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Measuring quality of life in trials including patients on hemodialysis: Methodological issues surrounding use of the Kidney Disease Quality of Life Questionnaire. A systematic review.

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Version 2 2023-08-10, 14:43
Version 1 2022-05-10, 05:30
journal contribution
posted on 2023-08-10, 14:43 authored by Hannah Worboys, Nicola Cooper, James Burton, Hannah Young, Ghazala Waheed, James Fotheringham, Laura Gray

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

Funding

National Institute for Health Research (NIHR) Applied Research Collaboration East Midlands

History

Author affiliation

Department of Health Sciences, University of Leicester

Version

  • VoR (Version of Record)

Published in

Nephrology Dialysis Transplantation

Volume

37

Pagination

2538-2554

Publisher

Oxford University Press (OUP)

issn

0931-0509

Acceptance date

2022-04-12

Copyright date

2022

Available date

2023-08-10

Language

en

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