Froud, Robert J., Eldridge, Sandra, Kovacs, Francisco M., Breen, Alan C., Bolton, Jenni, Dunn, Kate M., Fritz, Julie, Keller, Anne, Kent, P., Lauridsen, Henrik Hein, Ostelo, Raymond, Pincus, Tamar, Tulder, Maurits W. van, Vogel, Steven and Underwood, M.. (2011) Reporting outcomes of back pain trials : a modified Delphi study. European Journal of Pain, Vol.15 (No.10). pp. 1068-1074. ISSN 1090-3801

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Abstract

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.

Item Type:	Journal Article
Subjects:	R Medicine > R Medicine (General)
Divisions:	Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Backache, Delphi method, Clinical trials -- Reporting
Journal or Publication Title:	European Journal of Pain
Publisher:	Elsevier Ltd.
ISSN:	1090-3801
Official Date:	November 2011
Dates:	Date Event November 2011 Published
Volume:	Vol.15
Number:	No.10
Page Range:	pp. 1068-1074
Identification Number:	10.1016/j.ejpain.2011.04.015
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Restricted or Subscription Access
Funder:	Barts and the London Charity (BTLC)
URI:	http://wrap.warwick.ac.uk/id/eprint/39849

Data sourced from Thomson Reuters' Web of Knowledge

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