Prognostic value of the Quick Sepsis-related Organ Failure Assessment (qSOFA) score among critically ill medical and surgical patients with suspected infection in a resource-limited setting.

Background: The Quick Sequential Organ Failure Assessment (qSOFA) score is a simple bedside tool validated outside of the intensive care unit (ICU) to identify patients with suspected infection who are at risk for poor outcomes. Objectives: To assess qSOFA at the time of ICU referral as a mortality prognosticator in adult medical v. surgical patients with suspected infection admitted to an ICU in a resource-limited regional hospital in South Africa (SA). Methods: We conducted a retrospective cohort study on adult medical or surgical patients that were admitted to an ICU in a resource-limited hospital in SA. We performed univariate and multivariable logistic regression and compared nested models using likelihood ratio test, and we calculated the area under the receiver operating characteristic curve (AUROC). Results: We recruited a total of 1 162 (medical n=283 and surgical n=875) participants in the study who were admitted to the ICU with suspected infection. qSOFA at the time of ICU referral was highly associated with but poorly discriminant of in-ICU mortality among medical (odds ratio (OR) 2.60, 95% confidence interval (CI) 1.19 - 5.71; p=0.02; AUROC 0.60; 95% CI 0.53 - 0.67; p=0.02) and surgical (OR 2.74; 95% CI 1.73-4.36; p<0.001; AUROC 0.60; 95% CI 0.55 - 0.65; p=0.04) patients. qSOFA model performance was similar between medical and surgical subgroups (p≥0.26). Addition of qSOFA to a baseline risk factor model including age, sex, and HIV status improved the model discrimination in both subgroups (medical AUROC 0.64; 95% CI 0.56 - 0.71; p=0.049; surgical AUROC 0.69; 95% CI 0.64 - 0.74; p<0.0001). Conclusion: qSOFA was highly associated with, but poorly discriminant for, poor outcomes among medical and surgical patients with suspected infection admitted to the ICU in a resource-limited setting. These findings suggest that qSOFA may be useful as a tool to identify patients at increased risk of mortality in these populations and in this context.

The Critical Care Society of Southern Africa Consensus Statement on ICU Triage and Rationing (ConICTri).

Background. In South Africa (SA), intensive care is faced with the challenge of resource scarcity as well as an increasing demand for intensive care unit (ICU) services. ICU services are expensive, and practitioners in low- to middle-income countries experience daily the consequences of limited resources. Critically limited resources necessitate that rationing and triage (prioritisation) decisions are frequently necessary in SA, particularly in the publicly funded health sector. Purpose. The purpose of this consensus statement is to examine key questions that arise when considering the status of ICU resources in SA, and more specifically ICU admission, rationing and triage decisions. The accompanying guideline in this issue is intended to guide frontline triage policy and ensure the best utilisation of intensive care in SA, while maintaining a fair distribution of available resources. Fair and efficient triage is important to ensure the ongoing provision of high-quality care to adult patients referred for intensive care. Recommendations. In response to 14 key questions developed using a modified Delphi technique, 29 recommendations were formulated and graded using an adapted GRADE score. The 14 key questions addressed the status of the provision of ICU services in SA, the degree of resource restriction, the efficiency of resource management, the need for triage, and how triage could be most justly implemented. Important recommendations included the need to formally recognise and accurately quantify the provision of ICU services in SA by national audit; actively seek additional resources from governmental bodies; consider methods to maximise the efficiency of ICU care; evaluate lower level of care alternatives; develop a triage guideline to assist policy-makers and frontline practitioners to implement triage decisions in an efficient and fair way; measure and audit the consequence of triage; and promote research to improve the accuracy and consistency of triage decisions. The consensus document and guideline should be reviewed and revised appropriately within 5 years. Conclusion. In recognition of the absolute need to limit patient access to ICU because of the lack of sufficient intensive care resources in public hospitals, recommendations and a guideline have been developed to guide policy-making and assist frontline triage decision-making in SA. These documents are not a complete plan for quality practice but rather the beginning of a long-term initiative to engage clinicians, the public and administrators in appropriate triage decision-making, and promote systems that will ultimately maximise the efficient and fair use of available ICU resources.

The Critical Care Society of Southern Africa Consensus Guideline on ICU Triage and Rationing (ConICTri).

Background. In South Africa (SA), administrators and intensive care practitioners are faced with the challenge of resource scarcity as well as an increasing demand for intensive care unit (ICU) services. ICU services are expensive, and practitioners in low- to middle-income countries experience the consequences of limited resources daily. Critically limited resources necessitate that rationing and triage (prioritisation) decisions are routinely necessary in SA, particularly in the publicly funded health sector. Purpose. The purpose of this guideline is to utilise the relevant recommendations of the associated consensus meeting document and other internationally accepted principles to develop a guideline to inform frontline triage policy and ensure the best utilisation of adult intensive care in SA, while maintaining the fair distribution of available resources. Recommendations. An overall conceptual framework for the triage process was developed. The components of the framework were developed on the basis that patients should be admitted preferentially when the likely incremental medical benefit derived from ICU admission justifies admission. An estimate of likely resource use should also form part of the triage decision, with those patients requiring relatively less resources to achieve substantial benefit receiving priority for admission. Thus, the triage system should maximise the benefits obtained from ICU resources available for the community. Where possible, practical examples of what the consensus group agreed would be considered appropriate practice under specified South African circumstances were provided, to assist clinicians with practical decision-making. It must be stressed that this guideline is not intended to be prescriptive for individual hospital or regional practice, and hospitals and regions are encouraged to develop specified local guidelines with locally relevant examples. The guideline should be reviewed and revised if appropriate within 5 years. Conclusion. In recognition of the absolute need to limit patient access to ICU because of the lack of sufficient intensive care resources in public hospitals, this guideline has been developed to guide policy-making and assist frontline triage decision-making in SA. This document is not a complete plan for quality practice, but rather a template to support frontline clinicians, guide administrators and inform the public regarding appropriate triage decision-making.

Can a simple test of functional capacity add to the clinical assessment of diabetes?

AIM: To identify impairment in functional capacity associated with complicated and non-complicated diabetes using the 6-min walk distance test. METHODS: We enrolled 111 adults, aged ≥40 years, with Type 2 diabetes from a hospital facility and 150 healthy control subjects of similar age and sex from a community site in Lima, Peru. All participants completed a 6-min walk test. RESULTS: The mean age of the 261 participants was 58.3 years, and 43.3% were male. Among those with diabetes, 67 (60%) had non-complicated diabetes and 44 (40%) had complications such as peripheral neuropathy, retinopathy or nephropathy. The mean unadjusted 6-min walk distances were 376 m and 394 m in adults with and without diabetes complications, respectively, vs 469 m in control subjects (P<0.001). In multivariable regression, the subjects with diabetes complications walked 84 m less far (95% CI -104 to -63 m) and those without complications walked 60 m less far (-77 to -42 m) than did control subjects. When using HbA1c level as a covariate in multivariable regression, participants walked 13 m less far (-16.9 to -9.9 m) for each % increase in HbA1c . CONCLUSIONS: The subjects with diabetes had lower functional capacity compared with healthy control subjects with similar characteristics. Differences in 6-min walk distance were even apparent in the subjects without diabetes complications. Potential mechanisms that could explain this finding are early cardiovascular disease or deconditioning.

An assessment of the risks associated with the use of antibiotic resistance genes in genetically modified plants: report of the Working Party of the British Society for Antimicrobial Chemotherapy.

Development of genetically modified (GM) plants is contentious, in part because bacterial antibiotic resistance (AR) genes are used in their construction and often become part of the plant genome. This arouses concern that cultivation of GM plants might provide a reservoir of AR genes that could power the evolution of new drug-resistant bacteria. We have considered bacterial DNA transfer systems (conjugation, transduction and transformation) and mechanisms of recombination (homologous recombination, transposition, site-specific recombination and DNA repair) that together might productively transfer AR genes from GM plants to bacterial cells, but are unable to identify a credible scenario whereby new drug-resistant bacteria would be created. However, we cannot entirely rule out the possibility of rare transfer events that involve novel mechanisms. Hence, we also considered if occasional transfers of AR genes (bla(TEM), aph(3'), aadA) from GM plants into bacteria would pose a threat to public health. These AR genes are common in many bacteria and each is found on mobile genetic elements that have moved extensively between DNA molecules and bacterial cells. This gene mobility has already severely compromised clinical use of antibiotics to which resistance is conferred. Accordingly, the argument that occasional transfer of these particular resistance genes from GM plants to bacteria would pose an unacceptable risk to human or animal health has little substance. We conclude that the risk of transfer of AR genes from GM plants to bacteria is remote, and that the hazard arising from any such gene transfer is, at worst, slight.

Quantitative fMRI assessment of the differences in lateralization of language-related brain activation in patients with temporal lobe epilepsy.

Defining language lateralization is important to minimize morbidity in patients treated surgically for temporal lobe epilepsy (TLE). Functional magnetic resonance imaging (fMRI) offers a promising, noninvasive, alternative strategy to the Wada test. Here we have used fMRI to study healthy controls and patients with TLE in order to (i) define language-related activation patterns and their reproducibility; (ii) compare lateralization determined by fMRI with those from of the Wada test; and (iii) contrast different methods of assessing fMRI lateralization. Twelve healthy right-handed controls and 19 right-handed preoperative patients with TLE (12 left- and seven right-TLE) were studied at 3T using fMRI and a verbal fluency paradigm. A Wada test also was performed on each of the patients. Greater activation was found in several areas in the right hemisphere for the left-TLE group relative to controls or right-TLE patients. Relative hemispheric activations calculated based on either the extent or the mean signal change gave consistent results showing a more bihemispheric language representation in the left-TLE patients. There was good agreement between the Wada and fMRI results, although the latter were more sensitive to involvement of the nondominant right hemisphere. The reproducibility of the fMRI values was lowest for the more bihemispherically represented left-TLE patients. Overall, our results further demonstrate that noninvasive fMRI measures of language-related lateralization may provide a practical and reliable alternative to invasive testing for presurgical language lateralization in patients with TLE. The high proportion (33%) of left-TLE patients showing bilateral or right hemispheric language-related lateralization suggests that there is considerable plasticity of language representation in the brains of patients with intractable TLE.

Non-invasive magnetic resonance imaging assessment of myocardial changes and the effects of angiotensin-converting enzyme inhibition in diabetic rats.

A non-invasive cine magnetic resonance imaging (MRI) technique was developed to allow, for the first time, detection and characterization of chronic changes in myocardial tissue volume and the effects upon these of treatment by the angiotensin-converting enzyme (ACE) inhibitor captopril in streptozotocin (STZ)-diabetic male Wistar rats. Animals that had been made diabetic at the ages of 7, 10 and 13 weeks and a captopril-treated group of animals made diabetic at the age of 7 weeks were scanned. The findings were compared with the results from age-matched controls. All animal groups (n = 4 animals in each) were consistently scanned at 16 weeks. Left and right ventricular myocardial volumes were reconstructed from complete data sets of left and right ventricular transverse sections which covered systole and most of diastole using twelve equally incremented time points through the cardiac cycle. The calculated volumes remained consistent through all twelve time points of the cardiac cycle in all five experimental groups and agreed with the corresponding post-mortem determinations. These gave consistent myocardial densities whose values could additionally be corroborated by previous reports, confirming the validity of the quantitative MRI results and analysis. The myocardial volumes were conserved in animals whose diabetes was induced at 13 weeks but were significantly increased relative to body weight in animals made diabetic at 7 and 10 weeks. Captopril treatment, which was started immediately after induction of diabetes, prevented the development of this relative hypertrophy in both the left and right ventricles. We have thus introduced and validated quantitative MRI methods in a demonstration, for the first time, of chronic myocardial changes in both the right and left ventricles of STZ-diabetic rats and their prevention by the ACE inhibitor captopril.

Antibiotic therapy of community respiratory tract infections: strategies for optimal outcomes and minimized resistance emergence.

Widespread, increasing antibiotic resistance amongst the major respiratory pathogens has compromised traditional therapy of the major infective respiratory syndromes, including bacterial pneumonia and acute exacerbations of chronic bronchitis. Guidelines for antibiotic prescribing dating from the 1980s to 1990s, which attempted to address such problems, were commonly too prescriptive and difficult to apply, and took little account of end-user practice or locally prevalent resistance levels. Further confusion was caused by conflicting recommendations emanating from differing specialty groups. The evidence that such guidelines benefited either clinical outcomes or treatment costs has been disputed. They have probably had little effect on resistance emergence. We report the recommendations of an independent, multi-national, inter-disciplinary group, which met to identify principles underlying prescribing and guideline formulation in an age of increasing bacterial resistance. Unnecessary prescribing was recognized as the major factor in influencing resistance and costs. Antibiotic therapy must be limited to syndromes in which bacterial infection is the predominant cause and should attempt maximal reduction in bacterial load, with the ultimate aim of bacterial eradication. It should be appropriate in type and context of local resistance prevalence, and optimal in dosage for the pathogen(s) involved. Prescribing should be based on pharmacodynamic principles that predict efficacy, bacterial eradication and prevention of resistance emergence. Pharmacoeconomic analyses confirm that bacteriologically more effective antibiotics can reduce overall management costs, particularly with respect to consequential morbidity and hospital admission. Application of these principles should positively benefit therapeutic outcomes, resistance avoidance and management costs and will more accurately guide antibiotic choices by both individuals and formulary/guideline committees.

The effect of anthropometric and socioeconomic factors on the racial difference in lung function.

African-Americans have lower lung function than whites. However, the relative contributions of body habitus and socioeconomic factors are unknown. To address this question, we analyzed data from 1242 white (806 women, 436 men) and 1084 African-American (696 women, 388 men) asymptomatic, nonsmoking adult participants of the third National Health and Nutrition Examination Survey (NHANES III). African-Americans were poorer, had larger FEV(1)/FVC and body mass index (BMI), but lower sitting height, FEV(1) and FVC than whites. Cross-sectional regression analyses using spirometric, anthropometric, and socioeconomic data were performed separately by sex to investigate racial differences in lung function. Sitting height accounted for 35-39% of the race difference in both sexes. Poverty index accounted for about 7.5% and 2.5% of the racial difference in women and men, respectively, whereas the effect of education accounted for about 2% in women and 4.7% in men. With further adjustment for BMI, we could account for only about half of the racial difference in FEV(1) and FVC. We conclude that the racial difference in lung function is only partially explained by a shorter upper body segment in African-Americans. Although low socioeconomic indicators are related to lower lung function, they explain only a small proportion of this racial difference.

Unpredictability of deception in compliance with physician-prescribed bronchodilator inhaler use in a clinical trial.

OBJECTIVE: To identify subject characteristics that may be predictive of intentional dumping of metered-dose inhalers (MDIs) during a clinical trial. DESIGN: Nebulizer Chronologs (NCs; Medtrac Technologies; Lakewood, CO), which record the date and time of each MDI actuation, were attached to the MDIs of participants who were given a prescribed medication schedule to follow in a clinical trial. Participants were not informed of the function of the NC or that their medication use was being monitored. SETTING: The Lung Health Study, a 5-year clinical trial to evaluate the effect of intensive smoking cessation counseling and regular use of an inhaled bronchodilator on the progression of COPD. PARTICIPANTS: One hundred one smokers, 35 to 60 years of age, with mild to moderate airways obstruction enrolled in The Lung Health Study. MEASUREMENTS AND RESULTS: Thirty of these 101 participants (30%) actuated their inhalers > 100 times within a 3-h interval on at least one occasion during the first year of this 5-year trial. Only 1 of an additional 135 participants who had full foreknowledge of the MDI monitoring capability of the NC did so. Most of these dumping episodes occurred shortly before a clinic follow-up visit, suggesting an active attempt to hide noncompliance from the clinic staff. Whereas self-reported inhaler usage and canister weights were similar for the "dumpers" and "nondumpers," NC data indicated significantly lower compliance rates for dumpers (chi(2); p < 0.05). When demographic variables, treatment and clinic assignments, smoking status, pulmonary function test results, respiratory symptoms, and disease history of dumpers and nondumpers were analyzed, no predictors of dumping could be found. CONCLUSIONS: Deception among noncompliers occurs frequently in clinical trials, is often not revealed by the usual methods of monitoring, and cannot be predicted by data readily available in clinical trials.

Clinical efficacy and antimicrobial pharmacodynamics.

Changes in the susceptibility of bacterial pathogens and the availability of new antimicrobial drugs mean that physicians need to understand the underlying pharmacodynamics of each antimicrobial therapy. Antimicrobial pharmacodynamics determine clinical efficacy and should therefore be carefully considered when selecting appropriate antibiotic agents in the therapeutic setting.

Beyond the exchange--the future of B2B.

Using the Internet to facilitate business-to-business commerce promises many benefits, such as dramatic cost reductions and greater access to buyers and sellers. Yet little is known about how B2B e-commerce will evolve. The authors argue that changes in the financial services industry over the past two decades provide important clues. Exchanges, they say, are not the primary source of value in information-intensive markets; value tends to accumulate among a diverse group of specialists that focus on such tasks as packaging, standard setting, arbitrage, and information management. Because scale and liquidity are vitally important to efficient trading, today's exchanges will consolidate into a relatively small set of mega-exchanges. Originators will handle the origination and aggregation of complex transactions before sending them on to mega-exchanges for execution. E-speculators, seeking to capitalize on an abundance of market information, will tend to concentrate where relatively standardized products can be transferred easily among a large group of buyers. In many markets, a handful of independent solution providers with well-known brand names and solid reputations will thrive alongside mega-exchanges. Sell-side asset exchanges will create the networks and provide the tools to allow suppliers to trade orders among themselves, sometimes after initial transactions with customers are made on the mega-exchanges. For many companies, traditional skills in such areas as product development, manufacturing, and marketing may become relatively less important, while the ability to understand and capitalize on market dynamics may become considerably more important.

Quality assessment through patient self-report of symptoms prefiberoptic and postfiberoptic bronchoscopy.

STUDY OBJECTIVE: To apply the principles of quality improvement to measure the frequency and severity of symptoms that result from fiberoptic bronchoscopy (FOB), and to identify opportunities to improve FOB practice by identifying factors about patients and the process of care that predict these symptoms. DESIGN: Concurrent longitudinal cohort study. PATIENTS: Four hundred ninety-three adult patients who underwent FOB. MEASUREMENTS AND RESULTS: Patients completed questionnaires just prior to FOB and again at 48 h postprocedure. Patients were asked to rate the severity of nose pain, throat pain, swallowing pain, and chest pain, and the frequency of coughing, hemoptysis, phlegm, shortness of breath, wheezing, difficulty swallowing, fever, and chills. Symptom severity was reported on a four-point ordinal scale. FINDINGS: Significant worsening was found for nose pain, throat pain, swallowing pain, and hemoptysis. Shorter patients experienced more throat pain and hemoptysis, and longer procedure time predicted nose pain and hemoptysis. CONCLUSIONS: Bronchoscopy causes nose pain, throat pain, swallowing pain, and hemoptysis to a larger extent than previously has been recognized. There are opportunities to improve the patient experience with bronchoscopy by using smaller bronchoscopes in shorter patients, shortening the procedure length, and reanesthetizing the nares in longer procedures.

Vaccine Safety Datalink project: a new tool for improving vaccine safety monitoring in the United States. The Vaccine Safety Datalink Team.

OBJECTIVE: To fill the large "gaps and limitations" in current scientific knowledge of rare vaccine adverse events identified in recent reviews of the Institute of Medicine. METHODS: Computerized information on immunization, medical outcomes, and potential confounders on more than 500 000 children 0 to 6 years of age is linked annually at several health maintenance organizations to create a large cohort for multiple epidemiologic studies of vaccine safety. RESULTS: Analysis of 3 years of follow-up data shows that 549 488 doses of diphtheria-tetanus-pertussis (DTP) and 310 618 doses of measles-mumps-rubella (MMR) vaccines have been administered to children in the study cohort. Analyses for associations between vaccines and 34 medical outcomes are underway. Screening of automated data shows that seizures are associated with receipt of DTP on the same day (relative risk [RR], 2.1; 95% confidence interval [CI], 1.1 to 4.0) and 8 to 14 days after receipt of MMR (RR, 3.0; 95% CI, 2.1 to 4.2). The diversity of vaccination exposures in this large cohort permits us to show that an apparent association of seizures 8 to 14 days after Haemophilus influenzae type b vaccine (RR, 1.6; 95% CI, 1.2 to 2.1) was attributable to confounding by simultaneous MMR vaccination; the association disappears with appropriate adjustment (RR, 1.0; 95% CI, 0.7 to 1.4). CONCLUSION: Preliminary design, data collection, and analytic capability of the Vaccine Safety Datalink project has been validated by replication of previous known associations between seizures and DTP and MMR vaccines. The diversity in vaccine administration schedules permits potential disentangling of effects of simultaneous and combined vaccinations. The project provides a model of public health-managed care collaborations in addition to an excellent infrastructure for safety and other studies of vaccines.

Risk of hospitalization because of aseptic meningitis after measles-mumps-rubella vaccination in one- to two-year-old children: an analysis of the Vaccine Safety Datalink (VSD) Project.

OBJECTIVE: To assess the level of increased risk, if any, of hospitalizations for aseptic meningitis after Jeryl-Lynn mumps strain measles-mumps-rubella (MMR) vaccine in the Vaccine Safety Datalink population. STUDY DESIGN: A possible increased risk of aseptic meningitis 8 to 14 days after receipt of MMR was observed in a preliminary screening analysis of automated data from the Vaccine Safety Datalink (VSD) project Year 2 analysis. To further evaluate this association a retrospective 10-year matched case-control study was undertaken in the four health maintenance organizations (HMOs) in the VSD project. Cases ascertained from a broad scan of the automated data were validated against a standard case definition. Two controls matched on age, sex, HMO and HMO membership were assigned per case. RESULTS: The VSD project involves the cooperative collection of automated vaccination and medical outcome data from four large HMOs that currently have 500,000 children younger than 7 years of age under surveillance. Review of automated screening results from the first 2 years of data revealed a possible increased risk of aseptic meningitis 0 to 14 days after MMR with a relative risk of 3.61 (95% confidence interval, 1.0 to 13.1) although the total number of cases was small. Although the automated data had suggested a possible association of aseptic meningitis with MMR containing the Jeryl-Lynn strain of mumps, review of validated hospitalized cases during the observation period did not reveal evidence of an increased risk of aseptic meningitis after MMR containing the Jeryl-Lynn strain of mumps (odds ratio < 1.0 for all analyses). CONCLUSION: Although it is recognized that hospitalized cases represent a minority of the total cases of aseptic meningitis, it is reassuring that in this evaluation no increased risk of aseptic meningitis after MMR vaccine was found.

Beyond JCAHO: using competency models to change healthcare organizations. Part 2: Developing competence assessment systems.

In 1996, JCAHO required hospitals to assess, prove, track, and improve the competence of all employees. This article is the second part of a review of the concept of competency assessment and the implications of meeting and exceeding the JCAHO standards. Part 1 (in the previous issue of Hospital Topics) provided the theory of competence assessment, the current situation in JCAHO surveys, and an overview of the problems inherent in competency assessment. This part puts competence assessment in the context of quality improvement and provides the details of developing competence assessment systems.

Ramifications of the Family and Medical Leave Act of 1993.

Six months ago, the Family and Medical Leave Act of 1993 was signed into law, and key provisions of the act became effective on August 5, 1993. This article examines the main provisions of the act, explains how employee leaves will be granted in compliance with the act, outlines the consequences of noncompliance with the act, analyzes the operational ramifications of the act, quantifies the financial implications of the act, and discusses the role of the healthcare financial manager in assisting with the formulation of a hospital policy to comply with the act.

Assessment of occupational exposure to organophosphates in pest control operators.

An occupational study was conducted for a firm employing 22 pest control operators (PCOs) exposed to three organophosphorus insecticides. Measurements of 8-hour exposure levels were less than: 131.0 microgram/m3 for Vaponite; 41.0 microgram/m3 for Diazinon; and 27.6 microgram/m3 for Dursban. Twenty-four-hour urines analyzed for alkyl phosphates showed the presence of metabolites for these three pesticides. The effect of this exposure is reflected by a statistically significant inhibition of plasma acetylcholinesterase (AChE) among the PCOs as AChE values of either group. Although physical examinations detected no apparent toxic effects in the study group, biological sampling results indicated a need for personal protective equipment during the handling and application of these pesticides.