Recommendations for good clinical practice have been reported to be difficult to apply in real life by primary care clinicians. This could be because the clinical trials at the origin of the guidelines are based on explanatory trials, conducted under ideal conditions not reflecting the reality of primary care, rather than pragmatic trials conducted under real-life conditions. The objective of this study was to evaluate how pragmatic are the clinical trials used to build the French High Authority of Health’s recommendations on the management of type II diabetes. Trials from the 2013 Cochrane meta-analysis that led to the 2013 French High Authority of Health’s recommendations on the management of type II diabetes were selected. Each trial was analysed by applying the PRECIS-2 tool to evaluate whether the trial was pragmatic or explanatory, according to the nine domains of PRECIS-2. Each domain was scored between 1 (very explanatory) and 5 (very pragmatic) by two blinded researchers, and consensus was reached with a third researcher in case of discrepancy. Median scores were calculated for each of the nine domains. Twenty-three articles were analysed. Eight out of nine domains – namely eligibility, recruitment, setting, organisation, flexibility of delivery, flexibility of adherence, follow-up, and primary outcome – had a median score of less than 3, indicating a more explanatory design. Only the primary analysis domain had a score indicating a more pragmatic approach (median score of 4). In more than 25% of the articles, data to score the domains of recruitment, flexibility of delivery, flexibility of adherence, and primary analysis were missing. Trials used to build French recommendations for good clinical practice for the management of type 2 diabetes in primary care were more explanatory than pragmatic. Policy-makers should encourage the funding of pragmatic trials to evaluate the different strategies proposed for managing the patient’s treatment according to HbA1C levels and give clinicians feasible recommendations.

中文翻译：

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在一般实践中用于控制2型糖尿病患者糖基化血红蛋白水平的建议中使用的随机试验的实用性：PRECIS II工具的应用

据报道，初级保健临床医生很难在现实生活中采用良好临床实践的建议。这可能是因为该准则的起源是基于在理想条件下进行的解释性试验，该试验在不反映基层医疗现实的情况下进行，而不是在实际情况下进行的实用性试验。这项研究的目的是评估用于建立法国高级卫生总署关于II型糖尿病管理建议的临床试验的实用性。选择了2013年Cochrane荟萃分析中的试验，这些试验导致了2013年法国卫生部对II型糖尿病的管理建议。通过使用PRECIS-2工具对每个试验进行分析，以评估该试验是务实的还是解释性的，根据PRECIS-2的9个域。两位盲研究者对每个领域的评分在1（非常解释）至5（非常务实）之间，如果出现差异，则与第三位研究人员达成共识。计算这9个域中每个域的中位数。分析了23篇文章。九个领域中的八个（即资格，招聘，设置，组织，交付的灵活性，依从性的灵活性，随访和主要结果）的中位数得分小于3，表明设计更具解释性。只有主要分析领域的分数表明采用了更为实用的方法（中位数为4）。在超过25％的文章中，缺少用于对招聘领域，交付灵活性，依从灵活性和主要分析进行评分的数据。用于建立法国关于在初级保健中管理2型糖尿病的良好临床实践的法国建议的试验更具解释性，而不是实用性。决策者应鼓励进行实用试验的资金，以根据HbA1C水平评估提议的用于管理患者治疗的不同策略，并为临床医生提供可行的建议。