This study compared the bronchodilator effects of tiotropium, formoterol and both combined in chronic obstructive pulmonary disease (COPD).A total of 71 COPD patients (mean forced expiratory volume in one second (FEV1) 37% predicted) participated in a randomised, double-blind, three-way, crossover study and received tiotropium 18 mg q.d., formoterol 12 mg b.i.d. or both combined q.d. for three 6-week periods. The end-points were 24-h spirometry (FEV1, forced vital capacity (FVC)) at the end of each treatment, rescue salbutamol and safety.Compared with baseline (FEV1 prior to the first dose in the first period), tiotropium produced a significantly greater improvement in average daytime FEV1 (0-12 h) than formoterol (127 versus 86 mL), while average night-time FEV1 (12-24 h) was not different (tiotropium 43 mL, formoterol 38 mL). The most pronounced effects were provided by combination therapy (daytime 234 mL, night-time 86 mL); both differed significantly from single-agent therapies. Changes in FVC mirrored the FEV1 results. Compared with both single agents, daytime salbutamol use was significantly lower during combination therapy (tiotropium plus formoterol 1.81 puffs?day -1 , tiotropium 2.41 puffs?day -1 , formoterol 2.37 puffs?day -1 ). All treatments were well tolerated.In conclusion, in chronic obstructive pulmonary disease patients, tiotropium q.d. achieved a greater improvement in daytime and comparable improvement in night-time lung function compared with formoterol b.i.d. A combination of both drugs q.d. was most effective and provided an additive effect throughout the 24-h dosing interval.
Compared to single-agent therapy, combination therapy of tiotropium plus salmeterol in COPD provided clinically meaningful improvements in airflow obstruction and dyspnea as well as a reduction in reliever medication.
Aim
To evaluate the reliability and validity of the Children's Visual Impairment Test for 3‐ to 6‐year‐olds (CVIT 3–6).
Method
Reliability was assessed via test–retest correlation and intraclass correlation coefficient (ICC) in typically developing children, children with cerebral visual impairment (CVI), intellectual impairment, and simulated impaired vision (validation groups n=59, mean developmental age=4y 10mo, 27 females, 32 males). Internal validity was evaluated with a confirmatory factor analysis on the normative sample (n=301, median age=4y 8mo, SD=9.7mo, 148 females, 153 males). External validity was assessed by correlating performance on CVIT 3–6 with L94, the Beery‐Buktenica Developmental Test of Visuo‐Motor Integration (Beery‐VMI), the Freiburg Vision Test, the revised Snijders‐Oomen Nonverbal Intelligence Test for children between 2 years 6 months and 7‐years‐old (SON‐R 2.5–7), and the Social Responsiveness Scale (SRS) questionnaire and by comparing performance between validation groups.
Results
We observed very good test–retest reliability (r=0.82, p<0.001, ICC=0.80) and confirmed the hypothesized factor structure (comparative fit index=1; Tucker‐Lewis index=1.045). We found high correlations with tests with a strong visual perception component (L94: r=0.74, p<0.001; SON‐R 2.5–7: r=0.37, p=0.01) and low correlations with other tests (Beery‐VMI: r=0.25, p=0.09; SRS: r=0–0.26, p=0.09). Lowest scores were observed for children with CVI compared to the other validation groups (F[3,44]=5.1, p=0.003).
Interpretation
CVIT 3–6 is grounded in knowledge of visual perception. The tool specifically measures CVI‐related visual perception deficits and is not mediated by intellectual abilities or low visual acuity.
What the paper adds
Evidence for good test–retest reliability of the Children's Visual Impairment Test for 3‐ to 6‐year‐olds (CVIT 3–6).
Factor structure of normative data reflects CVIT 3–6's foundations in vision science.
CVIT 3–6 specifically measures visual perception impairments.
CVIT 3–6 performance is not influenced by intelligence or low visual acuity.
Other adverse effects due to vasoconstriction have been reported during bromocriptine therapy, such as myocardial infarction and arterial hypertension. This case suggests that a similar mechanism may be possible in cerebral arteries, although the cause of vasoconstriction remains uncertain.
Aim
To develop an assessment tool that measures a wide range of visual perceptual deficits common in cerebral visual impairment (CVI) and to provide normative data from typically developing children between 3 and 6 years of age.
Method
Test development reflected cross‐talk between vision research and clinical relevance for CVI. The Children's Visual Impairment Test for 3‐ to 6‐year‐olds (CVIT 3–6) includes 14 subtests covering four domains of visual perception: Object Recognition, Degraded Object Recognition, Motion Perception, and Global–Local Processing. Normative data were collected from 301 typically developing children (mean age 4y 8mo [SD 9.7mo]; 148 females, 153 males). A questionnaire was administered to parents about pregnancy duration, birth, and developmental problems.
Results
Average total CVIT 3–6 performance was 60.1 (SD 5.5) out of 70. The cut‐off score for normal visual perception (53) was set at the 10th centile of scores in typically developing children. Multiple regression indicated CVIT 3–6 visual perception scores increase with age for children born at 36 weeks’ gestational age or later (β=−18.03, 95% confidence interval −31.31 to −4.75).
Interpretation
CVIT 3–6 is a tool to assess a wide range of visual perceptual deficits common in CVI. Age‐dependent normative data are available because we found performance increased with age.
What the paper adds
A test for visual perceptual deficits common in cerebral visual impairment.
Visual perceptual functions improve with age in full‐term typically developing children.
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