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Blinded Assessments (blinded + assessment)
Selected AbstractsConduction block and glial injury induced in developing central white matter by glycine, GABA, noradrenalin, or nicotine, studied in isolated neonatal rat optic nerveGLIA, Issue 11 2009Stavros Constantinou Abstract The damaging effects of excessive glutamate receptor activation have been highlighted recently during injury in developing central white matter. We have examined the effects of acute exposure to four other neurotransmitters that have known actions on white matter. Eighty minutes of Glycine or GABA-A receptor activation produced a significant fall in the compound action potential recorded from isolated post-natal day 10 rat optic nerve. This effect was largely reversed upon washout. Nicotinic acetylcholine receptor (nAChR) or adrenoreceptor activation with noradrenalin resulted in an ,35% block of the action potential that did not reverse during a 30-min washout period. While the effect of nAChR activation was blocked by a nAChR antagonist, the effect of noradrenalin was not ablated by ,- or ,-adrenoreceptor blockers applied alone or in combination. In the absence of noradrenalin, co-perfusion with ,- and ,-adrenoreceptor blockers resulted in nonreversible nerve failure indicating that tonic adrenoreceptor activation is required for nerve viability, while overactivation of these receptors is also damaging. Nerves exposed to nAChR + adrenoreceptor activation showed no axon pathology but had extensive glial injury revealed by ultrastructural analysis. Oligodendroglia exhibited regions of membrane vacuolization while profound changes were evident in astrocytes and included the presence of swollen and expanded mitochondria, vacuolization, cell processes disintegration, and membrane breakdown. Blinded assessment revealed higher levels of astrocyte injury than oligodendroglial injury. The findings show that overactivation of neurotransmitter receptors other than those for glutamate can produce extensive injury to developing white matter, a phenomenon that may be clinically significant. © 2009 Wiley-Liss, Inc. [source] Efficacy and Feasibility of a Novel Tri-Modal Robust Exercise Prescription in a Retirement Community: A Randomized, Controlled TrialJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 1 2007Michael K. Baker BAppSc OBJECTIVES: To test the feasibility and efficacy of current guidelines for multimodal exercise programs in older adults. DESIGN: Randomized, controlled trial. SETTING: Retirement village. PARTICIPANTS: Thirty-eight subjects (14 men and 24 women) aged 76.6 ± 6.1. INTERVENTION: A wait list control or 10 weeks of supervised exercise consisting of high-intensity (80% of one-repetition maximum (1RM)) progressive resistance training (PRT) 3 days per week, moderate-intensity (rating of perceived exertion 11 to 14/20) aerobic training 2 days per week, and progressive balance training 1 day per week. MEASUREMENTS: Blinded assessments of dynamic muscle strength (1RM), balance, 6-minute walk, gait velocity, chair stand, stair climb, depressive symptoms, self-efficacy, and habitual physical activity level. RESULTS: Higher baseline strength and psychological well-being were associated with better functional performance. Strength gains over 10 weeks averaged 39±31% in exercise, versus 21±24% in controls (P=.10), with greater improvements in hip flexion (P=.01), hip abduction (P=.02), and chest press (P=.04) in the exercise group. Strength adaptations were greatest in exercises in which the intended continuous progressive overload was achieved. Stair climb power (12.3±15%, P=.002) and chair stand time (,7.1±15%, P=.006) improved significantly and similarly in both groups. Reduction in depressive symptoms was significantly related to compliance (attendance rate r=,0.568, P=.009, PRT progression in loading r=,0.587, P=.02, and total volume of aerobic training r=,0.541, P=.01), as well as improvements in muscle strength (r=,0.498, P=.002). CONCLUSION: Robust physical and psychological adaptations to exercise are linked, although volumes and intensities of multiple exercise modalities sufficient to cause significant adaptation appear difficult to prescribe and adhere to simultaneously in older adults. [source] Design and implementation of a randomized trial evaluating systematic care for bipolar disorderBIPOLAR DISORDERS, Issue 4 2002Gregory E Simon Objectives: Everyday care of bipolar disorder typically falls short of evidence-based practice. This report describes the design and implementation of a randomized trial evaluating a systematic program to improve quality and continuity of care for bipolar disorder. Methods: Computerized records of a large health plan were used to identify all patients treated for bipolar disorder. Following a baseline diagnostic assessment, eligible and consenting patients were randomly assigned to either continued usual care or a multifaceted intervention program including: development of a collaborative treatment plan, monthly telephone monitoring by a dedicated nurse care manager, feedback of monitoring results and algorithm-based medication recommendations to treating mental health providers, as-needed outreach and care coordination, and a structured psychoeducational group program (the Life Goals Program by Bauer and McBride) delivered by the nurse care manager. Blinded assessments of clinical outcomes, functional outcomes, and treatment process were conducted every 3 months for 24 months. Results: A total of 441 patients (64% of those eligible) consented to participate and 43% of enrolled patients met criteria for current major depressive episode, manic episode, or hypomanic episode. An additional 39% reported significant subthreshold symptoms, and 18% reported minimal or no current mood symptoms. Of patients assigned to the intervention program, 94% participated in telephone monitoring and 70% attended at least one group session. Conclusions: In a population-based sample of patients treated for bipolar disorder, approximately two-thirds agreed to participate in a randomized trial comparing alternative treatment strategies. Nearly all patients accepted regular telephone monitoring and over two-thirds joined a structured group program. Future reports will describe clinical effectiveness and cost-effectiveness of the intervention program compared with usual care. [source] Histological effects of tazarotene 0·1% cream vs. vehicle on photodamaged skin: a 6-month, multicentre, double-blind, randomized, vehicle-controlled study in patients with photodamaged facial skinBRITISH JOURNAL OF DERMATOLOGY, Issue 6 2004L.A. Machtinger Summary Background, Topical tazarotene has been shown to offer efficacy in ameliorating multiple effects of photodamage. Objectives, To evaluate the histological effects of tazarotene cream on photodamaged skin. Methods, In this multicentre, double-blind, randomized, vehicle-controlled study, 50 patients with photodamaged facial skin (at least mild fine wrinkling and mottled hyperpigmentation, with at least one of these being moderate) were randomized to apply tazarotene 0·1% cream or vehicle cream to their face, once daily for 24 weeks. Results, Blinded assessments showed that tazarotene was less likely than vehicle to be associated with an increase in keratinocytic and melanocytic atypia, and more likely than vehicle to be associated with a reduction in atypia. Between-group comparisons in distribution of change from baseline categories of severity were in favour of tazarotene (P = 0·055 for keratinocytic atypia, P = 0·034 for melanocytic atypia, and P < 0·001 for the number of granular cell layers). Compared with vehicle, tazarotene was associated with an increase in epidermal polarity (P = 0·008) and epidermal thickness (P = 0·012), and a tendency for stratum corneum compaction. Tazarotene was also associated with widened intercellular spaces (reported as epidermal oedema) relative to vehicle (P < 0·001). Conclusions, Treatment of photodamaged skin with tazarotene is associated with an amelioration of keratinocytic and melanocytic atypia, an improvement in epidermal polarity, and an increase in epidermal thickness. [source] Prescribing errors on medical wards and the impact of clinical pharmacistsINTERNATIONAL JOURNAL OF PHARMACY PRACTICE, Issue 1 2003Ms Alison Dale clinical services pharmacist Objectives To assess the incidence of prescribing errors, predict patient outcome from clinical pharmacists' recommendations made in response to identified prescribing errors, and evaluate the influence of clinical pharmacists on recommendation implementation. Method Clinical pharmacy activities were conducted on two wards, one of which had an existing clinical pharmacy service (intervention ward) while the other did not (control ward). For the control ward, prescribing errors were documented but not followed up unless a potentially life-threatening problem was identified. Prescribing errors were identified and recommendations made by pharmacists. A consultant physician and pharmacist conducted an independent, blinded assessment of these recommendations to predict the impact on patient outcome if implemented. Recommendations were communicated to medical staff or implemented by the pharmacist on the intervention ward only. The proportion of recommendations implemented for intervention and control group patients were recorded. Setting Two medical wards in a UK district general hospital. The study was carried out over 12 weeks. Key findings There were 740 errors recorded for 235 patients. Fourteen recommendations could not be assessed. For all recommendations, the consultant and pharmacist predicted patient outcomes with life-saving (one consultant vs three pharmacist), major (186 vs 318), minor (328 vs 324), neutral (211 vs 85) or harmful (five vs five) impact respectively. For the intervention group, 79% of recommendations were implemented, including 81 of 92 (88%) predicted by the consultant to have major impact on patient outcomes. In the control group, only 18% of recommendations were spontaneously implemented, including only 10 of 94 (11%) recommendations predicted by the consultant to have major impact. Conclusion Ward-based clinical pharmacists identified large numbers of prescribing errors and made clinically significant recommendations. Implementation of recommendations was predicted to improve the outcome of patient care. Further research, specifically assessing the outcome of pharmacists' recommendations on patient care, is warranted. [source] Followup radiographic data on patients with rheumatoid arthritis who participated in a two-year trial of prednisone therapy or placeboARTHRITIS & RHEUMATISM, Issue 5 2006Johannes W. G. Jacobs Objective In a previous clinical trial of patients with early rheumatoid arthritis (RA), it was determined that patients who received 10 mg of prednisone per day for 2 years had less radiographic joint damage compared with those who received placebo. Our goal was to investigate whether this beneficial effect persisted after the end of the trial. Methods A blinded assessment of radiographic joint damage was performed ,3 years after the end of the original 2-year study. Twenty-four patients from the original prednisone group (60%) and 28 patients from the original placebo group (68%) participated in this followup study. At the end of the original trial, prednisone dosages were tapered down in the prednisone group and stopped, if possible. Patients from the original prednisone group took prednisone during 35% of the followup period (,1 year) at a mean daily dose of ,5 mg. Two patients from the original placebo group started taking prednisone during followup. Radiographs of the hands and feet were scored according to the van der Heijde modification of the Sharp method. Results During 3 additional years of followup, radiographic scores showed significantly less progression in the original prednisone group than in the original placebo group. Radiographic damage in the original prednisone group did not show an accelerated rate of progression during the followup period. Conclusion The inhibition of radiographic joint damage in patients with early active RA treated with 10 mg of prednisone per day for 2 years seems to persist after the end of prednisone therapy. [source] Occupational exposure to crystalline silica and risk of systemic lupus erythematosus: A population-based, case,control study in the Southeastern United StatesARTHRITIS & RHEUMATISM, Issue 7 2002Christine G. Parks Objective Crystalline silica may act as an immune adjuvant to increase inflammation and antibody production, and findings of occupational cohort studies suggest that silica exposure may be a risk factor for systemic lupus erythematosus (SLE). We undertook this population-based study to examine the association between occupational silica exposure and SLE in the southeastern US. Methods SLE patients (n = 265; diagnosed between January 1, 1995 and July 31, 1999) were recruited from 4 university rheumatology practices and 30 community-based rheumatologists in 60 contiguous counties. Controls (n = 355), frequency-matched to patients by age, sex, and state of residence, were randomly selected from driver's license registries. The mean age of the patients at diagnosis was 39 years; 91% were women and 60% were African American. Detailed occupational and farming histories were collected by in-person interviews. Silica exposure was determined through blinded assessment of job histories by 3 industrial hygienists, and potential medium- or high-level exposures were confirmed through followup telephone interviews. Odds ratios (ORs) and 95% confidence intervals (95% CIs) were estimated by logistic regression. Results More patients (19%) than controls (8%) had a history of medium- or high-level silica exposure from farming or trades. We observed an association between silica and SLE (medium exposure OR 2.1 [95% CI 1.1,4.0], high exposure OR 4.6 [95% CI 1.4,15.4]) that was seen in separate analyses by sex, race, and at different levels of education. Conclusion These results suggest that crystalline silica exposure may promote the development of SLE in some individuals. Additional research is recommended in other populations, using study designs that minimize potential selection bias and maximize the quality of exposure assessment. [source] | ||||||||||