HIV-1 RNA levels and the development of clinical disease. North American Lamivudine HIV Working Group.

OBJECTIVE: To assess the prognostic value of HIV RNA levels for predicting clinical disease independently of the CD4 lymphocyte count in patients on antiretroviral therapy. DESIGN: Cohort of HIV-infected patients from two trials of lamivudine therapy. PATIENTS: For 620 patients randomized in the North American NUCA3001 and NUCA3002 trials of lamivudine, HIV RNA levels were measured (median, seven measures per patient) and CD4 counts were assessed at a central laboratory (median, 13 counts per patient). Patients were in the 1993 Centers for Disease Control and Prevention (CDC) stages A (n = 439), B (n = 135) or C (n = 46) at baseline. OUTCOME MEASURES: For patients who were in CDC stage A at baseline we considered the ability of HIV RNA levels and CD4 counts to predict the development of CDC stage B or C disease. A Cox proportional hazards model was used. In a second analysis, patients who were AIDS-free at baseline were considered, and the endpoint was AIDS (CDC stage C). RESULTS: Patients' initial CD4 counts ranged (5-95% centiles) from 104 to 529 x 10(6)/l (median, 274 x 10(6)/l) and HIV RNA levels from 1900 to 339680 copies/ml (median, 44240 copies/ml). For the first analysis, with CDC stage B or C disease as endpoint, both the most recent HIV RNA level and CD4 count predicted the development of clinical disease [relative hazard (RH) for HIV RNA, 1.96 per 10-fold difference in HIV RNA; 95% confidence interval (CI), 1.41-2.73; P = 0.0001; and RH for CD4 count, 1.82 per twofold difference in CD4 count; 95% CI, 1.27-2.56; P = 0.0009]. When both HIV RNA and CD4 count were included in a multiple regression model, both markers provided information additional to that given by the other (RH for HIV RNA, 1.75; 95% CI, 1.23-2.50; P = 0.002; and RH for CD4 count, 1.40; 95% CI, 0.95-2.07; P = 0.09). In the second analysis, with AIDS as endpoint, both HIV RNA level (P = 0.02) and CD4 count (P = 0.004) were independently associated with clinical progression. These results were essentially unchanged after adjustment for treatment arm (zidovudine/lamivudine versus control arms). CONCLUSION: The HIV RNA level shows ability to predict the development of clinical disease and may thus be of importance in addition to the CD4 count in patient monitoring.

Radiocaesium activity concentrations in the fruit-bodies of macrofungi in Great Britain and an assessment of dietary intake habits.

Radiocaesium activity concentrations in the fruit-bodies of some species of macrofungi are higher than in many other foodstuffs. The consumption of fruit-bodies contributes significantly to radiocaesium intake of humans in some countries. In the United Kingdom, the collection of wild fungi has generally been considered to be of minor importance and there are few data on consumption rates or radiocaesium activity concentrations in most edible species. Samples of commonly eaten species in Great Britain have been collected to assess radiocaesium contamination levels and geographical variation. Concurrently, surveys of consumption habits were conducted. A total of 425 samples representing 37 different species were collected. Significantly higher radiocaesium activity concentrations occurred in mycorrhizal compared to saprotrophic or parasitic species. The highest 137Cs activity concentration of 30.5 kBq kg-1 dry wt. was determined in a sample of Hydnum repandum collected in Wales. The transfer of radiocaesium from soil to fungal fruit-bodies was highly variable, ranging over three orders of magnitude within individual species. A number of approaches to quantifying radiocaesium transfer from soil to fungal fruit-bodies were used. Although these were in general agreement with previously measured values in other countries, all the approaches gave variable results. Over 200 people responded to the dietary habits questionnaire. The median intake rate was 0.75 kg year-1 (fresh wt.) and 60% of respondents consumed only one species (generally Agaricus campestris). However, intakes of up to 26 kg year-1 were recorded and a total of 82 species were consumed. The intake of 137Cs was determined by the amount of mycorrhizal fungi in the diet rather than the total intake of fungi. Assuming median recorded 137Cs activity concentrations in each fungal species, the estimated annual committed effective dose for over 95% of respondents was < 1 microSv. Hence, currently, the consumption of wild fungi in the UK would not be expected to significantly increase the dose above that attributable to the normal diet of most consumers. However, the results of this study demonstrate that, in the event of any future accidental release of radiocaesium, the potential ingestion dose received from the consumption of wild fungi would need to be considered.

A quality assurance process in health sciences libraries.

A goal of libraries is to assure the improvement of library services. Many organizations have attempted to use standards as a method to assure quality services, but often standards have failed through a lack of individual commitment to those standards and to the methodology used in establishing the standards. Many segments of the health care field have adopted the concept of quality assurance and are applying it to the service and care they provide. This process has the potential to raise or assure quality of service in health sciences libraries. The process involves: selecting a subject for review; developing measurable criteria; ratifying the criteria; evaluating existing services using the criteria; identifying problems; analyzing problems; developing solutions; implementing solutions; and reevaluating services. Two pilot quality assurance studies conducted in the Midwest Health Science Library Network during 1978 are described. Plans are under way to use this process on a regional basis.

Work analysis by random sampling.

Random sampling of work activities using an electronic random alarm mechanism provided a simple and effective way to determine how time was divided between various activities. At each random alarm the subject simply recorded the time and the activity. Analysis of the data led to reassignment of staff functions and also resulted in additional support for certain critical activities.

Behavioral assessment of a hydranencephalic neonate.

This study attempted to clarify the role of the cerebral cortex in neonatal behavior by administering the Neonatal Behavioral Assessment Scale-Kansas revision to a hydranencephalic infant; particularly of interest were behaviors that are implicated in infant social responsiveness. The examination revealed extremely deviant responses on portions of the exam, including items that measure response decrement and orientation. However, this infant was observed to approximate normal neonatal responding on items relating to motor maturity and reactivity. Other findings included that some response decrement occurred in response to auditory and visual, but not tactile, stimulation. The discussion focuses on similarities and differences between this study and early research on both normal infants and infants with imperfectly formed nervous systems. Particular emphasis is placed on the response decrement results, as well as the utility of the NBAS-K in measuring infant behaviors in atypical infant samples.

"Bridging the information gap" for Virginia public health nurses.

This project was designed to increase the public health nurse's knowledge and use of health science information resources available from the National Library of Medicine's databases through the use of the Grateful Med software program. In 1994, the Tompkins-McCaw Library located on the Medical College of Virginia Campus (MCV) of Virginia Commonwealth University (VCU) was awarded a Nursing Information Access Grant from the Southeastern/Atlantic Region of the National Network of Libraries of Medicine (NN/LM). This project was a collaboration of the Tompkins McCaw Library, the VCU School of Nursing, and The Virginia Department of Health. Sixty public health nurses received Grateful Med training. Session evaluations were conducted and indicate that although public health nurses received training and had access to health science information resources through Grateful Med, subsequent use of the resources was very limited. Similar to reports on information-seeking behaviors of physicians, public health nurses seek information from colleagues, personal collections, and other resources locally available. Reasons for the project's limited success in changing the health science information seeking and utilization practices of public health nurses are discussed, and potential solutions are proposed.

A two-phased model for library instruction.

This article describes two methods of library orientation and instruction: self-paced audiotapes and computer-assisted instruction (CAI). The tapes are used to orient the user to the libraries' physical facilities, policies, services, and tools, while CAI is used to provide detailed library information in an interactive mode.

Outreach services: issues and challenges.

Tompkins-McCaw Library of Virginia Commonwealth University has planned and implemented four one-year outreach service projects during the past two years. These projects were funded by the National Library of Medicine and the National Network of Libraries of Medicine Southeastern/Atlantic Region. The projects focus on information access for public health nurses, HIV/AIDS information access, and circuit librarian services in rural Southern Virginia. This article documents issues and challenges which have been identified from these projects and suggests ways to resolve them.

Comparison of cefuroxime axetil and amoxicillin-clavulanate suspensions in treatment of acute otitis media with effusion in children.

Two hundred sixty-three pediatric patients from the ages of 3 months to 11 years were enrolled in a randomized, investigator-blinded, multicenter study comparing the clinical and bacteriological efficacies and safety of cefuroxime axetil suspension (CAE) with those of amoxicillin-clavulanate suspension (AMX-CL) in the treatment of acute otitis media with effusion. Patients received CAE at 30 mg/kg of body weight per day (n = 165) in two divided doses or AMX-CL at 40 mg/kg/day (n = 98) in three divided doses for 10 days. The primary pathogens among 200 isolates from pretreatment cultures of middle ear fluid were identified as follows: Haemophilus influenzae (39%), over a third of which were beta-lactamase positive; Streptococcus pneumoniae (34%); and Moraxella catarrhalis (16%). Pathogens were eradicated or presumed to be eradicated from 81% (95 of 118) and 76% (50 of 66) of bacteriologically evaluable patients in the CAE and AMX-CL groups, respectively. A satisfactory clinical response (cure or improvement with or without resolution of effusion) occurred in 113 (77%) of 146 clinically evaluable patients in the CAE group and in 66 (74%) of 89 evaluable patients in the AMX-CL group. Clinical failure or recurrence (within 2 weeks following the completion of treatment) occurred in 22 and 26% of CAE- and AMX-CL-treated patients, respectively. Drug-related adverse events occurred in 18% of CAE-treated patients, whereas they occurred in 39% of AMX-CL-treated patients (P < 0.001); diarrhea or loose stools was the most commonly reported adverse event (CAE, 12%; AMX-CL, 31%; P < 0.001). These results indicate that CAE given twice daily is as effective as AMX-CL given three times daily in the treatment of acute otitis media with effusion in pediatric patients, but CAE was associated with significantly fewer drug-related adverse events.

Lamivudine plus zidovudine compared with zalcitabine plus zidovudine in patients with HIV infection. A randomized, double-blind, placebo-controlled trial. North American HIV Working Party.

OBJECTIVE: To compare the safety and activity of lamivudine plus zidovudine with the safety and activity of zalcitabine plus zidovudine in patients with moderately advanced human immunodeficiency virus (HIV) infection who had received zidovudine. DESIGN: A multicenter, randomized, double-blind, three-arm, 24-week study with a blinded extension through at least 52 weeks. SETTING: 21 sites in the United States, Canada, and Puerto Rico. PATIENTS: 254 patients who had received zidovudine (median duration of previous therapy, 20 months) and had absolute CD4+ cell counts of 100 to 300 cells/mm3. INTERVENTIONS: Patients were randomly assigned to receive one of three regimens: 150 mg of lamivudine twice daily plus 200 mg of zidovudine three times daily (low-dose lamivudine group); 300 mg of lamivudine twice daily plus 200 mg of zidovudine three times daily (high-dose lamivudine group); or 0.75 mg of zalcitabine plus 200 mg of zidovudine three times daily (zalcitabine group). MEASUREMENTS: Immunologic activity was assessed primarily by changes in absolute CD4+ cell counts; virologic activity was assessed by changes in plasma HIV RNA levels as measured by reverse transcriptase polymerase chain reaction. Safety of the treatment regimens was assessed through the reporting of adverse events. RESULTS: 78% of patients completed 24 weeks of study treatment, and 63% of patients completed 52 weeks of study treatment. Changes in absolute CD4+ cell counts were significantly better for the low-dose and the high-dose lamivudine groups than for the zalcitabine group (median changes at 52 weeks were +42.5 cells/mm3 in the low-dose lamivudine group, +23.33 cells/mm3 in the high-dose lamivudine group, and -29.58 cells/mm3 in the zalcitabine group). Suppression of plasma HIV RNA levels was similar for all groups (median changes at 52 weeks were -0.48 log10 copies/mL in the low-dose lamivudine group, -0.51 log10 copies/mL in the high-dose lamivudine group, and -0.39 log10 copies/mL in the zalcitabine group). No significant differences in safety were seen among the three regimens, although the low-dose lamivudine regimen appeared to be better tolerated than the others. CONCLUSIONS: In patients with HIV infection who had previously received zidovudine, 150 mg of lamivudine plus zidovudine resulted in greater immunologic evidence of benefit than did 0.75 mg of zalcitabine plus zidovudine and was better tolerated than 300 mg of lamivudine plus zidovudine.