Assessing External Validity of Therapies and Health Technologies

Assessing External Validity of Therapies and Health Technologies

Key Attributes (PSIPPOFSS)

  1. Patient Population

    • Flexible entry criteria to identify/enroll diverse patient populations.

    • Inclusion of (DRDC) demographic characteristics, risk factors, disease stage/severity, and comorbidities.

  2. Sample Size

    • Large enough population to conduct meaningful subgroup analyses, especially for pre-specified subgroups.

  3. Intervention Characteristics

    • Dosing, regimen, technique, and delivery consistent with anticipated practice.

    • Comparator should be standard care or a relevant, clinically acceptable intervention.

  4. Patient Monitoring

    • Patient adherence and monitoring should match practices in real-world settings.

    • Accompanying care should reflect what will be provided in practice.

  5. Provider Expertise

    • Training, expertise, and skills of clinicians similar to those who will deliver the intervention in practice.

  6. Outcome Measures

    • Selection of outcome measures relevant to the experiences of and important to intended patient groups.

  7. Follow-Up

    • Systematic efforts to minimize attrition through follow-up of all patients.

    • Use of intention-to-treat analysis to account for all study patients.

  8. Study Duration

    • Duration consistent with the course/episode of disease/condition to detect important outcomes.

  9. Study Sites

    • Multiple study sites that represent the type/level of health care settings and expected clinician and patient experience.