Articles: outcome-assessment-health-care.
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Randomized Controlled Trial
Performance of the EXAcerbations of chronic pulmonary disease tool patient-reported outcome measure in three clinical trials of chronic obstructive pulmonary disease.
The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) is a patient-reported outcome measure to standardize the symptomatic assessment of chronic obstructive pulmonary disease exacerbations, including reported and unreported events. The instrument has been validated in a short-term study of patients with acute exacerbation and stable disease; its performance in longer-term studies has not been assessed. ⋯ Data generated through the EXACT offers insight into the symptomatic nature of MTEs and the frequency, severity, and duration of unreported symptom-defined events. Clinical trials registered with www.clinicaltrials.gov (MPEX: NCT00739648; AZ 1: NCT00949975; AZ 2: NCT01023516).
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Bmc Pregnancy Childb · Jan 2014
Randomized Controlled Trial Multicenter Study Comparative StudyNifedipine versus atosiban in the treatment of threatened preterm labour (Assessment of Perinatal Outcome after Specific Tocolysis in Early Labour: APOSTEL III-Trial).
Preterm birth is the most common cause of neonatal morbidity and mortality. Postponing delivery for 48 hours with tocolytics to allow for maternal steroid administration and antenatal transportation to a centre with neonatal intensive care unit facilities is the standard treatment for women with threatening preterm delivery in most centres. However, there is controversy as to which tocolytic agent is the drug of first choice. Previous trials have focused on tocolytic efficacy and side effects, and are probably underpowered to detect clinically meaningfull differences in neonatal outcome. Thus, the current evidence is inconclusive to support a balanced recommendation for clinical practice. This multicenter randomised clinical trial aims to compare nifedipine and atosiban in terms of neonatal outcome, duration of pregnancy and maternal side effects. ⋯ This trial will provide evidence on the optimal drug of choice in acute tocolysis in threatening preterm labour.
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Randomized Controlled Trial Multicenter Study
The Reciprocal Effects of Pain Intensity and Activity Limitations: Implications for Outcomes Assessment in Clinical Trials.
To examine the reciprocal effects of pain intensity and limitations in physical functioning over time. ⋯ These analyses showed that a decrease in activity limitations results in a decrease in pain intensity. However, changes in pain intensity had no effect on subsequent activity limitations in the study sample. None of the 3 outcome variables emerged as being more responsive to treatment than the others.
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Psychother Psychosom · Jan 2014
Randomized Controlled TrialThe effects of mindfulness-based stress reduction program on the mental health of family caregivers: a randomized controlled trial.
Caregivers of people with chronic conditions are more likely than non-caregivers to have depression and emotional problems. Few studies have examined the effectiveness of mindfulness-based stress reduction (MBSR) in improving their mental well-being. ⋯ MBSR appears to be a feasible and acceptable intervention to improve mental health among family caregivers with significant care burden, although further studies that include an active control group are needed to make the findings more conclusive.
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Journal of critical care · Dec 2013
Randomized Controlled Trial Multicenter StudyImplementation of a protocol for integrated management of pain, agitation, and delirium can improve clinical outcomes in the intensive care unit: A randomized clinical trial.
Inappropriate diagnosis and treatment of pain, agitation, and delirium (PAD) in intensive care settings results in poor patient outcomes. We designed and used a protocol for systematic assessment and management of PAD by the nurses to improve clinical intensive care unit (ICU) outcomes. ⋯ The current randomized trial provided evidence for a substantial reduction in the duration of need to ventilatory support, length of ICU stay, and mortality rates in ICU-admitted patients through protocol-directed management of PAD.