Consort in clinical trial. PHASES CLINICAL TRIALS.EVIDENCE-BASED PRACTICE (EBP)

SEMINAR ON CONSORT IN CLINICAL TRIAL
Presented by
Selvaraj.p
Ph.D Scholar
Oct-2019 Batch Guide
Dr.Sasi.Vaithilingan
Professor Cum Vice-Principal
VMCON Pondicherry.

OBJECTIVES
Define the CONSORT and clinical trials
Understand the history of CONSORT and CONSORT statement
Explain the phases of clinical trial
List out the CONSORT 2010 checklist
Articulate CONSORT 2010 explanation and elaboration
Describe the CONSORT 2010 flow chart
State the CONSORT 2018 flow chart
Summarize protocols of CONSORT 5/4/2020
VMRF(DU) NSG 19 OCT 07

INTRODUCTION
• CONSORT (Consolidated Standards of Reporting
Trials) developed by the CONSORT Group
• CONSORT is a protocol developed by a group of
researchers not only to identify problems arising
from conducting RCTs, but also to report, in a full
and clear manner, the results yielded by research,
thereby facilitating RCTs reading and quality
assessment5/4/2020

THE CONSORT STATEMENT
• The main product of CONSORT is the CONSORT
Statement,
• which is an evidence-based, minimum set of
recommendations for reporting randomized trials.
• It offers a standard way for authors to prepare
reports of trial findings, facilitating their complete
and transparent reporting, and aiding their critical
appraisal and interpretation
5/4/2020

HISTORY
• 1993, 30 experts - met in Ottawa, Canada to discuss
ways of improving the reporting of randomized trials. -
(SORT)
• Another group of experts, the Asilomar Working Group
in California, USA, and were working on a similar
mandate.
• 1995 representatives from both these groups met
in Chicago, USA, This resulted in the Consolidated
Standards of Reporting Trials (CONSORT) Statement
5/4/2020 VMRF(DU) NSG 19 OCT 07

• 1996-CONSORT was first published
• 2001- Revised CONSORT Statement in 2001.
• 2007- A third CONSORT Group meeting was held
,resulting in publication of a newly revised
CONSORT Statement and explanatory document in
2010.
5/4/2020 VMRF(DU) NSG 19 OCT 07

CLINICAL TRIALS
• Clinical trials are experiments or observations done
in clinical research.
• Human participants are designed to answer specific
questions about biomedical or behavioral interventions
• They are conducted only after they have
received health authority/ethics ommittee approval
• Investigators initially enroll volunteers or patients into
small pilot studies
5/4/2020

PHASES CLINICAL TRIALS
• The drug development process will normally
proceed through phases I-IV
• If the drug successfully passes through phases I, II,
and III, it will usually be approved by the national
regulatory authority
• Phase IV trials are performed after the newly
approved drug, diagnostic or device is marketed,
5/4/2020 VMRF(DU) NSG 19 OCT 07

PHASE 0
• Aim : Pharmacodynamics and pharmacokinetics
in humans
• First-in-human trials.
• Therapeutic doses - treatment are given to a small
number of subjects (typically 10 to 15)
• Trial documents - absorption, distribution,
metabolization, and removal (excretion) of the
drug, and the drug's interactions within the body.
5/4/2020 VMRF(DU) NSG 19 OCT 07

PHASE I
• AIM : Screening for safety
• Often are first-in-person trials. Testing within a
small group of people (typically 20–80) to evaluate
safety, determine safe dosage ranges, and
identify side effects.
5/4/2020 VMRF(DU) NSG 19 OCT 07

PHASE II
• AIM: Establishing the preliminary efficacy of the
drug in a "treatment group", usually against
a placebo control group
• "proof of concept" for efficacy of the drug
candidate (100 people with the disease under
study),
• Phase II b trial is a "dose-finding“ study, with a
larger treatment group (typically 100–300),5/4/2020 VMRF(DU) NSG 19 OCT 07

PHASE III
• AIM: Final confirmation of safety and efficacy
• Testing with large groups of people (typically
1,000–3,000) to confirm its efficacy, evaluate
its effectiveness, monitor side effects,
compare it to commonly used treatments,
and collect information that will allow it to be
used safely.
5/4/2020

PHASE IV
• AIM :Safety studies during sales
• Post marketing studies delineate risks,
benefits, and optimal use. As such, they are
ongoing during the drug's lifetime of active
medical use.
5/4/2020 VMRF(DU) NSG 19 OCT 07

CONSORT 2010 CHECKLIST
• The CONSORT (Consolidated Standards of Reporting
Trials) Statement was developed to help biomedical
researchers report randomised controlled trials
(RCTs) transparently.
• CONSORT 2010 Statement for social and
psychological interventions (CONSORT-SPI 2018) to
help behavioural and social scientists report these
studies transparently.
5/4/2020

1. TITLE AND ABSTRACT
item 1a: Identification As A
Randomised Trial In The Title
Item 1b: Structured Summary of
Trial Design, Methods, Results,
and Conclusions5/4/2020 VMRF(DU) NSG 19 OCT 07

item 1a: Identification As A Randomised Trial In The
Title
• Placing the word ‘randomised’ in the title increases
the likelihood that an article will be indexed
• Providing information such as the name of the
intervention and the problem that the trial
addresses.
• Avoid uninformative titles (e.g. catchy phrases or
allusions)
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 1b: Structured Summary of Trial Design,
Methods, Results, and Conclusions
• Abstracts are the most widely read section of
manuscripts
• Clear, transparent, and sufficiently detailed
abstracts are important because readers often base
their assessment of a trial on such information.
5/4/2020 VMRF(DU) NSG 19 OCT 07

2. INTRODUCTION
Item 2a: Scientific Background
and Explanation Of Rationale
Item 2b: Specific Objectives or
Hypotheses
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 2a: Scientific Background and Explanation Of
Rationale
• A structured introduction should describe the
rationale for the trial and how the trial contributes
• The introduction should describe the targeted
problem or issue
• Ideally by referencing systematic reviews
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 2b: Specific Objectives or Hypotheses
• The objectives summarise the research
questions, including any hypotheses about
the expected magnitude and direction of
intervention effects.
• Should specify to whom or to what each
objective and hypothesis applies. (e.g.
individuals, groups, places),
5/4/2020 VMRF(DU) NSG 19 OCT 07

3.METHODS
Item 4b: Settings and Locations of Intervention Delivery
And Where The Data Were Collected
Item 4a: Eligibility Criteria for Participants
Participants
Item 3b: Important Changes to Methods after Trial
Commencement (Such As Eligibility Criteria), With Reasons
Item 3a: Description of Trial Design (Such As Parallel,
Factorial) Including Allocation Ratio
Trial Design

Item 6b: Any Changes to Trial Outcomes after the Trial
Commenced, With Reasons
Item 6a: Completely Define Pre-Specified Outcomes,
Including How and When They Were Assessed
Outcomes
Item 5: The Interventions for Each Group with Sufficient
Details to Allow Replication, Including How and When They
Were Actually Administered
Interventions
5/4/2020

Item 8b: Type of Randomisation; Details of Any
Restriction (Such As Blocking and Block Size)
Item 8a: Method Used To Generate the Random
Allocation Sequence
Randomisation—Sequence Generation
Item 7b: When Applicable, an Explanation of Any
Interim Analyses and Stopping Guidelines
Item 7a: How Sample Size Was Determined
Sample Size

Item 10: Who Generated the Random Allocation
Sequence, Who Enrolled Participants, and Who Assigned
Participants to Interventions
Randomisation—Implementation
Item 9: Mechanism Used To Implement the Random
Allocation Sequence, Describing Any Steps Taken To
Conceal the Sequence Until Interventions Were Assigned
Randomisation—Allocation Concealment Mechanism
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 12b: Methods for Additional Analyses, Such As
Subgroup Analyses, Adjusted Analyses, and Process
Evaluations
Analytical Methods
Item 12a: Statistical Methods Used To Compare Group
Outcomes
Item 11b: If Relevant, Description of the Similarity of
Interventions
Item 11a: Who Was Aware After Assignment to
Interventions (For Example, Participants, Providers, Those
Assessing Outcomes), and How Any Masking Was Done
Awareness of Assignment

Item 3a: Description of Trial Design (Such As Parallel,
Factorial) Including Allocation Ratio
• Explain their choice of design (especially if it is not
an individually randomised, two-group parallel
trial),
• State the allocation ratio and its rationale,
• Indicate whether the trial was designed to assess
the superiority, equivalence, or noninferiority of the
interventions.
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 3b: Important Changes to Methods after Trial
Commencement (Such As Eligibility Criteria), With
Reasons
• A trial report should refer to a trial registration and
protocol developed in advance
• The report should summarise all amendments to
the protocol and statistical analysis plan
• State any changes to the outcome definitions during
the trial.
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 4a: Eligibility Criteria for Participants
• Eligibility criteria should describe how participants
(i.e. individuals, groups, or places) were recruited.
• Describe all inclusion and exclusion criteria used to
determine eligibility, as well as the methods used to
screen and assess participants to determine their
eligibility
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 4b: Settings and Locations of Intervention
Delivery And Where The Data Were Collected
• The geographic location, day and time of trial
activities, space required, and features
• Inner setting (e.g. implementing organisation)
• Outer setting (e.g. external context and
environment)
• Mechanism of action when deciding what
information about setting and location to report.
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 5: The Interventions for Each Group with Sufficient
Details to Allow Replication, Including How and When
They Were Actually Administered
• Naming the interventions, what was actually delivered (e.g.
materials and procedures),
• Who provided the interventions, how, where, when, and
how much.
• Details about providers should include their professional
qualifications and education, expertise and training and
supervision for delivering the interventions.
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 6a: Completely Define Pre-Specified Outcomes,
Including How and When They Were Assessed
1. The domain (e.g. depression),
2. The measure (e.g. the Beck Depression Inventory II
Cognitive subscale),
3. The specific metric (e.g. a value at a time point, a change
from baseline),
4. The method of aggregation (e.g. mean, proportion), and
5. The time point (e.g. 3 months post-interventiongroups.
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 6b: Any Changes to Trial Outcomes after the Trial
Commenced, With Reasons
• All outcomes assessed should be reported.
• State which outcomes were added and which were
removed.
• Identify any changes to level of importance (e.g.
primary or secondary).
• Provide the rationale for any changes made and state
whether these were done before or after collecting the
data. 5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 7a: How Sample Size Was Determined
• The intended sample size for the trial and how it
was determined,
• Report the effect estimate used for the sample size
calculation and why it was chosen (e.g. the smallest
effect size of interest, from a meta-analysis of
previous trials).
• if an a priori sample size calculation was not
performed.
5/4/2020

Item 7b: When Applicable, an Explanation of Any
Interim Analyses and Stopping Guidelines
• Multiple statistical analyses can lead to false-positive
results, especially when using stopping guidelines
based on statistical significance.
• Any interim analyses should be described, (i.e. the
outcomes and methods of analysis),
• When they were conducted, and why (particularly
whether they were pre-specified.
• Describe the reasons for stopping the trial5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 8a: Method Used To Generate the Random Allocation
Sequence
• In a randomised trial, participants are assigned to groups by
chance using processes designed to be unpredictable.
• The method used to generate the allocation sequence (e.g.
a computer-generated random number sequence),
• Should not use the term ‘random’ to describe sequences
that are deterministic (e.g. alternation, order of
recruitment, date of birth).
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 8b: Type of Randomisation; Details of Any Restriction (Such As
Blocking and Block Size)
• Blocking restricts randomisation by grouping participants into 'blocks'
and by assigning participants using a random sequence within each
block.
• When blocking is used, how the blocks were generated, the size of
the blocks, whether and how block size varied, and if trial staff
became aware of the block size.
• When stratification is used, report why it was used and describe the
variables used for stratification, including cut-off values for categories
within each stratum.
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 9: Mechanism Used To Implement the Random
Allocation Sequence, Describing Any Steps Taken To
Conceal the Sequence Until Interventions Were Assigned
• Conceal the sequence to prevent fore knowledge of the
intervention assignment by persons enrolling
• Whether and how allocation was concealed.
• The mechanism and how this mechanism was monitored to
avoid tampering or subversion (e.g. centralised or 'third-
party' assignment, automated assignment system,
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 10: Who Generated the Random Allocation Sequence, Who
Enrolled Participants, and Who Assigned Participants to
Interventions
• The random sequence are different from the staff involved in
implementing the sequence. This can prevent tampering or
subversion.
• Other procedures may be used to ensure true randomisation in trials
(e.g. groups, places).
• Indicate who carried out each procedure (i.e. generating the random
sequence, enrolling participants, and assigning participants to
interventions) 5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 11a: Who Was Aware After Assignment to Interventions
(For Example, Participants, Providers, Those Assessing
Outcomes), and How Any Masking Was Done
• (a) participants, (b) providers, (c) data collectors, and (d) data
analysts were kept unaware of intervention assignment.
• If masking was not done (e.g. because it was not possible),
authors should describe the methods, if any, used to assess
performance and expectancy biases (e.g. masking trial
hypotheses, measuring participant expectations).
• The extent to which outcome assessors remained masked to
participants’ intervention status.
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 11b: If Relevant, Description of the Similarity of
Interventions
• Masking providers and participants is impossible in many
social and psychological intervention trials
• Describe any differences between interventions delivered
to each group that could lead to differences in the
performance and expectations of providers and
participants.
• Important details include differences in intervention
components and acceptability, co-interventions
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 12a: Statistical Methods Used To Compare Group
Outcomes
• The methods of analysis, including transformations and
adjustment for covariates,
• For cluster randomised trials, state whether the unit
analysed differs from the unit of assignment,
• Rationale for any transformations to the data To
facilitate full reproducibility,
• Report software used to run analyses and provide the
exact statistical code. 5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 12b: Methods for Additional Analyses, Such As
Subgroup Analyses, Adjusted Analyses, and Process
Evaluations
• Analysing impacts on primary and secondary outcomes,
• Indicate which subgroup analyses were specified a
priori in the trial registration or protocol, how
subgroups were constructed,
• For adjusted analyses, report the statistical procedures
and covariates used and the rationale for these
5/4/2020 VMRF(DU) NSG 19 OCT 07

4.RESULTS
Item 14b: Why the Trial Ended or Was Stopped
Item 14a: Dates Defining the Periods of Recruitment and
Follow-Up
Recruitment
Item 13b: For Each Group, Losses and Exclusions after
Randomisation, Together With Reasons
Item 13a: For Each Group, the Numbers Randomly
Assigned, Receiving Intended Treatment, and Analysed For
the Outcomes
Participant Flow

Item 17b: For Binary Outcomes, Presentation of both
Absolute and Relative Effect Sizes Is Recommended
Item 17a: For Each Outcome, Results For Each Group, And
the Estimated Effect Size and Its Precision (Such As 95%
Confidence Interval)
Outcomes and Estimation
Item 16: For Each Group, Number Included In Each Analysis
and Whether The Analysis Was By Original Assigned
Groups
Numbers Analysed
Item 15: A Table Showing Baseline Characteristics For Each
Group
Baseline Data

Item 19: All Important Harms or Unintended Effects
In Each Group (For Specific Guidance, See Consort
For Harms)
Harms
Item 18: Results of Any Other Analyses Performed,
Including Subgroup Analyses, Adjusted Analyses,
and Process Evaluations, Distinguishing Pre-
Specified From Exploratory
Ancillary Analyses
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 13a: For Each Group, the Numbers Randomly
Assigned, Receiving Intended Treatment, and
Analysed For the Outcomes
• The design and conduct of some RCTs is
straightforward, and the flow of participants,
particularly were there are no losses to follow-up or
exclusions,
• Discern whether and why some participants did not
receive the treatment as allocated, were lost to follow-
up, or were excluded from the analysis.
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 13b: For Each Group, Losses and Exclusions after
Randomisation, Together With Reasons
• Participant attrition and data exclusion by the research
team for each randomised group at each follow-up
point.
• Distinguish between the number of participants who
deviate from the intervention protocol but continue to
receive an intervention,
• Discontinue the trial altogether, and were excluded by
the investigators 5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 14a: Dates Defining the Periods of Recruitment
and Follow-Up
• Provide a complete schedule of trial activities,
including recruitment practices, pre-randomisation
assessments, periods of intervention delivery, a
schedule of post-randomisation assessments, and
when the trial was stopped.
• Define baseline assessment and follow-up times
relative to randomisation.
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 14b: Why the Trial Ended or Was Stopped
• Trials might be stopped for reasons decided a
priori (e.g. sample size reached and predetermined
follow-up period completed)
• For trials stopped early in response to interim analyses,
authors should state the reason for stopping (e.g. for
safety or futility)
• Describe other reasons for stopping, such as
implementation challenges (e.g. could not recruit
enough participants) 5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 15: A Table Showing Baseline Characteristics For
Each Group
• It is important to know the characteristics of the
participants who were actually included.
• This information allows readers, especially
clinicians, to judge how relevant the results of a trial
might be to an individual patient
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 16: For Each Group, Number Included In Each
Analysis and Whether The Analysis Was By Original
Assigned Groups
• The number of participants included in each
analysis often differs across outcomes and analyses.
• Report the number of participants per intervention
group for each analysis,
• Identify the analysis population and the method
used for handling missing data
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 17a: For Each Outcome, Results For Each Group,
And the Estimated Effect Size and Its Precision (Such
As 95% Confidence Interval)
• Report summary results for all analyses, including
results for each trial group and the contrast between
groups, the estimated magnitude of the difference
(effect size), the precision or uncertainty of the
estimate (e.g. 95% confidence interval or CI),
• Report precision even if the difference between groups
is not statistically significant.
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 17b: For Binary Outcomes, Presentation of both
Absolute and Relative Effect Sizes Is Recommended
• Neither relative measures nor absolute measures
provide comprehensive information about intervention
effects.
• Relative effect sizes (e.g. risk ratios) to express the
strength of effects and absolute effect sizes (e.g. risk
differences) to indicate actual differences in events
between interventions.
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 18: Results of Any Other Analyses Performed, Including Subgroup
Analyses, Adjusted Analyses, and Process Evaluations,
Distinguishing Pre-Specified From Exploratory
• Report the results for each additional analysis described in the
methods, indicating the number of analyses performed for each
outcome,
• Evaluating effects for subgroups, report interaction effects or other
appropriate tests for heterogeneity between groups, including the
estimated difference in the intervention effect between each
subgroup with confidence intervals.
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 19: All Important Harms or Unintended Effects In Each
Group (For Specific Guidance, See Consort For Harms)
• Social and psychological interventions have the potential to
produce unintended effects, both harmful and beneficial.
• Harms may include indirect effects such as increased
inequalities at the level of groups or places that result from
the intervention.
• Indicate how they were defined and measured, and the
frequency of each event per trial group.
• Report all results from qualitative investigations that identify
possible unintended effects 5/4/2020 VMRF(DU) NSG 19 OCT 07

5. DISCUSSION
Item 22: Interpretation Consistent With Results, Balancing
Benefits and Harms, and Considering Other Relevant
Evidence
Interpretation
Item 21: Generalisability (External Validity, Applicability) Of
the Trial Findings
Generalisability
Item 20: Trial Limitations, Addressing Sources of Potential
Bias, Imprecision, and, If Relevant, Multiplicity of Analyses
Limitations
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 20: Trial Limitations, Addressing Sources of
Potential Bias, Imprecision, and, If Relevant,
Multiplicity of Analyses
• Balanced discussion of the strengths and limitations
of the trial and its results.
• Consider issues related to risks of bias, precision of
effect estimates, the use of multiple outcomes and
analyses, and whether the intervention was
delivered and taken up as planned.
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 21: Generalisability (External Validity, Applicability)
Of the Trial Findings
• Authors should explain how statements about
generalisability relate to the trial design and execution.
• Discussion include: recruitment practices, eligibility
criteria, sample characteristics, facilitators and barriers
to intervention implementation, the choice of
comparator, what outcomes were assessed and how,
length of follow-up, and setting characteristics.
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 22: Interpretation Consistent With Results, Balancing
Benefits and Harms, and Considering Other Relevant
Evidence
• Provide a brief interpretation of findings in light of the trial’s
objectives or hypotheses.
• Contextualise results and identify the additional knowledge
gained by discussing how the trial adds to the results of other
relevant literature,
• Discuss how the results of the trial compare with previous
theories about how the interventions would work. describing
the practical significance of findings; practice and policy; and
specific areas of future research 5/4/2020 VMRF(DU) NSG 19 OCT 07

6. IMPORTANT INFORMATION
Item 25: Sources of Funding and Other
Support, Role of Funders
Funding
Item 24: Where the Full Trial Protocol Can Be
Accessed, If Available
Protocol
Item 23: Registration Number and Name of
Trial Registry
Registration

Item 23: Registration Number and Name of Trial
Registry
• Trial registration is the posting of a minimum
information set in a public database, including:
eligibility criteria, all outcomes, intervention
protocols, and planned analyses.
• Trial registration is now required for all trials
published by journals that endorse the International
Committee of Medical Journal Editors guidelines
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 24: Where the Full Trial Protocol Can Be
Accessed, If Available
• Details about trial design should be described in a
publicly accessible protocol (e.g. published
manuscript, report in a repository)
• Report where the trial protocol can be accessed.
Guidance on developing and reporting protocols
has recently been published.
5/4/2020 VMRF(DU) NSG 19 OCT 07

Item 25: Sources of Funding and Other Support, Role of
Funders
• Information about trial funding and support is
important in helping readers to identify potential
conflicts of interest.
• Identify and describe all sources of monetary or
material support for the trial, (e.g. space, intervention
materials, and assessment tools).
• Report the name of the persons or entities supported
the name of the funder, and the award
5/4/2020 VMRF(DU) NSG 19 OCT 07

CONSORT 2018 STATEMENT
Item 26a: Any Involvement of the
Intervention Developer in the Design,
Conduct, Analysis, or Reporting of the Trial
Item 26b: Other Stakeholder Involvement in
Trial Design, Conduct, or Analyses
Item 26c: incentives offered as part of the
trial
5/4/2020 VMRF(DU) NSG 19 OCT 07

CONSORT 2010 FLOW DIAGRAM
•
• Allocated to intervention (n= )
• Received allocated intervention (n= )
• Did not receive allocated intervention (give reasons)
(n= )
• Allocation
• Enrolment
• Analysed (n= )
Excluded from analysis (give reasons) (n= )
• Lost to follow-up (give reasons) (n= )
• Discontinued intervention (give reasons) (n= )
• Analysis
• Follow-Up
5/4/2020

CONCLUSION
• The results of RCTs are of optimal use when authors
report their methods and results accurately,
completely, and transparently.
• The CONSORT-2010 checklist can help researchers to
design and report future trials, and provide guidance to
peer reviewers and editors for evaluating manuscripts,
to funders in setting reporting criteria for grant
applications, and to educators in teaching trial
methods. 5/4/2020 VMRF(DU) NSG 19 OCT 07

• Each item should be addressed before or within the
main trial paper (e.g. in the text, as an online
supplement, or by reference to a previous report).
The level of detail required for some checklist items
will depend on the nature of the intervention being
evaluated, the trial phase, and whether the trial
involves an evaluation of process or implementatio
5/4/2020 VMRF(DU) NSG 19 OCT 07

EVIDENCE-BASED PRACTICE (EBP)
• Quality of reporting Randomized Controlled Trials
(RCTs) in the nursing literature: Application of the
Consolidated Standards of Reporting Trials (CONSORT)
• The purposes of this study were to apply the
Consolidated Standards of Reporting Trials (CONSORT)
statement to published reports of nursing science,
examine how adequately the published reports adhere
to the statement
5/4/2020 VMRF(DU) NSG 19 OCT 07

• One hundred RCTs from 2002-2005 were identified
from 4 nursing journals.
• Articles were randomly assigned to 4 reviewers and
the quality of the published reports was evaluated
using a modified CONSORT checklist.
• There was no difference between the 4 journals in
the quality of the published reports of RCTs based
on the modified CONSORT checklist employed (F =
1.27, P =.29).
5/4/2020 VMRF(DU) NSG 19 OCT 07

• The quality of reporting of RCTs improved significantly
in the only journal, Nursing Research, to adopt the
CONSORT statement
• Adoption of CONSORT is recommended as it may lead
to an overall improvement in quality of reporting of
RCTs in nursing journals.
• The profession may also wish to explore the use or
development of standards similar to CONSORT but ones
more appropriate for the types of research typical of
that published by nurse scientists.
5/4/2020 VMRF(DU) NSG 19 OCT 07

REFERENCE
1. The Standards of Reporting Trials Group. A proposal for structured reporting of
randomized controlled trials. The Standards of Reporting Trials Group. JAMA.
1994; 272(24):1926-1931.
2. http://www.consort-statement.org/
3. http://www.consort-
statement.org/Media/Default/Downloads/CONSORT%202010%20Explanation%2
0and%20Elaboration%20Document-BMJ.pdf
4. Grant, S., Mayo-Wilson, E., Montgomery, P. et al. CONSORT-SPI 2018 Explanation
and Elaboration: guidance for reporting social and psychological intervention
trials. Trials 19, 406 (2018). https://doi.org/10.1186/s13063-018-2735-z
5/4/2020 VMRF(DU) NSG 19 OCT 07

• Barbara A. Smith,Hyeon-Joo Lee,Ju Hee Lee,Mona
Choi,Deborah E. Jones,R. Barker Bausell,Marion E. Broome
Quality of reporting Randomized Controlled Trials (RCTs) in
the nursing literature: Application of the Consolidated
Standards of Reporting Trials (CONSORT)
,Publication: Nursing Outlook ,Publisher: Elsevier,
Date: January–February 2008
5/4/2020 VMRF(DU) NSG 19 OCT 07

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