Journal Club Assignment Exercise

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Name Victoria Adesina student ID 0283752 Journal Club Assignment Question 1: Yes patient were Randomized. Participants were randomly assigned to a placebo –controlled multicenter trial for smoking cessation in patients with mild to moderate COPD conducted in 27 centers in four countries: United states(17 sites), Spain( 3 sites), France(four sites) and Italy (3 sites). Patient were randomized at baseline into 2 groups to receive either Varenicline 0.5mg once daily for 3 days, 0.5mg bid for 4 days, then 1.0mg bid for a total of 12 weeks or Placebo (with identical regimen). The method used to generate the random allocation of product was not stated in the study. Question 2: Randomization concealment was not specified. Question 3: Yes the …show more content…

The trial consist of patient who were 35 years old or older with clinical diagnosis of mild to moderate COPD (confirmed FEV1/FVC LESS 70% and FEV1 % predicted normal value greater or equal to 50% and willingly to stop smoking. Participants has higher percentage of male and Caucasians populations, smoked for an average of 40 years also smoked 10 or more cigarettes per day over the past year. Participants treated with systematic steroids or hospitalized for COPD exacerbation during the 4 week period were excluded. Aslo excluded are participants with uncontrolled medical …show more content…

73.8% Participants receiving Varenicline and 65.3% receiving placebo reported an adverse event, which seldom led to treatment discontinuations in either group (5.2% and 5.6% respectively. Serious Adverse Event were few in both groups and were not considered to be treatment related. The most frequent Adverse events occurring in the Varenicline group compared with the placebo group were nausea (27.0% vs 8.0%), Abnormal dreams (10.9% VS 7%), sleep disorders or disturbances (20.6% vs 9.2%). Question 13: Overall Assessment of the study; Not a high quality Randomized control trial. Intention to treat Analysis was not detailed. Strength of the Trial include: Randomization. Patients were randomized in the group to which they were analyzed which help to balance prognostic factor within the two groups. Patient were also randomly assigned to treatments Trial was double blinded to minimize any form of bias Length of trial was sufficient for smoking cessation. Trial was not stopped early All study participants were analyzed. Intention to treat principle was applied to help reduce bias due to loss to

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