0 The 0 only · nia! • 0 • 0 – ... 0 • 0 0 0 0 220! • 0 ― 0 sGon0 ― 0 0 ― 0 0 ― 0...

Comparative Effectiveness and

the Pursuit of Value IDN Sum

mit

September 24, 2013

Robert P. M

aliff D

irector, Applied S

olutions rm

[email protected]

• 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


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


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)!

!


50

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


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


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


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

90

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


100

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


120

Compara;

ve!Effec;


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;


ent!of!Inguinal!H

ernia!• 

Types0of0procedures0

– Open0Repair0w

ithout0use0of0mesh0im

plant0– O

pen0Repair0with0a0m

esh0implant0

– Laparoscopic0repair0with0a0m

esh0implant0


140

Compara;

ve!Effec;


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


150

Compara;

ve!Effec;


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


160

Compara;

ve!Effec;


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


170

Compara;

ve!Effec;


ent!of!Inguinal!H

ernia!• 

Clinical0quesGons0– Laparoscopic0vs.0open0repair0in0adults0w

ith0painful0hernia0– Different0types0of0repair0for0the0pediatric0populaGon0– Surgery0vs..0w

atchful0waiGng0in0adults0w

ith0pain(free0or0minim

ally0sym

ptomaGc0inguinal0hernia0

– Different0types0of0open0surgery0– Different0types0of0laparoscopic0surgery0– Different0m

esh0materials0

– Different0mesh(fixaGon0approaches0


180

Compara;

ve!Effec;


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


190

Compara;

ve!Effec;


ent!of!Inguinal!H

ernia!


200

Compara;

ve!Effec;


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


210

The!CER!Process!

• Assess0the0“quality”0of0the0included0studies0― How

0likely0is0it0that0factors0other0than0the0intervenGon0led0to0the0m

easured0outcomes?0

― Also0described0as0the0“risk0of0bias”0

• Perform0the0analysis,0com

bining0data0from0sim

ilar0studies0using0the0techniques0of0m

eta(analysis00• M

ay0reveal0effects0that0were0not0apparent0in0sm

all0studies000


220

The!CER!Process!• Assess0the0“strength0of0evidence”0

― Risk0of0bias0in0the0studies0included0to0answ

er0the0quesGon0

― QuanGty0of0evidence0(num

ber0of0studies0and0paGents)0

― Consistency0of0the0findings0across0and0w

ithin0studies0

― Robustness0of0the0results0(sensiGvity0analyses)0

― Possible0grades:0high,0m

oderate,0low0or0

insufficient0


230

The!CER!Process!• Searching0for0inform

aGon0to0address0the0quesGons:0― Medical0librarians0use0“controlled0vocabularies”0in0

bibliographic0databases0to0idenGfy0all0potenGally0relevant0studies0

― Internet0and0other0also0used0to0search0for0regulatory,0cost,0policy0inform

aGon0― Bibliographies0of0arGcles0review

ed0to0idenGfy0missed0

studies0― Technical0Experts0and0Peer0Review

ers0point0out0missed0

studies0― Searches0updated0during0the0course0of0the0review

0


240

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


250

Transla;ng!CER!into!Prac;

ce:!Im

plica;ons!for!H

ospitals!

• CER0findings0are0ozen00gray.0Unless0there0is0

clear0evidence0of0benefit0for0one0alternaGve0over0another,0you0m

ay0need0to0offer0choices0based0on0paGent0preferences.0


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???


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


290

THA

NK

YOU

THA

NK

YOU


300

Robert P. M

aliff D

irector, Applied S

olutions E

CR

I Institute rm

[email protected]

0

0 The 0 only · nia! • 0 • 0 – ... 0 • 0 0 0 0 220! • 0 ― 0 sGon0 ― 0 0 ― 0 0 ― 0...

Documents

Transcript of 0 The 0 only · nia! • 0 • 0 – ... 0 • 0 0 0 0 220! • 0 ― 0 sGon0 ― 0 0 ― 0 0 ― 0...