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EDITORIAL
Year : 2018  |  Volume : 34  |  Issue : 1  |  Page : 1-2
 

Whose evidence do we follow?


Editor, Indian Journal of Urology, All India Institute of Medical Sciences, New Delhi, India

Date of Web Publication29-Dec-2017

Correspondence Address:
Rajeev Kumar
Editor, Indian Journal of Urology, All India Institute of Medical Sciences, New Delhi
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/iju.IJU_348_17

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How to cite this article:
Kumar R. Whose evidence do we follow?. Indian J Urol 2018;34:1-2

How to cite this URL:
Kumar R. Whose evidence do we follow?. Indian J Urol [serial online] 2018 [cited 2018 Jan 18];34:1-2. Available from: http://www.indianjurol.com/text.asp?2018/34/1/1/221975


Evidence-based medicine (EBM) is the cornerstone of current medical practice and education.[1] From its beginnings in the early 20th century, modern medicine grew on the basis of knowledge passed on by eminent practitioners, at times based purely on anecdotes and logic. But then, who would need a randomized trial to know that parachutes save lives? Some of the discoveries were so radical that to question them, or their innovators, would be blasphemous. The use of anesthesia, antisepsis, antibiotics, radical surgery for cancer, and chemotherapy delivered results that were so obviously superior to previous practice that they were rapidly adopted and disseminated. Over the last 30 years, the impact of new discoveries became progressively smaller. A new drug would provide improvement in 10% of patients and improve survival by 3 months, and a surgical technique would decrease hospital stay by 12 h. Along with smaller benefits came the growth of commerce and enterprise where each new discovery promised billions of dollars to its owners if it succeeded. Conflicting reports on outcomes with high-profile endorsements created an environment of uncertainty where EBM provided a solution.

However, has EBM been able to withstand the strength of market forces and publication bias? After all, what is evidence and who generates it? At the top of the pyramid of evidence sit randomized trials and meta-analyses derived from them.[2] Performing such trials requires money which increasingly comes from organizations that benefit directly from the outcomes of such trials. Despite the large amount of regulation that controls the conduct of trials to avoid conflicts of interest, negative trials frequently go unpublished and do not contribute to the available evidence.[3],[4] Does this mean that manufacturers are perfect punters who always get it right? Even if most poor performers get dropped before coming to trial, these would have been registered or reported. Therefore, is the evidence in the literature balanced? Publication bias within journals adds to the skewed evidence.[5],[6] When up to 41% revenues of a journal come from reprints of trials, and impact factors could decrease by 15% if industry-sponsored trials were omitted, it is difficult to believe that these do not influence decisions.[7]

Another issue about blindly using trial data is the lack of ability to replicate the conditions that prevail during a trial.[8] Trials carefully select patients for inclusion; patients who are fitter, are educated, or have access to healthcare and are subject to a strict follow-up schedule. Adverse effects are prevented, identified early, and treated aggressively without consideration of costs. This is quite different from real life, more so in countries like India with out-of-pocket expenses for most medical treatment and where finding forgotten stents in the ureter even years after surgery does not raise eyebrows. The expanding evidence for medical therapies, particularly for conditions where surgery is an option, is often viewed with skepticism in real-life practice where delays in the neoadjuvant setting may turn a curable disease incurable and in the adjuvant setting, 15-month survival at home into an 18-month survival in hospital in penury.

The Urological Society of India has embarked on a plan to develop guidelines for managing a number of common urological conditions. There is no doubt that considering the heterogeneous nature of training and wide discrepancies in practice patterns, guidelines would serve an important role in educating and defining standards of care. They may also help practitioners, patients, and courts weigh the impact of resources on deciding the best option. However, this seems a formidable task on two counts. First, EBM requires the identification of published literature, its extensive review, discussion, and synthesis which must be statistically sound. This is a resource-intensive task requiring finances and expertise, both of which are hard to come by and which end up dissuading societies from taking up such endeavors. The easier option then is to accept or adapt guidelines developed by other associations which have the required resources. The second problem, even if one were to accept the challenge, is to find literature which addresses local concerns. The lack of published data means authors end up reading the same literature or evidence that previous guidelines reviewed and come up with look-alike of existing guidelines.

It may thus be wise for us to avoid the pitfalls of EBM in its strictest form and resort to using experience to mould our guidelines. Developing a consensus model, based on a framework of evidence that includes local data even if it is of a lower quality, may serve our objectives better. With all due respect to Marie Antoinette, it is better to eat bread than starve for want of cake.

Financial support and sponsorship:

Nil.

Conflicts of interest:

There are no conflicts of interest.

 
   References Top

1.
Evidence-Based Medicine Working Group. Evidence-based medicine. A new approach to teaching the practice of medicine. JAMA 1992;268:2420-5.  Back to cited text no. 1
[PUBMED]    
2.
Oxford Centre for Evidence-Based Medicine – Levels of Evidence. Available from: http://www.cebm.net/oxford-centre-evidence-based-medicine-levels-evidence-march-2009. [Last accessed on 2017 Dec 01].  Back to cited text no. 2
    
3.
Hopewell S, Loudon K, Clarke MJ, Oxman AD, Dickersin K. Publication bias in clinical trials due to statistical significance or direction of trial results. Cochrane Database Syst Rev 2009:MR000006.  Back to cited text no. 3
[PUBMED]    
4.
Half of US Clinical Trials go Unpublished. Available from: http://www.nature.com/news/half-of-us-clinical-trials-go-unpublished-1.14286#/b2. [Last accessed on 2017 Dec 01].  Back to cited text no. 4
    
5.
Every-Palmer S, Howick J. How evidence-based medicine is failing due to biased trials and selective publication. J Eval Clin Pract. 2014;20:908-14.  Back to cited text no. 5
    
6.
Pearce W, Raman S, Turner A. Randomised trials in context: practical problems and social aspects of evidence-based medicine and policy. Trials 2015;16:394.  Back to cited text no. 6
[PUBMED]    
7.
Lundh A, Barbateskovic M, Hróbjartsson A, Gøtzsche PC. Conflicts of interest at medical journals: the influence of industry-supported randomised trials on journal impact factors and revenue – Cohort study. PLoS Med 2010;7:e1000354.  Back to cited text no. 7
    
8.
Prince RM, Atenafu EG, Krzyzanowska MK. Hospitalizations during systemic therapy for metastatic lung cancer: A Systematic review of real world vs. clinical trial outcomes. JAMA Oncol 2015;1:1333-9.  Back to cited text no. 8
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