Measuring Quality of Life in Trials Including Patients on Haemodialysis: Methodological Issues Surrounding the Use of the Kidney Disease Quality of Life Questionnaire

Overview

Journal Nephrol Dial Transplant

Publisher Oxford University Press

Specialties General Surgery
Nephrology

Date 2022 Jun 11

PMID 35689670

Authors

Hannah M Worboys

Nicola J Cooper

James O Burton

Hannah M L Young

Ghazala Waheed

James Fotheringham

Laura J Gray

Affiliations

Soon will be listed here.

Abstract

Background: Haemodialysis (HD) treatment causes a significant decrease in quality of life (QoL). When enrolled in a clinical trial, some patients are lost prior to follow-up because they die or they receive a kidney transplant. It is unclear how these patients are dealt with in the analysis of QoL data. There are questions surrounding the consistency of how QoL measures are used, reported and analysed.

Methods: A systematic search of electronic databases for trials measuring QoL in HD patients using any variation of the Kidney Disease Quality of Life (KDQoL) Questionnaire was conducted. The review was conducted in Covidence version 2. Quantitative analysis was conducted in Stata version 16.

Results: We included 61 trials in the review, of which 82% reported dropouts. The methods to account for missing data due to dropouts include imputation (7%) and complete case analysis (72%). Few trials (7%) conducted a sensitivity analysis to assess the impact of missing data on the study results. Single imputation techniques were used, but are only valid under strong assumptions regarding the type and pattern of missingness. There was inconsistency in the reporting of the KDQoL, with many articles (70%) amending the validated questionnaires or reporting only statistically significant results.

Conclusions: Missing data are not dealt with according to the missing data mechanism, which may lead to biased results. Inconsistency in the use of patient-reported outcome measures raises questions about the validity of these trials. Methodological issues in nephrology trials could be a contributing factor to why there are limited effective interventions to improve QoL in this patient group.

Prospero Registration: CRD42020223869.

References

Martin-Alemany G, Valdez-Ortiz R, Olvera-Soto G, Gomez-Guerrero I, Aguire-Esquivel G, Cantu-Quintanilla G . The effects of resistance exercise and oral nutritional supplementation during hemodialysis on indicators of nutritional status and quality of life. Nephrol Dial Transplant. 2016; 31(10):1712-20. DOI: 10.1093/ndt/gfw297. View

Thabut G, Crestani B, Porcher R, Richeldi L . Missing data in IPF trials: do not let methodological issues undermine a major therapeutic breakthrough. Eur Respir J. 2015; 46(3):607-14. DOI: 10.1183/13993003.02204-2014. View

Parsons T, Toffelmire E, King-Vanvlack C . Exercise training during hemodialysis improves dialysis efficacy and physical performance. Arch Phys Med Rehabil. 2006; 87(5):680-7. DOI: 10.1016/j.apmr.2005.12.044. View

Hewitt N, OConnor A, OShaughnessy D, Elder G . Effects of cholecalciferol on functional, biochemical, vascular, and quality of life outcomes in hemodialysis patients. Clin J Am Soc Nephrol. 2013; 8(7):1143-9. PMC: 3700687. DOI: 10.2215/CJN.02840312. View

Deziel C, Bouchard J, Zellweger M, Madore F . Impact of hemocontrol on hypertension, nursing interventions, and quality of life: a randomized, controlled trial. Clin J Am Soc Nephrol. 2007; 2(4):661-8. DOI: 10.2215/CJN.04171206. View

Cukor D, Ver Halen N, Asher D, Coplan J, Weedon J, Wyka K . Psychosocial intervention improves depression, quality of life, and fluid adherence in hemodialysis. J Am Soc Nephrol. 2013; 25(1):196-206. PMC: 3871769. DOI: 10.1681/ASN.2012111134. View

Zheng Z, Chen J, He D, Xu Y, Chen L, Zhang T . The effects of megestrol acetate on nutrition, inflammation and quality of life in elderly haemodialysis patients. Int Urol Nephrol. 2019; 51(9):1631-1638. DOI: 10.1007/s11255-019-02245-8. View

Heo E, Kim S, Park H, Kil S . The effects of a simulated laughter programme on mood, cortisol levels, and health-related quality of life among haemodialysis patients. Complement Ther Clin Pract. 2016; 25:1-7. DOI: 10.1016/j.ctcp.2016.07.001. View

Mansouri S, Jalali A, Rahmati M, Salari N . Educational supportive group therapy and the quality of life of hemodialysis patients. Biopsychosoc Med. 2020; 14:27. PMC: 7560021. DOI: 10.1186/s13030-020-00200-z. View

10.

Joshi V, Mooppil N, Lim J . Validation of the kidney disease quality of life-short form: a cross-sectional study of a dialysis-targeted health measure in Singapore. BMC Nephrol. 2010; 11:36. PMC: 3014913. DOI: 10.1186/1471-2369-11-36. View

11.

Huang M, Lv A, Wang J, Zhang B, Xu N, Zhai Z . The effect of intradialytic combined exercise on hemodialysis efficiency in end-stage renal disease patients: a randomized-controlled trial. Int Urol Nephrol. 2020; 52(5):969-976. DOI: 10.1007/s11255-020-02459-1. View

12.

Singer R . Vitamin C supplementation in kidney failure: effect on uraemic symptoms. Nephrol Dial Transplant. 2010; 26(2):614-20. DOI: 10.1093/ndt/gfq412. View

13.

Singer R, Chacko B, Talaulikar G, Karpe K, Walters G . Placebo-controlled, randomized clinical trial of high-dose cholecalciferol in renal dialysis patients: effect on muscle strength and quality of life. Clin Kidney J. 2019; 12(2):281-287. PMC: 6452192. DOI: 10.1093/ckj/sfy039. View

14.

Maynard L, de Menezes D, Liao N, de Jesus E, Andrade N, Santos J . Effects of Exercise Training Combined with Virtual Reality in Functionality and Health-Related Quality of Life of Patients on Hemodialysis. Games Health J. 2019; 8(5):339-348. DOI: 10.1089/g4h.2018.0066. View

15.

Worboys H, Cooper N, Burton J, Gray L . Measuring quality of life in trials including patients on dialysis: how are transplants and mortality incorporated into the analysis? A systematic review protocol. BMJ Open. 2021; 11(8):e048179. PMC: 8375767. DOI: 10.1136/bmjopen-2020-048179. View

16.

Fitschen P, Biruete A, Jeong J, Wilund K . Efficacy of beta-hydroxy-beta-methylbutyrate supplementation in maintenance hemodialysis patients. Hemodial Int. 2016; 21(1):107-116. DOI: 10.1111/hdi.12440. View

17.

Manfredini F, Mallamaci F, DArrigo G, Baggetta R, Bolignano D, Torino C . Exercise in Patients on Dialysis: A Multicenter, Randomized Clinical Trial. J Am Soc Nephrol. 2016; 28(4):1259-1268. PMC: 5373448. DOI: 10.1681/ASN.2016030378. View

18.

Baigent C, Herrington W, Coresh J, Landray M, Levin A, Perkovic V . Challenges in conducting clinical trials in nephrology: conclusions from a Kidney Disease-Improving Global Outcomes (KDIGO) Controversies Conference. Kidney Int. 2017; 92(2):297-305. PMC: 6326036. DOI: 10.1016/j.kint.2017.04.019. View

19.

Lins L, Carvalho F . SF-36 total score as a single measure of health-related quality of life: Scoping review. SAGE Open Med. 2016; 4:2050312116671725. PMC: 5052926. DOI: 10.1177/2050312116671725. View

20.

Kallich J, Hays R, Mapes D, Coons S, Carter W . The RAND Kidney Disease and Quality of Life instrument. Nephrol News Issues. 1995; 9(9):29, 36. View