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EDITORIAL

It is Time for Evidence Based Practice in India

 Naidu Maripuri S*, Ujjwal K Debnath, Padma Babburi

*University Hospital of Wales , Cardiff , UK

Address for Correspondence:

Naidu Maripuri S 
University Hospital of Wales , Cardiff , UK 
E-mail: naidumsuk@yahoo.co.in

“Knowledge is with in. It is you who have to discover it” Swami Vivekananda

J.Orthopaedics 2007;4(3)e2

 Introduction:  

India is one of the fastest developing countries in the world. Rapid changes are taking place in each and every field and more so in the health care system. With the changing trends in medical practice clinicians are bound to provide the best possible care for the patients. Evidence–based medicine (EBM) is one of the most exciting recent medical developments, found to be highly logical and systematic approach to clinical practice.  

                                    Motivation+ Competence

 Performance =            ------------------------------

                                              Barriers

Competence comes from good practice. Good practice should be based on best available evidence.

a scaphoid injury. This led them to refer to this entity as an illusionary diagnosis.

What is EBM?  

It is the process of systematically reviewing, appraising and using clinical research findings to aid the delivery of optimum clinical care to patients1. In simple terms, EBM is providing best health care to the patients based on the best available evidence. But where can we find the information to help us to make better decisions. The following are common sources.  

·         Personal experience

·         Expert opinion

·         Colleagues

·         Published evidence  

We clinicians would not be human if we ignored our personal clinical experiences, but we would be better advised to base our decisions on the collective experience of thousands of clinicians treating millions of patients, rather than on what we as individuals have seen and felt. Professor Cynthia Murlow, one of the founders of the science of systematic review has shown that experts in particular clinical field are actually less likely to provide an objective review of all available evidence than a non-expert who approaches the literature with unbiased eyes2. In extreme cases, an “expert review” may consist simply of life long bad habits and personal press cuttings of ageing clinician.  

It is only by concentrating on the last category that ineffective, dangerous or costly interventions can be reduced. In clinical care and health care policy-making one can notice an increased effort to base decisions on the outcomes of empirical studies. Instead of so-called ’opinion-based’ decision-making, health care policy and clinical practice, in this view, should become more ‘evidence based’ by the use of the best available scientific evidence. The best evidence is evidence that is produced in randomly controlled clinical trials (RCT), where the association between a specific intervention and its outcomes is researched within very strictly controlled conditions

Elements of EBM:

  • Formulate a clear clinical question from a patient's problem

  • Search the literature for relevant clinical articles

  • Evaluate (critically appraise) the evidence for its validity and usefulness

  • Implement useful findings in clinical practice

  • Evaluation of compliance with agreed practice guidance and patient out comes-this process includes clinical audit

Forms of evidence:  

The value of evidence can be ranked according to the following classification in descending order of credibility1  

Level 1a– Systematic review and meta-analysis

Level 1b – Randomised Controlled Trials (RCTs)

Level 2 – Cohort study

Level 3 – Case control study

Level 4 – Cross sectional study

Level 5 – Case reports  

Critical appraisal:  

It is one step in the process of evidence-based clinical practice. To determine what the best evidence is, we need critical appraisal skills that will help us to understand the methods and results of research and to asses the quality of research. It can help us to decide whether we think a reported piece of research is good enough to be used in decision-making 3.

Advantages EBM  

For individuals:

  • Enables clinicians to upgrade their knowledge base routinely

  • Improves clinicians' understanding of research methods and makes them more critical in using data

  • Improves confidence in management decisions

  • Improves computer literacy and data searching techniques

  • Improves reading habits

 

For clinical teams:  

  • Gives team a framework for group problem solving and for teaching

  • Enables juniors to contribute usefully to team for patients

  • More effective use of resources

  • Better communication with patients about the rationale behind management decisions

Scope of EBM in India:

 

In the United Kingdom (UK), we observed that clear guidelines exists on site for most clinical conditions, which are based on best available evidence and are constantly updated4, 5. There exists a system where from most junior house officer to most senior consultant shall have constant appraisals that keep practitioners up to date with recommended practices. The primary purpose of the National Health Service (NHS) in the UK is to secure through resources available, the greatest possible improvement in physical and mental health of the population6.  

The best way to teach both patient care EBM is by setting an example7.

To start with in India we do not have many randomised trials or other studies to produce evidence for a particular clinical condition. Most of our evidence exists from western-based studies .Education as medical students in India is textbook based which are mostly by western authors. These textbooks may not always contain most recent available evidence based recommendations. Once post graduate or other higher training is completed most of the practitioners start their own practice and many of them practice what they have learnt years ago. Some times the only way of updating themselves may be knowledge passed on from medical representatives.  

There is non-uniformity of the standards of the care of patients from place to place and hospital to hospital. The government institutions run low in health budget annually. Only the premier institutes in the country, which are autonomous organizations, have access to large funds and research facilities. Availability of modern equipment in the corporate hospitals has led to the difference in public opinion. A large proportion of affluent patient population seek health care in corporate hospitals.   

There are differences in the standards of training in various medical institutions and specialities. This creates a non-uniform environment where standards of care may be in question. Therefore one cannot assume that qualification means competence. There is lack of guidelines and protocols for most disease situations. Education and training of the allied medical professionals are inadequate and not everyone in the system takes equal interest in the quality of care.  

There is also lack of communication between the rural and urban areas, which leads to ignorance in the rural community regarding the best practice. The medical practice in some corporate hospitals and central institutions in India is comparable to that of developed countries and attracting patients from all over the world. But uniform standards have yet to be achieved across the country. So there is need for introduction of concept of EBM in India with the best patient care being the long-term goal.   

Evidence Based Orthopaedics in the UK

What could we do better? The burning desire to answer this question, Orthopaedic surgeons across the world are developing the modern methods of research and design of trials in realms of joint replacement or arthroplasty surgery, internal fixation of fractures and other fields of orthopaedics e.g. Spinal surgery. The fundamental issue is that the surgeon is part of the treatment and is, generally speaking, responsible for its innovation and development. To involve in a large trial involves a large input from various organizations esp. financial institutions, research councils, ethical committees and other charities. Without the large involvement from the implant industry it is not feasible to provide the implants for trials. Without sponsorship and financial support surgical trials are simply impractical. The implant industry is not compelled to introduce new products with phased trials. Without sponsorship and financial support surgical trials are simply impractical. An alternative to trial-based research is a register, but these have proved difficult to establish. The success of the National Joint Register in Sweden and probably in the United Kingdom is a good example of how levels of evidence could be improved in orthopaedic surgery.  

Examples of EBM in orthopaedic practice  

1.Above and below-the-elbow plaster casts for distal forearm fractures in children. A randomized controlled trial 8 -This is a randomised controlled blinded trial which concluded that below elbow plaster casts are as effective as above elbow plaster casts in treating distal forearm fractures in children. So the traditional method of immobilization of one joint above and one joint below is not necessary in these fractures.  

   2.Treatment of Acute Achilles tendon Ruptures. A Meta-Analysis of Randomized,     Controlled Trials 9 by Khan RJK et al.

     Treatment of Achilles tendon is always a subject of debate. The above meta analysis of twelve RCTs concluded that open operative treatment of acute Achilles tendon ruptures significantly reduces the risk of rerupture compared with non-operative treatment, but operative treatment is associated with a significantly higher risk of other complications. Performing surgery percutaneously may reduce operative risks. Postoperative splinting with use of a functional brace reduces the overall complication rate. Based on this Meta analysis one can formulate treatment protocol for the Achilles tendon rupture.

3. Simple elbow dislocation among adults: A comparative study of two different methods of treatment. S Naidu Maripuri et al 10.Injury.in press.  

Simple elbow dislocation has been traditionally treated with plaster immobilization for 2 weeks. In the above study, we compared the plaster treatment group with early mobilization group. The early mobilization group returned to function earlier, required less physiotherapy and the functional outcome was superior to plaster group. Based on this evidence it is safe to treat simple elbow dislocation with early mobilization.

Searching the literature for best evidence  

The Medline database: Medline is compiled by National Library of Medicine of the USA and indexes over 4000 journals published in over 70 countries. Three versions of the information in Medline are available.  

  • Printed (the Index Medicus, a manual index updated every year from which electronic version is compiled.

  • On-line (the whole database from 1966 to date on a mainframe computer, accessed over the Internet or the electronic server)

  • CD-ROM (the whole database on between 10 and 18 CDs, depending on who makes it).

The Cochrane Library: Published articles are entered onto the Cochrane databases by members of Cochrane collaboration, an international network of medically qualified volunteers who each take on the hand searching of a particular clinical journal back to very first issue.  The Cochrane Controlled Trials Register (CCTR), Cochrane Database of Systematic Reviews (CDSR) are updated quarterly. Abstracts are available free on http/hiru.mcmaster.ca/cochrane/revabstr/abidx.htm  

Embase: The database of Excerpta Medica, which focuses on drugs and pharmacology, but also includes other biomedical specialities. The CD-ROM version is updated monthly.  

EBM on-line: A website run by BMJ (British Medical Journal) assesses the quality of published papers. The purpose of Evidence-Based Medicine is to alert clinicians to important advances in biomedical literature those original and review articles whose results are most likely to be both true and useful. These articles are summarised in value-added abstracts and commented on by clinical experts.

If one is computer literate and wants to explore the subject of evidence based medicine there are over 200 web sites dedicated to subject of evidence-based medicine 2. Concepts of EBM, critical appraisal of literature, principles of teaching EBM and information about resources are well documented in recent literature.7, 11,  12,13

Obstacles to EBM practice in India

What if evidence is available? It may not always be possible to practice because of various reasons

  • Economic constraints and limited resources in public sector

  • Not all patients can afford treatment in fully equipped private sector

  • Lack of awareness of Evidence Based Medical Practice in medical professionals due to non-uniform standards of medical education

  • Unwilling to discard therapies validated by tradition and experience on the account of somebody else’s evidence

Recommendations:

  • Medical student education should be practical oriented as in the UK

  • Educate medical students about audit and research and encourage them to participate as a part of their curriculum

  • Their reading habits should be oriented towards medical journals, which help them to update themselves with recent advances and current evidence

  • Basic Computer education should be encouraged

  • Formation of national standards and guidelines for diagnosis and treatment based on the current evidence

  • Where applicable evidence can be adopted from studies elsewhere but local studies and trials should be encouraged as local epidemiology may differ and factors influencing various clinical situations are not the same in all places

  • Government and professional bodies should come forward to encourage research and provide funding

  • Need of a system where all practitioners update themselves with best available treatment modalities and have constant appraisals to check their practice

The Orthopaedic Surgeons should be encouraged to organise and work together towards a common goal i.e. participate in well-designed studies. Such organisations are far more likely to persuade charities, research councils and industry for funding. Government could also help in improving the standards by providing subsidies and grants to the implant industry so that they could provide funds for clinical trials. The answer must be to devise levels of evidence appropriate for surgical research. The ideal result would be both a wider participation in research and an improvement in published evidence upon which to base best practice. 14

References:

  1. Rosenberg W, Donald A. Evidence based medicine: an approach to clinical problem    solving. BMJ 1995; 310:1122-6

  2. Greenhalgh T.How to read apaper-The basics of evidence based medicine 2nd    edition BMJ  Books 2001

  3. Busse JW, Heetweld MJ.Critical appraisal of orthopaedic literature: Therapeutic   and economic analysis. Injury 2006:37: 312-320

  4. Scottish Intercollegiate Guidelines Network (SIGN)    http://www.sign.ac.uk/guidelines/published/

  5. National Institute for Health and Clinical Excellence (NICE)- http://www.nice.org.uk/

  6. Department of Health. Promoting clinical effectiveness: A framework for action in and through the NHS.London: DoH, 1996.

  7. Petrison BA, Bhandari M.Principles of teaching evidence- based medicine. Injury     2006:37: 335-339

  8. Bohm ER, Bubbar V, Yong-Hing K, et al. Above and below-the-elbow plaster    casts for distal forearm fractures in children. A randomized controlled trial.  J Bone Joint Surg Am 2006; 88:1–8

  9. Khan RJK, Fick D, Keogh A, Crawford J, Brammar T, and Parker M   Treatment of Acute Achilles tendon Ruptures. A Meta-Analysis of Randomized, Controlled Trials .J Bone Joint Surg Am 2005; 87:2202-2210

  10. Simple elbow dislocation among adults: A comparative study of two different     methods of treatment. Subramanyam Naidu Maripuri, Ujjwal K. Debnath , Prabhakar Rao, Khitish  Mohanty.Injury in press

  11. Sacket D.L, Rosenberg WM, Gray J.A.M, Haynes R.B, and Richardson W.S Evidence based medicine what is it and what it is not. It is about integrating individual clinical expertise and the best external evidence.Br Med J    1996:312:71-72

  12. Bhandari M, Giannoudis PV.Evidence based medicine: what is it and what it is  not. Injury 2006:37:302-306

  13. Zlowodoski M, Zelle BA,Keel M,Cole PA,Kregor PJ.Evidence-based resources   and search strategies for orthopaedic surgeons. Injury 2006:37:307-311

  14. Carr AJ. Editorial .What type of research will best improve clinical practice?  J  Bone Joint Surg [Br] Dec 2005; 87-B: 1593 - 1594

 

This is a peer reviewed paper 

Please cite as :Naidu Maripuri S :It is Time for Evidence Based Practice in India  

J.Orthopaedics 2007;4(3)e2

URL: http://www.jortho.org/2007/4/3/e2

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