Terug naar zoekresultaten

Veilig gebruik van contrastmiddelen

Volgen
Initiatief: NVvR Aantal modules: 54
Bijlagen
Download richtlijn

Prophylaxis of hypersensitivity reactions

Beoordeeld: 01-12-2024

Uitgangsvraag

Welke profylactische maatregelen moeten worden genomen bij kinderen (<18 jaar) met een verhoogd risico op overgevoeligheidsreacties na toediening van jodiumhoudende contrastmiddelen?

Aanbeveling

Overweeg een alternatieve beeldvormingsmodaliteit bij alle patiënten met een (gedocumenteerde) geschiedenis van een overgevoeligheidsreactie voor een contrastmiddel. Indien dit niet mogelijk is, overweeg het uitvoeren van het onderzoek zonder contrastmiddel, indien de reductie van diagnostische kwaliteit acceptabel is.

 

  • Indien de vorige overgevoeligheidsreactie mild* was:

Voer het radiologisch onderzoek uit zoals gebruikelijk gezien het lage risico op het ontwikkelen van een meer ernstige reactie.

Bij twijfel aan de ernst van de vorige overgevoeligheidsreactie: overweeg om de patiënt te verwijzen naar een allergoloog.

 

  • Indien de vorige overgevoeligheidsreactie matig tot ernstig** was:

Verwijs patiënt naar een allergoloog. Indien mogelijk, stel het beeldvormend onderzoek uit totdat de resultaten van de huidtesten bekend zijn. Pas het advies van de allergoloog toe met betrekking tot het kiezen van een alternatief contrastmiddel.

 

  • Indien acuut onderzoek noodzakelijk is:

Kies voor een alternatief contrastmiddel (obv lage kruisreactiviteit) of een alternatieve beeldvormingsmodaliteit zoals eerder beschreven. Indien het verdachte contrastmiddel van een eerdere reactie niet bekend is of er geen alternatief gegeven kan worden, wordt geadviseerd eerst 10% van de contrastmiddeldosis te geven. Observeer de patiënt minimaal 30 min met een infuus alvorens de overige 90% toe te dienen. Wees waakzaam om te reageren op een mogelijke nieuwe overgevoeligheidsreactie (zie module behandeling acute overgevoeligheidsreactie). De kans op een allergische reactie is heel klein en de kans op een eventuele ernstige allergische reactie wordt zo nog verder verkleint.

 

*milde reacties: alleen symptomen van de huid (erytheem, enkele urticaria, mild angio-oedeem, jeuk), rhinitis en/of conjunctivitis, niezen, kriebel in de keel.

 

**matig tot ernstige reacties: gegeneraliseerde urticaria, respiratoire klachten met stridor (expiratoir en/of inspiratoir), heesheid, zwelling van de tong en/of pharynx, herhaaldelijk braken, hypotensie, bewustzijnsverlies, shock.

 

NB bovenstaande laat het belang van een goede documentatie van symptomen van de reactie zien. Documenteer de naam en dosis van het gebruikte contrastmiddel in het radiologische verslag van het onderzoek en/of bij de beelden van het onderzoek.

Overwegingen

Pros and cons of the intervention and quality of evidence

The guideline development group conducted a systematic review of the optimal prophylactic treatment for acute and delayed hypersensitivity reactions to contrast agents. No articles were found that met the inclusion criteria. In most studies that included children and adults the average age was over 50 years and only few children were included. Therefore, no conclusions could be drawn about the effects of prophylactic treatments to prevent allergic / hypersensitivity reactions to contrast material in children. Consequently, a knowledge gap exists on this topic. A recent review however, suggests to be cautious about the use of corticosteroid premedication (Maloney, 2019).

 

As there are no comparative studies investigating the research question, the recommendations in this national guideline are based mainly on the guideline for prophylactic measures to prevent hypersensitivity reactions to contrast in adults (NVVR, 2022).

 

Literature shows that the prevalence of hypersensitivity reaction in children is very low, they experience less hypersensitivity reactions to contrast media compared to adults (Endrikat, 2022). In addition, severe reactions are very rare in children. A large retrospective study in the US found an incidence of 0.46% hypersensitivity reactions to contrast material in 12,494 patients. Most of these were mild (47 of 57 in total) and no severe reaction (Callahan, 2009). However, severe reactions with anaphylaxis have been described in pediatric patients (Dillman, 2007). In case of a severe reaction intramuscular adrenalin administration is the main treatment (see the module about Treatment of acute hypersensitivity reaction in children).

 

Pharmacologial prevention

For adults the evidence in the guideline regarding the effectivity for pharmacological prevention is very heterogeneous and of low quality. Prophylactic premedication mainly reduces the number of mild reactions and therefore the total number of reactions, but not the number of severe reactions. There is no evidence that this is different in children. One recent meta-analysis with five studies in patients with previous moderate to severe hypersensitivity reactions described a reduction in reactions with steroid premedication. However, there were several study limitations and only a few children were included (Hsieh, 2022). Therefore, in line with the Dutch guideline for adults, the guideline development group does not recommend premedication for children.

 

In line with the Dutch guideline for adults, major international guidelines do not recommend the use of premedication for non-severe nonimmediate reactions, however in case of more severe reactions they suggest performing allergologic skin testing and referral to an allergist (ACR, 2023; ESUR, 2018; Shaker 2020; Torres, 2021).

 

Antihistamines and corticosteroids

If premedication is required, two types of drugs are used: H1-antihistamines and corticosteroids. Often, they are used concomitantly, making their individual effect difficult to assess, particularly since there are many variations in premedication schedules. However, both have side effects that one should be aware of.

 

H1-antihistamines block histamine receptors on various effector cells, blocking the effect of one of the pivotal players in direct mast cell responses. However, mast cells and basophils secrete various other substances that are not blocked by these drugs. The main side effect of the older H1-antihistamines that are available for intravenous administration is drowsiness/sedation, but they also have a negative effect on blood pressure. Clemastine (Tavegyl) is one of the H1-antihistamines that is still widely used in treating allergic symptoms or as premedication and should be used with caution for this reason. For the newer nonsedating antihistamines this effect is usually mild, but these are mainly available for oral administration.

 

Corticosteroids have various effects on the immune system, including mast cells, and therefore can block both mast cell degranulation by upregulating inhibitory signaling receptors, and inhibit cytokine production through suppression of gene transcription. (Andrade, 2004; Park, 2009) These membrane stabilizing effects require that administration is started >6h before contrast media administration. Unfortunately, this comes with a less favourable side effect profile, particularly with higher doses and repeated exposure. It has been shown that corticosteroid premedication can cause brief hyperglycaemia (Davenport, 2010), but may also be associated with longer hospital stay, increased costs, and worse clinical outcomes (Davenport, 2016).

 

There are two widely used premedication protocols; the Greenberger and Lasser protocol in which high doses of corticosteroids and antihistamines (diphenhydramine) are used. (Greenberger, 1981; Greenberger, 1986; Lasser, 1994). In the Netherlands steroids and clemastine (Tavegyl®) are frequently used as premedication in elective procedures. There is no literature available to establish an optimal indication or protocol.

 

Pediatric medication dose:

  • Prednisolone 1mg/kg with a max of 20 mg IV. 12h and 2h before the procedure.
  • Clemastin IV 25-50 microgram/kg/dose with a max of 2mg. 1h before the procedure (Tmax within minutes). Note: this can give drowsiness/sedation.

In conclusion, there is a paucity of data on the benefits of premedication for hypersensitivity reactions in adults and even less in paediatric patients. Most of these reactions are self-limiting or can be treated symptomatically. In patients with a (documented) history of a hypersensitivity reaction to a contrast medium, an alternative imaging modality should be considered. The more severe the reaction, the stronger omitting a contrast medium should be considered. For mild reactions in which alternative imaging modalities are of substantially inferior quality, the risk – benefit ratio may shift. In many cases, CT with iodine-based contrast media can be replaced by ultrasound, with or without contrast agents, or MRI, with or without contrast agents. When this is not possible, consider performing the examination or imaging study without a contrast medium or with an alternative contrast medium (see next paragraph), but only if this has an acceptable degree of diagnostic quality. For this, close communication with the referring specialist is mandatory. Finally, in case of a suspected hypersensitivity, patients should be referred to a paediatric allergist.

 

Cross-reactivity between iodine-based contrast media (ICM):

Schrijvers (2018) found most cross-reactivity between agents with a N-(2,3 dihydroxypropyl)-carbamoyl side chain. This side chain is present in most media used in The Netherlands (Iopromide, Iohexol, Iomeprol, Ioversol and Iodixanol), but not in Iobitridol and Iopamidol. The table below shows cross-reactivity rates between pairs of ICM in skin positive patients with immediate hypersensitivity reactions. Risk of cross-reactivity is marked as very low (dark green, <10%), low (green, 10-20%), medium (orange 20-30%), high (red, 30-50%) and very high (dark red, >50%).

 

Table 1: Cross-reactivity rates between pairs of ICM in skin positive patients. The guideline for prophylactic measures to prevent hypersensitivity reactions to contrast in adults (NVVR, 2022).

 

Documentation of contrast medium

To prevent administration of a specific contrast media that previously triggered an allergic reaction, proper documentation in the electronic patient record (EPR) has become very important. In line with the recommendation in the guideline for prophylactic measures to prevent hypersensitivity reactions to contrast in adults (NVVR, 2022), the guideline development group recommends documenting the specific contrast medium name and dose which were administered to the patient in the imaging report and/or with the stored images.

 

Patient (and their caretakers) values and preferences

Allergic reactions can be a cause of concern for patients and their caregivers, especially if they have experienced allergic reactions in the past. It is important to inform patients that allergic reactions to contrast media are extremely rare in pediatric patients. Patients with previous allergic reactions often expect precautionary steps, but this is not always indicated. Time should be taken to discuss the reasoning for adapting the procedure (or not). There is no evidence that premedication reduces the risk of severe reactions. In case of a severe reaction, it is best to use a substitute contrast medium and when there is enough time to consult an allergist. It’s important to document previous reactions with timing of onset and type of symptoms, preferably with pictures of skin reactions. This helps the allergist to classify the type of hypersensitivity reaction and subsequently to give a good advice.

In case of an underlying disease like eczema of chronic spontaneous urticaria it is advised to inform the patient that the procedure can cause an increase in symptoms and patients should use their own medication more intensively before and after the procedure.

In case of using premedication, patients should be warned regarding the side effects of corticosteroids and clemastine. Second generation antihistamines have less side effects.

 

Costs

Severe hypersensitivity reactions are associated with additional healthcare costs. Currently physicians are likely to be extra careful in children and thus order additional (and often unnecessary) premedication and interventions for all children who have a hypersensitivity reaction in their history. The recommendations in this guideline can prevent unnecessary use of premedication in specific subgroups (such as for non-severe nonimmediate reactions), while simultaneously preventing unnecessary incidents of hypersensitivity reactions. In addition, there is evidence that corticosteroid premedication can enhance a prolonged hospital stay (Davenport 2017)

 

Acceptability, feasibility and implementation

The guideline development group does not anticipate any acceptance issues. The recommendations in the current guideline address longstanding uncertainty about the need for prophylactic measures to prevent hypersensitivity reactions. Therefore, it will contribute to a more unified and equal approach in children.

 

Rationale of the recommendations: weighing arguments for and against the interventions

There is a paucity of data on the benefits of prophylactic measures including premedication for prevention of recurrent hypersensitivity reactions in paediatric patients. Hypersensitivity reactions are very rare and most of these reactions are classified as mild and self-limiting.
In patients with a (documented) history of a hypersensitivity reaction to a contrast medium, an alternative imaging modality or a different contrast medium should be considered. In case of a more severe reaction a paediatric allergist should be consulted additionally. This recommendation contributes to a more unified and equal approach for prophylactic measures to prevent hypersensitivity reactions in children. One should be aware of unnecessary use of premedication in specific subgroups. Physicians are likely to accept the current recommendations, but it will be important to carefully inform patients and their caregivers regarding the low risk and possible side effects of premedication. Especially those patients who have experienced a mild allergic reaction in the past.

The risk of a severe allergic reaction is very rare, however staff should be trained how to treat and handle possible allergic symptoms that can occur.

Onderbouwing

The incidence of hypersensitivity reactions to Iodinated contrast administration is 0.18-0.46% in paediatric patients (Callahan, 2009; Dillman 2007). The incidence decreased after the switch to non-ionic iodine-based contrast media, which are the only ones still used in the Netherlands. Most of these reactions are mild to moderate, while severe reactions are very rare, especially in children. The most important risk factor for an allergic-like reaction is an history of an allergic reaction to contrast media. There is no consensus with respect to the prophylactic treatment in children with a higher risk of hypersensitivity reactions to contrast media. Furthermore, the current guideline “Safe use of contrast media” lacks advice regarding the treatment in pediatric patients in clinical practice.

- GRADE

No evidence was found regarding the effect of prophylactic measures to prevent allergic / hypersensitivity reactions to contrast in children (<18 years of age) undergoing radiological examinations.

Description of studies

No studies were included in the analysis of the literature.

 

Results

No studies were included in the analysis of the literature.

 

Level of evidence of the literature

The level of evidence could not be determined as no studies were included in the analysis of the literature.

A systematic review of the literature was performed to answer the following question:

Which prophylactic treatments should be used in children (<18 years) undergoing radiological examinations with iodine-based contrast agents to prevent symptoms of hypersensitivity reactions compared to other or no treatments?

 

P(atients): Children (<18 years) undergoing radiological examinations with iodine-based contrast media.
I(ntervention): Prophylactic measure to prevent hypersensitivity reactions after contrast media administration.
C(ontrol): No prophylactic measure or a different prophylactic measure to prevent hypersensitivity reactions after contrast media administration.
O(utcome):

Allergic reactions to contrast media, hypersensitivity reactions, type I/ type IV, severe allergic reaction.

 

Relevant outcome measures

The guideline development group considered allergic / hypersensitivity reactions to contrast as critical outcome measure for decision making.

 

A priori, the guideline development group did not define the outcome measures listed above but used the definitions used in the studies.

 

The guideline development group defined the following as a minimal clinically (patient) important difference:

  • allergic / hypersensitivity reactions to contrast: relative risk ≤0.8 or ≥1.25 (dichotomous); 0.5 SD (continuous)

Search and select (Methods)

The databases Medline (via OVID) and Embase (via Embase.com) were searched with relevant search terms from 1990 until 24-02-2023. The detailed search strategy is depicted under the tab Methods. The systematic literature search resulted in 201 hits. Studies were selected based on the following criteria:

  • Systematic review, randomized controlled trial, or observational research comparing prophylactic measures to prevent hypersensitivity reactions after contrast administration to other or no prophylactic measurements.
  • Including children (<18 years) undergoing radiological examinations with contrast media.
  • Reports predefined outcome measure: allergic / hypersensitivity reactions to contrast.

53 studies were initially selected based on title and abstract screening. After reading the full text, all studies were excluded (see the table with reasons for exclusion under the tab Methods), and no studies were included.

 

Results

No studies were included in the analysis of the literature.

  1. American College of Radiology. ACR Manual on contrast media, v2023.
  2. Andrade MV, Hiragun T, Beaven MA. Dexamethasone suppresses antigen-induced activation of phosphatidylinositol 3-kinase and downstream responses in mast cells. J Immunol. 2004 Jun 15;172(12):7254-62. doi: 10.4049/jimmunol.172.12.7254. PMID: 15187100.
  3. Callahan MJ, Poznauskis L, Zurakowski D, Taylor GA. Nonionic iodinated intravenous contrast material-related reactions: incidence in large urban children's hospital--retrospective analysis of data in 12,494 patients. Radiology. 2009 Mar;250(3):674-81. doi: 10.1148/radiol.2503071577. PMID: 19244041.
  4. Davenport MS, Cohan RH, Caoili EM, Ellis JH. Hyperglycemic consequences of corticosteroid premedication in an outpatient population. AJR Am J Roentgenol. 2010 Jun;194(6):W483-8. doi: 10.2214/AJR.09.3906. PMID: 20489066.
  5. Davenport MS, Mervak BM, Ellis JH, Dillman JR, Dunnick NR, Cohan RH. Indirect Cost and Harm Attributable to Oral 13-Hour Inpatient Corticosteroid Prophylaxis before Contrast-enhanced CT. Radiology. 2016 May;279(2):492-501. doi: 10.1148/radiol.2015151143. Epub 2015 Nov 4. PMID: 26536404.
  6. Dillman JR, Strouse PJ, Ellis JH, Cohan RH, Jan SC. Incidence and severity of acute allergic-like reactions to i.v. nonionic iodinated contrast material in children. AJR Am J Roentgenol. 2007 Jun;188(6):1643-7. doi: 10.2214/AJR.06.1328. Erratum in: AJR Am J Roentgenol. 2007 Sep;189(3):512. PMID: 17515388.
  7. Endrikat J, Chernova J, Gerlinger C, Pracz M, Lengsfeld P, Bhatti A, Michel A. Risk of Hypersensitivity Reactions to Iopromide in Children and Elderly: An Analysis of 132,850 Patients From 4 Observational Studies and Pharmacovigilance Covering >288 Million Administrations. Invest Radiol. 2022 May 1;57(5):318-326. doi: 10.1097/RLI.0000000000000840. PMID: 34860739; PMCID: PMC8983946.
  8. European Society of Urogenital Radiology Contrast Media Safety Committee. ESUR Guidelines on contrast safety, v10, 2018. Available at: https://www.esur.org/wp-content/uploads/2022/03/ESUR-Guidelines-10_0-Final-Version.pdf.
  9. Hsieh C, Wu SC, Kosik RO, Huang YC, Chan WP. Pharmacological Prevention of Hypersensitivity Reactions Caused by Iodinated Contrast Media: A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2022 Jul 9;12(7):1673. doi: 10.3390/diagnostics12071673. PMID: 35885578; PMCID: PMC9320945.
  10. NVvR, 2022. Richtlijn Veilig gebruik van contrastmiddelen - Module Profylactische maatregelen om hypersensitiviteitsreacties na contrastmiddel (CM) te voorkomen. Beoordeeld: 28-11-2022.
  11. Park SK, Beaven MA. Mechanism of upregulation of the inhibitory regulator, src-like adaptor protein (SLAP), by glucocorticoids in mast cells. Mol Immunol. 2009 Jan;46(3):492-7. doi: 10.1016/j.molimm.2008.10.011. Epub 2008 Nov 25. PMID: 19036452; PMCID: PMC2656921.
  12. Shaker MS, Wallace DV, Golden DBK, Oppenheimer J, Bernstein JA, Campbell RL, Dinakar C, Ellis A, Greenhawt M, Khan DA, Lang DM, Lang ES, Lieberman JA, Portnoy J, Rank MA, Stukus DR, Wang J; Collaborators; Riblet N, Bobrownicki AMP, Bontrager T, Dusin J, Foley J, Frederick B, Fregene E, Hellerstedt S, Hassan F, Hess K, Horner C, Huntington K, Kasireddy P, Keeler D, Kim B, Lieberman P, Lindhorst E, McEnany F, Milbank J, Murphy H, Pando O, Patel AK, Ratliff N, Rhodes R, Robertson K, Scott H, Snell A, Sullivan R, Trivedi V, Wickham A; Chief Editors; Shaker MS, Wallace DV; Workgroup Contributors; Shaker MS, Wallace DV, Bernstein JA, Campbell RL, Dinakar C, Ellis A, Golden DBK, Greenhawt M, Lieberman JA, Rank MA, Stukus DR, Wang J; Joint Task Force on Practice Parameters Reviewers; Shaker MS, Wallace DV, Golden DBK, Bernstein JA, Dinakar C, Ellis A, Greenhawt M, Horner C, Khan DA, Lieberman JA, Oppenheimer J, Rank MA, Shaker MS, Stukus DR, Wang J. Anaphylaxis-a 2020 practice parameter update, systematic review, and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) analysis. J Allergy Clin Immunol. 2020 Apr;145(4):1082-1123. doi: 10.1016/j.jaci.2020.01.017. Epub 2020 Jan 28. PMID: 32001253.
  13. Torres MJ, Trautmann A, Böhm I, Scherer K, Barbaud A, Bavbek S, Bonadonna P, Cernadas JR, Chiriac AM, Gaeta F, Gimenez-Arnau AM, Kang HR, Moreno E, Brockow K. Practice parameters for diagnosing and managing iodinated contrast media hypersensitivity. Allergy. 2021 May;76(5):1325-1339. doi: 10.1111/all.14656. PMID: 33170954.

Niet van toepassing bij deze richtijnmodule.

 

Table of excluded studies

Reference

Reason for exclusion

Hsieh C, Wu SC, Kosik RO, Huang YC, Chan WP. Pharmacological Prevention of Hypersensitivity Reactions Caused by Iodinated Contrast Media: A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2022 Jul 9;12(7):1673. doi: 10.3390/diagnostics12071673. PMID: 35885578; PMCID: PMC9320945.

 

Wrong population

Iordache, A. M. and Docea, A. O. and Buga, A. M. and Mitrut, R. and Albulescu, D. and Zlatian, O. and Ianosi, S. and Ianosi, G. and Neagoe, D. and Sifaki, M. and Rogoveanu, O. C. and Branisteanu, D. E. and Calina, D. The incidence of skin lesions in contrast media-induced chemical hypersensitivity. Experimental and Therapeutic Medicine. 2019; 17 (2) :1113-1124

 

Wrong treatment, wrong population

 

Lindsay, R. and Paterson, A. and Edgar, D. Preparing for severe contrast media reactions in children - Results of a national survey, a literature review and a suggested protocol. Clinical Radiology. 2011; 66 (4) :340-348

 

Wrong design

 

Hunt, C. H. and Hartman, R. P. and Hesley, G. K. Frequency and severity of adverse effects of iodinated and gadolinium contrast materials: Retrospective review of 456,930 doses. American Journal of Roentgenology. 2009; 193 (4) :1124-1127

 

Wrong population

 

Mervak, B. M. and Davenport, M. S. and Ellis, J. H. and Cohan, R. H. Rates of breakthrough reactions in inpatients at high risk receiving premedication before contrast-enhanced CT. American Journal of Roentgenology. 2015; 205 (1) :77-84

 

Wrong population

 

Thomas, M. and Peedicayil, J. and Koshi, T. and Korah, I. Adverse reactions to radiocontrast media in an Indian population. British Journal of Radiology. 1999; 72 :648-652

 

Wrong population

 

Vogl, T. J. and Honold, E. and Wolf, M. and Mohajeri, H. and Hammerstingl, R. Safety of iobitridol in the general population and at-risk patients. European Radiology. 2006; 16 (6) :1288-1297

 

Wrong population

Andrade PHS, Lobo IMF, da Silva WB. Risk factors for adverse drug reactions in pediatric inpatients: A cohort study. PLoS One. 2017 Aug 1;12(8):e0182327. doi: 10.1371/journal.pone.0182327. PMID: 28763499; PMCID: PMC5538648.

 

Wrong design, wrong treatment

 

Callahan, M. J. and Poznauskis, L. and Zurakowski, D. and Taylor, G. A. Nonionic Lodinated intravenous contrast material-related reactions: Incidence in large Urban children's hospital-retrospective analysis of data in 12 494 patients. Radiology. 2009; 250 (3) :674-681

 

Wrong design, wrong treatment

Connor, S. E. J. and Banerjee, A. K. and Dawkins, D. M. Intravenous contrast media: Are they being administered safely in radiology departments?. British Journal of Radiology. 1997; 70 :1104-1108

Wrong design

 

Davenport, M. S. and Cohan, R. H. and Caoili, E. M. and Ellis, J. H. Repeat contrast medium reactions in premedicated patients: Frequency and severity. Radiology. 2009; 253 (2) :372-379

 

Wrong population, wrong treatment

 

Dewachter, P. and Laroche, D. and Mouton-Faivre, C. and Bloch-Morot, E. and Cercueil, J. P. and Metge, L. and Carette, M. F. and Vergnaud, M. C. and Clément, O. Immediate reactions following iodinated contrast media injection: A study of 38 cases. European Journal of Radiology. 2011; 77 (3) :495-501

 

Wrong treatment, wrong population

Dillman, J. R. and Strouse, P. J. and Ellis, J. H. and Cohan, R. H. and Jan, S. C. Incidence and severity of acute allergic-like reactions to i.v. nonionic iodinated contrast material in children. AJR. American Journal of Roentgenology. 2007; 188 (6) :1643-7

 

Wrong design

 

Douglas, D. M. and Sukenick, E. and Andrade, W. P. and Brown, J. S. Biphasic systemic anaphylaxis: An inpatient and outpatient study. Journal of Allergy and Clinical Immunology. 1994; 93 (6) :977-985

Wrong treatment

Endrikat, J. and Chernova, J. and Gerlinger, C. and Pracz, M. and Lengsfeld, P. and Bhatti, A. and Michel, A. Risk of Hypersensitivity Reactions to Iopromide in Children and Elderly: An Analysis of 132,850 Patients From 4 Observational Studies and Pharmacovigilance Covering >288 Million Administrations. Investigative Radiology. 2022; 57 (5) :318-326

 

Wrong design, wrong treatment

 

Gottumukkala, R. V. and Glover, M. and Yun, B. J. and Sonis, J. D. and Kalra, M. K. and Otrakji, A. and Raja, A. S. and Prabhakar, A. M. Allergic-like contrast reactions in the ED: Incidence, management, and impact on patient disposition. American Journal of Emergency Medicine. 2018; 36 (5) :825-828

 

Wrong population, wrong design

Brar, S. S. and Aharonian, V. and Mansukhani, P. and Moore, N. and Shen, A. Y. J. and Jorgensen, M. and Dua, A. and Short, L. and Kane, K. Haemodynamic-guided fluid administration for the prevention of contrast-induced acute kidney injury: The POSEIDON randomised controlled trial. The Lancet. 2014; 383 (9931) :1814-1823

Wrong population, wrong treatment

Chen, J. Y. and Liu, Y. and Zhou, Y. L. and Tan, N. and Zhang, B. and Chen, P. Y. and Chen, L. B. Safety and tolerability of iopromide in patients undergoing cardiac catheterization: real-world multicenter experience with 17,513 patients from the TRUST trial. International Journal of Cardiovascular Imaging. 2015; 31 (7) :1281-1291

 

Wrong population

Laroche, D. and Aimone-Gastin, I. and Dubois, F. and Huet, H. and Gérard, P. and Vergnaud, M. C. and Mouton-Faivre, C. and Guéant, J. L. and Laxenaire, M. C. and Bricard, H. Mechanisms of severe, immediate reactions to iodinated contrast material. Radiology. 1998; 209 (1) :183-190

Wrong treatment, wrong design

Lövborg, H. and Eriksson, L. R. and Jönsson, A. K. and Bradley, T. and Hägg, S. A prospective analysis of the preventability of adverse drug reactions reported in Sweden. European Journal of Clinical Pharmacology. 2012; 68 (8) :1183-1189

 

Wrong population, wrong treatment

 

 

Mortelé, K. J. and Oliva, M. R. and Ondategui, S. and Ros, P. R. and Silverman, S. G. Universal use of nonionic iodinated contrast medium for CT: Evaluation of safety in a large urban teaching hospital. American Journal of Roentgenology. 2005; 184 (1) :31-34

Wrong design, wrong population

 

Power, S. and Talbot, N. and Kucharczyk, W. and Mandell, D. M. Allergic-like reactions to the MR imaging contrast agent gadobutrol: A prospective study of 32 991 consecutive injections. Radiology. 2016; 281 (1) :72-77

Wrong design, wrong population

Pradubpongsa, P. and Dhana, N. and Jongjarearnprasert, K. and Janpanich, S. and Thongngarm, T. Adverse reactions to iodinated contrast media: Prevalence, risk factors and outcome - The results of a 3-year period. Asian Pacific Journal of Allergy and Immunology. 2013; 31 (4) :299-306

 

Wrong study, wrong population

 

Muskula PR, Main ML. Safety With Echocardiographic Contrast Agents. Circ Cardiovasc Imaging. 2017 Apr;10(4):e005459. doi: 10.1161/CIRCIMAGING.116.005459. PMID: 28377467.

 

Wrong design

 

Pagani S, Lombardi N, Crescioli G, Vighi VG, Spada G, Andreetta P, Capuano A, Vannacci A, Venegoni M, Vighi GD, On Behalf Of The MEREAFaPS Study Group. Drug-Related Hypersensitivity Reactions Leading to Emergency Department: Original Data and Systematic Review. J Clin Med. 2022 May 16;11(10):2811. doi: 10.3390/jcm11102811. PMID: 35628936; PMCID: PMC9143688.

 

Wrong population

 

van der Molen, A. J. and Dekkers, I. A. and Bedioune, I. and Darmon-Kern, E. A systematic review of the incidence of hypersensitivity reactions and post-contrast acute kidney injury after ioversol: part 2—intra-arterial administration. European Radiology. 2022; 32 (8) :5546-5558

 

Wrong population, wrong treatment

 

Tian, X. Y. and Liu, B. and Shi, H. and Zhao, Z. R. and Zhou, X. P. and Zhang, T. and Sun, Q. N. and Zuo, Y. G. Incidence of adverse cutaneous drug reactions in 22,866 Chinese inpatients: a prospective study. Archives of Dermatological Research. 2015; 307 (9) :829-834

 

Wrong population, wrong treatment

 

Katsogiannou, M. and Carsin, A. and Mazenq, J. and Dubus, J. C. and Gervoise-Boyer, M. J. Drug hypersensitivity in children: a retrospective analysis of 101 pharmacovigilance reports. European Journal of Pediatrics. 2021; 180 (2) :495-503

 

Wrong design

 

Kim, Y. S. and Choi, Y. H. and Cho, Y. J. and Lee, S. and Yoon, S. H. and Park, C. M. and Kang, H. R. Incidence of breakthrough reaction in patients with prior acute allergic-like reactions to iodinated contrast media according to the administration route. Korean Journal of Radiology. 2018; 19 (2) :352-357

 

Wrong population, wrong treatment

 

Kyung EJ, Ryu JH, Kim EY. Evaluation of adverse reactions to contrast media in the hospital. Br J Radiol. 2013 Dec;86(1032):20130418. doi: 10.1259/bjr.20130418. Epub 2013 Nov 4. PMID: 24191123; PMCID: PMC3856550.

Wrong population, wrong design

 

Li X, Chen J, Zhang L, Liu H, Wang S, Chen X, Fang J, Wang S, Zhang W. Clinical observation of the adverse drug reactions caused by non-ionic iodinated contrast media: results from 109,255 cases who underwent enhanced CT examination in Chongqing, China. Br J Radiol. 2015 Mar;88(1047):20140491. doi: 10.1259/bjr.20140491. Epub 2015 Jan 13. PMID: 25582519; PMCID: PMC4651201.

 

Wrong population, wrong treatment

 

Li X, Liu H, Zhao L, Liu J, Cai L, Liu L, Zhang W. Clinical observation of adverse drug reactions to non-ionic iodinated contrast media in population with underlying diseases and risk factors. Br J Radiol. 2017 Feb;90(1070):20160729. doi: 10.1259/bjr.20160729. Epub 2016 Dec 8. PMID: 27928926; PMCID: PMC5685114.

 

Wrong population, wrong treatment

 

McDonald, J. S. and Larson, N. B. and Kolbe, A. B. and Hunt, C. H. and Schmitz, J. J. and Maddox, D. E. and Hartman, R. P. and Kallmes, D. F. and McDonald, R. J. Prevention of allergic-like reactions at repeat CT: Steroid pretreatment versus contrast material substitution. Radiology. 2021; 301 (1) :133-140

 

Wrong population

 

Nguyen, K. D. and Nguyen, H. A. and Vu, D. H. and Le, T. T. L. and Nguyen, H. A. and Dang, B. V. and Nguyen, T. N. and Nguyen, D. H. and Nguyen, T. B. and Montastruc, J. L. and Bagheri, H. Drug-Induced Anaphylaxis in a Vietnamese Pharmacovigilance Database: Trends and Specific Signals from a Disproportionality Analysis. Drug Safety. 2019; 42 (5) :671-682

 

Wrong treatment, wrong population

 

Nie X, Yu Y, Jia L, Zhao H, Chen Z, Zhang L, Cheng X, Lyu Y, Cao W, Wang X, Peng X. Signal Detection of Pediatric Drug-Induced Coagulopathy Using Routine Electronic Health Records. Front Pharmacol. 2022 Jul 20;13:935627. doi: 10.3389/fphar.2022.935627. PMID: 35935826; PMCID: PMC9348591.

 

Wrong treatment

 

Ryu J, Lee H, Suh J, Yang M, Kang W, Kim E. Differences between Drug-Induced and Contrast Media-Induced Adverse Reactions Based on Spontaneously Reported Adverse Drug Reactions. PLoS One. 2015 Nov 6;10(11):e0142418. doi: 10.1371/journal.pone.0142418. PMID: 26544039; PMCID: PMC4636266.

 

Wrong treatment,  wrong population

 

Schrijvers, R. and Breynaert, C. and Ahmedali, Y. and Bourrain, J. L. and Demoly, P. and Chiriac, A. M. Skin Testing for Suspected Iodinated Contrast Media Hypersensitivity. Journal of Allergy and Clinical Immunology: In Practice. 2018; 6 (4) :1246-1254

Wrong treatment, wrong population

 

Schumacher, G. and Genz, Th and Lorenz, H. P. and Buhlmeyer, K. Actual risk of cardiac catheterization and angiocardiography in infancy and childhood. A prospective study. Zeitschrift fur Kardiologie. 1990; 79 (5) :324-335

 

Wrong design

 

Tofil, N. M. and White, M. L. and Grant, M. and Zinkan, J. L. and Patel, B. and Jenkins, L. and Youngblood, A. Q. and Royal, S. A. Severe contrast reaction emergencies high-fidelity simulation training for radiology residents and technologists in a children's hospital. Academic Radiology. 2010; 17 (7) :934-40

 

Wrong treatment, wrong population

 

Wong SX, Tham MY, Goh CL, Cheong HH, Chan SY. Spontaneous cutaneous adverse drug reaction reports-An analysis of a 10-year dataset in Singapore. Pharmacol Res Perspect. 2019 Mar 13;7(2):e00469. doi: 10.1002/prp2.469. PMID: 30911397; PMCID: PMC6415979.

 

Wrong treatment, wrong population

 

Zhang B, Dong Y, Liang L, Lian Z, Liu J, Luo X, Chen W, Li X, Liang C, Zhang S. The Incidence, Classification, and Management of Acute Adverse Reactions to the Low-Osmolar Iodinated Contrast Media Isovue and Ultravist in Contrast-Enhanced Computed Tomography Scanning. Medicine (Baltimore). 2016 Mar;95(12):e3170. doi: 10.1097/MD.0000000000003170. PMID: 27015204; PMCID: PMC4998399.

 

Wrong treatment, wrong population

 

Ahn, Y. H. and Kang, D. Y. and Park, S. B. and Kim, H. H. and Kim, H. J. and Park, G. Y. and Yoon, S. H. and Choi, Y. H. and Lee, S. Y. and Kang, H. R. Allergic-like Hypersensitivity Reactions to Gadolinium-based Contrast Agents: An 8-year Cohort Study of 154539 Patients. Radiology. 2022; 303 (2) :329-336

 

Wrong population

 

Dillman, J. R. and Ellis, J. H. and Cohan, R. H. and Strouse, P. J. and Jan, S. C. Frequency and severity of acute allergic-like reactions to gadolinium-containing IV contrast media in children and adults. American Journal of Roentgenology. 2007; 189 (6) :1533-1538

 

Wrong treatment

 

Dillman, J. R. and Ellis, J. H. and Cohan, R. H. and Strouse, P. J. and Jan, S. C. Frequency and severity of acute allergic-like reactions to gadolinium-containing IV contrast media in children and adults. American Journal of Roentgenology. 2007; 189 (6) :1533-1538

 

Wrong treatment

 

Forbes-Amrhein, M. M. and Dillman, J. R. and Trout, A. T. and Koch, B. L. and Dickerson, J. M. and Giordano, R. M. and Towbin, A. J. Frequency and Severity of Acute Allergic-Like Reactions to Intravenously Administered Gadolinium-Based Contrast Media in Children. Investigative Radiology. 2018; 53 (5) :313-318

 

Wrong treatment

 

Dósa E, Heltai K, Radovits T, Molnár G, Kapocsi J, Merkely B, Fu R, Doolittle ND, Tóth GB, Urdang Z, Neuwelt EA. Dose escalation study of intravenous and intra-arterial N-acetylcysteine for the prevention of oto- and nephrotoxicity of cisplatin with a contrast-induced nephropathy model in patients with renal insufficiency. Fluids Barriers CNS. 2017 Oct 3;14(1):26. doi: 10.1186/s12987-017-0075-0. PMID: 28974245; PMCID: PMC5627439.

 

Wrong population

 

Gaca, A. M. and Frush, D. P. and Hohenhaus, S. M. and Luo, X. and Ancarana, A. and Pickles, A. and Frush, K. S. Enhancing pediatric safety: Using simulation to assess radiology resident preparedness for anaphylaxis from intravenous contrast media. Radiology. 2007; 245 (1) :236-244

 

Wrong treatment, wrong population

 

Mao M, Xia B, Chen W, Gao X, Yang J, Li S, Wang B, Mai H, Liu S, Wen F, Gan Y, Song J, Wei H, Yang W, Wu Y, Yang S, Yu W, Yu H, Fan S, Tao H, Feng X, Lin Z, Liu L. The Safety and Effectiveness of Intravenous Contrast-Enhanced Sonography in Chinese Children-A Single Center and Prospective Study in China. Front Pharmacol. 2019 Dec 5;10:1447. doi: 10.3389/fphar.2019.01447. PMID: 31866865; PMCID: PMC6906782.

 

Wrong treatment, wrong population

 

Zhang BC, Hou L, Lv B, Xu YW. Post-marketing surveillance study with iodixanol in 20 185 Chinese patients from routine clinical practices. Br J Radiol. 2014 Feb;87(1034):20130325. doi: 10.1259/bjr.20130325. Epub 2013 Dec 19. PMID: 24357597; PMCID: PMC4064546.

 

Wrong population

 

Hojreh A, Peyrl A, Bundalo A, Szepfalusi Z. Subsequent MRI of pediatric patients after an adverse reaction to Gadolinium-based contrast agents. PLoS One. 2020 Apr 3;15(4):e0230781. doi: 10.1371/journal.pone.0230781. PMID: 32243440; PMCID: PMC7122741.

 

Wrong design

 

Kim, S. H. and Jo, E. J. and Kim, M. Y. and Lee, S. E. and Kim, M. H. and Yang, M. S. and Song, W. J. and Choi, S. I. and Kim, J. H. and Chang, Y. S. Clinical value of radiocontrast media skin tests as a prescreening and diagnostic tool in hypersensitivity reactions. Annals of Allergy, Asthma and Immunology. 2013; 110 (4) :258-262

 

Wrong treatment, wrong population

 

McDonald, J. S. and Larson, N. B. and Kolbe, A. B. and Hunt, C. H. and Schmitz, J. J. and Kallmes, D. F. and McDonald, R. J. Acute reactions to gadolinium-based contrast agents in a pediatric cohort: A retrospective study of 16,237 injections. American Journal of Roentgenology. 2021; 216 (5) :1363-1369

 

Wrong design

 

Wendt-Nordahl, G. and Rotert, H. and Trojan, L. and Michel, M. S. and Peters, C. R. and Alken, P. and Knoll, T. Intravenous contrast media in uroradiology: Evaluation of safety and tolerability in almost 50,000 patients. Medical Principles and Practice. 2006; 15 (5) :358-361

 

Wrong population, wrong treatment

 

 

Autorisatiedatum en geldigheid

Laatst beoordeeld  : 01-12-2024

Laatst geautoriseerd  : 01-12-2024

Geplande herbeoordeling  : 01-12-2027

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.

Initiatief en autorisatie

Initiatief:
  • Nederlandse Vereniging voor Radiologie
Geautoriseerd door:
  • Nederlandse Vereniging voor Anesthesiologie
  • Nederlandse Vereniging voor Heelkunde
  • Nederlandse Vereniging voor Kindergeneeskunde
  • Nederlandse Vereniging voor Radiologie
  • Stichting Kind en Ziekenhuis

Algemene gegevens

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.

Samenstelling werkgroep

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

Belangenverklaringen

Conflicts of interest

The GDG members have provided written statements about (financially supported) relations with commercial companies, organisations or institutions that were 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 is related to externally financed research and interests related to knowledge valorisation. The statements on conflict of interest can be requested from the administrative office of Kennisinstituut van de Federatie Medisch Specialisten (secretariaat@kennisinstituut.nl) and were summarised below.

 

Last name

Function

Other positions

Personal financial interests

Personal relations

Reputation management

Externally financed research

Knowledge valorisation

Other interests

Signed

Actions

De Graaf

Radiologist, Erasmus Medical Centre Rotterdam,

Board member of the Technology section, Netherlands. Far. for Radiology (unpaid)

Board member Ned. Comm. Radiation dosimetry (NCS) (unpaid)

None

None

None

None

None

None

July 14th, 2022

 

No restrictions.

Geenen RWF

Radiologist, Noordwest ziekenhuisgroep/medisch specialisten Noordwest

Member of contrast media safety committee, European Society of Urogenital Radiology (no payment)

None

None

None

None

None

None

September 2nd, 2022

No restrictions

Emons

Pediatrician-allergologist, Erasmus MC-Sophia, paid

Editorial board NTvAAKI, unpaid

NVvAKI communications committee, unpaid

None

None

None

Epitope study, cutaneous immunotherapy for peanut, DBV

BAT cow's milk study, NWO

Itulizax study, tree pollen immunotherapy, ALK

None

None

July 7th, 2022

 

No restrictions, research has no link with hypersensitivity reactions after administration of contrast agents in children.

Jöbsis

Pediatrician, pediatric nephrologist

None

None

None

None

None

None

None

July 2nd, 2022

No restrictions

Sloots

Pediatric surgeon Erasmus MC Sophia Children's Hospital

None

None

None

None

None

None

None

August, 15th, 2022

 

No restrictions

Liebrand

Anaesthesiologist Sophia Children's Hospital/Erasmus MC

Pediatrician St. Antonius Hospital, Kleve

Notarzt Kreis Kleve

None

None

None

None

None

None

December, 20th, 2022

 

No restrictions

Zwaveling-Soonawala

Pediatrician-endocrinologist, Emma Children's Hospital, Amsterdam UMC

None

None

None

None

None

None

None

June, 13th, 2023

 

No restrictions

Advisory group

Molen AJ, van der

Radiologist LUMC

Member of contrast media safety committee, European Society of Urogenital Radiology (no payment).

Member, Gadolinium Research and Education Committee, European Society of Magnetic Resonance in Medicine, and Biology (no payment).

None

None

None

None

None

Received speaker fees from Guerbet, 2019-2022

June, 5th, 2023

 

No restrictions (given the role as a sounding board group member, no active contribution to texts and the mandate for decisions rests with the guideline development group, no further restrictions have been formulated for the ancillary activities at the gadopiclenol expert group)

Riedijk

Pediatrician

Amsterdam UMC - Emma Children's Hospital

Board member SICK: unpaid.

PICE board member: unpaid.

None

None

None

None

None

None

December, 6th, 2022

 

No restrictions

Doganer

Junior project manager/policy officer at the Child and Hospital Foundation

None

None

None

None

None

None

None

July, 25th, 2023

 

No restrictions

Inbreng patiëntenperspectief

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.

Implementatie

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’.

Werkwijze

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.

Zoekverantwoording

Zoekacties zijn opvraagbaar. Neem hiervoor contact op met de Richtlijnendatabase.