Regulatory Open Forum

 View Only

  • 1.  Narrowing CE/PMS literature search results

    Posted 13-Sep-2023 16:00

    Does anyone have suggestions for narrowing or sampling scientific literature results when a high number of results makes it unrealistic to review all?  I've been sorting by "relevance" and then cutting-off review at some arbitrary number, but is there a sounder method that stands-up to NB scrutiny?



    ------------------------------
    Tim White
    RA Manager
    Orchard Park NY
    ------------------------------


  • 2.  RE: Narrowing CE/PMS literature search results

    Posted 14-Sep-2023 05:57

    Hi Tim,

    without further information on your specific product, it is difficult to give you meaningful advice :D 

    If you are using PubMed library it can be a tedious job, however, you can use timeframes for your search, choose only abstracts, and narrow your search by specific article type, taking it in digestible chunks. 

    Once you find some relevant articles you can try different tools - I personally like Litmap for further digging :D but there are many more academic apps you find online,

    for my searches, I use lots of #codewords, documented in PMSP so I can at least be consistent with my review, 

    I recommend speaking with your science team, and engineers to include their #codewords in your search, which will significantly narrow down your search results,

    I hope this helps a bit :D 



    ------------------------------
    Tomasz Ciski
    Mr
    Loughborough
    United Kingdom
    ------------------------------

    Original Message


  • 3.  RE: Narrowing CE/PMS literature search results

    Posted 14-Sep-2023 07:30

    Hi Tim,

    I agree that the number of articles to review for a literature summary can get overwhelming, but the notified bodies are definitely looking for a justified, systematic approach to including and excluding articles. 

    Some tips on limiting the number of hits and reviewing efficiently:

    • Refine your search strings: Using the PICO strategy to define search strings helps you to narrow results to articles that are more likely to be relevant to your device, its indications, and the specific and measurable outcomes you are using to show safety and performance
    • Establish well-defined inclusion/exclusion criteria
    • Use screening software: There are options available to enable a more efficient screening process at both the title/abstract and full text level. Some options even include AI-assisted screening.

    Best, 

    Bethany



    ------------------------------
    Bethany Chung, PhD, RAC
    Principal Consultant
    MD, United States
    ------------------------------

    Original Message


  • 4.  RE: Narrowing CE/PMS literature search results

    Posted 14-Sep-2023 10:08

    Hello Tim,

    Bethany has some good advice, which I would second in refining your search strings.  Pubmed has decent ability to get a bit more refined on the search strings, but there are others which have much better capability, e.g. ScienceDirect (but most likely need the subscription to access all the features).  The better PICO strategy can develop to help identify the search terms, and then use some "play around" with these to create good search strings.  The better search strings which can be developed the better, but use caution because you do not want to miss some things having the search string maybe too specific.  Plus maybe need to use a little "magic" haha, but it does take some practice and experience running search strings on the different literature databases.  The post market databases are a little easier, because many the fields are quite limited already.



    ------------------------------
    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


Related Content