TY - JOUR
T1 - PACE - the first placebo controlled trial of paracetamol for acute low back pain
T2 - Statistical analysis plan
AU - Williams, Christopher M.
AU - Maher, Chris G.
AU - Latimer, Jane
AU - McLachlan, Andrew J.
AU - Hancock, Mark J.
AU - Day, Richard O.
AU - Billot, Laurent
AU - Lin, Chung Wei Christine
N1 - This version is archived for private and non-commercial use under the terms of this BioMed Central open access license ("license") (see http://www.biomedcentral.com/about/license). The work is protected by copyright and/or other applicable law. Any use of the work other than as authorized under this license is prohibited. For further rights please check the terms of the license, or contact the publisher.
PY - 2013/8/9
Y1 - 2013/8/9
N2 - Background: Paracetamol (acetaminophen) is recommended in most clinical practice guidelines as the first choice of treatment for low back pain, however there is limited evidence to support this recommendation. The PACE trial is the first placebo controlled trial of paracetamol for acute low back pain. This article describes the statistical analysis plan.Results: PACE is a randomized double dummy placebo controlled trial that investigates and compares the effect of paracetamol taken in two regimens for the treatment of low back pain. The protocol has been published. The analysis plan was completed blind to study group and finalized prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described.Conclusions: A standard analysis plan was developed for the results of the PACE study. This plan comprehensively describes the data captured and pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori plan will be followed to ensure rigorous standards of data analysis are strictly adhered to.
AB - Background: Paracetamol (acetaminophen) is recommended in most clinical practice guidelines as the first choice of treatment for low back pain, however there is limited evidence to support this recommendation. The PACE trial is the first placebo controlled trial of paracetamol for acute low back pain. This article describes the statistical analysis plan.Results: PACE is a randomized double dummy placebo controlled trial that investigates and compares the effect of paracetamol taken in two regimens for the treatment of low back pain. The protocol has been published. The analysis plan was completed blind to study group and finalized prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described.Conclusions: A standard analysis plan was developed for the results of the PACE study. This plan comprehensively describes the data captured and pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori plan will be followed to ensure rigorous standards of data analysis are strictly adhered to.
UR - http://www.scopus.com/inward/record.url?scp=84881130901&partnerID=8YFLogxK
UR - http://purl.org/au-research/grants/nhmrc/570883
U2 - 10.1186/1745-6215-14-248
DO - 10.1186/1745-6215-14-248
M3 - Article
C2 - 23937999
AN - SCOPUS:84881130901
SN - 1745-6215
VL - 14
SP - 1
EP - 9
JO - Trials
JF - Trials
M1 - 248
ER -