Randomized Crossover Trial (randomized + crossover_trial)

Distribution by Scientific Domains


Selected Abstracts


Accuracy and Efficiency of Computer-Aided Nursing Diagnosis

INTERNATIONAL JOURNAL OF NURSING TERMINOLOGIES AND CLASSIFICATION, Issue 3 2008
Sachiko Kurashima MSN
PURPOSE.,This study aims to determine whether a computer-aided nursing (CAN) diagnosis system improves diagnostic accuracy and efficiency. METHODS.,A randomized crossover trial was performed using two kinds of case studies with 42 nurses as subjects. The subjects were divided into a group using the CAN diagnosis system and a group using a handbook of nursing diagnosis. Degree of accuracy was judged by using Lunney's seven-point interval scale, while efficiency was evaluated by time required for diagnosis. FINDINGS.,There was no significant difference between the two groups in terms of diagnostic accuracy; however, time required for diagnosis was significantly shorter for subjects who used the CAN diagnosis system than for those who did not. Multiple regression analysis showed that the use of the CAN diagnosis system was the only factor associated with the time required for making the nursing diagnosis. CONCLUSIONS.,The use of the CAN diagnosis system improved the efficiency of the diagnostic process without reducing the level of accuracy of nursing diagnoses. PRACTICE IMPLICATIONS.,The use of a computerized system should be a useful tool for implementation of standardized nursing terminologies. [source]


Sex differences in the hemodynamic responses to mental stress: Effect of caffeine consumption

PSYCHOPHYSIOLOGY, Issue 4 2006
Noha H. Farag
Abstract The effect of caffeine on stress responses was compared in 25 men and 22 women in a 2-week placebo-controlled, double-blind, randomized crossover trial. On each week, participants abstained from all dietary sources of caffeine before undergoing a 6-h laboratory protocol under placebo or caffeine exposure followed by a 30-min mental stressor with blood pressure (BP) and cardiovascular hemodynamic assessments. On the placebo session, men and women showed a significant BP increase to stress, although women had significant cardiac responses whereas men had vascular responses. Caffeine ingestion before stress caused both men and women to have enhanced hemodynamic responses to the stressor associated with an increase in cardiac index and a drop in the peripheral resistance index. Caffeine enhances the cardiovascular fight-or-flight response pattern to stress in men and women. [source]


A randomized crossover trial of a wedged insole for treatment of knee osteoarthritis,

ARTHRITIS & RHEUMATISM, Issue 4 2007
Kristin Baker
Objective In uncontrolled studies, a lateral-wedge insole has reduced knee pain in patients with medial knee osteoarthritis (OA). The aim of this study was to test the efficacy of this simple, low-cost intervention for pain in patients with medial knee OA. Methods We conducted a double-blind, randomized, crossover trial designed to detect a small effect of treatment. Participants were at least 50 years of age and had medial joint space narrowing on posteroanterior semiflexed radiographs and scores indicating moderate pain for 2 of the 5 items on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scale. Participants were randomized to receive a 5° lateral-wedge insole or a neutral insole for 6 weeks. Following a 4-week washout period, participants crossed over to the other treatment for 6 weeks. Knee pain, the primary outcome, was assessed by the WOMAC pain scale (visual analog scale version). Secondary outcomes included the WOMAC disability subscale, overall knee pain, 50-feet walk time, chair-stand time, and use of medications for knee pain. Results Ninety patients were randomized. The mean difference in pain between the 2 treatments was 13.8 points on the WOMAC pain scale (95% confidence interval ,3.9, 31.4 [P = 0.13]). We observed similar small effects for the secondary outcomes. Conclusion The effect of treatment with a lateral-wedge insole for knee OA was neither statistically significant nor clinically important. [source]


Pharmacokinetics and tolerability of intranasal diazepam and midazolam in healthy adult volunteers

ACTA NEUROLOGICA SCANDINAVICA, Issue 5 2009
V. D. Ivaturi
Objective,,, The purpose of this pilot study was to determine the pharmacokinetics and tolerability of an investigational diazepam (DZP) formulation and a parenteral midazolam (MDZ) formulation following intranasal (i.n.) administration for the efficient treatment of seizure emergencies. Methods,,, Each subject received 5 mg of DZP and MDZ via both i.n. and intravenous routes in a four-way, randomized crossover trial. Blood samples were collected over 48 h. DZP and MDZ concentrations were measured using HPLC. Using analog scales, subjects rated tolerability (0 = no change from normal; 10 = maximum intolerability) and pain (0 = no pain; 4 = extreme pain) prior to and 0, 5, 15, 60 min, and 8 h after administration. Results,,, The Cmax and Tmax values for i.n. DZP and MDZ were 179.2 ng/ml and 28.8 min vs 62.8 ng/ml and 21.6 min, respectively. Immediately following i.n. administration, subjects reported tolerability scores of 6.75 and 6.0, and identical pain scores, 3.2, for DZP and MDZ, respectively. Conclusion,,, Both formulations were rapidly absorbed following i.n. administration with transient discomfort. DZP had a longer half-life, which may result in an extended duration of action. Further studies in large patient populations to evaluate the safety after long term use, efficacy and pharmacokinetics of i.n. DZP are warranted. [source]