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Justifying database coverage in device literature reviews

Connect source selection to the publication landscape of the device question and evidence that might otherwise be missed.

Representative research photograph: Justifying database coverage in device literature reviews
Photo: EU2016 NL from The Netherlands · License: CC BY 2.0 · Cropped and resized.
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One database may produce many results while covering different publication types unevenly. Assess suitability for the question before interpreting retrieval volume. The aim is not a longer source list, but an explanation of why important evidence domains are covered or remain limited.

Scope of the decision

Clinical use, technology and relevant outcomes may be reported across different publication settings. Distinguish overlap from complementary coverage. Adapt queries to each platform’s fields and indexing instead of copying one search mechanically. Do not assume that any source has unlimited or unchanging coverage.

Worked review

For example, a team reviewing an imaging device initially uses only a general biomedical source. Preliminary work finds relevant technical-performance studies concentrated elsewhere. The team assesses an appropriate additional source while making clear that technical findings and clinical evidence serve different purposes in the review.

Practical checks

  • Explain which question or evidence type each source contributes to.
  • Connect overlap between sources to the management of duplicate information.
  • State the possible effect of publication domains outside the selected coverage.

Acceptance and limits

Acceptance requires a rationale linked to the device and evaluation question. Adding databases does not repair a weak query. If a source yields only irrelevant material, investigate why and record a reasoned decision to retain or remove it.

Frequently asked questions

Does every device need the same databases?
One list may not suit all technologies and intended purposes; assess coverage with appropriate expertise.
Does the number of sources measure evidence strength?
No. The quality, relevance and remaining gaps of retrieved data need separate appraisal.

Sources

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