Development of a pulmonary nodule symptom scale based on the Delphi expert consensus method_Chinese Journal of Evidence-Based Medicine

Authors：

LI Yanlong ^1,2 , WANG Xin ³ , SHI Qiuling ⁴ , LIN Jietao ^5,6,7 , SUN Lingling ^5,6,7 , AN Bo ^5,6,7 , GUAN Minyi ^5,6,7 , DAI Jiajie ¹ ,  LIN Lizhu ^5,6,7

1. The First Clinical Medical School of Guangzhou University of Chinese Medicine, Guangzhou 510000, P. R. China;
2. Chinese Center for Disease Control and Prevention, Beijing 100000, P. R. China;
3. Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston 77036, USA;
4. College of Public Health, Chongqing Medical University, Chongqing 400016, P. R. China;
5. The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou 510000, P. R. China;
6. Guangdong Clinical Research Academy of Chinese Medicine, Guangzhou, Guangzhou 510000, P. R. China;
7. Lingnan Medical Research Center of Guangzhou University of Chinese Medicine, Guangzhou 510000, P. R. China;

Corresponding?author：

LIN Lizhu, Email: linlizhu@gzucm.edu.cn

Keywords：

Pulmonary nodule; Efficacy evaluation; Symptoms; Scale; Delphi; Traditional Chinese medicine

DOI：

10.7507/1672-2531.202412034

Video：

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Objective To develop a preliminary "pulmonary nodule symptom scale" based on the Delphi method, providing a tailored, standardized, normalized, and promotable symptomatic evaluation tool for the efficacy assessment of pulmonary nodule patients treated with traditional Chinese medicine or integrated traditional Chinese and Western medicine interventions. Methods A preliminary pool of scale items was formed through literature review, interviews with doctors and patients, and reference to guidelines and consensus on pulmonary nodules and patient-reported outcome (PRO) scales related to lung cancer. Two rounds of expert consultation were conducted using the Delphi method. Based on the concentration and variation indicators of expert evaluations, and considering experts’ suggestions for specific item deletions and modifications, a core group meeting was held to screen and refine the scale items. Results Invitations were sent to 54 experts, with 51 accepting the consultation. The active coefficient for the first round of consultation was 94.4%, and for the second round, it was 100%. The average authority coefficient for the 51 experts was 0.896. The Kendall’s coefficient of concordance and the average coefficient of variation for the first and second rounds of consultation were 0.215 (P<0.001) and (0.34±0.07), 0.162 (P<0.001) and (0.24±0.05), respectively. Through two rounds of Delphi expert consultation, a preliminary "pulmonary nodule symptom scale" covering 17 items across four dimensions - respiratory symptoms, systemic manifestations, psychological state, and overall assessment - was formed. Conclusion The experts participating in this Delphi consultation had high authority and enthusiasm, and they have a good level of acceptance and consistency for the preliminary "pulmonary nodule symptom scale". Subsequent empirical research will be conducted on a large sample cohort of pulmonary nodule patients to verify the scale’s stability and effectiveness.

Citation： LI Yanlong, WANG Xin, SHI Qiuling, LIN Jietao, SUN Lingling, AN Bo, GUAN Minyi, DAI Jiajie, LIN Lizhu. Development of a pulmonary nodule symptom scale based on the Delphi expert consensus method. Chinese Journal of Evidence-Based Medicine, 2025, 25(10): 1183-1190. doi: 10.7507/1672-2531.202412034 Copy

1.	Han B, Zheng R, Zeng H, et al. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent, 2024, 4(1): 47-53.
2.	Mazzone PJ, Lam L. Evaluating the patient with a pulmonary nodule: a review. JAMA, 2022, 327(3): 264-273.
3.	范亞光, 周清華, 喬友林, 等. 中國肺癌低劑量CT篩查指南(2023年版). 中國肺癌雜志, 2023, 26(1): 1-9.
4.	劉瑞, 李玥. 基于肺癌高風險人群篩查的肺結節中醫診療與管理專家共識. 中醫雜志, 2023, 64(17): 1824-1832.
5.	MacMahon H, Naidich DP, Goo JM, et al. Guidelines for management of incidental pulmonary nodules detected on ct images: from the Fleischner Society 2017. Radiology, 2017, 284(1): 228-243.
6.	中華醫學會呼吸病學分會肺癌學組, 中國肺癌防治聯盟專家組. 肺結節診治中國專家共識(2018年版). 中華結核和呼吸雜志, 2018, 41(10): 763-771.
7.	楊國旺, 張興涵, 張懷銳, 等. 肺結節中西醫結合全程管理專家共識. 中國實驗方劑學雜志, 2024, 30(1): 149-159.
8.	Au-Yong ITH, Hamilton W, Rawlinson J, et al. Pulmonary nodules. BMJ, 2020, 371: m3673.
9.	Walter K. Pulmonary nodules. JAMA, 2021, 326(15): 1544.
10.	朱沛文, 李芳, 肖沖, 等. 基于疾病全程管理探索肺結節中醫診療體系的構建. 中醫雜志, 2023, 64(23): 2397-2400.
11.	黎雪, 劉碩, 王學謙, 等. 中醫藥防治肺結節的優勢及思考. 中國中醫基礎醫學雜志, 2023, 29(11): 1814-1817.
12.	李夢乾, 姜良鐸, 張曉梅, 等. 肺結節中醫藥臨床療效評價體系探討. 北京中醫藥大學學報, 2023, 46(10): 1333-1337.
13.	景城陽, 劉瑞雪, 褚紅玲, 等. 醫學研究領域德爾菲法實施和報告標準(CREDES)解讀. 中國循證醫學雜志, 2023, 23(2): 233-239.
14.	Jünger S, Payne SA, Brine J, et al. Guidance on Conducting and REporting DElphi Studies (CREDES) in palliative care: recommendations based on a methodological systematic review. Palliat Med, 2017, 31(8): 684-706.
15.	戴維, 石丘玲, 李強, 等. 基于患者報告結局的癥狀管理在肺癌外科的應用現狀. 中國胸心血管外科臨床雜志, 2020, 27(10): 1228-1234.
16.	Dai W, Feng W, Zhang Y, et al. Patient-reported outcome-based symptom management versus usual care after lung cancer surgery: a multicenter randomized controlled trial. J Clin Oncol, 2022, 40(9): 988-996.
17.	Dai W, Wang Y, Liao J, et al. Electronic patient-reported outcome-based symptom management versus usual care after lung cancer surgery: long-term results of a multicenter, randomized, controlled trial. J Clin Oncol, 2024, 42(18): 2126-2131.
18.	Piccinin C, Basch E, Bhatnagar V, et al. Recommendations on the use of item libraries for patient-reported outcome measurement in oncology trials: findings from an international, multidisciplinary working group. Lancet Oncol, 2023, 24(2): e86-e95.
19.	Wang XS, Wang Y, Guo H, et al. Chinese version of the M. D. Anderson Symptom Inventory: validation and application of symptom measurement in cancer patients. Cancer, 2004, 101(8): 1890-1901.
20.	楊天舒, 張永生, 柴欣樓, 等. 基于“形神一體觀”探討肺結節并發肺外結節病機及治療. 北京中醫藥大學學報, 2023, 46(10): 1345-1349.
21.	李晏龍, 鄭鑫澤, 楊紅梅, 等. 肺結節診治相關指南共識的質量評價. 循證醫學, 2024, 24(3): 155-172.
22.	Bouazza YB, Chiairi I, El Kharbouchi O, et al. Patient-reported outcome measures (PROMs) in the management of lung cancer: a systematic review. Lung Cancer, 2017, 113: 140-151.
23.	梁昌昊, 尹冠翔, 王雅琪, 等. 中醫藥臨床實踐指南制訂和修訂中德爾菲法應用的方法流程及建議. 協和醫學雜志, 2023, 14(5): 1084-1090.
24.	周坤, 車國衛. 肺癌患者術后癥狀量表的建立和評價. 中國循證醫學雜志, 2020, 20(10): 1157-1163.
25.	張穎, 季聰華, 李秋爽, 等. 中醫臨床實踐指南制修訂中德爾菲法的統計分析方法. 中華中醫藥雜志, 2018, 33(1): 249-251.
26.	陳澈, 周晟, 孟慶剛. 量表在中醫臨床療效評價中的設計與應用探討. 中醫雜志, 2018, 59(15): 1279-1283,1287.
27.	賴長沙, 林國清, 陳文玲, 等. 中醫藥治療肺結節的Meta分析. 光明中醫, 2024, 39(10): 1903-1907.
28.	韓磊. 化痰活血散結方治療痰瘀互結型肺結節的臨床觀察. 合肥: 安徽中醫藥大學, 2023.
29.	李峻, 孟廣松, 陳明. 補中益氣湯合小柴胡湯對肺小結節患者肺功能及免疫炎癥指標的影響. 湖南中醫藥大學學報, 2022, 42(12): 2083-2087.
30.	何相紅. 宣肺散結方治療肺亞厘米結節痰瘀互結證的臨床觀察. 長沙: 湖南中醫藥大學, 2022.
31.	侯秋月. 理氣解郁、化痰散結法治療肺小結節的臨床研究. 南京: 南京中醫藥大學, 2019.
32.	王亨利. 解表擴絡湯治療孤立性肺實性結節(痰瘀互結型)的臨床研究. 濟南: 山東中醫藥大學, 2022.
33.	張曉宇. 消積散結方治療高危肺結節(陰虛證)的臨床研究. 長春: 長春中醫藥大學, 2023.
34.	李夢乾, 張曉梅, 胡家蕊, 等. 孤立性肺結節良惡性預測模型的系統評價. 腫瘤預防與治療, 2022, 35(4): 318-328.
35.	王昭玨, 趙靜, 王孟昭. 孤立性肺結節惡性概率預測模型的研究進展及臨床應用. 中國肺癌雜志, 2021, 24(9): 660-667.
36.	Wu Z, Wang F, Cao W, et al. Lung cancer risk prediction models based on pulmonary nodules: a systematic review. Thorac Cancer, 2022, 13(5): 664-677.
37.	李晏龍, 陳嘉慧, 鄭鑫澤, 等. 肺結節患者癥狀-證素-證候-體質辨治體系的系統評價. 世界中醫藥, 2025, 20(4): 613-622.
38.	朱澤林, 張洪春. 肺結節中醫證候及證候要素分布特征的文獻研究. 北京中醫藥, 2023, 42(7): 803-807.
39.	周淼, 趙棟梁, 謝洋, 等. 基于德爾菲法的肺結節中醫證候專家問卷分析. 中醫學報, 2020, 35(10): 2161-2167.
40.	許海杰, 莊偉濤, 王琪, 等. 肺結節患者呼吸系統癥狀分布及其影響因素的橫斷面研究. 中國胸心血管外科臨床雜志, 2023, 30(8): 1175-1180.
41.	林圣樂. 肺結節的中醫證型研究及相關因素分析. 南京: 南京中醫藥大學, 2020.
42.	許海柱, 祝佳佳, 張栩, 等. 基于聚類分析和因子分析的肺小結節患者中醫證候特點研究. 中國中醫藥信息雜志, 2020, 27(2): 84-87.
43.	李玥, 張馨月, 何姝霖, 等. 肺結節臨床癥狀及中醫證候分布特征. 中國中藥雜志, 2023, 48(17): 4782-4788.
44.	劉言, 李龍朝, 安鵬, 等. 419例肺結節患者中醫證候特點研究. 中醫藥導報, 2022, 28(12): 60-63.
45.	吳俊翰, 莊偉濤, 許海杰, 等. 肺結節患者焦慮、抑郁情緒及其影響因素的橫斷面研究. 中國胸心血管外科臨床雜志, 2023, 30(3): 357-363.
46.	Zhuang W, Wu J, Xu H, et al. Exploring the psychological profile: a cross-sectional study of 1, 185 patients with pulmonary nodules in an outpatient clinic. J Thorac Dis, 2022, 14(12): 4699-4712.
47.	Wang XH, Wang T, Ao M, et al. Prevalence and characteristics of anxiety in patients with unconfirmed pulmonary nodules. Clin Respir J, 2023, 17(3): 157-164.
48.	Li L, Zhao Y, Li H. Assessment of anxiety and depression in patients with incidental pulmonary nodules and analysis of its related impact factors. Thorac Cancer, 2020, 11(6): 1433-1442.
49.	李思敏, 張曉梅, 李夢乾, 等. 260例肺結節患者抑郁焦慮狀態、睡眠質量的相關研究. 中華中醫藥雜志, 2022, 37(11): 6667-6670.
50.	Wu J, Zhuang W, Xu H, et al. Investigation on sleep quality and psychological distress in patients with pulmonary nodules. BMC Psychol, 2023, 11(1): 258.
51.	Gould MK, Creekmur B, Qi L, et al. Emotional distress, anxiety, and general health status in patients with newly identified small pulmonary nodules: results from the watch the spot trial. Chest, 2023, 164(6): 1560-1571.
52.	管慧, 戴國華, 高武霖, 等. 中醫藥臨床研究中應用德爾菲法的系統評價. 中國循證醫學雜志, 2021, 21(2): 186-190.
53.	李明霞, 胡淑慧, 邵書銥, 等. 育齡女性患者生育力保存指導建議—基于改良德爾菲法. 復旦學報(醫學版), 2024, 51(2): 151-158, 165.
54.	莫洋, 袁磊, 劉蔚東, 等. 基于德爾菲法和層次分析法的日間手術質量與安全評價指標體系構建. 華西醫學, 2024, 39(2): 184-189.
55.	任玲, 何竟. 運用德爾菲法構建腦外傷康復醫學數據庫核心條目. 中國循證醫學雜志, 2019, 19(5): 609-613.

1. Han B, Zheng R, Zeng H, et al. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent, 2024, 4(1): 47-53.
2. Mazzone PJ, Lam L. Evaluating the patient with a pulmonary nodule: a review. JAMA, 2022, 327(3): 264-273.
3. 范亞光, 周清華, 喬友林, 等. 中國肺癌低劑量CT篩查指南(2023年版). 中國肺癌雜志, 2023, 26(1): 1-9.
4. 劉瑞, 李玥. 基于肺癌高風險人群篩查的肺結節中醫診療與管理專家共識. 中醫雜志, 2023, 64(17): 1824-1832.
5. MacMahon H, Naidich DP, Goo JM, et al. Guidelines for management of incidental pulmonary nodules detected on ct images: from the Fleischner Society 2017. Radiology, 2017, 284(1): 228-243.
6. 中華醫學會呼吸病學分會肺癌學組, 中國肺癌防治聯盟專家組. 肺結節診治中國專家共識(2018年版). 中華結核和呼吸雜志, 2018, 41(10): 763-771.
7. 楊國旺, 張興涵, 張懷銳, 等. 肺結節中西醫結合全程管理專家共識. 中國實驗方劑學雜志, 2024, 30(1): 149-159.
8. Au-Yong ITH, Hamilton W, Rawlinson J, et al. Pulmonary nodules. BMJ, 2020, 371: m3673.
9. Walter K. Pulmonary nodules. JAMA, 2021, 326(15): 1544.
10. 朱沛文, 李芳, 肖沖, 等. 基于疾病全程管理探索肺結節中醫診療體系的構建. 中醫雜志, 2023, 64(23): 2397-2400.
11. 黎雪, 劉碩, 王學謙, 等. 中醫藥防治肺結節的優勢及思考. 中國中醫基礎醫學雜志, 2023, 29(11): 1814-1817.
12. 李夢乾, 姜良鐸, 張曉梅, 等. 肺結節中醫藥臨床療效評價體系探討. 北京中醫藥大學學報, 2023, 46(10): 1333-1337.
13. 景城陽, 劉瑞雪, 褚紅玲, 等. 醫學研究領域德爾菲法實施和報告標準(CREDES)解讀. 中國循證醫學雜志, 2023, 23(2): 233-239.
14. Jünger S, Payne SA, Brine J, et al. Guidance on Conducting and REporting DElphi Studies (CREDES) in palliative care: recommendations based on a methodological systematic review. Palliat Med, 2017, 31(8): 684-706.
15. 戴維, 石丘玲, 李強, 等. 基于患者報告結局的癥狀管理在肺癌外科的應用現狀. 中國胸心血管外科臨床雜志, 2020, 27(10): 1228-1234.
16. Dai W, Feng W, Zhang Y, et al. Patient-reported outcome-based symptom management versus usual care after lung cancer surgery: a multicenter randomized controlled trial. J Clin Oncol, 2022, 40(9): 988-996.
17. Dai W, Wang Y, Liao J, et al. Electronic patient-reported outcome-based symptom management versus usual care after lung cancer surgery: long-term results of a multicenter, randomized, controlled trial. J Clin Oncol, 2024, 42(18): 2126-2131.
18. Piccinin C, Basch E, Bhatnagar V, et al. Recommendations on the use of item libraries for patient-reported outcome measurement in oncology trials: findings from an international, multidisciplinary working group. Lancet Oncol, 2023, 24(2): e86-e95.
19. Wang XS, Wang Y, Guo H, et al. Chinese version of the M. D. Anderson Symptom Inventory: validation and application of symptom measurement in cancer patients. Cancer, 2004, 101(8): 1890-1901.
20. 楊天舒, 張永生, 柴欣樓, 等. 基于“形神一體觀”探討肺結節并發肺外結節病機及治療. 北京中醫藥大學學報, 2023, 46(10): 1345-1349.
21. 李晏龍, 鄭鑫澤, 楊紅梅, 等. 肺結節診治相關指南共識的質量評價. 循證醫學, 2024, 24(3): 155-172.
22. Bouazza YB, Chiairi I, El Kharbouchi O, et al. Patient-reported outcome measures (PROMs) in the management of lung cancer: a systematic review. Lung Cancer, 2017, 113: 140-151.
23. 梁昌昊, 尹冠翔, 王雅琪, 等. 中醫藥臨床實踐指南制訂和修訂中德爾菲法應用的方法流程及建議. 協和醫學雜志, 2023, 14(5): 1084-1090.
24. 周坤, 車國衛. 肺癌患者術后癥狀量表的建立和評價. 中國循證醫學雜志, 2020, 20(10): 1157-1163.
25. 張穎, 季聰華, 李秋爽, 等. 中醫臨床實踐指南制修訂中德爾菲法的統計分析方法. 中華中醫藥雜志, 2018, 33(1): 249-251.
26. 陳澈, 周晟, 孟慶剛. 量表在中醫臨床療效評價中的設計與應用探討. 中醫雜志, 2018, 59(15): 1279-1283,1287.
27. 賴長沙, 林國清, 陳文玲, 等. 中醫藥治療肺結節的Meta分析. 光明中醫, 2024, 39(10): 1903-1907.
28. 韓磊. 化痰活血散結方治療痰瘀互結型肺結節的臨床觀察. 合肥: 安徽中醫藥大學, 2023.
29. 李峻, 孟廣松, 陳明. 補中益氣湯合小柴胡湯對肺小結節患者肺功能及免疫炎癥指標的影響. 湖南中醫藥大學學報, 2022, 42(12): 2083-2087.
30. 何相紅. 宣肺散結方治療肺亞厘米結節痰瘀互結證的臨床觀察. 長沙: 湖南中醫藥大學, 2022.
31. 侯秋月. 理氣解郁、化痰散結法治療肺小結節的臨床研究. 南京: 南京中醫藥大學, 2019.
32. 王亨利. 解表擴絡湯治療孤立性肺實性結節(痰瘀互結型)的臨床研究. 濟南: 山東中醫藥大學, 2022.
33. 張曉宇. 消積散結方治療高危肺結節(陰虛證)的臨床研究. 長春: 長春中醫藥大學, 2023.
34. 李夢乾, 張曉梅, 胡家蕊, 等. 孤立性肺結節良惡性預測模型的系統評價. 腫瘤預防與治療, 2022, 35(4): 318-328.
35. 王昭玨, 趙靜, 王孟昭. 孤立性肺結節惡性概率預測模型的研究進展及臨床應用. 中國肺癌雜志, 2021, 24(9): 660-667.
36. Wu Z, Wang F, Cao W, et al. Lung cancer risk prediction models based on pulmonary nodules: a systematic review. Thorac Cancer, 2022, 13(5): 664-677.
37. 李晏龍, 陳嘉慧, 鄭鑫澤, 等. 肺結節患者癥狀-證素-證候-體質辨治體系的系統評價. 世界中醫藥, 2025, 20(4): 613-622.
38. 朱澤林, 張洪春. 肺結節中醫證候及證候要素分布特征的文獻研究. 北京中醫藥, 2023, 42(7): 803-807.
39. 周淼, 趙棟梁, 謝洋, 等. 基于德爾菲法的肺結節中醫證候專家問卷分析. 中醫學報, 2020, 35(10): 2161-2167.
40. 許海杰, 莊偉濤, 王琪, 等. 肺結節患者呼吸系統癥狀分布及其影響因素的橫斷面研究. 中國胸心血管外科臨床雜志, 2023, 30(8): 1175-1180.
41. 林圣樂. 肺結節的中醫證型研究及相關因素分析. 南京: 南京中醫藥大學, 2020.
42. 許海柱, 祝佳佳, 張栩, 等. 基于聚類分析和因子分析的肺小結節患者中醫證候特點研究. 中國中醫藥信息雜志, 2020, 27(2): 84-87.
43. 李玥, 張馨月, 何姝霖, 等. 肺結節臨床癥狀及中醫證候分布特征. 中國中藥雜志, 2023, 48(17): 4782-4788.
44. 劉言, 李龍朝, 安鵬, 等. 419例肺結節患者中醫證候特點研究. 中醫藥導報, 2022, 28(12): 60-63.
45. 吳俊翰, 莊偉濤, 許海杰, 等. 肺結節患者焦慮、抑郁情緒及其影響因素的橫斷面研究. 中國胸心血管外科臨床雜志, 2023, 30(3): 357-363.
46. Zhuang W, Wu J, Xu H, et al. Exploring the psychological profile: a cross-sectional study of 1, 185 patients with pulmonary nodules in an outpatient clinic. J Thorac Dis, 2022, 14(12): 4699-4712.
47. Wang XH, Wang T, Ao M, et al. Prevalence and characteristics of anxiety in patients with unconfirmed pulmonary nodules. Clin Respir J, 2023, 17(3): 157-164.
48. Li L, Zhao Y, Li H. Assessment of anxiety and depression in patients with incidental pulmonary nodules and analysis of its related impact factors. Thorac Cancer, 2020, 11(6): 1433-1442.
49. 李思敏, 張曉梅, 李夢乾, 等. 260例肺結節患者抑郁焦慮狀態、睡眠質量的相關研究. 中華中醫藥雜志, 2022, 37(11): 6667-6670.
50. Wu J, Zhuang W, Xu H, et al. Investigation on sleep quality and psychological distress in patients with pulmonary nodules. BMC Psychol, 2023, 11(1): 258.
51. Gould MK, Creekmur B, Qi L, et al. Emotional distress, anxiety, and general health status in patients with newly identified small pulmonary nodules: results from the watch the spot trial. Chest, 2023, 164(6): 1560-1571.
52. 管慧, 戴國華, 高武霖, 等. 中醫藥臨床研究中應用德爾菲法的系統評價. 中國循證醫學雜志, 2021, 21(2): 186-190.
53. 李明霞, 胡淑慧, 邵書銥, 等. 育齡女性患者生育力保存指導建議—基于改良德爾菲法. 復旦學報(醫學版), 2024, 51(2): 151-158, 165.
54. 莫洋, 袁磊, 劉蔚東, 等. 基于德爾菲法和層次分析法的日間手術質量與安全評價指標體系構建. 華西醫學, 2024, 39(2): 184-189.
55. 任玲, 何竟. 運用德爾菲法構建腦外傷康復醫學數據庫核心條目. 中國循證醫學雜志, 2019, 19(5): 609-613.

Chinese Journal of Evidence-Based Medicine

Development of a pulmonary nodule symptom scale based on the Delphi expert consensus method

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