Wound Healing Outcomes

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    Wound Healing Outcomes: The Impact of Site of

    Care and Patient StraticationWilliam J. Ennis, DO, MBA, FACOS, Emily Fibeger, DO, Katie Messner, MS,

    Patricio Meneses, PhD

    Won!s. "##$%&'(&&)*"+-"'.

    Abstract and Introduction

    Abstract

    As healthcare /ro0i!ers /re/are 1or /ay 1or /er1ormance (P2P) an!

    otcomes-base! reimbrsement strategies, it is increasingly im/ortant to

    !ocment clinical reslts. 3istorically, healing rates ha0e been re/orte!

    1rom hos/ital-base!, ot/atient 4on! clinics. 5ime-to-healing cr0es 1rom

    one site o1 care may not accrately re6ect the entire healing 7e/iso!e o1

    care.7 Fe4 ot/atients 1rom a 4on! clinic re8ire hos/itali9ation an! e0en

    1e4er are a!mitte! to sb-acte care. Care setting an! /o/lation ris:

    strata mst be clearly i!enti;e! be1ore com/aring 4on! otcomes !ata.

    Aim. Primary ob 4on! 0olme re!ction o1 crrent an! /rior sb-acte

    care /rograms. Pre!icti0e 0ale o1 Minimm Data Set (MDS ".#) items on

    a!mission 4as also e?/lore! in !iscriminating healing 0erss nonhealing

    /atients. Metho!s. Won! otcomes 4ere analy9e! 1or all /atients (@

    &) treate! at a !e!icate! sb-acte 4on! nit 1rom Janary "##

    throgh A/ril "##$ in a /ros/ecti0e, longit!inal, intent-totreat, cohort

    st!y. eslts 4ere com/are! to /rior sb-acte care 4on! otcomes

    re/orte! by a similarly com/ose! team sing similar /rotocols. eslts. O1

    & e0alable /atients 4ith "#' 4on!s, 2&.> heale! in a me!ian o1 $.'

    4ee:s 4hile &.> achie0e! =#> 0olme re!ction. Otcomes 4ere

    similar to /rior sb-acte reslts, bt less than the $">-$2> healing rate

    re/orte! by a similar team in hos/ital ot/atient clinic /rograms. Minimm

    Data Set comorbi!ities analy9e! !i! not signi;cantly /re!ict nonhealing.

    Conclsion. 5o allo4 ris:-a!

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    care setting, an! case mi? se0erity to control 1or 0ariables associate! 4ith

    !ierent settings.

    Introduction

    3ealing rates ha0e become both clinical an! mar:eting tools 1or many

    4on! care centers. 5he recor!ing an! re/orting o1 clinical reslts are

    im/erati0e in to!ays health care mar:et/lace. Pblishe! articles, ho4e0er,

    rarely strati1y a /atients ris: in ot/atient settings. Patients not seen in

    clinic 1or # consecti0e !ays are consi!ere! lost to 1ollo4-/ an! that

    clinical e/iso!e is close! ot 1rom the !ata set. For e?am/le, a /atient

    /resents 1or a conslt 4ith a 0enos leg lceration o1 &-year !ration that

    4as nsccess1lly treate! in a /rimary care /hysicians oice. 5he 4on!

    carries a hea0y biobr!en an! ;brin loa! re8iring an oice-base!

    !ebri!ement 1ollo4e! by 4ee:s o1 moist !ressings an! com/ression. 5he

    /atient 1ails to im/ro0e an! is a!mitte! to the hos/ital 1or & 4ee: o1

    treatment incl!ing intra0enos (G) antibiotics an! srgical !ebri!ement.

    On !ischarge 1rom the hos/ital, the /atient is trans1erre! 1or a -4ee: stay

    in a sb-acte nit. A total o1 + 4ee:s later, the same /atient retrns to the

    ot/atient clinic 1rom home !e to a /latea in healing a1ter " 4ee:s o1

    home health thera/y an! is re-enrolle! in the clinic as a ne4 /atient. 5he

    4on! is no4 $=> smaller in area than at the time o1 the original conslt.

    Com/ression an! moist !ressings are again a//lie! an! the 4on!

    com/letely heals in = 4ee:s. 5he 0arios otcomes 1rom this single case

    incl!e, & year o1 treatment 4ithot im/ro0ement in a /rimary care oice, a

    ne4 conslt lost to 1ollo4-/ 4ithot healing in 4ee:s in the 4on! clinic,

    a hos/ital stay o1 = !ays 4ith an increase in 4on! si9e stats /ost srgical

    !ebri!ement, a 4ee: sb-acte stay 4ith a =#> 0olme re!ction in

    4ee:s, home health care 1or " 4ee:s 4ith no change in 4on! si9e, an! a

    com/letely heale! 4on! treate! in = 4ee:s in the ot/atient clinic. 5he

    7e/iso!e o1 care7 otcome, ho4e0er, !escribes a 0enos leg lceration that

    re8ire! ' 4ee:s o1 thera/y incl!ing /rimary care 0isits, 4on! clinic

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    treatment 1or + 4ee:s, home health care 1or " 4ee:s, a sb-acte care stay

    o1 4ee:s, an! &-4ee: hos/itali9ation. 5his clinical e?am/le is a common

    scenario an! re/resents the im/ortance o1 !e;ning the site o1 care 4hen

    analy9ing 4on! healing !ata. Each /oint along the continm o1 care acts

    as a 7silo7 o1 care an! not /art o1 a larger system o1 care. A!!itionally,

    crrent reimbrsement /olicies create the /otential 1or each site o1 care to

    ma?imi9e economic otcomes that may not ma:e clinical or economic sense

    i1 the entire 7e/iso!e o1 care7 4as integrate! across settings. Conce/ts sch

    as /ay 1or /er1ormance are a ste/ in the right !irection, bt also 1ocs on

    achie0ing benchmar:s 1rom in!i0i!al sites o1 care an!, there1ore, 1ail to

    achie0e tre integration across care settings.

    5he athors ha0e create! an integrate! care a//roach to 4on!

    healing sing a combination o1 strategically aligne! gro/s that !o not

    1nction n!er the same cor/orate mbrella. Patients are seen in an

    ot/atient, not 1or- /ro;t, hos/ital-base! 4on! clinic. n a!!ition, in/atient

    4on! care is /ro0i!e! 1or a secon! hos/ital that belongs to a com/letely

    !ierent not-1or-/ro;t organi9ation. 5he clinic a!mits !irectly to both o1 the

    hos/itals in 4hich in/atient care is /ro0i!e!. 5he athors sb-acte 4on!

    nit is a /ri0ately o4ne! 1or-/ro;t center 4ith no 1ormal bsinessrelationshi/ to either hos/ital. 5he home health agencies are o/erate! by

    each o1 the " /re0iosly !escribe! hos/itals. 5he athors /rosthetics an!

    orthotics gro/ /ro0i!e ser0ices at all locations an! are a small /ri0ately

    hel! ;rm. 5he s/ecialists that conslt an! 4or: 4ith the athors team are

    mainly 1rom /ri0ate /ractice mo!els. 5he entire team, incl!ing /hysicians,

    are salarie! an! ha0e no 0olme or /roce!re-!ri0en economic incenti0es at

    any o1 the sites o1 care. 5he single most !iiclt as/ect o1 /ro0i!ing care in

    this mo!el is case management. @ot only !oes it re/resent the most time

    consming com/onent o1 o0erall /atient care, it is the least economically

    /ro!cti0e. t seems /ara!o?ical that the most critical /iece o1 the ;nal

    clinical otcome carries 4ith it no 1orm o1 reimbrsement. 5he crrent

    mo!el encorages /roce!re 0olme an! 1ails to re4ar! otcomes.

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    With that as a bac:!ro/, i1 there is to be any change in the ;nancial

    strctre o1 4on! care, 4on! care clinicians nee! to collect, analy9e, an!

    /blish otcomes 1rom all sites o1 care an! 1or all strata o1 /atient ris: an!

    4on! com/le?ity. 5here1ore, the athors set ot to 0ali!ate earlier

    /blishe! reslts 1rom a sb-acte 4on! /rogram rn by the athors a 1e4

    years ago. Gali!ating those otcomes 4ol! con;rm re/ro!cibility o1 the

    clinical mo!el across settings. 5he hy/othesis 4as that a systematic

    a//roach to /atient care col! be re/ro!ce! in a similar, bt ne4 1acility,

    gi0en that the clinical 4on! team 4as hel! constant.

    Objective

    5he /rimary ob

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    by stan!ar!i9e! assessments. Orthotic an! /rosthetic consltation 4as

    a0ailable on site 1or ooa!ing an! com/ression. A /hysician s/eciali9ing in

    in1ectios !isease e0alate! all /atients 4ee:ly to monitor cltre reslts

    an! antibiotic le0els. 5he 4on! nrse an! 4on! clinic sta commnicate!

    !aily to organi9e /atient transition to an! 1rom the hos/ital 1or stage!

    /roce!res, an! ensre! that on !ischarge /atients 4ere transitione!

    smoothly bac: to the ot/atient /rogram.

    As /art o1 the a!mitting /rocess, the nrsing home con!cte! a

    1ormal inta:e history an! com/lete! the Minimm Data Set (MDS ".#)

    1orms. 5he nrsing home MDS coor!inator com/lete! this 1orm on

    a!mission, e0ery '# !ays, an! each time a /atient 4as either a!mitte! to

    the hos/ital setting or 4hen a signi;cant clinical e0ent occrre!. 5he MDS

    !ata 4ere ca/tre! electronically an! translate! into a 1ormat com/atible

    4ith SPSSN so1t4are. Each 4ee:ly clinical 0isit 4as entere! into this

    electronic !atabase. Parameters incl!ing 4on! length, 4i!th, !e/th,

    !ressings tili9e!, /roce!res /er1orme!, a!missions to the acte care

    setting, as 4ell as 4on! area an! 0olme, 4ere recor!e!. When the

    /atients 4on! 4as either heale!, or the /atient 4as rea!y to be

    transitione! to the ne?t site o1 care, a ;nal !is/osition 4as recor!e!electronically -- 4on! otcomes 4ere re/orte! as 7heale!,77more than =#>

    0olme re!ction,7 or 7=#> or less 0olme re!ction. 7A large !atabase 4as

    constrcte! combining the a!mitting MDS in1ormation 4ith the com/lete

    clinical recor! 1or each /atients entire sb-acte care stay. A1ter all

    in1ormation 4as entere! 1or an in!i0i!al /atient, all i!enti;ers 4ere

    eliminate! to /rotect /atient /ri0acy.

    5he st!y 4as a /ros/ecti0e, longit!inal, otcomes analysis 1rom a

    sb-acte 4on! care nit. Patients 4ere not ran!omi9e!.All /atients 4ith

    4on!s an! more than & 0isit 4ere incl!e! in the intent-to-treat analysis.

    5he com/rehensi0e 4on! assessment an! treatment system 4as tili9e! as

    stan!ar! o1 care.I& 5he reslts 4ere com/are! to /re0iosly /blishe!

    otcomes as a historical control.I"

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    Results

    A total o1 ' /atients 4ere enrolle! in the !atabase. 5here 4ere &

    /atients 4ith "#' e0alable 4on!s, e?cl!ing + /atients 4ho ha! & 0isit or

    a close! 4on! on a!mission. Demogra/hics are !escribe! in 5able &.

    Althogh there 4ere more 4omen enrolle! in the st!y, the nmber !i! not

    achie0e statistical signi;cance. 5here 4ere statistically more /atients in the

    &- to $#-year-ol! gro/ than in any other gro/ (P #.#'). @either age

    nor se? 4as correlate! 4ith healing otcomes ( 5able "). Otcomes 4ere

    !i0i!e! into " !istinct gro/s. ro/ & incl!e! those /atients achie0ing

    com/lete healing an! those 4ith mar:e! im/ro0ement (!e;ne! as =#>

    re!ction in 4on! 0olme). ro/ " consiste! o1 /atients 4ho im/ro0e!

    bt !i! not achie0e =#> 0olme re!ction, /atients 4hose 4on! si9e

    remaine! nchange!, an! those 4ith a !eteriorating 4on!. Ka/lan-Meier

    !eri0e! me!ian time to healing 4as $.' 4ee:s 1or /atients in ro/&

    (Figre &). A statistically signi;cant !ierence 4as note! 4hen 4on!

    otcomes 4ere se/arate! by 4on! etiology ( 5able ). 5ramatic 4on!s

    4ere note! to heal in a short time inter0al com/are! 4ith other 4on!

    etiologies.Won! location an! initial 4on! 0olmes are !escribe! in 5able

    2.

    iscussion

    Pre0iosly /blishe! !ata 1rom a single clinical team 4or:ing 1rom

    t4o !istinctly !ierent hos/ital base! 4on! /rograms, !emonstrate! that

    consistent otcomes are achie0able sing a ni1orm clinical a//roach to

    4on! care.I Patients in that st!y 4ere analy9e! 1rom a "##-be!

    commnity hos/ital base! 4on! /rogram, an! a $##-be! le0el & tertiary

    center. 5hose otcomes, 4hile consistent, 4ere ta:en 1rom a single care

    setting. E0en /rior !ataI" 1rom the /resent athors single sb-acte

    /rogram can be 1rther analy9e!. For e?am/le, the o0erall healing an! =#>

    0olme re!ction gro/ totale! only => in a st!y o1 2 /atients 4ith

    +# 4on!s /blishe! by the athors sing the same clinical team that

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    con!cte! the /resent st!y (Program & in 5able ).I An o0erall

    com/arison o1 !ata sets 1rom sb-acte 4on! /rograms clinically

    manage! by the athors an! their clinical team is sho4n in 5able . 5he

    !ataI"1rom Program " an! the crrent st!y re/resent /atients 4ho 4ere

    acce/te! only 1rom the athors t4o hos/ital /rograms. 5he 4on! care

    team case manage! these /atients starting 1rom the ot/atient center

    throgh the hos/ital a!mission, an! sbse8ently in the sb-acte 4on!

    /rogram. ong-term G access, srgical !ebri!ement, an! me!ical

    stabili9ation o1 the /atient occrre! be1ore !ischarge to the sb-acte nit.

    5hese " /rograms !emonstrate! statistically signi;cant increases in healing

    an! =#> 4on! 0olme re!ction com/are! to Program &. 3os/ital length

    o1 stay can be minimi9e! sing these s/eciali9e! nits, 4hich bene;ts the

    economics 1or the hos/ital 4hile minimi9ing nnecessary ris:s o1 /rolonge!

    hos/itali9ation 1or the /atient. When /atients are a!mitte! to a sb-acte

    4on! /rogram 1rom otsi!e hos/itals, as 4as the case in Program &, it is

    !iiclt to achie0e e8i0alent otcomes as the critical ste/s along the

    continm o1 care may not ha0e been o/timi9e!. 5he healing rates 1rom

    hos/ital ot/atient clinic /rograms range 1rom $">-$2> com/are! to

    2&.>-2=.'> in the sb-acte /rograms.I

    E0alating these /blicationsse/arately, one 4ol! concl!e that the clinical sccess rates 4ere

    e?cellent in the ot/atient setting an! sb-o/timal in the sb-acte

    /rogram, bt might not notice that the /blications 4ere 4ritten by the

    same clinical team, a//lying the same stan!ar!i9e! 4on! an! /atient

    assessments an! /rotocols o1 care. Otcomes !ata in 4on! care, there1ore,

    nee! to a!!ress the clinical team in0ol0e! an! its /oint o1 in0ol0ement

    along the continm o1 care, the setting o1 care, an! an analysis o1 the

    /atient /o/lation (case mi?se0erity in!e?e!, etc.).

    5he reslts o1 this st!y re/resent strong /atient selection bias. For

    e?am/le, o0er the /ast + years the athors ha0e generate! a hos/ital

    a!mission 1or e0ery "# clinic /atient 0isits. An a0erage /atient accmlates

    0isits !ring thera/y.With "=## /atient 0isits /er year, this yiel!s

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    a//ro?imately "=# ne4 /atients to the /rogram /er year. On a0erage, #

    /atients are a!mitte! to the hos/ital, 4ith &=# a!missions o0erall !ring a

    &-year /erio! (a =#> re-a!mission rate). 5here1ore, 2#> o1 all /atients seen

    in the clinic re8ire at least a &-!ay stay in the acte care setting.

    A//ro?imately "=> o1 a!mitte! /atients are trans1erre! to the sb-acte

    /rogram. n total, there1ore, only > o1 all /atients seen in the athors

    ot/atient 4on! clinic are a!mitte! to the sb-acte /rogram. t is 1air to

    assme that these /atients re/resent a me!ically com/le? sbgro/ 1rom

    the original cohort.5he healing rates in the acte care an! sb-acte care

    settings, there1ore, 4ol! not be e?/ecte! to mirror each other.

    Predictors of Healing

    S/eciali9e! 4on! centers ha0e been sho4n to achie0e im/ro0e!

    healing rates com/are! to more 1ractionate! care. I23o4e0er, com/arisons

    bet4een centers are !iiclt an! /ossibly mislea!ing. Wol! an ot/atient

    center that /rimarily 1ocses on 0enos leg lcers !emonstrate an

    e8i0alent healing rate com/are! to a 0asclar srgery base! /rogram that

    treats critical limb ischemiaQ KeyserI= re/orte! an ++> healing rate 1or

    !iabetic 1oot lcers, 4hile others re/ort healing rates o1 +>.I,$

    One re/ort

    in the literatre 8otes #> healing in an ot/atient clinic.I+ Frther

    research is nee!e! to !e;ne the /arameters that n!erlie sch 0arying

    otcomes. Otcomes o1 sccess an! mortality are no4 in the /blic !omain

    1or coronary artery by/ass gra1ting at most hos/itals. Clearly, there are

    !ierences in otcomes bet4een high 0olme centers o1 e?cellence an!

    those 1rom less e?/erience! centers. 5he 4i!e 0ariation in healing rates --

    re/orte! in the literatre 1rom +> to #> -- /robably re6ect case mi? an!

    re/orting !ierences rather than 4i!e clinical 0ariation.I-+

    n a!!ition to the otcomes re/orting /roblem, there is a relati0e

    absence o1 4on! care e!cation 1or healthcare /ro1essionals. A recent

    sr0ey o1 me!ical school crricla re0eals, on a0erage, a me!ical st!ent

    recei0es only ' hors o1 e!cation on 4on! healing o0er a 2-year

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    n!ergra!ate me!ical !egree /rogram.I'As no single /ro0i!er gro/ has

    com/lete e?/ertise in 4on! healing, it is not sr/rising that

    mlti!isci/linary teams can achie0e im/ro0e! clinical an! economic

    otcomes, es/ecially in the nrsing home en0ironment.I

    n an eort to assist clinicians in !etermining 4hich /atients 4ill

    res/on! to treatment, the athors hy/othesi9e! that there might be a

    clinical1nctional 7/ro;le7 that col! be se! as a /re!icti0e tool. 5he MDS

    ".# is a HS Centers 1or Me!icare an! Me!icai! (CMS) initiati0e that 4as

    intro!ce! as a /art o1 the @rsing 3ome e1orm Act o1 the Omnibs

    B!get econciliation Act o1 &'+$. MDS is /art o1 a com/rehensi0e resi!ent

    assessment instrment (A) 4hich contains in1ormation on

    clinical,beha0ioral, an! social stats o1 nrsing homes. I&&,&"5he A consists

    o1 the MDS, tili9ation gi!elines, an! esi!ent Assessment Protocols

    (AP).I&&When a /atient has a /articlar MDS stats that matches a trigger

    1or a AP,& or more o1 &+ /roblem-base! APs are /er1orme!. Se0eral MDS

    criteria ha0e been 0ali!ate! as /re!ictors o1 /ressre lcer !e0elo/ment.

    Ga/ et alI&!etermine! that the MDS 4as less sensiti0e bt more s/eci;c in

    /re!icting the !e0elo/ment o1 a /ressre lcer com/are! 4ith the more

    /o/lar Bra!en Score. Bates-Jensen et alI&2

    1on! /roblems sing a/atients be! bon! stats, one o1 the MDS 8ality in!icators, becase o1

    signi;cant n!erre/orting in the 1acility. n another st!y, Bates-Jensen et

    alI&= 4ere nable to correlate nrsing homes 4ith lo4 /ressre lcer

    /re0alence 4ith im/ro0e! clinical care /rocesses.

    Des/ite con6icting re/orts it a//ears that o0erall 8ality o1 care has

    im/ro0e! in nrsing homes since the release o1 the MDS. I&Althogh Jones

    et al ha0e recently trie! to i!enti1y clinical an! 1nctional as/ects o1 the

    /atient history to /re!ict /ressre lcer healing there is minimal /blishe!

    literatre on the to/ic.I&$Ga/ et al,I&1on! that s/eci;c MDS com/onents

    correlate 4ith /ressre lcer ris:. We attem/te! to tili9e some o1 these

    /arameters to !etermine i1 they col! be se! as /re!ictors o1 4on!

    healing. Be!1ast stats, bo4el incontinence, se o1 be! rails 1or trans1er,

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    an! the se o1 a trans1er ai!e, 4ere not 1on! to ha0e statistical correlation

    4ith the ltimate otcome o1 healing or mar:e! im/ro0ement ( 5able $).

    Conclusion

    n this /ros/ecti0e, longit!inal, intent-to-treat st!y o1 /atients

    4ithin a com/rehensi0e sb-acte 4on! /rogram, a 2&.> healing rate

    an! a =#> 4on! 0olme re!ction rate o1 &.> 4ere achie0e! in a

    me!ian time to healing o1 $.' 4ee:s. 5hese reslts 4ere similar to

    /blishe! otcomes 1rom a /re0ios /rogram manage! by the athors. I"

    5he similar otcomes o1 this st!y s//ort the /rimary conclsion that a

    4on! /rogram can be re/ro!ce! i1 the same clinical a//roach is ta:en,

    regar!less o1 /hysical /lant, staing, an! o4nershi/ o1 a nrsing home.

    3o4e0er, a com/arison o1 these reslts to /blishe! healing rates 1rom an

    ot/atient, hos/ital base! 4on! clinic rn by the same clinical team sing

    the same /rotocols o1 assessment an! care, highlight the im/ortance o1

    i!enti1ying the /o/lation n!er st!y, early inter0ention, an! the clinical

    site o1 care. A!!itionally, rea!ily a0ailable MDS criteria may /ro0e se1l 1or

    the /re!iction o1 4on! !e0elo/ment, bt are nli:ely to assist a clinician in

    /re!icting 4ho 4ill res/on! to thera/y.

    t is e0i!ent that some 1orm o1 4on! in!e?ing or se0erity in!ices are

    nee!e! to hel/ 4on! care clinicians ma?imi9e clinical otcomes an! select

    thera/etic o/tions 1rom the myria! crrently a0ailable to the 4on! care

    clinician.5he 4on! care ;el! is ni8e in that thera/etic o/tions ha0e

    ot/ace! !iagnostic an! /re!icti0e inno0ation. Part o1 the /roblem is that

    4on!care societies ha0e been nable to translate cogniti0e an! case

    management 4or: eorts into meaning1l, a//ro/riate e0alation an!

    management co!es, an! ltimately reimbrsement. Won! care clinicians

    can loo: 1or4ar! to 4on! /ro;ling, bioassay !e0elo/ment, 4on! se0erity

    scoring, an! gene e?/ression changes in 4on! tisse as !escribe! in the

    elo8ent 4or: by Brem et al,I&+as a /otential means to /re!ict otcomes,

    /re0ent occrrence, !etermine !ebri!ement margins, an! to select the most

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    economical an! clinical eecti0e thera/ies a0ailable 1or /atients. A se1l

    4on! scoring system 4ill nee! to incl!e /atient comorbi! con!itions an!

    8ality o1 li1e /arameters. 5he APAC3E score (acte /hysiology an! chronic

    health e0alation) score se! in the critical care in!stry /ro0i!es a se1l

    analogy.I&'Otcomes !ata are 0ery im/ortant an! there is a nee! 1or all

    clinicians in 0arios sites o1 care to re/ort on their 4or:.5he larger tas: at

    han! 4ill be to string these otcomes together in or!er to /ro0i!e accrate

    clinical an! economical e/iso!e o1 care !ata.

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