Dataset Information

Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial.

ABSTRACT:

Background

Back pain remains a challenge for primary care internationally. One model that has not been tested is stratification of the management according to the patient's prognosis (low, medium, or high risk). We compared the clinical effectiveness and cost-effectiveness of stratified primary care (intervention) with non-stratified current best practice (control).

Methods

1573 adults (aged ?18 years) with back pain (with or without radiculopathy) consultations at ten general practices in England responded to invitations to attend an assessment clinic. Eligible participants were randomly assigned by use of computer-generated stratified blocks with a 2:1 ratio to intervention or control group. Primary outcome was the effect of treatment on the Roland Morris Disability Questionnaire (RMDQ) score at 12 months. In the economic evaluation, we focused on estimating incremental quality-adjusted life years (QALYs) and health-care costs related to back pain. Analysis was by intention to treat. This study is registered, number ISRCTN37113406.

Findings

851 patients were assigned to the intervention (n=568) and control groups (n=283). Overall, adjusted mean changes in RMDQ scores were significantly higher in the intervention group than in the control group at 4 months (4·7 [SD 5·9] vs 3·0 [5·9], between-group difference 1·81 [95% CI 1·06-2·57]) and at 12 months (4·3 [6·4] vs 3·3 [6·2], 1·06 [0·25-1·86]), equating to effect sizes of 0·32 (0·19-0·45) and 0·19 (0·04-0·33), respectively. At 12 months, stratified care was associated with a mean increase in generic health benefit (0·039 additional QALYs) and cost savings (£240·01 vs £274·40) compared with the control group.

Interpretation

The results show that a stratified approach, by use of prognostic screening with matched pathways, will have important implications for the future management of back pain in primary care.

Funding

Arthritis Research UK.

SUBMITTER: Hill JC

PROVIDER: S-EPMC3208163 | biostudies-literature | 2011 Oct

REPOSITORIES: biostudies-literature

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Publications

Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial.

Hill Jonathan C JC Whitehurst David G T DG Lewis Martyn M Bryan Stirling S Dunn Kate M KM Foster Nadine E NE Konstantinou Kika K Main Chris J CJ Mason Elizabeth E Somerville Simon S Sowden Gail G Vohora Kanchan K Hay Elaine M EM

Lancet (London, England) 20110928 9802

<h4>Background</h4>Back pain remains a challenge for primary care internationally. One model that has not been tested is stratification of the management according to the patient's prognosis (low, medium, or high risk). We compared the clinical effectiveness and cost-effectiveness of stratified primary care (intervention) with non-stratified current best practice (control).<h4>Methods</h4>1573 adults (aged ≥18 years) with back pain (with or without radiculopathy) consultations at ten general pra ...[more]

PMID: 21963002

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Project description:BackgroundEvidence generated from reliable research is not frequently implemented into clinical practice. Evidence-based clinical practice guidelines are a potential vehicle to achieve this. A recent systematic review of implementation strategies of guideline dissemination concluded that there was a lack of evidence regarding effective strategies to promote the uptake of guidelines. Recommendations from this review, and other studies, have suggested the use of interventions that are theoretically based because these may be more effective than those that are not. An evidence-based clinical practice guideline for the management of acute low back pain was recently developed in Australia. This provides an opportunity to develop and test a theory-based implementation intervention for a condition which is common, has a high burden, and for which there is an evidence-practice gap in the primary care setting.AimThis study aims to test the effectiveness of a theory-based intervention for implementing a clinical practice guideline for acute low back pain in general practice in Victoria, Australia. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of patients who are referred for a plain x-ray, and improving mean level of disability for patients three months post-consultation.Methods/designThis study protocol describes the details of a cluster randomised controlled trial. Ninety-two general practices (clusters), which include at least one consenting general practitioner, will be randomised to an intervention or control arm using restricted randomisation. Patients aged 18 years or older who visit a participating practitioner for acute non-specific low back pain of less than three months duration will be eligible for inclusion. An average of twenty-five patients per general practice will be recruited, providing a total of 2,300 patient participants. General practitioners in the control arm will receive access to the guideline using the existing dissemination strategy. Practitioners in the intervention arm will be invited to participate in facilitated face-to-face workshops that have been underpinned by behavioural theory. Investigators (not involved in the delivery of the intervention), patients, outcome assessors and the study statistician will be blinded to group allocation.

Project description:BACKGROUND:Low back pain (LBP) is a common cause of contact with the primary healthcare sector. In some patients, symptoms quickly resolve, but others develop long-lasting pain and disability. To improve the care pathway for patients with LBP, the STarT Back Tool (STarT) questionnaire has been developed. It helps initial decision-making by subgrouping patients on the basis of their prognosis and helps to target treatment according to prognosis. An assumption behind the use of STarT is the ability to predict functional improvement. This assumption has never been tested in a population that consists exclusively of patients enrolled when consulting a Danish general practitioner for LBP. The aim of this study was to investigate STarT's ability to predict a 30% improvement in the Roland Morris Disability Questionnaire (RMDQ) score. METHODS:This was an ancillary analysis using data from a Danish guideline implementation study (registered at ClinicalTrials.gov NCT01699256). An inclusion criterion was age 18 to 65 years of age. Exclusion criteria were pregnancy, fractures, and signs of underlying pathology. Patient-reported STarT score and the Roland Morris Disability Questionnaire were administered at baseline and again after 4, 8, and 52 weeks. RESULTS:Between January 2013 and July 2014, 475 patients from the original trial participated with questionnaires. From this subpopulation, 441 (92.8%) patients provided information regarding STarT. Baseline and eight-week RMDQ data were available for 304 (64.0%) patients. After 8 weeks, 61 (65.6%) in the low-risk group, 67 (54.9%) in the medium-risk group, and 33 (37.1%) in the high-risk group had achieved a 30% improvement in the RMDQ score. After 8 weeks, high-risk patients were at 61% (95% CI: 20-125%, P < 0.001) higher risk of not achieving a 30% improvement in the RMDQ score compared with patients in either the low-risk group or the medium-risk group. CONCLUSION:STarT was predictive for functional improvement in patients from general practice with LBP. TRIAL REGISTRATION:ClinicalTrials.gov NCT01699256 , Nov 29, 2016 (registered retrospectively).

Project description:BackgroundAnkle sprains are the most commonly reported injury in netball. Approximately four in five netball athletes will sustain an ankle sprain, up to half will go on to sustain recurrent ankle sprains, and nine in ten report perceived ankle instability. Historically, prevention and management strategies of ankle sprains and injuries have been investigated for a variety of sports, however, no literature reviews have investigated these in netball athletes, or compared these with current best-practice within the literature. Therefore, this scoping review aims to understand how netball athletes currently prevent and manage ankle sprains and to compare these approaches with best-practice recommendations.MethodsA literature search was conducted using MEDLINE, CINAHL, and SPORTDiscus databases using keywords to capture studies with data or information related to the prevention and management of ankle sprains and injuries in netball.ResultsThe search strategy captured 982 studies across all databases, with 30 netball studies included in this scoping review. Studies suggest netball athletes are not commonly referred to health professionals, do not undertake adequate rehabilitation, and almost immediately return to court following an ankle sprain or injury. Current best-practices suggest injury prevention programs and external ankle support effectively reduce ankle sprains and injuries; however, poor compliance and implementation may be a significant barrier. Currently, there is a lack of evidence that netball-specific footwear reduces the risk of ankle sprains.ConclusionThe findings suggest netball athletes do not implement current best-practice prevention and management strategies following an ankle sprain. This is despite evidence of the effectiveness of injury prevention programs, external ankle support, and adequate rehabilitation in reducing ankle sprain rates. Current-best practice prevention and management of ankle sprains should be considered by clinicians, coaches, and athletes to reduce the prevalence and chronicity of ankle sprains in netball.

Project description:BackgroundEffective 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 findingsThis 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.ConclusionsFindings 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.Trial registrationACTRN12616000888460.

Project description:ObjectiveTo evaluate the effectiveness of transcranial direct current stimulation alone and in combination with cognitive behavioural management in patients with non-specific chronic low back pain.DesignDouble blind parallel group randomised controlled trial with six months' follow-up conducted May 2011-March 2013. Participants, physiotherapists, assessors, and analyses were blinded to group allocation.SettingInterdisciplinary chronic pain centre.Participants135 participants with non-specific chronic low back pain >12 weeks were recruited from 225 patients assessed for eligibility.InterventionParticipants were randomised to receive anodal (20 minutes to motor cortex at 2 mA) or sham transcranial direct current stimulation (identical electrode position, stimulator switched off after 30 seconds) for five consecutive days immediately before cognitive behavioural management (four week multidisciplinary programme of 80 hours).Main outcomes measuresTwo primary outcome measures of pain intensity (0-100 visual analogue scale) and disability (Oswestry disability index) were evaluated at two primary endpoints after stimulation and after cognitive behavioural management.ResultsAnalyses of covariance with baseline values (pain or disability) as covariates showed that transcranial direct current stimulation was ineffective for the reduction of pain (difference between groups on visual analogue scale 1 mm (99% confidence interval -8.69 mm to 6.3 mm; P=0.68)) and disability (difference between groups 1 point (-1.73 to 1.98; P=0.86)) and did not influence the outcome of cognitive behavioural management (difference between group 3 mm (-10.32 mm to 6.73 mm); P=0.58; difference between groups on Oswestry disability index 0 point (-2.45 to 2.62); P=0.92). The stimulation was well tolerated with minimal transitory side effects.ConclusionsThis results of this trial on the effectiveness of transcranial direct current stimulation for the reduction of pain and disability do not support its clinical use for managing non-specific chronic low back pain.Trial registration Current controlled trials ISRCTN89874874.

Dataset Information

Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial.

Background

Methods

Findings

Interpretation

Funding

Publications

Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial.

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