• Who is this pack for?
• Getting involved in research
• Undertaking original reserarch
• About this pack
• Advice for researchers in Complementary Medicine
• Methodological checklist for randomised controlled trials
• Checklist for RCTs
• Reading list of CAM
• Background reading on health research
• Complementray Medicine Journals
• General and specialist libraries for complementary medicine research

• Practitioners can (and should) use the results of research to modify their own practice. They require a basic understanding of the research process in order to understand and evaluate published studies.
• Some practitioners study their own practice in order to improve the service they provide to their patients. This is generally known as "audit" and is a method of ensuring high-quality care. The results of audits are often only relevant to the practice where the study was and are rarely published.
• A few practitioners wish to undertake original research which aims to answer a question of a general nature. Though this might be a question about the effectiveness of an intervention (eg. does traditional acupuncture lead to greater improvements in migraine symptoms than usual GP care"), there are many other important types of question in health research: a survey would be one example. Undertaking original research is difficult and time consuming and requires the development of specialist skills.

Undertaking original research
Anyone undertaking original research in complementary medicine needs to decide whether they want to take the lead in designing, conducting and analysing research or whether they want to collaborate in a study where someone else takes this role.
If you want to work on a study where some other researcher is the "principal investigator", it is important to have a basic grasp of the fundamentals of research. This ensures that you retain an understanding of the project you are engage in and can communicate your ideas effectively to others involved in the research.
If, on the other hand, you wish to be a principal investigator, designing the research, conducting the study and writing up the results, you will need to consider this as a major career decision. Developing the sort of skills required to undertake original research can take many years. Generally speaking, most researchers have postgraduate qualifications (such as a Masters or a Doctorate) in health research. A research project itself is also very time-consuming and can make considerable inroads onto clinical time.
Moreover, undertaking research requires computer, office and library facilities and a considerable investment "up front" in time and resources. Researchers often spend months developing a study and preparing an application for funding. Until this funding actually comes through (which is rarely guaranteed) they do so on an unpaid basis.

About this pack
This pack contains some basic information and advice for first time researchers including some reading lists and details of library services. Do remember that the RCCM is here to support complementary medicine researchers: feel free to give us a call to discuss any problems you might have. However, it would help us if you could work out some very specific questions before you get in contact. If you have made it so far as to develop a research protocol, do feel free to send it to us for comment.The RCCM has considerable experience of advising researchers with an interest in complementary medicine, particularly those without previous research experience. We have found the following general guidelines to be useful:

• Collaborate. Research has been likened to mountain climbing: first timers rarely get to the top without the guidance of an experienced individual. It is particularly useful for researchers to collaborate with someone based in an institution such as a medical school or university. Institutions have valuable resources, such as library facilities or statistical advice. Researchers without institutional support and advice often fail to bring research to a satisfactory conclusion.

• What is your question? As pointed out above, many aspects of research design depend on the question asked. Interestingly, most of the researchers contacting the RCCM find it hard to frame a simple question to illustrate their research interest, even after repeated prompting. For example: "to demonstrate the effectiveness of herbal medicine for cystitis" or "to investigate massage for cancer patients" might be prefered but these are clearly not questions.

• One question at a time. The adage about a journey of a thousand miles starting with one small step provides a particularly apt metaphor for health research. Questions such as "Does homoeopathy work?" or "What are the effects of patient expectations on outcome?" will not be resolved by a single research study. The researcher needs to break down large, global questions into manageable stages: a series of questions each associated with a single study.

• Understand your subject. Research requires an understanding of the subject under study: we would not expect, say, an osteopath, to be able to design a study of surgery without consulting a surgeon. Researchers without a thorough knowledge of complementary medicine should collaborate with complementary practitioners and should be sensitive to the sometimes subtle differences between therapeutic approaches.

• Keep things simple. Research almost always turns out more complicated than predicted. Studies involving multiple endpoints, complex designs or large numbers of patients should be avoided by all but the most experienced researchers. Generally speaking, the less data you aim to collect, the better.

• Get the fundamentals right. Research with basic methodological flaws is as good as worthless, no matter how appropriate it might seem for the special problems of complementary medicine. Researchers should have a thorough understanding of the criteria used to assess methodological rigour for the type of research they wish to undertake.

• Build on existing research. Science is a cumulative enterprise. A literature review can help a researcher to define a study topic, identify appropriate research designs and avoid the mistakes of previous workers. We normally recommend that researchers locate as many studies as possible on both the therapy and the condition under investigation. In-depth reading of the research literature may be the single most important preparation for a prospective researcher.

• Use a strategic approach to research. It is only logical to ask certain questions once the answer to other questions are known. A typical mistake has been to jump straight to fastidious, placebo controlled, randomised trials without good evidence that the intervention under examination is of benefit. This why initial observational data, and pilot studies, are so important.

• Use checklists. Methodological checklists are a useful means of ensuring that all aspects of a study have been taken into consideration in designing a protocol. A simple example of a checklist, in this case for clinical trials, is enclosed. When completing a checklist, researchers should be as detailed as possible. For example, in answering:

• "What is the treatment to be given to patients?" it is insufficient merely to state, say, "acupuncture".
  
• What form of acupuncture will be used?
  
• Will set points be indicated or will the practitioner be able to choose at will? Will moxibustion be allowed?
  
• What about diet and lifestyle changes, or the use of massage or herbs?

A methodological checklist for qualitative research is given by Mays N and Pope C. Rigour and qualitative research. British Medical Journal 1995; 311:109-112

• Plan to publish .For scientific work to be of value, it must enter the public arena
  

• "What is the treatment to be given to patients?" it is insufficient merely to state, say, "acupuncture".
• What form of acupuncture will be used?
• Will set points be indicated or will the practitioner be able to choose at will?
• What about diet and lifestyle changes?
• Will moxibustion or massage be allowed?
• How about the use of herbs?

In deciding these issues, you should concentrate on the question you are trying to answer. If the question concerns the effectiveness of acupuncture in practice, for example, then practitioners should be free to choose points at will.Other questions, concerning say, the placebo effect, may require that the intervention is more rigorously specified.

It is important to avoid vague or ambiguous language. For example, it is not sufficient to state that "patients with long-term use of antibiotics will be excluded." How long is long-term? What if a patient has used antibiotics for many years, but only once a year?

Another thing to think about is how you will check at the end of the trial that everything went according to plan. You may well think up a clever method of, say, making sure that patients are unaware whether they are receiving a real treatment or placebo. How will check that this was successful? It can be a good idea to put yourself in the shoes of a sceptical outsider who wished to make sure that the trial protocol has been adhered to.

One additional useful trick is to complete the checklist a second time, substituting the question "Who?" In other words, "What measurements will be taken?" becomes "Who will take the measurements?" and "What statistics will be used?" becomes "Who will do the statistical analysis?

The Checklist

1. From where will patients be recruited?
2. How will those referring patients be encouraged to participate?
3. How many patients will be recruited? Has statistical power been calculated?
4. What are the criteria for including patients?
5. What are the criteria for excluding patients?
6. What information will be given to patients before informed consent?
7. Are there any activities which patients will be asked to undertake or avoid?
8. How will patient consent be obtained ?
9. How will patients be assigned code numbers and what code numbers will be assigned?How will the randomisation list be generated
10. Will stratification or blocking be used?
11. Will the patient's allocation be concealed until the patient has been entered into trial?
12. What measurements will be taken before treatment?
13. What other information will be taken before treatment?
14. What is the treatment to be given to patients?
15. Will patients be blinded to their treatment allocation? If so, how?
16. How will you ensure that patients are treated identically apart from the intervention under trial?
17. How you will ensure that patients are treated according to their allocation?
18. Will the researchers be blinded to patient treatment allocation? If so, how?
19. What are the outcome measures which will be used? Have these been validated?
20. When will the outcome measurements be made?
21. How will you convert data from individual participants into a single score for a group?
22. What statistical comparisons will be made?
23. What statistical tests will be used to make comparisons?
24. If patients are to fill in questionnaires, what help or advice will they be given?
25. Will you specify a particular outcome at a particular time as the primary outcome?
26. If researchers assess outcome, what training will be given to ensure consistency?
27. What other information will be taken at the end of the trial?
28. How will you monitor adverse effects?
29. What will you do about patients who withdraw from the study?
30. What will you do about missing or illegible data?
31. Will any sub-group analyses be undertaken?
32. Will the statistician be blinded to group allocation?
33. Who will give ethical consent for the study?

Books

• British Medical Association Complementary Medicine:
  New Approaches to Good Practice Oxford: Oxford University Press, 1993. ISBN: 0-19-286166-2
• Brown L Working in Complementary and Alternative Medicine: A career guide
  London: Kogan Page, 1994. ISBN: 0-7494-1223-2
• Coward R, The Whole Truth: The Myth of Alternative Medicine
  London: Faber & Faber, 1989. ISBN: 0-571-15222-8
• Fulder S The Handbook of Complementary Medicine. 3rd ed. Oxford: Oxford University Press, 1996. ISBN: 0-19-262669-8
• Micozzi MS, Fundamentals of Complementary and Alternative Medicine Edinburgh: Churchill Livingstone, 1996. ISBN: 0-443-05355-3
• Pietroni P, The greening of medicine London: Gollancz, 1990. ISBN: 0-575-04359-8
• Rankin-Box D (ed.) The Nurses' Handbook of Complementary Therapies Edinburgh: Churchill Livingstone, 1995. ISBN: 0-443-051801
• Sharma U, Complementary Medicine Today: practitioners and patients London: Routledge, 1991. ISBN: 0-415-04793-5, 0-415-04794-3 (paperback
• Stalker D, Glymour C (eds.) Examining Holistic Medicine Buffalo, NY: Prometheus Books, 1989. ISBN: 0-87975-553-9
• Trevelyan J, Booth B, Complementary Medicine for nurses, midwives and health visitors London: Macmillan, 1994. ISBN: 0-333-59601-3
• Vickers AJ, Complementary Medicine and Disability London: Chapman and Hall, 1993. ISBN: 0-412-48690-3
• Vickers AJ, Health Options: complementary therapies for cerebral palsy and related conditions Shaftsbury: Element Books in association with the Spastics Society, 1994. ISBN: 1-85230-562-2
• Vickers AJ, Massage and Aromatherapy: A guide for health professionals. London: Chapman and Hall, 1996. ISBN: 0-412-57630-9

This list has been drawn up in response to a large number of requests for general information on complementary medicine. A list of journals is given overleaf. The inclusion of a text should not be interpreted as a recommendation. Further suggestions are welcome.

Introductory Texts on Research

• Studying Health and Disease. Ed: McConway K. Open University Press 1994.
• Medical Knowledge: Doubt and Certainty. Eds: Seale C, Pattison S. Open University Press 1994
• Experimental Research 1: an introduction to experimental design. Keeble S. Edinburgh, Churchill Livingstone 1995
• Experimental Research 2: conducting a reporting experimental research. Keeble S. Edinburgh, Churchill Livingstone 1995
• S Polgar & S Thomas. Introduction to research in the health sciences. Churchill Livingstone, Melbourne. 3rd edition, 1995
• Making Sense of Audit. Edited by Donald & Sally Irvine. Radcliffe Medical Press, Oxford. 7th edition, 1994
• A guide to audit in Osteopathic Practice, Vol 2 of your osteopathy: getting your professional message across. General Council and Register of Osteopaths. Reading, 1994 Technical Books
• Causal Relationships in Medicine. Elwood JM. Oxford: OUP 1992.
• Clinical Epidemiology: A Basic Science for Clinical medicine. Sackett DL, Haynes RB et al. Boston: Little Brown & Co 1991
• Medical Statistics. Campbell MJ, Machin D. Chichester: Wiley 1993.
• Bowling A. Measuring disease. Oxford: Open University Press 1995 Introductory Articles
• Oxman AD. Sackett DL. Guyatt GH. Users' guides to the medical literature. I. How to get started. The Evidence-Based Medicine Working Group. JAMA. 1993 ;270(17):2093-5
• Guyatt GH. Sackett DL. Cook DJ. Users' guides to the medical literature. II. How to use an article about therapy or prevention. A. Are the results of the study valid? Evidence-Based Medicine Working Group. JAMA. 1993 ;270(21):2598-601
• Guyatt GH. Sackett DL. Cook DJ. Users' guides to the medical literature. II. How to use an article about therapy or prevention. B. What were the results and will they help me in caring for my patients? JAMA. 1994 ;271(1):59-63
• Vickers AJ. A basic introduction to medical research. Part 1: what is research and why do it? Complementary Therapies in Nursing and Midwifery 1995;1:85-8
• Vickers AJ. A basic introduction to medical research. Part II: an overview of different research methods. Complementary Therapies in Nursing and Midwifery 1995;1:113-7
• Vickers AJ. A basic introduction to medical research. Part III: what can the practitioner do? Complementary Therapies in Nursing and Midwifery 1995;1
• Vickers AJ. Critical appraisal: how to read a clinical research paper. Complementary Therapies in Medicine 1995;3:158-66 Technical Articles
• Standards of Reporting Trials Group. A proposal for structured reporting of randomized controlled trials. Journal of the American Medical Association 1994;242:1926-31
• Chalmers TC, Celano P et al. Bias in treatment assignment in controlled clinical trials. N Eng J Med 1981; 309: 1358-61
• Diamond GA, Denton TA. Alternative perspectives on the biased foundations of medical technology assessment. Ann Int Med 1993; 118: 455-64
• Sacks HS, Chalmers TC et al. Sensitivity and Specificity of Clinical Trials: randomized versus historical controls. Arch Intern Med 1983; 143: 753-5
• Pocock SJ, Hughes MD, Lee RJ. Statistical Problems in the Reporting of Clinical Trials. New Engl J Med 1987;317: 426-432
• Camp AV. Acupuncture audit in rheumatology. Acupuncture in Medicine May 1994;12(1):47-54

• Studying Health and Disease. Ed: McConway K. Open University Press 1994. A good general introduction to the philosophy and rationale of a range of different research methods.
• Medical Knowledge: Doubt and Certainty. Eds: Seale C, Pattison S. Open University Press 1994. An historical introduction to the study of medicine and health.Experimental Research 1: an introduction to experimental design. & Experimental Research 2: conducting and reporting experimental research.
• Keeble S. Edinburgh: Churchill Livingstone 1995. A practical step-by-step introduction to research techniques.
• Systematic Reviews. Eds: Chalmers I, Altman D.London: BMJ Publishing 1995. A basic introduction to the rationale and methods of systematic literature review.
• Making Sense of Audit. Edited by Donald & Sally Irvine. Radcliffe Medical Press, Oxford. 7th edition, 1994.
  The principles of audit, illustrated by general practice case studies .
• Simple Statistics. Clegg F Cambridge Educational 1982 An excellent introduction

• Clinical Epidemiology: A Basic Science for Clinical medicine. Sackett DL, Haynes RB et al. Boston: Little Brown & Co 1991.
  The classic textbook: emphasis is practical, that is, how to use research results to benefit patients. Less emphasis on how to conduct research.
  
• Causal Relationships in Medicine. Elwood JM. Oxford: OUP 1992.Theoretical. Clinical Trials: a practical approach. Pocock SJ. Chichester: John Wiley & Sons 1983. An in-depth guide to conducting a clinical trial.
• Practical statistics for medical research. Altman DG. London: Chapman & Hall 1991. A good introduction to statistics.
• Measuring disease. Bowling A. Oxford: Open University Press 1995. A reference text: reviews commonly used outcome measurement scales.
• Handbook of Qualitative Research. Denzin NK, Lincoln YS (eds).Thousand Oaks: Sage Publications 1994. The most cited reference book for qualitative research. 600+ pages. Largely theoretical. Chapter 21 overviews clinical research.
  

• Complementary Therapies in Medicine (Quarterly, 1993-, ISSN: 0965-2299) Published by Churchill Livingstone Requests for sample copies should be sent to: Pearson Professional Ltd. PO Box 77, Harlow, Essex, CM19 5BQ. Tel 01279 623623 Fax 01279 639609
• Complementary Therapies in Nursing and Midwifery (Quarterly, 1995-) Published by Churchill Livingstone Enquiries: Tel 01279 623623 Fax 01279 639609
• Complementary Medical Research (1986-1992) Published by the British Library
• The Journal of Alternative and Complementary Medicine: Research on Paradigm, Practice and Policy (Quarterly, Spring 1995-, ISSN: 1075-5535) Subscription details: Mary Ann Liebert, Inc., 2 Madison Avenue, Larchmont, New York, NY 10538, USA. Fax: (914) 834 3688. Email: liebert@pipeline.com
• Alternative Therapies in Health and Medicine (Bimonthly, May 1995-, ISSN: 1078-6791) Subscription details: InnoVision, PO Box 627, Holmes, PA 19043, USA.

Journals that regularly include original research of a high standard. In addition to the journals and bulletins listed above, complementary medicine research is found in several different types of publication, most obviously in the large number of therapy-specific journals. Studies are also found in the main medical journals, such as the British Medical Journal and the Lancet, and in journals dedicated to particular systems of the body, to medical specialities or to specific conditions or complaints

Further information regarding research in complementary medicine can be obtained by using CISCOM, a bibliographic database run by the RCCM. CISCOM contains over 80,000 references to papers covering all aspects of complementary medicine research. Since the type and quality of published work varies enormously, searches can be carried out according to research and publication type. Literature searches can be arranged by telephoning the RCCM information department on 020-7935-7499.