(1995; 68 pages)
Clinical research design and rational use of acupuncture
Clinical research is carried out to allow:
1. the patient to receive more information about treatment;
2. the practitioner to make clearer decisions about treatment options;
3. health policy and funding authorities to make appropriate decisions about utility and cost-effectiveness.
The purpose of clinical acupuncture research is therefore:
1. to allow the patient to make decisions based on:
• effectiveness (absolute and relative)
• relationship with intercurrent conventional care
• cultural factors and patient preference; and
2. to develop guidelines for good clinical practice for acupuncturists.
A similar agenda exists for both the practitioner and the health funding organization.
This should lead to the rational use of acupuncture.
The methods of clinical research available to us include:
• randomized controlled clinical trials;
• cohort studies;
• retrospective studies/case control studies;
• outcome research;
• sequential trial design;
• single patient studies;
• clinical audit;
• acupuncture epidemiology;
• anthropological studies; and
• post-marketing surveillance.
A clinical trial is defined as a scientific experiment involving human subjects in which treatment is initiated for therapy evaluation.
The conduct of clinical trials is governed by the underlying purpose of the study and is therefore directly related to the outcome. A clinical trial has three fundamental components:
1. Input. This includes the patients entered, the people involved in study design and provision of therapy, data collection systems and treatment.
2. Evaluation mechanism (design), such as randomized controlled trials (RCTs), cohort studies, case control studies and clinical audits.
3. Outcome. When outcome is used as a measurement for evaluation purposes, it is usually called “endpoint”. The validity and reliability of endpoints always have to be considered. It may vary from “hard” (such as laboratory test) to “soft” (such as quality of life). The study of cost-effectiveness and cost-utility will be conducted utilizing these data.
RCTs as a “gold standard” in various methods of clinical trial, can be used to answer questions about most clinical problems. However, this approach is not always a practical and cost-effective solution. Pragmatic solutions that do not “unpack” all the treatment options may therefore be required. RCTs are open to error; for instance, patient preference may have an effect on outcome as may certain cultural environments.
Clinical audit may allow developmental research directed at identifying patients who can be helped swiftly, those whose condition can be maintained with acupuncture and those whose chronic problems can be contained to avoid potentially damaging adverse reactions from invasive conventional intervention.