Establishing clinically meaningful changes in pain experiences remains important for clinical trials of chronic pain treatments. Regulatory guidance and pain measurement initiatives have recommended including patient-reported global assessment measures (eg, Patient-Global Impression of Change [PGIC]) to aid interpretation of within-patient differences in domain-specific clinical trial outcomes (eg, pain intensity). The objectives of this systematic review were to determine the frequency of global assessment measures inclusion, types of measures, domains assessed, number and types of response options, and how measures were analyzed. Of 4172 abstracts screened across 6 pain specialty journals, we reviewed 96 clinical trials of chronic pain treatments. Fifty-two (54.2%) studies included a global assessment measure. The PGIC was most common (n = 28; 53.8%), with relatively infrequent use of other measures. The majority of studies that used a global assessment measure (n = 31; 59.6%) assessed change or improvement in an unspecified domain. Others assessed overall condition severity (n = 9; 17.3%), satisfaction (n = 8; 15.4%), or overall health status/recovery (n = 5; 9.6%). The number, range, and type of response options were variable and frequently not reported. Response options and reference periods even differed within the PGIC. Global assessment measures were most commonly analyzed as continuous variables (n = 24; 46.2%) or as dichotomous variables with positive categories combined to calculate the proportion of participants with a positive response to treatment (n = 18; 34.6%). This review highlights the substantial work necessary to clarify measurement and use of patient global assessment in chronic pain trials and provides short- and long-term considerations for measure selection, reporting and analysis, and measure development.

中文翻译：

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在慢性疼痛治疗临床试验中使用患者报告的全球评估措施：行动系统回顾和考虑因素。

对于慢性疼痛治疗的临床试验来说，建立具有临床意义的疼痛体验变化仍然很重要。监管指南和疼痛测量倡议建议包括患者报告的全局评估措施（例如患者整体变化印象[PGIC]），以帮助解释特定领域临床试验结果（例如疼痛强度）中患者内部的差异。本次系统审查的目的是确定纳入全球评估措施的频率、措施类型、评估领域、应对方案的数量和类型以及如何分析措施。我们筛选了 6 个疼痛专业期刊的 4172 篇摘要，回顾了 96 项慢性疼痛治疗的临床试验。五十二项 (54.2%) 研究纳入了全球评估措施。 PGIC 最常见（n = 28；53.8%），其他措施的使用相对较少。大多数使用全球评估措施的研究（n = 31；59.6%）评估了未指定领域的变化或改进。其他人则评估总体病情严重程度（n = 9；17.3%）、满意度（n = 8；15.4%）或总体健康状况/恢复情况（n = 5；9.6%）。响应选项的数量、范围和类型各不相同，并且经常没有报告。 PGIC 内的响应选项和参考期甚至有所不同。总体评估措施最常被分析为连续变量（n = 24；46.2%）或作为具有积极类别的二分变量，组合起来计算对治疗有积极反应的参与者的比例（n = 18；34.6%）。本综述强调了澄清慢性疼痛试验中患者整体评估的测量和使用所需的大量工作，并为测量选择、报告和分析以及测量开发提供了短期和长期考虑。