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Assessing language restrictions in device literature screening

Keep the effect of inaccessible or excluded languages visible in the scope and interpretation of evidence.

Representative research photograph: Assessing language restrictions in device literature screening
Photo: The U.S. Food and Drug Administration · License: Public domain · Cropped and resized.
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Clinical use of a device may be reported across several countries. Selecting only publications the team can readily read can change the balance of available information. Plan the language approach alongside source coverage and appraisal competence; language preference should not be recorded as scientific irrelevance.

Scope of the decision

Translation, eligibility screening and clinical interpretation can require different skills. Automated translation may support initial understanding, while important outcome or device details may need appropriate verification. If a restriction is used, state its reason, affected records and possible effect on interpretation.

Worked review

For example, a broad search identifies three potentially relevant papers in another language. The team flags language access separately instead of excluding them as irrelevant. Suitable translation and expert review find one concerns a different model and two concern the relevant population. Actual eligibility criteria then determine selection.

Practical checks

  • Record language restrictions separately from scientific eligibility criteria.
  • Verify accurate translation of important device and outcome descriptions.
  • Assess how inaccessible language groups may affect the evidence conclusion.

Acceptance and limits

Acceptance requires an understandable rationale and explicit remaining limitations. Complete access in every language may not be feasible for every project, but the constraint should not be hidden. An English abstract alone does not establish adequate assessment of full methodological and outcome details.

Frequently asked questions

Is automated translation sufficient by itself?
That depends on use; important scientific meaning may need suitably competent verification.
Does exclusion by language mean irrelevance?
No. Keep it as a separate reason and assess its potential contribution to bias.

Sources

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