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Only Evidenced Based Medicine? Evidently……not!

4 Feb
man-jumping_logoThe modern emergency medicine based most of his clinical practice on evidence-based trials. 
But really all that is not coming from randomized controlled trials does not exist?

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).

MedInfo_EBMtriadImage

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.

ebp_pyramid

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.

The adoption of an integrated approach between the explicit scientific evidence derived from clinical trials (EBM) and a “patient- centered approach” derived from the clinical experience, should be a stimulus and an intent to the future development of our approach to the critically ill patient.

It must always be clear in the mind of the emergency medicine professionals which treatment is scientifically more correct for a given disease, but he must contextualise, and implement it for the particular patient who is dealing with at that time

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Italian transcript

References:

Solo medicina basata sulle evidenze? Evidentemente….no!

13 Giu

man-jumping_logoLa moderna Medicina d’urgenza basa molte delle sue pratiche cliniche sulla Medicina basata sulle evidenze.

Ma veramente tutto ciò che non è randomizzato e controllato non esiste?

Il paradosso della dimostrazione dell’efficacia del paracadute con trials randomizzati e controllati, in accordo con il metodo EBM (The Parachute trial), provocatoriamente pone un quesito fondamentale:

  • Se le basi scientifiche di un qualsiasi intervento terapeutico sono già solide, e il beneficio per la popolazione notevole,  è eticamente corretto attendere trial di larga scala prima di attuarlo, ritardandone così i suoi potenziali benefici?

A questo interrogativo ha risposto in modo brillante un articolo del 2006 pubblicato sul BMJ Controversy Parachute approach to evidence based medicine che riporta alcuni esempi di malattie molto comuni nei paesi in via di sviluppo (HIV, disidratazione nei bambini, emorragia post-partum) e i cui rimedi attuati preventivamente rispetto agli esiti dei relativi trial hanno, salvato migliaia di vite umane.

Gli autori concludono che:

  1. In genere è necessario attendere i risultati di trails di buona qualità prima di adottare qualsiasi nuovo intervento terapeutico
  2. Se comunque le evidenze già disponibili sull’efficacia di un particolare intervento sono già convincenti, ed i benedfici potenziali grandi, l’eventuale ritardo nella sua adozione potrebbe essere non etico
  3. Gli esempi riportati nell’articolo, e che si riferiscono ai paesi in via di sviluppo, dimostrano il costo in termini di vite umane di tale eventuale ritardo.

La triade decisionale alla base della costruzione della Evidenced Based Medicine prevede un approccio integrato tra dati e espliciti (evidenze scientifiche derivati da trials di buona qualità) e taciti (esperienza clinica e bisogni del paziente).

MedInfo_EBMtriadImageLa decisione clinica infatti deriva dalla concomitanza di questi tre fattori:

  • Evidenze scientifiche
  • Esperienza clinica
  • Bisogni del paziente

La criticità arriva al momento della definizione del grado di qualità delle evidenze in base alla loro provenienza; quelle derivate dalla pratica clinica  e dall’esperienza vengono relegate alla base (grado inferiore) della piramide al cui apice (grado maggiore) stanno le evidenze scientifiche derivate da studi su larghe popolazioni di pazienti.

ebp_pyramid

La randomizzazione e la depersonalizzazione della ricerca scientifica così generata, mentre giustmente tende ad eliminare tutto ciò che di “non evidente” esiste in ricerca medica e ben si adatta ad un concetto di salute pubblica,  d’altra parte mantiene un gap incolmabile con quella che è la pratica medica quotidina incentrata sulla cura del singolo individuo.

Ma in pratica cosa si può fare:

  • E’ auspicabile l’integrazione dei dati espliciti, frutto delle evidenze, con il “tacit knowing” (elementi non espliciti) che si genera solo nel contatto diretto medico-paziente.
  • Il “tacit knowing” sta alla base della nostra formazione medica, come l’apprendimento del linguaggio sta ai bambini in età prescolare: non ha bisogno di insegnamento strutturato ma si apprende dall’esperienza diretta.
  • Il “tacit-knowing”, spesso sottovalutato o ridotto a dato soggettivo e quindi di minore dignità, è in effetti, proprio perchè “innato”, meno soggetto ai comuni bias dei dati espliciti;
  • Bisogna riconosce pari dignità ad entrambi i dati quelli “explicits” e quelli “tacits”.
  • Si deve tenere conto di entrambi gli elementi espliciti e taciti,nella formulazione dell’ipotesi diagnostica e della conseguente strategia terapeutica.

Si può e si deve andare quindi oltre l’uso esclusivo dell’EBM in ricerca medica ed in pratica clinica.

L’adozione di un atteggiamento integrato tra le evidenze  scientifiche esplicite derivate dai trials clinici(EBM) ed un “patient centered approach” frutto dell’esperienza clinica acquisita tramite il rapporto quotidiano del medico con i pazienti, deve rappresentare uno stimolo ed un intento per il futuro sviluppo del nostro approccio al paziente critico.

Deve essere sempre chiaro nella mente del medico di medicina d’urgenza quale sia il trattamento scientificamente più corretto per una determinata patologia, ma egli lo deve contestualizzare secondo la propria professionalità, ed attuarlo per il paziente che sta trattando in quel momento.

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English transcript

References:

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