Scientific research work should include:
1st SELECTION CRITERIA
The inclusion criteria are a group of conditions which should be met in order to take part in a clinical trial. That is, the standards used to determine whether it is advisable to authorize a person to take part in a clinical trial. The most important criteria used to determine participation in a clinical trial include age, sex, the type and stage of the disease, the treatment history, and other medical conditions.
2nd EXCLUSION CRITERIA
Specific conditions which make the entry of candidates impossible in a trial although they meet the inclusion criteria.
Exclusion criteria are the standards used to determine whether a person should not be authorized to take part in a clinical trial. The most important criteria used to determine whether it is advisable or not to authorize a person to participate in a clinical trial include the age, sex, the type and stage of the disease, the treatment history, and other medical conditions.
3rd TYPES OF STUDY
That is, double-blinded interobserver study with KAPPA coefficient.
4th STUDY GROUPS AND CONTROL GROUPS
Random samples (systematic chance)
Enough patients in each group (and balanced).
These depend on the inclusion-exclusion criteria.
- STUDY GROUP
This is the group which is going to be studied by comparing it with the reference group, to find out the validity of a diagnostic test, a technique or a treatment.
All the patients in the group should present exactly the same problem, the same lesions, the same symptoms, etc.
- CONTROL GROUP
This is a healthy patient group or a patient group with the same inclusion-exclusion factors: the reference group to compare.
The sample number must be identical to the study group.
In the study of a technique or the validation of a diagnostic test, it is also manipulated.
It may be untreated or subjected to a placebo treatment (according to ethics) or to another treatment.
DEFINITION OF PLACEBO
A placebo is a treatment (operation, therapy, chemical solution, sugar pill, etc) which is administered as if it was a therapy, but has no therapeutic value except for the placebo effect.
Etymologically, placebo means “I shall please” in Latin.
Medicine prescribed or administered to please a patient. Medicine without any active substance and therefore having no specific pharmacological action.
A placebo may be pharmacologically inert (pure placebo) or contain substances which are only active in certain circumstances, but not in the patient who is taking it (for example, a Vitamin B complex or ascorbic acid) (impure placebo).
In the clinical evaluation of drugs, a group treated with a placebo may be included in order to differentiate the specific pharmaco-dynamic effects of the psychological effects associated with the therapeutic act or of the fluctuations typical of the disease.