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

Williams CM, Maher CG, Latimer J, McLachlan AJ, Hancock MJ, Day RO, Billot L, Lin CW - Trials (2013)

Bottom Line: 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.

View Article: PubMed Central - HTML - PubMed

Affiliation: 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

ABSTRACT

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.

Trial registration: Australia and New Zealand Clinical Trials Registry ACTRN12609000966291.

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Related in: MedlinePlus

Consort flow diagram.
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Related In: Results  -  Collection

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Figure 1: Consort flow diagram.

Mentions: Flow of patients through the study will be displayed in a Consolidated Standards Of Reporting Trials (CONSORT) diagram. We will report the number of screened patients who met study inclusion criteria, reasons for exclusion of non-included patients, the number of participants randomized per group, and the number who completed follow-up, as shown in FigureĀ 1.


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

Williams CM, Maher CG, Latimer J, McLachlan AJ, Hancock MJ, Day RO, Billot L, Lin CW - Trials (2013)

Consort flow diagram.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3750911&req=5

Figure 1: Consort flow diagram.
Mentions: Flow of patients through the study will be displayed in a Consolidated Standards Of Reporting Trials (CONSORT) diagram. We will report the number of screened patients who met study inclusion criteria, reasons for exclusion of non-included patients, the number of participants randomized per group, and the number who completed follow-up, as shown in FigureĀ 1.

Bottom Line: 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.

View Article: PubMed Central - HTML - PubMed

Affiliation: 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

ABSTRACT

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.

Trial registration: Australia and New Zealand Clinical Trials Registry ACTRN12609000966291.

Show MeSH
Related in: MedlinePlus