DOI: 10.5061/dryad.4t375b2
title: Data from: The Fear Reduction Exercised Early (FREE) approach to management of low back pain in general practice: a pragmatic cluster-randomised controlled trial

description: 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
 Quality-Adjusted 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.
description: Main patient outcome
 dataMain patient outcome
 data (at baseline [immediately prior to GP appointment], 2 weeks, 6 weeks,
 12 weeks and 26 weeks) See Readme file (attached to this item) and data
 dictionary (separate item).FREE_Patient_Outcome_Data_v1_0.csvData Dictionary: for Main patient outcome dataFREE_Patient_Outcome_DataDictionary_v1_0.csvMain GP outcome dataMain GP outcome data (at baseline [immediately pre-training for intervention group], 4 weeks [post-training but prior to patient recruitment], and 16 weeks [towards end of patient recruitment]) See Readme file (attached to this item) and data dictionary (separate item).FREE_GP_Outcome_Data_v1_0.csvData Dictionary: for GP outcome dataFREE_GP_Outcome_DataDictionary_v1_0.csvPost-appointment data for PatientsInformation on the patient's appointment with the GP, as (a) reported by the patient immediately post-appointment, and (b) coded from notes kept in the Patient Management System. See ReadMe for more detail.FREE_Patient_PostApptAll_Data_v1_0.csvData Dictionary: Post-appointment data for PatientsFREE_Patient_PostApptAll_DataDictionary_v1_0.csv