Scope for Guideline Development & Use in India

1. Scope for Guideline Development & Use in India Taking Evidence to Practice Nerges Mistry The Foundation for Medical Research The Foundation for Research in Community Health ASCI, Hyderabad (3rd May 2011)

3. Guidelines • Defined as scientifically developed statements to assist practitioner and patient decision making about appropriate care for specific clinical conditions • Measures to rationalize resource consumption and promote quality • Part of professional quality systems – education, peer review, audits • Empower patients to make informed health care choices • Tools to practice Evidence based Medicine

4. Evidence Based Medicine Origin • ‘EBM’ coined at McMaster Medical School, Canada in 1980s • Developed as a method for teaching medical students in the context of : - Exponential growth of information leading to poverty of attention - High quality information gets drowned- costly to find specific information - Introduction of newer technology- often of doubtful utility • Enormous variations in standards and costs of care

5. EBM • EBM: ‘ to make use of explicit search criteria to find best available evidence’ • Conscientious, explicit and judicious use of current best research evidence in making decisions about care of individual patients • Expected results: better care, reduced costs by avoidance of less useful technology • Began as a “ bottom up paradigm” – teaching medical residents to search for best evidence and critically appraise it for making patient care decisions Continued…

6. Continued… from previous page • “Evidence based” practice movement as a ‘paradigm shift’ • Shift from traditional medicine emphasizing expertise of medical profession • Reined the “free style” nature of expert critical appraisal • Undercut autonomy and authority of the Dr and the resultant variability in care • Broke the hold of the profession over how medicine is practised and compensated

7. EBM in developing countries • EBM - widely accepted in developed world • Met with considerable resistance in developing world • Scarcity of resources and severity of health problems makes a strong case for EBM practice in developing world

8. Glimpses into EBM uptake • 58% maternal health practitioners (n=660) in 4 South East Asian countries had heard of EBM, … majority did not understand the concept - SEA-ORCHID (Thinkhamrop et al., 2009) • Studies in Iran, Brazil : Low number of practices recommended by evidence review were followed routinely. • Studies in rural Tamilnadu : Not a single doctor identified all three components of AMTSL (B. Subha Sri. 2009)

9. Is all bleak? • It is simply no longer possible to believe much of the clinical research that is published or to rely on the judgement of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion which I reached slowly and reluctantly over my two decades as editor of the New England Journal of Medicine – Marcia Angell (2009)

10. Systematic reviews • Systematic reviews – backbone of EBM • Are Systematic reviews relevant to developing countries? • Based largely on studies from developed countries • Lesser published studies from developing world available in widely used bibliographic databases • Review protocols include RCTs which are expensive to conduct; hence exclude developing country studies

11. Examining the book of nature – the dispute continues • Mistakes in decision making – dramatic repuccursions • RCT vs various forms of observational studies (Rawlins, 2008) • Problems in RCT : Probability not generalizable, expensive (GBP 3.2 m) • Observational studies : clearer causation identification of long term latent adverse effects • Judgements are an essential ingredient of most aspects of decision making processes.

12. “I am not happy with this doctor [from the government hospital]. I was not asked to come back after the abortion. Even if I had been called I would not have gone. The staff does not tell us anything. They immediately give the client an injection, make her unconscious conduct the abortion and send her home while she is still unconscious. That is the reason I will never go there. If there is really a need I would go to another clinic (25 years, urban block, visited a government facility) ”

13. Transferability of evidence derived from studies in developed world – differences in populations and delivery of care Comparison of the Health Care Experiences of Patients in the Less Developed and Developed Worlds • late presentation • self-medication of “prescription” drugs or traditional treatments • poor facilities may delay diagnosis • referral (if needed) not easily arranged • if a child, may be malnourished • if a woman, may be anaemic • will experience problems because of shortages of trained staff • …and because of poor infection control • …and because of a lack of follow-up care • patient may be unable (e.g., because of lack of funds) to fully adhere to treatment. • Features of the typical health care experience of a patient in a clinical trial in a developed country include • none of the above

14. Flaws in EBM concept • “File drawer problem”- non significant study results hidden from general view • Creates serious base rate fallacy, biased or skewed distribution of effect sizes and over estimation of published studies- mandatory trial registration attempted • Sometimes “evidence based recommendations” are understood to be as recommendations based on firm empirical data ; level of evidence is ignored Continued..

15. Continued from previous page • Funding and bias in conclusions - RCTs are more positive if funded by for profit organisations • Publication of industry supported trials is associated with increase in journal impact factors and revenue • Not only RCTs are biased by industry funding, even meta analysis is- meta analysis by persons with financial ties to drug companies are likely to come to more favourable conclusions although not with favorable results

16. EBM and Public Health • Evidence based decisions to guide resource use • Purchase of technology and choice of services provided through public funds guided by systematic analysis of potential health benefit and value for money • Use of local evidence and needs to inform local health decisions • Need of institutional arrangements and analytical tools to make evidence based decisions – eg. NICE,UK, Australian NGCH, …….. • But these are rare in developing countries, where they are needed most

17. Exceptions- examples of evidence based decision making in developing countries Thailand • Health Intervention and Technology Assessment Programme (HITAP) – 2007 • Research institute to inform health policy using best available evidence, local values and data • HITAP informed development of Thai essential drugs list, national vaccination programme, AIDS Rx strategy and alcohol policy

18. Why Thai government rejected inclusion of HPV vaccine in its national programme (though approved by Thai FDA)? • Govt commissioned HITAP for guidance on cervical cancer prevention and control programme • HITAP studied clinical and cost effectiveness of various screening and prevention strategies • Used Thai cost and epidemiological data on prevalence, risk and uptake of alternative interventions • Compared new vaccine to alternatives and combinations • Adopted a transparent, consultative and scientific process

19. Mexican National Institute of Public Health (INSP) focuses on evaluating health interventions • Evaluated Seguro Popular the expensive national health insurance programme with huge spending to improve access amongst the poor • Report could criticize the scheme openly, would not have been possible without INSP

20. NICE (1999 - ) • Blair established NICE calling NHS measures a prescribing lottery (Annual Budget 75 million for 300 staff and 2000 experts) • It’s branches include topic selection, information & communication system, R&D, HTA, patient and public involvement and implementation. • Guiding principles : Robust evidence base, inclusive of all stake-holders, transparent (all evidence and conclusion in public domain), independent. Economic evaluation is intrinsic. • Value for money is expressed as incremental cost effective ratio. i.e. cost / QALY e.g. ICER of GBP 15 – 20 k is cost effective. ICER above range of GBP 25 – 30 k needs examination and judgement. • R&D undertaken through Health Technology Assessment programme.

21. The NICE Dilemmas • Tensions between quality and efficiency, equity (common vs rare diseases) and choice and demand and resource. • Deciding on opportunity costs. • How the health care systems will judge affordability of these products in the face of finite resources and competing demands from other patients.

22. NICE International • Set up in 2009 by NICE board • Is a not-for-profit division with its own staff. Aims to • enable NICE to address international health issues in a professional way and enhance our reputation • offer NICE staff and partners the opportunity for international collaboration and learning • assist recruitment and retention of high caliber staff • help NICE deliver the UK government's global health policies. Work is on a cost-recovery basis through contracts and grants

23. Chalkidou et al., 2010

24. Requirements of CPG • Establishment of the multi disciplinary GD group • Involvement of consumers • Systematic searches of research evidence • A process of drafting recommendations • Clear identification of clinical and managerial issues • Provide approaches for implementation • Investment in updating and revision Main problems : inability to generate clinical questions AGREE : A widely used method for CPG appraisal shows that many fail to meet quality criteria Details from Guidelines International network

25. CPG VS PROTOCOLS / PROCEDURES Examination This is similar to the examination conducted during the first visit. It includes the following : • Check the pulse, BP [see Annexure A. I: “How to measure blood pressure”] and temperature • Look for pallor [see Annexure A. II: “How to look for pallor?”] • Conduct an abdominal examination to see if the uterus is well-contracted (hard and round) and to rule out the presence of any uterine tenderness • Examine the vulva and the perineum for the presence of any tear, swelling or pus discharge. • Examine the pad for bleeding and lochia. Assess if it is profuse and whether it is foul-smelling. • Examine the breasts for the presence of any lumps or tenderness. • Check the condition of the nipples. If they are cracked or sore, manage as given under “Management of sore and cracked nipples”. Manage accordingly [see Module 2, under “Management of sore and cracked nipples”] Guideline supplementation by tool kits and templates for guidance and for development of local protocols High quality central guidelines translated by local decisions based on resources ?

26. Achieving real change in practicePost guideline scrutiny – Lean and Mean • Assessment of health personnel : professional background + field testing of performance • Field inspection of availability and suitability of services • Compliance with performance standard to wide range of reporting • Rigorous analysis of data on care effectiveness to be supplemented with sample studies of patients records • Prompt and effective action on complaints including regulation … and after … Institution of feedbacks Generate local opinion and consensus - Terris, 2003, Grimshaw et al, 2001

27. Types of Assessment Mladovsky et al., 2009, Euro Observer

28. Timeliness in receiving maternal care Percentage distribution of those who sought care, by timeliness in receiving care Asia-Pacific Population Journal, April 2008 High impact comprehensive intervention packages addressing a particular outcome or proven intervention can become integrated and packaged as per local needs and capacity. Needs to be two dimensional : temporal and referral

29. Does India need NICE health care ? • Needs first a frame work for prioritizing health needs. Neglecting full portfolio will cost India dearly. • Prioritize range of intervention acceptable for funding by the public first. Needs mechanism for allocative decision making. • Take GD away from professional organizations that ignore cost effectiveness and limit recommendations to a single specialty focus. • Expert evidence is PART of evidence not THE evidence. • Focus on generation of opportunity cost. • Combined GD for therapeutic interventions with public health level guidelines. • Set up independent organization to monitor implementation, assess health outcome and set standard of care

30. If private enterprises can keep cola drinks or beer cold, even in remote areas of countries without stable power supplies, the same should be possible for oxytocin. (Mathai et al., 2007)

31. Why professionals may not buy ? • Lack of interest. Better buy-in from TBA for AMTSL. • Academic arrogance. • Quality and methods for assessing quality ignored during medical education. • CMU concept missing. • Guideline development is slow and expensive. • No time or capacity to review evidence. • Expertise for costing and cost-effectiveness studies very limited. • Poor dissemination and insistence of existing guidelines. • Inflexibility of central guidelines may discourage use in periphery particularly in diverse locations. • Pressure from industry. • Confusion in guideline development

32. NOT AN APPROACH FOR UNIVERSAL ACCESS TO HEALTH CARE / HEALTH INSURANCE / PPP MODULES COMPREHENSIVE GUIDELINES ARE THE RIGHTS OF CITIZENS FOR QUALITY STANDARDS OF CARE AS ENSHRINED IN RTI AND RIGHT TO BENEFITS OF SCIENTIFIC PROGRESS

33. ACKNOWLEDGEMENTS • JAMSETJI TATA TRUST, MUMBAI THROUGH THEIR CORPUS GRANT TO THE FOUNDATION FOR MEDICAL RESEARCH • ADMINISTRATIVE STAFF COLLEGE OF INDIA AND CENTRE FOR INNOVATION IN PUBLIC SYSTEMS, HYDERABAD FOR THEIR KEEN INTEREST AND THE ORGANIZATION OF THIS SEMINAR • DR. MALA RAO AND DR. KALIPSO, NICE INTERNATIONAL, U.K. FOR UNFAILING PARTNERSHIP.

34. Quality gap: How often is the right care provided at the right time ?