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Approbation of a series of questionnaires for comprehensive assessment of pruritus and its impact on quality of life in patients with chronic kidney disease receiving hemodialysis

https://doi.org/10.28996/2618-9801-2023-4-527-540

Abstract

Rationale: itching is one of the essential problems in patients with chronic kidney disease (CKD), including those receiving renal replacement therapy (RRT). For a comprehensive assessment of itching and its impact on various aspects of the quality of life in patients with CKD, questionnaires filled out by patients are used. Currently, there are no Russian versions of standardized instruments that have been tested on the domestic population of patients with CKD and are suitable for assessing the skin manifestations and their impact on the quality of life of this patient population. The aim of the study was to test the use of questionnaires for a comprehensive assessment of itching and various aspects of functioning in CKD patients receiving RRT, as well as validation of the Russian versions of the Itch MOS and Skindex-16 questionnaires. Methods: the Skindex-16, Itch MOS, 5D Elman scale, and WI-NRS scale questionnaires were tested in a group of adult patients with CKD who were on RRT during their hospitalization. To test Russian versions of the Skindex-16, Itch MOS, and 5D-Elman questionnaires, patients were interviewed in focus groups (n=5-8) to analyze the clarity and ease of filling them out by patients. Reliability was assessed by internal consistency (Cronbach's alpha coefficient) and by the test-retest method. Content, face, and convergent validity were evaluated. Also, specialists were interviewed to test the questionnaires. Statistical analysis was performed using the Student's t-test, paired t-test, or their nonparametric analogues. Spearman correlations were used to assess the relationship between the values of the questionnaire indicators. Results: the linguistic and cultural adaptation and validation of the Skindex-16 and Itch MOS questionnaires were performed. The Russian versions of the questionnaires were characterized by satisfactory reliability and validity. To test the use of the questionnaires among patients 100 patients with stage 5 CKD receiving HRT hemodialysis for 49.5 (Q1-Q3: 16; 79) months were included. 6 specialists took part in the testing of the questionnaires. All the questionnaires were shown to be convenient, informative, clinically interpretable, and appropriate for joint use. Conclusion: Russian versions of the Skindex-16 and Itch MOS questionnaires have been developed; their reliability and validity for assessing concerns associated with itching in patients with CKD undergoing hemodialysis have been demonstrated. The Russian versions of the Skindex-16, Itch MOS, 5D Elman, and WI-NRS questionnaires could be used in research and clinical practice to analyze various aspects of itching and its impact on quality of life in CKD patients receiving RRT.

About the Authors

T. P. Nikitina
Saint Petersburg State University
Russian Federation


E. V. Parshina
Saint Petersburg State University
Russian Federation


A. D. Tolkach
Saint Petersburg State University
Russian Federation


M. N. Lisova
Saint Petersburg State University
Russian Federation


M. V. Gromov
Saint Petersburg State University
Russian Federation


T. I. Ionova
Saint Petersburg State University
Russian Federation


References

1. Клинические практические рекомендации KDIGO 2012 по диагностике и лечению хронической болезни почек. Нефрология и диализ. 2017. 19(1):22-206. doi: 10.28996/1680-4422-2017-1-22-206

2. Потекаев Н.Н., Львов А.Н., Жукова О.В. и др. Использование оценочных шкал для пациентов с кожным зудом: Методические рекомендации № 7. Москва, 2021. 36 с.

3. Agarwal R., Burton J., Gallieni M. et al. Alleviating symptoms in patients undergoing long-term hemodialysis: a focus on chronic kidney disease-associated pruritus. Clinical Kidney Journal. 2022. sfac187. doi: 10.1093/ckj/sfac187

4. Kini S.P., DeLong L.K., Veledar E. et al. The impact of pruritus on quality of life: the skin equivalent of pain. Archives of dermatology. 2011. 147(10):1153-1156

5. van der Willik E.M., Lengton R., Hemmelder M.H. et al. Itching in dialysis patients: impact on health-related quality of life and interactions with sleep problems and psychological symptoms-results from the RENINE/PROMs registry. Nephrology Dialysis Transplantation. 2022. 37(9):1731-1741. doi: 10.1093/ndt/gfac022

6. Makar M., Smyth B., Brennan F. Chronic Kidney Disease-Associated Pruritus: A Review. Kidney and Blood Pressure Research. 2021. 46(6):659-669. doi: 10.1159/000518391

7. Kim D., Pollock C. Epidemiology and burden of chronic kidney disease-associated pruritus. Clinical Kidney Journal. 2021. 14(Suppl 3):i1-i7. doi: 10.1093/ckj/sfab142

8. Świerczyńska K., Białynicki-Birula R., Szepietowski J.C. Chronic Intractable Pruritus in Chronic Kidney Disease Patients: Prevalence, Impact, and Management Challenges - A Narrative Review. Therapeutics and Clinical Risk Management. 2021. 17:1267-1282. doi: 10.2147/TCRM.S310550

9. Poku E., Harnan S., Rooney G. et al. The relationship between chronic kidney disease-associated pruritus and health-related quality of life: a systematic review. Clinical Kidney Journal. 2022. 15(3):484-499. doi: 10.1093/ckj/sfab218

10. Huet F., Taieb C., Corgibet F. et al. Pruritus, pain, and depression associated with the most common skin diseases: data from the french study «Objectifs Peau». Dermatology. 2022. 238(3):448-453. doi: 10.1159/000518220

11. Manenti L., Leuci E. Do you feel itchy? A guide towards diagnosis and measurement of chronic kidney disease-associated pruritus in dialysis patients. Clinical Kidney Journal. 2021. 14 (Suppl. 3): i8-i15. doi: 10.1093/ckj/sfab143

12. Erikson S., Kim B.S. Research techniques made simple: Itch measurement in clinical trials. Journal of investigative dermatology. 2019. 139(2):264-269. doi: 10.1016/j.jid.2018.12.004

13. Vernon M.K., Swett L.L., Speck R.M. et al. Psychometric validation and meaningful change thresholds of the Worst Itching Intensity Numerical Rating Scale for assessing itch in patients with chronic kidney disease-associated pruritus. Journal of Patient-Reported Outcomes. 2021. 5(1):134. doi: 10.1186/s41687-021-00404-z

14. Elman S., Hynan L.S., Gabriel V., Mayo M.J. The 5-D itch scale: a new measure of pruritus. British Journal of Dermatology. 2009. 162(3):587-593. doi: 10.1111/j.1365-2133.2009.09586.x

15. Khan T.M., Al-Haider I., Syed Sulaiman S.A., Hassali M.A. Linguistic validation of the 5D itching scale to Arabic in patients with end-stage kidney disease. Journal of Renal Care. 2013. 39(4):222-227. doi:10.1111/j.1755-6686.2013.12038.x.

16. Rehman I.U., Wu D.B.-C., Pauline Lai S.M. et al. Translation of the 5D Itching scale from English to Malay, and its validation among patients with chronic kidney disease in Malaysia. Frontiers in Medicine. 2017. 4:189. doi: 10.3389/fmed.2017.00189

17. Yoosefinejad A.K., Karjalian F., Momennasab M. et al. Reliability and validity of the Persian version of 5-D itching scale among patients with chronic kidney disease. BMC Nephrology. 2021. 22:16. doi: 10.1186/s12882-020-02220-x

18. Chren M.M. The Skindex instruments to measure the effects of skin disease on quality of life. Dermatologic Clinics. 2012. 30(2):231-236, xiii. doi: 10.1016/j.det.2011.11.003

19. Chren M.M., Lasek R.J., Sahay A.P., Sands L.P. Measurement properties of Skindex-16: a brief quality-of-life measure for patients with skin diseases. Journal of Cutaneous Medicine and Surgery. 2001. 5(2):105-110. doi: 10.1007/BF02737863

20. Atherton P.J., Burger K.N., Loprinzi C.L. et al. Using the Skindex-16 and common terminology criteria for adverse events to assess rash symptoms: results of a pooled-analysis (N0993). Support Care Cancer. 2012. 20(8):1729-1735. doi: 10.1007/s00520-011-1266-x

21. Secrest A.M., Hopkins Z.H., Frost Z.E. et al. Quality of life assessed using Skindex-16 scores among patients with acne receiving isotretinoin treatment. Journal of the American Medical Association dermatology. 2020. 156(10):1098-1106. doi: 10.1001/jamadermatol.2020.2330

22. Wala K., Szepietowski J.C. Difelikefalin in the Treatment of Chronic Kidney Disease-Associated Pruritus: A Systematic Review. Pharmaceuticals. 2022. 15(8):934. doi: 10.3390/ph15080934

23. Narita I., Tsubakihara Y., Uchiyama T. et al. Efficacy and safety of difelikefalin in japanese patients with moderate to severe pruritus receiving hemodialysis: a randomized clinical trial. Journal of the American Medical Association Network Open. 2022. 5(5):e2210339. doi: 10.1001/jamanetworkopen.2022.10339

24. Hays R.D., Stewart A.L. Sleep measures. In: Measuring Functioning and Well-Being: The Medical Outcomes Study Approach / edited by Stewart A.L., Ware J.E., Durham: Duke University Press, 1992. Рp. 235-259.

25. Mathur V., Lindberg J., Germain M. et al. A longitudinal study of uremic pruritus in hemodialysis patients. Clinical journal of the American Society of Nephrology. 2010. 5:1410-1419. doi: 10.2215/CJN.00100110

26. Fishbane S., Mathur V., Germain M.J. et al. Randomized controlled trial of difelikefalin for chronic pruritus in hemodialysis patients. Kidney International Reports. 2020. 5(Issue 5):600-610. doi: 10.1016/j.ekir.2020.01.006

27. Fishbane S., Jamal A., Munera C. et al. A Phase 3 trial of difelikefalin in hemodialysis patients with pruritus. The New England Journal of Medicine. 2020. 382(3):222-232. doi: 10.1056/NEJMoa1912770

28. Guidelines for Best Practice in Cross-Cultural Surveys (4th edn). Michigan: Survey Research Center, Institute for Social Research, University of Michigan, 2016. 842 р.

29. Beaton D.E., Bombardier C., Guillemin F., Ferraz M.B. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine. 2000. 25(24):3186-3191. doi: 10.1097/00007632-200012150-00014

30. Wild D., Grove A., Martin M. et al. Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (PRO) measures: Report of the ISPOR task force for translation and cultural adaptation. Value Health. 2005. 8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x

31. Ионова Т.И. Принципы языковой и культурной адаптации опросников оценки качества жизни. Вестник Межнационального центра исследования качества жизни. 2018. 31-32:12-17

32. KDIGO.org [Интернет]. KDIGO Pruritus Infographic Set. Доступно по: https://kdigo.org/wp-content/uploads/2022/06/KDIGO-Pruritus-Infographic-Set.pdf. Ссылка активна на 11.09.2023.

33. He Z., Lu C., Chren M-M. et al. Development and psychometric validation of the Chinese version of Skindex-29 and Skindex-16. Health and Quality of Life Outcomes. 2014. 12:190. doi 10.1186/s12955-014-0190-4

34. El Fakir S., Baybay H., Bendahhou K. et al. Validation of the Skindex-16 questionnaire in patients with skin diseases in Morocco. Journal of Dermatological Treatment. 2014. 25:106-109. doi: 10.3109/09546634.2012.681016

35. Prinsen C.A.C., Mokkink L.B., Bouter L.M. et al. COSMIN guideline for systematic reviews of patient-reported outcome measures. Qual Life Res. 2018. 27(5):1147-1157. doi: 10.1007/s11136-018-1798-3

36. Lakens D. Calculating and reporting effect sizes to facilitate cumulative science: a practical primer for t-tests and ANOVAs. Front. Psychol. 2013. 4:863. doi https://doi.org/10.3389/fpsyg.2013.00863

37. Sukul N., Karaboyas A., Csomor P.A. et al. Self-reported pruritus and clinical, dialysis-related, and patient-reported outcomes in hemodialysis patients. Kidney Med. 2020. 3(1):42-53.e1. doi: 10.1016/j.xkme.2020.08.011


Supplementary files

1. 5D-шкала Elman
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2. Шкала качества сна при зуде Itch MOS
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3. Skindex-16
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4. WI-NRS
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For citations:


Nikitina T.P., Parshina E.V., Tolkach A.D., Lisova M.N., Gromov M.V., Ionova T.I. Approbation of a series of questionnaires for comprehensive assessment of pruritus and its impact on quality of life in patients with chronic kidney disease receiving hemodialysis. Nephrology and Dialysis. 2023;25(4):527-540. (In Russ.) https://doi.org/10.28996/2618-9801-2023-4-527-540

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ISSN 1680-4422 (Print)
ISSN 2618-9801 (Online)