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'Pq <strong>of</strong> Central Scan and Table 1-PIOPED Central Scan Interpretation Categories and Criteria'<br />

'gated<br />

)() ~o<br />

Angiogram Interpretations<br />

Two nuclear medic<strong>in</strong>e readers, not<br />

c,,-~ ---~-~,,~ -<br />

High probability<br />

;,,2 Large (> 750/0 <strong>of</strong> a segment) segmental perf1JSIOn defects WIthout correspond<strong>in</strong>g ~ntilation or roenlgenonetric<br />

from <strong>the</strong> center that performed <strong>the</strong> graphIC abnom1alitles or substantially larger than eI<strong>the</strong>r match<strong>in</strong>g ventIlation or chest roentgenogram<br />

nergy<br />

Ito an ~<br />

-atory<br />

or at<br />

llages<br />

..abnom181ltles<br />

<strong>scan</strong>, mdepe?dently Interpreted <strong>the</strong><br />

lung <strong>scan</strong>s WIth chest roentgenograms<br />

accordl 'ng to preestabl ' h d t d .t<br />

IS e S u y cn e-<br />

ria (Table 1). Angiograms were likewise<br />

d I . d ..Bordertlne<br />

ran om y asslgne. .w pairs <strong>of</strong> angIo-<br />

;,,2 Moderate segmental (;,,25% and ~75% <strong>of</strong> a segment) perf1JsK)n defects without match<strong>in</strong>g ~ntilation or chest<br />

roentgenogram abnOm1alitles and 1 large mIsmatched segmental defect<br />

;,,4 Moderate segmental perf1JsK)n defects without <strong>ventilation</strong> or chest roentgenogram abnom1alities<br />

IntermedIate probabIlity (Indetem1<strong>in</strong>ate)<br />

Not lall<strong>in</strong>g <strong>in</strong>to nom1al. ve~low-. low-, or high-probability categories<br />

high or borderlIne low<br />

DIfficult to categonze as low or high<br />

both<br />

terior<br />

ts<br />

per<br />

VIeW<br />

~ounts<br />

er latsame<br />

graphers from clInical centers o<strong>the</strong>r<br />

than <strong>the</strong> ori .nnat<strong>in</strong> g hos p ital The an-<br />

.e' .'.<br />

gIogram readers Interpreted <strong>the</strong> angIograms<br />

with lung <strong>scan</strong>s as hav<strong>in</strong>g <strong>acute</strong><br />

uI b I ..Large<br />

p m.onary e~ 0 I.sm present-which<br />

required <strong>the</strong> IdentIfication <strong>of</strong> an embo-<br />

I b t t . I th tl ' f<br />

US 0 S ruc mg a vesse or e ou me 0<br />

Low probability<br />

Nonsegmental perf1Jsion defects (~, ~ry small effusion caus<strong>in</strong>g blunt<strong>in</strong>g <strong>of</strong> <strong>the</strong> costophrenic angle. cardiomegaly.<br />

enlarged aorta. hIla. and medIastInum, and elevated dIaphragm)<br />

S<strong>in</strong>gle moderate mIsmatched segmental perfuSK)n defect with nom1al chest roentgenogram<br />

Any perf1JSlon defect with a substantially larger chest roentgenogram abnOm1ality<br />

or moderate segmental perf1JSIOn defects InvolvIng no more than 4 segments <strong>in</strong> 1 lung and no more than<br />

3 segments In 1 lung regIOn with match<strong>in</strong>g ~ntilation defects ei<strong>the</strong>r equal to or larger In size and chest<br />

roentgenogram eI<strong>the</strong>r nom1al or with abnom1alltles substantially smaller than perf1JSIOn defects<br />

>3 Small segmental perf1JsK)n defects «25% <strong>of</strong> a segment) with a nom1al chest roentgen.v.ram<br />

Very low probability .._"<br />

me~<br />

cm m<br />

an embolus (fill<strong>in</strong>g deti ct) with<strong>in</strong> a vesse<br />

I -a b sent, or uncert . m. If two read-<br />

~3 Small segmental perf1Jsion defects with a nom1al chest roentgenogram<br />

Nom1al No perf1Jsion defects present<br />

l<br />

-hole, ers disagreed, <strong>the</strong> <strong>in</strong>terpretations'were Perf1J$ion outl<strong>in</strong>es exactly <strong>the</strong> shape <strong>of</strong> <strong>the</strong> lungs as seen on <strong>the</strong> chest roentgenogram (hilar and aortic impressions<br />

ators. adjudicated by readers who were se- may be si3en. chest roentgenogram and/or <strong>ventilation</strong> study may be abnom1al)<br />

ry or le~t~d randomly fro~ .<strong>the</strong>. rema<strong>in</strong><strong>in</strong>g 'PIOPED <strong>in</strong>dicates Prospectiw Investigation <strong>of</strong> Pulmonary Embolism Dia nosis<br />

<strong>scan</strong>s clInical centers. If adJudIcatIng readers g<br />

did not agree with ei<strong>the</strong>r <strong>of</strong> <strong>the</strong> first two<br />

readers, <strong>scan</strong>s or angiograms went to<br />

panels <strong>of</strong> nuclear medic<strong>in</strong>e or angiogra- Table 2 -Recruitment <strong>of</strong> Patients and Completion <strong>of</strong> Angiography'<br />

phy readers. The f<strong>in</strong>al adjudicated V IQ<br />

tech- <strong>scan</strong> read<strong>in</strong>gs consisted <strong>of</strong> four catego- 0/. <strong>of</strong><br />

6F to . h. h b b ' l ' . d .Eligible No. <strong>of</strong> PfOPEO P.tlent. With<br />

nes- Ig pro a Ilty, mterme late Patient. Lung Scan. Who Were Seiec1ed for Angiogram.<br />

Small probability (<strong>in</strong>determ<strong>in</strong>ate), low proba- Cl<strong>in</strong>ical Center Recruited Anglographlc Pu..ult Obta<strong>in</strong>ed. No. ("!o}<br />

8mL) bility, and low/very low probability ~ukeU~n~~ity 46 --137 1,15-'84)'-'<br />

le pa- through normal (near normal/normal). Henry ~ord Hos~it81 62 228 177 (78)<br />

.~uo- The near-normal/normal category <strong>in</strong>- ~assachus~~ ~eneral Hospjtal 33 140 120 (86)<br />

d Into cludes read<strong>in</strong>gs <strong>of</strong> very low probability University <strong>of</strong> Michigan 52 102 65 (64)<br />

~ lun~ by one reader and low probability by <strong>the</strong> University 01 Pennsylvania 70 168 134 (80)<br />

~all- o<strong>the</strong>r, very low probability by both, ~aleuniversity 43 156 144 (92)<br />

1tero- very low probability by one and normal Total 50 931 755 (81)<br />

per- by <strong>the</strong> o<strong>the</strong>r, and normal by both. Re- ,<br />

1 was fu I. I.. bl t ' ts' PIOPED Indicates Prospective Investigation <strong>of</strong> Pulmonary Embolism Diagnosis<br />

ser me IgI e pa Ien <strong>scan</strong>s were .<br />

~or a read <strong>in</strong> each cl<strong>in</strong>ical center by <strong>the</strong> cl<strong>in</strong>i-<br />

'tlon). cal center's PIOPED nuclear medic<strong>in</strong>e<br />

for 3 reader(s) and not reread.<br />

1d for F II d lants and <strong>in</strong> whom no outcome event 900 to 1000 patients <strong>in</strong> <strong>the</strong> random sam-<br />

:ze <strong>of</strong> 0 ow-up an ..suggested <strong>pulmonary</strong> embolism. Pul- pie for PIOPED angiography was<br />

d or Outcome ClassIfication monary embolism status could be deter- planned to obta<strong>in</strong> estimates <strong>of</strong> sensitiv-<br />

12:1 Patients were contacted by telephone m<strong>in</strong>ed as positive or negative for 902 ityand specificity with 95% CIs no wid-<br />

1hic at I, 3, 6, and 12 months after study patients. A cl<strong>in</strong>ical assessment <strong>of</strong> <strong>the</strong> er than == 8%. To determ<strong>in</strong>e <strong>the</strong> sensi-<br />

; 80 entry. Deaths, new studies for pulmo- likelihood <strong>of</strong> <strong>pulmonary</strong> embolism was tivity and specificity <strong>of</strong> V IQ lung <strong>scan</strong>s<br />

,ec- nary embolism, and major bleed<strong>in</strong>g available for 887 (98%) <strong>of</strong> <strong>the</strong>se patients. without <strong>the</strong> biases associated with hap-<br />

1.2 complications were reviewed by an out- hazard patierlt selection (ie, conveere<br />

come classification committee us<strong>in</strong>g all Statistical Methods nience sampl<strong>in</strong>g).8.t a 933-patient sam-<br />

lted available <strong>in</strong>formation. Only 23 (2.5%) <strong>of</strong> Probability values for <strong>the</strong> comparison pie <strong>of</strong> <strong>the</strong> 1493 patients who consented<br />

mes) <strong>the</strong> 931 patients had <strong>in</strong>complete (16) or <strong>of</strong> percentages and proportions and 95% to PIOPED participation was selected<br />

\e ar- no (7) follow-up. Angiograms, follow-up confidence <strong>in</strong>tervals (CIs) were calcu- accord<strong>in</strong>g to random sampl<strong>in</strong>g sched-<br />

\lism, data, and outcome classifications were lated us<strong>in</strong>g standard: tests.' A ~ test ules created separately by <strong>the</strong> data and<br />

r-gap used to determ<strong>in</strong>e <strong>pulmonary</strong> embolism for homogeneity <strong>of</strong> proportions was coord<strong>in</strong>at<strong>in</strong>g center for each cl<strong>in</strong>ical cenoent-<br />

status as positive for patients with an- used to compare distributions.' Sensi- ter, The PIOPED protocol required<br />

1ge <strong>of</strong> giograms that showed <strong>pulmonary</strong> em- tivity is def<strong>in</strong>ed as <strong>the</strong> proportion <strong>of</strong> <strong>the</strong>se 933 patients to undergo angiogra-<br />

:onds boli and for patients for whom outcome cases <strong>of</strong> <strong>pulmonary</strong> embolism correctly phy if <strong>the</strong>ir <strong>scan</strong>s were abnormal, Of <strong>the</strong><br />

:00.6 review established <strong>the</strong> presence <strong>of</strong> pul- diagnosed and specificity as <strong>the</strong> pro- 933 patients selected for angiography, 1<br />

were monary emboli at <strong>the</strong> time <strong>of</strong> PIOPED portion <strong>of</strong> diagnoses that <strong>pulmonary</strong> patient died before <strong>the</strong> V/Q <strong>scan</strong> could<br />

lteral recruitment. Pulmonary embolism sta- embolism is absent for patients without be completed and 1 o<strong>the</strong>r patient's V/Q<br />

.was tus was determ<strong>in</strong>ed as negative for pa- <strong>pulmonary</strong> embolism. Sensitivity, spe- <strong>scan</strong> was determ<strong>in</strong>ed to be un<strong>in</strong>terpreused<br />

tients with angiograms that did not cificity, and percent agreement have table. These 2 patients are not fur<strong>the</strong>r<br />

.was show <strong>pulmonary</strong> emboli and no contrary been calculated accord<strong>in</strong>g to standard reported here<strong>in</strong>.<br />

ually outcome review and for patients who methods for proportion8,' Analyses<br />

.lImo- lacked a def<strong>in</strong>itive angiogram read<strong>in</strong>g were performed with <strong>the</strong> Statistical RESULTS<br />

.bet- who were discharged from <strong>the</strong> hospital Package for <strong>the</strong> Social Sciences statisti- Of <strong>the</strong> 3016 patients eligible for<br />

without a prescription for anticoagu- cal s<strong>of</strong>tware package.' Recruitment <strong>of</strong> PIOPED, 1493 (50%) gave consent to<br />

gators JAMA. May 23/30. 1990-VoI263, No 20 Ventilation/Perfusion Scan-PIOPED Investigators 2755<br />

~~- "';::: -I<br />

.

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