Department of Anesthesiology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA Department of Rehabilitation Medicine, University of Washington, Seattle, WA, USA Institute for Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA School of Professional Psychology, Pacific University, Hillsboro, OR, USA Department of Biostatistics and Computational Biology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA Evidera, Seattle, WA, USA LORA Group, LLC, Royal Oak, MD, USA University of Maryland, Baltimore, MD, USA Department of Pediatrics, Dalhousie University, Halifax, NS, Canada Department of Psychology and Neuroscience, Dalhousie University, Halifax, NS, Canada Centre for Pediatric Pain Research, IWK Health Center, Halifax, NS, Canada Palm Beach Gardens, FL, USA American Chronic Pain Association, Rocklin, CA, USA Desjardins Associates, Maplewood, NJ, USA Johnson & Johnson, Titusville, NJ, USA Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA, USA Department of Anesthesia, University of Pennsylvania, Philadelphia, PA, USA Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA Department of Anesthesiology & Perioperative Medicine, Queen's University, Kingston, ON, Canada Department of Biomedical & Molecular Sciences, Queen's University, Kingston, ON, Canada Jazz Pharmaceuticals, Palo Alto, CA, USA Purdue Pharma L.P., Stamford, CT, USA VA Connecticut Healthcare System, West Haven, CT, USA Department of Psychiatry, Yale University, New Haven, CT, USA Department of Neurology, Yale University, New Haven, CT, USA Department of Psychology, Yale University, New Haven, CT, USA Collegium Pharmaceutical, Inc, Canton, MA, USA Analgesic Concepts, Arlington, VA, USA Pfizer, Inc, New York, NY, USA Division of Immunology/Rheumatology, Stanford University, Palo Alto, CA, USA Chronic Pain Research Alliance, North Kingstown, RI, USA vZenium LLC, Arlington, MA, USA Department of Anesthesiology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA Center for Human Experimental Therapeutics, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.
Pain. 2016 May;157(5):1056-1064. doi: 10.1097/j.pain.0000000000000502.
Clinical trial participants often require additional instruction to prevent idiosyncratic interpretations regarding completion of patient-reported outcomes. The Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership developed a training system with specific, standardized guidance regarding daily average pain intensity ratings. A 3-week exploratory study among participants with low-back pain, osteoarthritis of the knee or hip, and painful diabetic peripheral neuropathy was conducted, randomly assigning participants to 1 of 3 groups: training with human pain assessment (T+); training with automated pain assessment (T); or no training with automated pain assessment (C). Although most measures of validity and reliability did not reveal significant differences between groups, some benefit was observed in discriminant validity, amount of missing data, and ranking order of least, worst, and average pain intensity ratings for participants in Group T+ compared with the other groups. Prediction of greater reliability in average pain intensity ratings in Group T+ compared with the other groups was not supported, which might indicate that training produces ratings that reflect the reality of temporal pain fluctuations. Results of this novel study suggest the need to test the training system in a prospective analgesic treatment trial.
临床试验参与者通常需要额外的指导，以防止对患者报告结果的完成产生特殊的解释。镇痛、麻醉和成瘾临床试验转化、创新、机遇和网络（ACTION）公私合作伙伴关系开发了一个培训系统，提供了关于日常平均疼痛强度评分的具体、标准化指导。在患有腰痛、膝关节或髋关节骨关节炎以及糖尿病周围神经痛的参与者中进行了为期 3 周的探索性研究，将参与者随机分配到以下 3 组之一：有人类疼痛评估的培训（T+）；有自动疼痛评估的培训（T）；或无自动疼痛评估的培训（C）。尽管有效性和可靠性的大多数衡量标准并未显示出组间的显著差异，但在判别有效性、缺失数据量以及组 T+中患者的最低、最差和平均疼痛强度评分的排序方面观察到了一些益处与其他组相比。在组 T+中，与其他组相比，对平均疼痛强度评分的更高可靠性的预测并未得到支持，这可能表明培训产生的评分反映了时间性疼痛波动的实际情况。这项新颖研究的结果表明，需要在前瞻性镇痛治疗试验中测试培训系统。
