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Checking device search sensitivity with known publications

Use known relevant reports as a limited check on retrieval without claiming complete coverage.

Representative research photograph: Checking device search sensitivity with known publications
Photo: NIH Image Gallery from Bethesda, Maryland, USA · License: Public domain · Cropped and resized.
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A search that retrieves many records has not necessarily found important studies. Known eligible publications can provide control examples for identifying obvious gaps in a query. This approach does not prove completeness; it helps reveal when the method misses a relevant target.

Scope of the decision

Justify the selection of control publications. Choosing only easy records using the same trade name does not challenge conceptual coverage. Suitable examples with different terminology, earlier model names or important safety questions may help. Overfitting the query to one known set can still miss new evidence.

Worked review

For example, an important clinical-context paper does not appear in the search. Review shows that an earlier device name or relevant clinical term was absent. The team develops the query appropriately and appraises additional retrieval rather than merely adding the missing paper’s exact title to the search.

Practical checks

  • Explain why each control publication is relevant and suitably representative.
  • Investigate whether a missed record reflects source coverage or query design.
  • Assess new coverage and limitations introduced by a query change.

Acceptance and limits

Acceptance depends on an understandable method rationale as well as finding the selected examples. Retrieving every control paper does not mean that all unknown relevant publications were identified. Consider the result alongside other coverage and bias checks rather than overstating one success percentage.

Frequently asked questions

Should control papers be chosen randomly?
Choose them for the defined purpose and explain representation and selection limits.
Does a missing paper prove a query error?
Not always. It may be absent from the database or outside the date scope.

Sources

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