Celebrating a prospective randomised control trial

Celebrate a prospective randomised control trial

M Felix freshwater
Voluntary Professor of surgery, University of Miami School of Medicine, 9100 s. Dadeland Blvd. Suite 502, Miami, FL 33156-7815, United States

Letters mailing address:
M Felix freshwater
Voluntary Professor of surgery, University of Miami School of Medicine, 9100 s. Dadeland Blvd. Suite 502, Miami, FL 33156-7815
United States

How to cite this article:
Freshwater MF. Celebrate a prospective randomised control trial. Indian J Plast Surg 2012; 45: 38-9

I am writing this comment on April 1, known as the April Fool's Day in the United States. Historically, it is a day of pranks played on people, printing, and is now also online. [1], [2], [3] [4].

If I were to say that was the preceding article of evidence-based medicine of better quality than the latest article on the subject will appear in the Journal, Hand Surgery, you would think that I drag an April Fool's prank you.

It is not a prank. It is the truth. Published ahead of print and available online in the journal of Hand Surgery, but not yet indexed in PubMed, is a retrospective study from Harvard Medical School/Massachusetts General Hospital. [5]

The importance of this study in the Indian Journal of plastic surgery cannot be sufficiently stressed. Why?

Not only is it a higher quality study than that from Massachusetts General Hospital, but is also discovered I, using database PubMed, that this is the first randomized controlled blinded trial to be published in this journal.

It is most impressive that writers began this study, almost ten years ago, before the concept of evidence-based medicine became au courant among our confreres.

One can quibble with certain aspects of that approach, for example, distributing alternating patients to control and treatment arms, pseudo-stickprovsmetoder. [6] in 2012 is random number generators, freely available on the internet. However, the distribution of points worth noting about this study:

That the authors tried to respond to a meaningful clinical question rather than continuing to employ the dogma which they had learned from their professorsThat, the authors continued in an ethical manner by obtaining approval from its institutional ethics committeeThat the authors clearly described the informed consent obtained from their patientsThat the results were measured by an independent therapist who was blind treatment armsThe ethical standards which the authors were included in the Declaration of Helsinki. Only ethical requirement that the authors did not meet, IJPS and Declaration of Helsinki now requires that all prospective trials shall be registered in a publicly accessible database before the first patient enrolled in. [7] the Trial registration is free.

With the wealth of patients who need treatment for their hand problems, Indian plastic surgeons has a golden opportunity to not only help their patients, but also for answering important clinical questions with high-quality, ethics, future, Blind randomised controlled trials. [8]

These authors have Indian pioneers. Others should follow in their footsteps.

 

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