An International Consensus on Appropriate Management of Corticosteroids in Clinical Trials in Inflammatory Bowel Disease.

Corticosteroids remain a cornerstone of IBD induction therapy, and many patients in trials are enrolled while taking corticosteroids.

皮质类固醇仍然是IBD诱导治疗的基础，许多试验中的患者在入组时正在使用皮质类固醇。

Despite this, approaches to corticosteroid management in RCTs have been highly heterogeneous, often differing from clinical practice.

尽管如此，随机对照试验（RCTs）中皮质类固醇管理的方法高度异质，常常与临床实践不同。

This negatively impacts patients' willingness to participate due to prolonged corticosteroid exposure and may potentially bias outcomes in the clinical trial. Our aim is to provide comprehensive standardized recommendations on key aspects of corticosteroid use in IBD clinical trials through a multiphase, international expert consensus, with a goal to help inform and standardize practice in future RCTs.

这会因长期暴露于皮质类固醇而负面影响患者参与临床试验的意愿，并可能潜在地在临床试验中产生偏倚。

Methods

The consensus was informed by a systematic reviewof MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials, which determined the corticosteroid management rules used in placebo-controlledtrials of advanced therapies in IBD.

共识是通过系统回顾MEDLINE、Embase和Cochrane中央对照试验登记处的文献来形成的，这确定了在炎症性肠病（IBD）高级治疗的安慰剂对照试验中使用的皮质类固醇管理规则。

International expert consensus recommendations for all aspects of corticosteroid management in RCTs were then developed using a modified Delphi process with 2 rounds of survey questions and a ratification meeting.

然后使用改良的德尔菲过程，通过两轮调查问卷和一个批准会议，为所有方面制定了国际专家共识建议，用于随机对照试验（RCTs）中的皮质类固醇管理。

Results

These recommendations propose management of corticosteroids during screening, induction, and maintenance phases of pharmacologic trials in IBD and define corticosteroid-related end points.

这些推荐意见提出了在炎症性肠病药物试验的筛查、诱导和维持阶段管理皮质类固醇的方法，并定义了与皮质类固醇相关的终点。

We emphasize the need for minimizing corticosteroid exposure through expedited tapering and shorter fixed-dosing periods that more closely reflect clinical care and provide recommendations for standardized definitions of corticosteroid-free remission.

我们强调了通过加快减量和缩短固定剂量期来最小化皮质类固醇暴露的必要性，这些措施更贴近临床护理，并提供了关于皮质类固醇自由缓解的标准定义的建议。

Conclusions

These recommendations will serve to optimize trial design and facilitate appropriate, acceptable, and standardized RCT corticosteroid handling practices.

这些建议将有助于优化试验设计，并促进适当、可接受和标准化的随机对照试验中皮质类固醇处理实践。