Article
Reporting of preferred study outcomes in randomized controlled trials of back schools for chronic low back pain – systematic review and meta-analysis
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Published: | August 27, 2015 |
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Introduction: Low back pain is very common and is also a common cause of absence from work and interference with work, despite a number of analgesic treatments that are available. Within the occupational medicine setting, “back schools”, for our study defined as educational and training programs with lessons given to patients by a therapist with the aim of treating low back pain, are an important non-pharmacological intervention. However, the efficacy of back schools for treating low back pain still needs to be firmly established. A Cochrane review on this subject exists [1], concluding that there was moderate evidence that back schools for chronic low back pain in an occupational setting were more effective than other treatments and placebo or waiting list controls, but, with a decade having passed since the publication of this Cochrane review and with new evidence having been published in the meantime, it was time for an up-to-date assessment of back schools in the form of a systematic review and meta-analysis. Guidance on the reporting of outcomes within systematic reviews in pain has recently been published [2]. Here we aim to investigate the adherence to and applicability of these recently described preferred study outcomes for systematic reviews in pain in the context of non-pharmacological interventions, specifically back schools.
Methods: A systematic review and meta-analysis of randomized controlled trials investigating the treatment of adults with chronic low back pain with back schools, compared to no intervention or any other intervention. Literature searching was conducted in Medline (PubMed), Embase and Cochrane Central, complemented by searching the reference lists of the included articles and reviews in the field. Studies were included in the systematic review if they were randomized controlled trials investigating back schools for the treatment of chronic low back pain. Data extraction was performed in duplicate with standardized data extraction forms; disagreements were resolved by consensus or by discussion with a third review author.
The reporting of the following preferred outcomes in the included studies is presented and discussed.
Pain: proportion with at least 50% pain reduction over baseline; proportion with at least 30% pain reduction over baseline; proportion below 30/100 mm on the visual analogue pain scale (no worse than mild pain); treatment group average scores of pain intensity or pain relief.
Function: workdays missed; pain interference with work (subjective rating scales); pain interference with activities of daily living
General: quality of life measures; patient global impression
Adverse Events: proportion with any adverse event; withdrawals due to adverse events; proportion with any serious adverse event
Results: Our literature search revealed 31 studies out of 273 abstracts that fulfilled our inclusion criteria. Regarding the above-mentioned preferred outcomes, we obtained the following results:
- 0/31 studies reported dichotomized pain outcomes
- 20/31 studies reported treatment group average pain scores
- 1/31 studies reported patient global impression
- 28/31 studies reported on patients function
- 4/31 studies reported on workdays missed, however data were reported only at baseline
- 15/31 studies reported quality of life measures
- 24/31 studies reported statistically significant superiority of back schools over their comparator in at least one outcome
Discussion: Our analysis revealed that the preferred outcomes are rarely used in studies. Especially dichotomized pain outcomes have not been reported at all, although recent guidance recommends using them in addition [2].
Acknowledgement: This Project is funded by the BMBF (Federal Ministry of Education and Research) in Germany (grant number 01KG1409).
References
- 1.
- Heymans MW, van Tulder MW, Esmail R, Bombardier C, Koes BW. Back schools for non-specific low back pain. Cochrane Database Syst Rev. 2004; (4): CD000261.
- 2.
- Moore RA, Eccleston C, Derry S, Wiffen P, Bell RF, Straube S, McQuay H; ACTINPAIN Writing Group of the IASP Special Interest Group on Systematic Reviews in Pain Relief; Cochrane Pain, Palliative and Supportive Care Systematic Review Group Editors. "Evidence" in chronic pain--establishing best practice in the reporting of systematic reviews. Pain. 2010; 150: 386-9.