Women s Health Technologies CRNs Kick-off Think-Tank

Transcription

1 Women s Health Technologies CRNs Kick-off Think-Tank Friday, September 15, 2017 White Oak Campus, Silver Spring, MD Chairs: Art Sedrakyan, Weill Cornell & Danica Marinac-Dabic, FDA Time Topic Presenter 8:30-8:50 Registration and Badge pick up 8:50-9:00 Introductions Art Sedrakyan, WCM 9:00-9:30 Regulatory vision and national and international John Wilkinson, MHRA efforts Danica Marinac-Dabic, FDA Rachael Fleurence, NEST 9:30-9:45 CRNs as foundation for device evaluation system: WH Art Sedrakyan, WCM CRN as an ecosystem effort 9:45-10:00 WHRA/ACOG perspective and needs Matt Barber, WHRA 10:00-10:15 Q & A discussion (Terri Cornelison, FDA) 10:15-11:10 CRN areas of interest, history and advancement plans 10:15-10:25 COMPARE-UF Evan Myers, Duke 10:25-10:45 PFDR & AQUIRE, and potential for expansion in New England/New York Samantha Pulliam, AUGS & Elisabeth Erekson, Dartmouth 10:45-10:55 Collaborative Review of Sterilization Therapies and Long-acting Reversible Contraception (CREST II) Nilsa Loyo-Berrios, FDA & Maura Whiteman, CDC 10:55-11:10 Q & A discussion 11:10-11:20 Coffee Break 11:20-12:00 Moderated Think-tank Discussion and Alignment: start with presentation about patient safety organization (M2S & Dartmouth) and EHR efforts by Societies 12:00-12:50 Lunch 12:50-2:15 Federal Partners and key stakeholders contributions 12:50-1:00 FDA TPLC Efforts Sharon Andrews, FDA 1:00-1:30 Perspectives on informatics leveraging FDA, NLM, Terrie Reed, FDA and ONC experience Lisa Lang, NLM Farrah Darbouze, ONC 1:30-1:40 Industry perspective Tara Federici, AdvaMed 1:40-1:50 Patient perspective Diane Zuckerman, NCHR 1:50-2:15 Moderated discussion on enabling collaborations (Danica Marinac-Dabic, FDA) 2:15-4:00 Clinical work group discussion/review FDA proposed data elements and DELPHI process as needed 2:15-4:00 Uterine fibroids Room 1406 (Evan Myers, Allison O Neill & Angie Lee) Mesh for incontinence and pelvic organ prolapse Great Room A (Tony Du, Jacqueline Cunkelman & Samantha Pulliam) CREST II Room 1404 (Nilsa Loyo-Berrios & Maura Whiteman) 4:00-4:45 Report back from groups with CRN focus 4:00-4:45 15 minute report and discussion from each group s moderated discussion on leveraging CRN for lifecycle needs/nesting clinical studies 4:45-5:00 Final Comments: Organizers

2 THE CONTEXT: RWE BY THE ECOSYSTEM FOR THE ECOSYSTEM Danica Marinac-Dabic, MD, PhD, MMSc, FISPE Director, Division of Epidemiology, FDA/Center for Devices and Radiological Health 1

3 Patients are at the Heart of What We Do CDRH Vision: Patients in the U.S. have access to high-quality, safe, and effective medical devices of public health importance first in the world William H. Maisel, MD, MPH MDMA

4 Coordinated Registry Network for Women s Health Technologies Goal: Address public health / ecosystem questions efficiently Health Care Providers Patients Harmonization/Interoperability Government ONC Device Industry States Data EHR CREST II EHR Vendors Structured Data Capture (SDC) Hospitals Integrated Delivery Systems Researchers 3

5 National System Paradigm Shift Passive Surveillance Challenging to find right pre/post market balance without confidence in postmarket data Active Surveillance to better protect patients Leverage RWE to support regulatory decisions throughout TPLC Current National System Parallel track to clinical practice Inefficient one-off studies Clinical research embedded in routine clinical care Shared system to inform the entire Ecosystem (patients, clinicians, providers, payers, FDA, device firms) 4

6 Foundational Work

7 MDRTF Recommendations to FDA for NEST August 2015 Coordinated Registry Networks (CRN) Principles: Link complementary sustainable registries/e-repositories (Professional society registries, EHRs, Claims data) TPLC as a true continuum of structured real world evidence Dual purpose existing site-base work flow Krucoff MW, Normand SL et al, JAMA

8 Strategically Coordinated Registry Networks (CRNs) National Ortho- CRN Vascular CRN VISION Cardiac CRN Neurology CRN DAISI Gastrointestinal CRN Obesity Prostate ablation SPARED Robotic Surgery CRN Women s Health Technologies TMJ VANGUARD International International Consortium Orthopedics Registries (ICOR) International Consortium Vascular Registries (ICVR) International Consortium of Cardiovascular Registries (ICCR) International Collaboration of Breast Registries Activities (I-COBRA) 7

9 Global MDEpiNet Existing MDEpiNet Chapter Future MDEpiNet Chapter Academic Centers Data Sources 8

10 Flexible Regulatory Paradigms Applied Across the Total Product Life Cycle FDA/CDRH Vision Patient-Centered, TPLC Approach Benefit-Risk Tradeoffs PMA, De Novo Benefit-Risk Determination Framework Guidance (2012) Postmarket Benefit-Risk Guidance (2016) Clinical Trials Evidence Generation Regulatory Science Real-World Evidence Premarket- Postmarket Balance Science of Patient Input Early Feasibility Study Paradigm Guidance (2013) IDE Benefit-Risk Determination Framework Guidance (2017) Bayesian Statistics (2010), Adaptive Trial Design (2016) Guidances MDDT Pilot Program RWE Draft Guidance (2016) Unique Device Identification Final Rule (2013) Expedited Access Pathway Program (2015) Balancing Premarket and Postmarket Data Collection Guidance (2015) Patient Preference Information Guidance (2016) Medical Device Innovation Consortium (MDIC) Patient Centered Benefit-Risk Project NEST MDIC 9

11 Novel Device Approvals Almost 4-fold Increase in # of Novel Device Approvals * Novel devices include original PMAs, panel track supplement PMAs, and de novos Number of Novel Devices Calendar Year 10

12 Example: PAS Cardiovascular Space Number of stand alone PAS studies is decreasing; replaced by CRN - embedded studies Note: CRN- coordinated registry network includes registry linked to other data sources (e.g. claims). 11

13 Women s Health Project Goal Collaborate with Stakeholders to Build a Strategically Coordinated Registry Network (CRN) to improve evaluation of women s health technologies across multiple care settings Single Purpose Registries Time / Cost-intensive Challenging to address questions involving multiple therapies Stand-alone design: Challenges with interoperability due to registry-specific data collection / normalization Coordinated Registry Network for Women s Health Technologies Support assessment of real world combinations of care Harmonized, interoperable platform to support standardized data capture Address priority questions from stakeholders Improve longitudinal evidence generation and reduce cost 12

14 Thank You!

15 Registries & CRNs as Pragmatic TPLC Approach for Devices Art Sedrakyan, MD, PhD Professor of HPR Director of Patient-Centered Comparative Effectiveness Research and Medical Device Epidemiology Science and Infrastructure Center SGE: US Centers for Medicare and Medicaid Services (CMS) Specialist Adviser, TGA, Australia

16 Organized system that continuously and consistently collects relevant data in conjunction with routine clinical care, evaluates meaningful outcomes and comprehensively covers the population defined by exposure to particular device(s) at a reasonably generalizable scale (e.g. international, national, regional, and health system) with a primary aim to improve the quality of patient care

17 Desired Attributes 1. DEVICE DATA: Contains sufficient information to identify the device 2. UALITY SYSTEM: Is part of a health care delivery quality improvement system 3. BENEFICIAL CHANGE: Has established mechanisms to bring about beneficial change (e.g. stakeholder engagement) 4. EFFICIENCY: The registry is embedded in the health care delivery system (i.e., not overly burdensome, not complicated, not costly) 5. ACTIONABLE DATA: The registry provides actionable information in a relevant and timely manner to decision makers 6. TRANPARENCY: The governance structure, data access, and analytical processes of the registry are transparent 7. LINKABILITY: Information in the registry can be linked with other data sources for enhancement 8. TOTAL DEVICE LIFE-CYCLE: The registry as infrastructure for seamless integration of evidence throughout the device life cycle

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19 GOAL & APPROACH Our focus of National and International Coordinated Registry Network (CRN) is to provide timely information on performance of specific medical devices for decision making by patients, physicians, regulators and all other stakeholders Approach is to facilitate and/or leverage national and international investments in registries and other relevant data systems (dual purposing) to create National Medical Device Evaluation System on a fairly immediate basis, greatly minimizing the cost or development resources needed

20 CRN IN USA is REALISTIC APPROACH HAVING HANDFUL OF NATIONAL REGISTRIES, AND FEW COLLECTING DETAILED DEVICE INFORMATION WE NEED TO INTEGREATE DATA Major Quality and safety registries initiated by professional societies, states, healthcare systems, NIH/AHRQ, other CMS claims including Part A,B,C,D Commercial claims PCORI CDRNs All payer State databases Comprehensive EHRs

21 CRN Example

22 Comparing Options for Management:PAtient-centered REsults for Uterine Fibroids Evan R. Myers, MD, MPH Department of Obstetrics & Gynecology and Duke Clinical Research Institute, Duke University, Durham, NC

23 COMPARE-UF Comparing Options for Management:PAtient-centered REsults for Uterine Fibroids

24 ORGANIZATION P50 ( Center of Excellence ) Grant Broad aim is to put infrastructure in place to conduct a range of studies Data Coordinating Center at Duke Clinical Research Institute 9 Clinical Centers Stakeholder Advisory Group (patients, payers, professional societies, government agencies, industry)

25 Mayo Clinic:Ebbie Stewart Brigham & Women s: Ray Anchan Northwestern:Erica Marsh Henry Ford HS:Ganesa Wegienka DoD: Bill Catherino UC Consortium:Vanessa Jacoby U of Mississippi:Kedra Wallace Inova: Larry Maxwell UNC:Wanda Nicholson

26 Main Aims Compare duration of symptom relief among available treatments Initial focus on procedures Compare impact of treatments on reproductive outcomes (time to menopause, fertility, pregnancy outcomes) Identify important subgroup effects (heterogeneity of treatment effect)

27 Patients Scheduled to undergo treatment at facility affiliated with Clinical Site Outreach methods vary by site E-mai/letter from attending physician Subsequent contact by /phone/in-person Electronic portal for E-consent Completion of baseline and follow-up data Other communications with patients Follow-up at post-procedure visit, 12, 24, 36 (and potentially more)

28 Data Collected: Baseline Demographics Age, race/ethnicity, education, income Medical/surgical history Reproductive history Fibroid history Duration of symptoms, prior treatments Quality of Life UFS-QOL EQ-5D Depression screen Menopause Rating Scale Financial Toxicity Subset: blood for AMH

29 Why So Much Data? Likely to be major differences in patient characteristics between procedures Need data on lots of potential confounders to adjust for those differences Unfortunately, has direct and indirect effect on recruitment Burden on patients Need to adjust reduces statistical power

30 Data Collected: Medical Records Imaging (within past 12 months) Procedure Details Pathology Short-term outcomes (complications, ER visits) Originally planned to be abstracted by study staff on site, moving to centralized abstraction

31 Data Collection Follow-Up (patient) Changes in medical history Pregnancy outcomes Additional fibroid treatments All QOL measures Subset: AMH at 12 months

32 Inherent Challenges Data Collection Diversity of Symptom type and severity Uterine anatomy Patient goals Hysterectomy still most common procedure (50%), followed by myomectomy (25-30%) Lower numbers of alternatives Substantial differences in patient characteristics by procedure type Limited time between identification of eligible patients and treatment for introduction, consent, collection of baseline PRO data Office-based treatments (ablation, IUD, ultimately drugs) even harder to identify

33 Inherent Challenges Data Collection Younger, more mobile patient population Very few Medicare patients (and those unique in some way) State-based all payer claims limited if patient moves out of state Lack of standardization of Symptom description (validated disease-specific QoL available but not widely used in clinical practice) Uterine anatomy (FIGO recommendations in progress) Procedure description/details Devices No analogy to mesh, sterilization in terms of implants Device issues would involve failure or injury at time of procedure, or uncomplicated use in inappropriate patient (morcellation)

34 Inherent Challenges-Quality No equivalent of 30 day risk-adjusted mortality Ongoing patient concerns about counseling about all options, availability of all options Constrained by overall lack of comparative effectiveness data Consider phased development of registry for QA/QI Did clinician have all relevant information needed for decision making available and documented? Were all appropriate options discussed with patient? Did patient receive treatment from appropriate options? Were outcomes of treatment within expected range given patient characteristics?

35 AUGS Registry Initiatives Women s Health CRN SPEAKERS: PAMELA MOALLI, MD, PHD; SAMANTHA PULLIAM, MD 1

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37 PFDR Background In 2011, FDA ordered manufacturers of transvaginal mesh products for prolapse to conduct post-marketing surveillance of the product and related procedures. AUGS developed the PFDR to provide information about the comparative effectiveness, quality of life and safety associated with various surgical and nonsurgical treatments and ultimately to improve the quality of care for women with these conditions. Two arms of the PFDR: Industry-sponsored Studies FDA 522 study for transvaginal mesh compared to native-tissue vaginal prolapse surgeries; provide financial support for maintenance of the registry AUGS Research Study Research registry studying prolapse treatments (surgery and pessary) 3

38 PFDR Statistics (as of Sept. 1) PFDR- IS : 3 Industry sponsors 4 active protocols 249 clinical sites 2,233 patients enrolled PFDR-R: Volunteer research registry 12 AUGS Pioneer Sites 721 patients enrolled (521 surgery, 200 pessary treatment)

39 PFDR Surgery (as of Sept. 1) Surgical Patient Summary N % Vaginal native tissue % Vaginal mesh/graft 6 1.5% Sacrocolpopexy % Combined approach mesh augmented 4 1.0% Abdominal approach native tissue 7 1.8% Obliterative %

40 Visits Baseline Visit Demographics, Contact Info, Medical/Surgical history, Examination, Treatment type, Pessary type epro Patient receives questionnaires via after baseline visit and after each follow up visit. Sites can see patient-entered data but cannot edit it Initial Procedure Form For primary procedure, includes OR and discharge information Follow-up Visits Visits are for months: 2, 6, 12, 18, 24, 36 or unscheduled Visits not required in AUGS Research Registry sites to follow usual standard of care (recommend 1 year follow-up)

41 PFDR Accomplishments Collaborative research effort - AUGS, FDA, industry, other organizations Definitions for outcomes and safety endpoints standardized Surgical and non-surgical treatments (pessary) under study (PFDR-R) Detailed clinical and patient-reported outcomes Provide unique multi-center effectiveness data on prolapse treatments (PFDR-R) Required post-marketing surveillance of vaginal mesh devices (PFDR-IS) Provides real-time benchmarking on important outcomes for sites

42 PFDR Hurdles Sites Obtaining Legal and IRB Approval Length of legal negotiations Institutions differ in terms for data usage and publication policy IRB required epro measures not part of standard care Database includes patient contact information ( ) Length of Time for Data Entry Coordinator/nurse staff needed to help with entry epro Functionality Length of survey high patient burden Problems with patients and use of Only recently became available on tablets and with alternate Internet platforms

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44 What is AQUIRE? A national urogynecology-focused registry designed to measure and report healthcare quality and patient outcomes Launched in 2016 Provides participants with benchmarking tools to monitor their outcomes and identify areas for continued improvement Contains 20 urogyn-focused quality measures SUI Surgery module in development Benefits Registry supports 2017 MIPS requirements Real-time access to benchmarking reports comparing outcomes nationally and regionally MOC Part IV

45 Requirements for Enrollment AUGS Physician Members Future expansion Non-member physicians Nurse Practitioners Other healthcare providers Business Associate/Data Use Addresses HIPAA requirements for the collection of patient data Registry Participation Agreement

46 Vendor FIGmd Web-based Registry Platform Modular, Flexible Structure Research protocol Quality improvement Qualified Clinical Data Registry (QCDR) Integrates with 70 EMR systems (not Cerner or Epic) Customizable dashboard for benchmarking

47 EMR Integration Status Urogyn EMR templates in development for prolapse, SUI, OAB and fecal incontinence Completion goal Q Launch to membership Q1 and Q Implementation in AQUIRE Q AQUIRE EMR integration Pilot sites identified (3) FIGmd developing extraction tool Pilot launch Q Assess data Q2 2018

48 AQUIRE SUI Module Objective and subjective outcomes of patients receiving surgery for SUI Physician and patient data entry Used by every surgeon performing SUI surgery as a way to track their outcomes related to surgery Quality improvement tool for physicians to improve their surgical outcomes Long-term vision - national, US-based registry on SUI surgery

49 Data Elements Surgeon Entered Age BMI Pre-operative use of topical estrogen Current Smoking Use of OAB Rx (past or current) Pre-op Quality Measures Informed consent Type of Incontinence procedure Concomitant Hysterectomy Concomitant prolapse surgery Intraoperative cystoscopy Urinary tract Injury (type) Transfusion 30-DAY Return to OR or Readmission Mesh exposure Pain attributed to mesh Reoperation for Mesh exposure Reoperation for Mesh-related pain SUI (demonstrated by CS) SUI Symptoms SUI Retreatment De Novo OAB

50 Data Elements Patient reported Mesh exposure Mesh related pain (observed) Mesh related pain (treatment type) Pain (vagina, groin, pelvis) Dyspareunia SUI (ICIQ-SF) Treatment for SUI De Novo OAB (ICIQ-SF) PGI-I Satisfaction (Likert scale)

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53 Patient Safety Organization Protects Patient Safety Work Product (PSWP) from legal discovery Allows for the collection of patient identifiers without IRB approval or patient consent (claims-linkage possible) Must comply HIPAA

54 Started as Vascular Surgery Group of Northern New England (VSGNNE) in 2002 Initial publications in 2007 (proof of concept) generated considerable interest from the SVS Launched as national registry in 2011 Became a AHRQ designated PSO in 2011

55 Society for Vascular Surgery Patient Safety Organization ( Allows systematic PHI Collection Without Need for Consent

56 Operates as regional networks that feed into a national registry Collects clinical data on all major open and endovascular procedures 1-year follow up from medical record/office visit Data linkage social security death index medicare Meets MOC requirements for participant members

57 17 Regional Quality Groups AK HI semi-annual meetings Anonymous data sharing Benchmarking Exploring practice variation

58 Regional quality groups with semi-annual meetings Anonymous data sharing Benchmarking Exploring practice variation

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60 Women s Health Registries ARE DIFFERENT Women undergoing treatment of fibroids and sterilization are not generally Medicare participants Primary outcomes are not 1, 5 and 10 year mortality Pathophysiology of different disease processes may not allow for minimum data set across different procedures Many procedures not performed in hospital setting

61 Questions How do we get the information out of the patient s chart across different healthcare systems/ehr vendors? Will a PSO help us with institutional barriers (e.g. participant and data-use agreements)? Could a core minimum data set allow for patient linkages across women s health registries? Do we want to concentrate on a specific geographic location to allow for all-payer claims linkage (e.g. New York)?

62 All-Payer Claims Databases

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64 Collaborative Review of Female Contraception Therapies Nilsa Loyo-Berríos, PhD, MSc Deputy Director, Division of Epidemiology Office of Surveillance and Biometrics, CDRH, FDA Women Health Technologies CRN Think-Tank September 15, 2017

65 Outline Background CREST - Original New Contraception Technologies since CREST Public Health Need Final Remarks 2

66 Modern birth control movement originated in 1912 out of concern about the health effects of high fertility on women and their children 1910 s 1930 s 1960 s 1970 s 1990 s 2000 s Limited fertility- control methods available, primarily coital dependent (e.g. condom and withdrawal) More modern methods of contraception became available in the 60 s: the pill, IUD Women had more options for birth control: hormonal methods (many types of birth control pills, injectable methods), implants, contraceptive patches, rings, and IUDs In 2010 more than half of the pregnancies in the United States were unintended, rage 36% in Utah and 62% in Mississippi and the District of Columbia a a Kost K, Guttmacher Institute, 2015 Report, 3

67 Background Tubal ligation or occlusion has traditionally been referred to as female sterilization. In some settings, the term sterilization can imply an involuntary or coercive process. The term permanent contraception offers an alternative to recognize a woman s active and informed decision to complete childbearing. Patil and Jensen, Current Opinion in Obstetrics and Gynecology,

68 Background Permanent contraception (PC) is common procedure Worldwide: 20.6% - 35% a, b United States: 687,000 in 1995 to 643,000 in 2006 c PC Traditional Options Post-Partum Tubal Ligation Interval Laparoscopic Tubal Ligation and Occlusion Electrocautery by mini-laparotomy or laparoscopy a Peterson HB, Obstet Gynecol b United Nations, Department of Economics and Social Affairs, World Contraceptive Patters 2013 c Chan Lm and Westhoff CL Fertil Steril 2010 d Turkow, AL, J Minim Invasive Gynecol Nov;18(6, Supplement):S38. e Thiel J, Rattray D, Cher DJ J Minim Invasive Gynecol Nov-Dec; 21(6): f Xu B, et al, Reprod Biol Endocrinol Jul 7; 12():61. PC Alternatives Bilateral Total Salpingectomy Hysteroscopic Tubal Occlusion Requires HSG confirmatory test New Hysteroscopic PC Methods being explored Immediately effective and does not require back-up contraception nor a confirmatory HSG d, e Immediately effective and potentially reversible f Long-Acting Reversible Contraception (LARC) Methods Increase in popularity and accessibility 5

69 % Percentage of women who have ever used the specified contraceptive method (among women who have ever had intercourse) Female Permanent Contraception* Intrauterine Device (IUD) Norlpant or Implanon Implant 3-month Injectable (Depo-Provera) Contraceptive Patch Source: CDC National Survey of Family Growth, *Referred as Female Sterilization in the Survey 6

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71 Multi-center cohort study in the US 10,685 women who underwent tubal ligation 8 to 14 years of follow-up 10-year risk for pregnancy Cumulative life-table probabilities and proportional hazards models 8

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73 Public Health Need for Update on CREST Since New Contraception Therapies Implants Injectable methods Patches Rings IUDs 10

74 CREST II Sub-Group CREST II Working Group Afternoon Session Start discussion on core data elements Focus on elements unique to contraception Is DELPHI process needed? Methods/Design EHRs, Linkages? 11

75 Comments by CDC Representative Maura Whiteman, PhD CDC/ONDIEH/NCCDPHP

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77 Total Product Life Cycle (TPLC) Sharon Andrews Branch Chief Obstetrics and Gynecology Devices Branch 1

78 TPLC 2

79 Flexible Regulatory Paradigms Applied Across the Total Product Life Cycle FDA/CDRH Vision Patient-Centered, TPLC Approach Benefit-Risk Tradeoffs PMA, De Novo Benefit-Risk Determination Framework Guidance (2012) Postmarket Benefit-Risk Guidance (2016) Clinical Trials Evidence Generation Regulatory Science Real-World Evidence Premarket- Postmarket Balance Science of Patient Input Early Feasibility Study Paradigm Guidance (2013) IDE Benefit-Risk Determination Framework Guidance (2017) Bayesian Statistics (2010), Adaptive Trial Design (2016) Guidances MDDT Pilot Program RWE Draft Guidance (2016) Unique Device Identification Final Rule (2013) Expedited Access Pathway Program (2015) Balancing Premarket and Postmarket Data Collection Guidance (2015) Patient Preference Information Guidance (2016) Medical Device Innovation Consortium (MDIC) Patient Centered Benefit-Risk Project NEST MDIC 3

80 Potential Usages of RWE for Total-Product Life-Cycle Device Evaluation ❶ Hypothesis Generation (e.g. treatment effect estimation for comparative studies) ❷ Inform prospective trial design Prototype Innovation Clinical Real-World Evidence Post- Market Market Release ❸ RWE as a control arm for a pivotal IDE ❹ Real-world data source as a platform to support a clinical trial (data collection / randomization) ❺ Data collection framework for postmarket condition-of-approval studies ❻ Post-market surveillance ❼ Post-market RWE to support indication expansions based on real-world experience 4

81 UDI in Registries Terrie L. Reed, MS Industrial Engineering Senior Advisor for UDI Adoption Center for Devices and Radiological Health (CDRH) US Food and Drug Administration (FDA)

82 Overview Why UDI is important in registries The role UDI plays in real world data RAPID: Development of core data including UDI 2

83 Why UDI is important in registries 3

84 Current Device Identification Device Identification problems Capturing unstructured data at point of care Each registry captures ID data differently Reliance on manual updates from manufacturers No standards for categorizing Limited data on size and safety issues Device Identification Problems Value of UDI Auto-populate fields based on scanning or EHR transmission Standard data to compare across registries One source - manufacturers submit ; registries obtain Core ID data available for all devices Value of UDI 4

85 Enhancing Registry Data Registries can use UDI NOW to: Conduct Model-specific outcomes searches Lower cost for device data entry Auto-populate and improve accuracy of device data in registries 5

86 Current Challenges GUDID REGISTRY 1 REGISTRY 2 Name Value Name Value Name Value Device Identifier Brand Name Epic Vascular Device Type Epic Vascular Self Expanding Stent (120 CM shaft) Desc. Epic Vascular Stent System 9.0 mm x 100 mm Company Name BOSTON SCIENTIFIC CORPORATION Device Mfr Boston Scientific Mfr Boston Scientific Corporation Catalog Number H Product Number Model or Version H

87 The role UDI plays in real world data 7

88 What is a UDI? Required on the device label, packages or, in some cases, on the device itself Code in plain text and machine readable format (AIDC) UDI = DI + PI *+X999123ABC0 /$$ A1234/S1234/16D J* GS1 HIBCC

89 AccessGUDID Standard reference source for FDA regulated devices Manufacturer submits once for multiple purposes Replace text, non-standard data with meta-data in AccessGUDID

90 1,600,000 1,400,000 1,200,000 1,000, , ,000 GUDID Records and Submission Compliance Deadlines Data Current as of September 5, 2017 I/LS/LS Class II Class I & Unclassified 400, ,000 Class III 0 Sep-2013 Sep-2014 Sep-2015 Sep-2016 Sep-2017 Sep-2018

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93 UDI in Health Data Regulatory ONC EHR Certification, Companion Guides CMS - Meaningful Use, CCDS requirements Infrastructure 5 Standard Messages - HL7 FHIR, O&O, CCDA, IHE profiles 2 National Data Models FHIM, OMOP 13

94 UDI in Health Data Demonstrations and Early Adoption 14 Major EHRs Cerner, Epic, McKesson, Allscripts etc Multiple health systems and hospitals UDI in OR 410 members of AHRMM Learning UDI Community 1 Registry includes UDI (VQI) as Core Data 5 Active Demonstrations BUILD, CATNIP, SPARED, RAPID (SPEED), WHT 14

95 UDI in Real World Data Vendor Allscripts Allscripts CureMD.com, Inc. Epic Systems Corporation Epic Systems Corporation Software Allscripts Professional EHR Materials Management: Allscripts TouchWorks EHR Improved Recall Management CureMD SMART Cloud EpicCare Ambulatory EHR Suite EpicCare Ambulatory EHR Suite Nursing: Operating Room Efficiency Epic Systems Corporation EpicCare Inpatient EHR Suite Epic Systems Corporation Cerner Corporation MEDHOST Henry Schein Medical Systems EpicCare Inpatient EHR Suite Clinical Engineers: Improved Tracking FirstNet (Clinical) MEDHOST Enterprise MicroMD Vendor Netsmart Technologies McKesson Cerner Corporation SRS-Health Greenway Health, LLC Allscripts Allscripts Software myavatar Certified Edition Paragon for Hospitals 2015 Certified EHR PowerChart (Clinical) SRS EHR SuccessEHS Sunrise Acute Care Risk Management: Sunrise Ambulatory Care Medical Transcription Billing Corporation (MTBC) TalkEHR Evident Evident Quality: Workflow Improvements Information Systems: Meaningful Use Patient Safety Projects Researchers: Medical Device Registries Thrive EHR Thrive Provider EHR 15

96 RAPID and Informatics: Development of Core Data including UDI 16

97 RAPID Working Groups Rapid Clinical Expert Working Group Analyzed a pool of data elements currently collected by stakeholders and prioritized those applicable across use cases & PAD devices for the RAPID core data set. Rapid Informatics Working Group Developed a core set of metadata and related technical specifications needed to support implementation and adoption of the core data elements across registries and beyond. Rapid Global Unique Device Identifiers (GUDID) Integration Working Group Explored operational opportunities to adopt and demonstrate the usefulness the GUDID as a means for standardizing device data and improving the ability to link across peripheral device registries 17

98 RAPID Core Data Elements Clinical the core data elements, value sets and core metadata for each. FDA Device Problems Codes A list of the FDA Device Problem Codes, names, and definitions that are relevant to peripheral arterial vascular intervention devices. This list serves as the value set for data element Device Failure. Medications When the CDEs are leveraged for any future registry, evaluation, or research project, it is intended that medication administration data will be pulled from medical record documentation systems to support specific projects. Devices the UDI data elements as well as representative examples of device types used in the treatment of peripheral artery disease. 18

99 GUDID Integration Workgroup Identification of Core GUDID data elements for use by registries Understand importance of Global Medical Device Nomenclature (GMDN) to meet peripheral vascular device categorization goals Evaluate gaps in UDI data for registry purposes 19

100 UDI as part of RAPID Core Data Enter data ONCE to support data capture and device evaluation WL GORE Vascular Quality Initiative

101 UDI Integration: Steps to Consider Develop UDI registry team that includes Manufacturers, Registry Owners, Vendors, FDA, Clinicians Education on common UDI gaps and issues Identify medical devices covered by your registry using: Product code x Company x Brand x GMDN /SNOMED terms Run AccessGUDID reports to pull DI device records Match DI records to registry device master files Identify gaps, improve GUDID Use UDI and GUDID data in Registry 21

102 Reference 22

103 UDI Regulatory Dates Compliance Date Must bear a UDI & submit data to GUDID Direct Marking (for certain intended uses) September 24, 2014 Class III devices Devices licensed under the PHS Act September 24, 2015 Implantable, life-supporting and lifesustaining (I/LS/LS) devices LS/LS devices September 24, 2016 Class II devices Class III devices and devices licensed under the PHS Act September 24, 2018 Class I devices and unclassified devices Class II devices September 24, 2020 Class I devices and unclassified Intend to extend devices

104 Linking Data across Data Sources FDA GUDID via NLM DI PI Point of Implant Record Item Master DI PI DI PI FDA Device Recalls Implantable Device List DI PI Incident Report DI PI Care Documents DI PI FDA Adverse Event Reporting DI PI Registry DI PI

105 RAPID Clinical Core Data Elements 25

106 RAPID Problem Code Common Data Elements 26

107 RAPID UDI Core Data Elements 27

108 Patient Provider Order 1 Device-focused Procedure Flowsheet Application 2 Device :UDI Continuity of Care Document 2 Monitor UDI Device Data 4 Patient :MRN Procedure 5 28 Operator Device :UDI Community Provider 28

109 Supporting Measure Development: Resources from the National Library of Medicine (NLM) for the Women s Health Technologies CRN Project Lisa A. Lang, MPP Assistant Director, Health Services Research Information Head, National Information Center on Heath Services Research and Health Care Technology National Library of Medicine, National Institutes of Health U.S. Department of Health and Human Services September 15, 2017

110 Establish the foundation Define your terms Develop the tools Clarify the workflow Gather the evidence Involve the experts, including patients/affected clients Confirm and, if needed, request, availability of terms that express the preconditions, observations, treatments and outcomes in clinical or administrative terminologies Find, reuse or -- as a last resort -- build new assessments Consider the flow of data from clinical decision support needed to identify the cohorts, to quality/performance measures that track progress toward resolution/registry goal NLM Terminology Resources 2

111 Foundation: Gather the Evidence NLM is world largest biomedical library. 27 million citations to high quality science and health care/health services research in PubMed and PubMed Central NEW: increasing number of articles free/full text and will also have data, promoting reuse 3

112 HSRProj: Database of funded HSR-projects in progress; more than 33,000 records from 350+ funders ClinicalTrials.gov: registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. 4

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116 Forms Case Report Forms Assessment Instruments Protocols Measures CDEs Individual data elements Very granular Parts of a variable Author and share collections Develop collections of data elements and forms via boards Collaborate with peers Compare CDEs to CDEs and forms to forms Manage Collections Export for use in electronic data capture system Current: JSON, XML/SDC, XML/ODM, REDCAP, others Under development: FHIR

117 NLM Value Set Authority Center public tool Initially created and currently in use to support the CMS ecqm initiative Always intended to support a broader audience interested in Authoring, especially in collaborative arrangements (using VSAC Collaboration Management Tool). Benefits: NLM VSAC tools validate the codes within value sets and hold the value sets in a searchable public repository VSAC implements most recent terminology updates and provides these for the value set authoring community 9

118 The Reportable Condition Knowledge Management System (RCKMS) Clinical Decision Support Pilot and Project use the Value Set Authority Center to help build trigger condition value sets 10

119 Collaboration Case Study: Newborn Screening Coding and Terminology Guide Problem: How to create a nationally consistent computable set of measures related to newborn screening from 51 separate state sets that reflect local technology, policy and medical practices? Vocabulary and guidance needed to send newborn screening results electronically. Solution: A consensus-derived superset of measures, encoded in LOINC, etc. Each state can choose the subset that fits their needs but if they report a specific variable it must use the codes and approach designated for that variable. Guide links to other NLM resources, including Genetics Home Reference and UMLS. 11

120 Newborn Screening Coding and Terminology Guide: Linking Conditions/terminologies to Analytes/Measures 12

121 Thanks! Lisa A. Lang, MPP Assistant Director, Health Services Research Information Head, National Information Center on Heath Services Research and Health Care Technology 13

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123 Use of natural language processing tools -- NLM terminology services and concept synonymy -- to assess and extract meaning from biomedical free-text, such as clinical notes, and to uncover previously unseen relationships in published literature Example: DRUG treats DISEASE: metformin (UMLS Concept C ) TREATS diabetes mellitus (C ) is a semantic predication extracted from the phrase Treatment of diabetes mellitus with metformin. 15

124 CDE.NIH.GOV 16

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126 AdvaMed Registry Principles National Women s Health Coordinated Registry Network (CRN) Think-Tank September 15, 2017

127 AdvaMed Registry Principles Developed by registry experts Thorough review and approval by both regulatory and reimbursement industry experts Approved by AdvaMed Board in December 2013

128 Key Elements of Registry Principles Definition Objectives for a registry Threshold questions Data Governance Committee Well-balanced registry design Registry data use Policies for use/publication of data

129 Definition of a Registry...an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. * *Gliklich RE, Dreyer NA, eds. Registries for Evaluating Patient Outcomes: A User s Guide. (Prepared by Outcome DEcIDE Center [Outcome Sciences, Inc. dba Outcome] under Contract No. HHSA TO1.) AHRP Publication No. 07-EHC Rockville, MD: Agency for Healthcare Research and Quality. April 2007.

130 Objectives for a Registry Improve patient care and outcomes Evaluate real-world safety and/or effectiveness of products Improve patient access to new therapies Meet regulatory requirements for postmarket surveillance and coverage value analyses

131 Threshold Questions Is registry the least-burdensome means to collect necessary data to achieve the scientific objectives? Do objectives warrant the level of investment required to develop and maintain a registry? Are there reliable data collection instruments available to collect the data? Will registry have a stable and diverse source of funding to promote long-term sustainability?

132 Data Governance Committee Representation by all stakeholders Rules governing review and access to data should be established: Review and acceptance process for data requests and data analysis plans. Controlled process for data access/data release Guidelines for data transparency Process for device safety data reporting, including how information is shared with the manufacturer

133 Well-Balanced Registry Design Research purpose hypothesis-based designs Collection of information definitions for success and failure Appropriate quality plan for monitoring, auditing, validation Collection of sufficient data to allow risk adjustments Defined process for considering changes after initiation of registry

134 Registry Data Use Industry financial support Company access to its own data and aggregate data Safety signals identified Reported to company for further investigation Regulatory bodies seek input from company before taking regulatory action based on registry data

135 Policies for Stakeholder and Outside Use of Data and Publication Data shared upon request by qualified scientific/medical researchers for purposes benefiting public health or patient care. System to manage process for reviewing requests Policies for use and publication of registry data Policies to protect against unauthorized use of data