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Authors should report the results for each additional analysis described in the methods (Item 12b), indicating the number of analyses performed for each outcome, which analyses were pre-specified, and which analyses were not pre-specified. When evaluating effects for subgroups, authors should 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. Comparing tests for the significance of change within subgroups is not an appropriate basis for evaluating differences between subgroups. If reporting adjusted analyses, authors should provide unadjusted results as well. Authors reporting any results from qualitative data analyses should follow reporting standards for qualitative research [ 86], though adequately reporting these findings will likely require more than one journal article [ 51]. Results: harms Item 19: all important harms or unintended effects in each group (for specific guidance, see CONSORT for Harms) [ 14]The objectives summarise the research questions, including any hypotheses about the expected magnitude and direction of intervention effects [ 48, 50]. For social and psychological interventions that have multiple units of intervention and multiple outcome assessments (e.g. individuals, groups, places), authors should specify to whom or to what each objective and hypothesis applies. CONSORT-SPI 2018 item 2b: if pre-specified, how the intervention was hypothesised to work
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Simera I, Altman DG, Moher D, Schulz K, Hoey J. The EQUATOR Network: facilitating transparent and accurate reporting of health research. Serials 2008 Nov 21 (3): 183-87 Chiu K, Grundy Q, Bero L. ‘Spin’ in published biomedical literature: a methodological systematic review. PLoS Biol. 2017;15(9):e2002173.Authors should state why the trial was stopped. Trials might be stopped for reasons decided a priori (e.g. sample size reached and predetermined follow-up period completed) or in response to the results. For trials stopped early in response to interim analyses (Item 7b), authors should state the reason for stopping (e.g. for safety or futility) and whether the stopping rule was decided a priori. If applicable, authors should describe other reasons for stopping, such as implementation challenges (e.g. could not recruit enough participants) or extrinsic factors (e.g. a natural disaster). Authors should indicate whether there are plans to continue collecting outcome data (e.g. long-term follow-up). Results: baseline data
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