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PubMed2005

Acceptance of HIV antibody testing among inpatients and outpatients at a public health hospital: a study of rapid versus standard testing.

Patients of unknown HIV status who were admitted to the inpatient unit or who were undergoing evaluation in the outpatient clinic of a public health hospital were randomized to receive either the standard HIV test or a rapid HIV test. Patients ranged from 21-71 years of age, and 71% were male. Eleven percent were Hispanic, 36% black, and 48% Caucasian. 35% were injection drug users (IVDU) and 3% men who have sex with men (MSM). The waiting period for the standard test was 2 weeks, and that for rapid testing was approximately 20 minutes. Patients were provided with a telephone number and told to call and schedule a follow-up appointment to receive their standard test results. We found no statistical difference in the acceptance rates of either testing modality overall or with respect to age or gender. We did find a significantly greater percentage of Hispanic patients accepting rapid testing over standard testing (p = 0.04). The overall acceptance rates of rapid and standard testing were 60% and 41%, respectively. This was far lower than expected, and was due in part to the 40% of patients who refused testing because of their having a previous HIV test. All patients who had received previous testing had tested HIV negative, and we did not discover any new cases of HIV in the 103 patients tested during the study. Of those we tested, 95% of those receiving the rapid test and 43% of those receiving the standard test were informed of their status (p < 0.001). Failure of patients to return for follow-up visits accounts for the low percentage of individuals successfully informed of their standard test results. The study suggests that rapid HIV testing is at least as palatable as standard testing in our population. In addition, a far greater percentage of patients are informed of their status using the rapid HIV test. HIV testing programs at our hospital may not be cost effective as our population appears to have been heavily tested previously. Prior to initiating an HIV testing program within a hospital setting, it is imperative to determine the percentage of patients previously tested for HIV.

AIDS Serodiagnosis↗
PubMed1994

Quality standard for assurance of measles immunity among health care workers. Infectious Diseases Society of America.

OBJECTIVE: The objective of this quality standard is to prevent nosocomial transmission of measles by assuring universal measles-mumps-rubella (MMR) vaccination of all health care workers who lack immunity to measles. Although the primary emphasis is on health care workers in hospitals, those at other sites, such as clinics, nursing homes, and schools, are also included. It will be the responsibility of designated individuals at these institutions to implement the standard. OPTIONS: We considered advocating the use of measles vaccine rather than MMR vaccine but chose the latter because it also protects against mumps and rubella and because it is more readily available. OUTCOMES: The desired outcome is a reduction in the nosocomial transmission of measles. EVIDENCE: Although direct comparative studies are lacking, nosocomial outbreaks of measles have been reported (as recently as 1992) in institutions where measles immunization of nonimmune health care workers is not universal, whereas such outbreaks have not been reported in institutions with universal immunization. VALUES AND VALIDATION: We consulted more than 50 infectious-disease experts from the fields of epidemiology, government, medicine, nursing, obstetrics and gynecology, pediatrics, and surgery. In light of disagreement regarding the implementation of the standard, we used group discussions to reach a consensus. BENEFITS, HARMS, AND COSTS: The consequences of the transmission of measles (and of mumps and rubella) in a health care institution include not only the morbidity and mortality attributable to the disease but also the significant cost of evaluating and containing an outbreak and the serious disruption of regular hospital routines when control measures are instituted. The potential harm to health care workers after the implementation of the standard consists of untoward effects of MMR vaccine, although the reactions of vaccinees should be minimal with adherence to recommended vaccination procedures. Implementation of the standard should entail no expense to health care workers; the precise cost to institutions is unknown, but the expense would be mitigated by the prevention of measles outbreaks. RECOMMENDATIONS: We recommend MMR vaccination of all health care workers who lack immunity to measles. SPONSORS: The Quality Standards Subcommittee of the Clinical Affairs Committee of the Infectious Diseases Society of America (IDSA) developed the standard. The subcommittee was composed of representatives of the IDSA (P.A.G. and J.E.M.), the Society for Hospital Epidemiology of America (R.P.W.), the Surgical Infection Society (E.P.D.), the Pediatric Infectious Diseases Society (P.J.K.), the Centers for Disease Control and Prevention (W.J.M.), the Obstetrics and Gynecology Infectious Diseases Society (R.L.S.), and the Association of Practitioners of Infection Control (T.L.B.). Funding was provided by the IDSA and the other cooperating organizations. The standard is endorsed by the IDSA.

Cross Infection↗
PubMed1999

Standardization and validation of DNA adduct postlabelling methods: report of interlaboratory trials and production of recommended protocols.

The aim of this project was to devise and test improved protocols of the 32P-postlabelling assay for the detection of carcinogen-DNA adducts. The intention was to reverse the drift of different investigators using increasingly divergent experimental conditions. This would lead to a more standardized assay that can be used in future applications by different investigators for the monitoring of human exposure to genotoxic agents, permitting more meaningful comparisons between different studies or between different participants in the same study. As part of this process, there was perceived to be a need for carcinogen-modified DNA standards of known levels of adducts for use as positive controls, as standards for normalization of results with unknown samples and to assist interlaboratory comparisons. The preparation of characterized DNA standards modified by benzo[a]pyrene (BaP), a polycyclic aromatic hydrocarbon (PAH), 4-aminobiphenyl (ABP), an aromatic amine, 2-amino-1-methyl-6-phenylimidazo[4,5-b]pyridine (PhIP), a heterocyclic amine, and N-methyl-N-nitrosourea (MNU), a methylating agent yielding DNA containing O6-methylguanine, was carried out. A critical appraisal of all aspects of the 32P-postlabelling procedure and investigations to examine the influence of a number of key variations on the assay were conducted. There followed testing of a consensus protocol in a first interlaboratory trial involving 25 participants in Europe and the USA, conducted on the prepared synthetic DNA standards, the assessment of interlaboratory variability and the reasons for it. Revision of the protocols was followed by further testing in a second interlaboratory trial in which liver DNA from mice treated with BaP or ABP were assayed together with the synthetic DNA standards. Adduct levels were found to be significantly lower by 32P-postlabelling than by 3H incorporation. A recommended set of procedures has been developed for the detection and quantitation of DNA adducts formed by PAHs, aromatic amines and methylating agents. These trials have led to a much clearer idea as to what are the critical features and procedures of the 32P-postlabelling assay and there is a set of standard DNA samples for use in quality control and against which biological samples can be normalized. Use of these standards and procedures has reduced interlaboratory variability in quantitation of DNA adducts.

DNA Adducts↗
PubMed2001

Why do we continue to use standardized mortality ratios for small area comparisons?

Public health practitioners are often faced with the necessity to compare the mortality experience of different geographical areas. Indirect standardization, producing a 'standardized mortality ratio' (SMR) is the most commonly used technique for doing this. However, as we show, indirect standardization is inappropriate for such comparisons, as SMRs for different geographical areas have different denominators. The fact that indirect standardization is usually chosen for this type of comparison is probably based on two beliefs: (1) that direct standardization yields only a rate rather than a more easily interpreted ratio or index; (2) that direct standardization cannot be carried out in many cases because the sub-group specific mortality rates in the groups to be compared are not available or, in at least some age classes, are based upon such small numbers as to be completely unreliable. In this paper we show that a simple index (the comparative mortality figure) can be calculated from the directly standardized rate in most cases. Using a comparison of the overall mortality experience of electoral wards in Sheffield between 1980 and 1987 we demonstrate also that the advantage gained by the smaller standard error of the SMR is outweighed by the bias inherent in its construction. We recommend that the SMR is used only when absolutely necessary, that is, in the rare circumstance when data are not available for the calculation of age- and sex-specific subgroup rates in the study population.

Adolescent↗
PubMed2006

Developing audit standards required for outbreaks of communicable diseases-lessons from a mumps outbreak.

BACKGROUND: A mumps outbreak occurred in 2004-05 in England and Wales. The outbreak in the Avon area of England led to mass vaccination of 16- to 24-year-olds with the measles, mumps and rubella vaccine (MMR). The response to the outbreak was audited. Literature and web searches for audit standards were undertaken, and experts in the field were contacted. No comprehensive audit standards for outbreaks of communicable diseases were found. This article describes an approach to developing audit standards for outbreaks of communicable diseases. METHODS: Audit standards were developed based on the memorandum of understanding between the National Health Service (NHS) and Health Protection Agency. The audit was undertaken involving 25 staff. RESULTS: The audit standards developed identified many areas for improvement including training, strategic co-ordination, inter-organizational communication, consistency and timeliness of communication. Conducting the audit was problematic because there were not pre-defined audit standards. CONCLUSIONS: Audit standards should be developed, which include issues relating to the structure, process and outcome of responses to outbreaks. The development of audit standards for the management of outbreaks is crucial to evaluate outbreak control and make necessary improvements.

Adolescent↗
PubMed1991

In defense of standardized regression coefficients.

The association between a risk factor and a disease can be expressed as a standardized regression coefficient derived from a logistic model. When exponentiated, this standardized coefficient equals the odds ratio associated with a one-standard-deviation change in the risk factor. Some epidemiologists have recently recommended that standardized regression coefficients not be used in epidemiologic research. We disagree and provide examples that demonstrate that, when a risk factor is continuous, standardized regression coefficients may be helpful for comparing variables measured in different units. Standardized regression coefficients may also be helpful for comparing the effect of the same risk factor in different populations. Misinterpretations can be avoided if the standard deviations of the variables of interest are also provided. There is no reason to abandon the use of standardized regression coefficients in epidemiologic analyses.

Epidemiologic Methods↗
PubMed2000

A randomized, double-blind trial of half versus standard dose of zidovudine plus zalcitabine in Thai HIV-1-infected patients (study HIV-NAT 001). HIV Netherlands Australia Thailand Research Collaboration.

BACKGROUND: Triple combination antiretroviral therapy, recommended as standard of care, is unaffordable for much of the developing world. OBJECTIVES: To establish whether half doses of zidovudine (AZT) and zalcitabine (ddC) are as effective as standard doses in a Thai population with lower body weight than Western populations and predominantly infected with HIV-1 subtype E. METHODS: A group of 116 antiretroviral naive patients, with CD4 cell counts 100-500 x 10(6) cells/l, were randomized to: AZT 200 mg three times daily plus ddC 0.75 mg three times daily versus AZT 100 mg three times daily plus ddC 0.375 mg three times daily and followed-up regularly for 48 weeks. RESULTS: The study enrolled 111 patients: 59 men and 52 women, body weight (mean +/- standard deviation) 56.4 +/- 12.3 kg, mean CD4 cell count 324 x 10(6) cells/l, mean HIV RNA 4.7 log10 copies/ml. There were no significant differences between the two groups. Twelve patients discontinued, including two deaths that were unrelated to study medication. No significant differences in adverse events were seen. Week 48 data for the standard dose and half dose arms, respectively, were mean CD4 cell count increases of 52 and 78 x 10(6) cells/l (P = 0.34), mean plasma HIV-1 RNA reduction of 1.4 and 1.1 log10 copies/ml (P = 0.10), HIV RNA of < 400 copies/ml in 52 and 20%[ (P = 0.001). Participants with higher than mean baseline CD8 cell counts (mean 1062 x 10(6) cells/l) showed greater decline in CD8 cells on standard doses. Further analysis showed improved reduction in HIV RNA (P < 0.0001) and in the percentage with undetectable HIV RNA (P = 0.0137) in the standard dose arm, corrected for baseline HIV RNA, which if < 4.75 log10 copies/ml significantly correlated with HIV RNA < 400 copies/ml at week 48. CONCLUSION: At week 48, the proportion with HIV RNA < 400 copies/ml was significantly higher in the standard dose arm; lower baseline HIV RNA correlated with better HIV RNA outcome at 48 weeks. The arms did not differ in CD4 cell response but standard doses correlated with greater CD8 cell decline.

Adult↗
PubMed1999

Effects of doxazosin in the gastrointestinal therapeutic system formulation versus doxazosin standard and placebo in mild-to-moderate hypertension. Doxazosin Investigators' Study Group.

The alpha 1-blocker doxazosin is a well-established therapy for hypertension and benign prostatic hyperplasia; however, in its standard form, a multiple-step titration regimen is usually required. The new gastrointestinal therapeutic system (GITS) formulation of doxazosin greatly minimizes the need for titration by changing drug-delivery rate and the pharmaco-kinetic profile. To demonstrate this in hypertensive patients, we assessed the effects of doxazosin GITS 4 or 8 mg once daily versus doxazosin standard 1-8 mg once daily, and placebo, in an integrated analysis of two multicenter, double-blind, randomized, parallel-group trials. Each trial included a 2-week washout period and 12 weeks of therapy. One study compared doxazosin GITS, doxazosin standard, and placebo in 392 patients with mild hypertension [blood pressure (BP) 95-105/ < or = 180 mm Hg]; the other study compared doxazosin GITS with doxazosin standard in 315 patients with mild-to-moderate hypertension (BP 95-115/ < or = 220 mm Hg). The primary outcome measure was the proportion of responders (sitting diastolic BP < 90 mm Hg or 10-mm Hg decrease from baseline 24 h after the dose) at the final visit for the per-protocol population. Mean baseline BP and heart rate were well matched in each group. Approximately 64% of patients with doxazosin GITS (198 of 309 patients) and 68% with doxazosin standard (207 of 304 patients) achieved goal BP response at the final visit versus 36% with placebo (25 of 70 patients; p < 0.05). The majority with doxazosin GITS (60%) remained at the initial 4-mg starting dose. Doxazosin GITS was as effective as doxazosin standard, and both were more effective than placebo in controlling BP in mild-to-moderate hypertension. Doxazosin GITS was well tolerated, and fewer patients with the GITS formulation discontinued therapy because of side effects compared with doxazosin standard or placebo. Syncope was not reported with doxazosin GITS. Whereas the efficacy of doxazosin GITS at 4 or 8 mg is equivalent to that of the standard regimen in this combined analysis, the GITS formulation appears to eliminate the need for titration in most patients.

Adult↗
PubMed1996

Simultaneous quantitation of cytokine mRNAs by reverse transcription-polymerase chain reaction using multiple internal standard cRNAs.

Cytokines produced in abnormal amounts or patterns contribute to many immunologically mediated human diseases. We describe a competitive reverse transcription-polymerase chain reaction (RT-PCR) assay to measure interleukin (IL)1-2, IL-4, and interferon-gamma (IFN-gamma) mRNAs within the sample. Internal standard cRNAs and native cytokine mRNAs are reverse transcribed and then amplified by PCR in the same reaction tubes to control for tube-to-tube variability in these reactions. In contrast to systems that use a single multigene internal standard cRNA, this method uses separate internal standard cRNAs for IL-2, IL-4, and IFN-gamma, allowing independent dosing of the internal standards, which reduces the number of tubes processed and the amount of starting mRNA required. Internal standards are produced from cytokine cDNAs by the insertion of short segments of DNA. The same oligonucleotide primers are used to amplify internal standard and native cytokine cDNAs. Each internal standard cDNA and its matching native cytokine cDNA are amplified with equal efficiency. The RT-PCR products of the internal standards and native cytokines are distinguished by size. This technique can detect a twofold difference in mRNA levels. Examples of using this technique to measure cytokine mRNAs in peripheral blood mononuclear cells and in bronchoalveolar lavage cells are given.

Bronchoalveolar Lavage Fluid↗
PubMed2004

Spiral stent versus standard stent in patients with midsize renal stones treated with extracorporeal shock wave lithotripsy: which stent works better? A prospective randomized trial.

PURPOSE: It has been proposed that stone fragment clearance with a new spiral Double-J stent (Medical Engineering Corp., New York, New York) is faster than with a standard Double-J stent. Therefore, we evaluated stent insertion, peri-interventional complications, as well as stone clearance in patients with midsize kidney stones treated with extracorporeal shock wave lithotripsy (3,500 shock waves) in a prospective randomized trial. MATERIALS AND METHODS: A total of 32 patients were randomized for preoperative insertion of a spiral stent (16) or a standard stent (16). Stone volume was measured from an abdominal plain film. Stent inserting time and stent handling problems, as well as perioperative and postoperative complications were evaluated. Clearance of stone fragments was analyzed by abdominal plain films and ultrasound on day 1, and at the end of weeks 1, 2 and 6 after treatment or until stone fragments were completely cleared. RESULTS: Median stone volume was 1.8 ccm (range 0.4 to 5.2) in the spiral stent group and 1.3 ccm (range 0.4 to 2.6) in the standard stent group (p = 0.08). Median stent inserting time was 21 minutes (range 10 to 60) in the spiral stent and 18 minutes (range 5 to 45) in the standard stent group (p = 0.94). Inserting difficulties occurred in 6 of 16 (38%) patients with spiral stents and in none with standard stents (p = 0.005). Spontaneous stent displacement occurred in 4 of 16 patients in the spiral stent group and did not occur in the standard stent group (p = 0.03). The percentage of stone-free patients 1 day, and 1, 2 and 6 weeks after treatment was 0%, 13%, 44% and 81% in the spiral stent group and 6%, 19%, 50% and 88% (p = 0.64) in the standard stent group, respectively. CONCLUSIONS: Spiral stents are more difficult to insert, spontaneously dislocate more often and have no advantage in overall stone clearance compared with standard stents.

Adolescent↗
PubMed2005

Evidence-based health care: development and audit of a clinical standard for research and its impact on an NHS trust.

BACKGROUND: Working within a modern National Health Service in the United Kingdom, the place for research and its dissemination is increasingly important. The organization of this within each National Health Service (NHS) Trust is challenging but nevertheless essential. If health care professionals are to be empowered to adopt an evidence-based approach in both the planning and delivery of care, research aware employees are crucial. AIMS AND OBJECTIVES: This paper highlights the importance of NHS hospital trusts implementing initiatives that will facilitate this process. One such initiative has been the development and survey of a clinical standard for research. The primary development aim was to provide a benchmark standard for all nursing research. The standard was developed to fit within the current dynamic quality improvement (DQI) programme and has directly contributed to an evolving culture of research by shaping nurses' awareness, and offering a support and consultancy network within the Trust. The standard is one aspect of a research awareness programme, with the primary objective of providing guidance and education whilst developing nurses throughout the research process. The planned strategic outcome is to see a positive outcome on the quality of research in the Trust. DESIGN: A baseline survey was conducted to provide a definitive snap shot of research understanding and practice within the Trust following the introduction of the research standard. METHODS: The standard was developed by a team of clinicians led by a member of the quality team, to ensure that it fitted the DQI structure, and a member of the Nursing Research Unit (NRU). The standard was distributed to every clinical area and 192 nurses were surveyed to evaluate its impact on their awareness of educational opportunities, their use of the consultancy and support service, their use of other support services, their research utilization and research quality. RESULTS: The survey demonstrated that the implementation of the standard had increased awareness related to both formal and informal educational and research opportunities. It identified current nurses' strengths and weaknesses relative to all aspects of the research process, particularly in obtaining ethical approval for studies. A rolling programme of research education enabled nurses to gain essential knowledge and skills in supporting their developing research awareness, consumption and conduct of research. RELEVANCE TO CLINICAL PRACTICE: The NRU, through this process, has formed an effective alliance between clinical nurses and research facilitators in promoting high quality research. The foundations to continue to support this within the Trust are now well established.

Attitude of Health Personnel↗
PubMed2006

Effect of implementing pain management standards.

BACKGROUND: Historical undertreatment of pain among inpatients has resulted in a national requirement for pain practice standards. OBJECTIVE: We hypothesized that adoption/promulgation of practice standards in January 2003 at 1 suburban teaching hospital progressively increased compliance with those standards and decreased pain. DESIGN: We retrospectively reviewed medical records each month during 2003, when pain standards were adopted with repeated, institution-wide, and nursing-unit-based interventions. Also, we reviewed discharges during 1 month in adjacent years. PATIENTS: We identified adult patients from 20 medical and surgical All-Payer Refined Disease Related Groupings (APRDRGs) in which opiate charges were most common in 2003. Among these, we considered patients actually receiving opiates and randomly chose equal numbers of matching subjects in each month of 2003. Matching was for APRDRG and complexity group. We also matched January 2003 discharges with those from January 2001, 2002, and 2004. MEASUREMENTS: For each patient, we captured 3 variables measuring standards compliance: percentage pain observations reported numerically, number of observations, and median time to reassessment after opiates. We also captured 3 pain variables: median pain score, rate of improvement in pain score, and total opiates dispensed. RESULTS: There were 360 qualifying discharges in 2003, and 75 in the other years. Numeric observations increased 15%, number of assessments 36%, and reassessment time decreased 60%. All changes were significant but occurred before standards implementation. Among pain measures, only rate of pain improvement changed, worsening slightly but significantly (-0.02 to -0.005 U/h), also before standards. CONCLUSIONS: Implementation of pain practice standards affected neither practice nor pain.

Analgesics↗
PubMed1986

The impact of pending technologies on a universal connector standard.

Standardization of pacemaker lead connectors promises to aid clinical practice. In the past, clinician concern for continued innovation has moderated calls for standardization. Today, connector standards are under consideration in the International Pacemaker Standards Working Group. Reliability, compatibility with existing implanted leads, and interchangeability between bipolar and unipolar leads are among the clinical concerns the standard process must address. Pending technologies will limit the future utility of the standard or be impeded by its regulatory imposition. Well-informed decision making in the standards process combined with a practical appraisal of the impact on future technology will help assure that, in balance, a net benefit to clinical practice results from connector standardization. The issues warrant broad review and discussion among individuals and groups interested in pacing.

Biomedical Engineering↗
PubMed1995

Controlled evaluation of BacT/alert standard anaerobic and FAN anaerobic blood culture bottles for the detection of bacteremia and fungemia.

FAN medium was formulated to improve microbial recovery, particularly for fastidious microorganisms and for microorganisms causing sepsis in patients receiving antimicrobial therapy. In a controlled clinical evaluation performed at four university-affiliated hospitals, FAN anaerobic bottles were compared with standard anaerobic bottles for yield, speed of detection of microbial growth, and detection of septic episodes. A total of 10,431 blood culture sets were received; both anaerobic bottles of 7,694 blood culture sets were adequately filled with blood. Altogether, 925 isolates were recovered: 557 that were the cause of sepsis, 99 that were indeterminate as the cause of sepsis, and 269 contaminants. More Staphylococcus aureus (P < 0.001), coagulase-negative staphylococci (P < 0.001), Escherichia coli (P < 0.02), and all microorganisms combined (P < 0.005) were recovered from FAN bottles; more nonfermentative gram-negative bacilli (P < 0.05), Torulopsis glabrata (P < 0.001), and other yeasts (P < 0.01) were recovered from standard bottles. Growth of S. aureus (P < 0.001), coagulase-negative staphylococci (P < 0.001), Enterococcus faecalis (P < 0.025), streptococci other than Streptococcus pneumoniae (P < 0.01), and all microorganisms combined (P < 0.001) was detected earlier in standard bottles; growth of more isolates of E. coli (P < 0.05) and anaerobic bacteria (P < 0.01) was detected earlier in FAN bottles. The mean times to detection were 14.2 and 16.1 h for standard and FAN bottles, respectively. More septic episodes caused by S. aureus (P < 0.001), coagulase-negative staphylococci (P < 0.005), members of the family Enterobacteriaceae (P < 0.02), and all microorganisms combined (P < 0.02) were detected in FAN bottles; more septic episodes caused by nonfermentative gram-negative bacilli (P < 0.025) and yeasts (P < 0.005) were detected in standard bottles. In summary, more isolates (except for strict aerobes) were recovered from FAN bottles than from standard anaerobic bottles. Similarly, significant more septic episodes (except for those caused by strict aerobes) were detected with FAN bottles than with standard anaerobic bottles. With the exception of E. coli and anaerobic bacteria, growth of more isolates was detected earlier in standard anaerobic bottles.

Aerobiosis↗
PubMed1989

Expression of the BZLF1 latency-disrupting gene differs in standard and defective Epstein-Barr viruses.

Previous experiments using gene transfer of plasmids with heterologous promoters identified an Epstein-Barr virus (EBV) gene (BZLF1) whose product (ZEBRA) switches the virus from a latent to a replicative state. We have now studied expression of ZEBRA in lymphoid cells harboring either standard virus or a mixture of standard and defective (heterogeneous [het]) viruses. A high-titer rabbit antiserum to a TrpE-BZLF1 fusion protein was used to identify ZEBRA expressed from standard and het EBV DNA. These ZEBRA proteins could be distinguished from each other on the basis of their electrophoretic mobilities. ZEBRA could not be detected in cells latently infected with standard EBV. However, within 6 h after induction of replication by sodium butyrate, ZEBRA appeared and persisted long thereafter. Synthesis of ZEBRA was insensitive to phosphonoacetic acid or acycloguanosine, behavior characteristic of an early replicative protein. ZEBRA was constitutively expressed in cells containing both defective and standard EBV genomes. ZEBRA was made predominantly from the het genome but also from the standard genome. Control of BZLF1 expression appears to occur at the transcriptional level. No BZLF1-specific transcript was detected in cells containing only standard latent EBV. BZLF1 transcripts could be detected in these cells if virus replication was induced by treatment with butyrate. Cells bearing both standard and het genomes did not require addition of an exogenous inducing agent to transcribe the BZLF1 gene. The experiments suggest that regulation of transcription of the BZLF1 gene is a pivotal event in the control of EBV replication.

Burkitt Lymphoma↗
PubMed2006

Peripheral arteries in diabetic patients: standard bolus-chase and time-resolved MR angiography.

PURPOSE: To prospectively determine the diagnostic performance of a combination of standard bolus-chase magnetic resonance (MR) angiography and MR angiography with time-resolved imaging of contrast kinetics (TRICKS) for depicting severity of peripheral vascular disease of the lower extremity, including the pedal arteries, in diabetic patients with digital subtraction angiography (DSA) as the reference standard. MATERIALS AND METHODS: An ethical committee approved this study; written informed consent was obtained from patients. Standard three-station and TRICKS MR angiography of the calf and foot were performed in 31 consecutive diabetic patients (23 men, eight women; mean age, 67 years; range, 43-81 years). Two readers separately assessed images of arterial segments as diagnostic or nondiagnostic and graded stenosis. Results were compared with those at DSA when the corresponding arterial segments were considered diagnostic at DSA. Wilcoxon signed rank test was used to determine if a significant difference between imaging techniques existed, and kappa statistics were used to determine interobserver agreement. RESULTS: The difference between standard MR angiography and DSA regarding the number of diagnostic segments in the thigh was not significant (P = .50). A significantly higher number of calf and foot segments was considered diagnostic at TRICKS MR angiography than at standard MR angiography (P < .025). Sixteen of 26 segments in the foot that were considered nondiagnostic at DSA were considered diagnostic at TRICKS MR angiography. Average sensitivity of standard MR angiography for depicting hemodynamically significant arterial stenosis was 84% (reader 1) and 83% (reader 2) in the thigh and 78% (reader 1) and 80% (reader 2) in the calf. For both readers, average specificity was 97% in the thigh and 90% in the calf. Sensitivity and specificity of TRICKS MR angiography in the calf and foot were improved compared with those at standard MR angiography. CONCLUSION: TRICKS MR angiography of the distal calf and pedal vessels is superior to standard MR angiography regarding the number of diagnostic segments and assessment of the degree of luminal narrowing.

Adult↗
PubMed1999

Modified standard pancreaticoduodenectomy for the treatment of pancreatic head cancer.

Since 1980 extended surgery has been used to treat pancreatic cancer in many institutions in Japan in the hope of achieving curative resection and a good outcome. The resection rate increased, but the final outcome was unsatisfactory, and the question of postoperative quality of life (QOL) following extended surgery has instead become the central issue. During the past 22 years (October 1976 to June 1998) 169 of the 188 patients with invasive pancreatic ductal carcinoma at Mie University Hospital were treated surgically. A standard operation was performed in the early period (October 1976 to April 1981, n = 34), an extended operation was performed in the middle period (May 1981 to March 1993, n = 100), and a modified standard operation was performed in the late period (April 1993 to June 1998, n = 35). 'Standard operation' means pancreaticoduodenectomy (PD) with D1 lymph node dissection (regional), and 'extended operation' means PD with D2-D3 lymph node dissection. Our 'modified standard operation' consists of PD with lymph node dissection limited to the anterior pancreaticoduodenal (APD), posterior pancreaticoduodenal (PPD), pyloric (PY), hepatoduodenal ligament (HDL), common hepatic artery (CH) and right half of the superior mesenteric (SM) nodes. Thus, the extent of lymph node dissection in the modified standard procedure lies between the level in the standard and extended procedure, but the PD is the same, with only slight modification in the reconstruction procedure. We consider the standard operation to be a less curative procedure and the extended operation to be a very stressful procedure and accordingly we have modified it (modified standard operation) in our recent cases out of consideration for patients' QOL. We found that postoperative QOL and survival were much better in the late period than in the early and middle periods.

Humans↗
PubMed1994

A randomized comparison of the effects of gradual prolonged versus standard primary balloon inflation on early and late outcome. Results of a multicenter clinical trial. Perfusion Balloon Catheter Study Group.

BACKGROUND: Observational studies have suggested that prolonged balloon inflation during coronary angioplasty is associated with a high clinical success rate. This randomized clinical trial sought to evaluate the impact of primary gradual and prolonged inflations versus standard short dilatations in patients undergoing elective angioplasty. METHODS AND RESULTS: In phase 1 of the study, patients were randomized to receive two to four standard (1 minute) dilatations or one or two prolonged (15 minutes) dilatations after a perfusion balloon had been placed across a single target lesion. Patients with unsuccessful angiographic appearance after phase 1 dilatations had further dilatations in phase 2. Patients were followed for 6 to 12 months after the procedure. Of 478 patients, 242 received a median of one prolonged dilatation of 15 minutes' duration, and 236 received three dilatations for a median of 1 minute. Patients assigned to prolonged dilatations had a higher success rate (< or = 50% residual visual stenosis) (95% versus 89%; P = .016), less severe residual stenosis by quantitative angiography (median [25th and 75th percentiles], 35% [26%, 42%] versus 38% [30%, 46%]; P = .001), and a lower rate of major dissections (3% versus 9%; P = .003) at the end of phase 1. A total of 114 patients had further dilatations in phase 2-43 in the prolonged arm and 71 in the standard arm. The final procedural success rate was 98% with both primary dilatation strategies, which included additional maneuvers such as prolonged dilatations in the patients randomized to the primary standard dilatation. Overall, 320 of 416 patients (77%) who were discharged after a successful procedure without any in-hospital event (death, myocardial infarction, coronary artery bypass graft surgery, abrupt closure, or repeat angioplasty in target vessel) returned for follow-up angiography. The restenosis rate (> 50% residual visual stenosis) was 44% (95% confidence interval, 37% to 52%) in the prolonged dilatation group and 44% (36% to 52%) in the standard dilatation group. The primary angiographic end point of failure at the end of phase 1, abrupt closure, or restenosis throughout the study period was similar in both groups (prolonged, 51%; standard, 49%; P = .62). The secondary end point of absence of clinical events (death, nonfatal myocardial infarction, coronary artery bypass graft surgery, or repeat angioplasty in target vessel) also was similar (prolonged, 66%; standard, 74%; P = .15). CONCLUSIONS: Primary gradual and prolonged dilatations caused less arterial trauma with a modestly larger arterial lumen compared with standard dilatations. This initial improvement in angiographic appearance did not lead to a significant reduction in restenosis or clinical adverse events during follow-up.

Angioplasty, Balloon, Coronary↗