Risk of hydroxychloroquine alone and in combination with azithromycin in the treatment of rheumatoid arthritis: a multinational, retrospective study

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Abstract

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  1. SciScore for 10.1101/2020.04.08.20054551: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    NIH rigor criteria are not applicable to paper type.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Observational healthcare databases mapped to the Observational Medical Outcomes Partnership (OMOP) common data model collaborated in an international effort with the Observational Health Data Science and Informatics (OHDSI) community.37,38 De-identified or pseudonymised data were obtained from routinely collected records from clinical practice in Germany, Spain, the UK, Japan, and the USA.
    Observational healthcare
    suggested: None
    Studies were performed locally and no patient level data shared using the following databases: IQVIA Disease Analyser Germany EMR (ambulatory EMR from Germany); JMDC (Japanese claims); IPCI (primary care EMR from Netherlands); SIDIAP (primary care EMR from Spain); CPRD and IMDR (primary care EMRs from UK); and CCAE, Optum, MDCR, MDCD, PanTher, IQVIA OpenClaims, Veteran Affairs (VA), and IQVIA US Ambulatory EMR (USA).
    PanTher
    suggested: (PANTHER, RRID:SCR_004869)
    For the cohort analysis, the CohortMethod package was used (https://ohdsi.github.io/CohortMethod/) using a large-scale propensity score (PS) constructed through the Cyclops package (https://ohdsi.github.io/Cyclops).
    CohortMethod
    suggested: (CohortMethod, RRID:SCR_018511)

    Results from OddPub: Thank you for sharing your code and data.


    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Another potential limitation in this study is the potential for patients to be included in more than one dataset in the US. Whilst we ran meta-analysis, which assume populations are independent, we wish to highlight we are likely to under-estimate variance in our meta-analytic estimates. The comparative new user cohort studies are anchored in patients using HCQ for RA, who therefore are likely to be using HCQ at a lower dose than is currently being proposed for use in the treatment of COVID-19. We have taken into consideration that patients with RA taking HCQ may also have further auto-immune conditions such as systemic lupus erythematosus (SLE) and therefore generate the potential for confounding by indication.50 We therefore ensured that when investigating covariate balance after propensity score stratification and matching and before unblinding study results, that we did not see unbalanced proportions of patients with a diagnosis of SLE between the groups. Negative control outcome analyses also did not identify any residual unobserved confounding in the PS analysis. Whilst patients with RA may have greater levels of comorbidities than the general population, the age and demographic profile of patients developing cardiovascular complications described in both the systematic review and FAERS database suggests that complications are not only restricted to those with multimorbidity.48 However, absolute risk in our study should be interpreted cautiously since patients with RA a...

    Results from TrialIdentifier: No clinical trial numbers were referenced.


    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.


    Results from JetFighter: We did not find any issues relating to colormaps.


    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

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