and disadvantages of an OSR are compared. Results The advantages of an OSR outweigh its disadvantages. Conclusion The creation of an OSR, similar to the existing Clinical Trials Registers, will improve the assessment of publication bias and will provide an opportunity to compare the original study protocol with the results reported in the publication. Reliability, credibility, and transparency of observational epidemiology studies are strengthened by the creation of an OSR. We propose a structured, collaborative, and coordinated approach for observational epidemiology studies that can provide solutions for existing weaknesses and will strengthen credibility and reliability, similar to the approach currently used in clinical trials, where Clinical Trials Registers have played a key role in strengthening their scientific value.