TFR Course 2016 PRELIMINARY PROGRAMME





QUICK FACTS WHEN: March 7-11, 2016 WHERE: Milan, Italy – Grand Visconti Palace Hotel MAXIMUM ATTENDEES: 30 participants, priority will be given to EUROSPINE members REGISTRATION FEE: EUR 400 for EUROSPINE Members, EUR 600 for Non-Members CME CREDITS: application in process LANGUAGE: English. IMPORTANT NOTE: Course must be attended from Monday through Friday!





CORE FACULTY

GUEST FACULTY

Margareta Nordin Dr. Med. Sci.* Christine Cedraschi PhD Pierre Côté PhD L. Rachid Salmi MD PhD *Course Director

Ferran Pellisé MD Marco Teli MD Marco Campello PhD Alessio Lovi MD Michael Ogon MD Marco Monticone MD,PhD Marek Szpalski MD



LOCAL HOST

PURPOSE The course is open to all clinicians interested in gaining a basic understanding of clinical research. This course will provide clinicians with an overview of the methodology used to conduct clinical research. The purpose of the course is to provide clinicians with the fundamental concepts and tools to design clinical studies.

STRUCTURE OF THE COURSE

The course includes five modules: 1) Conceptual overview of clinical research; 2) Study design such as randomized controlled trials, Cohort studies and other design; 3) Introduction to qualitative studies and 4) and basic principle for writing an abstract . Each module will include a morning lecture/group work and an afternoon lecture/group work, where clinicians will build their skills to participate to clinical studies or develop their own clinical study protocol.

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SCHEDULE Monday, March 7 Tuesday, March 8 (P. Côté) Wednesday, March 9 Thursday, March 10 Friday, March 11



Module 1: Conceptual overview of clinical research (Faculty) Module 2: Randomized controlled trials and other study designs Module 3: Module 4: Module 5: Module 6:

Study implementation and analysis (R. Salmi) Qualitative studies (C. Cedraschi) Communication of research (M. Nordin) Presentations of participants' research outline



COURSE OBJECTIVES The course will have five main objectives: 1. Learn how to develop a research question and formulate a research hypothesis • What is the problem to be solved? • How do I select a conceptual model? • How do I develop a research hypothesis? • What is the best study design to answer my question? 2. Learn the basic methodological steps involved in clinical research • How do I select my study sample? • What outcome measures do I use? • How long do I follow my sample population? • When and how often do I measure these variables? • How do I collect the data? The need to select valid and reliable methods of data collection. • What potential biases may compromise the validity of my study? How do I prevent these biases? 3. Learn how to implement a study proposal • Is my study feasible? • How do I make it feasible? • What are the clinical issues I have to deal with? • With whom do I have to collaborate? • What are the elements of a statistical analysis? • How many participants do I need in my study? 4. Understand the basic principles of qualitative research • When do I use it? • What is the added value to clinical research?

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5. Define the essential components of an abstract? • What are the essential components of a study report or proposal? • How do I write an abstract?

KNOWLEDGE ACQUIRED UPON COMPLETION OF COURSE • • • • • •

• • • •





Be able to develop a research question Be able to formulate a hypothesis from the research question Understand the importance of using a conceptual model for the study Be able to choose "best" study design for proposed study Be introduced to and gain knowledge of limitations to a proposed study design Be knowledgeable about basic methodological steps for clinical research including selection of study sample, outcome measures, data collection, confidentiality measures and potential biases Be introduced to appropriate statistical analysis for a selected study design Be knowledgeable about qualitative research Understand the essential components of a study or proposal abstract Understand the essential components presenting a study and answering questions posed by peers and examiners on study design



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SCIENTIFIC PROGRAM PER DAY Time 08h30-08h45 08h45-9h15 9h15-10h15 10h15-10h30 10h30-11h30 11h30-12h00 12h00-13h00 13h00-13h30 13h30-14h40 14h40-16h50

Coffee served during afternoon

16h50-17h00 17:00-18:30

NOTES:

MONDAY March 7, 2016 Module 1: Course Introduction (M. Nordin) Welcome address (M. Teli & A. Lovi) General overview of the course: Why do we need clinical studies? (M. Nordin) What is a good clinically relevant research question? How do I develop it into a hypothesis? What model do I use? (M. Nordin & C. Cedraschi) Coffee Break General methodological concepts of clinical research (P. Côté) Basic statistical concepts (R. Salmi) Lunch Search of the literature (M. Campello) Outcome domains in spine care. The methodologist's and clinicians’ perspective and panel discussion (R. Salmi, M. Campello, M. Teli) Group work (division into groups): Formulate a research question and derive a hypothesis for the evaluation of a treatment intervention (M. Nordin) Homework for the following day (P. Côté) Welcome cocktail







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TUESDAY

Time 8h30-10h00

10h00-10h15 10h15-12h00 12h00-13h00 13h00-14h30

14h30-16h50 Coffee served during afternoon

16h50-18h00

March 8, 2016 Module 2: Randomized controlled trials and other study designs (P. Côté) Clinical expert: A. Lovi Selecting the study design (P. Côté) - What is the question? - Definition of the design: What is the design? What other option - Purpose of the design: When do you use it? What type of question does it allow you to answer? Pros and cons of the design. - Sample selection Coffee Break Group work: Refine the research question and select the appropriate study design (Part 1) Lunch Basic principles of randomized controlled trials (P. Côté) - Selection of the data to be collected - Specific outcome instruments - Follow-up of study participants - Threats to the validity of randomized controlled trials • Selection bias: participation and loss to follow-up • Measurement bias: reliability and validity Group work: Refine the research question and select the appropriate study design (Part 2) Preparation for the following day (R. Salmi)

NOTES:



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WEDNESDAY

Time 8h30-10h00

10h00-10h15 10h15-12h00 12h00-13h00 13h00-14h30

March 9, 2016 Module 3: Study implementation and analysis (R. Salmi) Clinical expert: M. Monticone Writing the protocol of the study (R. Salmi) • How do you identify and select your participants? • How do you identify and select your outcome measures? • How do you plan the follow up of the participants? • How do you plan data collection? • How do you assure data validity? Coffee Break Group work: Start planning your study Lunch Planning the analysis and communication of results (R. Salmi) • How do you analyse quantitative variables? • How do you analyse categorical variables? • How do you analyse survival data? • How do you adjust for confounders? • How do you plan your sample size? • How do you plan communication of the results?

14h30-16h50

Group work: Continue planning your study

16h50-18h00

Preparation for the following day (C. Cedraschi, M. Nordin)

Coffee served during afternoon

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THURSDAY

Time 08h30-10h00

10h00-10h30 10h30-12h00 12h00-13h00 13h00-13h45 13h45-14h45 14h45-16h00

Coffee served during afternoon

16h00-17h00

March 10, 2016 Module 4: Qualitative Studies (C. Cedraschi) Clinical expert: M. Campello Basic principles of the qualitative studies - What is the question? - Definition of the design: What is the design? - Purpose of the design: When do you use it? What type of question does it allow you to answer? Pros and cons of the design. - Selection of the study sample - Selection of the methods for data collection - Basic principles of data analysis in qualitative studies - Do the concepts validity and reliability apply to qualitative studies? Coffee Break Group Work: Develop a qualitative question that complements your study Lunch Module 5: Communication of research (M. Nordin) How to write and rate an abstract (M.Szpalski/M.Nordin) Group work 1: Write the abstract for your research proposal Group work 2 and coffee: Complete presentations for Friday Editorial Guest Lecture. (F. Pellisé)

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FRIDAY

Time 08h00-08h20 08h20-12h00 12h00-12h15 12h15-12h30 12h30-12h45

March 11, 2016 Module 6: Presentations of participants' research outline Experts: All faculty, External Examiner: F. Pellisé, M. Ogon Research in the Clinical Environment (M. Ogon) Group presentations, Q & A on study design Appraisal of participants' presentation (all faculty) Course evaluation Certificates & Adjourn

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ORGANIZATIONAL MATTERS ACCOMMODATION EUROSPINE has secured an allotment at Grand Visconti Palace Hotel Viale Isonz0 14 20135 Milan-Italy http://www.grandviscontipalace.com/default-en.html Room rate: 168 € per night, per room includes breakfast Reservations: [email protected] Grand Visconti Palace Ref: EUROSPINE meeting REGISTRATION Sunday, March 22, from 6:00 pm to 7:00 pm (in the lobby of the hotel) Monday, March 23, from 7:30 am to 8:30 am (in front of the meeting rooms) COURSE START/ END Start: Monday, March 23 at 8:30 am End: Friday, March 27 at 12:30 pm VISA REQUIREMENTS Be aware of your visa requirements before arriving in Geneva. ONLINE BLACKBOARD A course blackboard has been set up where you are requested to download the course material incl. the final program. All materials will be available to delegates prior to the course. You are not supposed to upload anything! Username and password will be sent by Email. PLEASE TAKE FURTHER NOTE OF • It is strongly recommended to bring a laptop (or any other device that is able to read pdf, word or ppt documents)! All course material is on the web during the course. • This is a course, not a conference. Attendance for the whole course is mandatory to get a certificate of attendance. • Each day begins promptly according to schedule. Please be there on time! It is very distracting to faculty presenters to have people arrive after the start of a session • The dress code for the course is informal. The hotel provides writing material - notepad and pen - during the course.

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CONTACTS EUROSPINE, the Spine Society of Europe Seefeldstrasse 16 8610 Uster Switzerland www.eurospine.org www.eurospinemeeting.com Follow us on: facebook.com/EuroSpine twitter.com/#!/EuroSpineSoc ORGANIZATION Education Officer Erin Goddard +41 78 913 3080 [email protected] SCIENTIFIC CONTENT Margareta Nordin Dr. Med. Sci. Course Director E: [email protected]



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