Biomedical subjects

E Francis Cook

Publications and source records attributed to E Francis Cook.

At least 19 recordsLinked to original sources

PubMed2007

Linking surveillance to action: incorporation of real-time regional data into a medical decision rule.

OBJECTIVE: Broadly, to create a bidirectional communication link between public health surveillance and clinical practice. Specifically, to measure the impact of integrating public health surveillance data into an existing clinical prediction rule. We incorporate data about recent local trends in meningitis epidemiology into a prediction model differentiating aseptic from bacterial meningitis. DESIGN AND MEASUREMENTS: Retrospective analysis of a cohort of all 696 children with meningitis admitted to a large urban pediatric hospital from 1992 to 2000. We modified a published bacterial meningitis score by adding a new epidemiological context adjustor variable. We examined 540 possible rules for this adjustor, varying both the number of aseptic meningitis cases that needed to be seen, and the recent time window in which they were seen. We performed sensitivity analyses with each of 540 possibilities in order to identify the optimal rule--namely, the one that included the most cases of aseptic meningitis without missing additional cases of bacterial meningitis, as compared with the published prediction model. We used bootstrap methods to validate this new score. RESULTS: The optimal rule was found to be: "at least four cases of aseptic meningitis in the previous 10 days." The epidemiological context adjustor based on surveillance of recent cases of meningitis allowed the correct identification of an additional 47 cases (7%) of aseptic meningitis without missing any additional cases of bacterial meningitis. The epidemiological context adjustor was validated, showing significance in 84% of 1,000 bootstrap samples. CONCLUSION: Epidemiological contextual information can improve the performance of a clinical prediction rule. We provide a methodological framework for leveraging regional surveillance data to improve medical decision-making.

Child↗

PubMed2007

Advance care planning in patients undergoing hematopoietic cell transplantation.

Few data are available on the prevalence of advance care planning (ACP) in patients undergoing hematopoietic cell transplantation (HCT). We surveyed adult patients pre-HCT to ascertain completion of various elements of ACP. We also reviewed medical records for documentation of discussions regarding ACP and for the presence of written advance directives. Evaluable surveys were returned by 155 of 335 patients (46%) who underwent HCT during the study period; we obtained permission for medical record review from 137 of these 155 survey respondents (88%). We found that 69% of the respondents reported having designated a health care proxy, 44% had completed a living will, 61% had prepared an estate will, and 63% had discussed their wishes regarding life support with family and friends. In contrast, only 16% had discussed their wishes regarding life support with their clinicians. Documentation of discussions between clinicians and patients regarding most elements of ACP was rare. Written advance directives were present in the charts of 54 patients (39%). ACP was more common in older, college-educated, and allogeneic transplant patients. Even though ACP was more prevalent among this sample than in the general population, its use still could be enhanced, given the high risks of decisional incapacity and death that HCT patients face.

Adult↗

PubMed2006

Validation of the asthma impact survey, a brief asthma-specific quality of life tool.

BACKGROUND: The Asthma Impact Survey (AIS-6) is a new six question asthma outcome tool for which information on validity has not been published. OBJECTIVE: To provide validation for the AIS-6 as a brief asthma-specific quality of life tool. METHODS: Surveys were sent to a random sample of members of a large managed care organization who were at least 35 years of age and in the two-year period preceding the survey had either (1) at least one documented asthma-related medical encounter, or (2) at least a 6 months supply of asthma medication dispensed. In addition to the AIS-6, the survey included a validated quality of life tool [the mini-Asthma Quality of Life Questionnaire (AQLQ)]; a validated asthma control questionnaire [the Asthma Therapy Assessment Questionnaire (ATAQ)]; a validated symptom severity scale (AOMS); and information regarding demographics, co-morbidities, asthma severity, and asthma management. The results of the AIS-6 were compared to the results of the other tools by means of correlation and factor analysis. Independent predictors of AIS-6 and AQLQ scores were determined by multiple stepwise linear regression analyses. RESULTS: AIS-6 scores were significantly related to female sex, educational level, income, smoking, body mass index (BMI), COPD, steroid use, and hospitalization history in bivariate analyses. The AIS-6 score significantly correlated (r = - 0.84, p < 0.0001) with the AQLQ total score and loaded on the three factors (activity, symptoms, and concern/bother) reflected by the survey information and on which the AQLQ also loaded. Significant but somewhat smaller correlations were found between the AIS-6 and the ATAQ (r = 0.70, p < 0.0001) and the AOMS (r = 0.55, p < 0.0001). Independent predictors were the same for the AIS-6 and AQLQ and included oral steroid use, COPD history, BMI, female sex, educational level, and hospitalization in the past year. CONCLUSION: These data support the validity of the short six-question AIS-6 as an asthma-specific quality of life tool.

Adult↗

PubMed2006

Determinants of future long-term asthma control.

BACKGROUND: Asthma control has been hypothesized to be inversely related to asthma severity, directly related to effective management, and also related to other definable factors, but empiric data to support this construct are few. OBJECTIVE: We sought to identify independent prospective determinants of future long-term asthma control among asthma severity, management, demographic, and comorbidity predictors. METHODS: Surveys were completed by a random sample of 2250 health maintenance organization members aged 18 to 56 years with persistent asthma. Linked computerized pharmacy data provided baseline and follow-up year medication dispensings. The outcome was follow-up year long-term asthma control, as assessed by using a previously validated 4-level scale based on the number of short-acting beta-agonist canister dispensings. RESULTS: Oral corticosteroids (odds ratio [OR], 1.9) or unscheduled visits (OR, 1.2) in the prior year, any prior asthma hospitalizations (OR, 1.4), smoking (OR, 2.2), chronic obstructive pulmonary disease (OR, 1.9), male sex (OR, 1.5), black race (OR, 1.3), and lower educational level (OR, 1.1) were independently associated with poorer control in ordinal logistic regression analyses. Regular inhaled corticosteroids (OR, 0.7), long-acting beta-agonists (OR, 0.7) and asthma specialist care (OR, 0.6) were independently associated with better control. CONCLUSIONS: Markers of asthma severity and other patient characteristics are inversely related to future asthma control, but effective management strategies are associated with improved asthma control, even after accounting for these high-risk characteristics. CLINICAL IMPLICATIONS: Inhaled corticosteroids, long-acting beta-agonists, and asthma specialist care are associated with improved asthma control, even after accounting for markers of asthma severity.

Adolescent↗

PubMed2006

Validation of a beta-agonist long-term asthma control scale derived from computerized pharmacy data.

BACKGROUND: Asthma control has been defined clinically by using validated tools, but an asthma control scale using administrative data has not been reported. OBJECTIVE: We sought to validate a beta-agonist asthma control scale derived from administrative data. METHODS: Surveys that included validated asthma symptom and control tools were completed by a random sample of 2250 health maintenance organization members aged 18 to 56 years with persistent asthma. Linked computerized pharmacy data provided beta-agonist canister and oral corticosteroid dispensings. The proposed 4-level asthma control scale was based on the number of short-acting beta-agonist canisters dispensed in 12 months. Construct validity and predictive validity were assessed. RESULTS: For construct validity, factor analysis showed significant loading of the beta-agonist scale on the symptom control factor, and the beta-agonist scale was significantly related to the validated asthma control and symptom scales (r = 0.31, P < .0001). For predictive validity, each progressive level of the proposed beta-agonist control scale was associated with an increased risk of subsequent asthma hospitalizations or emergency department visits and oral corticosteroid use, independent of prior use. CONCLUSION: A scale based on the number of beta-agonists dispensed in a 1-year period and derived from administrative data reflects asthma symptom control over that period of time. This scale can help identify patients who are at risk for future acute asthma health care use. CLINICAL IMPLICATIONS: This information can be used in population management and by clinicians to assess long-term asthma control and identify patients who need intervention to prevent future morbidity.

Adolescent↗

PubMed2006

Tumor necrosis factor alpha antagonist use and cancer in patients with rheumatoid arthritis.

OBJECTIVE: Concerns persist about a possible association between tumor necrosis factor alpha (TNFalpha) antagonist treatment and development of cancers in patients with rheumatoid arthritis (RA). This study was undertaken to estimate the association between treatment with biologic disease-modifying antirheumatic drugs (DMARDs) and development of cancer in patients with RA. METHODS: We conducted a cohort study pooling administrative databases from 2 US states and 1 Canadian province. A cohort of patients who had received a diagnosis of RA on > or =1 occasion and had been prescribed DMARDs was identified. We categorized patients with a prescription for a biologic DMARD as biologic DMARD users, and those with a prescription for methotrexate (MTX) but no biologic DMARD as MTX users. We used time-varying propensity scores to adjust for the large number of possible confounders and stratified proportional hazards regression to estimate the effects of biologic DMARDs on cancer. The primary end points were hematologic malignancies (lymphoma, multiple myeloma, and leukemia) and common solid tumors (colorectal, lung, stomach, breast, prostate, uterine, ovarian, urinary tract/bladder, and melanoma). RESULTS: The pooled cohort included 1,152 biologic DMARD users and 7,306 MTX users. We identified 11 hematologic malignancies and 46 solid tumors during 2,940 person-years of biologic DMARD use, and 88 hematologic malignancies and 558 solid tumors during 30,300 person-years of MTX use. Comparing biologic DMARD users with MTX users, the propensity score-adjusted pooled hazard ratio was 1.37 (95% confidence interval 0.71-2.65) for hematologic malignancies and 0.91 (95% confidence interval 0.65-1.26) for solid tumors. CONCLUSION: Our results indicate that users of biologic agents are unlikely to have a substantial increase in the risk of hematologic malignancies and solid tumors as compared with MTX users. Despite the use of large combined data sets, studying the effect of an infrequent exposure (biologic DMARDs) on rare diseases (hematologic malignancies) remains a challenge.

Aged↗

PubMed2006

The new questionnaire health-related quality of life for eating disorders showed good validity and reliability.

BACKGROUND AND OBJECTIVES: To describe the development and investigate the psychometric properties of a new instrument to measure health-related quality of life (HRQoL) for individuals with an eating disorder (ED). METHODS: Seven focus groups were convened and an extensive literature review was carried out to generate the items. The first draft of the questionnaire was pilot tested. Three hundred twenty-four ED patients took part in the final field study. The 12-Item Short Form Health Survey, the Eating Attitudes Test-26, and two items from the Eating Disorders Inventory-2 also were applied to examine the concurrent validity. Factor analysis, item scale correlation correcting for overlap, test-retest, Cronbach's alpha coefficient, known-groups validation, and the sensitivity of the questionnaire in different populations also were examined. RESULTS: The final Health-Related Quality of Life in Eating Disorders (HeRQoLED) questionnaire consisted of 50 items. Principal axis factor analysis identified eight subscales. Concurrent validity showed correlations >.40 with the criteria measures. Excellent reliability and stability were obtained. The HeRQoLED was sensitive in discriminating both between known-different groups and from the general population. CONCLUSION: The results provide evidence of the good psychometric properties of the new HeRQoLED questionnaire, except for one domain, which had to be eliminated.

Adult↗

PubMed2006

The controller-to-total asthma medication ratio is associated with patient-centered as well as utilization outcomes.

BACKGROUND: The ratio of controller medication to total asthma medications has been related to asthma utilization outcomes, but its relationship to patient-centered outcomes has not been explored. METHODS: Surveys that included validated asthma quality-of-life, control, and symptom severity tools were completed by a random sample of 2,250 health maintenance organization members aged 18 to 56 years who had persistent asthma. Linked computerized pharmacy data provided dispensing information on beta-agonist canisters and asthma controller medication. The ratio was calculated as the number of controller medications dispensed during the year of the survey divided by the total number medications (ie, inhaled beta-agonist plus controller medications) dispensed. The relationships of the optimal ratio cutoff to patient-centered outcomes and to subsequent acute asthma exacerbations were determined. RESULTS: Mean asthma quality-of-life, asthma control, and symptom severity scale scores were significantly (p < 0.0001) more favorable in patients with ratios of > or = 0.5. After adjusting for demographic characteristics, patients with ratios of > or = 0.5 were significantly less likely to have adverse results regarding asthma quality of life (odds ratio [OR], 0.65; 95% confidence interval [CI], 0.52 to 0.80), asthma control (OR, 0.62; 95% CI, 0.50 to 0.77), and symptom severity (OR, 0.53; 95% CI, 0.43 to 0.65), and were also less likely to experience subsequent asthma hospitalizations or emergency department visits (OR, 0.44; 95% CI, 0.26 to 0.74) than patients with lower ratios. CONCLUSION: A higher controller medication/total asthma medication ratio is associated with better patient-centered asthma outcomes as well as with reduced emergency hospital utilization. This adds further support to the use of the medication ratio as an asthma quality-of-care measure.

Adrenal Cortex Hormones↗

PubMed2006

Higher survival rates among younger patients after pediatric intensive care unit cardiac arrests.

BACKGROUND: Age is an important determinant of outcome from adult cardiac arrests but has not been identified previously as an important factor in pediatric cardiac arrests except among premature infants. Chest compressions can result in more effective blood flow during cardiac arrest in an infant than an older child or adult because of increased chest wall compliance. We, therefore, hypothesized that survival from cardiac arrest would be better among infants than older children. METHODS: We evaluated 464 pediatric ICU arrests from the National Registry of Cardiopulmonary Resuscitation from 2000 to 2002. NICU cardiac arrests were excluded. Data from each arrest include >200 variables describing facility, patient, prearrest, arrest intervention, outcome, and quality improvement data. Age was categorized as newborn (<1 month; N = 62), infant (1 month to <1 year; N = 105), younger child (1 year to <8 years; N = 90), and older child (8 years to <21 years; N = 207). Multivariable logistic regression was performed to examine the association between age and survival. RESULTS: Overall survival was 22%, with 27% of newborns, 36% of infants, 19% of younger children and 16% of older children surviving to hospital discharge. Newborns and infants demonstrated double and triple the odds of surviving to hospital discharge from a cardiac arrest in an intensive care setting when compared with older children. When potential confounders were controlled, newborns increased their advantage to almost fivefold, while infants maintained their survival advantage to older children. CONCLUSIONS: Survival from pediatric ICU cardiac arrest is age dependent. Newborns and infants have better survival rates even after adjusting for potential confounding variables.

Age Factors↗

PubMed2006

Development and validation of a medication intensity scale derived from computerized pharmacy data that predicts emergency hospital utilization for persistent asthma.

OBJECTIVE: To validate a risk stratification scheme using computerized pharmacy data to predict emergency hospital utilization for persistent asthma. STUDY DESIGN: Retrospective cohort. METHODS: The development sample consisted of 1079 HMO members aged 18 to 56 years with persistent asthma. The scale used medication cut-points as predictors for next-year emergency hospital utilization in a stepwise logistic regression model. Prediction properties were evaluated in a validation sample of 24 370 patients aged 18 to 56 years in a separate persistent-asthma database. RESULTS: Increasing use of beta-agonists (odds ratio [OR] of 2.2 for 5-13 vs 0-4 canisters; OR of 2.4 for >13 vs 5-13 canisters) and oral corticosteroids (OR of 2.6 for >2 vs 0-2 dispensing events) in the first year independently predicted emergency hospital utilization in the second year. Assigning 1 point for exceeding each of the above 3 medication thresholds led to a 4-level medication intensity scale that was significantly (P <.0001) related to validated measures of asthma symptom severity, asthma control, and asthma quality of life in the development sample. In the validation sample, this scheme identified a high-risk group that was 6 times more likely than the low-risk group to require subsequent emergency hospital care, with overall sensitivity of 65% and specificity of 54%. This scale did not perform as well as a scale based on both baseline emergency hospital care and pharmacy data. CONCLUSION: This simple risk stratification scheme can be used for populations with persistent asthma for whom computerized pharmacy data, but not computerized prior utilization data, are available.

Adolescent↗

PubMed2005

Improved asthma outcomes from allergy specialist care: a population-based cross-sectional analysis.

BACKGROUND: Prior studies suggest that allergist care improves asthma outcomes, but many of these studies have methodological shortcomings. OBJECTIVE: We sought to compare patient-based and medical utilization outcomes in randomly selected asthmatic patients cared for by allergists versus primary care providers. METHODS: A random sample of 3568 patients enrolled in a staff model health maintenance organization who were given diagnoses of persistent asthma completed surveys. Of these participants, 1679 (47.1%) identified a primary care provider as their regular source of asthma care, 884 (24.8%) identified an allergist, 693 (19.4%) reported no regular source of asthma care, and 195 (5.5%) identified a pulmonologist. Validated quality of life, control, severity, patient satisfaction, and self-management knowledge tools and linked administrative data that captured medication use were compared between groups, adjusting for demographics and baseline hospital and corticosteroid use. RESULTS: Compared with those followed by primary care providers, patients of allergists reported significantly higher (P < .001) generic physical and asthma-specific quality of life, less asthma control problems, less severe symptoms, higher satisfaction with care, and greater self-management knowledge. Patients of allergists were less likely than patients of primary care providers to require an asthma hospitalization (odds ratio, 0.45) or unscheduled visit (odds ratio, 0.71) and to overuse beta-agonists (odds ratio, 0.47) and were more likely to receive inhaled steroids (odds ratio, 1.81) during their past year. CONCLUSIONS: Allergist care is associated with a wide range of improved outcomes in asthmatic patients compared with care provided by primary care providers.

Adult↗

PubMed2005

A randomized trial of electronic clinical reminders to improve quality of care for diabetes and coronary artery disease.

OBJECTIVE: The aim of this study was to evaluate the impact of an integrated patient-specific electronic clinical reminder system on diabetes and coronary artery disease (CAD) care and to assess physician attitudes toward this reminder system. DESIGN: We enrolled 194 primary care physicians caring for 4549 patients with diabetes and 2199 patients with CAD at 20 ambulatory clinics. Clinics were randomized so that physicians received either evidence-based electronic reminders within their patients' electronic medical record or usual care. There were five reminders for diabetes care and four reminders for CAD care. MEASUREMENTS: The primary outcome was receipt of recommended care for diabetes and CAD. We created a summary outcome to assess the odds of increased compliance with overall diabetes care (based on five measures) and overall CAD care (based on four measures). We surveyed physicians to assess attitudes toward the reminder system. RESULTS: Baseline adherence rates to all quality measures were low. While electronic reminders increased the odds of recommended diabetes care (odds ratio [OR] 1.30, 95% confidence interval [CI] 1.01-1.67) and CAD (OR 1.25, 95% CI 1.01-1.55), the impact of individual reminders was variable. A total of three of nine reminders effectively increased rates of recommended care for diabetes or CAD. The majority of physicians (76%) thought that reminders improved quality of care. CONCLUSION: An integrated electronic reminder system resulted in variable improvement in care for diabetes and CAD. These improvements were often limited and quality gaps persist.

Algorithms↗

PubMed2005

Prediction of missed myocardial infarction among symptomatic outpatients without coronary heart disease.

BACKGROUND: Missed diagnoses of acute myocardial infarction (AMI) in the ambulatory setting can cause patient suffering and malpractice litigation. Multiple algorithms have been developed to detect the presence of coronary heart disease (CHD) or acute coronary ischemia. METHODS: We performed a case-control study of patients with no prior history of CHD presenting to outpatient practices with potential cardiac ischemia. Malpractice claims files were used to identify 18 cases of patients with missed AMIs. For each case, we identified 3 control patients who had office visits for chest pain during the same month and assessed the association of 4 different prediction tools with missed AMI. RESULTS: The 18 cases of missed AMI had a 39% 1-month mortality rate. Cases were more likely than controls to be men (67% vs 26%, P = .001), to be smokers (88% vs 39%, P < .001), and to have low HDL cholesterol (39 mg/dL vs 59 mg/dL, P < .001) and elevated total cholesterol (236 mg/dL vs 213 mg/dL, P = .01). A Framingham risk score predicting a 10-year risk of CHD > or =10% and a positive score using the Goldman risk predictor were associated with an increased risk of missed AMI (odds ratio 5.7, 95% CI 1.8-18.4 for Framingham risk score; odds ratio 7.2, 95% CI 1.4-36.8 for Goldman risk predictor). CONCLUSIONS: Among ambulatory patients with possible cardiac ischemia and no prior CHD, multiple algorithms may be useful for improvement of risk stratification.

Algorithms↗

PubMed2005

Relationship of validated psychometric tools to subsequent medical utilization for asthma.

BACKGROUND: Risk stratification is used to identify patients with asthma at increased risk of experiencing morbidity and resource utilization. Validated psychometric tools are infrequently studied sources of data for this purpose. PURPOSE: To evaluate 4 types of validated psychometric tools as predictors for subsequent asthma utilization and determine their clinical usefulness. METHODS: Eleven hundred patients with active asthma from a Health Maintenance Organization completed surveys that included demographic information and validated psychometric tools measuring generic quality of life (physical and mental components), asthma-specific quality of life, asthma control, and asthma symptom severity. Survey records were linked to administrative data that captured emergency department and hospital care, short-acting beta-agonist, and oral corticosteroid utilization for the year of and the year following the survey. Relationships of survey variables with subsequent utilization were assessed, adjusting for both baseline demographic and asthma utilization factors. RESULTS: Scores of each psychometric tool were significantly related to subsequent utilization in univariate analyses and after adjusting for baseline utilization and demographic risk factors. Patients with higher scale-defined morbidity were as much as 4 times more likely to have subsequent utilization (sensitivity as high as 58%; specificity as high as 78%). Addition of an asthma-specific tool to either demographic or utilization prediction models added sensitivity (as much as 15%) but did not substantially improve the prediction properties of models containing both demographic and utilization predictors. CONCLUSION: Validated psychometric tools appear useful for asthma risk stratification in individuals and in populations in which both utilization and demographic predictors are not available.

Adolescent↗

PubMed2005

Relationships among quality of life, severity, and control measures in asthma: an evaluation using factor analysis.

BACKGROUND: Validated psychometric tools measuring quality of life, asthma control, and asthma severity have been developed, but their relationships with each other and with other important patient-centered outcomes have not been rigorously assessed. OBJECTIVE: To use factor analysis to evaluate the relationships of these validated tools with each other and with other patient-centered outcomes. METHODS: Surveys were completed by a random sample of 2854 Health Maintenance Organization members age 18 to 56 years with persistent asthma. Surveys included demographic information; validated tools measuring generic (Short Form-12; SF-12) and asthma-specific (Juniper Mini Asthma Quality of Life Questionnaire; AQLQ) quality of life, asthma control (Asthma Therapy Assessment Questionnaire), and asthma symptom severity (Asthma Outcomes Monitoring System); self-described severity, control, and course over time; and history of acute exacerbations. RESULTS: Principal component analysis suggested a 5-factor model that accounted for approximately 59% of the variability. The most prominent rotated factor reflected asthma symptom frequency (19.4% of variability), was measured by the symptom subscale of the AQLQ, and was the only factor significantly related to the Asthma Therapy Assessment Questionnaire, Asthma Outcomes Monitoring System, or the self-reported assessments of severity, control, or course. Other factors included symptom bother (12.1% of variability), reflected by the environment and emotion AQLQ subscales; activity limitation (13.9% of variability), reflected by the activity AQLQ subscale and the SF-12 physical component scale; mental health (8.3% of variability), reflected by the SF-12 mental component scale; and acute exacerbations (5.0% of variability), not measured by any of the validated scales. CONCLUSION: Distinct components of patient-reported asthma health status can be identified by factor analysis. Distinct constructs of severity versus control cannot be identified by the use of these tools alone.

Adolescent↗

PubMed2005

A controlled trial of smart infusion pumps to improve medication safety in critically ill patients.

OBJECTIVE: Intravenous medications are vital during inpatient management. Errors associated with the administration of medications through intravenous infusion pumps to critically ill patients can result in adverse drug events. We sought to assess the impact of smart pumps with integrated decision support software on the incidence and nature of medication errors and adverse drug events. DESIGN: We performed a prospective, randomized time-series trial and compared the serious medication error rate between intervention (decision support on) and control (decision support off) periods. Serious medication errors included both near-misses and preventable adverse drug events. Pump software produced log reports to help identify potential events. Events were presented to physicians for rating of event type, preventability, and severity. SETTING: Cardiac surgical intensive care and step-down units between February and December 2002. PATIENTS: Pump data were available for 744 cardiac surgery admissions. INTERVENTIONS: Decision support during medication administration provided feedback including alerts, reminders, and unit-specific drug rate limits. MEASUREMENTS AND MAIN RESULTS: We found a total of 180 serious medication errors, including 14 and 11 preventable adverse drug events and 73 and 82 nonintercepted potential adverse drug events in the control and intervention periods, respectively. The serious medication error rates in the control and intervention periods were 2.03 and 2.41 per 100 patient-pump-days, respectively (p = .124). We also found numerous opportunities for safety improvement. Violations of infusion practice during the intervention periods included 571 (25%) bypasses of the drug library. Medications were also frequently administered without documentation of physician orders in both periods (n = 823; 7.7%). CONCLUSION: Intravenous medication errors and adverse drug events were frequent and could be detected using smart pumps. We found no measurable impact on the serious medication error rate, likely in part due to poor compliance. Although smart pumps have great promise, technological and nursing behavioral factors must be addressed if these pumps are to achieve their potential for improving medication safety.

Aged↗

PubMed2004

Value of immediate postoperative electrocardiogram to update risk stratification after major noncardiac surgery.

Current consensus guidelines recommend postoperative electrocardiographic surveillance only in patients at relatively high risk of postoperative major cardiac complications, but the usefulness of electrocardiograms after major noncardiac surgery is unknown. We prospectively studied 3,570 patients who underwent major noncardiac procedures and had electrocardiograms performed in the recovery room. Rates of major cardiac complications (acute myocardial infarction, pulmonary edema, ventricular fibrillation or primary cardiac arrest, and complete heart block) were higher in patients who had new postoperative electrocardiographic abnormalities consistent with ischemia (ST-T elevation or depression or T-wave abnormalities compatible with ischemia) compared with those without ischemia (6.7% vs 1.9%, p <0.001). Multivariate analysis, after adjusting for pre- and intraoperative clinical data, indicated that the presence of ischemia on the immediate postoperative electrocardiogram was an independent predictor of major cardiac complications (odds ratio 2.2, 95% confidence interval 1.2 to 3.9, p <0.01). When patients were stratified by a preoperative Revised Cardiac Risk Index, ischemia on the immediate postoperative electrocardiogram identified patients with a higher risk of major cardiac complications in low- and high-risk subsets (odds ratio 4.9, 95% confidence interval 1.6 to 15 in lower risk patients; odds ratio 2.0, 95% confidence interval 1.0 to 3.7 in higher risk patients). We conclude that the immediate postoperative electrocardiogram is a valuable tool to adjust risk stratification, even in patients who have lower risks when undergoing noncardiac surgery.

Aged↗

PubMed2004

Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review.

BACKGROUND: Many oncologists believe that patients with cancer who enroll in clinical trials have better outcomes than those who do not enroll. We aimed to assess the empirical evidence that such a trial effect exists. METHODS: We developed a conceptual framework for comparison of trial and non-trial patients. We then did a comprehensive literature search to identify studies that compared outcomes between these groups. We critically evaluated these studies to assess whether they provide valid and generalizable support for a trial effect. FINDINGS: We identified 26 comparisons, from 24 published articles, of outcomes among cancer patients enrolled and not enrolled in clinical trials. 21 comparisons used retrospective cohort designs. 14 comparisons provided some evidence that patients enrolled in trials have improved outcomes. However, strategies to control for potential confounding factors were inconsistent and frequently inadequate. Only eight comparisons restricted non-trial patients to those meeting trial eligibility criteria. Of these, three noted better outcomes in trial patients than in non-trial patients. Children with cancer, patients with haematological malignant disease, and patients treated before 1986 were disproportionately represented in positive studies. INTERPRETATION: Despite widespread belief that enrollment in clinical trials leads to improved outcomes in patients with cancer, there are insufficient data to conclude that such a trial effect exists. Until such data are available, patients with cancer should be encouraged to enroll in clinical trials on the basis of trials' unquestioned role in improving treatment for future patients.

Clinical Trials as Topic↗