![Methodological issues in therapeutic trials of COPD PERSPECTIVE](http://s1.studyres.com/store/data/008921027_1-2de290661246108c3080702b4b424907-300x300.png)
Methodological issues in therapeutic trials of COPD PERSPECTIVE
... While all randomised trials have studied the rate of exacerbation during the time that subjects were being followed, and some trials have analysed the time to the first COPD exacerbation, none has specifically examined the pattern of COPD exacerbations subsequent to the first one. In particular, it ...
... While all randomised trials have studied the rate of exacerbation during the time that subjects were being followed, and some trials have analysed the time to the first COPD exacerbation, none has specifically examined the pattern of COPD exacerbations subsequent to the first one. In particular, it ...
Combination Anti-Cholinergic COPD Therapy – Safety and
... sent him here for abnormal lab values. Pt c/o nausea and pain 8/10 which he states is normal for him. Pt also states mild SOB which he says is slightly worse than what he's used to. Pt is under examination for possible need for dialysis. Pt is in no acute distress, and is speaking with doctor. Pt pl ...
... sent him here for abnormal lab values. Pt c/o nausea and pain 8/10 which he states is normal for him. Pt also states mild SOB which he says is slightly worse than what he's used to. Pt is under examination for possible need for dialysis. Pt is in no acute distress, and is speaking with doctor. Pt pl ...
Effect of Nesiritide in Patients with Acute Decompensated Heart
... independently of the sponsor by the executive and steering committees. The sponsor was allowed to comment on the manuscript before submission, but all final decisions were made by the executive committee. An independent data and safety monitoring board met after every 1000 patients had been recruite ...
... independently of the sponsor by the executive and steering committees. The sponsor was allowed to comment on the manuscript before submission, but all final decisions were made by the executive committee. An independent data and safety monitoring board met after every 1000 patients had been recruite ...
august 2013 - Practical Pointers
... What is the role of the caregiver? The caregiver should understand the patient’s underlying health status, the diagnosis, and prognosis for life expectancy and the expected trajectory over the coming months. The key to realistic decision making includes choices such as life-prolonging vs comfort-ca ...
... What is the role of the caregiver? The caregiver should understand the patient’s underlying health status, the diagnosis, and prognosis for life expectancy and the expected trajectory over the coming months. The key to realistic decision making includes choices such as life-prolonging vs comfort-ca ...
Research into biomarkers: how does drug procurement affect the
... Address for correspondence: [email protected], [email protected] ...
... Address for correspondence: [email protected], [email protected] ...
Evaluation of the Clinical Efficacy of Fractional
... acne lesions and control sites (p > .05). No significant changes in TEWL were noted (Figure 6). Dermal density decreased 2 and 6 weeks after treatment but increased 8 weeks after treatment, without significant differences (p > .05) (Figure 7A,B). On microscopic and composite images of the right chee ...
... acne lesions and control sites (p > .05). No significant changes in TEWL were noted (Figure 6). Dermal density decreased 2 and 6 weeks after treatment but increased 8 weeks after treatment, without significant differences (p > .05) (Figure 7A,B). On microscopic and composite images of the right chee ...
Linking evidence-based medicine to clinical decision analysis
... absolute risk difference (ARD) between event rates in the two groups, i.e., ARD = Risk1 – Risk2 , or as the proportional relative risk reduction (RRR) in event rates, i.e., RRR = (Risk1 – Risk2) / Risk1 = 1 – Risk2 / Risk1 (2, 5). Alternatively, NNT represents the reciprocal of the difference in eve ...
... absolute risk difference (ARD) between event rates in the two groups, i.e., ARD = Risk1 – Risk2 , or as the proportional relative risk reduction (RRR) in event rates, i.e., RRR = (Risk1 – Risk2) / Risk1 = 1 – Risk2 / Risk1 (2, 5). Alternatively, NNT represents the reciprocal of the difference in eve ...
Terlipressin acetate - Therapeutic Goods Administration
... Terlipressin is a dodecapeptide that has three glycyl residues attached to the N-terminal of lysine vasopressin (LVP). Terlipressin acts as a pro-drug and is converted via enzymatic cleavage of its three glycyl residues to the biologically active lysine vasopressin. A large body of evidence has cons ...
... Terlipressin is a dodecapeptide that has three glycyl residues attached to the N-terminal of lysine vasopressin (LVP). Terlipressin acts as a pro-drug and is converted via enzymatic cleavage of its three glycyl residues to the biologically active lysine vasopressin. A large body of evidence has cons ...
Oncology KOLS: AN IMPORTANT PIECE OF THE PUZZLE
... and specialty therapeutics practice at ZS. “In oncology, even more so than other specialty areas, thought leaders specialize in a category and the volume of patients they see is substantially higher than the average oncologist,” she says. “Many times, early adopters have been involved in the clinica ...
... and specialty therapeutics practice at ZS. “In oncology, even more so than other specialty areas, thought leaders specialize in a category and the volume of patients they see is substantially higher than the average oncologist,” she says. “Many times, early adopters have been involved in the clinica ...
Electrical stimulation for chronic non
... highly prescribed due to low cost and low occurrence of side effects [21]. Identification of electrotherapy treatments with quality evidence of efficacy, low cost, and low adverse effect profile would be expected to result in improved patient function, reduced pain, reduced morbidity, improved produ ...
... highly prescribed due to low cost and low occurrence of side effects [21]. Identification of electrotherapy treatments with quality evidence of efficacy, low cost, and low adverse effect profile would be expected to result in improved patient function, reduced pain, reduced morbidity, improved produ ...
In-/off-label use of biologic therapy in systemic lupus erythematosus Open Access
... to approval of belimumab for mild-to-moderate SLE. Belimumab is the first drug dedicated to SLE 50 years after corticosteroids and antimalarials, meaning no other firm evidence could be drawn so far for any other treatment ranging from traditional immunosuppressants to new biologic drugs. This is pr ...
... to approval of belimumab for mild-to-moderate SLE. Belimumab is the first drug dedicated to SLE 50 years after corticosteroids and antimalarials, meaning no other firm evidence could be drawn so far for any other treatment ranging from traditional immunosuppressants to new biologic drugs. This is pr ...
Understanding Farydak® (panobinostat)
... for the treatment of adult patients with relapsed and/or refractory myeloma who have received at least two prior regimens including Velcade + an immunomodulatory drug. Farydak has also been approved for use in Chile and Japan. ...
... for the treatment of adult patients with relapsed and/or refractory myeloma who have received at least two prior regimens including Velcade + an immunomodulatory drug. Farydak has also been approved for use in Chile and Japan. ...
Guidelines for the conduct of clinical trials for spinal cord injury as
... enrollment of fewer subjects to detect potentially statistically significant outcomes. On the other hand, a therapy that acts by enhancing plasticity of spared central pathways may be less likely to exert a detectable effect in patients with clinically complete injuries. The design of a trial must car ...
... enrollment of fewer subjects to detect potentially statistically significant outcomes. On the other hand, a therapy that acts by enhancing plasticity of spared central pathways may be less likely to exert a detectable effect in patients with clinically complete injuries. The design of a trial must car ...
Pulmonary gas exchange in cystic fibrosis: basal status and the
... forced vital capacity tension remain to be exhaled were significantly worse (p<0.05, respectively). Areas with a low V '/Q ' were significantly lower after amiloride compared to after the placebo period (p<0.05). Moderate ventilation/perfusion inequality was present in the majority of the studied cy ...
... forced vital capacity tension remain to be exhaled were significantly worse (p<0.05, respectively). Areas with a low V '/Q ' were significantly lower after amiloride compared to after the placebo period (p<0.05). Moderate ventilation/perfusion inequality was present in the majority of the studied cy ...
Using randomization tests to preserve type I error with response
... but our results below do not depend on this assumption. We assume that the ith patient is assigned treatment 1 with probability g (Hi ) where g is a pre-specified function that defines the adaptive assignment mechanism. For equal non-adaptive randomization, g (Hi ) = 0.5 for all i = 1, . . . , n. Fo ...
... but our results below do not depend on this assumption. We assume that the ith patient is assigned treatment 1 with probability g (Hi ) where g is a pre-specified function that defines the adaptive assignment mechanism. For equal non-adaptive randomization, g (Hi ) = 0.5 for all i = 1, . . . , n. Fo ...
therapy - UCSF | Department of Medicine
... to surgical or medical treatment using a process analogous to flipping a coin demonstrated that the only effect of surgery was to increase adverse outcomes in the immediate postsurgical period.3 Other surprises generated by randomized trials that contradicted the results of less rigorous trials incl ...
... to surgical or medical treatment using a process analogous to flipping a coin demonstrated that the only effect of surgery was to increase adverse outcomes in the immediate postsurgical period.3 Other surprises generated by randomized trials that contradicted the results of less rigorous trials incl ...
product monograph
... cellulitis. As well, infections of the abdomen, urinary tract, and ear, were more frequent in patients treated with PROLIA. Endocarditis was also reported more frequently in PROLIAtreated patients (< 0.1% PROLIA group; 0% placebo group). The incidence of opportunistic infections was balanced between ...
... cellulitis. As well, infections of the abdomen, urinary tract, and ear, were more frequent in patients treated with PROLIA. Endocarditis was also reported more frequently in PROLIAtreated patients (< 0.1% PROLIA group; 0% placebo group). The incidence of opportunistic infections was balanced between ...
Efficacy of high doses of oral penicillin versus amoxicillin in the
... greater community prescription of broad-spectrum antibiotics has been taking place in many countries, with amoxicillin-clavulanate and amoxicillin being the antibiotics most frequently prescribed by family practitioners in Spain [2,3]. Antimicrobial resistance may be a cause of therapeutic failure. ...
... greater community prescription of broad-spectrum antibiotics has been taking place in many countries, with amoxicillin-clavulanate and amoxicillin being the antibiotics most frequently prescribed by family practitioners in Spain [2,3]. Antimicrobial resistance may be a cause of therapeutic failure. ...
Carvedilol was more effective than metoprolol tartrate for lowering
... hanks to the remarkable successes in drug development, a variety of effective treatments are available for most medical conditions. The new challenge is often how to select the optimal therapy. For approval purposes, regulatory agencies require placebo controlled rather than active comparison trials ...
... hanks to the remarkable successes in drug development, a variety of effective treatments are available for most medical conditions. The new challenge is often how to select the optimal therapy. For approval purposes, regulatory agencies require placebo controlled rather than active comparison trials ...
Pathophysiology and Treatment Second Edition
... This book contains information from reputable sources and although reasonable efforts have been made to publish accurate information, the publisher makes no warranties (either express or implied) as to the accuracy or fitness for a particular purpose of the information or advice contained herein. Th ...
... This book contains information from reputable sources and although reasonable efforts have been made to publish accurate information, the publisher makes no warranties (either express or implied) as to the accuracy or fitness for a particular purpose of the information or advice contained herein. Th ...
CONTINGENCY MANAGEMENT
... withdrawal. Nicotine & Tobacco Research, Vol. 5, 205-213 In this study, smokers who were not trying to quit were offered monetary incentives to abstain from smoking while residing in their usual environments with the aim of assessing nicotine withdrawal during a 5-day period. The participants were a ...
... withdrawal. Nicotine & Tobacco Research, Vol. 5, 205-213 In this study, smokers who were not trying to quit were offered monetary incentives to abstain from smoking while residing in their usual environments with the aim of assessing nicotine withdrawal during a 5-day period. The participants were a ...
Understanding Ninlaro - International Myeloma Foundation
... Ninlaro) and the control arm (which substituted a placebo for Ninlaro) were treated until their myeloma progressed or they were unable to tolerate the treatment. The efficacy of Ninlaro was evaluated by the median duration of progression-free survival (PFS) in the two arms of the study. The median P ...
... Ninlaro) and the control arm (which substituted a placebo for Ninlaro) were treated until their myeloma progressed or they were unable to tolerate the treatment. The efficacy of Ninlaro was evaluated by the median duration of progression-free survival (PFS) in the two arms of the study. The median P ...
A Randomized, Double Blind, Placebo
... stimulant medications provided stable doses were used beginning five days prior to baseline and continuing until the end of the trial. Of the 136 patients entering the trial, 113 (83.1%) remained on a stable dose of stimulant. Those patients not taking previous medications entered baseline following ...
... stimulant medications provided stable doses were used beginning five days prior to baseline and continuing until the end of the trial. Of the 136 patients entering the trial, 113 (83.1%) remained on a stable dose of stimulant. Those patients not taking previous medications entered baseline following ...
Specific questions that need answering when considering the
... Common designs include parallel group, crossover, factorial, cluster and group sequential. Parallel group design: each group of participants receives only one of the study treatments. Cross-over design: participants are given all the study treatments sequentially in time. The order in which the part ...
... Common designs include parallel group, crossover, factorial, cluster and group sequential. Parallel group design: each group of participants receives only one of the study treatments. Cross-over design: participants are given all the study treatments sequentially in time. The order in which the part ...
Placebo-controlled study
![](https://commons.wikimedia.org/wiki/Special:FilePath/Cebocap.jpg?width=300)
Placebo-controlled studies are a way of testing a medical therapy in which, in addition to a group of subjects that receives the treatment to be evaluated, a separate control group receives a sham ""placebo"" treatment which is specifically designed to have no real effect. Placebos are most commonly used in blinded trials, where subjects do not know whether they are receiving real or placebo treatment. Often, there is also a further ""natural history"" group that does not receive any treatment at all.The purpose of the placebo group is to account for the placebo effect, that is, effects from treatment that do not depend on the treatment itself. Such factors include knowing one is receiving a treatment, attention from health care professionals, and the expectations of a treatment's effectiveness by those running the research study. Without a placebo group to compare against, it is not possible to know whether the treatment itself had any effect.Patients frequently show improvement even when given a sham or ""fake"" treatment. Such intentionally inert placebo treatments can take many forms, such as a pill containing only sugar, a surgery where nothing efficacious is actually done (just an incision and sometimes some minor touching or handling of the underlying structures), or a medical device (such as an ultrasound machine) that is not actually turned on. Also, due to the body's natural healing ability and statistical effects such as regression to the mean, many patients will get better even when given no treatment at all. Thus, the relevant question when assessing a treatment is not ""does the treatment work?"" but ""does the treatment work better than a placebo treatment, or no treatment at all?"" As one early clinical trial researcher wrote, ""the first object of a therapeutic trial is to discover whether the patients who receive the treatment under investigation are cured more rapidly, more completely or more frequently, than they would have been without it.""p.195 More broadly, the aim of a clinical trial is to determine what treatments, delivered in what circumstances, to which patients, in what conditions, are the most effective.Therefore, the use of placebos is a standard control component of most clinical trials, which attempt to make some sort of quantitative assessment of the efficacy of medicinal drugs or treatments. Such a test or clinical trial is called a placebo-controlled study, and its control is of the negative type. A study whose control is a previously tested treatment, rather than no treatment, is called a positive-control study, because its control is of the positive type.Government regulatory agencies approve new drugs only after tests establish not only that patients respond to them, but also that their effect is greater than that of a placebo (by way of affecting more patients, by affecting responders more strongly, or both). As a result, ""placebo-controlled studies often are designed in such a way that disadvantages the placebo condition"".