https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4876675/ need to…
Question Answered step-by-step https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4876675/ need to… 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 NoChecklist item Reported on page NoTitle and abstract1a Identification as a randomised trial in the title1b Structured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)Introduction2a Scientific background and explanation of rationaleBackground and objectives 2b Specific objectives or hypothesesMethods3a Description of trial design (such as parallel, factorial) including allocation ratioTrial design3b Important changes to methods after trial commencement (such as eligibility criteria), with reasons4a Eligibility criteria for participantsParticipants4b Settings and locations where the data were collectedInterventions 5 The interventions for each group with sufficient details to allow replication, including how and when they were actually administered6a Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessedOutcomes6b Any changes to trial outcomes after the trial commenced, with reasons7a How sample size was determinedSample size7b When applicable, explanation of any interim analyses and stopping guidelinesRandomisation: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 mechanism9 Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assignedImplementation 10 Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions11a If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and howBlinding11b If relevant, description of the similarity of interventions12a Statistical methods used to compare groups for primary and secondary outcomesStatistical methods12b Methods for additional analyses, such as subgroup analyses and adjusted analyses CONSORT 2010 checklist Page 2Results13a For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcomeParticipant flow (a diagram is strongly recommended) 13b For each group, losses and exclusions after randomisation, together with reasons14a follow-upRecruitment14b Why the trial ended or was stoppedBaseline data 15 A table showing baseline demographic and clinical characteristics for each groupNumbers analysed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups17a 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 estimation17b For binary outcomes, presentation of both absolute and relative effect sizes is recommendedAncillary analyses 18 Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratoryHarms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)DiscussionLimitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analysesGeneralisability 21 Generalisability (external validity, applicability) of the trial findingsInterpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidenceOther informationRegistration 23 Registration number and name of trial registryProtocol 24 Where the full trial protocol can be accessed, if availableFunding 25 Sources of funding and other support (such as supply of drugs), role of funders Health Science Science Nursing NURSING NUR400 Share QuestionEmailCopy link Comments (0)


