Antonio Carvajal, MD, SGH.

Chief Content Officer Global Voices for Change Initiative Centre for African Affairs and Global Peace

To assist consumers, clinicians, purchasers, and policymakers to make informed decisions that will improve health care at both the individual and population levels.

Systematic reviews of existing evidence on original research Informs health care decisions by providing evidence on the effectiveness, benefits, and harms of treatment options Evidence is found in 2 ways:
Researchers identify existing clinical trials
Researchers conduct studies that generate new

evidence

Provides objective information to make the best possible treatment choices Includes pros and cons of treatment options Informs clinicians on the comparative efficacy of treatment for different patient subgroups Offers an important tool to help understand the facts about different treatments

Growing concern over health spending

~$2.3 trillion per year in the US Greater costs do no necessarily mean better care

Uncertainty about best practice involving treatement and technologies Translates scientific advances to clinical practice Provides usable information for clinicians and patients

Created by the Medicare Prescription Drug, Improvement, and Modernization Act (MMA)
Section 1013 authorizes AHRQ to conduct and

suppport research that focuses on comparing outcomes and effectiveness of different treatments and clinical approaches Clinical evidence is synthesized and reviewed

Research Reviews
Comparative effectivenes reviews Technical briefs

Research Reports Research Summaries

Clinicians

Consumers
Policymakers

Places a focus on research questions about medical care and services that:
Impose high costs on Medicare, Medicaid, or the

Childrens Health Insurance Program (CHIP) May be over- or underutilized May significantly improve prevention, treatment, or cure of diseases and conditions that impose high costs Address conditions that place a great burden on atrisk populations:
eg. Women, children,elderly, disabled

Housed at the top universities or research organizations in North America Comparative effective research and systematic reviews are conducted at EPCs
Reviews the effectiveness of medications,

devices, and other health care services Goal is to help patients, physicians, and policymakers make better treatment decisions

Identify new and emerging clinical interventions Review and synthesize current medical research Identify gaps between existing medical research and the needs of clinical practice 4. Promote and generate new scientific evidence and analytic tools 5. Train and develop clinical researchers 6. Translate and disseminate research findings to diverse stakeholders 7. Reach out to stakeholders via a citizen forum
1. 2. 3.

Develop key research questions Establish criteria for literature search Abstract relevant data Conduct analyses Synthesize and interpret results Evaluate study quality and evidence strength Identify future research needs

Questions that are most important to patients and health care decision-makers are proposed and carefully chosen
Health outcomes are given more weight than

studies with intermediate outcomes (lab measures)

Types of research studies that provide useful evidence defined, collected, and assessed
Greater weight given to methods that reduce

biased results

START HERE: suggestions for research are submitted.

A new topic or prior research is used for a Research Review

A research abstract or set of ?s is posted online.

Research conducted outside EPC program and updated reports are warranted. Clinician and consumer summaries are created.

A draft report is published online for 4 weeks of public comment.

Future Research Needs identified.

Final research and executive summary are published online.

Nominate a topic according to the following criteria:

Burden, prevalence, incidence, and impact of

condition or disease Type of evidence supporting efficacy and safety of interventions and if reasonably well-defined patient population, interventions, and outcome measures exist Current controversy or important uncertainties Potential impact of topic, with higher ratings that address costs to patients or society Potential value of CER relative to existing information

A team of experts decide on questions that pose important issues for people with a specific condition Key questions are determined by considering Population, Intervention, Comparator, Outcome, Timing and Setting (PICOTS) Systematic reviews are conducted to identify evidence from databases such as MEDLINE, Cochrane Database of Systematic Reviews (CDSR), EMBASE, Database of Abstracts of Reviews of Effects (DARE) Draft reports of review findings available to the public for comment before it is officially published

Effectiveness trials aim to study patients likely to be offered the intervention in everyday practice
Determine importance in terms of the balance of

benefits and harms

Efficacy trials determine if interventions work under ideal situations

High

Ratings based on modified GRADE system Strength of evidence for each key clinical question graded as follows:
Consistent results have been reported in high-quality clinical trials; further research is very unlikely to change the conclusions Findings are supported, but further research could change the conclusions

Moderate

Low

Very few clinical trials are available, or existing trials are flawed Low confidence that the evidence reflects the true effect Further research is likely to change the conclusions
Evidence either is unavailable or does not permit estimation of an effect

Insufficient

GRADE: Grading of Recommendations Assessment, Development and Evaluation

Requires assessment of 4 domains: risk of bias, consistency, directness, and precision Additional domains include dose-response association, presence of confounders, and publication bias EPC investigators evaluate the strength of evidence separately for each important comparison for each key question Required criteria for assessing sufficient trial data includes determining the risk of bias, consistency, directness, and precision

Stakeholders are individuals or organizatons that have a personal or professional intereast in the topic Engaging stakeholders is a process of giving voice and involving Stakeholders in the EHC program related decision-making and research Serves the purposes or reciprocal learning and knowledge exchange to improve health outcomes

Provide Input on Research Priorities Suggest a Research Topic

Refine Research Topics and Develop Key Questions

Distribute Research Products and Lead Implementation

Stakeholder Roles

Help develop a research approach

Shape and inform research products and tools

Review draft research Findings

Clinicians Patients/Consumers Health outcomes Diagnostic/Treatment Treatment options Benefits/risks Benefits/risks Guidelines Quality of life Documentation

Policymakers Benefits/risks Guidelines Health outcomes Cost effectiveness

Is an approach where clinicians and patients communicate together using the best available evidence when faced with the task of making decisions, where patients are supported to deliberate about the possible attributes and consequences of options, to arrive at informed preferences in making a determination about the best action and which respects patient autonomy, where this is desired, ethical and legal.

Disease severity Rarity of disease Existing alternative treatments Cost (new vs existing treatment) Population affected Existing community standards for treatment Influence of future research on decisions Pharmacoeconomic analyses

Clinicians and patients can use CER to make shared decisions

Finding highlight current evidence about

effectiveness, risks, and side effects

CER can be used to inform the patient about:

The seriousness of the disease or condition to be

prevented or treated Risks, benefits, alternatives, and uncertainties of preventive methods or treatments

Can inform decision-making by providing consolidated evidence-based data Can identify and fill knowledge gaps that cause uncertainties in clinical practice Can determine best treatment options for patient with different medical histories, circumstances, or values Can validate existing clinical practice guidelines Can transform evidence into action