Measuring quality of life in trials including patients on dialysis: how are transplants and mortality incorporated into the analysis? A systematic review protocol

Introduction It is estimated that 25 000 people in the UK receive dialysis. Dialysis is an intrusive and time-consuming intervention that causes significant reductions in quality of life. When enrolled in a clinical trial, often some patients drop out of the study either because they die, receive a kidney transplant or are lost to follow-up for other reasons. It is unclear how these events are dealt with when analysing quality of life measures within clinical trials. This review will assess current practice for dealing with loss to follow-up in trials including patients on haemodialysis. The methods currently used will be analysed in terms of their adequacy and will form the basis of future work assessing the most appropriate methods to employ under these circumstances. The results of this review will feed into recommendations for future nephrology trials. Methods and analysis A systematic search of electronic databases including MEDLINE and the Cochrane Library will be conducted to find clinical trials enrolling patients on haemodialysis that measure quality of life using either the kidney disease quality of life (KDQoL) or the short form 36 health survey (SF-36) (or any variation of these two measures). Ongoing trials will be identified through a search of trial registers. Articles will be screened against inclusion/exclusion criteria and data will be extracted using a predetermined data extraction form. General information such as the title, location, trial design will be extracted along with more specific information on how the study dealt with patients that died or received a transplant before the end of the follow-up period. Two independent reviewers will perform screening and extraction. Disagreements will be resolved by discussion or by a third independent reviewer. Data synthesis will be performed as a narrative summary. Ethics and dissemination Ethics approval is not required. Dissemination will be by publication in a peer-reviewed journal. PROSPERO registration number CRD42020223869.

Automated summary

This review assesses current practices for handling loss to follow-up in clinical trials involving patients on haemodialysis. The adequacy of methods used will be analyzed to determine the most appropriate approach for future work. The results will inform recommendations for future nephrology trials.