OBJECTIVE:Attending physicians are only required to provide in-hospital coverage during daytime hours in many pediatric intensive care units. An in-hospital 24-hr pediatric intensive care unit ...attending coverage model has been increasingly popular, but the impact of 24-hr, in-hospital attending coverage on care processes and outcomes has not been reported. We compared processes of care and outcomes before and after the implementation of a 24-hr in-hospital pediatric intensive care unit attending physician model.
DESIGN:Retrospective comparison of before and after cohorts.
SETTING:A single large, academic tertiary medical/surgical pediatric intensive care unit.
PATIENTS:Pediatric intensive care unit admissions in 2000–2006.
INTERVENTION:Transition to 24-hr from 12-hr in-hospital pediatric critical care attending physician coverage model in January 2004.
MEASUREMENTS AND MAIN RESULTS:A total of 18,702 patients were admitted to intensive care unit8,520 in 24 hrs; 10,182 in 12 hrs. Duration of mechanical ventilation was lower (median 33 hrs interquartile range 12–88 vs. 48 hrs interquartile range 16–133, adjusted reduction of 35% 95% confidence interval 25%–44%, p < .001) and intensive care unit length of stay was shorter (median 2 days interquartile range 1–4 vs. 2 days interquartile range 1–5, adjusted p < .001) for 24 hr vs. 12 hr coverage. The reduction in mechanical ventilation hours was similar when noninvasive, mechanical ventilation was included in ventilation hours (median 42 hrs vs. 56 hrs, adjusted reduction in ventilation hours33% 95% confidence interval 20–45, p < .001). Intensive care unit mortality was not significantly different (2.2% vs. 2.5%, adjusted p =.23). These associations were consistent across daytime and nighttime admissions, weekend and weekday admissions, and among subgroups with higher Pediatric Risk of Mortality III scores, postsurgical patients, and histories of previous intensive care unit admission.
CONCLUSIONS:Implementation of 24-hr in-hospital pediatric critical care attending coverage was associated with shorter duration of mechanical ventilation and shorter length of intensive care unit stay. After accounting for potential confounders, this finding was consistent across a broad spectrum of critically ill children.
A previous randomized trial with 224 alcohol and/or cocaine addicts who had completed an initial phase of treatment indicated that 12 weeks of telephone-based continuing care yielded higher ...abstinence rates over 24 months than did group counseling continuing care. The current study examined mediators of this treatment effect. Results suggested that self-help involvement during treatment and self-efficacy and commitment to abstinence 3 months after treatment mediated subsequent abstinence outcomes. These analyses controlled for substance use prior to the assessment of mediators. Conversely, there was no evidence that self-help beliefs or social support mediated the treatment effect. These results are consistent with a model in which treatment effects are first accounted for by changes in behavior, followed by changes in self-efficacy and in commitment to abstinence.
Recognition of gaps between evidence gained from mental health research and clinical practice in the community together with changes in treatment patterns and patient/provider preferences for care ...have led to interest in enhancements in the designs and analyses of clinical and community trials of mental health interventions. Gaps between clinical trials and community care include differences in populations and treatment strategies. To bridge these gaps, we propose enhancing the simple randomized trial with several different designs with the immediate aims of improving patient recruitment and adherence in psychiatric intervention studies thus bringing study designs more in line with clinical practice. The goals are to estimate treatment efficacy and effectiveness so that both internal and external validity are optimized. In this discussion, we address design and analytic issues with respect to a number of enhancements of the randomized trial design, including partial patient-provider preference designs, randomized encouragement and consent designs, fixed adaptive design, and random between- and within-patient adaptive designs. Each has advantages and disadvantages depending on the effect under investigation. Some of these enhancements, such as the fixed adaptive design, have begun to be implemented in effectiveness trials in mental health services research, but all are worthy of more attention.
Antiretroviral medication refill adherence has not been compared directly to electronic drug monitoring (EDM) in any identifiable published study. We retrospectively studied adults with undetectable ...HIV titers on highly active antiretroviral therapy. We used Pearson correlation coefficients and receiver operating characteristic curves to relate the two adherence measures, and we used the Wilcoxon rank-sum test to assess the relation between adherence and viral load. In sixty-five subjects, the majority of whom were African American and male with median age of 44 years, pharmacy refill adherence was difficult to collect retrospectively, was not significantly correlated with EDM adherence, and was not significantly related to viral load. Ninety-day supply pharmacy refill adherence correctly classified 95% EDM adherence maximally at 94 days between refills, and the measure was most sensitive for non-adherence at <90 days. Reassessment of the relation between pharmacy refill data and EDM would be warranted when pharmacy refill data is collected as soon as feasible from sources with complete data capture.
OBJECTIVES: To test for simvastatin‐induced changes in affect and affective processes in elderly volunteers.
DESIGN: Randomized, clinical trial.
SETTING: The Geriatric Behavioral Psychopharmacology ...Laboratory at the University of Pennsylvania.
PARTICIPANTS: Eighty older volunteers, average age 70, with high normal/mildly elevated serum cholesterol.
INTERVENTION: Simvastatin up to 20 mg/d or placebo for 15 weeks.
MEASUREMENTS: Daily diary records of positive and negative affects and of events and biweekly measures of depressive symptoms. Affect ratings were obtained using the Lawton positive and negative affect scales; independent raters coded the valences of events.
RESULTS: Thirty‐one of 39 subjects assigned to placebo and 33 of 41 receiving simvastatin completed the study. During biweekly assessments, four subjects on simvastatin and one on placebo experienced depressive symptoms, as manifest by Center for Epidemiological Studies Depression scale scores greater than 16 (exact P=.36). Diary data demonstrated significant effects on affective processes. For positive affect, there was a significant medication‐by‐time interaction that reflected decreases in positive affect in subjects receiving simvastatin, greatest in those patients whose final total cholesterol levels were below 148 mg/dL. For negative affect, there were significant medication‐by‐event, and medication‐by‐event‐by‐time interactions, reflecting a time‐limited increase in the apparent effect of negative events.
CONCLUSION: Simvastatin has statistically significant effects on affect and affective processes in elderly volunteers. The decrease in positive affect may be significant clinically and relevant to the quality of life of many patients.
OBJECTIVE To demonstrate response to antimalarial agents in patients with cutaneous lupus erythematosus (CLE) using activity scores from the Cutaneous Lupus Erythematosus Disease Area and Severity ...Index, a validated outcome measure. DESIGN Prospective, longitudinal cohort study. SETTING University cutaneous autoimmune disease clinic. PARTICIPANTS A total of 128 patients with CLE who presented from January 2007 to July 2010 and had at least 2 visits with activity scores. INTERVENTION Administration of antimalarial agents. MAIN OUTCOME MEASURES Response was defined by a 4-point or 20% decrease in activity score. Response to initiation was determined by the difference between the scores before treatment and at the first visit at least 2 months after treatment. Response to continuation was determined by the difference between the scores at the first visit and the most recent visit while undergoing treatment. RESULTS Of 11 patients who initiated treatment with hydroxychloroquine, 55% were responders (n = 6), showing a decrease in median (interquartile range IQR) activity score from 8.0 (3.5-13.0) to 3.0 (1.8-7.3) (P = .03). Of 15 patients for whom hydroxychloroquine failed, 67% were responders to initiation of hydroxychloroquine-quinacrine therapy (n = 10), showing a decrease in median (IQR) activity score from 6.0 (4.8-8.3) to 3.0 (0.75-5.0) (P = .004). Nine of 21 patients who continued hydroxychloroquine treatment (43%), and 9 of 21 patients who continued hydroxychloroquine-quinacrine (43%) were responders, showing a decrease in median (IQR) activity score from 6.0 (1.5-9.5) to 1.0 (0.0-4.5) (P = .01) and 8.5 (4.25-17.5) to 5.0 (0.5-11.5) (P = .01), respectively. CONCLUSIONS The use of quinacrine with hydroxychloroquine is associated with response in patients for whom hydroxychloroquine monotherapy fails. Further reduction in disease activity can be associated with continuation of treatment with antimalarial agents.
Previous studies comparing low-carbohydrate and low-fat diets have not included a comprehensive behavioral treatment, resulting in suboptimal weight loss.
To evaluate the effects of 2-year treatment ...with a low-carbohydrate or low-fat diet, each of which was combined with a comprehensive lifestyle modification program.
Randomized parallel-group trial. (ClinicalTrials.gov registration number: NCT00143936)
3 academic medical centers.
307 participants with a mean age of 45.5 years (SD, 9.7 years) and mean body mass index of 36.1 kg/m(2) (SD, 3.5 kg/m(2)).
A low-carbohydrate diet, which consisted of limited carbohydrate intake (20 g/d for 3 months) in the form of low-glycemic index vegetables with unrestricted consumption of fat and protein. After 3 months, participants in the low-carbohydrate diet group increased their carbohydrate intake (5 g/d per wk) until a stable and desired weight was achieved. A low-fat diet consisted of limited energy intake (1200 to 1800 kcal/d; <or=30% calories from fat). Both diets were combined with comprehensive behavioral treatment.
Weight at 2 years was the primary outcome. Secondary measures included weight at 3, 6, and 12 months and serum lipid concentrations, blood pressure, urinary ketones, symptoms, bone mineral density, and body composition throughout the study.
Weight loss was approximately 11 kg (11%) at 1 year and 7 kg (7%) at 2 years. There were no differences in weight, body composition, or bone mineral density between the groups at any time point. During the first 6 months, the low-carbohydrate diet group had greater reductions in diastolic blood pressure, triglyceride levels, and very-low-density lipoprotein cholesterol levels, lesser reductions in low-density lipoprotein cholesterol levels, and more adverse symptoms than did the low-fat diet group. The low-carbohydrate diet group had greater increases in high-density lipoprotein cholesterol levels at all time points, approximating a 23% increase at 2 years.
Intensive behavioral treatment was provided, patients with dyslipidemia and diabetes were excluded, and attrition at 2 years was high.
Successful weight loss can be achieved with either a low-fat or low-carbohydrate diet when coupled with behavioral treatment. A low-carbohydrate diet is associated with favorable changes in cardiovascular disease risk factors at 2 years.
National Institutes of Health.
The morbidity and mortality associated with asthma are suspected to be a result, in part, of poor adherence to inhaled corticosteroid regimens. One influence on adherence may be the perception of ...symptoms. Because symptoms and adherence affect each other over time, a conventional statistical approach for studying these relationships may provide biased results.
To understand the influence of previous asthma symptoms and previous adherence on current symptoms.
A total of 76 adults, mean age 48 years ± 15 years, with moderate or severe persistent asthma underwent 6 weeks of electronic monitoring of their use of inhaled corticosteroids and completed a daily symptom diary. We estimated the effect of earlier adherence on final symptoms by using marginal structural models, estimated by using a weighted estimation technique.
Morning was better than evening adherence, which declined over the observation period. The variability of adherence appeared to increase over the observation period. In addition, earlier adherence predicted current adherence more strongly than earlier symptoms predicted current adherence. There was no overall significant relationship between cumulative adherence and final symptoms.
These data indicate that accurately determining past adherence will help identify patients to target to improve their future adherence. These analyses are important for understanding time-varying measures in the clinical setting.
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