Abstract
BackgroundNeurogenic claudication is a common spinal condition affecting older adults that has a major effect on mobility and implicitly independence. The effectiveness of conservative interventions in this population is not known. We describe the statistical analysis plan for the Better Outcomes for Older people with Spinal trouble (BOOST) randomised controlled trial.Methods/designBOOST is a pragmatic, multicentre, parallel, two-arm, randomised controlled trial. Participants are community-dwelling adults, 65 years or older, with neurogenic claudication, registered prospectively, and randomised 2:1 (intervention to control) to the combined physical and psychological BOOST group physiotherapy programme or best practice advice. The primary outcome is the Oswestry Disability Index at 12 months. Secondary outcomes include the Short Physical Performance Battery, Swiss Spinal Stenosis Scale, 6 Minute Walk Test, Fear Avoidance Beliefs Questionnaire, and Tilburg Frailty Indicator. Outcomes are measured at 6 and 12 months by researchers blinded to treatment allocation. The primary statistical analysis is by intention to treat. Further study design details are published in the BOOST protocol.DiscussionThe planned statistical analyses for the BOOST trial aim to reduce the risk of outcome reporting bias from prior data knowledge. Any changes or deviations from this statistical analysis plan will be described and justified in the final study report.Trial registrationThis study has been registered in the International Standard Randomised Controlled Trial Number registry, reference number ISRCTN12698674. Registered on 10 November 2015.
Highlights
Neurogenic claudication is a common spinal condition affecting older adults that has a major effect on mobility and implicitly independence
This paper reports the details of the analysis plan for the BOOST trial as agreed by the Data and Safety Monitoring Committee (DSMC) in July 2019 and has been prepared according to the published guidelines on the content of statistical analysis plans [8]
The primary objective of the study is to estimate the clinical effectiveness of a physiotherapist-delivered intervention combining physical and psychological components for older adults with neurogenic claudication, compared with best practice advice, based on observed differences in the Oswestry Disability Index (ODI) [11] between the trial treatment groups 12 months after randomisation
Summary
The BOOST trial will provide data on the effects of the BOOST physiotherapy intervention on the ODI in older adults with neurogenic claudication 12 months after randomisation, compared with best practice advice. One study limitation is that we cannot mask participants to their treatment allocation, as the type of intervention received is clearly notable. This paper describes the planned statistical analyses for BOOST. Any changes from the protocol or statistical analysis plan will be described and justified in the final statistical report. The aim of pre-specifying the analysis is to reduce the risk of data-driven results and outcome reporting bias [16]. We have recruited 438 participants from 14 sites. Follow-up for the trial outcome data is ongoing and expected to be completed by October 2019. Analysis will begin once this follow-up is complete
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