Literature DB >> 21596600

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

Robert Froud1, Sandra Eldridge, Francisco Kovacs, Alan Breen, Jenni Bolton, Kate Dunn, Julie Fritz, Anne Keller, Peter Kent, Henrik Hein Lauridsen, Raymond Ostelo, Tamar Pincus, Maurits van Tulder, Steven Vogel, Martin Underwood.   

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. Copyright Â
© 2011 European Federation of International Association for the Study of Pain Chapters. Published by Elsevier Ltd. All rights reserved.

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Year:  2011        PMID: 21596600     DOI: 10.1016/j.ejpain.2011.04.015

Source DB:  PubMed          Journal:  Eur J Pain        ISSN: 1090-3801            Impact factor:   3.931


  17 in total

1.  Clinicians' perceptions of reporting methods for back pain trials: a qualitative study.

Authors:  Robert Froud; Martin Underwood; Dawn Carnes; Sandra Eldridge
Journal:  Br J Gen Pract       Date:  2012-03       Impact factor: 5.386

2.  Report of the NIH Task Force on research standards for chronic low back pain.

Authors:  Richard A Deyo; Samuel F Dworkin; Dagmar Amtmann; Gunnar Andersson; David Borenstein; Eugene Carragee; John Carrino; Roger Chou; Karon Cook; Anthony Delitto; Christine Goertz; Partap Khalsa; John Loeser; Sean Mackey; James Panagis; James Rainville; Tor Tosteson; Dennis Turk; Michael Von Korff; Debra K Weiner
Journal:  Phys Ther       Date:  2015-02

3.  Report of the NIH Task Force on research standards for chronic low back pain.

Authors:  Richard A Deyo; Samuel F Dworkin; Dagmar Amtmann; Gunnar Andersson; David Borenstein; Eugene Carragee; John Carrino; Roger Chou; Karon Cook; Anthony DeLitto; Christine Goertz; Partap Khalsa; John Loeser; Sean Mackey; James Panagis; James Rainville; Tor Tosteson; Dennis Turk; Michael Von Korff; Debra K Weiner
Journal:  J Pain       Date:  2014-04-29       Impact factor: 5.820

Review 4.  Responder analyses in randomised controlled trials for chronic low back pain: an overview of currently used methods.

Authors:  Nicholas Henschke; Annefloor van Enst; Robert Froud; Raymond W G Ostelo
Journal:  Eur Spine J       Date:  2014-01-14       Impact factor: 3.134

5.  Focus article: report of the NIH Task Force on Research Standards for Chronic Low Back Pain.

Authors:  Richard A Deyo; Samuel F Dworkin; Dagmar Amtmann; Gunnar Andersson; David Borenstein; Eugene Carragee; John Carrino; Roger Chou; Karon Cook; Anthony DeLitto; Christine Goertz; Partap Khalsa; John Loeser; Sean Mackey; James Panagis; James Rainville; Tor Tosteson; Dennis Turk; Michael Von Korff; Debra K Weiner
Journal:  Eur Spine J       Date:  2014-10       Impact factor: 3.134

6.  Improving the reporting and interpretation of clinical trial outcomes.

Authors:  Robert Froud; Martin Underwood; Sandra Eldridge
Journal:  Br J Gen Pract       Date:  2012-10       Impact factor: 5.386

7.  Patient Priority Weighting of the Roland Morris Disability Questionnaire Does Not Change Results of the Lumbar Epidural Steroid Injections for Spinal Stenosis Trial.

Authors:  Una E Makris; Todd C Edwards; Danielle C Lavallee; Zoya Bauer; Bryan A Comstock; Jeffrey G Jarvik; Donald L Patrick; Mahshid Lotfi; Janna L Friedly
Journal:  Spine (Phila Pa 1976)       Date:  2017-01-01       Impact factor: 3.241

8.  Primary outcome measure use in back pain trials may need radical reassessment.

Authors:  Robert Froud; David Ellard; Shilpa Patel; Sandra Eldridge; Martin Underwood
Journal:  BMC Musculoskelet Disord       Date:  2015-04-14       Impact factor: 2.362

9.  Report of the NIH Task Force on Research Standards for Chronic Low Back Pain.

Authors:  Richard A Deyo; Samuel F Dworkin; Dagmar Amtmann; Gunnar Andersson; David Borenstein; Eugene Carragee; John Carrino; Roger Chou; Karon Cook; Anthony DeLitto; Christine Goertz; Partap Khalsa; John Loeser; Sean Mackey; James Panagis; James Rainville; Tor Tosteson; Dennis Turk; Michael Von Korff; Debra K Weiner
Journal:  Int J Ther Massage Bodywork       Date:  2015-09-01

Review 10.  Effectiveness guidance document (EGD) for Chinese medicine trials: a consensus document.

Authors:  Claudia M Witt; Mikel Aickin; Daniel Cherkin; Chun Tao Che; Charles Elder; Andrew Flower; Richard Hammerschlag; Jian-Ping Liu; Lixing Lao; Steve Phurrough; Cheryl Ritenbaugh; Lee Hullender Rubin; Rosa Schnyer; Peter M Wayne; Shelly Rafferty Withers; Bian Zhao-Xiang; Jeanette Young; Brian M Berman
Journal:  Trials       Date:  2014-05-13       Impact factor: 2.279

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