Reporting outcomes of back pain trials: a modified Delphi study.

BACKGROUND

Low back pain is a common and expensive health complaint. Many low back pain trials have been conducted, but these are reported in a variety of ways and are often difficult to interpret.

AIM

To facilitate consensus on a statement recommending reporting methods for future low back pain trials.

METHODS

We presented experts with clinicians' views on different reporting methods and asked them to rate and comment on the suitability reporting methods for inclusion in a standardized set. Panellists developed a statement of recommendation over three online rounds. We used a modified Delphi process and the RAND/UCLA appropriateness method as a formal framework for establishing appropriateness and quantifying panel disagreement.

RESULTS

A group of 63 experts from 14 countries participated. Consensus was reached on a statement recommending that the continuous patient-reported outcomes commonly used in back pain trials, are reported using between-group mean differences (accompanied by minimally important difference (between-group/population-level) thresholds where these exist), the proportion of participants improving and deteriorating according to established and relevant minimally important change thresholds, and the number needed to treat; all with 95% confidence intervals. Outcomes may additionally be reported using alternative approaches (e.g. relative risks, odds ratios, or standardized mean difference) according to the needs of a particular trial.

CONCLUSIONS

A group of back pain experts reached a high level of consensus on a statement recommending reporting methods for patient-reported outcomes in future low back pain trials. The statement has the potential to increase interpretability and improve patient care.