Understanding Comparative Effectiveness Research and Applicability to Practice

7/29/2019 Understanding Comparative Effectiveness Research and Applicability to Practice

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Antonio Carvajal, MD, SGH.Chief Content OfficerGlobal Voices for Change Initiative

Centre for African Affairs and Global Peace


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To assist consumers,clinicians, purchasers,and policymakers tomake informeddecisions that willimprove health care at

both the individual andpopulation levels.


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Systematic reviews of existing evidence onoriginal research

Informs health care decisions by providingevidence on the effectiveness, benefits, andharms of treatment options

Evidence is found in 2 ways:

Researchers identify existing clinical trials

Researchers conduct studies that generate new

evidence


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Provides objective information to make thebest 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


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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 involvingtreatement and technologies

Translates scientific advances to clinicalpractice Provides usable information for clinicians and

patients


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Created by the Medicare Prescription Drug,Improvement, and Modernization Act (MMA)

Section 1013 authorizes AHRQ to conduct andsuppport research that focuses on comparingoutcomes and effectiveness of different

treatments and clinical approaches

Clinical evidence is synthesized and reviewed


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Research Reviews

Comparative effectivenes reviews

Technical briefs

Research Reports Research Summaries

Clinicians Consumers

Policymakers


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Places a focus on research questions aboutmedical care and services that:

Impose high costs on Medicare, Medicaid, or theChildrens 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 at-

risk populations:

eg. Women, children,elderly, disabled


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Housed at the top universities or researchorganizations in North America

Comparative effective research andsystematic reviews are conducted at EPCs

Reviews the effectiveness of medications,

devices, and other health care services

Goal is to help patients, physicians, andpolicymakers make better treatment decisions


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1. Identify new and emerging clinical interventions2. Review and synthesize current medical research3. Identify gaps between existing medical research

and the needs of clinical practice4. Promote and generate new scientific evidence

and analytic tools5. Train and develop clinical researchers6. Translate and disseminate research findings to

diverse stakeholders7. Reach out to stakeholders via a citizen forum


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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


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Questions that are most important topatients and health care decision-makers areproposed and carefully chosen Health outcomes are given more weight than

studies with intermediate outcomes (labmeasures)

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

biased results


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START HERE:suggestions for

research aresubmitted.

A new topic orprior research is

used for aResearch Review

A researchabstract or set of

?s is postedonline.

A draft report ispublished online

for 4 weeks ofpublic comment.

Final research andexecutive summary are

published online.

Clinician andconsumer

summaries are

created.

Future Research Needs

identified.

Research conductedoutside EPCprogram and

updated reports are

warranted.


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Nominate a topic according to the followingcriteria: Burden, prevalence, incidence, and impact of

condition or disease Type of evidence supporting efficacy and safety of

interventions and if reasonably well-defined patientpopulation, interventions, and outcome measuresexist

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


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A team of experts decide on questions that poseimportant 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 ofEffects (DARE)

Draft reports of review findings available to the publicfor comment before it is officially published


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Effectiveness trials aim to study patientslikely to be offered the intervention in

everyday practice Determine importance in terms of the balance of

benefits and harms

Efficacy trials determine if interventions workunder ideal situations


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Ratings based on modified GRADE system Strength of evidence for each key clinical

question graded as follows:

High Consistent results have been reported in high-quality clinicaltrials; further research is very unlikely to change the conclusions

Moderate Findings are supported, but further research could change theconclusions

Low Very few clinical trials are available, or existing trials are flawedLow confidence that the evidence reflects the true effectFurther research is likely to change the conclusions

Insufficient Evidence either is unavailable or does not permit estimation of aneffect

GRADE: Grading of Recommendations Assessment, Development and Evaluation


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Requires assessment of 4 domains: risk of bias,consistency, directness, and precision

Additional domains include dose-response

association, presence of confounders, andpublication bias EPC investigators evaluate the strength of

evidence separately for each importantcomparison for each key question

Required criteria for assessing sufficient trialdata includes determining the risk of bias,consistency, directness, and precision


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Stakeholders are individuals or organizatonsthat have a personal or professional intereastin the topic

Engaging stakeholders is a process of givingvoice and involving Stakeholders in the EHCprogram related decision-making and

research Serves the purposes or reciprocal learning

and knowledge exchange to improve healthoutcomes


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StakeholderRoles

DistributeResearch Products

and LeadImplementation

Suggest aResearch Topic

Provide Input

on ResearchPriorities Refine Research

Topics and DevelopKey Questions

Help develop aresearchapproach

Shape and informresearch products

and tools

Review draftresearchFindings


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Patients/ConsumersHealth outcomes

Treatment optionsBenefits/risks

Quality of life

Clinicians

Diagnostic/Treatment

Benefits/risks

GuidelinesDocumentation

Policymakers

Benefits/risks

Guidelines

Health outcomesCost effectiveness


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Is an approach where clinicians and patientscommunicate together using the bestavailable evidence when faced with the taskof making decisions, where patients aresupported to deliberate about the possibleattributes and consequences of options, to

arrive at informed preferences in making adetermination about the best action andwhich respects patient autonomy, where thisis desired, ethical and legal.


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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


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Clinicians and patients can use CER to makeshared decisions

Finding highlight current evidence abouteffectiveness, 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


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Can inform decision-making by providingconsolidated evidence-based data

Can identify and fill knowledge gaps thatcause uncertainties in clinical practice

Can determine best treatment options forpatient with different medical histories,

circumstances, or values Can validate existing clinical practice

guidelines Can transform evidence into action

Documents

Understanding Comparative Effectiveness Research and Applicability to Practice