2. RESEARCH METHODS Dwain Daniel DC Ron Rupert DC

3. Today’s Objectives Discuss the research mission at PCC Describe the structure of the Research Institute Discuss why there is a need for a research class & the objectives Look briefly at some historical changes in biomedicine Present an overview of the history related to chiropractic research

4. Mission of Research at PCC Conduct research to support and improve chiropractic practice Publish research work Present research Involve faculty, students, staff & alumni in the research process Communication –Research Status Reports –Bulletin boards, etc.

5. Research Institute Director of Research –Ronald Rupert, M.S., D.C. Director of Clinical Science Research –Dwain Daniel D.C. Director of Basic Science Research –-Xeujun Song M.D., PhD. Faculty, Students & Alumni

6. Why this Class (Specific Objectives) Develop an understanding of the importance of research to the profession Provide the skills necessary to find the information you want. Develop critical reading skills to understand what you have found:

7. BOTTOM LINE- No matter where you practice…. you will be able to locate, understand and apply the scientific literature to keep you on the cutting edge of professional practice

8. Putting research into perspective within the chiropractic profession The art, science and philosophy of chiropractic Art: “a system of principles and methods employed in the performance of a set of activities”

9. Philosophy: “the investigation of reality, knowledge or values based on logical reasoning rather than on scientific/empirical methods” Science: “the observation, identification, description, experimental investigation and theoretical explanation of phenomena”

11. 100 Years Ago (Getting a Perspective of Change) only 8,000 cars in the US & only 144 miles of roads 14% of homes had bathtubs 8% of homes had telephones... Max. speed limit in cities was 10MPH Average U.S. wage was 22 cents per hr. 95% of births took place at home

12. 100 Years Ago There was no Mother’s or Father’s Day Coca-Cola contained cocaine not caffeine Most women washed their hair once per month with borax or egg yokes California was the twenty-first most populous state 6% in the U.S. graduated from high school

13. Medicine 100 Years Ago 90% of U.S. physicians had no college ed. Medical schools were condemned by the press and by the government as “substandard” Leading causes of death were: 1)Pneumonia & Influenza, 2)TB, 3)Diarrhea, 4)Heart Disease, and 5) Stroke. Marijuana, heroin & morphine could be bought over the counter

14. Historical Changes in Research (methods) 1900— Practice>>>theory>>limited science>>no clinical research 1950- Theory>>science>>practice>>clinical research 2000— Science>>theory>>clinical research>>practice –from Haldeman, DC, PhD, MD

15. Changes in Number of Scientists Publishing There were approximately 1,000 scientists in 1800 This grew to nearly 100,000 in 1900 And to more than 3,200,000 by 1972 –...Arch Dermatol 128: 1249-1256

16. Changes & the Challenge of Keeping Informed There are now approx. 18,000 biomedical journals By 1984 it was estimated that 7,000 scientific articles were published daily...all providing new information Without proper informatics & critical reading skills, this information simply can not be accessed or understood

17. Ergo..the Pragmatic Reasons for this Research Class help you provide the best patient care reduced risk of malpractice (risk management) evidence-based practice & getting paid information for patient education (newsletters, lectures, etc.) help with interprofessional relations (referral, consultation)

18. Pragmatic Reasons for Research Class … Continued Permit you to give informed presentations (written & oral) to civic groups Provide you skills for narrative reports & depositions Prepare you to conduct some practice based research for your profession

19. Teaching You to Fish The skills you will learn will help continue to learn after you graduate –this is a skill set that most chiropractors and medical providers do not have Much of the information you learn in all your other classes will change.. With the growing emphasis on evidence based practice, keeping informed is the key to a LOW RISK & SUCCESSFUL practice

20. History of Chiropractic Research and Education

21. Objectives To understand the importance of research to the profession, doctor and patient To know the four periods of chiropractic history To know the major events of each period To understand the significance of each period

22. Importance of research in chiropractic today Importance to the profession Importance to the individual doctor –80/10/10 rule –1/2 of information Importance to your patients

23. Periods of Chiropractic History Period of Early Growth, 1895-1925 –Dawn of the profession –Palmer School of Magnetic Cure 1896. –Oakley Smith 1899.

24. Period of Early Growth Explosive growth Palmer School B.J. Palmer Henry Herring.

25. 1925 82 schools 28000 chiropractors 4000 students

26. Periods of Chiropractic History Period of Early Growth, 1895-1925 –82/28000/4000 Period of Conflict, 1925-1940

27. Period of Conflict B. J. Palmer and the neurocalameter Morris Fishbein and the AMA. Great Depression Purpose of research in the profession –Reveal the will of God –Observation without experimentation sufficient –Main role was in marketing

28. 1940 40 schools 15000 chiropractors 1400 students

29. Periods of Chiropractic History Period of Early Growth, 1895-1925 –82/28000/4000 Period of Conflict, 1925-1940 –40/15000/1400 Period of Change, 1941-1970

30. Period of Change Committee on Educational Standards –Claude Watkins –John Nugent.

31. 1970 11 schools 15000 doctors 2500 students

32. Periods of Chiropractic History Period of Early Growth, 1895-1925 –82/28000/4000 Period of Conflict, 1925-1940 –40/15000/1400 Period of Change, 1941-1970 –11/15000/2500 Period of Professionalism, 1971-present

33. Period of Professionalism Prelude to the future –Chung Ha Suh, PhD. –NINDS. –US Office of Education

34. 1970’s 1973: First US government funding of Chiropractic research 1973: Chiropractic included in Medicare 1974: CCE recognized by USOE 1976: Wilk vs. AMA 1978: JMPT first published 1979: New Zealand Report

35. 1980’s 1982: JMPT indexed by Index Medicus (NLM) 1982: First RCT of chiropractic for any health problem

36. 1990’s 1991: First Rand Study published. Additional studies in 92, 94, 98 1994: “Federal Guidelines for Low Back Pain” published 1997: Consortium Center for Chiropractic Research Funded (2.7M) 1999: Inclusion of chiropractic care for all US military mandated

37. Periods of Chiropractic History Period of Early Growth, 1895-1925 –82/28000/4000 Period of Conflict, 1925-1940 –40/15000/1400 Period of Change, 1941-1970 –11/15000/2500 Period of Professionalism, 1971-present –23/55000/15000

38. George McAndrews “If the profession continues to publish theory, in the absence of scientific support, and continues to waste its funds on outrageous advertising rather than investigate the truth of the theory…the last 20 years will have been wasted.”

39. Anatomy of a Research Paper Dissecting the Basis Product of Research the Published Research Article.

40. Objectives To gain an understanding of the structure of a research article Understanding the history of human subject abuses and steps taken to prevent abuses through the use of the Institutional Review Board and “informed consent”.

41. Research Journals Editorials, commentaries, letters to the editor…..(points of view or opinion) Literature reviews…..(summarizes other work) Descriptive studies…..(observe/record and explain findings) Experiments…..(researcher actively designs and places controls on the study).

42. Critical Reading Knowing the elements of a article and what each element is supposed to accomplish gives us the knowledge upon which to evaluate the quality of research.

43. Elements of a Research Article (IMRaD format) Abstract Introduction Methods Results Discussion Conclusions References.

44. Abstract Summary of article (Usually 250 words or less) –Design –Objectives –Background –Methods –Results –Conclusions.

45. Abstract Dangerous to read only abstract due to limited information and possible author bias If the abstract is not structured, be very cautious If abstract does not address randomization, beware If results only expressed as “p” value, caution advised.

46. Introduction Discusses the importance and purpose of the research Reviews previous related research States hypothesis being tested.

47. Methods Most important portion of an article Includes: –Design –Subject or population used –Subject selection –Procedures –Variables measured –Statistical analysis (Descriptive and analytic).

48. Research Variables How measured Quality of measures (reliability, accuracy, validity) Incomplete information makes measuring the adequacy of the research difficult.

49. Results Summarizes all pertinent data Tables and graphs Results of statistical analysis Reports all research outcomes related to the stated hypothesis.

50. Discussion Interprets data and discusses the importance of the research Identifies weakness Outlines need for future research.

51. Cautions Especially subject to author bias Look for exaggerations or inappropriate conclusions Look for errors in statistics.

52. Abstract and Conclusion “doubtful or invalid statements were found in 76% of the conclusions or abstracts” –Controlled Clinical Trials, 1989, 10:31-56 44 abstracts from BMJ, JAMA, Lancet, NEJM, Ann Int Med –18% to 68% had inconsistent information JAMA, 2000 Jan 26:238(4):481.

53. References Author consideration of other work Quality of other work (JMPT, Gray’s Anatomy, National Inquirer, etc.) How recent the references Other important research omitted Do most supporting references come from the author?

54. Acknowledgements Usually in bottom left hand corner Describes funding and assistance Author contact and information about reprints.

55. Summary Abstract- Summary of the research Introduction- Importance, literature review, hypothesis Methods- Design, sample selection, data collection Results- Data summarized, analysis of data, tables and charts Discussion- Conclusions supported, no exaggerations, weakness stated.

56. References- Adequate, timely, quality.

57. Final Comments Critical reading of the scientific literature begins with an understanding of the purpose of the research and being able to verify the quality of the elements of the published article Sufficient detail must exist in the methods section to allow for reproduction of the work. If work cannot be repeated, it is valueless.

58. Human Subject Research Historically fraught with abusing human beings Historically norms for human subjects were left in the hands of investigators Some abuses were unintentional and others were part of the research design.

59. “Nurenburg Code” In response to NAZI atrocities after WW II Key concept was voluntary participation Considered by many unnecessary in the United States.

60. Thalidomide 1962 Dramatically changed the publics attitude toward biomedical research Congress passed laws requiring – “informed consent” –Safety as well as efficacy must be proved.

61. Brooklyn Jewish Chronic Disease Hospital NIH funded study 1964 Cancerous cells injected into debilitated patients –those that gave informed consent were not told the cells were cancerous.

62. Willowbrook State Hospital for the Retarded 1960’s Injection of mild hepatitis strain into children on admission to school.

63. Tuskegee Syphilis Study Began in 1932 Designed to trace natural history of syphilis Participants (poor black males) were misled to believing they were being treated for syphilis Exposed in 1972 by the New York Times National Commission for the Protection of Human Subjects of Biomedical and Behavior Research.

64. Face Lift Study 1995 Plastic surgeons at a New York City Hospital compared two facelift procedures To test procedures one half of the face tested one method the other side the other method Consent forms indicated only routine surgery.

65. Mosquito Study Annuals of Internal Medicine Subjects were exposed to large mosquito population… Protected subjects received 1 bite over an 8 hour period Unprotected subjects had 1,188 bites per hour, 9,504 for 8 hours.

66. Institutional Review Board Only entity within research with the primary purpose of protecting the participant Responsibilities –Reviewing research prior to study to ensure participants are protected –Monitor progress of research to ensure protection of participants –Ensure research is following its own protocols.

67. Informed Consent Designed to protect human subjects Participants must know risks and benefits of study.

68. Research not covered by the Federal system Some in vitro fertilization clinics Some weight loss or diet clinics Some physicians offices Some colleges and universities Research in development of genetic tests.