8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
1/22
"#$% & '"#$%%&'(&) $'* +,,-./0'1/1&) 2-. /#& 3)& -24567)0,,-./&* 89+ :--%) 1' "-;,$.$/1/1//,*% )/
81(#1%$,* 7))(+,-#1,)- L,12,- 12% >//,*% )/ 12% 345 U,(%*1)(V K2% P,%L.
=(%.%-1%+ 2%(% #(% .)6%69 12% (%.=)-.,;,6,19 )/ 12% #?12)(. #-+ +) -)1
-%*%..#(,69 (%=(%.%-1 12% )//,*,#6 P,%L. )/ 12% 3#1,)-#6 4-.1,1?1%. )/ 5%#612V
8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
2/22
"#$% & F
!"#$%#$&WX%*?1,P% 8?00#(9 VVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVV Y
7#.% 81?+,%. VVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVV Y
I#((,%(. #-+ 8)6?1,)-. VVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVV Y
81#A%2)6+%(. VVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVV R
3%X1 81%=. VVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVV R
4-1()+?*1,)- VVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVV H
!"#$% '( )*"+,"-,./%,0 1"$.,"*%, !22$3 42- 52$$%6*.+7 89:3 VVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVV H
7#.% 81?+,%. VVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVV Z
40=6%0%-1#1,)- )/ "#1,%-1?1*)0%. ,- # "%+,#1(,* 5%#612 89.1%0 VVVVVVVVVVVVVVVVVVVVVVVVVV Z
[%..)-. [%#(-%+ VVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVVV Z
"#1,%-1
8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
3/22
"#$% & Y
()%*+$,-% .+//012
S612)?$2 .1#-+#(+,_%+E P#6,+#1%+ 1))6. %X,.1 1) $#12%( +#1# )- =#1,%-1 +#1# ,- %6%*1()-,* 0%+,*#6 (%*)(+ .9.1%0.E
(%=(%.%-1#1,P%. /()0 12% 3#1,)-#6 4-.1,1?1%. )/ 5%#612 M345N 5%#612 7#(% 89.1%0. :%.%#(*2
7)66#;)(#1)(9 ":> 7)(% $#12%(%+ # $()?= )/ *6,-,*,#- 0%#.?(%. ,-1) *#(%E #-+ L)(A,-$ $()?=. *)-.,+%(%+ ;#((,%(. 1)
,-*)(=)(#1,-$ ":>. ,-1) ()?1,-% *#(% #-+ 2)L 12% ;#((,%(. 0,$21 ;% #++(%..%+V
!0&% .$+3,%&
4-P%.1,$#1)(. =(%.%-1%+ *#.% .1?+,%. /()0 12% "#1,%-1 7%-1%(%+ >?1*)0%. :%.%#(*2
3%1L)(A 4-,1,#1,P% M"7>:-%1NE ,-*6?+,-$ 'N ]#-+%(;,61 Q-,P%(.,19’s use of PROs in the J,+<
8)?12 76,-,*#6 U#1# :%.%#(*2 3%1L)(A M7U:3N #-+ FN 12% =#1,%-112%( *#.% .1?+,%.
,-*6?+%+ YN 12% Cincinnati Children’s 5).=,1#6 J%+,*#6 7%-1%(E #-+ RN 12% 345 5%#612*#(%
89.1%0. 7)66#;)(#1)(9 +%0)-.1(#1,)- =()a%*1E 7)66#;)(#1,P% 7#(% /)( "#,- ,- "(,0#(9 7#(%
M""S7KNV 8)0% *)0=)-%-1. )/ .?**%../?6 ":> ,0=6%0%-1#1,)- ,-*6?+%+\ ;?9. L,12,- 12% 2%#612*#(% .9.1%0V @)(A.2)= =#(1,*,=#-1. ;()A% ,-1)
12(%% $()?=. 1) *)-.,+%( 12%.% ;#((,%(. #-+ 12%,( =)1%-1,#6 .)6?1,)-.V :%$#(+,-$ 12% +%*,.,)-
)/ 2%#612*#(% .9.1%0.E *6,-,*.E )( ,-+,P,+?#6 *6,-,*,#-. 1) *)66%*1 ":>.E ;#((,%(. ,-*6?+% 6#*A
)/ 6%#+%(.2,= #-+ /,-#-*,#6 .?==)(1E ,-#+%^?#1% 4K (%.)?(*%.E 6#*A )/ *6,-,*,#- .?==)(1 #-+
?=1#A%E #-+ ,-.?//,*,%-1 0%..#$,-$V 8)0% *)((%.=)-+,-$ .)6?1,)-. ,-*6?+% +%0)-.1(#1,-$
(%1?(- )- ,-P%.10%-1E 19,-$ ":>. 1) =%(/)(0#-*% ,-+,*#1)(. #-+b)( (%,0;?(.%0%-1E #-+?.% )/ =()P,+%( #-+ =#1,%-1 *2#0=,)-. MS==%-+,X INV
@,12 (%.=%*1 1) ;#((,%(. #..)*,#1%+ L,12 +)0#,- #-+ ,-.1(?0%-1 .%6%*1,)-E 12%(% #(%
+,//%(%-*%. #*().. 12%(#=%?1,* #(%#. (%$#(+,-$ L2,*2 +)0#,-. #(% *)-.,+%(%+ ,0=)(1#-1E
?-*%(1#,-19 )/ 2)L 1) ,-*)(=)(#1% ":> .*)(%. ,-1) *6,-,*#6 +%*,.,)-12%( ,..?%. ,-*6?+%+ *?61?(#6b6,-$?,.1,* *2#66%-$%.E #-+ #+#=1#;,6,19 )/ 0%#.?(%. 1)
.?==)(1 ;)12 *6,-,*#6 *#(% #-+ 2,$2
8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
4/22
"#$% & R
,-*6?+%+ .1#A%2)6+%( %-$#$%0%-1 ,- #+)=1,-$ # ?-,P%(.#6 .%1 )/ +)0#,-.E *(%#1,)- )/
0%#.?(%0%-1 #==()#*2%. 12#1 ?.% ;(,%/ .*(%%-,-$ ,1%0. 12#1 *#- 1(,$$%( 0)(% =(%*,.%
0?61,.%11# 81)-% M# 1))6 12#1 =()P,+%. %^?,P#6%-1 .*)(%. /)( +,//%(%-1 .*#6%.
12#1 0%#.?(% 12% .#0% 2%#612 )?1*)0%N #-+ /?-+,-$ /)( #++,1,)-#6 *()... ,/ 12%9 *)-1(,;?1% 1) 12%
/,-#-*,#6 2%#612 )/ 12% ,-.1,1?1,)-E #(% ,- 6,-% L,12 12% institution’s 0,..,)-E #-+ +) -)1 ,-*?(
6%$#6 6,#;,6,19V 76,-,*,#-. L,66 .?==)(1 ":> +#1# *)66%*1,)- ,/ it saves time, doesn’t ,-1%(/%(%
L,12 *6,-,* L)(A/6)LE #-+ ,0=()P%. ^?#6,19 )/ *#(%V "#1,%-1. L,66 #$(%% 1) *)0=6%1% ":>. ,/
12%9 ?-+%(.1#-+ 12#1 12% +#1# L,66 ;% ?.%+ /)( 12%,( *#(%E L,66 %-#;6% 12%0 1) 1(#*A 12%,(
=()$(%..E #-+ L,66 ,-/)(0 )- 2)L 12%9 *)0=#(% 1) )12%(. L,12 .,0,6#( *)-+,1,)-.V
8%)$ .$%9&
3%X1 .1%=. /)( 12% 345 7)66#;)(#1)(9 ":> 7)(% ,-*6?+% +,..%0,-#1,-$ 12% (%.?61. /()0 12,.
L)(A.2)= ,- 12% /)(0 )/ # L2,1% =#=%( M12% =(%.%-1 +)*?0%-1N 12#1 L,66 ;% #P#,6#;6% )- 12%
345 7)66#;)(#1)(9 L%;.,1% #1 211=.\bbLLLV-,2*)66#;)(#1)(9V)($b"#$%.bc-)L6%+$%<
:%=).,1)(9V#.=XV K2% ":> 7)(% ,. #6.) +,.*?..,-$ )==)(1?-,1,%. 1) %-$#$% .1#A%2)6+%(. ,-
/?1?(% L)(A.2)=.E 7)66#;)(#1)(9 U%0)-.1(#1,)- "()a%*1.E #-+ /?1?(% =?;6,*#1,)-.V
8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
5/22
"#$% & H
:#$1"3+*$,"#
"#1,%-1. #(% /(%%69 #P#,6#;6% MK#;6% 'NE ;?1
12%.% (%.%#(*2 +)0#,-.E .%6%*1,-$ ":> 0%#.?(%.E #-+ ,-/)(0#1,*. ,..?%. L,12 ":> *)66%*1,)-V @)(A,-$
$()?=. L%(% #..%0;6%+ 1) *)-.,+%( 12% /)66)L,-$ ^?%.1,)-.\ L2%(% ,- 12% =()*%.. #(% 12%
;#((,%(.d L2#1 ,. 12% -#1?(% )/ 12% ;#((,%(d 2)L *#- 12,. ;#((,%( ;%.1 ;% #++(%..%+d #-+ L2)
,. ;%.1 =).,1,)-%+ 1) #++(%.. ,1e
K2,. L2,1% =#=%( L,66 ;(,%/69 .?00#(,_% 12% *#.% .1?+,%.E =#1,%-1 =%(.=%*1,P%E #-+ *()..<
*?11,-$ ,..?%.E #. L%66 #. 1) +%6P% ,-1) 12% ;#((,%(. #-+ .1(#1%$,%. /)( #++(%..,-$ ;#((,%(.
!"#$% '( )*"+,"-,./%,0 1"$.,"*%, !22$3 42- 52$$%6*.+7 89:3
#$% &'()*+#% ,)# -*% ./*0-*1%2)/('$%
3"4-$*4 5$6)(4$0
7/4')#$ 8$"9/($#$*4
:*;)(#"4-)* 2+94$#
3578:2 $
"99$99#$*4 );
*$/()=)1-'"= "*0
B$>"D-)("= ;/*'4-)*
!:< A))=B)C @)1*-4-D$E $#)4-)*"=E #)4)(E "*0
9$*9)(+ ;/*'4-)*
!:< F=/$6(-*4 ;)(
!$/()9'-$*'$ 5$9$"('>
!$/()?G7HI G/"=-4+ );
=-;$ -* *$/()=)1-'"=
0-9)(0$(9
!$/()?G7H
8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
6/22
"#$% & Z
!0&% .$+3,%&
U?(,-$ 12% /,(.1 +#9E ,-P%.1,$#1)(. L2) *)-+?*1 (%.%#(*2 .1?+,%. #-+ *)66%*1 ":> +#1# L,12,-
2%#612*#(% .9.1%0. L%(% ,-P,1%+ 1) .2#(% 12%,( %X=%(,%-*% L,12 ,-1%$(#1,-$ ":>. ,-1)*6,-,*#6 =(#*1,*% #-+ 12% WJ:V
:/95%/%#$0$,"# "; %9"1$%3 ?+$*"/%& ,# 0 . #. # 0%#.?(% )/ ^?#6,19 )/ *#(% ,- 12(%% #(%#.\ 0%+,*#6 #-+ ^?#6,19
)/ 6,/% )?1*)0%.E =#1,%-1 #-+ /#0,69 %X=%(,%-*%.E #-+ P#6?%V @2%- *6,-,*. +%*,+% 1) *)66%*1
=#1,%-1 (%=)(1%+ )?1*)0%. #1 775J7E # ":> .=%*,#6,.1 0%%1. L,12 12% 1%#0 1) #..%.. 12%,(
(%#+,-%..E ,+%-1,/9 12% )?1*)0%. 12%9 L#-1 1) 0%#.?(%E #-+ +%1%(0,-% 12%,( %X=%(,%-*%
L,12 ":>.V K2% .=%*,#6,.1 2%6=. 12% 1%#0 .%6%*1 12% 0).1 #==()=(,#1% 0%#.?(%.E L2,*2 #(%
.=%*,/,*#669 1#,6)(%+ 1) 12% -%%+. #-+ 0,..,)- )/ 12% *6,-,*V K2%.% =()=).%+ 0%#.?(%. #(%
12%- .%-1 # 0?61,+,.*,=6,-#(9 "#1,%-1 :%=)(1%+ >?1*)0%. f)P%(-#-*% 7)00,11%%E *)-.,.1,-$
)/ =.9*2)0%1(,*,#-.E *6,-,*,#- (%.%#(*2%(.E #-+ %X=%(1. ,- 4K #-+ g?#6,19 40=()P%0%-1 Mg4N
/)( /,-#6 #==()P#6V
S. # -)1. %0=6)9 g4
1))6. 1) $?,+% ,0=()P%0%-1.E /)( %X#0=6%E A%9 +(,P%( +,#$(#0. #(% ?.%+ 1) +)*?0%-1
specific and measurable aims, factors related to achieving the aims (“key drivers”), and
=6#--%+ ,-1%(P%-1,)-.V S DGh *)0=6%1,)- (#1% ,. +%.,(%+ 1) (%=)(1 +#1# 12#1 *#- ;%
*)-.,+%(%+ (%=(%.%-1#1,P%V
A%&&"#& A%01#%3
K2% /)66)L,-$ L%(% A%9 *)0=)-%-1. )/ .?**%../?6 ":> ,0=6%0%-1#1,)-\
4-.1,1?1,)-#6 ;?9 f)P%(-#-*% 1%#0 ,- =6#*%
":> ,-.1(?0%-1 #==(#,.#6 L,12 =%(,)+,* 0)-,1)(,-$ )/ =%(/)(0#-*% 0%1(,*. #-+
=()*%.. /)( ,-1%(P%-,-$
K(#,-,-$ =()P,+%(. #-+ =#1,%-1. ,- ":> ?.% #-+ ,-1%(=(%1#1,)- ,. # (%*)$-,_%+ $#=
."+$7 !C>8
U(V 8?-,6 c(,=#6#-, =(%.%-1%+ +#1# )- Vanderbilt’. ?.% )/ ":>. /)( (%.%#(*2 12()?$2 12% J,+<
8)?12 76,-,*#6 U#1# :%.%#(*2 3%1L)(A M7U:3NE L2,*2 ,. =#(1 )/ 12% "#1,%-1 7%-1%(%+
>?1*)0%. :%.%#(*2 3%1L)(A 4-,1,#1,P% M"7>:-%1NE #-+ 12% *2#66%-$%. )/ ?.,-$ #- ,-
8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
7/22
"#$% & T
W5: .9.1%0V J,+ +#1# #(% (%1?(-%+ 1) =#(1,*,=#-1. ,- # P#(,%19 )/ $(#=2,*. M%V$V *2#(1.#-+ +#.2;)#(+.N 12#1 +,.=6#9 /#1,$?% #-+ )12%( )?1*)0%. .*)(%. L,12 1(%-+. )P%( 1,0% #-+
.2)L *)0=#(,.)-. 1) .,0,6#( =#1,%-1. MO,$?(% 'NV
;.7
8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
8/22
"#$% & C
Dr. Kappelman’s team ,. *?((%-169 1%.1,-$ # -%L =#1,%-1 =)(1#6 12#1 L,66 #66)L =#1,%-1. 1)
?=6)#+ #-+ .9-* +#1# /()0 +%P,*%. M%V$VE /,1;,1E /?%6;#-+NV [,-A%+ L,12 +#1# ,- WJ:E 12%.%
":> +#1# *)?6+ ;% ?.%+ /)( /?1?(% );.%(P#1,)-#6 .1?+,%. #. L%66V K2% $()?= ,. #6.)
*)-+?*1,-$ ̂ ?#6,1#1,P% ,-1%(P,%L. L,12 =#1,%-1. 1) +%1%(0,-% L2,*2 ":>. 12%9 12,-A L)?6+
;%.1 *)-1(,;?1% 1) .%6/. ,- =(,0#(9 *#(%V 82%
2,$26,$21%+ 12% +#-$%(. )/ )=,),+ )P%(0%+,*#1,)-E #-+ 1)?1%+ 12% ,0=)(1#-*% )/ ":>. ,- 12%
0#-#$%0%-1 )/ *2()-,* =#,-V c#,.%( "%(0#-%-1% 2#. #- ,-,1,#1,P% 1) ,0=()P% .#/%19 ,- =#,-
0#-#$%0%-1 12#1 ,-*6?+%. ?.,-$ ":>. 1) #..%.. =#,-V
":> #+)=1,)- #1 c#,.%( "%(0#-%-1%E ,- =#(1,*?6#(E ,. )/1%- +(,P%- ;9 (%$?6#1)(9 #-+ .#/%19
*)-*%(-. (“stick”) rather than clinical utility (“carrot”). c#,.%( "%(0#-%-1% 2#. 2,.1)(,*#669
?.%+ 12% I(,%/ "#,- 4-P%-1)(9 MI"4N to track patients’ pain #-+ #..%.. )=,),+ 1(%#10%-1
program “risk” levelV @2%- +%.,$-,-$ 12% *2()-,* =#,- .1?+9E 12% 1%#0 ?.%+ 12% 6%$#*9 I"4
(#12%( 12#- #+)=1,-$ # -%L ":> ;%*#?.% 12% I"4 L#. .2)(1E %#.9 1) +%=6)9E #-+ /#0,6,#( 1)
;)12 =#1,%-1. #-+ *6,-,*,#-.V W.1#;6,.2,-$ 12% I"4 #. =#(1 )/ ()?1,-% *6,-,*#6 *#(% L#. # 0?61,<
.1%= =()*%.. 12#1 ,-P)6P%+ =6#--,-$E .%6%*1,-$ 0%#.?(% 6%-$12 MR P.V 'F ,1%0.NE );1#,-,-$
#==()P#6. /()0 $#1%A%%=%(. #-+ )12%( .1#A%2)6+%(.d 12%- +%P%6)=,-$ #-+ ,+%-1,/9,-$ *#(%
$#= *(,1%(,#E ,0=6%0%-1,-$ 12% I"4E *)00?-,*#1,-$ #;)?1 ,..?%. #-+ (%.?61.E #-+ 0)-,1)(,-$
+#1# *)66%*1,)-V
S..%..,-$ 12% %//%*1,P%-%.. )/ *)66%*1,-$ I"4 +#1# )-6,-% P,# 12% =%(.)-#6 2%#612 (%*)(+
=)(1#6 #-+ 2#P,-$ # =()*%.. /)( *)-1#*1,-$b(%0,-+,-$ =#1,%-1. 1) /,66 )?1 12% I"4 L#. #6.),0=)(1#-1V Q-/)(1?-#1%69E 12% W5: .9.1%0 #1 c#,.%( "%(0#-%-1% ,. -)1 ,+%#669 *)-/,$?(%+
/)( (%-+%(,-$ ":> +#1# #**%..,;6% 1) *6,-,*,#-.V >-*% *)66%*1%+E 12% ":> +#1# #(% ,-1%$(#1%+
,-1) 12% W5: ;?1 #(% %-1%(%+ ,- # .%=#(#1% *2#(1,-$ #(%#E -)1 ,- 12% *6,-,* -)1%.V K2?.E
(%P,%L,-$ I"4 +#1# (%^?,(%. #- %X1(# .1%= /)( *6,-,*,#-.V
A%&&"#& A%01#%3
U(V U%;#( )//%(%+ 12%.% 6%..)-. 6%#(-%+\
7?((%-1 ":> #+)=1,)- ,. more often driven by “stick .” (e.g., regulatory concerns)12#- “carrots” (e.g., clinical utility)
":> +#1# ,- W5: (frequency and amount) is often confounded by patient’s clinical
.%P%(,19 "?.2,-$ ":>. ,-1) 12% W5: 1) %-2#-*% *6,-,*#6 ?1,6,19 ,. # $))+ $)#6E ;?1 0?61,0)+#6
.?==)(1 0#9 ;% -%%+%+E #-+ *?((%-1 +,.=6#9. 6,0,1 *6,-,*#6 ?1,6,19 /)( =#1,%-1. L,12
*)0=6%X *)-+,1,)-.V K2%(% ,. 1%*2-)6)$9 #P#,6#;6% 1) %-2#-*% ":> +#1# +,.=6#9.E ;?1
?.,-$ # .9.1%0 ?-1%12%(%+ 1) WJ: 0#9 -)1 ;% /%#.,;6%V
8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
9/22
"#$% & D
!1"&&*+$$,#B K7%/%&
K2(%% ,-P,1%+ .=%#A%(.E U(.V S6;%(1 @?E 4(%-% c#1_#-E #-+ B#0%. @,66,$E L%(% #.A%+ 1)
=(%.%-1 )- *()..*?11,-$ 12%0%. )- .%6%*1,-$ ":>.E 0%#.?(,-$ ":> +)0#,-.E #-+ ,-/)(0#1,*.,..?%. ,- ":> 0%#.?(%0%-1E (%.=%*1,P%69V S++,1,)-#669E # =#1,%-1 (%=(%.%-1#1,P%E J,*2%66%
7#((#.E L#. #.A%+ 1) +,.*?.. =#1,%-1.’ =%(.=%*1,P%. )- ":> *)66%*1,)-V
I%0&+1,#B ? C"/0,#& ,# !5,#,*05 .%$$,#B&D 8%%3& 0#3 ?99"1$+#,$,%&
U(V @?E JUE J"5E ,. # "()/%..)( #-+ U,(%*1)( #1 12% 7%-1%( /)( 5%#612 8%(P,*%. #-+
>?1*)0%. :%.%#(*2 #1 12% B)2-. 5)=A,-. I6))0;%($ 8*2))6 )/ "?;6,* 5%#612V 4- 2,.
=(%.%-1#1,)-E 2% %0=2#.,_%+ 12% ()6% )/ =#1,%-1 %-$#$%0%-1 ,- 2%#612*#(%E .1#1,-$ 12#1
=#1,%-1. #-+ *6,-,*,#-. 2#P% 12% .#0% -%%+. M%V$VE .1#9,-$ 2%#6129E $%11,-$ ;%11%(E %1*VNE ;?1
12#1 =#1,%-1. 2#P% #++,1,)-#6 -%%+. 12#1 -%%+ 1) ;% 0%1 ;9 *6,-,*,#-.E ,-*6?+,-$ #**%.. 1)
,-/)(0#1,)-E *)00?-,*#1,)-E %-$#$%0%-1 ,- 12%,( )L- 2%#612*#(%E #-+ #?1)-)09V "#1,%-1.
#(% ,-1%(%.1%+ ,- 12%,( )L- +#1# #-+ ,- 2)L 12%9 *)0=#(% 1) )12%(. 6,A% 12%0.%6P%.V 4-1%(0. )/ ":>.E =#1,%-1. L#-1 1) .%% 12#1 12% 1,0% .=%-1 #-.L%(,-$ 12% 0%#.?(%. L,66 ;%
(%6%P#-1 1) 12%0E #-+ 12%9 L#-1 more control over the questions that they’re answering, a.
L%66 #. ^?%.1,)-. 12#1 *#=1?(% 12%,( $)#6. #-+ #.=,(#1,)-.V J)(% %//,*,%-1 +#1# *)66%*1,)- ,.
0)(% (%.=%*1/?6 #-+ #6.) $%1. $(%#1%( =#1,%-1 %-$#$%0%-1V K2,. ,-*6?+%. meeting patients’
-%%+. ;9 =()P,+,-$ +,//%(%-1 0)+%. )/ *)66%*1,)- M%V$VE =#=%(E ,-1%(P,%LE 1#;6%1E %1*VNE #. L%66
#. )//%(,-$ ":>. ,- patients’ native language. #-+ ,-*)(=)(#1,-$ /#0,69 /%%+;#*AV 76,-,*,#-.
*#- ;% (%.,.1#-1 1) #++,-$ #*1,P,1,%. 12#1 (%^?,(% 0)(% 1,0%E ;?1 12%9 L#-1 ,0=()P%+ =#1,%-1
)?1*)0%.V K2%9 #(% 0).1 ,-1%(%.1%+ ,- #*1,)-#;6% 12(%.2)6+.E =#-,* P#6?%.E #-+ 0%#-,-$/?6
*2#-$%. ,- .*)(%.V @2,6% ,1 ,. *?((%-169 -)1 .1#-+#(+ =(#*1,*%E 2#P,-$ ":> +#1# #P#,6#;6% ,-
12% W5: L)?6+ #++ $(%#1 P#6?%V 5)L%P%(E 12,. #P#,6#;,6,19 L,66 (%^?,(% # 6)1 )/ ,-.1,1?1,)-#6
(%.)?(*%. 1) 0#A% 12% +#1# ?.%(?1*)0%. :%.%#(*2 #-+ WP#6?#1,)- #1
12% 3%?()6)$,*#6 4-.1,1?1% #1 12% 76%P%6#-+ 76,-,*V 4- 2%( =(%.%-1#1,)-E .2% +,.*?..%+ 12%
,0=)(1#-*% )/ .%6%*1,-$ 0%#.?(%. 12#1 /,1 12% *)-1%X1 )/ ?.% #-+ )/ %-.?(,-$ 12#1 *)66%*1,-$ #
":> ,. 12% 0).1 #==()=(,#1% #==()#*2V 5)L 12% +#1# L,66 ;% ?.%+—*6,-,*#6 *#(%E ̂ ?#6,19
,0=()P%0%-1E )?1*)0%. #-#69.,. )( (%.%#(*2—L,66 +,*1#1% 12% 0).1 #==()=(,#1% 0%#.?(%V
O)( %X#0=6%E ":>J48 0%#.?(%. 0#9 ;% #==()=(,#1% /)( )?1*)0%. #..%..0%-1E ;?1 #-)12%(
1))6 0,$21 ;% 0)(% #==()=(,#1% /)( ?.% ,- *6,-,*#6 *#(% )( .*(%%-,-$V 4- #++,1,)-E +,.%#.%<
.=%*,/,* +)0#,-. 0#9 2#P% ;%%- +%P%6)=%+ /)( ?.% ,- .=%*,/,* =)=?6#1,)-. #-+ 0#9 -)1 ;%
#==()=(,#1% /)( 0#A,-$ *)0=#(,.)-. L,12 )12%( =)=?6#1,)-.V 76,-,*,#- (%.%#(*2%(. .2)?6+
*)-.,+%( # *)0;,-#1,)- )/ +,.%#.%12%( ,0=)(1#-1 /#*1)(. 1) *)-.,+%( L2%- .%6%*1,-$ #
0%#.?(% ,-*6?+% (%6,#;,6,19E P#6,+,19E #-+ (%.=)-.,P%-%..d /%#.,;,6,19 )/ *)66%*1,)- #-+ =#1,%-1
;?(+%-d ,-1%()=%(#;,6,19 #-+ *)0=#(#;,6,19d #-+ *)0/)(1 6%P%6V U(V c#1_#- -)1%+ 12#1 ,- 12%,(
%X=%(,%-*%E ":>J48 0%#.?(%. )?1=%(/)(0%+ )12%( 0%#.?(%. ,- 1%(0. )/ =.9*2)0%1(,*.E
%#.% )/ *)66%*1,)-E ,-1%(=(%1#;,6,19E *)0=#(#;,6,19E #-+ *)0/)(1 6%P%6V
8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
10/22
"#$% & 'G
?&D :#;"1/0$,*& 0#3 ?$7%1 :&&+%&
U(V B#0%. @,66,$E JUE ,. #- S..)*,#1% "()/%..)( #1 12% Q-,P%(.,19 )/ S6#;#0#. 2#. #,+%+ ;)12
*6,-,*#6 +%*,.,)-
8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
11/22
"#$% & ''
,0=6%0%-1#1,)-V K2(%% L)(A,-$ $()?=. L%(% /)(0%+ 1) +,.*?.. ;#((,%(. 1)
,-*)(=)(#1,-$ ":>. ,-1) 2%#612*#(% L,12 (%$#(+. 1) 12% /)66)L,-$\ 'N 12% +%*,.,)- 1) *)66%*1":>.d FN +)0#,-b ,-.1(?0%-1 .%6%*1,)-d #-+ YN ":> ,0=6%0%-1#1,)- #-+ +#1# *)66%*1,)-V
W#*2 $()?= L#. #$#,- #.A%+ 1) *)-.,+%( 12% /)?( =(,0#(9 ^?%.1,)-. 12#1 12% L)(A.2)=
.)?$21 1) #++(%..E .=%*,/,*#669\ M'N L2%(% ,- 12% =()*%.. #(% 12% ;#((,%(.d MFN L2#1 ,. 12%
-#1?(% )/ 12% ;#((,%(d MYN 2)L *#- 12,. ;#((,%( ;%.1 ;% #++(%..%+d #-+ MRN L2) ,. ;%.1
=).,1,)-%+ 1) #++(%.. ,1 /)( %#*2 #(%# ,- 12% ":> ,-*)(=)(#1,)- =()*%..V
S66 12(%% $()?=. ,+%-1,/,%+ .%P%(#6 ;#((,%(. #-+ .)6?1,)-. 1) ,-1%$(#1,)- )/ ":>. L,12 12%
2%#612*#(% .9.1%0 M.%% S==%-+,X INE #. L%66 #. .1#A%2)6+%(. L2) L)?6+ ;% *(,1,*#6 ,- /,-+,-$
.)6?1,)-. #()?-+ 12%.% *2#66%-$%. MS==%-+,X 7NV
f()?= ' L#. #..,$-%+ 1) +,.*?.. ;#((,%(. 1) 12% +%*,.,)- )/ 2%#612*#(% .9.1%0. )( *6,-,*,#-.
1) *)66%*1 ":>.V K2% $()?= ,+%-1,/,%+ .%P%(#6 *)00)- ;#((,%(.E ,-*6?+,-$ 6#*A )/ 6%#+%(.2,=
#-+ /,-#-*,#6 .?==)(1E 12% -%%+ /)( #++,1,)-#6 4K (%.)?(*%.E =()0)1,-$ 12% P#6?% )/ ":>. 1)
.1#A%2)6+%(.E #-+ %-$#$,-$ =#1,%-1. ,- 12% 1%#0 1) /#*,6,1#1% ,0=6%0%-1#1,)- #-+
*)0=6,#-*%V K2% $()?= /%61 12#1 12%.% ;#((,%(. *)?6+ ;% 6,/1%+ L,12 #==()=(,#1% 0#(A%1,-$E
=%(/)(0#-*% ,-+,*#1)(. 1,%+ 1) (%,0;?(.%0%-1E #-+ )12%( 0)1,P#1)(. MS==%-+,X INV
f()?= F /)*?.%+ )- ;#((,%(. #..)*,#1%+ L,12 +)0#,- #-+ ,-.1(?0%-1 .%6%*1,)-V K2% $()?=
/%61 12#1 12% *?((%-1 1%-+%-*9 ,. to “create your own” instrument, which has led to too many0%#.?(%. ,- /,%6+E ;,#. 1)L#(+. ,-.1(?0%-1 .%6%*1,)- #-+ ,-P%.10%-1 ,- *%(1#,- ,-.1(?0%-1.E
#-+ .)0% =))( ^?#6,19 ,-.1(?0%-1.V >12%( ,..?%. ,-*6?+%+ *?61?(#6b6,-$?,.1,* *2#66%-$%.E
#-+ #+#=1#;,6,19 )/ )-% 0%#.?(%0%-1 1) .?==)(1 ;)12 *6,-,*#6 *#(% #-+ 2,$2 ^?#6,19 (%.%#(*2
%-+=),-1.V 8)6?1,)-. 1) 12%.% =();6%0. ,-*6?+%+ ?.,-$ ":>.%11# 81)-%E # 1))6 12#1 =()P,+%.
%^?,P#6%-1 .*)(%. /)( +,//%(%-1 .*#6%. 12#1 0%#.?(% 12% .#0% 2%#612 )?1*)0%V >12%(
.)6?1,)-. ,-P)6P%+ ,-*(%#.%+ ,-1%$(#1,)- )/ ":>J48 0%#.?(%.E =()P,+,-$ /?-+,-$ /)(#++,1,)-#6 *()..
8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
12/22
"#$% & 'F
f()?= Y 6,.1%+ .%P%(#6 ;#((,%(. 1) ":> ,0=6%0%-1#1,)- #-+ +#1# *)66%*1,)-E ,-*6?+,-$\ 6#*A )/
;?937N
#-+ )12%(. *)?6+ =?.2 /)( 12% *(%#1,)- )/ # *)00)- 6#-$?#$% 1) (%*)(+ +#1# )( #.A WJ:
P%-+)(. 1) #**%=1 # *)00)- +#1# /)(0#1V S6.)E 12%.% $()?=. *)?6+ 6%#+ 12% %//)(1 ,- *(%#1,-$
.9.1%0. 12#1 #66)L /)( +#1# *)66%*1,)- ,- #-+ )?1 )/ 12% *6,-,*E $,P,-$ =#1,%-1. 0)(% )=1,)-. 1)
*2)).% 0%12)+. 12#1 ;%.1 /,1 12%,( -%%+.V :%$?6#1)(9 #-+ %12,*#6 ,..?%. *)?6+ =)1%-1,#669 ;%
(%.)6P%+ ;9 +%P%6)=,-$ $?,+#-*% +)*?0%-1. #-+ =()1)*)6. /)( *6,-,* ,-1%$(#1,)-E #. L%66 #.
/)( 4-.1,1?1,)-#6 :%P,%L I)#(+. M4:I.N #-+ ,-/)(0%+ *)-.%-1E +%=%-+,-$ )- ?.% *#.%V
@)(A/6)L ,..?%. *)?6+ ;% #++(%..%+ ;9 *(%#1,-$ =()1)*)6. 12#1 +,(%*1 *6,-,* ,-1%$(#1,)-d
=()P,+,-$ *)-.?61#-*9 #-+ 1(#,-,-$ 1) .1#//d #-+ +%P%6)=,-$ #6$)(,120. /)( 2)L 12% +#1# #(%*)66%*1%+ 1) #P),+ +?=6,*#1,)-V K2%.% #6$)(,120. .2)?6+ +%.*(,;% L2) ,. ,- *2#($% )/
(%.=)-+,-$ 1) .=%*,/,* ,..?%.E *)-+,1,)-#6 )- 12% *)-1%X1E #-+ 2%6= +%1%(0,-% =(,0#(9
(%.=)-.,;,6,19 /)( =()P,+,-$ )( +%.,$-#1,-$ (%.=)-.,;,6,19V K) #++(%.. =#1,%-1 /#*1)(. M%V$VE
6,1%(#*9E +#1# )L-%(.2,=E %1*VNE #..%..,-$ 12% -%%+. )/ 12% =#1,%-1 =)=?6#1,)- #-+ ,-*6?+,-$
=#1,%-1. ,- 12% +%.,$- )/ 12% .1?+9 L)?6+ 2%6= )P%(*)0% .)0% )/ 12% ;#((,%(.V
U%=%-+,-$ )- 12% ;#((,%(E +,//%(%-1 .1#A%2)6+%(. MS==%-+,X 7N #(% ;%.1 %^?,==%+ 1) #++(%..
*2#66%-$%.V 7)-$(%..E 12% 0,6,1#(9E #-+ %P%- *)0=#-,%. 6,A% 81#(;?*A.E L2) 2#P% ;%%-
.?**%../?6 #1 *(%#1,-$ 0#(A%1,-$ 1))6.E #(% =)..,;6% =#(1-%(. L2) *#- 2%6= (%0)P% .)0% )/
12% ;#((,%(.V K2% 2).=,1#6 #+0,-,.1(#1)( L,66 ?.?#669 +%*,+% L2%12%( )( -)1 1) *)66%*1 ":>.
#-+ L,66 ;% 0)(% =).,1,P% ,/ ":>. *)-1(,;?1% 12% /,-#-*,#6 2%#612 )/ 12% ,-.1,1?1,)-E #(% ,- 6,-%
L,12 12% 0,..,)-E #-+ ,/ 6%$#6 6,#;,6,19 *#- ;% #P),+%+V K2% *6,-,*,#- *#- 0#A%
(%*)00%-+#1,)-. 1) 6%#+%(.2,= #-+ ?.% ":>. L,12 12%,( )L- =#1,%-1.V 76,-,*,#-. L,66
support PRO data collection as long as it saves time, doesn’t conflict wit 2 =%(.)-#6 ,-1%(%.1.E
,0=()P%. ̂ ?#6,19 )/ *#(%E #-+ ,. #;6% 1) #++(%.. =#1,%-1 =();6%0. %//,*,%-169 #-+ %//%*1,P%69V
4K $()?=. 2#P% # ()6% ,- %-*)?(#$,-$ )( +,.*)?(#$,-$ (%*)00%-+#1,)-. 1) 6%#+%(.2,=V
[#.169E 12% =#1,%-1 2#. # ()6% ,- +%*,+,-$ L2%12%( )( -)1 1) *)0=6%1% #..%..0%-1.E L2,*2 L,66
+%=%-+ 2%#P,69 )- *6,-,*,#- #-+ .1#// %-*)?(#$%0%-1V "#1,%-1. L,66 0).1 6,A%69 *2)).% 1)
*)0=6%1% ":>. ,/ 12%9 /%%6 ,1 ,. # $))+ ?.% )/ 12%,( 1,0%E ?-+%(.1#-+ 12#1 12% +#1# L,66 ;%
?.%+ /)( 12%,( *#(%E L,66 %-#;6% 12%0 1) 1(#*A 12%,( =()$(%..E #-+ L,66 ,-/)(0 )- 2)L 12%9
*)0=#(% 1) )12%(. L,12 .,0,6#( *)-+,1,)-
8%)$ .$%9&
K2% L)(A.2)= L#. P%(9 .?**%../?6 ,- ,+%-1,/9,-$ # P#(,%19 )/ #(%#. )/ *)-*%(- /)( 12%
,-1%$(#1,)- )/ ":>. ,-1) ()?1,-% *6,-,*#6 *#(% #-+ 12% W5: iS==%-+,X IjV 81#A%2)6+%(. L2)
*)?6+ *)-1(,;?1% 1) 0)P,-$ 12,. ,-,1,#1,P% /)(L#(+ L%(% #6.) ,+%-1,/,%+E ,-*6?+,-$ /?-+,-$
,-.1,1?1,)-. 6,A% 7J8 #-+ "7>:4E /%+%(#6 )($#-,_#1,)-. M%V$VE 345NE #. L%66 =#1,%-1.E =#1,%-1
#+P)*#*9 $()?=.E *)-.?0%(
8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
13/22
"#$% & 'Y
3%X1 .1%=. /)( 12% 345 7)66#;)(#1)(9 ":> 7)(% ,-*6?+% +,..%0,-#1,-$ 12% (%.?61. /()0 12,.
L)(A.2)= ,- 12% /)(0 )/ # L2,1% =#=%( M12,. +)*?0%-1N 12#1 L,66 ;% #P#,6#;6% )- 12% 345
7)66#;)(#1)(9 L%;.,1% #1 211=.\bbLLLV-,2*)66#;)(#1)(9V)($b"#$%.bc-)L6%+$%<
:%=).,1)(9V#.=XV S++,1,)-#6 =?;6,*#1,)-. #(% #6.) ;%,-$ +,.*?..%+V K2% ":> 7)(% ,. #6.)
+,.*?..,-$ )==)(1?-,1,%. 1) %-$#$% .1#A%2)6+%(. ,- /?1?(% L)(A.2)=.E 7)66#;)(#1)(9
U%0)-.1(#1,)- "()a%*1.E #-+ /?1?(% =?;6,*#1,)-.V
8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
14/22
"#$% & 'R
M99%#3,) MD N"16&7"9 , &99)'-"4$ 3();$99)( ); 8$0-'-*$E ,-D-9-)*9 ); @=-*-'"= O6-0$#-)=)1+E
5>$/#"4)=)1+ "*0 5$96-("4)(+ O6-0$#-)=)1+ "*0 @=-*-'"= A(-"=9 Q*-4
8'R-== Q*-D$(9-4+ P 5)+"= S-'4)(-" &99-94"*4 3();$99)(E @"()=-*"?@>"6$= "#E 8, &99)'-"4$ 3();$99)( ); 8$0-'-*$T ,-($'4)(E U)>*9 (-4-9 @$*4$(E
U)>*9 , ,-($'4)(E @$*4$( ;)( 3"4-$*4?@$*4$($0 7/4')#$9 ? :*94-4/4$ ;)( 3/B=-'
H+** ,$B"(E 3>, 2$*-)( :*D$94-1"4)(E @$*4$( ;)( :*94-4/4$
Y"4>(+* .=+**E 3>, &99)'-"4$ 3();$99)( ); 8$0-'-*$E 8$0-'"= @)==$1$ ); Z-9')*9-*
5-'>"(0 R$(9>)*E 3>, &99)'-"4$ 3();$99)( -* 8$0-'"= 2)'-"= 2'-$*'$9 "*0 3($D$*4-D$ 8$0-'-*$?"-( ); Z)#$*[9 $ ,-($'4)( ); 4>$ ,-D-9-)* ); 8"4$(*"=?.$4"= 8$0-'-*$ "4 @$0"(9?2-*"-\
5)C"**$ U$*9$*E 3>, :*94(/'4)(E 3)6/="4-)* 2'-$*'$9E R$)(1$4)M* Q*-D$(9-4+
H"/(" H$$ U)>*9)*E 3>, .))0 "*0 ,(/1 &0#-*-94("4-)*
8-'>"$= Y"66$=#"*E 8, 3$0-"4(-' 1"94()$*4$()=)1-94E &99-94"*4 3();$99)( "4 Q*-D$(9-4+ ); !)(4> @"()=-*"
"4 @>"6$= 3();$99)(T ,-($'4)(E 2'=$()0$(#" 3()1("#E Q*-D$(9-4+ ); 8-'>-1"*
R($1)(+ Y)4VB"/$( 8"*"1$( ,-($'4)(E 24("4$1-' A$'>*)=)1+ :*-4-"4-D$9E ,"(4#)/4> :*94-4/4$
2/*-= Y(-6"="*-E 8,E 82 &99)'-"4$ 3();$99)( "*0 @>-$; ); 4>$ 2$'4-)* );
8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
15/22
"#$% & 'H
#$% &;;-=- 4-)*%
F(+'$ 5$$D$E 3>, &99)'-"4$ 3();$99)(E
@"()=-*"?@>"6$= K7F225L@>-$;E 2'-$*'$ ); 5$9$"('> "*0 A$'>*)=)1+ F("*'>
,-D-9-)* ); @"*'$( @)*4()= "*0 3)6/="4-)* 2'-$*'$9E !"4-)*"= @"*'$( :*94-4/4$
@="-($ 2*+0$(E 3>, &99)'-"4$ 3();$99)(E ,-D-9-)* ); R$*$("= :*4$(*"= 8$0-'-*$E U)>*9 , 3"4-$*4 5$6)(4$0 7/4')#$9 @)($ H$"0$(T 3();$99)( -* 39+'>-"4(+ "*0
F$>"D-)("= 2'-$*'$9E ,/N$ Q*-D$(9-4+
&9>=$+ Z-=0$(?2#-4>\ 3>,E
83<
3()1("# ,-($'4)( -* 4>$ 7/4')#$9 5$9$"('> F("*'> ); 4>$ &66=-$0 5$9$"('>
3()1("#E !@:
Z-==-"# A)*N-*9E U(E ,(\3< ,-D-9-)* ); 2N-* "*0 5>$/#"4-' ,-9$"9$9 E U)>*9
8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
16/22
"#$% & 'Z
M99%#3,) 4D O,#05 A,&$ "; 4011,%1& $" :#$%B10$,#B ?& ,#$" >"+$,#%
@%05$7*01% 0#3 ?99"1$+#,$,%& ;"1 >%;"1/
,$'-9-)*%4)%')==$'4%3579I%
F ((-$(9]% 2)=/4-)*9%
H"'N ); >$"=4>'"($ =$"0$(9>-6
"*0 ;-*"*'-"= 9/66)(4
,$#)*94("4$ ($4/(* )* -*D$94#$*4 B)4> ;-*"*'-"==+ "*0 B+
-#6()D$#$*49 -* '"($
A-$ 3579 4) ($-#B/(9$#$*49E 6$(;)(#"*'$ #$"9/($9E "*0 4>$
institution’s strategic plan, and use PROs to evaluate
6$(;)(#"*'$ -*4$(*"==+\
@($"4$P-0$*4-;+ '>"#6-)*9P"0D)'"4$9 M-4>-* =$"0$(9>-6
8"(N$4 9/''$99;/= '"9$ 94/0-$9E 6($9$*4 -*;) )* *$$09 ;()#
6"4-$*49 "*0 ;()# 6"4-$*4 "0D)'"'+ 1()/69
! Q9$ ')(6)("4$ #)0$=9 K$\1\E 24"(B/'N9E Z"=#"(4E $4'\L
!
Q9$ 6>"(#"'$/4-'"= ')(6)("4$ #)0$=9 "*0 $C"#6=$9 );
0)-*1 4>-9
Q9$ 3579 4) 6(-)(-4-V$ "'4-D-4-$9 "*0 9>"($ 6"4-$*4 9"4-9;"'4-)*
("4-*19
8)4-D"4$ ="(1$( 9+94$#9P')#6"*-$9 4) 0$D$=)6 -**)D"4-D$
;-*"*'-"= -*'$*4-D$9 ;)( 357 "0)64-)*
! ./*0$(9 "*0 4>-(0 6"(4+ 6"+$(9 K$\1\E @82E 3@75:L
H"'N ); '=-*-'-"* 9/66)(4 "*0
/64"N$
8"N$ 3579 6"(4 ); ($J/-($0 6$(;)(#"*'$ #$"9/($9 K$\1\E J/"=-4+
-#6()D$#$*4L "*0 4-$ 4) ($'$-64 ); ($9)/('$9
OD"=/"4$ "*0 0$#)*94("4$ >)M 3579 M-== 9"D$ '=-*-'-"* 4-#$ "*0
>$=6 0-($'4 '"($\ ,$#)*94("4$ 4>"4 '=-*-'-"*9 M-== B$ "B=$ 4)
"00($99 4>$ 6()B=$#9 4>"4 4>$+ "($ ')#;)(4"B=$ M-4>E "*0 )4>$(0$6"(4#$*49 M-== B$ *)4-;-$0 4) 6()D-0$ 9/66)(4 "*0 '"($ ;)(
)4>$( ')*'$(*9\
OD"=/"4$ "*0 0$#)*94("4$ >)M 3579 -#6()D$ 6"4-$*4?6>+9-'-"*
')##/*-'"4-)* "*0 6"4-$*4 )/4')#$9
O0/'"4$ "B)/4 D"=/$P0$#)*94("4$ >)M 3579 '"* "99-94 M-4> 6($?
D-9-4 4$"# 6="**-*1 "*0 4(-11$( "00-4-)*"= 9$(D-'$9 K$\1\E 9)'-"=
M)(NL
3()D-0$ 0"4" )* M>"4 6"4-$*49P'=-*-'-"*9 M"*4
O*9/($ "0$J/"4$ -*;("94(/'4/($ 4) ($0/'$ B/(0$*
5$9$"('> 0"4" #-*-*1E *$M 0"4" 1$*$("4-)*
@)=="B)("4$ M-4> 6"(4*$(9 4) 4"N$ *$C4 94$69
!
R("0/"4$ #$0-'"= )(1"*-V"4-)*9 K$\1\E 4>$ &99)'-"4-)* );$(-'"* 8$0-'"= @)==$1$9 ̂ &&8@_L
! 3"4-$*4 "0D)'"'+ 1()/69
! ./*0$(9
! @)*4-*/-*1 6();$99-)*"= $0/'"4-)* "*0 6();$99-)*"=
)(1"*-V"4-)*9
8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
17/22
"#$% & 'T
:*9/;;-'-$*4 B/01$4 ;)( :A 9/66)(4
); >-1> J/"=-4+ 357
-*4$1("4-)*P:0$*4-;+-*1 "*0
6()D-0-*1 "66()6(-"4$
:AP:*;)(#"4-'9 ($9)/('$9T :A
B)44=$*$'N 0/$ 4) ="'N );
6();$99-)*"=9
@($"4$ 6()'$99 ;)( 0-99$#-*"4-*1 =$99)*9 =$"(*$0
2>"($ B/01$49E 6()4)')=9E 9$'/(-4+ "*0 )4>$( 0)'/#$*49
5$'(/-4 >-1> =$D$= 4$'>*-'"= "99-94"*'$ M>$* 0$D$=)6-*1 9+94$#
@)=="B)("4$ M-4> 6"(4*$(9 4) 4"N$ *$C4 94$69
!
:*')(6)("4$ ;/*0$(9 "*0 D$*0)(9 -*4) 0-9'/99-)*9
! $(-'"* 8$0-'"= :*;)(#"4-'9 &99)'-"4-)* K&8:&L
! F(-*1 :AP:*;)(#"4-'9 ')##/*-4+ 4) 4>$ 4"B=$
! :*')(6)("4$ 6/B=-' >$"=4> -*;)(#"4-'-949
:*9/;;-'-$*4 #$99"1-*1
(“spreading the word”)
F$44$(E ;"94$( 0-99$#-*"4-)* ); #$99"1$ K$\1\E `)/A/B$E 9)'-"=
#$0-"E $4'\L
! Q9$ ($9)/('$9 =-N$ 3"4-$*49H-N$8$ "9 )/4=$49 ;)( #$99"1-*1
&'"0$#-' 0$4"-=-*1
! Q9$ #)0$=9 0$D$=)6$0 B+ 6>"(#"'$/4-'"= ')#6"*-$9
O*1"1-*1 6"4-$*49 -* 357 ')==$'4-)* "*0 /9$
! Q9$ 9)'-"= #$0-" 4) $*1"1$ 6"4-$*49E B/4 6"+ "44$*4-)* 4)
;("#-*1
2$=$'4-*1%,)# -*9I%F ((-$(9% 2)=/4-)*9%
5$')*'-=-*1 0-;;$($*'$9 "#)*1
0)#"-*9 4>"4 "($ KaL -#6)(4"*4
;)( $D"=/"4-*1 B$*$;-4P>"(# -*
($9$"('>E KbL 6()D-0-*1 '"($E KcL
($96$'4-*1 M>"4 6"4-$*49 ;$$= "($
-#6)(4"*4 4) ($6)(4
"4
0)#"-*9 "($ )*=+ -#6)(4"*4 -;
;$0$("= 6"(4*$(9 K$\1\E .,&L )(
)4>$( 94"N$>)=0$(9 4>-*N 4>$+
"($ -#6)(4"*4
R"-*-*1 "''$64"*'$ ); "
/*-D$(9"= 9$4 ); 0)#"-*9
%
Q6?;()*4 94"N$>)=0$( $*1"1$#$*4 -* "0)64-*1 " /*-D$(9"= 9$4
($')##$*0$0 B+ 4>$ @)=="B)("4)(+
! 5)=$ ;)( 3@75: "*0 @)=="B)("4)(+ =$"0$(9>-6E 4>$ 7;;-'$ );
4>$ !"4-)*"= @))(0-*"4)( ;)(
8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
18/22
"#$% & 'C
R$44-*1 "1($$#$*4 ($J/-($0 ;)(
0-9$"9$?96$'-;-' K"00?)*9L
2)=-'-4 ;$$0B"'N ;()# 9)'-$4-$9E ;)/*0"4-)*9E $4'\
3/9>B"'N )* '>)-'$ A"(1$4 #$99"1-*1 4>"4 $C6="-*9 M>+ 9)#$ 0)#"-*9 "($ B$44$(
;)( '$(4"-* 9$44-*19 "*0 >)M 4) /9$ 0-9$"9$?96$'-;-' 0)#"-*9
,$#)*94("4$ D"=/$ "*0 ($4/(* )* -*D$94#$*4 K57:L D$(9/9
B/(0$* )* 6"4-$*49 "*0 6()D-0$(
2$=$'4-*1%:*94(/#$*49I%
F ((-$(9% 2)=/4-)*9%
Clinicians don’t want to compare
6"4-$*49 4) 1$*$("= 6)6/="4-)*
R$*$("4$ 0-9$"9$?96$'-;-' ($;$($*'$ D"=/$9 "*0 /9$ -* 0-96="+
); 9')($9
.-*0-*1 9-*1=$ #$"9/($#$*4
"66()"'> 4>"4 9-#/=4"*$)/9=+
9/66)(49 B)4> "*"=+9-9 ); >-1>?J/"=-4+ ($9$"('> J/$94-)*9 "*0
'=-*-'"= '"($ K$\1\E #)*-4)(-*1
6"4-$*4 94"4/9 "*0 9'($$*-*1 ;)(
;)==)M?/6L
@($"4$ >+B(-0 #$"9/($#$*4 "66()"'> /9-*1 B(-$;E 9-*1=$?-4$#
9'($$*-*1 -4$#9 4>"4 '"* 4(-11$( #)($ 6($'-9$ #/=4-?-4$#
"99$99#$*49
H"'N ); ($9)/('$9 K$\1\E 94";;E
$4'\L 4) "0)64 )( -*')(6)("4$
*$M )( 0-;;$($*4 -*94(/#$*49
2>)M 0"4" 4>"4 9/66)(4 9/6$(-)(-4+ ); *$M #$"9/($9
[REFERENCE IRENE’s criteria]
Clinician’s comfort level with
6($;$(($0 -*94(/#$*49 )D$(
"=4$(*"4-D$ )*$9
:*')(6)("4$ ')?'"=-B("4-)* )( )4>$( =-*N-*1 #$4>)0)=)1-$9 4)
6$(#-4 4("*9="4-)* 4) ')##)* #$4(-'9
&D"-="B-=-4+ ); -*94(/#$*49 -*
#/=4-6=$ ="*1/"1$9
3578:2 -*4$1("4-)*
! &0)64-)* ); 3578:2 -*4$(*"4-)*"= #$"9/($9
Q*'$(4"-*4+ ); >)M 4)
-*')(6)("4$ 357 9')($9 -*4)
'=-*-'"= 0$'-9-)*?#"N-*1P;$$=-*1
4>"4 9')($9 "($ *)4 '=-*-'"==+
"'4-)*"B=$
5$9$"('> -9 *$$0$0 4) 0$(-D$ $94-#"4$9 ); #$"*-*1;/= '>"*1$9
(e.g., “panic values” etc.)
5$9$"('> -9 *$$0$0 4) 0$#)*94("4$ $;;$'4 ); -*4$1("4-*1 357?
B"9$0 0$'-9-)*?#"N-*1 "=1)(-4>#9 -*4) '"($
3()6(-$4"(+ #$"9/($9 "($ *)4 -*
6/B=-' 0)#"-*E >"D$ "99)'-"4$0
$C4(" ')949E "*0 -*4()0/'$ "*
$C4(" =$1"= 94$6
Q9$ $C-94-*1 6/B=-'?0)#"-* #$"9/($9
,$D$=)6 *$M 6/B=-'?0)#"-* #$"9/($9
5$96)*9$ '"4$1)(-$9 "($ *)4
#$"*-*1;/=P;(-$*0=+ 4) 6"4-$*49
,-;;$($*4 #$"9/($9 ); 9"#$
0)#"-* -* /9$ "'()99 0-;;$($*4
'=-*-'9 "*0 "'()99 4-#$
8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
19/22
"#$% & 'D
A)) #"*+ '>)-'$9 ;)(
-*94(/#$*49
3579$44" 24)*$E '()99?M"=N 94/0-$9 4) ')##)* #$4(-' K4?9')($LE
$#6)M$( 6$)6=$ 4) N$$6 4>$-( -*94(/#$*4 ); '>)-'$
3"'N"1-*1 ,$9-1* 0"9>B)"(09 "*0 '($"4$ 4>($9>)=09 ;)( '=-*-'"= /4-=-4+
!
./*0-*1 766)(4/*-4+ &**)/*'$#$*4 K.7&L *$$0$0
F"0P-*"66()6(-"4$ -*94(/#$*49 Q9$ -*94(/#$*4 ($')##$*0"4-)*9 6()D-0$0 B+ 8$0-'"=
7/4')#$9 A(/94 )* d "44(-B/4$9 )* J/"=-4+ #$"9/($9P
@7*9$*9/9?B"9$0 24"*0"(09 ;)( 4>$ 9$=$'4-)* ); >$"=4>
8$"9/($#$*4 :!94(/#$*49 K@728:!LP:*4$(*"4-)*"= 2)'-$4+ ;)(
G/"=-4+ ); H-;$ 5$9$"('> K:27G7HL
! 8$99"1-*1 "*0 ')=="B)("4-*1 M-4> 9/B96$'-"=4+ 9)'-$4-$9
! 3"4-$*49 '"* >$=6 $*9/($ ')*4$*4 D"=-0-4+ "*0 ;$"9-B-=-4+
@(-4$(-)* D"=/$9
:#6=$#$*4 4-)*E%@)==$'4-)*%
*0%8 -*4$* *'$%);%3579I%
F ((-$(9% 2)=/4-)*9%
H)M ($96)*9$ ("4$ 7;;$( D"(-)/9 #)0$9 ); 0"4" ')==$'4-)*
7;;$( 9)=/4-)*9 0$6$*0-*1 )* 6/(6)9$ ); 0"4" ')==$'4-)* K$\1\E
-*4$1("4-)* -*4) '"($L
:*9/;;-'-$*4 ($9)/('$9 "D"-="B=$
4) -*4$1("4$ -*4) '"($
Z)(N;=)M 0-9(/64-)* A"-=)( ')==$'4-)* 4) 96$'-;-' 1()/6
:*4$1("4$ ')==$'4-)* -*4) O#9 ;)( M>) -9 -* '>"(1$ ); ($96)*0-*1E
')*0-4-)*"= )* 4>$ ')*4$C4\ :0$*4-;+ " 6(-#"(+ ($96)*0$(
5$0/*0"*'+ ); J/$94-)*9
Q*>$=6;/= 0"4" 0-96="+ K'=-*-'-"*9
"*0 6"4-$*49L
H"'N ); B/+?-*PD"=/$ 6()6)9-4-)*
@($"4$ -*'$*4-D$9 B+ 6()D-0-*1 $D-0$*'$ ); D"=/$ "*00$#)*94("4-*1 #$"*-*1;/= /9$
! A>-9 '"* B$ =$0 B+ 6();$99-)*"= 9)'-$4-$9 M-4> 6"+$(9 "*0
($1/="4)(+ B)0-$9 4) '($"4$ -*'$*4-D$9
&/4)#"4$ 4) '($"4$ $;;-'-$*'-$9 "*0 0$'($"9$ -#6"'4 )*
M)(N;=)M
! A>-9 '"* B$ =$0 B+ :A ')#6"*-$9 "*0 6(-D"4$ -*0/94(+
8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
20/22
"#$% & FG
:*;("94(/'4/($ =-#-4"4-)*9 @($"4$ ')##)* ="*1/"1$ 4) ($')(0 0"4"
&9N O85 D$*0)(9 4) "''$64 0"4" ;)(#"4
! S$*0)(9 "*0 7;;-'$ ); !"4-)*"= @))(0-*"4)( "($ B$94 9/-4$0
4) 0) 4>-9
@($"4$ 9+94$#9 4>"4 "==)M ;)( ')==$'4-)* -* "*0 )/4 ); '=-*-'
R-D$ 6"4-$*49 '"6"B-=-4+ 4) '>))9$ 4>$ )64-)* 4>"4 -9 >$=6;/= ;)(
4>$#
@)*9-0$( $;;-'-$*'-$9 ); '$*4("=-V$0 ($9)/('$9
! @($"4-*1 '$*4("=-V$0 ($9)/('$9 ')/=0 B$ W)B ); D$*0)(9\
! &1$*'+ ;)( "#6-)*9P6"4-$*4 "0D)'"4$ 1()/69 "*0 4>$ :A ')##/*-4+
8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
21/22
"#$% & F'
M99%#3,) !D .$06%7"53%1 4%&$ (P+,99%3 $" M331%&& !7055%#B%&
24 N$>)=0$(% 5 4-)* =$%
$ 0$'-9-)* 4) ')==$'4
3579 "*0 M-== 0) 9) -; 3579 ')*4(-B/4$ 4>$ ;-*"*'-"= >$"=4> ); 4>$
-*94-4/4-)*E "($ -* =-*$ M-4> 4>$ #-99-)*E "*0 -; =$1"= =-"B-=-4+ '"* B$
"D)-0$0\
@=-*-'-"* A>$ '=-*-'-"* '"* #"N$ ($')##$*0"4-)*9 4) =$"0$(9>-6 "*0 /9$
3579 M-4> 4>$-( )M* 6"4-$*49\ @=-*-'-"*9 M-== 9/66)(4 357 0"4"
collection as long as it saves time, doesn’t conflict with personal
-*4$($949E -#6()D$9 J/"=-4+ ); '"($E "*0 >$=69 "00($99 6"4-$*4
6()B=$#9 $;;-'-$*4=+ "*0 $;;$'4-D$=+\
:A :A 1()/69 >"D$ " ()=$ -* $*')/("1-*1P0-9')/("1-*1
($')##$*0"4-)* 4) =$"0$(9>-6\
OC"#6=$I 5$9$"('>$(9 ;()# 4>$ $(-'"* 8$0-'"= :*;)(#"4-'9
&99)'-"4-)* "*0 6/B=-' >$"=4> -*;)(#"4-'-949 '"* B$ B()/1>4
4)1$4>$( 4) 0-9'/99 *$$09 "*0 )66)(4/*-4-$9 ;)( "00($99-*1 :A
=-#-4"4-)*9
3"4-$*4 A>$ 6"4-$*4 >"9 " ()=$ -* 0$'-0-*1 M>$4>$( )( *)4 4) ')#6=$4$
"99$99#$*49E "*0 6"(4-'-6"4-)* M-== 0$6$*0 >$"D-=+ )* '=-*-'-"* "*0
94";; $*')/("1$#$*4\ 3"4-$*49 M-== #)94 =-N$=+ '>))9$ 4) ')#6=$4$
3579 -; 4>$+ ;$$= -4 -9 " 1))0 /9$ ); 4>$-( 4-#$\ A>$+ *$$0 4)
/*0$(94"*0 4>"4 4>$ 0"4" M-== B$ /9$0 ;)( 4>$-( '"($E 1-D$ 4>$#
"B-=-4+ 4) 4("'N 4>$-( 6()1($99E "*0 >$=6 4>$# =$"(* >)M 4>$+
')#6"($ 4) )4>$(9 M-4> 9-#-="( ')*0-4-)*9
.-*"*'-"= 6"(4*$(9P./*0$(9 "*0
4>-(0 6"(4+ 6"+$(9 K$\1\E @82E
3@75:L
3()D-0-*1 ;-*"*'-"= -*'$*4-D$ ;)( "0)64-)* ); 3579E 6()#)4-)* );
O85 -*4$1("4-)*
@)(6)("4$ #)0$=9 K$\1\E 2";$M"+E
24"(B/'N9E Z"=#"(4E &$4*"L
@"* 9$(D$ "9 $C"#6=$9 ); B$94 #$4>)09 ); #"(N$4-*1 6()0/'49 4)
')*9/#$(9
:*4$(*"4-)*"= ($1/="4)(+ 1()/69
8-=-4"(+PS& 9+94$#
S$*0)(9 3()D-0$ =$"0$(9>-6 -* O85 -*4$1("4-)*
3"4-$*4 "0D)'"'+ 1()/69 "*0
6"4-$*4 '>"#6-)*9
5$0/'$ B"((-$(9 -*
8/20/2019 NIH Collaboratory Workshop PROs January 2015.pdf
22/22
"#$% & FF
24 N$>)=0$(% 5 4-)* =$%
@)*1($99PH)BB+-949
24"4$?96)*9)($0 )(1"*-V"4-)*9
K$\1\E 6/B=-' >$"=4>L
R("0/"4$ #$0-'"= )(1"*-V"4-)*9
K$\1\E &&8@LP3();$99-)*"=
)(1"*-V"4-)*9P@)*4-*/-*1
$0/'"4-)*
7(1"*-V"4-)*9P@)*4-*/-*1
$0/'"4-)*
&99-94 M-4> '=-*-'-"* =$"0$(9>-6 9/66)(4
F-1 3>"(#"P8$0-'"= 6()0/'4
-*0/94(+
Q9$ "9 #)0$=9 ;)( 0-99$#-*"4-*1 -*;)(#"4-)* "B)/4 3579
Top Related