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Section/topic No CONSORT 2025 checklist item description Reported
on page no.
Title and abstract Title and structured abstract 1a Identification as a randomised trial 1b Structured summary of the trial design, methods, results, and conclusions Open science Trial registration 2 Name of trial registry, identifying number (with URL) and date of registration Protocol and statistical analysis plan 3 Where the trial protocol and statistical analysis plan can be accessed Data sharing 4 Where and how the individual de-identified participant data (including data dictionary), statistical code and any other materials can be accessed Funding and conflicts of interest 5a Sources of funding and other support (eg, supply of drugs), and role of funders in the design, conduct, analysis and reporting of the trial 5b Financial and other conflicts of interest of the manuscript authors Introduction Background and rationale 6 Scientific background and rationale Objectives 7 Specific objectives related to benefits and harms Methods Patient and public involvement 8 Details of patient or public involvement in the design, conduct and reporting of the trial Trial design 9 Description of trial design including type of trial (eg, parallel group, crossover), allocation ratio, and framework (eg, superiority, equivalence, non-inferiority, exploratory) Changes to trial protocol 10 Important changes to the trial after it commenced including any outcomes or analyses that were not prespecified, with reason Trial setting 11 Settings (eg, community, hospital) and locations (eg, countries, sites) where the trial was conducted Eligibility criteria 12a Eligibility criteria for participants 12b If applicable, eligibility criteria for sites and for individuals delivering the interventions (eg, surgeons, physiotherapists) Intervention and comparator 13 Intervention and comparator with sufficient details to allow replication. If relevant, where additional materials describing the intervention and comparator (eg, intervention manual) can be accessed Outcomes 14 Prespecified primary and secondary outcomes, including the specific measurement variable (eg, systolic blood pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg, median, proportion), and time point for each outcome Harms 15 How harms were defined and assessed (eg, systematically, non-systematically) Sample size 16a How sample size was determined, including all assumptions supporting the sample size calculation 16b Explanation of any interim analyses and stopping guidelines Randomisation: Sequence generation 17a Who generated the random allocation sequence and the method used 17b Type of randomisation and details of any restriction (eg, stratification, blocking and block size)
Reported on page no. Allocation concealment mechanism 18 Mechanism used to implement the random allocation sequence (eg, central computer/telephone; sequentially numbered, opaque, sealed containers), describing any steps to conceal the sequence until interventions were assigned Implementation 19 Whether the personnel who enrolled and those who assigned participants to the interventions had access to the random allocation sequence Blinding 20a Who was blinded after assignment to interventions (eg, participants, care providers, outcome assessors, data analysts) 20b If blinded, how blinding was achieved and description of the similarity of interventions Statistical methods 21a Statistical methods used to compare groups for primary and secondary outcomes, including harms 21b Definition of who is included in each analysis (eg, all randomised participants), and in which group 21c How missing data were handled in the analysis 21d Methods for any additional analyses (eg, subgroup and sensitivity analyses), distinguishing prespecified from post hoc Results Participant flow, including flow diagram 22a For each group, the numbers of participants who were randomly assigned, received intended intervention, and were analysed for the primary outcome 22b For each group, losses and exclusions after randomisation, together with reasons Recruitment 23a Dates defining the periods of recruitment and follow-up for outcomes of benefits and harms 23b If relevant, why the trial ended or was stopped Intervention and comparator delivery 24a Intervention and comparator as they were actually administered (eg, where appropriate, who delivered the intervention/comparator, how participants adhered, whether they were delivered as intended (fidelity)) 24b Concomitant care received during the trial for each group Baseline data 25 A table showing baseline demographic and clinical characteristics for each group Numbers analysed, outcomes and estimation 26 For each primary and secondary outcome, by group: ● the number of participants included in the analysis ● the number of participants with available data at the outcome time point ● result for each group, and the estimated effect size and its precision (such as 95% confidence interval) ● for binary outcomes, presentation of both absolute and relative effect size Harms 27 All harms or unintended events in each group Ancillary analyses 28 Any other analyses performed, including subgroup and sensitivity analyses, distinguishing pre-specified from post hoc Discussion Interpretation 29 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence Limitations 30 Trial limitations, addressing sources of potential bias, imprecision, generalisability, and, if relevant, multiplicity of analyses Citation: Hopewell S, Chan AW, Collins GS, Hróbjartsson A, Moher D, Schulz KF, et al. CONSORT 2025 Statement: updated guideline for reporting randomised trials. BMJ. 2025; 388:e081123. https://dx.doi.org/10.1136/bmj- 2024 - 081123 © 2025 Hopewell et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. *We strongly recommend reading this statement in conjunction with the CONSORT 2025 Explanation and Elaboration and/or the CONSORT 2025 Expanded Checklist for important clarifications on all the items. We also recommend reading relevant CONSORT extensions. See www.consort-spirit.org.
