Startpagina - Veilig gebruik van contrastmiddelen (deel 2)
Last review: 24-06-2020Waar gaat deze richtlijn over?
Deze richtlijn beschrijft hoe contrastmiddel voor beeldvormend onderzoek veilig toegediend kan worden aan patiënten.
In de richtlijn wordt ingegaan op vier aspecten van het veilig toedienen van contrastmiddelen
- Overgevoeligheidsreacties na contrasttoediening
- Veilig gebruik van gadolinium houdende contrastmiddelen
- Veilige injectie van contrastmiddelen via centrale catheters en ports
- Contrastmiddel extravasatie
Voor wie is deze richtlijn bedoeld?
Deze richtlijn is bedoeld voor alle artsen, die werkzaam zijn in het ziekenhuis en die beeldvormend onderzoek, al dan niet met een interventie, met contrastmiddel aanvragen of uitvoeren.
Voor patiënten
Deze richtlijn beschrijft de zorg voor patiënten die een beeldvormend onderzoek krijgen, waarbij contrastmiddel wordt toegediend. De richtlijn is bedoeld voor volwassen (>18 jaar) patiënten. Het gaat om contrastmiddelen die via een infuus worden ingespoten in de bloedvaten voor röntgenonderzoek, vaatonderzoek of vaatbehandeling.
Wanneer contrastmiddel in de bloedvaten komt, kan een kleine groep patiënten overgevoelig reageren op het contrastmiddel. Deze richtlijn beschrijft hoe een dergelijke reactie moet worden behandeld. Er wordt ook beschreven wat voor voorzorgsmaatregelen patiënten moeten krijgen, wanneer zij eerder een overgevoeligheidsreactie na contrastmiddel hebben gehad, maar nu opnieuw onderzoek met een contrastmiddelen moeten krijgen.
Er wordt in de richtlijn ook aandacht besteed aan voorzorgsmaatregelen voor een speciaal type contrast dat voor MRI-scans wordt gebruikt: gadoliniumhoudend contrast.
In de richtlijn wordt beschreven hoe contrastmiddelen veilig kunnen worden toegediend, wanneer een patiënt al een toegang tot de bloedvaten heeft, bijvoorbeeld een centrale catheter.
Tenslotte beschrijft deze richtlijn ook hoe patiënten moeten worden behandeld, wanneer er per ongeluk contrastmiddel buiten de bloedvaten terechtkomt.
Thuisarts
https://www.thuisarts.nl/overgevoelig-voor-contrastmiddel
Hoe is de richtlijn tot stand gekomen?
De Nederlandse Vereniging voor Radiologie heeft een nieuwe set richtlijnen op het gebied van veiligheid van contrastmiddelen geprioriteerd als een belangrijk onderwerp van kwaliteitsbeleid. Reden hiertoe is dat er recentelijk veel onderzoeken zijn gepubliceerd op het gebied van veiligheid van het toedienen van contrastmiddelen. Het streven is om drie richtlijnen te publiceren over dit onderwerp, waarvan dit het tweede deel is.
Toepassen
Voor deze richtlijn zijn er strooomschema’s ontwikkeld waarin wordt beschreven:
- hoe een acute overgevoeligheidsreactie na contrasttoediening moet worden behandeld
- hoe zorgverleners moeten handelen bij patiënten die eerder een overgevoeligheidsreactie na een contrastmiddelen hebben gehad, en bij wie nu opnieuw een beeldvormend onderzoek met contrastmiddel geïndiceerd is
- hoe contrastmiddelen veilig kunnen worden geïnjecteerd via centrale catheters en ports
Authorization date and validity
Last review : 24-06-2020
Last authorization : 24-06-2020
The board of the Radiological Society of the Netherlands will determine at the latest in 2024 if this guideline (per module) is still valid and applicable. If necessary, a new working group will be formed to revise the guideline. The validity of a guideline can be shorter than 5 years, if new scientific or healthcare structure developments arise, that could be seen as a reason to commence revisions. The Radiological Society of the Netherlands is considered the keeper of this guideline and thus primarily responsible for the actuality of the guideline. The other scientific societies that have participated in the guideline development share the responsibility to inform the primarily responsible scientific society about relevant developments in their field.
Initiative and authorization
General details
The guideline development was assisted by the Knowledge Institute of the Federation Medical Specialists and was financed by the Quality Funds for Medical Specialists (Stichting Kwaliteitsgelden Medisch Specialisten: SKMS).
Scope and target group
Goal
The aim of the Part 2 of Safe Use of Contrast Media guidelines is to critically review the present recent evidence with the above trend in mind and tries to formulate new practical guidelines for all hospital physicians to provide the safe use of contrast media in diagnostic and interventional studies. The ultimate goal of this guideline is to increase the quality of care, by providing efficient and expedient healthcare to the specific patient populations that may benefit from this healthcare and simultaneously guard patients from ineffective care. Furthermore, such a guideline should ideally be able to save money and reduce day-hospital waiting lists.
Users
This guideline is intended for all hospital physicians that request or perform diagnostic or interventional radiologic or cardiologic studies for their patients in which CM are involved.
Samenstelling werkgroep
A multidisciplinary working group was formed for the development of the guideline in 2016. The working group consisted of representatives from all relevant medical specialization fields that are involved with intravascular contrast administration.
All working group members have been officially delegated for participation in the working group by their scientific societies. The working group has developed a guideline in the period from May 2016 until July 2019.
The working group is responsible for the complete text of this guideline.
Working group
- A.J. van der Molen, radiologist, Leiden University Medical Centre, Leiden (chairman)
- R.W.F. Geenen, radiologist, Noordwest Ziekenhuisgroep (NWZ), Alkmaar
- T. Leiner, radiologist, University Medical Centre Utrecht, Utrecht (until November 2018)
- H.M. Dekker, radiologist, Radboud University Medical Centre, Nijmegen
- I.A. Dekkers, clinical epidemiologist and radiologist in training, Leiden University Medical Centre, Leiden
- K. van der Putten, nephrologist, Tergooi, Hilversum
- J.G.R. de Monchy, allergologist, DC-Klinieken, Amsterdam
- H.R.H. de Geus, internist-intensivist, Erasmus Medical Centre, Rotterdam
- S.W. Zielhuis, hospital pharmacist, Medical Centre Leeuwarden, Leeuwarden
- O.R.M. Wikkeling, vascular surgeon, Heelkunde Friesland Groep, location: Nij Smellinghe Hospital, Drachten
- I. Brummer, emergency physician, Treant Healthcare Group, Emmen
- M. van der Vlugt, cardiologist, Radboud University Medical Centre, Nijmegen (until April 2018)
- M. Gotte, cardiologist, Free University Medical Centre, Amsterdam (from July 2018)
- S.H. Kardaun, dermatologist, University Medical Centre Groningen, Groningen (until March, 2018)
Methodological support
- I.M. Mostovaya, senior advisor, Knowledge Institute of the Federation Medical Specialists
- J. Buddeke, advisor, Knowledge Institute of the Federation Medical Specialists (from April 2018)
- W. Harmsen, advisor, Knowledge Institute of the Federation Medical Specialists (from April 2018)
Declaration of interest
The working group members have provided written statements about (financially supported) relations with commercial companies, organisations or institutions that are related to the subject matter of the guideline. Furthermore, inquiries have been made regarding personal financial interests, interests due to personal relationships, interests related to reputation management, interest related to externally financed research and interests related to knowledge valorisation. The statements on conflict of interest can be requested at the administrative office of the Knowledge Institute of Medical Specialists and are summarised below.
Last name |
Function |
Other positions |
Personal financial interests |
Personal relations |
Reputation management |
Externally financed research |
Knowledge valorisation |
Other interests |
Signed |
Van der Putten |
Internist nephrologist |
None |
None |
None |
None |
None |
None |
None |
14-10-2015 |
Van der Vlugt |
Cardiologist |
None |
None |
None |
Chairman of the working group Cardiac MRI & CT and Nuclear imaging of the Netherlands Society of Cardiology |
None |
None |
None |
03-01-206 |
Roodheuvel |
Emergency physician |
Instructor OSG/VvAA for courses on echography – paid position Member of department for burn treatment – unpaid. |
None |
None |
None |
None |
None |
None |
21-12-2015 |
Geenen |
Radiologist |
Member of commission prevention of PC-AKI |
None |
None |
None |
None |
None |
Has held several presentation about contrast media on invitation (GE, BAYER) |
25-3-2016 |
Zielhuis |
Hospital pharmacist |
None |
In the past (2013-2015) has participated in an advisory panel on expensive medication for the companies AbbVie and Novartis. Has received an expense allowance for this. Both forms do not produce contrast media that this guideline is about. Currently not active in an advisory panel. |
None |
None |
None |
None |
None |
8-1-2016 |
De Geus |
Internist-Intensivist Erasmus MC Rotterdam |
None |
None |
None |
None |
None |
None |
None |
Ja, 31-03-2016 |
Dekkers |
Radiologist in training and PhD-candidate |
None |
None |
Not applicable |
Not applicable |
Not applicable |
Not applicable |
Not applicable |
Ja, 8-7-2016 |
Wikkeling |
Vascular surgeon |
None |
None |
None |
None |
None |
None |
Not applicable |
19-7-2016 |
Dekker |
Radiologist |
None |
Not applicable |
Not applicable |
Not applicable |
Not applicable |
Not applicable |
Not applicable |
10-7-2016 |
Van der Molen |
Chairman |
None |
None |
None |
None |
None |
Not applicable |
One-off royalties Springer Verlag (2014) Incidental payments for presentations or being day chairman at contrast safety congress (2016 Netherlands + Europe |
6-9-2016 |
Kardaun |
Dermatologist - researcherUniversitair Medisch Centrum Groningen: unpaid |
Replacing dermatologist in clinical practice - unpaid |
None |
None |
None |
None |
None |
None |
24-2-2016 |
Brummer |
Emergency physician |
None |
None |
None |
None |
None |
None |
None |
23-2-2018 |
Patient involvement
It was challenging to find representation for the patient’s perspective, since the guideline does not discuss a specific group of patients with a disease. The Dutch Kidney Patients Association was invited to participate in an advisory board to the working group, but declined since this subject was not specific enough for them to give adequate input; The Dutch Kidney Patients Association did provide written feedback for specific modules during the commentary phase. The Dutch Kidney Patients Association and the Patient Federation of the Netherlands was invited to participate in the invitational conference in which the framework of the guideline was discussed. Furthermore, the concept guideline has been submitted for feedback during the comment process to the Patient Federation of the Netherlands and the Dutch Kidney Patient Association.
Method of development
Implementation
In the different phases of guideline development, the implementation of the guideline, and the practical enforceability of the guideline were taken into account. The factors that could facilitate or hinder the introduction of the guideline in clinical practice have been explicitly considered. The implementation plan can be found with the Related Products. Furthermore, quality indicators were developed to enhance the implementation of the guideline. The indicators can also be found with the Related Products.
Methods and proces
AGREE
This guideline has been developed conforming to the requirements of the report of Guidelines for Medical Specialists 2.0 by the advisory committee of the Quality Counsel. This report is based on the AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II) (www.agreetrust.org), a broadly accepted instrument in the international community and on the national quality standards for guidelines: “Guidelines for guidelines” (www.zorginstituutnederland.nl).
Identification of subject matter
During the initial phase of the guideline development, the chairman, working group and the advisor inventory the relevant subject matter for the guideline. Furthermore, an Invitational Conference was organized, where additional relevant subjects were discussed. A report of this meeting can be found in Related Products.
Clinical questions and outcomes
During the initial phase of guideline development, the chairman, working group and advisor identified relevant subject matter for the guideline. Furthermore, input was acquired for the outline of the guideline during an Invitational Conference. The working group then formulated definitive clinical questions and defined relevant outcome measures (both beneficial land harmful effects). The working group rated the outcome measures as critical, important and not important. Furthermore, where applicable, the working group defined relevant clinical differences.
Strategy for search and selection of literature
For the separate clinical questions, specific search terms were formulated and published scientific articles were sought after in (several) electronic databases. Furthermore, studies were scrutinized by cross-referencing for other included studies. The studies with potentially the highest quality of research were looked for first. The working group members selected literature in pairs (independently of each other) based on title and abstract. A second selection was performed based on full text. The databases, search terms and selection criteria are described in the modules containing the clinical questions.
Quality assessment of individual studies
Individual studies were systematically assessed, based on methodological quality criteria that were determined prior to the search, so that risk of bias could be estimated. This is described in the “risk of bias” tables.
Summary of literature
The relevant research findings of all selected articles are shown in evidence tables. The most important findings in literature are described in literature summaries. When there were enough similarities between studies, the study data were pooled.
Grading quality of evidence and strength of recommendations
The strength of the conclusions of the scientific publications was determined using the GRADE-method. GRADE stands for Grading Recommendations Assessment, Development and Evaluation (see http://www.gradeworkinggroup.org/) (Atkins, 2004).
GRADE defines four gradations for the quality of scientific evidence: high, moderate, low or very low. These gradations provide information about the amount of certainty about the literature conclusions. (http://www.guidelinedevelopment.org/handbook/).
Formulating conclusions
For diagnostic, etiological, prognostic or adverse effect questions, the evidence was summarized in one or more conclusions, and the level of the most relevant evidence was reported. For intervention questions, the conclusion was drawn based on the body of evidence (not one or several articles). The working groups weighed the beneficial and harmful effects of the intervention.
Considerations
Aspects such as expertise of working group members, patient preferences, costs, availability of facilities and organisation of healthcare aspects are important to consider when formulating a recommendation. These aspects were discussed in the paragraph Considerations.
Formulating recommendations
The recommendation answers the clinical question and was based on the available scientific evidence and the most relevant considerations.
Constraints (Organisation of healthcare)
During the development of the outline of the guideline and the rest of the guideline development process, the Organisation of healthcare was explicitly taken into account. Constraints that were relevant for certain clinical questions were discussed in the Consideration paragraphs of those clinical questions. The comprehensive and additional aspects of the Organisation of healthcare were discussed in a separate chapter.
Development of quality indicators
Internal (meant for use by scientific society or its members) quality indicators are developed simultaneously with the guideline. Furthermore, existing indicators on this subject were critically appraised; and the working group produces an advice about such indicators. Additional information on the development of quality indicators is available by contacting the Knowledge Institute for the Federation Medical Specialists. (secretariaat@kennisinstituut.nl).
Knowledge Gaps
During the development of the guideline, a systematic literature search was performed the results of which help to answer the clinical questions. For each clinical question the working group determined if additional scientific research on this subject was desirable. An overview of recommendations for further research is available in the appendix Knowledge Gaps.
Comment- and authorisation phase
The concept guideline was subjected to commentaries by the involved scientific societies. The commentaries were collected and discussed with the working group. The feedback was used to improve the guideline; afterwards the working group made the guideline definitive. The final version of the guideline was offered for authorization to the involved scientific societies and was authorized.
References
Brouwers MC, Kho ME, Browman GP, et al. AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010;182(18):E839-E842.
Medisch Specialistische Richtlijnen 2.0. Adviescommissie Richtlijnen van de Raad Kwalitieit, 2012. Available at: https://richtlijnendatabase.nl/over_deze_site/richtlijnontwikkeling.html.
Schünemann H, Brożek J, Guyatt G, et al. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available at: http://gdt.guidelinedevelopment.org/central_prod/_design/client/handbook/handbook.html.
Schünemann HJ, Oxman AD, Brozek J, et al. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ. 2008;336(7653):1106-10. Erratum published in: BMJ 2008;336(7654).
Ontwikkeling van Medisch Specialistische Richtlijnen: stappenplan. Kennisinstituut van Medisch Specialisten.