Strengthening the reporting of observational studies in epidemiology

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The STROBE(STrengthening the Reporting of OBservational studies in Epidemiology) Statement is a reporting guideline including a checklist of 22 items that are considered essential for good reporting of observational studies. It was published simultaneously in several leading biomedical journals in October and November 2007 and comprises both the checklist [1] and an explanation and elaboration article [2] which gives examples of good reporting and provides authors with more guidance on good reporting. It is also referred to in the Uniform Requirements for Manuscripts Submitted to Biomedical Journals established by the International Committee of Medical Journal Editors and is endorsed by hundreds of biomedical journals. [3]

Contents

Purpose

The STROBE Statement was developed by the STROBE Initiative, an international collaboration of epidemiologists, methodologists, statisticians, researchers and journal editors with the aim to assist authors when writing up analytical observational studies, to support editors and reviewers when considering such articles for publication, and to help readers when critically appraising published articles. [4]

Extensions

There are many extensions to the STROBE Statement which cover a variety of different topic domains such as nutritional epidemiology, [5] [6] [7] genetic association studies, [8] rheumatology, [9] [10] molecular epidemiology, [11] infectious disease molecular epidemiology, [12] respondent-driven sampling, [13] routinely collected health data [14] [15] (e.g., health administrative data, electronic health records, and registry data), antimicrobial stewardship programs, [16] seroepidemiologic studies for influenza, [17] medical abortion, simulation-based research, newborn infection, [18] veterinary, [19] and sports injury and illness.

A draft checklist for reporting observational studies in conference abstracts is also available. [20]


Adaptations and future

In 2010, three years after STROBE's publication, the original creators reconvened and deemed an update unnecessary at the time. [21] However, since, calls have supported for the reporting guideline to be updated, similarly to other reporting guidelines (like CONSORT and PRISMA) which have been updated as needed. An assessment of extension content [22] as well as a survey of authors of observational studies [23] [24] provided several areas to improve upon.

The STROBE Statement checklist is also available to use within a Writing Aid Tool [25] [26] add-in for Microsoft Word that includes the STROBE checklist within the software.

The STROBE Statement has also been adapted as a public, open-source repository for epidemiological research methods and reporting skills for observational studies. Epidemiologists, statisticians, and public health researchers are able to comment and edit the tool to inform future updates of the reporting guideline. [27]

See also

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References

  1. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP (November 2007). "The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies". Epidemiology. 18 (6): 800–4. doi: 10.1097/EDE.0b013e3181577654 . PMID   18049194.
  2. Vandenbroucke JP, von Elm E, Altman DG, Gøtzsche PC, Mulrow CD, Pocock SJ, et al. (November 2007). "Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration". Epidemiology. 18 (6): 805–35. doi: 10.1097/EDE.0b013e3181577511 . PMID   18049195. S2CID   44770054.
  3. "STROBE Statement: Endorsement". www.strobe-statement.org. Retrieved 2020-04-29.
  4. von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP (October 2007). "The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies". PLOS Medicine. 4 (10): e296. doi: 10.1371/journal.pmed.0040296 . PMC   2020495 . PMID   17941714.
  5. "STROBE-nut".
  6. Hörnell A, Berg C, Forsum E, Larsson C, Sonestedt E, Åkesson A, et al. (September 2017). "Perspective: An Extension of the STROBE Statement for Observational Studies in Nutritional Epidemiology (STROBE-nut): Explanation and Elaboration". Advances in Nutrition. 8 (5): 652–678. doi:10.3945/an.117.015941. PMC   5593101 . PMID   28916567.
  7. Lachat C, Hawwash D, Ocké MC, Berg C, Forsum E, Hörnell A, et al. (June 2016). "Strengthening the Reporting of Observational Studies in Epidemiology-Nutritional Epidemiology (STROBE-nut): An Extension of the STROBE Statement". PLOS Medicine. 13 (6): e1002036. doi: 10.1371/journal.pmed.1002036 . PMC   4896435 . PMID   27270749.
  8. Little J, Higgins JP, Ioannidis JP, Moher D, Gagnon F, von Elm E, et al. (February 2009). "STrengthening the REporting of Genetic Association Studies (STREGA): an extension of the STROBE statement". PLOS Medicine. 6 (2): e22. doi: 10.1371/journal.pmed.1000022 . PMC   2634792 . PMID   19192942.
  9. Dixon WG, Carmona L, Finckh A, Hetland ML, Kvien TK, Landewe R, et al. (September 2010). "EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology". Annals of the Rheumatic Diseases. 69 (9): 1596–602. doi:10.1136/ard.2009.125526. PMID   20525843. S2CID   23905174.
  10. Zavada J, Dixon WG, Askling J (March 2014). "Launch of a checklist for reporting longitudinal observational drug studies in rheumatology: a EULAR extension of STROBE guidelines based on experience from biologics registries". Annals of the Rheumatic Diseases. 73 (3): 628. doi:10.1136/annrheumdis-2013-204102. PMID   24058015. S2CID   10261301.
  11. Gallo V, Egger M, McCormack V, Farmer PB, Ioannidis JP, Kirsch-Volders M, et al. (January 2012). "STrengthening the Reporting of OBservational studies in Epidemiology - Molecular Epidemiology (STROBE-ME): an extension of the STROBE statement" (PDF). European Journal of Clinical Investigation. 42 (1): 1–16. doi:10.1111/j.1365-2362.2011.02561.x. hdl: 1874/274530 . PMID   22023344. S2CID   52871891.
  12. Field N, Cohen T, Struelens MJ, Palm D, Cookson B, Glynn JR, et al. (April 2014). "Strengthening the Reporting of Molecular Epidemiology for Infectious Diseases (STROME-ID): an extension of the STROBE statement" (PDF). The Lancet. Infectious Diseases. 14 (4): 341–52. doi:10.1016/S1473-3099(13)70324-4. PMID   24631223.
  13. White RG, Hakim AJ, Salganik MJ, Spiller MW, Johnston LG, Kerr L, et al. (December 2015). "Strengthening the Reporting of Observational Studies in Epidemiology for respondent-driven sampling studies: "STROBE-RDS" statement". Journal of Clinical Epidemiology. 68 (12): 1463–71. doi:10.1016/j.jclinepi.2015.04.002. PMC   4669303 . PMID   26112433.
  14. "What is RECORD?". RECORD-Statement.org.
  15. Benchimol EI, Smeeth L, Guttmann A, Harron K, Moher D, Petersen I, et al. (October 2015). "The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement". PLOS Medicine. 12 (10): e1001885. doi: 10.1371/journal.pmed.1001885 . PMC   4595218 . PMID   26440803.
  16. Tacconelli E, Cataldo MA, Paul M, Leibovici L, Kluytmans J, Schröder W, et al. (February 2016). "STROBE-AMS: recommendations to optimise reporting of epidemiological studies on antimicrobial resistance and informing improvement in antimicrobial stewardship". BMJ Open. 6 (2): e010134. doi:10.1136/bmjopen-2015-010134. PMC   4762075 . PMID   26895985.
  17. Horby PW, Laurie KL, Cowling BJ, Engelhardt OG, Sturm-Ramirez K, Sanchez JL, et al. (January 2017). "CONSISE statement on the reporting of Seroepidemiologic Studies for influenza (ROSES-I statement): an extension of the STROBE statement". Influenza and Other Respiratory Viruses. 11 (1): 2–14. doi:10.1111/irv.12411. PMC   5155648 . PMID   27417916.
  18. Fitchett EJ, Seale AC, Vergnano S, Sharland M, Heath PT, Saha SK, et al. (SPRING (Strengthening Publications Reporting Infection in Newborns Globally) Group) (October 2016). "Strengthening the Reporting of Observational Studies in Epidemiology for Newborn Infection (STROBE-NI): an extension of the STROBE statement for neonatal infection research" (PDF). The Lancet. Infectious Diseases. 16 (10): e202–e213. doi:10.1016/S1473-3099(16)30082-2. PMID   27633910.
  19. O'Connor AM, Sargeant JM, Dohoo IR, Erb HN, Cevallos M, Egger M, et al. (December 2016). "Explanation and Elaboration Document for the STROBE-Vet Statement: Strengthening the Reporting of Observational Studies in Epidemiology - Veterinary Extension". Zoonoses and Public Health. 63 (8): 662–698. doi: 10.1111/zph.12315 . PMID   27873473.
  20. "STROBE checklists". strobe-statement.org. Retrieved 15 May 2015.
  21. "STROBE Statement: Home". www.strobe-statement.org. Retrieved 2020-04-29.
  22. Sharp MK, Hren D, Altman DG (November 2018). "The STROBE Extensions: Considerations for Development". Epidemiology. 29 (6): e53–e56. doi:10.1097/EDE.0000000000000899. PMC   7659437 . PMID   30052544.
  23. Sharp MK, Bertizzolo L, Rius R, Wager E, Gómez G, Hren D (December 2019). "Using the STROBE statement: survey findings emphasized the role of journals in enforcing reporting guidelines". Journal of Clinical Epidemiology. 116: 26–35. doi: 10.1016/j.jclinepi.2019.07.019 . hdl: 2117/339689 . PMID   31398440.
  24. Sharp MK, Glonti K, Hren D (April 2020). "Online survey about the STROBE Statement highlighted divergent views about its content, purpose, and value". Journal of Clinical Epidemiology. 123: 100–106. doi: 10.1016/j.jclinepi.2020.03.025 . PMID   32259582.
  25. Hawwash D, Sharp MK, Argaw A, Kolsteren P, Lachat C (November 2019). "Usefulness of applying research reporting guidelines as Writing Aid software: a crossover randomised controlled trial". BMJ Open. 9 (11): e030943. doi:10.1136/bmjopen-2019-030943. PMC   6858139 . PMID   31699728.
  26. carllachat (2020-01-23). "carllachat/WritingAidTool". GitHub . Retrieved 2020-04-29.
  27. Sharp MK. Strengthening the Reporting of Observational Studies in Epidemiology STROBE (STROBE) Educational Expansion.