Data for A systematic review of outcome measures use, analytical approaches, reporting methods, and publication volume by year in low back pain trials published between 1980 and 2012: Respice, adspice, et prospice

Since 2011, there has been some consensus on the optimal methods for reporting back pain trial outcomes. We explored reporting practice, outcome measure use, and publications over time.

Methods

We performed a systematic review of LBP trials, searching the European Guidelines for the management of LBP, extending the search to 2012. We abstracted data on publications by year, outcome measure use, analytical approach, and approaches taken to reporting trials outcomes. Data were analysed using descriptive statistics and regression analyses.

Results: We included 401 trials. The number of published trials per year has increased by a factor of 4.5 from 5.4 (1980 - 1999) to 24.4 (2000 - 2012). The most commonly used outcome measures have been the Visual Analogue Scale for pain intensity, which has slowly increased in use since 1980/81 from 20% to 60% of trials by 2012, and the Roland-Morris Disability Questionnaire, which rose to 55% in 2002/2003, and then fell back to 28% by 2012.

Most trialists (85%) report between-group mean differences. Few (8%) report individual improvements, and some (4%) report only within-group analyses. Student's t test, ANOVA, and ANCOVA regression, or mixed models, were the most common approaches to analysis.

Conclusions: Recommendations for standardising outcomes may have had a limited or inconsistent effect on practice. Since the research community is again PLOS 1/15 considering outcome measures and modifying recommendations, groups offering recommendations should be cognisant that better ways of generating trialist buy-in may be required in order for their recommendations to have impact.<br><br>Note 1: If reporting outcomes data for an included trial utilising either the RMDQ or the VAS-P are missing from the main data file, these data may be obtailed using the look-up chart in the PDF entitled 'Additional_reporting_data_look_up_chart.pdf'.

Note 2: In all 9 cases where sample size calculation data is missing, the primary outcome is declared. Note 3: .dta file opens in Stata (Statacorp, Texas)