Evidence map›Paper›PMID 39675733›Full record

Trial reportDiving and hyperbaric medicine2024

Economic analysis of hyperbaric oxygen therapy for the treatment of ischaemic diabetic foot ulcers.

Robin J Brouwer, Nick S van Reijen, Marcel G Dijkgraaf, Rigo Hoencamp, Mark Jw Koelemay, Robert A van Hulst, Dirk T Ubbink

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Diving and hyperbaric medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Robin J Brouwer *Department of Anaesthesiology, Amsterdam UMC, Location AMC, Amsterdam, The Netherlands.
Nick S van Reijen *Department of Surgery, Amsterdam UMC, Location AMC, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.
Marcel G DijkgraafDepartment of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, Location AMC, Amsterdam, The Netherland.
Rigo HoencampDepartment of Surgery, Alrijne Hospital, Leiderdorp, The Netherlands.
Mark Jw KoelemayDepartment of Surgery, Amsterdam UMC, Location AMC, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.
Robert A van HulstDepartment of Anaesthesiology, Amsterdam UMC, Location AMC, Amsterdam, The Netherlands.
Dirk T UbbinkDepartment of Surgery, Amsterdam UMC, Location AMC, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: The aim was to determine the cost-effectiveness and cost-utility of additional hyperbaric oxygen therapy (HBOT) compared to standard care (SC) for ischaemic diabetic foot ulcers (DFUs) regarding limb salvage and health status. Methods: An economic analysis was conducted, comprising cost-effectiveness and cost-utility analyses, with a 12-month time horizon, using data from the DAMO₂CLES multicentre randomised clinical trial. Cost-effectiveness was defined as cost per limb saved and cost-utility as cost per quality-adjusted life year (QALY). The difference in cost effectiveness between HBOT+SC and SC alone was determined via an incremental cost-effectiveness ratio (ICER). Results: One-hundred and twenty patients were included, with 60 allocated to HBOT+SC and 60 to SC. No significant cost difference was found in the intention-to-treat analysis: €3,791 (bias corrected and accelerated [BCA] 95% CI, €3,556 - €-11,138). Cost per limb saved showed an ICER of €37,912 (BCA 95% CI €-112,188 - €1,063,561) for HBOT+SC vs. SC. There was no significant difference in mean QALYs: 0.54 for HBOT+SC vs. 0.56 for SC alone (-0.02; BCA 95% CI -0.11-0.08). This resulted in a cost-utility of minus €227,035 (BCA 95% CI €-361,569,550 - €-52,588) per QALY. Subgroup analysis for Wagner stages III/IV showed an ICER of €19,005 (BCA 95%CI, -€18,487 - €264,334) while HBOT did not show any benefit for Wagner stage II. Conclusions: HBOT as an adjunct to SC showed no significant differences in costs and effectiveness for patients with DFUs regarding limb salvage and health status. However, for patients with Wagner stage III/IV ischaemic DFUs there was a trend towards better effectiveness and cost-effectiveness.

Indexed as

Cost-Benefit AnalysisDiabetic FootHyperbaric OxygenationLimb SalvageQuality-Adjusted Life YearsAgedFemaleHealth StatusHumansIschemiaMaleMiddle AgedStandard of CareCost-effectivenessPeripheral arterial occlusive diseaseWound healing

Identifiers

PMID39675733
PMCPMC12018699

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.