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Finally, our study suggests that to better reach CONSORT objectives, a new rationale of reporting harm should be adopted, resting on the need for clinicians and policy makers to understand that almost all interventions have both benefits and harm.
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Readers are referred to the CONSORT PRO Extension for further information on the rationale for each item, examples of reporting and elaboration of the existing CONSORT 2010 statement in relation to PROs [ 11].
In our previous study [ 1] we defined the quality of reporting as the extent which the rationale, design, conduct and analysis of each RCT evaluated was reported [ 1].
We defined quality of reporting as the extent to which the rationale, method, conduct and results of the trial are reported.
We defined the overall quality of reporting as the degree to which the rationale, design, conduct and analysis of each RCT, evaluated in this study, were reported.
These questions covered the rationale, conduct, analysis, reporting, and feasibility of project developing and/or validating a risk prediction model using IPD from multiple studies.
Table 4 provides a classification of rationales and reports a simple count of the number of times each rationale was mentioned in the subsample, together with one or more examples transcribed from questionnaires.
The 58 questions covered the rationale, conduct, analysis, reporting [ 24, 25], and feasibility of the IMPF project (Table 1).
Therefore, the rationale of the present report was to examine the antimicrobial impact of Mediterranean natural extracts on oral microorganisms.
17 These studies, therefore, support the rationale of the trial design reported here for attempting to deliver cell therapy as soon as possible after AMI.
Objectives: We sought to evaluate the rationale, methodological quality, and reporting of cRCTs in critical care medicine (CCM).
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