FINAL PROGRAM FUNDAMENTALS OF CLINICAL RESEARCH: LEARNING TO DESIGN MY OWN CLINICAL STUDIES A COURSE OF EUROSPINE, THE SPINE SOCIETY OF EUROPE Mosque of Ortakoy Suat Eman
QUICK FACTS ü WHEN: Monday, 27 February - Friday, 2 March, 2012 ü WHERE: Sheraton Istanbul Atakoy Hotel, Istanbul, Turkey ü MAXIMUM ATTENDEES: 24 participants, priority will be given to SSE members ü REGISTRATION FEE: EUR 400, incl. Course documentation, Coffee s, Lunches, Welcome Reception and Goodbye Dinner. Course must be attended Monday to Friday ü CME CREDITS: 30 CME ü LANGUAGE: English 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 tools to design clinical studies. STRUCTURE OF THE COURSE The course includes five modules: 1) Conceptual overview of clinical research; 2) Randomized controlled trials; 3) Cohort studies; 4) Systematic Reviews and 5) Qualitative studies. Each module will include a morning lecture and an afternoon lab where clinicians will learn to critically appraise a published study. Date Sunday, February 26, 2012 Monday, February 27, 2012 Tuesday, February 28, 2012 Wednesday, February 29, 2012 Thursday, March 1, 2012 Friday, March 2, 2012 Module Welcome Reception Module 1: Conceptual overview of clinical research (Faculty) Module 2: Randomized controlled trials (P. Côté) Module 3: Cohort studies (L. Holm) Module 4: Systematic Reviews (M. Nordin) Module 5: Qualitative studies (C. Cedraschi) 2
FACULTY margareta.nordin@nyu.edu Department'of'Orthopedic'Surgery'and'Environmental' Medicine New'York'University New'York,'NY,'USA Christine.Cedraschi@hcuge.ch Multidisciplinary'Pain'Center Division'of'Clinical'Pharmacology'and'Toxicology,'&' Division'of'General'Medical'Rehabilitation Geneva'University'Hospitals Geneva,'Switzerland pierre.cote@uhnresearch.ca Dalla'Lana'School'of'Public'Health University'of'Toronto'and''Toronto'Western'Research' Institute'University'Health'Network Toronto,'Ontario,'Canada lena.holm@ki.se' Division'of'Epidemiology Institute'of'Environmental'Medicine'Karolinska'Institute Stockholm,'Sweden Emre'Acaroglu'MD acaroglue@gmail.com Ankara'Spine'Cente Iran'Caddesi'45/2,'Kaveklidere Ankara,'Turkey Federico'Balagué'MD' BalagueF@h[fr.ch Rheumatology'Service Hopital'Cantonal Fribourg,'Switzerland Haluk'Berk'MD Haluk.berk58@gmail.com Dept.'of'Orthopaedics'and'Traumatology Dokuz'Eylül'University School'of'Medicine' Inciralti[Izmir,'Turkey Marco'Campello'PhD' campem01@nyu.edu Department'of'Orthopedic'Surgery New'York'University New'York,'NY,'USA Björn'Rydevik'MD,'PhD' bjorn.rydevik@orthop.gu.se Department'of'Orthopaedics Gothenburg'University Sahlgren'Hospital' Gothenburg,'Sweden Marek'Szpalski'MD' mszp@skynet.be Orthopedic'Surgery Center'Hospitalier'Moliere'Longchamp Brussels,'Belgium yazioglu@hacettepe.edu.tr Hacettepe'University Faculty'of'Medicine Dept'of'Orthopaedics'and'Traumatology Sihhiye Ankara,'Turkey Margareta'Nordin'Dr.'Med.'Sci.'' (Course'Director) C O R E Christine'Cedraschi'PhD' F A Pierre'Côté'PhD' C U L T Y Lena'Holm'Dr.'Med.'Sci.' G U E S T F A C U L T Y TFR2012 FacultyDetails Muharrem'Yazici'MD 3
GENERAL COURSE OUTLINE Course Objective: The course will have three 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 scientific article and critically appraise the quality of the study. - What instrument (review criteria) do I use to critically appraise a study? - What are the strengths and the limitations of the study? How do I assess them? - How do I assess the internal validity of a study? - How far can the findings be generalized, in particular to my work/research environment? 4
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 bias - Be introduced to appropriate statistical analysis for a selected study design - Be knowledgeable about critical appraisal of the literature - Be introduced to available tools for critical review of the literature 5
SCIENTIFIC PROGRAMME - OVERVIEW Monday' Tuesday Wednesday Thursday Friday Time 27-February-2012 Time 28-February-2012 Time 29-February-2012 Time 01-March-2012 Time 02-March-2012 Module-2:--Randomized-controlled-trials- Module-3:--Cohort-studies- Module-4:--Systematic-Reviews- Module-5:--Qualitative-studies- Module-1:--Conceptual-overview-of-clinical- research- (Faculty) (P.+Côté)- (L.+Holm)+ (M.+Nordin) (C.+Cedraschi) Clinical-expert:-Marek-Szpalski Clinical-expert:-Federico-Balagué Expert:-Björn-Rydevik Basic'principles'of'the' study'design'of'the'day ' 4'''What'is'the'question?''Start'with'a'clinical' question 4'''Definition'of'the'design:''What'is'the'design? 4'''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?' 4'''Selection'of'the'study'sample'(purposive' sampling'vs'representative'sample) 4'''Selection'of'the'methods'for'data'collection'(for' example'in4depth'interview,'semi4structured' interview,'focus'group,'diary) 4'''Basic'principles'of'data'analysis'in'qualitative' studies:'grounded'content'analysis 4'''Do'the'concepts'of'validity'and'reliability'apply' to'qualitative'studies? 8h304 10h00 Historical'review'of'Whiplash'Associated'Disorders' (WAD)'and'Neck'Pain'Task'Force'(NPTF).' (Margareta'Nordin,'Pierre'Côté) 8h304 9h00 Basic'principles'of'the' study'design'of'the'day 4'''What'is'the'question?''Start'with'a'clinical' question. 4'''Definition'of'the'design:''What'is'the'design? 4'''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?' Retrospective'versus'prospective 4'''Sample'selection' 4'''Selection'of'the'data'to'be'collected'(exposure,' treatment,'outcomes,'qualitative'data,'search'of' published'literature)' 'Specific'outcome' instruments' 4'''Follow4up'of'study'participants 8h304 10h00 Basic'principles'of'the' study'design'of'the'day ' 4'''What'is'the'question?'' 4'''Definition'of'the'design:''What'is'the''design? 4'''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?' 4'''Sample'selection' 4'''Selection'of'the'data'to'be'collected'(exposure,' treatment,'outcomes,'qualitative'data,'search'of' published'literature)' 'Specific'outcome' instruments 4'''Follow4up'of'study'participants 8h304 10h00 Welcome'address'(Haluk'Berk) 08h304 9h00 General'overview'of'the'course:''Why'do'we'need' clinical'studies?'(margareta'nordin) Basic'principles'of'the' study'design'of'the'day 4'''What'is'the'question?''Start'with'a'clinical' question. 4'''Definition'of'the'design:''What'is'the'design? 4'''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?' 4'''Selection'of'articles 4'''Critical'appraisal 9h004 10h00 Overview'of'the'program'(Margareta'Nordin) 9h004 9h15 The'patho4anatomical'model'(Bjorn'Rydevik) 9h154 9h45 The'biopsychosocial'model'(Christine'Cedraschi) 9h454 10h15 10h00S 10h15 10h00S 10h15 10h00S 10h15 10h00S 10h15 10h15S 10h30 Presentation'of'a'qualitative'study' 'appraisal'of' quality'issues,'importance'of'mixed'methods 10h154 11h00 Synthesis:''Best'evidence,'Cochrane'and' Metaanalysis'(Margareta'Nordin,'Pierre'Côté) 10h154 12h00 Basic'principles'of'the' study'design'of'the'day ' 4'''Threats'to'the'internal'validity'of'clinical'studies' o'''selection'bias:''participation'and'loss'to'follow4 up o'''measurement'bias:'reliability'and'validity o'''confounding 4'''Preventing'bias 4'''Critically'appraising'a'published'study 10h154 12h00 Basic'principles'of'the' study'design'of'the'day ' 4'''Threats'to'the'internal'validity'of'clinical'studies' o'''selection'bias:''participation'and'loss'to'follow4 up o'''measurement'bias:'reliability'and'validity o'''confounding 4'''Preventing'bias 4'''Critically'appraising'a'published'study 10h154 12h00 Discussion'with'spine'faculty:''The'patho4 anatomical'and'biopsychosocial'models:'' implications'for'future'spinal'care'research'(emre' Acaroglu,'Christine'Cedraschi,'Bjorn'Rydevik' [Moderator],'Muharrem'Yazici).' 10h304 11h15 6 Examination 11h004 11h45 Synthesis:''Best'evidence,'Cochrane'and' Metaanalysis'(Margareta'Nordin,'Pierre'Côté) 10h154 12h00 What'is'a'good'research'question?''And'how'do'I' develop'it'into'a'hypothesis?'(margareta'nordin) 11h154 12h00 Course''Evaluation 11h454 12h15 Conclusions 12h004 12h30 Lunch Lunch 12h00S 13h00 Lunch 12h00S 13h00 12h00S 13h00 Critical-Appraisal-of-a-study-(with-Faculty) Critical-Appraisal-of-a-study-(with-Faculty) Critical-Appraisal-of-a-study-(with-Faculty) Expert s'note'(björn'rydevik) Expert s'note'(federico'balagué) 13h004 13h15 Expert s'note'(marek'szpalski) 13h004 13h15 Search'of'the'literature'(Marco'Campello) 13h004 13h15 13h004 13h45 Review'of'one'published'article'according'to'the' specific'criteria'described'in'critical'appraisal'tool' (Group). 13h154 14h00 Review'of'one'published'article'according'to'the' specific'criteria'described'in'critical'appraisal'tool' (Group). 13h154 14h00 Review'of'one'published'article'according'to'the' specific'criteria'described'in'critical'appraisal'tool' (Group). 13h154 14h00 General'methodological'concepts'of'clinical' research'(pierre'côté) 13h454 14h30 Synthesis'of'the'critical'appraisal'in'subgroups'(4' persons/subgroup)' 14h004 15h00 Synthesis'of'the'critical'appraisal'in'subgroups'(4' persons/subgroup)' 14h004 15h00 Synthesis'of'the'critical'appraisal'in'subgroups'(4' persons/subgroup)' 14h004 15h00 Outcome'domains'in'spine'care'research'(Lena' Holm) 14h304 15h00 Lunch 12h00S 13h00- - - 15h00S 15h15-15h00S 15h15 Coffee 15h00S 15h15 15h00S 15h15 Presentations'of'the'syntheses'of'the'different' subgroups 15h154 16h30' Presentations'of'the'syntheses'of'the'different' subgroups 15h154 16h30' Presentations'of'the'syntheses'of'the'different' subgroups 15h154 16h30' Critical'appraisal'of'the'literature'(Marco' Campello) 15h154 16h00 General'discussion'with'Expert'to'discuss'the' clinical'applicability'of'the'article'(björn'rydevik) 16h304 17h00' General'discussion'with'Expert'to'discuss'the' clinical'applicability'of'the'article'(federico' Balagué) 16h304 17h00' General'discussion'with'Expert'to'discuss'the' clinical'applicability'of'the'article'(marek'szpalski) 16h304 17h00' Group'assignment'and'discussion'of'final' examination'(margareta'nordin) 16h004 17h00
SOCIAL PROGRAMME GET TOGETHER WHEN: Sunday, 26 February 2012 at 19h00 WHERE: Sheraton Atakoy (= Course Venue) We would like to welcome everybody at the course venue for an informal get together before you all dig deep into the course topics. Cheers! GOODBYE DINNER WHEN: Thursday, 1 March 2012 at 20h00 WHERE: Köşebaşı Galleria, Galleria Shopping Mall, Ataköy Sahilyolu, Bakırköy İstanbul TRANSPORTATION: not needed as it is in walking distance After some hard working days we would like o take you out for a nice dinner in a typical Turkish restaurant where you can indulge some delicacies of the Turkish cuisine. We wish you a joyful night! 7
SCIENTIFIC PROGRAMME - PER DAY Monday Time 27 February 2012 Module 1: Course Introduction (M. Nordin) 08h30-9h00 9h00-9h15 9h15-9h45 9h45-10h15 10h15-10h30 10h30-11h15 11h15-12h00 12h00-13h00 13h00-13h45 13h45-14h30 14h30-15h00 15h00-15h15 15h15-16h00 16h00-17h00 Welcome address (Haluk Berk) General overview of the course: Why do we need clinical studies? (Margareta Nordin) Overview of the program (Margareta Nordin) The patho- anatomical model (Björn Rydevik) The biopsychosocial model (Christine Cedraschi) Discussion with spine faculty: The patho- anatomical and biopsychosocial models: implications for future spinal care research (Emre Acaroglu, Christine Cedraschi, Björn Rydevik [Moderator], Muharrem Yazici) What is a good research question? And how do I develop it into a hypothesis? (Margareta Nordin) Lunch Search of the literature (Marco Campello) General methodological concepts of clinical research (Pierre Côté) Outcome domains in spine care research (Lena Holm) Coffee Critical appraisal of the literature (Marco Campello) Group assignment and discussion of final examination (Margareta Nordin) 8
Tuesday Time 28 February 2012 Module 2: Randomized controlled trials (P. Côté) Clinical expert: Marek Szpalski 8h30-10h00 10h00-10h15 10h15-12h00 12h00-13h00 13h00-13h15 13h15-14h00 14h00-15h00 15h00-15h15 15h15-16h30 16h30-17h00 Basic principles of the study design of the day - 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 - Selection of the data to be collected (exposure, treatment, outcomes, qualitative data, search of published literature) Specific outcome instruments - Follow- up of study participants Basic principles of the study design of the day - Threats to the internal validity of clinical studies o Selection bias: participation and loss to follow- up o Measurement bias: reliability and validity o Confounding - Preventing bias - Critically appraising a published study Lunch Critical Appraisal of a study (with Faculty) Expert s note (Marek Szpalski) Review of one published article according to the specific criteria described in critical appraisal tool (Group). Synthesis of the critical appraisal in subgroups (3-4 persons/subgroup) Presentations of the syntheses of the different subgroups General discussion with Expert to discuss the clinical applicability of the article (Marek Szpalski) 9
Wednesday Time 29 February 2012 Module 3: Cohort studies (L. Holm) Clinical expert: Federico Balagué 8h30-10h00 10h00-10h15 10h15-12h00 12h00-13h00 13h00-13h15 13h15-14h00 14h00-15h00 15h00-15h15 15h15-16h30 16h30-17h00 Basic principles of the study design of the day - What is the question? Start with a clinical 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? Retrospective versus prospective - Sample selection - Selection of the data to be collected (exposure, treatment, outcomes, qualitative data, search of published literature) Specific outcome instruments - Follow- up of study participants Basic principles of the study design of the day - Threats to the validity of clinical studies o Selection bias: participation and loss to follow- up o Measurement bias: reliability and validity o Confounding - Preventing bias - Critically appraising a published study. Lunch Critical Appraisal of a study (with Faculty) Expert s note (Federico Balagué) Review of one published article according to the specific criteria described in critical appraisal tool (Group). Synthesis of the critical appraisal in subgroups (3-4 persons/subgroup) Presentations of the syntheses of the different subgroups General discussion with Expert to discuss the clinical applicability of the article (Federico Balagué) 10
Thursday Time 01 March 2012 Module 4: Systematic Reviews (M. Nordin) Expert: Björn Rydevik 8h30-9h00 9h00-10h00 10h00-10h15 10h15-12h00 12h00-13h00 13h00-13h15 13h15-14h00 14h00-15h00 15h00-15h15 15h15-16h30 16h30-17h00 Historical review of Whiplash Associated Disorders (WAD) and Neck Pain Task Force (NPTF). (Margareta Nordin, Pierre Côté) Basic principles of the study design of the day (Margareta Nordin) - What is the question? Start with a clinical 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 articles - Critical appraisal Synthesis: Best evidence, Cochrane and Metaanalysis (Pierre Côté) Lunch Critical Appraisal of a study (with Faculty) Expert s note (Björn Rydevik) Review of one published article according to the specific criteria described in critical appraisal tool (Group). Synthesis of the critical appraisal in subgroups (4 persons/subgroup) Presentations of the syntheses of the different subgroups General discussion with Expert to discuss the clinical applicability of the article (Björn Rydevik) 11
Friday Time 02 March 2012 Module 5: Qualitative studies (C. Cedraschi) 8h30-10h00 10h00-10h15 10h15-11h00 11h00-11h45 11h45-12h15 12h00-12h30 Basic principles of the study design of the day - What is the question? Start with a clinical 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 (purposive sampling vs representative sample) - Selection of the methods for data collection (for example in- depth interview, semi- structured interview, focus group, diary) - Basic principles of data analysis in qualitative studies: grounded content analysis - Do the concepts of validity and reliability apply to qualitative studies? Presentation of a qualitative study appraisal of quality issues, importance of mixed methods Examination Course Evaluation Conclusions 12
PERSONAL NOTES 13