Randomization: sequence generation 8a Method used to generate the random allocation sequence 8b Type of randomization; details of any restriction (such as blocking and block size) Allocation concealment 9 Mechanism used to implement the random allocation sequence (such mechanism 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 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
Table 4.1 CONSORT Checklist (Continued ).
Item Reported on Section/Topic No. Checklist Item Page No.
Participant ﬂow 13a For each group, the numbers of participants who were randomly (a diagram is strongly assigned, received intended treatment, and were analyzed for the recommended) primary outcome 13b For each group, losses and exclusions after randomization, 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 analyzed 16 For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups Outcomes and 17a For each primary and secondary outcome, results for each group, and estimation 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 prespecified from exploratory Harms 19 All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)∗
Limitations 20 Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses
Generalizability 21 Generalizability (external validity, applicability) of the trial findings
Interpretation 22 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence
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 f funding and other support (such as supply of drugs), role of funders *We strongly reconmiend 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 randomized trials, nonlnferiority and equivalence trials, nonpharmacological 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.
(Fig. 4.1) offer 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).
Clinical trials are considered a gold standard, because when done well they provide information about both relative and absolute risks and minimize concerns about bias and confounding (see the section on Presenting and Understanding the Results of Analytic Studies). Many clinical research questions are not amenable to clinical trials because of cost restraints, length of time required to complete the study, and feasibility of recruitment and implementation.
When evaluating the results from a clinical trial, consider how restrictive inclusion and exclusion criteria may narrow the participant population to such a degree that there may be concerns about external validity or generalizing the results. Other concerns include blinding, loss to follow-up, and clearly defining the outcome of interest. When the results of a randomized controlled trial do not show a significant effect of the treatment or intervention, the methods should be evaluated to understand what assumptions (expected power and effect size) were made to determine the necessary sample size for the study.