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<p><strong>You Are Here:</strong> <span class="crumb_link"><a href="/" class="crumb_link">AHRQ Archive Home</a> > <a href="/research/resarch.htm" class="crumb_link"><em>Research Activities</em> Archive</a> > <a href="." class="crumb_link">December 1997</a> </span></p>
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<tr>
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<td><h1><a name="h1" id="h1"></a>Feature Story </h1>
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</td>
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<td><div id="centerContent"><div class="headnote">
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<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 It was current when produced and may now be outdated. Archive material is no longer maintained, and some links may not work.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>
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<p>Please go to <a href="https://www.ahrq.gov/">www.ahrq.gov</a> for current information.</p></div>
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<a name="head1"></a>
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<a name="head2"></a><h2>Availability of free vaccine and other factors affect
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likelihood of timely childhood immunizations</h2>
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<p>The United States experienced a major measles epidemic between 1989 and 1991, and there was a
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resurgence of whooping cough in 1993. Experts predict that future outbreaks of other
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vaccine-preventable diseases will occur. Thus, a national priority for the year 2000 is full
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immunization of at least 90 percent of children by age 2. In 1996, the combined vaccination rate
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for children 19 to 35 months of age was 78 percent, although 91 percent had received measles
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vaccine.</p> <p>
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Two recent studies, supported by the Agency for Health Care Policy and Research (HS08068)
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and led by Richard K. Zimmerman, M.D., M.P.H., of the University of Pittsburgh School of
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Medicine and Graduate School of Public Health, looked at reasons for low immunization rates.
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Dr. Zimmerman and his colleagues found that uninsured children are less likely to be immunized
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than insured children, especially if their doctors don't receive free vaccines. Cost isn't the only
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factor; physicians' practice policies and beliefs about the risks associated with immunizations also
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determine whether children receive timely immunizations. The two studies are summarized
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below.</p>
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<p><strong>Zimmerman, R.K., Medsger, A.R., Ricci, E.M., and others (1997, September 24). "Impact
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of free vaccine and insurance status on physician referral of children to public vaccine
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clinics." <em>Journal of the American Medical Association</em> 278(12), pp. 996-1000.</strong></p><p>
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Uninsured children are less apt to be immunized when they see their primary care physician than
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are insured children, particularly if their doctor does not receive free vaccines, according to this
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study. The Federal Government provides free vaccines to States for distribution to public health
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departments and participating physicians' offices through the Vaccines for Children (VFC)
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program. The VFC program provides the free vaccines to be used for uninsured children, those
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eligible for Medicaid, and American Indian/Alaska Native children. The VFC program also
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provides free vaccines to insured children if their insurer does not cover vaccines and they are
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vaccinated at a public health clinic.</p>
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<p>Of the 1,236 physicians surveyed in this study, most (66 percent) said they would refer an
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uninsured child to the health department for vaccination. However, 90 percent of physicians who
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did not receive free vaccines, compared with 44 percent who did, said they would refer an
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uninsured child to a public health clinic. Only 11 percent of doctors not receiving free vaccines
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said they would refer an insured child to a clinic. It appears that physicians who receive free
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vaccines are more willing to absorb other uncovered immunization costs, including the cost of the
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office visit, according to Dr. Zimmerman.</p><p>
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Overall, 36 percent of physicians surveyed would refer to a public health clinic a child with
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insurance that did not cover vaccines, 26 percent would refer a child with Medicaid, but only 8
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percent would refer an insured child with coverage for the vaccines. Referral of children from
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primary care physicians' offices to public clinics results in delayed immunization (and often no
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immunization) and fragmented care, with parents having the added expense and burden of taking
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the child to one site for vaccines and another for other services, note the researchers. </p>
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<p><strong>Zimmerman, R.K., Schlesselman, J.J., Baird, A.L., and Mieczkowski, T.A. (1997, July). "A
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national survey to understand why physicians defer childhood immunizations." <em>Archives of
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Pediatric and Adolescent Medicine</em> 151, pp. 657-664.</strong></p><p>
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The continuing vulnerability of U.S. children to potential outbreaks of vaccine-preventable
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diseases is due in part to suboptimal vaccination practices of health care providers, according to
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this study. For example, contrary to national recommendations, many physicians are less apt to
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vaccinate a child with an upper respiratory infection (URI) because they think it will increase the
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vaccine's side effects or decrease its efficacy. </p>
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<p>Lack of vaccination during acute care visits (compared with well-child visits), overly cautious
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interpretation of contraindications (such as a URI), and lack of simultaneous administration of all
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needed vaccines (sometimes because of parental objection to multiple shots during one visit) are
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obstacles to age-appropriate vaccination, notes Dr. Zimmerman. Dr. Zimmerman and his
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colleagues conducted telephone interviews with primary care physicians across the United States
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to determine the likelihood that they would recommend vaccination in common clinical scenarios
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and to probe the reasons behind their decisions.</p><p>
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Only 4 percent of physicians who thought the risk for side effects was increased by URI were
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likely to vaccinate a child with a URI, compared with 55 percent of physicians who thought there
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would be no increased risk. Also, 83 percent of those who thought the efficacy of measles,
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mumps, and rubella vaccine would not be affected by a URI recommended vaccination, compared
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with only 8 percent of physicians who thought efficacy would decrease. Some physicians (11
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percent) would not administer three injectable vaccines simultaneously based on beliefs about side
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effects, parental objections, and vaccine efficacy. These findings have implications for both
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provider education and the development of practice policies, conclude the researchers. </p>
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<p class="size2"><a href=".">Return to Contents</a></p>
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<a name="head3"></a><h1>Primary Care/Managed Care</h1>
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<a name="head4"></a><h2>Routine use of antibiotics may not be the best way to
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manage children's middle ear infections</h2>
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<p>Except in the Netherlands, antibiotics are standard treatment for acute otitis media (AOM), that
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is, middle ear infection, in most developed countries—indeed, this is the most frequent use of
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antibiotics in the United States. However, routine use of antibiotics to prevent and treat children's
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middle ear infections has uncertain benefits and contributes to the growing worldwide problem of
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antibiotic resistance. Clinical trials provide only weak evidence that routine use of antibiotics
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decreases the duration and severity of symptoms and prevents complications, according to Jack
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Froom, M.D., of the State University of New York at Stony Brook, and Larry Culpepper, M.D.,
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M.P.H., of Boston University, and their colleagues, authors of a recent study supported by the
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Agency for Health Care Policy and Research (HS07035).</p> <p>
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In reviewing the scientific literature, the researchers found that more than 80 percent of children
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with AOM recover without antibiotics. They suggest that physicians use analgesics to treat AOM
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symptoms and observe children to make sure their condition improves. Children less than 2 years
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of age who are not treated with antibiotics require frequent re-evaluation. If antibiotics are used,
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they should be given for less than 10 days. Physicians also should work with parents to eliminate
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modifiable risk factors for AOM such as tobacco smoke. The most important risk factors for poor
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outcomes are young age and attendance at day care centers. </p>
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<p>More than 70 percent of AOM cases are immediately preceded by viral respiratory infections, and
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there is evidence that contaminated hands and surfaces are more important than airborne
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respiratory droplets in viral transmission. According to the researchers, increased hand washing by
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staff and children at day care centers and the use of virucidal agents to wipe surfaces might reduce
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this risk. For instance, in Iceland, penicillin-resistant pneumococci appeared in 1988 and increased
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to nearly 20 percent of pneumococcal infections by 1993. After a campaign to decrease antibiotic
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use, particularly for AOM, and to control spread of infections in day care centers, this rate
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declined to 17 percent in 1994. This improvement was accomplished without compromising
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clinical outcomes, note the researchers.</p><p>
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These findings are reported in detail in two recent articles. See "Routine antimicrobial treatment
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of acute otitis media. Is it necessary?" by Drs. Culpepper and Froom, in the November 26, 1997
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<em>Journal of the American Medical Association</em> 278(20), pp. 1643-1645; and
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"Antimicrobials for
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acute otitis media? A review from the international primary care network," by Drs. Froom,
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Culpepper, Max Jacobs, M.D., and others, in the July 1997 <em>British Medical Journal</em> 315,
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pp.
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98-102. </p>
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<a name="head5"></a><h2>NSAIDs greatly increase risk of GI bleeding in
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patients with dyspepsia</h2>
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<p>If you suffer from dyspepsia—with symptoms ranging from stomach pain or discomfort, to
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heartburn, nausea, and vomiting—you should minimize your use of nonsteroidal
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antiinflammatory
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drugs (NSAIDs). NSAIDs such as aspirin, ibuprofen (e.g., Advil, Motrin) and naproxen (e.g.,
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Aleve) are available over-the-counter; many others are available with a doctors prescription.
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NSAIDs increase the risk of gastrointestinal (GI) bleeding seven-fold in persons with dyspepsia,
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according to a study supported in part by the Agency for Health Care Policy and Research
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(HS07257). NSAIDs are mainstay medicine for those with arthritis and musculoskeletal problems,
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making these dyspeptic patients at most risk for GI complications, explain John H. Kurata, Ph.D.,
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M.P.H., of the University of California Los Angeles School of Medicine, and colleagues.</p> <p>
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The researchers studied 545 patients visiting a family medicine clinic for dyspepsia to identify
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predictors of GI bleeding and use of medical services for GI-related conditions after the initial
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dyspepsia visit. They used initial and 1-year followup data to examine the impact on GI bleeding
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and other GI problems of cigarette smoking, alcohol use, and NSAID use; existence of chronic
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medical conditions; and patient demographic characteristics. Results showed that 52 percent of
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patients were later seen for GI-related followup visits. The most important predictor of these
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visits was use of NSAIDs. </p>
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<p>Prior use of NSAIDs doubled the odds for any followup GI problem and increased the risk of GI
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bleeding by a factor of 7. Seventy-eight percent of bleeders used NSAIDs compared with 33
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percent of nonbleeders. In fact, current use of NSAIDs was the only significantly different variable
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between patients who returned with a GI-related problem and those who did not. Forty-one
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percent of patients with a followup GI-related service used NSAIDs compared with 26 percent of
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patients with no GI followup. There was a moderate association between alcohol use and
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bleeding; 44 percent of bleeders used alcohol compared with 16 percent of nonbleeders.</p> <p>
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See "NSAIDs increase risk of gastrointestinal bleeding in primary care patients with dyspepsia,"
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by Dr. Kurata, Aki N. Nogawa, M.S., and Dean Noritake, M.D., in the September 1997 issue of
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<em>The Journal of Family Practice</em> 45(3), pp. 227-235. </p>
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<a name="head6"></a><h2>Practice-based research project documents effects of
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low education on women's mammography decisions</h2>
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<p>The cost of a mammogram and lack of insurance are not the most prevalent barriers to
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mammography screening among poor New England women who receive care at community
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health centers (CHCs). Instead, thinking the test is not important ("don't need it" or "don't want
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it") is the most common reason for not receiving a mammogram. These women simply don't think
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a mammogram is necessary, according to a practice-based research project supported by the
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Agency for Health Care Policy and Research and the Bureau of Primary Health Care.</p> <p>
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As increasing numbers of patients become enrolled in managed care plans, concerns about
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cost—historically the greatest barrier to mammography—will cease to be an issue. The
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challenge then
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will be to improve patient acceptance, according to Anthony Valdini, M.D., M.S., of Tufts
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University Medical School, and Lucia C. Cargill, B.S.N., Ph.D., of Marlboro College, authors of
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the study.</p>
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<p>For the study, questionnaires were administered in 1995 by staff of 32 community health centers
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in 6 New England States to 2,943 low-income women; 932 of the women were 40 to 49 years of
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age, and 2,011 women were 50 years of age or older. Seventy percent of these women reported
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having had a breast examination by a provider within the preceding 2 years; 87 percent reported
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that mammography was recommended. More women 50 years of age or older (55 percent) had
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undergone mammography during the previous 2 years than women in the 40 to 49 age group (45
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percent). Most women who had not had a mammogram said it was because they thought that "the
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test was not important." Expense was a secondary reason within the community health center
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population, where a majority of patients have mammography costs covered by insurance.</p> <p>
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The national goal by the year 2000 is to have 60 percent of women 50 years of age and older
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receive a mammogram every 2 years. It is estimated that this approach could reduce breast cancer
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death rates by 30 percent. This study's results show that progress is being made toward this goal
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among low-income New England women seen in community health centers.</p>
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<p>For more information, see "Access and barriers to mammography in New England community
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health centers," by Drs. Valdini and Cargill, in the September 1997 <em>Journal of Family
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Practice</em>
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45(3), pp. 243-249.</p>
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<p class="size2"><a href=".">Return to Contents</a></p>
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<a name="head7"></a><h1>Outcomes/Effectiveness Research</h1>
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<a name="head8"></a><h2>Managing infants at risk for group B streptococcal
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disease, although costly, is cost effective</h2>
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<p>Group B streptococcus (GBS) is the most common cause of neonatal sepsis and a major cause of
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neonatal disease and death in the United States. The Centers for Disease Control and Prevention
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(CDC) recently recommended two strategies to treat pregnant women suspected of being infected
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with GBS to minimize the risk of early-onset GBS in newborns.</p> <p>
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Total costs are substantial for managing infants at risk for GBS whose mothers are treated in line
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with the CDC strategies, according to a study supported in part by the Agency for Health Care
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Policy and Research (PORT contract 290-92-0055). Nevertheless, these costs do not negate the
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value of a GBS neonatal prevention strategy, concludes the Patient Outcomes Research Team on
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Low Birthweight in Minority and High-Risk Women, which is led by Robert L. Goldenberg,
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M.D., of the University of Alabama at Birmingham. </p>
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<p>The researchers estimated the costs of pediatric care provided to full-term asymptomatic infants
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when pediatricians followed either of the CDC strategies for managing infants whose mothers
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received intrapartum antibiotics to treat suspected GBS infection. One strategy is based on
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positive maternal culture screening (as recommended by the American Academy of Pediatrics),
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and the other is based on maternal risk factors for GBS (as recommended by the American
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College of Obstetricians and Gynecologists). The CDC recommends that pediatricians observe
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asymptomatic infants for at least 48 hours if their mothers received more than 4 hours of
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antibiotics. If mothers at risk received less than 4 hours of intrapartum antibiotics, physicians
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should order a complete blood count and blood culture; asymptomatic infants with normal results
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should be observed for at least 48 hours.</p> <p>
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The research team found that the cost of managing an annual U.S. birth cohort of 3.95 million
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asymptomatic full-term infants in this way would be $41 million for a culture-based approach and
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$33 million for a risk-factor-based approach. Hospital and physician costs account for more than
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78 percent of this total. Incorporating pediatric costs into previous PORT cost-effectiveness
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analyses of obstetrical strategies increased the cost per sepsis case averted by as much as 51
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percent for culture-based strategies and 112 percent for risk- factor-based strategies. </p>
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<p>For more details, see "The pediatric costs of strategies for minimizing the risk of early-onset
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Group B streptococcal disease," by Crayton A. Fargason Jr., M.D., M.M., Myriam
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Peralta-Carcelen, M.D., M.P.H., Dwight J. Rouse, M.D., and others, in the September 1997
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<em>Obstetrics & Gynecology </em>90(3), pp. 347-352.</p>
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<a name="head9"></a><h2>ACE inhibitors are more effective than other blood
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pressure medicines at slowing kidney disease</h2>
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<p>Diabetes is the single largest cause of end-stage renal disease in the United States, accounting for
|
|
about 30 percent of new cases. Over the past decade, many clinical trials have shown that
|
|
angiotensin-converting enzyme (ACE) inhibitors are effective in slowing the progression of
|
|
diabetic renal disease. A recent study supported in part by the Agency for Health Care Policy and
|
|
Research (HS07782 and HS08532) shows that ACE inhibitors also are more effective than other
|
|
antihypertensive medications in delaying the onset of end-stage renal disease in individuals who do
|
|
not have diabetes. It is not clear, however, whether this beneficial effect is due to the greater
|
|
decline in blood pressure or to other effects of ACE inhibition, notes Joseph Lau, M.D., of Tufts
|
|
University School of Medicine.</p><p>
|
|
|
|
The researchers used a meta-analysis of 10 randomized studies (1,594 patients) to compare the
|
|
impact of ACE inhibitors with other antihypertensive agents on the development of end-stage
|
|
renal disease caused by factors other than diabetes. Among 806 patients receiving ACE inhibitors,
|
|
6 percent developed end-stage renal disease, and 2 percent died; in the 788 controls who received
|
|
other antihypertensive agents, the respective values were 9 percent and 1.5 percent. The pooled
|
|
relative risks were 0.70 (95 percent confidence interval [CI], 0.51-0.97; 1 is equal risk) for
|
|
end-stage renal disease and 1.24 (95 percent CI; 0.55-2.83) for mortality. Patients who received
|
|
ACE inhibitors had 4.9 mm Hg greater decrease in mean systolic and 1.2 mm Hg greater decrease
|
|
in mean diastolic blood pressure than control patients during followup. Therefore, the greater
|
|
decline in systolic blood pressure may have been large enough to account for the clinically
|
|
significant beneficial effect on progression of renal disease, according to the researchers. </p>
|
|
|
|
<p>Most study patients were men aged 44 to 66 years. Renal function was mildly impaired in patients
|
|
in three studies, moderately impaired among patients in five studies, and severely impaired in
|
|
patients in two studies. In most studies, the proportion of men who had hypertensive
|
|
nephrosclerosis, glomerular and interstitial diseases, and polycystic kidney disease was similar to
|
|
that of patients with nondiabetic end-stage renal disease. The researchers estimated decline in
|
|
renal function from serum creatinine level, creatinine clearance, or glomerular filtration rate.
|
|
Antihypertensive agents studied were enalapril, captopril, cilazapril, and benazepril.</p> <p>
|
|
|
|
Details are in "Effects of angiotensin-converting enzyme inhibitors on the progression of
|
|
nondiabetic renal disease: A meta-analysis of randomized trials," by Ioannis Giatras, M.D., Dr.
|
|
Lau, and Andrew S. Levey, M.D., in the September 1997 <em>Annals of Internal Medicine</em> 127(5), pp. 337-345. </p>
|
|
<a name="head10"></a><h2>Debate continues over appropriate treatment of BPH
|
|
and localized prostate cancer</h2>
|
|
<p>New technologies have become available over the past few years to diagnose and treat benign
|
|
prostatic hyperplasia (BPH, enlarged prostate) and prostate cancer, including drug therapies,
|
|
devices, and new surgical procedures, such as nerve-sparing prostatectomy (surgical removal of
|
|
the prostate). Dramatic increases in the incidence of prostate cancer are largely attributable to
|
|
increasing intensity of early detection efforts with digital rectal exams and prostate specific
|
|
antigen (PSA) testing. However, this has been accompanied by controversy about the best way to
|
|
treat clinically localized disease, ranging from watchful waiting (no treatment unless there is
|
|
evidence of disease progression) to radical prostatectomy, which can cause impotence and
|
|
incontinence, among other problems.</p> <p>
|
|
|
|
Three articles on BPH and prostate cancer research (supported by the Agency for Health Care
|
|
Policy and Research) were recently published and are summarized here. The first study,
|
|
conducted by the Prostate Patient Outcomes Research Team-II (PORT-II), reports results of a
|
|
nationwide survey on current management practices for both problems. The second study
|
|
(AHCPR grant HS06824) focuses on the rate of impotence and incontinence after nerve-sparing
|
|
radical prostatectomy. The third study describes the first 3 years of the Prostate Cancer
|
|
Intervention Versus Observation Trial (PIVOT) to find out whether watchful waiting or radical
|
|
prostatectomy results in better survival and quality of life for men with localized prostate
|
|
cancer.</p>
|
|
|
|
<p><strong>Barry, M.J., Fowler, Jr., F.J., Bin, L., and Oesterling, J.E. (1997). "A nationwide survey of
|
|
practicing urologists: Current management of benign prostatic hyperplasia and clinically
|
|
localized prostate cancer." (HS08397). <em>The Journal of Urology</em> 158, pp. 488-492.</strong> </p><p>
|
|
|
|
This nationwide survey of 394 practicing urologists provides insight into the current
|
|
treatment of
|
|
patients with BPH and localized prostate cancer. Not surprisingly, urologists reported seeing
|
|
many BPH patients, and while they commonly prescribed medication, many patients did not
|
|
require active treatment. Alpha-blockers were prescribed more than four times as often as
|
|
finasteride. Standard transurethral prostatectomy was by far the most common surgical procedure,
|
|
with variations such as transurethral incision or laser prostatectomy performed much less often.
|
|
Urologists used diagnostic practices consistent with published BPH guidelines, such as digital
|
|
rectal exams and PSA tests for men with suspected BPH. </p>
|
|
|
|
<p>However, urologists should more routinely use the American Urological Association symptom
|
|
index to gauge symptom severity and less routinely use upper tract imaging and cystoscopy,
|
|
according to the Prostate Patient Outcomes Research Team led by Michael J. Barry, M.D., of
|
|
Massachusetts General Hospital. The use of urinary flow and residual volume measurements,
|
|
which are optional according to the guidelines, varied among urologists.</p> <p>
|
|
|
|
The typical U.S. urologist performs about two prostate biopsies weekly and about one radical
|
|
prostatectomy per month. Whether this low surgical volume provides enough experience to result
|
|
in optimal outcomes is unknown, but higher volume often equates with better outcomes for many
|
|
surgical procedures. Cancer staging practices varied considerably. This is not surprising, given the
|
|
general lack of evidence relating particular staging practices to outcomes. However, recent
|
|
studies have suggested that bone scan and pelvic lymph node dissection have relatively low yields
|
|
in men with clinically localized cancer and low preoperative PSA levels. Also, pelvic
|
|
computerized tomography or magnetic resonance imaging may be insufficiently sensitive and
|
|
specific to guide therapeutic decisionmaking. The authors conclude that a more selective
|
|
approach to the use of these tests would decrease the costs of treatment for men with clinically
|
|
localized prostate cancer.</p>
|
|
|
|
<p><strong>Talcott, J.A., Rieker, P., Propert, K.J., and others (1997). "Patient-reported impotence
|
|
and incontinence after nerve-sparing radical prostatectomy." (HS06824). <em>Journal of the
|
|
National Cancer Institute</em> 89(15), pp. 1117-1123.</strong></p><p>
|
|
|
|
The rate of radical prostatectomy increased almost six-fold between 1984 and 1990, due in
|
|
part to
|
|
reported improvement in postoperative sexual potency after use of newly developed nerve-sparing
|
|
techniques, which prompted many men to choose surgery over radiation therapy. However, a new
|
|
study suggests that this approach, especially when nerves are spared on only one side, does not
|
|
improve postoperative sexual function nearly as much as had been thought. In nerve-sparing
|
|
radical prostatectomy, the surgeon identifies for potential preservation one or both of the
|
|
neurovascular bundles that lie adjacent to each side of the prostate, based on how close the cancer
|
|
is to the nerves. Thus, the operation that the patient receives—bilateral nerve-sparing,
|
|
unilateral
|
|
nerve-sparing, or non-nerve-sparing prostatectomy—is in some cases unpredictable prior to
|
|
surgery.</p>
|
|
|
|
<p>This study of 94 men before and after they underwent radical prostatectomy for early prostate
|
|
cancer involved questionnaires of sexual and urinary function before surgery and at 3 and 12
|
|
months after surgery, which the researchers correlated with the surgical technique used.
|
|
Compared with men who had not been treated with a nerve-sparing procedure, men who
|
|
underwent nerve-sparing radical prostatectomy, particularly of the bilateral type, were younger
|
|
and had better prognostic features, indicating less advanced cancers. Before surgery, 75 percent
|
|
of men not treated with a nerve-sparing procedure reported erections that were usually inadequate
|
|
for sexual intercourse compared with 33 percent and 5 percent of men who underwent unilateral
|
|
and bilateral nerve-sparing prostatectomies, respectively.</p> <p>
|
|
|
|
One year after surgery, most men reported inadequate erections, including 79 percent of men who
|
|
had bilateral nerve-sparing surgery. Unilateral nerve preservation provided no apparent benefit.
|
|
</p>
|
|
|
|
<p>In general, nerve-sparing surgery was associated with more use of absorbent pads at 3 and 12
|
|
months following treatment, and this approach was associated with substantial urinary
|
|
incontinence at 3 months but not at 12 months following surgery. Because men with preoperative
|
|
impotence and more advanced cancers receive nerve-sparing surgery less often, some of the
|
|
previously reported benefit of nerve preservation may be the result of patient selection and not of
|
|
the technique itself, concludes James A. Talcott, M.D., of Massachusetts General Hospital, who
|
|
led the study.</p>
|
|
|
|
<p><strong>Wilt, T.J., and Brawer, M.K., and PIVOT Executive Committee (1997). "The prostate
|
|
cancer intervention versus observation trial (PIVOT)." (Interagency Agreement; AHCPR,
|
|
VA, NCI). <em>Oncology</em> 11(8), pp. 1133-1143.</strong></p> <p>
|
|
|
|
It is still not known whether radical prostatectomy or expectant management (watchful
|
|
waiting)
|
|
provides longer survival and better quality of life for men with localized prostate cancer. The
|
|
Prostate Cancer Intervention Versus Observation Trial (PIVOT) is the first national randomized
|
|
controlled trial to compare the two strategies in men under age 75 with newly diagnosed prostate
|
|
cancer. It began 3 years ago, enrolled over 400 men by the fall of 1997, and will eventually enroll
|
|
1,000 men and have results in the year 2008. PIVOT, supported in part by an interagency
|
|
agreement between the Agency for Health Care Policy and Research, the Department of Veterans
|
|
Affairs, and the National Cancer Institute, is being conducted at over 50 Department of Veterans
|
|
Affairs and National Cancer Institute medical centers across the country. The men are randomized
|
|
to radical prostatectomy, with additional intervention for subsequent disease persistence or
|
|
recurrence, or to surveillance (watchful waiting), with palliative therapy generally reserved for
|
|
symptomatic or metastatic disease progression.</p>
|
|
|
|
<p>Both early intervention and expectant management involve potential risks and benefits. Radical
|
|
prostatectomy and radiation therapy offer the possibility of complete tumor eradication and cure.
|
|
They may reduce patient anxiety, the likelihood of cancer metastasis, and need for subsequent
|
|
interventions for disease progression. However, in individuals with poorly differentiated prostate
|
|
cancer, early intervention is less likely to completely eliminate cancer. These interventions also
|
|
may result in impotence and incontinence.</p><p>
|
|
|
|
In many men, treatment may not be necessary if expectant management is used. If men develop
|
|
symptoms due to local disease progression, relief can be provided by minor interventions
|
|
associated with minimal problems. The rate of metastasis may be similar regardless of whether
|
|
expectant management, surgery, or radiation is used. Therefore, expectant management may
|
|
improve quality of life compared with early intervention. On the other hand, expectant
|
|
management may miss an opportunity to prevent metastatic disease and prostate cancer-related
|
|
death. </p>
|
|
|
|
<p>The results from PIVOT will be useful, regardless of which strategy proves to be superior, since
|
|
randomized trials such as PIVOT can ensure that the treatment groups are balanced and that the
|
|
comparisons of outcomes are unbiased. The researchers stress the need for physicians to
|
|
encourage eligible men to enroll in PIVOT so that the preferred treatment approach for men with
|
|
clinically localized prostate cancer can be determined.</p>
|
|
<a name="head11"></a><h2>Elderly patients are unwilling to pay more to shorten
|
|
waiting time for cataract surgery</h2>
|
|
<p>Waiting lists for elective surgery are common in many countries. Because waiting lists are often
|
|
unpopular, countries have developed a variety of initiatives to reduce the total number of people
|
|
on the waiting lists, including subsidizing care in the private sector, priority-setting to identify
|
|
patients most in need, and other measures. A recent study, supported in part by the Agency for
|
|
Health Care Policy and Research (HS07085), investigated the preferences of patients in Denmark,
|
|
Manitoba, Canada, and Barcelona, Spain who were on waiting lists for cataract surgery.</p><p>
|
|
|
|
Despite dissatisfaction with long waits for cataract surgery, the majority of elderly people in this
|
|
study were unwilling to pay more to reduce the wait, according to Gerard F. Anderson, Ph.D., of
|
|
Johns Hopkins University, and colleagues. The researchers used a willingness-to-pay
|
|
questionnaire to interview 464 individuals in the three countries who had recently been placed on
|
|
waiting lists for cataract surgery. At the time they were placed on the list, these patients expected
|
|
to wait from 1 to 18 months for surgery. Subjects were interviewed three times: when they were
|
|
first put on the waiting list, upon completion of surgery, and 4 months later. </p>
|
|
|
|
<p>The majority of cataract surgery candidates in this study were unwilling to pay higher taxes to
|
|
reduce the length of the waiting list or to pay more out of pocket to have the surgery performed
|
|
earlier in the private sector—less than 2 percent of study participants actually had the
|
|
surgery done
|
|
in the private sector.</p> <p>
|
|
|
|
Willingness to pay was greater for persons with more education, lower visual acuity, more
|
|
problems with their vision, and longer anticipated waiting time. There was limited support for
|
|
higher taxation to reduce waiting time (12 percent of candidates from Spain, 24 percent from
|
|
Denmark, and 15 percent from Canada). The remainder either said they were unwilling or (in
|
|
Denmark) did not know if people should pay higher taxes for this option. </p>
|
|
|
|
<p>In all three countries, patients can go to a private clinic and pay an average of $1,000 out of
|
|
pocket for cataract surgery on one eye with a 1-month wait. As the out-of-pocket price increased
|
|
from $500 to $2,000, the percentage of candidates who would opt for private surgery declined.
|
|
For instance, 29 percent of those in Spain, 17 percent in Denmark, and 38 percent in Canada were
|
|
willing to pay $500 out of pocket; only 23 percent, 11 percent, and 7 percent, respectively, were
|
|
willing to pay $2,000. Patients waited an average of 0.2 months longer than they expected to wait
|
|
in Spain, 0.9 months longer in Denmark, and 0.6 months longer in Canada. When interviewed 4
|
|
months after surgery, about one-third of respondents said they waited longer or much longer than
|
|
they would have preferred.</p> <p>
|
|
|
|
The existence of waiting lists is often cited by U.S. policymakers as a reason why the United
|
|
States should not adopt the health care systems of other countries. Other countries have used
|
|
waiting lists to control the demand for services, with some success. Some managed care
|
|
organizations in the United States may begin to use waiting lists to constrain the demand for
|
|
services, although it is also possible that they would prove too unpopular in the marketplace,
|
|
conclude the researchers.</p>
|
|
|
|
<p>See "Willingness to pay to shorten waiting time for cataract surgery," by Dr. Anderson, Charlyn
|
|
Black, Elaine Dunn, and others, in the September/October 1997 <em>Health Affairs</em> 16(5), pp.
|
|
181-191.</p>
|
|
|
|
<p class="size2"><a href=".">Return to Contents</a><br />
|
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<a href="ra2.htm">Proceed to Next Section</a></p>
|
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<div class="footnote">
|
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<p> The information on this page is archived and provided for reference purposes only.</p></div>
|
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|
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