(1995; 68 pages)
Monitoring of studies
A formal procedure for the systematic monitoring of a research project or programme will greatly contribute to its success. Monitoring should be done throughout the period of implementation, and cease only at completion.
Because the therapeutic effect of acupuncture is often observed to continue for a period of time after the completion of a course of treatment, it is recommended that follow-up assessment of subjects should be conducted, particularly in exploratory protocols. The follow-up time may depend on the duration of effects of acupuncture. Inappropriately long or short follow-up times can skew results.
The following elements of the programme or project should be examined: goals, conformity of protocols with goals, progress of the research towards intended goals, and the impact of the research.
The outcome of the study should be evaluated with regard to:
1. the condition of the patient before treatment;
2. the progress of the patient’s disease stated in terms of both the objective observation made by the investigator or assessor and the patient’s own assessment; and
3. any adverse event that may have occurred during the study.