CONSORT-SPI: Montgomery P, Grant S, Mayo-Wilson E, Macdonald G, Michie S, Hopewell S, Moher D; on behalf of the CONSORT-SPI Group. Reflections on the application of theory in the development and evaluation of complex population health interventions. These may be identified in the protocol and relate to the theory of how the interventions are hypothesised to work (Item 2b) [ 56], or they may be unexpected events that were not pre-specified for assessment. If you’re redecorating your home or you’re on the lookout for new furniture for your house or flat, glass console tables represent a brilliant investment.

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Second, we conducted an international online Delphi process between September 2013 and February 2014 to prioritise the list of potential items for the CONSORT-SPI 2018 checklist and flow diagram that were identified in the systematic review. Some trials assign specific providers to different conditions to prevent expertise and allegiance from confounding the results.Concurrently, and independently, another group of experts, the Asilomar Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature, convened in California, USA, and were working on a similar mandate. Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada. The CONSORT-SPI 2018 checklist extends 9 of the 25 items (incorporating 14 sub-items) found in CONSORT 2010 (Table 1; new items are in the ‘CONSORT-SPI 2018’ column) and includes a modified flow diagram. It has also recently been published as a book for those involved in the planning, conducting and interpretation of clinical trials. It has improved the quality of reports in medicine [ 2, 3, 4, 5], and has been officially endorsed by over 600 journals and prominent editorial groups [ 6].

Consort-Statement Consort-Statement

The discussions during and after the consensus meeting yielded 17 items that elaborate on the CONSORT 2010 statement checklist items and are related to completely defining and justifying the trial outcomes, including how and when they were assessed (CONSORT 2010 statement checklist item 6a), defining and justifying the target difference between treatment groups during sample size calculations (CONSORT 2010 statement checklist item 7a), describing the statistical methods used to compare groups for the primary and secondary outcomes (CONSORT 2010 statement checklist item 12a), and describing the prespecified analyses and any outcome analyses not prespecified (CONSORT 2010 statement checklist item 18). Authors should provide the rationale for any changes made and state whether these were done before or after collecting the data. g. neighbourhoods), and specify the unit of each analysis, especially when the unit of analysis is not the unit of randomisation (e. Authors should indicate whether such analyses were undertaken or are planned (and where they are or will be reported if so). Update on the endorsement of CONSORT by high impact factor journals: a survey of journal ‘instructions to authors’ in 2014.Report from the panel on the case for registers of clinical trials at the eighth annual meeting of the Society for Clinical Trials. Authors should indicate which subgroup analyses were specified a priori in the trial registration or protocol (Items 23 and 24), how subgroups were constructed, and distinguish confirmatory analyses from exploratory analyses. CONSORT-CHM formulas: Cheng C-W, Wu T-X, Shang H-C, Li Y-P, Altman DG, Moher D, Bian Z-X; for the CONSORT-CHM Formulas 2017 Group.