Hyperbaric oxygen therapy
Uitgangsvraag
What is the added value of hyperbaric oxygen therapy, as opposed to medical treatment alone?
Aanbeveling
Do not use hyperbaric oxygen therapy as a treatment regimen for patients with necrotizing external otitis.
Overwegingen
Balance between desired and undesired effects
Evidence
Reviewing the results found in literature, we found only one study comparing the remission of patients treated with additional hyperbaric oxygen therapy, versus standard therapy consisting primarily of antibiotics (Mardassi, 2016). They found a rate of remission of 100% in the HBOT group, versus 74% in the group without HBOT (Relative risk: 1.35 (CI 95% 1.06 - 1.72)).. However, in the light of the overall quality of evidence, the effect of HBOT is uncertain.
Analogous to the methodology of this literature search, the same conclusion was drawn in the Cochrane review (Philips, 2013): no identified articles described randomized controlled trials of hyperbaric oxygen therapy in the treatment of malignant otitis externa.
Expert opinion
As there is only one comparative study on this topic, this caption summarizes the available literature with lower evidence level, including case series and retrospective observational studies opinion, along with the panel’s expert opinion.
According to the European Committee for Hyperbaric Medicine (ECHM) (Mathieu, 2017), during the 10th European Consensus Conference on Hyperbaric Medicine, recommendations were given for accepted and non-accepted clinical indications. The recommendations were given on three components: 1) level of evidence 2) the interpretation of the evidence 3) the type or strength of the recommended practice. In this paper the Committee acknowledges that there are several conditions of interest that are so complex or where there are so many variables that it would be impossible to design a study sufficiently powerful to assess any single procedure. For malignant otitis externa, no specific recommendations on the use of HBOT were given, owing to the very low levels of evidence (level D): the disease is placed in the category “non-accepted indications”. This should not be confused with evidence against the use of HBOT (this category of indications is mentioned separately). The ECHM ultimately advises, in case of treatment of patients with conditions in which HBOT (such as NOE) is considered not to be indicated, to discuss a benefit/risk balance for each specific patient before using HBOT.
A systematic review by Byun (2020) describes results of 58 pooled patients from 16 studies. The reported studies are studies in which additional HBOT was given, either concomitantly or in case of failing medical or surgical treatment. In most cases the HBOT regimen was well reported. An overall cure rate of 91.4% was found. The most extensive systematic review on NOE (Takata, 2023) reports on 70 papers on a total of over 2000 patients. 10 papers report on the use of HBOT, also either concomitant or as salvage treatment. There seems a regional preference for this treatment modality, as most papers are from the US, Turkey or Israel. The article states that there is no clear evidence to support HBOT use in NOE.
Unless this clear statement of the ECHM, research papers are published on case series describing the use of HBOT and case series in which a fraction of patients is treated with HBOT. This might be a reflection of the therapeutic dilemmas of clinicians in severe cases looking for additional treatment options, or the lack of opportunity to create a higher level of evidence due to the low incidence.
Studies on HBOT in patients with NOE / skull base osteomyelitis
Well-structured reports on HBOT for NOE are very limited. One study reports on the results of a single hyperbaric center in Portugal, summarizing the results of 16 patients over 9 years from 8 tertiary referral centers (Amaro, 2019). Patients were at least treated 3 months prior to HBOT (average 5 months). The majority of the patients had extensive disease with cranial nerve palsies and had had surgery prior HBOT. The overall disease-specific survival was 100%. The authors share these results along with the limitations and state that HBOT can be considered in in patients who failed conventional therapy and in severe cases. Although all cases are well documented, the most important limitation is that no proof about objective monitoring of disease control is given. Moreover, the study population is thought to be highly biased towards the extraordinarily severe case load.
A recent study reports on 15 patients treated with HBOT over the course of 15 years, all referred by tertiary care centers after failed medical, and in some cases, surgical treatment (Gomes, 2024). Although a detailed description of the prior treatment lacks, 100% remission is reported after combined medical and hyperbaric therapy.
Quality of the evidence
The overall quality of evidence is very low. This means that we are very uncertain about the estimated effect of the critical outcomes found. There was a downgrade due to:
- Risk of Bias: methodological limitations
- Indirectness: indirectness of the evidence, due to differences in population.
- Imprecision: inaccuracy, due to a very small number of events in a small sample size.
Values and preferences of patients (and possibly their caregivers)
Due to the unknown effects of HBOT. Any possible complications for the patient are very significant. Although often self-limiting after treatment, some complications such a pneumothorax can occur and should be taken into consideration for a treatment with unknown therapeutic effects for necrotizing otitis externa.
Costs (resources)
HBOT is not unreasonably expensive as a treatment option. However, if the added value is debatable, the cost aspect should definitely be weighed.
Equity ((health) equity/equitable)
The guideline panel expects no problems with health equity with regard to medical treatment of necrotizing otitis externa. HBOT treatment facilities however, are not widespread. Especially because patients are often frail and elderly, it is not obvious to offer HBOT as a (daily) treatment regimen if the nearest facility requires daily transport.
Acceptability
The guideline panel expects no problems with ethical acceptability with regard to HBOT treatment of necrotizing external otitis. A practical problem can be the limited availability of HBOT facilities. HBOT cannot be considered sustainable for a debatable indication in terms of resource use and costs. It requires extensive training and expensive infrastructure (the tanks) and has high energy consumption.
Feasibility
The implementation of HBOT as standard treatment modality for NOE is not feasible, due to the lack of evidence as well as the sparse availability of HBOT facilities.
Rationale of the recommendation: weighing arguments for and against the interventions
Literature on the efficacy of HBOT on NOE / skull base osteomyelitis is limited to case series, case reports and a single comparative study with its limitations and high risk of publication bias. Parallels are drawn with HBOT as a treatment modality for different conditions with similarities, such as complicated wound healing and refractory osteomyelitis, and are used to justify HBOT for this disorder. Although there are some reports that incline towards a positive effect of HBOT on NOE / skull base osteomyelitis, the quality of the evidence is low.
The guideline panel therefore confirms the opinion / position of the European Committee on Hyperbaric Medicine and does not recommend HBOT as a standard intervention for NOE / skull base osteomyelitis.
Apart from the uncertain beneficial effects of HBOT, possible side effects should also be taken into account: barotrauma, dental problems, sinus compression, claustrophobia, seizures and pulmonary oxygen toxicity. These are rare, but can occur even when the procedure is performed correctly. Costs and availability also play a role when the quality of evidence is considered too low.
Final judgment:
Weak recommendation against the standard treatment of NOE / skull base osteomyelitis with HBOT.
Onderbouwing
Achtergrond
Hyperbaric oxygen therapy (HBOT) is a treatment modality used for enhanced recovery of tissues. It consists of exposure to more than 99% oxygen at a pressure higher than the atmospheric pressure. A patient is placed in a pressure vessel during a predetermined treatment schedule. HBOT has proven efficacy for several medical conditions (Moon, 2019). The main principle is to increase the availability of oxygen throughout the body (Gordon, 2023), which is thought to result in fibroblast activation, upregulation of growth factors, downregulation of inflammatory cytokines and reduction of leukocyte chemotaxis (Sethuraman, 2022). Several diagnoses have been widely approved as an indication for HBOT and can be divided into two main categories: disorders primary related to gas exchange (carbon monoxide poisoning, decompression sickness) and disorders related to tissue perfusion, amongst others: wound problems, necrotizing soft tissue infections, refractory osteomyelitis (Moon, 2019). Necrotizing otitis externa, or skull base osteomyelitis is not explicitly mentioned as such, but can be interpreted as a necrotizing soft tissue infection as well as refractory osteomyelitis.
Conclusies / Summary of Findings
Population: Patients with proven necrotizing otitis externa
Intervention: Hyperbaric oxygen therapy, with or without additional standard therapy
Comparator: Standard therapy
|
Outcome Timeframe |
Study results and measurements |
Absolute effect estimates |
Certainty of the evidence (Quality of evidence) |
Summary |
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|
Standard therapy |
Hyperbaric oxygen therapy, with or without additional standard |
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Difference: 63 fewer per 1000 (CI 95% 68 fewer - 37 more) |
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Remission3 1 year |
Relative risk: 1.35 (CI 95% 1.06 - 1.72) Based on data from 42 participants in 1 studies5 Follow up unknown |
776 per 1000 |
1048 per 1000 |
Very low By serious risk of bias and indirectness. Extremely serious imprecision5
|
We are unsure if hyperbaric oxygen therapy, will improve the remission of disease in patients with proven necrotizing otitis externa
(Mardassi, 2016) |
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Difference: 272 more per 1000 (CI 95% 47 more - 559 more) |
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Length of treatment6 1 year |
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No GRADE (no evidence was found)
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No evidence was found regarding the length of treatment with hyperbaric oxygen therapy. |
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1. Primary study [2] Baseline/comparator Systematic review [1] .
2. Risk of Bias: serious. loss to follow up; Indirectness: very serious. Imprecision: extremely serious.
3. Remission of disease afther therapy. Also known as curation rate
4. Primary study [2] Baseline/comparator Systematic review [1] .
5. Risk of Bias: serious. Indirectness: very serious. Imprecision: extremely serious.
6. Total duration of treatment
Samenvatting literatuur
Description of studies
A total of 1 study was included in the analysis of the literature. Important study characteristics and results are summarized in table 1. The assessment of the risk of bias is summarized in the risk of bias tables (under the tab ‘Evidence tables’).
Table 1. Characteristics of included study
|
Study |
Participants (number, age, other important characteristics) |
Comparison |
Follow-up |
Outcome measures |
Comments |
Risk of bias (per outcome measure)* |
|
Individual study, non-randomized comparative study |
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Mardassi, 2016 |
N at baseline Intervention: 19 Control: 23
Age 67 (50 to 84) Sex: male to female ratio was 0.82
All patients had diabetes.
|
Intervention: 19 patients underwent standard medical care (see control) with added HBOT (daily 90 minute sessions with a mean of 20 sessions per patient) Control: Standard medical therapy: Antibiotics intravenously and then orally for a mean period of 8 weeks (5 to 15 weeks). |
The period of inclusion was 9 years. No length of follow up was specified. |
Remission and recurrence |
High for recurrence and remission |
|
*For further details, see risk of bias table in the appendix
Results
Remission
The study of Mardassi (2016) included 42 patients, in which 19 underwent HBOT, in addition to standard antibiotic treatment (i.v. 3rd generation cephalosporin for 3 to 4 weeks, followed by oral fluoroquinolones for a total mean period of 8 weeks (5 to 15 weeks). In the group with HBOT, there was total remission in 19 of 19 patients (100%). The group with only antibiotic treatment had a remission in 17 out of 23 (74%)
Length of treatment
No studies regarding length of treatment as an outcome measure were found.
Zoeken en selecteren
A systematic review of the literature was performed to answer the following question(s):
What are the benefits of hyperbaric oxygen therapy, as opposed to standard medical treatment.
| Patients | Patients with proven necrotizing otitis externa |
| Intervention |
Hyperbaric oxygen therapy, with or without added standard medical therapy |
| Control | Standard medical therapy |
| Outcomes | Remission, length of treatment |
| Other selection criteria |
Study design: systematic reviews and randomized controlled trials, observational studies [Minimal follow-up: not defined] |
Relevant outcome measures
The guideline panel considered remission, recurrence and length of treatment as a critical outcome measure for decision making;
The guideline panel defined the outcome measures as follows:
- Remission: cure rate of disease after treatment, sometimes defined in the numbers of failure of treatment
- Length of treatment: the time of treatment until successful curation of disease
The guideline panel defined the following as a minimal clinically (patient) important difference.
- Remission: GRADE standard limits*
- Length of treatment: GRADE standard Limits*
* Default thresholds proposed by the international GRADE working group were used: a 25% difference in relative risk (RR) for dichotomous outcomes (RR <0.80 or RR >1.25), or 0.5 standard deviations (SD) for continuous outcomes
Search and select (Methods)
The databases [Medline (via OVID) and Embase (via Embase.com)] were searched with relevant search terms until 11-07-2023 The detailed search strategy is listed under the tab ‘Literature search strategy’. The systematic literature search resulted in 143 hits. Studies were initially selected based on title and abstract screening. After reading the full text, 35 studies were excluded (see the exclusion table under the tab ‘Evidence tabellen’), and 1 non-randomized comparative study was included.
Referenties
- Amaro C, Espiney R, Radu L, Guerreiro F. Malignant (necrotizing) externa otitis: the experience of a single hyperbaric centre. Eur Arch Otorhinolaryngol. 2019 Jul;276(7):1881-1887. doi: 10.1007/s00405-019-05396-7. Epub 2019 Jun 4.
- Betts J, Desaix P, Johnson E, Johnson J, Oksana K, Kruse D, Poe B, Wise J, Womble M, Young K. 2023. Anatomy & Physiology. Houston: OpenStax CNX. 22.4 Gas exchange. ISBN 978-1-947172-04-3.
- Byun YJ, Patel J, Nguyen SA, Lambert PR. Necrotizing Otitis Externa: A Systematic Review and Analysis of Changing Trends. Otol Neurotol. 2020 Sep;41(8):1004-1011. doi: 10.1097/MAO.0000000000002723. PMID: 32569149.
- Byun YJ, Patel J, Nguyen SA, Lambert PR. Hyperbaric oxygen therapy in malignant otitis externa: A systematic review of the literature. World J Otorhinolaryngol Head Neck Surg. 2020 May 4;7(4):296-302. doi: 10.1016/j.wjorl.2020.04.002. PMID: 34632343; PMCID: PMC8486695.
- Mardassi A, Turki S, Lahiani R, Mbarek H, Benzarti S, Gharsallah H. Is there a real benefit of hyperbaric oxygenotherapy in the treatment of necrotizing otitis externa? Tunis Med. 2016 Dec;94(12):863. PMID: 28994886.
- Mathieu D, Marroni A, Kot J. Tenth European Consensus Conference on Hyperbaric Medicine: recommendations for accepted and non-accepted clinical indications and practice of hyperbaric oxygen treatment. Diving Hyperb Med. 2017 Mar;47(1):24-32. doi: 10.28920/dhm47.1.24-32.
- Moon RE. Hyperbaric oxygen therapy indications.14th edition. North Palm Beach: Best Publishing Company; 2019.
- Philips J, Jones S. Hyperbaric oxygen as an adjuvant treatment for malignant otitis externa (Review). Cochrane Database Syst Rev 2005 Apr 8:(2):CD004617.doi: 10.1002/14651858.CD004617.pub2.
- Sethuraman KN, Smolin R, Henry S. Is There a Place for Hyperbaric Oxygen Therapy? Adv Surg. 2022 Sep;56(1):169-204. doi: 10.1016/j.yasu.2022.02.011. PMID: 36096567.
- Takata J, Hopkins M, Alexander V, Bannister O, Dalton L, Harrison L, Groves E, Kanona H, Jones GL, Mohammed H, Andersson MI, Hodgson SH. Systematic review of the diagnosis and management of necrotising otitis externa: Highlighting the need for high-quality research. Clin Otolaryngol. 2023 May;48(3):381-394. doi: 10.1111/coa.14041. Epub 2023 Feb 22. PMID: 36759416.
- Gomes P, Cabral D, Costa J, Fernandes T, Camacho O, Penêda J, Duarte D, Viana M. Eur Arch Otorhinolaryngol. 2024 Oct;281(10):5153-5157. doi: 10.1007/s00405-024-08734-6. Epub 2024 May 20.
Evidence tabellen
Risk of Bias tables
Risk of bias table for interventions studies (cohort studies based on risk of bias tool by the CLARITY Group at McMaster University)
|
Author, year |
Selection of participants
Was selection of exposed and non-exposed cohorts drawn from the same population?
|
Exposure
Can we be confident in the assessment of exposure?
|
Outcome of interest
Can we be confident that the outcome of interest was not present at start of study?
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Confounding-assessment
Can we be confident in the assessment of confounding factors? |
Confounding-analysis
Did the study match exposed and unexposed for all variables that are associated with the outcome of interest or did the statistical analysis adjust for these confounding variables |
Assessment of outcome
Can we be confident in the assessment of outcome?
|
Follow up
Was the follow up of cohorts adequate? In particular, was outcome data complete or imputed?
|
Co-interventions
Were co-interventions similar between groups?
|
Overall Risk of bias
|
|
Mardassi, 2016 |
Definitely yes
Reason: Participants were selected from a registry |
Probably yes
|
Probably yes
|
Definitely no
Reason: counfounding factor were not stated |
Definitely no
Reason: not stated and not taken into account in the multivariate analysis. |
Probably yes
|
Definitely no
Reason: follow up was not stated |
Definitely yes
Reason: Additional used medication was balanced between groups |
High : Remission And recurrence
|
Table of excluded studies
|
Reference |
Reason for exclusion |
|
Phillips JS, Jones SE. Hyperbaric oxygen as an adjuvant treatment for malignant otitis externa. Cochrane Database Syst Rev. 2013 May 31;2013(5):CD004617. doi: 10.1002/14651858.CD004617.pub3. PMID: 23728650; PMCID: PMC7389256.
|
Systematic review with no RCT’s found, therefore no data |
|
Sandner A, Henze D, Neumann K, Kösling S. Nutzen der HBO bei der Therapie der fortgeschrittenen Schädelbasisosteomyelitis [Value of hyperbaric oxygen in the treatment of advanced skull base osteomyelitis]. Laryngorhinootologie. 2009 Oct;88(10):641-6. German. doi: 10.1055/s-0029-1214394. Epub 2009 Apr 3. PMID: 19347797. |
Paper not in English |
|
Amaro CE, Espiney R, Radu L, Guerreiro F. Malignant (necrotizing) externa otitis: the experience of a single hyperbaric centre. Eur Arch Otorhinolaryngol. 2019 Jul;276(7):1881-1887. doi: 10.1007/s00405-019-05396-7. Epub 2019 Jun 4. PMID: 31165255. |
Expert opinion |
|
Davis JC, Gates GA, Lerner C, Davis MG Jr, Mader JT, Dinesman A. Adjuvant hyperbaric oxygen in malignant external otitis. Arch Otolaryngol Head Neck Surg. 1992 Jan;118(1):89-93. doi: 10.1001/archotol.1992.01880010093022. PMID: 1728284. |
No comparison made |
|
Al Siyabi A, Al Farsi B, Al-Shidhani A, Al Hinai Z, Al Balushi Y, Al Qartoobi H. Management of Malignant Otitis Externa with Hyperbaric Oxygen Therapy: A Case Series of 20 Patients. Oman Med J. 2023 May 31;38(3):e512. doi: 10.5001/omj.2023.19. PMID: 37325261; PMCID: PMC10264722. |
No comparison made |
|
Khan MA, Quadri SAQ, Kazmi AS, Kwatra V, Ramachandran A, Gustin A, Farooqui M, Suriya SS, Zafar A. A Comprehensive Review of Skull Base Osteomyelitis: Diagnostic and Therapeutic Challenges among Various Presentations. Asian J Neurosurg. 2018 Oct-Dec;13(4):959-970. doi: 10.4103/ajns.AJNS_90_17. PMID: 30459850; PMCID: PMC6208218. |
No comparison made |
|
Narozny W, Kuczkowski J, Stankiewicz C, Kot J, Mikaszewski B, Przewozny T. Value of hyperbaric oxygen in bacterial and fungal malignant external otitis treatment. Eur Arch Otorhinolaryngol. 2006 Jul;263(7):680-4. doi: 10.1007/s00405-006-0033-y. Epub 2006 Apr 22. PMID: 16633825. |
Case report |
|
Fischer HG, Gey A, Fischer M, Plontke SK. Hyperbare Sauerstofftherapie : Ausgewählte Indikationen im Fachgebiet HNO-Heilkunde [Hyperbaric oxygen therapy : Selected indications in the discipline of otorhinolaryngology]. HNO. 2022 Nov;70(11):848-860. German. doi: 10.1007/s00106-022-01227-0. Epub 2022 Sep 29. PMID: 36173420. |
Paper not in english |
Verantwoording
Beoordelingsdatum en geldigheid
Laatst beoordeeld : 25-09-2025
Algemene gegevens
For more details on the guideline methodology used, we refer you to the Werkwijze. Relevant information for the development of this guideline is presented below.
The revision of this guideline module was supported by the Knowledge Institute of the Federation of Medical Specialists (www.demedischspecialist.nl/kennisinstituut) and was funded by the Quality Funds for Medical Specialists (SKMS).
Samenstelling werkgroep
For the development of the guideline, a multidisciplinary guideline development group was established in 2022, consisting of representatives from all relevant specialties (see Composition of the working group) involved in the care of patients with necrotizing otitis externa.
Werkgroep
- Dr. J.J. (Jérôme) Waterval (chairman), Nederlandse Vereniging voor Keel-Neus-Oorheelkunde en Heelkunde van het Hoofd-Halsgebied, otorhinolaryngologist, Maastricht University Medical Center, Maastricht; Academic Alliance Skull Base Pathology Maaastricht University Medical Center – Radboud University Medical Center
- Dr. M.J. (Mark) van Tilburg, Nederlandse Vereniging voor Keel-Neus-Oorheelkunde en Heelkunde van het Hoofd-Halsgebied, otorhinolaryngologist, Elistabeth-TweeSteden Ziekenhuis, Tilburg
- Drs. S.A.H. (Sjoert) Pegge, Nederlandse Vereniging voor Radiologie, radiologist, Radboud University Medical Center, Nijmegen; Academic Alliance Skull Base Pathology Maaastricht University Medical Center – Radboud University Medical Center
- Prof. Dr. A.W.J.M. (Andor) Glaudemans, Nederlandse Vereniging voor Nucleaire Geneeskunde, nuclear physicist UMCG, Groningen
- Dr. M. (Moniek) Heusinkveld, Nederlandse Vereniging voor Medische Microbiologie, medical microbiologist, Gelderse Vallei Hospital, Ede
- Dr. E.J.G. (Edgar) Peters, Nederlandse Internisten Vereniging, infectious disease specialist, Amsterdam University Medical Center (tot oktober 2022)
- Dr. J.J. (Jonne) Sikkens, Nederlandse Internisten Vereniging, infectious disease specialist, Amsterdam University Medical Center (vanaf october 2022)
- Dr. I.R. (Raluca) Mihailescu, Nederlandse Internisten Vereniging, infectious disease specialist, Onze Lieve Vrouwe Gasthuis, Amsterdam (vanaf juli 2024)
- Dr. S.H. (Selwyn) Lowe, Nederlandse Internisten Vereniging, infectious disease specialist, Maastricht University Medical Center, Maastricht (vanaf juli 2024)
Klankbordgroep
- Dr. N.G.L. (Nynke) Jager, NVZA, hospital pharmacist Radboud University Medical Center, Nijmegen
- Drs. F.S. (Fleur) Sinkeler, NVZA, hospital pharmacist Radboudumc Nijmegen
Ondersteuning
- Drs. J.M.H. (Jasper) Janssen, NVKNO, otorhinolaryngologist in training, Maastricht University Medical Center, Maastricht
- Dr. A. (Anja) van der Hout, advisor Knowledge Institute of the Dutch Association of Medical Specialists
Belangenverklaringen
An overview of the conflicts of interests of the guideline development group members and the assessment of how potential conflicts of interest were addressed can be found in the table below. The signed declarations of interest are available upon request from the Secretariat of the Knowledge Institute of the Dutch Federation of Medical Specialists at secretariaat@kennisinstituut.nl.
|
Werkgroeplid |
Functie |
Nevenfuncties |
Gemelde belangen |
Ondernomen actie |
|
Waterval (voorzitter) |
KNO-arts MUMC |
Accreditatiecommissie Stichting Audiciensregister |
Geen |
Geen |
|
Glaudemans |
Nucleair geneeskundige UMCG
|
Voorzitter NVNG (onbetaald) |
We hebben als ziekenhuis en afdeling een samenwerking met Siemens (UMCG-Siemens PUSH collaboration/Partnership of UMCG-Siemens for building the future of Health). Hieruit vloeit uit voort dat de nieuwste camera’s bij ons komen (bv UMCG neemt nieuwe Whole-Body PET/CT-scanner in gebruik) en dat er gezamenlijk onderzoek gedaan wordt. Hierbij heb ik een aantal promovendi die door Siemens betaald worden (niet op het gebied van osteomyelitis schedelbasis) |
Geen restricties. Extern gefinancierd onderzoek valt buiten bestek richtlijn
|
|
Heusinkveld |
Arts-microbioloog in ziekenhuis Gelders Vallei |
Richtlijn otitis externa
Bestuur SKML sectie infectieserologie (onbetaald) |
Geen |
Geen |
|
Peters (tot oktober 2022) |
Internist-infectioloog-acute geneeskundige, Amsterdam UMC |
richtlijnontwikkeling: Covid-19 FMS, diabetische voet NIV, diabetische voet IWGDF, alle onbetaald
|
afdeling krijgt geld van Roche voor biomarker onderzoek bij diabetische voet osteomyelitis Diabetische voet onderzoek (extern gefinancierd)
|
Geen restricties. Extern gefinancierd onderzoek valt buiten bestek richtlijn
|
|
Pegge |
Radioloog (Neuro/Hoofdhals) Radboud UMC Nijmegen |
Geen |
Geen |
Geen |
|
Van Tilburg |
KNO-arts ETZ
|
Geen |
Geen |
Geen |
|
Sikkens |
Internist acute geneeskunde & infectioloog, Amsterdam UMC |
post-doc onderzoeker Amsterdam UMC, onbetaald
|
Ja, via ZonMw (onderzoek naar COVID bij een medewerkerscohort, onderwerp infectiepreventie en vaccin-immunologie)
|
Geen restricties. Extern gefinancierd onderzoek valt buiten bestek richtlijn
|
|
Lowe
|
Internist-infectioloog. Afdeling Medische Microbiologie, Infectieziekten en Infectiepreventie (MMI), Maastricht UMC+
|
Geen |
Geen |
Geen |
|
Mihailescu
|
Internist-infectioloog OLVG Amsterdam |
Geen |
Geen |
Geen |
|
Jasper Janssen
|
KNO-arts in opleiding bij het MUMC+ (0,8 FTE), promovendus (0,2 FTE). |
Geen |
Geen |
Geen |
|
Sinkeler
|
Ziekenhuisapotheker AmsterdamUMC
|
Geen |
Geen |
Geen |
|
Jager |
Ziekenhuisapotheker
|
Geen |
Geen |
Geen |
Inbreng patiëntenperspectief
Attention was paid to the patient perspective by inviting Stichting Hoormij and Patiëntenfederatie Nederland for the invitational conference, and close contact with Stichting Hoormij during the development of the guideline. The report of this [see related products] was discussed in the guideline development group. The input obtained was taken into account when formulating the key questions, selecting the outcome measures, and drafting the considerations. The draft guideline was also submitted for comments to Stichting Hoormij and Patiëntenfederatie Nederland, and any comments received were reviewed and processed.
Kwalitatieve raming van mogelijke financiële gevolgen in het kader van de Wkkgz
Bij de richtlijnmodule voerde de werkgroep conform de Wet kwaliteit, klachten en geschillen zorg (Wkkgz) een kwalitatieve raming uit om te beoordelen of de aanbevelingen mogelijk leiden tot substantiële financiële gevolgen. Bij het uitvoeren van deze beoordeling is de richtlijnmodule op verschillende domeinen getoetst (zie het stroomschema bij Werkwijze).
|
Module |
Uitkomst raming |
Toelichting |
|
Hyperbaric oxygen therapy |
geen financiële gevolgen |
Uit de toetsing volgt dat de aanbeveling(en) niet breed toepasbaar zijn (<5.000 patiënten) en daarom naar verwachting geen substantiële financiële gevolgen zal hebben voor de collectieve uitgaven. |
Zoekverantwoording
Algemene informatie
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Richtlijn: NVKNO Osteomyelitis Schedelbasis – Maligne Otitis Externa |
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Uitgangsvraag: Wat zijn de voor- en nadelen van hyperbare zuurstoftherapie t.o.v. standaard behandeling bij maligne otitis externa? |
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Database(s): Ovid/Medline, Embase |
Datum: 11-7-2023 |
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Periode: nvt |
Talen: nvt |
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Literatuurspecialist: Ingeborg van Dusseldorp |
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BMI zoekblokken: voor verschillende opdrachten wordt (deels) gebruik gemaakt van de zoekblokken van BMI-Online https://blocks.bmi-online.nl/ Bij gebruikmaking van een volledig zoekblok zal naar de betreffende link op de website worden verwezen. |
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Toelichting: Voor deze vraag is gezocht met de volgende concepten: Maligne otitis externa EN hyperbare zuurstoftherapie Omdat weinig literatuur wordt gevonden worden alle referenties aangeboden in Rayyan. Het sleutelartikel wordt gevonden |
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Te gebruiken voor richtlijnen tekst: In de databases Embase en Ovid/Medline is op met relevante zoektermen gezocht naar studies over hyperbare zuurstoftherapie bij maligne otitis externa. De literatuurzoekactie leverde 143 unieke treffers op. |
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Zoekopbrengst
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EMBASE |
OVID/MEDLINE |
Ontdubbeld |
|
SRs |
11 |
6 |
11 |
|
Clinical trials RCTs |
7 |
3 |
7 |
|
Observationele studies |
30 |
22 |
36 |
|
Overig |
84 |
38 |
89 |
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Totaal |
|
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143 |
Zoekstrategie
Embase.com
|
No. |
Query |
Results |
|
#14 |
#10 OR #11 OR #12 OR #13 |
132 |
|
#13 |
#3 NOT #10 NOT #11 NOT #12 Overige |
84 |
|
#12 |
#3 AND (#8 OR #9) NOT #10 NOT #11 Overige OBS |
30 |
|
#11 |
#3 AND #7 NOT #10 Clinical trials, RCts |
7 |
|
#10 |
#3 AND #6 SR |
11 |
|
#9 |
'case control study'/de OR 'comparative study'/exp OR 'control group'/de OR 'controlled study'/de OR 'controlled clinical trial'/de OR 'crossover procedure'/de OR 'double blind procedure'/de OR 'phase 2 clinical trial'/de OR 'phase 3 clinical trial'/de OR 'phase 4 clinical trial'/de OR 'pretest posttest design'/de OR 'pretest posttest control group design'/de OR 'quasi experimental study'/de OR 'single blind procedure'/de OR 'triple blind procedure'/de OR (((control OR controlled) NEAR/6 trial):ti,ab,kw) OR (((control OR controlled) NEAR/6 (study OR studies)):ti,ab,kw) OR (((control OR controlled) NEAR/1 active):ti,ab,kw) OR 'open label*':ti,ab,kw OR (((double OR two OR three OR multi OR trial) NEAR/1 (arm OR arms)):ti,ab,kw) OR ((allocat* NEAR/10 (arm OR arms)):ti,ab,kw) OR placebo*:ti,ab,kw OR 'sham-control*':ti,ab,kw OR (((single OR double OR triple OR assessor) NEAR/1 (blind* OR masked)):ti,ab,kw) OR nonrandom*:ti,ab,kw OR 'non-random*':ti,ab,kw OR 'quasi-experiment*':ti,ab,kw OR crossover:ti,ab,kw OR 'cross over':ti,ab,kw OR 'parallel group*':ti,ab,kw OR 'factorial trial':ti,ab,kw OR ((phase NEAR/5 (study OR trial)):ti,ab,kw) OR ((case* NEAR/6 (matched OR control*)):ti,ab,kw) OR ((match* NEAR/6 (pair OR pairs OR cohort* OR control* OR group* OR healthy OR age OR sex OR gender OR patient* OR subject* OR participant*)):ti,ab,kw) OR ((propensity NEAR/6 (scor* OR match*)):ti,ab,kw) OR versus:ti OR vs:ti OR compar*:ti OR ((compar* NEAR/1 study):ti,ab,kw) OR (('major clinical study'/de OR 'clinical study'/de OR 'cohort analysis'/de OR 'observational study'/de OR 'cross-sectional study'/de OR 'multicenter study'/de OR 'correlational study'/de OR 'follow up'/de OR cohort*:ti,ab,kw OR 'follow up':ti,ab,kw OR followup:ti,ab,kw OR longitudinal*:ti,ab,kw OR prospective*:ti,ab,kw OR retrospective*:ti,ab,kw OR observational*:ti,ab,kw OR 'cross sectional*':ti,ab,kw OR cross?ectional*:ti,ab,kw OR multicent*:ti,ab,kw OR 'multi-cent*':ti,ab,kw OR consecutive*:ti,ab,kw) AND (group:ti,ab,kw OR groups:ti,ab,kw OR subgroup*:ti,ab,kw OR versus:ti,ab,kw OR vs:ti,ab,kw OR compar*:ti,ab,kw OR 'odds ratio*':ab OR 'relative odds':ab OR 'risk ratio*':ab OR 'relative risk*':ab OR 'rate ratio':ab OR aor:ab OR arr:ab OR rrr:ab OR ((('or' OR 'rr') NEAR/6 ci):ab))) |
14236747 |
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#8 |
'major clinical study'/de OR 'clinical study'/de OR 'case control study'/de OR 'family study'/de OR 'longitudinal study'/de OR 'retrospective study'/de OR 'prospective study'/de OR 'comparative study'/de OR 'cohort analysis'/de OR ((cohort NEAR/1 (study OR studies)):ab,ti) OR (('case control' NEAR/1 (study OR studies)):ab,ti) OR (('follow up' NEAR/1 (study OR studies)):ab,ti) OR (observational NEAR/1 (study OR studies)) OR ((epidemiologic NEAR/1 (study OR studies)):ab,ti) OR (('cross sectional' NEAR/1 (study OR studies)):ab,ti) |
6767914 |
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#7 |
'clinical trial'/exp OR 'randomization'/exp OR 'single blind procedure'/exp OR 'double blind procedure'/exp OR 'crossover procedure'/exp OR 'placebo'/exp OR 'prospective study'/exp OR rct:ab,ti OR random*:ab,ti OR 'single blind':ab,ti OR 'randomised controlled trial':ab,ti OR 'randomized controlled trial'/exp OR placebo*:ab,ti |
3302394 |
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#6 |
'meta analysis'/exp OR 'meta analysis (topic)'/exp OR metaanaly*:ti,ab OR 'meta analy*':ti,ab OR metanaly*:ti,ab OR 'systematic review'/de OR 'cochrane database of systematic reviews'/jt OR prisma:ti,ab OR prospero:ti,ab OR (((systemati* OR scoping OR umbrella OR 'structured literature') NEAR/3 (review* OR overview*)):ti,ab) OR ((systemic* NEAR/1 review*):ti,ab) OR (((systemati* OR literature OR database* OR 'data base*') NEAR/10 search*):ti,ab) OR (((structured OR comprehensive* OR systemic*) NEAR/3 search*):ti,ab) OR (((literature NEAR/3 review*):ti,ab) AND (search*:ti,ab OR database*:ti,ab OR 'data base*':ti,ab)) OR (('data extraction':ti,ab OR 'data source*':ti,ab) AND 'study selection':ti,ab) OR ('search strategy':ti,ab AND 'selection criteria':ti,ab) OR ('data source*':ti,ab AND 'data synthesis':ti,ab) OR medline:ab OR pubmed:ab OR embase:ab OR cochrane:ab OR (((critical OR rapid) NEAR/2 (review* OR overview* OR synthes*)):ti) OR ((((critical* OR rapid*) NEAR/3 (review* OR overview* OR synthes*)):ab) AND (search*:ab OR database*:ab OR 'data base*':ab)) OR metasynthes*:ti,ab OR 'meta synthes*':ti,ab |
733409 |
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#5 |
#3 AND #4 sleutelartikel gevonden |
1 |
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#4 |
'hyperbaric oxygen therapy in malignant otitis externa: a systematic review of the literature' |
1 |
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#3 |
#1 AND #2 |
124 |
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#2 |
'hyperbaric oxygen therapy'/exp OR ((hyperbaric NEAR/3 (medicine OR therap* OR treatment OR o2 OR oxygen*)):ti,ab,kw) OR hbot:ti,ab,kw OR ((pressur* NEAR/3 'oxygen therap*'):ti,ab,kw) OR 'hbo therap*':ti,ab,kw OR (((hyperoxygenat* OR 'high oxygen') NEAR/3 (therap* OR treatment)):ti,ab,kw) |
23088 |
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#1 |
'malignant otitis externa'/exp OR (((maligna* OR necroti* OR necros*) NEAR/3 ('otitis externa' OR 'external otitis')):ti,ab,kw) OR ('otitis externa'/mj AND (maligna*:ti,kw OR necroti*:ti,kw OR necrosis:ti,kw)) OR (('osteomyelitis'/exp/mj OR 'osteomyelitis':ti,kw) AND ('skull'/exp/mj OR 'skull disease'/exp/mj OR skull*:ti,ab,kw OR cranial:ti,ab,kw OR cranium:ti,ab,kw)) |
3354 |
Ovid/Medline
|
# |
Searches |
Results |
|
12 |
8 or 9 or 10 or 11 |
69 |
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11 |
3 not 8 not 9 not 10 Overige |
38 |
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10 |
(3 and (6 or 7)) not 8 not 9 Overige OBS |
22 |
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9 |
(3 and 5) not 8 Clinical trials, RCTs |
3 |
|
8 |
3 and 4 SR |
6 |
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7 |
Case-control Studies/ or clinical trial, phase ii/ or clinical trial, phase iii/ or clinical trial, phase iv/ or comparative study/ or control groups/ or controlled before-after studies/ or controlled clinical trial/ or double-blind method/ or historically controlled study/ or matched-pair analysis/ or single-blind method/ or (((control or controlled) adj6 (study or studies or trial)) or (compar* adj (study or studies)) or ((control or controlled) adj1 active) or "open label*" or ((double or two or three or multi or trial) adj (arm or arms)) or (allocat* adj10 (arm or arms)) or placebo* or "sham-control*" or ((single or double or triple or assessor) adj1 (blind* or masked)) or nonrandom* or "non-random*" or "quasi-experiment*" or "parallel group*" or "factorial trial" or "pretest posttest" or (phase adj5 (study or trial)) or (case* adj6 (matched or control*)) or (match* adj6 (pair or pairs or cohort* or control* or group* or healthy or age or sex or gender or patient* or subject* or participant*)) or (propensity adj6 (scor* or match*))).ti,ab,kf. or (confounding adj6 adjust*).ti,ab. or (versus or vs or compar*).ti. or ((exp cohort studies/ or epidemiologic studies/ or multicenter study/ or observational study/ or seroepidemiologic studies/ or (cohort* or 'follow up' or followup or longitudinal* or prospective* or retrospective* or observational* or multicent* or 'multi-cent*' or consecutive*).ti,ab,kf.) and ((group or groups or subgroup* or versus or vs or compar*).ti,ab,kf. or ('odds ratio*' or 'relative odds' or 'risk ratio*' or 'relative risk*' or aor or arr or rrr).ab. or (("OR" or "RR") adj6 CI).ab.)) |
5464865 |
|
6 |
Epidemiologic studies/ or case control studies/ or exp cohort studies/ or Controlled Before-After Studies/ or Case control.tw. or cohort.tw. or Cohort analy$.tw. or (Follow up adj (study or studies)).tw. or (observational adj (study or studies)).tw. or Longitudinal.tw. or Retrospective*.tw. or prospective*.tw. or consecutive*.tw. or Cross sectional.tw. or Cross-sectional studies/ or historically controlled study/ or interrupted time series analysis/ [Onder exp cohort studies vallen ook longitudinale, prospectieve en retrospectieve studies] |
4482444 |
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5 |
exp clinical trial/ or randomized controlled trial/ or exp clinical trials as topic/ or randomized controlled trials as topic/ or Random Allocation/ or Double-Blind Method/ or Single-Blind Method/ or (clinical trial, phase i or clinical trial, phase ii or clinical trial, phase iii or clinical trial, phase iv or controlled clinical trial or randomized controlled trial or multicenter study or clinical trial).pt. or random*.ti,ab. or (clinic* adj trial*).tw. or ((singl* or doubl* or treb* or tripl*) adj (blind$3 or mask$3)).tw. or Placebos/ or placebo*.tw. |
2609251 |
|
4 |
meta-analysis/ or meta-analysis as topic/ or (metaanaly* or meta-analy* or metanaly*).ti,ab,kf. or systematic review/ or cochrane.jw. or (prisma or prospero).ti,ab,kf. or ((systemati* or scoping or umbrella or "structured literature") adj3 (review* or overview*)).ti,ab,kf. or (systemic* adj1 review*).ti,ab,kf. or ((systemati* or literature or database* or data-base*) adj10 search*).ti,ab,kf. or ((structured or comprehensive* or systemic*) adj3 search*).ti,ab,kf. or ((literature adj3 review*) and (search* or database* or data-base*)).ti,ab,kf. or (("data extraction" or "data source*") and "study selection").ti,ab,kf. or ("search strategy" and "selection criteria").ti,ab,kf. or ("data source*" and "data synthesis").ti,ab,kf. or (medline or pubmed or embase or cochrane).ab. or ((critical or rapid) adj2 (review* or overview* or synthes*)).ti. or (((critical* or rapid*) adj3 (review* or overview* or synthes*)) and (search* or database* or data-base*)).ab. or (metasynthes* or meta-synthes*).ti,ab,kf. |
679922 |
|
3 |
1 and 2 |
69 |
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2 |
Hyperbaric Oxygenation/ or (hyperbaric adj3 (medicine or therap* or treatment or o2 or oxygen*)).ti,ab,kf. or hbot.ti,ab,kf. or (pressur* adj3 oxygen therap*).ti,ab,kf. or hbo therap*.ti,ab,kf. or ((hyperoxygenat* or high oxygen) adj3 (therap* or treatment)).ti,ab,kf. |
15954 |
|
1 |
((maligna* or necroti* or necrosis) adj3 ('otitis externa' or 'external otitis')).ti,kf. or (exp *Otitis Externa/ and (maligna* or necroti* or necrosis).ti,ab,kf.) or ((exp *Osteomyelitis/ or 'osteomyelitis'.ti,kf.) and (exp Skull/ or skull*.ti,ab,kf. or cranial.ti,ab,kf. or cranium.ti,ab,kf.)) |
2707 |