Biostatistics for Clinical Investigators



Biostatistics for Clinical Investigators, Fall 2014

Course Overview

Course Goals:

To be able to:

1) Determine which statistical tests are appropriate for data analyses in most clinical studies

2) Perform and interpret statistical analyses using common statistical tests/methods, including sample size and power calculations

3) Recognize when complex (eg, regression) analyses are indicated; be able to discuss these analyses with biostatistical consultants

4) Recognize errors and limitations of published statistical analyses

5) Present data analyses clearly with appropriate conclusions and interpretations

Course Structure:

Weekly lectures and in-class problem solving

Weekly homework assignments (cumulative)

Use the Stata 13 statistical package

Show all work including the statistical program output when applicable.

You may discuss the homework with others but you are expected to complete your own assignments.

Three take-home exams (cumulative)

Use the Stata 13 statistical package

Show all work including the statistical program output when applicable.

You may use books, notes and other written references, but you are expected to complete your own test without help from others.

Requirements for Credit:

1) Enrolling in the class for credit (email deborah.garcia@uth.tmc.edu)

2) Completion of the Stata online tutorial ()

3) Attendance at all 14 lectures (may be viewed on videostream - must email Deb Garcia after viewing videostream ( - see instructions at bottom of page) to get credit for “attendance”

4) Completion of all homework assignments and tests within 2 weeks after the date assigned (see exception below for final), unless prior arrangements have been made in writing (by email) with Dr. Kennedy (must have email verification of receipt from Deb)

5) Average score of at least 80% on the three take-home exams

6) Completion of the final exam and all other coursework by 12/19/14 [unless permission granted in writing (email) in advance by Kathleen Kennedy]. Note: last test will be given on 12/10/14.

Course Directors:

Kathleen A. Kennedy, MD, MPH

(713) 500-6708

kathleen.a.kennedy@uth.tmc.edu

Charles Green, PhD

(713) 500-6402

charles.green@uth.tmc.edu

Claudia Pedroza, PhD

713 500-5721

claudia.pedroza@uth.tmc.edu

Clinical Research Curriculum Course Schedule:

Biostatistics for Clinical Investigators

|DATE |SESSION |TOPIC |LECTURER |CHAPTER: PAGES |

| | | | |(Dawson/Trapp) |

|9/3/14 |1 |Types of Data, Summarizing Data |Kathleen Kennedy |3: 24-42, 4: 76-90 |

|9/10/14 |2 |Principles of Statistical Analysis and Hypothesis|Kathleen Kennedy |3: 50-53, 4: 62-75, 5: 94-114 |

| | |Testing | | |

|9/17/14 |3 |Comparing Two or More Groups - Continuous Data |Kathleen Kennedy |5: 114-118, 121-125, 6: 135-146, |

| | | | |7: 163-175, 182-185 |

|9/24/14 |4 |Comparing Two Groups - Categorical Data |Kathleen Kennedy |5: 119-121, 6: 146-154, |

| | | | |8: 200-201 |

|10/1/14 |5 |Review and Test |Kathleen Kennedy | |

|10/8/14 |6 |Survival Analysis |Charles Green |9: 222-242, 10: 264-267 |

|10/15/14 |7 |Interim/Sequential Analysis and Sample Size |Charles Green |5: 125-131, 6: 154-158, |

| | | | |7: 185-186 |

|10/22/14 |8 |Simple Regression and Measures of Association |Charles Green |3: 47-50, 53-58, |

| | | | |8: 191-200, 201-216 |

|10/29/14 |9 |Review and Test |Charles Green | |

|11/5/14 |10 |Confounding and Interaction - Matched and |Kathleen Kennedy |7: 175-182 |

| | |Stratified Analyses | | |

|11/12/14 |11 |Multiple Regression 1 |Claudia Pedroza |10: 246-255 |

|11/19/14 |12 |Multiple Regression 2 and Other Multivariate |Claudia Pedroza |10: 255-264 |

| | |Techniques | | |

|11/26/14 | |Thanksgiving Break | | |

|12/3/14 |13 |Bayesian Approaches (including Diagnostic Tests) |Claudia Pedroza |5: 118-119 |

| | | | |12: 303-311, 313-315 |

|12/10/14 |14 |Review and Test |Claudia Pedroza | |

Course Textbook:

Dawson B, Trapp RG. Basic and clinical biostatistics. 4th edition. Lange Medical Books/McGraw Hill, 2004. Clinical/epidemiologic approach to biostatistics, lots of examples and exercises, all from clinical medicine/research. Includes student version of NCSS and PASS software as well as data sets on CD-ROM. Available at UT Bookstore or on for $55.91.

Course Software:

Stata (at least version 11) is required for coursework. Stata 13 is strongly recommended for those who plan to take the advanced course. Stata is available at discounted pricing for students and faculty teaching in the University of Texas system as follows.

FOR STUDENTS ONLY (student ID not required but must use .edu email address)

-------------

Stata/IC 13 - $69.00/six month license

Small Stata 13 - (can only accommodate smaller data sets, adequate for the Introductory course but not the Advanced courses) - $35.00/six month license

FOR STUDENTS AND FACULTY (must use .edu email address)

--------------------

Stata/IC 13 - $189.00/perpetual license

For more information about products:

To order:

Be sure to include your .EDU email address when ordering.

Suggested Other Reading (General Statistics):

Altman DG, Machin D, Bryant TN, Gardner TN. Statistics with confidence 2nd ed. BMJ Publishing, 2000. Excellent reference for calculating, using, and interpreting confidence intervals.

Armitage P and Berry G: Statistical methods in medical research. 4th ed. London: Blackwell Publishers, 2001. Good explanations of statistics commonly used in medical research.

Bailar JC, Hoaglin D. Medical uses of statistics, 3rd ed. Wiley 2009. Easy to read description of statistical concepts, study design, statistical writing.

Berry DA. Statistics: A Bayesian perspective. Wadsworth Publishing 1995. Very easy to read, lots of examples.

Essex-Sorlie D. Medical biostatistics and epidemiology. Appleton & Lange, 1995. Very brief but complete to-the-point discussion of common statistical tests, doesn't deal with more complex analyses.

Glantz SA. Primer of biostatistics, 7th ed. McGraw-Hill, 2011. Very easy to read, good examples from the medical literature.

Inglefinger JA, Ware JH, Thibideau LA. Biostatistics in clinical medicine 3rd ed. McGraw-Hill, 1993. Tests presented as solutions to clinical problems, good explanations, many illustrations from the medical literature.

Katz MH. Multivariable analysis: a practical guide for clinicians and public health researchers, 3rd ed. Cambridge University Press, 2011. Very easy to read and understand discussion of more complex analyses.

Khan Academy online course: . The Kahn Academy offers a collection of short (5-10 min) videos by Sal Kahn on important concepts in statistics).

Motulsky H. Intuitive biostatistics: a nonmathematical guide to statistical thinking, 3rd ed. Oxford University Press 2014. Concepts of analysis and interpretation are explained with real-world examples that are intuitively apparent.

Norman GR and Streiner DL. Biostatistics: The bare essentials. 3rd ed. BC Decker Inc, 2008. Very easy to read, limited math, excellent coverage of essential information, lots of examples, main limitation is frat-boy humor.

Rosner B. Fundamentals of biostatistics, 7th . Brooks/Cole, 2011. Traditional approach to biostatistics but more readable than other texts, strong on examples from medical research.

StatSoft on-line textbook: . Reasonable reference for those needing a fast easy-to-use statistical resource. 

Zar JH. Biostatistical Analysis 5th ed. Prentice Hall, 2009. Traditional approach to biostatistics, heavy reading.

Suggested Other Reading (Stata):

Acock AC. A Gentle Introduction to Stata, 4th ed. Stata Press, 2014 (ISBN: 978-1597181426) Best overview for material covered in introductory class.

Rabe-Hesketh S and Everitt B. A Handbook of Statistical Analyses Using Stata, 4th Ed, Chapman & Hall/CRC 2007 (ISBN: 978-1-58488-756-0) Also covers some advanced topics, good for the more serious user.

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