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The Pregnancy Algorithm CErtaInty Tool (ACE-IT) effectively assesses real-world data algorithms for pregnancy outcomes. It is deemed acceptable and appropriate for evaluating algorithm fitness for purpose in decision-making.

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Area of Science:

  • Pharmacoepidemiology
  • Health Informatics
  • Biostatistics

Background:

  • Real-world data (RWD) are crucial for generating real-world evidence (RWE) through algorithm validation studies.
  • The Algorithm CErtaInty Tool (ACE-IT) was initially developed to assess the fitness of RWD-based algorithms for specific health outcomes.
  • Existing tools require tailoring to evaluate algorithms specifically for pregnancy and birth outcomes.

Purpose of the Study:

  • To refine, develop, and tailor the ACE-IT for evaluating the fitness of algorithms related to pregnancy and birth outcomes.
  • To assess the feasibility, acceptability, appropriateness, and content validity of the Pregnancy ACE-IT.
  • To determine if validated algorithms for pregnancy/birth outcomes are fit for purpose in specific decision contexts.

Main Methods:

  • Engaged an expert panel of pharmacoepidemiologists and regulators to guide the development of the Pregnancy ACE-IT.
  • Developed a vignette focusing on neural tube defects as a specific pregnancy outcome for evaluation.
  • Utilized 27 external raters to appraise a peer-reviewed algorithm for identifying neural tube defects using the Pregnancy ACE-IT.

Main Results:

  • The Pregnancy ACE-IT was found to be acceptable and appropriate by most raters.
  • Some users reported challenges with the ease of use of the tool.
  • The tool demonstrated suitability, flexibility, and relevant content for its intended purpose.

Conclusions:

  • The Pregnancy ACE-IT is a suitable, flexible, acceptable, and appropriate tool for assessing the fitness of pregnancy outcome algorithms for specific decision contexts.
  • Future work should focus on improving user-friendliness and broadening acceptance.
  • Further studies are needed to evaluate the tool's suitability across diverse pregnancy/birth outcomes and therapeutic areas.