Introduction to Research: What is it? Why should homeopathic clinicians care?

1. Introduction to Research: What is it? Why should homeopathic clinicians care? Janet Kahn, PhD, LMT 6th Annual Joint American Homeopathic Conference April 8th, 2011 Alexandria, VA

2. Agenda • Review the meaning of evidence-based practice and how to apply research to your clinical practice • Define Research • Explore types of research and uses of each • Explore how clinicians can engage in meaningful research • Clinical case reports • Basic quantitative research • Generate research topics from your clinical experience and learn how to turn them into researchable questions

3. ?????? Your Questions ??????

4. Evidence-based practice Sackett et al. (2000) offered a tripartite structure for EBP saying, “Evidence based medicine is the integration of best research evidence with clinical expertise and patient values.” So what is the best research evidence??

5. What is research? • Systematic inquiry…using orderly, agreed upon methods to • answer questions, • test hypotheses • solve puzzles, • learn more about something, • generate theory

6. Why research important to homeopathy? • Uses for an individual clinician – e.g. best practices, successful marketing techniques… • Uses for the profession as a whole – Surveys, insurance claims research… • Uses for other types of clinician • Uses for patients • Uses for policymakers – CER

7. Its all about the question • What do you want to know? • How do you plan to use the information? • Now, what do you really want to know?

8. Types of Research 2 basic types of research Quantitative Qualitative Deals with things that can be measured Experimentation Observation Deals with meaning and processes

9. Types of Quantitative Research • Surveys • Basic Science (bench science) • Clinical trials – including CER • Literature Reviews • Case Reports

10. Survey – non-experimental research that focuses on obtaining information about activities, beliefs, attitudes, etc. of people through direct questioning. • Unconventional medicine in the United States. Prevalence, costs, and patterns of use.Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR, Delbanco TL. N Engl J Med. 1993 Jan 28;328(4):246-52. • Trends in alternative medicine use in the United States, 1990-1997: results of a follow-up national survey.Eisenberg DM, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, Kessler RC. JAMA. 1998 Nov 11;280(18):1569-75. • Courses involving complementary and alternative medicine at US medical schools.Wetzel MS, Eisenberg DM, Kaptchuk TJ. JAMA. 1998 Sep 2;280(9):784-7. • Characteristics of licensed acupuncturists, chiropractors, massage therapists, and naturopathic physicians.Cherkin DC, Deyo RA, Sherman KJ, Hart LG, Street JH, Hrbek A, Cramer E, Milliman B, Booker J, Mootz R, Barassi J, Kahn JR, Kaptchuk TJ, Eisenberg DM. J Am Board FamPract. 2002 Sep-Oct;15(5):378-90.

11. Clinical Trial • An experiment designed to test the safety / effectiveness / efficacy / cost / etc. of a specific treatment (or intervention). • Key design issues focus on the • intervention, • the expected outcomes, • population • other important factors (variables).

12. Efficacy - In a healthcare context, efficacy indicates the capacity for beneficial change (or therapeutic effect) of a given intervention (e.g. a medicine, medical device, surgical procedure, or a public health intervention) under controlled conditions. • Effectivenessis the capacity for beneficial change under typical conditions of practice – or real world effectiveness. • Comparative Effectiveness Research (CER) is the direct comparison of existing health care interventions to determine which work best for which patients and which pose the greatest benefits and harms. The core question of comparative effectiveness research is which treatment works best, for whom, and under what circumstances.

13. RCT • Brigo B, Serpelloni G, Homoeopathic Treatment of MigraineBerlin Journal on Research in Homoeopathy, 1, 2, March, 1991, 98-106. In this randomised, placebo controlled double blind study, 60 people suffering from migraine were treated using constitutional homoeopathy over a period of 4 months. Those patients in the control group experienced a reduction in migraine frequency from 9.9 attacks per month to 7.9 per month, while those in the treatment group reduced their monthly attack rate from 10 to between 1.8 and 3 per month.

14. Literature Reviews • Narrative Review • Meta-analysis • Systematic Review

15. Meta-analysis • A technique for quantitatively combining and thus integrating the results of multiple studies on a given topic. • Very challenging to do because… • Barnes J., Resch K-L., Ernst E. Homoeopathy for Post-Operative Ileus: A Meta-Analysis. Journal of Clinical Gastroenterology, 1997, Dec, 25, 4, 628- 633. 7 separate trials examining the effects of homoeopathic treatment for post-operative ileus after abdominal or gynaecological surgery when compared with placebo, specifically, for the time to first flatus after surgery. Subsequent analysis showed that homoeopathy provided superior results to placebo.

16. Systematic Review • A summary of the literature on a particular topic, using explicit methods to perform a thorough literature search and critical appraisal of individual studies and appropriate statistical techniques to combine the valid studies. • www.cochrane.org/reviews • Kassab S, Cummings M, Berkovitz S, van Haselen R, Fisher P. Homeopathic Medicines for Adverse effects of Cancer Treatments. Cochrane Database Systematic Review. 2009 Apr 15;(2):CD004845.

17. Research about research • Refining the methods • Investigating researcher effects • Etc.

18. Journal of Bodywork and Movement Therapies (]]]]) ], ]]]–]]] The attitudes toward massage (ATOM) scale: Reliability, validity, and associated findings Christopher A. Moyer, Ph.D.a,, James Rounds, Ph.D.b Summary: Despite the key role of attitudes in guiding behavior, no systematic examination of attitudes toward massage has been conducted and no standard assessments have been created. We developed the attitudes toward massage (ATOM) scale, a nine-item measure of an overall attitude toward massage that includes two distinct subscales assessing the attitudes of Massage as Healthful and Massage as Pleasant. These subscales are reliable (a4.70 and 4.80, respectively), covary with major personality traits and dispositional sensitivities, and are positively correlated with broader attitudes toward complementary and alternative medicine. Clinical evidence suggests that these attitudes change in response to receiving massage, though further research is needed. Supplemental items administered with the ATOM illustrate a general preference for female massage therapists while also showing this preference to be stronger in men. Attitudes pertaining to massage and sexual arousal, which may stand in the way of trying massage for some persons, are also examined. With or without the supplemental items, the ATOM scale is an easily administered measure for assessing attitudes toward massage that can be used in research or practice settings.

19. Quantitative research • It’s all about the question, • a theory, • specific hypotheses, and • relationships between variables • Theory – an abstract generalization that presents a systematic explanation (often not yet fully tested) about relationships among phenomena. • Hypothesis – a statement of predicted relationships between variables

20. Variables • An attribute of a person or object that varies (takes on different values). Almost anything can be a variable: • Physiological characteristics – weight, blood pressure, soft tissue elasticity, degree of allergic response to goldenrod… • Behavior – average daily caffeine intake, seat belt usage, hours spent sleeping, charitable donation patterns… • Attitudes – views on CAM, support for health care reform, preference for spicy or non-spicy food…

21. Places and things also have variables • % of US households using OTC homeopathic remedies for pediatric applications • # of rainy days per year Alexandria, VA Research inquires about the relationship between variables and good research inquires about the relationships between well-chosen and well-defined variables.

22. Kinds of Variables • Continuous – values can be represented on a continuum, e.g. age • Discrete – have a finite number of values between any two points, e.g. the number of children you have • Categorical – have a small number of values that do not inherently represent a quantity, e.g. gender.

23. Clinical Case Reports • A case report is a systematic, in-depth description and discussion of a single case.

24. Functions of a Case Report • It can call attention to something new, surprising, unexplained … • Identification of AIDS began with the case report of a single unexplained case of Kaposi’s Sarcoma in a young man. • A case report is a teaching tool • A case report is a time-honored tool of medical education, from daily ward presentations to grand rounds to published clinical case reports. Through having to report on cases they have admitted to hospital, new residents learn to observe carefully and report accurately • A clinical case report is form of conversation • Through it, one clinician speaks to others about what s/he has noticed and believes is important. It is an integral part of medical culture, relied upon “...to enrich professional experience, lead to better clinical reasoning, and prompt further research.” (Milos Jenicek, Clincial Case Reporting in Evidence-based Medicine, 1999, p7.)

25. Why is a Case Report Not an Anecdote? • A clinical case report advances knowledge through: • careful description, • relevant detail, • a thorough literature search, • a compelling rationale, and • by analyzing potential implications for decision making in clinical practice.

26. What is the Purpose of a Case Report? Case reports also help advance knowledge by: • generating new theories and hypotheses • refuting old theories and hypotheses • recognizing and describing new diseases/conditions or … • novel treatment approaches • unusual or confusing combinations of conditions or events • unusual or unexpected outcomes • adverse responses • personal impact

27. What from your clinical practice might you want to report on?

28. ??????QUESTIONS??????