Evidence-Informed Health Policy

1. Evidence-Informed Health Policy Prathap Tharyan MD, MRCPsych Professor of Psychiatry & Director The South Asian Cochrane Network & Centre (An Independent Centre of the Cochrane Collaboration) Prof BV Moses Centre for Evidence-Informed Healthcare & Health Policy Christian Medical College, Vellore

2. What is Evidence-Informed health Policy • The use of reliable evidence from existing research that is relevant, affordable and practical to inform decisions regarding health policies in order to improve health outcomes and reduce inequity

3. Generating reliable evidence to inform health desicions Getting the evidence right Needs a systematic review “A review in which bias has been reduced by the systematic identification, critical appraisal, and, if relevant, statistical aggregation (meta-analysis) of all relevant studies on a specific topic according to a predetermined and explicit method.” Research Evidence Modified from Moher et al Lancet 1999

4. Archie Cochrane “It is surely a great criticism of our profession that we have not organised a critical summary, by specialty or subspecialty, adapted periodically, of all relevant randomised controlled trials.” Est. 1993 www.cochrane.org

6. www.cochrane.org • Largest organization in the world devoted to producing, disseminating and maintaining systematic reviews (SRs) of the effects of interventions • Also involved in producing SRs of the accuracy of diagnostic tests • >32,000 volunteers from over 100 countries who share common principles • Main output is The Cochrane Library Official partner of the WHO Seat on the World Health Assembly

7. Free to anyone in India thanks to a National Subscription purchased by the ICMR www.thecochranelibrary.com The best single source of evidence of the effects of interventions

8. The Cochrane Library is a collection of EBM databases Cochrane reviews can be downloaded in full as pdf documents

9. The Cochrane Database of Systematic Reviews • Over 7,000 full text Cochrane reviews and protocols (html & PDF format) • Cochrane reviews adhere to a strict process, minimizing bias and ensuring reliability. • The process begins with a protocol – a plan or set of steps to be followed in a study.

11. Cochrane Reviews are now the “gold standard” for systematic reviews in such key publications as • The Lancet • New England Journal of Medicine • British Medical Journal • Journal of the American Medical Association • and routinely appear in these as well as in specialized medical journals. • Inform guidelines of WHO

12. Are Cochrane Systematic Reviews different from other systematic reviews? • Only about 20% of reviews published each year are Cochrane Systematic Reviews • Cochrane Systematic Reviews emphasize methodological rigour • Found to be of better quality, more up to date, & less biased in methods and interpretation than non-Cochrane systematic reviews • Free of conflicted sources of funding • Used to inform practice guidelines of the WHO, many policy making bodies world-wide; have changed health practices too Jadad et al. Methodology and reports of systematic reviews and meta-analyses: a comparison of Cochrane reviews with articles published in paper-based journals. JAMA 1998;280:278-280. MoherD, et al. Epidemiology and reporting characteristics of systematic reviews. PLoS Med 2007; 4(3): e78. doi:10.1371/journal. pmed.0040078

13. The South Asian Cochrane Network & Centre www.cochrane-sacn.org

14. What do we do? • We provide training and mentoring • for authors to develop protocols for, and to complete, systematic reviews and meta-analysis of the effects of interventions relevant to healthcare in the region and to the world. • We disseminate the results of these systematic reviews • securing a national provision to The Cochrane Library & • through evidence summaries, presentations, workshops, mailing lists, newsletters, and other means. • We advocate and inform healthcare and policy • by working with clinicians, health providers, and policy makers, in accessing, understanding, using, and preparing systematic reviews of relevant healthcare intervention, and identifying gaps in the evidence. • We work strategically towards improving primary research and the culture of research • The design, responsible and ethical conduct, and reporting of research, particularly interventional research, in the region.

15. We try to address the gaps between research and practice Research Practice Evidence Getting the evidence straight Getting the evidence used Glasziou P, Haynes B. ACP J Club. 2005

16. 5 days versus 14 days of primaquine to prevent relapses due to P. vivax Malaria?

17. Changing Health Policy: Primaquine for preventing relapses in people with Malaria due to Plasmodium vivax.

18. Review Published Jan 2007 Policy Changed May 2007 Park & Park Text Book of Preventive and Social Medicine changed recommendation in 2008

19. Informed WHO malaria guidelines

20. Routine supplementation may not make much difference Informed discussions of GOI

22. Addressing the gaps between evidence and practice GRADE process for guideline developers Summary of Findings Practice Evidence Research Getting the evidence right Getting the evidence used Glasziou P, Haynes B. ACP J Club. 2005

23. Summarizing the results of a systematic review:Linking numerical outcomes with overall quality of the evidence • In order to evaluate the results of a systematic review to inform policy decisions, we need to know: • What are the pooled results of the effect estimates for clinically important outcomes (effect estimates -risk ratios- and 95% confidence intervals) • Efficacy • Safety • Adherence • Costs • Resources • Quality of life • Other • How confident are we that these estimates are likely to be seen in practice? How certain are we that further research will not change these estimates?

24. Numerical results linked to the overall quality of evidence In order to understand (and have confidence in) the results of a systematic review we need to know: The risk of bias of the included trials: (Study Limitations) Can we trust the evidence? A lot about the characteristics of the individual trials: (Directness) Does it apply to my setting? (population/comparisons/outcomes/health systems) Are the results consistent in all the trials: can heterogeneity be explained by a subgroup analysis? (Consistency) Does the intervention work the same in all trials or does it work better in some and not in other trials? Are the results precise? (Precision) Do the results clearly indicate statistical significance and clinical importance Is there evidence of publication bias? (Publication bias) Did the review search for all relevant trials or only published and easily accessed ones?

27. Linking the numerical results to our confidence in that effect estimate Levels of certainty or uncertainty RCTs Observational

28. Using the evidence: to inform policy decisions The overall quality of the evidence and confidence in the result Strength of the recommendations • Strong recommendations: most informed patients would choose the recommended management • Weak recommendations: patients’ choices will vary according to their values and preferences Balance of benefits/harms/ cost/resources/burdens/preferences

29. What happens when health CARE is not based on reliable evidence?

30. De-worming

32. Results and conclusions • 42 trials (65,168 participants) • Screening children for intestinal helminths and then treating infected children appears promising, but the evidence base is small. • Routine deworming drugs given to school children has been more extensively investigated, and has not shown benefit on weight in most studies, except for substantial weight changes in three trials conducted 15 years ago or more. Two of these trials were carried out in the same high prevalence setting.

33. Results and conclusions • For haemoglobin, community deworming seems to have little or no effect, and the evidence in relation to cognition, school attendance, and school performance is generally poor, with no obvious or consistent effect. • Our interpretation of this data is that it is probably misleading to justify contemporary deworming programmes based on evidence of consistent benefit on nutrition, haemoglobin, school attendance or school performance as there is simply insufficient reliable information to know whether this is so.

35. Background • General health checks are common elements of health care in some countries. • These aim to detect disease and risk factors for disease with the purpose of reducing morbidity and mortality. • Most of the commonly used screening tests offered in general health checks have been incompletely studied. • Also, screening leads to increased use of diagnostic and therapeutic interventions, which can be harmful as well as beneficial. • It is, therefore, important to assess whether general health checks do more good than harm.

36. Results • 16 trials, (182,880 participants). (US; Europe) • Nine trials provided data on total mortality (155,899 participants, 11,940 deaths) • median follow-up time nine years • Eight trials provided data on cardiovascular mortality (152,435 participants, 4567 deaths), • Eight trials provided data on cancer mortality (139,290 participants, 3663 deaths),

37. Summary of findings

38. Conclusions • General health checks did not reduce morbidity or mortality, neither overall nor for cardiovascular or cancer causes, although the number of new diagnoses was increased. • Important harmful outcomes, such as the number of follow-up diagnostic procedures or short term psychological effects, were often not studied or reported and many trials had methodological problems. • With the large number of participants and deaths included, the long follow-up periods used, and considering that cardiovascular and cancer mortality were not reduced, general health checks are unlikely to be beneficial.

39. Facilitators of evidence-informed health policy

40. Facilitators to evidence informed health policy • Forging effective partnerships • between policy makers, knowledge-brokers, and researchers and involving other key stakeholders in a consultative process from the outset • Seeking support and capacity development • from other organizations that have the experience and success with the methods and challenges of evidence-informed policy making; can minimize duplication of effort; and help build capacity • Instituting organizational mechanisms and processes to • delineate governance and advisory structures, the methods that will be used to prioritize work-flows, ensure financial support, manage conflicts of interest, involve stakeholders, ensure transparency and accountability, and maintain credibility and independence.

41. Facilitators to evidence informed health policy • Using robust methods to • clarify the problem; seeking appropriate evidence to assess options by framing answerable questions and finding one or more systematic reviews to answer them • Establishing effective mechanisms to frame recommendations for guideline documents or policy options • using a consultative process that involves representatives of all relevant stakeholders, and • utilises policy briefs based on the evidence summaries that were graded for overall quality of the relative and absolute estimates of effects of the interventions evaluated; and • contextualising the evidence in the light of the balance between anticipated benefits and harms, as well as practical implementation issues, resource use, resource costs and opportunity costs, as well as other options, and priorities.

42. Facilitators to evidence informed health policy • Involving the public • in dialogues around the policy itself; • the options; • the recommendations based on evidence; • implementation issues; and • considerations of equity in how implementation might affect various disadvantaged sections of society. • Effectively utilising the media and other dissemination strategies to • create a demand, • enlist the support of local agencies, • identify implementation issues, create a sense of ownership in the process and the programme, and to ensure that the programme is seen as in the interests of the public.

43. Facilitators to evidence informed health policy • Building capacity among technical groups at various levels to perform these tasks effectively and using them to train others to enlarge the scope of activities in a phased manner • Creating knowledge-related public goods for health that can be used by different categories of health professionals and the public.

44. The Research-Evidence-Policy-Practice Gaps Epistemic community: Thoughtful committed citizens who can change the world Priorities Priorities Guidelines/ Policies Policy Briefs Implementation Managerial domain

45. Requires investments and partnerships between: Those who generate the evidence Those who disseminate the evidence Those who frame health policy Those who implement health policy decisions And systems and processes that support and facilitate transparent, inclusive and collaborative decision making that is informed by reliable local and global evidence Evidence-informed health policy & Health Systems

46. Potential partnerships • South Asian Cochrane Network & Centre & the Centre for Innovations in Public Systems • Ministry of Health & Family Welfare • Central and State Institutes for Health & Family Welfare • Central and State National Rural Health Mission technical cells • ICMR & ICMR institutions • Medical Colleges in various states • Civil Society

47. The South Asian Cochrane Network & Centre: www.cochrane-sacn.orgn Don’t “Just do it”; Do it Right!