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

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          Summary

          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.

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          Most cited references37

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          Low back pain: what is the long-term course? A review of studies of general patient populations.

          Charlotte Leboeuf-Yde, Lise Hestbaek, Claus Manniche (2003)
          It is often claimed that up to 90% of low back pain (LBP) episodes resolve spontaneously within 1 month. However, the literature in this area is confusing due to considerable variations regarding the exact definitions of LBP as well as recovery. Therefore, the claim--attractive as it might be to some--may not reflect reality. In order to investigate the long-term course of incident and prevalent cases of LBP, a systematic and critical literature review was undertaken. A comprehensive search of the topic was carried out utilizing both Medline and EMBASE databases. The Cochrane Library and the Danish Article Base were also screened. Journal articles following the course of LBP without any known intervention were included, regardless of study type. However, the population had to be representative of the general patient population and a follow-up of at least 12 months was a requirement. Data were extracted independently by two reviewers using a standard check list. The included articles were also independently assessed for quality by the same two reviewers before they were studied in relation to the course of LBP using various definitions of recovery. Thirty-six articles were included. The results of the review showed that the reported proportion of patients who still experienced pain after 12 months was 62% on average (range 42-75%), the percentage of patients sick-listed 6 months after inclusion into the study was 16% (range 3-40%), the percentage who experienced relapses of pain was 60% (range 44-78%), and the percentage who had relapses of work absence was 33% (range 26-37%). The mean reported prevalence of LBP in cases with previous episodes was 56% (range 14-93%), which compared with 22% (range 7-39%) for those without a prior history of LBP. The risk of LBP was consistently about twice as high for those with a history of LBP. The results of the review show that, despite the methodological variations and the lack of comparable definitions, the overall picture is that LBP does not resolve itself when ignored. Future research should include subgroup analyses and strive for a consensus regarding the precise definitions of LBP.
          Article 0 comments Cited 127 times – based on 0 reviews     Review now
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            Responsiveness of functional status in low back pain: a comparison of different instruments.

            A Beurskens, H. C. W. de Vet, A Köke (1996)
            This study compares the responsiveness of three instruments of functional status: two disease-specific questionnaires (Oswestry and Roland Disability Questionnaires), and a patient-specific method (severity of the main complaint). We compared changes over time of functional status instruments with pain rated on a visual analog scale. Two strategies for evaluating the responsiveness in terms of sensitivity to change and specificity to change were used: effect size statistics and receiver-operating characteristic method. We chose global perceived effect as external criterion. A cohort of 81 patients with non-specific low back pain for at least 6 weeks assessed these measures before and after 5 weeks of treatment. According to the external criterion 38 patients improved. The results of both strategies were the same. All instruments were able to discriminate between improvement and non-improvement. The effect size statistics of the instruments were higher in the improved group than in the non-improved group. For each instrument the receiver-operating characteristic curves showed some discriminative ability. The curves for the Roland Questionnaire and pain were closer to the upper left than the curves for the other instruments. The sensitivity to change of the rating of Oswestry Questionnaire was lower than that of the other instruments. The main complaint was not very specific to change. The two strategies for evaluating the responsiveness were very useful and appeared to complement each other.
            Article 0 comments Cited 102 times – based on 0 reviews     Review now
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              Prognosis and prognostic research: application and impact of prognostic models in clinical practice.

              Doug G. Altman, Patrick Royston, K. G. M. Moons … (2008)
              Article 0 comments Cited 98 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Jonathan C Hill
                Journal
                Journal ID (nlm-ta): Lancet
                Journal ID (iso-abbrev): Lancet
                Title: Lancet
                Publisher: Lancet Publishing Group
                ISSN (Print): 0140-6736
                ISSN (Electronic): 1474-547X
                Publication date PMC-release: 29 October 2011
                Publication date (Print): 29 October 2011
                Volume: 378
                Issue: 9802
                Pages: 1560-1571
                Affiliations
                [a ]Arthritis Research UK Primary Care Centre, Primary Care Sciences, Keele University, Stoke-on-Trent, UK
                [b ]School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada
                [c ]Centre for Clinical Epidemiology and Evaluation, Vancouver Coastal Health Research Institute, Vancouver, BC, Canada
                Author notes
                [* ]Correspondence to: Dr Jonathan C Hill, Arthritis Research UK Primary Care Centre, Primary Care Sciences, Keele University, Keele, ST5 5BG, UK j.hill@ 123456cphc.keele.ac.uk
                Article
                Publisher ID: LANCET60937
                DOI: 10.1016/S0140-6736(11)60937-9
                PMC ID: 3208163
                PubMed ID: 21963002
                SO-VID: c4e25e9b-eadb-48bf-8cfe-d676af802ce5
                Copyright © © 2011 Elsevier Ltd. All rights reserved.
                License:

                This document may be redistributed and reused, subject to certain conditions.

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                ScienceOpen disciplines: Medicine

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