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Resolving device literature screening disagreements

Use explicit eligibility criteria and rationale rather than treating disagreement as a simple majority vote.

Representative research photograph: Resolving device literature screening disagreements
Photo: Happi Raphael · License: CC BY-SA 4.0 · Cropped and resized.
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Different eligibility decisions for one publication do not necessarily mean that a search failed. They may reveal an unclear criterion or missing detail in the report. Keeping disagreements visible helps the screening process apply a consistent scientific scope.

Scope of the decision

Identify the criterion causing divergence, such as device, population, outcome or study type. Uncertainty at title and abstract level may require full-text assessment. Define a route to suitable expert input without presenting one practical adjudication method as a universal legal rule.

Worked review

For example, one reviewer includes a study of a similar device while another excludes it. Discussion shows that the first considered it relevant to general clinical context and the second considered direct product evidence. The record separates those uses and revisits the decisions against the appropriate criteria.

Practical checks

  • Record which eligibility criterion produced the disagreement.
  • Distinguish uncertainty requiring full text or suitable expert input.
  • Assess earlier comparable decisions when clarification changes how a criterion is applied.

Acceptance and limits

Acceptance requires a traceable final rationale and the correct evidence role. A high agreement rate alone does not establish reliable screening. Both reviewers might apply the same unclear criterion incorrectly, so selected control examples and scope checks can be useful.

Frequently asked questions

Does disagreement mean a paper must be included?
No. Make a reasoned decision using the relevant criterion and sufficient information.
Should adjudication erase the first decisions?
No. Preserve initial interpretations and the final rationale so that the decision’s development remains understandable.

Sources

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