Cost-effectiveness of bioimpedance guided fluid management in patients undergoing haemodialysis: the BISTRO RCT

Mandana Zanganeh*, John Belcher, James Fotheringham, David Coyle, Elizabeth Lindley, Fergus J Caskey, Et Al

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

Abstract

Background
The BISTRO randomized controlled trial (RCT) investigated the effect of bioimpedance spectroscopy added to a standardized fluid management protocol on the risk of anuria and preservation of residual kidney function (primary trial outcomes) in incident haemodialysis patients. Despite the economic burden of kidney disease, the cost-effectiveness of using bioimpedance measurements to guide fluid management in haemodialysis is not known.

Objectives
To assess the cost-effectiveness of bioimpedance guided fluid management (BGFM) against current fluid management (CFM) without bioimpedance.

Design
Within-trial economic evaluation (cost-utility analysis) carried out alongside the open-label, multicentre BISTRO RCT.

Setting
34 UK outpatient haemodialysis centres, both main and satellite units, and their associated inpatient hospitals.

Participants
439 adult haemodialysis patients with >500 ml urine/day or residual glomerular filtration rate >3 ml/min/1.73m2.

Intervention
The study intervention was the incorporation of bioimpedance technology-derived information about body composition into the clinical assessment of fluid status in patients with residual kidney function undergoing haemodialysis. Bioimpedance measurements were used in conjunction with usual clinical judgement to set a target weight that would avoid excessive fluid depletion at the end of a dialysis session.

Main outcome measures
The primary outcome measure of the BISTRO economic evaluation was incremental cost per additional quality-adjusted life-year (QALY) gained over 24 months following randomization. In the main (base-case) analysis, this was calculated from the perspective of the National Health Service and Personal Social Services. Sensitivity analyses explored the impact of different scenarios, sources of resource use data and value sets.

Results
The BGFM group was associated with £382 lower average cost per patient (95% CI: –£3319 to £2556) and 0.043 more QALYs (95% CI: –0.019 to 0.105) compared to the CFM group, with neither values being statistically significant. The probability of BGFM being cost-effective was 76% and 83% at commonly cited willingness-to-pay threshold of £20,000 and £30,000 per QALY gained, respectively. The results remained robust to a series of sensitivity analyses.

Limitations
Missing data level was high for some resource use categories collected through case report forms, due to COVID-19 disruptions and a significant dropout rate in the informing BISTRO trial.

Conclusions
Compared with current fluid management, bioimpedance-guided fluid management produced a marginal reduction in costs and a small improvement in QALYs. Results from both the base-case and sensitivity analyses suggested that use of bioimpedance is likely to be cost-effective.

Future work
Future work exploring the association between primary outcomes and longer-term survival would be useful. Should an important link be established, and relevant evidence becomes available, it would be informative to determine whether and how this might affect longer term costs and benefits associated with BGFM.
Original languageEnglish
JournalNIHR Health Technology Assessment
Publication statusAccepted/In press - 7 May 2024

Bibliographical note

This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme under assigned grant number: 14/216/01, and will be published in full in Health Technology Assessment Journal; Vol. XX, No. XX. See the NIHR Journals Library website for further project information.

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