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For primary aims 1 and 2, the trial will be monitored for possible early stopping due to a large intervention effect using a Haybittle-Peto approach.
30 31 Cohen's power tables suggested that we needed 30 matched pairs for 80% power to detect a large intervention effect (g=0.25).
The intervention had a rapid and substantial impact after 6 months of treatment on parental communication style with their child with ASD, with a large intervention effect size (ES=1.37) compared to regular UK treatment as usual.
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Sufficient and large intervention effects are based on the quality of the outcomes, magnitude of effect sizes, and population reach of the intervention.
As pointed out by Lindley, the apparent paradox of small trials seemingly contributing with evidence of large intervention effects while large trials tend to rule out smaller intervention effects and thereby also larger intervention effects, is bound to confuse the average clinical researcher and reader [ 36].
Studies with large intervention effects gave low p values despite their high standard errors, and studies with p < 0.05 were more likely to be published.
For boys, the FUn Group reported significantly more positive responses than the Comparison Group, with medium to large intervention effects for peer problems, prosocial behaviour and other-group orientation.
In other words, if unrealistically large intervention effects are anticipated, then observed unbiased data will often show smaller and more realistic intervention effects which will result in a relative high Bayes factor.
Regression models looking at associations of the intervention with changes in blood glucose during the patient stay using the same quasi-experimental study design also showed large intervention effects.
Trialists might be tempted to perform a sample size calculation based on unrealistically large anticipated intervention effects in order to reduce the necessary number of participants in a trial (relatively few patients are needed to demonstrate or discard large intervention effects) [ 25, 26].
An ROR < 1 or ∆SMD < 0 indicated that split-mouth RCTs yielded larger intervention effect estimates than parallel-arm RCTs.
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