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,...

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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, K.E., Stock, J.L., Barrett‐Connor, E., Grady, D., Mosca, L., Khaw, K.T., Zhao, Q., Agnusdei, D. and Cauley, J.A., 2008. Effects of raloxifene on fracture risk in postmenopausal women: the Raloxifene Use for the Heart Trial.Journal of bone and mineral research,23(1), pp.112-120.For each part of the checklist state where in the investigators report the requirement has been reported and give a summary (a couple of lines) of what this is.At the end of the report, please also include a report summarisinghow the paper/report has met the consort reporting requirements. You should evaluate and explainthe trial design witha critical analysis of the trial with regards to design, methodsand limitations. You shoulduse extraliterature to support analysis and demonstrate independent learning.



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 1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts) Introduction Background and objectives 2a Scientific background and explanation of rationale 2b Specific objectives or hypotheses Methods Trial design 3a Description of trial design (such as parallel, factorial) including allocation ratio 3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons Participants 4a Eligibility criteria for participants 4b Settings and locations where the data were collected Interventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered Outcomes 6a Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed 6b Any changes to trial outcomes after the trial commenced, with reasons Sample size 7a How sample size was determined 7b When applicable, explanation of any interim analyses and stopping guidelines Randomisation:  Sequence generation 8a Method used to generate the random allocation sequence 8b Type of randomisation; details of any restriction (such as blocking and block size)  Allocation concealment mechanism 9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned  Implementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions Blinding 11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how 11b If relevant, description of the similarity of interventions Statistical methods 12a Statistical methods used to compare groups for primary and secondary outcomes 12b Methods for additional analyses, such as subgroup analyses and adjusted analyses Results Participant flow (a diagram is strongly recommended) 13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome 13b For each group, losses and exclusions after randomisation, together with reasons Recruitment 14a Dates defining the periods of recruitment and follow-up 14b Why the trial ended or was stopped Baseline data 15 A table showing baseline demographic and clinical characteristics for each group Numbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups Outcomes and estimation 17a For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) 17b For binary outcomes, presentation of both absolute and relative effect sizes is recommended Ancillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms) Discussion Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses Generalisability 21 Generalisability (external validity, applicability) of the trial findings Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence Other information Registration 23 Registration number and name of trial registry Protocol 24 Where the full trial protocol can be accessed, if available Funding 25 Sources of funding and other support (such as supply of drugs), role of funders *We strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see www.consort-statement.org. CONSORT 2010 checklist Page
Answered Same DayMay 15, 2022

Answer To: Assignment: You have been provided with arandomisedcontrolled trial of a drug(s) from the literature...

P answered on May 16 2022
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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 random
ised or non-randomised.
    112
    
    1b
    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 nonvertebral fractures but, there is significant reduction in the vertebral fractures. Irrespective of factors of age, smoking, physical activity there is a significant reduction of vertebral 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 vertebral fractures among the postmenopausal women with osteoporosis but in this study the effect of the Raloxifene on the risk of fracture was analysed irrespective of osteoporosis among the postmenopausal women.
    113
    
    2b
    Specific objectives or hypotheses
The objective of this study is to analyse the Raloxifene effect on the coronary events and the breast 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
    
    3b
    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
    
    4b
    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 vertebral 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
    
    6b
    Any changes to trial outcomes after the trial commenced, with reasons
Yes, the risk associated with the vertebral fractures was minimised whereas there is no significant results were observed with the non-vertebral 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 vertebral and non-vertebral risks among the postmenopausal women.
    113
    
    7b
    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
    
    8b
    Type of randomisation; details of any restriction (such as blocking and block size) not mentioned
Randomisation...
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