Assignment: You have been provided with arandomisedcontrolled trial of a drug(s) from the literature and you are asked to evaluate the trial report using the CONSORT reporting checklist. Paper:Ensrud,...

CONSORT 2010 checklist of information to include when reporting a randomised trial*
    Section/Topic
    Item No
    Checklist item
    Reported on page No
    Title and abstract
    
    1a
    Identification as a randomised trial in the title
The title of this study is “Effects of Raloxifene on Fracture Risk in Postmenopausal Women: The Raloxifene Use for The Heart Trial”. From this title it can be identified as a trial but it was not clear whether the trail is randomised or non-randomised.
    112
    
    1
    Structured summary of trial design, methods, results, and conclusions
A randomised clinical trial by using 10,101 with age >55 years were randomised and given the treatment by Raloxifene for the experimental group whereas the standard group has received placebo for a period of 5 years. It was observed that there is no difference in the results among the women with the risk of nonverte
al fractures but, there is significant reduction in the verte
al fractures. I
espective of factors of age, smoking, physical activity there is a significant reduction of verte
al fractures when treated with Raloxifene for 5 years.
    113
    Introduction
    Background and objectives
    2a
    Scientific background and explanation of rationale
The Raloxifene is a nonsteroidal receptor being used to minimise the verte
al fractures among the postmenopausal women with osteoporosis but in this study the effect of the Raloxifene on the risk of fracture was analysed i
espective of osteoporosis among the postmenopausal women.
    113
    
    2
    Specific objectives or hypotheses
The objective of this study is to analyse the Raloxifene effect on the coronary events and the
east cancer.
Another objective of this study is risk analysis of fractures when treated with the Raloxifene.
    113
    Methods
    Trial design
    3a
    Description of trial design (such as parallel, factorial) including allocation ratio
The trial Is a randomised double-blinded trial with 10,101 postmenopausal women >55 years of age. The experiment group with 5044 participants received 60 mg of oral dosage of Raloxifene. Whereas, the placebo group with 5057.
    113
    
    3
    Important changes to methods after trial commencement (such as eligibility criteria), with reasons
No Changes in the methods were reported in this study and the initial participants were considered for the entire study.
    113
    Participants
    4a
    Eligibility criteria for participants
The eligibility criteria are > 55 years of age, considered the risk factors based on the medical history, smoking, physical activity
    113
    
    4
    Settings and locations where the data were collected for the analysis of the risk score of fractures.
The study was conducted at 177 sites in nearly 26 countries and the analysis was performed by employing the statistical methods.
    113
    Interventions
    5
    The interventions for each group with sufficient details to allow replication, including how and when they were actually administered
The interventions were continued for a period of 5 years and for the experimental group 60 mg of the placebo was given whereas, for the standard group placebo was given daily for a period of 5 years reduced the verte
al fractures.
    114
    Outcomes
    6a
    Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed
Yes, all the outcomes were pre-specified and clearly mentioned to calculate the scores at semi-annual visits based on the X-ray reports.
    114
    
    6
    Any changes to trial outcomes after the trial commenced, with reasons
Yes, the risk associated with the verte
al fractures was minimised whereas there is no significant results were observed with the non-verte
al fractures.
    115
    Sample size
    7a
    How sample size was determined
It was not clearly stated and those who registered with the RUTH at different sites are considered for conducting the Raloxifene effects on. Minimising the verte
al and non-verte
al risks among the postmenopausal women.
    113
    
    7
    When applicable, explanation of any interim analyses and stopping guidelines
No, this study has not described about the interim analysis and the stopping guidelines of this randomised clinical trial.
    Not mentioned
    Randomisation:
    
    
    
     Sequence generation
    8a
    Method used to generate the random allocation sequence
Randomisation blinded clinical trial was used in this study and the process of randomisation was not mentioned.
    Not mentioned
    
    8
    Type of randomisation; details of any restriction (such as blocking and block size) not mentioned
Randomisation...