PACE--the first placebo controlled trial of paracetamol for acute low back pain: statistical analysis plan.
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.


BACKGROUND
Australia and New Zealand Clinical Trials Registry ACTRN12609000966291.
The George Institute for Global Health and Sydney Medical School, University of Sydney, PO Box M201, Missenden Rd, 2040 Camperdown, NSW, Australia. cwilliams@georgeinstitute.org.au
Christopher M
CM
Williams
Chris G
CG
Maher
Jane
J
Latimer
Andrew J
AJ
McLachlan
Mark J
MJ
Hancock
Richard O
RO
Day
Laurent
L
Billot
Chung-Wei Christine
CW
Lin
D000082:Acetaminophen / Q000009:adverse effects / Q000627:therapeutic use*; D059787:Acute Pain / Q000175:diagnosis / Q000188:drug therapy*; D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use*; D003627:Data Interpretation, Statistical; D004185:Disability Evaluation; D004311:Double-Blind Method; D006801:Humans; D017116:Low Back Pain / Q000175:diagnosis / Q000188:drug therapy*; D009517:New South Wales; D010147:Pain Measurement; D011237:Predictive Value of Tests; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012107:Research Design / Q000706:statistics & numerical data*; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D000700:Analgesics; D000082:Acetaminophen