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Particularly, in the design and execution of large clinical trials, even small differences in sample processing and handling can have dramatic effects in analytical reliability, results interpretation, trial management and outcome.
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Our analysis depicts a considerably more nuanced picture of adherence and emphasizes the need for more standardised approaches to reporting adherence data in order to facilitate interpretation of trial results and comparisons across trials of similar interventions.
The current lack of specified criteria makes analysis and interpretation of trial results difficult, and comparison across trials impossible.
Measurement of recovery and the analysis of the number of recoveries in trials is emphatically useful, since it facilitates interpretation of trial outcomes [ 25, 26].
Such approaches will undoubtedly see increasing application in the selection of patients for early-stage clinical trials, providing the potential for better response rates and improved interpretation of trial results.
155 Although there is no consensus on the acceptable minimum adherence level in clinical trials, low adherence can have a substantial effect on statistical power and interpretation of trial results.
Premature discontinuation causes loss of information, potentially resulting in attrition bias leading to problems during interpretation of trial findings.
Some of the potential pitfalls, particularly relating to bias, that can affect the interpretation of trial results are described along with the mechanisms that the Network has used to avoid or minimize them.
and others have recommended public disclosure of the full protocol to enable reliable interpretation of trial findings [3], [12], [26], [27].
The application of this more inclusive and robust interpretation of trial results will facilitate their application directly to the bedside, and will hopefully further improve the care of our patients with severe sepsis.
Competing interests and lack of blinding might be relevant issues in the interpretation of trial results.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com