Editorials

See article on page 871.

Improvement in Current Approaches to Lipid Lowering

BENJAMIN J. ANSELL, M.D.
University of California, Los Angeles, School of Medicine
Los Angeles, California

The National Cholesterol Education Program (NCEP) has updated its recommendations for cholesterol screening and therapeutic strategies based on coronary risk assessment.¹ In this issue of American Family Physician, Safeer and Ugalat² review the changes in the new NCEP Adult Treatment Panel III (ATP III) guidelines, which include more intensive low-density lipoprotein (LDL) cholesterol control in patients with multiple coronary risk factors, diabetes mellitus, and low levels of high-density lipoprotein (HDL) cholesterol.

These recommendations follow the recognition that a large number of persons have hyperlipidemia that warrants treatment even according to the less aggressive NCEP­ATP II goals. Last year, it was estimated that 10.4 million Americans required pharmacologic lipid modification based on the ATP II guidelines.

This number rises to 28.4 million when we include persons covered by the NCEP "clinical judgment" criteria³ and climbs to 35.6 million when we apply the new ATP III guidelines. Yet only a small minority of these persons--4.5 million--is receiving such therapy. Of particular concern is the revelation from a recent nationwide study that only 32 percent of patients hospitalized with acute myocardial infarction were discharged on cholesterol medication.⁴

For many patients who are prescribed lipid-lowering therapy, the treatment they are given is inadequate. For example, the Lipid Treatment Assessment Project (L-TAP)⁵ found that only 38 percent of patients being treated for hyperlipidemia are at NCEP LDL cholesterol target levels. The patients who were most likely to benefit were the least likely to achieve their target levels: only 37 percent of high-risk patients and 18 percent of patients with coronary heart disease reached target LDL cholesterol levels.⁵

The basis for this treatment gap is multifactorial and includes physician, pharmacologic, and patient factors. Lipid-lowering treatment may be inadequate because of an inappropriate choice of agent or dosage, drug intolerance, or lack of patient adherence.

To close this treatment gap, physicians need to improve their strategies for recognizing and managing the risks associated with dyslipidemia. Chart reminders, hospital discharge protocols, and the involvement of nonphysician health care professionals improve the rate of effective lipid therapy.

In the next several years, the introduction of agents with novel lipid-modifying effects should also allow for further improvement in treatment rates. Although current statins have a safe and effective track record as monotherapy, they frequently require combination with other agents to control severe or combined dyslipidemias. An agent now in development, pitivastatin, is reported to have brought 86 percent of dyslipidemic patients to NCEP LDL cholesterol target levels.⁶ Another agent, rosuvastatin, was reported to have a significant effect on LDL cholesterol, lowering levels by up to 65 percent; among hypercholesterolemic patients, a higher fraction of those taking this agent (87 percent) achieved ATP II target LDL cholesterol levels, compared with those taking pravastatin (53 percent) or simvastatin (64 percent).⁷

Other drugs in development that modify lipid levels through novel mechanisms may prove useful as mono- or adjunctive therapy. These include bile acid transport inhibitors, acyl-CoA cholesterol acyl-transferase (ACAT) inhibitors, and peroxisome proliferator-activated receptor (PPAR) agonists. The potential for additional coronary risk reduction with these agents exists, but further clinical study is needed before their use will affect treatment recommendations.

The ATP III guidelines advise that we take a more aggressive posture in identifying and treating dyslipidemia to prevent cardiovascular diseases in our patients. These recommendations must be followed through continued educational efforts, practice improvements, and pharmaceutical development to help patients achieve the new target levels.

Benjamin J. Ansell, M.D., is director of the UCLA Center for Primary Care-Based Cardiovascular Disease Prevention in the Department of Medicine at the University of California, Los Angeles, School of Medicine.

Address correspondence to Benjamin J. Ansell, M.D., UCLA Dept. of Medicine, Div. of General Internal Medicine and Health Services Research, 200 UCLA Medical Plaza, Suite 370, Los Angeles, CA 90095 (e-mail: bansell@mednet.ucla.edu).

REFERENCES

1. Executive summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA 2001;285:2486-97.
2. Safeer RS, Ugalat PS. Cholesterol treatment guidelines update. Am Fam Physician 2002;65:871-80.
3. Jacobson TA, Griffiths GG, Varas C, Gause D, Sung JC, Ballantyne CM. Impact of evidence-based "clinical judgment" on the number of American adults requiring lipid-lowering therapy based on updated NHANES III data. National Health and Nutrition Examination Survey. Arch Intern Med 2000;160: 1361-9.
4. Fonarow GC, French WJ, Parsons LS, Sun H, Malmgren JA. Use of lipid-lowering medications at discharge in patients with acute myocardial infarction: data from the National Registry of Myocardial Infarction 3. Circulation 2001;103:38-44.
5. Pearson TA, Laurora I, Chu H, Kafonek S. The Lipid Treatment Assessment Project (L-TAP): a multicenter survey to evaluate the percentages of dyslipidemic patients receiving lipid-lowering therapy and achieving low-density lipoprotein cholesterol goals. Arch Intern Med 2000;160:459-67.
6. Kajinami K, Koizumi J, Ueda K, Miyamoto S, Takegoshi T, Mabuchi H. Effects of NK-104, a new hydroxymethylglutaryl-coenzyme reductase inhibitor, on low-density lipoprotein cholesterol in heterozygous familial hypercholesterolemia. Hokuriku NK-104 Study Group. Am J Cardiol 2000; 85:178-83.
7. Olsson AG. Statin therapy and reductions in low-density lipoprotein cholesterol: initial clinical data on the potent new statin Rosuvastatin. Am J Cardiol 2001;87:33B-36B.

End-of-Life Care

RUSSELL G. ROBERTSON, M.D.
Medical College of Wisconsin
Milwaukee, Wisconsin

Organized medicine has proved to be somewhat unprepared for the current intensity of public interest in a domain--end-of-life care--that was once the province of physicians. Physicians have been appropriately criticized for providing expensive, futile care as well as being insensitive to the needs of dying patients and their families.^1,2 Physicians have been described as being uncomfortable with the notion of death and being death-denying in the context of their personal belief systems. Physicians have been accused of withholding potentially comforting resources from patients who need them.^3,4 Slow responses and patriarchal attitudes have left physicians vulnerable to criticism, some of which is justifiable. However, new directions in end-of-life care may soon change these attitudes and help physicians better adapt to the needs of patients who are dying. Following are some of the areas where innovation is currently taking place.

• A changing definition of the terminally ill. Cancer patients beyond cure are frequently used to set the defining standard for terminal illness.¹ This narrow definition may lead to decreased sensitivity toward patients with chronic diseases for whom death is also certain. Patients with class IV heart failure, diabetic patients with renal failure, and those in the latter stages of Alzheimer's disease are examples of other patients who are at the end of life and deserve the same considerations typically afforded to patients dying of cancer.
• A less rigid approach to advance directives. Emanuel and Emanuel⁵ looked at advance directives and identified several concerns with them. First, patients may find it difficult to understand all of the relevant medical issues. Second, people change their minds about the types of medical treatments they want. Third, a patient's previously stated preferences may need to be applied to unanticipated circumstances.
• Brett⁶ also demonstrated significant problems associated with attempts to present proxies with lists of potential medical interventions in an attempt to craft a useful advance directive. He found that such lists may divert attention from overall treatment goals or lead to inappropriate care. Furthermore, listing interventions in advance does not necessarily enhance self-determination or reduce uncertainty in decision making. For family physicians, the major advantage of or usefulness for advance directives may not be in their application, but that they serve as an indication that a patient has considered the probability of death and demonstrated an effort to plan accordingly. Not surprisingly, at most, 15 to 20 percent of the at-risk patient population has completed advance directives.⁷
• Increased knowledge of prognostic indicators. Family physicians need to acquire the skills necessary to determine when patients are in need of hospice care and recognize the value of using the topic of hospice care to talk about the imminence of death. Prognostic indicators have been developed to determine both hospice eligibility and the likelihood of impending death. All physicians caring for patients at the end of life should be familiar with these indicators and their application (Table 1⁸). It is particularly important for physicians to become more familiar with these indicators because, while patients qualify for hospice care when their life expectancy is six months or less, hospice patients, on average, die within three to six weeks of initiation of hospice care.⁹

  Physicians owe it to themselves, their patients, and their patients' families to truthfully represent the status of an illness. Phrases such as "poor prognosis" and "guarded condition" should be discarded because they are deceptive and avoidant terms that are often used to misrepresent the fact that a patient is dying. Physicians must learn to engage in gentle but direct truth-telling in the dispensation of their duty to patients who depend on them for accurate yet compassionate descriptions of their condition. Doing so allows all who are engaged in the journey to better prepare themselves for the death of the patient.

TABLE 1 Prognostic Indicators to Assist in Determining Hospice Eligibility Indicators suggesting a life expectancy of fewer than 14 days Anuric--no dialysis Confusion/delirium with no obvious cause Minimal or no oral intake Cheyne-Stokes respirations/mottled skin/cool extremities Pooled oropharyngeal secretions (death rattle) Indicators suggesting a life expectancy of 3 months or less In bed >50 % of time Hypercalcemia (in cancer patients, with the exception of patients with new myeloma or breast cancer) Dyspnea (HIV, cancer patients) Carcinomatous meningitis or malignant pericardial effusion Liver metastases with jaundice Indicators suggesting a life expectancy of 6 months or less Brain metastases Metastatic solid cancers--no treatment planned or none effective (with the exception of patients with breast or prostate cancer) Malignant ascites or pleural effusion Severe dementia--no speech, bed bound, incontinent Central nervous system lymphoma (HIV) Congestive heart failure/chronic obstructive pulmonary disease Symptomatic despite maximal treatment Weight loss Frequent hospitalization Rest dyspnea/tachycardia HIV = human immunodeficiency virus. Adapted from Medical guidelines for determining prognosis in selected non-cancer diseases, 2d ed. National Hospice Organization, 1996.

• Enhanced teamwork and communication skills. Because it is not unusual for patients to return to their family physicians for care after therapeutic efforts by consultants have failed, family physicians must be prepared to invest their time in caring for patients who are at the end of life. The importance of physicians knowing themselves cannot be underestimated in terms of its value for enabling them to respond appropriately. All physicians should have a clear understanding of their feelings about death and how those feelings can facilitate their ability to provide care or inhibit their ability to make good decisions. Patients and their families require attentive, compassionate, and well-worded explanations of what is transpiring. Inattention on the part of the physician can result in alienation, a sense of abandonment, and, occasionally, malpractice litigation.

  Anticipating the needs of patients who are dying is worthwhile. Patients have significant fears about pain and abandonment, and they may present those in the form of a request for euthanasia.⁹ Knowledge of pain management modalities is necessary.¹⁰ Many protocols for pain management are available, and physicians should select from among them.^11,12 Physicians must be available to their patients or have a surrogate available at all times. Family physicians know that providing care for a patient during the final stages of death bears much resemblance to providing care for a woman during delivery and requires similar attentiveness.

  Steinmetz and Gabel¹³ have proposed a comprehensive theoretic model (Table 2) that describes three dimensions of care. The first dimension focuses on direct involvement with the patient and family; the second on the physician's own needs and development; and the third on cooperation with other caregivers.

TABLE 2 The Family Physician's Role in Caring for the Dying Patient and Family: A Comprehensive Theoretical Model Dimension I: involvement with patientdirect Death education Doctor-patient relations Family Grief and bereavement Legal and ethical Symptom relief Dimension II: physician's own needs/development Continuing medical education Own feelings Supervision Support groups Dimension III: cooperation with other caregivers As educator/team leader Community facilities Other professionals Adapted with permission from Steinmatz D, Gabel LL. The family physician's role in caring for the dying patient and family: a comprehensive theoretical model. Fam Pract 1992;9:433-6.

REFERENCES

1. Emanuel EJ, Emanuel LL. The economics of dying: the illusion of cost savings at the end of life. N Engl J Med 1994;330:540-4.
2. Foley K. A 44-year-old woman with severe pain at end of life. JAMA 1999;281:1937-45.
3. Latimer E. Caring for seriously ill and dying patients: the philosophy and ethics. Can Med Assoc J 1991;144:859-64.
4. Smith TJ, Swisher K. Telling the truth about terminal cancer [Editorial]. JAMA 1998;279:1746-8.
5. Emanuel LL, Emanuel EJ. Decisions at the end of life: guided by communities of patients. Hastings Cent Rep 1993;23(5):6-14.
6. Brett AS. Limitations of listing specific medical interventions in advance directives. JAMA 1991; 266:825-8.
7. Larson EJ, Eaton TA. The limits of advance directives: a history and assessment of the Patient Self-Determination Act. Wake Forest Law Rev 1997;32: 249-93.
8. Medical guidelines for determining prognosis in selected non-cancer diseases, 2d ed. Arlington, Va.: National Hospice Organization, 1996.
9. Lassauniere JM, Vinant P. Prognostic factors, survival and advanced cancer. J Palliat Care 1992;8(4): 52-4.
10. Miles SH. Physicians and their patients' suicides. JAMA 1994;271:1786-8.
11. Management of Cancer Pain Guideline Panel. Management of cancer pain. Clinical practice guideline no. 9. AHCPR Publication No. 94-0592. Rockville, MD: Agency for Health Care Policy and Research, U.S. Department of Health and Human Services, Public Health Service, 1994.
12. Palliative Oncology Committee, American Association for Cancer Education. Cancer pain objectives for medical students and residents in primary care specialties. J Cancer Educ 1996;11(1):7-10.
13. Steinmetz D, Gabel LL. The family physician's role in caring for the dying patient and family: a comprehensive theoretical model. Fam Pract 1992;9: 433-6.

Russell G. Robertson, M.D., is an assistant professor in the Department of Family and Community Medicine at the Medical College of Wisconsin, Milwaukee. Dr. Robertson holds a CAQ in geriatrics.

Address correspondence to Russell G. Robertson, M.D., Department of Family and Community Medicine, 8701 Watertown Plank Road, Milwaukee, WI 53226.

Perinatal HIV Testing

RICHARD D. FELDMAN, M.D.
Indianapolis St. Francis Family Practice Residency Beech Grove, Indiana

What is the best approach to achieve human immunodeficiency virus (HIV) testing in pregnant women? This is a critical question because one of the great advances in HIV treatment has been the potential for virtual elimination of HIV transmission in perinatally exposed infants. Successful treatment, however, depends on the identification of HIV-positive women before or during pregnancy. Studies^1,2 have shown that if treatment is initiated during pregnancy, continued through labor and delivery (including appropriate use of cesarean section and antiviral medications), and administered to neonates after delivery, the HIV infection rate in these infants can be as low as 2 percent.

The preferred approach to perinatal HIV testing has been controversial. The traditional approach consists of counseling and voluntary HIV testing. Another approach, promoted by the Institute of Medicine (IOM) over the past few years, involves routine HIV testing with the right of "informed refusal" (i.e., the pregnant woman is informed that she will have an HIV test but has the right to refuse testing).

Although the differences between the two approaches are subtle, I prefer counseling and voluntary HIV testing. Studies have shown that regardless of apparent risk, 95 to 97 percent of pregnant women are willing to undergo HIV testing if such testing is strongly recommended.^3-5 However, it is not enough to merely offer an HIV test. High rates of voluntary HIV testing can only be achieved if physicians and their staff are committed to encouraging testing of every pregnant woman and every woman who is contemplating becoming pregnant.

With appropriate education about HIV infection, pregnant women acquire knowledge that benefits their own health, as well as the health of their babies. An approach that consists of patient education and voluntary HIV testing empowers women and allows them to engage in mutual decision-making with their physician. This approach also encourages a trusting relationship with the physician, which is essential for effective communication and compliance with the long, extensive, and complex treatment of HIV infection.

Routine HIV testing with the right of informed refusal has been proposed to address the problem that HIV testing is not offered to all pregnant women in the United States.⁶ The rationale is that the HIV counseling guidelines established by the Centers for Disease Control and Prevention (CDC)⁷ are onerous, costly, and burdensome to health care professionals--and, thus, a barrier to testing. It is also believed that an informed refusal policy will eliminate disparate testing of lower socioeconomic and minority groups.

Routine prenatal HIV testing with the right of informed refusal may be a more convenient and less time-consuming approach for health care professionals. However, experience in Indiana indicates that it is not necessary to employ the extensive CDC guidelines in counseling patients. Instead, health care professionals and their staff can use a one-page patient education handout to convey necessary information effectively, easily, and quickly. This form was developed by Indiana's Department of Health in association with the state's medical, health care, and public health communities. Women in Indiana are given this educational form to sign and then are universally offered voluntary HIV testing.

Like many public health professionals, I believe that routine HIV testing with the right of informed refusal will not eliminate disparate testing of minority groups. In fact, it could easily facilitate selective testing by giving health care professionals the opportunity to promote refusal of testing in patients who are not considered to be at risk for HIV infection and whom they do not wish to offend. Likewise, health care professionals could withhold information regarding testing from patients felt to be at increased risk to avoid drawing attention to the HIV test being ordered.

In minority groups, routine HIV testing with the right of informed refusal may also further isolate and alienate women who may already feel estranged from the health care system. Many of these women may be sensitive about being tested or treated without having given their explicit consent. They may be especially concerned about not being able to control what happens to them in the health care system, as well as the message that they are less than able to be a full participant in the decision-making process.

Unfortunately, HIV infection/acquired immunodeficiency syndrome (AIDS) is not like other diseases, and a prenatal HIV test is not like other prenatal tests. For many people, there is still a stigma attached to having AIDS. Sadly, HIV testing does not guarantee successful treatment of the mother or baby.⁸ No evidence or data suggest that a policy of routine HIV testing with the right of informed refusal will result in the testing of more women or the identification of more HIV-positive women. The policy also raises an important question: Will the very women the medical system wishes to identify avoid prenatal care if HIV testing is perceived as being expected or difficult to refuse?⁹

Most importantly, an informed refusal policy will de-emphasize the importance and role of patient education, which is so fundamental to the specialty of family medicine. Provision of knowledge through patient education is the only strategy that will prevent HIV infection in women. Patient-physician communication will also help to identify at-risk women who may be in the window period early in pregnancy and become HIV positive later in pregnancy. These women should undergo HIV testing a second time before delivery.¹⁰

Richard D. Feldman, M.D., is director of medical education and program director of the family practice residency program at St. Francis Hospital, Beech Grove, Ind. Previously, he served as Indiana's state health commissioner.

Address correspondence to Richard D. Feldman, M.D., Indianapolis St. Francis Family Practice Residency, 1500 Albany St., Room 807, Beech Grove, IN 46107-1555 (e-mail: r_feldman@iquest.net).

REFERENCES

1. Wade NA, Birkhead GS, Warren BL, Charbonneau TT, French PT, Wang L, et al. Abbreviated regimens of zidovudine prophylaxis and perinatal transmission of the human immunodeficiency virus. N Engl J Med 1998;339:1409-14.
2. The mode of delivery and the risk of vertical transmission of human immunodeficiency virus type 1--a meta-analysis of 15 prospective cohort studies. The International Perinatal HIV Group. N Engl J Med 1999;340:977-87.
3. Lindsay MK, Peterson HB, Feng TI, Slade BA, Willis S, Klein L. Routine antepartum human immunodeficiency virus infection screening in an inner-city population. Obstet Gynecol 1989;74(3 pt 1):289-94.
4. Barbacci M, Repke JT, Chaisson RE. Routine prenatal screening for HIV infection. Lancet 1991;337 (8743):709-11.
5. Cozen W, Mascola L, Enguidanos R, Bauch S, Giles M, Paxton P, et al. Screening for HIV and hepatitis B virus in Los Angeles County prenatal clinics: a demonstration project. J Acquir Immune Defic Syndr 1993;6:95-8.
6. Stoto MA, Almario DA, McCormick MC, eds. Reducing the odds: preventing perinatal transmission of HIV in the United States. Washington D.C.: National Academy Press, 1999.
7. U.S. Public Health Service recommendations for human immunodeficiency virus counseling and voluntary testing for pregnant women. MMWR Morb Mortal Wkly Rep 1995;44(RR-7):1-15.
8. Wilson TE, Minkoff H. Mandatory HIV testing of infants and rates of follow-up care. Am J Public Health 1999;89:1583.
9. Nakchbandi IA, Longenecker JC, Ricksecker MA, Latta RA, Healton C, Smith DG. A decision analysis of mandatory compared with voluntary HIV testing in pregnant women. Ann Intern Med 1998;128: 760-7.
10. Van Tine BA, Shaw GW, Aldrovandi G. Mother-to-infant transmission of the human immunodeficiency virus during primary infection. N Engl J Med 1999;341:1548.