Ovchinsky Alexander, Ovchinsky Nadia, Rosenfeld Richard M
Department of Otolaryngology, State University of New York Downstate Medical Center, Brooklyn, New York, USA.
Otolaryngol Head Neck Surg. 2004 Sep;131(3):280-7. doi: 10.1016/j.otohns.2004.03.003.
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.
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.
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.
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.
Reemphasizing the therapeutic potential of the doctor-patient relationship may improve quality of care and disease outcomes.
安慰剂反应被定义为由患者或代理人赋予医患接触的象征意义所导致的健康状况变化。我们的目标是验证PR12调查问卷作为安慰剂反应衡量指标的有效性,并将安慰剂反应作为与耳鼻喉科医生日常门诊接触中一个离散且可测量的组成部分进行分析。
这是一项在大城市学术性儿科耳鼻喉科诊所对95名6个月至12岁儿童进行的前瞻性前后临床结局研究。护理人员在入组时和至少4周后完成PR - 12调查问卷。该问卷包括3个领域(每个领域4个问题),反映了安慰剂反应的主要组成部分:有意义的解释、关心和关注以及掌控和控制。PR - 12与基线访视后至少1至2个月的健康状况纵向变化相关。结局指标包括疾病特异性生活质量变化的直接和间接测量以及对变化的满意度。
大多数PR - 12调查问卷项目的重测信度一般(R = 0.41至0.76),但领域的重测信度较高(0.60至0.66),总体调查得分的重测信度为(0.66)。PR - 12具有出色的内部一致性(克朗巴哈系数0.91)和适当的结构效度。随访时护理人员的满意度变化与PR - 12相关(r = -0.25,P = 0.036)。相反,PR - 12与疾病特异性生活质量变化的直接和间接测量之间未发现相关性。
安慰剂反应是临床接触中一个重要且可能可测量的方面。PR - 12是创建一个简短、可靠且有效的工具来评估安慰剂反应的有前景的第一步。
再次强调医患关系的治疗潜力可能会改善护理质量和疾病结局。