HOW TO MAKE YOUR RESEARCH MORE RELEVANT,

FEASIBLE AND PUBLISHABLE

PRELIMINARY PROGRAMME

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QUICK FACTS

WHEN: March 12-16, 2018 WHERE: Crowne Plaza, Avenida da Boavista 1466, Porto, Portugal MAXIMUM ATTENDEES: 30 participants, priority will be given to EUROSPINE members REGISTRATION FEE: EUR 400 for residents/students, EUR 600 for EUROSPINE Members, EUR 800 for Non-Members CME CREDITS: 31 CME credits LANGUAGE: English

IMPORTANT NOTE: Attendance throughout the whole course from Monday through Friday is mandatory. PURPOSE The course is open to all clinicians interested in gaining a basic understanding of clinical research. This course will provide 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) Randomised controlled trials and other study designs 3) Study implementation and analysis 4) Applications of research 5) Communication of research Each module will include combinations of lectures and workshops, where clinicians will build their skills to participate in clinical studies or develop their own clinical study protocol.

CORE FACULTY GUEST FACULTY LOCAL HOST

L. Rachid Salmi, MD PhD (Course Director) Marco Campello PT PhD Christine Cedraschi, PhD Pierre Côté, DC PhD

Fabio Miguel Araujo Robert Gunzburg, MD PhD Anne Mannion, PhD Margareta Nordin, PT Dr. Med. Sci. Pedro Santos Silva, MD Karin Würtz-Kozak, R.PH. PhD MBA

Paulo Pereira, MD PhD

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C O R E F A C U L T Y

COURSE DIRECTOR: Rachid Salmi MD PhD louis-rachid.salmi@u-bordeaux.fr

ISPED/Bordeaux School of Public Health INSERM U-1219, Centre de Recherche Bordeaux Population Health

PU-PH, Service d’information médicale, CHU de Bordeaux Institut de Santé Publique, d’Epidémiologie et de Développement (ISPED)

Université de Bordeaux, Bordeaux, France

Marco Campello PhD marco.campello@nyu.edu

Director Occupational and Industrial Orthopaedic Center (OIOC)

Clinical Associate Professor Department of Orthopedic Surgery

Program of Ergonomics and Biomechanics NYU Langone Orthopedic Hospital

New York University Langone Health New York University School of Medicine New York University, New York, NY USA

Christine Cedraschi PhD Christine.cedraschi@hcuge.ch

Multidisciplinary Pain Center Division of Clinical Pharmacology and Toxicology &

Division of General Medical Rehabilitation Geneva University Hospitals

Geneva, Switzerland

Pierre Côté DC, PhD pierre.cote@uoit.ca

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

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G U E S T F A C U L T Y

LOCAL HOST: Paulo Pereira, MD PhD pereira.paulom@gmail.com

Department of Clinical Neurosciences and Mental Health Faculty of Medicine University of Porto

Department of Neurosurgery Sao Joao Hospital Center

Porto, Portugal

Fabio Miguel Araujo ft.fabio.araujo@gmail.com

Robert Gunzburg, MD PhD robert@gunzburg.be

Cavell Spine Centre Edith Cavell street 32 1180 Uccle, Belgium

Anne Mannion, PhD anne.mannion@yahoo.com

Senior Research Fellow, Spine Center Division Dept Teaching, Research and Development

Schulthess Klinik Zürich, Switzerland

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G U E S T F A C U L T Y

Margareta Nordin, Dr. Med, Sci. dmn2@nyu.edu

Departments of Orthopedic Surgery

and Environmental Medicine New York University, New York, NY, USA

Pedro Santos Silva, MD pedrodossantossilva@gmail.com

Department of Clinical Neurosciences and Mental Health Faculty of Medicine University of Porto

Department of Neurosurgery Sao Joao Hospital Center

Porto, Portugal

Karin Wuertz-Kozak, R.Ph., Ph.D., MBA kwuertz@ethz.ch

Institute for Biomechanics, D-HEST, ETH Zurich Hönggerbergring 64, HPP-O12

8093 Zurich, Switzerland

Schoen Clinic Munich Harlaching Spine Center

Academic Research Hospital and Spine Research Institute of the Paracelsus Medical University (PMU),

Salzburg, AU Harlachinger Str. 51

D-81547 Munich, Germany

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SCHEDULE

Monday, 12 March Module 1: Conceptual overview of clinical research (Faculty) Tuesday, 13 March Module 2: Evaluation of treatment effectiveness and prognosis (P.

Côté) Wednesday, 14 March Module 3: Study implementation and analysis (R. Salmi) Thursday, 15 March Module 4: Qualitative Research (C. Cedraschi) Module 5: Dissemination of Research Findings (M. Campello) Friday, 16 March Presentations of participants' research outline COURSE OBJECTIVES

At the end of the course, attendees will be able to: 1. Develop a research question and formulate a 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. Apply 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. Develop a study protocol

• 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. Discuss the basic principles of qualitative research

• When do I use it? • What is the added value to clinical research?

5. Contribute clinical experience to evidence-based decision making in spinal care

• Why it is important to standardize data collection in clinical practice? • What are the roles of registries?

6. Understand the process of research publishing

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SCIENTIFIC PROGRAMME DAY 1

Time 12 March 2018, Monday Course Introduction (All faculty) 08h30-08h45 Welcome address (R. Salmi, P. Pereira) 08h45-09h15 General overview of the course: Why do we need clinical studies? (R. Salmi) 09h15-09h45 How to develop a relevant research question? (M. Campello) 09h45-10h15 How do I turn a question into a hypothesis? What model do I use? (C. Cedraschi) 10h15-10h30 Coffee Break 10h30-11h30 Group work (division into groups): Formulate a research question and derive a

hypothesis for the evaluation of a treatment intervention (Faculty) 11h30-12h00 General methodological concepts of clinical research (P. Côté) – PART 1 12h00-13h00 Lunch 13h00-13h30 General methodological concepts of clinical research (P. Côté) – PART 2 13h30-14h15 Basic statistical concepts (R. Salmi) 14h15-15h00 Outcome domains in spine care. The methodologist's and clinicians’ perspective

and panel discussion (R. Salmi, M. Campello) 15h00-16h00 Coffee served during afternoon

Group work (division into groups): continue on research question and derive a hypothesis for the evaluation of a treatment intervention (Faculty)

16h00-16h45 Presentation of research questions and feedback (M. Campello) 17:00-18:30 Welcome cocktail

NOTES:

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SCIENTIFIC PROGRAMME DAY 2

Time 13 March 2018, Tuesday Evaluating treatment effectiveness, treatment safety, and prognosis (P. Côté) Clinical expert: Pedro Santos Silva 08h30-10h00 Selecting the appropriate study design (P. Côté)

- Is your question addressing treatment effectiveness, treatment safety or prognosis?

- Treatment effectiveness: How you design a randomized clinical trial? • Key methodological concepts: Study architecture, sample selection,

randomization, concealment, blinding, measurement of outcomes, follow-up, and incidence

• What are the treats to the validity of randomized clinical trial? • How do I compute a sample size estimate for a randomized clinical

trial? 10h00-10h15 Coffee Break 10h15-12h00 Group work: Using the research question developed on day 1, and start

designing your study (Part 1) 12h00-13h00 Lunch 13h00-14h00 - Prognosis: How do you design a cohort study?

• Key methodological concepts: Study architecture, population at risk, incidence, prognostic factor (exposure), measurement of outcomes, follow-up, confounding

• What are the treats to the validity of cohort studies? • How do I compute a sample size estimate for a cohort study?

14h00-16h00 Coffee served during afternoon

Group work: Continue designing your study (Part 2)

16h00-16h45 Feedback on group work (P. Côté) NOTES:

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SCIENTIFIC PROGRAMME DAY 3

Time 14 March 2018, Wednesday Do’s and don’ts of successful clinical research (R. Salmi) Clinical expert: Pedro Santos Silva 08h30-10h00 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?

10h00-10h15 Coffee Break 10h15-12h00 Group work: Start planning participant selection and data collection 12h00-13h00 Lunch 13h00-14h30 Planning the analysis and sample size (R. Salmi)

• How do you define your analysis strategy? • How do you choose adequate statistical methods? • 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?

14h30-16h00 Coffee served during afternoon

Group work: Start planning your sample size calculation

16h00-16h45 Feedback on group work (R. Salmi) NOTES:

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SCIENTIFIC PROGRAMME DAY 4

Time 15 March 2018, Thursday Considering patients’ perspective in clinical research (C. Cedraschi) Clinical expert: M. Campello, Pedro Santos Silva 08h30-10h00 Basic principles of qualitative studies

• What is the question? • Definition of the design: What is the design? • Purpose of the design: When to use it? What type of question does it

allow you to answer? • How do you get prepared to discuss with a qualitative methodologist? • Selection of the study sample • Selection of the methods for data collection • Basics of data analysis in qualitative studies • Pros and cons of the qualitative and mixed studies

10h00-10h30 Coffee Break 10h30-12h00 Workshop: using the focus group method to define disability 12h00-13h00 Lunch 13h00-14h00 Reporting and discussion of the focus group results From research to clinical practice (M. Nordin)

Clinical expert: M. Campello 14h00-14h45 Publishing your research (R. Gunzburg) 14h45-15h15 The role of clinical experience in evidence-based spinal care (M. Campello/P.

Pereira) 15h15-16h00 The use of Spine Tango registry data for clinical research (A. Mannion) 16h00-17h15 Coffee served during afternoon

Group work: Complete presentations for Friday

NOTES:

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SCIENTIFIC PROGRAMME DAY 5

NOTES:

Time 16 March 2018, Friday Presentations of participants' research outline Experts: All faculty, external Examiner: F. Araujo, R. Gunzburg, A. Mannion, M. Nordin, P. Perreira, K. Würtz 08h00-08h20 Why research is rewarding and fun (M. Nordin) 08h20-12h00 Group presentations, Q & A on proposed studies 12h00-12h15 Appraisal of participants' presentation (all faculty) 12h15-12h30 Course evaluation 12h30-12h45 Certificates & Adjourn

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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: www.eurospinemeeting.org facebook.com/EUROSPINE twitter.com/EUROSPINESoc youtube.com/EUROSPINE COURSE ORGANISATION Julie-Lyn Noël MD MBA Director of Education and Research EUROSPINE, the Spine Society of Europe E: noel@eurospine.org T: +41 76 417 90 03 Sandy Sutter Manager of Education and Research EUROSPINE, the Spine Society of Europe E : sutter@eurospine.org T :+41 79 316 92 78 SCIENTIFIC CONTENT Björn Rydevik MD PhD Chair, EUROSPINE Research Council Rachid Salmi MD PhD Course Director, EUROSPINE Task Force Research