Купить
Открытый доступ
Только для подписчиков
Исходы хронической болезни почек с точки зрения пациента
Аннотация
В обзоре приведено определение понятия «исходы с точки зрения пациента» (patient-reported outcomes – PRO). К основным компонентам PRO относят качество жизни (КЖ), связанное со здоровьем; симптоматику, оцениваемую пациентом; функциональный статус; удовлетворенность лечением. Представлено описание наиболее часто применяемых опросников для оценки КЖ пациентов с хронической болезнью почек (ХБП). Показано, что на додиализных стадиях ХБП страдает, в первую очередь, физическая составляющая КЖ. По мере прогрессирования ХБП снижаются суммарный показатель физического здоровья опросника SF-36, а также оценки шкал физического функционирования, влияния физического здоровья на повседневную деятельность, боли, общего здоровья. Из специфических для ХБП шкал КЖ отмечается ухудшение оценок шкал «симптомы/проблемы», «бремя заболевания почек», «влияние заболевания почек на повседневную деятельность». Убедительных данных в пользу снижения показателей психосоциальной компоненты КЖ у больных с ХБП в литературе не представлено. В обзоре приведено определение понятия «всесторонняя консервативная помощь», предложенное экспертами, присутствовавшими на состоявшейся в 2013 году Согласительной конференции KDIGO по поддерживающей помощи. Показано, что всесторонняя консервативная помощь может быть достаточно эффективным методом выбора для пожилых пациентов с 5-й стадией ХБП. Продемонстрировано, что снижение суммарного показателя физического здоровья опросника SF-36 независимо ассоциировано с прогрессированием ХБП и повышением риска смерти. Вместе с тем, исследования КЖ пациентов с ХБП додиализных стадий немногочисленны. Сопоставимость данных затруднена вследствие использования различных опросников для оценки КЖ. Практически отсутствуют рандомизированные клинические исследования, что снижает ценность полученных результатов.
Об авторах
И. А. Васильева
Первый Санкт-Петербургский государственный медицинский университет имени академика И. П. Павлова
Россия
Россия
Васильева Ирина Андреевна, д-р психол. наук, научно-исследовательский институт нефрологии, лаборатория почечной недостаточности, старший научный сотрудник
197022, Санкт-Петербург, ул. Л. Толстого, д. 17, корп. 54
Тел.: +7(812)338-69-34
В. А. Добронравов
Первый Санкт-Петербургский государственный медицинский университет имени академика И. П. Павлова
Россия
Россия
Проф. Добронравов Владимир Александрович, д-р мед. наук, заместитель директора по научной работе научно-исследовательского института нефрологии, профессор кафедры пропедевтики внутренних болезней с клиникой
197022, Санкт-Петербург, ул. Л. Толстого, д. 17, корп. 54
Тел.: +7(812)338-69-01
Список литературы
1. United States Food and Drug Administration. Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. United States Food and Drug Administration, Rockville, MD, 2009. Available from: https://www.fda.gov/media/77832/download
2. Halyard MY. The use of real-time patient-reported outcomes and quality-of-life data in oncology clinical practice. Expert Rev Pharmacoecon Outcomes Res 2011;11(5):561-570. doi: 10.1586/erp.11.62
3. Bottomley A, Pe M, Sloan J et al. Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards. Lancet Oncol 2016;17(11):e510-e514. doi: 10.1016/S1470-2045(16)30510-1
4. Deshpande PR, Rajan S, Sudeepthi BL, Abdul Nazir CP. Patient-reported outcomes: a new era in clinical research. Perspect Clin Res 2011;2(4):137-144. doi: 10.4103/2229-3485.86879
5. Schick-Makaroff K, Thummapol O, Thompson S et al. Strategies for incorporating patient-reported outcomes in the care of people with chronic kidney disease (PRO kidney): a protocol for a realist synthesis. Syst Rev 2019;8(1):20. doi: 10.1186/s13643018-0911-6
6. Salek S, Ionova T, Oliva E et al. Patients' needs in hematology: whose perspectives? Haematologica 2013;98(6):828-830. doi: 10.3324/haematol.2013.090399
7. Reeve BB, Wyrwich KW, Wu AW et al. ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Qual Life Res 2013;22(8):1889-1905. doi: 10.1007/s11136-012-0344-y
8. Burke L. History of patient-reported outcome measurement at FDA: My perspective. Patient Reported Outcomes (PRO) Newsletter 2014;52:6
9. Ware JE, Snow KK, Kosinski M, Gandek B. SF-36 Health Survey: Manual and Interpretation Guide. The Health Institute, New England Medical Center, Boston, MA, 1993; 316 p
10. Ware JE, Kosinski M. The SF-36 Physical and Mental Health Summary Scales: A Manual for Users of Version 1, 2nd ed. QualityMetric Incorporated, Lincoln, RI, 2001; 238 p
11. Skevington SM, Lotfy M, O’Connell KA; WHOQOL group. The World Health Organization’s WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res 2004;13(2):299-310. doi:10.1023/B:QURE.0000018486.91360.00
12. Hays RD, Kallich JD, Mapes DL et al. Development of the kidney disease quality of life instrument. Qual Life Res 1994;3(5):329-338
13. Hays RD, Kallich J, Mapes DL et al. Kidney Disease Quality of Life Short Form (KDQOL-SF), Version 1.3: A Manual for use and scoring. RAND, Santa Monica, CA., 1997; 43 p
14. Васильева ИА. Российская версия опросника Kidney Disease and Quality of Life Short Form (KDQOL-SF™) – ценного диагностического инструмента для оценки качества жизни больных на диализе. Нефрология 2007;11(1): 64-70. doi: 10.24884/1561-6274-2007-11-1-64-70
15. Vasilieva IA. Validation of the Russian version of the Kidney Disease Quality of Life Short Form (KDQOL-SFTM ) Instrument. Patient Reported Outcomes (PRO) Newsletter 2006;36:14-15
16. Васильева ИА, Смирнов АВ. Оценка качества жизни больных на гемодиализе при помощи опросника KDQOL-SFTM . Нефрология 2017;21(4):55-60. doi: 10.24884/1561-6274-201721-4-55-60
17. Coulter ID, Danielson C. The Chiropractic Satisfaction Questionnaire. Topics in Clinical Chiropractic 1994;1(4):40-43
18. Barotfi S, Molnar MZ, Almasi C et al. Validation of the Kidney Disease Quality of Life-Short Form questionnaire in kidney transplant patients. J Psychosom Res 2006;60(5):495-504. doi: 10.1016/j.jpsychores.2005.09.009
19. Abd ElHafeez S, Sallam SA, Gad ZM et al. Cultural adaptation and validation of the "Kidney Disease and Quality of Life-Short Form (KDQOL-SF™) version 1.3" questionnaire in Egypt. BMC Nephrol 2012;13:170. doi: 10.1186/1471-2369-13-170
20. Cheung YB, Seow YY, Qu LM, Yee ACP. Measurement properties of the Chinese version of the Kidney Disease Quality of Life-Short Form (KDQOL-SFTM ) in end-stage renal disease patients with poor prognosis in Singapore. J Pain Symptom Manage 2012;44(6):923-932. doi: 10.1016/j.jpainsymman.2011.12.282
21. Ricardo AC, Hacker E, Lora CM et al. Validation of the Kidney Disease Quality of Life Short Form 36 (KDQOL-36™) US Spanish and English versions in a cohort of Hispanics with chronic kidney disease. Ethn Dis 2013;23(2):202-209
22. Wu AW, Fink NE, Cagney KA et al. Developing a health-related quality-of-life measure for end-stage renal disease: The CHOICE Health Experience Questionnaire. Am J Kidney Dis 2001;37(1):11-21. doi: 10.1053/ajkd.2001.20631
23. Weisbord SD, Fried LF, Arnold RM et al. Development of a symptom assessment instrument for chronic hemodialysis patients: the Dialysis Symptom Index. J Pain Symptom Manage 2004;27(3):226-240. doi: 10.1016/j.jpainsymman.2003.07.00
24. Franke GH, Reimer J, Kohnle M et al. Quality of life in endstage renal disease patients after successful kidney transplantation: development of the ESRD symptom checklist – transplantation module. Nephron 1999;83(1):31-39. doi: 10.1159/000045470
25. Agarwal R. Developing a self-administered CKD symptom assessment instrument. Nephrol Dial Transplant 2010;25(1):160-166. doi: 10.1093/ndt/gfp426
26. Aiyegbusi OL, Kyte D, Cockwell P et al. Measurement properties of patient-reported outcome measures (PROMs) used in adult patients with chronic kidney disease: a systematic review. PLoS One 2017;12(6):e0179733. doi: 10.1371/journal.pone.0179733
27. Verberne WR, Das-Gupta Z, Allegretti AS et al. Development of an international standard set of value-based outcome measures for patients with chronic kidney disease: a report of the International Consortium for Health Outcomes Measurement (ICHOM) CKD Working Group. Am J Kidney Dis 2019;73(3):372-384. doi: 10.1053/j.ajkd.2018.10.007
28. Breckenridge K, Bekker HL, Gibbons E et al. How to routinely collect data on patient-reported outcome and experience measures in renal registries in Europe: an expert consensus meeting. Nephrol Dial Transplant 2015;30(10):1605-1614. doi: 10.1093/ndt/gfv209
29. Fukuhara S, Lopes AA, Bragg-Gresham JL et al. Healthrelated quality of life among dialysis patients on three continents: the Dialysis Outcomes and Practice Patterns Study. Kidney Int 2003;64(5):1903-1910. doi: 10.1046/j.1523-1755.2003.00289.x
30. van Loon I, Hamaker ME, Boereboom FTJ et al. A closer look at the trajectory of physical functioning in chronic hemodialysis. Age Ageing 2017;46(4):594-599. doi: 10.1093/ageing/afx006
31. Tsuji-Hayashi Y, Sizer Fitts S, Takai I et al. Health-related quality of life among dialysis patients in Seattle and Aichi. Am J Kidney Dis 2001;37(5):987-996. doi: 10.1016/s0272-6386(05)80015-0
32. Добронравов ВА, Васильева ИА, Бабарыкина ЕВ. Физическое функционирование как предиктор отдаленной общей выживаемости больных на хроническом гемодиализе. Нефрология 2015;19(1):54-60
33. Mapes DL, Lopes AA, Satayathum S et al. Health-related quality of life as a predictor of mortality and hospitalization: the Dialysis Outcomes and Practice Patterns Study (DOPPS). Kidney Int 2003;64(1):339-349. doi: 10.1046/j.1523-1755.2003.00072.x
34. Chin HJ, Song YR, Lee JJ et al. Moderately decreased renal function negatively affects the health-related quality of life among the elderly Korean population: a population-based study. Nephrol Dial Transplant 2008;23(9): 2810-2817. doi: 10.1093/ndt/gfn132
35. Mujais SK, Story K, Brouillette J et al. Health-related quality of life in CKD patients: correlates and evolution over time. Clin J Am Soc Nephrol 2009;4(8):1293-1301. doi: 10.2215/CJN.05541008
36. Pagels AA, Söderkvist BK, Medin C et al. Health-related quality of life in different stages of chronic kidney disease and at initiation of dialysis treatment. Health Qual Life Outcomes 2012;10:71. doi: 10.1186/1477-7525-10-71
37. Stengel B, Metzger M, Combe C et al. Risk profile, quality of life and care of patients with moderate and advanced CKD: the French CKD-REIN cohort study. Nephrol Dial Transplant 2019;34(2):277-286. doi: 10.1093/ndt/gfy058
38. Wyld MLR, Morton RL, Clayton P et al. The impact of progressive chronic kidney disease on health-related quality-of-life: a 12-year community cohort study. Qual Life Res 2019;28(8):20812090. doi: 10.1007/s11136-019-02173-1
39. Perlman RL, Finkelstein FO, Liu L et al. Quality of life in chronic kidney disease (CKD): a cross-sectional analysis in the Renal Research Institute–CKD study. Am J Kidney Dis 2005;45(4):658-666. doi: 10.1053/j.ajkd.2004.12.021
40. Kusek JW, Greene P, Wang SR et al. Cross-sectional study of health-related quality of life in African Americans with chronic renal insufficiency: the African American Study of Kidney Disease and Hypertension Trial. Am J Kidney Dis 2002;39(3):513-524. doi: 10.1053/ajkd.2002.31401
41. Chow FY, Briganti EM, Kerr PG et al. Health-related quality of life in Australian adults with renal insufficiency: a populationbased study. Am J Kidney Dis 2003;41(3):596-604. doi: 10.1053/ajkd.2003.50121
42. Васильева ИА. Особенности качества жизни больных с хронической почечной недостаточностью при лечении гемодиализом. Изв Рос гос пед ун-та им АИ Герцена 2008;(57):75-86
43. Poppe C, Crombez G, Hanoulle I et al. Improving quality of life in patients with chronic kidney disease: influence of acceptance and personality. Nephrol Dial Transplant 2013;28(1):116-121. doi: 10.1093/ndt/gfs151
44. Gemmell LA, Terhorst L, Jhamb M et al. Gender and racial differences in stress, coping, and health-related quality of life in chronic kidney disease. J Pain Symptom Manage 2016;52(6):806-812. doi: 10.1016/j.jpainsymman.2016.05.029
45. Wyld MLR, Morton RL, Aouad L. The impact of comorbid chronic kidney disease and diabetes on health-related quality-oflife: a 12-year community cohort study. Nephrol Dial Transplant 2020;gfaa031. doi: 10.1093/ndt/gfaa031
46. Wong MG, Ninomiya T, Liyanage T et al. Physical component quality of life reflects the impact of time and moderate chronic kidney disease, unlike SF-6D utility and mental component SF-36 quality of life: an AusDiab analysis. Nephrology (Carlton) 2019;24(6):605-614. doi: 10.1111/nep.13445
47. Porter AC, Lash JP, Xie D et al. CRIC Study Investigators. Predictors and outcomes of health-related quality of life in adults with CKD. Clin J Am Soc Nephrol 2016;11(7):1154-1162. doi: 10.2215/CJN.09990915
48. Tsai YC, Hung CC, Hwang SJ et al. Quality of life predicts risks of end-stage renal disease and mortality in patients with chronic kidney disease. Nephrol Dial Transplant 2010;25(5):1621-1626. doi: 10.1093/ndt/gfp671
49. van Loon IN, Goto NA, Boereboom FTJ et al. Quality of life after the initiation of dialysis or maximal conservative management in elderly patients: a longitudinal analysis of the Geriatric assessment in OLder patients starting Dialysis (GOLD) study. BMC Nephrol 2019;20(1):108. doi: 10.1186/s12882-019-1268-3
50. EQ-5D-3L User Guide. Version 2.1. Available at: https://euroqol.org/publications/user-guides/
51. Seow YY, Cheung YB, Qu LM, Yee AC. Trajectory of quality of life for poor prognosis stage 5D chronic kidney disease with and without dialysis. Am J Nephrol 2013;37(3):231-238. doi: 10.1159/000347220
52. De Biase V, Tobaldini O, Boaretti C et al. Prolonged conservative treatment for frail elderly patients with end-stage renal disease: the Verona experience. Nephrol Dial Transplant 2008;23(4):1313-1317. doi: 10.1093/ndt/gfm772
53. Yong DS, Kwok AO, Wong DM et al. Symptom burden and quality of life in end-stage renal disease: a study of 179 patients on dialysis and palliative care. Palliat Med 2009;23(2):111-119. doi: 10.1177/0269216308101099
54. Brown MA, Collett GK, Josland EA et al. CKD in elderly patients managed without dialysis: survival, symptoms, and quality of life. Clin J Am Soc Nephrol 2015;10(2):260-268. doi: 10.2215/CJN.03330414
55. Da Silva-Gane M, Wellsted D, Greenshields H et al. Quality of life and survival in patients with advanced kidney failure managed conservatively or by dialysis. Clin J Am Soc Nephrol 2012;7(12):2002-2009. doi: 10.2215/CJN.01130112
56. Murtagh FE, Burns A, Moranne O et al. Supportive care: comprehensive conservative care in end-stage kidney disease. Clin J Am Soc Nephrol 2016;11(10):1909-1914. doi: 10.2215/CJN.04840516
57. Song MK. Quality of life of patients with advanced chronic kidney disease receiving conservative care without dialysis. Semin Dial 2016;29(2):165-169. doi: 10.1111/sdi.12472
58. Davison SN, Levin A, Moss AH et al. Kidney Disease: Improving Global Outcomes. Executive summary of the KDIGO Controversies Conference on Supportive Care in Chronic Kidney Disease: developing a roadmap to improving quality care. Kidney Int 2015;88(3):447-459. doi: 10.1038/ki.2015.110
59. Evangelidis N, Tong A, Manns B et al. Standardized Outcomes in Nephrology–Hemodialysis (SONG-HD) Initiative. Developing a set of core outcomes for trials in hemodialysis: an International Delphi Survey. Am J Kidney Dis 2017;70(4):464-475. doi: 10.1053/j.ajkd.2016.11.029
60. Schell JO, Da Silva-Gane M, Germain MJ. Recent insights into life expectancy with and without dialysis. Curr Opin Nephrol Hypertens 2013;22(2):185-192. doi: 10.1097/MNH.0b013e32835ddb69
61. Lerner B, Desrochers S, Tangri N. Risk prediction models in CKD. Semin Nephrol 2017;37(2):144-150. doi: 10.1016/j.semnephrol.2016.12.004
62. Kim KM, Oh HJ, Choi HY et al. Impact of chronic kidney disease on mortality: a nationwide cohort study. Kidney Res Clin Pract 2019;38(3):382-390. doi: 10.23876/j.krcp.18.0128
63. Han SS, Kim KW, Na KY. Quality of life and mortality from a nephrologist's view: a prospective observational study. BMC Nephrol 2009;10:39. doi: 10.1186/1471-2369-10-39
64. Porter A, Fischer MJ, Wang X et al. AASK Study Group. Quality of life and outcomes in African Americans with CKD. J Am Soc Nephrol 2014;25(8):1849-1855. doi: 10.1681/ASN.2013080835
65. Oh TR, Choi HS, Kim CS et al. Association between health related quality of life and progression of chronic kidney disease. Sci Rep 2019;9(1):19595. doi: 10.1038/s41598-019-56102-w
66. Broers NJ, Usvyat LA, Kooman JP et al. Quality of life in dialysis patients: a retrospective cohort study. Nephron 2015;130(2):105-112. doi: 10.1159/000430814
67. Painter P, Carlson L, Carey S et al. Low-functioning hemodialysis patients improve with exercise training. Am J Kidney Dis 2000;36(3):600-608. doi: 10.1053/ajkd.2000.16200
68. Padilla J, Krasnoff J, Da Silva M et al. Physical functioning in patients with chronic kidney disease. J Nephrol 2008;21(4):550-559
Для цитирования:
Васильева И.А., Добронравов В.А. Исходы хронической болезни почек с точки зрения пациента. Нефрология. 2020;24(6):9-18. https://doi.org/10.36485/1561-6274-2020-24-6-9-18
For citation:
Vasilieva I.A., Dobronravov V.A. Patient-reported outcomes in chronic kidney disease. Nephrology (Saint-Petersburg). 2020;24(6):9-18. (In Russ.) https://doi.org/10.36485/1561-6274-2020-24-6-9-18
Просмотров: 111
Послать статью по эл. почте 