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Biomedical subjects

George Wells

Publications and source records attributed to George Wells.

At least 19 recordsLinked to original sources

Prospective validation of the San Francisco Syncope Rule to predict patients with serious outcomes.

STUDY OBJECTIVE: We prospectively validate the San Francisco Syncope Rule (history of congestive heart failure, Hematocrit <30%, abnormal ECG result [new changes or non-sinus rhythm], complaint of shortness of breath, and systolic blood pressure <90 mm Hg during triage). METHODS: In a prospective cohort study, consecutive patients with syncope or near syncope presenting to an emergency department (ED) of a teaching hospital were identified and enrolled from July 15, 2002, to August 31, 2004. Patients with trauma, alcohol, or drug-associated loss of consciousness and definite seizures were excluded. Physicians prospectively applied the San Francisco Syncope Rule after their evaluation, and patients were followed up to determine whether they had had a predefined serious outcome within 30 days of their ED visit. RESULTS: Seven hundred ninety-one consecutive visits were evaluated for syncope, representing 1.2% of all ED visits. The average age was 61 years, 54% of patients were women, and 59% of patients were admitted. Fifty-three visits (6.7%) resulted in patients having serious outcomes that were undeclared during their ED visit. The rule was 98% sensitive (95% confidence interval [CI] 89% to 100%) and 56% specific (95% CI 52% to 60%) to predict these events. In this cohort, the San Francisco Syncope Rule classified 52% of the patients as high risk, potentially decreasing overall admissions by 7%. If the rule had been applied only to the 453 patients admitted, it might have decreased admissions by 24%. CONCLUSION: The San Francisco Syncope Rule performed with high sensitivity and specificity in this validation cohort and is a valuable tool to help risk stratify patients. It may help with physician decisionmaking and improve the use of hospital admission for syncope.

Arrhythmias, Cardiac↗

Shelter-based managed alcohol administration to chronically homeless people addicted to alcohol.

BACKGROUND: People who are homeless and chronically alcoholic have increased health problems, use of emergency services and police contact, with a low likelihood of rehabilitation. Harm reduction is a policy to decrease the adverse consequences of substance use without requiring abstinence. The shelter-based Managed Alcohol Project (MAP) was created to deliver health care to homeless adults with alcoholism and to minimize harm; its effect upon consumption of alcohol and use of crisis services is described as proof of principle. METHODS: Subjects enrolled in MAP were dispensed alcohol on an hourly basis. Hospital charts were reviewed for all emergency department (ED) visits and admissions during the 3 years before and up to 2 years after program enrollment, and the police database was accessed for all encounters during the same periods. The results of blood tests were analyzed for trends. A questionnaire was administered to MAP participants and staff about alcohol use, health and activities of daily living before and during the program. Direct program costs were also recorded. RESULTS: Seventeen adults with an average age of 51 years and a mean duration of alcoholism of 35 years were enrolled in MAP for an average of 16 months. Their monthly mean group total of ED visits decreased from 13.5 to 8 (p = 0.004); police encounters, from 18.1 to 8.8 (p = 0.018). Changes in blood test findings were nonsignificant. All program participants reported less alcohol consumption during MAP, and subjects and staff alike reported improved hygiene, compliance with medical care and health. INTERPRETATION: A managed alcohol program for homeless people with chronic alcoholism can stabilize alcohol intake and significantly decrease ED visits and police encounters.

Alcoholism↗

Sequential response-adapted induction and consolidation regimens idarubicin/cytarabine and mitoxantrone/etoposide in adult acute myelogenous leukemia: 10 year follow-up of a study by the Canadian Leukemia Studies Group.

PURPOSE: The Canadian Leukemia Studies Group (CLSG) sought to test the safety and efficacy of response-adapted, non-cross resistant chemotherapy in de novo acute myeloid leukemia (AML). The combinations of idarubicin 12 mg/m(2)/d on days 1 - 3 and Ara-C (200 mg/m(2)/d) on days 1 - 7 (IDAC) followed by mitoxantrone 10 mg/m(2)/day, and etoposide 100 mg/m(2)/day, on days 1 - 5 (NOVE) were used according to patient response to induction and consolidation. PATIENTS AND METHODS: In this multi-centre open-label phase II study, 140 patients up to age 80 were given induction with IDAC. Patients were entered between March 1993 and August 1995. If patients had persistent blasts at day 14 or on recovery, they were given NOVE. As consolidation, patients achieving complete remission (CR) with IDAC were given 1 further cycle of IDAC and 1 cycle of NOVE. Patients achieving CR after NOVE were given 2 further cycles of NOVE. RESULTS: 76% of all patients achieved remission after IDAC +/- NOVE, 81% in patients aged < or =60 years and 67% in patients aged >60. Overall, induction mortality was 11% and toxicity was similar to other cooperative group studies. Median follow-up was 104.0 months with 95% CI: (100.0, 105.2). Median overall survival (OS) in responding patients < or =60 was not reached: of the 79 responders < or =60, 35 died. The median disease free survival (DFS) in these responding patients was 22.7 (14.9, na) months. Median OS and DFS in responding patients >60 was 10.0 (7.3, 15.2) months and 7.5 (6.2, 15.2) months, respectively. CONCLUSION: The results of this trial are very encouraging and suggest that there may be long-term benefit to this method. On the basis of these results, a randomized phase III trial has been performed.

Adult↗

Transcutaneous electrical nerve stimulation for the treatment of chronic low back pain: a systematic review.

STUDY DESIGN: Systematic review. OBJECTIVE: To determine the effectiveness of transcutaneous electrical nerve stimulation (TENS) in the management of chronic LBP. SUMMARY OF BACKGROUND DATA: Chronic low back pain (LBP) affects a significant proportion of the population. TENS was introduced more than 30 years ago as an adjunct to pharmacologic pain management. However, despite its widespread use, the usefulness of TENS in chronic LBP is still controversial. METHODS: We searched MEDLINE, EMBASE, PEDro, and the Cochrane Central Register of Controlled Trials (Issue 2, 2005), up to April 1, 2005. Only randomized controlled clinical trials (RCTs) evaluating the effect of TENS on chronic LBP were included. Two reviewers independently selected trials and extracted data using predetermined forms. Heterogeneity was tested with Cochrane's Q test. A fixed effect model was used throughout for calculating continuous variables, except where heterogeneity existed, in which case a random effects model was used. Results are presented as weighted mean differences with 95% confidence intervals (95% CI), where the difference between the treated and control groups was weighted by the inverse of the variance. Standardized mean differences were calculated by dividing the difference between the treated and control by the baseline variance. Standardized mean differences were used when different scales were used to measure the same concept. Dichotomous outcomes were analyzed with odds ratios. RESULTS: Two RCTs (175 patients) were included. They differed with respect to study design, methodologic quality, inclusion and exclusion criteria, characteristics of TENS application, treatment schedule, cointerventions, and measured outcomes. In one RCT, TENS produced significantly greater pain relief than the placebo control. However, in the other RCT, no statistically significant differences between treatment and control groups were shown for multiple outcome measures. Preplanned subgroup analyses, intended to examine the impact of different stimulation parameters, sites of TENS application, treatment durations, and baseline patient characteristics were not possible because of the small number of included trials. CONCLUSIONS: Evidence for the efficacy of TENS as an isolated intervention in the management of chronic LBP is limited and inconsistent. Larger, multicenter, RCTs are needed to better resolve its role in this condition. Increased attention should be given to the risks and benefits of long-term use, which more appropriately addresses the realities of managing chronic low back pain.

Chronic Disease↗

Out-of-hospital pediatric cardiac arrest: an epidemiologic review and assessment of current knowledge.

STUDY OBJECTIVE: We systematically summarize pediatric out-of-hospital cardiac arrest epidemiology and assess knowledge of effects of specific out-of-hospital interventions. METHODS: We conducted a comprehensive review of published articles from 1966 to 2004, available through MEDLINE, Cumulative Index to Nursing and Allied Health Literature, EmBase, and the Cochrane Registry, describing outcomes of children younger than 18 years with an out-of-hospital cardiac arrest. Patient characteristics, process of care, and outcomes were compared using pediatric Utstein outcome report guidelines. Effects of out-of-hospital care processes on survival outcomes were summarized. RESULTS: Forty-one studies met inclusion criteria; 8 complied with Utstein reporting guidelines. Included in the review were 5,363 patients: 12.1% survived to hospital discharge, and 4% survived neurologically intact. Trauma patients (n=2,299) had greater overall survival (21.9%, 6.8% intact); a separate examination of studies with more rigorous cardiac arrest definition showed poorer survival (1.1% overall, 0.3% neurologically intact). Submersion injury-associated arrests (n=442) had greater overall survival (22.7%, 6% intact). Pooled data analysis of bystander cardiopulmonary resuscitation and witnessed arrest status showed increased likelihood of survival (relative risk 1.99, 95% confidence interval 1.54 to 2.57) for witnessed arrests. The effect of bystander cardiopulmonary resuscitation is difficult to determine because of study heterogeneity. CONCLUSION: Outcomes from out-of-hospital pediatric cardiac arrest are generally poor. Variability may exist in survival by patient subgroups, but differences are hard to accurately characterize. Conformity with Utstein guidelines for reporting and research design is incomplete. Witnessed arrest status remains associated with improved survival. The need for prospective controlled trials remains a high priority.

Adolescent↗

A randomized trial comparing 2 low-molecular-weight heparins for the outpatient treatment of deep vein thrombosis and pulmonary embolism.

BACKGROUND: Low-molecular-weight heparins (LMWHs) are now standard therapy for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). No published trials have compared LMWHs, and few studies have examined outpatient therapy for PE. Only tinzaparin sodium has demonstrated superiority to unfractionated heparin in a clinical trial. METHODS: We compared 2 LMWH products, tinzaparin and dalteparin sodium, for the treatment of acute DVT and PE in a randomized, controlled clinical trial of consecutive outpatients presenting to a venous thromboembolism service at 4 tertiary-care hospitals. Patients were treated with subcutaneous tinzaparin sodium, 175 IU/kg every 24 hours, or subcutaneous dalteparin sodium, 200 IU/kg every 24 hours, for at least 5 days. Warfarin sodium therapy was started simultaneously and continued for 90 days. The primary end point was efficacy (recurrence of venous thromboembolism); safety (bleeding) was a composite end point. RESULTS: Two hundred fifty-four patients received tinzaparin (39 with PE and 215 with DVT) and 251 received dalteparin (51 with PE and 200 with DVT). Most patients had an active malignancy or idiopathic DVT/PE. The outcome events occurred in 11 (4.4%; 95% confidence interval [CI], 2.2%-7.7%) and 15 patients (5.9%; 95% CI, 3.3%-9.5%) in the dalteparin and tinzaparin groups, respectively, including 9 and 10 recurrences, respectively, and 2 and 5 major hemorrhages, respectively (P = .44). The 95% CI on the difference of -1.5% was -5.3% to 2.4%. CONCLUSIONS: Tinzaparin and dalteparin are safe and effective for the outpatient treatment of DVT or PE. Our finding of no differences between the LMWHs based on major clinical end points means that practical issues can be the deciding factor on which drug to use.

Acute Disease↗

Randomized controlled trial on low level laser therapy (LLLT) in the treatment of osteoarthritis (OA) of the hand.

BACKGROUND AND OBJECTIVES: Low level laser therapy (LLLT) offers promising symptomatic relief of osteoarthritic (OA) pain. We examined efficacy of active LLLT versus sham LLLT on finger joints and three superficial nerves. STUDY DESIGN/MATERIALS AND METHODS: OA-patients randomly assigned, received three treatments per week for 6 weeks of LLLT (n = 42) or sham LLLT (n = 46). RESULTS: Pain relief, morning stiffness, and functional status did not significantly improve for LLLT versus placebo. No significant differences were found in finger range of motion, except carpometacarpal opposition (P = 0.011), grip strength, and patient global assessment which improved for active LLLT participants (P = 0.041). CONCLUSIONS: LLLT is no better than placebo at reducing pain, morning stiffness, or improving functional status for OA-hand patients.

Aged↗

Does cryosupernatant plasma improve outcome in thrombotic thrombocytopenic purpura? No answer yet.

A randomized prospective trial compared cryosupernatant plasma (CSP) to fresh frozen plasma (FFP) for treatment of thrombotic thrombocytopenic purpura (TTP). A total of 236 patients were required: 28 patients were treated with CSP and 24 with FFP within 30 months. There were no differences in survival at 1 month. By day 9, 17 of 26 patients with CSP and 18 of 24 with FFP had a platelet count >100 x 10(9)/l. At entry, von Willebrand factor (VWF) multimers were normal in all patients (range 1.1-3.95 IU/ml). ADAMTS-13 levels showed large variations ranging from 10% to 100% activity. At entry, no individual had <5% VWF cleaving protease. By day 9 (end of cycle), 89% (FFP) and 67% (CSP) had levels >50% of the controls. At 6 months some patients showed inhibitors to the enzyme in spite of adequate or normal platelet counts. The data from this study do not show an apparent advantage to the use of CSP in TTP. A large number of patients will be required to determine appropriate replacement therapy. We were not able to find a statistically significant relationship between the low level of protease activity at presentation of TTP and response.

ADAM Proteins↗

Consumer-driven health care: building partnerships in research.

Over the past four decades, there has been a widespread movement to increase the involvement of patients and the public in health care. Strategies to effectively foster consumer participation are occurring within all research activities from research priority setting to utilization. One of the ten principles of the Cochrane Collaboration is to 'enable wide participation', and this includes consumers. The Cochrane Musculoskeletal Group (CMSG) is a review group of 50 within the Collaboration that has been working to increase consumer participation since its inception in 1993. Based in Canada, the CMSG has embraced the concept of knowledge translation as advocated by the Canadian Institutes of Health Research. The emphasis in knowledge translation is on interactions or partnerships between researchers and users to facilitate the use of relevant research in decision making. While the CMSG recognizes the importance of reaching all users, much of its work has focused on developing relationships with people with musculoskeletal diseases to enhance consumer participation in research. The CMSG has built a network of consumer members who guide research priorities, peer review systematic reviews and also promote and facilitate consumer-appropriate knowledge dissemination. Consumers were recruited through links with other arthritis organizations and the recruitment continues. Specific roles were established for the consumer team and responsibilities of the CMSG staff developed. The continuing development of a diversified team of consumer participants enables the CMSG to produce and promote access to high quality relevant systematic reviews and summaries of those reviews to the consumer.

Biomedical Research↗

Prostaglandin E vaginal gel to treat dystocia in spontaneous labour: a multicentre randomised placebo-controlled trial.

OBJECTIVE: To test the safety and efficacy of prostaglandin E(2) (PgE(2)) as a treatment for dystocia in spontaneous labour. DESIGN: Randomised, double-blind, placebo-controlled trial. SETTING: Multicentre study in nine university-affiliated hospitals in Canada. Population Three hundred and thiry-two nulliparous women with spontaneous labour at term. METHODS: Women who had progressed < 2 cm of cervical dilation in the 4 hours following the diagnosis of labour were randomly assigned to receive a single dose of either 1 mg (n= 112) or 2 mg (n= 111) PgE(2) vaginal gel or placebo gel (n= 109). MAIN OUTCOME MEASURES: The primary outcome was resolution of dystocia, defined as a change in cervical dilatation of >0.5 cm per hour in the 6 hours following gel administration. Secondary outcomes were progress of labour, uterine hyperstimulation (more than five contractions in 10 minutes or a contraction lasting more than 2 minutes), use of oxytocin, method of delivery, maternal and neonatal morbidity. RESULTS: Dystocia resolved more often after PgE(2) 1 mg (49%), RR 1.53 (95% CI 1.1, 2.1) and PgE(2) 2 mg (49%), RR 1.5 (CI 1.1, 2.1), compared with placebo (32%). Hyperstimulation was increased after PgE(2) 2 mg treatment (15%), RR 5.6 (95% CI 1.7, 18), but not after PgE(2) 1 mg (5.4%), RR 1.9 (CI 0.50, 7.6) when compared with placebo (2.8%). There was an increase in caesarean sections performed in the second stage of labour in the PgE(2) groups versus placebo. There were no differences in measures of maternal or neonatal morbidity. CONCLUSION: A single 1-mg dose of PgE(2) vaginal gel is more effective than placebo in resolving dystocia, without increasing uterine hyperstimulation, but may be associated with an increase in the incidence of second stage caesarean section.

Adult↗

Use of implantable cardioverter defibrillators after out-of-hospital cardiac arrest: a prospective follow-up study.

BACKGROUND: Survivors of out-of-hospital cardiac arrest are at high risk of recurrent arrests, many of which could be prevented with implantable cardioverter defibrillators (ICDs). We sought to determine the ICD insertion rate among survivors of out-of-hospital cardiac arrest and to determine factors associated with ICD implantation. METHODS: The Ontario Prehospital Advanced Life Support (OPALS) study is a prospective, multiphase, before-after study assessing the effectiveness of prehospital interventions for people experiencing cardiac arrest, trauma or respiratory arrest in 19 Ontario communities. We linked OPALS data describing survivors of cardiac arrest with data from all defibrillator implantation centres in Ontario. RESULTS: From January 1997 to April 2002, 454 patients in the OPALS study survived to hospital discharge after experiencing an out-of-hospital cardiac arrest. The mean age was 65 (standard deviation 14) years, 122 (26.9%) were women, 398 (87.7%) had a witnessed arrest, 372 (81.9%) had an initial rhythm of ventricular tachycardia or ventricular fibrillation (VT/VF), and 76 (16.7%) had asystole or another arrhythmia. The median cerebral performance category at discharge (range 1-5, 1 = normal) was 1. Only 58 (12.8%) of the 454 patients received an ICD. Patients with an initial rhythm of VT/VF were more likely than those with an initial rhythm of asystole or another rhythm to undergo device insertion (adjusted odds ratio [OR] 9.63, 95% confidence interval [CI] 1.31-71.50). Similarly, patients with a normal cerebral performance score were more likely than those with abnormal scores to undergo ICD insertion (adjusted OR 12.52, 95% CI 1.74-92.12). INTERPRETATION: A minority of patients who survived cardiac arrest underwent ICD insertion. It is unclear whether this low usage rate reflects referral bias, selection bias by electrophysiologists, supply constraint or patient preference.

Age Distribution↗

Factors associated with pressure ulcers in adults in acute care hospitals.

OBJECTIVES: To identify and describe the relationship of factors associated with pressure ulcers in adults in acute care hospitals. DESIGN: Cross-sectional prevalence studies. SETTING: University teaching hospital. PATIENTS: Prevalence studies conducted from 1993 to 1995 with a total of 1992 subjects served as the derivation sample and a 1996 prevalence study with 581 subjects served as the validation sample. MAIN OUTCOME MEASURES: Pressure ulcers and the Braden risk assessment subscale scores. DATA ANALYSIS: Logistic regression analysis was used to derive a model that fit the data and performed well at identifying factors associated with pressure ulcers. Performance of the model, in terms of calibration, was statistically evaluated using the Hosmer-Lemeshow goodness-of-fit test. The effectiveness of the model, in terms of discrimination, was assessed by considering the cut-off values using 2 by 2 classification tables to measure the overall percentage of subjects correctly classified in the validation sample. MAIN RESULTS: Factors associated with pressure ulcers in adults in acute care hospitals were identified as age, male gender, sensory perception, moisture, mobility, nutrition, and friction/shear. Three interactions were also found to be associated with pressure ulcers; 2 interactions (age and sensory perception and moisture and sensory perception) were negatively associated and 1 interaction (nutrition and gender/male) was positively associated with pressure ulcers. The Hosmer-Lemeshow goodness-of-fit test for the derivation sample (.76) and the validation sample (.79) indicated that the model was well calibrated and a good fit. The overall percentage of subjects correctly classified using the validation sample was 88%, indicating that the model performed well. CONCLUSIONS: : This study enhances the knowledge of the relationship of factors associated with pressure ulcers in adults in acute care populations and enhances the use and relative importance of particular Braden Scale sub-scales.

Acute Disease↗

The effect of adjuvant calcium phosphate coating on a porous-coated femoral stem.

A prospective, randomized, double-blind, multicenter trial was done to determine if the addition of hydroxyapatite and tricalcium phosphate to the porous coating of a cementless femoral component would result in improved clinical and radiographic outcomes. Patients were randomized to receive identical porous-coated stems with (n = 159 hips) or without (n = 159 hips) hydroxyapatite and tricalcium phosphate coating. At 2 to 5 years followup (mean, 37 months), no implants were revised for aseptic loosening. There was no difference in clinical function between the two groups with respect to the Harris hip score or Western Ontario and McMaster Universities Osteoarthritis Index scores. Bony ingrowth occurred frequently in both groups with 99% of the hydroxyapatite and tricalcium phosphate group and 98% of the control group showing radiographic evidence of osseointegration. Implants coated with hydroxyapatite and tricalcium phosphate had significantly fewer radiolucencies adjacent to the porous coating, indicative of improved osseointegration. Radiolucencies were present in Gruen Zones 1, 7, 8, or 14 in 25% of the control group and in 7% of the hydroxyapatite and tricalcium phosphate group. This improved osseointegration could serve as an added barrier to particulate debris migration and increase the long-term survivorship of the implant.

Calcium Phosphates↗

Is a restrictive transfusion strategy safe for resuscitated and critically ill trauma patients?

BACKGROUND: An analysis from the prospective multicenter randomized controlled trial (Transfusion Requirements in Critical Care Trial) compared the use of restrictive and liberal transfusion strategies with resuscitated critically ill trauma patients. METHODS: Critically ill trauma patients with a hemoglobin concentration less than 90 g/L within 72 hours of admission to the intensive care unit were randomized to a restrictive (hemoglobin concentration, 70 g/L) or liberal (hemoglobin concentration, 100 g/L) red blood cell transfusion strategy. RESULTS: The baseline characteristics in the restrictive (n = 100) and liberal (n = 103) transfusion groups were comparable. The average hemoglobin concentrations (82.7 +/- 6.2 g/L vs. 104.3 +/- 12.2 g/L; p < 0.0001) and the red blood cell units transfused per patient (2.3 +/- 4.4 vs. 5.4 +/- 4.3; p < 0.0001) were significantly lower in the restrictive group than in the liberal group. The 30-day all-cause mortality rates in the restrictive group were 10%, as compared with 9% in the liberal group (p = 0.81). The presence of multiple organ dysfunction (9.2 +/- 6.3 vs. 9.0 +/- 6.0; p = 0.81), the changes in multiple organ dysfunction from baseline scores adjusted for death (1.2 +/- 6.1 vs. 1.9 +/- 5.7; p = 0.44), and the length of stay in the intensive care unit (9.8 +/- 8.1 vs. 10.2 +/- 8.7 days; p = 0.73) and hospital (31.4 +/- 17.1 vs. 33.7 +/- 17.7 days; p = 0.34) also were similar between the restrictive and liberal transfusion groups. CONCLUSIONS: A restrictive red blood cell transfusion strategy appears to be safe for critically ill multiple-trauma patients. A randomized controlled trial would provide the appropriate level of evidence with regard to the daily use of blood in this population of patients.

Adult↗

Efficacy of continuous passive motion following total knee arthroplasty: a metaanalysis.

OBJECTIVE: The objective of this metaanalysis is to examine the effectiveness of continuous passive motion (CPM) following total knee arthroplasty (TKA). METHODS: This metaanalysis used the methodology proposed by the Cochrane Collaboration. RESULTS: This review of 14 studies (952 patients) found significant improvements in active knee flexion and analgesic use 2 weeks postoperatively with the use of CPM and physiotherapy (PT) compared to PT alone. In addition, length of hospital stay and need for knee manipulations were significantly decreased in the CPM group. Not enough data were available to compare the degree of knee flexion applied or number of hours of application of CPM. However, significant results were not found for other comparisons such as short term CPM application versus longterm CPM application and wide treatment range versus small treatment range for the outcomes of active knee flexion, passive knee flexion and extension, presence of a fixed flexion deformity, use of analgesic, or total knee range of motion. CONCLUSION: CPM combined with PT may offer beneficial results for patients post-TKA. However, the potential benefits will need to be carefully weighed against the inconvenience and expense of CPM. More research is necessary to assess the differences in effectiveness with different characteristics of application such as total duration of treatment and intensity of CPM interventions.

Arthritis, Rheumatoid↗

Health-related quality of life is better for cardiac arrest survivors who received citizen cardiopulmonary resuscitation.

BACKGROUND: This study evaluated the prehospital factors associated with better health-related quality of life for survivors of out-of-hospital cardiac arrest. METHODS AND RESULTS: This prospective, 20-community, cohort study involved consecutive, adult out-of-hospital cardiac arrest patients who survived to 1 year. Patients were contacted by telephone and evaluated for the Health Utilities Index Mark III (HUI3), which describes health as a utility score on a scale from 0 (dead) to 1.0 (perfect health). The 8091 cardiac arrest patients had overall survival rates of 5.2% to hospital discharge and 4.0% to 1 year. We successfully contacted and evaluated 268 of 316 (84.8%) of known 1-year survivors. The median HUI3 score was 0.80 (interquartile range, 0.50 to 0.97), which compares well with age-adjusted values for the general population (0.83). Logistic regression identified 2 factors independently associated with very good quality of life (HUI3 >0.90) and their odds ratios (95% CIs), as follows: age 80 years or older, 0.3 (0.1 to 0.84), and citizen-initiated cardiopulmonary resuscitation (CPR), 2.0 (1.2 to 3.4) (Hosmer-Lemeshow goodness-of-fit statistic, 0.74). CONCLUSIONS: This study is the largest ever conducted for out-of-hospital cardiac arrest survivors, clearly shows that these patients have good quality of life, and is the first to demonstrate that citizen-initiated CPR is strongly and independently associated with better quality of life. These results emphasize the importance of optimizing community citizen CPR readiness. Given the low rate of citizen-initiated CPR in many communities, we believe that local and national initiatives should vigorously promote the practice of bystander CPR.

Aged↗

Outpatient oral prednisone after emergency treatment of chronic obstructive pulmonary disease.

BACKGROUND: In this randomized, double-blind, placebo-controlled trial, we studied the effectiveness of prednisone in reducing the risk of relapse after outpatient exacerbations of chronic obstructive pulmonary disease (COPD). METHODS: We enrolled 147 patients who were being discharged from the emergency department after an exacerbation of COPD and randomly assigned them to 10 days of treatment with 40 mg of oral prednisone once daily or identical-appearing placebo. All patients received oral antibiotics for 10 days, plus inhaled bronchodilators. The primary end point was relapse, defined as an unscheduled visit to a physician's office or a return to the emergency department because of worsening dyspnea, within 30 days after randomization. RESULTS: The overall rate of relapse at 30 days was lower in the prednisone group than in the placebo group (27 percent vs. 43 percent, P=0.05), and the time to relapse was prolonged in those taking prednisone (P=0.04). After 10 days of therapy, patients in the prednisone group had greater improvements in forced expiratory volume in one second than did patients in the placebo group (mean [+/-SD] increase from base line, 34+/-42 percent vs. 15+/-31 percent; P=0.007). Patients in the prednisone group also had significant improvements in dyspnea, as measured by the transitional dyspnea index (P=0.04) and by the dyspnea domain of the Chronic Respiratory Disease Index Questionnaire (P=0.02), but not in health-related quality of life (P=0.14). CONCLUSIONS: Outpatient treatment with oral prednisone offers a small advantage over placebo in treating patients who are discharged from the emergency department with an exacerbation of COPD.

Acute Disease↗

Evaluation of outcome and cost-effectiveness using an FDG PET-guided approach to management of patients with coronary disease and severe left ventricular dysfunction (PARR-2): rationale, design, and methods.

Patients with severe ventricular dysfunction and coronary disease have high morbidity and mortality. They may benefit from revascularization but have significant perioperative morbidity and mortality. Positron emission tomography (PET) imaging with F-18-fluorodeoxyglucose (FDG) can detect viable myocardium that may recover from revascularization in such patients. It is unclear whether use of FDG PET in this population improves outcome or is cost-effective. The principal aim of this study is to determine whether FDG PET-guided therapy improves clinical outcome compared to standard care. Secondary objectives are to determine whether FDG PET-guided therapy improves left ventricular (LV) function, improves quality of life, and provides a cost benefit versus standard care. Included in this multicenter randomized controlled trial are patients with coronary artery disease and severe LV dysfunction who are referred for revascularization, heart failure, or cardiac transplantation or in whom FDG PET is potentially useful. Consenting subjects will be randomized to therapy directed by FDG PET or standard care. The primary outcome is the composite cardiovascular endpoint of cardiac death, myocardial infarction, transplantation, or rehospitalization for unstable angina or heart failure. Secondary outcomes include health-related quality of life, costs, mortality, cardiovascular events, and LV function. Assuming two-sided alpha=0.05, power=80%, a sample size of 206 patients per group is required to detect a 15% absolute difference in the primary outcome between PET-directed therapy compared to standard care. Analyses will be conducted on an intention-to-treat basis. To our knowledge, this is the first large trial to evaluate whether FDG PET-directed therapy is effective and provides a cost benefit in patients with severe LV dysfunction. If so, thousands of such patients can be risk-stratified to select who is likely to benefit from revascularization.

Cost-Benefit Analysis↗