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The choice of a non-inferiority margin, i.e. the smallest clinical difference that is acceptable between the two treatments, is based on a combination of clinical judgment and statistical reasoning.
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At 24 months after the operation, functioning in the women who had undergone ALND (+/– SLNB) was poorer than preoperatively (small clinical difference).
According to Osoba et al. [ 11] a difference of at least 5 points is considered a small clinical difference on the QLQ-C30 scales, whereas a difference of at least 10 points reflect a moderate clinical difference.
Another explanation might be that the AKS and OKS may not be accurate enough to detect small clinical differences.
The increase in preschool and participant numbers might enable us to grasp smaller clinical differences than originally planned.
Self-rated disability and stress returned small clinical differences (0.7 and 1.2 points) and small effect sizes (Cohen's d 0.23 and 0.43) between groups supporting IM (Table 2).
This suggests that a larger controlled-feeding study evaluating differences in dietary protein sources is not warranted given the small clinical differences.
But patient availability may also be a factor: the potential for including patients with cardiovascular diseases into clinical trials is grater than for rare diseases, so that researchers can afford to explore smaller clinical differences.
This observation might be explained by the small clinical differences of these two groups: While almost all patients (38/40) underwent BAL, only very few patients showed relevant amounts of secretions in contrast to prior expectations before the procedure.
The current results with generally small clinical differences and effect sizes between groups may challenge a narrow use of outcomes measures in isolation to understand the relevance of IM in primary care.
However, the consistency of small clinical differences between treatment groups and the paucity of cost-effectiveness evidence means that a degree of uncertainty exists regarding the value of low back pain treatments.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com