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Observational studies are instrumental in health research as they provide important insights into disease patterns, treatment efficacy, and patient outcomes in real-world settings. However, the reporting of these studies has been a persistent challenge in the scientific community, thanks to inadequate documentation that usually hinders the evaluation of a study’s strengths, limitations, and generalizability to wider contexts. Observational research, unlike randomized controlled trials (RCTs), is especially prone to bias and confounding, necessitating transparent and systematic reporting for credibility and applicability.(1)

Identifying this need, the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) Statement was developed by collaborative efforts of epidemiologists, methodologists, and journal editors. First published in 2007, STROBE gives an exhaustive 22-item checklist to lead researchers, journal editors, and readers through the key components of cohort, case-control, and cross-sectional studies.(2) By promoting clarity in study objectives, selection of participant, data sources, variables, and analytical methods, STROBE empowers authors to accurately put forth their research design, methodology, and outcomes. Consequently, it enhances the clarity, generalizability, and validity of observational research while helping readers critically evaluate study reliability.(2, 3)

The increasing dependence on routinely collected health data, including data from electronic health records (EHRs), insurance claims, and registries, gave rise to new challenges that were not fully addressed by STROBE alone. To address these, the RECORD (REporting of studies Conducted using Observational Routinely collected health Data) guidelines were created as an extension to STROBE in 2015.(4) RECORD introduced a 13-item checklist addressing concerns pertinent to these data sources, such as database connections, coding procedures, algorithms, population hierarchies, and data cleaning methods. Considering that routinely collected data are mainly intended for administrative or clinical objectives rather than research, RECORD plays a significant role in ensuring transparent, complete, and accurate reporting, making findings more understandable and actionable for both health policy and clinical decision-making.(4)

Although the original STROBE and RECORD guidelines have not been updated, new extensions like STROBE-Equity,(5) STROBE-Vision,(6) and STROBE-MetEpi (6) have been or are being developed to address particular areas. Researchers are encouraged to use these extensions along with the main STROBE and RECORD checklists, as the basic frameworks remain the same.(5, 6)

A critical development in reporting standards is the emphasis on health equity; since  observational studies offer important equity-related data, although with limited guidance on reporting. The STROBE-Equity extension addresses this by including 10 additional equity-specific items to the STROBE checklist, enabling clearer reporting of discrepancies and their consequences. Its implementation by researchers and endorsement by journals can reinforce the inclusion of health equity in observational research to guide fairer and more socially relevant decision-making.(5)

Endorsement and execution of both STROBE and RECORD by authors, reviewers, and journals have already been linked to enhanced reporting quality. These guidelines promote full disclosure of study strengths and limitations, while mitigating risks of bias and misinterpretation originating from incomplete reporting. With evolving research approaches and data sources, the enhancement and consistent adoption of reporting standards like STROBE and RECORD continues to remain crucial. By reinforcing transparency, reproducibility, and reliability, these guidelines allow observational studies to efficiently contribute important and dependable evidence to the advancement of science, healthcare practice, and policy.

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References

1. Grosman S, Scott IA. Quality of observational studies of clinical interventions: a meta-epidemiological review. BMC Med Res Methodol. 2022 Dec 7;22(1):313.
2. von Elm E, Altman DG, Egger M, et al; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. PLoS Med. 2007 Oct 16;4(10):e296.
3. Vandenbroucke JP, von Elm E, Altman DG, et al; STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and elaboration. Value Health. 2014; 12(12):1500-1524.
4. Benchimol EI, Smeeth L, Guttmann A, Harron K, Moher D, Petersen I, Sørensen HT, von Elm E, Langan SM; RECORD Working Committee. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. PLoS Med. 2015 Oct 6;12(10):e1001885.
5. Dewidar O, Shamseer L, Melendez-Torres GJ, et al. Improving the reporting on health equity in observational research (STROBE-Equity): extension checklist and elaboration. BMJ 2025;390:e083882.
6. Equator Network. Reporting guidelines under development for observational studies2021. [Accessed on 16^th September 2025]. Available online at: https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-observational-studies/#STROBEV