Secondary Research in Health Research

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1 Secondary Research in Health Research A/Prof Edwin S-Y Chan, PhD Centre for Quantitative Medicine, Office of Clinical Sciences, Duke-NUS Graduate Medical School Head of Epidemiology, Singapore Clinical Research Institute Director, Singapore Branch Australasian Cochrane Centre Head of Evidence-based Medicine, Health Services Research & Evaluation Division, Ministry of Health

2 Topics Introduction to Systematic Reviews Applications of Systematic Reviews to inform practice in education & research for guideline development Issues for evidence-based policy development

3 INTRODUCTION

4 INTRODUCTION

5 Definitions Primary research collection & analysis of de novo data (raw data) firsthand from research subjects according to a preplanned research protocol Secondary research collation and synthesis of results from multiple primary research studies addressing the same question literature reviews

6 Why we need reviews on the horns of a dilemma INFORMATION OVERLOAD TIME LIMITATIONS

7 Lots of information not a bad thing For specific focused health questions, rarely do we have too much information Repetitions of observational & experimental studies are valuable generalizability across populations & healthcare settings increased precision of treatment effect estimates quantification of natural & experimental random variability

8 But Time & Resource pressures Information is not easily accessible diverse publications grey literature unfamiliar languages unpublished data Response timelines are short rapid HTA Expertise to appraise primary literature is limited

9 Not all reviews are worth reading The traditional Expert review methodology not clearly described vulnerable to reviewer s bias lacking in quantitative synthesis of study data Systematic reviews the gold standard for conduct of reviews clearly stated aim clearly described methodology written & valid protocol

10 APPLICATION

11 Systematic reviews in healthcare In principle any topic can be the subject of a systematic review provided primary research data on that topic is accessible It has even been argued that even when there is no primary research data, a systematic review is still valuable in order to highlight knowledge gaps and frame future research

12 Systematic reviews in healthcare In practice, the commonly reviewed topics in healthcare revolve around issues of effectiveness of healthcare interventions (drugs, surgery, devices, complex programmes, strategies & policies) e.g. breast cancer screening & reduction in mortality safety of interventions e.g. COX2 inhibitors & CVE diagnostic accuracy of tests e.g. rapid D-dimer tests for PE harmfulness from exposure to risk factors e.g. 2 nd hand smoke & lung cancer

13 The Cochrane Collaboration An international not-for-profit organization dedicated to the production, updating, dissemination and application of systematic reviews of effectiveness of healthcare interventions Reviews are accumulated in the Cochrane Library a suite of databases of which in addition includes the most comprehensive bibliographic database of controlled clinical trials

14 Systematic Reviews & EBM Evidenced-based medicine (EBM) is the deliberate and judicious combination of the best research evidence, together with local experience & patient values in order to deliver appropriate medical care to individuals Systematic reviews of clinical studies are important means of summarizing the relevant evidence for practitioners

15 Systematic Reviews & medical education Modern clinicians need certain core skills to survive in the Information Age, because they can no longer assume that their patients don t know don t need to be convinced don t want to be involved

16 Core skills of EB-practice - the 5 A s ASK - clearly specifying the clinical problem (focusing the question) ACQUIRE - Searching for evidence comprehensively APPRAISE - appraising relevance & validity APPLY applying the findings to patients ASSESS assessing the outcomes

17 Local & regional Workshops & Fora Singapore APEBMN workshop (NUHS, Singapore Branch ACC, Duke-NUS GMS, SCRI) National EBMN workshop (Brunei MOH & Singapore) Cochrane SR workshops (Taiwan EBM Assoc & Singapore) East Asian Cochrane Alliance (JCQHC Japan, Korean Br ACC, Taiwan, HK Br Chinese CC, Singapore Br ACC)

18 See one, do one Learning how to do a systematic review teaches clinicians 3 of these core-skills in an integrated manner Ask Acquire Appraise Cost-effective & meaningful way to begin research skills training for fledgling researchers

19 Cutting research inefficiency me too research Ideally, justification for primary research funding should involve producing a systematic review of the relevant published literature Conclusions of systematic reviews could be a useful means by which Funding Agencies identify important knowledge gaps for prioritization of funding

20 Systematic Reviews as research yes & no Systematic reviewing is a research activity as it involves answering a focused question (identical to that of the primary studies) using a preplanned methodologically valid protocol, with intention to produce generalizable knowledge Not classified as research for ethics purposes i.e. do not need to have approval from REC/IRB (advantage)

21 Systematic Reviews & public education Several countries have a National License for the Cochrane Library UK, Australia, India, developing countries Empowerment of the health-consuming public plain language summary of reviews translations of abstracts & summaries of reviews

22 Systematic reviews & Clinical practice guidelines from evidence to action EVIDENCE sources: Primary studies & Sys Reviews CPG RECOMMENDATIONS: Guidelines

23 Evidence-based Recommendations Clinical guidelines are specific actionable recommendations on courses of action to achieve stated health objectives for defined groups of people Role of systematic reviews efficient summary of the evidence-base degree of confidence depends on trust in the methodology of the review & the quality of the reporting (PRISMA)

24 Considered judgment process Recommendations are ultimately arrived at by a consensus process that takes into account risk of methdological bias direction and magnitude of effect precision of estimates consistency of effects trade-off between benefits & harm local applicability issues cost-effectiveness

25 Policy development challenges

26 Analogy with Policy development There is a useful parallel between the process of CPG development & policy formulation - both processes belong to the stage of taking the evidence and formulating action plans The increased demand for evidence-based rigor in CPG development provides an important model on how policy development can be made more transparent and evidence-based

27 Systematic reviews & Policy EVIDENCE sources: Primary studies & Sys Reviews POLICY: Rules, regulations, laws which mandate processes & programmes

28 Evidence-based policy development By policy I mean guiding principles which are translated into actionable regulations (rules, laws) that are used to achieve clear goals A misnomer, it is not the policy (principle) itself that is developed or needs to be evidence-based but the regulations erected to bring it into effect

29 Evidence-based policy development Begin with the applicable principle/s (policy) Give a clear statement of the goal Develop evidence-based actionable rules & regulations to achieve the goal

30 Example 1: Extended HOTA Act Policy: to improve HRQoL of Singaporeans with organ failure Goal: to increase the local supply of organs for transplantation to Singaporeans with organ failure Actionable regulation: Extension of HOTA Act to allow for harvest of kidney, liver, heart & corneas from victims who have died from any cause

31 Evidence-based perspective What is the evidence that such a law will achieve the stated goal? deductive logical evidence empirical evidence Being explicit about the goal allows for evaluation of the plausible impact of the policy action before implementation i.e. decision-making actual impact of the policy action after implementation

32 Evidence-based perspective Being explicit about the policy (principle) allows us to consider alternative or multiple synergistic goals consistent with that policy Improving HRQoL of Singaporeans with organ failure can be also achieved by means other than increasing the local supply of donor organs

33 Example 2: Chronic Disease Management Policy: to improve HRQoL of Singaporeans with chronic diseases Goal: to improve the management of chronic metabolic & neurological diseases in Singaporeans Actionable regulation: Permission to use patient s Medisave to pay for outpatient followup care for these diseases

34 Challenges for the evidence-based paradigm Policy actions are often complex interventions Populations are the natural observation unit, not individuals Nothing similar has been done/published before Qualitative data evidence is as important as quantitative data

35 Challenges for the evidence-based paradigm The randomized trial is often not a feasible way of evaluating the impact of the policy Limitations of health economic analyses to drive change Data silos restrict access to data

36 Thank You Thank you

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