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Comparative Effectiveness and
the Pursuit of Value IDN Sum
mit
September 24, 2013
Robert P. M
aliff D
irector, Applied S
olutions rm
• An#independent,#nonprofit#organiza0on#that#researches#best#prac0ces#for#im
proving#pa0ent#care#
• The!only!Consum
er!Reports(like!evaluator0of!0healthcare0technology0
• An0Evidence2Based!Prac6
ce!Center!designated0by0the0Agency0for0Healthcare0Research0and0Q
uality0(AHRQ)0
– Other0AHRQ
0efforts0include0the0U.S.!H
ealthcare!Horizon!Scanning!System
,0Na6
onal!Guidelines!Clearinghouse!&
0Na6
onal!Quality!M
easures!Clearinghouse!
• One0of0the0first0federally(designated0Pa6
ent!Safety!Organiza6
ons!(PSO
)0in0the0country0–
Collect0and0analyze0adverse0event0informaGon0from
0several0states0including0PA,0MI,0FL,0CA,0TN
0and0KY0
©ECRI0InsGtute.20130
20
ECRI0InsGtute0
©ECRI0InsGtute.20130
30
!!Technology!!Assessm
ent!!
Evidence(based0resources00recom
mendaGons,00
Strategic0technology0planning/assistance0
Procurement0Intelligence0tools0
!!
Value!A
nalysis!(Evidenced7Based)!
!
Procurement0Assistance,!
Product0evaluaGons,00raGngs,0specificaGons,00recom
mendaGons,0price00
benchmarking0and00m
ore0
!!
Pa;ent!Safety,!
Quality,!Risk!M
gt.!PaGent0Safety0(PSO
),0Risk0m
anagement,00
hazards0and0recalls,00problem
0reports,00care0standards0and00
guidelines0
ConsulGng0and0Expert0Advisory0Services0
ECRI Institute Overview!
0More0than05,0000hospitals0and0health0system
s,0GPO’s,0
public0and0private0payers,0U.S.0federal0and0state0
government0agencies,0and0m
inistries0of0health,0voluntary0sector0organizaGons,0associaGons,0and0accrediGng0agencies0w
orldwide.0
0
©ECRI0InsGtute.20130
What!is!Com
para;ve!Eff
ec;veness?!
Defini;
on:!!Compara6
ve!effec6
veness!research!is!designed!to!inform
!health2care!decisions!by!providing!evidence!on!the!eff
ec6veness,!benefits,!and!harm
s!of!diff
erent!treatment!op6
ons.!The!evidence!is!generated!from
!research!studies!that!compare!drugs,!m
edical!devices,!tests,!surgeries,!or!w
ays!to!deliver!health!care.!!!2!A
gency!for!Healthcare!Q
uality!and!Research!!!(w
ww.eff
ec6vehealthcare.ahrq.gov)!
!
©ECRI0InsGtute.20130
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What!is!Com
para;ve!Eff
ec;veness!
Research!(CER)?!!•
CER0compares0one0intervenGon0to0one0or0m
ore0other0intervenGons0– Prim
ary!CER:0generaGon0of0clinical0evidence0on0the0outcom
es0of0one0intervenGon0in0comparison0to0one0or0
more0others0(e.g.,0random
ized0controlled0head(to(head0trials,0prospecGve0observaGonal0studies)0
– Secondary!CER:0analysis0of0results0of0mulGple0prim
ary0studies00
• Com
parisons0may0be0in0the0sam
e0“class”…0or0not00
– Device0vs.0device0– Device0vs.0drug0– Device0vs.0drug0vs.0procedure0
©ECRI0InsGtute.20130
60
AHRQ
!Priority!Condi;ons!
• Care0coordinaGon00
• Self(m
anagement/health0literacy00
• Asthm
a0•
Cancer0screening00(0colorectal0and0cervical00•
Children0with0special0health0care0needs0
• Diabetes—
managem
ent0of0early0disease0•
End0of0life0with0advanced0organ0system
0failure—
focus0on0congesGve0heart0failure0and0chronic0obstrucGve0pulm
onary0disease0
• Frailty0associated0w
ith0old0age0•
Hypertension—managem
ent0of0early0disease0
• Im
munizaGon—
children0and0adults0•
Ischemic0heart0disease—
prevenGon,0reducGon0of0recurring0events,0and0opGm
izaGon0of0funcGonal0capacity00
• Pregnancy0and0childbirth—
0appropriate0prenatal0and0intrapartum
0care.0•
Severe0and0persistent0mental0illness0
• Stroke—
early0intervenGon0and0rehabilitaGon0
• Tobacco0dependence0treatm
ent0in0adults.0•
Obesity0(em
erging0area)0•
Major0depression—
screening0and0treatm
ent0•
MedicaGon0m
anagement—
0prevenGng0medicaGon0errors0and0overuse0of0
anGbioGcs0•
Nosocom
ial0infecGons—prevenGon0and0
surveillance0•
Pain0control0in0advanced0cancer0
©ECRI0InsGtute.20130
70
AHRQ
!7!Na;
onal!Healthcare!H
orizon!!!!Scanning!System
!•
IdenGfy0and0monitor0new
0healthcare0technologies0that0will0
have0significant0impact0on0paGent0care0and0health0outcom
es00•
Scope:0Technologies0defined0as0drugs,0medical0devices,0
procedures,0services,0and0care0delivery0innovaGons0that0could0signal0im
portant0changes0in0paGent0care,0health0outcomes,0or0
the0healthcare0system.00
• Contributes0to0AHRQ
’s0deliberaGons0for0allocaGng0resources0for0paGent(centered0outcom
es0research,0and0be0a0resource0for0the0public0m
ore0broadly.0
©ECRI0InsGtute.20130
80
Pa;ent7Centered!O
utcomes!Research!
Ins;tute!(PCO
RI)!•
Independent,0nonprofit0established0by020100PaGent0ProtecGon0and0Affordable0Care0Act0
• Purpose:0Created0to0conduct0research0to0provide0inform
aGon0about0the0best0available0evidence0to0help0paGents0and0their0health0care0providers0m
ake0more0inform
ed0decisions.0•
Mission:!PCO
RI0helps0people0make0inform
ed0health0care0decisions0–0and0im
proves0health0care0delivery0and0outcomes0–0
by0producing0and0promoGng0high0integrity,0evidence(based0
informaGon0–0that0com
es0from0research0guided0by0paGents,0
caregivers0and0the0broader0health0care0community.0!
0©ECRI0InsGtute.20130
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Case!Study!7!Compara;
ve!Effec;
veness!!
• Describe0the0process0of0developing0a0compara;
ve!eff
ec;veness!review
0
• Public0sector0example0from
0AHRQ
!Evidence7based!Prac;
ce!Center!(EPC)!– “Surgical!M
anagement!of!Inguinal!H
ernia”,!!!May!2013!
0
©ECRI0InsGtute.20130
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Case!Study!7!Compara;
ve!Effec;
veness!!
• Topics0are0nominated0through0a0public0process0
• A0systemaGc0review
0of0all0relevant0clinical0studies0conducted0by0independent0researchers,0funded0by0AHRQ
,0to0synthesize0the0evidence0summarizing0w
hat#is#know
n0and0what#is#not#know
n#• Research0quesGons0and0report0results0are0subject0to0peer0review
,0expert0input0and0public0comment0
• Results,0in0both0a0consumer0research0sum
mary0and0
clinician0research0summary,0are0available0at0
– www.effecGvehealthcare.ahrq.gov0
0©ECRI0InsGtute.20130
110
Compara;
ve!Effec;
veness!of!Surgical!Managem
ent!of!Inguinal!H
ernia!•
Assessed0the0comparaGve0effecGveness0and0the0adverse0
effects0of0different0surgical0opGons0for0inguinal0hernias0in0adults0and0children.000
• Approxim
ately0500,0000new0inguinal0hernias0diagnosed0
annually0
• LifeGm
e0risk0is0@025%
0for0men0and02%
0for0wom
en;00incidence0in0children0ranges0up0to04.8%
00
©ECRI0InsGtute.20130
120
Compara;
ve!Effec;
veness!of!Surgical!Managem
ent!of!Inguinal!H
ernia!•
Direct0and0indirect0inguinal0hernias0
• Sym
ptoms0include0abdom
inal0pain0and0a0lump0in0the0groin0
area0
• If0sever0enough0to0restrict0blood0supply,0im
mediate0correcGve0
surgery0is0needed.0
• Surgical0repair0is0m
ost0commonly0perform
ed0general0surgical0procedure0in0the0U
.S.0©ECRI0InsGtute.20130
130
Compara;
ve!Effec;
veness!of!Surgical!Managem
ent!of!Inguinal!H
ernia!•
Types0of0procedures0
– Open0Repair0w
ithout0use0of0mesh0im
plant0– O
pen0Repair0with0a0m
esh0implant0
– Laparoscopic0repair0with0a0m
esh0implant0
©ECRI0InsGtute.20130
140
Compara;
ve!Effec;
veness!of!Surgical!Managem
ent!of!Inguinal!Hernia!
• Open0Repair0w
ith0Mesh0
– Kugel0Patch®00– Lichtenstein0technique0– M
esh0Plug00– O
pen0preperitoneal0mesh0–0
– Prolene0Hernia0System0
– Read(Rives0repair0– Stoppa0technique0– Trabucca0technique0
• Laparoscopic0M
esh(based0Repair0– Intraperitoneal0onlay0– Totally0extraperitoneal0
technique0– Transabdom
inal0technique0
©ECRI0InsGtute.20130
150
Compara;
ve!Effec;
veness!of!Surgical!Managem
ent!of!Inguinal!H
ernia!•
Surgical0Mesh0Products0
– Typically0made0form
0polypropylene0(PP)0or0polyester0– O
ther0opGons0include:0•
Polytetrafluoroethylene0(PTFE)0•
PolyglacGn0•
Polyglycolic0acid0•
Polyamide0
– Main0criteria0for0selecGon:0M
echanical0support0provided0by0the0mesh00
to0the0defected0abdominal0w
all00•
PP0is0the0standard0in0most0com
parisons0
©ECRI0InsGtute.20130
160
Compara;
ve!Effec;
veness!of!Surgical!Managem
ent!of!Inguinal!H
ernia!•
Important0properGes0of0surgical0m
esh0– Is0it0strong0enough0to0w
ithstand0physiologic0stresses0over0a0long0Gme0
– Conformity0w
ith0abdominal0w
all0– Prom
otes0strong0host0Gssue0in(growth,0w
hich0mim
ics0normal0Gssue0
healing0– Resists0the0form
aGon0of0bowel0adhesions0and0erosions0into0visceral0
structure0– Does0not0induce0allergic0reacGon0or0adverse0foreign0body0reacGons0– Resists0infecGon0– N
oncarcinogenic0
©ECRI0InsGtute.20130
170
Compara;
ve!Effec;
veness!of!Surgical!Managem
ent!of!Inguinal!H
ernia!•
Clinical0quesGons0– Laparoscopic0vs.0open0repair0in0adults0w
ith0painful0hernia0– Different0types0of0repair0for0the0pediatric0populaGon0– Surgery0vs..0w
atchful0waiGng0in0adults0w
ith0pain(free0or0minim
ally0sym
ptomaGc0inguinal0hernia0
– Different0types0of0open0surgery0– Different0types0of0laparoscopic0surgery0– Different0m
esh0materials0
– Different0mesh(fixaGon0approaches0
©ECRI0InsGtute.20130
180
Compara;
ve!Effec;
veness!of!Surgical!Managem
ent!of!Inguinal!Hernia!
• Outcom
es0of0Interest0• Hernia0recurrence0• Hospital(related0info0like0LO
S0• Return0to0daily0acGviGes0• Return0to0w
ork0• Q
uality0of0life0• PaGent0saGsfacGon0• Short(term
0pain0(<010month0post(surgery)0
• Intermediate0pain0
• Long0term0pain0(>060
months)0
• InfecGon0
• PercepGon0of0foreign0body0
• Sm
all0bowel0perforaGon/
obstrucGon0•
Hematom
a0•
Epigastric0vessel0injury0•
Urinary0retenGon0
• Sperm
aGc0cord0injury0
©ECRI0InsGtute.20130
190
Compara;
ve!Effec;
veness!of!Surgical!Managem
ent!of!Inguinal!H
ernia!
©ECRI0InsGtute.20130
200
Compara;
ve!Effec;
veness!of!Surgical!Managem
ent!of!Inguinal!H
ernia!•
Total0Included0Studies:00N0=01510
• Open0vs.0laparoscopic0repair0in0adults:0
– Primary0hernias:0n0=0380
– Bilateral0hernia:00n0=060– Recurrent0hernia:00n=080
• Repair0vs.0w
atchful0waiGng:00n0=020
• Open0m
esh(based0procedures:00n0=0210•
Laparoscopic0procedures:00n0=0110•
Mesh0m
aterials:0n0=0320•
FixaGon0methods:0n0=0230
• Surgical0experience0and0hernia0recurrence:0n0=0320
©ECRI0InsGtute.20130
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The!CER!Process!
• Assess0the0“quality”0of0the0included0studies0― How
0likely0is0it0that0factors0other0than0the0intervenGon0led0to0the0m
easured0outcomes?0
― Also0described0as0the0“risk0of0bias”0
• Perform0the0analysis,0com
bining0data0from0sim
ilar0studies0using0the0techniques0of0m
eta(analysis00• M
ay0reveal0effects0that0were0not0apparent0in0sm
all0studies000
©ECRI0InsGtute.20130
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The!CER!Process!• Assess0the0“strength0of0evidence”0
― Risk0of0bias0in0the0studies0included0to0answ
er0the0quesGon0
― QuanGty0of0evidence0(num
ber0of0studies0and0paGents)0
― Consistency0of0the0findings0across0and0w
ithin0studies0
― Robustness0of0the0results0(sensiGvity0analyses)0
― Possible0grades:0high,0m
oderate,0low0or0
insufficient0
©ECRI0InsGtute.20130
230
The!CER!Process!• Searching0for0inform
aGon0to0address0the0quesGons:0― Medical0librarians0use0“controlled0vocabularies”0in0
bibliographic0databases0to0idenGfy0all0potenGally0relevant0studies0
― Internet0and0other0also0used0to0search0for0regulatory,0cost,0policy0inform
aGon0― Bibliographies0of0arGcles0review
ed0to0idenGfy0missed0
studies0― Technical0Experts0and0Peer0Review
ers0point0out0missed0
studies0― Searches0updated0during0the0course0of0the0review
0
©ECRI0InsGtute.20130
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Databases!Searched!
• EM
BASE0(Excerpta0Medica)00
• Health0Technology0Assessm
ent0Database0(HTA)0
• ECRI0Healthcare0Standards0
• InternaGonal0Health0Technology0Assessm
ent0(IHTA)0•
MEDLIN
E0•
PreMEDLIN
E0•
U.K.0N
aGonal0Health0Service0Econom
ic0EvaluaGon0Database0(NHS0EED)0
• U.S.0N
aGonal0Guideline0Clearinghouse™
0(NGC)0
• CIN
AHL0(CumulaGve0Index0to0
Nursing0and0Allied0Health0
Literature)0•
The0Cochrane0Central0Register0of0Controlled0Trials0(CEN
TRAL)0•
The0Cochrane0Database0of0Methodology0Review
s0(M
ethodology0Reviews)0
• The0Cochrane0Database0of0System
aGc0Reviews0(Cochrane0
Reviews)0
• Database0of0Abstracts0of0Review
s0of0Effects0(DARE)00
• ECRI0InsGtute0Library0Catalog0
©ECRI0InsGtute.20130
250
Transla;ng!CER!into!Prac;
ce:!Im
plica;ons!for!H
ospitals!
• CER0findings0are0ozen00gray.0Unless0there0is0
clear0evidence0of0benefit0for0one0alternaGve0over0another,0you0m
ay0need0to0offer0choices0based0on0paGent0preferences.0
©ECRI0InsGtute.20130
260
Transla;ng!CER!into!Prac;
ce:!What!to!do!for!Surgical!repair!of!
Inguinal!Hernia?!
• www.effecGvehealthcare.ahrq.gov0
• CER0Num
ber0700©ECRI0InsGtute.20130
270
“Predic;on!is!very!hard,!!
!!!!!!!!!!!!!especially!about!the!future”!!
((Yogi0Berra0
What Im
plications do you see???
©ECRI0InsGtute.20130
280
Discussion:!Com
para;ve!Eff
ec;veness!!
Impact!on!Supply!Chain!
• Physician0Preference?0• Value0Analysis/Technology0Assessm
ent0Programs?0
• Capital0BudgeGng/Planning?0• Reim
bursement0opGm
izaGon?0• Supplier0furnished0evidence(based0inform
aGon?0• Internal0skill0sets0and0other0needs?0• O
ther?0
©ECRI0InsGtute.20130
290
THA
NK
YOU
THA
NK
YOU
©ECRI0InsGtute.20130
300
Robert P. M
aliff D
irector, Applied S
olutions E
CR
I Institute rm
0