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BOOKS OF RtfiDIfGS - PAHO/WHO

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VoL XIX. N. a<br />

- 102 -<br />

f tdie outeonie of interest delries two<br />

distinct categories (lfor exunple, death versus<br />

surival). outcome rates in different<br />

groups can, in theory, be compared by the<br />

case-ontrol ("retrospective") method." ' & '<br />

This method inivolves the election of a<br />

series of earso (btho~ persons experiencing<br />

the outo«me event) and the selection of a<br />

reference series ofnoncases ("onrols" or<br />

"referents") for comiparison to the case<br />

series. Vasious itaitica4l techniques allow<br />

estimion of differences in outiom occurrence<br />

between groups based on the<br />

cae-onatwl data'-provided the casecontrol<br />

study satisfies certain conditions<br />

requised for the validity of results. A primary<br />

advantage of the case-control method<br />

is that the number of subjects necessary is<br />

usually much les tan that required for a<br />

prospective comparison.' In the monitorlng<br />

exnple, a cas~o ntrol study would<br />

require fewer than 400 deliveries (200<br />

cases and 200 controls) to detect a 50 per<br />

cent reduction in the neonatal death rute<br />

due to monitoring with 90 per cent probability<br />

(power), at a 0.05 significance level t<br />

(assuming a 50 per cent monitoring rto in<br />

the target population).<br />

More than 20 yean ago. Cornfield and<br />

Haenszel' summrized the two critical<br />

represmntativeness' conditions that were<br />

thought necessary for the validity of a<br />

cse-control study: 1) it should be "possible<br />

to enumerate all new cases of a disease.<br />

or a representative sample of them, without<br />

haviig to doserve all the isdlviduals ¡i<br />

the population"; and 2) "the sample of individuals<br />

not developing the dierse ithe<br />

contrulsl Ishould supplyl an unbiased estimrte<br />

of the prevalence of the chtraceristic<br />

under study among the entire nondiseased<br />

population of interest. The authors<br />

then went un tu lamuint that most retrospective<br />

studies of dtit day had dificulty<br />

assuring the saislacwtion of the seond reqOtler authors of<br />

that period put forth simnilar criteria.u'<br />

More recent writers have cxpressed related<br />

criteria lor the validity oícal-cmotrol<br />

CASEV-COXNlTOL MTHOD<br />

resultl in a samplinig theory fraunework,?<br />

while other authors have rejected representativeness<br />

criteria and ilnstead have<br />

empha>sized the importance ofcompanbility<br />

ofcases and controls." A conimon feature<br />

of all these points of view. however. is<br />

un emphasis on the importance of "section<br />

validity" in casfcontrol studies, in<br />

that subject selection should be unbiased<br />

in order to achieve valid results.<br />

aIn the time since the early commentaries,<br />

genend resevatioa s onceming the<br />

utility of the caa.control method have<br />

been put forth, largely o the grouds that<br />

representativeness or selection validity<br />

conditions ar difficult to fulfll or auure in<br />

ordinary practice." Thbe purpose of our<br />

commentary is to offer an appreciation of<br />

the particular suitability of the case-control<br />

approach for many problems in medical<br />

cae evaluation. We will discuss why the<br />

clasic problems of selection validity are<br />

frequently absent in medical care evaluation<br />

settinr. and how odither common problemns<br />

ofordinary case-control resarch will<br />

often be miimizod as well.<br />

Coalidera~ Favorina the<br />

CaM-Cotil Method in .<br />

Evaluadon Sem~is<br />

bepresenaatveanrs ad Se~oo<br />

Co.sldodnlooe<br />

A menlioned above, problem of selection<br />

bias and subject nonrepresentativeness<br />

haive loed o a curin degree of dinstrus<br />

ofl s-control methods among many clinical<br />

researchers. Yet it is precisely in the<br />

realm of preliminary comparisons or<br />

evaluations of medical care or medicld<br />

teehnology tht the -control metdihod is<br />

most often immune to such problems.<br />

This is because many evaluation setting<br />

involve amall, well-defined turget populabions,<br />

such as a hospital inpatient population<br />

or several co¡nbsied hospital pupulations.<br />

In such settings it is usually possible<br />

to enuumeraite the entire target population.<br />

selecL representative wmlples froinm hud<br />

a

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