Department of Clinical Epidemiology and Biostatistics, McMaster University, 1200 Main Street West, Hamilton, Ontario L8N 3Z5, Canada.
BMC Anesthesiol. 2013 Nov 19;13(1):44. doi: 10.1186/1471-2253-13-44.
Methodologists have proposed the formation of a good research question to initiate the process of developing a research protocol that will guide the design, conduct and analysis of randomized controlled trials (RCTs), and help improve the quality of reporting such studies. Five constituents of a good research question based on the PICOT framing include: Population, Intervention, Comparator, Outcome, and Time-frame of outcome assessment. The aim of this study was to analyze if the presence a structured research question, in PICOT format, in RCTs used within a 2010 meta-analysis investigating the effectiveness of femoral nerve blocks after total knee arthroplasty, is independently associated with improved quality of reporting.
Twenty-three RCT reports were assessed for the quality of reporting and then examined for the presence of the five constituents of a structured research question based on PICOT framing. We created a PICOT score (predictor variable), with a possible score between 0 and 5; one point for every constituent that was included. Our outcome variable was a 14 point overall reporting quality score (OQRS) and a 3 point key methodological items score (KMIS) based on the proper reporting of allocation concealment, blinding and numbers analysed using the intention-to-treat principle. Both scores, OQRS and KMIS, are based on the Consolidated Standards for Reporting Trials (CONSORT) statement. A multivariable regression analysis was conducted to determine if PICOT score was independently associated with OQRS and KMIS.
A completely structured PICOT score question was found in 2 of the 23 RCTs evaluated. Although not statistically significant, higher PICOT was associated with higher OQRS [IRR: 1.267; 95% confidence interval (CI): 0.984, 1.630; p = 0.066] but not KMIS (1.061 (0.515, 2.188); 0.872). These results are comparable to those from a similar study in terms of the direction and range of IRRs estimates. The results need to be interpreted cautiously due to the small sample size.
This study showed that PICOT framing of a research question in anesthesia-related RCTs is not often followed. Even though a statistically significant association with higher OQRS was not found, PICOT framing of a research question is still an important attribute within all RCTs.
方法论学家提出了形成一个好的研究问题，以启动研究方案的制定过程，该方案将指导随机对照试验（RCT）的设计、实施和分析，并有助于提高此类研究报告的质量。基于 PICOT 框架的好研究问题的五个组成部分包括：人群、干预、对照、结局和结局评估的时间框架。本研究旨在分析在一项 2010 年的荟萃分析中，用于调查全膝关节置换术后股神经阻滞效果的 RCT 中，是否存在结构化的 PICOT 格式的研究问题，是否与报告质量的提高有关。
评估 23 份 RCT 报告的报告质量，然后根据 PICOT 框架检查是否存在结构化研究问题的五个组成部分。我们创建了一个 PICOT 评分（预测变量），可能的分数在 0 到 5 之间；每个组成部分各得一分。我们的结局变量是 14 分的整体报告质量评分（OQRS）和 3 分的关键方法项目评分（KMIS），这两个评分是基于正确报告分配隐藏、盲法和使用意向治疗原则分析的数量。这两个评分，OQRS 和 KMIS，都是基于 CONSORT 声明。进行多变量回归分析，以确定 PICOT 评分是否与 OQRS 和 KMIS 独立相关。
在评估的 23 项 RCT 中，有 2 项完全是结构化的 PICOT 评分问题。尽管没有统计学意义，但较高的 PICOT 与较高的 OQRS 相关[IRR：1.267；95%置信区间（CI）：0.984，1.630；p=0.066]，但与 KMIS 无关（1.061（0.515，2.188）；0.872）。这些结果与类似研究的方向和范围的 IRR 估计值相当。由于样本量小，结果需要谨慎解释。
本研究表明，在麻醉相关 RCT 中，研究问题的 PICOT 框架并不常见。尽管没有发现与较高的 OQRS 有统计学意义的关联，但研究问题的 PICOT 框架仍然是所有 RCT 的一个重要属性。
