This document outlines a 25-item checklist for reporting randomized controlled trials according to the CONSORT 2010 guidelines. The checklist includes items such as trial design, participants, interventions, outcomes, sample size, randomization, blinding, statistical methods, participant flow, recruitment dates, baseline characteristics, numbers analyzed, outcomes, harms, limitations, generalizability, and other trial details. Adhering to this checklist aims to improve transparency and completeness in randomized trial reporting.
Literature Critique InstructionsStudents will complete and submit .docxjeremylockett77
Literature Critique Instructions
Students will complete and submit a critique of an assigned literature. A modified version of the CONSORT (Consolidated Standards of Reporting Trials) 2010 checklist will be utilized to complete and grade this assignment. Total attainable points in this assignment is 45 points which accounts for 15% of the overall course grade. Students are highly encouraged to read “CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials.” and “CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomized trials.” well in advance of the literature critique due date. These articles serve as a great resource aiding in the completion of this assignment. A link to these articles as well as other resources can be found below.
Resources:
· CONSORT website: http://www.consort-statement.org/home/
· A useful resource for general background information regarding CONSORT
· Provides examples of good reporting
· Offers resources glossary of terminology, links to published literature, and more
· CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials. http://annals.org/article.aspx?articleid=745807
· CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomized trials.
http://www.consort-statement.org/Media/Default/Downloads/CONSORT%202010%20Explanation%20and%20Elaboration%20Document-BMJ.pdf
Course Number and Name
PHAR 610—Evidence Based Practice 2 Literature Critique & Journal Club
3
CONSORT 2010 checklist of information to include when reporting a randomised trial*
Section/Topic
Item No
Checklist item (each item is worth 1 point)
Reported on page No
& Line(s)
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
8a
Method used to generate the random allocation sequence
gener.
Literature Critique InstructionsStudents will complete and submit .docxcroysierkathey
Literature Critique Instructions
Students will complete and submit a critique of an assigned literature. A modified version of the CONSORT (Consolidated Standards of Reporting Trials) 2010 checklist will be utilized to complete and grade this assignment. Total attainable points in this assignment is 45 points which accounts for 15% of the overall course grade. Students are highly encouraged to read “CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials.” and “CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomized trials.” well in advance of the literature critique due date. These articles serve as a great resource aiding in the completion of this assignment. A link to these articles as well as other resources can be found below.
Resources:
· CONSORT website: http://www.consort-statement.org/home/
· A useful resource for general background information regarding CONSORT
· Provides examples of good reporting
· Offers resources glossary of terminology, links to published literature, and more
· CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials. http://annals.org/article.aspx?articleid=745807
· CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomized trials.
http://www.consort-statement.org/Media/Default/Downloads/CONSORT%202010%20Explanation%20and%20Elaboration%20Document-BMJ.pdf
Course Number and Name
PHAR 610—Evidence Based Practice 2 Literature Critique & Journal Club
3
CONSORT 2010 checklist of information to include when reporting a randomised trial*
Section/Topic
Item No
Checklist item (each item is worth 1 point)
Reported on page No
& Line(s)
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
8a
Method used to generate the random allocation sequence
gener ...
Literature Critique InstructionsStudents will complete and submit .docxjeremylockett77
Literature Critique Instructions
Students will complete and submit a critique of an assigned literature. A modified version of the CONSORT (Consolidated Standards of Reporting Trials) 2010 checklist will be utilized to complete and grade this assignment. Total attainable points in this assignment is 45 points which accounts for 15% of the overall course grade. Students are highly encouraged to read “CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials.” and “CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomized trials.” well in advance of the literature critique due date. These articles serve as a great resource aiding in the completion of this assignment. A link to these articles as well as other resources can be found below.
Resources:
· CONSORT website: http://www.consort-statement.org/home/
· A useful resource for general background information regarding CONSORT
· Provides examples of good reporting
· Offers resources glossary of terminology, links to published literature, and more
· CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials. http://annals.org/article.aspx?articleid=745807
· CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomized trials.
http://www.consort-statement.org/Media/Default/Downloads/CONSORT%202010%20Explanation%20and%20Elaboration%20Document-BMJ.pdf
Course Number and Name
PHAR 610—Evidence Based Practice 2 Literature Critique & Journal Club
3
CONSORT 2010 checklist of information to include when reporting a randomised trial*
Section/Topic
Item No
Checklist item (each item is worth 1 point)
Reported on page No
& Line(s)
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
8a
Method used to generate the random allocation sequence
gener.
Literature Critique InstructionsStudents will complete and submit .docxcroysierkathey
Literature Critique Instructions
Students will complete and submit a critique of an assigned literature. A modified version of the CONSORT (Consolidated Standards of Reporting Trials) 2010 checklist will be utilized to complete and grade this assignment. Total attainable points in this assignment is 45 points which accounts for 15% of the overall course grade. Students are highly encouraged to read “CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials.” and “CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomized trials.” well in advance of the literature critique due date. These articles serve as a great resource aiding in the completion of this assignment. A link to these articles as well as other resources can be found below.
Resources:
· CONSORT website: http://www.consort-statement.org/home/
· A useful resource for general background information regarding CONSORT
· Provides examples of good reporting
· Offers resources glossary of terminology, links to published literature, and more
· CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials. http://annals.org/article.aspx?articleid=745807
· CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomized trials.
http://www.consort-statement.org/Media/Default/Downloads/CONSORT%202010%20Explanation%20and%20Elaboration%20Document-BMJ.pdf
Course Number and Name
PHAR 610—Evidence Based Practice 2 Literature Critique & Journal Club
3
CONSORT 2010 checklist of information to include when reporting a randomised trial*
Section/Topic
Item No
Checklist item (each item is worth 1 point)
Reported on page No
& Line(s)
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
8a
Method used to generate the random allocation sequence
gener ...
Pr. Peivand Pirouzi - Writing a Study Protocol for Therapeutic Recreation Studies in Canada. Publication, All rights reserved
#peivandpirouzi #training #canada #pirouzi #international #funding #immigrants #refugees #canada #immigration #education
• The PRISMA 2020 Statement was published in 2021.
• It consists of a checklist and a flow diagram, and is intended
to be accompanied by the PRISMA 2020 Explanation and
Elaboration document.
A clinical trial protocol is a comprehensive document that outlines the objectives, design, methodology, procedures, and statistical considerations of a clinical research study. It serves as a detailed blueprint for conducting the trial and provides guidance to the investigators, study staff, ethics committees, and regulatory authorities involved in the study. Here are the key components typically included in a clinical trial protocol
DMID Interventional Protocol TemplateVersion 2.028 April 2005DustiBuckner14
DMID Interventional Protocol Template Version 2.0
28 April 2005
Protocol Title Version number and date
GENERAL INSTRUCTIONS – delete this box from the submitted Protocol
This template is for students in the Virginia University of Lynchburg Doctor of Healthcare Administration Research Practicum course who are preparing a detailed protocol for a study involving human subjects. Depending on the nature of what you are doing, some sections may not be applicable to your research. If a section is not applicable, delete. You may delete subsections that are not applicable. The full research protocol must be uploaded to Moodle to be considered complete. This includes the IRB Application with research protocol, Informed Consent Document (s), Recruitment Collateral, and any other supporting documentation. Applications with ANY missing elements will be considered incomplete and will be graded accordingly.
Use this template to create a study protocol as follows:
· Red text represents instructions to you – to be deleted from the final version
· Blue text represents guidance on suggested content – to be edited and changed to black or replaced with black in the final version.
· Black text represents text that should ordinarily be incorporated as-is, if applicable
Note that the table of contents is automatically included, so do not change the content or formatting of the headings. Be sure to right click on the table of contents and select “Update field” before saving the protocol and uploading it to Moodle. As always, make sure to proofread the document before submission.
Please make sure to complete the header on this page with the protocol title and version number and date.
The submitted protocol should have no red or blue text (including the header and instruction boxes like this one). The submitted protocol should have no spelling or grammar errors. All references MUST be in APA 7 format. PROTOCOL TITLEProtocol Version Number: CompleteProtocol Version Date: day, month, year [Include if there is an external funder; otherwise, delete heading] Funding Mechanism: organization and grant or contract #[Include if there is industry support; otherwise, delete heading] Industry Support provided by: name of industryPrincipal Investigator: name Phone: Complete E-mail: Complete[Include if the study has a medical monitor; otherwise, delete heading] Medical Monitor: name
Table of Contents
1List of Abbreviations4
2Protocol Summary4
3Background/Rationale & Purpose5
3.1Background Information5
3.2Rationale and Purpose5
4Objectives5
4.1Study Objectives5
4.2Study Outcome Measures6
4.2.1Primary Outcome Measures6
4.2.2Secondary Outcome Measures6
5Study Design6
6Potential Risks and Benefits7
6.1Risks7
6.2Potential Benefits8
6.3Analysis of Risks in Relation to Benefits8
7Study Subject Selection8
7.1Subject Inclusion Criteria8
7.2Subject Exclusion Criteria8
7.3Recruitment Methods9
7.4Compensation for Participation in Research Activities9
7.5Withdrawal of Pa ...
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Pr. Peivand Pirouzi - Writing a Study Protocol for Therapeutic Recreation Studies in Canada. Publication, All rights reserved
#peivandpirouzi #training #canada #pirouzi #international #funding #immigrants #refugees #canada #immigration #education
• The PRISMA 2020 Statement was published in 2021.
• It consists of a checklist and a flow diagram, and is intended
to be accompanied by the PRISMA 2020 Explanation and
Elaboration document.
A clinical trial protocol is a comprehensive document that outlines the objectives, design, methodology, procedures, and statistical considerations of a clinical research study. It serves as a detailed blueprint for conducting the trial and provides guidance to the investigators, study staff, ethics committees, and regulatory authorities involved in the study. Here are the key components typically included in a clinical trial protocol
DMID Interventional Protocol TemplateVersion 2.028 April 2005DustiBuckner14
DMID Interventional Protocol Template Version 2.0
28 April 2005
Protocol Title Version number and date
GENERAL INSTRUCTIONS – delete this box from the submitted Protocol
This template is for students in the Virginia University of Lynchburg Doctor of Healthcare Administration Research Practicum course who are preparing a detailed protocol for a study involving human subjects. Depending on the nature of what you are doing, some sections may not be applicable to your research. If a section is not applicable, delete. You may delete subsections that are not applicable. The full research protocol must be uploaded to Moodle to be considered complete. This includes the IRB Application with research protocol, Informed Consent Document (s), Recruitment Collateral, and any other supporting documentation. Applications with ANY missing elements will be considered incomplete and will be graded accordingly.
Use this template to create a study protocol as follows:
· Red text represents instructions to you – to be deleted from the final version
· Blue text represents guidance on suggested content – to be edited and changed to black or replaced with black in the final version.
· Black text represents text that should ordinarily be incorporated as-is, if applicable
Note that the table of contents is automatically included, so do not change the content or formatting of the headings. Be sure to right click on the table of contents and select “Update field” before saving the protocol and uploading it to Moodle. As always, make sure to proofread the document before submission.
Please make sure to complete the header on this page with the protocol title and version number and date.
The submitted protocol should have no red or blue text (including the header and instruction boxes like this one). The submitted protocol should have no spelling or grammar errors. All references MUST be in APA 7 format. PROTOCOL TITLEProtocol Version Number: CompleteProtocol Version Date: day, month, year [Include if there is an external funder; otherwise, delete heading] Funding Mechanism: organization and grant or contract #[Include if there is industry support; otherwise, delete heading] Industry Support provided by: name of industryPrincipal Investigator: name Phone: Complete E-mail: Complete[Include if the study has a medical monitor; otherwise, delete heading] Medical Monitor: name
Table of Contents
1List of Abbreviations4
2Protocol Summary4
3Background/Rationale & Purpose5
3.1Background Information5
3.2Rationale and Purpose5
4Objectives5
4.1Study Objectives5
4.2Study Outcome Measures6
4.2.1Primary Outcome Measures6
4.2.2Secondary Outcome Measures6
5Study Design6
6Potential Risks and Benefits7
6.1Risks7
6.2Potential Benefits8
6.3Analysis of Risks in Relation to Benefits8
7Study Subject Selection8
7.1Subject Inclusion Criteria8
7.2Subject Exclusion Criteria8
7.3Recruitment Methods9
7.4Compensation for Participation in Research Activities9
7.5Withdrawal of Pa ...
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Model Attribute Check Company Auto PropertyCeline George
In Odoo, the multi-company feature allows you to manage multiple companies within a single Odoo database instance. Each company can have its own configurations while still sharing common resources such as products, customers, and suppliers.
Operation “Blue Star” is the only event in the history of Independent India where the state went into war with its own people. Even after about 40 years it is not clear if it was culmination of states anger over people of the region, a political game of power or start of dictatorial chapter in the democratic setup.
The people of Punjab felt alienated from main stream due to denial of their just demands during a long democratic struggle since independence. As it happen all over the word, it led to militant struggle with great loss of lives of military, police and civilian personnel. Killing of Indira Gandhi and massacre of innocent Sikhs in Delhi and other India cities was also associated with this movement.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
Honest Reviews of Tim Han LMA Course Program.pptxtimhan337
Personal development courses are widely available today, with each one promising life-changing outcomes. Tim Han’s Life Mastery Achievers (LMA) Course has drawn a lot of interest. In addition to offering my frank assessment of Success Insider’s LMA Course, this piece examines the course’s effects via a variety of Tim Han LMA course reviews and Success Insider comments.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
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Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdf
CONSORT 2010 Checklist.pdf
1. CONSORT 2010 checklist Page 1
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
2. CONSORT 2010 checklist Page 2
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.