https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4876675/ need to understand the formal summary of the A. Question
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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4876675/ need to understand the formal summary of the Analysis of Strengths and Weaknesses that you will notice is on the CONSORT checklist.
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
2a Scientific background and explanation of rationaleBackground and
objectives 2b Specific objectives or hypotheses
Methods
3a Description of trial design (such as parallel, factorial) including allocation ratioTrial design
3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons
4a Eligibility criteria for participantsParticipants
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
6a Completely defined pre-specified primary and secondary outcome measures, including how and when they
were assessed
Outcomes
6b Any changes to trial outcomes after the trial commenced, with reasons
7a How sample size was determinedSample size
7b When applicable, explanation of any interim analyses and stopping guidelines
Randomisation:
8a Method used to generate the random allocation sequence Sequence
generation 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
11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those
assessing outcomes) and how
Blinding
11b If relevant, description of the similarity of interventions
12a Statistical methods used to compare groups for primary and secondary outcomesStatistical methods
12b Methods for additional analyses, such as subgroup analyses and adjusted analyses
CONSORT 2010 checklist Page 2
Results
13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and
were analysed for the primary outcome
Participant flow (a
diagram is strongly
recommended) 13b For each group, losses and exclusions after randomisation, together with reasons
14a follow-upRecruitment
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
17a For each primary and secondary outcome, results for each group, and the estimated effect size and its
precision (such as 95% confidence interval)
Outcomes and
estimation
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
SCIENCE
HEALTH SCIENCE
NURSING
NURSING NUR400
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4876675/ need to understand the formal summary of the A
