Objectives Placebo response is defined as a change in health status resulting from the symbolic significance attributed by the patient or proxy to the physician encounter. Our goals were to validate the PR12 survey as a measure of placebo response and to analyze the placebo response as a discrete and measurable component of everyday office encounters with the otolaryngologist. Study design This was a prospective, before-and-after clinical outcomes study of 95 children aged 6 months to 12 years conducted in an academic metropolitan pediatric otolaryngology practice. Caregivers completed the PR-12 survey at entry and at least 4 weeks later. The survey included 3 domains (4 questions each) reflecting the main components of the placebo response: meaningful explanation, care and concern, and mastery and control. PR-12 was correlated with longitudinal change in health status at least 1 to 2 months after the baseline visit. Outcome measures included direct and indirect measures of change in disease-specific quality of life and satisfaction with change. Results Test-retest reliability was fair for most PR-12 survey items (R = 0.41 to 0.76) but was higher for domains (0.60 to 0.66) and the overall survey score (0.66). PR-12 had excellent internal consistency (Cronbach's alpha 0.91) and appropriate construct validity. Caregiver satisfaction change at follow-up correlated with the PR-12 (r = -.25, P = 0.036). Conversely, no correlation was seen between the PR-12 and direct and indirect measures of change in disease specific quality of life. Conclusion Placebo response is an important and potentially measurable aspect of clinical encounters. PR-12 is a promising first step at creating a brief, reliable, and valid instrument to assess the placebo response. Significance Reemphasizing the therapeutic potential of the doctor-patient relationship may improve quality of care and disease outcomes.
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