Updating the guideline developmentmethodology of the HealthcareInfection Control Practices AdvisoryCommittee (HICPAC)

Craig A. Umscheid, MD, MSCE, Rajender K. Agarwal, MD, MPH, and Patrick J. Brennan, MD, for the Healthcare InfectionControl Practices Advisory CommitteePhiladelphia, Pennsylvania

This article describes the recent update to the guideline development methodology of the Healthcare Infection Control PracticesAdvisory Committee (HICPAC). These methods are being used to develop future HICPAC guidelines, beginning with the guideline onpreventing catheter-associated urinary tract infections released in 2009. The article includes a background on HICPAC, thestrengths and limitations of the methods it’s used over the last two decades, and the rationale behind these recent updates. Inaddition, we describe the new infrastructure used to develop guidelines at HICPAC, keychanges in methodology, and newelementsof HICPAC guidelines, like the implementation and audit section. We also describe current challenges to the development of infection control guidelines. The current update builds on past strengths and current advances in guideline development andimplementation, and enables HICPAC to improve the validity and usability of its guidelines while also addressing emergingchallenges in guideline development in the area of infection prevention and control.

Key Words:

Practice guideline, as topic; infection control; evidence-based medicine; quality of health care; methods; HICPAC.

2010 by the Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rightsreserved. (Am J Infect Control 2010;38:264-73.)

The Healthcare Infection Control Practices AdvisoryCommittee (HICPAC) is a federal advisory committeemade up of 14 external infection control and publichealth experts, who provide guidance to the CentersforDiseaseControlandPrevention(CDC)andtheSecre-tary of the Department of Health and Human Services(DHHS) regarding the practice of health care infectionprevention and control, strategies for surveillance, andprevention and control of health care-associated infec-tions (HAIs) in United States health care facilities. Assuch, one of the primary functions of the committee isto issue recommendations for preventing and control-lingHAIsintheformofguidelinesandlessformalcom-munications.

1,2

Currently,HICPACguidancedocumentsare available on its Web site fordownload,

and a num-berofadditionaldocumentshave been published sinceHICPAC’s inception, most commonly in

Morbidity and Mortality Weekly Report

(

MMWR

Infection Control and Hospital Epidemiology

(

ICHE

), and the

American Journal of Infection Control

(

AJIC

).The strength of the HICPAC guidance documentsstemfromtheirprocessofdevelopmentaswellastheircontent and organization. HICPAC’s processes were setin motion at the time of its creation by the Secretary of DHHS in 1991. The committee was organized at therequest of CDC to provide a setting for guideline devel-opment that was free from political or financial influ-ence and that enabled multidisciplinary and publicinput. Members are recommended by the CDC andappointed by the Secretary of DHHS from experts inthe fields of infectious diseases, HAIs, nursing, surgery,epidemiology, public health, health outcomes, andrelated areas of expertise. In fact, the Federal AdvisoryCommittee Act mandates that membership includeindividuals with a variety of interests, backgrounds,

FromtheCenterforEvidence-basedPractice,UniversityofPennsylvaniaHealth System, Philadelphia, PA.Address correspondence to Craig A. Umscheid, MD, MSCE, Universityof Pennsylvania, 3535 Market St. Mezzanine, Suite 50, Philadelphia, PA19104.

E-mail:craig.umscheid@uphs.upenn.edu.

Members of the Healthcare Infection Control Practices Advisory Com-mittee are included inAppendix 1.Conflicts of interest: The authors C.A.U., R.K.A., and P.J.B. report noactual or potential conflicts of interest. C.A.U. and R.K.A. receivedfunding from the CDC to support the guideline development process.Disclaimer: The findings and conclusions in this report are those of theauthors and do not necessarily represent the official position of theCenters for Disease Control and Prevention.0196-6553/$36.00Copyright

2010 by the Association for Professionals in InfectionControl and Epidemiology, Inc. Published by Elsevier Inc. All rightsreserved.doi:10.1016/j.ajic.2009.12.005

264

and expertise.

All HICPAC members are required toregularly disclose potential conﬂicts of interest. Thecommittee also has ex ofﬁcio members such as theAgency for Healthcare Research and Quality as wellas liaisons from professional organizations such asthe Association for Professionals in Infection Controland Epidemiology, Inc., and the Society for HealthcareEpidemiology of America. Other such nonvoting repre-sentatives are included as the secretary deems neces-sary to carry out the functions of the committeeeffectively. Since the creationof the HICPAC, guidelineshave been drafted by the CDC in collaboration withoutside experts, reviewed and revised within HICPAC,and published in the

Federal Re gister

for public com-ment before ﬁnal publication.

1-3

The content and organization of HICPAC’s guidancedocuments include the following: (1) a thorough yetconcise review of the guideline topic and (2) a recom-mendations section that communicates strength of recommendations as well as supporting evidencegrades. This structure has enabled the committee todifferentiate those practices for which the availablescientific evidence provides strong support or rejection(category I) from those practices where there is onlysuggestive or less definitive evidence (category II).The grading of the evidence behind the recommenda-tion has also allowed the committee to differentiatestrong recommendations with a firm scientific founda-tion (category IA) from strong recommendations with a weaker scientific foundation (category IB). The morerecent introduction of category IC recommendationshas enabled a further distinction of strong recommen-dations mandated by federal and/or state statutes, reg-ulations, or standards.The value of HICPAC documents is reflected in theiruse by individual inf ection preventionists and healthcare epidemiologists,

as well as national societiescommitted to infection prevention and control.

In ad-dition, the value of HICPAC documents is reﬂected in a growing body of evidence suggesting tha t they en-hance the quality and safety of patient care.

6-10

For ex-ample, Manangan et al demonstrated an associationbetweenahighlevelofawarenessandadoptionofHIC-PACrecommendationswithadecreaseintheincidenceof ventilator-associated pneumonia among 188 hospi-tals.

Likewise, almost 90% of direct care providerswere aware of recommendations in the CDC’s HandHygiene Guideline, and increased adherence withthese recommendations correlated with a lower inci-denceof central line-associated bloodstream infec-tions.

Several other recent investigations haveprovided indirect evidence that HICPAC recommenda-tions applied in ‘‘bundles’’ can result in signiﬁcant re-ductions in the incidenceof central line-associatedbloodstream infections.

6,8,9

STRENGTHENING HICPAC GUIDELINES TOADDRESS EMERGING NEEDS

Despite the strengths of HICPAC’s guidance docu-ments and the processes used in their development, a number of recent advances in guideline developmentand implementation have emerged that offer HICPACan opportunity to further strengthen the validity andimpact of their guidelines. Many of these advanceshave been integrated into the guideline developmentprocesses of societies on the forefront of guideline de-velopment, providing HICPAC with excellent modelsfor updating its guideline methodology.

11-16

Advancesin guideline development and implementation havealso been promoted by authors, committees, and orga-nizations focused onimproving the validity and usabil-ity of guidelines.

17-21

Importantly, these advances also allow the HICPACto address emerging challenges in guideline develop-ment in the area of infection prevention and control.Such challenges include the following: (1) an immenseand rapidly growing evidence base that makes it moreimportant than ever to utilize strategies that allow oneto efﬁciently locate and use the most valid and clini-cally relevant studies available; (2) emerging infectionsfor which infection preventionists require guidance yetfor which there is little evidence on which to base rec-ommendations; (3) increasing attention to infectionprevention and control by surveyors, regulatoryagencies, government, and commercial payors in theUnited States and abroad, making the need forrigorousevidence-based guidelines more pressing

22,23

; and (4)escalating quantity of guidelines available to guidecare on any given topic, which makes clear communi-cation, recommendation bundles, andimplementationplans key to any guideline’s success.

24,25

In addition,the threats of commercial and political bias are as im-portant now as they were at the time the HICPAC wascreated, particularly with the potential ﬁnancial bene-ﬁts to industry of guideline endorsements

21,26

andthe challenge that payors and health care facilitieshave to improve the value of their health care dollar.Given these challenges, the needs of HICPAC areclear.Thecommitteemust (1)createthe processesnec-essarytorapidlydevelopandupdateguidelinestoallowanappropriateresponsetoemergingneedsandnewsci-entificevidence,(2)addressthekeyclinicalquestionsof infectionpreventionistsandprovidersinatargetedway,(3)usethebestavailableevidencetoanswerthoseques-tions efficiently, (4) provide transparent recommenda-tions without bias, and (5) prioritize recommendationsforimplementation.Thisdocumentprovidesanupdateon the methods used by the HICPAC to address theseneeds.Specifically,wedescribehowtheHICPACisusingemerging methods in guideline development to create

www.ajicjournal.orgVol. 38 No. 4

Umscheid, Agarwal, and Brennan

265

guidelines based on targeted systematic reviews of thebest available evidence, with explicit links betweenthe evidence and recommendations, which can be efﬁ-ciently updated and provide priorities for practitionersas well as future research agendas. We also discussmethodsusedtoenhancethereachandimpactoftheseguidelines on the quality, safety, and value of patientcare. These methodologiesareapprovedby the HICPACandwillbeusedforsubsequentguidelinesissuedbytheHICPAC, beginning with the Prevention of Catheter-Associated Urinary Tract Infection Guideline, whichwas initiated in the fall of 2007.

ORGANIZING TO ACCOMPLISH OUR GOALS

Tore-engineeritsguidelinedevelopmentprocess,theHICPAC first restructured its approach. In its new ap-proach,eachguidelineisdevelopedbyaworkinggroupinconsultationwithapanelofcontentexpertsandHIC-PAC(Fig1).AllfundingisprovidedbytheCDC.Financialconflictsofinterestarevettedanddisclosedforallwork-ing group, content experts, and HICPAC members.The working group has accountability for all phasesof methodology, including development of the keyquestions aroundwhich the guideline is based,the sys-tematic reviewof the evidence, and the guideline itself.It also is responsible for providing content experts andHICPAC members with progress updates at agreed-ondates. Each working group includes but is not limitedto3mainstakeholders:aHICPACmember,astaffmem-berfromtheCDC,andoutsideexpertsinthemethodol-ogy of guideline development. Each member hasindividual as well as overlapping accountabilities.The HICPAC member is responsible for helping todevelop the key questions, reviewing abstracts andfull text articles for inclusion in the guideline, review-ing summaries of the evidence and the guideline rec-ommendations, and communicating progress of theworking group at regular HICPAC meetings, as well ascommunicating progress to and soliciting input fromexperts who are external to HICPAC.The CDC staff member comes from the Division of Healthcare Quality Promotion in the National Centerfor Preparedness, Detection, and Control of InfectiousDiseases, and responsibilities include helping to de-velop key questions, reviewing abstracts and full textfor inclusion, and writing the evidence summaries andrecommendations as well as the following guidelinesections: the executive summary, summary of recom-mendations, implementation and audit, recommenda-tions for further research and background.Theexpertsinguidelinemethodologyincludeapro- ject manager, an analyst, and a medical librarian. Therole of the project manager includes developing andmaintaining guideline methods, setting the time line,and reviewing and integrating all aspects of guidelinedevelopment. The analyst extracts data from includedstudies, builds evidence tables, and grades the overallquality of the evidence for guideline questions usingformal processes. The librarian assists the workinggroup in developing search strategies and choosing re-sources to find relevant references, run searches, andmanage included and excluded references.The panel of content experts consists of 3 or morecontent experts both internal and external to the HIC-PAC. These experts are chosen at the discretion of theHICPAC. The expert panel participates and providesfeedback in regular progress updates and provides in-depthreviewsofkeyquestions,thebibliographyresult-ing from the initial literature search, the draft evidencereport, and the guideline recommendations.HICPAC members and liaisons participate in theguideline development process and provide feedbackin regular progress updates, as well as on the draft ev-idence reportand guideline recommendations. HICPACmembers then vote to approve the final guideline.The expertise and experience of relevant profes-sional societies is also critical to this process. As

STAKEHOLDERS IN GUIDELINE DEVELOPMENT