Veilig gebruik van contrastmiddelen

Initiatief: NVvR Aantal modules: 48

Veilig gebruik van contrastmiddelen bij patiënten met multipel myeloom

Uitgangsvraag

Welke preventiestrategieën zijn effectief om contrastmiddel-geassocieerde acute nierschade (CA-AKI) bij patiënten met multipel myeloom te voorkomen?

Aanbeveling

Neem altijd de algemene principes voor preventie van acute nierschade in acht, die al werden gepubliceerd in hoofdstuk 2. PC-AKI:

  • Optimale nefrologische zorg dient het primaire doel te zijn bij alle patiënten met chronische nierziekten, met specifieke aandacht voor hydratiestatus en medicatiegebruik.
  • Streef naar klinische euvolemie, gebruik normaal saline of Ringer’s lactaat, voorafgaand aan een onderzoek met intravasculair jodiumhoudend CM, ongeacht de eGFR waarde.
  • Beschouw patiënten met een eGFR <30 ml/min/1,73m2 tot een hoogrisico-groep voor CA-AKI.
  • Consulteer een internist/nefroloog bij patiënten met een eGFR <30 ml/min/1,73m2.

Bepaal bij elke patiënt met een multipel myeloom of toediening van jodiumhoudend CM noodzakelijk is, of dat alteratieve beeldvorming mogelijk is:

  • Pas dezelfde voorzorgsmaatregelen toe om CM-geassocieerde acute nierschade (CA- AKI) te voorkomen bij patiënten met multipel myeloom als bij patiënten zonder deze ziekte, wanneer er geen extra risicofactoren zijn, geassocieerd met multipel myeloom, voor het ontwikkelen van acute nierinsufficiëntie.
  • Voor (euvolemische) patiënten met een eGFR <30 ml/min/1,73m2 waarbij intravasculair jodiumhoudend CM toegediend zal worden, prehydreer de patiënt met 3ml/kg/u NaHCO3 1,4% gedurende 1 uur (of 250ml in totaal) voor toediening van het CM.

Bij geselecteerde patiënten met extra risicofactoren voor het ontwikkelen van acute nierinsufficiëntie (bijv. hypercalciëmie, lichte keten nefropathie, amyloïdose) is voorafgaand overleg tussen hematoloog en radioloog of cardioloog nodig om een betrouwbare inschatting te maken van de voordelen en de risico’s. Hierbij moet worden bepaald of er een absolute indicatie is voor de toediening van jodiumhoudend CM en of preventieve maatregelen in dat geval noodzakelijk zijn.

Overwegingen

The discussion whether multiple myeloma per se is an independent risk factor for contrast- associated acute kidney injury (CA-AKI) goes back as far as the early 1990s (McCarthy, 1992; Pahade, 2011). CA-AKI is synonymous with post-contrast acute kidney injury (PC-AKI) used in part 1 and part 2 of this guideline, but CA-AKI is currently more frequently used than PC-AKI for this condition.

 

Pros and cons of the intervention and quality of the evidence

The systematic review belonging to the ESUR guideline (Stacul, 2018) and the retrospective cohort study by Crowley (2018) were excluded from the literature analysis because of limited study quality and the lack of a control group without multiple myeloma. Results will be discussed descriptively.

 

The systematic review for the ESUR guideline (Stacul, 2018) reported on CA-AKI in patients with multiple myeloma and monoclonal gammopathies. CA-AKI was defined as cases in which kidney injury could not be explained by other causes than contrast medium administration. Twelve cohort studies and one case control study were included, the majority uncontrolled and of limited quality (Newcastle-Ottawa scores of 5-6 out of a scale until 9). Reference values of a control group without multiple myeloma were not reported. High osmolality contrast media were used in eleven studies, whereas low osmolality contrast media were used in the remaining two studies. Many important variables were not reported such as the multiple myeloma description (subtype, stage, disease load), baseline serum creatinine and calcium concentration, or number of examinations per patient. In addition, existing kidney injury after one month and the need for dialysis were not reported. A total of 642 patients and 824 iodine-based CM administrations were studied.

 

Crowley et al. (Crowley, 2018) reported on CA-AKI in patients with multiple myeloma. The study was retrospective and carried out in a university hospital in Ireland using a medical record database to retrieve information. CA-AKI was defined as a > 25% increase or a rise of more than 44.2 mmol/L (0.5 mg/dL) in serum creatinine level above baseline level after receiving IV contrast material within three days of administration of contrast media. In contrast to the ESUR guideline (Stacul, 2018), characteristics of the multiple myeloma patients (demographics, subtype, stage, disease load), baseline serum creatinine and calcium concentration were described. The study was uncontrolled and of limited study quality. The type of contrast medium used was not described, patients on dialysis were excluded, and information on infection, hydration status or use of nephrotoxic drugs was not available. The study, however, did report on existing kidney failure after one month. In total 94 patients with multiple myeloma, including 165 procedures with contrast media, were available for analysis.

 

The incidence of CA-AKI will be described separately because of the different definitions of CA-AKI, different inclusion criteria and the inclusion of monoclonal gammopathies patients besides multiple myeloma patients (Stacul, 2018).

 

CA-AKI

The reported CA-AKI case incidence in the ESUR guideline (Stacul, 2018) was 12/824 procedures (1.6%) among 642 patients with multiple myeloma or monoclonal gammopathies. The two studies using low osmolality contrast media comprised 210 CT examinations in 76 patients, in whom CA-AKI was observed in 4/210 cases (1.9%).

The reported CA-AKI incidence by Crowley (2018) was 17/165 procedures (10%) among 94 patients with multiple myeloma. The severity of the CA-AKI was not described. The 94 patients received on average two procedures with iodinated contrast (2.1±1.5). In 47% of procedures (77 procedures) baseline creatinine was elevated and 4% of procedures (6 procedures) had elevated baseline calcium. In the whole group, there was no significant difference between the serum creatinine concentration before and after the contrast- enhanced procedure (p=0.08).

 

Existing acute kidney injury after 1 month

The cohort study by Crowley (2018) reported 10/17 CA-AKI cases (59%) demonstrated a normalised serum creatinine within one month of the procedure. This means that kidney function was not restored to normal in 7/17 (41%) of cases. However, the severity of renal function loss was not quantified. Moreover, it is not clear to which extent these 7 cases represented the same individuals who showed an elevated serum creatinine at baseline.

 

From evidence to decision

About 50% of patients with multiple myeloma may develop acute or chronic renal failure in the course of the disease. Major causes of renal failure are light chain cast nephropathy and hypercalcemia. Other causes of renal failure in multiple myeloma are e.g., amyloidosis, nephrotoxic drugs, or hyperuricemia. The literature does not provide clear evidence that multiple myeloma per se predisposes to a higher risk for development of CA-AKI independent of the renal function. The available literature is, however, of limited quality. In general, administration of contrast media in patients with multiple myeloma seems to be safe. In view of the enhanced overall risk for renal failure, however, an alternative imaging technique that does not require iodine-containing CM should always be considered. When administration of iodine-containing CM is deemed necessary, special attention in these patients is required to provide optimal nephrology care as outlined in Safe Use of Contrast Media part 1. In particular, to avoid dehydration and nephrotoxic stimuli and medications, and to provide intravenous prehydration in patients with eGFR <30 ml/min/1.73m2.

In selected patients with additional risk factors such as light chain cast nephropathy, hypercalcemia, or amyloidosis, close consultation between the haematologist and the imaging physician is recommended to assess the benefit-risk ratio of ICM administration and whether preventive measures or an alternative imaging technique are warranted.

 

Evidence from other contrast media is very scarce. In line with iodine-based contrast media, the use of gadolinium-based contrast agents does not seem to negatively affect renal function in myeloma patients (Hillengass, 2015).

 

Costs

Although keeping a low threshold for application of volume expansion protocols may seem a safe strategy of prevention of CA-AKI, such protocols present a logistic and financial burden to the hospital system (Kooiman, 2013). Particularly the longer pre- and post-hydration schedules will require admission of patients that could otherwise have their CT performed in an outpatient setting. To admit all patients at increased risk for AKI in day-hospital wards for intravenous volume expansion is expensive, and the volume expansion itself may lead to complications as well. Cost arguments differ for in-hospital patients if it does not lead to an extended hospital stay.

 

Recommendations

 

In general, administration of contrast media in patients with multiple myeloma seems to be safe. These patients, however, have an enhanced overall risk for renal failure as a result of several concomitant risk factors that might be present.

 

Always consider the general principles of prevention of acute kidney injury that were outlined in Safe Use of Contrast Media, Part 1:

  • Optimal nephrology care should be the primary goal in all chronic kidney disease patients, with attention to hydration status and medication use.
  • Aim for clinical euvolemia, using normal saline or Ringer’s lactate, before administration of intravascular iodine-based contrast media, regardless of eGFR.
  • Consider patients with an eGFR <30 ml/min/1.73m2 at risk for CA-AKI.
  • Consult a nephrologist/internist for patients with an eGFR <30 ml/min/1.73m2.

 

Determine in each patient with multiple myeloma whether administration of iodine-based contrast media is indicated or if an alternative imaging technique is possible:

  • Apply the same precautions to prevent contrast-associated acute kidney injury (CA- AKI) in patients with multiple myeloma as in subjects without this disease, if there are no additional risk factors associated with multiple myeloma for development of acute renal insufficiency.
  • For (euvolemic) patients with an eGFR <30 ml/min/1,73m2 undergoing intravascular administration of iodine-based contrast media prehydrate with 3ml/kg/h NaHCO3 1.4% for 1h (or a total of 250ml) pre-CM administration.

 

In a minority of patients with multiple myeloma, several precipitating factors for acute kidney insufficiency might be present, necessitating consultation between the imaging physician and the treating haematologist.

 

In selected patients with additional risk factors associated with multiple myeloma for development of acute renal insufficiency (e.g., hypercalcemia, light chain cast nephropathy, amyloidosis), close consultation between the haematologist and imaging physician is needed to ensure an optimal risk-benefit balance, including whether administration of contrast media is warranted and if preventive measures are needed.

Onderbouwing

Multiple myeloma (MM) is a plasma cell neoplasm accounting for 1.0-1.8% of all cancers. It represents the second most common haematological malignancy with an incidence in Europe of 4.5-6.0/100,000/year (Dimopoulos, 2021; Sprangers, 2018). It has been suggested that patients with multiple myeloma are more prone to develop contrast-associated acute kidney injury (CA-AKI) (synonymous with post-contrast acute kidney injury (PC-AKI)) than would be expected based on their renal function (LeBlanc, 2002). The question arises whether multiple myeloma represents a risk factor for CA-AKI, necessitating additional preventive measurements irrespective of the renal function.

A systematic review of the literature was performed to answer the following question: What is the risk of contrast-associated acute kidney injury (CA-AKI), existing kidney injury after one month or the need for dialysis in multiple myeloma patients following administration of contrast media compared to patients without multiple myeloma?

 

P (Patients): Patients with multiple myeloma.

I (Intervention): Administration of contrast media.

C (Comparison): Patients without multiple myeloma.

O (Outcomes): Contrast-associated acute kidney injury (CA-AKI), existing acute kidney injury after 1 month, need for dialysis.

 

Relevant outcome measures

The guideline development group considered existing kidney injury after 1 month and the need for dialysis as critical outcome measures for decision making; and CA-AKI as important outcome measures for decision making.

 

Search and select (Methods)

The databases Medline (via OVID) and Embase (via Embase.com) were searched with relevant search terms until February 17th, 2021. The detailed search strategy is depicted under the tab Methods. The systematic literature search resulted in 124 hits. Studies were selected based on the following criteria: (1) patients with multiple myeloma (2) examination with contrast media (3) comparison to patients without multiple myeloma (if possible) and (4) one of the previously described outcomes. Fifteen studies were initially selected based on title and abstract screening. After reading the full text, fifteen studies were excluded (see Table of excluded studies in ‘Appendices to modules’) and no studies were included. One systematic review by Stacul (2018) and one retrospective cohort study by Crowley (2018) were found. These papers could not be included in the literature analysis because of the limited quality of the included studies and the lack of a comparable control group without multiple myeloma or reference values. These two publications, however, will be described in more detail in the justifications, as they represent the best available evidence.

 

Results

No studies were included in the literature analysis, and therefore, no systematic literature analysis was performed.

  1. Crowley MP, Prabhakaran VN, Gilligan OM. Incidence of contrast-induced nephropathy in patients with multiple myeloma undergoing contrast-enhanced procedures. Pathol Oncol Res. 2018; 24(4): 915-919.
  2. Dimopoulos MA, Moreau P, Terpos E, Mateos MV, Zweegman S, Cook G, et al.; EHA Guidelines Committee. Multiple myeloma: EHA-ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2021; 32(3): 309-322.
  3. Hillengass J, Stoll J, Zechmann CM, Kunz C, Wagner B, Heiss C, et al. The application of gadopentate-dimeglumine has no impact on progression free and overall survival as well as renal function in patients with monoclonal plasma cell disorders if general precautions are taken. Eur Radiol. 2015; 25(3): 745-750.
  4. Kooiman J, van der Molen AJ, Cannegieter SC, Rabelink TJ. Prevention of contrast-induced nephropathy: time for nuance and a new guideline [in Dutch]. Ned Tijdschr Geneeskd. 2013; 157(12): A5475.
  5. LeBlanc R, Bergstrom DJ, Côté J , Kotb R, Louzada ML, Sutherland HJ. Management of myeloma manifestations and complications: The cornerstone of supportive care: Recommendation of the Canadian Myeloma Research Group (formerly Myeloma Canada Research Network) Consensus Guideline Consortium. Clin Lymphoma Myeloma Leuk. 2022; 22(1): e41-e56.
  6. McCarthy CS, Becker JA. Multiple myeloma and contrast media. Radiology. 1992; 183(2): 519-521.
  7. Pahade JK, LeBedis CA, Raptopoulos VD, Avigan DE, Yam CS, Kruskal JB, et al. Incidence of contrast-induced nephropathy in patients with multiple myeloma undergoing contrast-enhanced CT. AJR Am J Roentgenol. 2011; 196(5): 1094-1101.
  8. Sprangers B. Aetiology and management of acute kidney injury in multiple myeloma.
    Nephrol Dial Transplant. 2018; 33(5): 722-724.
  9. Stacul F, Bertolotto M, Thomsen HS, Pozzato G, Ugolini D, Bellin MF, Bongartz G, Clement O, Heinz-Peer G, van der Molen A, Reimer P, Webb JAW; ESUR Contrast Media Safety Committee. Iodine-based contrast media, multiple myeloma and monoclonal gammopathies: literature review and ESUR Contrast Media Safety Committee guidelines. Eur Radiol. 2018; 28(2): 683-691.

Autorisatiedatum en geldigheid

Laatst beoordeeld  : 28-11-2022

Laatst geautoriseerd  : 28-11-2022

Geplande herbeoordeling  :

Validity

The Radiological Society of the Netherlands (NVvR) will determine around 2027 if this guideline (per module) is still valid and applicable. 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, that could be a reason to commence revisions. The Radiological Society of the Netherlands is the owner of this guideline and thus 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 Internisten Vereniging
  • Nederlandse Vereniging van Maag-Darm-Leverartsen
  • Nederlandse Vereniging voor Cardiologie
  • Nederlandse Vereniging voor Heelkunde
  • Nederlandse Vereniging voor Neurologie
  • Nederlandse Vereniging voor Obstetrie en Gynaecologie
  • Nederlandse Vereniging voor Radiologie
  • Nederlandse Vereniging voor Klinische Chemie en Laboratoriumgeneeskunde
  • Patiëntenfederatie Nederland
  • Nederlandse Vereniging voor Allergologie en Klinische Immunologie
  • Nederlandse Vereniging voor Endocrinologie
  • Nederlandse Vereniging voor Vaatchirurgie

Algemene gegevens

General Information

The Kennisinstituut van de Federatie Medisch Specialisten (www.kennisinstituut.nl) 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

Guideline development group (GDG)

A multidisciplinary guideline development group (GDG) was formed for the development of the guideline in 2020. 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 2020 until November 2022. The GDG is responsible for the complete text of this guideline.

 

Guideline development group

  • Dekkers I.A. (Ilona), clinical epidemiologist and radiologist, Leiden University Medical Center, Leiden
  • Geenen R.W.F. (Remy), radiologist, Noordwest Ziekenhuisgroep, Alkmaar
  • Kerstens M.N. (Michiel), internist-endocrinologist, University Medical Centre Groningen
  • Krabbe J.G. (Hans), clinical chemist-endocrinologist, Medisch Spectrum Twente, Enschede
  • Rossius M.J.P. (Mariska), radiologist, Erasmus Medical Centre, Rotterdam
  • Uyttenboogaart M. (Maarten), neurologist and neuro-interventionalist, University Medical Centre Groningen
  • van de Luijtgaarden K.M. (Koen), vascular surgeon, Maasstad Ziekenhuis, Rotterdam
  • van der Molen A.J. (Aart), chair guideline development group, radiologist, Leiden University Medical Center, Leiden
  • van der Wolk S.L. (Sabine), gynaecologist-obstetrician, Haga Ziekenhuis, Den Haag
  • van de Ven A.A.J.M. (Annick), internist-allergologist-immunologist, University Medical Centre Groningen (until 1.7.2022)
  • van der Houwen, T.B. (Tim), internist-allergologist-immunologist, Amsterdam University Medical Center (from 1.7.2022)

Invited experts

  • van Maaren M.S. (Maurits), internist-allergologist-immunologist, Erasmus MC, Rotterdam

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 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

Dekkers IA

Radiologist, LUMC

Clinical Epidemiologist

 

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)

No

No

No

No

No

Received consultancy fees from Guerbet, 2019-

2022

July 24th, 2020, Reaffirmed October 12th, 2022

No restrictions: received in part 3 of the guideline speaker fees, but this guideline does not mention specific medication, not of working mechanism, nor of side effects.

Geenen RWF

Radiologist, Noordwest ziekenhuisgroep

/Medisch specialisten

Noordwest

Member of contrast media safety

committee, European

Society of Urogenital

Radiology (no payment)

No

No

No

No

No

No

April 11th, 2020, Reaffirmed October 12th,

2022

No restrictions

Houwen T, van der

Internist - Immunologist - Allergologist, Amsterdam UMC, also seconded allergologist in Huid Medisch

Centrum

None

None

None

None

None

None

None

July 11th, 2022 Reaffirmed October 12th, 2022

No restrictions

Kerstens MN

Internist- endocrinologist, UMCG

Chairman Bijniernet (no payment)

No

No

No

No

No

No

July 1st, 2020, reaffirmed October 25th,

2022

No restrictions

Krabbe JG

Clinical chemist, Medisch Spectrum Twente

No

No

No

No

No

No

No

September 1st, 2020,

Reaffirmed October 13th, 2022

No restrictions

Luijtgaarden KM, van de

Vascular surgeon, Maasland Ziekenhuis

No

No

No

No

No

No

No

August 1st, 2020,

reaffirmed October 26th, 2022

No restrictions

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)

No

No

No

No

No

Received consultancy fees from Guerbet, 2019-

2022

July, 24th, 2020 Reaffirmed October 12th, 2022

No restrictions: received in part 3 of the guideline speaker fees, but this guideline does not mention

Specific medication, not

of working mechanism, nor of side effects.

Rossius MJP

Radiologist Erasmus Medical Centre

Medical coordinator (no payment)

No

No

No

No

No

No

April 7th, 2020, Reaffirmed October 13th,

2022

No restrictions

Uyttenboogaart M

Neurologist and neuro- interventionalist UMCG

Advisor International Federation of Orthopaedic Manipulative Physical Therapist / Nederlandse Vereniging Manuele Therapie

No

No

Subsidy Hart Stichting for CONTRAST

(Consortium of New Treatments in Acute Stroke): WP8 Stroke logistics and Epidemiology: financing of 2 PhD students by the Hart Stichting / PPS

Allowance

Work package leader CONTRAST

(Consortium of New Treatments in Acute Stroke): WP8 Stroke logistics and Epidemiology

No

No

June 30th, 2020, reaffirmed October 26th, 2022

No restrictions: the CONTRAST

consortium wp8 is only about organisation and treatment of stroke.

Stroke is not in this guideline.

Ven AAJM, van de

Internist- allergologist- immunologist, UMCG

Education and research related to work as internist-

allergist

No

No

No

No

No

No

April 7th, 2020, Reaffirmed October 19th, 2022

No restrictions

Wolk S, van der

Gynaecologist- obstetrician, Haga Ziekenhuis

No

No

No

No

No

No

No

June 30th, 2021, reaffirmed October 25th,

2022

No restrictions

Inbreng patiëntenperspectief

Input of patient’s perspective

The guideline does not address a specific adult patient group, but a diverse set of diagnoses. Therefore, it was decided to invite a broad spectrum of patient organisations for the stakeholder consultation. 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 pregnancy and lactation was developed for Thuisarts.nl, a platform to inform patients about health and disease.

Implementatie

Implementation

During different phases of 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 and 2 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, where 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 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 aspects 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 with 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 GDG made the guideline definitive. 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.

Volgende:
Jodiumhoudend CM en Diabetes Mellitus (DM)