AGREE beoordeling ECTRIMS/EAN (2018)

  1. SCOPE AND PURPOSE
    1. The overall objective(s) of the guideline is (are) specifically described. YES (“This guideline focuses on disease-modifying treatment for the adult population with MS, including all immunomodulatory and immunosuppressive drugs authorized by the EMA. It does not include recommendations concerning combination therapies or new active agents in the final stages of clinical evaluation that are not approved by the EMA at the time of publication. This guideline does not include treatments usually considered complementary and/or alternative medicine or aspects of symptomatic treatment and/or treatment of relapses”. p. 217).

1.

Strongly disagree

2

3

4

5

6

X

7

Strongly agree
    1. The health question(s) covered by the guideline is (are) specifically described (zie p. 217-218 richtlijn)

1.

Strongly disagree

2

3

4

5

6

X

7

Strongly agree
    1. The population (patients, public, etc.) to whom the guideline is meant to apply is specifically described. YES. (CIS; relapsing-remitting MS, secondary progressive MS, primary progressive MS; p. 217; sub groups pregnant women or women planning pregnancy. It is not clear whether specific comorbidities were/have been considered).

1.

Strongly disagree

2

3

4

5

X

6

 

7

Strongly agree

 

Domain score: 100*(17-3)/(21-3)=78%.

 

  1. STAKEHOLDER INVOLVEMENT
    1. The guideline development group includes individuals from all relevant professional groups. Difficult to assess, but doubtful (family physican?; nurse?, p. 215).

1.

Strongly disagree

2

3

4

X

5

 

6

 

7

Strongly agree
    1. The views and preferences of the target population (patients, public, etc.) have been sought. European Multiple Sclerosis Platform (“The voice of people with MS in Europe”) has been involved (p. 215). But unclear what impact they had.

1.

Strongly disagree

2

3

4

X

5

 

6

 

7

Strongly agree

 
    1. The target users of the guideline are clearly defined.YES. physicians, patients, healthcare providers and health policy makers in Europe and worldwide in the decision-making process (p. 217).

1.

Strongly disagree

2

3

4

 

5

 

6

X

7

Strongly agree

Domain score: 100*(14-3)/(21-3)=61%.

 

  1. RIGOUR OF DEVELOPMENT
    1. Systematic methods were used to search for evidence. YES. (Searches were performed following a predefined review protocol (Appendix S1) and conducted in the following databases: the Cochrane Central Register of Controlled Trials (Central), Excerpta Medica Database (Embase), Medical Literature Analysis and Retrieval System Online (MEDLINE)/MEDLINE In-Process, and Psychological Information Database (PsycINFO). All search terms for each search are listed in Appendix S2.p. 218).

1.

Strongly disagree

2

3

4

 

5

 

6

 

7

Strongly agree
X
    1. The criteria for selecting the evidence are clearly described. YES. (Titles and abstracts of identified studies were screened for inclusion against agreed criteria. Eligibility criteria for therapeutic intervention questions included systematic reviews (SRs), randomized controlled trials (RCTs) with at least 1 year follow-up (48 weeks acceptable) and long-term extensions on included RCTs. Studies on paediatric populations, studies evaluating combinations of drugs, unlicensed doses, those published in non-English language and those with <10 participants per arm were excluded. For clinical management questions, SRs, RCTs and observational studies were included. Exclusion criteria varied between the different clinical management questions and details can be found in Appendix S1. All primary-level studies included after the first. The full-text papers were screened by two reviewers using the inclusion criteria for reference; p. 218).

1.

Strongly disagree

2

3

4

 

5

 

6

 

7

Strongly agree

X
    1. The strengths and limitations of the body of evidence are clearly described. YES. (Quality appraisal and data synthesis, Grading the quality of the evidence, p. 218; see also descriptions in results section).

1.

Strongly disagree

2

3

4

 

5

 

6

 

7

Strongly agree

X
    1. The methods for formulating the recommendations are clearly described. YES. (Consensus was reached by use of the modified nominal group technique following a two-stage process etc. p. 218-219).

1.

Strongly disagree

2

3

4

 

5

 

6

X

7

Strongly agree
    1. The health benefits, side effects, and risks have been considered in formulating the recommendations. YES. (The panel formulated practice recommendations on the basis of the quality of the evidence and the balance between health benefits and harms for both therapeutic and clinical management questions. P. 218; however, it was not specified whether or not there was (large) variation in patient values, being considered. Relative weight of benefits and harms in assessing the balance was not reported).

1.

Strongly disagree

2

3

4

 

5

X

6

 

7

Strongly agree
    1. There is an explicit link between the recommendations and the supporting evidence. NO. (It is unclear what factors were taken into account in developing recommendations. Also a rationale for the recommendations is lacking).

1.

Strongly disagree

2

3

X

4

 

5

 

6

 

7

Strongly agree
    1. The guideline has been externally reviewed by experts prior to its publication. NO (not reported)

1.

Strongly disagree

2
X

3

 

4

 

5

 

6

 

7

Strongly agree
    1. A procedure for updating the guideline is provided). NO (Only an update statement was presented: The present guideline will be updated in 5 years. In the case of major changes in the evidence on the existing benefits and harms of included interventions or if new interventions become available this update could be approached earlier. P. 231).

1.

Strongly disagree

2
X

3

 

4

 

5

 

6

 

7

Strongly agree

 

Domain score: 100*(39-8)/(56-8)=65%.

 

  1. CLARITY OF PRESENTATION
    1. The recommendations are specific and unambiguous. (It seems several recommendations lack specificity or are not concrete).

1.

Strongly disagree

2

3

 

4

 

5

X

6

 

7

Strongly agree
    1. The different options for management of the condition or health issue are clearly presented. (options are infrequently reported).

1.

Strongly disagree

2

3

 

4

X

5

 

6

 

7

Strongly agree
    1. Key recommendations are easily identifiable. NO (all recommendations have the same format. So, one can’t distinguish the key recommendations).

1.

Strongly disagree

2

3

 

4

X

5

 

6

 

7

Strongly agree


Domain score: 100*(13-3)/(21-3)=56%.

  1. APPLICABILITY
    1. The guideline describes facilitators and barriers to its application. NO (The document is a joint venture of ECTRIMS and EAN and, as such, the recommendations have been drawn up considering its European scope, including both the outpatient and in-hospital setting, but it does not address specific organizational issues, management models or country-specific regulations required to implement the recommendations. Users of these guidelines should adapt the recommendations to be consistent with their local regulations and/or team capacities, infrastructure and cost-benefit strategies).

1.

Strongly disagree

2
X

3

 

4

 

5

 

6

 

7

Strongly agree
    1. The guideline provides advice and/or tools on how the recommendations can be put into practice. NO

1.

Strongly disagree

2
X

3

 

4

 

5

 

6

 

7

Strongly agree
    1. The potential resource implications of applying the recommendations have been considered. NO

1.

Strongly disagree

2
X

3

 

4

 

5

 

6

 

7

Strongly agree
    1. The guideline presents monitoring and/or auditing criteria. NO

1.

Strongly disagree

2
X

3

 

4

 

5

 

6

 

7

Strongly agree

 

Domain score: 100*(8-4)/(28-4)=17%.

  1. EDITORIAL INDEPENDENCE
    1. The views of the funding body have not influenced the content of the guideline. (Probably not).

1.

Strongly disagree

2

3

 

4

 

5

 

6

X

7

Strongly agree
    1. Competing interests of guideline development group members have been recorded and addressed. (recorded: YES; addressed: not reported)

1.

Strongly disagree

2

3

 

4

X

5

 

6

 

7

Strongly agree

 

Domain score: 100*(10-2)/(14-2)=67%.

 

OVERALL GUIDELINE ASSESSMENT

The best parts of this guideline are the following domains: scope and purpose, stakeholder involvement, and methodology (limited to search strategy, evidence synthesis), Weak parts: methodology (unclear what factors were considered in developing recommendations, no rationale for recommendations), applicability.

 

We recommend: use key questions/PICO, search strategies, evidence synthesis, but do not adopt clinical recommendations. Use GRADE factors for developing clinical recommendations: quality of the evidence, values& preferences, balance of desirable and undesirable effects, resources/cost, acceptability and feasibility of clinical recommendations.