Jaber Fouad, Ahmed Khalid, Hamid Osama, Johnson Willie Mohammed, Alsakarneh Saqr, Abdalla Abubaker O, Abboud Yazan, Mohamed Mouhand, Dahiya Dushyant Singh, Umar Shifa, Abdallah Mohamed, Bilal Mohammad, Shaukat Aasma
Division of Gastroenterology and Hepatology, Baylor College of Medicine, Houston, Texas.
Department of Internal Medicine, University of Missouri-Kansas City, Kansas City, Missouri.
Gastro Hep Adv. 2024 Jun 21;3(7):1012-1019. doi: 10.1016/j.gastha.2024.06.003. eCollection 2024.
In 2013, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) steering group published recommendations to standardize reporting quality in randomized controlled trials (RCTs). We aim to assess adherence to SPIRIT reporting guidelines in RCTs on endoscopic colorectal cancer (CRC) screening and participants' adherence to trial protocols.
We searched databases for RCTs evaluating flexible sigmoidoscopy or colonoscopy for CRC screening published in English language through September 2023. Each eligible study was evaluated using the 8 core SPIRIT statement areas, totaling 51 points. Each item received 1 point if it met the criteria and 0 points if it did not. Adherence to SPIRIT items was calculated, and participant adherence to RCT protocols was assessed as the proportion of participants screened compared to those invited.
Five RCTs, including 4 on flexible sigmoidoscopy and 1 on colonoscopy, were analyzed. Adherence to SPIRIT guidance ranged from 82.4% to 92.2%. The most missed recommendation was item 2b (trial registrations), scored 0 across all studies. Additionally, item 32 (informed consent materials) scored 20%, and items 17a & b (blinding) scored 40% each. In total, 587,572 participants were randomized across the 5 RCTs. Of these, 37% (200,610) underwent CRC screening, with 69.8% (139,983/200,610) adhering to the protocol. The Nordic-European Initiative on Colorectal Cancer (NordICC) trial, employing a unique invitation method, had a lower adherence rate of 42%. Excluding this trial would raise the adherence rate to 74.3% (128,050/172,390).
The published CRC screening trials have acceptable adherence to the SPIRIT reporting guidelines. However, reporting appended consent form materials and disclosing all WHO trial registration data can be improved.
2013年，标准方案项目：干预性试验建议（SPIRIT）指导小组发布了相关建议，以规范随机对照试验（RCT）的报告质量。我们旨在评估关于内镜下结直肠癌（CRC）筛查的随机对照试验对SPIRIT报告指南的遵循情况以及参与者对试验方案的依从性。
我们检索了数据库，以查找截至2023年9月以英文发表的评估乙状结肠镜检查或结肠镜检查用于CRC筛查的随机对照试验。每项符合条件的研究均使用SPIRIT的8个核心声明领域进行评估，共计51分。每项内容符合标准得1分，不符合得0分。计算对SPIRIT项目的遵循情况，并将参与者对随机对照试验方案的依从性评估为接受筛查的参与者与受邀参与者的比例。
分析了5项随机对照试验，其中4项关于乙状结肠镜检查，1项关于结肠镜检查。对SPIRIT指南的遵循率在82.4%至92.2%之间。最常缺失的建议是项目2b（试验注册），所有研究该项得分均为0。此外，项目32（知情同意材料）得分为20%，项目17a和b（盲法）每项得分为40%。在这5项随机对照试验中，共有587,572名参与者被随机分组。其中，37%（200,610名）接受了CRC筛查，69.8%（139,983/200,610）遵循了方案。采用独特邀请方法的北欧-欧洲结直肠癌倡议（NordICC）试验的依从率较低，为42%。排除该试验后，依从率将提高至74.3%（128,05万/172,390）。
已发表的CRC筛查试验对SPIRIT报告指南的遵循情况尚可。然而，在报告附加的同意书材料以及披露所有世界卫生组织试验注册数据方面仍有改进空间。
