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For example, in clinical trials in the nursing field, Polit and Gillespie (2009) found that for 10.5% of studies, researchers who stated they had used an ITT approach had actually conducted per protocol analyses.
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Since assessment was conducted at 6 weeks only, we conducted per-protocol analyses, since intent-to-treat analyses do not apply (efficacy was assessed at a single point in time).
As secondary analyses, we will also conduct per-protocol (PP) and completers-only analyses.
In addition, we will conduct per-protocol analyses; these are restricted to those participants who complied fully with the intervention protocol and outcome measurements.
Additionally, we will conduct per protocol and on treatment analysis at the end of the study.
If the waitlist control group and the natural history control group are comparable we will conduct per protocol analyses including the natural history control group.
We conducted a per protocol analysis for the primary outcome variable (score on Oswestry disability index).
We conducted a per protocol analysis of each primary outcome, in which the per protocol population comprised comparison-arm participants and those intervention-arm participants who attended the introductory and initial three core-intervention sessions.
We will use an intention-to-treat analysis, but will explore the effect of switching by conducting a per protocol secondary analysis.
Data will be analysed on an intention-to-treat basis; however, as a secondary analysis we will also conduct a per protocol analysis.
In addition, we will conduct a per protocol analysis using data from participants who received at least a minimum exposure to the interventions and for whom MPR was available at 6 months.
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