FORCE-TJR 2015 Annual Report · After successful TKR, patients achieve pain relief in their...

FORCE-TJR 2015 Annual Report

University of Massachusetts Medical School Department of Orthopedics and Physical Rehabilitation

T: 855 993 6723 (855 99FORCE) E: force-‐[email protected] W: www.force-‐tjr.org

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FORCE-TJR

2015 Annual Report | 2

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FORCE-TJR 2015 Annual Report

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Executive Summary

The 2015 FORCE-‐TJR Annual Report celebrates two major milestones: (1) the successful completion of the AHRQ funding period and (2) the introduction of the new FORCE VALUE management system. 1. Celebrating initial FORCE-‐TJR accomplishments FORCE-‐TJR exceeded the original goals of the AHRQ award (2010-‐2015). We summarize the major research and registry accomplishments that serve patients, surgeons, hospitals, insurers, implant manufacturers, and policy leaders. Our Bibliography includes more than 30 publications (with dozens more in the queue), and more than 100 presentations at scientific meetings across the globe. In the past year, we received five (5) federal research awards to continue our innovative comparative effectiveness research. Beyond research, clinicians and hospitals use the FORCE-‐TJR data and infrastructure to improve quality of care. Specifically:

• FORCE-‐TJR is the first US national cohort of TJR patients with risk-‐adjusted outcome norms for representative, diverse practices (e.g., urban and rural, high and low volume), and patients of all ages. Because the new CMS Comprehensive Joint Replacement program was informed by the FORCE-‐TJR risk factors and adopted identical outcome measures, FORCE-‐TJR benchmarks are critical for CJR hospitals.

• Hospitals and surgeons use the FORCE-‐TJR infrastructure to monitor quality of care, including readmissions and complications across 90 days that occur at any hospital and patient-‐reported pain relief and functional gain.

• FORCE-‐TJR is designated a CMS Qualified Clinical Data Registry so that reporting hospitals/surgeons receive incentive payments from CMS quality programs.

• FORCE-‐TJR data submission meets the American Board of Surgeons maintenance of certification requirements for orthopedic surgeons.

• FORCE-‐TJR is collaborating with FDA to monitor implant survivorship, as FORCE-‐TJR matches implant components to the international library.

2. Introducing FORCE VALUE management system We are excited to introduce the interactive FORCE VALUE management system to guide optimal patient care across the episode of surgery and recovery. The core FORCE-‐TJR attributes of expert data collection, real-‐time reports, and risk-‐adjusted benchmarks are included to serve surgeons and hospitals managing episodes of care from hospital to home. In addition, new process monitoring and improvement tools will assure efficient post-‐discharge utilization management in the new bundled payment environment. Finally, these tools go beyond TJR to other high volume orthopedic conditions including shoulder replacement and spine. Please contact us to discuss how FORCE-‐TJR and FORCE VALUE management can support you! Sincerely, Patricia D. Franklin, MD MBA MPH David C. Ayers, MD

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CONTENTS

Executive Summary 3

FORCE-TJR Accomplishments (2010-2015) 6

PolicyinformedbyFORCE-TJRanalyses 6

PROImplementationexpertiseforTJRandbeyond 6

FORCE-TJRRegistryaccomplishments 6

FORCE-TJRComparativeEffectivenessResearch 8

The future: FORCE VALUE Management System 9

Highlights from new FORCE-TJR research 11

PROImplementationframeworktoguidesuccessfulcapture 12

Post-TJRreadmissionsareassociatedwithpoorerfunctionalgainafterTJR 13

AftersuccessfulTKR,patientsachievepainreliefintheirnon-operativehipsandknee 14

Post-TKRbenefitsdemonstratedacrossdiversepre-operativeprofiles 15

Today’sTJRpatientsareyounger,heavier,andjustasdisabled 16

PatientswithhighBMIreportsignificantfunctionalimprovementafterTJR 17

Appendices 19

Appendix1.FORCE-TJRBibliography 19

Appendix2.HowFORCE-TJRDiffersfromotherRegistries 27

Appendix3.FORCE-TJRDataElements,CohortSummary 28

Appendix4.FORCE-TJRMethods/DataQuality 29

Appendix5:FORCE-TJRPublicationsandAncillaryStudiesCommitteeProcedures 31

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The FORCE-‐TJR Team

Data and Research Director: Patricia D. Franklin, MD

Orthopedic Director: David C. Ayers, MD Chair, National Stakeholder Committee

Operations Team

Christina P. Bond, MS Celeste Lemay, MPH RN Maria Polsinelli Betsy Costello Kim Smith Michael Kenny Rebecca Sullivan Kim Baczko Cynthia Lindgren

Scientific Team

Patricia Franklin, MD MBA MPH Wenjun Li, PhD Hua Zheng, PhD Wenyun Yang, MS UyenSa Nguyen, DSc Barbara Gandek, PhD John Ware, PhD Jeroan Allison, MD MS Norman Weissman, Ph.D.

National Stakeholder Committee

Graphic Design and Report: Sylvie Puig, PhD

Jeroan Allison, MD MS University of Massachusetts Medical School

Elise Berliner, PhD Agency for Healthcare Research and Quality (AHRQ)

Patricia Franklin, MD MPH MBA University of Massachusetts Medical School

Deborah Freund, MPH MA PhD Claremont Graduate University (PORT-‐TKR)

Terence Goie, MD University of Minneapolis, VA (AAOS/AJRR)

Gillian Hawker, MD MSc FRCPC University of Toronto, Ontario, Canada

William A Jiranek, MD VCU Health System (Knee Society)

Norman Johanson, MD Drexel University College of Medicine (Hip Society)

Catarina Kiefe, PhD MD University of Massachusetts Medical School

Courtland Lewis, MD Hartford Hospital (AAHKS)

Danica Marinac-‐Dabic, MD PhD Food and Drug Administration (FDA)

Joan McGowan, PhD National Institutes of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Mark Melkerson, MS Food and Drug Administration (FDA)

Carol Oatis, PT, PhD Arcadia University

Jyme H. Schafer, MD MPH Center for Medicare and Medicare Services (CMS)

Patricia Skolnik, MSW Citizens for Patient Safety

Paul Voorhorst, MS MBA DePuy Orthopaedics, A J&J company

Jing Xie, PhD Biomet, Inc.

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FORCE-TJR Accomplishments (2010-2015)

TheAHRQawardexplicitystatedthatFORCE-TJRshouldservebothasaTJRqualityandoutcomesregistryandasacomparativeeffectivenessresearchprogram.FORCE-TJRwentbeyondthesegoalstoinformCMSpaymentpolicyandtobuildgeneralizablePROimplementationstrategies.

Policy informed by FORCE-TJR analyses

• CMS/CMMIValue-basedpaymentinTJR.FORCE-TJRanalysesinformedtherisk-adjustmentandoutcomemeasuresforthe2016CMS/CMMI implementationofthemandatoryTJRvalue-basedpaymentsystemin67USmetropolitanareas (Comprehensive Care for Joint Replacement program). Comprehensive risk-adjustment for readmissions,complications, and patient-reported outcomes is essential to assure equitable comparisons across hospitals and tosupportuniformpatientaccesstoTJR.Inaddition,theFORCE-TJRcohortwasusedtovalidatebriefpatient-reportedmeasures (HOOS/KOOSJR).Thus, theFORCE-TJRproduces risk-adjusted,nationalnorms for the twoCJRpatient-reportedoutcomemeasures:HOOS/KOOSJRandthefullHOOS/KOOS.

• US/CMS and UK comparison of patient-reported outcomes in TJR. FORCE-TJR data were highlighted in a CMS-sponsoredcomparisonofpatient-reportedoutcomesbetweentheUSandUnitedKingdomforobeseandnon-obesepatients.TheanalyseswerepresentedattheHealthcareDatapaloozainJune2015.

• FDAandMDEpiNet. FORCE-TJR, in collaborationwithWeill Cornell and other regionalUS registries,will formanorthopedicnetworktomonitorTJRimplantoutcomes.Uniquely,FORCE-TJRwillassesstheroleofpatient-reportedpainandfunctionthroughanewphoneAPPtomonitorearlyimplantfailure.

• InternationalConsortiumofHealthOutcomeMeasures (ICHOM).TheFORCE-TJRPI (Franklin) leadan internationalosteoarthritisandTJRworkgroupofexpertstoendorseanoutcomemeasuresetandcollectionmethods.Ofnote,theICHOMOsteoathritis/TJRmeasuresetparallelsthecoreFORCE-TJRmeasures.

PRO Implementation expertise for TJR and beyond The collection of complete longitudinal outcome data is critical in this era of value and qualitymeasurement.

FORCE-TJR’s unique direct-to-patient outcome methods, refined web-based infrastructure, and novel risk-adjustedoutcome reporting system achieved 85% complete data over the first year. No other US registry reports this level ofcompleteness.While the InternationalSocietyofArthroplastyRegistriesexpectsover 70% long-termdata for sufficientdataquality,otherUSregistriesarereporting20-40%response.SpecificFORCE-TJRproductstoimprovePROcollectionmethodsinclude:

• PRO implementation framework for all conditions.With funding from AHRQ, and in collaboration with AcademyHealth’sElectronicDataMethodsteamandotherUSregistries,FORCE-TJRinvestigatorsdevelopedaframeworktoguideimplementationofPROs.Basedoninterviewswithmorethan30PROleadersinmedical,surgical,pediatric,andbehavioralhealthfields,thisframeworkguidesplanningandimplementationforcliniciansandhospitals.

• APP for PRO collection. With AHRQ and FDA funding, the FORCE-TJR team is converting direct-to-patient PROcapturethroughasimplephoneAPP.Patientandclinicianfocus-groupsinformedtheusabilityanddesign.EarlyAPPtestinginunderwaywithtestdeploymentthisyear.

• PROs inpharmaceuticaloutcomes.FORCE-TJRwill support thePROanalyses in the team implementing thenewlyfunded PCORI pragmatic trial to assess comparative effectiveness of three different anti-thrombotic prophylacticmedicationsinTJRpatients.

FORCE-TJR Registry accomplishments Since October 2010, the Function and Outcomes Research for Comparative Effectiveness in Total Joint

Replacement(FORCE-TJR)registryhasbeenaUSleaderinTJRoutcomemeasurement.Byfall2015,theoriginalAHRQ-

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funding goals were achieved with data from more than 25,000 patients collected from a representative sample of more than 200 surgeons in 28 states. Sites and surgeons were selected to assure that the FORCE-‐TJR national norms represent the profile of patients and surgeons in the US today. Thus, FORCE-‐TJR has the only risk-‐adjusted, US national benchmarks for peri-‐operative adverse events, patient-‐reported outcomes, and early implant failure in all US patients. Of note, these are the only national outcome data available for the 48% of TJR patients who are under 65 years of age. The FORCE-‐TJR data collection and analytic methods informed the recently announced CMS mandatory bundled payment program for TJR. While this report includes early data and lessons, registry data become even more valuable over time as the natural history of the patient and implant outcomes emerge. Thus, FORCE-‐TJR’s foundation will inform TJR best practice and outcomes for years to come.

FORCE-‐TJR is a comprehensive registry generating high value TJR care and new knowledge of best practice guidelines to meet the goals of diverse stakeholders.

1. For Patient Care Delivery: While electronic medical records systems struggle to collect, score, and trend patient-‐reported outcomes (PROs)

over time, FORCE-‐TJR offers real-‐time scoring and pain and function trends. Real-‐time patient-‐reported outcome scoring allows the patient and surgeon to view trended pain and function (both decline and improvement) before and after TJR.

• Before surgery, patient pain and function scores can be compared to national TJR norms to guide timing for surgery.

• After TJR, pain relief and functional gain can be quantified and care tailored to support optimal recovery. Finally, with AHRQ funding, FORCE is developing a phone APP to guide shared decision-‐making when faced with a TJR decision. TJR patients express enthusiastic support for web-‐based and phone data support methods: “When he [the surgeon] saw the PRO survey, he saw how my function was, how bad it was… without the survey he wouldn’t have known.” Patient, age 72, TKR, PA “It’s important to participate [in FORCE-‐TJR] so that people who have knee replacements in the future can benefit from my experience.” Patient, age 53, TKR, MA

2. For Surgeons and Hospital Quality Monitoring: FORCE-‐TJR includes benchmarks that match those measures included in the CMS/CMMI pilot proposal (CJR).

Sites in the 67 mandatory bundled payment regions can receive reimbursement for collecting FORCE outcome measures. • The revised FORCE-‐TJR secure MD Website delivers quarterly outcome reports to answer three critical questions

that previously surgeons could not answer: (1) How do my patients’ pre-‐operative risk profiles compare to other surgeons? (2) How does the timing of my patients’ surgery, as described by pain and functional limitations, compare to national practice? (3) Is the degree of pain relief and improved function in my patients comparable to the national norm?

Orthopedic surgeons express appreciation for these methods: “Again, thank you for allowing us to participate in what I feel will be of significant value to the quality of care that joint replacement surgery can offer to the public. Also, all three of us, and our nurse manager, thank you for managing this effort so effectively.” Surgeon, OK.

3. For Insurer Value Monitoring: • CMS initiated public reporting of post-‐TJR readmissions and complications in 2014. In collaboration with AAHKS,

FORCE-‐TJR significantly improved the risk-‐adjustment readmission models so that members receive risk-‐adjusted comparative reports to support quality improvement before these data are publicly reported.

• Private insurers anticipate using pre-‐operative PROs as one way to determine appropriate use of TJR. FORCE-‐TJR is deploying new decision-‐support tools to guide surgeons and patients in the clinic before payer review.

4. For FDA and industry implant monitoring:

• The FORCE-‐TJR data provide early post-‐marketing surveillance data. In contrast to registries that solely define

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implant failure as revision surgery, FORCE-‐TJR surveillance includes post-‐TJR implant complications and patient-‐reported pain, both events that precede revision surgery. FORCE is now monitoring implant performance using direct-‐to-‐patient assessment strategies for implant manufacturers.

• Implant evaluation. The comprehensive FORCE-‐TJR clinical and patient data are merged with the international library of implant design and materials to evaluate outcomes associated with varied implant characteristics. Outcomes of specific implants are now being monitored.

FORCE-TJR Comparative Effectiveness Research

Generating new knowledge to guide best practice: FORCE-‐TJR comparative effectiveness research.

• Defining a practical, but precise, brief PRO. To minimize patient response burden, ideally, a subset of PRO items will reliably generate knee and hip PRO scores. However, it is important to maintain the specificity of current measures for pain and function in any brief form. As a first step toward deploying brief surveys, FORCE-‐TJR data validated the recently developed HOOS JR and KOOS JR. (See Bibliography). Second, a new 2016 AHRQ award to the FORCE-‐TJR team will develop and validate brief knee and hip scores to monitor function and pain and retain the specificity of the long forms. The resulting surveys will be available next year to efficiently collect pain and function while maintaining specificity and comparability to legacy (long) versions.

• Defining patients at risk for readmission. The sub-‐group of patients with early readmissions also has poorer functional gain. Identifying this high-‐risk patient group is important to reduce morbidity and financial risk in an era of bundled payments. FORCE-‐TJR publications in the Journal of Bone and Joint Surgery and other orthopedic journals are disseminating methods to define high-‐risk patients and analyze comparable outcomes (see Bibliography). These methods were recently presented at the AAOS-‐CMS summit on patient-‐reported outcomes to guide the CMS bundled payment pilot program.

• Defining sub-‐groups of patients at risk for early revision. Using implant data and patient-‐reported outcomes, FORCE-‐TJR is evaluating outcomes of patients with different implant components and fixation techniques. FDA funding will extend the implementation of new methods.

• Defining outcome benchmarks for patients under 65 years of age. Some believe the shift to a younger TJR population suggests a less complex patient pool, but FORCE-‐TJR data dispute this assumption. Younger patients report the same, or greater, joint-‐specific and global pain and decreased function pre-‐operatively compared to older adults. In addition, patients under 65 years of age are more obese and more likely to smoke as compared to older patients. For the first time, FORCE-‐TJR has national norms for pre-‐operative and post-‐operative pain and function in these working aged adults who are the fastest growing users of TJR.

• Optimal patient timing of TKR and THR. In contrast to recent public reports suggesting that one-‐third of TKR procedures may be “inappropriate,” FORCE-‐TJR’s patient-‐reported data illustrate that the vast majority of today’s TJR patients have advanced disability and severe knee or hip pain at the time of surgery. However, approximately 8% of TKR and THR patients report few symptoms at the time of TJR prompting further exploration about surgical indications and appropriateness in this sub-‐group.

• Defining impact of co-‐existing lumbar spine and contralateral joint disease on outcomes. The burden of musculoskeletal comorbidities, specifically moderate or severe pain in the lumbar spine and non-‐operative hips and knees, negatively affects self-‐reported function at 6 months after both TKR and THR. Future public comparisons of PROs after TJR must adjust for co-‐existing musculoskeletal conditions.

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FutureFORCE-TJRresearchIn the next years, using 2-5 year outcomes on 25,000 FORCE-TJR patients, we will evaluate the interactions

among patient-comorbidity-implant factors in key patient sub-groups to define tailored best practices associatedwithpersistentpost-operativepain relief, functional gain, andminimalpost-TJRadverseevents. FORCE-TJR cohortpatientsagreetoannualassessmentsforthenext20years.

FORCE-TJRBibliographyThe current FORCE-TJR Bibliography is included in Appendix 1. Since the initial overview paper published in

JAMA, 30manuscripts have been published (with additional papers under review) in diverse journals serving primarilyorthopedicsurgeonsandresearchmethodologists. Inaddition, fiveancillary researchgrantswereawarded fromAHRQ,PCORI,FDA,andNIHandsixmoreapplicationsareunderreview.Finally,morethan100internationalandnationalpeer-reviewed abstracts have been presented at diverse professional meetings serving orthopedics, rheumatology, publichealth,healthservicesresearch,psychometrics,andinformatics.

FORCE-TJRMembershipModelwillexpandpatientdataToassuresustainabilityof theFORCE-TJR infrastructure,paidFORCE-TJRmembershipsarenowopentoUSand

international hospitals and surgeons committed to high-value care. In the first months after offering membership, thenumberofsurgeonsparticipatinginFORCE-TJRgrewby40%,andmembershipcontinuestoclimb.Thefirstinternationalparticipant just joined.Memberhospitalsandsurgeonsreceivethesamerisk-adjustedbenchmarksastheinitialFORCE-TJRsiteswhilecontributing largernumbersofTJRprocedures fromevenmorediversesettings.TheFORCE-TJRcohortcontinuestogrow!

The future: FORCE VALUE Management System

Theintroductionofbundledpaymentprogramsbringsnewresponsibilitiesandrisksforhospitalsandaffiliatedorthopedicsurgeons.Hospitalsandsurgeonsarecollaboratingtomanagethetotalcareandresourceuseacrossthe90daysofthesurgicalepisode.Pre-operativerisk-profilesarethefirststepinselectingandpreparingpatientsforTJRsurgery,tailoringin-hospitalandpost-dischargecare,andguidingrehabilitation.TheoriginalFORCE-TJRmodelhasbeenadaptedinthreeimportantwaystomeetthesenewdemands,forhipandkneereplacement,shoulder,andspinecare.

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The FORCE VALUE Management System includes:

1. REAL-‐TIME PRE-‐OPERATIVE risk factor profiles to tailor patient care and improve outcomes.

a. Inform shared decisions: Patient-‐reported pain and function guide timing and use of TJR.

b. Tailor peri-‐operative and post-‐discharge care: Medical and musculoskeletal risk profiles inform surgical preparation and peri-‐operative care to minimize complications.

c. Optimize in-‐home post-‐discharge care and rehabilitation needs.

2. EPISODE MANAGEMENT: In hospital and post-‐discharge monitoring reports to minimize emergency room use or hospital readmission.

a. Manage across the 90 day episode with new web-‐based surveys to integrate monitoring data from hospital to home and rehabilitation.

b. Prioritize staff coordination activities using new reports based on known risk factors, in-‐hospital experience, and patient and clinician reports.

3. ASSURE BEST PRACTICES: FORCE supports best practices in two ways:

a. Risk-‐adjusted national comparative outcome reports will anticipate your performance in public reporting and CMS initiatives.

b. FORCE consultation and training for your clinical team to assure complete pre-‐operative and post-‐operative data collection, including optimal use of the new real-‐time episode monitoring tools.

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Highlights from new FORCE-TJR research In the following pages, we present brief summaries of recently reported findings from FORCE-‐TJR research, including:

§ PRO Implementation Framework to guide complete data capture in orthopedics and other conditions

§ Post-‐TJR readmissions are associated with poorer global function after TJR

§ After successful TKR, patients achieve pain relief in their non-‐operative hips and knee

§ Post-‐TKR benefits demonstrated across diverse pre-‐operative profiles

§ Today’s TJR patients are younger, heavier, and just as disabled

§ Patients with high BMI report significant functional improvement after TJR

In addition, we include a new summary document on ‘How to Select a TJR Registry’: guidelines from the FORCE-‐TJR team.

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PRO Implementation framework to guide successful capture As the value of patient reported outcomes (PROs) expands, a framework to guide the planning, collection, and use of PROs to serve multiple goals and stakeholders is needed. To define this framework, registry leaders from FORCE-‐TJR, SCOAP (spine), Kaiser Permanente, and California identified diverse clinical, quality, and research settings where PROs have been successfully integrated into care and routinely collected and analyzed. Unifying themes emerged from these successful examples in behavioral health, primary care, oncology, orthopedics, pediatric gastroenterology, and neurology. The proposed framework will guide future PRO implementation efforts across learning healthcare systems to assure that complete PROs are captured at the correct time, and with associated risk factors, to generate meaningful information to serve diverse stakeholders. (Funded by AHRQ through Academy Health Electronic Data Methods.)

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Post-TJR readmissions are associated with poorer functional gain after TJR CMS is publicly reporting 30 day readmission rates after total joint replacement (TJR) by hospital and is planning to add patient-‐reported function and pain. On average, 5% of TJR patients are readmitted to the hospital after surgery for medical or orthopedic-‐related issues. FORCE-‐TJR data for primary TJR patients from over 150 surgeons practicing in 22 states and who were over 65 years were identified. Overall 4.7% of patients were readmitted; 2.0% due to limb related diagnoses. Readmitted patients had significantly greater number of medical comorbidities; more severe OA in non-‐operated knees and hips; were more likely to smoke; and have poorer pre-‐TJR function (all p<0.05). The FORCE-‐TJR readmission model predicted 80-‐85% of readmissions. See figures below. CMS patients with readmissions within 30 days have significantly poorer mean global function at 6 months than patients without readmission. More readmitted patients had poor global function (PCS<30= 14%) as compared to patients with no readmission (8%; p<0.008) but knee/hip function was similar in both groups. Joint pain improvement did not differ by readmit status. These data support the importance of joint-‐specific PRO measures to assess TJR outcomes in quality of care programs.

Figure 1. Primary TKR risk model predicts 80% of Readmissions

Figure 2. Primary THR risk model predicts 85% of Readmissions

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Area under ROC curve = 0.7971

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Area under ROC curve = 0.8596

Patients who were readmitted were more likely to report poor global function at 6 months after TJR.

Ayers, Fehring, Odum, Franklin. Using Joint Registry Data from FORCE-‐TJR to Improve the Accuracy of Risk-‐Adjustment Prediction Models for Thirty-‐Day Readmission After Total Hip Replacement and Total Knee Replacement. J Bone Joint Surg Am, 2015 Apr 15; 97 (8): 668 -‐671 .

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After successful TKR, patients achieve pain relief in their non-operative hips and knee To assess the effect of successful TKR on short-‐term pain relief of the non-‐operated joints (hips and contralateral knee), we evaluated the change in pain in each joint after TKR. We found that patients who undergo TKR may achieve pain relief in their non-‐operated hip and knee joints. Those patients who report moderate to severe pain levels are more likely to experience improvement, in up to 78% of the cases. It is possible that these patients are able to unload the remaining non-‐operated joints at 6 months and rely more on their TKA during their activities of daily living.

Approximately 15% of the patients who were pain free in their non-‐operative joints developed worsening pain

Variable Reported no Pain Prior to TKR Reported Worsening Pain (was pain free prior to TKR)

Contralateral hip 61% 12%

Ipsilateral Hip 50% 11% Contralateral Knee 14% 20% Patients with severe preoperative pain in their contralateral hip had the greatest chance of improvement Contralateral Hip HOOS Baseline Pain Score

% of Patients with Improvement Chi-‐square p-‐value

Mild 49% 55.98 p<0.0001 Moderate 77%

Severe 86% Patients with severe preoperative pain in their ipsilateral hip had the greatest chance of improvement Ipsilateral Hip HOOS Baseline Pain Score


Mild 59% 54.39 p<0.0001 Moderate 81%

Severe 89% Patients with severe preoperative pain in their contralateral knee had the greatest chance of improvement Contralateral Knee KOOS Baseline Pain Score


Mild 35% 239.81 p<0.0001 Moderate 63%

Severe 79%

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Post-TKR benefits demonstrated across diverse pre-operative profiles We examined 6-‐month change in pain, function, and quality of life (QOL) by pre-‐surgery pain and function profiles. More than 91% of TKR patients report significant pain and/or limited function before surgery. We found that patients with high pain and poor function pre-‐TKR had the greatest mean improvement in pain relief and function 6-‐month post TKR. Also, while TKR patients with little pain and high function at baseline had the lowest mean change in pain and function, they reported better absolute outcomes 6-‐month post TKR. Finally we found that there was much improvement in QOL across all groups by 6 month post TKR.

Clinical Characteristics by Pre-‐TKR Pain and Function

Group 1 Little Pain / High Function n=234 (5%)

Group 2 Little Pain / Poor Function n=173 (4%)

Group 3 High Pain / High Function n=718 (16%)

Group 4

High Pain / Poor Function n=3,288 (75%)

Pain & Function Status 6-‐mth Post-‐TKR Remained in Same Classification Group Optimal Improvement > to Little Pain-‐High Function Worst Decline > to High Pain-‐Poor Function

85% NA 4%

25% 65% 6%

11% 79% 7%

18% 52% NA

6-‐month Change in Pain Pain, KOOS Mean (SD)-‐Pre Pain, KOOS Mean (SD)-‐Post Change over 6 months Mean (SD) Unadjusted Mean Differences Unadjusted Standardized Differences, ES*

80.6 (7.8) 88.8 (13.1) 8.2 (14.6)

REF REF

79.4 (7.5) 89.8 (11.4) 10.5 (13.0)

2.3 0.1

54.0 (11.3) 84.4 (14.5) 30.4 (16.7)

22.2 0.3

42.8 (14.3) 79.9 (17.3) 37.2 (19.6)

29.0 0.6

6-‐month Change in Function Function, SF36 PCS, Mean (SD)-‐Pre Function, SF36 PCS, Mean (SD)-‐Post Change over 6 months Mean (SD) Unadjusted Mean Differences Unadjusted Standardized Differences, ES*

47.4 (4.7) 49.9 (7.5) 2.5 (7.8) REF REF

34.0 (4.4) 44.0 (8.5) 10.0 (7.8)

7.5 0.7

44.5 (3.6) 49.4 (6.9) 4.8 (6.9)

2.3 0.1

30.1 (6.0) 41.9 (9.5) 11.8 (9.0)

9.3 0.9

6-‐mth Post-‐TKR Self-‐Evaluated Transitions Better Health compared to 1 year ago-‐ More Capable everyday physical activity More able to accomplish daily work Better Health compared to before surgery

60% 79% 79% 60%

53% 79% 78% 56%

62% 82% 78% 63%

63% 82% 78% 65%

Quality of Life (QOL) Issues Pre-‐ and Post-‐TKR Awareness Knee Problem Daily/Constantly-‐Pre Awareness Knee Problem Daily/Constantly-‐Post Pain Frequency Daily/Always-‐Pre Pain Frequency Daily/Always-‐Post

87% 46% 47% 19%

92% 52% 55% 16%

99% 55% 94% 28%

100% 65% 98% 35%

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Today’s TJR patients are younger, heavier, and just as disabled At the time of TKR and THR, younger (<65) patients have fewer medical illnesses, but higher rates of obesity and smoking as well as lower mental health scores compared to older (>65) patients. Younger patients have the same or greater joint specific and global functional impairment compared to older patients, which suggest that surgeons use comparable standards for selecting TKR and THR candidates in younger and older adults.

THR PATIENTS TKR PATIENTS

Characteristics Age <65 Age ≥65 p value Age <65 Age ≥65 p value Gender (% female) 47.5 52.5 0.012 61.7 63.1 0.307 BMI (mean ) 29.9 28.5 0.000 33.1 30.5 0.000 Race: nonwhite (%) 9.7 5.3 0.000 13.1 6.6 0.000 Smoking status (%) current past never

13.2 33.7 53.0

3.4 48.9 47.7

0.000 10.2 33.7 56.1

2.8 45.3 51.9

0.000

Baseline sf-‐36 PCS (mean )

31.2 31.5 0.300 32.0 33.0 0.000

Baseline sf-‐36 MCS (mean ) 48.4 51.5 0.000 49.1 52.6 0.000

Charlson comorbidities index (%) 0 1 2-‐5 >=6

66.0 17.8 7.8 8.4

49.1 21.1 12.0 17.9

0.000

57.9 21.7 11.9 8.5

45.8 23.1 13.5 17.7

0.000

Pain in non-‐operative hip/knee joints (%)*

37.6 35.7 0.237 38.2 31.1 0.000

*Based on the HOOS/KOOS

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Patients with high BMI report significant functional improvement after TJR

At 6 months after THR, all patients reported significant functional gains although patients with BMI>35 had lower mean functional gain than those with BMI≤35. All patients reported excellent pain relief. At 6 months after TKR, severely obese patients (BMI>35) reported improvements in both pain and function equal to or greater than patients with BMI≤35.

THR Patients TKR Patients

Baseline 6 month Delta Baseline 6 month Delta

% SF Physical function (Mean) % SF Physical function (Mean)

Under/normal weight 26% 32.4 46.5 14.1 13% 35.2 44.7 9.5

Overweight 37% 32.7 45.7 13.1 33% 34.3 44.2 9.9

Obese 22% 30.2 44.8 14.6 29% 33.0 42.3 9.3

Severely obese 10% 28.3 41.2 12.9 15% 31.3 41.1 9.8

Morbidly obese 4% 26.6 39.6 13.0 9% 29.9 40.4 11.0

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SELECTING A TOTAL JOINT REPLACEMENT REGISTRY

FORCE-TJR QI brings comprehensive TJR registry outcomes (patient-reported measures, readmission and complications, and implant failures) FORCE-TJR QI is a national leader in risk-adjusted outcome analyses and benchmarks. Below is a checklist to help you (1) define your registry needs, (2) illustrate how specific functions can assist you, and (3) guide your questions when selecting a registry to meet your needs.

Hospital/Surgeon needs Required strategies/solutions FORCE-TJR QI

1. Manage TJR utilization and outcomes to meet CJR and bundled payment goals.

Registry system follows the patient across time and locations, and is not linked to the hospital. Example: FORCE-TJR QI system is web-based and starts in the surgeon office captures data in the hospital, and for 12 months after TJR.

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a. Capture complete risk factors BEFORE surgery to guide patient pre-operative preparation and minimize risks.

Registry system returns data immediately in scored, trended format with national norms to support decisions. Example: FORCE-TJR QI Patient Risk Summary is generated real-time prior to surgery. It includes medical, emotional, and musculoskeletal risk factors, trended pain and function before surgery, and social needs.

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b. Capture pre-operative preparation steps, in-hospital events, and post-discharge monitoring to flag at-risk patients.

Registry system supports patient and clinician data entry, including process measures that address family, social supports, and in hospital needs. Example: FORCE-TJR QI coordinated care system integrates clinical observations and pre-operative risks to flag patients requiring close post-discharge follow-up.

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c. Capture >70% of post-TJR outcomes at all locations

Registry system tracks and delivers PROs at9-12 months after surgery and successfully captures more than 70%. Example: FORCE-TJR QI is the only registry in the US that has successful capture rates >80% and offers training for hospitals and surgeons to replicate this rate.

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2. Provide risk-adjusted national benchmarks to guide quality improvement and anticipate public reporting.

a. Risk-adjusted readmission rates Registry has statistical risk-adjustment models based on CMS that will display readmit rates to be publicly released. Example: FORCE-TJR has the most comprehensive risk-adjusted measures— no waiting to see public reports. In fact, CMS plans to adopt the additional FORCE risk factors.

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b. Risk-adjusted PRO measures Registry provides norms and risk-adjusted PRO measures to guide care. Example: FORCE-TJR QI is the ONLY US registry with risk-adjusted PRO measures! ✔

c. Risk profiles to understand how your patients differ from national norms

Registry has a statistical sample of US patients—not just a convenience sample—that represents the total US TJR population. Example: FORCE-TJR QI was funded to build national norms and is the only software that includes a sample of surgeons and patients that truly represents the US. Thus, benchmarks reflect true US practice.

✔3. Collect data once and meet multiple goals

and regulatory requirements.

a. CJR and bundled payment metrics Registry collects ALL CJR pilot measures and has national norms for benchmarking. (No additional data collection required).

Example: FORCE-TJR informed what measures should be collected to allow for national norms and risk-adjustment.

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b. PQRS incentives Registry collects measures that will meet ALL PQRS expectations. Example: Our 16 QCDR approved measures are all PROs and include both process and outcome measures across 3 NQS Domains.

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c. ABOS Maintenance of Certification Registry collects outcomes that will meet ALL ABOS maintenance of Certification expectations. Example: No additional work required FORCE-TJR QI collects and meets all ABOS.

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d. JCAHO standards for Excellence Registry collects all measures required for JCAHO Excellence. Example: FORCE-TJR QI collects PR functional status on pre-op patients ✔

Choosing the best TJR registry to meet your needs can be challenging. All registries are not alike; each has different data collection resources, reporting, and analytic capabilities.

Feel free to call us if we can assist you in understanding these criteria and selecting a TJR outcome registry. 1-855-993-6723

Copyright 2015 FORCE-TJR/University of Massachusetts Medical School

Copyright 2015 FORCE-‐TJR / University of Massachusetts Medical School

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Appendices

Appendix 1. FORCE-TJR Bibliography

PUBLICATIONS

1. Nguyen USDT, Ayers D, Li W, Harrold L, Franklin PD. Pre-‐operative Pain and Function: Profiles of Patients Selected for Total Knee Replacement. (Submitted)

2. Franklin PD, Miozzari H, Christofilopoulos P, et al. Important Patient Characteristics Differ Prior To TKA And THA Between Switzerland And The United States. Acta Orthopaedica. (Submitted)

3. Harrold L, Ayers D, Li W, Franklin PD. Differences In Total Hip Replacement Outcomes Based On Age. J Bone Joint Surg Am. (Submitted)

4. Gandek B, Ware JE, Anatchkova M. Development and Evaluation of a Knee-‐Specific Function Item Bank in Total Knee Replacement Patients. Arthritis Care & Res. (Submitted)

5. Rolfson O, Wissig S, van Maasakkers L, et al. Defining an International Standard Set of Outcomes Measures for Patients with Hip or Knee Osteoarthritis: Consensus of the International Consortium of Health Outcome Measurement Hip and Knee Osteoarthritis Working Group. Arthritis Care Res. 2016 Feb 16. doi: 10.1002/acr.22868. [Epub ahead of print]

6. Lavallee D, Chenok K, Love R, Franklin PD. Incorporating Patient-‐Reported Outcomes in Healthcare to Engage Patients and Enhance Care. Health Affairs. 2016 April.

7. Lyman S, Lee Y, Franklin PD, et al. HOOS, JR. A Short-‐Form Hip Replacement Outcomes Survey. Clin Orthop Relat Res. 2016 PMID: 26926772

8. Lyman S, Lee Y, Franklin PD, Li W, et al. KOOS, JR. a short-‐form knee replacement outcomes survey. Clin Orthop Relat Res. 2016 PMID: 26926773

9. Franklin PD. Direct-‐To-‐Patient Registry Designs. AHRQ Handbook. (In Press)

10. Rolfson O, Bohm E, Franklin PD, et al. Patient-‐Reported Outcome Measures In Arthroplasty Registers: Report of the Patient-‐Reported Outcome Measures Working Group of the International Society of Arthroplasty Registers. Part I. Overview and rationale for patient-‐reported outcome measures. Acta Orthop Scand. (In Press)

11. Rolfson O, Bohm E, Franklin PD, et al. Patient-‐Reported Outcome Measures In Arthroplasty Registers: Report of the Patient-‐Reported Outcome Measures Working Group of the International Society of Arthroplasty Registers. Part II. Recommendations For Selection, Administration, And Analysis. Acta Orthop Scand. (In Press)

12. Chimenti P, Drinkwater C, Li W, et al. Factors Associated with Early Improvement in Low Back Pain after Total Hip Arthroplasty: a Multi-‐Center Study. J Arthroplasty. 2015;Jul 17.pii:S0883-‐5403(15)00642-‐7. PMID: 26276572

13. Ayers DC, Fehring TK, Odum SM, et al. Using Joint Registry Data To Improve The Accuracy Of Risk Adjustment Prediction Models For 30-‐Day Readmission After THR and TKR. J Bone Joint Surg Am. 2015;97:668-‐71. PMID: 25878312

14. Zheng H, Li W, Harrold L, Ayers DC, et al. Web-‐Based Comparative Patient-‐Reported Outcome Feedback to Support Quality Improvement and Comparative Effectiveness Research in Total Joint Replacement. eGEMs (Generating Evidence & Methods to improve patient outcomes). 2014(2);Iss. 1, Article 21. DOI: http://dx.doi.org/10.13063/2327-‐9214.1130. Available at: http://repository.academyhealth.org/egems/vol2/iss1/21

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15. Franklin PD, Nguyen US, Ayers DC, et al. Letter In Response To The Arthritis And Rheumatology Paper (Riddle, Jiranek et al) and Katz commentary; Appropriateness of TKR utilization. Arthritis Rheumatol. Arthritis Rheumatol. 2014(Nov); doi: 10.1002/art.38926. [Epub ahead of print] PMID: 25371025

16. Franklin PD, Lewallen D, Bozic K, et al. Implementation Of Patient-‐Reported Outcomes In US Total Joint Replacement Registries: Rationale, Status, And Plans. J Bone Joint Surg Am. 2014 (Dec)17;96(Supplement 1):104-‐109. http://dx.doi.org/10.2106/JBJS.N.00328. PMID: 25520425

17. Ayers DC, Li W, Harrold L, et al. Reply to the Letter to the Editor: Preoperative Pain and Function Profiles Reflect Consistent TKA Patient Selection Among US Surgeons. Clin Orthop Relat Res. 2015;473:395–396 / DOI 10.1007/s11999-‐014-‐4036-‐5. [Epub ahead of print] PMID: 25367113

18. Harrold L, Pascal S, Lewis C, et al. (2014). Patient Report Improves Posthospital Discharge Event Capture in Total Joint Replacement: A Novel Approach to Capturing All Posthospital Event Data, eGEMS (Wash DC). 2014 Oct 22;2(1):1107. doi: 10.13063/2327-‐9214.1107. eCollection 2014. PMID: 25848596; PMCID: PMC4371383.

19. Ayers DC and Franklin PD. Joint Replacement Registries In The United States: A New Paradigm. J Bone Joint Surg Am. 2014(Sep);96(18):1567-‐1569. PMID: 25232081

20. Hubbell L. Joint replacement registry bears early fruit -‐ Surprises In Data Point To Unknown Safety Issues. HPR 2014;39(9):105-‐7.

21. Oatis CA, Li W, DiRusso JM, et al. Variations in Delivery and Exercise Content of Physical Therapy Rehabilitation Following Total Knee Replacement Surgery: A Cross-‐Sectional Observation Study. International Journal of Physical Medicine & Rehabilitation. 2014;S5:002. PMID: 26594649; PMCID: PMC4651458

22. Gandek B. Measurement properties of the Western Ontario and McMaster Universities Osteoarthritis Index: A systematic review. Arthritis Care Res (Hoboken). 2014(Feb);67(2):216-‐29; doi: 10.1002/acr.22415. PMID: 25048451

23. Ayers DC, Li W, Harrold LR, et al. Pre-‐Operative Pain And Function Profiles Reflect Consistent TKR Patient Selection Among US Surgeons. Clin Orthop Relat Res; 2015 (Jan);473(1):76-‐81. DOI: 10.1007/s11999-‐014-‐3716-‐5. PMID: 24957788

24. Ibrahim SA, Franklin PD. Race And Elective Joint Replacement: Where A Disparity Meets Patient Preference. Am J Public Health. 2013 Apr;103(4):583-‐4. doi: 10.2105/AJPH.2012.301077. Epub 2013(Feb). PMID: 23409914.

25. Ayers DC and Franklin PD. Hip Outcome Assessment. In Callaghan JJ, Rosenberg AG, Rubash HE, editors. The Adult Hip (Callaghan, Aaron, Rubash) Lippincott Williams & Wilkins; 2014.

26. Devers K, Gray B, Ramos C, et al. Key Informant Interview: Patricia Franklin, MD, University of Massachusetts Medical School (FORCE-‐TJR). In ASPE Report: The Feasibility of Using Electronic Health Data for Research on Small Populations;2013.

27. Franklin PD, Harrold LR, Ayers DC. Incorporating Patient Reported Outcomes In Total Joint Arthroplasty Registries: Challenges And Opportunities. Clin Orthop Relat Res. 2013;471(11):3482-‐3488. PMID: 23897504 PMCID: PMC3792256

28. Ayers DC. Zheng H, Franklin PD. Integrating Patient-‐Reported Outcomes (Pros) Into Orthopedic Clinical Practice: Proof Of Concept From FORCE-‐TJR. Clin Orthop Relat Res; 2013. 471(11):3419-‐3425. PMID: 23925525 PMCID: PMC3792269

29. Franklin PD, Rosal MC. Can Knee Arthroplasty Play A Role In Weight Management In Knee Osteoarthritis? Arthritis Care Res. 2013 May; 65 (5): 667–668. PMID: 23139226

30. Franklin PD, Allison JJ, Ayers DC. Beyond Implant Registries: A Patient-‐Centered Research Consortium For Comparative Effectiveness In Total Joint Replacement. JAMA. 2012(Sep); 308(12): 1217-‐8. PMID: 23011710

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SELECT PRESENTATIONS: INTERNATIONAL and NATIONAL MEETINGS

(Website: www.force-‐tjr.org)

2016

1. Franklin PD, Li W, Lemay C, Ayers DC. Are Post-‐TJR Readmissions Associated With Poorer Functional Gain After TJR? Paper presented at: American Academy of Orthopaedic Surgeons (AAOS); Orlando, FL (March 2016) (paper P#156)

2. Ayers DC, Franklin PD. Pain and Function Profiles in Patients Undergoing THR; Are Readmissions Associated With Poorer Functional Gain? American Academy of Orthopaedic Surgeons (AAOS) Orlando, FL (March 2016) (paper P#593)

3. Franklin PD. Understanding PRO (Patient Reported Outcomes). Orthopaedic Research Society (ORS) Session I Orlando, FL (March 2016) (invited lecture)

4. Collins K, Bowen T, Parilla E, Franklin PD, Lemay C, Ghanem E. The effect of Total Hip Replacement on the non-‐operated lower extremity joints. American Academy of Orthopaedic Surgeons (AAOS) Orlando, FL (March 2016) (paper #593)

5. Collins K, Kolessar D, Gotoff J, Franklin PD, Lemay C, Ghanem E. The Effect of Total Knee Replacement on the Non-‐operated Lower Extremity Joints. American Academy of Orthopaedic Surgeons (AAOS) Orlando, FL (March 2016) (poster #P146) 2015

6. Gandek B, Ware J, Anatchkova M, Lewis C, Franklin PD. Can short but reliable measures of knee-‐specific function be estimated using item response theory? American Association of Hip and Knee Surgeons (AAHKS) Dallas, TX (November 2015) (podium)

7. Ayers D, Li W, Franklin PD. Does pain and function differ after primary TKR with cemented vs. cementless fixation? American Association of Hip and Knee Surgeons (AAHKS) Dallas, TX (November 2015) (podium)

8. Collins K, Bowen T, Parilla E, Franklin PD, Lemay C, Ghanem E. The effect of Total Hip Replacement on the non-‐operated lower extremity joints. American Association of Hip and Knee Surgeons (AAHKS) Dallas, TX (November 2015) (poster)

9. Collins K, Kolessar D, Gotoff J, Franklin PD, Lemay C, Ghanem E. The effect of Total Knee Replacement on the non-‐operated lower extremity joints. American Association of Hip and Knee Surgeons (AAHKS) Dallas, TX (November 2015) (poster)

10. Ware J, Gandek B, Franklin P, Lemay C. Cutting edge solutions to improving the efficiency of PRO measurement: from real-‐data simulations to pilot testing before and after total joint replacement in a national registry. International Society for Quality of Life Research (ISOQOL) Vancouver, BC (October 2015) (podium)

11. Zheng H, Li W, Lemay C, Ayers DC, Franklin PD. Translating Comparative TJR Outcomes for Performance Improvement to Guide Surgical Quality Improvement. AHRQ Research Conference. Washington DC. (October 2015) (poster)

12. Ayers D, Franklin PD. Pain and Function Profiles in patients undergoing THR: are readmissions associated with poorer functional gain? Summer Meeting of the Hip Society. Sonoma, CA (October 2015) (podium)

13. Ayers D, Li W, Franklin PD. Does pain and function differ after primary TKR with cemented vs. cementless fixation? Knee Society Meeting. San Francisco, CA. (September) (podium)

14. Benzakour T, Nelissen R, Rolfson O, Wissing S, Stowell C, Franklin P and ICHOM. Defining an international standard set of outcomes measures for patients with hip or knee osteoarthritis: Consensus of the International Consortium of Health Outcome Measurement Hip and Knee Osteoarthritis Working Group. World Congress of Orthopaedic, Xi’an, China. (Sept 2015) (podium).

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15. Franklin PD. Patient reported outcomes: Innovative approaches to bridging clinical practice and research. Academy Health Annual Research Meeting (ARM), MN (June 2015) ( panelist)

16. Li W, Ayers DC, Harrold L, Lewis C, Franklin PD. A novel covariate adjustment method for functional outcomes after Total Knee Replacement. Academy Health Annual Research Meeting (ARM), Minneapolis, MN (June 2015) (Poster)

17. Franklin PD. A US-‐UK comparison of PRO outcomes after TJR: lessons for a learning health system. Healthcare Datapalooza, Washington, DC. (May 2015) (Invited; Panel)

18. Ayers DC, Li W, Franklin PD. Using six month post-‐TKR pain and function measures by implant category for surveillance of early revision risk. International Congress of Arthroplasty Registries (ISAR), Gothenburg, Sweden. (May 2015) (Podium)

19. Li W, Ayers DC, Harrold L, Lewis C, Franklin PD. Novel risk-‐adjustment method for functional outcomes after total knee replacement. International Congress of Arthroplasty Registries (ISAR), Gothenburg, Sweden. (May 2015) (Podium)

20. Franklin PD, Li W, Ayers DC. US patient risk factors for medical and surgical readmissions after TJR. International Congress of Arthroplasty Registries (ISAR), Gothenburg, Sweden. (May 2015) (Podium)

21. Franklin PD, Fehring T, Odum S, Lewis C, Ayers DC. Addition of clinical measures improves risk-‐prediction models of 30-‐day post-‐TJR readmission. OARSI World Congress on Osteoarthritis, Seattle, WA (May 2015) (podium presentation)

22. Franklin PD, Li W, Harrold L, Rosal MC, Ayers DC. A novel patient-‐centered, national TJR comparative effectiveness research cohort. OARSI World Congress on Osteoarthritis (OARSI) Seattle, WA (May 2015) (poster)

23. Nguyen U-‐SD, Ayers DC, Li W, Harrold L, Franklin PD. Profiles of pre-‐operative pain and function in patients selected for total hip replacements among US surgeons. OARSI World Congress on Osteoarthritis (OARSI) Seattle, WA (May 2015) (poster)

24. Zheng H, Li W, Harrold L, Ayers DC, Franklin PD. Real-‐Time Scoring of Patient-‐Reported Outcomes in FORCE-‐TJR: National Total Joint Replacement Research Registry. American Medical Informatics Association Summit on Clinical Research Informatics, San Francisco, CA. March, 2015. (Podium)

25. Harrold L, Ayers DC, Li W, Pellegrini V, Grady-‐Benson J, Allison J, Franklin PD. Differences in Total Knee Replacement Outcomes based on Age. Las Vegas, Orthopaedic Research Society (ORS) Las Vegas, Nevada (March 2015) (Poster)

26. Zheng H, Harrold L, Li W, O’Keefe R, Lewis C, Noble P, Pelligrini V, Allison J, Ayers DC, Franklin PD. Risk-‐adjusted Comparative TJR Outcomes To Anticipate Bundled Payment And Public Reporting Of Quality Data. American Academy of Orthopaedic Surgeons (AAOS) Las Vegas, Nevada (March 2015) (scientific exhibition)

27. Chimenti P, Drinkwater C, Li W, Lemay CA, Franklin PD, O’Keefe R. Factors Associated With Early Improvement In Back Pain After Hip Arthroplasty: A Multi-‐center Study. American Academy of Orthopaedic Surgeons (AAOS) Las Vegas, Nevada (March 2015) (paper presentation)

28. Pascal S, Ayers DC, Li W, Harrold L, Allison J, Franklin PD. Pre-‐operative Musculoskeletal Comorbidities Limit Improvement In Functional Outcomes And Hip Pain In THA Patients. American Academy of Orthopaedic Surgeons (AAOS) Las Vegas, Nevada (March 2015) (paper presentation)

29. Harrold L, Ayers DC, Li W, Lewis C, Noble P, O’Keefe R, Allison J, Franklin PD. Differences in Total Hip Replacement Outcomes based on Age. American Academy of Orthopaedic Surgeons (AAOS) Las Vegas, Nevada (March 2015) (paper presentation)

30. Harrold L, Ayers DC, Noble P, O’Keefe R, Bowen T, Allison J, Franklin PD. Location of All Cause 30-‐Day Readmissions Following Total Joint Replacement: Surgical Versus Outside Hospital. American Academy of Orthopaedic Surgeons (AAOS) Las Vegas, Nevada (March 2015) (paper)

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2014

31. Franklin PD and Ayers DC. Implementing and Collecting Patient-‐Reported Outcomes measures. Institute for Healthcare Improvement (IHI) Annual National Forum. Orlando, FL. December 2014) (Invited talks)

32. Nguyen US, Ayers DC, Li W, Harrold L, Franklin PD. Pre-‐Operative Pain and Function: Profiles of Patients Selected for Total Knee Replacement Among Surgeons in the United States. ACR/ARHP Annual Meeting. Boston, MA (November 2014) (Poster)

33. Pascal S, Ayers DC, Li W, Harrold L, Allison J, Franklin PD. Pre-‐Operative Musculoskeletal Comorbidities Limit Improvement In Functional Outcomes And Hip Pain In Total Hip Arthroplasty Patients. ACR/ARHP Annual Meeting. Boston, MA (November 2014) (Poster)

34. Singh JA, Lemay C, Saag K, Allison J, Franklin PD. Effect of Family Support on Short-‐ and Intermediate-‐term Pain Outcomes after Knee or Hip Replacement. ACR/ARHP Annual Meeting. Boston, MA (November 2014) (Poster)

35. Singh JA, Lemay C, Allison J, Franklin PD. Use of non-‐traditional modalities for pain management after Knee or Hip Replacement. ACR/ARHP Annual Meeting. Boston, MA (November 2014) (Poster)

36. Chimenti P, Drinkwater C, Li W, Lemay C, Franklin PD, O’Keefe R. Factors Associated with Early Improvement in Back Pain After Hip Arthroplasty: a Multi-‐center Study. American Association of Hip and Knee Surgeons (AAHKS) Dallas, TX (November 2014) (Poster)

37. Fehring T, Ayers DC, Odum S, Lewis C, Ash A, Franklin PD. Addition of Clinical Measures Improves Administrative Risk-‐prediction Models of 30 Day Post-‐total Joint Replacement Readmission. American Association of Hip and Knee Surgeons (AAHKS) Dallas, TX (November 2014) (Poster)

38. Harrold L, Ayers DC, Noble P, O’Keefe R, Bowen T, Allison J, Franklin PD. All Cause 30-‐day Readmissions Following Total Joint Replacement Care: Patients Returning to the Surgical Hospital Versus Seeking Care Elsewhere. American Association of Hip and Knee Surgeons (AAHKS) Dallas, TX (November 2014) (Poster)

39. Lemay C, Harrold L, Li W, Grady-‐Benson J, Allison J, Ayers DC, Franklin PD. Total Joint Replacement Outcomes in Patients Living Alone Vs. Living with Others. American Association of Hip and Knee Surgeons (AAHKS) Dallas, TX (November 2014) (Poster)

40. Porter A, Ayers DC, Li W, Harrold L, Allison J, Franklin PD. Functional Outcomes Research for Comparative Effectiveness in Total Joint Replacement. 2014 National Caucus on Arthritis and Musculoskeletal Health Disparities, Washington, DC (November)

41. Ayers DC, Franklin PD. All Cause 30-‐Day Readmissions Rates Following Total Joint Replacement. Knee Society Charlotte, NC (October 2014) (paper presentation)

42. Franklin PD. Patient-‐reported outcomes in TJR: implementation, interpretation, and value. Michigan Arthroplasty Registry for Quality Improvement Meeting, Mi, August 2014.

43. Franklin PD. Risk-‐adjustment for TJR: Lessons from cardiac surgery. Combined AOA/COA, Montreal Canada. (June 2014)

44. Franklin PD. Big data: FORCE-‐TJR and national data to inform TJR practice. Combined AOA/COA, Montreal Canada. (June 2014)

45. Franklin PD, Harrold L, Li W, Ash A, Ayers DC. Improving risk prediction models for readmission: adding clinical variables to administrative data. International Congress of Arthroplasty Registries, Boston, MA. (June 2014)

46. Ayers DC, Harrold L, Li W, Noble P, Allison JJ, Franklin PD. Pre-‐op THR and TKR pain and functional limitation profiles are consistent across U.S. surgeons. International Congress of Arthroplasty Registries, Boston, MA. (June 2014) (Podium)

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47. Franklin PD, Harrold L, Li W, Allison JJ, Lewis C, Ayers DC. Are all important predictors of pain and function after TKR and THR included in registry data? International Congress of Arthroplasty Registries, Boston, MA. (June 2014)

48. Noble P, Harrold L, Li W, Allison JJ, Ayers DC, Franklin PD. Disability at time of surgery in younger vs. Older THR and TKR patients: lessons from force-‐TJR. International Congress of Arthroplasty Registries, Boston, MA. (June 2014) (Poster)

49. Zheng H, Li W, Harrold L, Allison JJ, Ayers DC, Franklin PD. Surgeon-‐Specific Web Reports to Support Quality Improvement in National Patient-‐Centered Outcomes Research for Comparative Effectiveness in Total Joint Replacement. Electronic Data Methods Forum, San Diego, CA. (June 2014) (Poster)

50. Franklin PD, Harrold L, Li W, OKeefe R, Allison JJ, Ayers DC. Providing comprehensive, comparative post-‐TJR outcome feedback to surgeons for quality monitoring and value decisions. AcademyHealth Annual Research Meeting (ARM), San Diego, CA. (June 2014) (Poster)

51. Franklin PD. Activity measurement in TJR comparative effectiveness/outcomes research. UMCCTS (May 2014) (podium)

52. Porter A, Li W, Harrold L, Rosal M, Noble P, Ayers DC, Franklin PD, Allison J. Musculoskeletal pain explains differences in function at time of surgery in Black TKR and THR patients. ACR/ARHP Annual Scientific Meeting, San Diego, CA. (October 2013) and UMCCTS (May 2014) (Poster)

53. Lemay CA, Harrold L, Li W, Ayers DC, Franklin PD. Social support and total joint replacement: Differences preoperatively between patients living alone and those living with others. UMCCTS (May 2014) (poster)

54. Franklin PD. Patient Outcomes Research Registry: Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-‐TJR). Worldwide Orthopedic Arthroplasty Registries. March 12, 2014 New Orleans, LA. (Podium)

55. Franklin PD, Ayers DC. Patient-‐reported outcomes in research. Orthopaedic Research Society, New Orleans, LA. (March 2014) (Panel)

56. Harrold L, Snyder B, Li W, Ayers DC, Franklin PD. Poor pre-‐operative emotional health limits gain in function after total hip replacement. Orthopaedic Research Society, New Orleans, LA. (March 2014) (Presentation)

57. Ayers DC, Harrold L, Li W, Allison JJ, Noble P, Franklin PD. Do younger TKR and THR patients have similar disability at time of surgery as older adults? Lessons From FORCE-‐TJR. Orthopaedic Research Society, New Orleans, LA. (March 2014) (Poster)

58. Franklin PD, Harrold L, Li W, Lewis C, Allison JJ. Important musculoskeletal predictors of patient-‐reported outcomes after TKR and THR are not included in risk models based on administrative data. Orthopaedic Research Society, New Orleans, LA. (March 2014) (Poster)

59. Franklin PD. Harrold L, Miozzari M, Hoffmeyer P, Ayers DC, Lubbeke A. Differences In patient characteristics prior to TKA and THA between Switzerland and the US. UMCCTS May 2014 and Orthopaedic Research Society, New Orleans, LA. (March 2014) (Panel) )

60. Li W., Ayers DC, Harrold L, Allison J, Lewis CG, R. Bowen TR, Franklin PD. Do functional gain and pain relief after THR differ by patient obese status? American Academy of Orthopaedic Surgeons, New Orleans, LA. (March 2014) (Paper)

61. Lubbeke A, Miozzari H, Harrold L, Ayers DC, Franklin PD. Differences in patient characteristics prior to total hip arthroplasty between Switzerland and the US American Academy of Orthopaedic Surgeons, New Orleans, LA. (March 2014) (Paper)

62. Franklin PD, Barton B, Harrold L,Li W, O'Keefe R, Allison J, Ayers DC. Comprehensive, comparative post-‐TJR outcome feedback to surgeons for quality monitoring and value decisions. American Academy of Orthopaedic Surgeons, New Orleans, LA. (March 2014) (Scientific Exhibit)

63. Harrold L, Ayers DC, O'Keefe R, Lewis CG, Pellegrini V, Franklin PD. The validity of patient-‐reported short-‐

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term complications following total hip and knee arthroplasty. UMCCTS May 2014 and American Academy of Orthopaedic Surgeons, New Orleans, LA. (March 2014) (Paper)

64. Ayers DC, Harrold L, Li W, Franklin PD. Pre-‐op THR pain and functional limitation profiles are consistent across U.S. surgeons. American Academy of Orthopaedic Surgeons, New Orleans, LA. (March 2014) (Poster)

65. Franklin PD, Harrold L, Li W, Lewis CG, Allison J, Ayers DC. Predictors of patient-‐reported outcomes after TKR not included in risk models based on administrative data. American Academy of Orthopaedic Surgeons, New Orleans, LA. (March 2014) (Poster)

66. Johnson JK, Donahue KL, DeWan TE, Li W, Franklin PD, Oatis CA. Identifying the effect of physical therapy interventions on functional outcomes following unilateral total knee arthroplasty: A retrospective study. Combined Sections Meeting of the APTA, Las Vegas, NV. (Feb 2014) (Poster)

67. Ayers DC, Franklin PD. Risk-‐adjustment using clinical data when comparing clinical outcomes following TJR. American Association of Hip and Knee Surgeons, Dallas, TX. (November 2013) (Panel)

68. Ayers DC, Harrold L, Li W, Franklin PD. Pre-‐Op THR Patient pain and functional limitation profiles are consistent across US surgeons. American Association of Hip and Knee Surgeons, Dallas, TX. (November 2013) (Poster)

69. Johnson JK, Donahue KL, DeWan TE, Li W, Franklin PD, Oatis CA. What elements of physical therapy interventions contribute to improved outcomes following total knee arthroplasty? ACR/ARHP Annual Scientific Meeting, San Diego, CA. (October 2013) (Poster)

70. Franklin PD, Harrold L, Li W, Allison JJ, Ayers DC, Lewis C. Important predictors of patient-‐reported outcomes after TKR and THR are not included in risk models based on administrative data. ACR/ARHP American College of Rheumatology, San Diego, CA. (October 2013) (Poster)

71. Li W, Harrold L, Allison J, Bowen T, Franklin PD, Ayers DC. Does functional gain and pain relief after TKR and THR differ by patient obese status? ACR/ARHP American College of Rheumatology, San Diego, CA. (October 2013) and UMCCTS (May 2014) (Poster)

2013

72. Franklin PD, Barton BA, Harrold L, Li W, OKeefe R, Allison JJ, Ayers DC. Providing comprehensive, comparative post-‐tjr outcome feedback to surgeons for quality monitoring and value decisions. ACR/ARHP American College of Rheumatology, San Diego, CA. (October 2013) (Podium)

73. Harrold L, Ayers DC, OKeefe R, Lewis C, Pellegrini V, Franklin PD. The validity of patient-‐reported short-‐term complications following total hip and knee arthroplasty. ACR/ARHP American College of Rheumatology, San Diego, CA. (October 2013) (Podium)

74. Franklin PD, Allison JJ, Li W, Harrold L, Barton B, Snyder B, Rosal M, Weismann N, Ayers DC. FORCE-‐TJR: TJR function and outcomes research for comparative effectiveness in US national cohort. Combined Meeting of Orthopaedics Societies, Venice, Italy. (October 2013) (Poster)

75. Harrold L, Ayers DC, Reed G, Franklin PD. Differences in functional gain between rheumatoid arthritis and osteoarthritis patients undergoing arthroplasty: Results from the FORCE-‐TJR national research consortium. Combined Meeting of Orthopaedics Societies, Venice, Italy. (October 2013) (Podium)

76. Harrold L, Li W, Allison JJ, Noble P, Ayers DC, Franklin PD. Do younger TKR patients have similar disability at time of surgery as older adults? Lessons from FORCE-‐TJR. Combined Meeting of Orthopaedics Societies, Venice, Italy. (October 2013) and UMCCTS (May 2014) (Poster)

77. Ayers DC, Harrold L, Li W, Allison JJ, Noble P, Franklin PD. Differences in pre-‐op characteristics between TKR and THR patients: results from FORCE-‐TJR a national us cohort. Combined Meeting of Orthopaedics Societies, Venice, Italy. (October 2013) (Podium)

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78. Franklin PD, Allison JJ, Harrold L, Li W, Ayers DC. FORCE-‐TJR: a new us paradigm for a national TJR registry collecting level 1, 2, and 3 outcomes. International Congress of Arthroplasty Registries, Stratford-‐Upon-‐Avon, UK. (June 2013) (Podium)

79. Franklin PD, Harrold L, Miozzari H, Ayers DC, Lubbeke A. Differences in patient characteristics prior to TKA between Switzerland and the US. Annual meeting of the Swiss Society of Orthopaedic Surgeons and Traumatologists. Lausanne, Switzerland. (June 2013) (podium)

80. Franklin PD, Harrold L, Li W, Ayers DC. Has the level of disability at time of TKR changed over the past 10 years? Results from two US cohorts. International Congress of Arthroplasty Registries, Stratford-‐Upon-‐Avon, UK. (June 2013) (Podium)

81. Harrold L, Li W, Allison JJ, Franklin PD. for the FORCE-‐TJR Investigators. Do younger TKR patients have similar disability at time of surgery as older adults? Lessons from force-‐TJR. International Congress of Arthroplasty Registries, Stratford-‐Upon-‐Avon, UK. (June 2013) (Poster)

82. Ayers DC, Harrold L, Li W, Allison JJ, Franklin PD. for the FORCE-‐TJR Investigators. Differences in pre-‐op characteristics between TKR and THR patients: results from force-‐TJR a national US cohort. International Congress of Arthroplasty Registries, Stratford-‐Upon-‐Avon, UK. (June 2013) (Poster

83. Franklin PD, Harrold L, Ayers DC, Hoffmeyer P, Lubbeke A. Differences in patient characteristics prior to TKA between Switzerland and the US. International Congress of Arthroplasty Registries, Stratford-‐Upon-‐Avon, UK and European Federation of National Associations of Orthopaedics and Traumatology, Istanbul, Turkey. (June 2013) (Poster)

84. Lubbeke A, Miozzari H, Harrold L, Ayers DC, Franklin PD. Differences in patient characteristics prior to THA between Switzerland and the US. International Congress of Arthroplasty Registries, Stratford-‐Upon-‐Avon, UK and European Federation of National Associations of Orthopaedics and Traumatology, Istanbul, Turkey (June 2013) (Poster) )

85. Franklin PD, Allison JJ, Li W, Harrold L, Rosal M, Ayers DC. FORCE-‐TJR: Novel Design for National TJR Comparative Effectiveness Research Based on Patient-‐Centered Outcomes. Academy Health Annual Research Meeting. Baltimore, MD. (June 2013) (poster)

86. Zheng H, Barton BA, Li W, Allison JJ, Ayers DC, Franklin PD. Comprehensive data management system for national patient-‐centered outcomes research for comparative effectiveness in total joint replacement. Electronic Data Methods Forum, Baltimore, MD. (June 2013) (Poster)

87. Franklin PD, Li W, Harrold L, Snyder B, Lewis C, Noble P. Level of pain and disability at time of TKR across the past 10 years: results from two national cohorts. Orthopaedic Research Society, San Antonio, TX. (January 2013) (Podium)

88. Ayers DC, Franklin PD, Harrold L, Lewis C, Snyder B, Rosal M. Differences between women and men undergoing TKR and THR in a national research consortium. Orthopaedic Research Society, San Antonio, TX. (January 2013) (Poster)

89. Ayers DC, Harrold L, Snyder B, Person S, Franklin PD. Clinical profile and disability levels of younger vs. older TKR and THR patients: results from a national research consortium. Orthopaedic Research Society, San Antonio, TX. (January 2013) (Poster)

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Appendix 2. How FORCE-TJR Differs from other Registries

Why is FORCE-TJR important to US patients, surgeons and policy makers?

Arthritis is a significant public health issue

n 50 million U.S. adults diagnosed with osteoarthritis (OA)

n OA is leading cause of disability in US adults

n OA is #1 chronic condition among women and #2 most costly chronic condition in US

n Employer costs are >$9000 per OA employee

Total joint replacement is common, costly, growing

n More than 1,000,000 Total Hip and Knee Replacement surgeries each year

n Between 1997 and 2004, aggregate charges (the ‘national bill’) for primary TJR surgeries

increased dramatically: from $8.9 billion to $50.5 billion (knees > hips).

n By 2030 the demand for THR and TKR is projected to grow by 174% and 673%, respectively

n Fastest growth among patients < 65 years of age

Patients’ goals after TJR are pain relief and functional gain

n TJR is a technically successful procedure

n Functional outcomes vary with both patient factors (e.g., gender, age, comorbidities) and

health system delivery factors (e.g., hospital volume)

Early registries primarily monitor revisions, while FORCE-TJR measures comprehensive quality and patient-reported outcomes.

n Implant tracking TJR registries have existed for decades in Europe and Australia.

n US efforts have emerged to monitor implant revisions, including American Joint

Replacement Registry and state-‐based registries (California, Michigan, Virginia).

n FORCE-‐TJR was designed to monitor comprehensive TJR outcomes including pain relief and

functional gain (PROs), quality of care, and implant outcomes. All patients report pre-‐

operative and post-‐operative PROs, 30 and 90 day post-‐operative events are monitored, and

sub-‐optimally performing implants, both revised and not revised, are identified.

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Appendix 3. FORCE-TJR Data Elements, Cohort Summary FORCE-‐TJR data elements include:

FORCE-‐TJR Cohort FORCE-‐TJR patient sociodemographic and clinical profiles parallel national data (HCUP, CMS) demonstrating that

the cohort is representative of US TJR patients. In addition, the first patient-‐reported normative data for before and after hip and knee replacement are now available.

The typical unilateral primary TKR patient is 66 years (45%<65 years), 63% female, mean BMI of 32, 33% with high school education or less, 39% with household income less than $45,000, 9% non-‐Caucasian, 24% with more than 2 medical comorbidities, and 29% with co-‐existing moderate-‐severe low back pain.

The typical unilateral primary THR patient is 64 years of age, 57% female, mean BMI of 29, 26% with high school education or less, 33% with household income less than $45,000, 7% non-‐Caucasian, 20% with more than 2 medical comorbidities, and 38% with co-‐existing moderate-‐severe low back pain.

Data Elements

Patient Attributes Age, sex, date of birth, race, education, employment, smoking

Comorbidities BMI, co-‐morbid diagnoses (Modified Charlson), previous TKR /THR, smoking

Musculoskeletal comorbidities

HOOS/KOOS: Pain location: pain in both knees, both hips, and low back; ADL function; symptoms; sport/activity, and quality of life.

Global Health SF36: physical (PCS) and mental (MCS) composite scores

TJR Outcome HOOS/KOOS: hip or knee pain, symptoms, function (ADL), sports, and quality of life

Implant/Surgery Component types; fixation techniques; surgical details

Health System Surgeon: TJR volume; years in practice; sex; race; geography

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Appendix 4. FORCE-TJR Methods/Data Quality Procedures and infrastructure for data collection: FORCE-‐TJR built a centralized information technology

system to automate timely distribution of PRO surveys via secure email with an individualized web link or mailed scannable paper, automated reminders, tracking for completion, and personal reminders, as needed, to assure complete follow-‐up. This flexibility in method of survey administration based on patient preference is practical with the direct-‐to-‐patient design.

Cohort Design: The FORCE-‐TJR cohort design optimized site and patient recruitment and retention to meet key goals:

• Minimize patient and surgeon burden.

o User-‐friendly web-‐based and paper surveys to allow quick and complete data capture;

o Primary outcomes from patients, validated clinically;

o Follow-‐up data collection performed by FORCE-‐TJR staff.

• Maximize participant retention.

o FORCE-‐TJR developed recruitment and retention methods to collect pre-‐TJR PROs on 96% of patients and

post-‐TJR PROs on 85% of patients;

o FORCE-‐TJR returned registry data to surgeons (surgeon-‐specific comparative outcome reports)

encouraging active participation and supporting practice-‐level quality monitoring and improvement efforts

in patient care.

• Optimize data collection flexibility.

o Survey options meet patient and office needs;

o Web-‐based data entry from home or office, supplemented with scannable paper surveys met all participant

needs. FORCE-‐TJR used direct-‐to-‐patient data collection supplemented with existing data obtained through either

electronic data capture or manual chart review, depending on site capability. In both scenarios a standardized clinical review is performed to apply pre-‐defined standardized definitions and algorithms for each diagnoses. For example, the diagnosis of infection is not a code from the EMR. Clinic notes, labs, and treatment records are reviewed to assure standard definitions independent of the data were sent. The majority of the FORCE-‐TJR data are obtained from the patient, particularly through questionnaires summarizing pain and function. In addition, patients report key data including medical and musculoskeletal comorbidities. The ability to capture patient-‐centric outcomes over long-‐term follow-‐up is valuable for surgical procedures or implants since these are often intended to be long-‐lasting treatments. These patient-‐reported data are supplemented by electronic health record (EHR) information for patients who report post-‐operative adverse events and surgical data for all patients.

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Toassurecompletedatacapturefromcommunity-basedsurgeonofficesthatcomprise75%ofallcohortparticipants,theFORCE-TJRdatacoordinatingcenterusedacentralizedtelephone-basedenrollmentprocess.

Datawerecollectedprimarilyfrompatients,supplementedbyORandclinicalmeasuresasneeded.Thefollowing

figureillustratesthetypeofdatacollected,thedatasource,anddatacollectiontimeframe.

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Appendix 5: FORCE-TJR Publications and Ancillary Studies Committee Procedures

FORCE-TJRwelcomesscientificcollaborations.Theguidelinesforresearchcollaborations(publications,presentationsandancillarystudies)arehighlightedontheFORCE-TJR.orgwebsite.

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