POSTER AWARD 2018: Inclusion and exclusion criteria used in non-specific low back pain trials – A review of randomised controlled trials

Author: Pål Andre Amundsen (B.Sc., D.O., M.Sc.), Kristiania University College, Norway

 

Background

 

  • Low back pain is a common health complaint resulting in substantial economic burden. Each year, upwards of 20 randomised controlled trials (RCTs) evaluating interventions for non-specific low back pain are published.
  • Use of the term non-specific low back pain has been criticised on the grounds of encouraging heterogeneity and hampering interpretation of findings due to possible heterogeneous causes, challenging metaanalyses.
  • We explored selection criteria used in trials of treatments für nsLBP.

 

Methods

 

  • A systematic review of English-language reports of RCTs in nsLBP population samples, published between 2006 and 2012, identified from MEDLINE, EMBASE, and the Cochrane Library databases, usind a mixed-methods approach to analysis.
  • Study inculusion and exclusion criteria were extracted, thematically categorised, and then descriptive statistics were used to summarise the prevalence by emerging category.
  • To identify the categories of reported inclusion and exclusion criteria, we developed a coding framework with themes and subthemes.

 

Discussion

  • Terms used to describe pathological conditions were ambigueous or vague, making it difficult to ascertain exactly what type of patients had been recruited into the trial.
  • The use of umbrella, over-arching terms ans vagueness of description was commonly noted across all categories of symptoms, signs, and conditions.
  • Interpretation of current systematic reviews, and authors of future systematic reviews of treatments for nsLBP population should therefore tale into consideration these heterogeneous populations, as it is difficult to compare studies of competing or similar interventions, pool the data from several studies, replicate the findings, and develop consensus within a discipline or between disciplines.

 

Conclusion

  • RCTs of interventions for non-specific low back pain have incorporated diverse inclusion and exclusion criteria, and terms and descriptions used are inconsistent and often described ambiguously using over-arching terms.
  • Guidance on standardisation of inclusion and exclusion criteria for nsLBP trials will increase clinical homogeneity, facilitating greater interpretation of between-trial comparisons and meta-analyses.
  • We propose a template for reporting inclusion and exclusion criteria (see publication).

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