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Allocation Concealment and Intention-To-Treat Analysis Do Not Influence the Treatment Effects of Physical Therapy Interventions in Low Back Pain Trials: a Meta-epidemiologic Study.

Abstract：

OBJECTIVE:To evaluate if allocation concealment and intention-to-treat (ITT) analysis influence the treatment effects of physical therapy interventions in low back pain (LBP) trials. DATA SOURCES:We searched on PubMed, Embase, Cochrane Database of Systematic Reviews, Physiotherapy Evidence Database (PEDro), and CINAHL up to February 2017. STUDY SELECTION:We included LBP trials that compared physical therapy interventions to placebo or no intervention or minimal intervention with pain or disability outcomes. DATA EXTRACTION:Information about allocation concealment and ITT analysis was extracted from PEDro and pain and disability outcomes converted to a 0-100 scale. A meta-regression was performed to evaluate the influence of these methodological features of interest on treatment effects. Other covariates included in the meta-regression were sample size and sequence generation. DATA SYNTHESIS:We identified 128 eligible trials (pooled N=20,555 participants). A total of 44.5% of the trials achieved allocation concealment, while 32% performed ITT analysis. Meta regression analyses showed no influence of allocation concealment on treatment effects for pain (regression coefficient 0.009; 95% confidence interval [CI] -2.91 to 2.91) and disability (regression coefficient 1.13; 95% CI -1.35 to 3.62), and no influence of ITT analysis for pain (regression coefficient 1.38; 95% CI -1.73 to 4.50) or disability (regression coefficient 1.27; 95% CI -1.39 to 3.64). For the other covariates, there was also no clinically significant influence on the treatment effects. CONCLUSION:There is no influence of allocation concealment or ITT analysis on treatment effects of physical therapy interventions for pain and disability in LBP trials.

journal_name

Arch Phys Med Rehabil

journal_title

Archives of physical medicine and rehabilitation

authors

de Almeida MO,Saragiotto BT,Maher C,Costa LOP

doi

10.1016/j.apmr.2018.12.036

subject

Has Abstract

pub_date

2019-07-01 00:00:00

pages

1359-1366

issue

eissn

0003-9993

issn

1532-821X

pii

S0003-9993(19)30081-4

journal_volume

100

pub_type

杂志文章,meta分析,评审

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Allocation Concealment and Intention-To-Treat Analysis Do Not Influence the Treatment Effects of Physical Therapy Interventions in Low Back Pain Trials: a Meta-epidemiologic Study.