PRECISE--pregabalin in addition to usual care: statistical analysis plan

Sciatica is a severe, disabling condition that lacks high quality evidence for effective treatment strategies. This a priori statistical analysis plan describes the methodology of analysis for the PRECISE study. PRECISE is a prospectively registered, double blind, randomised placebo controlled trial...

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Published in:Current controlled trials in cardiovascular medicine 2016-01, Vol.17 (1), p.53-53, Article 53
Main Authors: Mathieson, Stephanie, Billot, Laurent, Maher, Christopher G, McLachlan, Andrew J, Latimer, Jane, Koes, Bart W, Hancock, Mark J, Harris, Ian, Day, Richard O, Pik, Justin, Jan, Stephen, Lin, Chung-Wei Christine
Format: Article
Language:English
Subjects:
Analgesics
Analgesics - therapeutic use
Anticonvulsants
Back pain
Data Interpretation, Statistical
Double-Blind Method
Drug dosages
Employment
Genetic aspects
Humans
Medicine
Outcome Assessment (Health Care)
Pregabalin
Pregabalin - adverse effects
Pregabalin - therapeutic use
Prospective Studies
Questionnaires
Sample Size
Sciatica
Sciatica - drug therapy
Sciatica - physiopathology
Statistical analysis
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Summary:Sciatica is a severe, disabling condition that lacks high quality evidence for effective treatment strategies. This a priori statistical analysis plan describes the methodology of analysis for the PRECISE study. PRECISE is a prospectively registered, double blind, randomised placebo controlled trial of pregabalin compared to placebo, in addition to usual care in patients with sciatica. The aim of this study is to determine the efficacy and cost-effectiveness of pregabalin in reducing leg pain intensity (primary outcome). Secondary outcomes include disability (key secondary), back pain intensity, quality of life, participants' perceived global effect, work absenteeism and health utilisation. Information about medication usage and tolerability are also collected. Outcomes are collected over one year (weeks 2, 4, 8, 12, 26 and 52). Double data entry will be conducted for primary and key secondary outcomes. Other outcomes will be checked using a risk-based approach. Analyses will be consistent with the intention-to-treat principle. Statistical tests will be two-tailed with a p value
ISSN:1745-6215
1745-6215
DOI:10.1186/s13063-016-1174-y