A short introduction on European Stroke Conference / Stroke Guidelines A short introduction on George Ntaios MD, MSc (ESO Stroke Medicine), PhD, FESO University of Thessaly, Larissa, Greece Nice 08/05/2014

Honoraria: Medtronic; Quintiles. Disclosures Scholarships: European Stroke Organization; Hellenic Society of Atherosclerosis. Honoraria: Medtronic; Quintiles. Speaker fees: Sanofi; Boehringer-Ingelheim. Consultant fees: Boehringer-Ingelheim. Support to attend conferences: Bayer; Sanofi-Aventis; Pfizer; Lundbeck; Boehringer-Ingelheim; Galenica; Elpen; Bristol Myers Squibb. Participation in trials: ENOS / National co-ordinator (Greece). BPREVISE / Principal investigator. FOURIER / Sub-investigator. GLORIA / Sub-investigator.

Grading of Recommendations, Assessment, Development and Evaluation GRADE Grading of Recommendations, Assessment, Development and Evaluation Thank you Mr chairman. Dear colleagues, in the next couple of minutes, we will make a short introduction to the GRADE system. The GRADE approach is a method of grading the quality of evidence and strength of recommendations in health. It stands for …… , and it is used to develop clinical practice guidelines and other health care recommendations.

And these are a few organizations that have endorsed the GRADE system.

Population Intervention Comparator Outcome* Specify the PICO question(s) Population In children during summertime Intervention chocolate ice-cream Comparator studying mathematics Outcome* happiness Now, we will try to give a brief view on the methodology which is followed according to GRADE. First, you need to define your PICO questions, and PICO stands for ….. . So, as a non-medical example, your PICO question could be the following one:…. So, now we have to answer this question, although I think we don’t need a randomized controlled trial to answer this one.

Observational studies start low Assessment of quality of studies After you have defined your PICO question, you have to search the literature for related data. And you need to make a broad search including all available databases, not only Medline. Now, it’s up to you whether you will include only randomized controlled trials or also non-randomized data. Then, as soon as you are finished with the literature search, you have to assess the quality of these data. If you include only RCTs, then you start high. If you include also observational studies, then you start low. RCTs start high Observational studies start low

Assessment of quality of studies (downgrade) Study design and execution (bias) Inconsistency (heterogeneity, I2) Indirectness Imprecision (number of events, confidence intervals) Publication bias (funnel plot) Then, you have to assess several parameters which will either downgrade or upgrade the quality of the data. Such parameters which may downgrade the quality of the studies include ….

Large magnitude of the effect Dose – response relation Assessment of quality of studies (upgrade) Large magnitude of the effect Dose – response relation On the other hand, the quality of the included studies may be upgraded if the magnitude of the estimated effect is large, and if there is a dose-response relation.

Grade of evidence Then, you come to grade your evidence, which may be high, meaning that …., moderate meaning that …, low meaning that … or very low meaning that ….

Summary of Findings (SoF) tables And then, you can generate this kind of tables, which are called summary of findings tables, which contain all necessary information. Of course, they may seem complicated but they are a great summary including all important information like the outcomes assessed, number of participants and studies included, the grading of evidence, and others.

Panel discussion Overview Finally, your committee needs to discuss and finalize its recommendation. So, this is an overview of the whole process, as we summarized it. Of course, if you are lucky and your PICO question is very simple like the ice-cream question of our example, then you could just skip all this work and you just have a look at your child and you get a straightworward reliabe answer! Thank you!