**6. Clinical application of EBM: considerations**

In daily clinical practice, the application and implementation of EBM simply means that choosing a treatment for a patient is based on the strongest available evidence. However, the concept of EBM does not consider as much, but should consider patient's values and beliefs or other factors such as experiences of the treating team and facilities available at that hospital. Sackett et al. defined EBM as "Evidence-based medicine is the integration of best research evidence with clinical expertise and patient values" [11]. In that definition "Patient values" is not clearly explained in that definition which may refer to what does the patient want? In fact, the implementation of EBM does not generally seek patients sharing in decision-making. The science, practice, and application of EBM do not consider that patient's values, faith, and culture are factors for grading or leveling evidence (hierarchy of evidence). Several studies showed the importance of the patient being a partner in decision-making [12, 13].

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"Grade III Evidence."

*Values-Based Medicine (VsBM) and Evidence-Based Medicine (EBM)*

Evidence-based medicine has been popularized in the last 30 years and to a certain extent has been considered a good measure of medical practice. However,

I.Patient preferences and values were not always considered during the

II.Limitations in incorporating health-related quality of life (HRQoL) [14] .

III.EBM is based on finding and following the highest-quality evidence. However, in the absence of randomized clinical trials, the veracity of the

Ethically there are a few serious questions regarding presumed evidence collection. Those queries are legitimate as most of the evidence is obtained from the analysis of large data (meta-analysis) which has subsequently inherited all the problems of analyzing the large data of multiple sources. This problem has been discussed by several authors including Dagi [15]. He mentioned "The ethical question is what to do about the data once it has been collected and analyzed. It is ethically important to separate the results of statistical analysis from, for example, [1] statistically significant but clinically irrelevant outcomes, [2] judgments about how data about the set should be applied to specific individuals within the set, [3] the protection of the prerogatives of individual patients in the face of population-based protocols, and [4] the protection of the surgeon's prerogatives in personalizing the treatment of individual patients. The question of what should be done with probabilities and statistics is not statistical in the least: it is entirely a value judgment." Both scientifically and ethically, there is a clear line between what is considered fact and what should be or ought to be. The philosophical debate about is/ought (fact/value) has continued for hundreds of years and remains unsettled. Hume produced what is called Hume's law "From causes which appear similar we expect similar effects. This is the sum of all our experimental conclusions." He recognized as well the "is-ought" controversy. The idea of linking

what ought to be to what is, is seriously ethically and clinically challenged.

Randomized controlled studies are the main factors that were used to level validity and strength of evidence. The value of evidence from randomized controlled studies is considered the strongest or best evidence and top leveled and graded as "Grade I Evidence." Evidence obtained from nonrandomized studies is considered as "Grade II Evidence." However, evidence based on valid experiences and thoughts and opinions of distinguished medical and surgical authorities are considered as

Ethical concerns have been raised about double-blind randomized controlled studies. It has been debated that denying a group of patients (control group), the experimental treatment or method of management believed to be beneficial, is ethically challenged. There is also an ethical issue concerning the validity of evidence which is a result of double-blind randomized controlled studies which were carried out in certain circumstances, homogenous or not subjects, variable controls, and particular role to be used as the base for making decision for treating patients in different circumstances. Therefore, the integration of the best research evidence with clinical expertise and patient values should be carefully and cautiously considered.

*DOI: http://dx.doi.org/10.5772/intechopen.88393*

the use of EBM shows these limitations:

decision-making process [7].

evidence comes into question.

**8. Collecting evidence**

**7. How evidence is ethically evidence?**
