Abstract

Aim In a trial to increase physical activity in sedentary adults, there was no evidence of effect on the primary outcome, though large significant effects amongst eight related SF36 measures of general health [1]. How could such differences arise? Could they be: a true effect mediated through receiving the intervention, another systematic effect such as self-reporting bias, and/or chance? The aim was to develop reliable methods to investigate whether effects of the intervention on the SF36 outcomes were mediated through truly receiving the intervention delivered in intervention sessions.

Highlights

  • Important factors affecting detection were identified to be the size of the trial effect and the degree to which the mediator is predictable from baseline covariates

  • The effect of analysing four SF36 outcomes to estimate an assumed common mediation effect was to reduce the standard error of the estimated effect by up to 40%, equivalent to offering an increase in power to detect mediation from 50% to 80%

  • A simulation study was designed to establish the factors driving the lack of precision

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Summary

Open Access

Aim In a trial to increase physical activity in sedentary adults, there was no evidence of effect on the primary outcome, though large significant effects amongst eight related SF36 measures of general health [1]. Could they be: a true effect mediated through receiving the intervention, another systematic effect such as self-reporting bias, and/or chance? The aim was to develop reliable methods to investigate whether effects of the intervention on the SF36 outcomes were mediated through truly receiving the intervention delivered in intervention sessions How could such differences arise? Could they be: a true effect mediated through receiving the intervention, another systematic effect such as self-reporting bias, and/or chance? The aim was to develop reliable methods to investigate whether effects of the intervention on the SF36 outcomes were mediated through truly receiving the intervention delivered in intervention sessions

Results
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