We thank Dr. Schildkraut et al. for their thoughtful commentary and the acknowledgment of the importance of our study in demonstrating that existing bowel preparation quality assessment instruments, typically used in the general population, are also reliable and valid for patients with Crohn's disease (CD) [1]. The implications of these findings are that instrument selection for use in clinical practice should be based on familiarity and local practice. The ease of use and interpretability of these instruments are critical for effective clinical application and need further exploration. Instruments that are simple to administer and reduce ambiguity in score interpretation could significantly enhance clinician confidence, making them more suitable for routine practice and future guideline development. Our results also support the inclusion of patients with CD in studies to evaluate novel bowel preparation formulations, which are historically conducted on healthy subjects [2].

The 50 endoscopy videos evaluated in our study included recordings of 34 colonoscopies with terminal ileal evaluation, 14 colonoscopies, and two flexible sigmoidoscopies, involving a total of 40 patients with CD. We rigorously justified the sample size using formal sample size calculation as outlined by Zou [3]. We adhered to the fundamental principle that a study too small may lack the power to adequately address the research question, while an overly large study can result in unnecessary use of resources and may raise ethical concerns. In this study, assuming an intraclass correlation coefficient of 0.80, scoring 50 videos by three central readers provided over 86% probability of obtaining a one-sided 95% lower bound exceeding 0.65, meeting the “substantial” agreement threshold per Landis and Koch's criteria [4]. We also highlight that this estimate was conservative, as we ultimately analysed the data using a two-way random effects model, which is more efficient and yields stronger reliability estimates [3].

At diagnosis, disease location was ileocolonic in 38.5%, colonic in 15.4% and ileal in 12.8% of patients. Disease behaviour was non-stricturing/non-penetrating in 46.1%, penetrating in 20.5%, and stricturing in 7.7% of patients. We acknowledge that our study population was heterogeneous, reflecting the real-world diversity of patients with CD compared to the general population. This heterogeneity, while presenting interpretive challenges, is an inherent characteristic of CD and underscores the importance of evaluating novel bowel preparation formulations within this group [5]. We concur with the authors that there is a need for further research specifically targeting the CD population to better understand not only the reliability of bowel preparation instruments but also the effectiveness of novel bowel preparation formulations, particularly in subgroups such as those with penetrating, stricturing or perianal fistulising disease. This is especially important for these subgroups given their high disease burden and substantial treatment needs [6].

In summary, our study provided strong evidence for including patients with CD in clinical trials evaluating new bowel preparation formulations and supports the standardised assessment of bowel preparation quality in trials of novel therapies. We look forward to future studies that build on these findings and further explore their applicability in larger and more specific CD subgroups.

我们感谢 Schildkraut 博士等人的深思熟虑的评论，并承认我们的研究在证明现有的肠道准备质量评估工具（通常用于普通人群）对克罗恩病 （CD） 患者也是可靠和有效的 [1]。这些发现的意义在于，临床实践中使用的器械选择应基于熟悉程度和当地实践。这些工具的易用性和可解释性对于有效的临床应用至关重要，需要进一步探索。易于管理并减少评分解释歧义的工具可以显著增强临床医生的信心，使其更适合常规实践和未来的指南制定。我们的结果还支持将 CD 患者纳入评估新型肠道准备制剂的研究，这些研究历来是在健康受试者中进行的 [2]。

我们研究中评估的 50 个内窥镜视频包括 34 次结肠镜检查和末端回肠评估、14 次结肠镜检查和两次软式乙状结肠镜检查的记录，共涉及 40 名 CD 患者。我们使用 Zou [3] 概述的正式样本量计算严格证明了样本量的合理性。我们坚持一个基本原则，即太小的研究可能缺乏充分解决研究问题的能力，而过大的研究可能会导致不必要的资源使用，并可能引发道德问题。在这项研究中，假设类内相关系数为 0.80，由三个中心读者对 50 个视频进行评分，获得超过 0.65 的单侧 95% 下限的概率超过 86%，满足 Landis 和 Koch 标准的“实质性”一致性阈值 [4]。我们还强调，这个估计是保守的，因为我们最终使用双向随机效应模型分析了数据，该模型效率更高，并产生了更强的可靠性估计 [3]。

诊断时，38.5% 的患者为回肠结肠，15.4% 的患者为结肠，12.8% 的患者为回肠。46.1% 的患者疾病行为为非限制性/非穿透性，20.5% 的患者为穿透性，7.7% 的患者为狭窄。我们承认我们的研究人群是异质性的，这反映了与一般人群相比，CD 患者在现实世界中的多样性。这种异质性虽然存在解释挑战，但却是 CD 的固有特征，并强调了在该群体中评估新型肠道准备制剂的重要性 [5]。我们同意作者的观点，即有必要专门针对 CD 人群进行进一步研究，以更好地了解肠道准备器械的可靠性，以及新型肠道准备制剂的有效性，特别是在患有穿透性、狭窄性或肛周瘘管疾病等亚组中。鉴于这些亚组的疾病负担高且治疗需求量大，这对他们来说尤其重要 [6]。

总之，我们的研究为将 CD 患者纳入评估新肠道准备制剂配方的临床试验提供了强有力的证据，并支持在新疗法试验中对肠道准备质量进行标准化评估。我们期待未来的研究以这些发现为基础，并进一步探索它们在更大、更具体的 CD 亚组中的适用性。