Only Evidenced Based Medicine? Evidently……not!

The paradox of the demonstration of the effectiveness of the parachute with randomized controlled trials, in accordance with the method EBM (The Parachute trial), provocatively poses a fundamental question:

If the scientific basis of any therapeutic intervention are already strong, and the benefit for the population is large, is ethically correct to wait large-scale trial to implement it, delaying its potential benefits?

A 2006 article published in the BMJ Controversy Parachute approach to evidence based medicine brilliantly responded to this question.

It contains some examples of very common diseases in developing countries (HIV, dehydration in children, postpartum hemorrhage) whose remedies, implemented previously than results of relative trials where available, have saved thousands of lives.

The authors conclude that:

1. Randomised controlled trials are usually required before new interventions are implemented

2. If other evidence of effectiveness is good, and potential benefits large, the resultant delays may be unethical

3. Examples from poor countries show the price of delaying interventions

The triad of decision-making at the base of the construction of Evidenced Based Medicine provides an integrated approach between explicit data (scientific evidence derived from trials of good quality) and tacit data(clinical expertise and the patient’s needs).

The clinical decision is derived from the combination of these three factors:
• Scientific evidence
• Clinical Experience

• Needs of the patient

But when defining the level of quality of evidence those derived from clinical practice and experience are relegated to the base (lower level) of the pyramid whose apex (higher degree) are the evidence derived from studies on large patient populations.

Randomisation and de-personalization of scientific research, while eliminates everything that is “non-evident” in medical research, and is well suited to a concept of public health, on the other hand maintains an unbridgeable gap with daily clinical practice that is focused on the care of the individuals.

But in practice what we can do:

• Integration of explicit data, result of the evidence, with the “tacit knowing” that is generated only from the direct doctor-patient relationship is desirable.
• The “tacit knowing” is the basis of our medical education, such as learning the language is to pre-school children: it does not need structured teaching but it is learned from direct experience.
• The “tacit-knowing”, often reduced to subjective data and therefore of lesser dignity, is in fact, just because “innate”, less prone to the common bias of explicit data;
• We must recognize equal dignity to both those data “explicits” and “tacits.”
• We must take into account both explicit and tacit elements in the formulation of the hypothesis and the resulting diagnostic therapeutic strategy.

We can and we must go beyond the exclusive use of EBM in medical research and clinical practice.