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In addition to doing no harm, the intervention increased women's intentions to stop smoking in the next month evident both at 2- and 10-week follow-ups.
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Although we would not conduct the trial if we anticipated such harm, the interventions are complex and there is always the chance for unanticipated outcomes.
The prime concern, however, is that there could be potential harm from the intervention through exacerbation of IDH and subsequent myocardial micro-injury.
There was deliberate misrepresentation of the results in one trial, in which a statistically significant increase in harm in the intervention group was suppressed.
They comprised 2011 women, and relevant data on benefit and harm in the intervention and control groups could be extracted (Table 2).
In addition, the documentation for each outcome is based on relatively few events which in many cases lead to wide confidence intervals comprising the possibility of large benefit, no difference, and potential harm from the intervention.
This level of precision corresponds to what has been proposed as a minimal clinically important difference of health-related quality of life measures 59 allowing us to identify clinically significant harm from the intervention if it existed.
38 49 59 63–67 In one study about the potential to access and identify medication errors, there was significant difference between the number of discrepancies in medication with potential for severe harm in the intervention group compared with controls (0.03 intervention vs 0.08 control per patient, adjusted RR 0.31, 95% CI 0.10 to 0.92, p=0.04).
It is also illustrates why clinicians need to assess the risks and harms of the intervention in question.
Does the story adequately explain/quantify the harms of the intervention?
The balance between the benefit and harms of the intervention seems delicate.
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Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com