Using the national registry of HIV-infected veterans in research: lessons for the development of disease registries.

Disease-specific registries have many important applications in epidemiologic, clinical and health services research. Since 1989 the Department of Veterans Affairs has maintained a national HIV registry. VA's HIV registry is national in scope, it contains longitudinal data and detailed resource utilization and clinical information. To describe the structure, function, and limitations of VA's national HIV registry, and to test its accuracy and completeness. The VA's national HIV registry contains data that are electronically extracted from VA's computerized comprehensive clinical and administrative databases, called Veterans Integrated Health Systems Technology and Architecture (VISTA). We examined the number of AIDS patients and the number of new patients identified to the registry, by year, through December 1996. We verified data elements against information obtained from the medical records at five VA sites. By December 1996, 40,000 HIV-infected patients had been identified to the registry. We encountered missing data and problems with data classification. Missing data occurred for some elements related to the computer programming that creates the registry (e.g., pharmacy files), and for other elements because manual entry is required (e.g., ethnicity). Lack of a standardized data classification system was a problem, especially for the pharmacy and laboratory files. In using VA's national HIV registry we have learned important lessons, which, if taken into account in the future, could lead to the creation of model disease-specific registries.

Geographic variation in the management and outcome of patients with AIDS-related Pneumocystis carinii pneumonia.

Pneumocystis carinii pneumonia (PCP) is one of the most common reasons for the hospitalization of AIDS patients; however, geographic differences in PCP management have not been evaluated previously. Therefore, we abstracted data on socioeconomic characteristics, prior HIV care, severity of illness, timeliness and intensity of in-hospital care, duration of hospitalization, and survival from 1547 randomly selected medical records of patients hospitalized with AIDS-related PCP between 1987 and 1990 at 82 hospitals in Chicago, Los Angeles, Miami, New York City, and Raleigh-Durham, North Carolina. Multivariate regression models were used to assess factors associated with longer hospital stays and increased inpatient mortality. Our results showed that in-hospital mortality ranged from 15% to 27%, bronchoscopy rates from 53% to 70%, and mean length of stay from 14 days to 23 days. Geographic variations in mortality were accounted for by differences in severity of illness at admission, insurance status, and in-hospital patient management. However, significant regional variations in hospital length of stay persisted, even after adjusting for patient demographics, severity of illness, and use of diagnostic and therapeutic care resources.

Patterns of care for HIV-related Pneumocystis carinii pneumonia in a university medical program: a case study.

BACKGROUND/OBJECTIVE: Previous studies have identified large variations in patterns of in-hospital acquired immunodeficiency syndrome (AIDS) care among groups of hospitals and physicians. We evaluated the patterns of care for patients with AIDS-related Pneumocystis carinii pneumonia (PCP) care at a single university program with patients treated at an adjacent county and Veterans' Administration (VA) hospital. All medical care was provided by physicians in a single residency program, but attending physician staffs were separate. SETTING AND PATIENTS: A randomized sample of patients with human immunodeficiency virus (HIV)-related PCP from the two hospitals who received care between 1987 and 1990. RESULTS: During the study years, the VA hospital provided care for approximately one fourth as many AIDS patients as the county hospital. Patients at the VA hospital had a higher bronchoscopy rate (39.7% versus 27.7%, P = .05), higher intensive-care unit (ICU) rate (11.8% versus 2.9%, P = .008), longer hospitalizations (mean length of stay of 18.9 versus 13.9 days, P = .004), but delayed initiation of anti-PCP therapy (median of day 2 versus day 1, P < .05). The odds of death were significantly different between the VA and county hospitals, even after adjusting for differences in important patient characteristics. CONCLUSION: Patterns of in-hospital PCP care differed between the two hospitals of this medical school. Possible explanations include organizational differences related to level of attending physician HIV experience, hospital case loads of AIDS patients, or specific hospital considerations such as concerns over tuberculosis exposure.

Predictors of resource utilization for hospitalized patients with Pneumocystis carinii pneumonia (PCP): a summary of effects from the multi-city study of quality of PCP care.

To determine whether patient and hospital characteristics were significantly associated with variations in Pneumocystis carinii (PCP) care and outcomes, we analyzed the use of diagnostic tests, intensive care units (ICUs), anti-PCP medications for persons hospitalized with human immunodeficiency virus (HIV)-related PCP, and hospital discharge status. We conducted retrospective chart reviews of a cohort of 2,174 patients with PCP hospitalized in 1987-1990. Outcomes included process of care for PCP and in-hospital mortality rates. Persons with PCP who were more severely ill at admission were more likely to have early medical care, to receive care in an intensive care unit, and to die in hospital. After we adjusted for differences in this severity of illness, we noted that Medicaid patients, injection drug users (IDUs), and patients treated at VA or county hospitals were significantly less likely than others to have diagnostic bronchoscopies and that persons covered by Medicaid, with a previous diagnosis of acquired immunodeficiency syndrome (AIDS), who did not receive prior zidovudine (AZT) or who received care in a VA hospital had the highest chances of in-hospital death. Insurance and risk group characteristics, severity of illness, and hospital characteristics appear to be the most important determinants of the intensity and timing of medical care and outcomes among patients hospitalized with PCP.

Long-term follow-up of symptomatic HIV-infected patients originally randomized to early versus later zidovudine treatment; report of a Veterans Affairs Cooperative Study. VA Cooperative Study Group on AIDS Treatment.

Following a 4-year controlled trial comparing early and later zidovudine treatment, we conducted an additional 3-year follow-up. Of the original 338 patients, 275 participated. Clinical outcome measures were AIDS and death. In the early therapy group (n = 170), 67 patients progressed to AIDS compared with 85 in the later therapy group (n = 168); the relative risk (RR) comparing early with later therapy was 0.72% (95% confidence interval [CI] 0.52-0.99; p = 0.044). The early therapy group had 74 deaths compared with 73 in the later therapy (RR = 0.98; 95% CI, 0.71-1.36; p = 0.91). The early group had a peak CD4+ count increase at 1-2 months and a delay of 1 year before CD4+ counts fell below baseline. For patients who received zidovudine for more than the median duration (20.3 months) before their first AIDS diagnosis, the RR for death was 2.08 (95% CI, 1.36-3.19, p = 0.001). Additional factors independently associated with poor prognosis following AIDS were a CD4+ count of < 100 cells/mm3 and increased severity of the first AIDS diagnosis, whereas use of another antiretroviral agent was associated with improved survival. We conclude that early zidovudine therapy delays progression to AIDS but does not affect survival. Patients who progress to AIDS while on prolonged zidovudine monotherapy many benefit from a change to other antiretroviral therapy(ies).

Relationship between procedures and health insurance for critically ill patients with Pneumocystis carinii pneumonia.

The objective of the present study was to assess the association between type of health insurance coverage and use of diagnostic tests and therapies among patients with AIDS-related Pneumocystis carinii pneumonia (PCP). Fifty-six private, public, and community hospitals in Chicago, Los Angeles, and Miami were selected for the study, and the charts of 890 patients with empirically treated or cytologically confirmed PCP, hospitalized during 1987 to 1990 were retrospectively reviewed. Patients were classified by insurance status: self-pay (n = 56), Medicaid (n = 254), or private insurance, including health maintenance organizations and Medicare (n = 580). Primary outcomes were the use and timing of bronchoscopy, the type and timing of PCP therapy, and in-hospital mortality. The results indicate that Medicaid patients were less likely than privately insured patients to undergo bronchoscopy (relative odds = 0.61; 95% CI = 0.40, 0.93; p = 0.02) or to have their diagnosis of PCP confirmed (relative odds = 0.51; 95% CI = 0.33, 0.77), after adjusting for patient, severity of illness, and hospital characteristics. Medicaid patients were approximately three-fourths more likely than privately insured patients (relative odds = 1.73; 95% CI = 1.01, 2.96; p = 0.04) to die in-hospital, after adjusting for patient, severity of illness, and hospital characteristics. However, with further adjustment for confirmation of PCP, Medicaid patients no longer had a significantly higher likelihood of dying in-hospital. We conclude that Medicaid patients are less likely to receive diagnostic bronchoscopy than privately insured or self-insured patients, more likely to be empirically treated for PCP, and more likely to die in-hospital.(ABSTRACT TRUNCATED AT 250 WORDS)

Antimicrobial prophylaxis of infection.

Antimicrobial agents are used to prevent infections in a variety of clinical circumstances. In certain instances, the precise indications for prophylaxis remain controversial, and the preferred regimens undergo alterations based upon evolving clinical experience, changing patterns of microbial susceptibility, and innovations in medical and surgical practice. This article outlines the general principles underlying the use of antimicrobial prophylaxis and presents recommendations for the use of such prophylaxis in three areas: (1) surgery involving contaminated, clean-contaminated, and clean procedures; (2) prevention of infections due to specific pathogens, including Neisseria meningitidis, Hemophilus influenzae, Streptococcus pneumoniae, and Streptococcus pyogenes; and (3) prevention of infective endocarditis.

Racial differences in care among hospitalized patients with Pneumocystis carinii pneumonia in Chicago, New York, Los Angeles, Miami, and Raleigh-Durham.

BACKGROUND: While strategies for medical care for human immunodeficiency virus-related Pneumocystis carinii pneumonia (PCP) are well established, racial variations in care have not been evaluated. OBJECTIVE: To determine whether sociodemographic characteristics influence patterns of care and patient outcomes, by analyzing the use of diagnostic tests and anti-PCP medications and in-hospital mortality rates for persons who were hospitalized with human immunodeficiency virus-related PCP. METHODS: Retrospective chart review of a cohort of 627 Veterans Administration (VA) patients and 1547 non-VA patients with empirically treated or cytologically confirmed PCP who were hospitalized from 1987 to 1990. Outcomes included representative aspects of the process of care for PCP and short-term mortality rates. RESULTS: Among VA patients, black and Hispanic patients were not significantly different from white patients with regard to in-hospital mortality rates, use and timing of a bronchoscopy, or receipt of timely anti-PCP medications. Among non-VA patients, black and Hispanic patients were more likely to die in the hospital and less likely to undergo a diagnostic bronchoscopy in the first 2 days of hospitalization. These racial and ethnic group differences in the use of a bronchoscopy and in-hospital mortality among non-VA patients were almost fully accounted for by differences in health insurance status and hospital characteristics. CONCLUSIONS: Racial factors do not appear to be an important determinant of the intensity of diagnostic or therapeutic care among patients who are hospitalized with PCP. Variations in care are largely attributable to differences in health insurance and admitting hospital characteristics.

Empirically treated Pneumocystis carinii pneumonia in Los Angeles, Chicago, and Miami: 1987-1990.

Many patients infected with the human immunodeficiency virus (HIV) with symptoms suggestive of pneumonia are treated empirically for Pneumocystis carinii pneumonia (PCP), although other bacterial infections (e.g., tuberculosis) and pulmonary Kaposi's sarcoma may cause identical symptoms. Empiric treatment for PCP may result in misdiagnosis and mistreatment. When the outcomes of cytologically confirmed versus empirically treated PCP cases were evaluated, the most important predictors of in-hospital mortality were severity of illness and use of bronchoscopy. Persons who did not undergo bronchoscopy had higher mortality rates than patients negative by bronchoscopy or cytologically confirmed as positive for PCP (22% vs. 11% vs. 14%, P < .01), although severity of illness and timing of anti-PCP medications did not differ significantly. Compared with cytologically confirmed cases, persons who did not have bronchoscopy were more likely to die than were bronchoscopy-negative patients (P < .05), after adjusting for severity of illness. Bronchoscopy use may have contributed to better outcomes for persons treated for HIV-related PCP.

A rapid preadmission method for predicting inpatient course of disease for patients with HIV-related Pneumocystis carinii pneumonia.

Pneumocystis carinii pneumonia (PCP) has been the most common reason for hospitalization and the most common cause of death for persons with HIV infection. Hospital mortality rates for PCP range from 10 to 60%. Studies that evaluate differences in hospital mortality rates must control for differences in patient severity of illness. We developed a simple staging system for categorizing severity of illness in patients with PCP. We analyzed the relation between clinical factors and in-hospital mortality for 576 hospitalized patients with HIV-related PCP treated at 56 hospitals for the years 1987 to 1990. Four stages of PCP could be identified based on three routinely measured clinical variables: alveolar-arterial oxygen difference, total lymphocyte count, and body mass index. The mortality rate increased by stage: 1% for Stage 1, 8% for Stage 2, 23% for Stage 3, and 48% for Stage 4. The four-stage severity system compared well with previous models developed for AIDS and for PCP, and is easier to use in clinical practice. Our staging system identifies patients with a high and low risk of in-hospital death upon admission. Physicians may benefit from consideration of PCP stage in deciding on management strategies. In addition, researchers involved in clinical trials of new agents for PCP might consider stratification by PCP stage in order to define homogenous groups.

Nocardiosis in 30 patients with advanced human immunodeficiency virus infection: clinical features and outcome.

A total of 30 patients (aged 6-56 years) with nocardiosis and infection due to human immunodeficiency virus type 1 (HIV-1) were identified in our institution between January 1985 and June 1989. Eighteen patients had an AIDS-defining illness before or concurrently with nocardiosis. The mean CD4 lymphocyte count was 109/mm3. Pulmonary nocardiosis in 21 patients, extra-pulmonary nocardiosis in 8, and pulmonary and extrapulmonary nocardiosis in 1 patient was diagnosed. Chest radiographs showed alveolar patterns of infiltrates in 14 patients, reticulonodular patterns in 2, mixed alveolar and reticulonodular patterns in 6, cavitation in 4, and pleural effusion in 3. Of 27 patients treated, the conditions of 22 improved, but the extensive disease in 5 progressed. For 14 patients, recurrence was rapid after their treatment was discontinued. Nocardiosis caused or contributed to the death of 19 patients; in six patients, there was no evidence of nocardial infection at death. Nocardiosis can be a fatal complication of advanced HIV-1 disease. Delayed diagnosis, extensive disease, and early discontinuation of treatment were associated with poor outcome.

Parasitic causes of pancreatic and biliary tract disease: a growing concern in a highly mobile population.

A leading cause of biliary tract disease and pancreatitis worldwide is parasitic disease. In the United States, increased global travel and the AIDS epidemic has led to a rise in the frequency of parasitic disease. Biliary disease and pancreatic disease secondary to parasitic infestation is relatively new in this country, with the first case being described in 1977. These diseases are no longer the exclusive realm of infectious disease specialists and require general practitioners and gastroenterologists to be well versed in the spectrum of parasitic pancreatic and biliary disease.

Infections associated with prosthetic devices: clinical considerations.

The successful development of synthetic materials and introduction of artificial devices into nearly all body systems has been shadowed by the adaptation of microorganisms to the opportunities these devices afford for eluding defenses and invading the host. Clinicians are faced with the task of recognizing the manifestations of device-associated infection, predicting the likely pathogens involved, knowing the appropriate diagnostic methods, and initiating appropriate therapy. Infections associated with prosthetic heart valves are particularly challenging to successfully treat; surgical replacement may be necessary. Infection associated with an artificial joint usually requires removal of the device in addition to appropriate antibiotics. Intravascular associated infections are the leading cause of nosocomial bacteremias and, because of their intravascular location, these infections are often life catheter threatening if not promptly diagnosed and treated. Even contact lenses, external to epithelial surfaces, may give rise to serious sight-threatening infections. Although artificial devices play a paramount role in medicine today, infection is an ever present potential with which clinicians must be familiar.

Absence of HIV transmission from an infected dentist to his patients. An epidemiologic and DNA sequence analysis.

OBJECTIVE: To determine if a general dentist with human immunodeficiency virus (HIV) infection transmitted HIV to any of his patients. DESIGN: A cohort study in which all patients treated by a dentist who developed the acquired immunodeficiency syndrome (AIDS) were identified and attempts were made to contact all patients for HIV antibody testing. SETTING: A general dentistry clinic operated by the Department of Veterans Affairs in southeastern Florida. PARTICIPANTS: All patients treated by a dentist during the 5 3/4 years before he developed AIDS were identified in a computerized registry of dental care. MAIN OUTCOME MEASURES: Attempts were made to contact all living patients for counseling and HIV antibody testing. Living patients with newly identified HIV infection were interviewed, and DNA sequence analysis was performed to compare genetic relatedness of their HIV to that of the dentist. Death certificates were obtained for decreased patients, and the medical records of those with diagnoses suggestive of HIV disease or drug abuse and those dying under the age of 50 years were reviewed in detail. RESULTS: There were 1192 patients who had undergone 9267 procedures, of whom 124 were deceased. A review of the death certificates of the deceased patients identified five who had died with HIV infection, all of whom were either homosexuals or users of illicit intravenous drugs. We were able to locate 962 (92%) of the remaining 1048 patients, and 900 agreed to be tested. Infection with HIV was documented in five of the 900 patients, including four who had clear evidence of risk factors for acquiring HIV infection. One patient who had only a single evaluation by the dentist denied high-risk behavior. Comparative DNA sequence analysis demonstrated that the viruses from the dentist and these five patients were not closely related. CONCLUSION: This study indicates that the risk for transmission of HIV from a general dentist to his patients is minimal in a setting in which universal precautions are strictly observed. Programs to ensure compliance with universal precautions would appear preferable to programs for widespread testing of dentists.

A controlled trial of early versus late treatment with zidovudine in symptomatic human immunodeficiency virus infection. Results of the Veterans Affairs Cooperative Study.

BACKGROUND: Zidovudine is recommended for asymptomatic and early symptomatic human immunodeficiency virus (HIV) infection. The best time to initiate zidovudine treatment remains uncertain, however, and whether early treatment improves survival has not been established. METHODS: We conducted a multicenter, randomized, double-blind trial that compared early zidovudine therapy (beginning at 1500 mg per day) with late therapy in HIV-infected patients who were symptomatic and had CD4+ counts between 0.2 x 10(9) and 0.5 x 10(9) cells per liter (200 to 500 per cubic millimeter) at entry. Those assigned to late therapy initially received placebo and began zidovudine when their CD4+ counts fell below 0.2 x 10(9) per liter (200 per cubic millimeter) or when the acquired immunodeficiency syndrome (AIDS) developed. RESULTS: During a mean follow-up period of more than two years, there were 23 deaths in the early-therapy group (n = 170) and 20 deaths in the late-therapy group (n = 168) (P = 0.48; relative risk [late vs. early], 0.81; 95 percent confidence interval, 0.44 to 1.59). In the early-therapy group, 28 patients progressed to AIDS, as compared with 48 in the late-therapy group (P = 0.02; relative risk, 1.76; 95 percent confidence interval, 1.1 to 2.8). Early therapy increased the time until CD4+ counts fell below 0.2 x 10(9) per liter (200 per cubic millimeter), and it produced more conversions from positive to negative for serum p24 antigen. Early therapy was associated with more anemia, leukopenia, nausea, vomiting, and diarrhea, whereas late therapy was associated with more skin rash. CONCLUSIONS: In symptomatic patients with HIV infection, early treatment with zidovudine delays progression to AIDS, but in this controlled study it did not improve survival, and it was associated with more side effects.

Automated severity classification of AIDS hospitalizations.

To validate an automated AIDS severity-of-illness prognostic algorithm, 2,113 discharge summaries of HIV-infected patients were merged with the Problem-Oriented Medical Synopsis (POMS) and an HIV risk registry. The combination of a medically derived classification and staging algorithm with multivariate statistical techniques was used for automated severity-of-illness disease staging and prognostic assignment. The model correctly predicted the outcomes of 82% of all cases (death, survivorship) at discharge, and 66% of deaths.

A multicenter clinical trial of oral ribavirin in HIV-infected patients with lymphadenopathy. The Ribavirin-LAS Collaborative Group.

A double-blind, randomized, placebo-controlled trial comparing two daily doses of oral ribavirin and placebo was conducted at four medical centers. One hundred sixty-four adult men with lymphadenopathy were enrolled over a 2-month period and randomized to receive ribavirin 800 mg (53 subjects), ribavirin 600 mg (55 subjects), or placebo (56 subjects). Active treatment was administered for 24 weeks followed by a 4-week washout period. Nine subjects receiving placebo, four receiving ribavirin 600 mg, and none in the 800 mg group developed AIDS during the 24 weeks of active treatment. One patient randomized to the 800 mg group had Kaposi's sarcoma at study entry and was included in the intent-to-treat analysis. An overall significant difference in progression to AIDS was observed among the three treatment groups (p = 0.028) with patients randomized to receive 800 mg having a significantly longer time to AIDS than placebo patients (p = 0.012; relative risk, 9.0; 95% confidence interval, 1.1 to 70.8). There was no significant difference between the 600 mg and placebo groups (p = 0.15; relative risk, 2.3; 95% confidence interval, 0.7 to 7.6). Baseline CD4 cell count and hematocrit made independent contributions and formed a multivariate prognostic set for these progression data. The significant treatment superiority of 800 mg compared to placebo remained after adjustment for these factors (p = 0.019). After deletion of patients with major protocol violations at entry, the difference between the 800 mg and placebo treatment remained significant (p = 0.021).(ABSTRACT TRUNCATED AT 250 WORDS)

Infections associated with indwelling devices: infections related to extravascular devices.

PIP: Infection complications of indwelling extravascular devices are reviewed including endotracheal tubes, urological catheters, cerebrospinal shunts, ocular prostheses, orthopedic protheses, peritoneal dialyses catheters, and IUDs. For each device a small number of pathogens accounts for the majority of infections. For most devices, infections of host skin origin, especially coagulase negative staphylococci are responsible. IUDs are exceptional because most are associated with bacteria which cannot be detected by usual culture methods. Acute endometritis may follow insertion, and pelvic inflammatory disease may develop rarely. For urinary catheters, gram negative bacilli from the bowel or antibiotic resistant hospital acquired organisms are common. Most foreign body infections require removal of the device before cure is possible. Exceptions are peritoneal dialysis catheters, intraocular lenses and some cases of prosthetic valve endocarditis by penicillin susceptible streptococci. Most infections originate during surgical implantation. Minimizing tissue trauma and operating time will reduce risk. Prophylactic antibiotics are appropriate for placement of artificial heart valves, joints and vascular grafts.^ieng