Home About us Contact
|
Home About us Contact | ||
|
|
||
Parallel Group Design (parallel + group_design)
Selected AbstractsEffect of tick parasitism on the health status of a passerine birdFUNCTIONAL ECOLOGY, Issue 6 2008D. J. A. Heylen Summary 1Little information is available on the ecological interactions between ticks and their hosts under natural conditions, and particularly so for avian hosts. To understand this host,parasite interaction it is necessary to assess the physiological harm ticks can do to their host. 2We combined observational and experimental (field and laboratory) data to examine the effects of a common tick species with major economic importance, the sheep tick (Ixodes ricinus), on the health status of a common passerine bird, the great tit (Parus major). 3In the laboratory experiment a parallel group design was carried out in which the birds of the experimental group were infested with 3,10 nymphs, whereas the birds of the control group were kept free of ticks and received a sham treatment. Both groups were stratified according to age and sex. Health parameters were measured the day before and 3 days after infestation or sham treatment: haematocrit level, erythrocyte sedimentation rate, leucocyte concentration and general body condition (body mass corrected for body size). 4No effects of age were observed on any of the health parameters. The decrease in haematocrit level in the experimental group was significantly greater than in the control group. Moreover, infested males suffered more blood depletion than infested females. The increase in sedimentation rate was greater in the experimental group than in the control group. Surprisingly, no treatment effects were found on leucocyte concentrations, which may indicate immunoregulation by the ticks on components of the birds' cellular immune response. Also no difference in general body condition between the treatment groups was found. None of the infested birds died during infestation. 5Lower haematocrit levels in infested birds, but unaffected leucocyte concentrations and general body condition are confirmed by field data (experimental and observational) of adult birds during breeding season. 6Neither haematocrit level nor general body condition was associated with parasite intensity among infested birds, suggesting that immature Ixodes ricinus are not resource limited at high natural densities. Still, the measurable direct harm caused by sheep tick infestations calls for further study on its importance for the evolutionary ecology of passerine hosts. [source] Acute cholecystokinin effects on event-related potentials in healthy volunteersHUMAN PSYCHOPHARMACOLOGY: CLINICAL AND EXPERIMENTAL, Issue 6 2002Verner J. Knott Abstract This study investigated the effects of a continuous slow infusion of cholecystokinin tetrapeptide (CCK-4), a neuropeptide with panicogenic properties, on brain event-related potentials (ERPs) in healthy adults. Twenty-four volunteers, 15 females and 9 males, were assigned to infusion with either placebo or CCK-4 in a randomized, double-blind, parallel group design. ERPs, elicited within a standard auditory odd-ball paradigm requiring the counting of rare (20%) occurring ,deviant' tones interspersed among more frequent (80%) occurring ,standard' tones, were assessed once before infusion, and at 10,min and 40,min after the onset of infusion. Compared with the placebo, CCK-4 delayed the latencies of N100 and P200 components elicited by ,deviant' stimuli. No significant treatment differences were observed with respect to N200, P300b, mood or adverse symptoms. These preliminary findings suggest that CCK-4 may interfere with information processing relating to the selection of significant stimuli and as such, may be of relevance to mechanisms underlying panic disorder. Copyright © 2002 John Wiley & Sons, Ltd. [source] Assessing the trade-offs between crossover and parallel group designs in sleep researchJOURNAL OF SLEEP RESEARCH, Issue 4 2006CHARLES C. BERRY Summary Sleep researchers invariably struggle with decisions regarding the optimal design for their studies. Whether such studies involve treatment for insomnia, obstructive sleep apnea, or any other sleep disorder, questions arise regarding the respective trade-offs between a parallel group and a crossover design. This study analyzed the variance structure of commonly measured polysomnographic variables in an effort to describe the statistical impact of these alternate designs. The study examined the effects of opioids on sleep and employed multiple crossovers between placebo, MS-contin, and methadone using a double-blind, randomized crossover design. Thirty-seven healthy subjects were studied. Four of the subjects were unable to complete the protocol for a variety of reasons, and polysomnogram data was unavailable for one subject. Data from 37 subjects provide the basis for this analysis. Despite dropouts, the crossover study was approximately four times as efficient as the parallel group design in terms of being able to recognize differences in deep sleep across these conditions. Other polysomnographic variables also favored the crossover design to varying extents. Despite the operational complexity of a crossover design, the statistical efficiency of this approach makes it a preferable approach for designing intervention studies in sleep research. [source] The New European Medicines Agency Guideline on the Investigation of BioequivalenceBASIC AND CLINICAL PHARMACOLOGY & TOXICOLOGY, Issue 3 2010José Augusto Guimarães Morais Several new features have been added to this guideline, as well as changes aimed at improving the clarity of the guidance provided. The first issue to be addressed was to limit the scope of the guideline to bioequivalence studies for immediate release dosage forms with systemic action. Therefore, the guideline refers to bioequivalence alone. Moreover, the new definition of Generic Medicinal Product has been incorporated. Clearer guidance covering more specific cases is now given on sections such as: fed/fasting conditions, use of metabolite data, enantiomers and strength to be used in the bioequivalence study. Steady-state design is now restricted and other designs, such as parallel group design, replicate design and two-stage design, are now incorporated in a more explicit form. New practical guidance on Highly Variable Drug Products and Narrow Therapeutic Index Drugs has been incorporated. The possibility for a biowaiver based on the Biopharmaceutics Classification System is now more explicit for Class I drugs and can be extended to Class III drugs under restricted conditions. We are aware that the initial goal of providing a very specific and clear guidance on these issues has not been entirely achieved, mainly because it is almost impossible to cover all individual cases and predict every possible situation that may arise. Demonstration of bioequivalence will still require in many instances a case by case approach. [source] Heavy silicone oil versus standard silicone oil as vitreous tamponade in inferior PVR (HSO Study): design issues and implicationsACTA OPHTHALMOLOGICA, Issue 6 2007Antonia M. Joussen Abstract. Purpose:, Proliferative vitreoretinopathy (PVR) is the most important reason for blindness following retinal detachment. Presently, vitreous tamponades such as gas or silicone oil cannot contact the lower part of the retina. A heavier-than-water tamponade displaces the inflammatory and PVR-stimulating environment from the inferior area of the retina. The Heavy Silicone Oil versus Standard Silicone Oil Study (HSO Study) is designed to answer the question of whether a heavier-than-water tamponade improves the prognosis of eyes with PVR of the lower retina. Methods:, The HSO Study is a multicentre, randomized, prospective controlled clinical trial comparing two endotamponades within a two-arm parallel group design. Patients with inferiorly and posteriorly located PVR are randomized to either heavy silicone oil or standard silicone oil as a tamponading agent. Three hundred and fifty consecutive patients are recruited per group. After intraoperative re-attachment, patients are randomized to either standard silicone oil (1000 cSt or 5000 cSt) or Densiron® as a tamponading agent. The main endpoint criteria are complete retinal attachment at 12 months and change of visual acuity (VA) 12 months postoperatively compared with the preoperative VA. Secondary endpoints include complete retinal attachment before endotamponade removal, quality of life analysis and the number of retina affecting re-operation within 1 year of follow-up. Results:, The design and early recruitment phase of the study are described. Conclusions:, The results of this study will uncover whether or not heavy silicone oil improves the prognosis of eyes with PVR. [source] Assessing the trade-offs between crossover and parallel group designs in sleep researchJOURNAL OF SLEEP RESEARCH, Issue 4 2006CHARLES C. BERRY Summary Sleep researchers invariably struggle with decisions regarding the optimal design for their studies. Whether such studies involve treatment for insomnia, obstructive sleep apnea, or any other sleep disorder, questions arise regarding the respective trade-offs between a parallel group and a crossover design. This study analyzed the variance structure of commonly measured polysomnographic variables in an effort to describe the statistical impact of these alternate designs. The study examined the effects of opioids on sleep and employed multiple crossovers between placebo, MS-contin, and methadone using a double-blind, randomized crossover design. Thirty-seven healthy subjects were studied. Four of the subjects were unable to complete the protocol for a variety of reasons, and polysomnogram data was unavailable for one subject. Data from 37 subjects provide the basis for this analysis. Despite dropouts, the crossover study was approximately four times as efficient as the parallel group design in terms of being able to recognize differences in deep sleep across these conditions. Other polysomnographic variables also favored the crossover design to varying extents. Despite the operational complexity of a crossover design, the statistical efficiency of this approach makes it a preferable approach for designing intervention studies in sleep research. [source] Impact of baseline ECG collection on the planning, analysis and interpretation of ,thorough' QT trialsPHARMACEUTICAL STATISTICS: THE JOURNAL OF APPLIED STATISTICS IN THE PHARMACEUTICAL INDUSTRY, Issue 2 2009Venkat Sethuraman Abstract The current guidelines, ICH E14, for the evaluation of non-antiarrhythmic compounds require a ,thorough' QT study (TQT) conducted during clinical development (ICH Guidance for Industry E14, 2005). Owing to the regulatory choice of margin (10,ms), the TQT studies must be conducted to rigorous standards to ensure that variability is minimized. Some of the key sources of variation can be controlled by use of randomization, crossover design, standardization of electrocardiogram (ECG) recording conditions and collection of replicate ECGs at each time point. However, one of the key factors in these studies is the baseline measurement, which if not controlled and consistent across studies could lead to significant misinterpretation. In this article, we examine three types of baseline methods widely used in the TQT studies to derive a change from baseline in QTc (time-matched, time-averaged and pre-dose-averaged baseline). We discuss the impact of the baseline values on the guidance-recommended ,largest time-matched' analyses. Using simulation we have shown the impact of these baseline approaches on the type I error and power for both crossover and parallel group designs. In this article, we show that the power of study decreases as the number of time points tested in TQT study increases. A time-matched baseline method is recommended by several authors (Drug Saf. 2005; 28(2):115,125, Health Canada guidance document: guide for the analysis and review of QT/QTc interval data, 2006) due to the existence of the circadian rhythm in QT. However, the impact of the time-matched baseline method on statistical inference and sample size should be considered carefully during the design of TQT study. The time-averaged baseline had the highest power in comparison with other baseline approaches. Copyright © 2008 John Wiley & Sons, Ltd. [source] | ||||||||||