Appraisal of Guidelines and Consensuses on Management of Pulmonary Nodules
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摘要:目的
基于AGREEⅡ（the Appraisal of Guidelines for Research & Evaluation Instrument Ⅱ）对肺结节诊治相关指南共识的方法学质量进行评价。
方法检索CNKI、WanFang、VIP、SinoMed、Yiigle、PubMed、Embase、Web of Science数据库和WHO、GIN、NGC、NICE、中华人民共和国国家卫生健康委员会、中华医学会、中华中医药学会、中国中西医结合学会等官方网站，采集肺结节诊治相关的指南共识，并从医脉通进行补充，检索时限均为从建库至2023-12-16。由4名研究人员基于AGREE Ⅱ对纳入的指南共识进行方法学质量评价。
结果共纳入肺结节诊治相关的指南共识37部，其中指南11部、共识26部，中文22部、英文15部。纳入的37部指南共识，在AGREE Ⅱ的6个领域的平均标准化得分依次为：范围和目的（76.28%）、利益相关者的参与（41.82%）、严谨性（36.78%）、清晰性（71.55%）、应用性（34.88%）、编辑独立性（48.03%）。亚组分析结果显示，中英文文献在6个领域的得分皆无统计学差异；但在其他亚组，6个领域的得分皆为指南高于共识、基于循证证据高于基于专家意见、更新版本高于初版、参与制订的专家数≥20高于专家数≤19。
结论肺结节诊治相关指南共识在制订过程中利益相关者的参与、形成推荐意见的严谨性、对于预期应用性的考虑、制订过程独立性的报道这4个方面的方法学质量还有待提高。建议国内外学术组织在未来能够参考AGREE Ⅱ等规范进行指南共识的制订和更新。
Abstract:ObjectiveTo evaluate the methodological quality of guidelines and consensuses related to the management of pulmonary nodules according to AGREE II (The Appraisal of Guidelines for Research & Evaluation Instrument II).
MethodsCNKI, WanFang, VIP, SinoMed, Yiigle, PubMed, Embase, Web of Science databases and the official websites of WHO, GIN, NGC, NICE, National Health Commission of People’s Republic of China, Chinese Medical Association, China Association of Chinese Medicine, Chinese Association of Integrative Medicine, etc. were searched to collect guidelines and consensuses related to the management of pulmonary nodules, supplemented from Medlive, the search period ranged from the conception of the databases to 2023-12-16. The methodological quality of the included guidelines and consensuses was evaluated by four researchers according to AGREE Ⅱ.
ResultsA total of 37 guidelines and consensuses related to the management of pulmonary nodules were included, including 11 guidelines and 26 consensuses, 22 in Chinese and 15 in English. The mean standardized scores of the 37 included documents in the six domains of AGREE Ⅱ were: scope and purpose (76.28%), stakeholder involvement (41.82%), rigor of development (36.78%), clarity of presentation (71.55%), applicability (34.88%), and editorial independence (48.03%). Subgroup analyses demonstrated no statistically significant difference found between the scores of Chinese and English literatures in any of the six domains; however, in other subgroups, the scores in all six domains were higher for guidelines than for consensuses, evidence-based than for expert opinion-oriented, updated versions than for first editions, and the number of participated experts ≥20 than for the number ≤19.
ConclusionThe methodological quality of guidelines and consensuses for the management of pulmonary nodules needs to be improved in terms of stakeholder involvement in the development process, rigor in the process from evidence into recommendations, consideration of intended applicability, and the reporting of editorial independence. It is recommended that domestic and international academic organizations should refer to standards such as AGREE Ⅱ for the development and updating of guidelines and consensuses in the future.
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Keywords:
- pulmonary nodule /
- guideline /
- consensus /
- quality appraisal /
- AGREE Ⅱ
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前 言
据国家癌症中心2022年发布数据，肺癌以粗发病率59.89/10万和粗死亡率47.51/10万，居我国恶性肿瘤发病率和死亡率的第一位[1-2]。而早期肺癌或肺癌前病变主要是以影像学上的肺部结节形式出现，肺结节是肺癌早诊早治的关键窗口[3-5]。肺结节的系统化管理和规范化诊治对于构建肺癌的二级预防体系意义重大。虽然目前国内外已有若干肺结节诊治相关的指南共识发布，但其方法学质量参差不齐，推荐意见莫衷一是，临床应用无从着手，国内对肺结节的诊治仍然呈现多样化和随机化的态势，在临床上还没有形成对肺结节真正的规范化管理，这一方面可能导致医疗资源的浪费，另一方面可能延误患者的诊治[6-8]。指南共识的价值取决于其本身的质量，指南制订过程中恰当的方法和严谨的策略对于形成正确的推荐意见并成功应用到临床实际非常重要[9]。本研究拟采用指南研究与评价工具Ⅱ（the Appraisal of Guidelines for Research & Evaluation Instrument Ⅱ, AGREE Ⅱ）对肺结节诊治相关的指南共识进行方法学评价，系统地呈现目前国内外肺结节诊治相关指南共识的方法学质量，以期为临床医生选择指南共识提供参考，并为我国临床工作者和相关学术组织专家在今后对肺结节诊治指南的制订或更新提供参考依据。
1. 资料和方法
1.1 纳排标准
纳入标准：①国内外在期刊、官方网站、会议论坛上公开发表的肺结节诊治相关指南和共识；②制订或发布机构为国家政府、医疗单位、学术组织或专家团体；③若指南和共识存在更新版本，只纳入最新版本。
排除标准：①无法获得全文；②非中英文文献；③重复发表的指南共识；④指南共识的翻译版本；⑤指南共识的勘误、评论、解读或应用效果研究；⑥已明确结节病理诊断的相关指南共识；⑦会议摘要、科普类文章等文献类型。
1.2 检索策略
在中英文数据库、国内外官方平台进行指南共识的检索，从医脉通（Medive）和纳入指南共识的参考文献列表进行补充。中文数据库包括：中国知网（CNKI）、万方（WanFang）、维普（VIP）、中国生物医学文献数据库（SinoMed）、中华医学期刊全文数据库（Yiigle）；英文数据库包括：PubMed、Embase、Web of Science；国内官网包括：中华人民共和国国家卫生健康委员会、中华医学会、中华中医药学会、中国中西医结合学会；国外官网包括：世界卫生组织（World Health Organization, WHO）、国际指南协作网（Guidelines International Network, GIN）、美国国立指南数据库（National Guideline Clearinghouse, NGC）、英国国家卫生医疗质量标准署（National Institute for Health and Care Excellence, NICE）。检索时间范围为建库至2023年12月16日；中文检索式以“肺结节”“肺部结节”“肺小结节”“指南”“共识”为关键词进行搭建，英文检索式以“pulmonary nodule”“lung nodule”“guideline”“consensus”“recommendation”等主题词结合自由词进行搭建。具体检索式见表1。
表 1 文献检索式Table 1. Literature search strategyDatabase Search query Items CNKI (TI % (肺结节 + 肺部结节 + 肺小结节)) AND (TI % (指南 + 共识))
(TI % (pulmonary nodule + lung nodule + small pulmonary nodule)) AND (TI % (guideline + consensus))36 Wanfang (TI=(肺结节 OR 肺部结节 OR 肺小结节)) AND (TI=(指南 OR 共识))
(TI=(pulmonary nodule OR lung nodule OR small pulmonary nodule)) AND (TI=(guideline OR
consensus))46 VIP (T=(肺结节 OR 肺部结节 OR 肺小结节)) AND (T=(指南 OR 共识))
(T=(pulmonary nodule OR lung nodule OR small pulmonary nodule)) AND (T=(guideline OR consensus))48 SinoMed ( "肺结节"[标题:智能] OR "肺部结节"[标题:智能] OR "肺小结节"[标题:智能]) AND( "指南"[标题:智
能] OR "共识"[标题:智能])
( "pulmonary nodule"[Tite: Intelligent] OR "lung nodule"[Tite: Intelligent] OR "small pulmonary
nodule"[Tite: Intelligent]) AND( "guideline"[Tite: Intelligent] OR "consensus"[Tite: Intelligent])35 Yiigle (TI=(肺结节 OR 肺部结节 OR 肺小结节)) AND (TI=(指南 OR 共识))
(TI=(pulmonary nodule OR lung nodule OR small pulmonary nodule)) AND (TI=(guideline OR
consensus))7 PubMed ((pulmonary nodule*[Title]) OR (lung nodule*[Title])) AND ((Guideline[Publication Type]) OR
(Guidelines as Topic[MeSH Terms]) OR (Consensus[MeSH Terms]) OR (guideline*[Title]) OR
(consensus*[Title]) OR (recommendation*[Title]) OR (shared understanding*[Title]))125 Embase (‘lung nodule*’:ti OR ‘pulmonary nodule*’:ti) AND (‘guideline*’:ti OR ‘consensus*’:ti OR
‘recommendation*’:ti OR ‘shared understanding*’:ti)129 Web of Science (TI=((lung nodule*) OR (pulmonary nodule*))) AND (TI=((guideline*) OR (consensus*) OR
(recommendation*) OR (shared understanding*)))131 1.3 文献筛选与数据提取
由2名研究人员严格按照所制定的纳排标准独立开展文献筛选和数据提取并进行交叉核对，如有分歧则与第3名研究人员进行讨论解决。将在8个数据库检索得到的文献题录导入EndNote 20进行机器去重后，再与从医脉通和官方平台获取的文献进行人工对比去重；去重后通过阅读文献的标题和摘要进行初步筛选，初筛后下载文献全文阅读进一步纳排。对最终纳入的指南共识进行数据提取，包括：①基本信息：题目、发布年份、文献类型、制订方法、初版或更新版、发布期刊或平台、制订机构或发布单位等；②方法学质量评价的基本要素：参与成员数目、参考文献数目、推荐或共识的等级和依据、证据的等级和分级依据、利益冲突、基金资助等；③完整下载指南共识所带附件。
1.4 质量评价
由4名经过统一专业培训的研究人员使用AGREE Ⅱ评价工具，独立地对纳入指南共识的方法学进行质量评价 [9]。AGREE Ⅱ是一个国际通用的用于评估已发布指南的开发方法是否严谨和透明的工具，为临床工作者对指南的选择提供参考；同时其也为新指南的开发提供方法学策略，帮助专家学者明确什么信息应当在指南中加以报告及如何报告 [10]。AGREE Ⅱ以23个条目对指南共识的6个领域进行评价：范围和目的、利益相关者的参与、严谨性、清晰性、应用性、编辑独立性。每个条目1~7分，完全不符合1分，完全符合7分；指南共识在某一领域的标准化得分为：各领域得分标准化百分比=（实际得分−可得最低分）/（可得最高分−可得最低分）×100% [9]。
1.5 统计分析
运用SPSS 26.0进行统计分析。计量资料采用秩和检验；以P值作为统计学评价标准，当P>0.05，说明数据间的差异无统计学意义；当P<0.05，说明数据间的差异具有统计学意义[11]。采用组内相关系数（intraclass correlation coefficient，ICC）检验4名研究人员对纳入指南共识进行评价的一致性；模型选择双向混合，类型选择一致性，结果选择平均测量。ICC值介于0~1之间，ICC<0.4表示一致性较差，0.4~0.7表示一致性一般，ICC>0.7表示一致性较好 [12]。
2. 结 果
2.1 文献检索结果
检索8个中英文数据库获得557条文献，检索国内外官方平台和医脉通得到30条文献，合并去重后剩256条；阅读标题和摘要后保留93条进行全文下载，阅读全文后剩36篇文献，从参考文献补充1篇[13]，最终纳入指南共识37部[5, 13-48]。具体文献筛选流程见图1。
2.2 纳入指南共识的基本特征
纳入文献中，指南11部，共识26部；初版32部，更新版5部；循证制订16部，专家意见21部；中文22部，英文15部；政府机构、学术组织、医疗单位发布35部，专家团体发布2部；参与人员≤19的18部，≥20的19部。纳入指南共识的基本特征见表2。
表 2 纳入指南共识的基本特征Table 2. Basic characteristics of included guidelines and consensusesTitle Year Language Version Type Affiliation Expert Reference Methodology 孤立性肺结节的处理
Chinese consensus on treatment of
solitary pulmonary nodule2009 Chinese Initial Consensus Lung Cancer
Professional
Committee of the
Chinese Anti-
Cancer Association56 19 Evidence-oriented 肺部孤立小结节的诊治及随访共识
（2013年，上海）
Consensus on the diagnosis, treatment,
and follow-up of small solitary nodule
in the lung (Shanghai, 2013)2013 Chinese Initial Consensus Lung Cancer Group of
the Respiratory
Disease Branch of
the Shanghai
Medical Association12 8 Expert opinion-oriented Evaluation of individuals with pulmonary
nodules: when is it lung cancer?
Diagnosis and management of lung
cancer, 3rd ed: American College of
Chest Physicians evidence-based
clinical practice guidelines2013 English Updated Guideline American College of
Chest Physicians7 183 Evidence-oriented Guideline on management of solitary
pulmonary nodule2014 English Initial Guideline Spanish Society of
Pneumology and
Thoracic Surgery8 35 Evidence-oriented 肺亚实性结节影像处理专家共识
Expert consensus on imaging management
of sub-solid pulmonary nodules2015 Chinese Initial Consensus Cardiothoracic Group
of the Radiology
Branch of the
Chinese Medical
Association29 39 Expert opinion-oriented British Thoracic Society guidelines for the
investigation and management of
pulmonary nodules2015 English Initial Guideline British Thoracic
Society15 359 Evidence-oriented An official American Thoracic Society
research statement: A research
framework for pulmonary nodule
evaluation and management2015 English Initial Consensus American Thoracic
Society8 90 Expert opinion-oriented 中国肺部结节分类、诊断与治疗指南
（2016年版）
China national guideline of classification,
diagnosis and treatment for lung
nodules (2016 version)2016 Chinese Initial Guideline China Expert Panel on
Early Diagnosis
and Treatment of
Lung Cancer11 20 Expert opinion-oriented Evaluation of pulmonary nodules:
Clinical practice consensus guidelines
for Asia2016 English Initial Guideline American College of
Chest Physicians10 56 Expert opinion-oriented Recommendations for measuring
pulmonary nodules at CT: A statement
from the Fleischner Society2017 English Updated Consensus Fleischner Society 6 67 Evidence-oriented Guidelines for management of incidental
pulmonary nodules detected on CT
images: From the Fleischner Society
20172017 English Updated Guideline Fleischner Society 15 97 Evidence-oriented 上海市肺科医院磨玻璃结节早期肺腺癌
的诊疗共识（第一版）
Shanghai Pulmonary Hospital experts
consensus on the management of
ground-glass nodules suspected as
lung adenocarcinoma (version 1)2018 Chinese Initial Consensus Shanghai Pulmonary
Hospital28 76 Expert opinion-oriented 肺结节诊治中国专家共识（2018年版）
Chinese expert consensus on the diagnosis
and treatment of pulmonary nodules
(2018 edition)2018 Chinese Updated Consensus Lung Cancer Group of
the Respiratory
Disease Branch of
the Chinese Medical
Association etc.48 31 Evidence-oriented 肺小结节术前辅助定位技术专家共识
（2019版）
Expert consensus on preoperative assisted
localization techniques for small
pulmonary nodules (2019 edition)2019 Chinese Initial Consensus Lung Cancer
Prevention and
Control Branch of
the China
International
Exchange and
Promotive
Association for
Medical and Health
Care etc.26 43 Evidence-oriented 人工智能平台下肺结节的三维可视化定
位与手术规划专家共识
Expert consensus on three-dimensional
visual localization and surgical
planning of pulmonary nodules with
artificial intelligence platforms2019 Chinese Initial Consensus Thoracic Surgery
Committee of China
Medicine Education
Association, etc.36 26 Evidence-oriented Management of lung nodules and lung
cancer screening during the COVID-
19 Pandemic: CHEST expert panel
report2020 English Initial Consensus American College of
Chest Physicians etc.24 14 Expert opinion-oriented 肺结节诊治西北地区专家共识
（2021年版）
Expert consensus on diagnosis and
treatment of pulmonary nodules in
Northwest China (2021 Version)2021 Chinese Initial Consensus Minimally Invasive
Therapy Professional
Committee of
Shaanxi Anti-
cancer Association
etc.55 42 Expert opinion-oriented 热消融治疗肺部亚实性结节专家共识
（2021年版）
Expert consensus for thermal ablation of
pulmonary subsolid nodules (2021
edition)2021 Chinese Initial Consensus The Expert Group on
Tumor Ablation
Therapy of Chinese
Medical Doctor
Association etc.53 179 Expert opinion-oriented Tubeless video-assisted thoracic surgery
for pulmonary ground-glass nodules:
expert consensus and protocol
(Guangzhou)2021 English Initial Consensus Jianxing He et al. 129 43 Expert opinion-oriented 人工智能在肺结节诊治中的应用专家共
识（2022年版）
Chinese experts consensus on artificial
intelligence assisted management for
pulmonary nodule (2022 version)2022 Chinese Initial Consensus Thoracic Surgery
Committee,
Department of
Simulated Medicine,
Wu Jieping Medical
Foundation41 60 Expert opinion-oriented 高危肺结节单孔胸腔镜手术诊治重庆地
区专家共识
Expert consensus on diagnosis and
treatment of single-port thoracoscopic
surgery for high-risk pulmonary
nodules in Chongqing area2022 Chinese Initial Consensus Lung Cancer
Professional
Committee of
Chongqing Medical
Biotech Association14 35 Expert opinion-oriented 肺结节活检术风险管理瑞金专家共识
Ruijin expert consensus on risk
management of pulmonary nodule
biopsy2022 Chinese Initial Consensus Expert Group of
Disciplinary Cluster
for Diagnosis,
Treatment and
Management of Small
Pulmonary Nodules
from Ruijin Hospital
of Shanghai Jiao Tong
University School of
Medicine17 60 Expert opinion-oriented 肺部多发磨玻璃结节中西医结合防治一
体化专家共识
Expert consensus on the diagnosis and
treatment of pulmonary multiple
ground-glass nodules by
integrated traditional Chinese and
western medicine2022 Chinese Initial Consensus Shanghai Medical
Association
Integrative Medicine
Branch38 74 Expert opinion-oriented 基于术中快速冰冻切片指导外周型
直径≤2 cm肺结节手术决策的胸外科
专家共识
Expert consensus of thoracic surgeons on
guiding surgical decision-making based
on intraoperative frozen sections for
peripheral pulmonary nodules with
diameter≤2 cm2022 Chinese Initial Consensus Thoracic Surgery Branch
of Shanghai Medical
Association etc.69 65 Evidence-oriented 影像学引导下肺结节冷冻消融专家共识
（2022版）
Expert consensus for image-guided
cryoablation of pulmonary nodule
(2022 Edition)2022 Chinese Initial Consensus Asian Society of
Cryosurgery etc.3 26 Expert opinion-oriented Low-dose computed tomography
screening, follow-up, and management
of lung nodules-An expert consensus
statement from Taiwan2022 English Initial Consensus Taiwan Lung Cancer
Institute etc.5 68 Expert opinion-oriented Malignancy risk stratification for solitary
pulmonary nodule: A clinical practice
guideline2022 English Initial Guideline Xin Sun, Weimin Li etc. 22 28 Evidence-oriented EarlyCDT Lung for assessing risk of lung
cancer in solid lung nodules2022 English Initial Guideline UK National Institute for
Health and Care
Excellence7 246 Expert opinion-oriented 肺部结节（≤2 cm）楔形切除胸外科全国
专家共识（2023版）
Wedge resection of pulmonary nodules
(≤2 cm): A consensus statement by
specialists of thoracic surgery
(2023 edition)2023 Chinese Initial Consensus Thoracic Surgery Branch
of the China
International
Exchange and
Promotive
Association for
Medical and Health
Care etc.172 46 Evidence-oriented 肺结节多学科微创诊疗中国专家共识
Chinese expert consensus on
multidisciplinary minimally invasive
diagnosis and treatment of
pulmonary nodules2023 Chinese Initial Consensus Lung Cancer Medical
Education Committee
of the Chinese
Medicine Education
Association72 103 Evidence-oriented 基于肺癌高风险人群筛查的肺结节中医
诊疗与管理专家共识
Expert consensus from traditional Chinese
medicine perspective on diagnosis,
treatment and management of
pulmonary nodules based on screening
of high-risk groups for lung cancer2023 Chinese Initial Consensus China Traditional
Chinese Medicine
Tumor Prevention and
Control Union, etc.38 87 Evidence-oriented 导航引导下经支气管肺结节介入诊断与
治疗中国专家共识
Consensus of Chinese experts on
navigation guided transbronchial
interventional diagnosis and treatment
of pulmonary nodules2023 Chinese Initial Consensus Committee for the Prevention and
Treatment of Senile
Tumors, Chinese
Society of Clinical
Oncology17 25 Expert opinion-oriented 新型冠状病毒感染后肺结节治疗专家
共识
Expert consensus for the treatment of post
COVID-19 patients with pulmonary
nodules2023 Chinese Initial Consensus Chinese Society for
Thoracic and
Cardiovascular
Surgery36 55 Expert opinion-oriented AI-derived computer-aided detection
(CAD) software for detecting and
measuring lung nodules in CT scan
images2023 English Initial Guideline UK National Institute for
Health and Care
Excellence14 99 Expert opinion-oriented European guidelines for the surgical
management of pure ground-glass
opacities and part-solid nodules: Task
Force of the European Association of
Cardio-Thoracic Surgery and the
European Society of Thoracic Surgeons2023 English Initial Guideline European Association of
Cardio-Thoracic
Surgery etc.15 148 Evidence-oriented ACR Appropriateness Criteria®
incidentally detected indeterminate
pulmonary nodule2023 English Updated Guideline American College of
Radiology18 75 Evidence-oriented 肺结节中西医结合全程管理专家共识
Expert consensus on whole-process
management of pulmonary nodules
with integrated traditional Chinese and
Western Medicine2024 Chinese Initial Consensus Cancer Committee of
Chinese Association
of Integrative
Medicine etc.24 69 Expert opinion-oriented 2.3 纳入指南共识的质量评价
2.3.1 总体情况
纳入的37部指南共识，在6个领域得分的平均标准化百分比依次为：范围和目的（76.28%）、利益相关者的参与（41.82%）、严谨性（36.78%）、清晰性（71.55%）、应用性（34.88%）、编辑独立性（48.03%）。37部指南共识中，仅有英国胸科学会（British Thoracic Society，BTS）在2015年发布的“British Thoracic Society guidelines for the investigation and management of pulmonary nodules”[18]在5个领域的标准化得分≥60%，没有得分<30%的领域，其6个领域的标准化得分依次为：范围和目的（91.67%）、利益相关者的参与（72.22%）、严谨性（85.94%）、清晰性（88.89%）、应用性（61.46%）、编辑独立性（33.33%）。37部指南共识的具体得分情况见表3。
表 3 方法学质量评价结果Table 3. Results of methodological quality assessmentTitle Scope and
purpose
(%)Stakeholder
involvement
(%)Rigor of
development
(%)Clarity of
presentation
(%)Applicability
(%)Editorial
independence
(%)Domains
< 30%Domains
≥ 60%ICC (95%CI) 孤立性肺结节的处理
Chinese consensus on treatment of solitary
pulmonary nodule56.94 25.00 28.65 77.78 28.13 0.00 4 1 0.94
(0.89, 0.97)肺部孤立小结节的诊治及随访共识（2013年，上海）
Consensus on the diagnosis, treatment, and follow-
up of small solitary nodule in the lung (Shanghai,
2013)70.83 20.83 20.31 63.89 26.04 0.00 4 2 0.94
(0.88, 0.97)Evaluation of individuals with pulmonary nodules:
when is it lung cancer? Diagnosis and management
of lung cancer, 3rd ed: American College of Chest
Physicians evidence-based clinical practice guidelines93.06 41.67 76.56 90.28 48.96 100.00 0 4 0.96
(0.93, 0.98)Guideline on management of solitary pulmonary nodule 76.39 33.33 35.42 81.94 36.46 39.58 0 2 0.93
(0.86, 0.97)肺亚实性结节影像处理专家共识
Expert consensus on imaging management of sub-solid
pulmonary nodules62.50 26.39 22.40 55.56 19.79 39.58 3 1 0.93
(0.86, 0.96)British Thoracic Society guidelines for the investigation
and management of pulmonary nodules91.67 72.22 85.94 88.89 61.46 33.33 0 5 0.84
(0.70, 0.93)An official American Thoracic Society research
statement: A research framework for pulmonary
nodule evaluation and management72.22 79.17 25.00 63.89 31.25 89.58 1 4 0.90
(0.80, 0.95)中国肺部结节分类、诊断与治疗指南（2016年版）
China national guideline of classification, diagnosis
and treatment for lung nodules (2016 version)75.00 26.39 19.27 72.22 30.21 39.58 2 2 0.93
(0.87, 0.97)Evaluation of pulmonary nodules: Clinical practice
consensus guidelines for Asia75.00 47.22 31.77 75.00 35.42 85.42 0 3 0.78
(0.58, 0.90)Recommendations for measuring pulmonary nodules
at CT: A statement from the Fleischner Society75.00 52.78 32.81 84.72 36.46 50.00 0 2 0.89
(0.79, 0.95)Guidelines for management of incidental pulmonary
nodules detected on CT images: From the
Fleischner Society 201784.72 56.94 50.52 80.56 45.83 50.00 0 2 0.85
(0.71, 0.93)上海市肺科医院磨玻璃结节早期肺腺癌的诊疗共识
（第一版）
Shanghai Pulmonary Hospital experts consensus on the
management of ground-glass nodules suspected as
lung adenocarcinoma (version 1)75.00 22.22 28.13 73.61 20.83 0.00 4 2 0.96
(0.93, 0.98)肺结节诊治中国专家共识（2018年版）
Chinese expert consensus on the diagnosis and
treatment of pulmonary nodules (2018 edition)88.89 30.56 26.56 80.56 44.79 39.58 1 2 0.94
(0.88, 0.97)肺小结节术前辅助定位技术专家共识（2019版）
Expert consensus on preoperative assisted localization
techniques for small pulmonary nodules (2019
edition)69.44 25.00 31.77 63.89 45.83 0.00 2 2 0.94
(0.89, 0.97)人工智能平台下肺结节的三维可视化定位与手术规
划专家共识
Expert consensus on three-dimensional visual
localization and surgical planning of pulmonary
nodules with artificial intelligence platforms62.50 34.72 32.29 72.22 32.29 79.17 0 3 0.91
(0.83, 0.96)Management of lung nodules and lung cancer
screening during the COVID-19 Pandemic: CHEST
expert panel report80.56 63.89 39.58 81.94 40.63 35.42 0 3 0.81
(0.64, 0.91)肺结节诊治西北地区专家共识（2021年版）
Expert consensus on diagnosis and treatment of
pulmonary nodules in Northwest China (2021
Version)79.17 34.72 22.40 70.83 30.21 41.67 1 2 0.95
(0.90, 0.97)热消融治疗肺部亚实性结节专家共识（2021年版）
Expert consensus for thermal ablation of pulmonary
subsolid nodules (2021 edition)79.17 41.67 27.08 56.94 43.75 0.00 2 1 0.91
(0.83, 0.96)Tubeless video-assisted thoracic surgery for pulmonary
ground-glass nodules: expert consensus and protocol
(Guangzhou)88.89 43.06 27.60 73.61 26.04 97.92 2 3 0.95
(0.91, 0.98)人工智能在肺结节诊治中的应用专家共识
（2022年版）
Chinese experts consensus on artificial intelligence
assisted management for pulmonary nodule
(2022 version)66.67 29.17 23.96 66.67 11.46 4.17 4 2 0.91
(0.82, 0.96)高危肺结节单孔胸腔镜手术诊治重庆地区专家共识
Expert consensus on diagnosis and treatment of single-
port thoracoscopic surgery for high-risk pulmonary
nodules in Chongqing area62.50 38.89 22.92 54.17 25.00 39.58 2 1 0.91
(0.84, 0.96)肺结节活检术风险管理瑞金专家共识
Ruijin expert consensus on risk management of
pulmonary nodule biopsy75.00 36.11 22.92 54.17 18.75 0.00 3 1 0.94
(0.89, 0.97)肺部多发磨玻璃结节中西医结合防治一体化专家共识
Expert consensus on the diagnosis and treatment of
pulmonary multiple ground-glass nodules by
integrated traditional Chinese and western medicine62.50 36.11 27.60 52.78 41.67 27.08 2 1 0.87
(0.76, 0.94)基于术中快速冰冻切片指导外周型直径≤2 cm肺结
节手术决策的胸外科专家共识
Expert consensus of thoracic surgeons on guiding
surgical decision-making based on intraoperative
frozen sections for peripheral pulmonary nodules
with diameter≤2 cm75.00 41.67 40.10 81.94 36.46 79.17 0 3 0.94
(0.88, 0.97)影像学引导下肺结节冷冻消融专家共识（2022版）
Expert consensus for image-guided cryoablation of
pulmonary nodule (2022 Edition)73.61 27.78 22.40 48.61 33.33 39.58 2 1 0.87
(0.75, 0.94)Low-dose computed tomography screening, follow-up,
and management of lung nodules-An expert
consensus statement from Taiwan88.89 50.00 31.25 79.17 34.38 81.25 0 3 0.89
(0.80, 0.95)Malignancy risk stratification for solitary pulmonary
nodule: A clinical practice guideline93.06 55.56 56.77 80.56 45.83 77.08 0 3 0.80
(0.63, 0.91)EarlyCDT Lung for assessing risk of lung cancer in
solid lung nodules81.94 65.28 58.85 77.78 50.00 85.42 0 4 0.64
(0.32, 0.83)肺部结节（≤2 cm）楔形切除胸外科全国专家共识
（2023版）
Wedge resection of pulmonary nodules (≤2 cm): A
consensus statement by specialists of thoracic
surgery (2023 edition)72.22 36.11 34.90 81.94 50.00 39.58 0 2 0.92
(0.84, 0.96)肺结节多学科微创诊疗中国专家共识
Chinese expert consensus on multidisciplinary minimally
invasive diagnosis and treatment of pulmonary nodules72.22 41.67 40.63 76.39 23.96 45.83 1 2 0.95
(0.91, 0.98)基于肺癌高风险人群筛查的肺结节中医诊疗与管理
专家共识
Expert consensus from traditional Chinese medicine
perspective on diagnosis, treatment and management
of pulmonary nodules based on screening of
high-risk groups for lung cancer80.56 34.72 61.98 77.78 33.33 81.25 0 4 0.95
(0.90, 0.97)导航引导下经支气管肺结节介入诊断与治疗中国专
家共识
Consensus of Chinese experts on navigation guided
transbronchial interventional diagnosis and treatment
of pulmonary nodules56.94 41.67 20.31 47.22 35.42 41.67 1 0 0.90
(0.80, 0.95)新型冠状病毒感染后肺结节治疗专家共识
Expert consensus for the treatment of post COVID-19
patients with pulmonary nodules70.83 38.89 21.35 41.67 13.54 39.58 2 1 0.95
(0.90, 0.98)AI-derived computer-aided detection (CAD) software
for detecting and measuring lung nodules in CT scan
images83.33 62.50 54.17 77.78 39.58 81.25 0 4 0.65
(0.35, 0.84)European guidelines for the surgical management of
pure ground-glass opacities and part-solid nodules:
Task Force of the European Association of Cardio-
Thoracic Surgery and the European Society of
Thoracic Surgeons81.94 48.61 75.00 90.28 45.83 93.75 0 4 0.82
(0.66, 0.92)ACR Appropriateness Criteria® incidentally detected
indeterminate pulmonary nodule84.72 52.78 59.38 87.50 37.50 60.42 0 3 0.90
(0.81, 0.95)肺结节中西医结合全程管理专家共识
Expert consensus on whole-process management of
pulmonary nodules with integrated traditional
Chinese and Western Medicine83.33 31.94 22.40 62.50 30.21 39.58 1 2 0.91
(0.83, 0.96)Average standardized percentage 76.28 41.82 36.78 71.55 34.88 48.03 0 2 Items with average standardized percentage <30% 0 8 18 0 10 8 Items with average standardized percentage ≥ 60% 35 5 4 29 1 13 注：CI, confidence interval，可信区间。
Notes: CI, confidence interval.2.3.2 六个领域具体情况
2.3.2.1 范围和目的
该领域的总体得分情况较好，在6个领域中的平均标准化百分比最高（76.28%）；其中有3部共识的得分>90%，最高为93.06%[15, 38]；仅有2部共识的得分<60%，最低为56.94%[13]。对于每部指南的范围，其中21部未限定肺结节的直径或密度等具体特征，1部针对磨玻璃结节[31]，1部针对多发磨玻璃结节[35]，1部针对实性结节[40]，3部针对亚实性结节[17, 30, 45]，1部针对直径<1 cm的结节[26]，2部针对直径≤2 cm的结节[36, 41]，1部针对高危结节[33]，1部针对疑似肺腺癌的结节[24]，4部针对孤立性结节[13-14, 16, 38]，1部针对新型冠状病毒感染后结节[44]；16部为综合性诊治相关的指南共识，3部关注中医/中西医结合诊治[5, 35, 48]，6部关注手术治疗[26, 31, 33, 36, 41, 45]，3部关注介入治疗[30, 37, 43]，3部关注人工智能（artificial intelligence，AI）辅助诊治[27, 32, 46]，3部关注影像处理[17, 22, 47]，2部关注风险评估[38, 40]，1部关注结节活检[34]。
2.3.2.2 利益相关者的参与
该领域的总体得分较低（41.82%），其中仅有2部指南共识的得分>70%，最高为79.17%[19]；另有8部指南共识的得分<30%，最低为20.83%[14]。在该领域，纳入的37部指南共识中，详细记录参与人员的单位和专业的仅5部（13.5%），另有33部（89.2%）并未提及目标人群的观点和意愿相关内容。
2.3.2.3 严谨性
该领域的总体得分较低（36.78%），其中仅有3部指南的得分>70%，最高为85.94%[18]；另有18部指南共识的得分<30%，最低为19.27%[20]。在该领域，纳入的37部指南共识中，详细报道检索方法的6部（16.2%），详细陈述纳排标准的4部（10.8%），推荐或共识具有等级划分的15部（40.5%），参考证据具有等级划分的10部（27.0%）；另有27部（73.0%）并未报告检索方法、28部（75.7%）并未报告证据的选择标准、19部（51.4%）对证据的强度和局限性描述不足、26部（70.3%）对外部评审的程序报告不足、24部（64.9%）对指南的更新程序报告不足。
2.3.2.4 清晰性
该领域的总体得分较高（71.55%），其中有2部指南的得分>90%，均为90.28%[15, 45]；仅有3部共识的得分<50%，最低为41.67%[44]。
2.3.2.5 应用性
该领域的总体得分情况较差，在6个领域中的平均标准化百分比最低（34.88%）；其中仅有1部指南的得分>60%，为61.46%[18]；另有10部指南共识的得分<30%，最低为11.46%[32]。在该领域，纳入的37部指南共识中，8部（21.6%）对于推荐或共识应用时的促进因素和阻碍因素陈述不足、11部（29.7%）对应用所需资源的陈述不足、2部（5.4%）对于意见落实的审计标准不够量化。
2.3.2.6 编辑独立性
该领域的总体得分情况一般（48.03%）；其中有1部指南共识为满分[15]，6部指南共识为0分[13-14, 24, 26, 30, 34]。在该领域，纳入的37部指南共识中，18部（48.6%）并未报告是否有获得赞助，14部（37.8%）并未报告是否有利益冲突的存在。
2.3.3 亚组分析
亚组分析的结果显示，中英文文献在6个领域的得分皆未提示具有统计学意义的差异（P>0.05）；但在指南共识的类型、制订方法、版本、参与制订的专家数目方面，6个领域的得分均具有较显著的统计学差异（P<0.05）；且在6个领域皆为指南高于共识、基于循证证据高于基于专家意见、更新版本高于初版、专家数≥20高于专家数≤19。亚组分析的结果详见表4。
表 4 亚组分析[M (Q1, Q3)]Table 4. Subgroup analysis [M (Q1, Q3)]Characteristic n Scope
and
purpose (%)Stakeholder
involvement (%)Rigor
of
development (%)Clarity
of
presentation (%)Applicability (%) Editorial
independence (%)Type Guideline 11 0.83 (0.79, 0.88) 0.53 (0.44, 0.60) 0.57 (0.43, 0.67) 0.81 (0.78, 0.88) 0.46 (0.37, 0.47) 0.77 (0.45, 0.85) Consensus 26 0.73 (0.67, 0.79) 0.36 (0.30, 0.42) 0.27 (0.23, 0.32) 0.69 (0.56, 0.78) 0.32 (0.25, 0.36) 0.40 (0.10, 0.49) P* 0.001 0.008 <0.001 0.001 0.001 0.016 Methodology Evidence-
oriented16 0.83 (0.80, 0.89) 0.53 (0.46, 0.63) 0.45 (0.32, 0.59) 0.81 (0.77, 0.85) 0.39 (0.35, 0.46) 0.79 (0.47, 0.86) Expert
opinion-
oriented21 0.72 (0.62, 0.75) 0.35 (0.26, 0.39) 0.27 (0.22, 0.32) 0.67 (0.54, 0.76) 0.30 (0.24, 0.36) 0.40 (0.00, 0.42) P* <0.001 <0.001 0.001 <0.001 0.006 <0.001 Version Initial 32 0.75 (0.70, 0.81) 0.36 (0.30, 0.42) 0.28 (0.23, 0.35) 0.73 (0.61, 0.81) 0.33 (0.26, 0.41) 0.40 (0.32, 0.57) Updated 5 0.83 (0.82, 0.85) 0.56 (0.53, 0.62) 0.59 (0.57, 0.59) 0.81 (0.78, 0.88) 0.46 (0.40, 0.46) 0.81 (0.77, 0.85) P* 0.014 0.004 0.001 0.032 0.016 0.014 Language Chinese 22 0.75 (0.71, 0.81) 0.39 (0.31, 0.52) 0.30 (0.23, 0.40) 0.74 (0.64, 0.80) 0.35 (0.30, 0.43) 0.40 (0.10, 0.50) English 15 0.76 (0.73, 0.84) 0.39 (0.33, 0.48) 0.32 (0.25, 0.48) 0.75 (0.67, 0.81) 0.35 (0.26, 0.41) 0.60 (0.40, 0.82) P* 0.435 0.963 0.703 0.658 0.614 0.119 Expert ≤19 18 0.72 (0.64, 0.75) 0.33 (0.26, 0.36) 0.27 (0.23, 0.31) 0.69 (0.56, 0.76) 0.30 (0.24, 0.40) 0.40 (0.00, 0.40) ≥20 19 0.82 (0.76, 0.87) 0.50 (0.42, 0.60) 0.40 (0.29, 0.59) 0.79 (0.74, 0.83) 0.36 (0.34, 0.46) 0.77 (0.41, 0.85) P* <0.001 <0.001 0.006 0.013 0.036 <0.001 注：M, median, 中位数；Q1, first quartile, 25%分位数；Q3, third quartile, 75%分位数。*Mann-Whitney秩和检验，精确显著性。
Notes: M, median; Q1, first quartile; Q3, third quartile. *Mann-Whitney rank-sum test with exact significance.2.3.4 一致性检验
4名研究人员进行评价的总体一致性检验ICC=0.909（95%CI 0.899~0.919），提示评价结果一致性良好，研究人员对AGREE Ⅱ工具的评价条目的理解基本一致，评价结果的信度较高。具体对每篇指南共识的评价ICC见表3。
3. 讨 论
本研究基于AGREE Ⅱ对国内外37篇肺结节诊治相关的指南共识进行了方法学质量评价，结果提示肺结节诊治相关指南共识的质量有限，虽然指南的应用范围和目的比较明确，整体内容比较清晰，但指南共识的制订、应用及利益相关人员的参与和报告还不够全面和具体，制订过程的严谨性水平还有待提高，对于实际的应用考虑得还不够周全，制订过程独立性的报道还有待完善。
在应用范围和目的方面，尽管总体内容比较明确，但对于预期益处或结局、健康照护的设置或情景、临床条件、疾病的具体阶段、排除人群等的定义还不够清晰。在利益相关者的参与方面，对于参与指南共识制订的相关专家，一方面是一部分文献没有纳入循证医学、流行病学、医学统计学、卫生经济与管理学、大数据与医学信息等方面的专家，另一方面是很大一部分文献没有报告专家的具体学科专业及在文件制订过程中的角色或负责的工作；对于在指南共识预期应用的范畴内将涉及的其他利益相关人群的参与也是很缺乏的，特别是对于指南共识所针对的目标人群的观点和倾向性没有得到适当的体现；对于指南共识的预期使用者和预期应用方式，文献也仅是默认相关的医务人员，或影像医生、或病理医生、或呼吸科医生、或胸外科医生、或肿瘤内科医生、或相关护理人员，如此一些具体的人群定义并未得到明确的界定。在严谨性方面，大部分文献忽视了对检索方法和证据选择标准的报告；对于证据的强度和局限性，大部分文献是并未报告，而少部分报告了证据强度但依据的标准又并不统一，3部[15, 22, 23]采用美国胸科医师学会（American College of Chest Physicians, ACCP）标准，2部[16, 47]采用推荐分级的评估、制订与评价系统（the Grading of Recommendations Assessment, Development and Evaluation, GRADE）标准，1部[38]采用GRADE结合美国卫生保健研究与质量机构（Agency for Healthcare Research and Quality, AHRQ）的标准，1部[5]采用Cochrane标准结合《传统医学证据体的构成及证据分级的建议》，1部[18]采用苏格兰校际指南网（Scottish Intercollegiate Guidelines Network, SIGN）分级标准，另有2部[42, 45]采用自定义的证据分级标准；对于从证据到推荐意见的形成，绝大部分文献都有一定的利弊考虑陈述，且在推荐意见与证据之间的联系还是较为紧密，但对于专家如何达成共识或从证据形成推荐意见的方法的报道还很缺乏；对于外部评审，一部分指南未报道评审的程序，一部分指南为内审，极少指南进行了外审；对于指南更新，大部分文献即使更新后版本的指南共识亦未提及相应内容。在清晰性方面，纳入的指南共识基本能做到推荐意见的清楚明白，并能在一定程度上提供在特定情景下的不同选择，且善于归纳汇总推荐意见或运用图例推荐意见进行可视化呈现。在应用性方面，纳入的指南共识对于在应用时的可能存在的促进因素和阻碍因素、所需的潜在相关资源的考虑和陈述都很有限，比如利益相关者的反馈、在广泛应用指南前的预实验、推荐意见的实施者所需的技能水平以及相应的环境和设备要求、预期的费用所需和经济效益评估等；对于应用推荐意见的建议或工具，指南共识大多提供的对肺结节进行逐步分类分级管理的决策路线图；对于监督和审计，绝大部分文献都能提供具体量化的指标。对于编辑独立性，相当一部分文献可能考虑到没有赞助单位或不存在利益冲突就未尽心相关内容的报道，但这是一种错误的观点，即使不存在相关的情况也得如实进行报道以正视听；而一部分报道存在基金资助或利益关系的文献并未陈述资助者的观点或利益关系的存在对相应指南共识制订过程的影响。
亚组分析的结果显示，中英文文献在6个领域的得分皆无统计学差异，提示国内发布的指南共识已和国际接轨，逐步踏上标准化和规范化道路。对于指南在6个领域的得分都优于共识，这是由指南与共识制订的要求不同造成的[49]。美国医学科学院（Institute of Medicine，IOM）在2011年将临床实践指南（clinical practice guidelines）定义为：基于对证据的系统评价和对不同干预措施的利弊评估，形成的旨在为患者提供最佳医疗照护的推荐意见[50]。而对于共识（expert consensus），WHO在2014年发布的指南制订手册中将其作为在指南形成过程中达成决策的一种方法[51]。可以看出指南强调对证据进行系统评价，而共识的形成则着意在专家意见达成一致；但是指南的形成也需要专家进行讨论将证据转化为推荐意见，共识也得是具有证据支撑的共识；而在实际工作中，也并不总是冠名“指南”的文件就比冠名“共识”的文件的方法学质量更高、更具有实际应用意义[49]。本次纳入的37部指南共识，虽然总体上指南在6个领域的得分都优于共识，但是有4部指南对于循证方法的描述并不充分，而有9部共识却强调了证据或推荐意见的等级或强度。对于基于循证证据制订的文献得分高于基于专家意见、更新版本高于初版、专家数≥20高于专家书≤19，亦是在方法学上的更加规范化所致。
本研究的局限性：①尽管4名研究人员的ICC值较高，但限于AGREE Ⅱ量表的主观性打分形式，评价结果亦不能做到完全客观化、标准化。②本研究仅纳入中英文指南共识，可能存在语言偏倚。③目前肺结节相关的诊治实践仍处在探索阶段，相关的证据质量亦存在局限性。
对于指南共识的制订或报告，国际公认的主要有3个规范，分别是WHO在2014年发布的指南制订手册（第2版）[51]，卫生保健实践指南的报告条目（Reporting Items for practice Guidelines in Healthcare, RIGHT）工作组在2016年发表的RIGHT报告清单[52]，和AGREE工作组在2017年更新后的AGREE Ⅱ评价工具[52]；而中华医学会亦在2022年发布了符合国内临床实际的《中国制订/修订临床诊疗指南的指导原则（2022版）》[53]。目前肺结节诊治相关的证据还很有限，肺结节诊治相关的指南共识的方法学质量也有待提高，特别是在制订过程中利益相关者的参与、形成推荐意见的严谨性、对于预期应用性的考虑、对制订过程独立性的报道这4个方面。建议国内外学术组织在未来能够依据标准的流程、按照国际公认的规范进行指南共识的制订、报告和更新，以坚强有力的证据和言之有理的推荐意见切实推进全球肺结节诊治领域的发展进步。
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表 1 文献检索式
Table 1 Literature search strategy
Database Search query Items CNKI (TI % (肺结节 + 肺部结节 + 肺小结节)) AND (TI % (指南 + 共识))
(TI % (pulmonary nodule + lung nodule + small pulmonary nodule)) AND (TI % (guideline + consensus))36 Wanfang (TI=(肺结节 OR 肺部结节 OR 肺小结节)) AND (TI=(指南 OR 共识))
(TI=(pulmonary nodule OR lung nodule OR small pulmonary nodule)) AND (TI=(guideline OR
consensus))46 VIP (T=(肺结节 OR 肺部结节 OR 肺小结节)) AND (T=(指南 OR 共识))
(T=(pulmonary nodule OR lung nodule OR small pulmonary nodule)) AND (T=(guideline OR consensus))48 SinoMed ( "肺结节"[标题:智能] OR "肺部结节"[标题:智能] OR "肺小结节"[标题:智能]) AND( "指南"[标题:智
能] OR "共识"[标题:智能])
( "pulmonary nodule"[Tite: Intelligent] OR "lung nodule"[Tite: Intelligent] OR "small pulmonary
nodule"[Tite: Intelligent]) AND( "guideline"[Tite: Intelligent] OR "consensus"[Tite: Intelligent])35 Yiigle (TI=(肺结节 OR 肺部结节 OR 肺小结节)) AND (TI=(指南 OR 共识))
(TI=(pulmonary nodule OR lung nodule OR small pulmonary nodule)) AND (TI=(guideline OR
consensus))7 PubMed ((pulmonary nodule*[Title]) OR (lung nodule*[Title])) AND ((Guideline[Publication Type]) OR
(Guidelines as Topic[MeSH Terms]) OR (Consensus[MeSH Terms]) OR (guideline*[Title]) OR
(consensus*[Title]) OR (recommendation*[Title]) OR (shared understanding*[Title]))125 Embase (‘lung nodule*’:ti OR ‘pulmonary nodule*’:ti) AND (‘guideline*’:ti OR ‘consensus*’:ti OR
‘recommendation*’:ti OR ‘shared understanding*’:ti)129 Web of Science (TI=((lung nodule*) OR (pulmonary nodule*))) AND (TI=((guideline*) OR (consensus*) OR
(recommendation*) OR (shared understanding*)))131 
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表 2 纳入指南共识的基本特征
Table 2 Basic characteristics of included guidelines and consensuses
Title Year Language Version Type Affiliation Expert Reference Methodology 孤立性肺结节的处理
Chinese consensus on treatment of
solitary pulmonary nodule2009 Chinese Initial Consensus Lung Cancer
Professional
Committee of the
Chinese Anti-
Cancer Association56 19 Evidence-oriented 肺部孤立小结节的诊治及随访共识
（2013年，上海）
Consensus on the diagnosis, treatment,
and follow-up of small solitary nodule
in the lung (Shanghai, 2013)2013 Chinese Initial Consensus Lung Cancer Group of
the Respiratory
Disease Branch of
the Shanghai
Medical Association12 8 Expert opinion-oriented Evaluation of individuals with pulmonary
nodules: when is it lung cancer?
Diagnosis and management of lung
cancer, 3rd ed: American College of
Chest Physicians evidence-based
clinical practice guidelines2013 English Updated Guideline American College of
Chest Physicians7 183 Evidence-oriented Guideline on management of solitary
pulmonary nodule2014 English Initial Guideline Spanish Society of
Pneumology and
Thoracic Surgery8 35 Evidence-oriented 肺亚实性结节影像处理专家共识
Expert consensus on imaging management
of sub-solid pulmonary nodules2015 Chinese Initial Consensus Cardiothoracic Group
of the Radiology
Branch of the
Chinese Medical
Association29 39 Expert opinion-oriented British Thoracic Society guidelines for the
investigation and management of
pulmonary nodules2015 English Initial Guideline British Thoracic
Society15 359 Evidence-oriented An official American Thoracic Society
research statement: A research
framework for pulmonary nodule
evaluation and management2015 English Initial Consensus American Thoracic
Society8 90 Expert opinion-oriented 中国肺部结节分类、诊断与治疗指南
（2016年版）
China national guideline of classification,
diagnosis and treatment for lung
nodules (2016 version)2016 Chinese Initial Guideline China Expert Panel on
Early Diagnosis
and Treatment of
Lung Cancer11 20 Expert opinion-oriented Evaluation of pulmonary nodules:
Clinical practice consensus guidelines
for Asia2016 English Initial Guideline American College of
Chest Physicians10 56 Expert opinion-oriented Recommendations for measuring
pulmonary nodules at CT: A statement
from the Fleischner Society2017 English Updated Consensus Fleischner Society 6 67 Evidence-oriented Guidelines for management of incidental
pulmonary nodules detected on CT
images: From the Fleischner Society
20172017 English Updated Guideline Fleischner Society 15 97 Evidence-oriented 上海市肺科医院磨玻璃结节早期肺腺癌
的诊疗共识（第一版）
Shanghai Pulmonary Hospital experts
consensus on the management of
ground-glass nodules suspected as
lung adenocarcinoma (version 1)2018 Chinese Initial Consensus Shanghai Pulmonary
Hospital28 76 Expert opinion-oriented 肺结节诊治中国专家共识（2018年版）
Chinese expert consensus on the diagnosis
and treatment of pulmonary nodules
(2018 edition)2018 Chinese Updated Consensus Lung Cancer Group of
the Respiratory
Disease Branch of
the Chinese Medical
Association etc.48 31 Evidence-oriented 肺小结节术前辅助定位技术专家共识
（2019版）
Expert consensus on preoperative assisted
localization techniques for small
pulmonary nodules (2019 edition)2019 Chinese Initial Consensus Lung Cancer
Prevention and
Control Branch of
the China
International
Exchange and
Promotive
Association for
Medical and Health
Care etc.26 43 Evidence-oriented 人工智能平台下肺结节的三维可视化定
位与手术规划专家共识
Expert consensus on three-dimensional
visual localization and surgical
planning of pulmonary nodules with
artificial intelligence platforms2019 Chinese Initial Consensus Thoracic Surgery
Committee of China
Medicine Education
Association, etc.36 26 Evidence-oriented Management of lung nodules and lung
cancer screening during the COVID-
19 Pandemic: CHEST expert panel
report2020 English Initial Consensus American College of
Chest Physicians etc.24 14 Expert opinion-oriented 肺结节诊治西北地区专家共识
（2021年版）
Expert consensus on diagnosis and
treatment of pulmonary nodules in
Northwest China (2021 Version)2021 Chinese Initial Consensus Minimally Invasive
Therapy Professional
Committee of
Shaanxi Anti-
cancer Association
etc.55 42 Expert opinion-oriented 热消融治疗肺部亚实性结节专家共识
（2021年版）
Expert consensus for thermal ablation of
pulmonary subsolid nodules (2021
edition)2021 Chinese Initial Consensus The Expert Group on
Tumor Ablation
Therapy of Chinese
Medical Doctor
Association etc.53 179 Expert opinion-oriented Tubeless video-assisted thoracic surgery
for pulmonary ground-glass nodules:
expert consensus and protocol
(Guangzhou)2021 English Initial Consensus Jianxing He et al. 129 43 Expert opinion-oriented 人工智能在肺结节诊治中的应用专家共
识（2022年版）
Chinese experts consensus on artificial
intelligence assisted management for
pulmonary nodule (2022 version)2022 Chinese Initial Consensus Thoracic Surgery
Committee,
Department of
Simulated Medicine,
Wu Jieping Medical
Foundation41 60 Expert opinion-oriented 高危肺结节单孔胸腔镜手术诊治重庆地
区专家共识
Expert consensus on diagnosis and
treatment of single-port thoracoscopic
surgery for high-risk pulmonary
nodules in Chongqing area2022 Chinese Initial Consensus Lung Cancer
Professional
Committee of
Chongqing Medical
Biotech Association14 35 Expert opinion-oriented 肺结节活检术风险管理瑞金专家共识
Ruijin expert consensus on risk
management of pulmonary nodule
biopsy2022 Chinese Initial Consensus Expert Group of
Disciplinary Cluster
for Diagnosis,
Treatment and
Management of Small
Pulmonary Nodules
from Ruijin Hospital
of Shanghai Jiao Tong
University School of
Medicine17 60 Expert opinion-oriented 肺部多发磨玻璃结节中西医结合防治一
体化专家共识
Expert consensus on the diagnosis and
treatment of pulmonary multiple
ground-glass nodules by
integrated traditional Chinese and
western medicine2022 Chinese Initial Consensus Shanghai Medical
Association
Integrative Medicine
Branch38 74 Expert opinion-oriented 基于术中快速冰冻切片指导外周型
直径≤2 cm肺结节手术决策的胸外科
专家共识
Expert consensus of thoracic surgeons on
guiding surgical decision-making based
on intraoperative frozen sections for
peripheral pulmonary nodules with
diameter≤2 cm2022 Chinese Initial Consensus Thoracic Surgery Branch
of Shanghai Medical
Association etc.69 65 Evidence-oriented 影像学引导下肺结节冷冻消融专家共识
（2022版）
Expert consensus for image-guided
cryoablation of pulmonary nodule
(2022 Edition)2022 Chinese Initial Consensus Asian Society of
Cryosurgery etc.3 26 Expert opinion-oriented Low-dose computed tomography
screening, follow-up, and management
of lung nodules-An expert consensus
statement from Taiwan2022 English Initial Consensus Taiwan Lung Cancer
Institute etc.5 68 Expert opinion-oriented Malignancy risk stratification for solitary
pulmonary nodule: A clinical practice
guideline2022 English Initial Guideline Xin Sun, Weimin Li etc. 22 28 Evidence-oriented EarlyCDT Lung for assessing risk of lung
cancer in solid lung nodules2022 English Initial Guideline UK National Institute for
Health and Care
Excellence7 246 Expert opinion-oriented 肺部结节（≤2 cm）楔形切除胸外科全国
专家共识（2023版）
Wedge resection of pulmonary nodules
(≤2 cm): A consensus statement by
specialists of thoracic surgery
(2023 edition)2023 Chinese Initial Consensus Thoracic Surgery Branch
of the China
International
Exchange and
Promotive
Association for
Medical and Health
Care etc.172 46 Evidence-oriented 肺结节多学科微创诊疗中国专家共识
Chinese expert consensus on
multidisciplinary minimally invasive
diagnosis and treatment of
pulmonary nodules2023 Chinese Initial Consensus Lung Cancer Medical
Education Committee
of the Chinese
Medicine Education
Association72 103 Evidence-oriented 基于肺癌高风险人群筛查的肺结节中医
诊疗与管理专家共识
Expert consensus from traditional Chinese
medicine perspective on diagnosis,
treatment and management of
pulmonary nodules based on screening
of high-risk groups for lung cancer2023 Chinese Initial Consensus China Traditional
Chinese Medicine
Tumor Prevention and
Control Union, etc.38 87 Evidence-oriented 导航引导下经支气管肺结节介入诊断与
治疗中国专家共识
Consensus of Chinese experts on
navigation guided transbronchial
interventional diagnosis and treatment
of pulmonary nodules2023 Chinese Initial Consensus Committee for the Prevention and
Treatment of Senile
Tumors, Chinese
Society of Clinical
Oncology17 25 Expert opinion-oriented 新型冠状病毒感染后肺结节治疗专家
共识
Expert consensus for the treatment of post
COVID-19 patients with pulmonary
nodules2023 Chinese Initial Consensus Chinese Society for
Thoracic and
Cardiovascular
Surgery36 55 Expert opinion-oriented AI-derived computer-aided detection
(CAD) software for detecting and
measuring lung nodules in CT scan
images2023 English Initial Guideline UK National Institute for
Health and Care
Excellence14 99 Expert opinion-oriented European guidelines for the surgical
management of pure ground-glass
opacities and part-solid nodules: Task
Force of the European Association of
Cardio-Thoracic Surgery and the
European Society of Thoracic Surgeons2023 English Initial Guideline European Association of
Cardio-Thoracic
Surgery etc.15 148 Evidence-oriented ACR Appropriateness Criteria®
incidentally detected indeterminate
pulmonary nodule2023 English Updated Guideline American College of
Radiology18 75 Evidence-oriented 肺结节中西医结合全程管理专家共识
Expert consensus on whole-process
management of pulmonary nodules
with integrated traditional Chinese and
Western Medicine2024 Chinese Initial Consensus Cancer Committee of
Chinese Association
of Integrative
Medicine etc.24 69 Expert opinion-oriented
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表 3 方法学质量评价结果
Table 3 Results of methodological quality assessment
Title Scope and
purpose
(%)Stakeholder
involvement
(%)Rigor of
development
(%)Clarity of
presentation
(%)Applicability
(%)Editorial
independence
(%)Domains
< 30%Domains
≥ 60%ICC (95%CI) 孤立性肺结节的处理
Chinese consensus on treatment of solitary
pulmonary nodule56.94 25.00 28.65 77.78 28.13 0.00 4 1 0.94
(0.89, 0.97)肺部孤立小结节的诊治及随访共识（2013年，上海）
Consensus on the diagnosis, treatment, and follow-
up of small solitary nodule in the lung (Shanghai,
2013)70.83 20.83 20.31 63.89 26.04 0.00 4 2 0.94
(0.88, 0.97)Evaluation of individuals with pulmonary nodules:
when is it lung cancer? Diagnosis and management
of lung cancer, 3rd ed: American College of Chest
Physicians evidence-based clinical practice guidelines93.06 41.67 76.56 90.28 48.96 100.00 0 4 0.96
(0.93, 0.98)Guideline on management of solitary pulmonary nodule 76.39 33.33 35.42 81.94 36.46 39.58 0 2 0.93
(0.86, 0.97)肺亚实性结节影像处理专家共识
Expert consensus on imaging management of sub-solid
pulmonary nodules62.50 26.39 22.40 55.56 19.79 39.58 3 1 0.93
(0.86, 0.96)British Thoracic Society guidelines for the investigation
and management of pulmonary nodules91.67 72.22 85.94 88.89 61.46 33.33 0 5 0.84
(0.70, 0.93)An official American Thoracic Society research
statement: A research framework for pulmonary
nodule evaluation and management72.22 79.17 25.00 63.89 31.25 89.58 1 4 0.90
(0.80, 0.95)中国肺部结节分类、诊断与治疗指南（2016年版）
China national guideline of classification, diagnosis
and treatment for lung nodules (2016 version)75.00 26.39 19.27 72.22 30.21 39.58 2 2 0.93
(0.87, 0.97)Evaluation of pulmonary nodules: Clinical practice
consensus guidelines for Asia75.00 47.22 31.77 75.00 35.42 85.42 0 3 0.78
(0.58, 0.90)Recommendations for measuring pulmonary nodules
at CT: A statement from the Fleischner Society75.00 52.78 32.81 84.72 36.46 50.00 0 2 0.89
(0.79, 0.95)Guidelines for management of incidental pulmonary
nodules detected on CT images: From the
Fleischner Society 201784.72 56.94 50.52 80.56 45.83 50.00 0 2 0.85
(0.71, 0.93)上海市肺科医院磨玻璃结节早期肺腺癌的诊疗共识
（第一版）
Shanghai Pulmonary Hospital experts consensus on the
management of ground-glass nodules suspected as
lung adenocarcinoma (version 1)75.00 22.22 28.13 73.61 20.83 0.00 4 2 0.96
(0.93, 0.98)肺结节诊治中国专家共识（2018年版）
Chinese expert consensus on the diagnosis and
treatment of pulmonary nodules (2018 edition)88.89 30.56 26.56 80.56 44.79 39.58 1 2 0.94
(0.88, 0.97)肺小结节术前辅助定位技术专家共识（2019版）
Expert consensus on preoperative assisted localization
techniques for small pulmonary nodules (2019
edition)69.44 25.00 31.77 63.89 45.83 0.00 2 2 0.94
(0.89, 0.97)人工智能平台下肺结节的三维可视化定位与手术规
划专家共识
Expert consensus on three-dimensional visual
localization and surgical planning of pulmonary
nodules with artificial intelligence platforms62.50 34.72 32.29 72.22 32.29 79.17 0 3 0.91
(0.83, 0.96)Management of lung nodules and lung cancer
screening during the COVID-19 Pandemic: CHEST
expert panel report80.56 63.89 39.58 81.94 40.63 35.42 0 3 0.81
(0.64, 0.91)肺结节诊治西北地区专家共识（2021年版）
Expert consensus on diagnosis and treatment of
pulmonary nodules in Northwest China (2021
Version)79.17 34.72 22.40 70.83 30.21 41.67 1 2 0.95
(0.90, 0.97)热消融治疗肺部亚实性结节专家共识（2021年版）
Expert consensus for thermal ablation of pulmonary
subsolid nodules (2021 edition)79.17 41.67 27.08 56.94 43.75 0.00 2 1 0.91
(0.83, 0.96)Tubeless video-assisted thoracic surgery for pulmonary
ground-glass nodules: expert consensus and protocol
(Guangzhou)88.89 43.06 27.60 73.61 26.04 97.92 2 3 0.95
(0.91, 0.98)人工智能在肺结节诊治中的应用专家共识
（2022年版）
Chinese experts consensus on artificial intelligence
assisted management for pulmonary nodule
(2022 version)66.67 29.17 23.96 66.67 11.46 4.17 4 2 0.91
(0.82, 0.96)高危肺结节单孔胸腔镜手术诊治重庆地区专家共识
Expert consensus on diagnosis and treatment of single-
port thoracoscopic surgery for high-risk pulmonary
nodules in Chongqing area62.50 38.89 22.92 54.17 25.00 39.58 2 1 0.91
(0.84, 0.96)肺结节活检术风险管理瑞金专家共识
Ruijin expert consensus on risk management of
pulmonary nodule biopsy75.00 36.11 22.92 54.17 18.75 0.00 3 1 0.94
(0.89, 0.97)肺部多发磨玻璃结节中西医结合防治一体化专家共识
Expert consensus on the diagnosis and treatment of
pulmonary multiple ground-glass nodules by
integrated traditional Chinese and western medicine62.50 36.11 27.60 52.78 41.67 27.08 2 1 0.87
(0.76, 0.94)基于术中快速冰冻切片指导外周型直径≤2 cm肺结
节手术决策的胸外科专家共识
Expert consensus of thoracic surgeons on guiding
surgical decision-making based on intraoperative
frozen sections for peripheral pulmonary nodules
with diameter≤2 cm75.00 41.67 40.10 81.94 36.46 79.17 0 3 0.94
(0.88, 0.97)影像学引导下肺结节冷冻消融专家共识（2022版）
Expert consensus for image-guided cryoablation of
pulmonary nodule (2022 Edition)73.61 27.78 22.40 48.61 33.33 39.58 2 1 0.87
(0.75, 0.94)Low-dose computed tomography screening, follow-up,
and management of lung nodules-An expert
consensus statement from Taiwan88.89 50.00 31.25 79.17 34.38 81.25 0 3 0.89
(0.80, 0.95)Malignancy risk stratification for solitary pulmonary
nodule: A clinical practice guideline93.06 55.56 56.77 80.56 45.83 77.08 0 3 0.80
(0.63, 0.91)EarlyCDT Lung for assessing risk of lung cancer in
solid lung nodules81.94 65.28 58.85 77.78 50.00 85.42 0 4 0.64
(0.32, 0.83)肺部结节（≤2 cm）楔形切除胸外科全国专家共识
（2023版）
Wedge resection of pulmonary nodules (≤2 cm): A
consensus statement by specialists of thoracic
surgery (2023 edition)72.22 36.11 34.90 81.94 50.00 39.58 0 2 0.92
(0.84, 0.96)肺结节多学科微创诊疗中国专家共识
Chinese expert consensus on multidisciplinary minimally
invasive diagnosis and treatment of pulmonary nodules72.22 41.67 40.63 76.39 23.96 45.83 1 2 0.95
(0.91, 0.98)基于肺癌高风险人群筛查的肺结节中医诊疗与管理
专家共识
Expert consensus from traditional Chinese medicine
perspective on diagnosis, treatment and management
of pulmonary nodules based on screening of
high-risk groups for lung cancer80.56 34.72 61.98 77.78 33.33 81.25 0 4 0.95
(0.90, 0.97)导航引导下经支气管肺结节介入诊断与治疗中国专
家共识
Consensus of Chinese experts on navigation guided
transbronchial interventional diagnosis and treatment
of pulmonary nodules56.94 41.67 20.31 47.22 35.42 41.67 1 0 0.90
(0.80, 0.95)新型冠状病毒感染后肺结节治疗专家共识
Expert consensus for the treatment of post COVID-19
patients with pulmonary nodules70.83 38.89 21.35 41.67 13.54 39.58 2 1 0.95
(0.90, 0.98)AI-derived computer-aided detection (CAD) software
for detecting and measuring lung nodules in CT scan
images83.33 62.50 54.17 77.78 39.58 81.25 0 4 0.65
(0.35, 0.84)European guidelines for the surgical management of
pure ground-glass opacities and part-solid nodules:
Task Force of the European Association of Cardio-
Thoracic Surgery and the European Society of
Thoracic Surgeons81.94 48.61 75.00 90.28 45.83 93.75 0 4 0.82
(0.66, 0.92)ACR Appropriateness Criteria® incidentally detected
indeterminate pulmonary nodule84.72 52.78 59.38 87.50 37.50 60.42 0 3 0.90
(0.81, 0.95)肺结节中西医结合全程管理专家共识
Expert consensus on whole-process management of
pulmonary nodules with integrated traditional
Chinese and Western Medicine83.33 31.94 22.40 62.50 30.21 39.58 1 2 0.91
(0.83, 0.96)Average standardized percentage 76.28 41.82 36.78 71.55 34.88 48.03 0 2 Items with average standardized percentage <30% 0 8 18 0 10 8 Items with average standardized percentage ≥ 60% 35 5 4 29 1 13 注：CI, confidence interval，可信区间。
Notes: CI, confidence interval.
下载: 导出CSV
表 4 亚组分析[M (Q1, Q3)]
Table 4 Subgroup analysis [M (Q1, Q3)]
Characteristic n Scope
and
purpose (%)Stakeholder
involvement (%)Rigor
of
development (%)Clarity
of
presentation (%)Applicability (%) Editorial
independence (%)Type Guideline 11 0.83 (0.79, 0.88) 0.53 (0.44, 0.60) 0.57 (0.43, 0.67) 0.81 (0.78, 0.88) 0.46 (0.37, 0.47) 0.77 (0.45, 0.85) Consensus 26 0.73 (0.67, 0.79) 0.36 (0.30, 0.42) 0.27 (0.23, 0.32) 0.69 (0.56, 0.78) 0.32 (0.25, 0.36) 0.40 (0.10, 0.49) P* 0.001 0.008 <0.001 0.001 0.001 0.016 Methodology Evidence-
oriented16 0.83 (0.80, 0.89) 0.53 (0.46, 0.63) 0.45 (0.32, 0.59) 0.81 (0.77, 0.85) 0.39 (0.35, 0.46) 0.79 (0.47, 0.86) Expert
opinion-
oriented21 0.72 (0.62, 0.75) 0.35 (0.26, 0.39) 0.27 (0.22, 0.32) 0.67 (0.54, 0.76) 0.30 (0.24, 0.36) 0.40 (0.00, 0.42) P* <0.001 <0.001 0.001 <0.001 0.006 <0.001 Version Initial 32 0.75 (0.70, 0.81) 0.36 (0.30, 0.42) 0.28 (0.23, 0.35) 0.73 (0.61, 0.81) 0.33 (0.26, 0.41) 0.40 (0.32, 0.57) Updated 5 0.83 (0.82, 0.85) 0.56 (0.53, 0.62) 0.59 (0.57, 0.59) 0.81 (0.78, 0.88) 0.46 (0.40, 0.46) 0.81 (0.77, 0.85) P* 0.014 0.004 0.001 0.032 0.016 0.014 Language Chinese 22 0.75 (0.71, 0.81) 0.39 (0.31, 0.52) 0.30 (0.23, 0.40) 0.74 (0.64, 0.80) 0.35 (0.30, 0.43) 0.40 (0.10, 0.50) English 15 0.76 (0.73, 0.84) 0.39 (0.33, 0.48) 0.32 (0.25, 0.48) 0.75 (0.67, 0.81) 0.35 (0.26, 0.41) 0.60 (0.40, 0.82) P* 0.435 0.963 0.703 0.658 0.614 0.119 Expert ≤19 18 0.72 (0.64, 0.75) 0.33 (0.26, 0.36) 0.27 (0.23, 0.31) 0.69 (0.56, 0.76) 0.30 (0.24, 0.40) 0.40 (0.00, 0.40) ≥20 19 0.82 (0.76, 0.87) 0.50 (0.42, 0.60) 0.40 (0.29, 0.59) 0.79 (0.74, 0.83) 0.36 (0.34, 0.46) 0.77 (0.41, 0.85) P* <0.001 <0.001 0.006 0.013 0.036 <0.001 注：M, median, 中位数；Q1, first quartile, 25%分位数；Q3, third quartile, 75%分位数。*Mann-Whitney秩和检验，精确显著性。
Notes: M, median; Q1, first quartile; Q3, third quartile. *Mann-Whitney rank-sum test with exact significance.
下载: 导出CSV
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