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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 CONSORT statement - PMC - National Center for The CONSORT statement - PMC - National Center for
Yang W, Li W, Guo C, Wang Z, Wu S, Feng L, Yang Z, Xie X, Tian J. Yang W, et al. Knee Surg Sports Traumatol Arthrosc. 2023 Oct 14. doi: 10.1007/s00167-023-07618-2. Online ahead of print. Knee Surg Sports Traumatol Arthrosc. 2023. PMID: 37837576 CONSORT for multi-arm parallel-group randomised trials: Juszczak E, Altman DG, Hopewell S, Schulz K. Reporting of Multi-Arm Parallel-Group Randomized Trials: Extension of the CONSORT 2010 Statement. JAMA. 2019;321(16):1610-1620. PMID: 31012939 STRICTA Controlled trials of acupuncture: MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D; STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med. 2010;7(6):e1000261. PMID: 20543992 Li T, Hutfless S, Scharfstein DO, et al. Standards should be applied in the prevention and handling of missing data for patient-centered outcomes research: a systematic review and expert consensus. J Clin Epidemiol. 2014;67(1):15–32. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.Appelbaum M, Cooper H, Kline RB, Mayo-Wilson E, Nezu AM, Rao SM. Journal article reporting standards for quantitative research in psychology: the APA publications and communications board task force report. Am Psychol. 2018;73(1):3 a b c Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar23;340:c332
Consolidated Standards of Reporting Trials - Wikipedia
Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials. gov results database—update and key issues. N Engl J Med. 2011;364(9):852–60.
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Department of Chronic Disease Epidemiology, School of Public Health, Yale University, New Haven, Connecticut. Medical Research Council. Developing and evaluating complex interventions: New guidance. London: Medical Research Council; 2008. www.mrc.ac.uk/documents/pdf/complex-interventions-guidance. Moher D, Hopewell S, Schultz KF, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869. The 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