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I N H I S I S S U E :

Page 1 New Methods Guide

Chapter Focuses onObservational Studies forSystematic Reviews

Page 2 Methods SymposiumPapers Published

Page 3 Education Modules ProvideInstruction to New

Researchers on ReviewingEvidence

A L S O I N H I S I S S U E :

Page 3 National Action Plan on HealthLiteracy Launched

Page 4 EHC Program Spotlight: TheUniversity of ConnecticutHartford Hospital Evidence-basedPractice Center

Building the Foundation: Research

Methods for Patient-CenteredOutcomes ResearchTHIS ISSUE OF COMPARATIVE EFFECTIVENESS NEWS demonstrates AHRQs

commitment to the development and dissemination of quality research methods.

Research methods serve as the ounda-

tion o AHRQs Eective Health Care

(EHC) Program. Behind each o the

many reports and systematic reviews

created by the Program are hundredso critical decisions that AHRQ-und-

ed researchers must make about how

to consider and coordinate disparate

sets o data so that valid and useable

conclusions can be drawn. Well-devel-

oped methods enable EHC Program

reports to become trustworthy and

actionable assessments o benets and

harms across multiple subpopulations

or a wide variety o conditions.

Te research methods are constantly

JULY 2010 VOLUME 2, ISSUE 4

New Methods Guide Chapter Focuses on Observational Studies forSystematic ReviewsA NEWLY PUBLISHED CHAPTERo theMethods Guide or Eectiveness andComparative Eectiveness Reviews oersa conceptual ramework or Agencyor Healthcare Research and Quality(AHRQ) researchers who are consider-

ing observational studies to determinethe benets o pharmacotherapeutic, de-vice, or procedural interventions. Posted

to the Eective Health Care (EHC)Program Web site on June 14, 2010, thechapter oers researchers a clear set odecision criteria or whether to includeor exclude observational studies whenconducting systematic reviews.

While most researchers agree thatobservational studies are appropriateor identiying and quantiying adverseevents, the use o data rom observa-tional studies to answer questions aboutintended eects or benets is more con-troversial. Some researchers believe thatobservational studies cannot provide

valid or useul evidence o benet.Te ramework ocuses on two ques-

tions: (1) Are there gaps in the evidencerom randomized controlled trials(RCs)? (2) Will observational studies

provide valid and useul inormation? Techapter then describes in detail how toanswer these questions in order to make anal determination about the inclusion oobservational studies, such as reocusingthe review questions on the gaps in theevidence rom RCs, and assessing the

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being rened and broadly disseminat-

ed through a variety o channels. Te

various methods projects are intend-

ed to ensure a high level o transpar-

ency, consistency, and scientic rigor

across the ndings reported by the

EHC Program.

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risk o bias in the observational studies.A set o criteria are provided to assistresearchers in making an assessment othe data in an RC to determine i gaps

exist. Te chapter also includes scenarioswhere decisions to include or exclude ob-servational studies were made, as well as

New Methods Guide Chapter

Focuses on Observational Studies

for Systematic Reviews

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a ow diagram or considering observa-tional studies or answering comparativeeectiveness questions.

Te authorsa team o scientists romseven o the Evidence-based PracticeCenters (EPCs), AHRQ, and the VAQuality Enhancement Research Initia-tive (QUERI)remind readers that theramework o comparative eectiveness

reviews (CERs) diers rom traditionalsystematic reviews. As they state, CERsmore closely parallel the decisions ac-

ing clinicians, patients, and policymak-ers, who must choose among a varietyo alternatives in making diagnostic,treatment, and health care delivery deci-sions. Te authors suggest, however,that comparative eectiveness review-ers should routinely assess whether theinclusion o observational studies isappropriate or questions o benet, and

that reviewers should explicitly statetheir rationale or including or excludingobservational studies in the reviews.

Methods Symposium Papers PublishedPAPERS ORIGINALLY PRESENTED at theJune 2009 invitational symposium onresearch methods or clinical and com-parative eectiveness studies have nowbeen published in the June 2010 supple-mental issue o the journalMedical Care.Te collection is available ree online or

through PubMed.Te symposium brought together

an internationalgroup o scientiststo continue theongoing discussionand subsequentdevelopment oresearch methodsor comparative e-ectiveness research,a timely endeavor inlight o the addition-al unding providedby the AmericanRecovery and Rein-

vestment Act (ARRA) o 2009. Sympo-sium speakers and authors addressedtwo main themes: (1) including moredata rom clinically heterogeneouspopulations into comparative eective-ness research projects, and (2) employ-ing longitudinal investigative methodsintended to capture patient-reportedoutcomes over a longer term.

More than 75 abstracts were reviewedby a planning committee o expertsrom academia, the private sector, andthe Federal Government. Authors ochosen abstracts were also invited tosubmit a manuscript or publication intheMedical Care supplement. Submittedmanuscripts went through a blind edito-rial review, and the nal collection oaccepted articles was published in recordtime. We were able to get the paperspublished in a short time by academic

journal standards, said Kathleen N.

Lohr, Ph.D., o RI International, wholed the sta o the RI DEcIDE (De-

veloping Evidence to Inorm Decisionsabout Eectiveness) Center in organiz-ing the event and supplemental pub-lication. As this eld is relatively new,continuing to pave the road o improved

methods through publications o peer-reviewed literature that are reachable

around the globe is criti-cally important.

Te collection includesan editorial rom AHRQProgram Director ScottR. Smith, Ph.D., that pro-

vides an overview o thecrucial role o AHRQ andits Eective Health CareProgram in advancingmethods or comparativeeectiveness research, anoverview o the originalsymposium by Dr. Lohr;

and an introduction by Harold C. Sox,M.D., who served as the chair o the Com-mittee on Comparative Eectiveness Re-search Priorities convened by the Instituteo Medicine and is a past president o theAmerican College o Physicians.

In his introduction, Dr. Sox ocusedon the importance o having a cleardenition o comparative eectiveness

research to guide the methods process.In his article based on the Symposiumskeynote address, he states: DeningCER [comparative eectiveness re-search] orces decisionmakershealthproessionals and patientsto identiythe inormation that they need. Tedenitions o CER all ocus on mak-ing head-to-head comparisons in studypopulations that are typical o clinicalpractice. Tat health proessionals seemto agree on these attributes o the inputsto decisionmaking is reason to celebrate.

An additional 20 articles round outthe collection and all under one oour major content areas: (1) studydesign, (2) data collection, (3) statisticsand analytic methods, and (4) policyissues and applications. Several o thearticles address specic methodological

approaches such as prediction model-ing and Bayesian meta-analysis; othersocus on particular patient populationssuch as the elderly or cancer patients.

Te 2009 event marks the secondtime that an AHRQ-supported eortto advance methods was developedby members o the DEcIDE Network,whose primary duty is to generate newcomparative evidence or the EectiveHealth Care Program. Papers rom the2006 AHRQ Conerence on EmergingMethods in Comparative Eectivenessand Saety, which was also published asa supplement inMedical Care, ocusedprimarily on methods or generatingdata on the benets and saety o phar-maceutical interventions.

Dr. Lohr believes that both publica-tions represent an ongoing conversa-tion that will continue or many years.Nothing in these articles puts an endto the issues, but certainly they addmaterially to the literature and to theknowledge base. I give great credit to

AHRQ or recognizing and supportingthe importance o developing methodsor DEcIDE researchers and others, andI hope well see more symposiums andpublications in the uture, she said.

A printed copy o the supplement,AHRQ Publication No. OM10-0067,is available ree o charge through theAHRQ Publications Clearinghouse.o order the supplement, call 800-358-9295 or send an e-mail to AHRQpubs@ahrq.hhs.gov.

As this feld is relatively new,

continuing to pave the road o

improved methods through

publications o peer-reviewed

literature that are reachable

around the globe is critically

important.

Kathleen N. Lohr, Ph.D.RI International

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Education Modules Provide Instruction to NewResearchers on Reviewing Evidence

and students about the systematic reviewprocess in graduate training programsaround the globe. A slide library allowsaculty to select a complete set o lecture

slides by topic or to create their ownpresentation by mixing andmatching slides.

Tirteen education mod-ules, along with an introducto-ry slide set written by AHRQocers Stephanie Chang,M.D., M.P.H., and ElizabethKato, M.D., M.R.P., takeresearchers who are unamil-iar with the systematic reviewprocess through a series osteps rom topic renement to

reporting review results. Teintroductory module introduces utureresearchers to the goals o the EHCProgram, the many partners and stake-holders involved in the Program, and thekey terms and concepts o the Program.Most importantly, a conceptual modelo the EHC systematic review processis presented or the AHRQ systematicreview process. Te slides and lecturenotes in the introductory module explainconusing terminology such as subtle

INCREASING INTEREST FORcompara-tive eectiveness research has createdthe need to expand the Nations capacityto conduct systematic reviews. o help

train new generations o researchersin the methods used toconduct these reviews, theEective Health Care (EHC)Program recently contractedwith our Evidence-basedPractice Centers (EPCs)to create training modulesbased on chapters rom theEHC ProgramMethodsGuide or Eectiveness andComparative EectivenessReviews. Composed o

PowerPoint presentations,case examples, and linkages to otherreerences and tools, the modules havenow been posted on the EHC ProgramWeb site or use ree o charge.

In addition to their use by aculty withinthe EPCs to mentor and teach new investi-gators, the training modules are also avail-able to (1) investigators interested in thesel-study o systematic review methodsorAMA PRA Category 1 Credit, and (2)instructors who teach clinical researchers

National Action Plan on Health Literacy Launched

dierences between systematic review,eectiveness review, and comparativeeectiveness review, as well as the role othe PICO typology (or ramework) used

in systematic reviews. PICO stands orthe our elements to be considered whendeveloping the overarching questionso the review: Population, Intervention,Comparison, and Outcome. wo otherelementsiming and Setting (or StudyDesign)are sometimes added, with theterm PICOS used instead.

Te ve EPCs responsible or themodulesR InternationalUniversityo North Carolina, ufsNew EnglandMedical Center, Vanderbilt University, theUniversity o ConnecticutHartord Hos-

pital, and the University o Ottawadevel-oped a research protocol and conceptualmodel o the EHC Program systematicreview process to guide the creation o themodules. Each module was then peer-re-

viewed by ve experts in the eld to ensurequality and consistency with theMethodsGuide and other relevant literature, andedited by sta at the John M. EisenbergCenter or Clinical Decisions and Com-munications Science.

ACCORDING TO RESEARCH rom theU.S. Department o Education, only 12percent o English-speaking adults in theUnited States have procient health-liter-acy skills. Te overwhelming majority oadults have diculty understanding andusing everyday health inormation thatcomes rom many sources, including themedia, Web sites, nutrition and medicine

labels, and health proessionals. A 2004AHRQ systematic research review o theimpact o health literacy ound associa-tions between limited health literacyand adverse outcomes such as increaseddisease prevalence and severity, lowerutilization o screening and preventativeservices, and higher hospitalization rates.

o help address these issues, theUnited States Department o Healthand Human Services (HHS) launched aNational Action Plan to Improve Health

Literacy. According to the National Ac-tion Plan (NAP) document publishedin May, 2010, the national eort seeksto engage organizations, proessionals,policymakers, communities, individu-als, and amilies in a linked, multisectoreort to improve health literacy. TeInstitute o Medicine denes health lit-eracy as "the degree to which individu-

als have the capacity to obtain, process,and understand basic health inorma-tion and services needed to make ap-propriate health decisions.

wo principles guide the NAP: (1) every-one has the right to health inormation thathelps them make inormed decisions and(2) health services should be delivered inways that are understandable and benecialto health, longevity, and quality o lie.

Organized into our sections andthree appendixes, the NAP reviews the

research on limited health literacy asa public health problem, discusses thedevelopment o a health literate societythat supports lielong learning and skillsto promote good health, and outlinesseven goals or the improvement ohealth literacy, with several that are im-mediately relevant to the translation anddissemination o AHRQ research:

1. Develop and disseminate health andsaety inormation that is accurate,accessible, and actionable.

2. Promote changes in the health care sys-tem that improve health inormation,communication, inormed decision-making, and access to health services.

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3. Incorporate accurate, standards-based, and developmentally appropri-ate health and science inormationand curricula in child care and educa-tion through the university level.

4. Support and expand local eorts toprovide adult education, English-lan-guage instruction, and culturally andlinguistically appropriate health inor-mation services in the community.

5. Build partnerships, develop guidance,and change policies.

6. Increase basic research and the devel-opment, implementation, and evalua-tion o practices and interventions toimprove health literacy.

7. Increase the dissemination and use o

evidence-based health literacy prac-tices and interventions.

Te plan presents a set o strategiesper goal that can be employed by par-ticular organizations or proessions toaccomplish the seven goals. For example,

in the section o the NAP that discussesgoal 6increase basic research and evalu-ation o practices and interventionssomeo the suggestions or researchers, evalua-tors, and unders include:

Identiy and address gaps, such asnumeracy and visual communication,in health literacy research.

Collaborate to develop a nationalresearch agenda and include healthliteracy innovations and interventionsin research plans and goals.

Develop more rigorous and compre-hensive methods to measure indi-

vidual and population health-literacyskills that capture the ull range oskills, including listening and speak-ing, writing, numeracy, and culturaland conceptual knowledge.

Develop methods to measure the ullrange o health literacy skills o healthproessionals and organizations.

Conduct studies o the economicimpact o limited health literacy.

Explore technology-based interven-tions to improve health literacy.

Assess barriers and strategies to im-prove access to health inormation andnavigation o the health care system.

Te Eective Health Care Programis currently in the process o updatingits 2004 systematic review o researchon health literacy, with a draf avail-able this month or public comment.In alignment with the NAP, the update,

titled Health Literacy Interventions andOutcomes: An Update o the Literacyand Health Outcomes Systematic Reviewo the Literature, expands its synthesisbeyond the outcomes o limited healthliteracy and also includes research nd-ings on literacy assessment toolsand interventions.

Te NAP was led by the Health Liter-acy Workgroup o the U.S. Departmento Health and Human Services. Te in-ormation within the plan was based onthe 2006 Surgeon Generals Workshop

on Improving Health Literacy, a serieso town hall meetings held in 2007 and2008, and eedback rom stakeholderorganizations in 2009.

EHC PROGRAM SPOTLIGHT:

University of ConnecticutHartford Hospital Evidence-based Practice Center

THE UNIVERSITY OF CONNECTICUT (UCONN) AND

HARTFORD HOSPITAL (HH) were jointly selected as anEvidence-based Practice Center (EPC) by the Agency for

Healthcare Research and Quality (AHRQ) in July 2007. The

UCONN-HH EPC is part of the Health Outcomes Policy and

Economics (HOPE) Collaborative, a multi-

faceted group interested in evidence-based

medicine, health economics, and health care

policy at the University of Connecticut School

of Pharmacy and the Hartford Hospital.

EPCs are top-ranking institutions where re-

search reviews are conducted on behalf of the

Effective Health Care (EHC) Program. These

centers review existing scientic research about

important health care topics to help patients,

physicians, and policymakers make better

decisions about tests, treatments, or therapies. EPCs produce

comparative effectiveness reviews or effectiveness reviews on

medications, devices, and other health care services.

C. Michael White, Pharm.D., FCP, FCCP, Professor of

Pharmacy Practice at the University of Connecticut School

of Pharmacy, is the Director of the UCONN-HH EPC. He

is a fellow of both the American College of Clinical Pharma-

cologists and the American College of Clinical Pharmacists.

Working with Dr. White are Co-Director Craig I. Coleman,Pharm.D., Associate Director and Medical Chief Jeffrey Kluge,

M.D., FACC, and Project Manager Diana Sobered, Pharm.D.

Dr. Whites group received the Drug Therapy Research

Award, an annual award for the best research

publications by a pharmacist, from the American

Society for Health System Pharmacists in 2000,

2002, 20042006, and 2008.

In October of 2009, the UCONN-HH EPC

published a systematic review entitled Com-

parative Effectiveness of Angiotensin Converting

Enzyme Inhibitors or Angiotensin II Receptor

Blockers Added to Standard Medical Therapy for

Treating Stable Ischemic Heart Disease for the

EHC Program. Members of the UCONN-HH

EPC were also involved in writing a chapter entitled Using

Existing Systematic Reviews To Replace De Novo Processes

in Comparative Effectiveness Reviews, which was published

in the EHC ProgramsMethods Guide for Effectiveness and

Comparative Effectiveness Reviews. Ongoing and future research

projects will continue to utilize the UCONN-HH EPCs exper-

tise in pharmacology and cardiac therapies.

National Action Plan on

Health Literacy Launched

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