FUNDAMENTALS OF SPINE RESEARCH METHODOLOGY:
HOW TO MAKE YOUR RESEARCH MORE RELEVANT, FEASIBLE AND PUBLISHABLE
TFR Course 2015 granted 27 European CME credits (ECMEC)
PRELIMINARY PROGRAMME
Update December 5, 2014
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QUICK FACTS
WHEN: March 23-‐27, 2015 WHERE: Barcelona, Spain – venue to be confirmed 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: 27 LANGUAGE: English. IMPORTANT NOTE: Course must be attended from Monday through Friday!
*Course Director **Clinical Course Director 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 seven modules: 1) Conceptual overview of clinical research; 2) Randomized controlled trials; 3) Cohort studies; 4) Critical Appraisal, 5) Qualitative studies and 6) Systematic reviews. 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. Module 7) Presentations of participants' research outline concludes the programme. SCHEDULE
Monday, March 23 Module 1: Conceptual overview of clinical research (Faculty) Tuesday, March 24 Module 2: Randomized controlled trials (P. Côté) Wednesday, March 25 Module 3: Cohort studies (R. Salmi) Thursday, March 26 Module 4: Critical Appraisal (P. Côté, R. Salmi) Module 5: Qualitative studies (C. Cedraschi) Module 6: Systematic reviews (M. Nordin) Friday, March 27 Module 7: Presentations of participants' research outline
CORE FACULTY GUEST FACULTY LOCAL HOST Margareta Nordin Dr. Med. Sci. * Marco Campello PhD Ferran Pellisé MD PhD** Christine Cedraschi PhD Björn Rydevik MD PhD Pierre Côté DC, PhD Marek Szpalski MD L. Rachid Salmi MD PhD Haluk Berk MD
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FACULTY
C O R E F A C U L T Y
Margareta Nordin Dr. Med, Sci., Course Director [email protected]
Department of Orthopedic Surgery and Environmental Medicine
New York University, New York, NY, USA
Christine Cedraschi PhD [email protected]
Multidisciplinary Pain Center Division of Clinical Pharmacology and Toxicology
Division of General Medical Rehabilitation Geneva University Hospitals, Geneva, Switzerland
Pierre Côté DC, PhD [email protected]
Canada Research Chair in Disability Prevention and Rehabilitation Associate Professor, Faculty of Health Sciences
Director, UOIT-‐CMCC Centre for the Study of Disability Prevention and Rehabilitation
University of Ontario Institute of Technology (UOIT) Oshawa, Ontario, Canada
Rachid Salmi MD PhD [email protected]‐bordeaux2.fr
Directeur/Head, ISPED/Bordeaux School of Public Health INSERM U-‐897, Centre de Recherche Epidémiologie et Biostatistique
PU-‐PH, Service d’information médicale, CHU de Bordeaux Institut de Santé Publique, d’Epidémiologie et de Développement (ISPED)
Université de Bordeaux, Bordeaux, France
G U E S T F A C U L T Y
Marco Campello PhD [email protected]
Department of Orthopedic Surgery New York University, New York, NY, USA
Björn Rydevik MD PhD [email protected]
Department of Orthopaedics University of Gothenburg, Sahlgrenska University Hospital
Gothenburg, Sweden
Marek Szpalski MD [email protected]
Department of Orthopedics Iris South Teaching Hospitals, Brussels, Belgium
Haluk Berk MD [email protected]
Professor at Dokuz Eylul University School of medicine, Izmir, Turkey
LOCAL HOST
Ferran Pellisé MD PhD [email protected]
Associate Professor UAB Chief spine Unit Hospital Vall d’Hebron
Director Spine Unit, Hospital Quirón Barcelona Barcelona, Spain
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COURSE OBJECTIVES
The course will have four 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? • 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 read a systematic review and critically appraise the quality of the review. • What instrument (review criteria) do I use to critically appraise a scientific article? • What are the strengths and the limitations of the systematic review? • How do I assess the internal validity of a systematic review? • How far can the findings be generalized, in particular to my work/research
environment?
4. Learn how to make a study acceptable • 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?
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 critical appraisal of the literature • Be introduced to study administration
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SCIENTIFIC PROGRAMME PER DAY
MONDAY Time March 23, 2015 Module 1: Course Introduction (M. Nordin) 08h30-‐08h45 Welcome address (F. Pellisé) 08h45-‐9h15 General overview of the course: Why do we need clinical studies? (M. Nordin) 9h15-‐10h00 What questions are relevant to spine research? (M. Nordin)
What is a good research question? And how do I develop it into a hypothesis? 10h00-‐10h15 Coffee Break 10h15-‐11h15 From theory to practice (C. Cedraschi, F. Pellisé & faculty) 11h15-‐12h00 General methodological concepts of clinical research (P. Côté) 12h00-‐13h00 Lunch 13h00-‐13h30 Search of the literature (M. Campello) 13h30-‐14h30 Outcome domains in spine care. The methodologist's and clinician's perspective
(R. Salmi, M. Campello) 14h30-‐16h50 Coffee served during afternoon
Group work (division into groups): formulate two research questions and derive hypotheses for the evaluation of a treatment intervention and course of disease (M. Nordin)
16h50-‐17h00 Homework for the following day (P. Côté) NOTES:
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TUESDAY Time March 24, 2015 Module 2: Randomized controlled trials (P. Côté) Clinical expert: F. Pellisé 8h30-‐10h00 Basic principles of randomized controlled trials (P. Côté)
-‐ 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. -‐ Sample selection
10h00-‐10h15 Coffee Break 10h15-‐12h00 Group work: start from the intervention research question from day one and
develop the outline of a randomized controlled trial (Part 1) 12h00-‐13h00 Lunch 13h00-‐14h15 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 • Confounding
14h15-‐14h45 Publishing randomized controlled trails – a view from a journal editor (F. Pellisé) 14h45-‐16h50 Coffee served during afternoon
Group work: start from the intervention research question from day one and develop the outline of a randomized controlled trial (Part 2)
16h50-‐17h00 Homework for the following day (R. Salmi) NOTES:
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WEDNESDAY Time March 25, 2015 Module 3: Cohort studies (R. Salmi) Clinical expert: M. Campello 8h30-‐10h00 Basic principles of cohort studies (R. Salmi)
-‐ 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. -‐ Sample selection"
10h00-‐10h15 Coffee Break 10h15-‐12h00 Group work: start from the course of disease research question from day one
and develop the outline of a cohort study (Part 1) 12h00-‐13h00 Lunch 13h00-‐14h30 Basic principles of cohort studies (R. Salmi)
-‐ 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 • Confounding
14h30-‐16h50 Coffee served during afternoon
Group work: start from the course of disease research question from day one and develop the outline of a cohort study (Part 2)
16h50-‐17h00 Homework for the following day, critical appraisal and SIGN criteria (M. Nordin) 17h00-‐17h30 Special guest lecture “Current and future trends in spine surgery” (B. Rydevik)
NOTES:
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THURSDAY Time March 26, 2015 Module 4: Critical Appraisal (P. Côté, R. Salmi) 8h00-‐08h30 Introduction to critical appraisal, SIGN criteria (R. Salmi) 8h30-‐10h00 Evaluating the quality and relevance of a published study (P. Côté, R. Salmi) 10h00-‐10h15 Coffee Break Module 5: Qualitative studies (C. Cedraschi) 10h15-‐12h00 Indication for qualitative studies
-‐ When do you need a qualitative study? -‐ What kind of questions does is it allow you to answer? -‐ How do you get prepared to discuss with a qualitative methodologist?
12h00-‐13h00 Lunch Module 6: Systematic reviews (M. Nordin) -‐ Interactive session Clinical expert: M. Szpalski 13h00-‐13h15 Introduction: How to solve contradiction in clinical practice (P. Côté) 13h15-‐13h45 Two systematic reviews of the literature of vertebroplasty (M. Campello) 13h45-‐14h15 Vertebroplasty has positive outcomes (M. Szpalski) 14h15-‐14h45 Vertebroplasty is there really efficacy? (M. Nordin) 14h45-‐15h30 Coffee served during afternoon
Group work and coffee
15h30-‐16h00 Discussion Moderator P. Côté 16h00-‐17h00 Faculty available for informal consultation for Friday participant presentation NOTES:
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FRIDAY Time March 27, 2015 Module 7: Presentations of participants' research outline Experts: All faculty 8h00-‐08h30 Aspects on educational requirements in Europe for surgeons (H. Berk) 8h30-‐11h30 Group presentation, Q & A on study design 11h30-‐12h00 Appraisal of participants' presentation (all faculty) 12h00-‐12h15 How to seek funding from EUROSPINE for research (M. Nordin) 12h15-‐12h30 Adjourn NOTES:
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ORGANIZATIONAL MATTERS
MEETING VENUE & ACCOMMODATION EUROSPINE has secured an allotment at Barceló Hotel Sants, Plaça dels Països Catalans, 08014 Barcelona, Spain Phone +353 1 887 2400 | Fax +34 93 503 53 21 | E-‐Mail [email protected] which is at the same time the course venue. Room rate: EUR 120 per double room single use / night, incl. breakfast, WIFI EUR 130 per double room / night, incl. breakfast, WIFI 10% VAT not included EUR 1,21 City tax per person / night not included To make a reservation, please contact Barceló Hotel Sants, attn. Reservations Dpt. Email: [email protected]
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 entering Spain!
ONLINE BLACKBOARD A course blackboard has been set up where you are requested to download the course material incl. the final programme. All material will be available from Sunday, March 8. 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 Claudia Ortner Membership & Marketing Officer E: [email protected] SCIENTIFIC CONTENT Margareta Nordin Dr. Med. Sci. Course Director E: [email protected]
