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Baseline Observations (baseline + observation)
Selected AbstractsPremenopausal Smoking and Bone Density in 2015 Perimenopausal WomenJOURNAL OF BONE AND MINERAL RESEARCH, Issue 4 2000Dr. A. P. Hermann Abstract The importance of cigarette smoking in relation to bone mass remains uncertain, especially in younger women. In a recent meta-analysis including 10 studies in premenopausal women no effect was seen in this age group. We used baseline data from a large national cohort study (Danish Osteoporosis Prevention Study [DOPS]) to study the cumulated effect of pre- and perimenopausal smoking on bone mineral density (BMD) measured shortly after the cessation of cyclic bleedings. Baseline observations on 2015 recently menopausal women were available. Eight hundred thirty-two women were current smokers and 285 were exsmokers. Significant negative associations of cigarette smoking coded as current, ex-, or never smoking were seen on bone mass in the lumbar spine (P = 0.012), femoral neck (P < 0.001), and total body (P < 0.001). Quantitatively, the differences between current smokers and never smokers were limited to 1.6, 2.9, and 1.9%, respectively. A statistical interaction was found between smoking and fat mass, indicating that women in the highest tertile of fat mass were unaffected by cigarette smoking. Serum vitamin D levels and osteocalcin were inversely related to the number of cigarettes smoked per day (r = 0.11 and P < 0.001; r = 0.17 and P = 0.04), respectively. Bone alkaline phosphatase (BALP) and urinary hydroxyproline (U-OHP) were unaffected by current smoking. The average cumulated effect of premenopausal smoking on bone is small but biologically significant. Reduced body mass in smokers explains part of the negative effect on the skeleton and a complex interaction between smoking and fat mass on the skeleton is indicated. Serum levels of 25-hydroxyvitamin D (25-OHD) and osteocalcin are lower in smokers, which may effect rate of bone loss. [source] Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: Results of a randomized, double-blind, placebo-controlled trial,ARTHRITIS & RHEUMATISM, Issue 9 2010Lesley M. Arnold Objective To assess the efficacy and safety of milnacipran at a dosage of 100 mg/day (50 mg twice daily) for monotherapy treatment of fibromyalgia. Methods A double-blind, placebo-controlled trial was performed to assess 1,025 patients with fibromyalgia who were randomized to receive milnacipran 100 mg/day (n = 516) or placebo (n = 509). Patients underwent 4,6 weeks of flexible dose escalation followed by 12 weeks of stable-dose treatment. Two composite responder definitions were used as primary end points to classify the response to treatment. The 2-measure composite response required achievement of ,30% improvement from baseline in the pain score and a rating of "very much improved" or "much improved" on the Patient's Global Impression of Change (PGIC) scale. The 3-measure composite response required satisfaction of these same 2 improvement criteria for pain and global status as well as improvement in physical function on the Short Form 36 (SF-36) physical component summary (PCS) score. Results After 12 weeks of stable-dose treatment, a significantly greater proportion of milnacipran-treated patients compared with placebo-treated patients showed clinically meaningful improvements, as evidenced by the proportion of patients meeting the 2-measure composite responder criteria (P < 0.001 in the baseline observation carried forward [BOCF] analysis) and 3-measure composite responder criteria (P < 0.001 in the BOCF). Milnacipran-treated patients also demonstrated significantly greater improvements from baseline on multiple secondary outcomes, including 24-hour and weekly recall pain score, PGIC score, SF-36 PCS and mental component summary scores, average pain severity score on the Brief Pain Inventory, Fibromyalgia Impact Questionnaire total score (all P < 0.001 versus placebo), and Multidimensional Fatigue Inventory total score (P = 0.036 versus placebo). Milnacipran was well tolerated by most patients, with nausea being the most commonly reported adverse event (placebo-adjusted rate of 15.8%). Conclusion Milnacipran administered at a dosage of 100 mg/day improved pain, global status, fatigue, and physical and mental function in patients with fibromyalgia. [source] Improvements in early care in Russian orphanages and their relationship to observed behaviorsINFANT MENTAL HEALTH JOURNAL, Issue 2 2005Christina J. Groark This article describes a unique study that attempts to promote positive social-emotional relationships and attachment between caregivers and children in orphanages in St. Petersburg, Russia. The children who reside in these orphanages are typically between birth and 48 months of age; approximately 50% are diagnosed with disabilities, and approximately 60% leave through foreign adoption. Initially, their orphanage caregivers showed a high level of current anxiety and depression and were detached from and communicated little with the children. Likewise, during baseline observations, the children demonstrated poor attachment behaviors such as indiscriminant friendliness, lack of eye contact with adults, aggression, and impulsive behavior. Two interventions were used in a quasiexperimental design: (a) training of caregivers to promote warm, responsive caregiving and (b) staffing and structural alterations to support relationship building, especially increasing the consistency of caregivers. The methodology required that both the training and staffing interventions be provided to one orphanage, only the training to a second, and neither to a third. (At any one time, ns = 80,120 in each condition.) Initial informal observations reveal positive behaviors for both the caregivers and the children, such as increased two-way conversations, animated and enthusiastic emotional responses, and positive social and language interactions. Early data analyses show an increase in the consistency and stability of caregivers and increased scores for caregivers on every subscale of the HOME Scales. Children showed improvements in physical growth, cognition, language, motor, personal-social, and affect, with children having severe disabilities improving the most. The implications of these findings suggest that training staff with modest educational backgrounds and structural changes are effective, can increase socially responsive caregiving behaviors, and improves social interactions of children, at least temporarily. ©2005 Michigan Association for Infant Mental Health. [source] On the Role of Baseline Measurements for Crossover Designs under the Self and Mixed Carryover Effects ModelBIOMETRICS, Issue 1 2010Yuanyuan Liang Summary It is well known that optimal designs are strongly model dependent. In this article, we apply the Lagrange multiplier approach to the optimal design problem, using a recently proposed model for carryover effects. Generally, crossover designs are not recommended when carryover effects are present and when the primary goal is to obtain an unbiased estimate of the treatment effect. In some cases, baseline measurements are believed to improve design efficiency. This article examines the impact of baselines on optimal designs using two different assumptions about carryover effects during baseline periods and employing a nontraditional crossover design model. As anticipated, baseline observations improve design efficiency considerably for two-period designs, which use the data in the first period only to obtain unbiased estimates of treatment effects, while the improvement is rather modest for three- or four-period designs. Further, we find little additional benefits for measuring baselines at each treatment period as compared to measuring baselines only in the first period. Although our study of baselines did not change the results on optimal designs that are reported in the literature, the problem of strong model dependency problem is generally recognized. The advantage of using multiperiod designs is rather evident, as we found that extending two-period designs to three- or four-period designs significantly reduced variability in estimating the direct treatment effect contrast. [source] | ||||||||||