Foroutan Farid, Vandvik Per Olav, Helsingen Lise M, Kalager Mette, Rutter Matt, Selby Kevin, Pilonis Nastazja Dagny, Anderson Joseph C, McKinnon Annette, Fuchs Jonathan M, Quinlan Casey, Buskermolen Maaike, Senore Carlo, Wang Pu, Sung Joseph J Y, Haug Ulrike, Bjerkelund Silje, Triantafyllou Konstantinos, Shung Dennis L, Halvorsen Natalie, McGinn Thomas, Hafver Tandekile Lubelwana, Reinthaler Valerie, Guyatt Gordon, Agoritsas Thomas, Sultan Shahnaz
MAGIC Evidence Ecosystem Foundation, Oslo, Norway
Ted Rogers Centre for Heart Research, University Health Network, Toronto, Canada.
BMJ. 2025 Mar 27;388:e082656. doi: 10.1136/bmj-2024-082656.
In adult patients undergoing colonoscopy for any indication (screening, surveillance, follow-up of positive faecal immunochemical testing, or gastrointestinal symptoms such as blood in the stools) what are the benefits and harms of computer-aided detection (CADe)?
Colorectal cancer (CRC), the third most common cancer and the second leading cause of cancer-related death globally, typically arises from adenomatous polyps. Detection and removal of polyps during colonoscopy can reduce the risk of cancer. CADe systems use artificial intelligence (AI) to assist endoscopists by analysing real-time colonoscopy images to detect potential polyps. Despite their increasing use in clinical practice, guideline recommendations that carefully balance all patient-important outcomes remain unavailable. In this first iteration of a living guideline, we address the use of CADe at the level of an individual patient.
Evidence for this recommendation is drawn from a living systematic review of 44 randomised controlled trials (RCTs) involving more than 30 000 participants and a companion microsimulation study simulating 10 year follow-up for 100 000 individuals aged 60-69 years to assess the impact of CADe on patient-important outcomes. While no direct evidence was found for critical outcomes of colorectal cancer incidence and post-colonoscopy cancer incidence, low certainty data from the trials indicate that CADe may increase positive endoscopy findings. The microsimulation modelling, however, suggests little to no effect on CRC incidence, CRC-related mortality, or colonoscopy-related complications (perforation and bleeding) over the 10 year follow-up period, although low certainty evidence indicates CADe may increase the number of colonoscopies performed per patient. A review of values and preferences identified that patients value mortality reduction and quality of care but worry about increased anxiety, overdiagnosis, and more frequent surveillance.
For adults who have agreed to undergo colonoscopy, we suggest against the routine use of CADe (weak recommendation).
An international panel, including three patient partners, 11 healthcare providers, and seven methodologists, deemed by MAGIC and to have no relevant competing interests, developed this recommendation. For this guideline the panel took an individual patient approach. The panel started by defining the clinical question in PICO format, and prioritised outcomes including CRC incidence and mortality. Based on the linked systematic review and microsimulation study, the panel sought to balance the benefits, harms, and burdens of CADe and assumed patient preferences when making this recommendation UNDERSTANDING THE RECOMMENDATION: The guideline panel found the benefits of CADe on critical outcomes, such as CRC incidence and post-colonoscopy cancer incidence, over a 10 year follow up period to be highly uncertain. Low certainty evidence suggests little to no impact on CRC-related mortality, while the potential burdens-including more frequent surveillance colonoscopies-are likely to affect many patients. Given the small and uncertain benefits and the likelihood of burdens, the panel issued a weak recommendation against routine CADe use.The panel acknowledges the anticipated variability in values and preferences among patients and clinicians when considering these uncertain benefits and potential burdens. In healthcare settings where CADe is available, individual decision making may be appropriate.
This is the first iteration of a living practice guideline. The panel will update this living guideline if ongoing evidence surveillance identifies new CADe trial data that substantially alters our conclusions about CRC incidence, mortality, or burdens, or studies that increase our certainty in values and preferences of individual patients. Updates will provide recommendations on the use of CADe from a healthcare systems perspective (including resource use, acceptability, feasibility, and equity), as well as the combined use of CADe and computer aided diagnosis (CADx). Users can access the latest guideline version and supporting evidence on MAGICapp, with updates periodically published in .
对于因任何指征(筛查、监测、粪便免疫化学检测阳性的随访或胃肠道症状,如便血)而接受结肠镜检查的成年患者,计算机辅助检测(CADe)的益处和危害是什么?
结直肠癌(CRC)是全球第三大常见癌症,也是癌症相关死亡的第二大主要原因,通常由腺瘤性息肉发展而来。在结肠镜检查期间检测并切除息肉可降低患癌风险。CADe系统利用人工智能(AI)分析实时结肠镜检查图像,以协助内镜医师检测潜在息肉。尽管其在临床实践中的应用日益广泛,但仍缺乏仔细权衡所有对患者重要结局的指南建议。在这份实用指南的首次迭代中,我们探讨了在个体患者层面使用CADe的情况。
本推荐的证据来自一项对44项随机对照试验(RCT)的动态系统评价,这些试验涉及30000多名参与者,以及一项配套的微观模拟研究,该研究模拟了100000名60 - 69岁个体的10年随访情况,以评估CADe对患者重要结局的影响。虽然未找到关于结直肠癌发病率和结肠镜检查后癌症发病率等关键结局的直接证据,但试验中的低确定性数据表明,CADe可能会增加内镜检查的阳性发现。然而,微观模拟模型显示,在10年随访期内,CADe对结直肠癌发病率、结直肠癌相关死亡率或结肠镜检查相关并发症(穿孔和出血)几乎没有影响,尽管低确定性证据表明CADe可能会增加每位患者进行结肠镜检查的次数。一项关于价值观和偏好的综述发现,患者重视死亡率降低和医疗质量,但担心焦虑增加、过度诊断以及更频繁的监测。
对于已同意接受结肠镜检查的成年人,我们建议不要常规使用CADe(弱推荐)。
一个国际专家小组制定了本推荐,该小组包括三名患者代表、11名医疗保健提供者和七名方法学家,经MAGIC评估且认为他们没有相关利益冲突。对于本指南,专家小组采用了个体患者的方法。专家小组首先以PICO格式定义临床问题,并将包括结直肠癌发病率和死亡率在内的结局列为优先事项。基于相关的系统评价和微观模拟研究,专家小组在做出本推荐时力求平衡CADe的益处、危害和负担,并考虑患者的偏好。
指南专家小组发现,在10年随访期内,CADe对诸如结直肠癌发病率和结肠镜检查后癌症发病率等关键结局的益处高度不确定。低确定性证据表明对结直肠癌相关死亡率几乎没有影响,而潜在负担(包括更频繁的监测结肠镜检查)可能会影响许多患者。鉴于益处微小且不确定,以及负担很可能存在,专家小组发布了一项不常规使用CADe的弱推荐。专家小组承认,在考虑这些不确定的益处和潜在负担时,患者和临床医生的价值观和偏好可能存在差异。在可使用CADe的医疗环境中,个体决策可能是合适的。
这是实用指南的首次迭代。如果正在进行的证据监测发现新的CADe试验数据,这些数据实质性地改变了我们对结直肠癌发病率、死亡率或负担的结论,或者有研究提高了我们对个体患者价值观和偏好的确定性,专家小组将更新本实用指南。更新将从医疗系统角度(包括资源使用、可接受性、可行性和公平性)提供关于CADe使用的建议,以及CADe与计算机辅助诊断(CADx)联合使用的建议。用户可在MAGICapp上获取最新版指南及支持证据,更新内容将定期在[具体期刊名称]上发表。