Centre for Health Sciences, Queen Mary University of London, Yvonne Carter Building, Turner Street, Whitechapel, London E12AT, UK.
Eur J Pain. 2011 Nov;15(10):1068-74. doi: 10.1016/j.ejpain.2011.04.015. Epub 2011 May 18.
Low back pain is a common and expensive health complaint. Many low back pain trials have been conducted, but these are reported in a variety of ways and are often difficult to interpret.
To facilitate consensus on a statement recommending reporting methods for future low back pain trials.
We presented experts with clinicians' views on different reporting methods and asked them to rate and comment on the suitability reporting methods for inclusion in a standardized set. Panellists developed a statement of recommendation over three online rounds. We used a modified Delphi process and the RAND/UCLA appropriateness method as a formal framework for establishing appropriateness and quantifying panel disagreement.
A group of 63 experts from 14 countries participated. Consensus was reached on a statement recommending that the continuous patient-reported outcomes commonly used in back pain trials, are reported using between-group mean differences (accompanied by minimally important difference (between-group/population-level) thresholds where these exist), the proportion of participants improving and deteriorating according to established and relevant minimally important change thresholds, and the number needed to treat; all with 95% confidence intervals. Outcomes may additionally be reported using alternative approaches (e.g. relative risks, odds ratios, or standardized mean difference) according to the needs of a particular trial.
A group of back pain experts reached a high level of consensus on a statement recommending reporting methods for patient-reported outcomes in future low back pain trials. The statement has the potential to increase interpretability and improve patient care.
下背痛是一种常见且昂贵的健康问题。已经进行了许多下背痛试验，但这些试验的报告方式多种多样，往往难以解释。
促进对推荐未来下背痛试验报告方法的声明达成共识。
我们向专家介绍了临床医生对不同报告方法的看法，并要求他们对适合纳入标准化方案的报告方法进行评分和评论。小组成员在三轮在线会议上制定了一份推荐声明。我们使用了改良德尔菲法和 RAND/UCLA 适宜性方法作为建立适宜性和量化小组分歧的正式框架。
来自 14 个国家的 63 名专家参加了研究。专家们就一份声明达成了共识，该声明建议在报告下背痛试验中常用的连续患者报告结局时，使用组间均值差异（伴有最小临床重要差异（组间/人群水平）阈值，如果存在的话）、根据既定和相关最小临床重要变化阈值改善和恶化的参与者比例，以及需要治疗的人数；所有结果均具有 95%置信区间。根据特定试验的需求，还可以使用替代方法（例如相对风险、优势比或标准化均数差）报告结果。
一组下背痛专家就推荐未来下背痛试验中患者报告结局的报告方法达成了高度共识的声明。该声明有可能提高可解释性并改善患者护理。
