wow-inequalities/02-data/intermediate/wos_sample/a85ba518af76aa8245b354e02395d75d-darlow-ben-and-stan/info.yaml

abstract: 'Background

  Effective and cost-effective primary care treatments for low back pain

  (LBP) are required to reduce the burden of the world''s most disabling

  condition. This study aimed to compare the clinical effectiveness and

  cost-effectiveness of the Fear Reduction Exercised Early (FREE) approach

  to LBP (intervention) with usual general practitioner (GP) care

  (control).

  Methods and findings

  This pragmatic, cluster-randomised controlled trial with process

  evaluation and parallel economic evaluation was conducted in the Hutt

  Valley, New Zealand. Eight general practices were randomly assigned

  (stratified by practice size) with a 1:1 ratio to intervention (4

  practices; 34 GPs) or control group (4 practices; 29 GPs). Adults

  presenting to these GPs with LBP as their primary complaint were

  recruited. GPs in the intervention practices were trained in the FREE

  approach, and patients presenting to these practices received care based

  on the FREE approach. The FREE approach restructures LBP consultations

  to prioritise early identification and management of barriers to

  recovery. GPs in control practices did not receive specific training for

  this study, and patients presenting to these practices received usual

  care. Between 23 September 2016 and 31 July 2017, 140 eligible patients

  presented to intervention practices (126 enrolled) and 110 eligible

  patients presented to control practices (100 enrolled). Patient mean age

  was 46.1 years (SD 14.4), and 46\% were female. The duration of LBP was

  less than 6 weeks in 88\% of patients. Primary outcome was change from

  baseline in patient participant Roland Morris Disability Questionnaire

  (RMDQ) score at 6 months. Secondary patient outcomes included pain,

  satisfaction, and psychosocial indices. GP outcomes included attitudes,

  knowledge, confidence, and GP LBP management behaviour. There was active

  and passive surveillance of potential harms. Patients and outcome

  assessors were blind to group assignment. Analysis followed

  intention-to-treat principles. A total of 122 (97\%) patients from 32

  GPs in the intervention group and 99 (99\%) patients from 25 GPs in the

  control group were included in the primary outcome analysis. At 6

  months, the groups did not significantly differ on the primary outcome

  (adjusted mean RMDQ score difference 0.57, 95\% CI - 0.64 to 1.78; p =

  0.354) or secondary patient outcomes. The RMDQ difference met the

  predefined criterion to indicate noninferiority. One control group

  participant experienced an activity-related gluteal tear, with no other

  adverse events recorded. Intervention group GPs had improvements in

  attitudes, knowledge, and confidence compared with control group GPs.

  Intervention group GP LBP management behaviour became more guideline

  concordant than the control group. In cost-effectiveness, the

  intervention dominated control with lower costs and higher

  QualityAdjusted Life Year (QALY) gains. Limitations of this study were

  that although adequately powered for primary outcome assessment, the

  study was not powered for evaluating some employment, healthcare use,

  and economic outcomes. It was also not possible for research nurses

  (responsible for patient recruitment) to be masked on group allocation

  for practices.

  Conclusions

  Findings from this study suggest that the FREE approach improves GP

  concordance with LBP guideline recommendations but does not improve

  patient recovery outcomes compared with usual care. The FREE approach

  may reduce unnecessary healthcare use and produce economic benefits.

  Work participation or health resource use should be considered for

  primary outcome assessment in future trials of undifferentiated LBP.'
affiliation: 'Darlow, B (Corresponding Author), Univ Otago, Dept Primary Hlth Care
  \& Gen Practice, Wellington, New Zealand.

  Darlow, Ben; Garrett, Sue; Dowell, Anthony, Univ Otago, Dept Primary Hlth Care \&
  Gen Practice, Wellington, New Zealand.

  Stanley, James, Univ Otago, Biostat Grp, Wellington, New Zealand.

  Dean, Sarah, Univ Exeter, Med Sch, Coll Med \& Hlth, Exeter, Devon, England.

  Abbott, J. Haxby; Wilson, Ross, Univ Otago, Dept Surg Sci, Dunedin, New Zealand.

  Mathieson, Fiona, Univ Otago, Dept Psychol Med, Wellington, New Zealand.'
article-number: e1002897
author: Darlow, Ben and Stanley, James and Dean, Sarah and Abbott, J. Haxby and Garrett,
  Sue and Wilson, Ross and Mathieson, Fiona and Dowell, Anthony
author-email: ben.darlow@otago.ac.nz
author_list:
- family: Darlow
  given: Ben
- family: Stanley
  given: James
- family: Dean
  given: Sarah
- family: Abbott
  given: J. Haxby
- family: Garrett
  given: Sue
- family: Wilson
  given: Ross
- family: Mathieson
  given: Fiona
- family: Dowell
  given: Anthony
da: '2023-09-28'
doi: 10.1371/journal.pmed.1002897
eissn: 1549-1676
files: []
issn: 1549-1277
journal: PLOS MEDICINE
keywords-plus: MULTIPLE IMPUTATION
language: English
month: SEP
number: '9'
number-of-cited-references: '35'
orcid-numbers: 'Abbott, J. Haxby/0000-0001-6468-7284

  Wilson, Ross/0000-0001-8505-8081

  Dean, Sarah/0000-0002-3682-5149

  Darlow, Ben/0000-0002-6248-6814'
papis_id: 23b1c64f7c7488c24ffdee7dfb3b113f
ref: Darlow2019fearreduction
researcherid-numbers: 'Abbott, J. Haxby/AAK-4346-2020

  Wilson, Ross/AAH-3161-2019

  Darlow, Ben/N-9905-2013'
times-cited: '16'
title: 'The Fear Reduction Exercised Early (FREE) approach to management of low back
  pain in general practice: A pragmatic cluster-randomised controlled trial'
type: Article
unique-id: WOS:000559715700001
usage-count-last-180-days: '0'
usage-count-since-2013: '1'
volume: '16'
web-of-science-categories: Medicine, General \& Internal
year: '2019'