Epidemiology and Biostatistics

Fall 2004/2005

Selection of types of distributions. (Image adapted by Tufts OCW.)

Highlights of this Course

This course teaches the basic skills needed to critique the medical literature by providing a fundamental understanding of epidemiology and biostatistics. One highlight of the course is the Small Group Session. The small group format provides one with an excellent opportunity to closely interact with a faculty member by enhancing the concepts taught in the lectures and clarifying questions concerning the lecture material.

Course Description

The primary purpose of this course is to teach you basic skills to critique the medical literature. As future physicians you have an obligation to remain current in your field of practice and to treat patients according to generally accepted standards of care. To do this well you will need to read those journals that are considered the most important sources of new information impacting on your field of medicine.

For example, internal medicine physicians generally read the New England Journal of Medicine (NEJM) which is published by the Massachusetts Medical Society. Perhaps the most influential medical journal, its articles are widely reviewed by the media. Most surgeons read the Annals of Surgery. In short, each field of medicine has its own specialty journals.

As your patients hear media reports about the latest research results, they will most certainly ask for your opinion: Should adult patients take antioxidants to help prevent heart disease? Do the potential benefits of hormonal replacement in postmenopausal women outweigh the potential risks?

Your responses, in part, will be based on your interpretation of the medical literature. True, your opinions should be formed with other input too: What do physicians with expertise I respect say? Has a specialty society, such as the American College of Pediatrics, issued an opinion? What does the Surgeon General think?

The primary goals of the small group sessions are to clarify questions you may have concerning lecture material and to enhance the concepts taught in lectures. The small group format provides you with an excellent opportunity to closely interact with a faculty member. Your instructor will spend the first portion of each lab reviewing lectures since the last small group session. This is your opportunity to ask questions. Don't feel embarrassed to ask a question. As physicians you must fully understand all the complicated issues that might exist with your patients, and you should not hesitate to ask consultants to explain points you might not understand. Students unable to attend a small group session should so inform their small group instructor before the small group session and arrangements should be made for the instructor to receive the completed homework before class.

Popular Content

    * Lecture 2: Observational Studies
    * Lecture 3: Descriptive Epidemiology
    * Lecture 4 - Threats to Validity
    * Lecture 9: Common Statistical Tests
    * Epidemiology-Biostatistics Exam 1, 2000

Syllabus

Objectives

    * Students will be able to demonstrate the principles of epidemiological research related to the prevention and control of disease.
    * Students will be able to critically evaluate the medical literature with respect to study design, statistical analysis, and interpretation of results.
    * Students will demonstrate the importance of maintaining a population perspective in the practice of clinical medicine.
    * To critique the medical literature, you must understand the jargon. You therefore need a fundamental understanding of epidemiology and biostatistics. If you can't interpret a p-value, a confidence interval, a relative risk or power, for examples, you can't critique the medical literature. If you don't understand the basic concepts of epidemiology study designs, you won't understand the potential strengths and weaknesses of the article. That's why teaching you the fundamentals of epidemiology and biostatistics is an additional course goal. On a more practical level, Part I of the USMLE Boards, given after the second year of medical school, will challenge your knowledge in these areas.
    * Some physicians wrongly believe that all studies published in a peer review publication must be good studies otherwise they would never get printed. This course may shake your belief in such blind faith. Rather, you will be taught skills that will help you to systematically determine if a published study is or is not a good one. As one must learn the particular steps to perform a complete physical examination, one must also learn special skills to critique the medical literature. It's simply not adequate to read a study and form some opinion based solely on a gut reaction.

Grades

There are 1,000 maximum points one can receive:

    * Homework assignments: 15% (150 points) The points are calculated as the number of correct answers for all assignments divided by the total number of questions for all assignments, times 150.
    * Small group evaluation: 20% (200 points) Students who pass will receive 200 points, 180 points or 160 points. Students who fail will receive 120 points. Small group instructors will use their best judgement when assigning small group grades. Your instructor will evaluate you on such issues as your preparedness for class, your understanding of the course materials and your comments in small group.
    * Paper critique: 20% (200 points) Students who pass may receive 200 points, 180 points, 160 points or 150 points on the paper. Students who fail will receive 120 points. Small group instructors will use their best judgement when assigning paper critique grades. This evaluation will include whether or not you appropriately address key issues in the paper, whether you correctly use epidemiology and biostatistics terms, the level of your insights into the paper, how well the paper is written and how it compares overall to papers written by other students in your small group. Students must Email any questions they have concerning their paper critique grade to their small group instuctors no later than mid-semester.

The final grades for the course will be Honors, Pass or Fail

Exams

There are two exams, the first representing 20% of your grade and the second 25% of your grade. The second exam will include concepts tested on the first exam. Before each exam, the course director will ask the class if they would like a formal review session. If the answer is yes - and it always has been - a time and location will be selected. Review sessions generally run about 90 minutes to two hours.

    * Exam one: 20% (200 points) The points are calculated as the number of correct answers divided by the total number of questions, times 200.
    * Exam two: 25% (250 points) The points are calculated as the number of correct answers divided by the total number of questions, times 250.

Please note that the exams represent only 45% of your evaluation. It is certainly possible for students to score above 90% on each exam and to obtain a grade of pass, not honors, for the course.
Readings

Required Texts

The two course textbooks were selected based on three criteria: (1) do they address most of the concepts the faculty wants you to know (2) will they serve as good resources for you as interns and residents participating in journal clubs; and (3) will they be adequate resources for you as attending physicians.

Epidemiology by Leon Gordis is the epidemiology text while the biostatistics text is Principles of Biostatistics by Marcello Pagano and Kimberlee Gauvreau. The texts are on reserve in the library. The texts contain some concepts that you'll not be expected to learn for this course. Like your own studies, the faculty must prioritize based on course goals and time.
Reading List for Small Groups

Following is a list of articles for the Epidemiology-Biostatistics reading list.

   1. Effects of Lifestyle Activity vs Structured Aerobic Exercise In Obese Women; JAMA, January 27, 1999, Vol 281, No 4, pages 335 - 340
   2. Effect of Risedronate On the Risk Of Hip Fracture In Elderly Women; NEJM, February 1, 2001, Vol 344, No 5, pages 333 - 340
   3. A Case-Control Study of Baldness In Relation To Myocardial Infarction In Men; JAMA, February 24, 1993, Vol 269, No 8, pages 998 - 1003
   4. Clinical And Genetic Features Of Ehlers-Danlos Syndrome Type IV, The Vascular Type; NEJM, March 9, 2000, Vol 342, No 10, pages 673 - 680
   5. A Comparison Of Enoxaparin With Placebo For The Prevention of Venous Thromboembolism In Acutely Ill Medical Patients; NEJM, September 9, 1999, Vol 341, No 11, pages 793 - 799
   6. A Prospective Study Of Walking As Compared With Vigorous Exercise In The Prevention Of Coronary Heart Disease In Women; NEJM, August 26, 1999, Vol 341, No 9, pages 650 - 658
   7. Phenylpropanolamine And The Risk Of Hemorrhagic Stroke; NEJM, December 21, 2000, Vol 343, No 25, pages 1826 - 1832
   8. Direct-to-Consumer Marketing of High-Technology Screening Tests; NEJM, 2-14-02, Vol 346, No 7, pages 529-532
   9. Intake of Fish and Omega-3 Fatty Acids and Risk of Stroke in Women; JAMA, 1-17-01, Vol 285, No 3, pages 304-312
  10. Evaluation of Acupuncture for Pain Control After Oral Surgery; Arch Otolaryngol Head Neck Surg; 5-99, Vol 125, pages 567-572
  11. Cognitive and Motor Outcomes of Cocaine-Exposed Infants; JAMA, 4-17-02, Vol 287, No 15, pages 1952-1960
  12. A Comparison of Enoxaparin With Placebo for the Prevention of Venous Thromboembolism in Acutely ill Medical Patients; NEJM, 9-9-99, Vol 341, Number 11, pages 793-799
  13. A Prospective Study of Walking as Compared With Vigorous Exercies in the Prevention of Coronary Heart Disease in Women; NEJM, 8-26-99, Vol 341, No 7, pages 529-532
  14. Screening For Lung Cancer; NEJM, November 30, 2000, Vol 343, No 22, pages 1627 - 1633
  15. Reporting Number Needed to Treat and Absolute Risk Reduction in Randomized Controlled Trials; JAMA, 6-5-02, Vol 287, No. 21, pages 2813-2814
  16. Extrapolation of Correlation Between 2 Variables in 4 General Medical Journal ; JAMA, 6-5-02, Vol 287, No. 21, pages 2815-2816
  17. How Statistical Expertise Is Used in Medical Research; JAMA, 6-5-02, Vol 287, No. 21, pages 2817-2820
  18. Publication Bias in Editorial Decision Making; JAMA, 6-5-02, Vol 287, No. 21, pages 2825-2828
  19. Postpublication Criticism and the Shaping of Clinical Knowledge; JAMA, 6-5-02, Vol 287, No 21, pages 2843-2847
  20. Media Coverage of Scientific Meetings: Too Much, Too Soon?; JAMA, 6-5-02, Vol 287, No 21, pages 2859-2863
  21. Analysis of Cases of Harm Associated With Use of Health Information on the Internet; JAMA, 6-5-02, Vol 287, No 21, pages 2869-2871
  22. Quality of Systematic Reviews of Economic Evaluations in Health Care; JAMA, 6-5-02, Vol 287, No 21, pages 2809-2812
  23. Users Guide to the Medical Literature 1. How to Get Started; JAMA, 11-3-93, Vol 270, No 17, pages 2093-2095
  24. Users Guide to the Medical Literature, How to Use an Article About Therapy or Prevention, Are the Results of the Study Valid ; JAMA, 12-1-93, Vol 270, N0 21, pages 2598-2601
  25. Users Guide to the Medical Literature, How to Use an Article About a Diagnostic Test, Are the Results of the Study Valid?; JAMA, 2-2-94, Vol 271, No 5, pages 389-391
  26. Users Guide to the Medical Literature, How to Use an Article About Therapy or Prevention, What Were the Results and Will They Help Me in Caring for My Patients?; JAMA, 1-5-94, Vol 271, No 1, pages 59-63
  27. Users Guide to the Medical Literature, How to Use an Article About a Diagnostic Test, What Are the Results and Will They Help Me in Caring for My Patients; JAMA, 3-2-94, Vol 271, No 9, pages 703-707
  28. Ten Rules for Reading Clinical Research Reports; American Journal of Surgery, June, 1990, Vol 159, pages 533-539
  29. Multivariate Analysis: A Primer for Readers of Medical Research ; Annals of Internal Medicine, 4-15-03, Vol 138, Number 8, pages 644-650
  30. Clinical Trials and Rare Disease; NEJM, Vol 348, No 24, pages 2455-2456
  31. The Continuing Unethical Conduct of Underpowered Clinical Trials ; JAMA, 7-17-02, Vol 288, No 3, pages 358-362
  32. Composite Outcomes in Randomized Trials: Greater Precision But With Greater Uncertainty; JAMA, 5-21-03, Vol 289, No 19, pages 2554-2559
  33. Clinical Trials, Multiple Treatments, Multiple End Points, and Multiple Lessons; JAMA, 5-21-03, Vol 289, No 19, pages 2575-2577
  34. Television Watching and Other Sedentary Behaviors in Relation to Risk of Obesity and Type 2 Diabetes Mellitus in Women; JAMA, 4-09-03, Vol 289. No 14, pages 1785-1791
  35. Academic Freedom in Clinical Research; NEJM, 10-14-02, Vol 347, No 17, pages 1368-1370
  36. Scope and Impact of Financial Conflicts of Interest in Biomedical Research, A Systemic Review; JAMA, 1-22/29-03, Vol 289, No 4, pages 454-465
  37. The Integral Role of Clinical Research in Clinical Care; NEJM, 4-03-03, Vol 348, No 114, pages 1368-1388
  38. The Therapeutic Orientation to Clinical Trials; NEJM, 4-03-03, Vol 348, No 114, pages 1383-1386
  39. Enrolling the uninsured in clinical trials: An ethical perspective; Crit Care Med, 2003, Vol 31, No 3 (Suppl.), pages S121-S125
  40. Ethical framework for the use of sham procedures in clinical trials; Crit Care Med, 2003, Vol 31, No 3 (Suppl.), pages S126-S129
  41. Research in children; Crit Care Med, 2003, Vol 31, No 3 (Suppl.), pages S131-S141
  42. Is the concept of informed consent applicable to clinical research involving critically ill patient?; Crit Care Med, 2003, Vol 31, N0 3 (Suppl.), pages S153-S159
  43. Ethical considerations for research in critically ill patients; Crit Care Med, 2003, Vol 31, No 3 (Suppl.), pages S178-S181
  44. Research ethics and the intensive care unit: Getting behind the wheel; Crit Care Med, 2003, Vol 31, No 3, pages S119-S120
  45. Statistical guidelines for the British Medical Journal; Br. J. Surgery, July 1991, Vol 78, pages 782-783
  46. Cost-Effectiveness and Cost-Benefit Analysis in the Medical Literature, Are the Methods Being Used Correctly?; Annals of Internal Medicine, 2-1-92, Vol 116, No 3, pages 238-244
  47. Factors Associated With Failure to Publish Large Randomized Trials Presented at an Oncology Meeting; JAMA, July 23/30, 2003, Vol 290, No 4, pages 495-501
  48. Registering Clinical Trials; JAMA, July 23/30, 2003, Vol 290, No 4, pages 516-523
  49. Coffee Consumption and Risk of Type 2 Diabetes Mellitus Among Middle-aged Finnish Men and Women; JAMA, March 10, 2004, Vol 291, No 10, pages 1213-1219
  50. Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement; Annals of Internal Medicine, November 16, 2004, Vol 141, Number 10, pages 781-788
  51. Clinical Research and the Physician-Patient Relationship, Annals of Internal Medicine, April 15, 2003, Volume 138, Number 8, pages 669-672
  52. Duplicate Publication, Multiple Problems, JAMA, October 13, 2004, Vol 292, No 14, pages 1745-1746
  53. Public Registration of Clinical Trials, NEJM, July 22, 2004, Vol 35, No 4, pages 315-317
  54. Trial Registration: A Great Idea Switches From Ignored to Irresistible, JAMA, September 15, 2004, Vol 292, No 11, pages 1359-1362
  55. The Discrepancy between Observat ional Studies and Randomized Trials of Menopausal Hormone Therapy: Did Expectations Shape Experience?, Annals of Internal Medicine, December 2, 2003, Volume 139, Number 11, pages 923-929
  56. Effectiveness of Acupuncture as Adjunctive Therapy in Osteoarthritis of the Knee, a Randomized, Controlled Trial, Annals of Internal Medicine, December 21, 2004, Vol 141, No 12, 901-910
  57. Improving Informed Consent and Enhancing Recruitment for Research by Understanding Economic Behavior, JAMA, Feb. 2, 2005, Vol 293, No 5, pages 609-612
  58. Research Compensation and the Monetarization of Medicine, JAMA, Feb 2, 2005, Vol 293, N0 5, pages 613-614