Malignancy risk stratification for solitary pulmonary nodule: A clinical practice guideline

Bojiang Chen; Qianrui Li; Qiukui Hao; Jing Tan; Lan Yan; Yuqi Zhu; Chengping Hu; Guisheng Qian; Guozhen Zhang; Liangan Chen; Chengzhi Zhou; Jian Zhang; Jiayuan Sun; Li Jiang; Li Zhang; Qi Wang; Xiaoju Zhang; Yang Jin; Yong He; Yong Song; Xin Sun; Weimin Li

doi:10.1111/jebm.12476

Malignancy risk stratification for solitary pulmonary nodule: A clinical practice guideline

J Evid Based Med. 2022 Jun;15(2):142-151. doi: 10.1111/jebm.12476. Epub 2022 Jul 1.

Authors

Bojiang Chen^{1

2}, Qianrui Li^{3

4

5

6}, Qiukui Hao^{7

8}, Jing Tan^{3

4

5}, Lan Yan^{1

2}, Yuqi Zhu^{1

2}, Chengping Hu⁹, Guisheng Qian¹⁰, Guozhen Zhang¹¹, Liangan Chen¹², Chengzhi Zhou¹³, Jian Zhang¹⁴, Jiayuan Sun¹⁵, Li Jiang¹⁶, Li Zhang¹⁷, Qi Wang¹⁸, Xiaoju Zhang¹⁹, Yang Jin²⁰, Yong He²¹, Yong Song²², Xin Sun^{3

4

5}, Weimin Li^{1

2}

Affiliations

¹ Department of Respiratory and Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, China.
² Frontiers Science Center for Disease-related Molecular Network, West China Hospital, Sichuan University, Chengdu, China.
³ Chinese Evidence-Based Medicine Center, Cochrane China Center and MAGIC China Center, West China Hospital, Sichuan University, Chengdu, China.
⁴ National Medical Products Administration (NMPA) Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, China.
⁵ Sichuan Center of Technology Innovation for Real-World Data, Chengdu, China.
⁶ Department of Nuclear Medicine, West China Hospital, Sichuan University, Chengdu, China.
⁷ The Center of Gerontology and Geriatrics/National Clinical Research Center of Geriatrics, West China Hospital, Sichuan University, Chengdu, China.
⁸ School of Rehabilitation Science, McMaster University, Hamilton, Ontario, Canada.
⁹ Department of Respiratory Medicine, National Key Clinical Specialty, Branch of National Clinical Research Center for Respiratory Disease, Xiangya Hospital, Central South University, Changsha, China.
¹⁰ Institute of Respiratory Disease, The Second Affiliated Hospital, Army Medical University, Chongqing, China.
¹¹ Department of Radiology, Huadong Hospital Fudan University, Shanghai, China.
¹² Department of Respiratory Medicine, Chinese People's Liberation Army General Hospital, Beijing, China.
¹³ State Key Laboratory of Respiratory Disease, National Clinical Research Centre for Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital, Guangzhou, China.
¹⁴ Department of Pulmonary and Critical Care Medicine, Xijing Hospital, Air-Force Medical University, Xi'an, China.
¹⁵ Department of Respiratory and Critical Care Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
¹⁶ Department of Respiration, the Second Clinical Medical College of North Sichuan Medical College, Nanchong Central Hospital, Nanchong, China.
¹⁷ Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing, China.
¹⁸ Department of Respiratory and Critical Care Medicine, Second Affiliated Hospital, Dalian Medical University, Dalian, China.
¹⁹ Department of Respiratory and Critical Care Medicine, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, Zhengzhou, China.
²⁰ Department of Respiratory Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
²¹ Department of Respiratory Disease, Daping Hospital, Army Medical University, Chongqing, China.
²² Department of Respiratory and Critical Medicine, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.

PMID: 35775869
DOI: 10.1111/jebm.12476

Abstract

Clinical question: The detection rate of the solitary pulmonary nodule (SPN) is increasing with the popularization of CT scanning. Malignancy risk stratification for SPN is a major clinical difficulty.

Current practice: There have been several guidelines for SPN assessment. Inconsistency of these guidelines makes the clinical application difficult and confusing.

Recommendations: In this Rapid Recommendation, solid and subsolid SPNs are recommended to be evaluated respectively. Six factors, namely the combination of age with sex, smoking history, history of malignancy, family history of malignancy, and nodule size, are recommended for malignancy risk stratification for both kinds of SPNs; the border of nodules (spiculation and lobulation) is recommended for evaluating solid SPNs and the density of nodules (pure or mixed ground-glass nodule) is recommended for subsolid nodules. Among them, smoking history and radiologic features (nodule diameter, border, and density) are of relatively higher importance. A scoring system was proposed to assist malignancy risk stratification of SPNs, with a total score ranging from six points to 15 points (if solid) or 17 points (if subsolid). For each SPN, regardless of solid or subsolid in nature, a total score of ≤ 7 points suggested a low risk of being malignant, while 7 to 9 points suggested medium risk, and ≥ 9 points suggested high risk.

How this guideline was created: This rapid recommendation was developed using the MAGIC (Making GRADE the Irresistible Choice) methodological framework. First, a clinical subcommittee identified the topic of recommendation and requested evidence. Then, an independent evidence synthesis subcommittee performed a comprehensive literature review and evaluated the evidence. Finally, based on findings from the systematic review and use of real-world data, the clinical subcommittee formulated recommendations, including the scoring system, through a consensus procedure.

The evidence: A total of 13857 patients with SPNs were included in the meta-analysis and the association between 12 candidate factors and the risk of SPNs being malignant was studied. Eventually, seven factors were recommended for SPNs evaluation, and a scoring system was proposed.

Understanding the recommendation: The parameters included are objective. Therefore, this recommendation is feasible in clinical practice. However, there are several uncertainties, such as a lack of further verification. It might be misclassified by the scoring system. Clinicians could choose the most suitable scheme according to the recommendation, along with their own experience in specific situations.

Keywords: clinical practice guideline; malignancy risk stratification; solitary pulmonary nodule.

MeSH terms

Humans
Lung Neoplasms* / diagnostic imaging
Lung Neoplasms* / pathology
Practice Guidelines as Topic
Risk Assessment
Solitary Pulmonary Nodule* / diagnostic imaging
Solitary Pulmonary Nodule* / pathology
Tomography, X-Ray Computed