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<td><h1><a name="h1" id="h1"></a>Medical Effectiveness/Outcomes Research</h1>
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<td><div id="centerContent"><div class="headnote">
<p>This information is for reference purposes only. It was current when produced and may now be outdated. Archive material is no longer maintained, and some links may not work. Persons with disabilities having difficulty accessing this information should contact us at: <a href="https://info.ahrq.gov/">https://info.ahrq.gov</a>. Let us know the nature of the problem, the Web address of what you want, and your contact information. </p>
<p>Please go to <a href="https://www.ahrq.gov/">www.ahrq.gov</a> for current information.</p></div>
<a name="head1"></a>
<h2>Recent findings from the Cardiac Arrhythmia PORT</h2>
<p>The following two studies were reported recently by members of
the Cardiac Arrhythmia Management Patient Outcomes Research Team
(PORT-II), which is led by Mark A. Hlatky, M.D., of Stanford
University and supported by the Agency for Health Care Policy and
Research (HS08362). The goal of the PORT-II researchers is to
develop a comprehensive decision model for use in screening and
treating patients at risk for sudden cardiac death due to
ventricular arrhythmias.</p><p>
<strong>Sim, I., Gupta, M., McDonald K., and others. (1995). "A
meta-analysis of randomized trials comparing coronary artery
bypass grafting with percutaneous transluminal coronary
angioplasty in multivessel coronary artery disease." <em>American
Journal of Cardiology</em> 76, pp. 1025-1029.</strong></p>
<p>Heart attack patients who have more than one coronary artery
blocked are as likely to die or have a nonfatal heart attack
within 1 to 3 years whether they undergo percutaneous
transluminal coronary angioplasty (PTCA) or coronary artery
bypass graft (CABG) surgery. These revascularization procedures
open up blocked arteries to reestablish blood flow (reperfusion).
However, CABG provides better relief of angina (severe heart
pain) and leads to fewer repeat revascularization procedures,
according to Cardiac Arrhythmia PORT-II investigators.</p><p>
They performed a meta-analysis of all randomized trials published
from 1985 to 1995 that directly compared CABG surgery and PTCA in
patients with multivessel coronary disease. Results showed that
the overall risk of death and nonfatal heart attack did not
differ over a 1- to 3-year followup period. Patients randomized
to CABG tended to have a slightly higher risk of death or heart
attack during hospitalization but a lower risk in subsequent
followup.</p>
<p>CABG patients were much less likely than PTCA patients to undergo
either a subsequent CABG (1 percent vs. 19 percent) or PTCA (6
percent vs. 23 percent) and were more likely to be angina-free
(81 percent vs. 73 percent). The researchers point out that
published data do not provide sufficient detail to allow analysis
by number of diseased vessels. However, observational data
suggest that PTCA yields better outcomes than CABG for 2-vessel
disease but poorer outcomes for 3-vessel disease.</p><p>
<strong>Weaver, W.D., Parsons, L., and Every, N. (1995). "Primary
coronary angioplasty in hospitals with and without surgery
backup." The <em>Journal of Invasive Cardiology</em> 7 (Suppl F),
pp. 34F-39F.</strong></p>
<p>Use of coronary angioplasty as the first approach to treating
heart attack patients is increasing. Sometimes patients who
undergo angioplasty subsequently need coronary artery bypass
graft surgery, if the angioplasty fails to open up clogged
arteries. Nevertheless, angioplasty is being performed more often
at hospitals that have freestanding cardiac catheterization
laboratories but no backup cardiac surgery facilities.</p><p>
Yet patients undergoing angioplasty at these hospitals have
acceptable outcomes compared with patients undergoing the
procedure at hospitals with cardiac surgery facilities. Patient
age, a history of prior heart attack, and ECG evidence of
anterior ST elevation&#8212;but not the availability of on-site
surgical backup&#8212;are associated with patient outcomes,
according to the Cardiac Arrhythmia PORT-II investigators.</p>
<p>As part of the Myocardial Infarction Triage and Intervention
(MITI) project&#8212;a registry of all admissions to Kings County,
WA, hospitals for acute cardiac disease&#8212;they compared the
outcomes of 470 persons who received coronary angioplasty as
their first treatment for heart attack in hospitals without
on-site coronary surgery capability with those of similar
patients treated in hospitals with on-site surgery. The
researchers found no differences in procedural success rates or
initial and long-term mortality rates in patients treated in the
two types of hospitals. The mortality rate at discharge was 7
percent for this procedure in both types of facilities. These
data suggest that with appropriate patient selection, trained
operators, and provision for hospital transfer, primary coronary
angioplasty can be successfully accomplished in centers without
on-site surgery capability.</p>
<a name="head2"></a>
<h2>Recurrent cardiac ischemia after TT remains a frequent,
serious, and costly problem</h2>
<p>The early use of thrombolytic therapy (TT) opens up clogged
coronary arteries in patients with acute myocardial infarction
(AMI), but it does not remove the clot-producing (thrombogenic)
stimulus, which can cause recurrent ischemia (reduced blood
flow). A new study, supported in part by the Agency for Health
Care Policy and Research (HS05635), shows that recurrent
myocardial ischemia after TT remains a frequent and expensive
clinical problem, and it is difficult to predict which patients
will develop this serious condition.</p><p>
Researchers from the Fundacion Favaloro, Buenos Aires, Argentina;
Duke University Medical Center; the Cleveland Clinic Foundation;
and other U.S. sites, examined patients enrolled in the
Thrombolysis and Angioplasty in Myocardial Infarction (TAMI)
studies at five centers; 552 patients were treated with tissue
plasminogen activator (t-PA), 293 were treated with urokinase,
and 385 received both thrombolytic agents.</p>
<p>Results showed that recurrent ischemia alone occurred in 18
percent of patients, and both recurrent ischemia and reinfarction
(newly destroyed heart tissue due to lack of blood flow) occurred
in 3.4 percent of patients; 78 percent of patients experienced
neither cardiac problem. Women, older patients, and those with
diabetes or hyperlipidemia had more reinfarction and recurrent
ischemia. Patients with reinfarction had significantly higher
rates of in-hospital death (21 percent) and heart failure (50
percent) than patients with recurrent ischemia alone (11 percent
and 31 percent, respectively) or no ischemic events (4 percent
and 17 percent). As expected, median in-hospital costs were
highest in patients with reinfarction ($26,802), intermediate for
those with recurrent ischemia alone ($18,422), and lowest in
patients with neither event ($15,623).</p><p>
More details are in "Frequency, significance, and cost of
recurrent ischemia after thrombolytic therapy for acute
myocardial infarction," by Alejandro Barbagelata, M.D.,
Christopher B. Granger, M.D., Eric J. Topol, M.D., and others, in
the November 15, 1995 <em>American Journal of Cardiology</em> 76,
pp. 1007-1013.</p>
<a name="head3"></a>
<h2>Low Birthweight PORT examines use of prenatal testing and
corticosteroids in prevention of preterm birth</h2>
<p>Potential problems with the use of prenatal testing at
progressively earlier gestational ages, prevention of preterm
deliveries in pregnant women with bacterial vaginosis, and
controversies surrounding the use of prenatal corticosteroids are
discussed in three recent articles, summarized here, by members
of the Patient Outcomes Research Team (PORT) on Low Birthweight
in Minority and High-Risk Women. Supported by the Agency for
Health Care Policy and Research (contract 282-92-0055), the PORT
examines ways to prevent low birthweight and improve the outcomes
of low-birthweight infants. The Low Birthweight PORT is led by
Robert L. Goldenberg, M.D., of the University of Alabama at
Birmingham.</p><p>
<strong>Rouse, D.J., Owen, J., Goldenberg, R.L., and Cliver, S.P. (1995,
November). "Determinants of the optimal time in gestation to
initiate antenatal fetal testing: A decision-analytic approach."
<em>American Journal of Obstetrics and Gynecology</em> 173(5), pp.
1357-1363.</strong></p>
<p>Antenatal fetal testing is widely used in clinical obstetric
practice as a method of determining fetal well-being. However,
according to this decision analysis by the Low Birthweight PORT,
the use of fetal testing at progressively earlier gestational
ages is particularly dangerous because the tests do not have
perfect specificity, resulting in high false-positive rates. For
example, acting on a false-positive test by effecting delivery at
28 weeks' gestation will predictably have more harmful
consequences for the infant than at 34 weeks. The PORT
researchers used decision analytic techniques to model the most
important determinants of the optimal timing to begin antenatal
fetal testing. Because pregestational insulin-dependent diabetes
mellitus is one of the more common maternal indications for these
tests, the analysis uses a contemporary estimate for the risk of
stillbirth in these pregnancies as the baseline fetal death risk.
The results of the analysis showed that even with the increased
risk of fetal death associated with maternal conditions such as
insulin-dependent diabetes, very high test specificity (more than
99 percent) is required to recommend testing before 30 weeks.
Because of the lower specificity (higher false-positive rates) of
these tests, neonatal deaths will increase due to an increase in
unnecessary and earlier preterm deliveries. The analysis also
showed that the increased risk of neonatal deaths is not offset
by a corresponding decrease in fetal deaths. Under the baseline
assumptions of this model, the researchers conclude that 34 weeks
is a more optimal time to initiate antenatal testing than 30
weeks because it results in more neonatal survivors.</p><p>
<strong>Hauth, J.C., Goldenberg, R.L., Andrews, W.W., and others. (1995,
December). "Reduced incidence of preterm delivery with
metronidazole and erythromycin in women with bacterial
vaginosis." <em>The New England Journal of Medicine</em> 333, pp.
1732-1736.</strong></p>
<p>Treatment with metronidazole plus erythromycin (M+E) reduces
rates of premature delivery in pregnant women with bacterial
vaginosis who also are at risk of preterm delivery, according to
this study by Low Birthweight PORT investigators. The study
recruited 624 pregnant women identified for one of two risk
factors for preterm delivery: previous spontaneous preterm
delivery or prepregnancy weight of less than 50 kg (approximately
111 lb). These women were subsequently screened for several lower
genital tract infections, including asymptomatic bacterial
vaginosis (BV), and randomized (2:1) to receive M+E versus
placebo at 23 weeks' gestation. Of the 624 women randomized, 258
had asymptomatic bacterial vaginosis at baseline examination, 358
were negative for BV, and 8 were lost to followup. The initial
analysis indicated that, overall, the treatment group receiving
metronidazole plus erythromycin had a preterm delivery rate of 26
percent compared with 36 percent in the placebo group. However,
after further subanalysis, a lower rate of prematurity in the M+E
versus placebo-treated women was observed only in the 258
subjects with BV at baseline examination: 31 percent versus 49
percent. There was virtually no difference in the rate of
prematurity between the study treatment and placebo groups in the
358 women who did not have BV at baseline examination (22 percent
vs. 25 percent, respectively). The lower rate of preterm delivery
in the 258 BV-positive women who received the study treatment
versus placebo was observed both in the previous preterm delivery
risk group (39 percent treatment vs. 57 percent placebo) and in
the group of women with a prepregnancy weight of less than 50 kg
(14 percent treatment vs. 33 percent placebo).</p><p>
<strong>Gardner, M.O., and Goldenberg, R.L. (1995, December). "The
clinical use of antenatal corticosteroids." <em>Clinical
Obstetrics and Gynecology</em> 38(4), pp. 746-754.</strong></p>
<p>Prenatal use of corticosteroids has been shown to have many
beneficial effects for the preterm infant, including reducing the
incidence and severity of respiratory distress syndrome,
intraventricular hemorrhage, necrotizing enterocolitis
(inflammation of the small intestine and colon), and neonatal
death. Nevertheless, the available estimates of use suggest that
only 20 percent of eligible mothers who deliver before 34 weeks
receive corticosteroids. Concern about the disparity between
scientific evidence of benefit and clinical practice led the
National Institutes of Health (NIH) to convene a consensus
conference in February 1994. In this paper, members of the Low
Birthweight PORT examine areas of controversy, such as
corticosteroid treatment in pregnancies with premature rupture of
membranes. They also review practice patterns in the United
States, including surveys of physician attitudes toward
corticosteroid use, and summarize the NIH consensus conference
recommendations.</p>
<a name="head4"></a>
<h2>Surgery found effective in reducing seizures and medications
needed to control intractable epilepsy</h2>
<p>Adults and adolescents with intractable epilepsy who are treated
surgically have better seizure control with less antiepileptic
medication than patients who do not undergo surgery, according to
a study supported in part by the Agency for Health Care Policy
and Research (HS06856). Surgical treatment of epilepsy requires a
substantial series of presurgical diagnostic tests to identify
the brain region producing the epileptic attacks and determine if
surgical removal of the affected tissue is possible without
damaging other brain functions.</p><p>
No randomized trials have been conducted to determine the
effectiveness of surgical treatment for epilepsy. This is the
first prospective, multivariate analysis of outcomes comparing
epilepsy patients who were treated surgically with those who were
not.</p>
<p>Researchers, led by Barbara G. Vickrey, M.D., of the University
of California, Los Angeles, and the RAND Corporation, evaluated
the impact of epilepsy surgery on seizures, medication use,
employment, and quality of life in 248 adults and adolescents
with hard-to-control epilepsy, who underwent diagnostic
evaluation for surgery at the UCLA medical center between 1974
and 1990. Those in whom an epileptogenic focus could not be found
did not undergo surgery and were treated medically. After
undergoing screening, 202 patients qualified for and underwent
surgery.</p><p>
Results showed that nearly 6 years later, on average, over 80
percent of non-surgery patients, but only 25 percent of surgery
patients, were still having more than one seizure per month at
followup. Nearly 60 percent of surgery patients were either
completely seizure-free or having only auras or one seizure,
compared with 11 percent of non-surgery patients.</p>
<p>On average, surgery patients were taking almost one fewer
antiepileptic drug at followup than at study enrollment (1.4 vs.
2.0 antiepileptic medications). Although the surgery group showed
no advantage at followup in employment status or self-reported
quality of life according to prospectively collected measures,
quality-of-life scores were higher with surgery on 5 of 11 scales
of a measure designed for epilepsy patients but administered only
at followup. These outcomes need to be assessed in larger
prospective studies, according to the researchers.</p> <p>
For more details, see "Outcomes in 248 patients who had
diagnostic evaluations for epilepsy surgery," by Dr. Vickrey, Ron
D. Hays, Ph.D., Rebecca Rausch, Ph.D., and others, in the
December 2, 1995 issue of <em>Lancet</em> 346, pp. 1445-1449.</p>
<a name="head5"></a>
<h2>High mortality found for patients with community-acquired
pneumonia</h2>
<p>Nearly 14 percent of patients with community-acquired pneumonia
(CAP) die, according to a meta-analysis of 122 studies involving
more than 33,000 patients conducted by the Pneumonia Patient
Outcomes Research Team (PORT). The Pneumonia PORT is led by
Wishwa N. Kapoor, M.D., M.P.H., of the University of Pittsburgh,
and supported by the Agency for Health Care Policy and Research
(HS06468). Mortality ranged from 5 percent for studies that
covered both ambulatory and hospitalized patients and 14 percent
for studies that included only hospitalized patients to 31
percent for nursing home residents and 37 percent for intensive
care unit patients.</p><p>
Men were more likely to die than women, as were patients with
hypothermia, systolic hypotension, tachypnea (a condition marked
by quick, shallow breathing), diabetes mellitus, neoplastic
disease, neurologic disease, bacteremia, leukopenia, and
pulmonary infiltrate found in more than one lobe of the lungs on
x-ray. Mortality was strongly associated with the cause of
pneumonia. In the case of viral pneumonia, mortality was lowest
for patients with influenza B (0 percent) and adenovirus
pneumonia (0 percent) and ranged from 5 to 9 percent for the
remaining viral etiologies. For bacterial pneumonia, mortality
was highest for patients with Pseudomonas aeruginosa (61.1
percent), Klebsiella species (35.7 percent), Escherichia coli
(35.3 percent), and Staphylococcus aureus (31.8 percent).</p>
<p>Patients suspected of having one of these high-risk,
gram-negative rod or staphylococcal bacterial infections should
be considered appropriate candidates for inpatient care and
broad-spectrum antibiotic therapy, according to Michael J. Fine,
M.D., M.Sc., lead author of this study, and other PORT members.
They recommend more widespread use of pneumococcal vaccination in
at-risk persons because of the high prevalence and mortality
associated with pneumococcal pneumonia and the increased
resistance of this bacteria to penicillin.</p><p>
Details are in "Prognosis and outcomes of patients with
community-acquired pneumonia," by Dr. Fine, Melanie A. Smith,
M.P.I.A., Catherine A. Carson, Ph.D., and others, in the January
10, 1996 <em>Journal of the American Medical Association</em> 275(2), pp.
134-141.</p>
<p class="size2"><a href=".">Return to Contents</a><br />
<a href="dept3.htm">Proceed to Next Article</a></p>
<div class="footnote">
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