Microbiology and histopathology
Uitgangsvraag
What is the added value of microbiological and histopathological tests in patients with proven or suspected NOE?
Aanbeveling
Take, at least, a culture swab for bacterial and fungal examination before starting systemic treatment.
Consider taking (surgical, deep tissue) biopsies in case of:
- No clear pathogen is identified in previous microbial swab-cultures.
- No clinical improvements are demonstrated after 1-2 weeks of systemic antibiotic therapy.
- Send these biopsies for histopathological and microbiological examination (including fungal cultures).
If clinically feasible: cease topical and systemic antibiotics prior to taking the culture swab or biopsy (up to 1 week).
Overwegingen
Balance between desired and undesired effects
There is very limited literature describing the optimal process for obtaining a microbiological diagnosis for necrotizing otitis externa. Therefore, the guideline committee has arrived at a pragmatic proposal, supported by general principles within microbiology.
Microbiology
The majority of patients (62%) has NOE because of an infection with Pseudomonas aeruginosa (Takata, 2023). Other relevant pathogens include Staphylococcus aureus (6%), other bacteria or Aspergillus spp (9%). Since these other causative agents are not susceptible to most antipseudomonal antibiotics it is important to continue finding the causative agent in case of negative culture results (from swabs).
Taking a culture with a swab from the external ear is non-invasive, easy to perform, and cost-effective. This is and stays the most favorable primary way of obtaining culture material. The guideline committee considers it useful to take cultures from the ear canal (swab or biopsy) in cases where the clinical presentation is consistent with (necrotizing) otitis externa with pus or debris in the ear canal. If the ear canal does not show signs of infection and previous cultures were negative or inconclusive, and if there is a need for a microbiological diagnosis due to stagnation or deterioration of the clinical condition, a deep or surgical biopsy may be considered.
The patient has usually been treated with topical and systemic antibiotics, which can result in a false-negative culture. Although for NOE there is no specific evidence for the optimal microbiological work-up, it is known from other diseases (such as osteomyelitis in patients with diabetic chronic ulcers) that antibiotic treatment prior to taking a culture might lead to false-negative results. Therefore, it is recommended to discontinue antibiotics for up to 7 days prior to obtaining cultures (Gramberg, 2023).
When obtaining a swab from the ear canal, skin-colonizing bacteria and non-pathogenic organisms, such as yeast-like fungi, are likely to be included in the culture. These microorganisms can mask the real pathogen.The advantage of taking a tissue biopsy is the higher change of culturing the micro-organism. Especially fungi are not easily grown from a swab but might only be detected in a biopsy (Swab guideline ‘Invasieve schimmelinfecties’). In the study conducted by Abu Eta (2018), a higher number of fungal cultures were identified in patients who underwent deep surgical biopsies compared to those with ear canal swab cultures (RR 2.55, 95% CI 0.93–6.97). Furthermore other forms of osteomyelitis it is shown that putting a tissue biopsie in culture is preferable over skin-swabs to identify the right causing agent (Senneville, 2006).
A distinction can be made between two types of biopsies: a biopsy from the ear canal is taken from abnormal-appearing tissue, usually granulation tissue or a granulation polyp. This biopsy is obtained through the ear canal under local anesthesia. Alternatively, a biopsy may be taken from abnormal tissue at another location. This type of biopsy requires a surgical approach, for example, guided by specific abnormalities identified in imaging studies.Tissue biopsies have downsides which should be taken into account. An ear canal biopsy is limited to patient discomfort and minor bleeding after the procedure. A deep surgical biopsy requires surgery under general anesthesia to obtain these samples.
Ultimately, in case of absent or insufficient improvement of the clinical situation after 1-2 weeks of empirical treatment in patients with negative swab cultures microbiological diagnostics should be repeated. For this purpose biopsies for culture and histopathological examination are recommended because of the higher likelihood of finding the actual causative micro-organism, especially fungi. In case of negative culture results from biopsies, collaboration with the medical microbiologist for PCR-techniques might be of help to find the causative agent.
Histolopathology
The added benefit of a tissue biopsy could be to exclude other (severe) diseases. However, this is only scarcely described in the literature. A retrospective study by Sekar (2022) analyzed a cohort of patients in which 68 out of 79 patients with necrotizing otitis externa underwent histopathological biopsies. Biopsies were performed when granulation tissue was observed, and the material taken was the granulation tissue itself. The authors, however, do not mention the results of the biopsies. It can be presumed that the biopsies were negative for malignancies, as only patients with proven NOE were included retrospectively. Nothing was mentioned about biopsies leading to other diagnoses.
Other authors emphasize the importance of biopsies, as histopathology can sometimes reveal diagnoses such as squamous cell carcinoma in patients previously thought to have necrotizing otitis externa based on clinical findings (Saravanam, 2013). Additionally, other diseases can mimic the clinical presentation of necrotizing otitis externa, including granulomatous and inflammatory processes, tumors with different histology, bone disorders, and collagen vascular or autoimmune diseases (Maniu, 2016; Walton, 2014).
Quality of the evidence
The overall quality of evidence is very low. This means that the working group is very uncertain about the estimated effect of the outcomes found.
There is downgrading due to:
- Risk of bias: patient selection; index test
- Imprecision: inaccuracy, due to a very small number of events in a small sample size.
- Indirectness: indirectness due to differences in interventions and outcomes.
Values and preferences of patients (and possibly their caregivers)
Swabs of the external ear canal are non invasive procedures. No problems for the patients should be expected. When taking biopsies of the external ear canal, the procedure can be performed in the outpatient clinic. With local anesthesia, only a small discomfort is expected for the patient. Extended surgery is more demanding, with general anesthesia and hospital admissions. The effects of surgery to obtain patient material in the case of NOE are barely described. However, general ear surgery has in general a low length of admission and a relatively small amount of complications.
Costs (resources)
Microbiological cultures are low in costs. Histopathology is also low in costs. In the very rare case of surgery, costs for this kind of treatment are negligible considering total treatment costs. However, no studies have been performed to show cost-effectiveness of the treatment, let alone for the surgery done in a small percentage of cases.
Equity ((health) equity/equitable)
The guideline panel expects no problems with health equity with regard to medical treatment of necrotizing otitis externa.
Acceptability
The guideline panel expects no problems with ethical acceptability or sustainability with regard to medical treatment of necrotizing otitis externa.
Feasibility
The feasibility depends on the available modalities in the treatment centre. This includes a laboratory with the adequate equipment and personell for microbiology and pathology. It also requires the specialists to execute the recommendations (ENT, microbiologist, pathologist).
Onderbouwing
Achtergrond
Necrotizing otitis externa is an infectious process, due to a bacterial or fungal infection. Identifying the correct pathogen is of vital importance for starting the right treatment regimen. Cultures, obtained via ear canal swabs, are standard practice. However, by taking a swab from the canal, skin colonizing bacteria and unharmful microorganisms are likely to get included in the culture. Furthermore, the patient has often been treated with topical antiobiotics. For these reasons the pathogenic microorganism might not be found superficially anymore. The question is therefore whether deeper biopsies have a higher yield of finding pathogens in cultures, or histopathologic examination opposed to ear canal swabs, and whether the current diagnostic workup is sufficient to exclude most other diseases, making histopathological examination redundant. Other added benefits of such a test could be the histopathological findings, in which other diagnoses could be diagnosed, such as neoplasms of the ear canal or inflammatory diseases, clinically mimicking NOE.
Conclusies / Summary of Findings
biopsy versus swab
Diagnostic accuracy
|
No GRADE |
No evidence was found regarding the diagnostic accuracy of biopsies compared to swabs for cultures in patients with suspected skull base osteomyelitis
Source: - |
Missed diagnosis/diagnostic error, biopsy versus swab for cultures
|
Very low GRADE |
The evidence is very uncertain, but a higher rate of microbiological diagnoses might be achieved with deep tissue biopsies compared to swabs for cultures in patients with necrotizing otitis externa.
Source: Abu Eta, 2018 |
biopsy versus no biopsy
Missed diagnosis/diagnostic error
|
No GRADE |
No evidence was found regarding the difference in diagnostic error/missed diagnosis using histopathological biopsies over no biopsies in patients with suspected skull base osteomyelitis.
Source: - |
Samenvatting literatuur
Description of studies
Only one studie is included in the analysis of the literature. Important study characteristics and results are summarized in table 2. The assessment of the risk of bias is summarized in the risk of bias tables (under the tab ‘Evidence tables’).
Table 2. Characteristics of included studies
|
Study |
Participants (number, age, other important characteristics) |
Comparison |
Follow-up |
Outcome measures |
Risk of bias (per outcome measure)* |
|
Abu Eta, (2018) |
Baseline, 52 patients in total: 27 in the intervention group and 25 in the control group. The cohort consisted of 29 men and 23 women, with a mean age of 70.6 years. All patients were referred from other tertiary hospitals in the region due to the failure of initial conventional treatment for necrotizing otitis externa. Following consultation with an infectious disease specialist, all patients were treated with broad-spectrum antibiotics based on culture results |
Twenty-seven patients (51.9%) underwent local treatment and surgical debridement of necrotic bone and soft tissue, with tissue samples obtained for culturing, including fungal cultures. The comparison group of 25 patients received only antibiotic or antifungal medication. |
There was no mention of follow-up.
|
Diagnostic error/missed diagnosis |
High |
*For further details, see risk of bias table in the appendix
Results
In a study performed by Abu Eta (2018), 52 patients with necrotizing otitis externa were treated with culture-directed antimicrobial therapy. Cultures were obtained by swabs technique. In case of a negative culture, anti-pseudomonal antibiotics were given. 27 of 52 (51.9%) patients with NOE underwent surgery, including 7 patients who underwent mastoidectomy, 6 patients who underwent debridement of the ear canal of soft tissue and bone of external ear canal and 14 (26.9%) who had both debridement and mastoidectomy. The decision to operate was made according to clinical, laboratory and imaging parameters; however, the main decision-making parameter was the clinical examination.
Patients, who had shown no clinical improvement on physical examination during the course of conservative treatment, or who had severe edema, granulation tissue or necrosis of the external ear canal skin. This article did not directly compare cultures obtained by swab versus biopsy, and therefore we conclude that no literature was found that answers the PICO question.
Zoeken en selecteren
To answer the primary question, two search questions were formulated. A systematic review of the literature was performed to answer the following questions:
Question 1: biopsy versus swab
What is the added value of deep tissue biopsy versus ear canal swab in order to identify the pathogen and/or making the correct diagnosis?
| Patients | Patients with proven or suspected NOE |
| Intervention | Biopsy for microbiological culture |
| Control | Swab for microbiological culture |
| Outcomes | Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value, missed diagnosis/diagnostic error) |
| Referral | Outcomes after 1 year |
| Other selection criteria | Systematic reviews, RCT, observational studies |
Relevant outcome measures
The guideline development group considered diagnostic accuracy as a critical outcome measure for decision making, as displayed in Table 1. The outcome represented comes from any type of culture, either superficial or deep. Missed diagnosis/diagnostic error was considered a critical outcome measure.
Table 1. Consequences of diagnostic test
|
Properties Outcome |
Consequence |
|
True positives (TP) |
Patient has NOE; the pathogen is correctly identified by culture of deep tissue the patient will get appropriate treatment. |
|
True negatives (TN) |
Patient is correctly identified as not having NOE, no pathogens are found and the patient is managed accordingly. |
|
False positives (FP) |
Patients with NOE; there is a positive culture, which is not the causitive agent. Risk of inappropriate / falsely directed treatment. |
|
False negatives (FN) |
No microbiological diagnosis. Patient with NOE, but no pathogen is found in culture (deep tissue) ; empirical therapy has to be continued . |
Any number of missed diagnoses or diagnostic errors was considered by the working group to be clinically relevant.
Question 2: biopsy vs no biopsy
Is additional histopathological examination relevant in order to exclude other pathology in patients with suspected NOE?
| Patients | Patients with proven or suspected NOE |
| Intervention | Histopathological biopsy |
| Control | No biopsy |
| Outcomes | Remission, survival, quality of life |
| Other selection criteria | Missed diagnosis/diagnostic error |
Relevant outcome measures
The guideline development group considered missed diagnosis as a critical outcome measure for decision making. Missed diagnosis or diagnostic error is mostly described as a number of patients or a percentage. All numbers of missed diagnosis or diagnostic error were considered clinically important differences.
Search and select (Methods)
The databases Medline (via OVID) and Embase (via Embase.com) were searched using relevant search terms until July 7, 2023. Due to overlap in search terms, both search questions were combined into a single literature search. The detailed search strategy is provided under the "Methods" tab. The systematic literature search yielded 347 unique hits. Studies were selected based on the following criteria: systematic reviews, RCTs, observational studies, and other non-comparative research on the value of surgical treatment for malignant external otitis.
Article selection for both search questions was conducted. Twenty-four studies were initially selected based on title and abstract screening. After full-text review, 23 studies were excluded for question 1, and 1 study was included. For question 2, 24 studies were excluded, and no studies were included. (See the table with reasons for exclusion under the "Methods" tab.)
Referenties
- Abu Eta R, Gavriel H, Stephen K, Eviatar E, Yeheskeli E. The significance of tissue biopsy for fungi in necrotizing otitis externa. Eur Arch Otorhinolaryngol. 2018 Dec;275(12):2941-2945. doi: 10.1007/s00405-018-5151-9. Epub 2018 Oct 5. PMID: 30291437.
- Gramberg MCTT, Van Hattem JM, Dijkstra JA, Dros E, Nieuwdorp M, Sabelis LWE, Peters EJG. Effect of Prior Antibiotic Use on Culture Results in People with Diabetes and Foot Osteomyelitis. Antibiotics (Basel). 2023 Mar 31;12(4):684. doi: 10.3390/antibiotics12040684. PMID: 37107046; PMCID: PMC10135220.
- Maniu AA, Harabagiu O, Damian LO, Ştefănescu EH, FănuŢă BM, Cătană A, Mogoantă CA. Mastoiditis and facial paralysis as initial manifestations of temporal bone systemic diseases - the significance of the histopathological examination. Rom J Morphol Embryol. 2016;57(1):243-8. PMID: 27151715.
- Saravanam, Prasanna & Ravikumar, Arunachalam & Somu, Lakshmanan & Ismail, Nazrin. (2013). Malignant otitis externa: An emerging scourge. Journal of Clinical Gerontology and Geriatrics. 4. 128–131. 10.1016/j.jcgg.2013.02.003.
- Senneville E, Melliez H, Beltrand E, Legout L, Valette M, Cazaubiel M, Cordonnier M, Caillaux M, Yazdanpanah Y, Mouton Y. Culture of percutaneous bone biopsy specimens for diagnosis of diabetic foot osteomyelitis: concordance with ulcer swab cultures. Clin Infect Dis. 2006 Jan 1;42(1):57-62. doi: 10.1086/498112. Epub 2005 Nov 21. PMID: 16323092.
- Sekar R, Raja K, Ganesan S, Alexander A, Saxena SK. Clinical and Current Microbiological Profile with Changing Antibiotic Sensitivity in Malignant Otitis Externa. Indian J Otolaryngol Head Neck Surg. 2022 Dec;74(Suppl 3):4422-4427. doi: 10.1007/s12070-021-03068-9. Epub 2022 Jan 22. PMID: 36742648; PMCID: PMC9895493.
- 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.
- Walton J, Coulson C. Fungal malignant otitis externa with facial nerve palsy: tissue biopsy AIDS diagnosis. Case Rep Otolaryngol. 2014;2014:192318. doi: 10.1155/2014/192318. Epub 2014 Feb 5. PMID: 24649388; PMCID: PMC3933303.
Evidence tabellen
Risk of bias table for intervention studies (observational: non-randomized clinical trials, cohort and case-control studies)
|
Study reference
(first author, year of publication) |
Bias due to a non-representative or ill-defined sample of patients?1
(unlikely/likely/unclear) |
Bias due to insufficiently long, or incomplete follow-up, or differences in follow-up between treatment groups?2
(unlikely/likely/unclear) |
Bias due to ill-defined or inadequately measured outcome ?3
(unlikely/likely/unclear) |
Bias due to inadequate adjustment for all important prognostic factors?4
(unlikely/likely/unclear) |
|
Abu-Eta, 2018 |
Likely |
Unlikely |
Likely |
unclear |
Table of excluded studies
|
Reference |
Reason for exclusion PICO 1 |
Reason for exclusion PICO 2 |
|
Bernheim J, Sade J. Histopathology of the soft parts in 50 patients with malignant external otitis. J Laryngol Otol. 1989 Apr;103(4):366-8. doi: 10.1017/s0022215100108977. PMID: 2715689. |
No outcomes reported |
No outcomes reported |
|
Johnson AK, Batra PS. Central skull base osteomyelitis: an emerging clinical entity. Laryngoscope. 2014 May;124(5):1083-7. doi: 10.1002/lary.24440. Epub 2013 Nov 7. PMID: 24115113. |
Non comparitive research |
No outcomes reported |
|
Sekar R, Raja K, Ganesan S, Alexander A, Saxena SK. Clinical and Current Microbiological Profile with Changing Antibiotic Sensitivity in Malignant Otitis Externa. Indian J Otolaryngol Head Neck Surg. 2022 Dec;74(Suppl 3):4422-4427. doi: 10.1007/s12070-021-03068-9. Epub 2022 Jan 22. PMID: 36742648; PMCID: PMC9895493. |
No deep tissue biopsies were send for cultures |
No outcomes reported |
|
S. Prasanna Kumar, A. Ravikumar, L. Somu, Nazrin Mohd Ismail, Malignant otitis externa: An emerging scourge, Journal of Clinical Gerontology and Geriatrics, Volume 4, Issue 4, 2013, Pages 128-131, ISSN 2210-8335, https://doi.org/10.1016/j.jcgg.2013.02.003. (https://www.sciencedirect.com/science/article/pii/S2210833513000282) |
Non comparive research |
No outcomes reported |
|
Bertrand K, Lamy B, De Boutray M, Yachouh J, Galmiche S, Leprêtre P, de Champfleur NM, Reynes J, Le Moing V, Morquin D. Osteomyelitis of the jaw: time to rethink the bone sampling strategy? Eur J Clin Microbiol Infect Dis. 2018 Jun;37(6):1071-1080. doi: 10.1007/s10096-018-3219-5. Epub 2018 Mar 7. PMID: 29516234. |
Wrong population |
Wrong population |
|
Maniu AA, Harabagiu O, Damian LO, Ştefănescu EH, FănuŢă BM, Cătană A, Mogoantă CA. Mastoiditis and facial paralysis as initial manifestations of temporal bone systemic diseases - the significance of the histopathological examination. Rom J Morphol Embryol. 2016;57(1):243-8. PMID: 27151715. |
Non comparative research |
Non comparative research |
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 |
|
Microbiology and histopathology |
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
|
Richtlijn: NVKNO Osteomyelitis Schedelbase -maligne otitis externa |
|
|
Uitgangsvraag: 1. Wat is de meerwaarde van het biopt t.o.v. van een swab voor vinden een pathogeen, danwel stellen van diagnose? 2. Is aanvullend histopathologisch onderzoek zinvol om andere pathologie uit te sluiten? |
|
|
Database(s): Ovid/Medline, Embase |
Datum: 17-7-2023 |
|
Periode: nvt |
Talen: nvt |
|
Literatuurspecialist: Ingeborg van Dusseldorp |
|
|
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. |
|
|
Toelichting:
Omdat voor beide vragen wordt gezocht naar maligne otitis externa en biopsie en er weinig literatuur wordt gevonden, is in overleg met de adviseur afgesproken dat er 1 vraag wordt geformuleerd met de volgende concepten: Maligne otitis externe EN biopsie Vanwege het beperkte aantal referenties worden alle artikelen exclusief dierstudies in Rayyan aangeboden. |
|
|
Te gebruiken voor richtlijnen tekst: In de databases Embase en Ovid/Medline is op 17-7-2023 met relevante zoektermen gezocht naar studies over de waarde van een biopt bij maligne otitis externa. De literatuurzoekactie leverde unieke treffers op. |
|
Zoekopbrengst
|
|
EMBASE |
OVID/MEDLINE |
Ontdubbeld |
|
SRs |
7 |
1 |
8 |
|
RCTs |
4 |
3 |
5 |
|
Observationele studies |
35 |
32 |
56 |
|
Overig |
221 |
109 |
278 |
|
Totaal |
|
|
347 |
Zoekstrategie
Embase.com
|
No. |
Query |
Results |
|
#12 |
#8 NOT #9 NOT #10 NOT #11 Overige |
221 |
|
#11 |
(#6 OR #7) AND #8 NOT #9 NOT #10 Overige observationeel |
35 |
|
#10 |
#5 AND #8 NOT #9 Clinical trials, RCTs |
4 |
|
#9 |
#4 AND #8 SR |
7 |
|
#8 |
#3 NOT ('conference abstract'/it OR 'editorial'/it OR 'letter'/it OR 'note'/it) NOT (('animal'/exp OR 'animal experiment'/exp OR 'animal model'/exp OR 'nonhuman'/exp) NOT 'human'/exp) |
267 |
|
#7 |
'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))) |
14246308 |
|
#6 |
'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 |
|
#5 |
'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 |
|
#4 |
'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 |
|
#3 |
#1 AND #2 |
367 |
|
#2 |
'biopsy'/exp OR 'biopsy':ti,ab,kw OR biopt*:ti,ab,kw OR rebiops*:ti,ab,kw OR rebiopt*:ti,ab,kw |
1088201 |
|
#1 |
'malignant otitis externa'/exp OR (((maligna* OR necroti* OR necrosis) 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 OR osteitis: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)) |
3634 |
Ovid/Medline
|
# |
Searches |
Results |
|
12 |
8 or 9 or 10 or 11 |
145 |
|
11 |
3 not 8 not 9 not 10 Overige |
109 |
|
10 |
(3 and (6 or 7)) not 8 not 9 Overige OBS |
32 |
|
9 |
(3 and 5) not 8 Clinical trials, RCTs |
1 |
|
8 |
3 and 4 SR |
3 |
|
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.)) |
5466913 |
|
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] |
4484618 |
|
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. |
2610273 |
|
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. |
680557 |
|
3 |
1 and 2 |
145 |
|
2 |
exp Biopsy/ or biopsy.ti,ab,kf. or biopt*.ti,ab,kf. or rebiops*.ti,ab,kf. or rebiopt*.ti,ab,kf. |
535397 |
|
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.)) |
2710 |