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The primary outcome endpoint was safety.
The PP population was the primary analysis population for the primary outcome endpoint.
The primary outcome endpoint was the four month follow-up as this represented the period at which we expected to observe the largest effect between groups.
The propensity score was included as a covariate in multiple regression analysis for the primary outcome endpoint, death while in the hospital (hospital death), and for the secondary outcome endpoint, discharge to a care facility (disability).
The expectation was that at least five sessions, including one face to face meeting, would have been completed well before the primary outcome endpoint at four months post-randomisation.
Before the primary outcome endpoint at three months 64/568 (11%) participants died in the intervention arm and 52/474 (11%) in the control arm (116 participants in total).
Similar(52)
In the context of multiple outcome measures, and without a gold standard or obvious choice of measure to be used as primary outcome, composite endpoint measures are useful to avoid multiple testing and to increase statistical power.
The primary outcome measure and endpoint will be the WOMAC Pain score measured 1 year following knee arthroplasty [ 63- 67].
Hip Disability and Osteoarthritis Outcome Score (HOOS 2.0), subscale "Physical Function Short form (HOOS-PS)", will be used as the primary outcome, with primary endpoint after twelve months.
We encouraged greater specificity by stating that descriptions of interventions should include "sufficient details to allow replication" 3 Item 6 (outcomes)—We added a sub-item on identifying any changes to the primary and secondary outcome (endpoint) measures after the trial started.
The study has three objectives; each has a primary outcome and secondary endpoints.
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