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Placebo responses raise significant challenges for the design of clinical trials. We report changes in agitation outcomes in the placebo arm of a recent trial of citalopram for agitation in Alzheimer's disease (CitAD).
In the CitAD study, all participants and caregivers received a psychosocial intervention and 92 were assigned to placebo for nine weeks. Outcomes included Neurobehavioral Rating Scale agitation subscale (NBRS-A), modified AD Cooperative Study-Clinical Global Impression of Change (CGIC), Cohen-Mansfield Agitation Inventory (CMAI), the Neuropsychiatric Inventory (NPI) Agitation/Aggression domain (NPI A/A) and Total (NPI-Total) and ADLs. Continuous outcomes were analyzed with mixed-effects modeling and dichotomous outcomes with logistic regression.
Agitation outcomes improved over nine weeks: NBRS-A mean (SD) decreased from 7.8 (3.0) at baseline to 5.4 (3.2), CMAI from 28.7 (6.7) to 26.7 (7.4), NPI A/A from 8.0 (2.4) to 4.9 (3.8), and NPI-Total from 37.3 (17.7) to 28.4 (22.1). The proportion of CGI-C agitation responders ranged from 21 to 29% and was significantly different from zero. MMSE improved from 14.4 (6.9) to 15.7 (7.2) and ADLs similarly improved. Most of the improvement was observed by three weeks and was sustained through nine weeks. The major predictor of improvement in each agitation measure was a higher baseline score in that measure.
We observed significant placebo response which may be due to regression to the mean, response to a psychosocial intervention, natural course of symptoms, or nonspecific benefits of participation in a trial.
The purpose of this study was to evaluate stress levels in emergency medical services personnel across the United States.
Confidential, 20-question survey tool, Medical Personnel Stress Survey-Abbreviated (MPSS-R). A total score of 50 indicates average stress levels. A score of 12.5 on the subset measurements of somatic distress, job dissatisfaction, organizational stress, and negative attitudes towards patients indicates average levels of stress. Data were analyzed using ANOVA and t-test.
A total of 658 of 3,000 emergency medical technicians (EMTs) (22%) completed the survey. The mean value of 69.3±6.3 for the total stress scores was very high Mean values for the subset scores were: somatic distress = 19.6±3.3; organizational stress = 17.3±2.4; job dissatisfaction = 17.0±2.6; negative attitudes towards patients = 15.5±2.3. Characteristics predicting higher stress were EMT-basic (A) licensure, basic life support (BLS) only service provider, volunteer status, new employee working in a small EMS organization, and providing service to a small town.
Stress levels in EMS personnel were very high, were manifested primarily as somatic distress, secondarily as organizational stress and job dissatisfaction, and lastly as negative patient attitudes. Stress levels and subset manifestations of occupational stress among EMS personnel varied depending on gender, marital status, age, level of training and function, on salaried or volunteer status, length of time as an EMT, and size of the organization, city, and population served. Care should be taken to address stresses peculiar to individual EMS system needs.
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