MECOR Turkey 2014 LEVEL 1
American Thoracic Society
Turkish Thoracic Society
Level 1 Course Schedule
MECOR Turkey 2014
(Methods in Epidemiologic, Clinical
& Operations Research)
Cesme, Turkey
November 17-22, 2014
ACKNOWLEDGMENTS
The American Thoracic Society is the primary sponsor of the 2014 MECOR Turkey Course in Cesme, Turkey
The Turkish Thoracic Society has provided the principle support for MECOR Turkey 2014.
Our sincere thanks to all who have shared the vision and support this program
The American Thoracic Society acknowledges and gratefully thanks
Füsun Eyüpoğlu, country coordinator of MECOR Turkey 2014 and her colleagues who assisted in its organization.
MECOR Turkey 2014 Course Staff
A. Sonia Buist, ATS MECOR Program Director
Füsun Eyüpoğlu, MECOR Turkey Country Course Director
Fran Du Melle, Sr. Director, International Activities, American Thoracic Society
E-mail:
“Improving global lung health through development of
local, country and regional lung disease research capacity”
TABLE OF CONTENTS
Acknowledgements i
Welcome 1
Course Overview 1
Expectations
Resources 1
Text
Helpful Websites
Other Helpful Resources
Faculty 3
Competencies 6
Protocol Outline 8
FINER Criteria 9
2 x 2 Table Format 10
Course Schedule 11
16
MECOR Turkey 2014 LEVEL 1
WELCOME TO MECOR TURKEY 2014!
Congratulations and welcome to the MECOR family. In the next week you’ll deepen your understanding of research epidemiology and establish new friendships with others in your field. We’ll begin by introducing all MECOR faculty and participants in Monday morning’s plenary session. Come prepared to introduce yourself, including your degree, institution and area of research interest.
Please review this syllabus before the course begins. We will address any questions you have in the first session.
COURSE OVERVIEW
The main focus of Level 1 is to learn how to develop a study protocol. Students will learn the fundamentals of posing a testable research question, the various study design options for generating and testing hypotheses, and basic analytic skills. Students will spend time in lectures or working in small groups with or without a faculty member.
By the end of the week, each student should have a research study protocol and PowerPoint summary to be used in a final presentation to MECOR faculty and students.
Expectations
We expect all participants in MECOR Turkey Level 1 to:
· Participate fully in all course activities, including daily check-ins, lectures and small group work;
· Read relevant sections of the textbook (see below);
· Seek help from Level 1 or other faculty when they encounter problems or need to review their plans/progress; and,
· Fully engage in preparing and presenting their research protocol.
To enable you to meet these expectations, the faculty will be available during breaks and meals as well as after class. Please feel free to make appointments to meet with us. We welcome the opportunity to discuss your research interests with you.
NOTE: Each Level 1 MECOR student is expected to bring his/her own laptop to the course. No computers or laptops will be provided. Nor will it be possible for students to share laptops since each person will be working concurrently on their own study.
RESOURCES
Textbook
The MECOR course textbook for all levels is:
Hulley SB, et al. Designing clinical research: an epidemiologic approach. 4th edition. Philadelphia: Lippincott Williams & Wilkins, 2007.
Please bring this text to the course. Note: The earlier (3rd) edition is perfectly suitable and is available used at lesser cost.
Helpful Websites
Statistics at Square One (British Medical Journal): http://bmj.bmjjournals.com/collections/statsbk/
This is an excellent review of basic medical statistics.
Southwest Oncology Group for clinical trials: http://www.swogstat.org/statoolsout.html
This site is primarily designed for clinical trials work but can be used for other analyses. Designs covered include one-sample and two-sample binomial, normal and survival calculations, plus two-stage clinical trials designs. Does not cover regression models. Logistic regression works only for one dichotomous predictor (via two-sample binomial). Note that it also has some simple statistical calculations (2x2 tables) and probability calculations (binomial, normal).
UCLA: http://socr.ucla.edu/htmls/SOCR_Analyses.html
UCLA’s statistical calculators run JAVA applets to estimate sample size needs for two-sample Poisson, ANOVA, Fisher’s exact test, correlation/regression, t-test with unequal variances, nonparametric rank sum and sign tests, and other features.
Dartmouth-Hitchcock Norris Cotton Cancer Center:
http://biostat.hitchcock.org/MeasurementError/Analytics/PowerCalculationsforLogisticRegression.asp
This site does logistic regression with a continuous exposure variable and one additional continuous covariate or confounder.
Vanderbilt University: http://biostat.mc.vanderbilt.edu/twiki/bin/view/Main/PowerSampleSize
This site is posted by Vanderbilt’s CTSC group, which has developed a downloadable free program for Power and Sample Size calculation.
University of Iowa: http://www.stat.uiowa.edu/~rlenth/Power/index.html
Russ Length’s excellent website covers many ANOVA and regression designs, repeated measures, and a lot more. This is a superb resource with the ability to work out power for contrasts, generate power curves, and so on.
Other Helpful Resources
1. Gordis L. Epidemiology. Third edition. Elsevier Saunders, Philadelphia, PA 2004.
2. Glantz, Stanton A. Primer of biostatistics / Stanton A. Glantz. 6th ed. New York: McGraw-Hill Medical Pub. Division, 2005.
3. IUATLD Monograph: “Research Methods for the Promotion of Lung Health, A Guide to Protocol Development for Low-Income Countries."
You will find this at the International Union against Tuberculosis and Lung Disease web site at:
http://www.theunion.org/what-we-do/publications/technical/research-methods-for-the-promotion-of-lung-health-a-guide-to-protocol-development-for-low-income-countries
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MECOR Turkey 2014 LEVEL 1
LEVEL 1 FACULTY
Tricia LeVan, PhD, CPH
Associate Professor
University of Nebraska Medical Center
985910 Nebraska Medical Center
Omaha, NE 68198-5910
Telephone: 402-559-3985
Dr. LeVan is an Associate Professor in the Division of Pulmonary, Critical Care, Sleep and Allergy and the Department of Epidemiology. She is Molecular Biologist and Genetic Epidemiologist with a research emphasis on genetic, epigenetic and environmental influences of chronic obstructive pulmonary disease (COPD). Her research focuses on susceptibility genes that modulate lung innate immune response to acute and chronic exposure to bacteria, using organic dust from the agricultural environment as a model system. She currently teaches an ‘Introduction to Epidemiology’ core course and a Genetic Epidemiology course for Certificate, MPH and PhD graduate students in the College of Public Health. She has been teaching MECOR courses since 2011 including courses in China, India, and Turkey.
Sonia Buist, MD
Pulmonary and Critical Care Medicine
Oregon Health & Science University
3181 SW Sam Jackson Park Road
Portland, OR 97239
Dr. Sonia Buist is currently Professor Emerita of Medicine at the Oregon Health & Science University. Dr. Buist obtained her medical degree from St Andrews University in Scotland, did her residency at the University of Colorado School of Medicine in Denver, and completed fellowships in pulmonary medicine and pulmonary physiology at the University of Oregon Medical School. Dr. Buist has been a member of numerous federal and international advisory groups. She is a past member of the New England Journal of Medicine Editorial Board and is a current member of the editorial board of Thorax and the Clinical Respiratory Journal. She has held numerous positions in the American Thoracic Society and was President in 1990-91. Dr. Buist's research interests are primarily in the areas of asthma and COPD, with particular emphasis on the epidemiology and management of these diseases.
Dr. Buist, together with Dr. Jon Samet, started the ATS IRE Program in 1994. Since then, the program, now called the MECOR (Methods in Epidemiologic, Clinical & Operations Research) Program has been held annually in Latin America (Mexico, Chile, Brazil, Argentina, Peru, Uruguay and Ecuador). The MECOR Program began in Africa in 2007, in Turkey in 2008, and in India in 2009.
Dr Stefano Guerra is an associate professor in Medicine and the Dahlberg Chair in Pulmonary Medicine at the University of Arizona in Tucson, AZ, and he also holds a jointappointment as associate professor at the CREAL Center in Barcelona, Spain. He received his MD from the University of Milan, Italy, and his Master in Public Health and PhD (Epidemiology / Genetics) from the University of Arizona, where he now teaches a graduate level course in genetic epidemiology. He is involved in several long-term cohort studies on respiratory diseases with a major focuson the genetic and molecular components of complex obstructive lung diseases, including asthma and COPD. Among thesestudies arethe 40-year long adult cohort of the Tucson Epidemiological Study of Airway Obstructive Disease and the 32-year long Tucson Children's Respiratory Study, for both of which he acts as the principal investigator of biomarker-related projects.
Dr Özge Yılmaz is currently Associate professor of Pediatrics in Celal Bayar University Medical Faculty, Department of Pediatric Allergy and Pulmonology. She graduated from Hacettepe University Medical Faculty in 2001 and completed her Pediatric residency in 2007 in Celal Bayar University Medical Faculty, Manisa. She completed her fellowship in Pediatric Allergy at the same university in 2011. She was a student in the first three levels of MECOR courses between 2008 and 2011 in Turkey and she finished the Global MECOR course in 2011. She has worked as a teaching assistant in MECOR for two years and since last year she is working as a faculty. She is the secretary of Experimental Research Assembly of Turkish Thoracic Society and a member of School committee. She is currently a member of the Pediatrics Assembly planning committee and international relations committee of American Thoracic Society. Moreover, she is a member of European Respiratory Society and European Academy of Allergy and Clinical Immunology. Her work focuses on pathophysiological aspects of pediatric asthma and wheezing in children as well as the quality of life in pediatric allergic diseases.
Pinar Ay is a professor of Public Health at Marmara University, School of Medicine since 2013. Dr. Ay graduated from Istanbul University School of Medicine in 1994. She got her MPH degree from Hadassah Braun School of Public Health and Community Medicine in 2000. She completed her residency in Public Health at Istanbul University School of Medicine in 2002. Since then she has been working at Marmara University, School of Medicine Department of Public Health. Dr. Ay is the co-author of a book on Evidence-Based Medicine. Her research interests are epidemiology, biostatistics, evidence-based medicine, qualitative research methods, women’s health, child health, health seeking behavior and community mental health.
I'm a pulmonary diseases specialist. I had my medical school degree from Ege University School of Medicine in 2004 and I had a five year long education in Dokuz Eylul University School of Medicine, Department of Pulmonary Diseases. I worked on environmental and occupational medicine during my education in Dokuz Eylul University. I had studies on dental technicians pneumoconiosis, biomass exposure and spirometry standardization. I also made 3 studies on pulmonary arterial hypertension rat model. One of our studies hadPulmonary Circulation Award by Turkish Thoracic Society in 2010. I now live in Gaziantep and work in Nizip State Hospital. At the same time, I study on primary mesothelial cell cultures and cell lines in Gazinatep University School of Medicine Cell Culture Laboratory. I'm also a master student in Basic Respiratory Biology Programme. I had Level 3 in MECOR and as Sonia said: I'm a MECOR product :)
LEVEL 1 COMPETENCIESOverall Goals
Level 1 is designed for academic physicians who will be involved in conducting medical research. Participants will learn the fundamentals of posing testable research questions, choosing among various study designs for generating and testing hypotheses, and develop basic bio-statistical skills. Participants will gain an understanding of statistics that will help them to collaborate effectively with statistical co-investigators.
Epidemiology
Descriptive Epidemiology / Understand the basis of an epidemiologic approach to disease,
e.g. populations, prevalence, incidence
Research design
Research Design / Become familiar with the major study types (cross-sectional,
case-control, cohort, and clinical trial) and their respective measures of effect
Research Questions / Be able to pose simple research questions and recognize the most appropriate study design for the question posed
Research methods
Sampling & Population Selection / Differentiate between populations and samples and understand how they may affect results
Sample Size Power / Appreciate the importance of adequate power and the factors affecting power
Questionnaires, Measures, & Measurement Procedures / Comprehend valid and reliable measurements; sensitivity, specificity and predictive value
Quality Control / Review techniques for maximizing data quality
Ethics & Informed Consent / Value the Importance of ethical conduct of human research
Study Proposal Stages / 1) One-sentence hypothesis
2) Two-page summary
3) Full proposal
4) Operations manual
LEVEL 1 COMPETENCIES
Statistics
Descriptive Statistics / Summarize continuous and categorized data; understand and use measures of central tendency and measures of dispersion
Measures of Association Effect / Understand prevalence, incidence, cumulative incidence, and their odds ratios
Sources of Error / Comprehend bias, confounding chance, Type I and Type 2 errors, standard error and confidence intervals
Univariate & Bivariate Analyses / Differentiate t-test and ANOVA; Wilcoxon and Kruskall-Wallis; chi-squared
Multivariate Analyses / Understand the principles behind multiple linear regression
Logistic Regression / Grasp the application of multiple logistic regression
Reading & writing the presentation
Reading a scientific paper / Addressed in subsequent MECOR levels
Evidence-based medicine / Addressed in subsequent MECOR levels
Writing a scientific paper / Addressed in subsequent MECOR levels
Presentation
Protocol / Present a research protocol developed during the course
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MECOR Turkey 2014 LEVEL 1
PROTOCOL OUTLINE[1]
1. Title
Clear and descriptive
2. Research Question
One sentence concisely stating your question, answer by yes/no/number
3. Objective
Overall purpose, primary and secondary objectives: statement
4. Hypothesis
Anticipated results
5. Rationale/Background
One to several paragraphs indicating why the question is important
6. Study Design
Cross-sectional vs. case-control, vs. cohort, etc. (2x2 table)
7. Participants/Study Population
Inclusion and exclusion criteria (location, age, sex etc.)
Recruitment strategy/Sampling
Human subject informed consent and ethics review
8. Variables
Outcome (dependent variable, response variable)
Exposure (risk factor, independent variable, predictor, explanatory variable, treatment)
Covariates and Confounders
Data collection and quality control methods (questionnaire, medical record review, etc.)
9. Statistical Analysis
Hypothesis
Sample size and power
Analytic Approach
10. Timeline
Phases of research plan, recruitment, screening, data collection, follow up, data analysis, report preparation