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FACE VALIDITY OF BACK PAIN OUTCOME REPORTING METHODS (FABO)



Abstract

Background and Purpose: How outcomes of clinical trials are reported alters the way treatment effectiveness is perceived. Clinicians interpret outcomes of trials more favourably when results are presented in relative rather than in absolute terms. However, the face validity of different methods is unclear. We aimed to explore which methods clinicians find clearest, most interpretable, and useful.

Methods and Results: We purposively sampled clinicians who see patients with low back pain (LBP) and presented them with summary reports of a hypothetical trial, reporting the results using a variety of different methods. We explored participants’ preferences for these different methods and how they would like to see future trials reported. We interviewed 14 clinicians (GPs, manual therapists, psychologists, a rheumatologist, and surgeons). Participants felt that clinical trial reports were not written with them in mind. They were familiar with mean differences, proportion improved, and number needed to treat (NNT); and unfamiliar with standardised mean difference (SMD), odds ratios and relative risk. They found the proportion improved, relative risk and NNT more intuitively understandable, and were concerned that between-group mean difference, relative risk and odds ratios may mislead. Participants thought each method uniquely contributed to their overall understanding, and that using a variety of methods to report future trials may prevent erroneous portrayal of treatment effect.

Conclusion: Clinicians who see patients with low back pain currently find it difficult to interpret LBP trials. Using a suite of methods to report outcomes may aid clinicians’ interpretation and the transition of research into practice.

Conflict of Interest: None

Sources of Funding: Barts and the London Charity

Correspondence should be addressed to: SBPR at the Royal College of Surgeons, 35–43 Lincoln’s Inn Fields, London WC2A 3PE, England.