Advancing practice for back pain through stratified care (STarT Back)

BackgroundLow back pain (LBP) is common, however research comparing the effectiveness of different treatments over the last two decades conclude either no or small differences in the average effects of different treatments. One suggestion to explain this is that patients are not all the same and important subgroups exist that might require different treatment approaches. Stratified care for LBP involves identifying subgroups of patients and then delivering appropriate matched treatments. Research has shown that stratified care for LBP in primary care can improve clinical outcomes, reduce costs and increase the efficiency of health-care delivery in the UK. The challenge now is to replicate and evaluate this approach in other countries health care systems and to support services to implement it in routine clinical care.ResultsThe STarT Back approach to stratified care has been tested in the National Health Service, within the UK, it reduces unnecessary overtreatment in patients who have a good prognosis (those at low risk) yet increases the likelihood of appropriate healthcare and associated improved outcomes for those who are at risk of persistent disabling pain. The approach is cost-effective in the UK healthcare setting and has been recommended in recent guidelines and implemented as part of new LBP clinical pathways of care. This approach has subsequently generated international interest, a replication study is currently underway in Denmark, however, some lessons have already been learnt. There are potential obstacles to implementing stratified care in low-and-middle-income settings and in other high-income settings outside of the UK, however, implementation science literature can inform the development of innovations and efforts to support implementation of stratified care.ConclusionsThe STarT Back approach to stratified care for LBP is a promising method to advance practice that has demonstrated clinical and cost effectiveness in the UK. Over time, further evidence for both the effectiveness and the adaptations needed to test and implement the STarT Back stratified care approach in other countries is needed

Consensus on exercise reporting template (Cert): Modified delphi study

© 2016 American Physical Therapy Association. Background. Exercise interventions are often incompletely described in reports of clinical trials, hampering evaluation of results and replication and implementation into practice. Objective. The aim of this study was to develop a standardized method for reporting exercise programs in clinical trials: the Consensus on Exercise Reporting Template (CERT). Design and Methods. Using the EQUATOR Network’s methodological framework, 137 exercise experts were invited to participate in a Delphi consensus study. A list of 41 items was identified from a meta-epidemiologic study of 73 systematic reviews of exercise. For each item, participants indicated agreement on an 11-point rating scale. Consensus for item inclusion was defined a priori as greater than 70% agreement of respondents rating an item 7 or above. Three sequential rounds of anonymous online questionnaires and a Delphi workshop were used. Results. There were 57 (response rate=42%), 54 (response rate=95%), and 49 (response rate=91%) respondents to rounds 1 through 3, respectively, from 11 countries and a range of disciplines. In round 1, 2 items were excluded; 24 items reached consensus for inclusion (8 items accepted in original format), and 16 items were revised in response to participant suggestions. Of 14 items in round 2, 3 were excluded, 11 reached consensus for inclusion (4 items accepted in original format), and 7 were reworded. Sixteen items were included in round 3, and all items reached greater than 70% consensus for inclusion. Limitations. The views of included Delphi panelists may differ from those of experts who declined participation and may not fully represent the views of all exercise experts. Conclusions. The CERT, a 16-item checklist developed by an international panel of exercise experts, is designed to improve the reporting of exercise programs in all evaluative study designs and contains 7 categories: materials, provider, delivery, location, dosage, tailoring, and compliance. The CERT will encourage transparency, improve trial interpretation and replication, and facilitate implementation of effective exercise interventions into practice

The prognostic ability of the STarT Back Tool was affected by episode duration

Purpose: The prognostic ability of the STarT Back Tool (SBT) reportedly varies, but the factors affecting this are unclear. This study investigated the influences of care setting (chiropractic, GP, physiotherapy, spine centre), episode duration (0–2, 3–4, 4–12, > 12 weeks), and outcome time period (3, 6, 12 months) on SBT prognostic ability. Methods: This was a secondary analysis of data from three primary care cohorts [chiropractic (n = 416), GP (n = 265), and physiotherapy (n = 200) practices] and one cohort from a secondary care outpatient spine centre (n = 974) in Denmark. Care pathways were not systematically affected by SBT risk subgroup (non-stratified care). Using generalised estimating equations, we investigated statistical interactions between SBT risk subgroups and potentially influential factors on the prognostic ability of the SBT subgroups, when Roland Morris Disability Questionnaire scores were the outcome. Results: SBT risk subgroup, age, care setting, and episode duration were all independent prognostic factors. The only investigated factor that modified the prognostic ability of the SBT subgroups was episode duration. Conclusions: These results indicate that the prognostic ability of the SBT in these non-stratified care settings was unaffected by care setting on its own. However, the prognosis of patients is affected by diverse clinical characteristics that differ between patient populations, many of which are not assessed by the SBT. When controlling for some of those factors and testing potential interactions, the results showed that only episode duration affected the SBT prognostic ability and, specifically, that the SBT was less predictive in very acute patients ( < 2 weeks duration)

The effectiveness of a stratified care model for non-specific low back pain in Danish primary care compared to current practice: study protocol of a randomised controlled trial

Abstract Background Prior studies indicate that stratified care for low back pain results in better clinical outcome and reduced costs in healthcare compared to current practice. Stratified care may be associated with clinical benefits for patients with low back pain at a lower cost, but evidence is sparse. Hence this study aims to evaluate the clinical effects and cost-effectiveness of stratified care in patients with non-specific low back pain compared to current practice. Methods/design The study is a two-armed randomised controlled trial in primary care in the Regions of Southern and Central Denmark (2.5 million citizens). Patients with non-specific low back will be recruited by paticpating GPs. Patients are randomised to either (1) stratified care or (2) current practice at participating physiotherapy clinics. In the stratified care arm, the intervention is based on the patient’s STarT Back Tool classification and trained accordingly, whereas physiotherapists in the current pratice arm are blinded to the STarT score. Primary outcomes in the trial will be group differences in time off work, improvement in LBP disability measured by the Roland Morris Disability Questionnaire (RMDQ) and patient-reported global change. Secondary measures will be pain intensity, patient satisfaction, data on patient healthcare resource utilisation and quality-adjusted life year based on the EQ-5D-5L. Discussion Stratified care that effectively targets treatment to relevant sub-groups of patients has potentially great impact on the treatment pathways of low back pain. Thus, if effective, this could result in better patient outcomes and at the same time reduce the costs for treatment of low back pain. Trial registration ClinicalTrials.gov, NCT02612467. Registered on 16 November 2015

The effectiveness of a stratified care model for non-specific low back pain in Danish primary care compared to current practice: study protocol of a randomised controlled trial

Abstract Background Prior studies indicate that stratified care for low back pain results in better clinical outcome and reduced costs in healthcare compared to current practice. Stratified care may be associated with clinical benefits for patients with low back pain at a lower cost, but evidence is sparse. Hence this study aims to evaluate the clinical effects and cost-effectiveness of stratified care in patients with non-specific low back pain compared to current practice. Methods/design The study is a two-armed randomised controlled trial in primary care in the Regions of Southern and Central Denmark (2.5 million citizens). Patients with non-specific low back will be recruited by paticpating GPs. Patients are randomised to either (1) stratified care or (2) current practice at participating physiotherapy clinics. In the stratified care arm, the intervention is based on the patient’s STarT Back Tool classification and trained accordingly, whereas physiotherapists in the current pratice arm are blinded to the STarT score. Primary outcomes in the trial will be group differences in time off work, improvement in LBP disability measured by the Roland Morris Disability Questionnaire (RMDQ) and patient-reported global change. Secondary measures will be pain intensity, patient satisfaction, data on patient healthcare resource utilisation and quality-adjusted life year based on the EQ-5D-5L. Discussion Stratified care that effectively targets treatment to relevant sub-groups of patients has potentially great impact on the treatment pathways of low back pain. Thus, if effective, this could result in better patient outcomes and at the same time reduce the costs for treatment of low back pain. Trial registration ClinicalTrials.gov, NCT02612467. Registered on 16 November 2015

The predictive ability of the STarT Back Screening Tool in a Danish secondary care setting

Introduction: The predictive ability of the STarT Back Tool (SBT) in secondary care settings has not been investigated. The aim of this study was to determine the SBT's predictive ability in a Danish secondary care setting and compare this to a Danish primary care setting. Methods: Poor clinical outcome at 6 months ( < 30 points on a 0-100 Roland Morris Disability Scale) was calculated in secondary care (n = 960) and primary care (n = 172) cohorts. The cohorts were stratified into SBT subgroups and estimates of additional risk for poor outcome were calculated [relative risk (RR), unadjusted and adjusted odds ratios]. The discriminative ability was determined using the area under the curve statistic. Results: In secondary care 69.0% and in primary care 40.2% had poor outcome on activity limitation. Although significant, the predictive ability of the SBT in secondary care (medium-risk RR 1.5, high-risk RR 1.7) was not as strong as in primary care (medium-risk RR 2.3, high-risk RR 3.5). Adjusting for episode duration and pain intensity only changed the predictive ability marginally in secondary care. The discriminative ability of the SBT was similar in both cohorts despite differences in the predictive ability. Conclusion The SBT had less predictive ability in a Danish secondary care setting compared to a Danish primary care setting for persistent activity limitation at 6 months follow-up. SBT-targeted treatment implications in secondary care were not investigated in this study

Consensus on Exercise Reporting Template (CERT) : A Modified Delphi Study

BACKGROUND: Exercise interventions are often incompletely described in reports of clinical trials hampering evaluation of results and replication and implementation into practice. OBJECTIVE: To develop a standardized method for reporting exercise programs in clinical trials, the Consensus on Exercise Reporting Template (CERT). DESIGN AND METHODS: Using the EQUATOR Network's methodological framework we invited 137 exercise experts to participate in a Delphi consensus study. A list of 41 items was identified from a meta-epidemiologic study of 73 systematic reviews of exercise. For each item, participants indicated agreement on an 11-point rating scale. Consensus for item inclusion was defined a priori as greater than 70% agreement of respondents rating an item seven or above. We used three sequential rounds of anonymous online questionnaires and a Delphi workshop. RESULTS: There were 57 (response rate 42%), 54 and 49 respondents to Rounds 1-3 respectively from 11 countries and a range of disciplines. In Round One, two items were excluded; 24 items reached consensus for inclusion (eight items in original format); and 16 items revised in response to participant suggestions. Of 14 items in Round Two, three were excluded; 11 reached consensus for inclusion (four items accepted in original format); and seven reworded. Sixteen items were included in Round Three and all items reached greater than 70% consensus for inclusion. CONCLUSIONS: The CERT, a 16-item checklist developed by an international panel of exercise experts, is designed to improve the reporting of exercise programs in all evaluative study designs and contains seven categories: materials, provider, delivery, location, dosage, tailoring, and compliance. The CERT will encourage transparency, improve trial interpretation and replication and facilitate implementation of effective exercise interventions into practice