PROM – современный подход к оценке качества жизни пациентов с онкологическими заболеваниями

Хатьков И.Е., Минаева О.А., Домрачев С.А., Приймак М.А., Соловьев Н.О., Тютюнник П.С. PROM – современный подход к оценке качества жизни пациентов с онкологическими заболеваниями. Терапевтический архив. 2022;94(1):122–128.
DOI: 10.26442/00403660.2022.01.201343

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Khatkov IE, Minaeva OA, Domrachev SA, Priymak MA, Solovyev NO, Tyutyunnik PS. PROM a contemporary approach to assessing the quality of life of patients with cancer. Terapevticheskii Arkhiv (Ter. Arkh.). 2022; 94 (1):122–128. DOI: 10.26442/00403660.2022.01.201343

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Аннотация

Результаты, сообщаемые пациентом (PRO – patient reported outcomes) – это субъективная оценка пациентом его здоровья и качества жизни, без интерпретации со стороны специалиста. Для анализа этих данных используются опросные листы PROM (patient reported outcomes measure) – «оценка результатов, сообщаемых пациентом». Анализ качества жизни пациентов является перспективным и актуальным направлением, позволяющим улучшить оказание медицинской помощи и результаты лечения. На сегодняшний день существует большое количество опросных форм PROM, их надежность и валидность доказаны в многочисленных исследованиях. Разработаны единые стандарты и методы создания и оценки опросных листов, а интерес к применению опросных форм качества жизни неуклонно растет. Однако исследования, анализирующие данные опросных форм PROM, редко встречаются в отечественной литературе. Также недостаточно широко качество жизни изучается в клинической практике. Цель обзора литературы – представить современные методы оценки качества жизни пациентов, в особенности больных онкологическими заболеваниями. Проведен обзор наиболее распространенных и надежных опросных форм и оценочных средств качества жизни пациента. Выполнен анализ мирового опыта их применения в клинической практике у пациентов с онкологическими заболеваниями. Приведены примеры как общих, так и специфичных опросных листов. Таким образом, опросные формы PROM нашли широкое применение среди пациентов с онкологическими заболеваниями. Однако в литературе встречается некорректное использование PROM, а у больных с определенными нозологиями данные PROM недостаточно широко изучены. Требуются дальнейший анализ потенциальных возможностей применения опросных форм PROM, а также их перевод и адаптация для использования в российском здравоохранении.

Ключевые слова: PROM, результаты, сообщаемые пациентом, качество жизни, амбулаторная хирургия, онкология, послеоперационный контроль

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PRO (patient reported outcomes) is a patient's subjective assessment of health and quality of life, without interpretation by a specialist. PROM (patient reported outcomes measure) – questionnaires are used to analyzing this data. Assessment of the quality of life is a perspective direction, which allows to improve the quality of medical care and treatment results. Today, there are many questionnaires PROM, their reliability and validity has been proven in numerous studies. Unified standards and methods for developing and evaluating questionnaires have been developed. Interest in the use of quality of life questionnaires is increasing constantly. However, studies analyzing the data of the PROM questionnaires are rarely found in the national literature. Quality of life is also poorly researched in clinical practice. The aim of the literature review is to present modern methods for assessing the quality of life of patients, especially with cancer. A review of the most widespread and reliable questionnaires and assessment instruments for the quality of life of a patient has been carried out. The analysis of world experience of their use in clinical practice, for patients with cancer has been performed. Examples of both general and specific questionnaires are given. PROM questionnaires are widely used among patients with cancer. However, incorrect use of PROMs is found in the literature, and in patients with certain nosologies PROM data studied poorly. Further analysis of the potential of PROM questionnaires implementation is required, as well as their translation and adaptation for use in Russian health care.

Keywords: PROM, patient reported outcomes, quality of life, ambulatory surgery, oncology, postoperative control

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Список литературы

1. Weldring T, Smith SM. Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs). Health Serv Insights. 2013;6:61-8. DOI:10.4137/HSI.S11093
2. Callahan LF. The History of Patient-Reported Outcomes in Rheumatology. Rheum Dis Clin North Am. 2016;42(2):205-17. DOI:10.1016/j.rdc.2016.01.012
3. Swedish Association of Local Authorities and Regions. Quality registries. Available at: www.kvalitetsregister.se/om_kvalitetsregister/quality_registries. Accessed: 08.12.2021.
4. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims Guidance for Industry 2009. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-me.... Accessed: 08.12.2021.
5. Mak KS, van Bommel AC, Stowell C, et al. Defining a standard set of patient-centred outcomes for lung cancer. Eur Respir J. 2016;48(3):852-60. DOI:10.1183/13993003.02049-2015
6. Australian Commission on Safety and Quality in Health Care (the Commission). Available at: https://www.safetyandquality.gov.au/our-work/indicators-measurement-and-reporting/patient-reported-o.... Accessed: 08.12.2021.
7. Новик А.А., Ионова Т.И. Руководство по исследованию качества жизни в медицине. СПб., 2002 [Novik AA, Ionova TI. Rukovodstvo po issledovaniiu kachestva zhizni v meditsine. Saint Petersburg, 2002 (in Russian)].
8. Janssen MF, Pickard AS, Golicki D, et al. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013;22(7):1717-27. DOI:10.1007/s11136-012-0322-4
9. Hunt SM, McEwen J, McKenna SP. Measuring health status: a new tool for clinicians and epidemiologists. J R Coll Gen Pract. 1985;35(273):185-8.
10. Richards HS, Blazeby JM, Portal A, et al. A real-time electronic symptom monitoring system for patients after discharge following surgery: a pilot study in cancer-related surgery. BMC Cancer. 2020;20(1):543. DOI:10.1186/s12885-020-07027-5.
11. Ong WL, Schouwenburg MG, van Bommel ACM, et al. A Standard Set of Value-Based Patient-Centered Outcomes for Breast Cancer: The International Consortium for Health Outcomes Measurement (ICHOM) Initiative. JAMA Oncol. 2017;3(5):677-85.
DOI:10.1001/jamaoncol.2016.4851
12. Kerrigan K, Patel SB, Haaland B, et al. Prognostic Significance of Patient-Reported Outcomes in Cancer. JCO Oncol Pract. 2020;16(4):e313-23. DOI:10.1200/JOP.19.00329
13. Dai WF, Beca J, Guo H, et al. Are population-based patient-reported outcomes associated with overall survival in patients with advanced pancreatic cancer? Cancer Med. 2020;9(1):215-24. DOI:10.1002/cam4.2704
14. Pusic AL, Klassen AF, Scott AM, et al. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009;124(2):345-53. DOI:10.1097/PRS.0b013e3181aee807
15. Davies CF, Macefield R, Avery K, et al. Patient-Reported Outcome Measures for Post-mastectomy Breast Reconstruction: A Systematic Review of Development and Measurement Properties. Ann Surg Oncol. 2021;28(1):386-404. DOI:10.1245/s10434-020-08736-8
16. Santosa KB, Qi J, Kim HM, et al. Long-term Patient-Reported Outcomes in Postmastectomy Breast Reconstruction. JAMA Surg. 2018;153(10):891-9. DOI:10.1001/jamasurg.2018.1677
17. Nelson JA, Allen RJ Jr, Polanco T, et al. Long-term Patient-reported Outcomes Following Postmastectomy Breast Reconstruction: An 8-year Examination of 3268 Patients. Ann Surg. 2019;270(3):473-83. DOI:10.1097/SLA.0000000000003467
18. Zerillo JA, Schouwenburg MG, van Bommel ACM, et al. An International Collaborative Standardizing a Comprehensive Patient-Centered Outcomes Measurement Set for Colorectal Cancer. JAMA Oncol. 2017;3(5):686-94. DOI:10.1001/jamaoncol.2017.0417
19. Besson A, Deftereos I, Chan S, et al. Understanding patient-reported outcome measures in colorectal cancer. Future Oncol. 2019;15(10):1135-46. DOI:10.2217/fon-2018-0723
20. Rees JR, Whale K, Fish D, et al. Patient-reported outcomes in randomised controlled trials of colorectal cancer: an analysis determining the availability of robust data to inform clinical decision-making. J Cancer Res Clin Oncol. 2015;141(12):2181-92. DOI:10.1007/s00432-015-1970-x
21. Rutherford C, Campbell R, White K, King M. Patient-reported outcomes as predictors of survival in patients with bowel cancer: a systematic review. Qual Life Res. 2019;28(11):2871-87. DOI:10.1007/s11136-019-02255-0
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;113:140-51. DOI:10.1016/j.lungcan.2017.09.011
23. Polański J, Chabowski M, Jankowska-Polańska B, et al. Histological subtype of lung cancer affects acceptance of illness, severity of pain, and quality of life. J Pain Res. 2018;11:727-33. DOI:10.2147/JPR.S155121
24. Brønserud MM, Iachina M, Green A, et al. Patient-reported outcomes (PROs) in lung cancer: Experiences from a nationwide feasibility study. Lung Cancer. 2019;128:67-73. DOI:10.1016/j.lungcan.2018.12.014
25. Martin NE, Massey L, Stowell C, et al. Defining a standard set of patient-centered outcomes for men with localized prostate cancer. Eur Urol. 2015;67(3):460-7. DOI:10.1016/j.eururo.2014.08.075
26. Morgans AK, van Bommel AC, Stowell C, et al. Development of a Standardized Set of Patient-centered Outcomes for Advanced Prostate Cancer: An International Effort for a Unified Approach. Eur Urol. 2015;68(5):891-8. DOI:10.1016/j.eururo.2015.06.007
27. Protopapa E, van der Meulen J, Moore CM, Smith SC. Patient-reported outcome (PRO) questionnaires for men who have radical surgery for prostate cancer: a conceptual review of existing instruments. BJU Int. 2017;120(4):468-81. DOI:10.1111/bju.13896
28. Hoffman KE, Penson DF, Zhao Z, et al. Patient-Reported Outcomes Through 5 Years for Active Surveillance, Surgery, Brachytherapy, or External Beam Radiation With or Without Androgen Deprivation Therapy for Localized Prostate Cancer. JAMA. 2020;323(2):149-63. DOI:10.1001/jama.2019.20675
29. Nguyen-Nielsen M, Møller H, Tjønneland A, Borre M. Patient-reported outcome measures after treatment for prostate cancer: Results from the Danish Prostate Cancer Registry (DAPROCAdata). Cancer Epidemiol. 2020;64:101623. DOI:10.1016/j.canep.2019.101623
30. Xu J, Evans TJ, Coon C, et al. Measuring patient-reported outcomes in advanced gastric cancer. Ecancermedicalscience. 2013;7:351. DOI:10.3332/ecancer.2013.351
31. Straatman J, van der Wielen N, Joosten PJ, et al. Assessment of patient-reported outcome measures in the surgical treatment of patients with gastric cancer. Surg Endosc. 2016;30(5):1920-9. DOI:10.1007/s00464-015-4415-3
32. Maharaj AD, Samoborec S, Evans SM, et al. Patient-reported outcome measures (PROMs) in pancreatic cancer: a systematic review. HPB (Oxford). 2020;22(2):187-203. DOI:10.1016/j.hpb.2019.09.002

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1. Weldring T, Smith SM. Patient-Reported Outcomes (PROs) and Patient-Reported Outcome Measures (PROMs). Health Serv Insights. 2013;6:61-8. DOI:10.4137/HSI.S11093
2. Callahan LF. The History of Patient-Reported Outcomes in Rheumatology. Rheum Dis Clin North Am. 2016;42(2):205-17. DOI:10.1016/j.rdc.2016.01.012
3. Swedish Association of Local Authorities and Regions. Quality registries. Available at: www.kvalitetsregister.se/om_kvalitetsregister/quality_registries. Accessed: 08.12.2021.
4. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims Guidance for Industry 2009. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-me.... Accessed: 08.12.2021.
5. Mak KS, van Bommel AC, Stowell C, et al. Defining a standard set of patient-centred outcomes for lung cancer. Eur Respir J. 2016;48(3):852-60. DOI:10.1183/13993003.02049-2015
6. Australian Commission on Safety and Quality in Health Care (the Commission). Available at: https://www.safetyandquality.gov.au/our-work/indicators-measurement-and-reporting/patient-reported-o.... Accessed: 08.12.2021.
7. Novik AA, Ionova TI. Rukovodstvo po issledovaniiu kachestva zhizni v meditsine. Saint Petersburg, 2002 (in Russian).
8. Janssen MF, Pickard AS, Golicki D, et al. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013;22(7):1717-27. DOI:10.1007/s11136-012-0322-4
9. Hunt SM, McEwen J, McKenna SP. Measuring health status: a new tool for clinicians and epidemiologists. J R Coll Gen Pract. 1985;35(273):185-8.
10. Richards HS, Blazeby JM, Portal A, et al. A real-time electronic symptom monitoring system for patients after discharge following surgery: a pilot study in cancer-related surgery. BMC Cancer. 2020;20(1):543. DOI:10.1186/s12885-020-07027-5.
11. Ong WL, Schouwenburg MG, van Bommel ACM, et al. A Standard Set of Value-Based Patient-Centered Outcomes for Breast Cancer: The International Consortium for Health Outcomes Measurement (ICHOM) Initiative. JAMA Oncol. 2017;3(5):677-85.
DOI:10.1001/jamaoncol.2016.4851
12. Kerrigan K, Patel SB, Haaland B, et al. Prognostic Significance of Patient-Reported Outcomes in Cancer. JCO Oncol Pract. 2020;16(4):e313-23. DOI:10.1200/JOP.19.00329
13. Dai WF, Beca J, Guo H, et al. Are population-based patient-reported outcomes associated with overall survival in patients with advanced pancreatic cancer? Cancer Med. 2020;9(1):215-24. DOI:10.1002/cam4.2704
14. Pusic AL, Klassen AF, Scott AM, et al. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009;124(2):345-53. DOI:10.1097/PRS.0b013e3181aee807
15. Davies CF, Macefield R, Avery K, et al. Patient-Reported Outcome Measures for Post-mastectomy Breast Reconstruction: A Systematic Review of Development and Measurement Properties. Ann Surg Oncol. 2021;28(1):386-404. DOI:10.1245/s10434-020-08736-8
16. Santosa KB, Qi J, Kim HM, et al. Long-term Patient-Reported Outcomes in Postmastectomy Breast Reconstruction. JAMA Surg. 2018;153(10):891-9. DOI:10.1001/jamasurg.2018.1677
17. Nelson JA, Allen RJ Jr, Polanco T, et al. Long-term Patient-reported Outcomes Following Postmastectomy Breast Reconstruction: An 8-year Examination of 3268 Patients. Ann Surg. 2019;270(3):473-83. DOI:10.1097/SLA.0000000000003467
18. Zerillo JA, Schouwenburg MG, van Bommel ACM, et al. An International Collaborative Standardizing a Comprehensive Patient-Centered Outcomes Measurement Set for Colorectal Cancer. JAMA Oncol. 2017;3(5):686-94. DOI:10.1001/jamaoncol.2017.0417
19. Besson A, Deftereos I, Chan S, et al. Understanding patient-reported outcome measures in colorectal cancer. Future Oncol. 2019;15(10):1135-46. DOI:10.2217/fon-2018-0723
20. Rees JR, Whale K, Fish D, et al. Patient-reported outcomes in randomised controlled trials of colorectal cancer: an analysis determining the availability of robust data to inform clinical decision-making. J Cancer Res Clin Oncol. 2015;141(12):2181-92. DOI:10.1007/s00432-015-1970-x
21. Rutherford C, Campbell R, White K, King M. Patient-reported outcomes as predictors of survival in patients with bowel cancer: a systematic review. Qual Life Res. 2019;28(11):2871-87. DOI:10.1007/s11136-019-02255-0
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;113:140-51. DOI:10.1016/j.lungcan.2017.09.011
23. Polański J, Chabowski M, Jankowska-Polańska B, et al. Histological subtype of lung cancer affects acceptance of illness, severity of pain, and quality of life. J Pain Res. 2018;11:727-33. DOI:10.2147/JPR.S155121
24. Brønserud MM, Iachina M, Green A, et al. Patient-reported outcomes (PROs) in lung cancer: Experiences from a nationwide feasibility study. Lung Cancer. 2019;128:67-73. DOI:10.1016/j.lungcan.2018.12.014
25. Martin NE, Massey L, Stowell C, et al. Defining a standard set of patient-centered outcomes for men with localized prostate cancer. Eur Urol. 2015;67(3):460-7. DOI:10.1016/j.eururo.2014.08.075
26. Morgans AK, van Bommel AC, Stowell C, et al. Development of a Standardized Set of Patient-centered Outcomes for Advanced Prostate Cancer: An International Effort for a Unified Approach. Eur Urol. 2015;68(5):891-8. DOI:10.1016/j.eururo.2015.06.007
27. Protopapa E, van der Meulen J, Moore CM, Smith SC. Patient-reported outcome (PRO) questionnaires for men who have radical surgery for prostate cancer: a conceptual review of existing instruments. BJU Int. 2017;120(4):468-81. DOI:10.1111/bju.13896
28. Hoffman KE, Penson DF, Zhao Z, et al. Patient-Reported Outcomes Through 5 Years for Active Surveillance, Surgery, Brachytherapy, or External Beam Radiation With or Without Androgen Deprivation Therapy for Localized Prostate Cancer. JAMA. 2020;323(2):149-63. DOI:10.1001/jama.2019.20675
29. Nguyen-Nielsen M, Møller H, Tjønneland A, Borre M. Patient-reported outcome measures after treatment for prostate cancer: Results from the Danish Prostate Cancer Registry (DAPROCAdata). Cancer Epidemiol. 2020;64:101623. DOI:10.1016/j.canep.2019.101623
30. Xu J, Evans TJ, Coon C, et al. Measuring patient-reported outcomes in advanced gastric cancer. Ecancermedicalscience. 2013;7:351. DOI:10.3332/ecancer.2013.351
31. Straatman J, van der Wielen N, Joosten PJ, et al. Assessment of patient-reported outcome measures in the surgical treatment of patients with gastric cancer. Surg Endosc. 2016;30(5):1920-9. DOI:10.1007/s00464-015-4415-3
32. Maharaj AD, Samoborec S, Evans SM, et al. Patient-reported outcome measures (PROMs) in pancreatic cancer: a systematic review. HPB (Oxford). 2020;22(2):187-203. DOI:10.1016/j.hpb.2019.09.002

Авторы

И.Е. Хатьков1,2, О.А. Минаева1, С.А. Домрачев1,2, М.А. Приймак1, Н.О. Соловьев*1, П.С. Тютюнник1,2

1 ГБУЗ «Московский клинический научно-практический центр им. А.С. Логинова» Департамента здравоохранения г. Москвы, Москва, Россия;
2 ФГБОУ ВО «Московский государственный медико-стоматологический университет им. А.И. Евдокимова» Минздрава России, Москва, Россия
*niks97@list.ru

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Igor E. Khatkov1,2, Olga A. Minaeva1, Sergey A. Domrachev1,2, Maxim A. Priymak1, Nikita O. Solovyev*1, Pavel S. Tyutyunnik1,2

1 Loginov Moscow Clinical Scientific and Practical Center, Moscow, Russia;
2 Yevdokimov Moscow State University of Medicine and Dentistry, Moscow, Russia
*niks97@list.ru

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