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Quality of reporting in hyperbaric medicine clinical trials: a cross-sectional study
Yeonjung Yoo1, Angélique Cléroux2, Neal W Pollock3,4, Sylvain Boet1,5,6,7
1 Ottawa Hospital Research Institute, Acute Care Research Program, Ottawa, ON, Canada
2 Department of Medicine, University of Ottawa, Ottawa, ON, Canada
3 Hyperbaric Medicine Unit, CISSS Chaudière-Appalaches (CHAU-Hôtel-Dieu de Lévis), Lévis, QC, Canada
4 Department of Kinesiology, Université Laval, Quebec, QC, Canada
5 Department of Anesthesiology and Pain Medicine, The Ottawa Hospital, University of Ottawa, Ottawa, ON, Canada
6 Subaquatic and Hyperbaric Medicine Unit (UMSH), Division of Emergency Medicine, Department of Acute Care Medicine, Geneva University Hospitals, Switzerland
7 Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Faculty of Medicine, University of Geneva, Switzerland
Corresponding author: Dr Sylvain Boet, Unité de médecine subaquatique et hyperbare, Service des urgences des Hôpitaux Universitaires de Genève, Rue Gabrielle Perret-Gentil 2, CH-1201 Genève, Switzerland
ORCiD: 0000-0002-1679-818X
Keywords
CONSORT; EQUATOR; Evidence-based medicine; Hyperbaric oxygenation; Reporting quality; STROBE
Abstract
(Yoo Y, Cléroux A, Pollock NW, Boet S. Quality of reporting in hyperbaric medicine clinical trials: a cross-sectional study. Diving and Hyperbaric Medicine. 2025 December 20;55(4):352−368. doi: 10.28920/dhm55.4.352-368. PMID: 41364859.)
Introduction: Research in hyperbaric oxygen (HBO) medicine is growing, but the quality of HBO studies is variable. Low study quality may compromise evidence-based decision-making and clinical translation.
Methods: This cross-sectional study examined the adherence of 50 randomly selected HBO clinical trials (25 randomised controlled trials [RCTs] and 25 observational studies) to relevant core reporting guidelines: consolidated standards of reporting trials (CONSORT), non-pharmacologic treatments (NPT), and strengthening the reporting of observational studies in epidemiology (STROBE). Studies published in peer-reviewed journals between January 2018 and May 2023 and indexed on PubMed were analysed. Reporting quality was classified as ‘excellent’ (> 85% of guideline items adequately reported), ‘good’ (50–85%), or ‘poor’ (< 50%).
Results: The sample represented 29% of RCTs and 16% of observational studies for the timeframe assessed. No study was rated as ‘excellent’ for completeness, 28 (56%) were rated as ‘good’, and 22 (44%) as ‘poor’. In RCTs, only one study (4%) adequately reported protocol adherence and eight studies (32%) reported blinding procedures. The NPT checklist showed that key items, including care provider adherence (0 studies) and participant adherence (one study; 4%), were frequently not reported. For observational studies, basic design elements were adequately reported, but with significant gaps in bias management (nine studies; 36%) and missing data handling (13 studies; 52%). Only six studies (12%) mentioned the use of reporting guidelines.
Conclusions: Our results showed that quality of reporting of HBO studies is suboptimal. These findings highlight the need for increased awareness and implementation of reporting guidelines, as well as the potential development of HBO-specific guidelines.
Copyright: This article is the copyright of the authors who grant Diving and Hyperbaric Medicine a non-exclusive licence to publish the article in electronic and other forms.