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人工智能软件分析胸部 X 光图像以识别疑似肺癌:证据综合早期价值评估。

Artificial intelligence software for analysing chest X-ray images to identify suspected lung cancer: an evidence synthesis early value assessment.

机构信息

Effective Evidence, Waterlooville, UK.

Warwick Medical School, University of Warwick, Coventry, UK.

出版信息

Health Technol Assess. 2024 Aug;28(50):1-75. doi: 10.3310/LKRT4721.

Abstract

BACKGROUND

Lung cancer is one of the most common types of cancer in the United Kingdom. It is often diagnosed late. The 5-year survival rate for lung cancer is below 10%. Early diagnosis may improve survival. Software that has an artificial intelligence-developed algorithm might be useful in assisting with the identification of suspected lung cancer.

OBJECTIVES

This review sought to identify evidence on adjunct artificial intelligence software for analysing chest X-rays for suspected lung cancer, and to develop a conceptual cost-effectiveness model to inform discussion of what would be required to develop a fully executable cost-effectiveness model for future economic evaluation.

DATA SOURCES

The data sources were MEDLINE All, EMBASE, Cochrane Database of Systematic Reviews, Cochrane CENTRAL, Epistemonikos, ACM Digital Library, World Health Organization International Clinical Trials Registry Platform, clinical experts, Tufts Cost-Effectiveness Analysis Registry, company submissions and clinical experts. Searches were conducted from 25 November 2022 to 18 January 2023.

METHODS

Rapid evidence synthesis methods were employed. Data from companies were scrutinised. The eligibility criteria were (1) primary care populations referred for chest X-ray due to symptoms suggestive of lung cancer or reasons unrelated to lung cancer; (2) study designs that compared radiology specialist assessing chest X-ray with adjunct artificial intelligence software versus radiology specialists alone and (3) outcomes relating to test accuracy, practical implications of using artificial intelligence software and patient-related outcomes. A conceptual decision-analytic model was developed to inform a potential full cost-effectiveness evaluation of adjunct artificial intelligence software for analysing chest X-ray images to identify suspected lung cancer.

RESULTS

None of the studies identified in the searches or submitted by the companies met the inclusion criteria of the review. Contextual information from six studies that did not meet the inclusion criteria provided some evidence that sensitivity for lung cancer detection (but not nodule detection) might be higher when chest X-rays are interpreted by radiology specialists in combination with artificial intelligence software than when they are interpreted by radiology specialists alone. No significant differences were observed for specificity, positive predictive value or number of cancers detected. None of the six studies provided evidence on the clinical effectiveness of adjunct artificial intelligence software. The conceptual model highlighted a paucity of input data along the course of the diagnostic pathway and identified key assumptions required for evidence linkage.

LIMITATIONS

This review employed rapid evidence synthesis methods. This included only one reviewer conducting all elements of the review, and targeted searches that were conducted in English only. No eligible studies were identified.

CONCLUSIONS

There is currently no evidence applicable to this review on the use of adjunct artificial intelligence software for the detection of suspected lung cancer on chest X-ray in either people referred from primary care with symptoms of lung cancer or people referred from primary care for other reasons.

FUTURE WORK

Future research is required to understand the accuracy of adjunct artificial intelligence software to detect lung nodules and cancers, as well as its impact on clinical decision-making and patient outcomes. Research generating key input parameters for the conceptual model will enable refinement of the model structure, and conversion to a full working model, to analyse the cost-effectiveness of artificial intelligence software for this indication.

STUDY REGISTRATION

This study is registered as PROSPERO CRD42023384164.

FUNDING

This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR135755) and is published in full in ; Vol. 28, No. 50. See the NIHR Funding and Awards website for further award information.

摘要

背景

肺癌是英国最常见的癌症类型之一。它通常被诊断为晚期。肺癌的 5 年生存率低于 10%。早期诊断可能会提高生存率。具有人工智能开发算法的软件可能有助于辅助识别疑似肺癌。

目的

本综述旨在确定用于分析疑似肺癌的胸部 X 光片的辅助人工智能软件的证据,并开发一个概念性成本效益模型,为未来经济评估中开发完全可执行的成本效益模型所需的内容提供信息。

数据来源

数据来源为 MEDLINE All、EMBASE、Cochrane 系统评价数据库、Cochrane 中心、Epistemonikos、ACM 数字图书馆、世界卫生组织国际临床试验注册平台、临床专家、塔夫茨成本效益分析注册处、公司提交和临床专家。搜索于 2022 年 11 月 25 日至 2023 年 1 月 18 日进行。

方法

采用快速证据综合方法。对公司提交的数据进行了审查。纳入标准为(1)因疑似肺癌或与肺癌无关的原因而出现肺癌症状的初级保健人群接受胸部 X 光检查;(2)研究设计比较放射科专家评估胸部 X 光片与放射科专家与辅助人工智能软件的结果;(3)与测试准确性、使用人工智能软件的实际影响和患者相关结果相关的结果。开发了一个概念性决策分析模型,为辅助人工智能软件分析胸部 X 光图像以识别疑似肺癌的潜在全成本效益评估提供信息。

结果

搜索或公司提交的研究中没有一项符合审查的纳入标准。不符合纳入标准的六项研究提供的背景信息表明,放射科专家结合人工智能软件解读胸部 X 光片时,肺癌检测(而非结节检测)的敏感性可能高于放射科专家单独解读时。特异性、阳性预测值或检测到的癌症数量均无显著差异。六项研究均未提供有关辅助人工智能软件临床效果的证据。概念模型强调了诊断途径中缺乏输入数据,并确定了进行证据关联所需的关键假设。

局限性

本综述采用快速证据综合方法。这包括只有一名审查员进行审查的所有要素,并进行了仅以英语进行的有针对性的搜索。没有确定符合条件的研究。

结论

目前,在初级保健有肺癌症状或因其他原因转诊的人群中,关于使用辅助人工智能软件检测疑似肺癌的胸部 X 光检查,本综述没有可应用的证据。

未来的工作

需要开展未来的研究来了解辅助人工智能软件检测肺部结节和癌症的准确性,以及其对临床决策和患者结果的影响。生成概念模型关键输入参数的研究将能够改进模型结构,并将其转换为全功能模型,以分析该适应症下人工智能软件的成本效益。

研究注册

本研究由英国国家卫生与保健研究院(NIHR)证据综合计划(NIHR 资助:NIHR135755)资助,并全文发表于 ; 第 28 卷,第 50 期。有关该奖项的更多信息,请访问 NIHR 资助和奖项网站。

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