title: Core outcome domains for clinical trials in non-specific low back pain.
abstract: OBJECTIVE
  Inconsistent reporting of outcomes in clinical trials of patients with non-specific low back pain (NSLBP) hinders comparison of findings and the reliability of systematic reviews. A core outcome set (COS) can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials. In 1998, Deyo et al. recommended a standardized set of outcomes for LBP clinical research. The aim of this study was to update these recommendations by determining which outcome domains should be included in a COS for clinical trials in NSLBP.
  
  
  METHODS
  An International Steering Committee established the methodology to develop this COS. The OMERACT Filter 2.0 framework was used to draw a list of potential core domains that were presented in a Delphi study. Researchers, care providers and patients were invited to participate in three Delphi rounds and were asked to judge which domains were core. A priori criteria for consensus were established before each round and were analysed together with arguments provided by panellists on importance, overlap, aggregation and/or addition of potential core domains. The Steering Committee discussed the final results and made final decisions.
  
  
  RESULTS
  A set of 280 experts was invited to participate in the Delphi; response rates in the three rounds were 52, 50 and 45%. Of 41 potential core domains presented in the first round, 13 had sufficient support to be presented for rating in the third round. Overall consensus was reached for the inclusion of three domains in this COS: 'physical functioning', 'pain intensity' and 'health-related quality of life'. Consensus on 'physical functioning' and 'pain intensity' was consistent across all stakeholders, 'health-related quality of life' was not supported by the patients, and all the other domains were not supported by two or more groups of stakeholders. Weighting all possible argumentations, the Steering Committee decided to include in the COS the three domains that reached overall consensus and the domain 'number of deaths'.
  
  
  CONCLUSIONS
  The following outcome domains were included in this updated COS: 'physical functioning', 'pain intensity', 'health-related quality of life' and 'number of deaths'. The next step for the development of this COS will be to determine which measurement instruments best measure these domains.
authors.affiliation: Department of Health Sciences, Faculty of Earth and Life Sciences, EMGO+ Institute for Health and Care Research, VU University Amsterdam, de Boelelaan 1085, room U-601, 1081 HV, Amsterdam, The Netherlands, a.chiarotto@vu.nl.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Chiarotto
authors.forename: Richard A
authors.initials: RA
authors.lastname: Deyo
authors.forename: Caroline B
authors.initials: CB
authors.lastname: Terwee
authors.forename: Maarten
authors.initials: M
authors.lastname: Boers
authors.forename: Rachelle
authors.initials: R
authors.lastname: Buchbinder
authors.forename: Terry P
authors.initials: TP
authors.lastname: Corbin
authors.forename: Leonardo O P
authors.initials: LO
authors.lastname: Costa
authors.forename: Nadine E
authors.initials: NE
authors.lastname: Foster
authors.forename: Margreth
authors.initials: M
authors.lastname: Grotle
authors.forename: Bart W
authors.initials: BW
authors.lastname: Koes
authors.forename: Francisco M
authors.initials: FM
authors.lastname: Kovacs
authors.forename: Chung-Wei Christine
authors.initials: CW
authors.lastname: Lin
authors.forename: Chris G
authors.initials: CG
authors.lastname: Maher
authors.forename: Adam M
authors.initials: AM
authors.lastname: Pearson
authors.forename: Wilco C
authors.initials: WC
authors.lastname: Peul
authors.forename: Mark L
authors.initials: ML
authors.lastname: Schoene
authors.forename: Dennis C
authors.initials: DC
authors.lastname: Turk
authors.forename: Maurits W
authors.initials: MW
authors.lastname: van Tulder
authors.forename: Raymond W
authors.initials: RW
authors.lastname: Ostelo
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D003697:Delphi Technique; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000628:therapy*; D008297:Male; D063868:Patient Outcome Assessment
references.citation: Arthritis Care Res (Hoboken). 2010 May;62(5):640-6
references.pmid: 20461785
references.citation: J Pain. 2014 Jun;15(6):569-85
references.pmid: 24787228
references.citation: Lancet. 2012 Dec 15;380(9859):2163-96
references.pmid: 23245607
references.citation: BMC Musculoskelet Disord. 2014 Feb 21;15:50
references.pmid: 24559519
references.citation: BMJ. 2008 Dec 22;337:a2718
references.pmid: 19103627
references.citation: Spine (Phila Pa 1976). 2009 Aug 15;34(18):1929-41
references.pmid: 19680101
references.citation: Trials. 2014 Jun 25;15:247
references.pmid: 24962012
references.citation: Cochrane Database Syst Rev. 2005 Jul 20;(3):CD000335
references.pmid: 16034851
references.citation: BMJ. 2006 Jun 17;332(7555):1430-4
references.pmid: 16777886
references.citation: Trials. 2007 Nov 26;8:38
references.pmid: 18039364
references.citation: Trials. 2012 Aug 06;13:132
references.pmid: 22867278
references.citation: J Rheumatol. 2003 Apr;30(4):868-72
references.pmid: 12672218
references.citation: Arthritis Res Ther. 2011;13(5):R152
references.pmid: 21933393
references.citation: J Rehabil Med. 2007 May;39(5):353-7
references.pmid: 17549324
references.citation: Pain. 2003 Dec;106(3):337-45
references.pmid: 14659516
references.citation: Eur Spine J. 2009 Aug;18 Suppl 3:367-73
references.pmid: 19319578
references.citation: Cochrane Database Syst Rev. 2014 Sep 02;(9):CD000963
references.pmid: 25180773
references.citation: Trials. 2014 Feb 05;15:49
references.pmid: 24495582
references.citation: Spine (Phila Pa 1976). 2006 May 20;31(12):1372-9; discussion 1380
references.pmid: 16721302
references.citation: PLoS Med. 2011 Jan 25;8(1):e1000393
references.pmid: 21283604
references.citation: BMJ. 2010 Feb 15;340:c365
references.pmid: 20156912
references.citation: Lancet. 2012 Dec 15;380(9859):2197-223
references.pmid: 23245608
references.citation: Spine (Phila Pa 1976). 2013 Nov 15;38(24):2118-23
references.pmid: 23970112
references.citation: JAMA. 1995 Jan 4;273(1):59-65
references.pmid: 7996652
references.citation: Pain. 2005 Jan;113(1-2):9-19
references.pmid: 15621359
references.citation: Rheumatology (Oxford). 2010 Dec;49(12):2346-56
references.pmid: 20713495
references.citation: Spine (Phila Pa 1976). 2000 Dec 15;25(24):3100-3
references.pmid: 11124724
references.citation: Trials. 2013 Jan 22;14:21
references.pmid: 23339751
references.citation: J Clin Epidemiol. 2014 Jul;67(7):745-53
references.pmid: 24582946
references.citation: Cochrane Database Syst Rev. 2010 Jul 07;(7):CD002014
references.pmid: 20614428
references.citation: J Rheumatol. 2005 Nov;32(11):2250-6
references.pmid: 16265712
references.citation: Spine (Phila Pa 1976). 1998 Sep 15;23(18):2003-13
references.pmid: 9779535
references.citation: Spine (Phila Pa 1976). 1987 Sep;12(7):632-44
references.pmid: 2961080
references.citation: Trials. 2007 Nov 26;8:39
references.pmid: 18039365
references.citation: Spine (Phila Pa 1976). 2011 Jun;36(13):1050-8
references.pmid: 21150697
references.citation: Cochrane Database Syst Rev. 2012 Sep 12;(9):CD008880
references.pmid: 22972127
references.citation: N Engl J Med. 2001 Feb 1;344(5):363-70
references.pmid: 11172169
references.citation: Phys Ther. 1993 Mar;73(3):138-50; discussion 150-5
references.pmid: 8438002
references.citation: Trials. 2014 Dec 26;15:511
references.pmid: 25540987
references.citation: Arthritis Rheum. 2012 Jun;64(6):2028-37
references.pmid: 22231424
references.citation: Lancet. 2012 Feb 4;379(9814):482-91
references.pmid: 21982256
references.citation: Cochrane Database Syst Rev. 2014 Mar 14;(3):CD003007
references.pmid: 24627325
references.citation: Spine J. 2008 Jan-Feb;8(1):8-20
references.pmid: 18164449
references.citation: J Rehabil Med. 2004 Jul;(44 Suppl):69-74
references.pmid: 15370751