Indian Journal of Dermatology
IJD SYMPOSIUM: EVIDENCE-BASED DERMATOLOGY
Year
: 2014  |  Volume : 59  |  Issue : 2  |  Page : 123--126

Editorial: Evidence-based dermatology in India: Problems and prospects


Saumya Panda 
 Executive Editor, Indian Journal of Dermatology, Kolkata, India

Correspondence Address:
Saumya Panda
Executive Editor, Indian Journal of Dermatology, Kolkata
India




How to cite this article:
Panda S. Editorial: Evidence-based dermatology in India: Problems and prospects.Indian J Dermatol 2014;59:123-126


How to cite this URL:
Panda S. Editorial: Evidence-based dermatology in India: Problems and prospects. Indian J Dermatol [serial online] 2014 [cited 2019 Dec 9 ];59:123-126
Available from: http://www.e-ijd.org/text.asp?2014/59/2/123/127669


Full Text

Evidence-based dermatology (EBD) is the application of high quality evidence to the care of individual patients with skin disease. [1] It belongs to the episteme known as 'Evidence-based Medicine' (EBM) that has as its objective the integration of current best evidence with clinical experience and patients' values and preferences in the clinical decision making process. [2] In 1981, a group of clinical epidemiologists at McMaster University in Ontario, Canada, led by David Sackett, published the first of a series of articles advising clinicians how to read clinical journals (critical appraisal). In the early 1990s, a group of McMaster clinicians and epidemiologists formally coined the term 'evidence-based medicine'.

The original model of EBM presented in 1992 by the EBM Working Group of the American Medical Association visualized the following scenario: A clinical question would arise at the point of care, and the physician would conduct a literature search yielding multiple (sometimes hundreds of) articles. The physician would then select the best articles from the results, evaluate the research, determine their validity, and decide what to do - all the while the patient would be waiting in the examination room. This was, of course, a totally impractical approach. [3] In order to obviate this improbable situation, EBM has developed what are arguably among its greatest achievements, the systematic reviews (SRs) and meta-analyses that summarize the best available evidence on a clinical question. The way to practice EBM is to use its resources that continually search, appraise, and summarize the literature and give a useful, actionable recommendation based on the evidence. [4]

A fast-enlarging information pool, the complex structure of the practice of modern medicine, and the limits of time as a resource and that of human cognitive ability make clinical uncertainty a fact of life. In a 1999 study, researchers found that clinical questions arose 3.2 times for every 10 patients seen, but physicians did not seek an answer 64% of the time. If the physicians, on the other hand, did pursue an answer, about 80% of the time they got a reasonable one. [5] This is the utility of EBM - it is the only guide to reasonable assumptions in the increasingly unsure world of clinical decision making.

There has been persistent criticism regarding the use value of EBM by some who have claimed that SRs always conclude that there is insufficient evidence to recommend anything concrete. This might be true for quite a few skin conditions where the evidence base is characterized by many small, poorly reported studies. However, a review of Cochrane dermatology SRs found that clear clinical recommendations could be made in around 40% of cases. [6] Thus, such criticism of low (or, no) use value of EBD (and, EBM) is nothing but gross exaggeration and stems from misperception.

In recent years, attention has been drawn to a number of medical myths, that dermatologists learned in their training, becoming established as standards of practice. One such example is radical vulvectomy for lichen sclerosus, which is thankfully a thing of the past. However, the practice continued for decades on the basis of anecdotal reports, and was handed down uncritically over generations during medical training. [7] The same applies to high-dose oral corticosteroids for treating pemphigoid or the use of thalidomide for toxic epidermal necrolysis, both of which have been shown to cause more harm than benefit when compared with potent topical corticosteroids or good supportive care, respectively. [8],[9]

Thus, EBM as a process of problem-solving and self-directed lifelong learning as well as a strategy to deal with the ever-increasing quantity of information of widely dispersed quality is here to stay. The paradigm shift that EBM has ushered in the way healthcare practitioners make clinical decisions can only be ignored at our peril. Not only the means of EBM but the very end, that is obtaining clinical decisions that maximize benefit-risk and benefit-cost ratios to the patients, has a global relevance across all clinical disciplines, and dermatology is no exception. When evidence is weak, EBM empowers the patients, whereas when evidence is strong, EBM empowers the measures taken to improve the quality of care. [10]

 EBM in India: The Problems



The EBM movement in India is still at a nascent stage. Methods to formulate clinical questions, finding the current best evidence, critically appraising as well as applying the evidence, and knowing how to report clinical researches in a methodical and transparent manner according to current best standards are very much basic and essential learnable skills. To exemplify in dermatological terms, these are as important as learning how to make a clinical diagnosis, knowing sufficient dermatopathology so as to be able to do clinicopathological correlation, and grasping basic dermatosurgical techniques. But this awareness is simply nonexistent among our medical curriculum planners and teachers, so that EBM is not a part of our undergraduate (UG) and postgraduate (PG) courses. The reason is two-fold: The origins of EBM having been of historically recent vintage, most of our senior faculty and curriculum planners themselves have had little or no exposure to EBM themselves, and thus are naturally skeptical about its possibilities; and two, EBM being intrinsically interdisciplinary in nature, the training calls for participation of clinicians, clinical pharmacologists, statisticians, epidemiologists, and social scientists in equal measure. The structure of medical education in this country being too rigid, there is systemic resistance to such fluid exchange among specialities. The exceptional example of the Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGIMS) may be cited in this regard. It is the only institute where there is formal introduction to EBM at the beginning of every session, backed up with a huge library and free internet facilities with online access to a large number of journals in wards, outpatients' departments, laboratories, and residents' rooms. But such an outlook of delivering EBM-based education and medical care supported by liberal budget, logistics, and infrastructure is unheard of among the Medical Colleges in India. It is no coincidence either that SGPGIMS was created with the aim of providing interdisciplinary medical education and research.

Just as one swallow does not make a summer, so also the exception of SGPGIMS proves the rule regarding the sorry state of affairs of EBM in India. If you search the PubMed for the term 'evidence based medicine', you will find a total of 89,749 articles. Out of this, only 512, that is, a measly 0.57%, were from India. In a survey conducted on the use of computer-based electronic literature search (as a surrogate marker of EBM) among PG medical students in India, presentation in a lecture or seminar was cited as a motivating factor in 90% of cases, while it was used much less frequently for research (65%) and patient management (60.3%). [11] This suggests that though EBM has already been introduced in this country, its utilization is inefficient due to lack of training. Another study among surgical trainees found a positive attitude towards EBM, but only 50% of actual practice was considered to be based on evidence. [12]

 EBM and EBD in India: The Beginnings - Role of the Cochrane Collaboration



The formal inception of EBM activities in India was announced with the formation of the South Asian Cochrane Network (SACN) in January 2005 at the initiative of the Christian Medical College, Vellore as a branch of the Australasian Cochrane Centre. [13] With the efforts of SACN, from January 2007 the Cochrane Library is available free to all residents of India, courtesy the program named INCLEN. This acronym stands for the Indian Council of Medical Research's (ICMR) national subscription for the Cochrane Library that has made it possible to gain its full and free access from any computer with an internet connection in India. As of now, this is the most significant step taken towards utilization of EBM in the education, research, and practice of medicine in India.

The Cochrane Library is the online repository of Cochrane reviews, a body of SRs covering all aspects of human medicine, contributed by over 50 review groups. The library also contains the largest database of clinical trials in the world and other useful methodological resources. The library is the single most important resource for EBM, and is the showpiece of the International Cochrane Collaboration that took shape as a nonprofit organization in 1993 in response to Professor Archie Cochrane's exhortation (in the 1970s) to the medical profession to systematically collate evidence from high quality randomized controlled trials (RCTs).

The Cochrane Skin Group (CSG) is one of the review groups that was formed in 1997. It has its editorial base at the Centre of Evidence Based Dermatology at Nottingham with Professor Hywel Williams as the coordinating editor. There are now well over a hundred reviews published on the Cochrane Library that are relevant to dermatology, of which 62 have been contributed by the CSG. The Skin Group reviews are typically contributed by authors (reviewers) from all over the world, including India, [14] and these are of high relevance to people around the world.

There are certain problems demanding unique solutions involving the implementation of EBM in this country. One of these concerns the complementary and alternative medicine (CAM) that are recognized by the Government of India, namely, Ayurveda, Siddha, Yoga, Unani, Homeopathy, etc., Patients often attempt to receive simultaneous treatment from multiple systems. For example, a patient attending a clinic run by a specialist in western medicine may very well go to a traditional healer in the evening to receive a herbal powder or the like. [15] In order to harness the scientific basis of the ancient Indian system of medicine, the Institute of Applied Dermatology (IAD), Kerala has developed a model of therapy integrating elements of western medicine and Ayurveda for conditions, viz., lymphatic filariasis, lichen planus, and vitiligo. This model has been named Integrative Dermatology (ID). Hywel Williams, on behalf of the CSG, helped IAD develop a framework for conducting evidence-based studies in ID that has helped it gain acceptance among the broader scientific community. [16]

If the above was an example of how EBM can work in exploring India's scientific heritage situating it in the context of modern scientific medicine, there are other areas in our clinical practice that can imminently benefit from the employment of tools of EBM. One such area concerns the porous system of drug licensing in this country that has spurred the emergence of numerous irrational and downright unethical, formulations in the drug market. An easily identifiable example from dermatology will suffice, that of cosmeceuticals. This term refers to the combination of cosmetics and pharmaceuticals. These are essentially cosmetic products containing biologically active ingredients purporting to have pharmacological benefits. In India, these are marketed as cosmetic products with cosmetic licence. As these products are not saddled with regulations for obtaining drug licence, they need not undergo the rigors of clinical trials prior to marketing. For the companies promoting these products, it means a double bonus, as they do not have to incur a major part of cost in product development in the form of clinical trials, and even if any of these products became very popular, they are never going to be under the purview of drug price control regulations. So the potential for quoting profits for these products in enormous, if not endless. It is not surprising that even the major pharma corporations are making a foray in this segment, sometimes at the cost of genuine drug development, resulting in a skewed market where cosmetic dermatology is getting precedence over dermatologic therapy.

For the consumer, however, this means a double whammy. If the consumer interprets a cosmeceutical to be similar to a pharmaceutical product, which one will tend to do as more and more of these products get marketed by the pharma industry and are prescribed by the dermatologists, (s)he may conclude that cosmeceuticals are required to undergo the same level of testing for efficacy and quality control as required for a drug. This allows the market to charge the consumers more for a product, though it may actually be less effective and/or of poorer quality than perceived, [17] and may potentially do undisclosed harm. An independent consolidation of scientists versed in EBD could establish the benefit-harm and cost-effectiveness ratios of such products, and could actually restore the balance in the market.

 EBD in India: Future Prospects



EBD in India is at a promising crossroads. In January 2013, the National Conference of the Indian Association of Dermatologists, Venereologists, and Leprologists (IADVL) had as its theme "Evidence-based Dermatology", a first of its kind here that, hopefully, would have familiarized this paradigm to a large segment of Indian dermatologists. Such kindling of interest in EBD, however, will not ensure its continued propagation in the absence of systemic and infrastructural change. Incorporation of EBM within the medical curricula, both UG and PG, can give it the necessary fillip. The logistic support of providing free electronic data searches must be made more broad-based, bringing more and more residents within the fold of free access. The internet facilities must be accessible round the clock whenever a clinical question arises. The system should have many user stations available at strategic points within tertiary care hospitals, if possible in the wards themselves. The required reference must be available instantly if dealing with a question on patient care, and within 48 h in all other situations. Journal selection should be maximized, and additional hospital funding must be provided to expand library resources. If increasing the number of available journals is not feasible due to fund constraint, the mechanism of an interlibrary lending network must be developed. Finally, the role of the librarian as a team member in the EBM training process should not be overlooked.

As a parallel process, research methodology workshops need be conducted for students, residents and physicians all over the country. The Dermatology Clinical Trials Special Interest Group (SIG) that has been set up under the aegis of the IADVL Academy of Dermatology has taken the lead in organizing such workshops throughout the country. The SIG also has among its objectives the twin tasks of identifying areas of research in dermatology in which independent collaborative clinical trials can be conducted, and to locate sites and identify collaborators for such trials. [18] Subsequently, such a group of dermatologists well-versed in the nuances of EBD may meaningfully collaborate with international consolidations like the CSG and the International Federation of Dermatology Clinical Trial Networks (IFDCTN). Both these organizations have Indian representation. While CSG is by now a well-known entity, IFDCTN has been formed in 2012, and comprises 36 scientists from 21 countries; its objectives being prioritizing, developing, and delivering independent collaborative clinical trials in dermatology. [19] So we can now realistically visualize a futuristic best case scenario for EBD in India, where in a 'wheel within wheels' model, the SIG Dermatology Clinical Trials would function as a nodal hub that would actively develop a core of individual dermatologists well-versed in the language and methods of EBD who would identify and prioritize clinical uncertainties and would address these uncertainties by means of RCTs, and at a later stage, would collaborate with international consolidations like IFDCTN in conducting independent clinical trials, utilizing resources like that of the Cochrane Library and of organizations like the CSG.

The Indian Journal of Dermatology has always played a progressive role of acting as a medium for the ever-changing developments of scientific research in dermatology in this part of the world. True to its character, from the beginning of 2013 it has made adherence to CONSORT 2010 mandatory for publishing clinical trial reports. [20] The journal has also made pre-registration of clinical trials compulsory from 2014, and in another crucial step, has decided to assign a level of evidence to each published article.

It is a great privilege for me to have been assigned to edit this symposium on 'Evidence-Based Dermatology', with representative contributions from three experts in the discipline. Hywel Williams' article on 'Strengths and limitations of evidence-based dermatology', that is actually an extract of the last chapter of the forthcoming 3 rd edition of the authoritative textbook entitled 'Evidence-based Dermatology' (John Wiley and Sons Ltd), is a polemical take on EBD and EBM. It may surprise some, as he has chosen to play the role of a devil's advocate, yet again, with aplomb. Michael Bigby's contribution named 'Understanding and evaluating systematic reviews and meta-analyses', obviously more technical, is a thorough, lucid exposition on the subject, and will be an invaluable resource for anyone wishing to pursue EBD sincerely. Arnold Oranje's 'Evidence-based pharmacological treatment of atopic dermatitis: An expert opinion and new expectations' is an exemplar for evidence-based review - concise, pithy, and categorical.

As the Editor of this Symposium, it is my firm belief that this will be considered as a ground breaking exercise in the dissemination of EBD in India, and perhaps, beyond. Enjoy!

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