Biostatistics Unit, Father Sean O'Sullivan Research Centre, St Joseph's Healthcare, 50 Charlton Avenue East, Hamilton ON L8N 4A6, Canada.
BMC Med Res Methodol. 2010 Feb 5;10:11. doi: 10.1186/1471-2288-10-11.
Experts recommend formulating a structured research question to guide the research design. However, the basis for this recommendation has not been formally evaluated. The aim of this study was to examine if a structured research question using the PICOT (Population, Intervention, Comparator, Outcome, Time-frame) format is associated with a better reporting quality of randomized controlled trials (RCTs).
We evaluated 89 RCTs reports published in three endocrinology journals in 2005 and 2006, the quality of reporting of which was assessed in a previous study. We examined whether the reports stated each of the five elements of a structured research question: population, intervention, comparator, outcome and time-frame. A PICOT score was created with a possible score between 0 and 5. Outcomes were: 1) a 14-point overall reporting quality score (OQS) based on the Consolidated Standards for Reporting Trials; and 2) a 3-point key score (KS), based on allocation concealment, blinding and use of intention-to-treat analysis. We conducted multivariable regression analyses using generalized estimating equations to determine if a higher PICOT score or the use of a structured research question were independently associated with a better reporting quality. Journal of publication, funding source and sample size were identified as factors associated with OQS in our previous report on this dataset, and therefore included in the model.
A higher PICOT score was independently associated with OQS (incidence rate ratio (IRR) = 1.021, 95% CI: 1.012 to 1.029) and KS (IRR = 1.142, 95% CI: 1.079 to 1.210). A structured research question was present in 33.7% of the reports and it was associated with a better OQS (IRR = 1.095, 95% CI 1.059-1.132) and KS (IRR = 1.530, 95% CI 1.311-1.786).
Better framing of the research question using the PICOT format is independently associated with better overall reporting quality - although the effect is small - and better reporting of key methodologies.
专家建议制定结构化的研究问题来指导研究设计。然而，这一建议的依据尚未经过正式评估。本研究旨在检验使用 PICOT（人群、干预、对照、结局、时间）格式的结构化研究问题是否与随机对照试验（RCT）的报告质量更高有关。
我们评估了 2005 年和 2006 年在三种内分泌学杂志上发表的 89 项 RCT 报告，这些报告的质量在之前的研究中进行了评估。我们检查了报告是否陈述了结构化研究问题的五个要素：人群、干预、对照、结局和时间框架。创建了一个 PICOT 评分，得分为 0 至 5 分。结局为：1）基于 CONSORT 报告标准的 14 分总体报告质量评分（OQS）；2）基于分配隐藏、盲法和意向治疗分析的 3 分关键评分（KS）。我们使用广义估计方程进行多变量回归分析，以确定更高的 PICOT 评分或使用结构化研究问题是否与更好的报告质量独立相关。在我们之前对该数据集的报告中，杂志出版、资金来源和样本量被确定为与 OQS 相关的因素，因此纳入了模型。
更高的 PICOT 评分与 OQS（发病率比（IRR）=1.021，95%CI：1.012 至 1.029）和 KS（IRR = 1.142，95%CI：1.079 至 1.210）独立相关。33.7%的报告中存在结构化研究问题，与更好的 OQS（IRR = 1.095，95%CI 1.059-1.132）和 KS（IRR = 1.530，95%CI 1.311-1.786）相关。
使用 PICOT 格式更好地构建研究问题与更好的总体报告质量独立相关-尽管效果很小-以及更好地报告关键方法。
