Measuring Clinical Significance

Clinical significance can be assessed or measured in different ways. Each method answers a somewhat different question about clinical significance. A summary of these approaches is provided in Table 17.1.

TABLE 17.1 Summary of Approaches for Measuring Clinical Significance


Examples of Method/Measures

Comparison approaches: Comparison of individuals who receive an intervention with other individuals (e.g., normative samples)

  • ? Change score approach (Jacobson and Truax method): People who receive the intervention are compared on a measure (e.g., depressive symptoms) with individuals who did not receive the treatment but had a similar level of symptoms pretreatment (Jacobson & Truax, 1991)
  • ? Normative comparison: The behavior or symptoms of individuals at posttreatment are compared to a sample of peers who are functioning well or without significant problems on the outcome measure of interest (Kendall, Marrs-Garcia, Nath, & Sheldrick, 1999)

Number needed to treat (NNT); number needed to harm (NNH)

Subjective evaluations: Determination of the importance of the outcome of an intervention through subjective ratings by the targeted individual, family members/ friends, or clinicians who have contact with the individual

  • ? NNT and NNH reflect two helpful metrics that can help clinicians, in particular, determine whether a treatment is worth the risk for its relative benefits
  • ? Social validity: Subjective ratings of acceptability, usability, value, and benefits/impact of an intervention
  • ? Quality of life (QoL): Ratings of physical well-being, social well-being, and emotional well-being as well as behavioral competence
  • ? QoL: WHOQOL-BREF (World Health Organization, 1996)
  • ? Satisfaction with Life Scale (Diener, Emmons, Larsen, & Griffin, 1985)
  • ? Health-related QoL (HRQoL): Ratings of the impact of health status on aspects of QoL (e.g., social, emotional, physical functioning)
  • ? Short-Form Health Survey (SF-36) (Ware & Sherbourne, 1992)
  • ? Sickness Impact Profile (Bergner, Bobbitt, Carter, & Gilson, 1981)
  • ? PROMIS (

Social impact measures: The impact an intervention has on communities and society as a whole

  • ? Patient placement
  • ? Rehospitalization
  • ? Use of respite services

PROMIS, Patient Reported Outcomes Measurement Information System.

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