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This trial includes a number of key methodological features which will minimise bias including randomisation, concealed allocation, blinded outcome assessment and intention to treat analysis.
The strengths of this study include adequate randomisation, allocation concealment, blinded outcome assessment, and intention to treat analysis, all of which minimises the risk of bias.
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Furthermore, single-blind assessment and intention-to-treat analysis were not conducted in either study.
Only one of these studies reported using allocation concealment, blinded assessment, and intention-to-treat analysis [ 10].
A number of methodological elements have been included in the trial to minimize bias such as power calculation, randomization, concealed allocation, blinded outcome assessment and intention-to-treat analysis.
Design: Multicentre randomised controlled trial with concealed allocation, blinded assessments and intention-to-treat analysis.
We did, however, find that Attitude had a positive direct effect on Behaviour: process and Behaviour: Assessment and that Intention had a negative direct effect on Behaviour: process.
Post-implementation there was a significant increase in: self-reported past behaviour (pre mean score 5.38; post mean score 7.11; p = 0.002) and subjective norms scores (pre mean score 3.62; post mean score 4.18; p = 0.016) for bowel assessment; and behaviour intention (pre mean score 5.22; post mean score 5.65; p = 0.048) for administration of enema.
The following suggestions made by the systematic reviews have been incorporated to strengthen our methodology; applying a larger sample and long-term follow-up measurements, incorporating randomization of patients to appropriate comparison groups, including concealed allocation and blinded outcome assessment, and using intention-to-treat and per protocol analyses.
However, Attitude was only related to Behaviour: assessment, and not to Intention.
Recent reviews of computer-based interventions found significant methodological flaws in research designs, evaluations of treatment exposure and adherence, rates of follow-up assessment, and conformity to intention-to-treat principles (Kiluk et al. 2011).
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com