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In assessment of clinical trials there are different potential problems faced by the researchers in order to reach accurate results.
Subjective clinical outcomes are the measurements that would reflect the perceptions of the person being accessed, the subject. However, subjective measurements are not very reliable and are inconsistent. It also reflects quality of the procedure used to access; hence, imperfection in performing a procedure may affect the measurement. Subjective assessments are also influenced by bias introduced by the observer.
While making clinical decisions, individuals tend to use their own assessments, relying on subjectivity, rather than being objective in every aspect. This means that most results are obtainable on the basis of perception. However, these results are not to be relied on wholly, as they are not scientific, and there is a need to measure clinical outcomes that are subjective (pain, etc.), in order to attain optimum results.
There are various methodologies employed for measurements of clinical outcomes, according to the type of assessment to be made. The area of physical therapy, that involves the ‘pain’ element, does not have adequate standardized clinical measures. There are a few methods and procedures used in the criteria for identification of clinical measures, which include measures of spasticity, balance, muscle tone, and shortness of breath. But these are assessed through unstandardized methods and techniques, which lead to negative outcomes. Firstly, the values obtained are of little significance to the clinician, because there is no guarantee that the measure applied does not contain any errors. Secondly, there are no records of any clinical investigations that newly found results can relate to. All current tests and outcomes are done in accordance with traditional physiological tests.
The inconsistency of clinical measures is dependent on three elements, the individual who is examined, the examiner, and the examination. The assessment of all three is essential in determining the clinical measure. The individual who is examined has to be studied for body weight, blood pressure and pulse every hour, or every day, as per requirement. These elements vary according to the lifestyles of individuals, and vary from person to person. If an examination is carried out at one time producing extremely high or low results, the same examination may be repeated at a different time only to produce values closer to the mean.
There are several criteria to determine the adequacy of assessment methods. These are reliability, validity, efficacy and sensibility. Reliability is consistency of scores from different participants, validity indicates how adequately a measurement is assessing the main points needed to assess. Efficacy determines whether the main purpose has been determined or not. Sensibility determines if the procedure is sensible enough to reach its goals. The data obtained must be reliable, consistent, valid, accurate and sensible enough so that it can be trusted on for various studies. Adequacy of data is very important in all scientific measurements. Reliability of the results is the most important and fundamental.
Studies show that whatever we believe influences our behavior. Especially what we expect influences the findings of subjective assessments. Blinding is one of the methods to reduce such discrepancies in results. Blinding is sometimes done only with patients and sometime with both patients and medical staff in order to produce best results. Masking the treatment is important to get responses most accurate. However, in some cases this is unavoidable to mask the treatment and it’s evident to both staff and patients. Masking treatment is useful only in cases where it’s known that it will affect the assessment process. This is very crucial in evaluation of a diagnostic test, hence, the one who is performing the diagnosis and the subject must be unaware of the diagnosis in order not to affect the results. In some studies exposure of treatment is mandatory for example interviewing the subjects will clear everything to them, hence, masking is not possible.
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It is therefore essential for clinicians and medical practitioners to employ tests that produce as authentic results as possible, to produce optimum outcomes in different settings. There has to be a way in which there is no bias of opinions, and no personal judgments in clinical settings.
Day, S.J. & D.G. Altman, Statistics Notes: Blinding in clinical trials and other studies. British Medical Journal (2000);321, p 504. Web.
Marquis, P., et al, Patient-reported outcomes and health-related quality of life in effectiveness studies: pros and cons, Drug Development Research, 2006 vol. 67(3), pp 193-201. Web.
Jette, A.M., Measuring Subjective Clinical Outcomes. Physical Therapy (1989) 69, pp 580-584. Web.