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The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.
Open accessAbstract
Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September, 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles.18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies.A detailed explanation and elaboration document is published separately and is freely available on the websites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE statement will contribute to improving the quality of reporting of observational studies
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“This study was designed and reported in accordance with the CONSORT 2010 guidelines to ensure transparency, reproducibility, and completeness of reporting [13].”
From Blood PCSK9 Impacts Alzheimer's Disease Risk in an APOE Genotype‐Dependent Manner: A Prospective Cohort Study (2026) · cites this paper as [13]
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“This retrospective observational cohort study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline.25”
From Discontinuation and Reinitiation of Dual-Labeled GLP-1 Receptor Agonists Among US Adults With Overweight or Obesity (2025) · cites this paper as [25]
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“This multivariate prediction scale was reported according to the TRIPOD (Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis) Statement and according to the guidelines for reporting observational studies as described in the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) Statement [18,26].”
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“We followed the STROBE reporting guideline for observational studies [17].”
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“To improve the quality of the reporting, this study adhered to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines [35].”
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In the citing paper
“The study adhered to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) declaration standards [26].”
From Financial barriers to healthcare access among reproductive-age women in Sierra Leone: evidence from demographic health surveys of 2008, 2013, and 2019 (2026) · cites this paper as [26]
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In the citing paper
“The reporting of this study conforms to CONSORT guidelines [12].”
From Mindfulness intervention, homogeneous medical concept, and concentrated solution nursing for colorectal cancer patients: a retrospective study (2024) · cites this paper as [12]
Experimental — accuracy not yet measuredIn the citing paper
“Thus a 22-item checklist was generated to enhance the reporting of observational studies across disciplines.25,26”
From Observational studies: Cohort and case-control studies (2010) · cites this paper as [25]
In the citing paper
“The quality assessment of the included studies was carried out using the Strobe-checklist (28).”
From Digital Media Use and Adolescents' Mental Health During the Covid-19 Pandemic: A Systematic Review and Meta-Analysis (2022) · cites this paper as [28]
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“The study follows the Strengthening the Reporting of Observational studies in Epidemiology guidelines.15”
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“This study was performed following the ethical standards of our institution's Committee on Human Experimentation (Institutional Review Board N°00006477, approval 15-062) and reported according to the Strengthening the Reporting of Observational Studies Epidemiology (STROBE) guidelines [16].”
From Improving clinical suspicion of acute mesenteric ischemia among patients with acute abdomen: A cross-sectional study from an intestinal stroke center (2023) · cites this paper as [16]
In the citing paper
“This study was performed following the ethical standards of our institution's Committee on Human Experimentation (Institutional Review Board N°00006477, approval 15-062) and reported according to the Strengthening the Reporting of Observational Studies Epidemiology (STROBE) guidelines [16].”
From Improving clinical suspicion of acute mesenteric ischemia among patients with acute abdomen: A cross-sectional study from an intestinal stroke center (2023) · cites this paper as [16]
In the citing paper
“Most guidelines, such as the STROBE guidelines for the reporting of observational studies or the REMARK guidelines for tumour marker prognostic studies, specifically advise investigators to report both unadjusted results (i.e., from univariable analysis, yielding the association of each candidate predictor with the outcome) and adjusted results (i.e., from a multivariable analysis) [4],[38],[63].”
From Reporting and Methods in Clinical Prediction Research: A Systematic Review (2012) · cites this paper as [38]
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“The quality of the quantitative studies was assessed using an adaptation of the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement”
From The Mistreatment of Women during Childbirth in Health Facilities Globally: A Mixed-Methods Systematic Review (2015) · cites this paper as [30]
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Citations
Cites
von Elm, E., Altman, D. G., Egger, M., Pocock, S. J., Gøtzsche, P. C., Vandenbroucke, J. P., & Initiative, F. T. S. (2007) · PLoS Medicine · doi:10.1371/journal.pmed.0040296 · Cited by 23,020
Self-citationVandenbroucke, J. P., von Elm, E., Altman, D. G., Gøtzsche, P. C., Mulrow, C. D., Pocock, S. J., Poole, C., Schlesselman, J. J., Egger, M., & Initiative, F. T. S. (2007) · PLoS Medicine · doi:10.1371/journal.pmed.0040297 · Cited by 8,613
Self-citationMoher, D., Schulz, K. F., & Altman, D. G. (2001) · The Lancet · doi:10.1016/s0140-6736(00)04337-3 · Cited by 5,373
Self-citationMoher, D., Cook, D. J., Eastwood, S., Olkin, I., Rennie, D., & Stroup, D. F. (1999) · The Lancet · doi:10.1016/s0140-6736(99)04149-5 · Cited by 4,826
Consort 2010 statement: extension to cluster randomised trials
Campbell, M. K., Piaggio, G., Elbourne, D. R., Altman, D. G., & for the CONSORT Group (2012) · BMJ · doi:10.1136/bmj.e5661 · Cited by 3,510
Self-citationAssessing the quality of controlled clinical trials
Jüni, P., Altman, D. G., & Egger, M. (2001) · BMJ · doi:10.1136/bmj.323.7303.42 · Cited by 3,309 · cited 1×
“Transparent reporting is also needed to judge whether and how results can be included in systematic reviews (4, 5).”
Self-citationTowards complete and accurate reporting of studies of diagnostic accuracy: The STARD Initiative.
Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L. M., Lijmer, J. G., Moher, D., Rennie, D., de Vet, H. C. W., et al. (2003) · Annals of Internal Medicine · doi:10.7326/0003-4819-138-1-200301070-00010 · Cited by 3,219
Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative
Bossuyt, P. M., Reitsma, J. B., Bruns, D. E., Gatsonis, C. A., Glasziou, P. P., Irwig, L. M., Lijmer, J. G., Moher, D., Rennie, D., & de Vet, H. C. W. (2003) · BMJ · doi:10.1136/bmj.326.7379.41 · Cited by 3,215
Vandenbroucke, J. P., von Elm, E., Altman, D. G., Gøtzsche, P. C., Mulrow, C. D., Pocock, S. J., Poole, C., Schlesselman, J. J., & Egger, M. (2007) · Epidemiology · doi:10.1097/ede.0b013e3181577511 · Cited by 2,779
Self-citationCONSORT statement: extension to cluster randomised trials
Campbell, M. K., Elbourne, D. R., & Altman, D. G. (2004) · BMJ · doi:10.1136/bmj.328.7441.702 · Cited by 2,557
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Inouye, S. K., Westendorp, R. G., & Saczynski, J. S. (2014) · The Lancet · doi:10.1016/s0140-6736(13)60688-1 · Cited by 3,722
Genome-wide association studies for complex traits: consensus, uncertainty and challenges
McCarthy, M. I., Abecasis, G. R., Cardon, L. R., Goldstein, D. B., Little, J., Ioannidis, J. P. A., & Hirschhorn, J. N. (2008) · Nature Reviews Genetics · doi:10.1038/nrg2344 · Cited by 2,891
Rotenstein, L. S., Ramos, M. A., Torre, M., Segal, J. B., Peluso, M. J., Guille, C., Sen, S., & Mata, D. A. (2016) · JAMA · doi:10.1001/jama.2016.17324 · Cited by 2,479
Nepogodiev, D., Bhangu, A., Glasbey, J. C., Li, E., Omar, O. M., Simoes, J. F., Abbott, T. E., Alser, O., Arnaud, A. P., Bankhead-Kendall, B. K., et al. (2020) · The Lancet · doi:10.1016/s0140-6736(20)31182-x · Cited by 1,711
Bohren, M. A., Vogel, J. P., Hunter, E. C., Lutsiv, O., Makh, S. K., Souza, J. P., Aguiar, C., Saraiva Coneglian, F., Diniz, A. L. A., Tunçalp, Ö., et al. (2015) · PLOS Medicine · doi:10.1371/journal.pmed.1001847 · Cited by 1,656
Metadata
- Authors
- von Elm, E., Altman, D. G., Egger, M., Pocock, S. J., Gøtzsche, P. C., & Vandenbroucke, J. P.
- Affiliations
- University of Oxford (GB)
- University of Bern (CH)
- University of London (GB)
- Cochrane (DK)
- Leiden University Medical Center (NL)
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2007-10
- Volume
- 370
- Issue
- 9596
- Pages
- 1453-1457
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2275737843
- Semantic Scholar
- 1b33b74fe5eac26cd9e207bc0d5a477e7aa5391b
- Cited by
- 21,320
- References
- 33
- Citations by year
- 2026: 5336 · 2025: 3610 · 2024: 2953 · 2023: 1928 · 2022: 1503 · 2021: 1392 · 2020: 1065 · 2019: 731 · 2018: 566 · 2017: 498 · 2016: 419 · 2015: 337 · 2014: 270 · 2013: 198 · 2012: 167
- FWCI
- 71.06
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- ePrints Soton (University of Southampton) (submittedVersion, cc-by-nc)
- Funders
- European Science Foundation
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Health Sciences › Nursing › Research and Theory › Methodologies in Health Research and Practice
- Keywords
- STROBE statement, reporting guidelines, observational studies, cohort studies, case-control study, cross-sectional study, reporting quality, checklists, study design reporting
- MeSH terms
- Cross-Sectional Studies, Publishing, Cohort Studies, Epidemiologic Research Design, Case-Control Studies, Observation
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