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Mobile health (mHealth) apps lack evidence, creating uncertainty for users and professionals. Establishing clear guidelines for app development and outcome measurement is crucial for ensuring quality and promoting evidence-based decision-making.

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MENTAL HEALTHSTATISTICS & RESEARCH METHODS

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Area of Science:

  • Digital Health
  • Health Technology Assessment
  • Evidence-Based Medicine

Background:

  • Mobile health (mHealth) apps are widely available but often lack a robust evidence base regarding safety and effectiveness.
  • Unlike pharmaceuticals and traditional therapies, app-based interventions face fewer regulatory hurdles, leading to variable quality.
  • Healthcare professionals and users face uncertainty due to the low evidence base for many mHealth apps.

Purpose of the Study:

  • To highlight the need for standardized outcome measures in app-based interventions.
  • To address the ambiguity surrounding 'acceptable evidence' for mHealth app development.
  • To encourage app developers to generate real-world effectiveness data by clarifying evidence requirements.

Main Methods:

  • The study critically reviews the current landscape of mHealth app evaluation.
  • It identifies the lack of established guidelines for health technology assessment of app-based interventions.
  • It emphasizes the need for consensus on patient-reported outcome measures (PROMs) for app development.

Main Results:

  • There is a significant gap in evidence generation for mHealth apps compared to established medical interventions.
  • 'Acceptable evidence' for app effectiveness is poorly defined, hindering consistent evaluation.
  • The absence of standardized outcome measurement tools leads to incomparable assessments of different apps.

Conclusions:

  • Clear guidance and consensus on PROMs are essential for developing clinically useful mHealth apps.
  • Standardized evaluation frameworks will reduce uncertainty and encourage developers to invest in evidence generation.
  • Establishing clear standards for evidence will foster trust and facilitate evidence-based decision-making in digital health.