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TJR 
FORCE-TJR 
ANNUAL REPORT 2014 
University 
of 
Massachusetts 
Medical 
School 
Department 
of 
Orthopedics 
and 
Physical 
Rehabilitation 
T: 
!"" 
$$% 
&'(% 
(! 
$$FORCE) 
E: 
force-­‐tjr@umassmed.edu 
W: 
www.force-­‐tjr.or
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 
“ 
”
FORCE-TJR 
ANNUAL REPORT 2014 | 3 
TJR 
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 
“ 
”
FORCE-TJR 
ANNUAL REPORT 2014 | 4 
TJR 
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 
“ 
”
FORCE-TJR 
ANNUAL REPORT 2014 | 5 
TJR 
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 
Map of Participating Core Centers and Community Sites 
WY 
CO 
WA 
OR 
Core Clinical Centers 
UMass 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 
PA 
VA 
VT NH ME 
Community Sites currently enrolled 
ID 
MT ND 
MN MI 
MI 
SD 
NE 
KS 
TX LA 
AL GA 
SC 
NC 
NY 
MA 
CT RI 
NJ 
DE 
MD 
DC 
WV 
FL 
MS 
OK 
IA 
MO 
IL 
IN 
OH 
KY 
TN 
WI 
AR 
NV UT 
AZ NM 
CA 
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 
“ 
”
FORCE-TJR 
ANNUAL REPORT 2014 | 6 
TJR 
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
FORCE-TJR 
ANNUAL REPORT 2014 | 7 
TJR 
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 
JJ 
company 
Jing 
Xie, 
PhD 
Biomet, 
Inc.
FORCE-TJR 
ANNUAL REPORT 2014 | 8 
TJR 
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 
(%) 
10.2 
2.8 
13.2 
3.4 
current 
33.7 
45.3 
33.7 
48.9 
0.000 
0.000 
past 
56.1 
51.9 
53.0 
47.7 
never 
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
FORCE-TJR 
ANNUAL REPORT 2014 | 9 
TJR 
Patients with high BMI report significant improvement 
At 
6 
months 
after 
THR, 
all 
patients 
reported 
significant 
functional 
gains 
although 
patients 
with 
BMI35 
had 
lower 
mean 
functional 
gain 
than 
those 
with 
BMI35. 
All 
patients 
reported 
excellent 
pain 
relief. 
At 
6 
months 
after 
TKR, 
severely 
obese 
patients 
(BMI35) 
reported 
improvements 
in 
both 
pain 
and 
function 
equal 
to 
or 
greater 
than 
patients 
with 
BMI35. 
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)
FORCE-TJR 
ANNUAL REPORT 2014 | 10 
TJR 
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.
FORCE-TJR 
ANNUAL REPORT 2014 | 11 
TJR 
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
FORCE-TJR 
ANNUAL REPORT 2014 | 12 
TJR 
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) 
Implant(X(Pa+ents(by((6(month(Pain( 
TJR 
Implant 
X 
patients 
by 
6-­‐month 
pain 
KOOS$ 
Pain75$ 
KOOS$ 
Pain=75$ 
POST(KOOS(Pain((mean)( 58( 89( P0.0000( 
PRE1TKR$PROFILE$ 
Pre(KOOS(Pain((mean)( 37( 50( p0.0002( 
Pre(SF36/PCS((mean)( 30( 33( P0.04( 
Pre(KOOS(ADL((mean)( 43( 56( p0.0001( 
ModMSevere(Low(Back(Pain( 52%( 24%( P0.027( 
Charlson(Index(((((((((((((((((((((0M1( 89%( 75%( 
(((((((((((((((((((((((((((((((((((((((((((((((2M5( 10.5%( 3%( p0.288( 
POST1TKR$FUNCTION$ 
Post(SF36/PCS((mean)( 37( 45( p0.0000( 
Post(KOOS(ADL( 65( 88( p0.0000(
FORCE-TJR 
ANNUAL REPORT 2014 | 13 
TJR 
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 
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. 
Figure 
2. 
Example 
of 
knee 
surgery 
PRO 
available 
to 
surgeon.
FORCE-TJR 
ANNUAL REPORT 2014 | 14 
TJR 
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]
FORCE-TJR 
ANNUAL REPORT 2014 | 15 
TJR 
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.
FORCE-TJR 
ANNUAL REPORT 2014 | 16 
TJR 
Goals and benefits 
Function varies widely after Total Knee Replacement (TKR) 
Distribution of SF36 PCS Score 
0 20 40 60 80 
What are FORCE-TJR research goals? 
SF36 PCS 
Franklin, Li and Ayers, 2008 
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.
FORCE-TJR 
ANNUAL REPORT 2014 | 17 
TJR 
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
FORCE-TJR 
ANNUAL REPORT 2014 | 18 
TJR 
Data 
primarily 
from 
patients; 
supplemented 
by 
OR 
and 
clinical 
measures. 
MD and Hospital OPTIONAL Medical Record Data 
Enroll 
over 
10,000 
patients 
annually
FORCE-TJR 
ANNUAL REPORT 2014 | 19 
TJR 
Patient 
enrollment 
process 
!#$%'()*$ 
*+$,--$+.*$ 
/+)*0*$ 
1+23$ 
456($%'()*$ 
178/9:;8$ 
%0#(*$ 
1=$/+)*0*$ 
1+23$*+$ 
178/9:;8$ 
*?$ 
/--$%'()*$*+$ 
@(025A($178/9: 
;8$ 
8(65(B$0+)()*C 
3(@50-$2(-(($ 
D+23$)@$ 
)B(2$E.('+)$ 
!5*$F'()*$ 
B5*G$0+3F-(')H$$ 
.26(I$ 
5H)$/+)()*C 
3(@50-$2(-(($ 
1+23$ 
/+3F-(*($.26(I$65$ 
0+3F.*(2$+2$FF(2$ 
J5-$5H)(@$ 
0+)()*C3(@50-$ 
2(-(($$ 
K)@$0+3F-(*(@$ 
FF(2$.26(IL$ 
*+$178/9:;8$*?$
FORCE-TJR 
ANNUAL REPORT 2014 | 20 
TJR 
Sample Data Collected 
Below 
is 
a 
sample 
of 
the 
data 
collected: 
PQRS and FORCE-TJR Data Elements, Sample Questions 
Patient Pain and Function Survey 
Survey Schedule: Pre-Surgery, 6 months Post-Surgery, Annually 
Self-Report--Takes 15-20 min to complete 
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 
ANNUAL REPORT 2014 | 21 
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 
Chart Data 
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? 
None 
Mild 
Moderate 
Severe 
Extreme 
1. Sitting or lying down 
ർ 
ർ 
ർ 
ർ 
ർ 
2. Going up or down stairs 
ർ 
ർ 
ർ 
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): 
None 
Mild 
Moderate 
Severe 
Extreme 
1.Getting in/out of car 
ർ 
ർ 
ർ 
ർ 
ർ 
2. Rising from sitting 
ർ 
ർ 
ർ 
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: 
Never 
Rarely 
Sometimes 
Often 
1.Do you have swelling in your surgical knee 
ർ 
ർ 
ർ 
ർ 
2.Difficulties to stride out when walking 
ർ 
ർ 
ർ 
ർ 
Always 
ർ 
ർ
FORCE-TJR 
ANNUAL REPORT 2014 | 22 
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 
ANNUAL REPORT 2014 | 23 
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 
ANNUAL REPORT 2014 | 24 
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 
ANNUAL REPORT 2014 | 25 
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 
ANNUAL REPORT 2014 | 26 
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 
ANNUAL REPORT 2014 | 27 
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 
ANNUAL REPORT 2014 | 28 
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

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Force TJR Annual Report 2014

  • 1. TJR FORCE-TJR ANNUAL REPORT 2014 University of Massachusetts Medical School Department of Orthopedics and Physical Rehabilitation T: !"" $$% &'(% (! $$FORCE) E: force-­‐tjr@umassmed.edu W: www.force-­‐tjr.or
  • 2. 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 “ ”
  • 3. FORCE-TJR ANNUAL REPORT 2014 | 3 TJR 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 “ ”
  • 4. FORCE-TJR ANNUAL REPORT 2014 | 4 TJR 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 “ ”
  • 5. FORCE-TJR ANNUAL REPORT 2014 | 5 TJR 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 Map of Participating Core Centers and Community Sites WY CO WA OR Core Clinical Centers UMass 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 PA VA VT NH ME Community Sites currently enrolled ID MT ND MN MI MI SD NE KS TX LA AL GA SC NC NY MA CT RI NJ DE MD DC WV FL MS OK IA MO IL IN OH KY TN WI AR NV UT AZ NM CA 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 “ ”
  • 6. FORCE-TJR ANNUAL REPORT 2014 | 6 TJR 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
  • 7. FORCE-TJR ANNUAL REPORT 2014 | 7 TJR 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 JJ company Jing Xie, PhD Biomet, Inc.
  • 8. FORCE-TJR ANNUAL REPORT 2014 | 8 TJR 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 (%) 10.2 2.8 13.2 3.4 current 33.7 45.3 33.7 48.9 0.000 0.000 past 56.1 51.9 53.0 47.7 never 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
  • 9. FORCE-TJR ANNUAL REPORT 2014 | 9 TJR Patients with high BMI report significant improvement At 6 months after THR, all patients reported significant functional gains although patients with BMI35 had lower mean functional gain than those with BMI35. All patients reported excellent pain relief. At 6 months after TKR, severely obese patients (BMI35) reported improvements in both pain and function equal to or greater than patients with BMI35. 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)
  • 10. FORCE-TJR ANNUAL REPORT 2014 | 10 TJR 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.
  • 11. FORCE-TJR ANNUAL REPORT 2014 | 11 TJR 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
  • 12. FORCE-TJR ANNUAL REPORT 2014 | 12 TJR 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) Implant(X(Pa+ents(by((6(month(Pain( TJR Implant X patients by 6-­‐month pain KOOS$ Pain75$ KOOS$ Pain=75$ POST(KOOS(Pain((mean)( 58( 89( P0.0000( PRE1TKR$PROFILE$ Pre(KOOS(Pain((mean)( 37( 50( p0.0002( Pre(SF36/PCS((mean)( 30( 33( P0.04( Pre(KOOS(ADL((mean)( 43( 56( p0.0001( ModMSevere(Low(Back(Pain( 52%( 24%( P0.027( Charlson(Index(((((((((((((((((((((0M1( 89%( 75%( (((((((((((((((((((((((((((((((((((((((((((((((2M5( 10.5%( 3%( p0.288( POST1TKR$FUNCTION$ Post(SF36/PCS((mean)( 37( 45( p0.0000( Post(KOOS(ADL( 65( 88( p0.0000(
  • 13. FORCE-TJR ANNUAL REPORT 2014 | 13 TJR 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 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. Figure 2. Example of knee surgery PRO available to surgeon.
  • 14. FORCE-TJR ANNUAL REPORT 2014 | 14 TJR 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]
  • 15. FORCE-TJR ANNUAL REPORT 2014 | 15 TJR 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.
  • 16. FORCE-TJR ANNUAL REPORT 2014 | 16 TJR Goals and benefits Function varies widely after Total Knee Replacement (TKR) Distribution of SF36 PCS Score 0 20 40 60 80 What are FORCE-TJR research goals? SF36 PCS Franklin, Li and Ayers, 2008 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.
  • 17. FORCE-TJR ANNUAL REPORT 2014 | 17 TJR 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
  • 18. FORCE-TJR ANNUAL REPORT 2014 | 18 TJR Data primarily from patients; supplemented by OR and clinical measures. MD and Hospital OPTIONAL Medical Record Data Enroll over 10,000 patients annually
  • 19. FORCE-TJR ANNUAL REPORT 2014 | 19 TJR Patient enrollment process !#$%'()*$ *+$,--$+.*$ /+)*0*$ 1+23$ 456($%'()*$ 178/9:;8$ %0#(*$ 1=$/+)*0*$ 1+23$*+$ 178/9:;8$ *?$ /--$%'()*$*+$ @(025A($178/9: ;8$ 8(65(B$0+)()*C 3(@50-$2(-(($ D+23$)@$ )B(2$E.('+)$ !5*$F'()*$ B5*G$0+3F-(')H$$ .26(I$ 5H)$/+)()*C 3(@50-$2(-(($ 1+23$ /+3F-(*($.26(I$65$ 0+3F.*(2$+2$FF(2$ J5-$5H)(@$ 0+)()*C3(@50-$ 2(-(($$ K)@$0+3F-(*(@$ FF(2$.26(IL$ *+$178/9:;8$*?$
  • 20. FORCE-TJR ANNUAL REPORT 2014 | 20 TJR Sample Data Collected Below is a sample of the data collected: PQRS and FORCE-TJR Data Elements, Sample Questions Patient Pain and Function Survey Survey Schedule: Pre-Surgery, 6 months Post-Surgery, Annually Self-Report--Takes 15-20 min to complete 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.
  • 21. FORCE-TJR ANNUAL REPORT 2014 | 21 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 Chart Data 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? None Mild Moderate Severe Extreme 1. Sitting or lying down ർ ർ ർ ർ ർ 2. Going up or down stairs ർ ർ ർ 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): None Mild Moderate Severe Extreme 1.Getting in/out of car ർ ർ ർ ർ ർ 2. Rising from sitting ർ ർ ർ 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: Never Rarely Sometimes Often 1.Do you have swelling in your surgical knee ർ ർ ർ ർ 2.Difficulties to stride out when walking ർ ർ ർ ർ Always ർ ർ
  • 22. FORCE-TJR ANNUAL REPORT 2014 | 22 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
  • 23. FORCE-TJR ANNUAL REPORT 2014 | 23 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)
  • 24. FORCE-TJR ANNUAL REPORT 2014 | 24 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)
  • 25. FORCE-TJR ANNUAL REPORT 2014 | 25 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)
  • 26. FORCE-TJR ANNUAL REPORT 2014 | 26 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)
  • 27. FORCE-TJR ANNUAL REPORT 2014 | 27 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)
  • 28. FORCE-TJR ANNUAL REPORT 2014 | 28 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