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Context: Activation of the coagulation system and depletion of endogenous anticoagulants are frequently found in patients with severe sepsis and septic shock. Diffuse microthrombus formation may induce organ dysfunction and lead to excess mortality in septic shock. Antithrombin III may provide protection from multiorgan failure and improve survival in severely ill patients.Objective: To determine if high-dose antithrombin III (administered within 6 hours of onset) would provide a survival advantage in patients with severe sepsis and septic shock.Design and Setting: Double-blind, placebo-controlled, multicenter phase 3 clinical trial in patients with severe sepsis (the KyberSept Trial) was conducted from March 1997 through January 2000.Patients: A total of 2314 adult patients were randomized into 2 equal groups of 1157 to receive either intravenous antithrombin III (30 000 IU in total over 4 days) or a placebo (1% human albumin).Main Outcome Measure: All-cause mortality 28 days after initiation of study medication.Results: Overall mortality at 28 days in the antithrombin III treatment group was 38.9% vs 38.7% in the placebo group (P =.94). Secondary end points, including mortality at 56 and 90 days and survival time in the intensive care unit, did not differ between the antithrombin III and placebo groups. In the subgroup of patients who did not receive concomitant heparin during the 4-day treatment phase (n = 698), the 28-day mortality was nonsignificantly lower in the antithrombin III group (37.8%) than in the placebo group (43.6%) (P =.08). This trend became significant after 90 days (n = 686; 44.9% for antithrombin III group vs 52.5% for placebo group; P =.03). In patients receiving antithrombin III and concomitant heparin, a significantly increased bleeding incidence was observed (23.8% for antithrombin III group vs 13.5% for placebo group; P<.001).Conclusions: High-dose antithrombin III therapy had no effect on 28-day all-cause mortality in adult patients with severe sepsis and septic shock when administered within 6 hours after the onset. High-dose antithrombin III was associated with an increased risk of hemorrhage when administered with heparin. There was some evidence to suggest a treatment benefit of antithrombin III in the subgroup of patients not receiving concomitant heparin. [ABSTRACT FROM AUTHOR] more...

Context: Several nutrients have been shown to influence immunologic and inflammatory responses in humans. Whether these effects translate into an improvement in clinical outcomes in critically ill patients remains unclear.Objective: To examine the relationship between enteral nutrition supplemented with immune-enhancing nutrients and infectious complications and mortality rates in critically ill patients.Data Sources: The databases of MEDLINE, EMBASE, Biosis, and CINAHL were searched for articles published from 1990 to 2000. Additional data sources included the Cochrane Controlled Trials Register from 1990 to 2000, personal files, abstract proceedings, and relevant reference lists of articles identified by database review.Study Selection: A total of 326 titles, abstracts, and articles were reviewed. Primary studies were included if they were randomized trials of critically ill or surgical patients that evaluated the effect of enteral nutrition supplemented with some combination of arginine, glutamine, nucleotides, and omega-3 fatty acids on infectious complication and mortality rates compared with standard enteral nutrition, and included clinically important outcomes, such as mortality.Data Extraction: Methodological quality of individual studies was scored and necessary data were abstracted in duplicate and independently.Data Synthesis: Twenty-two randomized trials with a total of 2419 patients compared the use of immunonutrition with standard enteral nutrition in surgical and critically ill patients. With respect to mortality, immunonutrition was associated with a pooled risk ratio (RR) of 1.10 (95% confidence interval [CI], 0.93-1.31). Immunonutrition was associated with lower infectious complications (RR, 0.66; 95% CI, 0.54-0.80). Since there was significant heterogeneity across studies, we examined several a priori subgroup analyses. We found that studies using commercial formulas with high arginine content were associated with a significant reduction in infectious complications and a trend toward a lower mortality rate compared with other immune-enhancing diets. Studies of surgical patients were associated with a significant reduction in infectious complication rates compared with studies of critically ill patients. In studies of critically ill patients, studies with a high-quality score were associated with increased mortality and a significant reduction in infectious complication rates compared with studies with a low-quality score.Conclusion: Immunonutrition may decrease infectious complication rates but it is not associated with an overall mortality advantage. However, the treatment effect varies depending on the intervention, the patient population, and the methodological quality of the study. [ABSTRACT FROM AUTHOR] more...

Context: Whether venous catheterization at the femoral site is associated with an increased risk of complications compared with that at the subclavian site is debated.Objective: </bold>To compare mechanical, infectious, and thrombotic complications of femoral and subclavian venous catheterization.Design and Setting: Concealed, randomized controlled clinical trial conducted between December 1997 and July 2000 at 8 intensive care units (ICUs) in France.Patients: Two hundred eighty-nine adult patients receiving a first central venous catheter.Interventions: Patients were randomly assigned to undergo central venous catheterization at the femoral site (n = 145) or subclavian site (n = 144).Main Outcome Measures: Rate and severity of mechanical, infectious, and thrombotic complications, compared by catheterization site in 289, 270, and 223 patients, respectively.Results: Femoral catheterization was associated with a higher incidence rate of overall infectious complications (19.8% vs 4.5%; P<.001; incidence density of 20 vs 3.7 per 1000 catheter-days) and of major infectious complications (clinical sepsis with or without bloodstream infection, 4.4% vs 1.5%; P =.07; incidence density of 4.5 vs 1.2 per 1000 catheter-days), as well as of overall thrombotic complications (21.5% vs 1.9%; P<.001) and complete thrombosis of the vessel (6% vs 0%; P =.01); rates of overall and major mechanical complications were similar between the 2 groups (17.3% vs 18.8 %; P =.74 and 1.4% vs 2.8%; P =.44, respectively). Risk factors for mechanical complications were duration of insertion (odds ratio [OR], 1.05; 95% confidence interval [CI], 1.03-1.08 per additional minute; P<.001); insertion in 2 of the centers (OR, 4.52; 95% CI, 1.81-11.23; P =.001); and insertion during the night (OR, 2.06; 95% CI, 1.04-4.08; P =.03). The only factor associated with infectious complications was femoral catheterization (hazard ratio [HR], 4.83; 95% CI, 1.96-11.93; P<.001); antibiotic administration via the catheter decreased risk of infectious complications (HR, 0.41; 95% CI, 0.18-0.93; P =.03). Femoral catheterization was the only risk factor for thrombotic complications (OR, 14.42; 95% CI, 3.33-62.57; P<.001).Conclusion: Femoral venous catheterization is associated with a greater risk of infectious and thrombotic complications than subclavian catheterization in ICU patients. [ABSTRACT FROM AUTHOR] more...

This series provides clinicians with strategies and tools to interpret and integrate evidence from published research in their care of patients. The 2 key principles for applying all the articles in this series to patient care relate to the value-laden nature of clinical decisions and to the hierarchy of evidence postulated by evidence-based medicine. Clinicians need to be able to distinguish high from low quality in primary studies, systematic reviews, practice guidelines, and other integrative research focused on management recommendations. An evidence-based practitioner must also understand the patient's circumstances or predicament; identify knowledge gaps and frame questions to fill those gaps; conduct an efficient literature search; critically appraise the research evidence; and apply that evidence to patient care. However, treatment judgments often reflect clinician or societal values concerning whether intervention benefits are worth the cost. Many unanswered questions concerning how to elicit preferences and how to incorporate them in clinical encounters constitute an enormously challenging frontier for evidence-based medicine. Time limitation remains the biggest obstacle to evidence-based practice but clinicians should seek evidence from as high in the appropriate hierarchy of evidence as possible, and every clinical decision should be geared toward the particular circumstances of the patient. [ABSTRACT FROM AUTHOR] more...

Quantitative research is designed to test well-specified hypotheses, determine whether an intervention did more harm than good, and find out how much a risk factor predisposes persons to disease. Equally important, qualitative research offers insight into emotional and experiential phenomena in health care to determine what, how, and why. There are 4 essential aspects of qualitative analysis. First, the participant selection must be well reasoned and their inclusion must be relevant to the research question. Second, the data collection methods must be appropriate for the research objectives and setting. Third, the data collection process, which includes field observation, interviews, and document analysis, must be comprehensive enough to support rich and robust descriptions of the observed events. Fourth, the data must be appropriately analyzed and the findings adequately corroborated by using multiple sources of information, more than 1 investigator to collect and analyze the raw data, member checking to establish whether the participants' viewpoints were adequately interpreted, or by comparison with existing social science theories. Qualitative studies offer an alternative when insight into the research is not well established or when conventional theories seem inadequate. JAMA. 2000;284:357-362 [ABSTRACT FROM AUTHOR] more...

Context: Early administration of thrombolysis for acute myocardial infarction (AMI) may improve survival if safely and appropriately delivered. No systematic reviews that have comprehensively examined this topic exist in the literature.Objective: To perform a meta-analysis of randomized controlled trials of prehospital vs in-hospital thrombolysis for AMI measuring in-hospital mortality.Data Sources: The Cochrane search strategy was used to search MEDLINE, EMBASE, and the Science Citation Index (1982-1999); Dissertation Abstracts (1987-1999); and Current Contents (1994-1999) for the terms thrombolysis, thrombolysis therapy, prehospital, and acute myocardial infarction. In addition, text and journal article bibliographies were hand searched, the National Institutes of Health Web site was reviewed, and primary authors and thrombolytic drug manufacturers were contacted for unpublished studies.Study Selection: Randomized controlled trials of prehospital vs in-hospital thrombolysis for AMI measuring all-cause hospital mortality were included. Two authors independently reviewed 175 citations by title, abstract, or complete article. After exclusion of 30 duplicate citations, 145 studies remained, of which 6 studies and 3 follow-up studies met the inclusion criteria.Data Extraction: Independent data abstraction by 2 reviewers blinded to the journal, title, and author was confirmed by consensus. Trial quality was independently assessed by 2 other coauthors, blinded to the author, title, journal, introduction, and discussion.Data Synthesis: The results of the 6 randomized trials (n=6434) were pooled and indicated significantly decreased all-cause hospital mortality among patients treated with prehospital thrombolysis compared with in-hospital thrombolysis (odds ratio, 0.83; 95% confidence interval, 0.70-0.98). Results were similar regardless of trial quality or training and experience of the provider. Estimated (SE) time to thrombolysis was 104 (7) minutes for the prehospital group and 162 (16) minutes for the in-hospital thrombolysis group (P=.007).Conclusions: Our meta-analysis suggests that prehospital thrombolysis for AMI significantly decreases the time to thrombolysis and all-cause hospital mortality. JAMA. 2000;283:2686-2692. [ABSTRACT FROM AUTHOR] more...

Context: Endotracheal intubation (ETI) is widely used for airway management of children in the out-of-hospital setting, despite a lack of controlled trials demonstrating a positive effect on survival or neurological outcome.Objective: To compare the survival and neurological outcomes of pediatric patients treated with bag-valve-mask ventilation (BVM) with those of patients treated with BVM followed by ETI.Design: Controlled clinical trial, in which patients were assigned to interventions by calendar day from March 15, 1994, through January 1, 1997.Setting: Two large, urban, rapid-transport emergency medical services (EMS) systems.Participants: A total of 830 consecutive patients aged 12 years or younger or estimated to weigh less than 40 kg who required airway management; 820 were available for follow-up.Interventions: Patients were assigned to receive either BVM (odd days; n = 410) or BVM followed by ETI (even days; n = 420).Main Outcome Measures: Survival to hospital discharge and neurological status at discharge from an acute care hospital compared by treatment group.Results: There was no significant difference in survival between the BVM group (123/404 [30%]) and the ETI group (110/416 [26%]) (odds ratio [OR], 0.82; 95% confidence interval [CI], 0.61-1.11) or in the rate of achieving a good neurological outcome (BVM, 92/404 [23%] vs ETI, 85/416 [20%]) (OR, 0.87; 95% CI, 0.62-1.22).Conclusion: These results indicate that the addition of out-of-hospital ETI to a paramedic scope of practice that already includes BVM did not improve survival or neurological outcome of pediatric patients treated in an urban EMS system. [ABSTRACT FROM AUTHOR] more...

Background: The Quality of Reporting of Meta-analyses (QUOROM) conference was convened to address standards for improving the quality of reporting of meta-analyses of clinical randomised controlled trials (RCTs).Methods: The QUOROM group consisted of 30 clinical epidemiologists, clinicians, statisticians, editors, and researchers. In conference, the group was asked to identify items they thought should be included in a checklist of standards. Whenever possible, checklist items were guided by research evidence suggesting that failure to adhere to the item proposed could lead to biased results. A modified Delphi technique was used in assessing candidate items.Findings: The conference resulted in the QUOROM statement, a checklist, and a flow diagram. The checklist describes our preferred way to present the abstract, introduction, methods, results, and discussion sections of a report of a meta-analysis. It is organised into 21 headings and subheadings regarding searches, selection, validity assessment, data abstraction, study characteristics, and quantitative data synthesis, and in the results with "trial flow", study characteristics, and quantitative data synthesis; research documentation was identified for eight of the 18 items. The flow diagram provides information about both the numbers of RCTs identified, included, and excluded and the reasons for exclusion of trials.Interpretation: We hope this report will generate further thought about ways to improve the quality of reports of meta-analyses of RCTs and that interested readers, reviewers, researchers, and editors will use the QUOROM statement and generate ideas for its improvement. [ABSTRACT FROM AUTHOR] more...

Context: Despite the success of some countries in controlling endemic methicillin-resistant Staphylococcus aureus (MRSA), such programs have not been implemented for some hospitals with endemic infection because of concerns that these programs would be costly and of limited benefit.Objective: To compare the costs and benefits of an MRSA control program in an endemic setting.Design and Setting: Case-control study conducted at a medical intensive care unit (ICU) of a French university hospital with a 4% prevalence of MRSA carriage at ICU admission.Patients: Twenty-seven randomly selected patients who had ICU-acquired MRSA infection between January 1993 and June 1997, matched to 27 controls hospitalized during the same period without MRSA infection.Main Outcome Measures: Intensive care unit costs attributable to MRSA infection, computed from excess therapeutic intensity in cases using estimates from a cost model derived in the same ICU, were compared with costs of the control program, derived from time-motion study of nurses and physicians. The threshold for MRSA carriage that would make the control strategy dominant was determined; sensitivity analyses varied rates of MRSA transmission and ratio of infection to transmission, length of ICU stay, and costs of isolation precautions.Results: The mean cost attributable to MRSA infection was US $9275 (median, $5885; interquartile range, $1400-$16,720). Total costs of the control program ranged from $340 to $1480 per patient. A 14% reduction in MRSA infection rate resulted in the control program being beneficial. In sensitivity analyses, the control strategy was dominant for a prevalence of MRSA carriage on ICU admission ranging from 1% to 7%, depending on costs of control measures and MRSA transmission, for infection rates greater than 50% following transmission.Conclusions: In this example of a hospital with endemic MRSA infection, selective screening and isolation of carriers on ICU admission are beneficial compared with no isolation. [ABSTRACT FROM AUTHOR] more...

Context: Relapses of acute asthma following emergency department (ED) discharge can be reduced with systemic corticosteroid treatment. However, whether inhaled corticosteroids (ICSs) provide additional benefit is not known. Objective To determine whether the addition of ICSs to oral corticosteroid treatment would reduce relapses in patients with acute asthma discharged from the ED.Design and Setting: Placebo-controlled, double-blind, randomized clinical trial conducted in a community teaching hospital ED in Canada between November 1995 and September 1997, with a 21-day follow-up.Participants: A total of 1006 consecutive patients aged 16 to 60 years presented to the ED with acute asthma; after excluding those using oral and/or inhaled corticosteroids as well as those meeting other exclusion criteria, 188 were included in the study.Interventions: Patients were discharged with a nontapering course of oral prednisone (50 mg/d) for 7 days. In a double-blind fashion, patients were randomly assigned to 1600 microg/d of inhaled budesonide (n = 94) or identical placebo (n = 94) for 21 days.Main Outcome Measures: Incidence of relapse, defined as an unscheduled visit for worsening asthma symptoms, in budesonide vs placebo groups. Secondary outcomes included response to the Asthma Quality of Life Questionnaire, beta2-agonist use, symptom score, global asthma improvement assessment, and pulmonary function.Results: Five patients in the budesonide group and 3 in the placebo group either dropped out or were lost to follow-up but were included in primary analyses. After 21 days, 12 (12.8%) of 94 patients in the budesonide group experienced a relapse compared with 23 (24.5%) of 94 in the placebo group, a 48% relapse reduction (P=.049). Asthma Quality of Life Questionnaire scores were higher (better quality) in the budesonide group (P=.001), as well as for all domain scores (P=.001 to .01). Fewer beta2-agonist activations were used at the end of the trial by patients receiving budesonide (2.4/d vs 4.2/d; P=.01). Symptom scores (P=.001 to .004) and self-assessed asthma improvement scores (based on a 7-point Likert scale) (6.2 vs 5.2; P<.001) were higher (indicating fewer symptoms) for budesonide vs placebo. There were no differences in pulmonary function between the groups (peak expiratory flow rate: budesonide, 437 vs placebo, 453 L/min; P= .39) at 21 days. Using this approach, as few as 9 patients would require budesonide to prevent 1 relapse.Conclusions: Patients discharged from the ED following treatment for acute asthma benefit from added treatment with high-dose inhaled budesonide for 21 days compared with oral corticosteroids alone. [ABSTRACT FROM AUTHOR] more...

Clinicians can often find treatment recommendations in traditional narrative reviews and the discussion sections of original articles and meta-analyses. Making a treatment recommendation involves framing a question, identifying management options and outcomes, collecting and summarizing evidence, and applying value judgments or preferences to arrive at an optimal course of action. Each step in this process can be conducted systematically (thus protecting against bias) or unsystematically (leaving the process open to bias). Clinicians faced with a plethora of recommendations may wish to attend to those that are less likely to be biased. Therefore, we propose a hierarchy of rigor of recommendations to guide clinicians when judging the usefulness of particular recommendations. Recommendations with the highest rigor consider all relevant options and outcomes, include a comprehensive collection of the methodologically highest quality data with an explicit strategy for summarizing the data (that is, a systematic review), and make an explicit statement of the values or preferences involved in moving from evidence to action. High rigor recommendations come from systematically developed, evidence-based practice guidelines or rigorously conducted decision analyses. Systematic reviews, which typically do not consider all relevant options and outcomes or make the preferences underlying recommendations explicit, offer intermediate rigor recommendations. Traditional approaches in which the collection and assessment of evidence remains unsystematic, all relevant options and outcomes may not be considered, and values remain implicit, provide recommendations of weak rigor. In an era in which clinicians are barraged by recommendations as to how to manage their patients, this hierarchy provides a potentially useful set of guides. [ABSTRACT FROM AUTHOR] more...

Disease management is an approach to patient care that emphasizes coordinated, comprehensive care along the continuum of disease and across health care delivery systems. Evidence-based medicine is an approach to practice and teaching that integrates pathophysiological rationale, caregiver experience, and patient preferences with valid and current clinical research evidence. Using diabetes mellitus as an example, we describe the importance of evidence-based medicine to the development of disease management programs. We present a method for developing and implementing evidence-based clinical guidelines, clinical pathways, and algorithms and describe the creation of systems to measure and report processes and outcomes that could drive quality improvement in diabetes care. Multidisciplinary teams are ideally suited to develop, lead, and implement evidence-based disease management programs, since they play an essential role in the preventive, diagnostic, and therapeutic decisions for patients with diabetes throughout the course of their disease. [ABSTRACT FROM AUTHOR] more...

Objective: To review the effect of calcium supplementation during pregnancy on blood pressure, preeclampsia, and adverse outcomes of pregnancy.Data Source: We searched MEDLINE and EMBASE for 1966 to May 1994. We contacted authors of eligible trials to ensure accuracy and completeness of data and to identify unpublished trials.Study Selection: Fourteen randomized trials involving 2459 women were eligible.Data Extraction: Reviewers working independently in pairs abstracted data and assessed validity according to six quality criteria.Data Synthesis: Each trial yielded differences in blood pressure change between calcium supplementation and control groups that we weighted by the inverse of the variance. The pooled analysis showed a reduction in systolic blood pressure of -5.40 mm Hg (95% confidence interval [CI], -7.81 to -3.00 mm Hg; P<.001) and in diastolic blood pressure of -3.44 mm Hg (95% CI, -5.20 to -1.68 mm Hg; P<.001). The odds ratio for preeclampsia in women with calcium supplementation compared with placebo was 0.38 (95% CI, 0.22 to 0.65).Conclusions: Calcium supplementation during pregnancy leads to an important reduction in systolic and diastolic blood pressure and preeclampsia. While pregnant women at risk of preeclampsia should consider taking calcium, many more patient events are needed to confirm calcium's impact on maternal and fetal morbidity. [ABSTRACT FROM AUTHOR] more...

Background: To develop the Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: ACCP Evidence-Based Clinical Practice Guidelines (AT9), the American College of Chest Physicians (ACCP) assembled a panel of clinical experts, information scientists, decision scientists, and systematic review and guideline methodologists.Methods: Clinical areas were designated as articles, and a methodologist without important intellectual or financial conflicts of interest led a panel for each article. Only panel members without significant conflicts of interest participated in making recommendations. Panelists specified the population, intervention and alternative, and outcomes for each clinical question and defined criteria for eligible studies. Panelists and an independent evidence-based practice center executed systematic searches for relevant studies and evaluated the evidence, and where resources and evidence permitted, they created standardized tables that present the quality of the evidence and key results in a transparent fashion.Results: One or more recommendations relate to each specific clinical question, and each recommendation is clearly linked to the underlying body of evidence. Judgments regarding the quality of evidence and strength of recommendations were based on approaches developed by the Grades of Recommendations, Assessment, Development, and Evaluation Working Group. Panel members constructed scenarios describing relevant health states and rated the disutility associated with these states based on an additional systematic review of evidence regarding patient values and preferences for antithrombotic therapy. These ratings guided value and preference decisions underlying the recommendations. Each topic panel identified questions in which resource allocation issues were particularly important and, for these issues, experts in economic analysis provided additional searches and guidance.Conclusions: AT9 methodology reflects the current science of evidence-based clinical practice guideline development, with reliance on high-quality systematic reviews, a standardized process for quality assessment of individual studies and the body of evidence, an explicit process for translating the evidence into recommendations, disclosure of financial as well as intellectual conflicts of interest followed by management of disclosed conflicts, and extensive peer review. [ABSTRACT FROM AUTHOR] more...

Background: This guideline addressed VTE prevention in hospitalized medical patients, outpatients with cancer, the chronically immobilized, long-distance travelers, and those with asymptomatic thrombophilia.Methods: This guideline follows methods described in Methodology for the Development of Antithrombotic Therapy and Prevention of Thrombosis Guidelines: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines in this supplement.Results: For acutely ill hospitalized medical patients at increased risk of thrombosis, we recommend anticoagulant thromboprophylaxis with low-molecular-weight heparin (LMWH), low-dose unfractionated heparin (LDUH) bid, LDUH tid, or fondaparinux (Grade 1B) and suggest against extending the duration of thromboprophylaxis beyond the period of patient immobilization or acute hospital stay (Grade 2B). For acutely ill hospitalized medical patients at low risk of thrombosis, we recommend against the use of pharmacologic prophylaxis or mechanical prophylaxis (Grade 1B). For acutely ill hospitalized medical patients at increased risk of thrombosis who are bleeding or are at high risk for major bleeding, we suggest mechanical thromboprophylaxis with graduated compression stockings (GCS) (Grade 2C) or intermittent pneumatic compression (IPC) (Grade 2C). For critically ill patients, we suggest using LMWH or LDUH thromboprophylaxis (Grade 2C). For critically ill patients who are bleeding or are at high risk for major bleeding, we suggest mechanical thromboprophylaxis with GCS and/or IPC at least until the bleeding risk decreases (Grade 2C). In outpatients with cancer who have no additional risk factors for VTE we suggest against routine prophylaxis with LMWH or LDUH (Grade 2B) and recommend against the prophylactic use of vitamin K antagonists (Grade 1B).Conclusions: Decisions regarding prophylaxis in nonsurgical patients should be made after consideration of risk factors for both thrombosis and bleeding, clinical context, and patients' values and preferences. [ABSTRACT FROM AUTHOR] more...

This chapter describes the system used by the American College of Chest Physicians to grade recommendations for antithrombotic and thrombolytic therapy as part of the Antithrombotic and Thrombolytic Therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Clinicians need to know if a recommendation is strong or weak, and the methodologic quality of the evidence underlying that recommendation. We determine the strength of a recommendation by considering the balance between the desirable effects of an intervention and the undesirable effects (incremental harms, burdens, and for select recommendations, costs). If the desirable effects outweigh the undesirable effects, we recommend that clinicians offer an intervention to typical patients. The uncertainty associated with the balance between the desirable and undesirable effects will determine the strength of recommendations. If we are confident that benefits do or do not outweigh harms, burden, and costs, we make a strong recommendation in our formulation, Grade 1. If we are less certain of the magnitude of the benefits and risks, burden, and costs, and thus their relative impact, we make a weaker Grade 2 recommendation. For grading methodologic quality, randomized controlled trials (RCTs) begin as high-quality evidence (designated by "A"), but quality can decrease to moderate ("B"), or low ("C") as a result of poor design and conduct of RCTs, imprecision, inconsistency of results, indirectness, or a high likelihood for reporting bias. Observational studies begin as low quality of evidence (C) but can increase in quality on the basis of very large treatment effects. Strong (Grade 1) recommendations can be applied uniformly to most patients. Weak (Grade 2) suggestions require more judicious application, particularly considering patient values and preferences and, when resource limitations play an important role, issues of cost. [ABSTRACT FROM AUTHOR] more...

Purpose: This study describes the evaluation of a 2-year plan to train 10 percent of Kansas' multidisciplinary health professionals for response to terrorism and emerging infections. This project was part of a national effort covering 19 states funded by the Health Resources and Services Administration in 2003.Methods: The initial training occurred in six 2-day workshops. A terrorism preparedness questionnaire was developed to assess Health Resources and Services Administration terrorism response competencies/learning objectives. These were measured before, after, and 3 months after training in a hybrid cross-sectional and cohort follow-up design.Results: Health professionals' mean scores significantly improved on all four Health Resources and Services Administration terrorism self-reported competencies from pretest to posttest. Three months posttraining, health professionals' mean scores decreased slightly but remained significantly higher than their pretest scores.Conclusions: This project prepared healthcare professionals to respond to the medical consequences of terrorism. The integration of core competencies into the evaluation plan allowed for trainees to evaluate their confidence and abilities. The evaluation plan and curriculum may serve as useful tools for preparation of healthcare workers nationwide, with the potential to rebuild the public health infrastructure to assume preparedness responsibilities. [ABSTRACT FROM AUTHOR] more...

Oncology services have been provided by telemedicine from the University of Kansas Medical Center (KUMC) for almost 10 years. We have analysed the costs associated with providing tele-oncology clinics to a rural Kansas town for two fiscal years, 1995 and 2000. The aim was to compare recent tele-oncology costs with those of the first year of tele-oncology practice. A study conducted in 1995 showed that the average cost was $812 per telemedicine consultation. Data from fiscal year 2000 showed that the average cost was $410 per telemedicine consultation, a decrease of almost 50%. As the tele-oncology practice in Kansas continues to grow, it can be expected that the costs associated with providing tele-oncology services will continue to decline. [ABSTRACT FROM AUTHOR] more...

In contrast to primarily deductive quantitative research, qualitative research aims to interpret data to develop theoretical insights that describe and explain phenomena such as interactions, experiences, roles, perspectives, and organizations. In this review, we summarize qualitative studies that used primarily in-depth personal interviews as a data collection method and a grounded theory analytic approach. The liberal use of illustrative excerpts and interpretive descriptions offer clinicians vicarious accounts of patient experiences of weaning from mechanical ventilation. Important experiences of patients during their weaning from mechanical ventilation included frustration, uncertainty, hopelessness, fear, and lack of mastery. The extent to which, in at least some patients, these experiences were determinants of weaning failure, consequences of weaning failure, or both, was difficult to establish. An assumption of this genre of research is that if clinicians understand the lived experiences of patients, they can better appreciate patient needs during the weaning process, and by inference, their role as clinicians during weaning from mechanical ventilation. [ABSTRACT FROM AUTHOR] more...

Health-care professionals (HCPs) can provide protocol-based care that has a measurable impact on critically ill patients beyond their liberation from mechanical ventilation (MV). Randomized controlled trials have demonstrated that protocols for liberating patients from MV driven by nonphysician HCPs can reduce the duration of MV. The structure and features of protocols should be adapted from published protocols to incorporate patient-specific needs, clinician preferences, and institutional resources. As a general approach, shortly after patients demonstrate that their condition has been stabilized on the ventilator, a spontaneous breathing trial (SBT) is safe to perform and is indicated. Ventilator management strategies for patients who fail a trial of spontaneous breathing include the following: (1) consideration of all remediable factors (such as electrolyte derangements, bronchospasm, malnutrition, patient positioning, and excess secretions) to enhance the prospects of successful liberation from MV; (2) use of a comfortable, safe, and well-monitored mode of MV (such as pressure support ventilation); and (3) repeating a trial of spontaneous breathing on the following day. For patients who pass the SBT, the decision to extubate must be guided by clinical judgment and objective data to minimize the risk of unnecessary reintubations and self-extubations. Protocols should not represent rigid rules but, rather, guides to patient care. Moreover, the protocols may evolve over time as clinical and institutional experience with them increases. Useful protocols aim to safely and efficiently liberate patients from MV, reducing unnecessary or harmful variations in approach. [ABSTRACT FROM AUTHOR] more...

We identified three randomized controlled trials (RCTs) that addressed whether preextubation steroid administration reduces postextubation complications in children. The pooled analysis of primary extubation in children demonstrated significantly less stridor (relative risk [RR], 0.57; 95% confidence interval [CI], 0.40 to 0.81) and a trend toward less reintubation (RR, 0.50; 95% CI, 0.02 to 13.87) with corticosteroids. One non-RCT in children who had failed extubation the first time found a significant reduction in duration of prolonged reintubation (> or = 6 days) and in failed reextubations. The four RCTs in adults reported very low reintubation rates, and no conclusions can be drawn. Only one RCT assessed postextubation stridor and found little difference. Overall, we found that corticosteroids decreased the risk of postextubation stridor in children by about 40%. However, the effect of corticosteroids in children and adults to reduce postextubation complications such as reintubation is uncertain. [ABSTRACT FROM AUTHOR] more...

We identified 16 randomized controlled trials (RCTs) of methods for weaning patients from mechanical ventilation, 8 of which were trials of discontinuation assessment strategies, 5 of which were trials of stepwise reduction in mechanical ventilatory support, and 3 of which were trials comparing alternative ventilation modes for weaning periods lasting < 48 h. We found that different thresholds for deciding when a patient is ready for a trial of spontaneous breathing, different criteria for a successful trial, and different thresholds for extubation may overwhelm the impact of alternative ventilation strategies. Nevertheless, the results of these studies suggest the possibility that multiple daily T-piece weaning or pressure support may be superior to synchronized intermittent mandatory ventilation. Other RCTs suggest that early extubation with the back-up institution of noninvasive positive-pressure ventilation as needed may be a useful strategy in selected patients. [ABSTRACT FROM AUTHOR] more...

Introduction: Death is universal, yet relatively little is known about how Canadians experience their death. Using novel decedent interview data from the Canadian Longitudinal Study on Aging we describe the prevalence and characteristics of peace with dying among older Canadians., Methods: We conducted a secondary analysis of decedent interview data from the Canadian Longitudinal Study on Aging. Proxies of deceased Canadian Longitudinal Study on Aging participants reported on participants' end-of-life experiences between January 2012 to March 2022. We examined end-of-life characteristics and their association with proxy reports of experiencing peace with dying. We conducted regression analysis to explore the association between demographic and end-of-life characteristics and experiencing peace with dying., Results: Of 3,672 deceased participants, 1,287 (35.0%) had a completed decedent questionnaire and were included in the analysis. Respondents reported that two-thirds (66.0%) of the deceased experienced peace with dying and 17% did not experience peace with dying. The unadjusted odds of experiencing peace with dying were higher for those with an appointed power of attorney (OR 1.80; CI 1.39-2.33), those who died of cancer (OR 1.71; CI 1.27-2.30), those in hospice/receiving palliative care (OR 1.67; CI 1.19-2.37), individuals older than 75 years (OR 1.55; CI 1.04-2.30), or widowed (OR 1.53; CI 1.12-2.10). Widowhood (OR 1.51; CI 1.01-2.29), having an end-of-life SDM (OR 1.58; CI 1.14-2.17), and dying of cancer (OR 1.67; CI 1.19-2.23) increased the adjusted odds of dying with peace., Conclusions: Close to 1 in 5 older Canadians may not experience peace with dying, which supports greater focus on improving the end-of-life care. Our findings suggest that advanced planning may enhance the experience of a peaceful death in Canada., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2025 Aryal et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.) more...

Background: Surviving COVID-19 critical illness may be associated with important long-term sequelae, but little is known regarding mental health outcomes., Research Question: What is the association between COVID-19 critical illness and new mental health diagnoses after discharge?, Study Design and Methods: We conducted a population-based cohort study in Ontario, Canada (January 1, 2020-March 31, 2022). We included consecutive adult survivors (age ≥ 18 years) of COVID-19 critical illness and compared them with consecutive adult survivors of critical illness from non-COVID-19 pneumonia. The primary outcome was a new mental health diagnosis (a composite of mood, anxiety, or related disorders; schizophrenia or psychotic disorders; and other mental health disorders) after hospital discharge. We compared patients using overlap propensity score-weighted, cause-specific proportional hazard models., Results: We included 6,098 survivors of COVID-19 critical illness and 2,568 adult survivors of critical illness from non-COVID-19 pneumonia at 102 centers. Incidence of new mental health diagnosis among survivors of COVID-19 critical illness was 25.3 diagnoses per 100 person-years (95% CI, 24.0-26.6 diagnoses), and 25.9 diagnoses per 100 person-years (95% CI, 24.0-27.8 diagnoses) among survivors of non-COVID-19 pneumonia. After propensity weighting, COVID-19 critical illness was not associated with increased risk of new mental health diagnosis overall (hazard ratio [HR], 1.08; 95% CI, 0.96-1.23), but was associated with increased risk in the category of new mood, anxiety, or related disorders (HR, 1.21; 95% CI, 1.05-1.40). No difference was seen in psychotic disorders, other mental health diagnoses, social problems, or deliberate self-harm., Interpretation: As compared with survival after critical illness resulting from non-COVID-19 pneumonia, survival after COVID-19 critical illness was not associated with increased risk of the composite outcome of new mental health diagnosis, but was associated with elevated risk of new mood, anxiety, or related disorders., Clinical Trial Registry: Center for Open Science; URL: www.archive.org/details/osf-registrations-pfn6q-v1., Competing Interests: Financial/Nonfinancial Disclosures The authors have reported to CHEST the following: E. F. reports receiving personal fees from ALung Technologies, Aerogen, Baxter, Boehringer-Ingelheim, GE Healthcare, Inspira, and Vasomune outside of the submitted work. M. M. S. reports financial or in-kind support from AstraZeneca, Otsuka, Bayer, and GlaxoSmithKline outside of the submitted work. D. M. N. reports financial or in-kind support for consultancy or research from Baxter Healthcare Corporation, and Reck Medical Devices, outside of the submitted work. D. B. reports receiving research support from and is a consultant for LivaNova, outside of the submitted work; has been on the medical advisory boards for Abiomed, Xenios, Medtronic, Inspira, and Cellenkos; and he writes for UpToDate. A. S. S. reports consulting for Baxter International, Inc., and Xenios. K. K. reports receiving personal fees from Edwards Life Sciences, outside of the submitted work. None declared (S. M. F., D. Q., R. T., D. I. M., S. N. V., D. T. M., C. L. H., B. R., L. M., K. M. F., O. J. B., N. D. F., R. A. F., D. J. C., D. C. S., M. S. H., P. T.)., (Copyright © 2025. Published by Elsevier Inc.) more...

Background: Ambient air pollution, detrimental built and social environments, social isolation (SI), low socioeconomic status (SES), and rural (versus urban) residence have been associated with cognitive decline and risk of Alzheimer's disease and related dementias (ADRD). Research is needed to investigate the influence of ambient air pollution and built and social environments on SI and cognitive decline among rural, disadvantaged, ethnic minority communities. To address this gap, this cohort study will recruit an ethnoracially diverse, rural Florida sample in geographic proximity to seasonal agricultural burning. We will (1) examine contributions of smoke-related fine particulate matter (PM2.5) exposures to SI and cognitive function; (2) determine effects of built and social environments on SI and cognitive function; and (3) contextualize SI and cognitive function among residents from different ethnoracial groups during burn and non-burn seasons., Methods: We will recruit 1,087 community-dwelling, dementia-free, ≥45-year-olds from five communities in Florida's Lake Okeechobee region. Over 36 months, participants will complete baseline visits to collect demographics, health history, and health measurements (e.g., blood pressure, body mass index) and 6-month follow-ups assessing cognitive function and social isolation at each visit. A subsample of 120 participants representative of each community will wear smartwatches to collect sensor data (e.g., heart rate) and daily routine and predefined activities (e.g., GPS-captured travel, frequent destinations) over two months. Ecological momentary assessments (EMA) (e.g., whether smoke has bothered participant in last 30 minutes) will occur over two months during agricultural burning and non-burning months. PurpleAir monitors (36 total) will be installed in each community to continuously monitor outdoor PM2.5 levels., Discussion: We expect to identify individual- and community-level factors that increase the risk for SI and cognitive decline in a vulnerable rural population., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2025 Besser et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.) more...