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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

Nephrol Dial Transplant. 2022 Jun 11:gfac170. doi: 10.1093/ndt/gfac170. Online ahead of print.


BACKGROUND: Hemodialysis treatment causes significant reductions in quality of life (QoL). When enrolled in a clinical trial, some patients are lost prior to follow-up either because they die or 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 hemodialysis patients using any variation of the Kidney Disease Quality of Life (KDQoL) Questionnaire. The review was conducted in Covidence version2. Quantitative analysis was conducted in STATA version16.

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 sensitivity analysis to assess the impact of missing data on the study results. Single imputation techniques were used which are only valid under strong assumptions regarding the type and pattern of missingness. There was inconsistency in the reporting of the KDQoL, with many papers (54%) 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.


PMID:35689670 | DOI:10.1093/ndt/gfac170

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