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PubMed2001

Different outcomes for different interventions with different focus!--A cross-country comparison of community interventions in rural Swedish and US populations.

OBJECTIVES: There is a need among healthcare providers to acquire more knowledge about small-scale and low budget community intervention programmes. This paper compares risk factor outcomes in Swedish and US intervention programmes for the prevention of cardiovascular disease (CVD). The aim was to explore how different intervention programme profiles affect outcome. METHODS: Using a quasi-experimental design, trends in risk factors and estimated CVD risk in two intervention areas (Norsjö. Sweden and Otsego-Schoharie County, New York state) are compared with those in reference areas (Northern Sweden region and Herkimer County, New York state) using serial cross-sectional studies and panel studies. RESULTS: The programmes were able to achieve significant changes in CVD risk factors that the local communities recognized as major concerns: changing eating habits in the Swedish population and reducing smoking in the US population. For the Swedish cross-sectional follow-up study cholesterol reduction was 12%, compared to 5% in the reference population (p for trend differences <0.000). The significantly higher estimated CVD risk (as assessed by risk scores) at baseline in the intervention population was below that of the Swedish reference population after 5 years of intervention. The Swedish panel study provided the same results. In the US, both the serial cross-sectional and panel studies showed a > 10% decline in smoking prevalence in the intervention population, while it increased slightly in the reference population. When pooling the serial cross-sectional studies the estimated risk reduction (using the Framingham risk equation) was significantly greater in the intervention populations compared to the reference populations. CONCLUSIONS: The overall pattern of risk reduction is consistent and suggests that the two different models of rural county intervention can contribute to significant risk reduction. The Swedish programme had its greatest effect on reduction of serum cholesterol levels whereas the US programme had its greatest effect on smoking prevention and cessation. These outcomes are consistent with programmatic emphases. Socially less privileged groups in these rural areas benefited as much or more from the interventions as those with greater social resources.

Adult↗

PubMed1988

Guidelines for use of dietary intake data.

This article presents the guidelines from the report of the ad hoc Expert Panel on Guidelines for Use of Dietary Intake Data. The report was prepared under terms of a contract with the Life Sciences Research Office of the Federation of American Societies for Experimental Biology to provide the Food and Drug Administration with a working reference for evaluating dietary intake data. The guidelines represent the Expert Panel's conclusions on appropriate ways to interpret dietary data relating to (a) prevalence of consumption of particular levels of foods or food components, (b) comparisons of intake of different groups within the U.S. population, (c) time trends in consumption of foods or food components, and (d) relationships of intake of a food or food component to a given health outcome. The guidelines address general issues concerning dietary data collection and statistical concerns as well as specific issues important in interpretation of dietary data.

Data Collection↗

PubMed2005

Gastroenterologists overestimate the appropriateness of colonoscopies they perform: an international observational study.

BACKGROUND AND STUDY AIM: Little is known about how gastroenterologists perceive the appropriateness of colonoscopies they perform. The objective of this study was to compare the appropriateness and necessity of colonoscopies as assessed by an expert panel and by the gastroenterologists performing the colonoscopies. METHODS: This observational study included 21 centers in 11 countries. Patients referred for colonoscopy were consecutively included. Appropriateness and necessity of colonoscopies were independently rated on a 9-point scale by the gastroenterologists performing them and by an expert panel using a validated method (RAND). The differences between the ratings from the two groups were examined. RESULTS: 6004 patients were included in the study. Comparisons of ratings were possible for 5381 (89.6 %) patients. The gastroenterologists' mean appropriateness rating was 7.2 +/- 1.7, and the panel's mean appropriateness rating was 5.4 +/- 2.3 ( P < 0.001). The percentages of indications rated inappropriate, uncertain, appropriate, and necessary were 4.1 %, 23.8 %, 14.2 %, and 58.0 % for the gastroenterologists and 27.2 %, 26.7 %, 25.0 %, and 21.1 % for the panel, respectively. Agreement between the two groups' ratings was poor (28.8 %, kappa = 0.11). Differences between the two groups' ratings decreased with increasing patient age, decreasing health status, and decreasing expertise level of the referring physician. However, the gastroenterologists produced consistently higher ratings. CONCLUSIONS: Compared with an expert panel, gastroenterologists tend to overestimate the appropriateness of colonoscopies they perform. Except for well-delineated reasons, participating gastroenterologists weighed patient characteristics differently from the panel when judging appropriateness. Ways to increase the prospective use of appropriateness criteria in order to improve appropriateness and reduce overuse of colonoscopies should be examined further.

Adult↗

PubMedDate not supplied

Selecting specialist registrars by station interview.

Appointments to the specialist registrar (SpR) grade depend almost entirely on performance at interview, yet standard panel interviews do not directly assess the competences required of a medical trainee. In this study, station interviews were used to select neurology SpRs. Eighteen candidates were assessed in three interviews, each involving three stations: a curriculum vitae (CV)-based interview, an interview with a simulated patient, and a discussion of scenarios based upon teaching, audit and research. Two or three assessors at each station ranked candidates independently before discussing the pooled rankings and reading written references. The CV-based interview rankings (resembling a traditional panel interview) correlated less well with the overall rankings (r=0.54) than did research (r=0.83), information giving (r=0.75), audit (r=0.70) or teaching presentation (r=0.59). Station interviews appear fairer (providing more time, more independent examiners, fresh starts at each station), although they require more planning and expense. Competency-based assessments should be more widely used in selecting medical trainees.

Clinical Competence↗

PubMed1985

Evaluation of commercial methods of enzyme immunoassay (EIA) for the measurement of rubella-specific IgM.

Four commercial EIA methods for measuring rubella-specific IgM (three indirect tests and one anti-mu capture test) were evaluated, using sucrose gradient centrifugation and hemagglutination inhibition as the reference method. Evaluation was conducted with the aid of four serum panels, including 53 primary rubella cases, 30 healthy pregnant women, 21 sera positive for rheumatoid factor(s) (RF) and 35 sera from 29 cases of heterophil-positive infectious mononucleosis with EBV-specific IgM detected by immunofluorescence. All EIA methods were more sensitive than the reference method when applied to very early samples (1-5 days post-exanthema) and no differences in sensitivity were found between them. On the other hand, we observed a significant incidence of false-positive results if an indirect EIA method is applied to RF-positive samples. False positivity is significantly reduced, but not totally eliminated, when samples are preabsorbed with anti-human IgG serum and, in all cases, the absorbance values obtained were low. In contrast, there were no false-positive results using an anti-mu capture method, even in sera from cases of infectious mononucleosis. The basis for choosing between an indirect method and an anti-mu capture method for the diagnosis of congenital and post-natal rubella virus infection is discussed.

Antibodies, Heterophile↗

PubMed2004

Evaluation of drug interaction software to identify alerts for transplant medications.

BACKGROUND: The ability of computerized physician order entry (CPOE) systems to identify clinically significant drug interactions is dependent upon the integrity of the drug information populating the software. A CPOE system with incomplete or inaccurate drug information will fail to identify clinically important drug interactions and, therefore, fail to reduce preventable adverse drug events (pADEs). OBJECTIVE: To evaluate, from the prescribers' perspective, the ability of a common drug interaction database to identify clinically important drug interactions involving drugs used in transplantation. METHODS: The clinical significance of drug interactions involving 5 transplant drugs was evaluated by an expert panel to determine whether alerts should be generated for physicians not involved in the transplant at the time of order entry. Drug interactions included in the analysis were generated from the expert panel, a common drug interaction database, and 2 standard drug interaction references. Responses on the clinical significance were used to calculate the sensitivity, specificity, and positive and negative predictive values for each severity setting of a common electronic drug interaction database. RESULTS: Overall, the database failed to identify approximately 70% of interactions considered significant by the expert panel. Of the alerts that were generated, >85% were considered clinically significant. The database was most deficient in identifying interactions resulting from additive toxicity. CONCLUSIONS: To expect a decrease in pADEs caused by drug interactions, the information used to populate CPOE systems must be validated. Establishing consistency and integrity of this information may be a future role for pharmacists.

Databases as Topic↗

PubMed2000

Combined evidence-based literature analysis and consensus guidelines for stocking of emergency antidotes in the United States.

STUDY OBJECTIVE: To develop guidelines for the stocking of antidotes at hospitals that accept emergency admissions using combined evidence-based and consensus methods. METHODS: Study participants were 12 medical care providers from disciplines that are affected by insufficient stocking of emergency antidotes (clinical pharmacology, critical care, clinical pharmacy, emergency medicine, hospital pharmacy, internal medicine, managed care pharmacy, clinical toxicology, pediatrics, poison control centers, pulmonary medicine, regulatory medicine). Selection of individuals for the study panel was based on evidence of previous antidote research or perspective regarding the purchase and use of antidotes. The literature regarding each antidote was systematically amassed using pre-1966 literature files, current MEDLINE searches, the reference lists of major medical textbooks, and citations solicited from the consensus panel. Articles relevant to 4 defined core questions were included. These articles formed the basis of an evidence-based analysis performed by the principal investigator. After literature analysis, a literature summary and proposed guidelines for antidote stocking were submitted to the panel. Consensus was formed by electronic iterative presentation of alternatives to each panel member using a modified Delphi method. All panel members participated in 5 rounds of guideline analysis of 20 antidotes. RESULTS: Of the 20 antidotes, 16 antidotes were ultimately recommended for stocking (N -acetylcysteine, atropine, Crotalid snake antivenin, calcium gluconate and chloride, cyanide antidote kit, deferoxamine, digoxin immune Fab, dimercaprol, ethanol, fomepizole, glucagon, methylene blue, naloxone, pralidoxime, physostigmine, sodium bicarbonate), 2 were not recommended for stocking (black widow antivenin, ethylenediamine tetraacetic acid), and consensus could not be reached for 2 antidotes (flumazenil, physostigmine). CONCLUSION: These guidelines provide a tool to be used in revising or creating policies and procedures with regard to the stocking of antidotes in hospitals that accept emergency patients.

Antidotes↗

PubMed1992

Potyviruses, monoclonal antibodies, and antigenic sites.

Virus-specific and cross-reactive monoclonal antibodies have been produced to at least 19 different aphid-transmitted potyviruses. This report summarizes the development of these monoclonal antibodies as well as presents information on the delineation of the virus-specific and group-common epitopes defined by these monoclonal antibodies. Virus-specific and group-common antigenic determinants were mapped by a variety of techniques, including analysis of antigen: antibody reactivity patterns, determination of N-terminal vs. trypsin-resistant core peptide-specificity, immunoanalysis of overlapping synthetic peptides, and immunoanalysis of bacterially expressed coat-protein gene products. Of those monoclonal antibodies that have been examined, monoclonal antibody-defined virus-specific epitopes are virion surface-located within the 30+ amino acid amino terminus, whereas the group-common epitopes are found in the trypsin-resistant core protein not usually located on the virion surface, as has been shown previously with certain polyclonal antibodies. New information is presented on the analysis of bean yellow mosaic virus amino terminal epitopes as well as on the identification of amino terminal antigenic determinants shared between strains of bean yellow mosaic virus and pepper mottle virus. A recommendation on the evaluation and use of a panel of potyvirus broad-spectrum reacting monoclonals as reference monoclonal antibodies for the detection and classification of aphid-transmitted potyviruses is also presented.

Amino Acid Sequence↗

PubMed2002

Association of bovine neonatal Fc receptor alpha-chain gene (FCGRT) haplotypes with serum IgG concentration in newborn calves.

This report describes allelic variation in FCGRT (which encodes the alpha-chain of FcRn) and its association with variation of IgG concentration in neonatal calves. Five SNPs were identified by sequencing 1305 bp of FCGRT genomic DNA from a multi-breed panel of 96 cattle and 27 founders of a reference population. These SNPs defined five FCGRT haplotypes that were verified by segregation and used to test association of FCGRT with neonatal IgG concentration in a case-control study. This study established that dams with FCGRT haplotype 3 had a significantly greater risk of failure of passive transfer in their calves (odds ratio [OR] = 3.80, CI95% 1.10-13.18, p = 0.035). Calves with FCGRT haplotype 2 were less likely to have high levels of passively acquired immunoglobulin (OR = 0.18, CI95% 0.05-0.68, p = 0.011). These results indicate that the bovine FCGRT haplotype markers are in linkage disequilibrium with genetic risk factors affecting passive transfer of IgG in beef cattle, an important determinant of neonatal calf morbidity and mortality.

Animals↗

PubMed1994

Intrahippocampal administration of the NO synthase inhibitor L-NAME prevents working memory deficits in rats exposed to transient cerebral ischemia.

A 5-min period of cerebral ischemia increased the number of errors in a working memory task with three-panel runway paradigm, while it had no effect on reference memory errors. The nitric oxide (NO) synthase inhibitor, NG-nitro-L-arginine methyl ester (L-NAME), infused into the bilateral dorsal hippocampus at 100 micrograms/side immediately after blood flow reperfusion, significantly reduced the increase in working memory errors expected to occur 24 h after 5 min of ischemia. Intrahippocampal administration of the inactive isomer D-NAME at 100 micrograms/side immediately after reperfusion had no effect on the increase in working memory errors in the ischemic rats. These findings suggest that the mechanism mediated by hippocampal NO synthesis during the early reperfusion phase contributes to the postischemic impairment of working memory.

Amino Acid Oxidoreductases↗

PubMed1994

Method for determining the equilibrium constant and the concentration of influenza virus IgG antihaemagglutinin antibody molecules by use of EIA titres determined with and without guanidine hydrochloride.

A novel technique for determining the concentration of influenza virus antihaemagglutinin antibody molecules (A) of the IgG class and their equilibrium constant (K) is described which is based on recording EIA (enzyme-linked immunosorbent assay) guanidine titre ratios R (EIA titre determined in the absence of guanidine divided by EIA titre determined in the presence of 0.25 M guanidine hydrochloride). K is determined by using a regression line relating values of K to values of R. The line was established by testing antisera comparatively for K by means of equilibrium filtration and for R by EIA. The assay of A is based on the finding that the concentration of antibody molecules adsorbed at serum dilutions yielding an O.D. reading of 0.9 in the EIA test is within the experimental limits constant. Since K is known, this point of reference can be used to calculate A. For a panel of 57 influenza antisera, the A and K values determined by equilibrium filtration agreed well with the respective values determined by use of the novel technique.

Animals↗

PubMed1997

Characteristics of memory dysfunction in olfactory bulbectomized rats and the effects of cholinergic drugs.

The memory impairment of olfactory bulbs (OB)-lesioned rats was characterized using 4 different tasks of learning/memory, and the effects of certain cholinergic drugs on such memory impairment were examined. In reference memory and working memory tasks using a 3-panel runway apparatus, OB-lesioned rats showed a marked increase in errors. In the 3-lever operant task using delayed matching to a sample (DMTS) procedure, OB lesions significantly decreased the correct response in choice (test) trials without affecting the in sample (training) trials. An interesting finding is that impairment in the DMTS performance did not appear immediately after the OB lesion, but tended to appear after a delay. Based on this finding, it is unlikely that memory impairment in the OB-lesioned rats is due to the olfactory deficit itself. However, OB lesions significantly reduced the choice accuracy and delayed the choice reaction time during the 3-choice serial time task for assessing attentional function, using a 3-lever operant apparatus. These findings suggest that marked impairment of learning and memory in OB-lesioned rats may be caused by the attention deficit. Furthermore, the memory impairment in OB-lesioned rats was reduced by cholinesterase inhibitors, physostigmine and NIK-247. These finding suggest that dysfunction of the cholinergic system is involved, at least in part, in the memory impairment of OB-lesioned rats.

Animals↗

PubMed2003

The comprehensive care team: a description of a controlled trial of care at the beginning of the end of life.

OBJECTIVE: To describe the characteristics, acceptability, and basic efficacy of an outpatient palliative care consultation service for patients with serious illness continuing to receive treatment for their underlying disease. DESIGN: Structured interviews of intervention patients enrolled in a prospective, nonrandomized, controlled trial. SETTING: General medicine practice in an urban, academic medical center. PATIENTS: Ninety outpatients with cancer, advanced congestive heart failure, or advanced chronic obstructive pulmonary disease. INTERVENTIONS: Palliative care consultation to primary care physicians (PCPs); educational and supportive services to patients and their families. OUTCOME MEASURES: Physician referrals, program assessment by patients, observations of clinical consultation team members. RESULTS: A majority of PCPs (61%) referred patients to the project, which provided an extensive panel of services despite significant financial constraints. Patients reported improved satisfaction with their family (85.7%), PCP (80%), and the medical center at large (65.7%) as a result of these services. Patients found discussing advance care planning difficult (66%), but desired these conversations (66%). Team members observed significant palliative care needs among this population of outpatients, however, PCPs did not implement a significant number of the consultation team's recommendations. CONCLUSIONS: Outpatient palliative care consultation and services for patients continuing to pursue treatment of their underlying disease are acceptable and helpful to patients. However, barriers to implementation of palliative care treatments in this population must be explored.

Aged↗

PubMed1997

Kinetics study of human retrovirus antigens expression in T lymphocytic cell lines by indirect immunofluorescence assay.

Indirect immunofluorescence assay (IFA) is a well-accepted assay for the confirmation of human retrovirus infection. Fluctuations in HIV-1 antigen expression in infected E-B2 cells depending on several factors have been reported. Cells kept in log phase expressed the highest levels of viral antigen. Thus, we studied the time kinetics of IFA positivity in MT-2 (HTLV-I), MO-T (HTLV-II), CEM, and H9 (HIV-1) cell lines. Uninfected T cell line, HT, was used as nonspecific control. Reference HTLV-I/II and HIV-1 serum panels from the Centers for Disease Control and Prevention (CDC) were tested by conventional IFA procedure on slides of each cell line made on different days. On the second day after subculture, HTLV-I strongly positive sera reacted on MT-2 and MO-T cells with a bright pericytoplasmic fluorescence pattern. Weakly positive sera showed a faint staining from the fifth day on, when all the sera showed the highest degree of fluorescence. With HIV-1 cell lines, sera predominantly reacted with a diffuse cytoplasmic pattern, although some sera showed a granular and pericytoplasmic capping staining. The highest degree of fluorescence was found at 3-5 days after subculture. We demonstrated that the sensitivity of the IFA for the detection of antibodies against human retroviruses depended on the day when the slides were assayed and on the serum antibody titer. The fifth day was the most appropriate for HTLV-I/II and HIV-1/H9 systems, whereas for HIV-1/CEM, the fourth day was better. Furthermore, the intensity of the immunofluorescence pattern differed with the antibody titers and the level of antigens expressed on the four cell lines studied. The IFA, improved in our laboratory, proved to be very sensitive, specific, and rapid and could be used as a supplementary/confirmatory assay for retrovirus infection.

Cell Line, Transformed↗

PubMed2003

Cost-effectiveness of drotrecogin alfa (activated) in the treatment of severe sepsis.

OBJECTIVE: To assess the cost-effectiveness of drotrecogin alfa (activated) therapy, which was recently shown to reduce mortality in severe sepsis. DESIGN: Estimates of effectiveness and resource use were based on data collected prospectively as part of a multicenter international trial. Estimates of hospital costs were based on a subset of the patients treated in the United States (33% of all enrolled patients). Lifetime projections were modeled from published sources and tested in sensitivity analyses. Analyses were conducted from the United States societal perspective, limited to healthcare costs, and using a 3% annual discount rate. SETTING: A total of 164 medical institutions in 11 countries. PATIENTS: Adults > or = 18 yrs of age with severe sepsis INTERVENTIONS: Eligible patients were randomly assigned to receive a 96-hr intravenous infusion of drotrecogin alfa (activated) at 24 microg/kg/hr (n = 850) or placebo (n = 840). MEASUREMENTS AND MAIN RESULTS: Base Case: incremental short-term (days 1-28) healthcare costs per day-28 survivor; Panel on Cost-Effectiveness in Health and Medicine Reference Case: incremental lifetime healthcare costs per quality-adjusted life-year. Over the first 28 days (short-term Base Case), drotrecogin alfa (activated) increased the costs of care by $9,800 and survival by 0.061 lives saved per treated patient. Thus, drotrecogin alfa (activated) cost $160,000 per life saved (with 84.7% probability that ratio is <$250,000 per life saved). Projected to lifetime (lifetime Reference Case), drotrecogin alfa (activated) increased the costs of care by $16,000 and quality-adjusted survival by 0.33 quality-adjusted life-years per treated patient. Thus, drotrecogin alfa (activated) cost $48,800 per quality-adjusted life-year (with 82% probability that ratio is <$100,000 per quality-adjusted life-year). Estimates were generally robust to sensitivity analyses, although cost-effectiveness deteriorated to >$100,000 per quality-adjusted life-year if survivors lived <4.6 yrs on average. Drotrecogin alfa (activated) cost $27,400 per quality-adjusted life-year when limited to patients with an Acute Physiology and Chronic Health Evaluation II score > or = 25 and was cost-ineffective when limited to patients with a score <25. CONCLUSIONS: Drotrecogin alfa has a cost-effectiveness profile similar to that of many well-accepted healthcare strategies and below commonly quoted thresholds.

Adult↗

PubMed2003

Commercial broth microdilution panel validation and reproducibility trials for garenoxacin (BMS-284756), a novel desfluoroquinolone.

Results from garenoxacin dry-form broth microdilution MIC panels prepared commercially (Sensititre, TREK Diagnostics) were compared to reference frozen-form MICs to ensure the validity of the longer-shelf-life product. A total of 1078 organisms from seven major organism groups were used in this trial. All commercial MIC results were within +/- one log(2) dilution of reference garenoxacin values, and reproducibility trials produced identical MIC results for 90.5 to 92.1% of garenoxacin MIC comparisons. Control quinolones (ciprofloxacin and gatifloxacin) also performed at a similarly high level of accuracy.

Anti-Infective Agents↗

PubMed2004

Simple subtyping assay for human immunodeficiency virus type 1 subtypes B, C, CRF01-AE, CRF07-BC, and CRF08-BC.

After the initial development of a human immunodeficiency virus type 1 (HIV-1) subtype-screening tool by nested multiplex PCR, we further improve it through the redesign of subtype-specific primers based on subtype signature pattern (SSP) analyses and optimization of the PCR conditions. Extracted RNA from plasma samples was used in reverse transcription and the cDNA products were added to the first round PCR, in which universal primers in the gag region were used to detect HIV-1 M group isolates. In the second round of PCR, three pairs of subtype-specific primers, detecting subtypes B, C, and CRF01-AE, were added in one tube. Subtype determination was based on the different size of PCR products on the agarose gel electrophoresis. An additional set of primers detecting only the prevalent recombinant strains CRF07-BC and CRF08-BC was used to discriminate CRF07- and CRF08-BC from pure subtype C. Testing for all kinds of HIV subtype reference strains indicated that this assay was applicable. A panel of 252 HIV-positive samples and 30 HIV-negative samples was further used to evaluate and validate this assay. Compared to the assay of sequence-based phylogenetic analysis, the newly developed assay has an adequate designated subtype sensitivity, 93.2% (69 of 74) for subtype B, 95.1% (117 of 123) for subtype C, 94.0% (47 of 50) for CRF01-AE, and 95.0% (115 of 121) for CRF07-BC and CRF08-BC. Most importantly, the intersubtype specificity of the assay was found to be 100%. The assay specificity was also found to be 100% when used to test 30 HIV-negative samples. The average reproducibility was 96.0% for subtype B, 96.7% for subtype C, and 95.0% for CRF01-AE. We have developed a simple, rapid, and low cost assay for screening subtypes B, C, CRF01-AE, CRF07-BC, and CRF08-BC in China.

Acquired Immunodeficiency Syndrome↗

PubMed1983

Report of a joint DMRQC/Organon field trial to detect hepatitis A IgM by ELISA.

The results of a field trial of a joint DMRQC/Organon ELISA kit for the detection of hepatitis A IgM antibody are reported. The participating laboratories were asked to use the kit to test a panel of 360 specimens consisting of duplicate coded samples of 180 sera. The panel was also tested by MACRIA in the Virus Reference Laboratory, Colindale. The ELISA was shown to be specific and sensitive giving good discrimination between acute and late convalescent hepatitis A sera. It was proposed that the same cut-off control as is used in the RIA (equivalent to 10 RIA units) should be adopted for the ELISA also.

Acute Disease↗