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Arthritis treatment: more constructive criticism ARTHRITIS TREATMENT: MORE CONSTRUCTIVE CRITICISM
Weaknesses in human trial procedures
The first criticism in this section has to be one of the so called 'objectivity' claimed to be the essence of clinical testing when live patients are involved.
Objectivity is not restricted to the patient but also involves the people running the trials; personal bias should not sway their judgement or their actions. This ideal of perfect objectivity, however, is difficult to achieve. To demonstrate this point we might consider the trials of a substance on human subjects in the treatment of, say, rheumatoid arthritis; If we consider the circumstances which can influence the so called objectivity of the trial procedure we will see that in some cases the results of such a trial would be almost entirely 'subjective'. However, because of the system by which the results were obtained they would be classed as objective evidence. This would tend to conflict with the fact that 'subjective' evidence is regarded as being unacceptable for the clinical assessment of a substance. For instance, if the patient relates changes in pain or movement as he sees it, the information is 'subjective' and not valid evidence. But let us examine this so-called objectivity a little more deeply.
Hidden subjectivity
It is usual in trials on human beings to have the patients perform tests and answer questions in the presence of the doctor controlling the trials. The procedure is repeated at regular intervals with changes in condition, as indicated by the tests and questions being recorded.
The effort put into the physical tests and the answers to the questions involve the patient attitude and are 'subjective'. If the patient really wants to help the doctor, perhaps because of a personal liking, then it is quite likely that more effort will be made. This means that the patient will try to do the physical tests in a way that will please the doctor. The patient may even exaggerate the answers to questions regarding pain or degrees of stiffness in an attempt to make the physician feel that the therapy is working.
On the other hand, if the patient does not like the doctor, or is feeling bad tempered, it is quite probable that he will exaggerate in the opposite direction when questions are put to him. It is also probable that less effort will be made in physical tests. This is subjective evidence in anyone's terms.
Some of the questions involved in the trial work for rheumatoid arthritis would be: How long did your morning stiffness last? How many tender joints have you? How much pain do you feel, and how many pain-killing tablets are you taking? The physical tests include things like grip strength, the time taken to walk ten meters, and movements which involve use of the affected joints or regions. No criticism is being made of the questions or the physical tests. The comment being made is that the results of these trial procedures are subjective.
There are tests involving the measurement of bodily changes, in trial patients for rheumatoid arthritis that can be classed as objective. However, even these are subject to such influences as stress factors, and thus the emotional condition of the patient is an important consideration. At best we might say that we have a 'subjective-objective' assessment.
Most doctors are aware of these factors, of course, and usually try to eliminate obviously emotional patients from trials. A problem (or a weakness in the system) can arise as a result of stress factors creeping in with patients on trial work who are not particularly emotional by nature. Such people may be under a stress condition that they hide particularly well outwardly but which takes its normal course internally. This can result in adverse influences being involved in the course of the patient's progress. The obvious way to eliminate this sort of effect in clinical tests is to use a large number trial patients. Statistically, this would eliminate spurious results. Unfortunately, this is not always done. The reasons vary. Cost, difficulty in finding sufficient patients wit appropriate symptoms in a given area and poor trial design are possibly the main ones.
*25/48/5*
ARTHRITIS
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