Raccomandazioni <strong>per</strong> <strong>la</strong> <strong>sicurezza</strong> <strong>in</strong> sa<strong>la</strong> o<strong>per</strong>atoria - Ottobre 2009Tl( NEW ENOLAND JOUX-NAt. •/ MEDICINEDATA COLLECTIONWe obtajned data on each o<strong>per</strong>aàon frena aandardòeddata sheets completed by thè locai datacofiectors or die dioica! teams ùwohred <strong>in</strong> surgìcaJcare. The data coUectors recejred tra<strong>in</strong><strong>in</strong>g andsu<strong>per</strong>vision fiora thè primary <strong>in</strong>vestigatore <strong>in</strong> thèidentificatk» and dassìficatìon of compUcationsand process rneasures, Petio<strong>per</strong>atire data <strong>in</strong>dudedthè demographfc characteristics of pacients,procedura! data, type of anestbeticused, and safètfdata. Data co&ectots foUowed patients prospeawelyunta discaarge « fot 30 days, whichenrcarne firn, far deatb and complications,Ou&comes were identified throogh durt monitoriogand caramamcatJoa whh dìnical staff Con>pteted data fbcms wae strippai of diteci identifìenof patieots aod txansm<strong>in</strong>ed to thè ptimaiyiorestigatocs. We zìroed to coUect data on 500cocsecutrreJy emoifed patients at eacb sce wìthma <strong>per</strong>iod of less than 3 monti» fix each rf dieoro phases of thè smdy. At thè thiee sites a wtùchthis goal could not be achieved, thè petjod ofdata coUectioowas ettmded fi» yp to 3 addhìonalmonths to allcw fi» accnial of a suffictem numberof patients. The sampie «ze was calcu<strong>la</strong>ted todeteaa 20% nductìon <strong>in</strong> complications after thèchecklist was imptemented, with a statàticalpower of 80% and an alpha «lue of 0X6.o UT co M csTbe primaiy ad pomi was tue occarience cfaaymajor complication, ìnctad<strong>in</strong>g death, daóttg thèpetìod of posti<strong>per</strong>ative bospitalizatjon, tip to 30days. CompUcatJorw went defioed as they are mthè American College of Surgeoas' Natkmal SurgkalQoality Improrement Program17: acute cenaifatiate, Weed<strong>in</strong>g requir<strong>in</strong>g thè transfiiskm of 4 ormore units of red oeOs wìth<strong>in</strong> thè first 72 hourcafter sutgery, cantiac arrest requirìag cardiopulmonaryissuscitatkxi, coma of 24 houcs' duntìonor more, deep-vàn thromhosis, nyocardial feiÉirctton,nnp<strong>la</strong>na«d <strong>in</strong>tubation, «ntf<strong>la</strong>tor ose Gx 48hoon or more, pneumonìa, pdraooary anbdism,Btroke, major disrupòan of wound, ìnfectioo ofBirgkal àte, sepsis, septìc shock, thè systenuc<strong>in</strong>f<strong>la</strong>mmatorr response srndrome, uopianned retntnto thè o<strong>per</strong>atìfig toom, vascu<strong>la</strong>r grafi fàilure,and death. Utìnaiy tract ìnfectioo was noecoasidered a m^or compjjcation, A groop of phyùcìaiiterieweis determ<strong>in</strong>ed, by coosensus, wbetherposto<strong>per</strong>anVe enats reported as "otfaet corapUcatìons"qoalified as major conipUcatìons,uàng thè tìwjen dasèfàcatìon fbr guldance.We assessed adherence to a subgioop of sh;safety meaniics as an ìodicaior of process adheteace.The sh measures were thè objectìve eraltationand documentation of thè status of thèpatienft airwjy beforcadm<strong>in</strong>iRratìont of thè anesthetic;thè use of pulse oxìroetry at thè thne ofmtóation of anesthesia; dw picseoce of at: ieastwo peccherà] huravenons cathetos or a centraiTCOODS catfaeter befbce <strong>in</strong>osion m caies UTratvktgan esdroated Wood loss of 500 m] or more; thèadm<strong>in</strong>istiatfa» of ptophy<strong>la</strong>ctìc antibiotìcs wìth<strong>in</strong>60 mimttes belbie <strong>in</strong>dsk» except ia die case ofpreoistìng itifectìon, a procedure oot ìnrotv<strong>in</strong>gJncìaon, or a coatarómated o<strong>per</strong>ative fidd; oca!confirmation, immediatety befbce <strong>in</strong>cjskHi, of thèParasi Temi BrhftngFVnpenrtì» Porto*»*'eYe*YnYecYMNoNoYwY«NoNeY«NoNoNoNoY«sT«YesYnNoY«NoNoNoNoNoNoNoNeNoNoNeNeNoNoNoNeNaNoNoNoNeNeNoNeNoNeSha Ithn»ugh4 ve located <strong>in</strong> hìgtt-tncDme counlriei; A«t 3 thraugh 4 iw locMed hltw-er middle-<strong>in</strong>come courtrìec.1'ileo /jr<strong>sicurezza</strong> dei pazioiti53
Raccomandazioni <strong>per</strong> <strong>la</strong> <strong>sicurezza</strong> <strong>in</strong> sa<strong>la</strong> o<strong>per</strong>atoria - Ottobre 2009A SUP.OICAL SAFETlf CHECK LISTidentity of die patient, thè o<strong>per</strong>ative site, and thèprocedure to be <strong>per</strong>fbrmed; and compdttioo ofa spenge count at thè end of thè procedale, ifan Incitò» was made. We lecorded whether aliax of these safèty measures were taken for eachpatient.ITKTIITICAL ANALTSISStatistial aaaljnes were <strong>per</strong>ibrmed wìth die useof thè SAS statistica! software package, vernai 9.1(SAS Insa<strong>la</strong>te). To m<strong>in</strong>jmjze thè efiect of dìfièrenceslo die nambers ofpatìems at each site, wettandardìied thè rates of various end poma toreflect thè proportioa of patients ftom cadi àte.These Handardìged rates were used to computetfeefiequenctes of <strong>per</strong>formance of spetified safétymeasures, major complJcations, and deadi ateach site befbce and afte* ìmplemeatatian of thèchecldjst1* We used logìstk-regrwsian analysisto calco<strong>la</strong>» wo-sKted P values far each cooipar}-son, wfeh she as a fixed efiècL We used genetalteeoVestìmatiDg^uatkmmethods to test fbr aayefièct of duster<strong>in</strong>g accord<strong>in</strong>g to site,We <strong>per</strong>fbtmed additìonal analyses to test thècobusmess of otti fmd<strong>in</strong>gs, iododìag logisticcegressionaoaljrses <strong>in</strong> which thè presene? or abaeaceof a data coflectot m thè o<strong>per</strong>at<strong>in</strong>g toomand thè case mix were added as rariaUes. Wedanì6ed caaes as orthopedìc, thccacìc, nonobstaricabdomioopeWc,obttetoc,Tascu<strong>la</strong>i; endoscopic,or othet. To detennìnc whether tìie effect ofthè cheddist at any one she dom<strong>in</strong>ated thè resolts,we <strong>per</strong>focmed cros*-vaUdatìc» by sequentìaìlyretnov<strong>in</strong>g each site from thè analjrèis. Ftnally,we djsaggregated thè shes on thè baais ofwhether they were Iccated <strong>in</strong> high-<strong>in</strong>come or kwormiddle-<strong>in</strong>come owntries and repeated ouranaJysis of prìmary end poìntt. Ali reportedP vahiefi are two-sided, and oo adJustmeDts weremade fbr multiple compansoos.B.ESULTSWe enrolled 3733 patìents duriag thè baseUoe<strong>per</strong>iod and 3955 pittóncs afta implementatjonofthè cheddist. Table 4 ] jsts charactenstìcs of thèpadeots and theit distributkn among thè sìtes;there were no sgnificant dififeimces between thèpatìents <strong>in</strong> thè mo phases of thè swdjr.The rate of any complicatimi at ali àtesdropped fìnm 11.0% at baseUoe to 7Sfk aftaiatroductìoo of thè cheddist (P to0^% (P=0.003) (TaUe 5), The orerall rates ofsur^ica-l-fiit£ ìnfèctiao and onp<strong>la</strong>itoed reo<strong>per</strong>monalso ded<strong>in</strong>ed s^ùfkantty (P 0,0 49.1 55.921,9 05 OJZ 97.5 94J46.7*175 56J S7.6 22.3 23J 9.9 9.4 Tifi 7730.63 0.21 0-2fi 0.40 o.aRw-mviui vilues ire meim &SD. Uient cases were those <strong>in</strong> whicti lurgery wfth<strong>in</strong> 24 houn was deened neos«wr by thè dìnkal team,Outprtent procedurec were ihose for whkk ifischarge from thè hotpittl ocaimd on thè une diy M thè o<strong>per</strong>alion. P viluw tre >hown forthè oomptmon of thè totd vtlue dtw eheditrt impìémentiboo with thè total vilue before implementitioaScurezza dei parenti54