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Handling indexing lag at literature search cutoffs

Distinguish publication, online availability and database entry dates when evaluating update gaps.

Representative research photograph: Handling indexing lag at literature search cutoffs
Photo: EU2016 NL from The Netherlands · License: CC BY 2.0 · Cropped and resized.
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A search may look current while some publications enter the database later. Publication and indexing dates can differ, leaving gaps between consecutive updates. Explain which date field is used and how this difference is addressed in the search method.

Scope of the decision

A cutoff defines the information boundary of one evaluation version; it is not a claim of continuous currency. Understand the platform’s date fields and update behaviour. Overlapping periods or an appropriate additional check may help, but these remain method choices justified for the device context.

Worked review

For example, an earlier search closes in June and the next begins with July publications. A June paper indexed in August may be missed between them. The team examines date fields, uses a justified overlap and manages records retrieved again without counting the same publication as a new study.

Practical checks

  • Record whether date filters use publication or database-entry information.
  • Examine possible gaps and overlaps between update periods.
  • Assess whether later-added records affect previous conclusions.

Acceptance and limits

Acceptance requires interpreting the cutoff together with its update method. An overlap does not guarantee recovery of every delayed record. If important new information is identified, an appropriate clinical and regulatory assessment should determine whether action can wait for the routine update.

Frequently asked questions

Is widening the date range enough?
Not always. The chosen date field and source update behaviour also matter.
Can a publication after the cutoff enter the report?
Yes, when its relationship to the report version and any method change is made explicit.

Sources

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