force tjr annual report 2014

FORCE-TJR ANNUAL REPORT 2014

University of Massachusetts Medical School Department of Orthopedics and Physical Rehabilitation

T: !"" $$% &'(% �(!"" $$FORCE) E: force-‐[email protected] W: www.force-‐tjr.or

TJR

FORCE-TJR

ANNUAL REPORT 2014 | 2

TJR

Executive Summary In October 2010, the Agency for Healthcare Research and Quality awarded a program project grant to the University of Massachusetts Medical School following a competitive application process. Since that time, the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-‐TJR) program has established a novel TJR registry with a national sample of US patients and surgeons to conduct comparative effectiveness research. As of June 2014, over 20,000 patients were enrolled from 136 surgeons in 22 states, with hundreds more patients enrolled weekly. FORCE-‐TJR is the first US national cohort of TJR patients representing all regions of the US, with varied practice settings (e.g., urban and rural, high and low volume) to collect comprehensive TJR outcome data. FORCE-‐TJR data are collected directly from patients, including patient-‐reported outcomes of pain and function, early post-‐operative adverse events, and implant failures, assuring more than 85% response for valid, longitudinal analyses. Patient-‐reported data are augmented with clinical data from surgeons and hospitals.

FORCE-‐TJR research is underway and will continue indefinitely as patients signed a consent allowing annual follow-‐up for years into the future. During the past year alone, FORCE-‐TJR delivered over 50 presentations at eight national and international meetings to broadly disseminate the research power of the database, 10 manuscripts are under review or were published, and seven ancillary grants are under review. The rapidly expanding FORCE-‐TJR Bibliography is attached to this report.

Beyond research, the FORCE-‐TJR registry provides comprehensive, comparative arthroplasty practice feedback to TJR surgeons to support quality improvement efforts. In addition, these data can be used to meet regulatory requirements such as the CMS Patient Quality Reporting System, and value-‐based proposals for accountable care. Site-‐specific comparisons of patient risk factors and outcomes allow surgeons to understand the similarities and differences among their patients and practices.

In less than four years, the FORCE-‐TJR infrastructure and expertise has emerged as a leader in the orthopedic community in patient-‐reported outcome collection and interpretation, clinical care and implant surveillance, and best practice models to assure consistent TJR patient outcomes.

In brief, FORCE-‐TJR impacts a wide array of stakeholders.

o For Patients: While electronic medical records systems struggle to collect, score and integrate patient-‐reported outcomes (PROs), FORCE-‐TJR deployed a web-‐based system that collects, scores, and trends over time PROs to guide

As a former educator, I

think that research is so

important. I was amazed at

how much my joint problem

affected my quality of life

before my first hip was

replaced. I’m looking

forward to having my other

hip replaced by the same

surgeon, and am happy to

participate in the FORCE-

TJR Registry if it will help

anybody.

Patient participant, Diane D., age 66

(hip replacement) Lake Havasu, AZ

“

”

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care for tens of thousands of TJR patients served by member surgeons. New 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 disability scores can be compared to national TJR norms when determining the timing for surgery. After TJR, improvement can be quantified and care tailored to support recovery

o For Surgeons and Hospitals: Our unique national database and risk adjustment models allow FORCE-‐TJR to provide comparative valuable feedback to member surgeons to guide practice. Quarterly reports address three critical questions that previously surgeons could not answer: 1. How do my patient risk factors such as BMI and comorbidities compare to other surgeons? 2. How does the timing of patient surgery as described by pain and functional limitations compare to national practice? and 3. Is the degree of pain relief and improved function in my patients comparable to the national norm?

o For CMS and Private Insurers: CMS initiated public reporting of post-‐TJR readmissions and complications in 2014. To anticipate and monitor quality, arthroplasty surgeons need timely and risk-‐adjusted data to monitor outcomes to meet or exceed national goals. FORCE-‐TJR comparative reports support quality monitoring efforts. Second, CMS issued a draft report proposing PRO collection and analysis following TJR. Two FORCE surgeons contributed to this planning effort, and participants in the FORCE network already meet the future expectations. Finally, FORCE-‐TJR proposed collaborations with both CMS and private insurers to clarify the role of PROs in defining TJR need and outcomes. These future studies will guide efficient and effective patient selection and TJR care.

o For FDA and implant manufacturers: The FORCE-‐TJR data provide early post-‐marketing surveillance data. In contrast to registries that define 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 testing novel methods for monitoring implant performance using direct to patient strategies, including a pilot of an FDA developed APP for patient event reporting.

o Translational research: Ongoing ancillary research includes collection of serum and discarded cartilage to evaluate potential biomarkers for arthritis and software to aid x-‐ray interpretation.

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, do thank

you for managing this

effort so effectively.

Surgeon participant, OK

“

”

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v FORCE-‐TJR quality improvement value

o FORCE-‐TJR QITM is expanding beyond the initial AHRQ-‐funded cohort to provide real-‐time PROs and post-‐TJR adverse event surveillance to a growing number of orthopedists. The membership model allows us to increase the number of surgeons and patients benefiting from the FORCE-‐TJR infrastructure through quality monitoring. In addition, orthopedic surgeons can use the FORCE-‐TJR data to meet the CMS Patient Quality Reporting System incentives, as well as state and regional reporting requirements.

o In parallel with CMS’ public reporting of 30 day readmission and 90 day complications following TJR, the American Association of Hip and Knee Surgeons (AAHKS) and FORCE-‐TJR collaborated to enhance the precision of the CMS risk-‐adjustment models to assure more fair and accurate comparisons. Ongoing discussions will determine how to implement this enhanced model.

o Implant evaluation. Uniquely, the rich FORCE-‐TJR clinical and patient data was merged with the international library of implant design and materials to evaluate outcomes associated with varied implant characteristics. Look for future information in the upcoming year.

While we report on the early lessons learned and activities in this report, 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 serve TJR practice and policy for years to come.

v Highlights from current analyses

o FORCE-‐TJR disseminated the early comparative effectiveness lessons learned

through more than 50 presentations at 8 national and international meetings and the research is accelerating as longitudinal data are collected.

o Some believe the shift to a younger TJR population may suggest a less

complex patient pool-‐ not so! 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.

I want to get back to where

I was before it all went in

the bucket. I want normal

mobility again. If it (the

study) paves the way for

something even better in

the future, then it’s a

worthwhile use of my time.

Patient participant, Nick L., age 79

(knee replacement) Oklahoma

“

”

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o Patient self-‐reported Pre-‐operative 25th, 50th, and 75th percentile pain and function scores are remarkably consistent across surgeons in FORCE suggesting comparable indications for surgery.

o While greater BMI is a risk factor for peri-‐operative complications, FORCE-‐

TJR found that at 6 months after total hip or knee replacement, patients with a BMI higher than 35, also, reported significant gains in pain relief and physical function.

o 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 surgery. Future public comparisons of PROs after TJR must be cautious to adjust for co-‐existing musculoskeletal conditions.

Patricia D. Franklin, MD MBA MPH David C. Ayers, MD

PI FORCE-‐TJR Chair, National Stakeholder Committee

Core Clinical CentersUMass Medical School, Worcester, MA

Connecticut Joint Replacement Institute, Hartford, CT

The University of Rochester Medical Center, Rochester, NY

Medical University of South Carolina, Charleston SC

Baylor College of Medicine, Houston, TX

Community Sites currently enrolled

Map of Participating Core Centers and Community Sites

ID

MT NDMN MI

MISD

NE

KS

TX LAAL GA

SCNC

VA

PA

NY

VT NH ME

MARICT

NJDE

MDDC

WV

FL

MS

OK

IA

MO

ILIN

OH

KY

TN

WI

AR

NV UT

AZ NM

CO

WY

CA

OR

WA

Community Sites

It’s important to

participate [in FORCE-

TJR] so that people who

have knee replacements in

the future can benefit from

my experience.

Patient participant, Michael L., age 53

(knee replacement) MA

“

”

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CONTENTS

Executive Summary 2

The FORCE-TJR Team 7

Highlights from previously presented research 8

Today’s TJR patients are younger, heavier, and just as disabled 8

Patients with high BMI report significant improvement 9

Pre-‐op pain and function are consistent across surgeons 10

Pre-‐operative musculoskeletal comorbidities limit post-‐op gain in function 11

FORCE-‐TJR Implant Research 12

MD website: comparative quality data 13

Why is FORCE-TJR important to US patients, surgeons and policy makers? 15

Arthritis is a significant public health issue 15

Total joint replacement is common, costly, growing 15

Patients’ goals after TJR are pain relief and functional gain 15

International registries monitor revisions, while FORCE-‐TJR measures comprehensive quality and patient-‐reported outcomes. 15

Goals and benefits 16

Function varies widely after Total Knee Replacement (TKR) 16

What are FORCE-‐TJR research goals? 16

How will FORCE-‐TJR design and methods assure succcess and benefit our patients? 17

Sample Data Collected 20

Patients’ Characteristics 22

Appendix 1: FORCE-TJR Bibliography (through June 2014) 23

Appendix 2: FORCE-TJR Ancillary Research Funding (all funded grants and contracts) 28

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The FORCE-TJR Team PI: Patricia D. Franklin, MD MBA MPH

Operations Team

Christine P. Bond, MS Christine Goddard Celeste Lemay, MPH RN Pamela Wiley, MPH

Clinical Team

David Ayers, MD Courtland Lewis, MD Regis O’Keefe, MD Philip Noble, PhD Vincent Pellegrini, MD

Scientific Team

Patricia Franklin, MD MBA MPH Leslie Harrold, MD MPH Wenjun Li, PhD Hua Zheng, PhD Jeroan Allison, MD MS Bruce Barton, PhD John Ware, PhD Norman Weissman, Ph.D.

National Stakeholder Committee

Graphic Design and Report: Sylvie Puig, PhD

David C. Ayers, MD Chair University of Massachusetts Medical School/UMASS Memorial Medical Center

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

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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Highlights from previously presented research

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 (n=2035)

Age ≥65 (n=3084)

p value Age <65 (n=1780)

Age ≥65 (n=1831)

p value

Gender (% female) 47.5 52.5 0.012 61.7 63.1 0.307

BMI (mean ± SD) 29.9±6.1 28.5±5.3 0.000 33.1±6.7 30.5±5.6 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

Estimated WOMAC* (operative joint) pain (mean ± SD ) stiffness (mean ± SD ) function (mean ± SD)

44.9±20.1 34.6±21.5 43.2 ± 19.3

50.6±19.2 40.6±21.4 45.6±19.2

0.000 0.000 0.000

47.3±18.3 38.1±21.4 50.0 ± 18.2

53.9±18.7 46.3±21.7 52.8±18.2

0.000 0.000 0.000

Baseline sf-‐36 PCS (mean ± SD )

31.2±8.5 31.5±8.6 0.300 32.0±8.1 33.0±8.4 0.000

Baseline sf-‐36 MCS (mean ± SD )

48.4±12.9 51.5±12.1 0.000 49.1±13.0 52.6±11.7 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 improvement

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 Obesity status Baseline 6 month Delta Baseline 6 month Delta

N % Physical function (Mean (SE)) N % Physical function (Mean (SE))

Under/normal weight

530 26% 32.4 (0.4) 46.5 (0.4) 14.1 (0.5) 396 13% 35.2 (0.4) 44.7 (0.5) 9.5 (0.4)

Overweight 763 37% 32.7 (0.3) 45.7 (0.4) 13.1 (0.4) 978 33% 34.3 (0.3) 44.2 (0.3) 9.9 (0.3)

Obese 453 22% 30.2 (0.4) 44.8 (0.5) 14.6 (0.5) 861 29% 33.0 (0.3) 42.3 (0.3) 9.3 (0.3)

Severely obese 204 10% 28.3 (0.6) 41.2 (0.7) 12.9 (0.8) 457 15% 31.3 (0.4) 41.1 (0.5) 9.8 (0.4)

Morbidly obese 90 4% 26.6 (0.8) 39.6 (1.0) 13.0 (1.1) 272 9% 29.9 (0.5) 40.4 (0.6) 11.0 (0.6)

N % WOMAC Pain (Mean (SE)) N % WOMAC Pain (Mean (SE))

Under/normal weight

515 26% 51.0 (0.9) 91.8 (0.6) 40.9 (0.9) 371 13% 56.4 (0.9) 85.5 (0.7) 29.0 (1.1)

Overweight 745 38% 51.1 (0.7) 90.6 (0.5) 39.5 (0.8) 927 33% 55.4 (0.6) 85.8 (0.5) 30.4 (0.7)

Obese 442 22% 47.3 (0.9) 89.7 (0.6) 42.5 (1.0) 817 29% 53.0 (0.6) 83.6 (0.6) 30.5 (0.7)

Severely obese 194 10% 45.5 (1.5) 88.4 (1.1) 43.0 (1.8) 426 15% 50.6 (0.9) 84.0 (0.8) 33.3 (1.0)

Morbidly obese 86 4% 38.2 (2.1) 88.4 (1.4) 50.2 (2.2) 252 9% 47.1 (1.2) 82.6 (1.1) 35.4 (1.3)

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Pre-op pain and function are consistent across surgeons

Consistent 25th to 75th %ile scores are reported across sites with HOOS/KOOS pain scores from 30 to 55, and PCS from 25 to 37, representing significant impairment.

Despite the large numbers of patients electing THR and TKR, pre-‐operative pain and function scores suggest consistent patient selection across surgeons of significantly impaired adults. These data suggest the growing TKA and THR utilization is reaching appropriate patients.

Figure 1. Baseline HOOS/KOOS Pain Score by Site. The red line represents median across sites. Pain free is a score of 90-‐100.

Figure 2. Baseline SF36 PCS Score by Site. The red line represents median across sites. National norm is PCS of 50.

Figure 3. Baseline HOOS/KOOS ADL Score by Site. The red line represents median across sites. Ideal function is a score of 90-‐100.

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Pre-operative musculoskeletal comorbidities limit post-op gain in function

Predictors of change in pre-‐to-‐6 month post-‐THR and post-‐TKR pain and function were examined using linear mixed models adjusting for clustering within site in the first 5300 patients (3084 TKR; 2233 THR).

After adjusting for sociodemographic factors, significant predictors of poorer 6 month post-‐THR pain included poorer pre-‐operative emotional health, poorer physical function, and any lumbar pain at time of surgery. These factors, as well as greater BMI and moderate/severe pain in the non-‐operative knees and hips, predicted poorer 6 month function.

Significant predictors of poorer 6 month post-‐TKR pain included poorer emotional health, higher Charlson comorbidity scores and any lumbar pain at time of surgery. These factors also predicted poorer 6 month function.

THR PATIENTS TKR PATIENTS

Variable Function PCS Pain Function PCS Pain

Coef. P value Coef. P value Coef. P value Coef. P value

Administrative data

Race, non White -‐0.088 0.938 -‐4.164 0.008 -‐2.005 0.013 -‐7.336 <0.001

Age group, < 65 years of age 2.042 0.002 -‐0.388 0.675 1.513 0.001 -‐2.085 0.019

SES, < 25,000/year -‐1.662 0.024 -‐2.763 0.007 -‐1.706 0.002 -‐1.629 0.115

BMI -‐0.187 <0.001 -‐0.039 0.448 -‐0.082 0.003 -‐0.021 0.676

Non administrative PROs

SF 36, MCS 0.146 <0.001 0.151 <0.001 0.111 <0.001 0.166 <0.001

SF 36, PCS -‐0626 <0.001 -‐ -‐ -‐0.551 <0.001 -‐ -‐

WOMAC pain score -‐ -‐ -‐0.971 <0.001 -‐ -‐ -‐0.874 <0.001

Charlson Comorbidity Index 1 -‐2.094 <0.001 -‐1.470 0.062 -‐1.206 0.005 -‐1.544 0.054

Charlson Comorbidity Index 2 to 5 -‐1.528 0.061 -‐1.183 0.297 -‐2.245 <0.001 -‐1.66 0.122

Charlson Comorbidity Index ≥ 6 -‐1.141 0.049 -‐0.914 0.258 -‐1.478 0.001 -‐2.057 0.015

Lower back pain, Mild -‐1.114 0.024 -‐1.682 0.015 -‐1.266 0.001 -‐2.515 <0.001

Lower back pain, Moderate -‐1.974 <0.001 -‐2.269 0.002 -‐2.598 <0.001 -‐2.673 0.001

Lower back pain, Severe -‐2.052 0.005 -‐3.866 <0.001 -‐4.434 <0.001 -‐4.088 0.002

One non-‐surgical joint with mod/sev pain -‐0.780 0.106 -‐2.207 0.001 -‐1.401 <0.001 -‐2.866 <0.001

Two non-‐surgical joints mod/sev pain -‐3.166 <0.001 -‐3.916 0.001 -‐1.630 0.037 -‐4.414 0.003

Three non-‐surgical joints with mod/sev pain -‐5.556 <0.001 -‐3.170 0.080 -‐2.262 0.059 -‐7.848 <0.001

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FORCE-TJR Implant Research

Understanding implant performance in patients with specific clinical profiles

The FORCE-‐TJR implant library includes over 54,000 components of TKR and THR implants from all US manufacturers. To assure uniform component definitions, the FORCE-‐TJR implant library was merged with the International Consortium of Orthopedic Registries (ICOR) component library housed by the Australian Registry. The comprehensive FORCE-‐TJR database, together with the implant components, allows implant outcome analyses for sub-‐groups of patients with specific clinical profiles—something that has not been possible in other registries. Tracking patient-‐reported symptoms allows early identification of differences in implant performance.

For example, FORCE-‐TJR asked: do TKR patients under 65 years of age achieve comparable pain relief with Implant X as compared to all other implants? Figure 1 shows that a sub-‐group of patients with implant X (blue) report persistent moderate pain at 12 months post-‐TKR. The implant X pain distribution appears bimodal (blue) as compared to patients with all other implants (black). Next, at 2 and 5 years, we will determine if the sub-‐group of patients reporting greater pain at 12 months after TKR have a higher revision rate. We will also evaluate differing implants categories to identify outcome variation by design (rotating platform), material (ceramic), fixation (cementless), and other attributes.

Figure 1. Distribution of pain at 12 months post-‐TKR with Implant X (blue), as compared to all other implants (black)

TJR

Implant(X(Pa+ents(by((6(month(Pain(

KOOS$Pain<75$

KOOS$Pain>=75$

POST(KOOS(Pain((mean)( 58( 89( P<0.0000(

PRE1TKR$PROFILE$

Pre(KOOS(Pain((mean)( 37( 50( p<0.0002(

Pre(SF36/PCS((mean)( 30( 33( P<0.04(

Pre(KOOS(ADL((mean)( 43( 56( p<0.0001(

ModMSevere(Low(Back(Pain( 52%( 24%( P<0.027(

Charlson(Index(((((((((((((((((((((0M1( 89%( 75%(

(((((((((((((((((((((((((((((((((((((((((((((((2M5( 10.5%( 3%( p<0.288(

POST1TKR$FUNCTION$

Post(SF36/PCS((mean)( 37( 45( p<0.0000(

Post(KOOS(ADL( 65( 88( p<0.0000(

Implant X patients by 6-‐month pain

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MD website: comparative quality data

As of April 2014, over 19,000 patients were enrolled from more than 130 surgeons in 22 states. The reporting website was launched in September 2012. It has been updated quarterly for all surgeons to review their site-‐ and individual-‐specific data. A random sample of the 130 surgeons found an average of 6.2 logins per user.

Returning registry data to surgeons encourages active participation while supporting practice-‐level quality monitoring and improvement efforts in patient care. We anticipate that returning data to surgeons will facilitate complete data capture and enhance future secondary uses of the data to drive quality enhancement, in addition to patient-‐centered outcomes research.

Figure 2. Example of knee surgery PRO available to surgeon.

Figure 1. This screen shot of the MD website home page shows what a surgeon can access after entering his/her secure login information. Graphs depicting enrollment data as well as tables of PROs are available at the site level, practice level and individual surgeon patients level as well as comparison with all sites enrolled in FORCE-‐TJR.

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Quarterly MD Report

This executive summary of the quarterly surgeon report addresses 3 questions:

1. How do my patients compare to patients at other sites on key risk-‐adjustment factors? [Patient Mix] 2. How do my patients compare to other sites on pre-‐TJR pain and function? [Patient Selection and Timing of Surgery] 3. How do my risk-‐adjusted 6 and 12 month pain and function compare to other sites? [TJR patient-‐reported

outcomes]

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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 U.S. adults

n OA is #1 chronic condition among women and #2 most costly chronic condition in U.S.

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)

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

n Scandinavian TJR registries have existed for decades; UK, Australia and others have parallel

registries

n US efforts emerging: American Joint Replacement Registry and state-‐based registries

(California, Michigan, Virginia)

n Primary outcome = Implant failure and REVISION

n FORCE-‐TJR begins with patient goals: pain relief and functional gain (PROs) and adds quality

and implant outcomes.

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Goals and benefits

Function varies widely after Total Knee Replacement (TKR)

What are FORCE-TJR research goals?

n Establish a comprehensive data collection of over 30,000 diverse patients from 130

orthopedic surgeons representing all regions of the US and varied hospital/surgeon practice

settings (e.g., urban/rural, low and high volume).

n Data collection platform will minimize patient and surgeon data entry burden, emphasize

patient-‐reported data, collect most information at the time of surgery, and use Internet

technology to minimize data entry.

n Conduct research to guide surgical practice to optimize function and patient outcomes.

Construct, validate, and refine prediction algorithms for patients at risk for lack of post-‐TJR

functional gain, and for optimal TJR outcomes. Develop a survey platform to answer

questions related to TJR benefits among working-‐age adults and issues of disparities.

0 20 40 60 80

SF36 PCS Franklin, Li and Ayers, 2008

Distribution of SF36 PCS Score

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How will FORCE-TJR design and methods assure succcess and benefit our patients?

Design optimizes retention

n 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

n Maximize participant retention.

o FORCE-‐TJR has developed new methods to collect pre-‐TJR PROs on 96% of patients

and post-‐TJR PROs on approximately 85% of patients.

o FORCE-‐TJR is returning registry data to surgeons (surgeon-‐specific comparative

outcome reports), thus encouraging active participation and supporting practice-‐

level quality monitoring and improvement efforts in patient care

n Optimize data collection flexibility.

o Survey options meet patient and office needs

o Web-‐based from home or office, computer in office, paper

Comprehensive Data on a National Sample of Patients

n Patient Characteristics

o Gender, Age, Race/ethnicity

o BMI and Physical Health

o Co-‐existing Medical and Musculoskeletal Conditions (

o Emotional Health

o Pre-‐operative level of Disability

n Surgical Factors

o Surgical Approach

o Implant Design and Material

n System Factors

o TJR Hospital Volume

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Data primarily from patients; supplemented by OR and clinical measures. Enroll over 10,000 patients annually

MD and Hospital Medical Record Data OPTIONAL

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Patient enrollment process

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FORCE-TJR


TJR

Sample Data Collected

Below is a sample of the data collected:

PQRS and FORCE-TJR Data Elements, Sample Questions

Pat

ient

Pai

n an

d Fu

nctio

n Su

rvey

Se

lf-Re

port

--Tak

es 1

5-20

min

to c

ompl

ete

Surv

ey S

ched

ule:

Pre

-Sur

gery

, 6 m

onth

s Pos

t-Su

rger

y, A

nnua

lly

PQRS Measure(s)

Personal (22 items)

Contact Information/ Demographic data Needed for all Risk-adjustment measures, including: # 217 Functional Status Knee impairments , #218 Functional Status Hip impairments, and #220 Functional Status Lumbar Spine impairments #358 Patient-centered Surgical Risk adjustment

Name, address, phone number, email address, date of birth, marital status, education level, race, gender, etc. Body Mass Index, Smoking status

PQRS Measure(s)

SF36 (36 items)

General health status Needed for all Functional Status measures including: #109 OA function & pain #131 Pain assessment and follow-up #178 RA function and pain #182 Functional outcome assessment #217 Functional Status Knee impairments , #218 Functional Status Hip impairments, and #220 Functional Status Lumbar Spine impairments #358 Patient-centered Surgical Risk adjustment TKR Group Measure item – Shared decision making (1 of 4)

During the past 4 weeks, how much of the time have you had any of the following problems with your work or other regular daily activities as a result of your physical health: 1. Accomplished less than you would like 2. Had difficulty performing work

All of the time

ർ

ർ

Most of the time

ർ

ർ

Some of the time

ർ

ർ

A little of the time

ർ

ർ

None of the time

ർ

ർ

Activity limitations due to current health Does your health now limit you in activities you might do during a typical day? If so, how much?

1. Bathing or dressing yourself 2. Lifting or carrying groceries

Limited a lot ർ ർ

Limited a little ർ ർ

Not limited at all ർ ർ

PQRS Measure(s)

Comorbidity Index

(14 items)

Co-Occurring Medical Conditions Needed for all Risk-adjustment measures, including: # 217 Functional Status Knee impairments , #218 Functional Status Hip impairments, and #220 Functional Status Lumbar Spine impairments #358 Patient-centered Surgical Risk adjustment

Indicate if you have been diagnosed with any of the following conditions: COPD, Connective Tissue Disease, Diabetes, Cancer, etc.

FORCE-TJR


TJR

OR

Data

PQRS Measure(s) Implant

Data (14Items) Data

(14 Items)

14 AJRR elements

TKR Group Measure - Identification of implanted prosthesis in operative note (1 of 4)

Institution, Patient First Name, Patient Last Name, Date of Birth, Date of Procedure, Type of Procedure, Implant Manufacturer, Component Catalogue #, Component Lot #, (Repeat catalogue and lot # for each component) Cement Type, Cement Antibiotics, Bone Graft Type and Bone Graft Volume

Char

t Dat

a

PQRS Measure(s) Treatment

Surgery/Post-Surgery treatment #131 Pain assessment & follow-up #182 Functional outcome assessment TKR Group Measure item – Shared decision making (1 of 4) TKR Group Measure item – Venous thromboembolic &cardiovascular risk evaluation (1 of 4) TKR Group Measure item – preoperative antibiotic infusion with proximal tourniquet (1 of 4) Adverse events reporting

Documentation of follow-up plan after pain assessment Documentation of care plan based on identified functional outcome deficiencies on date of identified deficiencies Documentation of shared decision-making discussion of conservative (non-surgical) therapy prior to procedure Pre-operative note with evaluation of venous thromboembolic cardiovascular risk evaluation 30 day prior to surgery Operative note with preoperative antibiotic infusion with proximal tourniquet Discharge Summary ICD9 procedure code ICD9 primary diagnosis code Hip/Knee surgical approach data Post-surgery events/complications

PQRS Measure(s)

Back Pain (1 item)

Severity of Back Pain

Needed for all Functional

status & Risk adjustment

measures including:

#109 OA function & pain #131 Pain assessment & follow-up #178 RA function and pain #182 Functional outcome assessment #217 Functional Status Knee impairments #218 Functional Status Hip impairments #220 Functional Status Lumbar Spine impairments #358 Patient-centered Surgical Risk adjustment

My back pain at the moment is:

No back pain--Very mild--Moderate--Fairly severe--Very severe--Worst imaginable

PQRS Measure(s)

HOOS/ KOOS

(68 items/ 71 items)

Symptoms, stiffness, and pain associated with the surgical joint Needed for all Functional

status and Risk adjustment

measures including:

#109 OA function & pain #131 Pain assessment and follow-up #178 RA function and pain #182 Functional outcome assessment #217 Functional Status Knee impairments #218 Functional Status Hip impairments #220 Functional Status Lumbar Spine impairments #358 Patient-centered Surgical Risk adjustment TKR Group Measure item – Shared decision making (1 of 4)

What amount of pain have you experienced in the last week in your surgical (hip/knee) during the following activity?

1. Sitting or lying down 2. Going up or down stairs

None ർ ർ

Mild ർ ർ

Moderate ർ ർ

Severe ർ ർ

Extreme ർ ർ

Physical function (Surgical Joint)

For each of the following activities, please indicate the degree of difficulty you have experienced in the last week due to your surgical (hip/ knee): 1.Getting in/out of car 2. Rising from sitting

None

ർ ർ

Mild

ർ ർ

Moderate

ർ ർ

Severe

ർ ർ

Extreme

ർ ർ

Physical function (Non-Surgical Joint)

For each of the following activities, please indicate the degree of difficulty you have experienced in the last week due to your non-surgical (hip/ knee):

1.Getting in/out of car 2. Rising from sitting

None ർ ർ

Mild ർ ർ

Moderate ർ ർ

Severe ർ ർ

Extreme ർ ർ

Surgical joint specific

Please rate your symptoms and difficulties in your surgical (hip/ knee) during the last week when doing these activities: 1.Do you have swelling in your surgical knee 2.Difficulties to stride out when walking

Never ർ ർ

Rarely ർ ർ

Sometimes ർ ർ

Often ർ ർ

Always ർ ർ

FORCE-TJR


TJR

Patients’ Characteristics

Patients’ pre-‐op characteristics and 6 month outcomes

Characteristic Primary TKR Primary THR

Age (mean years) 66.6 64.4

Female (%) 61.7 57.0

BMI (mean) 31.5 29.1

HOOS/KOOS (operative joint) Pain (mean)

Function (mean)

46.0 52.1

42.0 44.4

Baseline SF-‐36 MCS (mean) PCS (mean)

51.4 32.7

50.1 31.3

6 mo. HOOS/KOOS (operative joint) Pain (mean)

Function (mean)

84.5 82.6

90.5 85.8

6 mo. SF-‐36 MCS (mean) PCS (mean)

54.3 42.9

54.2 45.1

FORCE-TJR


TJR

Appendix 1: FORCE-TJR Bibliography (through June 2014) PUBLICATIONS

1. Franklin PD, Lewallen D, Bozic K, Hallstrom B, Jiranek W, Ayers D. Implementation of patient-‐reported outcomes in US total joint replacement registries: rationale, status, and plans. The Journal of Bone & Joint Surgery. ICOR suppl (in press)

2. Gandek B. Measurement properties of the Western Ontario and McMaster Universities Osteoarthritis Index: A systematic review”. Arthritis Care & Research. (Hoboken). 2014 Jul 21. doi: 10.1002/acr.22415. [Epub ahead of print]

3. Ayers DC, Li W, Harrold LR, Allison JA, Franklin PD. Pre-‐operative pain and function profiles reflect consistent TKR patient selection among US surgeons. Clinical Orthopaedics and Related Research. Clinical Orthopaedics and Related Research. 2014; Jun 2014 Epub ahead of print DOI 10.1007/s11999-‐014-‐3716-‐5

4. 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.

5. Devers K, Gray B, Ramos C, Shah A, Blavin F, Waidmann T. 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.

6. FORCE-‐TJR In: An Introduction to AHRQ's Third Edition of "Registries for Evaluating Patient Outcomes. AHRQ 2013.

7. Franklin PD, Harrold LR, Ayers DC. Incorporating patient reported outcomes in total joint arthroplasty registries: challenges and opportunities. Clinical Orthopaedics and Related Research. 2013; 471(11):3482-‐3488. PMCID: PMC3792256

8. Ayers DC. Zheng H, Franklin PD. Integrating Patient-‐Reported Outcomes (PROs) into orthopedic clinical practice: proof of concept from FORCE-‐TJR. Clinical Orthopaedics and Related Research. 2013; 471(11):3419-‐3425. PMCID: PMC3792269

9. Franklin PD, Rosal MC. Can knee arthroplasty play a role in weight management in knee osteoarthritis? Arthritis Care & Research 2013 May; 65 (5): 667–668.

10. 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.

PRESENTATIONS AT INTERNATIONAL AND NATIONAL MEETINGS

1. 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)

2. 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)

3. 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)

FORCE-TJR


TJR

4. 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)

5. 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)

6. Franklin PD, Harrold L, Li W, Lewis C, Allison JJ, Ayers DC. Important predictors of patient-‐reported outcomes after THR and TKR not included in risk models based on administrative data. UMCCTS May 2014 and AcademyHealth Annual Research Meeting (ARM), San Diego, CA. (June 2014) (Poster)

7. 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)

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

9. 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)

10. 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)

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

12. 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)

13. 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)

14. 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)

15. 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) )

16. 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)

17. 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)

18. 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)

FORCE-TJR


TJR

19. Harrold L, Ayers DC, O'Keefe R, Lewis CG, Pellegrini V, Franklin PD. The validity of patient-‐reported short-‐term complications following total hip and knee arthroplasty. UMCCTS May 2014 and American Academy of Orthopaedic Surgeons, New Orleans, LA. (March 2014) (Paper)

20. 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)

21. 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)

22. 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)

23. 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)

24. 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)

25. Porter A, Li W, Harrold L, Rosal M, Noble P, Ayers D, Franklin P, 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 (May2014) (Poster)

26. 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)

27. 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)

28. Li W, Harrold L, Allison J, Bowen T, Franklin P, Ayers D. 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)

29. 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)

30. 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)

31. 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)

32. 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)

FORCE-TJR


TJR

33. 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)

34. 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)

35. 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)

36. 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)

37. 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)

38. 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)

39. 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

40. 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)

41. 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) )

42. 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)

43. 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)

44. 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)

45. 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)

FORCE-TJR


TJR

46. 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)

47. Ayers DC, Harrold L, Li W, Snyder B, Allison JJ, Lewis C. Greater musculoskeletal pain in TKR and THR patients correlates with poorer function in a national consortium. Orthopaedic Research Society, San Antonio, TX. (January 2013) (Poster)

48. Snyder B, Yang W, Franklin PD, Ayers DC. Pre-‐operative emotional health affects post-‐operative patient function but not patient satisfaction following primary total hip arthroplasty. Orthopaedic Research Society, San Antonio, TX. (January 2013) and UMCCTS (May 2014) (Poster)

49. Franklin PD, Ayers DC, Allison JJ, Harrold L, Noble P. Building a national consortium of orthopedic practices for function and outcomes research in total joint replacement. European Federation of National Associations or Orthopaedics and Traumatology, Berlin, Germany. (May 2012) (Poster)

50. Franklin PD, Ayers DC, Allison JJ, Li W, Harrold L, Snyder B. FORCE-‐TJR: TJR Function and Outcomes Research for Comparative Effectiveness in US national cohort. International Congress of Arthroplasty Registries, Bergen, Norway. (May 2012) (Poster)

51. Franklin PD, Li W, Oatis CA, Snyder B, Rosal M, Ayers DC. Importance of musculoskeletal co-‐morbidities in the TJR registries that evaluate patient-‐reported outcomes. International Congress of Arthroplasty Registries, Bergen, Norway. (May 2012) (Poster)

52. Franklin PD, Snyder B, Allison JJ, Li W, Rosal M, Harrold L. Differences in baseline characteristics between TKR and THR patients: results from a national research consortium. ACR/ARHP American College of Rheumatology, Washington, DC. (November 2012) (Poster) )

53. Franklin PD, Li W, Snyder B, Lewis C, Noble P, Ayers DC. Has the level of disability at time of TKR changed over the past 10 years? Results from two national cohorts. ACR/ARHP American College of Rheumatology, Washington, DC. (November 2012) (Poster)

54. Franklin PD, Li W, Harrold L, Snyder B, Lewis C, Noble P. Do younger TKR patients have similar disability at time of surgery as older adults? ACR/ARHP American College of Rheumatology, Washington, DC. (November 2012) (Poster)

55. Franklin PD. Role of risk adjustment in TJR surgery-‐ lessons learned from NYS cardiac surgery process. American Association of Hip and Knee Surgeons, Dallas, TX. (November 2012) (Presentation)

FORCE-TJR


TJR

Appendix 2: FORCE-TJR Ancillary Research Funding (all funded grants and contracts) FUNDED GRANTS

1. Patricia Franklin, PI; David Ayers, CO-‐I ; Jeroan Allison, CO-‐I ; Leslie Harrold, CO-‐I ; Wenjun Li, CO-‐I ; Paul Fanning, CO-‐I; Norm Weissman, CO-‐I Title: Improving Orthopedic Outcomes Through a National TJR Registry Sponsor: NIH-‐Agency for Healthcare Research and Quality Funding Period: 9/30/2010 -‐ 9/29/2014 (No cost extension; 9/30/2014-‐9/28/2015)

2. David Ayers, PI; Patricia Franklin, CO-‐PI; Arlene Ash, CO-‐I Title: Enhancing 30-‐Day Post-‐Operative Prediction Models with the Addition of Pre-‐Operative Patient and Surgeon -‐ Reported Variables Sponsor: AAHKS Funding Period: 2/1/2013 -‐ 12/31/2013

3. Patricia Franklin, PI; Jeroan Allison, CO-‐I Title: UAB Deep South Arthritis and Musculoskeletal CERTs

Sponsor: AHRQ P60; sub-‐award UAB Funding Period: 3/1/2012 -‐ 2/28/2015

4. Patricia Franklin, PI; David Ayers, CO-‐I ; Paul Fanning, CO-‐I ; Wenjun Li, CO-‐I Title: Peripheral blood microRNAs as Biomarkers for disease stage in RA and OA

Sponsor: UMass Memorial

Funding Period: 3/1/2012 -‐ 2/28/2014

TRAINEE AWARDS

1. Anthony Porter, PI; David Ayers, CO-‐I; Patricia Franklin, CO-‐I Title: Disparities in Total Joint Replacement Patients from the FORCE National Database

Sponsor: J. Robert Gladden Orthopaedic Society Funding Period: 1/3/2013 -‐ 1/2/2014

2. Barbara Gandek, PI; John Ware, CO-‐I; Patricia Franklin, CO-‐I Title: Psychometric Evaluation of Joint-‐Specific Patient-‐Reported Outcome Measures Before and

After Total Knee Replacement Sponsor: Alvin R. Tarlov & John E. Ware Jr. Doctoral Dissertation and Post-‐Doctoral Award

Funding Period: 1/3/2013 -‐ 1/2/201