Research status of patient-reported outcome in esophageal carcinoma surgery_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

LIN Lin ¹ , ZHENG E ¹ , YANG Mei ¹ , YUAN Yong ² , CHE Guowei ² ,  NING Ning ³

1. West China School of Nursing, Sichuan University/Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China;
2. Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China;
3. West China School of Nursing, Sichuan University/Department of Orthopedics, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China;

Corresponding author：

NING Ning, Email: gkningning@126.com

Keywords：

Esophageal carcinoma; patient-reported outcomes; research status; review

DOI：

10.7507/1007-4848.202106033

Video：

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Esophageal carcinoma is a malignant tumor with high morbidity and mortality worldwide, and surgery is the main treatment currently. With the development of patient-centered care, the effect of surgery should not be limited to the improvement of the incidence of postoperative complications, mortality and other indicators. It is also important to provide experience related to disease and surgery from the perspective of patients. Therefore, more and more attention is paid to patient-reported outcomes by scholars. This paper will provide an overview of the international widely used, reliable and effective scales and researches about patient-reported outcomes in esophageal carcinoma.

Citation： LIN Lin, ZHENG E, YANG Mei, YUAN Yong, CHE Guowei, NING Ning. Research status of patient-reported outcome in esophageal carcinoma surgery. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2022, 29(12): 1660-1664. doi: 10.7507/1007-4848.202106033 Copy

1.	Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin, 2021, 71(3): 209-249.
2.	Wormald JC, Bennett J, van Leuven M, et al. Does the site of anastomosis for esophagectomy affect long-term quality of life? Dis Esophagus, 2016, 29(1): 93-98.
3.	He Y, Liang D, Li D, et al. Incidence and mortality of laryngeal cancer in China, 2015. Chin J Cancer Res, 2020, 32(1): 10-17.
4.	U. S. Department of Health and Human Services FDA Center for Drug Evaluation and Research. Guidance for industry: Patient-reported outcome measures: Use in medical product development to support labeling claims: Draft guidance. Health Qual Life Outcomes, 2006, 4: 79.
5.	刘砚燕, 陈如男, 姚静静, 等. 患者报告结局的国内外研究进展. 现代预防医学, 2013, 40(12): 2268-2271, 2279.
6.	Acquadro C, Berzon R, Dubois D, et al. Incorporating the patient's perspective into drug development and communication: An ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001. Value Health, 2003, 6(5): 522-531.
7.	Broderick JE, DeWitt EM, Rothrock N, et al. Advances in patient-reported outcomes: The NIH PROMIS(®) measures. EGEMS (Wash DC), 2013, 1(1): 1015.
8.	European Medicines Agency. Reflection paper on the regulatory guidance for the use of health related quality of life (HRQL) measures in the evaluation of medicinal products. URL: https://www.ema.europa.eu/documents/scientific-guideline/reflection-paper-regulatory-guidance-use-health-related-quality-life-hrql-measures-evaluation_en.pdf. [2005-07-27].
9.	Sloan JA, Halyard MY, Frost MH, et al. The Mayo Clinic manuscript series relative to the discussion, dissemination, and operationalization of the Food and Drug Administration guidance on patient-reported outcomes. Value Health, 2007, 10(Suppl2): S59-S63.
10.	Basch E, Abernethy AP, Mullins CD, et al. Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology. J Clin Oncol, 2012, 30(34): 4249-4255.
11.	Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). Ⅰ. Conceptual framework and item selection. Med Care, 1992, 30(6): 473-483.
12.	Scarpa M, Valente S, Alfieri R, et al. Systematic review of health-related quality of life after esophagectomy for esophageal cancer. World J Gastroenterol, 2011, 17(42): 4660-4674.
13.	李春林, 特木热, 鲁志刚, 等. 胸腹腔镜联合根治术治疗老年胸段食管癌60例. 中国临床研究, 2017, 30(2): 214-216.
14.	Bulamu NB, Chen G, Ratcliffe J, et al. Health-related quality of life associated with Barrett's esophagus and cancer. World J Surg, 2019, 43(6): 1554-1562.
15.	张素雯, 温玉枝, 窦晓蒙. 临床心理护理程序对食管癌患者生活质量及术后恢复情况的影响分析. 实用临床护理学电子杂志, 2019, 4(39): 137, 157.
16.	Aaronson NK, Ahmedzai S, Bergman B, et al. The European organization for research and treatment of cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst, 1993, 85(5): 365-376.
17.	Blazeby JM, Conroy T, Hammerlid E, et al. Clinical and psychometric validation of an EORTC questionnaire module, the EORTC QLQ-OES18, to assess quality of life in patients with oesophageal cancer. Eur J Cancer, 2003, 39(10): 1384-1394.
18.	Malmström M, Klefsgard R, Ivarsson B, et al. Quality of life measurements as an indicator for timing of support after oesophagectomy for cancer: A prospective study. BMC Health Serv Res, 2015, 15: 96.
19.	Straatman J, Joosten PJ, Terwee CB, et al. Systematic review of patient-reported outcome measures in the surgical treatment of patients with esophageal cancer. Dis Esophagus, 2016, 29(7): 760-772.
20.	Blazeby JM, Kavadas V, Vickery CW, et al. A prospective comparison of quality of life measures for patients with esophageal cancer. Qual Life Res, 2005, 14(2): 387-393.
21.	Cleeland CS, Mendoza TR, Wang XS, et al. Assessing symptom distress in cancer patients: The M.D. Anderson Symptom Inventory. Cancer, 2000, 89(7): 1634-1646.
22.	Wang XS, Williams LA, Eng C, et al. Validation and application of a module of the M. D. Anderson Symptom Inventory for measuring multiple symptoms in patients with gastrointestinal cancer (the MDASI-GI). Cancer, 2010, 116(8): 2053-2063.
23.	Myles PS, Weitkamp B, Jones K, et al. Validity and reliability of a postoperative quality of recovery score: The QoR-40. Br J Anaesth, 2000, 84(1): 11-15.
24.	Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: The QoR-15. Anesthesiology, 2013, 118(6): 1332-1340.
25.	Gornall BF, Myles PS, Smith CL, et al. Measurement of quality of recovery using the QoR-40: A quantitative systematic review. Br J Anaesth, 2013, 111(2): 161-169.
26.	Frosch DL. Patient-reported outcomes as a measure of healthcare quality. J Gen Intern Med, 2015, 30(10): 1383-1384.
27.	朱瑞, 黄青梅, 吴傅蕾, 等. 成人患者报告结局测量信息系统简表的应用及研究进展. 护士进修杂志, 2021, 36(4): 298-301, 362.
28.	李丹钰, 臧娴, 黄青梅, 等. 患者报告结局测量信息系统健康组织管理架构介绍. 护士进修杂志, 2020, 35(19): 1744-1747.
29.	Kidane B, Ali A, Sulman J, et al. Health-related quality of life measure distinguishes between low and high clinical T stages in esophageal cancer. Ann Transl Med, 2018, 6(13): 270.
30.	Mariette C, Markar S, Dabakuyo-Yonli TS, et al. Health-related quality of life following hybrid minimally invasive versus open esophagectomy for patients with esophageal cancer, analysis of a multicenter, open-label, randomized phase Ⅲ controlled trial: The MIRO Trial. Ann Surg, 2020, 271(6): 1023-1029.
31.	Noordman BJ, Verdam MGE, Lagarde SM, et al. Effect of neoadjuvant chemoradiotherapy on health-related quality of life in esophageal or junctional cancer: Results from the randomized CROSS trial. J Clin Oncol, 2018, 36(3): 268-275.
32.	Djärv T, Metcalfe C, Avery KN, et al. Prognostic value of changes in health-related quality of life scores during curative treatment for esophagogastric cancer. J Clin Oncol, 2010, 28(10): 1666-1670.
33.	Kidane B, Sulman J, Xu W, et al. Baseline measure of health-related quality of life (functional assessment of cancer therapy-esophagus) is associated with overall survival in patients with esophageal cancer. J Thorac Cardiovasc Surg, 2016, 151(6): 1571-1580.
34.	Kidane B, Sulman J, Xu W, et al. Pretreatment quality-of-life score is a better discriminator of oesophageal cancer survival than performance status. Eur J Cardiothorac Surg, 2017, 51(1): 148-154.
35.	Derogar M, Lagergren P. Health-related quality of life among 5-year survivors of esophageal cancer surgery: A prospective population-based study. J Clin Oncol, 2012, 30(4): 413-418.
36.	Wikman A, Johar A, Lagergren P. Presence of symptom clusters in surgically treated patients with esophageal cancer: Implications for survival. Cancer, 2014, 120(2): 286-293.
37.	韩芳, 李丽, 伊力亚尔·夏合丁, 等. 食管癌化疗患者术后症状群困扰及其对病患日常生活的影响. 新疆医科大学学报, 2017, 40(2): 156-159, 166.
38.	郭敏, 殷秀敏, 王翠, 等. 食管癌患者术后3个月症状群的调查. 中华护理杂志, 2019, 54(8): 1189-1193.
39.	Malmström M, Ivarsson B, Klefsgård R, et al. The effect of a nurse led telephone supportive care programme on patients' quality of life, received information and health care contacts after oesophageal cancer surgery—A six month RCT-follow-up study. Int J Nurs Stud, 2016, 64: 86-95.
40.	冯芳茗, 周嫣, 巢黔, 等. 癌症化疗患者消化道症状群的干预及效果评价. 中国护理管理, 2017, 17(9): 1190-1194.
41.	姜玲君, 黄甫晓彤. 食管癌术后居家康复患者链式管理护理干预模式应用实践研究. 山西医药杂志, 2016, 45(17): 2082-2085.
42.	Stacey D, Carley M, Kohli J, et al. Remote symptom support training programs for oncology nurses in Canada: An environmental scan. Can Oncol Nurs J, 2014, 24(2): 78-88.

1. Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin, 2021, 71(3): 209-249.
2. Wormald JC, Bennett J, van Leuven M, et al. Does the site of anastomosis for esophagectomy affect long-term quality of life? Dis Esophagus, 2016, 29(1): 93-98.
3. He Y, Liang D, Li D, et al. Incidence and mortality of laryngeal cancer in China, 2015. Chin J Cancer Res, 2020, 32(1): 10-17.
4. U. S. Department of Health and Human Services FDA Center for Drug Evaluation and Research. Guidance for industry: Patient-reported outcome measures: Use in medical product development to support labeling claims: Draft guidance. Health Qual Life Outcomes, 2006, 4: 79.
5. 刘砚燕, 陈如男, 姚静静, 等. 患者报告结局的国内外研究进展. 现代预防医学, 2013, 40(12): 2268-2271, 2279.
6. Acquadro C, Berzon R, Dubois D, et al. Incorporating the patient's perspective into drug development and communication: An ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001. Value Health, 2003, 6(5): 522-531.
7. Broderick JE, DeWitt EM, Rothrock N, et al. Advances in patient-reported outcomes: The NIH PROMIS(®) measures. EGEMS (Wash DC), 2013, 1(1): 1015.
8. European Medicines Agency. Reflection paper on the regulatory guidance for the use of health related quality of life (HRQL) measures in the evaluation of medicinal products. URL: https://www.ema.europa.eu/documents/scientific-guideline/reflection-paper-regulatory-guidance-use-health-related-quality-life-hrql-measures-evaluation_en.pdf. [2005-07-27].
9. Sloan JA, Halyard MY, Frost MH, et al. The Mayo Clinic manuscript series relative to the discussion, dissemination, and operationalization of the Food and Drug Administration guidance on patient-reported outcomes. Value Health, 2007, 10(Suppl2): S59-S63.
10. Basch E, Abernethy AP, Mullins CD, et al. Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology. J Clin Oncol, 2012, 30(34): 4249-4255.
11. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). Ⅰ. Conceptual framework and item selection. Med Care, 1992, 30(6): 473-483.
12. Scarpa M, Valente S, Alfieri R, et al. Systematic review of health-related quality of life after esophagectomy for esophageal cancer. World J Gastroenterol, 2011, 17(42): 4660-4674.
13. 李春林, 特木热, 鲁志刚, 等. 胸腹腔镜联合根治术治疗老年胸段食管癌60例. 中国临床研究, 2017, 30(2): 214-216.
14. Bulamu NB, Chen G, Ratcliffe J, et al. Health-related quality of life associated with Barrett's esophagus and cancer. World J Surg, 2019, 43(6): 1554-1562.
15. 张素雯, 温玉枝, 窦晓蒙. 临床心理护理程序对食管癌患者生活质量及术后恢复情况的影响分析. 实用临床护理学电子杂志, 2019, 4(39): 137, 157.
16. Aaronson NK, Ahmedzai S, Bergman B, et al. The European organization for research and treatment of cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst, 1993, 85(5): 365-376.
17. Blazeby JM, Conroy T, Hammerlid E, et al. Clinical and psychometric validation of an EORTC questionnaire module, the EORTC QLQ-OES18, to assess quality of life in patients with oesophageal cancer. Eur J Cancer, 2003, 39(10): 1384-1394.
18. Malmström M, Klefsgard R, Ivarsson B, et al. Quality of life measurements as an indicator for timing of support after oesophagectomy for cancer: A prospective study. BMC Health Serv Res, 2015, 15: 96.
19. Straatman J, Joosten PJ, Terwee CB, et al. Systematic review of patient-reported outcome measures in the surgical treatment of patients with esophageal cancer. Dis Esophagus, 2016, 29(7): 760-772.
20. Blazeby JM, Kavadas V, Vickery CW, et al. A prospective comparison of quality of life measures for patients with esophageal cancer. Qual Life Res, 2005, 14(2): 387-393.
21. Cleeland CS, Mendoza TR, Wang XS, et al. Assessing symptom distress in cancer patients: The M.D. Anderson Symptom Inventory. Cancer, 2000, 89(7): 1634-1646.
22. Wang XS, Williams LA, Eng C, et al. Validation and application of a module of the M. D. Anderson Symptom Inventory for measuring multiple symptoms in patients with gastrointestinal cancer (the MDASI-GI). Cancer, 2010, 116(8): 2053-2063.
23. Myles PS, Weitkamp B, Jones K, et al. Validity and reliability of a postoperative quality of recovery score: The QoR-40. Br J Anaesth, 2000, 84(1): 11-15.
24. Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: The QoR-15. Anesthesiology, 2013, 118(6): 1332-1340.
25. Gornall BF, Myles PS, Smith CL, et al. Measurement of quality of recovery using the QoR-40: A quantitative systematic review. Br J Anaesth, 2013, 111(2): 161-169.
26. Frosch DL. Patient-reported outcomes as a measure of healthcare quality. J Gen Intern Med, 2015, 30(10): 1383-1384.
27. 朱瑞, 黄青梅, 吴傅蕾, 等. 成人患者报告结局测量信息系统简表的应用及研究进展. 护士进修杂志, 2021, 36(4): 298-301, 362.
28. 李丹钰, 臧娴, 黄青梅, 等. 患者报告结局测量信息系统健康组织管理架构介绍. 护士进修杂志, 2020, 35(19): 1744-1747.
29. Kidane B, Ali A, Sulman J, et al. Health-related quality of life measure distinguishes between low and high clinical T stages in esophageal cancer. Ann Transl Med, 2018, 6(13): 270.
30. Mariette C, Markar S, Dabakuyo-Yonli TS, et al. Health-related quality of life following hybrid minimally invasive versus open esophagectomy for patients with esophageal cancer, analysis of a multicenter, open-label, randomized phase Ⅲ controlled trial: The MIRO Trial. Ann Surg, 2020, 271(6): 1023-1029.
31. Noordman BJ, Verdam MGE, Lagarde SM, et al. Effect of neoadjuvant chemoradiotherapy on health-related quality of life in esophageal or junctional cancer: Results from the randomized CROSS trial. J Clin Oncol, 2018, 36(3): 268-275.
32. Djärv T, Metcalfe C, Avery KN, et al. Prognostic value of changes in health-related quality of life scores during curative treatment for esophagogastric cancer. J Clin Oncol, 2010, 28(10): 1666-1670.
33. Kidane B, Sulman J, Xu W, et al. Baseline measure of health-related quality of life (functional assessment of cancer therapy-esophagus) is associated with overall survival in patients with esophageal cancer. J Thorac Cardiovasc Surg, 2016, 151(6): 1571-1580.
34. Kidane B, Sulman J, Xu W, et al. Pretreatment quality-of-life score is a better discriminator of oesophageal cancer survival than performance status. Eur J Cardiothorac Surg, 2017, 51(1): 148-154.
35. Derogar M, Lagergren P. Health-related quality of life among 5-year survivors of esophageal cancer surgery: A prospective population-based study. J Clin Oncol, 2012, 30(4): 413-418.
36. Wikman A, Johar A, Lagergren P. Presence of symptom clusters in surgically treated patients with esophageal cancer: Implications for survival. Cancer, 2014, 120(2): 286-293.
37. 韩芳, 李丽, 伊力亚尔·夏合丁, 等. 食管癌化疗患者术后症状群困扰及其对病患日常生活的影响. 新疆医科大学学报, 2017, 40(2): 156-159, 166.
38. 郭敏, 殷秀敏, 王翠, 等. 食管癌患者术后3个月症状群的调查. 中华护理杂志, 2019, 54(8): 1189-1193.
39. Malmström M, Ivarsson B, Klefsgård R, et al. The effect of a nurse led telephone supportive care programme on patients' quality of life, received information and health care contacts after oesophageal cancer surgery—A six month RCT-follow-up study. Int J Nurs Stud, 2016, 64: 86-95.
40. 冯芳茗, 周嫣, 巢黔, 等. 癌症化疗患者消化道症状群的干预及效果评价. 中国护理管理, 2017, 17(9): 1190-1194.
41. 姜玲君, 黄甫晓彤. 食管癌术后居家康复患者链式管理护理干预模式应用实践研究. 山西医药杂志, 2016, 45(17): 2082-2085.
42. Stacey D, Carley M, Kohli J, et al. Remote symptom support training programs for oncology nurses in Canada: An environmental scan. Can Oncol Nurs J, 2014, 24(2): 78-88.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Research status of patient-reported outcome in esophageal carcinoma surgery

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