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Managing missing full texts in device evidence appraisal

Separate relevance suggested by an abstract from evidence available for complete methodological appraisal.

Representative research photograph: Managing missing full texts in device evidence appraisal
Photo: EU2016 NL from The Netherlands · License: CC BY 2.0 · Cropped and resized.
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An abstract may appear relevant without providing enough detail to evaluate methods and results. Keep missing full-text access visible. Do not label a source irrelevant merely because it is inaccessible or use a favourable abstract result as though the complete study had been assessed.

Scope of the decision

Pursue access through appropriate lawful routes. Publisher access, institutional arrangements or suitable author contact may be considered in context. Record attempts and their outcomes. Failure to obtain the text creates a separate limitation affecting the source’s role and the uncertainty of the evaluation.

Worked review

For example, an abstract mentions an important long-term result but does not describe loss to follow-up. The team cannot obtain the full report. Its evidence map records both the finding and the methodological gap; the reported percentage is not used alone as a definitive benefit claim. Appraisal is updated if access later becomes available.

Practical checks

  • Track abstract relevance separately from full-text appraisal status.
  • Record access attempts and important details that remain unavailable.
  • Explain effects on evidence weight and the claim under evaluation.

Acceptance and limits

Acceptance means an honest account of access and supportable conclusions. Obtaining the text later does not automatically validate the earlier abstract appraisal; examine methods and results afresh. Important uncertainty may become an additional information or evidence-generation need in the evaluation plan.

Frequently asked questions

Does an unanswered author request justify exclusion?
Record access limits separately and justify the scientific decision using eligibility and available information.
Are abstract numbers unusable?
Assess purpose and limitations, and do not imply that complete appraisal occurred.

Sources

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