Validity

The Radiological Society of the Netherlands (NVvR) will determine if this guideline (per module) is still valid and applicable around 2029. If necessary, the scientific societies will form a new guideline group to revise the guideline. The validity of a guideline can be shorter than 5 years, if new scientific or healthcare structure developments arise, asking for a revision of the guideline. The Radiological Society of the Netherlands is the owner of this guideline and therefore primarily responsible for the actuality of the guideline. 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.

General Information

The Kennisinstituut van de Federatie Medisch Specialisten assisted the guideline development group. The guideline was financed by Stichting Kwaliteitsgelden Medisch Specialisten (SKMS) which is a quality fund for medical specialists in The Netherlands.

A multidisciplinary guideline development group (GDG) was formed for the development of the guideline in 2022. The GDG consisted of representatives from all relevant medical specialization fields which were using intravascular contrast administration in their field.

All GDG members have been officially delegated for participation in the GDG by their scientific societies. The GDG has developed a guideline in the period from June 2022 until July 2024. The GDG is responsible for the complete text of this guideline.

Guideline development group

• de Graaf N. (Nanko), chair guideline development group, radiologist, Erasmus Medical Center, Rotterdam
• Den Dekker M.A.M. (Martijn), radiologist, Ziekenhuis ZorgSaam
• Emons J.A.M. (Joyce), paediatric allergist, Sophia Children’s Hospital, Erasmus Medical Center, Rotterdam
• Geenen R.W.F. (Remy), radiologist, Noordwest Ziekenhuisgroep, Alkmaar
• Jöbsis, J.J. (Jasper), paediatrician and nephrologist, Onze Lieve Vrouwe Gasthuis, Amsterdam
• Liebrand C.A. (Chantal), anaesthesiologist, Erasmus Medical Centre, Rotterdam
• Sloots C.E.J. (Pim), surgeon, Erasmus Medical Centre, Rotterdam
• Zwaveling-Soonawala N. (Nitash), paediatrician -endocrinologist, Amsterdam University Medical Center, Amsterdam.

Advisory group

• Doganer E.C. (Esen), Kind & Ziekenhuis, Patient representative
• Riedijk M.A. (Maaike), paediatrician and intensive care physician, Emma Hospital, Amsterdam University Medical Centre
• Van der Molen A.J. (Aart), radiologist, Leiden University Medical Centre, Leiden

Methodological support

•          Houtepen L.C. (Lotte), advisor, Knowledge Institute of the Federation Medical Specialists

•          Mostovaya I.M. (Irina), senior advisor, Knowledge Institute of the Federation Medical Specialists

Input of patient’s perspective

The guideline does not address a specific child patient group, but a diverse set of diagnoses. Therefore, it was decided to invite a broad spectrum of patient organisations for the stakeholder consultation, and invite the patient organisation Kind & Ziekenhuis (translated as Child and Hospital Foundation) in the Advisory group. The stakeholder consultation was performed at the beginning of the process for feedbacking on the framework of subjects and clinical questions addressed in the guideline, and during the commentary phase to provide feedback on the concept guideline. The list of organisations which were invited for the stakeholder consultation can be requested from the Kennisinstituut van de Federatie Medisch Specialisten (secretariaat@kennisinstituut.nl). In addition, patient information on safe use of contrast media in children was developed for Thuisarts.nl, a platform to inform patients about health and disease.

Implementation

During different phases of the guideline development, implementation and practical enforceability of the guideline were considered. 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 in the ‘Appendices to modules’. Furthermore, quality indicators were developed to enhance the implementation of the guideline. The indicators can also be found in the ‘Appendices to modules’.

Methodology

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 (www.kwaliteitskoepel.nl). 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 based 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 GDG identified the relevant subject matter for the guideline. The framework is consisted of both new matters, which were not yet addressed in Part 1, 2 and 3 of the guideline, and an update of matters that were subject to modification (for example in case of new published literature). Furthermore, a stakeholder consultation was performed, whre input on the framework was requested.

Clinical questions and outcomes

The outcome of the stakeholder consultation was discussed with the GDG, after which definitive clinical questions were formulated. Subsequently, the GDG formulated relevant outcome measures (both beneficial and harmful effects). The GDG rated the outcome measures as critical, important and of limited importance (GRADE method). Furthermore, where applicable, the GDG defined relevant clinical differences.

Search and select

For clinical questions, specific search strategies were formulated, and scientific articles published in several electronic databases were searched. First, the studies that potentially had the highest quality of research were reviewed. The GDG selected literature in pairs (independently of each other) based on the title and abstract. A second selection was performed by the methodological advisor based on full text. The databases used, selection criteria and number of included articles can be found in the modules, the search strategy can be found in the appendix.

Quality assessment of individual studies

Individual studies were systematically assessed, based on methodological quality criteria that were determined prior to the search. For systematic reviews, a combination of the AMSTAR checklist and PRISMA checklist was used. For RCTs the Cochrane risk of bias tool and suggestions by the CLARITY Group at McMaster University were used, and for cohort studies/observational studies the risk of bias tool by the CLARITY Group at McMaster University was used. The risk of bias tables can be found in the separate document “Appendices to modules”.

Summary of literature

The relevant research findings of all selected articles were shown in evidence tables. The evidence tables can be found in the separate document “Appendices to modules”. The most important findings in literature were 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 included studies 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 levels for the quality of scientific evidence: high, moderate, low, or very low. These levels provide information about the certainty level of the literature conclusions (http://www.guidelinedevelopment.org/handbook).

The evidence was summarized in the literature analysis, followed by one or more conclusions, drawn from the body of evidence. The level of evidence for the conclusions can be found above the conclusions. Aspects such as expertise of GDG members, local expertise, patient preferences, costs, availability of facilities and organisation of healthcare are important to consider when formulating a recommendation. These aspects are discussed in the paragraph “Justifications”. The recommendations provide an answer to the clinical question or help to increase awareness and were based on the available scientific evidence and the most relevant “Justifications”.

Appendices

Internal (meant for use by scientific society or its members) quality indicators were developed during the conception of the guideline and can be found in the separate document “Appendices to modules”. In most cases, indicators were not applicable. For most questions, additional scientific research on the subject is warranted. Therefore, the GDG formulated knowledge gaps to aid in future research, which can be found in the separate document “Appendices to modules”.

Commentary and authorisation phase

The concept guideline was subjected to commentaries by the involved scientific societies. The list of parties that participated in the commentary phase can be requested from the Kennisinstituut van de Federatie Medisch Specialisten (secretariaat@kennisinstituut.nl).
The commentaries were collected and discussed with the GDG. The feedback was used to improve the guideline; afterwards the guideline was made definitive by the GDG. The final version of the guideline was offered to the involved scientific societies for authorization and was authorized.

Literature

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 Kwaliteit, 2012. Available at: [URL].

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: [URL].

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):1106-1110. Erratum published in: BMJ 2008;336(7654).

Ontwikkeling van Medisch Specialistische Richtlijnen: stappenplan. Kennisinstituut van Medisch Specialisten, 2020.

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