182 lines
5.7 KiB
YAML
182 lines
5.7 KiB
YAML
abstract: 'Background
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Effective and cost-effective primary care treatments for low back pain
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(LBP) are required to reduce the burden of the world''s most disabling
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condition. This study aimed to compare the clinical effectiveness and
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cost-effectiveness of the Fear Reduction Exercised Early (FREE) approach
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to LBP (intervention) with usual general practitioner (GP) care
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(control).
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Methods and findings
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This pragmatic, cluster-randomised controlled trial with process
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evaluation and parallel economic evaluation was conducted in the Hutt
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Valley, New Zealand. Eight general practices were randomly assigned
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(stratified by practice size) with a 1:1 ratio to intervention (4
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practices; 34 GPs) or control group (4 practices; 29 GPs). Adults
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presenting to these GPs with LBP as their primary complaint were
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recruited. GPs in the intervention practices were trained in the FREE
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approach, and patients presenting to these practices received care based
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on the FREE approach. The FREE approach restructures LBP consultations
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to prioritise early identification and management of barriers to
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recovery. GPs in control practices did not receive specific training for
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this study, and patients presenting to these practices received usual
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care. Between 23 September 2016 and 31 July 2017, 140 eligible patients
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presented to intervention practices (126 enrolled) and 110 eligible
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patients presented to control practices (100 enrolled). Patient mean age
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was 46.1 years (SD 14.4), and 46\% were female. The duration of LBP was
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less than 6 weeks in 88\% of patients. Primary outcome was change from
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baseline in patient participant Roland Morris Disability Questionnaire
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(RMDQ) score at 6 months. Secondary patient outcomes included pain,
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satisfaction, and psychosocial indices. GP outcomes included attitudes,
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knowledge, confidence, and GP LBP management behaviour. There was active
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and passive surveillance of potential harms. Patients and outcome
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assessors were blind to group assignment. Analysis followed
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intention-to-treat principles. A total of 122 (97\%) patients from 32
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GPs in the intervention group and 99 (99\%) patients from 25 GPs in the
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control group were included in the primary outcome analysis. At 6
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months, the groups did not significantly differ on the primary outcome
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(adjusted mean RMDQ score difference 0.57, 95\% CI - 0.64 to 1.78; p =
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0.354) or secondary patient outcomes. The RMDQ difference met the
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predefined criterion to indicate noninferiority. One control group
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participant experienced an activity-related gluteal tear, with no other
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adverse events recorded. Intervention group GPs had improvements in
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attitudes, knowledge, and confidence compared with control group GPs.
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Intervention group GP LBP management behaviour became more guideline
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concordant than the control group. In cost-effectiveness, the
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intervention dominated control with lower costs and higher
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QualityAdjusted Life Year (QALY) gains. Limitations of this study were
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that although adequately powered for primary outcome assessment, the
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study was not powered for evaluating some employment, healthcare use,
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and economic outcomes. It was also not possible for research nurses
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(responsible for patient recruitment) to be masked on group allocation
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for practices.
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Conclusions
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Findings from this study suggest that the FREE approach improves GP
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concordance with LBP guideline recommendations but does not improve
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patient recovery outcomes compared with usual care. The FREE approach
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may reduce unnecessary healthcare use and produce economic benefits.
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Work participation or health resource use should be considered for
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primary outcome assessment in future trials of undifferentiated LBP.'
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affiliation: 'Darlow, B (Corresponding Author), Univ Otago, Dept Primary Hlth Care
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\& Gen Practice, Wellington, New Zealand.
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Darlow, Ben; Garrett, Sue; Dowell, Anthony, Univ Otago, Dept Primary Hlth Care \&
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Gen Practice, Wellington, New Zealand.
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Stanley, James, Univ Otago, Biostat Grp, Wellington, New Zealand.
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Dean, Sarah, Univ Exeter, Med Sch, Coll Med \& Hlth, Exeter, Devon, England.
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Abbott, J. Haxby; Wilson, Ross, Univ Otago, Dept Surg Sci, Dunedin, New Zealand.
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Mathieson, Fiona, Univ Otago, Dept Psychol Med, Wellington, New Zealand.'
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article-number: e1002897
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author: Darlow, Ben and Stanley, James and Dean, Sarah and Abbott, J. Haxby and Garrett,
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Sue and Wilson, Ross and Mathieson, Fiona and Dowell, Anthony
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author-email: ben.darlow@otago.ac.nz
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author_list:
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- family: Darlow
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given: Ben
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- family: Stanley
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given: James
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- family: Dean
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given: Sarah
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- family: Abbott
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given: J. Haxby
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- family: Garrett
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given: Sue
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- family: Wilson
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given: Ross
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- family: Mathieson
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given: Fiona
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- family: Dowell
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given: Anthony
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da: '2023-09-28'
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doi: 10.1371/journal.pmed.1002897
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eissn: 1549-1676
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files: []
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issn: 1549-1277
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journal: PLOS MEDICINE
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keywords-plus: MULTIPLE IMPUTATION
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language: English
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month: SEP
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number: '9'
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number-of-cited-references: '35'
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orcid-numbers: 'Abbott, J. Haxby/0000-0001-6468-7284
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Wilson, Ross/0000-0001-8505-8081
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Dean, Sarah/0000-0002-3682-5149
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Darlow, Ben/0000-0002-6248-6814'
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papis_id: 23b1c64f7c7488c24ffdee7dfb3b113f
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ref: Darlow2019fearreduction
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researcherid-numbers: 'Abbott, J. Haxby/AAK-4346-2020
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Wilson, Ross/AAH-3161-2019
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Darlow, Ben/N-9905-2013'
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times-cited: '16'
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title: 'The Fear Reduction Exercised Early (FREE) approach to management of low back
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pain in general practice: A pragmatic cluster-randomised controlled trial'
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type: article
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unique-id: WOS:000559715700001
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usage-count-last-180-days: '0'
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usage-count-since-2013: '1'
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volume: '16'
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web-of-science-categories: Medicine, General \& Internal
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year: '2019'
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