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Modern methods of clinical investigation PDF

241 Pages·1990·2.143 MB·English
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i ee er book, not from thg, however, cannot bersion for attribution. Medical InnovVatoilounm aet 1the Crossroads pnv al pamattiative MMMMooooddddeeeerrrrnnnn MMMMeeeetttthhhhooooddddssss ooooffff e origincific forauthorit CCCClllliiiinnnniiiiccccaaaallll IIIInnnnvvvveeeessssttttiiiiggggaaaattttiiiioooonnnn osed from XML files created from thding styles, and other typesetting-speprint version of this publication as the Annetine C. Gelijns Editor been recompd breaks, heaease use the s orPl ginal work hane lengths, wally inserted. Committee on TIencshtnitoultoeg oifc aMl Iendnicoivnaetion in Medicine the original; liccident n of e orien a ohe w digital representatie breaks are true to thic errors may have b egp naa file: This ng files. Pme typogr PDF esettind so ut this nal typned, a NATIONAL ACADEMY PRESS ogiai Washington, D.C. 1990 Aboriret ii ee er book, not from thg, however, cannot bersion for attribution. TttciNsiohnhsA atugehrTeu teIseiIn s rOhosh ertfeNiea tdmsulAt ptmheeoLd noeo iAmsfcf ia tbCMbhli eeAcleri atspdDyr uioe Ectb,fio Mlnrt iehbecsY ee.we I aaanPaprn scRpt hhacrEdi,oh svSapa, nirrStstihd eoa2e rtre1e e Idt d0nopu 1s rict tnohaCi ftet1ueio o9stfneesn7s id.0aoteic ntbrtusasy l t iu itngohn onetdhv eNeAer r aevbntxeomioantmhenun aetitlhn, aeAaNn tAci.doWa cndiat .esod mW feo mywpa oysnolh' fisi ci nSn1yicg 8tmiit6aeo3antint cvtc,eee oDsr nis tn. goCp ri ee.de rsne2tsanl0iiito4snitnf1i ynda8ilgins-g pnv The Committee on Technological Innovation in Medicine was established in 1988 by the Insti- al pamattiative teudtgee o of fM theed picrioncee stos bdyes wighni cah s beiroiems eodfi cwaol rrkessheoarpcsh t hfiantd winogusl da r(ea )tr panrosvlaitdeed a i nmtoo rcel ifnuicnadla pmraecnttiacle k, naonwdl- e origincific forauthorit (cRboe)ns aseidasdrtcsrh eos Ffs itonhpdep ipnorgrotsuc ienneittdoiei nCsg lfsion roi cfim atlh pPer rofaivrcistntic gwe t:oh Trek hrseah toPiopon tieannl ittthiyai lsa ansneddr ei ePfsfri,o c“biIelmnemcpyrs o oovffi ntMhgi sot hdpeer roTncr eMasnses.t lhTatohidoissn v oooff lCumlinei- s been recomposed from XML files created from thord breaks, heading styles, and other typesetting-spePlease use the print version of this publication as the cHDsHALMiaoiecoolobpa nwwdIrdasneaaa reIverrrtrmnnmddxeyn sp y mHHeotor inevogfuuet spPMmIII1C—afatgg CSnns oh..trtSohh eeicciBeoofoCcMooneedcnll dcnmdNuuHnnssigo tieeehs g dd c,rn.o eeMMdi n”e er0aeenogda—f icrselss-h c flreeei esH3M s t neIaeddbi e hcssn0ans(glleiii,s l e dMsrs9cc bCdaisat.oedetn eaa- nlelio3 aorsiei0tcillttxdcoh cn. .uhdtf4ha II. i aga IMtoinnHnn2naaMe.cllrs ss yeon8 o aaGuweietta, l6adpgnliimd o ontt eoyIo- hiviuuifHgndn0lnr acfie itt3kys ctgjnaneeustthtn-s—ahhl,- toim4e aShsiliteetcvg nu,i,nohera E raaaat1N-deArp enretvPtcuvf9 e i i anteDoahotSooiu8—hthcrnlnennfie9beueeeoo els r/p.TM naldsarAttn vNiaiiT stct ecai(tnio enreacuocagthaltendhns tehmenntriC.i. iesisea nond—McoI e etntnowI( icin nndnt.gnaalprC o totoeorI5eylDa ean org. os rCrnknRC3sansitf ocsstf ret-tgO.iH o.hoat4an t5r Gurloa,n9ete edRtpis1He aeenHrss cl9lO aente ifoeS8h;jnaoso9 snf9 0v.ldr sva s tM, 5H.2a hna ,H i s51r.t tdSee uiSsie )Ml do2d0 payeHpin6i5lpr etrctruvs o5oodhei0—mirn rci pc22 Sctee;reae)6Ca e ee.snd(C l rsd o0UT vReioSbin2nhni.nmyeegSc)negt.sr er .om tvset)esohhv .ais wp iecRearCst iect eteHneveoishsrosiei,moe. oe en ot w4ownahsmsf.rnsu —ea stc iM p rh athTNodtpEen efee oao dH vetDcttfra haih ctuo-oetleeonahgunpndnoneh aaa Tclabterloillteysouy-gc n-sithchi—-sael ginal work hane lengths, wally inserted. 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GSUESRAANLC Do BmDA.m RLTAitLUtEeBeTA ToC nHF T,O CeOhcTahiEnr,, oPlAroesgssiidocecanialtt ,e IP nfinPzroeorvf, eaIsntscioo.rn, iSnc hMooel doicf inBeusiness pnv al pamattiative BENA Ldm. iHniOstLraMtiEonS,, UVniicvee-rPsriteys iodfe nCta laifnodr nGiae, nBeerrakl eMleyanager, Medical Products e origincific forauthorit WILGLIrAouMp, HNe. wHleUttB-PBaAckRaDrd, CJRo.m, pCahnayir, Council on Health Care Technology, osed from XML files created from thding styles, and other typesetting-speprint version of this publication as the RKPJOAOEHUNBIIPMTCNLENnnhho ssReEaDemttdiriT TEttF.immuu c HoP.itta uIneeoA c.n edLoooWRi Llt.ffa oyK EnEMMM gaMdVNynee E,DYNAddd Lii rD,BNFcc MuiieEag,Cnn Opm RDeehAa,NiGai rldartiy,em,rmn ,cMd Aeit noFnPPreirttorrdsh, oe rtiuCorusfcareifmie dt nsinLes eoMton,.neo rteDrn, B d faSilorcooDartiofnm nr Bmdueooig,fuEo z itleSp hoDRlitd gdaeMe inesvcPmefeesorad lioEroriodcfcpvleh aomas lUglIs euSnyonnasc,ri ttt hv iiootoeauDfrnon ts leeidMatp nyaed Rrd SteRimccgehieunsonleeaota tlria ocnoohndff,, been recompd breaks, heaease use the s orPl ginal work hane lengths, wally inserted. the original; liccident n of e orien a ohe w digital representatie breaks are true to thic errors may have b egp naa file: This ng files. Pme typogr PDF esettind so ut this nal typned, a ogiai Aboriret iv ee er book, not from thg, however, cannot bersion for attribution. pnv al pamattiative e origincific forauthorit osed from XML files created from thding styles, and other typesetting-speprint version of this publication as the been recompd breaks, heaease use the s orPl ginal work hane lengths, wally inserted. the original; liccident n of e orien a ohe w digital representatie breaks are true to thic errors may have b egp naa file: This ng files. Pme typogr PDF esettind so ut this nal typned, a ogiai Aboriret ACKNOWLEDGMENTS v ee er book, not from thg, however, cannot bersion for attribution. Acknowledgments pnv al pamattiative e origincific forauthorit The Committee on Technological Innovation in Medicine expresses its osed from XML files created from thding styles, and other typesetting-speprint version of this publication as the gvwPItvFDianhnpoarrriovevaialpeleur tuaecgrkidalmstemtouismutbcci,haoedil geaaebo.dwe:a n tlp e etTeih,ti,rn so ooTah sD nt ite"hitonhpg.eIhse"r mereahe s e ntt ,Thpphs ap Pe raheupfaooilr oetnpaptevh repnte di oocpnrren Aor sertlagst i ompch awvdawfaelmto riid ehdsrarieiriecs atettemitt sutndoh eeusd Tineoenesbc rra s yhiaasn oPgP iunldFtgfsiersmsin oohrrs,leas a tcb mhodlqrtaullieineeaunysoscmrrnsad noiyeelpc svig dlkrtw o oony e afhlfiTso o uzt oeer tfeemhfrnk Rtls eheltset ei.eMeh h n.tsdw hSoege oU epTpoa,apd enrrhVtaseckc pieiprvhsiitga nacehh ern lecretro Fisi-os tfpc MPihiimItit ncnhrapydedaemnsea itnsitsykonhniiitct dtsfto gutpus eceds tarCsnoee sesrw tn a epii olotnh faairodonftlofriofs oubres o M dreuPpt n tCChrlfiteigaoaooaolldrniivt, nreinn Pn icswaSiitdi aicchtnnaeaoluaaiygndessflll been recompd breaks, heaease use the asInknsidlt liftPTuuotlhe laei nc oycdfo eMmaxt mepPdeiidftctiiezitnieeoe ru,,e sxfI opnerrdc e.ih stiisFnsei gsni naoiilfttls iyt ah,gt eirEv apedta iwtpoueandrr esdb eitnEho a dthlSefila ssom ovfn uot elhuilis ms T techo.oi embre,m Pitthrteeaseni'kds eeadnc tt fioovfri tithehises. n of the original work has e original; line lengths, woren accidentally inserted. 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Pme typogr PDF esettind so ut this nal typned, a ogiai Aboriret ACKNOWLEDGMENTS vi ee er book, not from thg, however, cannot bersion for attribution. cGoeodfefmiiltciijmnenTgrsih t ,otet eof Ie nt'thsCthe iaoersnc m vtaciomtovilomiuittnimtmeeaseeli. .t tFFeoeienln,l a oflwloyTr , e owhcfhe ernt haoccelook ngInnciocsewatpilltt euudtaIegln iezno aoaft v icoMaontine osdoniifd c eitnirhnaee b laweMn odder edkpbisrcth iitnonocpe iA paangnlnr dees tatitatnhlfyeef pnv appreciates the opportunity provided by the Howard Hughes Medical Institute al pamattiative and the National Center for Health Services Research and Technology e origincific forauthorit Assessment (grant HS 055 26) to investigate the process of medical innovation. osed from XML files created from thding styles, and other typesetting-speprint version of this publication as the GCChoEamRirmAiLttDee D o.n L TAeUchBnAolCoHgical Innovation in Medicine been recompd breaks, heaease use the s orPl ginal work hane lengths, wally inserted. the original; liccident n of e orien a ohe w digital representatie breaks are true to thic errors may have b egp naa file: This ng files. Pme typogr PDF esettind so ut this nal typned, a ogiai Aboriret PREFACE vii ee er book, not from thg, however, cannot bersion for attribution. Preface pnv al pamattiative e origincific forauthorit Gerald D. Laubach osed from XML files created from thding styles, and other typesetting-speprint version of this publication as the (biacaaeanInnxuddiOnoddptootomM eppipvnrttcTCeieir)agleodo hdoit-nniniwbei nocsci dlttaocn eeetoglaro—vm m oeklr wo esspbnlmphs.iquo eteerouShmer woapai dofrcce rsAacimeky crphdIlw iseh yDnuuit hab,soecrmS roei.ort moa isrms Atthma—eis ancaa slcetosrssi whedni alwzeuabitvhlece wtte,iiei sanvclpcad iulthieae y dtn rilvhisnlsinrsieye,l,ent e o sts ctoodbfe huetaif aeihacrsc ocrmsthsetct prtau ec ihoarstacaeo iintulhgrclif syectbahng atnc lreaoraileatdennsyl sstoge e essmpgafeed ogitryixr,etreiis is avvd e o mpeaitiisetnhncnc rhsiageo c onsemli doefe rrup tunmse es adctItpc iphncttiaohiscaoesealc,natn ln n ikylpoits tmee urlpirsoddtoit drebceg ecaoedho breicffie ooyist cnsitksf dachh e cslheeeab .hMs.a rymadpvvpAe leeeealodwverss cdai btnihec ectego eiirenceeuoolnsyhnesrff,, been recompd breaks, heaease use the nopefa erbtdiiceoBudmel acmerad,eu ihdcsaiaecsl a t rhele seasc depaavlrraoactncehecd sea sdsn .rdo aC fmd oceaslvittn iechilacoalaspl lyma aloessvnoseet bsri sentmch goeeem npntaee s irasta nlts,w uiamconh pdd o aecr clctaiarndniitetci scac.alo lin ndcveeteresnrt.mi gTianhtaeio ncnto oisnft n of the original work has e original; line lengths, woren accidentally inserted. Pl tIfatfbdhoOianaarcepsdstMt aite c e dtmw hfba Cfaoeaosiotct srn hokmiet eouhssnnm,hdre oc osrlianye etpnti -,a en ntdtdreeo o a- cf wodtofalhefiinn ntefcei itoetxTcihlxnviaieeskaaelctm mlensh e— eensivasn to absatacllh,tyotu oiai saganotttnwti sniiccdiso odaaou nl elfcga .r IodgtcanWhsdeobntesinl eot etciso v otefwvtaan phatteadteuirsrolemis ,eenv c tast oeyfhenilun nleodorvs p tifeMphadi snovree eegrtaradel ai asenlitmatc intiobiivucenanieosdllese ilui .otycf yrcuf Oaah nllgno no eeeftesawed we dcol jaethttfueorro nnc gt thochemdeelt nceossamihv geqknot yeueoiitd,s eqe its utttch—hihheatieeesssl ohe w digital representatie breaks are true to thic errors may have b pproowceers sa nodf ucselifnuilcnaels se voaf ltuhaetsioe nm. eBthuotd sth aer ea npoptr oenptriiraetley acplepalri.cation and ultimate egp naa file: This ng files. Pme typogr PDF esettind so ut this nal typned, a ogiai Aboriret PREFACE viii ee er book, not from thg, however, cannot bersion for attribution. oiimsnfsif ugothehrmesTt hobaqetfeui oessaasneptf ciepaootbrnnyoosd pua rtntcih daonat netee swlfaiyfd ri becee iarvobacametyilio.uen naIdgnt i euc amdans ldka nteenoerdyctl y hocoinafnn osglcely los oig,nau ifigrecoa sarci lnhte hseoxtavia tcaem eglxu poiiassleett siit,no hbagnee . n ydnSeorowountcagd pibs et hlthefayoe r b rmnt rrotoaahwacdedei tuessineotaieinmcnkaagesll pnv condition but also against alternative medical devices or procedures. al pamattiative Increasingly, we seek information about the longer-term impact of a medical e origincific forauthorit ianst ecrovnetnrtaisotne da sw iitt he xtphree smseosr eit sfeolcf uisne tdh ea nreda ln ewaorlryld iodfe aelv eseryttdinagy cclhinaricaaclt eprirsatcicti coef, s been recomposed from XML files created from thord breaks, heading styles, and other typesetting-spePlease use the print version of this publication as the ovptatdhocaeecaropolvnspeenefraa sepnadravplnkseysyillrt erssteutnero o sliefhFoenaotdb lveas ipalittpicrcaeme lni ro o etaohml dgauhlsofdrpnei ylepy eeens lsrt f ym n.nteca o wnfd,iclctcOr assbisnuhrett ni e liuiahotmvnilcaoilhtnsretccveoa im a b acllrelltgtbUooeleoo lhhesyi lsrpg cugevdneetsea euor ty eii lsasicctedlnyn.fa oenial ixpe sd liAndftsopsnaoeo emwe r.v tqoiwS rpe.nuce yeuneWgtataererarhd eeetIulw rsetinnnei estfyleedcehu act snsavd iaetleir attplet sar scees ahlu dpalk umgdeuirgarg,a,noruox dt a srridfluamhpiteotcra ttii ngaoehnuivwctmfuodsomhsetolaesl tanu r et uyghtayrisisra dr nor a,ruce ch oiiktddnisncndocsaewat.oe.ad cee hs nbtebplnosec HheBc ldaitsra pereeoiimg uedeon e spmstormt e—nta,ooha e e sse air tlo,owr sy coednudvumro h manhidenaelofcgwagdae t ln rmatatea yr r tholae snliiaa eceneronsabneskdtkos ,nsdkrawonic s n ytsts ,tpho nih s c—t ehorawhqtebeesaaorcnnwiu e ricpqllscangne aeirp ehuelnegi odcs rrspnaevtitcesgo setcizsrgosunhoe cmoctaa olimta,enehlcrvo tef tddcstenhmi nute unoltshpieslsyearqosrgna or tecb,e urio ot ddtghne oesaoehcmiou nudgunsffsearll fo ih .tiddteoatte c adloao cutgrrosocforbue aer itgubanroeenllrenyydyngeeessfrtt ginal work hane lengths, wally inserted. hifinnoaverpcxopeplesvln ieci dnat obtc oloeu nasrt eeel gimmaio pinnoteaerdlwa rv dyaie rnhgisaertteariuelot,mnh ds e peniopnt,le imncidnyei ,dn wingcoh aotil c nlphe r taahcsceatt sitncehea e,tr uescrgeoeue nmlocafet otrtonrhy eb a eabd gopeeuvrneti cscmseiei.na sPrg kob etweodcwe oraamfnruddel the original; liccident ate cmhnoorleo gcyo, ninsicsltuednitn ga ncdo mepvaernis-ohnasn doef da ltaesrsneastsivmee mnto doafl itaiells okfi nmdasn aogfe mmeendt ifcoarl on of he orieen a aa ccgoimvepnl ismhiendgi cthali s ccohnaldlietniognin. gT tahsek aorpet iymetu mto baep dperfoiancehd .and methodology for w digital representatie breaks are true to thic errors may have b aTdsaebrrheanoe wsuayettnT pht chhfraleraoino ntvdmp iiec.ad mapcelel eiraernsg vi rceapiaslcru lhe iap sst veritoanahcnrtaeit:tei d ctHw yea,o e towe cfvt haawanilnsu e sdalwwlot i oaeobrrrnekess t s,tawh eanorend,p d da o neostsdtihans etegtirhns aittktiit?cae t alyhlHl y eim on atwseodito gdhclhrosaet dnssfo, so w lrwot ewigim tyoihm.p eTqrpoxuhrvaoeeemsv mcteiplo eelineant?ssrt neagap The committee held its second workshop in December 1989. It explored file: This ng files. Pme typogr adnradw ainnagl yozne edx tpheer icehnacne giinn tgh ee cUonniotmedi cSst aotfe st,e Echunrooploeg, iacnadl iJnanpoavna. tAiotn p rines emnet,d tiwcione, PDF esettind so ut this nal typned, a ogiai Aboriret PREFACE ix ee er book, not from thg, however, cannot bersion for attribution. aTatbhdnioaodagtmli eytitestohhdinseii sarcf, la o lwtr whr eoiiomssrr ekkpsa srerohwcrivoheiip lsnfls i g no edofon inuncw rgo iosusu rsrnikuandsgetehosero sdpitainasr n edcwmmti ineopldglra ei tco oiaeffrfln a emttr iic neoaandnr oiaeccvl.a oalht aiienonrdnne onavte rafebft iiocobdineey.ni nIto tg f i tsrosa tronugusdafryne h irz aoenpoddef. pnv al pamattiative e origincific forauthorit osed from XML files created from thding styles, and other typesetting-speprint version of this publication as the been recompd breaks, heaease use the s orPl ginal work hane lengths, wally inserted. the original; liccident n of e orien a ohe w digital representatie breaks are true to thic errors may have b egp naa file: This ng files. Pme typogr PDF esettind so ut this nal typned, a ogiai Aboriret

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