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Reproducing a device literature search

Record the executed method, date and filters rather than relying only on the number of retrieved publications.

Representative research photograph: Reproducing a device literature search
Photo: EU2016 NL from The Netherlands · License: CC BY 2.0 · Cropped and resized.
Published
Updated

Finding hundreds of publications for a clinical evaluation does not explain how the search was performed. Another reviewer should be able to investigate the same question using the recorded method. Reproducibility helps assess scope and execution differences, but does not itself guarantee that all relevant evidence was identified.

Scope of the decision

The research question and database query are separate but connected records. Platform, execution date, full query, searched fields and active filters may affect retrieval. If the planned and executed strategies differ, preserve the change and its rationale. These are practical tools for examining the method.

Worked review

For example, a team reruns a query for a device family and obtains very different results. The earlier record contains only a keyword list. Review reveals that the original search used a title filter. The updated record retains both query and filters and examines which publications the scope difference affected.

Practical checks

  • Retain the executed query together with its platform and date.
  • Explain deviations from the planned method and their effect on results.
  • Test whether another reviewer can understand an example search from the record.

Acceptance and limits

Acceptance means traceable steps and known limitations. A database update may prevent identical counts later, which is not automatically an error. It should still be possible to investigate whether the difference arose from changed methods or updated content.

Frequently asked questions

Is a screenshot alone sufficient?
Not if it omits the query or context; necessary method details should remain accessible.
Do identical counts establish a good search?
No. Relevance to the question and suitability of the strategy need separate assessment.

Sources

  1. MDCG 2020-13 — Clinical evaluation assessment report, literature section
  2. EU 2017/745 — Medical Device Regulation, Article 61 and Annex XIV