Regards, David C. Grossman, M.D., M.P.H. Chair, U.S. Preventive Services Task Force

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1 Thnk you for your interest in the U.S. Preventive Services Tsk Force (USPSTF or Tsk Force), n independent, volunteer group of ntionl experts in prevention nd evidence-sed medicine. Our mission is to improve the helth of ll Americns y mking evidence-sed recommendtions out clinicl preventive services nd helth promotion. These recommendtions, which re developed for primry cre clinicins nd re grounded in science, include screening tests, counseling out helthful ehviors, nd preventive medictions. Ultimtely, we seek to help clinicins nd ptients mke informed helth cre decisions. Enclosed you will find informtion out our pproch to developing evidence-sed recommendtions nd how helth cre professionls cn use these recommendtions to help people live helthier lives, including: Who we re, including how nd why our memers re selected Our process for selecting topics nd developing recommendtions, including how we define nd ssign grdes nd how memers re screened for conflicts of interest How we collorte with our dissemintion nd implementtion prtners How we engge with experts, including specilists, throughout the development of our recommendtions How we solicit input from the pulic, including ptients nd other stkeholders, throughout the development of our recommendtions How our finl recommendtions re connected to the Affordle Cre Act How we shre our recommendtions with clinicins, ptients, consumers, nd other stkeholders nd collorte with our journl of record We lso encourge you to visit our We site t or emil us t coordintor@uspstf.net to lern more out our mission nd recommendtions. Regrds, Dvid C. Grossmn, M.D., M.P.H. Chir, U.S. Preventive Services Tsk Force

2 Who We Are The U.S. Preventive Services Tsk Force is mde up of 16 volunteer memers, led y chir nd two vice chirs, who re ntionlly recognized experts in prevention, evidence-sed medicine, nd primry cre. We work to improve the helth of ll Americns y mking evidence-sed recommendtions out preventive services such s screenings, counseling, nd preventive medictions. Our recommendtions re sed on review of the est ville reserch on the potentil enefits nd hrms of the service. The Tsk Force does not conduct originl reserch studies; we review nd ssess the ville reserch using scientificlly rigorous methods. Ultimtely, we seek to help clinicins nd their ptients mke informed helth cre decisions. Our recommendtions pply only to people who hve no recognized signs or symptoms of the disese or condition. The Tsk Force s recommendtions only ddress services offered in the primry cre setting or services referred y primry cre clinicin. This is why Tsk Force memers re experts in primry cre, prevention, nd evidence-sed medicine. Memers expertise is in fields such s fmily medicine, geritrics, internl medicine, peditrics, ostetrics nd gynecology, ehviorl medicine, nursing, nd pulic helth, mong others. In ddition, most Tsk Force memers re prcticing clinicins. Our memers iogrphies cn e found on our We site. Support From the Agency for Helthcre Reserch nd Qulity Since 1998, the Agency for Helthcre Reserch nd Qulity (AHRQ), n gency within the U.S. Deprtment of Helth nd Humn Services, hs provided the resources scientific, dministrtive, nd dissemintion support for the Tsk Force to mke independent recommendtions out clinicl preventive services. Specificlly, the USPSTF progrm within AHRQ s Center for Evidence nd Prctice Improvement is chrged with: Assisting with the dy-to-dy opertions of the Tsk Force Coordinting the development of systemtic evidence reviews Supporting the Tsk Force in the consistent nd trnsprent ppliction of its methods Providing ssistnce with the promotion nd dissemintion of Tsk Force mterils nd recommendtions Ech yer, the Director of AHRQ ppoints new Tsk Force memers to serve 4-yer terms, replcing those who hve completed their service. Any orgniztion or individul cn nominte one or more persons for the Tsk Force on the Tsk Force Memer Nomintion pge of the AHRQ We site. While nomintions re welcomed t ny time during the yer, they must e received y mid-my to e considered for ppointment the following yer. All potentil memers re screened to ensure tht they hve no sustntil conflicts of interest tht could ffect the scientific integrity of the Tsk Force s work (see section on Minimizing Potentil Conflicts of Interest)

3 Developing Recommendtions The Tsk Force develops new recommendtions nd routinely updtes its existing recommendtions so they re s current s possile following the sme process for ech of its recommendtions, regrdless of topic. This process includes four distinct steps. Step 1 Topic Nomintion nd Prioritiztion Anyone cn nominte new topic, or n updte to n existing topic, t ny time vi the Tsk Force We site. The Tsk Force then prioritizes nomintions sed on severl criteri, including: The topic s relevnce to prevention nd primry cre nd importnce for pulic helth The potentil for the recommendtion to ffect clinicl prctice Whether there is new evidence tht my chnge current recommendtion Step 2 Drft nd Finl Reserch Plns Once topic is selected, the Tsk Force nd reserchers from n Evidence-sed Prctice Center (EPC) develop drft reserch pln for the topic. This pln includes the key questions to e nswered y the review nd descries the trget popultions, interventions, conditions, outcomes, nd settings to e considered. The drft reserch pln is posted on the We site for four weeks, during which nyone cn comment on the pln. In ddition, expert reviewers re invited y the Tsk Force to review the pln nd provide input (see sections on Expert Input nd Engging With the Pulic). The Tsk Force nd the EPC review ll comments nd consider them while mking ny necessry revisions to the reserch pln. The Tsk Force then finlizes the pln nd posts it on the We site. Wht Is n Evidence-sed Prctice Center? AHRQ funds Evidence-sed Prctice Centers (EPCs), which re cdemic or reserch orgniztions with expertise in conducting systemtic evidence reviews. EPC reserchers work with the Tsk Force to develop reserch plns nd conduct the evidence reviews tht the Tsk Force uses to determine its recommendtions. A list of ll EPCs is ville on AHRQ s We site. c Step 3 Drft Evidence Review nd Drft Recommendtion Sttement Using the finl reserch pln s guide, EPC reserchers gther, review, nd nlyze evidence on the topic from studies pulished in peer-reviewed scientific journls. The EPC then develops one or more drft evidence reviews summrizing the evidence on the topic. The Tsk Force memers discuss the evidence review(s) nd use this informtion to determine the effectiveness of service y weighing the potentil enefits nd hrms. Tsk Force memers then develop drft recommendtion sttement sed on this discussion. How Does the Tsk Force Define Benefits nd Hrms? Potentil enefits of preventive services cn include helping people sty helthy throughout their lifetime nd detecting diseses erly when tretment my e more effective. Erly detection cn help people void helth issues in the future nd help them improve their qulity of life. Sometimes the test or preventive mediction cn cuse hrms. No screening test is perfect, nd potentil hrms cn include inccurte test results, hrms from tretment of disese or condition, or receiving tretment when it is not needed (lso known s overdignosis ). c 3

4 Developing Recommendtions Ech drft recommendtion is issued letter grde of A, B, C, or D, or clssified s n I sttement. The tle elow outlines how the Tsk Force defines ech grde. This informtion is lso ville on our We site. Grde A B C D I Sttement Definition The USPSTF recommends the service. There is high certinty tht the net enefit is sustntil. The USPSTF recommends the service. There is high certinty tht the net enefit is moderte or there is moderte certinty tht the net enefit is moderte to sustntil. The USPSTF recommends selectively offering or providing this service to individul ptients sed on professionl judgment nd ptient preferences. There is t lest moderte certinty tht the enefit is smll. The USPSTF recommends ginst the service. There is moderte or high certinty tht the service hs no net enefit or tht the hrms outweigh the enefits. The USPSTF concludes tht the current evidence is insufficient to ssess the lnce of enefits nd hrms of the service. Evidence is lcking, of poor qulity, or conflicting, nd the lnce of enefits nd hrms cnnot e determined. The drft recommendtion sttement nd drft evidence review(s) re posted on the Tsk Force We site for four weeks, during which nyone cn comment on these mterils. Expert reviewers re lso invited y the Tsk Force to review these mterils nd provide input (see sections on Expert Input nd Engging With the Pulic). Wht Does n I Sttement Men? An I sttement mens tht the current ville evidence is insufficient. Becuse evidence is lcking or uncler, the Tsk Force hs determined tht it cnnot mke recommendtion for or ginst service. It is not recommendtion ginst providing preventive service. If the service is offered, ptients should understnd the uncertinty out the lnce of enefits nd hrms. Step 4 Finl Evidence Review nd Finl Recommendtion Sttement The Tsk Force nd EPC consider ll comments on drft evidence review(s) nd the Tsk Force considers ll comments on the drft recommendtion sttement. The EPC revises nd finlizes the evidence review(s) nd the Tsk Force finlizes the recommendtion sttement sed on oth the finl evidence review nd the pulic comments. All finl recommendtion sttements nd evidence reviews re posted on the Tsk Force s We site. c The finl recommendtion sttement nd evidence summry, document tht outlines the evidence the Tsk Force reviewed, re lso pulished in peer-reviewed scientific journl (see section on the Journl of the Americn Medicl Assocition). c 4

5 Developing Recommendtions Minimizing Potentil Conflicts of Interest The Tsk Force tkes conflicts of interest very seriously to ensure tht our recommendtions remin lnced, independent, ojective, nd scientificlly rigorous. Our memers re required to disclose ll informtion regrding ny potentil finncil nd nonfinncil conflicts for ll topics in development. Tsk Force memers routinely updte their disclosure forms to ensure tht they re up to dte. All disclosures re clssified s Level 1, 2, or 3. How Does the Tsk Force Define Potentil Conflicts of Interest? The Tsk Force defines potentil conflicts of interest ccording to three levels: Level 1 disclosures include nonfinncil disclosures tht would not ffect the judgment of Tsk Force memer. These disclosures do not require ny ction. Level 2 disclosures include finncil disclosures of $1,000 or less nd nonfinncil disclosures tht re relevnt to topic ut not nticipted to ffect the judgment of the Tsk Force memer. These disclosures do not limit the Tsk Force memer s prticiption in the topic process. Level 3 disclosures include finncil disclosures lrger thn $1,000 nd significnt nonfinncil disclosures tht my ffect the Tsk Force memer s view on the topic. A Level 3 disclosure my prevent the memer from tking prt in topic ctivities. The Tsk Force chirs determine the finl ction on the memer s eligiility to prticipte on specific topic, sed on the nture nd significnce of the potentil conflict. All Level 3 disclosures mde y Tsk Force memers re posted on the Tsk Force We site nd t the end of ech recommendtion sttement tht is pulished in the Journl of the Americn Medicl Assocition (JAMA), the Tsk Force s journl of record

6 Prtners Dissemintion nd Implementtion Prtners The Tsk Force works with group of dissemintion nd implementtion prtner orgniztions who represent primry cre clinicins, consumer orgniztions, nd other stkeholders involved in the delivery of preventive services. Prtners review nd provide feedck on the Tsk Force s work throughout the entire recommendtion process vi pulic comment periods (see section on Engging With the Pulic). Prtners lso help the Tsk Force ensure tht its recommendtions re meningful to the groups tht prtners represent nd re powerful vehicle for ensuring tht Americ s primry cre workforce remins up to dte on Tsk Force recommendtions. A list of the Tsk Force s dissemintion nd implementtion prtners cn e found on the Tsk Force We site. Federl Agencies nd Institutions The Tsk Force lso prtners with numer of different federl gencies nd institutions throughout the recommendtion development process. These orgniztions keep the Tsk Force pprised of mjor federl inititives tht my produce new evidence or duplicte the Tsk Force s efforts on given topic. The Tsk Force lso engges experts t federl gencies for ll topics throughout the entire recommendtion process. For exmple, the Tsk Force works with scientists t the Ntionl Institutes of Helth on cncer topics, with the Food nd Drug Administrtion on topics relted to preventive medictions, nd with the Centers for Disese Control nd Prevention on topics relted to infectious diseses. All immuniztion recommendtions re referred to the Centers for Disese Control nd Prevention s Advisory Committee on Immuniztion Prctices. Federl prtners lso hve the opportunity to review nd provide comments on ll drft reserch plns, evidence reviews, nd recommendtion sttements. The Tsk Force We site hs full list of federl prtners. Additionlly, mny of the Tsk Force s recommendtions re fetured on pulic helth We sites nd incorported into ptient nd clinicin tools, such s AHRQ s electronic Preventive Services Selector (epss) nd the Office of Disese Prevention nd Helth Promotion s MyHelthFinder (see section on We Tools nd Resources)

7 Expert Input The Tsk Force routinely invites the input of topic experts nd specilists relevnt to the topics eing reviewed, s well s stkeholders nd the pulic, throughout its recommendtion process. The Tsk Force seeks input from different types of experts including specilists such s rdiologists, oncologists, crdiologists, nd surgeons. In ddition, the tems tht conduct the evidence reviews for ech topic lwys include content experts. This input helps the Tsk Force develop effective nd relevnt recommendtions. For ll topics, experts re invited to review nd provide input t criticl points in the process Topic Nomintion: Experts cn nominte new topic or n updte to n existing topic t ny time s prt of the Tsk Force s pulic nomintion process. Drft & Finl Reserch Plns: Content experts help the Tsk Force develop the nlytic frmework. Expert reviewers provide guidnce on the key questions, popultions of concern, nd the reserch pproch. Experts cn lso comment on the drft reserch pln during the pulic comment period. Drft Evidence Review & Drft Recommendtion Sttement: Content experts work with the tem tht conducts the systemtic evidence review. Expert reviewers provide input on the evidence ehind the drft recommendtion sttement. Experts cn comment on the drft evidence review nd recommendtion sttement during the pulic comment period. Finl Evidence Review & Finl Recommendtion Sttement: Content experts provide input in the finliztion of the evidence review. Expert reviewers re given the option to e cknowledged in the pulished evidence summry. Expert Reviews The Tsk Force recognizes tht topic experts nd specilists ply crucil role in the prevention of specific diseses nd conditions, nd for this reson, we consult topic experts nd specilists to review our findings nd conclusions throughout the recommendtion development process. For exmple, we invite topic-relevnt medicl specilists such s rdiologists, crdiologists, oncologists, nd surgeons, to review nd comment on our evidence mterils in dvnce of the pulic comment period. Topic experts nd specilists re lso welcome to sumit comments on ll of our mterils, long with other key stkeholders nd the generl pulic, during the stndrdized pulic comment periods for drft reserch plns nd drft recommendtion sttements. 7

8 Engging With the Pulic The Tsk Force is committed to mking our recommendtions cler nd our processes trnsprent. As prt of this commitment, we offer severl opportunities for the pulic to provide input nd work with mny stkeholders to disseminte our recommendtions. Tsk Force Memer nd Topic Nomintion The Tsk Force looks to the pulic for oth nomintions of new memers nd topics to review. Anyone cn nominte one or more individuls for considertion on the Tsk Force Memer Nomintion pge of the AHRQ We site. Pulic nomintions for new topics or requests to updte n existing topic cn e mde t ny time on the Topic Nomintion pge on our We site. Pulic Comment Periods The Tsk Force welcomes feedck from the pulic throughout the entire recommendtion process through pulic comment periods. Ech drft document is open for pulic comment for four weeks, nd nyone cn comment on these mterils y visiting the Opportunities for Pulic Comment pge on our We site. c Once the pulic comment period hs ended, the Tsk Force reviews ll the comments nd considers them while mking ny necessry revisions to the finl documents. Mny times, finl recommendtion sttements include revisions mde in response to pulic comments, such s clrifictions out the popultion included in the recommendtion nd dditionl informtion out the preventive service. At times, individuls sumit personl stories or protected helth informtion s prt of their comments. All comments re kept confidentil to protect the privcy of these individuls. However, ll finl reserch plns nd recommendtion sttements include section summrizing ny chnges tht were mde s result of the pulic comments. Keeping the Pulic Informed The Tsk Force vlues ll pulic input tht we receive. To keep the pulic informed out Tsk Force news, we send notifictions through our emil list when drft mterils re posted for pulic comment, when finl mterils re posted or pulished, nd out other Tsk Force ctivities. Any individul or orgniztion cn sign up for these updtes nd nnouncements y visiting the Tsk Force emil updtes pge of the USPSTF We site. d c d 8

9 The USPSTF nd the Affordle Cre Act The Tsk Force supports improved ccess to effective preventive services. In 2010, Congress creted link etween the Tsk Force s recommendtions nd vrious coverge requirements for privte nd pulic insurers in the Affordle Cre Act. Although the Affordle Cre Act hs provided n opportunity to link evidence to coverge for the most highly recommended services, the Tsk Force s recommendtions re not recommendtions for or ginst insurnce coverge. A nd B recommended services my e used y others s floor, rther thn ceiling, on coverge of preventive services. All of the Tsk Force s A nd B recommendtions cn e found on the Helthcre.gov We site, preventive-cre-enefits/. The Tsk Force is committed to using the est science to identify the most effective preventive services to improve the helth of the pulic. The pssge of the Affordle Cre Act hs not influenced the methods or evidence thresholds the Tsk Force uses to ssign letter grdes. Coverge nd costs re not used in ssigning grdes to services. Coverge decisions re determined y pyors nd policymkers. From: Evidence-Bsed Clinicl Prevention in the Er of the Ptient Protection nd Affordle Cre Act: The Role of the US Preventive Services Tsk Force JAMA, 2015;314(19): doi: /jm Tle. USPSTF Recommendtion Grdes, Suggestions for Prctice, nd Reltive Roles ofthe USPSTF. Lwmkers, nd Insurers in Determining Coverge USPSTF Role in Estimting Certinty of Net Benefit nd Assigning Grde Grde Definition Suggestions for Prctice ACA Linkge Role of Insurers A Recommends (high certinty of sust ntil net enefit) Offer or provide B C D Recommends (high certinty tht net enefit is moderte or moderte certinty tht net enefit is moderte to sustntil) Recommends selectively offering or providing to individul ptients sed on professionl judgment nd ptient preferences (t lest moderte certinty of smll net enefit) Recommends ginst the service (moderte or high certinty of no net enefit or tht hrms outweigh enefits) Concludes tht current evidence is insufficient to ssess lnce of enefits nd hrms of the service; evidence is lcking, of poor qulity, or conflicting, nd lnce of enefits nd hrms cnnot e determined Offer or provide Offer or provide for selected ptients depending on individul circumstnces Discourge the use of this service Red clinicl considertions section of USPSTF Recommendtion Sttement; if clinicins offer these services, ptients should understnd the uncertinty out lnce of enefits nd hrms Arevitions: ACA, Affordle Cre Act; USPSTF. US Preventive Services Tsk Force. Brest cncer screening for women in their 40s currently hs seprte mndte for coverge with no cost shring. ACA mndtes coverge with no cost shring ACA does not deny coverge nd does not prohiit pln from providing coverge Estlish coverge policy consistent with USPSTF grde nd ACA Determine coverge policy sed on effectiveness, consumer demnd, community norms, nd other considertions Coverge policy might include specifying the ctul service nd trget popultion. which clinicins cn provide the service. nd where. when. nd how often they cn provide it Americn Medicl Assocition. All rights reserved 9

10 Disseminting Recommendtions At the finl recommendtion stge, the Tsk Force dissemintes its recommendtions rodly to clinicins, ptients, nd the generl pulic. In ddition to posting recommendtions nd relted mterils on our We site, we work with JAMA nd our dissemintion nd implementtion nd federl prtners to disseminte informtion out our work. We Tools nd Resources The Tsk Force offers vriety of We-sed resources nd tools for clinicins, the pulic, nd stkeholders to enhnce understnding of our recommendtions nd process. The Electronic Preventive Services Selector (epss) ppliction is designed to help primry cre clinicins identify clinicl preventive services tht re pproprite for their ptients. It includes serch nd rowse feture of ll Tsk Force recommendtions on tlet or moile device. In ddition, is ptient nd consumer-friendly tool sed on Tsk Force recommendtions tht helps people determine which preventive services they my need sed on ge, sex, nd helth sttus. We invite memers of the pulic to sign up to receive emil notifictions. Emils re sent t ll stges of the recommendtion process, including when drft mterils re posted for pulic comment nd when finl mterils re posted or pulished, nd updtes out other Tsk Force ctivities. Any individul or orgniztion cn sign up for updtes nd nnouncements y visiting the Tsk Force emil list pge of our We site. Our We site fetures complete list of current recommendtions, c s well s those tht re eing updte. d Additionl informtion on the Tsk Force cn e ccessed on the Tsk Force 101 Resources pge e of our We site, including fct sheets nd presenttions on our recommendtions process nd how the Tsk Force works, AHRQ s support of the Tsk Force, nd our enggement with the pulic nd stkeholders. Reports to Congress Ech yer, the Tsk Force issues n nnul report to Congress tht identifies gps in the evidence se for clinicl preventive services nd recommends priority res tht deserve further exmintion. We distriute the report to Congress nd leding reserch funding gencies, including the Ntionl Institutes of Helth, AHRQ, nd the Ptient-Centered Outcomes Reserch Institute, nd mke it pulicly ville through our We site. f By nnully highlighting high-priority evidence gps, the Tsk Force ssists reserchers nd pulic nd privte reserch funders in trgeting their efforts to the most criticl res in clinicl prevention. Journl of the Americn Medicl Assocition All finl recommendtion sttements nd evidence summries re pulished in JAMA nd mde ville to nonsuscriers free of chrge. In ddition, JAMA develops supplementl mterils, including pges for ptients nd podcst interviews, for ll finl recommendtion sttements pulished in the journl. Lstly, for some recommendtions, JAMA produces dditionl explntory mterils, including videos nd whiteord nimtions. Thnk You We hope tht you found this informtion on the work of the Tsk Force helpful. Further inquiries cn e sent to coordintor@uspstf.net, or you cn visit our We site. g hhttp://epss.hrq.gov/pda/index.jsp c d e f g

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