Changes in the rRNA levels of specific microbial groups in activated sludge during sample handling and storage.

AIMS: To quantitatively analyse the changes in group-specific rRNA levels in activated sludge as a function of sample handling and storage procedure. METHODS AND RESULTS: Quantitative membrane hybridizations with (32)P-labelled oligonucleotide probes were used to analyse the effects of different sample handling and storage conditions on the relative rRNA levels of the alpha, beta, and gamma-Proteobacteria, the Cytophaga-Flavobacteria group, and the mycolic acid-containing actinomycetes in activated sludge. Group-specific rRNA levels, expressed as percentages of total 16S rRNA detected with a universal probe, in samples maintained at room temperature significantly changed after 48 h. Group-specific rRNA levels in samples treated with chloramphenicol showed significant change after 72 h. CONCLUSIONS: Sample storage at room temperature is a viable option if freezing or analysis can be performed within 24 h, while treatment with chlorampenicol can extend that time to at least 48 h. SIGNIFICANCE AND IMPACT OF THE STUDY: Handling, shipping, and storage of environmental samples under several conditions may result in inaccurate determination of the microbial populations in microbial ecology studies.

Recurrence and malignancy rates in a benign colorectal neoplasm patient cohort: results of a 5-year analysis in a managed care environment.

OBJECTIVE: To estimate the apparent recurrence rates of benign neoplasms and the development of malignant colorectal neoplasms over a 5-yr period in a high risk managed care population. METHODS: Using the CPT and ICD-9 CM codes, a cohort of subjects with benign neoplasms were identified with a colonoscopy in 1992 from a longitudinal claims database (MarketScan). Three groups of subjects (benign neoplasms with polypectomy, benign neoplasms without polypectomy, and no neoplasms) were evaluated. Five-year recurrence rates of benign or new malignant colorectal neoplasms were determined for the baseline benign neoplasms with polypectomy and no neoplasm groups. For the benign neoplasm without polypectomy, only rates for malignancy were evaluated. RESULTS: Of 16,293 subjects at baseline, 39.50% were diagnosed with benign and 5.50% with malignant neoplasms. The 5-yr cumulative incidence of benign neoplasms in subjects without an index neoplasm (n = 8,967) was 7.92% compared to the recurrence of 40.93% in subjects with a benign neoplasm and polypectomy (n = 4,046) at baseline (p < 0.001). The 5-yr cumulative incidence rates of malignant colorectal neoplasms in the no neoplasm (n = 8,967) and benign neoplasm groups (n = 6,438) were 1.81% and 2.55%, respectively (p < 0.005). A lower 5-yr malignancy rate was observed in benign neoplasm group with polypectomy (2.17%) compared to the benign neoplasm group without polypectomy (3.18%) (p < 0.05). CONCLUSION: The high recurrence rate of benign colorectal neoplasms and a higher incidence of colorectal cancer in subjects at high risk (history of benign colorectal neoplasm) highlight a healthcare opportunity for surveillance and/or interventions to reduce the morbidity associated with colorectal neoplasms.

Economic impact of neutropenia and febrile neutropenia in breast cancer: estimates from two national databases.

STUDY OBJECTIVE: To estimate the economic burden of neutropenia and febrile neutropenia in female breast cancer hospital admissions in the United States. DESIGN: Retrospective database analysis. PATIENTS: Female admissions with a breast cancer diagnosis. MEASUREMENTS AND MAIN RESULTS: By reviewing two national databases (Healthcare Costs and Utilization Project, MarketScan), length of stay and charge or payment/admission were estimated from 1994-1996. Neutropenic and febrile neutropenic admissions were longer and incurred higher charges and payments than nonneutropenic and afebrile neutropenic admissions, respectively (p<0.05). The difference in mean charges between neutropenic and nonneutropenic admissions decreased from $13,143 in 1994 to $6913 in 1996, whereas the difference in payment was $4957 (adjusted to 1996 dollars). The difference in mean charges between febrile and afebrile neutropenic admissions decreased from $11,570 in 1994 to $2873 in 1996, whereas the difference in payment was $2390 (adjusted to 1996 dollars). CONCLUSION: There was a trend toward decreased charges for inpatient admissions with neutropenia in patients with breast cancer (1994-1996). Interventions that reduce the frequency of neutropenia and febrile neutropenia could reduce hospitalization costs of breast cancer admissions.

Reliability and validity of French, German, Italian, Dutch, and UK English translations of the Medical Outcomes Study HIV Health Survey.

OBJECTIVES: Test the reliability and validity of 5 translations of the 34-item version of the MOS HIV for use in multinational clinical trials. RESEARCH DESIGN: Investigators in five countries followed a standardized protocol and recruited HIV+ patients stratified by disease stage: asymptomatic; symptomatic; and AIDS. During routine clinic visits, patients completed the MOS HIV and a checklist of HIV-related symptoms. Clinicians reported patients' demographics, most recent CD4+ count and disease stage. SUBJECTS: Three hundred and sixty three HIV+ outpatients attending AIDS clinics in The Netherlands, France, Germany, Italy, and England. MEASURES: Dutch, French, German, Italian, and UK English translations of the MOS HIV CD4+ cell count and the SCL-57. RESULTS: All translations recruited roughly equal proportions of each disease stage, although the number of patients recruited differed by translation (n: German = 92, French = 86; Italian = 88; UK English = 72; and Dutch = 25). Internal consistency reliability was similar across translations and adequate (alpha >.70) for all scales except for Mental Health in the French sample. Multi-trait analyses supported structural validity of the MOS HIV scales in each translation. Principal component analysis of scale scores identified 2 dimensions for all translations except German. For all translations, scores were significantly correlated with symptom severity scores but were uncorrelated with CD4+ cell counts. CONCLUSIONS: In general, the 5 translations of the MOS HIV had similar psychometric properties to those reported in the validation study for the original US English version of the MOS HIV. With some revision, these translations promise to provide useful quality of life data from HIV+ subjects in clinical trials.

Effects of comorbidity on health-related quality-of-life scores: an analysis of clinical trial data.

Coexisting diseases may have unforeseen yet clinically significant effects on patients' well-being. Both generic and disease-specific measures are frequently used to assess health-related quality of life (QOL). The present study assessed the effects of comorbidity on the results of QOL measures through an analysis of longitudinal data from 3 double-masked, randomized, placebo-controlled clinical trials dealing with heartburn, asthma, and ulcer. Patients were assigned to subgroups by comorbidity status: those with no comorbid diseases and those whose principal disease was heartburn, asthma, or ulcer and whose comorbid condition was chronic obstructive pulmonary disease, asthma, or chronic bronchitis; hypertension; migraine, coronary artery disease, or varicose veins; chronic gastrointestinal conditions; arthritis or back pain; diabetes; or depression. Multivariate analysis of covariance was used to test the study hypotheses. The study results suggest that comorbid conditions significantly and extensively affect patients' scores on generic QOL measures and estimation of treatment effect, whereas their influence on disease-specific QOL scores and estimation of treatment effect is considerably smaller. Further, the most important comorbidities in the 3 trial populations were arthritis or back pain and depression, which respectively accounted for 17% and 5% of the patient population. These findings have significant practical implications for the estimation of true treatment effects, control of comorbidity effects, and design of QOL trials.

The development of an instrument for assessing the quality of life of people with diabetes. Diabetes-39.

OBJECTIVES: The aim of this 2-year research project was to develop an instrument specifically designed to assess the quality of life of people with diabetes. METHODS: The project was divided into two phases. In the first phase, information from a detailed literature review, from existing quality-of-life instruments, and from interviews with health professionals and people with diabetes was used to develop an initial instrument of 92 items considered to address important aspects of patients' lives. This questionnaire was mailed to 1,000 people with diabetes, and data from the 516 respondents were used to select the most important and useful items. Fifty items were excluded, leaving 42 items that constituted the pilot instrument. During phase 2, the pilot instrument was used to assess the quality of life of 427 diabetic patients who completed the revised questionnaire. After analyzing this data, three additional items were dropped. The final instrument consists of 39 items and covers five dimensions of patients' lives: Energy and Mobility, Diabetes Control, Anxiety and Worry, Social Burden, and Sexual Functioning. RESULTS: The results of validity and reliability tests conducted to date testify to the relevance of the 39-item questionnaire (Diabetes-39) as a valid discriminative instrument, one which shows significant correlations with an overall quality-of-life assessment, the pattern of diabetes severity, and comorbidity. Further, the results from Diabetes-39 correlate well with the results from the established generic quality-of-life instrument, the Medical Outcomes Study 36-Item Short-Form Health Survey. CONCLUSIONS: Validation of a quality-of-life instrument, however, is an ongoing process. Further research is required to corroborate these early findings and to ensure that this is an instrument that can capture data of greatest relevance to the diabetic patient and that is responsive to change in quality of life.

Influence of asthma or allergies on the utilization of health care resources and quality of life of college students.

The objectives of this study were to describe the treatment regimens of college students with asthma or allergies, to determine how asthma or allergies affect the lives of college students, and to evaluate the health care resources utilized by college students with asthma or allergies. A mail survey was sent to 275 students who received treatment for asthma or allergies at the Thomson Student Health Center at The University of South Carolina (TSHC-USC) during the fall 1991 semester. This survey, consisting of 46 questions, covered three key areas: current asthma or allergy management, class and work days missed, and utilization of health care resources. Students with "asthma and allergy" missed on average 2.4 days of class during the fall semester, whereas those with "asthma only" and "allergy only" missed on average 0.8 day and 1.5 days of class, respectively. Students with "allergy only" appeared to have a greater interference in their daily class and academic activities than students with "asthma and allergy" and "asthma only." In conclusion, students reported interference in their college activities and reported missing days of work and school because of asthma or allergies. This study also showed that a majority of these college students have not received asthma or allergy patient education nor utilized appropriate asthma or allergy management skills.

Establishing value through pharmacoeconomics: the emerging third objective in clinical trials.

Establishing the value of a new medicine by applying the tools and methods of pharmacoeconomics has become an important third objective in many clinical trials. The pharmacoeconomic investigator conducting research in clinical trials must understand and conform to the rules and procedures governing the clinical trial process. This article addresses some of the vital yet often overlooked details associated with conducting pharmacoeconomic research in clinical trials. The protocol, the informed consent form, the data collection instruments, the study initiation, and the final study report are all discussed. Additionally, limitations of the study results are reviewed.

Guidelines for performing a pharmacoeconomic analysis.

The fundamentals of pharmacoeconomics are presented. Pharmacoeconomic research is used to identify, measure, and compare the costs, risks, and benefits of programs, services, or therapies and determine which alternative produces the best health outcome for the resources invested. Each pharmacoeconomic method measures costs in monetary terms; the differences lie in the valuation of outcomes. In cost-minimization analysis, the outcomes are considered to be equal and therefore are not measured. Cost-benefit analysis measures outcomes in dollars, whereas cost-effectiveness analysis measures outcomes in nonmonetary units. In cost-utility analysis, outcomes expressed in nonmonetary units are adjusted for health-related quality of life. A well-designed pharmacoeconomic analysis involves 10 steps: (1) defining the problem, (2) determining the study's perspective, (3) determining the alternatives and outcomes, (4) selecting the appropriate pharmacoeconomic method, (5) placing monetary values on the outcomes, (6) identifying study resources, (7) establishing the probabilities of the outcomes, (8) applying decision analysis, (9) discounting costs or performing a sensitivity or incremental cost analysis, and (10) presenting the results, along with any limitations of the study. By adhering to the analytic steps described, the pharmacist undertaking a pharmacoeconomic evaluation has the greatest likelihood of obtaining valid and useful results.