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Accessing PCORnet’s Data andNetwork ResourcesChristopher Forrest, MD, PhDPI, PEDSnet (pedsnet.org)Chair, PCORnet Research Committee

Our national clinical researchsystem is well-intentioned but flawedWe are not generating the evidence we need to support the healthcaredecisions that patients and their doctors have to make every day.High percentage of decisions are not supported by evidenceHealth outcomes and disparities are not improvingCurrent clinical research system faces several problems:TooslowTooexpensiveDoesn’t answerquestions thatmatter most topeople2

But what if we could improve?What if we could decrease the time it takesto get clinical insights?What if we could achieve significantcost savings over a traditional clinicalstudy?What if we could have at our fingertipstrustworthy, high-quality data from healthsystems, people and partnerships to bringpeople the real-world answers they seek?3

PCORnet: the National Patient-CenteredClinical Research NetworkPCORnet is a large, highly representative,national patient-centered clinical researchnetwork.Our vision is to support a learning U.S.healthcare system and to enable large-scaleclinical research conducted with enhancedquality and efficiency.Our mission is to enable faster, moretrustworthy clinical research that helpspeople make informed health decisions.4

With PCORnet, we have developed a nationwidefunctional research network that Creates infrastructure, tools, and policies to supportrapid, efficient clinical researchUtilizes multiple electronic health records,insurance claims data, data reported directly bypeople, and other data sourcesEngages people, clinicians, and health systemleaders throughout5

PCORnet embodies a “community of research”by uniting people, clinicians & systems20Patient-Powered ResearchNetworks (PPRNs) 13Clinical DataResearch Networks(CDRNs) PCORnetA national infrastructurefor people-centeredclinical research6

CDRNsAccelerating Data Value Across a NationalCommunity Health Center Network(ADVANCE)Oregon Community Health InformationNetwork (OCHIN)Chicago Area Patient Centered OutcomesResearch Network (CAPriCORN)The Chicago Community TrustGreater Plains Collaborative (GPC)University of Kansas Medical CenterKaiser Permanente & Strategic PartnersPatient Outcomes Research To AdvanceLearning (PORTAL) NetworkKaiser Foundation Research InstituteResearch Action for Health Network(REACHnet)Louisiana Public Health Institute (LPHI)Mid-South CDRNVanderbilt UniversityNational PEDSnet: A Pediatric LearningHealth SystemThe Children’s Hospital of PhiladelphiaNew York City Clinical Data ResearchNetwork (NYC-CDRN)Weill Medical College of Cornell UniversityOneFlorida Clinical Data Research NetworkUniversity of FloridaPatient-Centered Network of LearningHealth Systems (LHSNet)Mayo ClinicPatient-oriented SCAlable National Networkfor Effectiveness Research (pSCANNER)University of California, San Diego (UCSD)PaTH: Towards a Learning Health SystemUniversity of PittsburghScalable Collaborative Infrastructure for aLearning Healthcare System (SCILHS)Harvard University7

PPRNsAmerican BRCA Outcomes and Utilization ofTesting Patient-Powered Research Network(ABOUT Network)University of South FloridaARthritis patient Partnership with comparativeEffectiveness Researchers (AR-PoWER PPRN)Global Healthy Living FoundationCCFA Partners Patient Powered ResearchNetworkCrohn’s and Colitis Foundation of AmericaCollaborative Patient-Centered Rare EpilepsyNetwork (REN)Epilepsy FoundationCommunity and Patient-Partnered Centers ofExcellence for Behavioral HealthUniversity of California Los AngelesCommunity-Engaged Network for All (CENA)Genetic Alliance, Inc.COPD Patient Powered Research NetworkCOPD FoundationDuchenneConnect Registry NetworkParent Project Muscular DystrophyHealth eHeart AllianceUniversity of California, San Francisco (UCSF)ImproveCareNow: A Learning Health System forChildren with Crohn’s Disease and Ulcerative ColitisCincinnati Children’s Hospital Medical CenterInteractive Autism NetworkKennedy Krieger InstituteMood Patient-Powered Research NetworkMassachusetts General HospitalMultiple Sclerosis Patient-Powered ResearchNetworkAccelerated Cure Project for Multiple SclerosisNational Alzheimer’s and Dementia Patient andCaregiver-Powered Research NetworkMayo ClinicNephCure Kidney InternationalArbor Research Collaborative for HealthPatients, Advocates and Rheumatology TeamsNetwork for Research and Service (PARTNERS)ConsortiumDuke UniversityPhelan-McDermid Syndrome Data NetworkPhelan-McDermid Syndrome FoundationPI Patient Research Connection: PI-CONNECTImmune Deficiency FoundationPopulation Research in Identity and Disparities forEquality Patient-Powered Research Network(PRIDEnet)University of California San FranciscoVasculitis Patient Powered Research NetworkUniversity of Pennsylvania8

With coverage in every state —PCORnet represents thousands of conditionsThis map depicts the number of PCORI-funded Patient-Powered orClinical Data Research Networks that have coverage in each state.

Resulting in a national evidence systemwith unparalleled research singAge0–45–1422–6415–2165 Pool ofpatientsFor clinical trials42,545,341For observational studies83,131,45010

Underpinned by a Common Data ModelBiospecimen& icClaims

Underpinned by a Common Data ModelSame data are represented differently at different institutions(e.g., Type of Encounter)SITE 1Common Data ModelSITE 2Ambulatory Visit (AV)Social Work VisitOffice VisitEmergency Department (ED)Allied HealthSpecimenED Admit to Inpatient (EI)Office VisitPostpartum VisitInpatient Hospital (IP)Nurse VisitClinical SupportNon-Acute Inst. Stay (IS)Procedure VisitInitial PrenatalOther Ambulatory (OA)Employee HealthOther (OT)Vascular LabUnknown (UN)Sleep Study VisitSocial Work VisitSITE 3No Information (NI)Home Care Visit(null)Office VisitAmbulatory Visit (AV)Therapy VisitOrders OnlyCardiology TestingHospital EncounterIn order to be able to trustresults of an analysis,need to have consistentrepresentations

Here’s how PCORnet’s distributedresearch network worksThe Researcher sendsa question to thePCORnet CoordinatingCenter through theFront DoorThe Coordinating Centerconverts the question into aquery with an underlyingexecutable code, and sendsit to PCORnet partnersFront DoorPCORnet partners review thequery and provide a response,which is sent back through theFront Door to the ordinatingCenter

Demographics: Initial Results from 26 Data Marts thatincluded 23 million persons with a 2014 encounterPCORnet*Age0-2021-4445-6465-7475 SexFemaleMaleRaceBlack/African ng2010 US 32%13%72%15%19%52%29%16%84%*Number of patients with given characteristic with an encounter in any care settingdivided by the total number of patients with an encounter in any care setting (2014).14

Selected Condition: Counts of Patients (23Data Marts)ConditionCountDiabetes530,000Pulmonary Disease1,900,000Any Malignancy740,000MI230,000Stroke230,000Rheumatoid Arthritis139,000Ulcerative Colitis46,000Hypertension3,420,000Renal Disease671,000Influenza/Pneumonia578,000*Number of patients with condition of interest in any care setting divided by the total number of patients with anencounter in any care setting (2014).**Most estimates are based on adults only.***Prevalence of CKD15N 23,134,890

You can use PCORnetfor many kinds of researchPre-researchInterventional studies Feasibility queries Engagement Match-making Clinical trials Pragmatic randomizedclinical trialsObservational studies Cross-sectionalEpidemiologyHealth servicesComparative effectivenessor safety p Cluster randomization

Even more enhancements in data andexpertise are coming soonNew data streams Claims data People-reported data Medicare data Registry dataMore expertise Collaborative researchgroups — both organicallygrown and funded — in themonths and years to come17

PCORnet Projects (n 18)NetworkLeadPITitleCC - DukeAdrianHernandez,Matthew RoePORTALDavid Arterburn PCORnet Bariatric StudyCC - HPHCCOPDADAPTABLE: Aspirin Dosing: A Patient-centric Trial AssessingBenefits and Long-Term EffectivenessStudyPhaseSponsorEnrollingPCORI: 14 millionAwarded,PlanningPCORI: 4.5 millionJason BlockObesity – Short and Long-Term Effects of Antibiotics on Childhood Awarded,GrowthPlanningPCORI: 4.5 millionJerry KrishnanRELIANCE; Roflumilast or Azithromycin to Prevent COPDExacerbationsAwarded,PlanningPCORI: 13.7 millionUniversity ofWisconsinMadisonImproveCareNowScott SolomonOrly VardenyINfluenza Vaccine to Effectively Stop Cardio Thoracic Events andDecompensated heart failure (INVESTED)Awarded,PlanningPCORI: 1.3 millionMichaelKappelmanCOMBINE; AntiTNF Monotherapy versus Combination Therapywith Low Dose Methotrexate in Pedatric Crohn’s DiseaseAwarded,PlanningOneFloridaBill HoganSurveillance for MicrocephalyProposalCAPriCORNWilliam TrickAntimicrobial Use and ReportingProposalPCORI: 7.8 millionFDA/ReaganUdall/PCORI: 500KFDA/ReaganUdall/PCORI: 500KCC – DukeSreekanthVemulapalliImproving Data Completeness and Expanding Available DataElements in the TVT Registry through the use of Electronic HealthRecord Based Data: Linking the TVT Registry and PCORnetProposalFDA/ReaganUdall/PCORI: 500K18

PCORnet ProjectsNetworkLeadPICPPRNBowen ChungAR-PoWERJeffrey CurtisCOPDCCFAMOODTitleResiliency Education to Reduce Depression DisparitiesHarnessing PCORnet to Study Comparative Effectiveness and SafetyBiologic TherapiesMonitoring and Peer Support to Improve Treatment Adherence andDavid Mannnino Outcomes in Patients with Overlap Chronic Obstructive Pulmonary Diseaseand Sleep Apnea via a Large PCORnet Collaboration (O2VERLAP)Comparative Effectiveness of Specific Carbohydrate and MediterraneanJames LewisDiets to Induce Remission in Patients with Crohn’s DiseaseAndrewHealthy Hearts Healthy Minds: A PPRN Demonstration Pragmatic arded,PlanningPCORI 2.5 millionPCORI: 2.5 millionAwarded,PlanningPCORI: 2.48 millionAwarded,PlanningAwarded,PlanningPCORI: 2.5 millionPCORI: 2.49 millionGPCMaureen SmithVariation in Case Management Programs and Their Effectiveness inManaging High-Risk Patients for Medicare ACOsAwarded,PlanningPCORI: 1.4 millionADVANCEScott FieldsThe Impact of Patient Complexity on Healthcare UtilizationAwarded,PlanningPCORI: 1 millionPEDSnetKathleen WalshAutomating Quality and Safety Benchmarking for Children: Meeting theNeeds of Health Systems and PatientsAwarded,PlanningPCORI: 670,000NYC-CDRNRainu KaushalIdentifying and Predicting Patients with Preventable High UtilizationAwarded,PlanningPCORI: 1.2 million19

Administrative Efficiencies Common data sharing agreement Single IRB arrangement Streamlined contracting20

Social Resources Governance Relationship network Engagement Communications21

PCORnet Single IRBSMART IRB (formerly IRBrely) Endorsed by NCATS SOPs and Forms available; Electronic platform in development atHarvard Will be implemented among CTSAs Fall-Winter 2016PCORnet SMART IRB Pilot Test 14 PCORnet institutions have signed SMART IRB Master Agreement Conducting evaluation of process, including cost and timerequirements Coordinating efforts with NCATS/CTSA to implement among allPCORnet sites Fall-Winter 2016 Designated IRB Coordinator in Coordinating Center22

Think of all the different ways you canleverage PCORnetFaster answers topre-research queriesSUBMITData NetworkRequestValuable expertise vianetwork collaborationSUBMITRequest for NetworkCollaborationEnhanced credibilityvia PCORnet studydesignationSUBMITRequest for PCORnetStudy Designation23

A Front Door is opening soon take your research to the next levelThrough PCORnet Front Door,we invite PCORnet researchers and other investigators,patient groups, healthcare organizations, clinicians orclinician groups, government and industry scientists, andsponsors to collaborate on important patient-centeredclinical research studies.For general questions, contact us atfrontdoor@pcornet.org

PORTAL David Arterburn PCORnet Bariatric Study Awarded, Planning PCORI: 4.5 million CC - HPHC Jason Block Obesity -Short and Long-Term Effects of Antibiotics on Childhood Growth Awarded, Planning PCORI: 4.5 million COPD Jerry Krishnan RELIANCE; Roflumilast or Azithromycin to Prevent COPD Exacerbations Awarded, Planning PCORI: 13.7 million .