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AHCPR announces increased funding for small project grants

The Agency for Health Care Policy and Research will award more than $2 million in small project grants this fiscal year, according to John M. Eisenberg, M.D., AHCPR's Administrator. This is more than three times the amount expended for small project grants in FY 1996.

Applicants are encouraged to focus on the strategic goals described in the Notice of Program Emphases for the AHCPR Small Project Grant Program published in the NIH Guide to Grants and Contracts, volume 26, number 5, March 21, 1997.

The Notice of Program Emphases (AHCPR Publication No. 97-0038) is available online.

Applications for AHCPR small project grants are accepted on an ongoing basis and should be submitted to: Small Grants: Research Projects, Agency for Health Care Policy and Research, 2101 East Jefferson Street, Suite 400, Rockville, MD 20852-4908. Notice of this increase in funding for small project grants was published in the NIH Guide to Grants and Contracts, volume 26, number 13, April 25, 1997.

Note: To be considered for FY 1997 funding, applications must be received by AHCPR no later than July 7, 1997.

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Patient Outcomes/Effectiveness Research

Women are treated less aggressively than men after a heart attack and are more likely to die in the hospital

Women who suffer heart attacks are less apt than men to receive coronary angiography to diagnose the extent of heart damage, and they are less likely to undergo bypass surgery. They also are more apt to die in the hospital. Differences in age and severity of illness do not explain these treatment differences, concludes Lisa I. Iezzoni, M.D., M.Sc., of Harvard Medical School. In a study supported by the Agency for Health Care Policy and Research (HS06742), Dr. Iezzoni and colleagues considered 10 severity-of-illness measures—four using clinical medical record data and six using hospital discharge abstracts—to study the treatment and outcomes of 14,083 patients admitted in 1991 for heart attack to 100 U.S. hospitals. Previous studies have consistently shown that women receive fewer cardiac procedures than men, but the findings were based on different data sources and severity-of-illness measures. This study shows that, regardless of the data source or severity measure used, severity is not the reason that women lag behind men in both treatment received and outcomes.

After adjusting for age and severity of illness, women were significantly more likely than men to die in the hospital and less likely to receive coronary angiography (x-ray image of the heart using a contrast dye) and bypass surgery. However, men and women had about equal odds of receiving coronary angioplasty (insertion of a balloon catheter to open up the artery), a procedure usually used for less extensive blockage than bypass surgery. The researchers cite the need for more studies to rule out the possibility that the lower CABG rates for women found in this study were suitable and the rates for men were inappropriately high.

See "Differences in procedure use, in-hospital mortality, and illness severity by gender for acute myocardial infarction patients," by Dr. Iezzoni, Arlene S. Ash, Ph.D., Michael Shwartz, Ph.D., and Yevgenia D. Mackiernan, B.A., in Medical Care 35(2), pp. 158-171, 1997.

Black and white heart patients receive different levels of care

The following two studies, which were supported in part by the Agency for Health Care Policy and Research, document racial disparities in the provision of care for patients who have suffered a heart attack. The first study, conducted by researchers at Duke University Medical Center, found that blacks were significantly less likely than whites to undergo coronary revascularization following a heart attack. In the second study, researchers at the University of Alabama at Birmingham found racial differences in the use of clot-busting medication in elderly heart attack patients.

Peterson, E.D., Shaw, L.K., DeLong, E.R., and others (1997, February 13). "Racial variation in the use of coronary revascularization procedures." New England Journal of Medicine 336(7), pp. 480-486.

Blacks with coronary heart disease are 32 percent less likely to undergo bypass surgery and 13 percent less likely to undergo angioplasty than are whites with similarly severe heart disease. These treatment differences correlate with poorer survival among blacks, who are 18 percent more apt to die than whites within 5 years. This suggests that revascularization procedures, particularly bypass surgery, are not adequately used for blacks who need them, according to a study conducted by the Ischemic Heart Disease Patient Outcomes Research Team (PORT) and supported in part by AHCPR (HS06503 and HS05635).

The fact that the treatment differences found in this study were not due to differences in severity of disease or coexisting illnesses is disturbing, notes the study's lead author Eric Peterson, M.D., M.P.H. Dr. Peterson and his colleagues examined the treatment and outcomes of 12,402 patients who underwent a first cardiac catheterization at Duke University Medical Center between March 1984 and December 1992. The researchers found that the greatest racial disparity in use of bypass surgery was among patients who stood the most to gain from it. After adjusting for severity of heart disease, 48 percent of blacks with severe disease underwent surgery versus 65 percent of severely ill whites, while 12 percent of black patients without severe disease underwent surgery compared with 15 percent of similarly sick white patients.

Although there was a large racial disparity in use of bypass surgery, the difference in use of angioplasty (insertion of a balloon catheter to flatten plaque against and open up the coronary arteries) was only marginal among patients with either mild or severe angina (sharp, suffocating chest pain). Either there is a racial difference in preference for angioplasty or bypass surgery or physicians explain the risks and benefits of these procedures differently to black and white patients, suggests Dr. Peterson.

Allison, J.J., Kiefe, C.I., Centor, R.M., and others (1996). "Racial differences in the medical treatment of elderly Medicare patients with acute myocardial infarction." Journal of General Internal Medicine 11, pp. 736-743.

Clot-busting (thrombolytic) medications are used nearly twice as often in white compared with black elderly patients (17 percent vs. 9 percent) who have suffered a heart attack and are eligible for the medication, according to a recent study supported in part by AHCPR (HS09446). The comparison was also made of patients who were deemed ideal candidates for thrombolysis. Here the differences by race persist, but numbers are small, cautions lead investigator Catarina I. Kiefe, Ph.D., M.D.

Dr. Kiefe and Jeroan J. Allison, M.D., and their colleagues at the University of Alabama School of Medicine and the Alabama Quality Assurance Foundation compared various medications used to treat acute myocardial infarction (AMI, or heart attack) in Medicare patients (86 percent white and 14 percent black) discharged from Alabama hospitals with an AMI diagnosis during a 9-month period in 1992 and 1993. They identified patients who were ideal candidates for and those who should be excluded for medical reasons from one of three therapies: beta blockers, aspirin, and thrombolytics. Analysis showed that about 16 percent of both black and white patients received beta blockers, and 45 percent of both races received aspirin, representing an overall low use of both medications by Alabama physicians.

After excluding patients due to a history of stroke, uncontrolled hypertension, or other factors, only 22 black patients and 216 white patients remained candidates for thrombolytic therapy. Just 11 percent of the eligible black patients received thrombolysis compared with 68 percent of eligible white patients. This racial inequity persisted even after adjustment for severity of illness and coexisting medical conditions. Also, the same proportion of blacks and whites refused thrombolytic therapy, so racial differences in treatment preference were not the source of the difference. The researchers point out that this suggests but does not prove inappropriate withholding of thrombolytic therapy from black patients.

Study compares effectiveness of implantable defibrillators and medication for treating irregular heart beat

Implantable cardioverter defibrillators (ICDs) effectively stop irregular heart beat, which can cause sudden death in patients with this problem known as ventricular arrhythmia. ICDs are expensive, however, costing as much as $40,000 to $60,000 for implanting the device, which has to be replaced every 4 years. An alternative treatment is amiodarone, the antiarrhythmic drug typically prescribed for this condition. But it can cause serious problems ranging from pulmonary fibrosis to thyroid abnormalities.

A recent study compared the two treatments and found that the cost-effectiveness of ICDs depends critically on the extent to which total mortality is reduced. The study, supported in part by the Agency for Health Care Policy and Research (HS08362), was conducted by the Cardiac Arrhythmia and Risk of Death Patient Outcomes Research Team (PORT), which is led by Mark A. Hlatky, M.D., of Stanford University. The researchers used data from ongoing randomized trials and data on the costs of third-generation ICDs to develop a decision model to evaluate the cost-effectiveness of three treatments: use of an ICD (implanted without opening up the chest), use of amiodarone, and use of an ICD for patients who had an arrhythmia during amiodarone treatment.

The researchers calculated that if an ICD reduces total mortality by 20 percent in high-risk patients—usually defined as those who have survived previous cardiac arrest—the patients live for 4.18 quality-adjusted life-years and spend about $88,400 for related costs over a lifetime. Patients receiving amiodarone live for 3.68 quality-adjusted life-years and have lifetime expenditures of $51,000. Using these figures, the cost-effectiveness of the ICD is $74,400 per quality-adjusted life-year saved ($49,300 for a 30 percent reduced mortality rate and $37,300 for a 40 percent reduced mortality rate).

The cost-effectiveness of ICD implantation changes only modestly for intermediate-risk patients, such as those with congestive heart failure. Patients who started on amiodarone and then switched to an ICD had a relatively high mortality rate, as well as expenditures for amiodarone plus the ICD. For this reason, early implantation is more cost-effective than delayed implantation, concludes the study's lead author, Douglas K. Owens, M.D., M.Sc., of the Veterans Affairs Palo Alto Health Care System, Palo Alto, CA.

More details are in "Cost-effectiveness of implantable cardioverter defibrillators relative to amiodarone for prevention of sudden cardiac death," by Douglas K. Owens, M.D., M.Sc., Gillian D. Sanders, A.B., Ryan A. Harris, M.S., and others, in the January 1, 1997, Annals of Internal Medicine 126, pp. 1-12.

Chest pain patients prefer care in a chest pain observation unit over hospitalization

Patients who arrive at the emergency department (ED) with acute chest pain can be admitted to the hospital to rule out a heart attack or to the ED's chest pain observation unit (CPOU). But patients clearly prefer rapid diagnosis in the CPOU to hospital stays, according to a study supported by the Agency for Health Care Policy and Research (HS07103).

Patients rate CPOUs higher than inpatient wards for effective treatment, quality of care, and overall satisfaction with care. CPOUs apparently provide patients with more attention to special needs, emotional support, physical comfort, and patient education, as well as effective treatment. That a busy emergency department could outperform the hospital inpatient services in these areas surprises Robert J. Zalenski, M.D., of Cook County Hospital and Wayne State University, who led the research team.

The authors point out the implications of these findings for emergency medicine. About 17 percent of the ED chest pain population now being referred to inpatient hospital services could be better served by an ED-based service. Persons with chest pain may be more encouraged to go to the ED if they think that they won't necessarily be hospitalized. First author Robert J. Rydman, Ph.D., Dr. Zalenski, and their colleagues suggest that the field of emergency medicine carefully plan for the availability, quality, and cost of ED-based chest pain centers in the United States. Such centers already exist in 23 percent of urban EDs, with a projected growth of 11 percent per year.

It is unlikely that a 12-hour stay in an ED-based center would cost more than an inpatient hospital stay of 1 to 3 days to rule out heart attack, according to Dr. Zalenski and colleagues. An exact cost comparison is the subject of a separate report (under review) by Rebecca Roberts, M.D., Dr. Zalenski, economist E. Mensah, and their colleagues.

The researchers prospectively studied 104 ED chest pain patients who were found to have a low risk of heart attack but still might have benefited from a diagnostic workup to rule it out. The researchers randomized the patients (aged 24 to 81 years) to the CPOU or the hospital inpatient ward and assessed their satisfaction with care by means of an interview prior to hospital discharge.

See "Patient satisfaction with an emergency department chest pain observation unit," by Robert J. Rydman, Ph.D., Dr. Zalenski, Rebecca R. Roberts, M.D., and others, in the January 1997 Annals of Emergency Medicine 29(1), pp. 109-115.

Researchers report recent findings on diagnosing and managing back pain

Patients seeking medical care for back pain typically want to know how long the pain will last, and physicians want to give them an accurate prognosis. However, back pain is characterized by variability and change rather than stability and predictability. Thus, like blood pressure, one measurement does not give an accurate picture.

Investigators supported by the Agency for Health Care Policy and Research (Low Back Pain Patient Outcomes Research Team (PORT), HS06344; and grant HS08194) and led by Richard A. Deyo, M.D., M.P.H., of the University of Washington recently published the five articles summarized here. Three of the articles discuss back pain patients seen in primary care settings. The authors suggest a better way to measure back pain and describe which patients take longer to recover, examine educational and behavioral interventions for chronic back pain, and discuss ways to better diagnose and predict the outcomes of spinal problems. The other two articles discuss the classification of spinal disorders and diagnosis of herniated lumbar discs.

VonKorff, M., and Saunders, K. (1996). "The course of back pain in primary care." Spine 21(24), pp. 2833-2839.

A majority of patients with an initial episode of back pain experience recurrences. Therefore, describing only the outcome of the initial episode may convey a more favorable picture of long-term outcome than warranted, according to this study. Although back pain typically improves considerably within 1 week of a visit to the primary care provider, it is common for less severe back pain to continue for 1 to 3 months. This finding is based on a review of studies on the short-term and long-term course of back pain among primary care patients.

The studies show that 1 month following treatment, about 33 percent of patients report continuing pain of at least moderate intensity, and 20-25 percent report substantial activity limitations. The researchers suggest that—because back pain may not be present every day and because pain varies in severity from day to day when present—long-term outcomes need to be assessed for a defined period (for example, 1, 3, or 6 months) rather than a single day. A better assessment of back pain status would be use of measures like the percentage of days a patient has back pain during a defined interval, the average intensity of back pain when present, and the extent of interference with activities because of back pain during the reporting interval.

Cherkin, D.C., Deyo, R.A., Street, J.H., and Barlow, W. (1996). "Predicting poor outcomes for back pain seen in primary care using patients' own criteria." Spine 21(24), pp. 2900-2907.

More primary care patients with back pain have poor outcomes than is generally recognized, according to this study of how patients view their symptoms. The researchers used a simple "symptom satisfaction" questionnaire to measure patients' evaluation of how their back pain symptoms affected their lives, rather than scores on pain and dysfunction scales, to evaluate outcomes. Results indicated that it usually takes about 3 weeks for patients to reach a point where they would be mostly satisfied if they had their current symptoms for the rest of their lives. One in three patients feels satisfied after only 1 week, while another third still has significant problems after 7 weeks. Only 71 percent are satisfied with their condition 1 year later. Patients who are younger, have pain below the knee, are depressed, or are less satisfied with their jobs generally take longer to recover than other back pain patients, note the researchers.

Their findings are based on data collected from 219 primary care clinic patients who were making their first visit for a current episode of back pain and who were participating in a randomized trial of educational interventions for low back pain during 1992 and 1993. Patients answered the questionnaire via telephone in weeks 1, 3, 7, and 52 after the initial back pain visit. The symptom satisfaction measure had moderately high correlations with traditional measures of symptoms and dysfunction associated with back pain.

Turner, J.A. (1996). "Educational and behavioral interventions for back pain in primary care." Spine 21(24), pp. 2851-2859.

When diagnostic evaluation fails to show a specific cause for a patient's back pain, clinicians should switch from a curative to a rehabilitation model of pain therapy. Treatment goals should change from identification and elimination of the cause of the pain to improvement in patient functioning and lessening of suffering. Physicians who must help patients make this cognitive shift may find a cognitive-behavioral therapy helpful, recommends Judith A. Turner, Ph.D., of the University of Washington, Seattle. Her findings are based on a meta-analysis of randomized trials of cognitive and behavioral treatments for chronic low back pain published from 1966 through April 1994.

One approach might consist of 6 to 12 individual or group sessions of information, reassurance that most people can learn to manage back pain themselves, and instruction in self-management methods such as relaxation, identification and modification of maladaptive thoughts, stress management, and regular exercise. Brief therapist-contact interventions may also help. In this approach, the patient is given a self-help manual and audiotapes with information about back pain causes and prognosis, as well as detailed instructions on how to self-manage back pain and improve functioning. The patient sees the therapist twice during treatment, and the therapist in turn contacts the patient by telephone every 10 days to monitor progress and discuss problems. This same technique can be used with a primary care provider and nurse who provide telephone followup.

Atlas, S.J., Deyo, R.A., Patrick, D.L., and others (1996). "The Quebec task force classification for spinal disorders and the severity, treatment, and outcomes of sciatica and lumbar spinal stenosis." Spine 21(24), pp. 2885-2892.

There are a large number of classifications for patients with spinal disorders. But few have been evaluated systematically to assess their ability to predict outcome or discriminate between spinal problems, including the Quebec Task Force Classification (QTFC) of spinal disorders. Proposed in 1987, the QTFC emphasizes simple clinical criteria based on patient history, physical examination findings, radiologic tests, and response to treatments. The researchers assessed the usefulness of the QTFC to classify 516 patients participating in the Maine Lumbar Spine Study (MLSS), a large prospective study of patients with sciatica or lumbar spinal stenosis. QTFC categories could be low, such as 2 for pain radiation to the proximal extremity, to high, such as 6 for sciatica with evidence of nerve root compression.

Results showed that, among patients with sciatica, higher QTFC categories were associated with increased initial severity of symptoms. QTFC scores were not associated with initial functional status but were strongly associated with the likelihood of receiving surgical treatment. Nonsurgically treated patients in the QTFC categories reflecting nerve root compression had greater improvement than those with pain symptoms alone. These results provide validation for this classification system and its wider use for patients with sciatica.

Andersson, G.B., and Deyo, R.A. (1996). "History and physical examination in patients with herniated lumbar discs." Spine 21(24S), pp. 10S-18S.

Herniated lumbar discs can cause pain and/or dysfunction, which typically means that there is pressure on nerve roots or the cauda equina. A detailed medical history and physical exam can suggest the probable spine level of the neurologic compromise and can direct the timing and choice of other diagnostic tests. No diagnostic test has a high diagnostic accuracy by itself, and thus it must be combined with other tests when making treatment decisions such as surgery, according to this study.

The patient with a herniated lumbar disc typically has a history of back pain that is gradually, or more often suddenly, accompanied by a "sharp, burning, stabbing, electrical" pain radiating down the posterior or lateral aspect of one leg below the knee to the heel or foot. The pain is superficial and localized, often associated with numbness or tingling, and aggravated by increased pressure with specific movements. There is usually substantial but not complete relief with rest. Pain distribution is important to the diagnosis of a herniated disc, as is identification of neurologic impairment. Neurologic tests are important, not only to determine if nerve roots are irritated, but also to assess the level of any involvement. Most neurologic tests have only moderate sensitivity and specificity, but their accuracy can be improved by considering combined test results.

Reducing scope of radiation treatment for localized prostate cancer results in fewer complications

Radiation therapy is one treatment option for men with localized prostate cancer. The smaller the area that is irradiated, the fewer treatment-related complications, according to a pilot study supported by the Agency for Health Care Policy and Research (HS06824).

Some physicians prefer to irradiate the whole pelvis just in case the cancer has spread to the nearby lymph nodes, while others choose to irradiate only the prostate, seminal vesicles, and a small margin of surrounding tissues (small-field therapy). Still other physicians choose to use computerized tomography to obtain a three-dimensional image of the patient's internal anatomy and irradiate only the area that conforms to the shape of the prostate and seminal vesicles (conformal therapy), thus sparing as much normal tissue as possible.

Men who receive conformal therapy may have fewer genitourinary and sexual function problems and less fatigue than those who receive whole-pelvis treatment, say the Boston researchers who reported the study. They asked 121 men with localized prostate cancer to complete a questionnaire about specific symptoms and quality of life prior to radiation therapy and 3 months and 12 months following therapy (25 received whole-pelvis treatment, 60 underwent small-field therapy, and 36 received conformal irradiation). In general, the men were in overall good health and received the same dose of radiation.

Nearly twice as many men who received whole-pelvis treatment reported bowel tenderness and urgent movements 12 months following irradiation compared with men in the other groups (30 percent vs. 16 percent). One year after therapy, twice as many men who received whole-pelvis irradiation were impotent compared with men in the conformal group (44 percent vs. 20 percent), suggesting an association between the size of the radiation field and subsequent sexual dysfunction.

See "Complications after treatment with external-beam irradiation in early-stage prostate cancer patients: A prospective multiinstitutional outcomes study," by Clair J. Beard, M.D., Kathleen Joy Propert, Sc.D., Patricia P. Rieker, Ph.D., and others, in the January 1997 Journal of Clinical Oncology 15(1), pp. 223-229.

Biliary tract PORT publishes latest findings

Gallbladder disease affects an estimated 20 million Americans, and each year 300,000 to 450,000 persons undergo cholecystectomy (surgical removal of the gallbladder). The Biliary Tract Disease Patient Outcomes Research Team (PORT) was supported by the Agency for Health Care Policy and Research (HS06481) to assess alternative procedures for diagnosing and managing patients with biliary tract (gallstone) disease. Led by J. Sanford Schwartz, M.D., of the University of Pennsylvania, the PORT researchers recently examined factors that influence physician adoption of laparoscopic cholecystectomy, a less invasive surgical technique than open cholecystectomy. Researchers also looked at one drawback associated with the technique.

Escarce, J.J. (1996). "Externalities in hospitals and physician adoption of a new surgical technology: An exploratory analysis." Journal of Health Economics 501, pp. 1-19.

Open cholecystectomy, surgery to remove a diseased gallbladder that requires a deep incision and relatively long recovery, has been replaced with the minimally invasive laparoscopic cholecystectomy, which was introduced in 1989.

By 1992 about 80 percent of cholecystectomies were done via laparoscopy (insertion of a tubal instrument through the skin into the peritoneal cavity), which is now considered the treatment of choice for most gallstone patients.

Surgeons in single specialty groups adopted the technique earlier than surgeons in solo practice and multispecialty group practice. Also surgeons who performed more operations adopted the technique earlier than less busy surgeons, and urban surgeons adopted it earlier than rural surgeons. Surgeons who were 35 years old adopted the technique earlier than either younger or older surgeons, and board certification—as expected—was associated with earlier adoption.

Contrary to expectations, full-time affiliation with a surgical residency program was associated with later adoption, perhaps because faculty surgeons may be relatively insulated from the competition for referrals experienced by surgeons in community practice. The adoption of the technique by another surgeon in the same hospital had a greater impact on adoption than most other factors, leading most surgeons to adopt the technique 1 year earlier than they otherwise would have.

These findings were based on a 1992 survey of a 15 percent random sample of non-Federal general surgeons in the United States.

Abboud, P-A.C., Malet, P.F., Berlin, J.A., and others (1996). "Predictors of common bile duct stones prior to cholecystectomy: A meta-analysis." Gastrointestinal Endoscopy 44(4), pp. 450-459.

One drawback of laparoscopic cholecystectomy is that, unlike open surgery, it is difficult to view the common bile duct (CBD) for gallstones. Surgeons have to rely on preoperative clinical indicators to predict which patients are more likely to have CBD stones, so that they can better decide if they need to use other invasive and costly procedures to detect or extract the stones.

The most powerful indicators of gallstones are cholangitis (inflammation of a bile duct), CBD stones found on ultrasound, and preoperative jaundice, according to this meta-analysis of 22 studies by the Biliary Tract Disease PORT researchers. A patient with any one of these indicators had at least 10 times the odds of CBD stones when compared with a patient lacking the indicator. The presence of CBD dilation on ultrasound, while somewhat less powerful as an indicator, nonetheless increased the likelihood of CBD stones almost seven-fold. Other common indicators are much less accurate in predicting CBD stones before cholecystectomy, and the absence of indicators does not rule out the possibility of CBD stones.

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