It is common that WSR is suggested as an alternative to classical clinical research methodology in the field of CAM, which does not have many limitations of classic RCT designs? Can anyone explain what the exact difference between these research methodologies is?
In my view classical medicine is highly efficient in acute pathology, when the patient is young with a high regenerative capacity, when there is organic tissular damage visible on medical imagery leading to high specific treatment. The efficacy is less when the pathology became chronic, in elder patients with diminished regenerative capacity, or when patient is young but with functional complaints not (yet) visible on medical imagery and specific treatment therefore would be less clear.
Indications for CAM might be chronicity, multiple complaints at the same time (comorbidity), chronic ad escalating polypharmacologic treatment etc. So there is need for whole system investigation with parallel estimation of outcome improvement (and not only causal working mechanism), functional rehabilitation as individual or social (re)integration (and not only efficiency in analgesia e.g.).
Clinical studies could include parallel estimation of clinical scales of improvement in complaint(s), evaluation of autonomic nervous system (e.g. heart rate variability), questionnaire for psychological context, estimation quality of life etc. It seems to me you are already very well engaged on this path in your studies (educational priorities in primary care, cardiology...).
Do you concur with that view? Suggestions are welcome.
In my understanding WSR is a paradigm shift that allows for questions to be asked in different and perhaps more profound ways. CAM methodology has historically been fettered somewhat with drug based RCT methods. The WSR paradigm allows for those of us researching or practicing functional medicine to ask more abstract questions and still be able to assess them intelligently.
Two readings which elucidate the topic in my opinion are:
1. Ritenbaugh C, Verhoef M, Fleishman S, Boon H, Leis A. Whole systems research: a discipline for studying complementary and alternative medicine. Alternative Therapies 2003;9(4):32-36.
2. (Book) Integrating East Asian Medicine into Contemporary Healthcare. ISBN:9780702030215.
A classical RCT design seeks to determine the cause and effect of one variable only, and traditionally has been applied to drug efficacy studies. This design doesn't suit CAM so well, as there are many known elements to CAM which can influence a health outcome such as the therapeutic relationship, the setting, the patient expectations, on top of the actual complementary therapy being practiced. Furthermore when you assess the effectiveness of a CAM approach to health, you are acknowleding that all aspects of the person are important and affect how they feel. How a person feels is measured often with Health Related Quality of LIfe Questionnaires, however these questionnaires do not always contain all the items that are deemed important to a patient. Thus you can incorporate tools that allow a patient to nominate items that concern them (see MYMOP and MYCaW). When you analyse these types of data you can see that there are many elements that patients consider important in relation to their health. A whole system approach to health research seeks to incorporate the evaluation of the whole person, on the understanding that total quality of life is contributed to by all aspects such as physical, social, functional, emotional, psychological and spiritual health. This means you have more variables to consider when carrying out statistical analysis in comparison to a straightforward analysis that you would carry out in an RCT. For the CAM field specifically thisWSR approach can acknowledge the broader effects of holistic healthcare in a way that RCT designs do not. It can also identify variables that should be incorporated into comparative effectiveness research design
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