READUS-PV

The REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance

Useful references

Reporting checklists for other data sources and methods useful in pharmacovigilance :

  • Case reports: CARE or ISoP/ISPE guideline [1,2]
  • Systematic reviews and meta-analyses: PRISMA [3]
  • Observational studies: STROBE or RECORD-PE [4,5]
  • Observed–to-expected: no specific guideline but READUS-PV and STROBE/RECORD-PE can be used [4,5]
  • Pre-clinical research: ARRIVE [6]

References :

[1]  Gagnier JJ, Kienle G, Altman DG, Moher D, Sox H, Riley D, et al. The CARE Guidelines: Consensus-based Clinical Case Reporting Guideline Development. Glob Adv Health Med 2013;2:38. https://doi.org/10.7453/gahmj.2013.008.

[2]  Kelly WN, Arellano FM, Barnes J, Bergman U, Edwards IR, Fernandez AM, et al. Guidelines for submitting adverse event reports for publication. Pharmacoepidemiol Drug Saf 2007;16:581–7. https://doi.org/10.1002/pds.1399.

[3]  Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. https://doi.org/10.1136/bmj.n71.

[4]  Langan SM, Schmidt SA, Wing K, Ehrenstein V, Nicholls SG, Filion KB, et al. The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE). BMJ 2018;363:k3532. https://doi.org/10.1136/bmj.k3532.

[5]  von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP, et al. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. J Clin Epidemiol 2008;61:344–9. https://doi.org/10.1016/j.jclinepi.2007.11.008.

[6]  Percie du Sert N, Hurst V, Ahluwalia A, Alam S, Avey MT, Baker M, et al. The ARRIVE guidelines 2.0: Updated guidelines for reporting animal research. PLoS Biol 2020;18:e3000410. https://doi.org/10.1371/journal.pbio.3000410.