Jonathan C. Hill

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

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 patients 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.

A primary care back pain screening tool: identifying patient subgroups for initial treatment.

OBJECTIVE To develop and validate a tool that screens for back pain prognostic indicators relevant to initial decision making in primary care. METHODS The setting was UK primary care adults with nonspecific back pain. Constructs that were independent prognostic indicators for persistence were identified from secondary analysis of 2 existing cohorts and published literature. Receiver operating characteristic curve analysis identified single screening questions for relevant constructs. Psychometric properties of the tool, including concurrent and discriminant validity, internal consistency, and repeatability, were assessed within a new development sample (n = 131) and tool score cutoffs were established to enable allocation to 3 subgroups (low, medium, and high risk). Predictive and external validity were evaluated within an independent external sample (n = 500). RESULTS The tool included 9 items: referred leg pain, comorbid pain, disability (2 items), bothersomeness, catastrophizing, fear, anxiety, and depression. The latter 5 items were identified as a psychosocial subscale. The tool demonstrated good reliability and validity and was acceptable to patients and clinicians. Patients scoring 0-3 were classified as low risk, and those scoring 4 or 5 on a psychosocial subscale were classified as high risk. The remainder were classified as medium risk. CONCLUSION We validated a brief screening tool, which is a promising instrument for identifying subgroups of patients to guide the provision of early secondary prevention in primary care. Further work will establish whether allocation to treatment subgroups using the tool, linked with targeting treatment appropriately, improves patient outcomes.

Acupuncture as an adjunct to exercise based physiotherapy for osteoarthritis of the knee: randomised controlled trial.

Objective To investigate the benefit of adding acupuncture to a course of advice and exercise delivered by physiotherapists for pain reduction in patients with osteoarthritis of the knee. Design Multicentre, randomised controlled trial. Setting 37 physiotherapy centres accepting primary care patients referred from general practitioners in the Midlands, United Kingdom. Participants 352 adults aged 50 or more with a clinical diagnosis of knee osteoarthritis. Interventions Advice and exercise (n=116), advice and exercise plus true acupuncture (n=117), and advice and exercise plus non-penetrating acupuncture (n=119). Main outcome measures The primary outcome was change in scores on the Western Ontario and McMaster Universities osteoarthritis index pain subscale at six months. Secondary outcomes included function, pain intensity, and unpleasantness of pain at two weeks, six weeks, six months, and 12 months. Results Follow-up rate at six months was 94%. The mean (SD) baseline pain score was 9.2 (3.8). At six months mean reductions in pain were 2.28 (3.8) for advice and exercise, 2.32 (3.6) for advice and exercise plus true acupuncture, and 2.53 (4.2) for advice and exercise plus non-penetrating acupuncture. Mean differences in change scores between advice and exercise alone and each acupuncture group were 0.08 (95% confidence interval −1.0 to 0.9) for advice and exercise plus true acupuncture and 0.25 (−0.8 to 1.3) for advice and exercise plus non-penetrating acupuncture. Similar non-significant differences were seen at other follow-up points. Compared with advice and exercise alone there were small, statistically significant improvements in pain intensity and unpleasantness at two and six weeks for true acupuncture and at all follow-up points for non-penetrating acupuncture. Conclusion The addition of acupuncture to a course of advice and exercise for osteoarthritis of the knee delivered by physiotherapists provided no additional improvement in pain scores. Small benefits in pain intensity and unpleasantness were observed in both acupuncture groups, making it unlikely that this was due to acupuncture needling effects. Trial registration Current Controlled Trials ISRCTN88597683.

Subgrouping low back pain: A comparison of the STarT Back Tool with the Örebro Musculoskeletal Pain Screening Questionnaire

Introduction Clinicians require brief, practical tools to help identify low back pain (LBP) subgroups requiring early, targeted secondary prevention. The STarT Back Tool (SBT) was recently validated to subgroup LBP patients into early treatment pathways.

Psychosocial Influences on Low Back Pain, Disability, and Response to Treatment

Evidence suggests that psychosocial factors have an influence on the outcome of physical therapy treatment and that the extent of their influence differs considerably among patients. As a consequence, substantial research efforts are focused on developing new clinical tools designed to identify and highlight when psychosocial factors are present at a level relevant to decision making. The conceptual differences in the ways that psychosocial factors influence outcome are described, structured around 3 common research terms: (1) prognostic factors, (2) treatment effect modifiers or moderators, and (3) treatment mediators. Prognostic factors are those characteristics that help estimate a patients likely outcome irrespective of the chosen management. Treatment effect modifiers or moderators are factors measured at baseline that influence the relationship between a specific intervention and outcome. Treatment mediators are factors that have an intermediary role in the link between treatment and outcome. How these different influences on outcome can be translated into useful and complementary tools that aim to reduce treatment variability in clinical practice is described. One approach is to use prognostic factors to develop screening tools that identify an individuals risk status, typically based on predictive psychosocial factors such as catastophizing and depression. Another approach is to identify specific treatment effect modifiers to derive treatment decision aids or prediction rules to help match a patients characteristics to the interventions available. A third approach is to use treatment mediators (eg, self-efficacy) to develop monitoring tools to inform the clinician about which aspects of treatment to strengthen.

Effect of stratified care for low back pain in family practice (IMPaCT Back): a prospective population-based sequential comparison.

PURPOSE We aimed to determine the effects of implementing risk-stratified care for low back pain in family practice on physician’s clinical behavior, patient outcomes, and costs. METHODS The IMPaCT Back Study (IMplementation to improve Patient Care through Targeted treatment) prospectively compared separate patient cohorts in a preintervention phase (6 months of usual care) and a postintervention phase (12 months of stratified care) in family practice, involving 64 family physicians and linked physical therapy services. A total of 1,647 adults with low back pain were invited to participate. Stratified care entailed use of a risk stratification tool to classify patients into groups at low, medium, or high risk for persistent disability and provision of risk-matched treatment. The primary outcome was 6-month change in disability as assessed with the Roland-Morris Disability Questionnaire. Process outcomes captured physician behavior change in risk-appropriate referral to physical therapy, diagnostic tests, medication prescriptions, and sickness certifications. A cost-utility analysis estimated incremental quality-adjusted life-years and back-related health care costs. Analysis was by intention to treat. RESULTS The 922 patients studied (368 in the preintervention phase and 554 in the postintervention phase) had comparable baseline characteristics. At 6 months follow-up, stratified care had a small but significant benefit relative to usual care as seen from a mean difference in Roland-Morris Disability Questionnaire scores of 0.7 (95% CI, 0.1–1.4), with a large, clinically important difference in the high risk group of 2.3 (95% CI, 0.8–3.9). Mean time off work was 50% shorter (4 vs 8 days, P = .03) and the proportion of patients given sickness certifications was 30% lower (9% vs 15%, P = .03) in the postintervention cohort. Health care cost savings were also observed. CONCLUSIONS Stratified care for back pain implemented in family practice leads to significant improvements in patient disability outcomes and a halving in time off work, without increasing health care costs. Wider implementation is recommended.

A randomised clinical trial of subgrouping and targeted treatment for low back pain compared with best current care. The STarT Back Trial Study Protocol

BackgroundBack pain is a major health problem and many sufferers develop persistent symptoms. Detecting relevant subgroups of patients with non-specific low back pain has been highlighted as a priority area for research, as this could enable better secondary prevention through the targeting of prognostic indicators for persistent, disabling symptoms. We plan to conduct a randomised controlled trial to establish whether subgrouping using a novel tool, combined with targeted treatment, is better than best current care at reducing long-term disability from low back pain.Methods/DesignWe will recruit 800 participants aged 18 years and over with non-specific low back pain from 8–10 GP practices within two Primary Care Trusts in Staffordshire, England. Our primary outcome measures are low back pain disability and catastrophising. Secondary outcomes include back pain intensity, global change, leg pain, fear avoidance, anxiety, depression, illness perceptions, patient satisfaction, overall health status and cost-effectiveness. Data will be collected before randomisation, and 4 and 12 months later. Participants are randomised to receive either newly developed interventions, delivered by trained physiotherapists and targeted according to subgroups defined by tool scores, or best current care.DiscussionThis paper presents detail on the rationale, design, methods and operational aspects of the trial.Trial registrationCurrent Controlled Trials ISRCTN37113406.

The Knee Clinical Assessment Study – CAS(K). A prospective study of knee pain and knee osteoarthritis in the general population

BackgroundKnee pain affects an estimated 25% of the adult population aged 50 years and over. Osteoarthritis is the most common diagnosis made in older adults consulting with knee pain in primary care. However, the relationship between this diagnosis and both the current disease-based definition of osteoarthritis and the regional pain syndrome of knee pain and disability is unclear. Expert consensus, based on current evidence, views the disease and the syndrome as distinct entities but the clinical usefulness of these two approaches to classifying knee pain in older adults has not been established. We plan to conduct a prospective, population-based, observational cohort study to investigate the relative merits of disease-based and regional pain syndrome-based approaches to classification and prognosis of knee pain in older adults.MethodsAll patients aged 50 years and over registered with three general practices in North Staffordshire will be invited to take part in a two-stage postal survey. Respondents to this survey phase who indicate that they have experienced knee pain within the previous 12 months will be invited to attend a research clinic for a detailed assessment. This will consist of clinical interview, physical examination, digital photography, plain x-rays, anthropometric measurement and a brief self-complete questionnaire. All consenting clinic attenders will be followed up by (i) general practice medical record review, (ii) repeat postal questionnaire at 18-months.

Comparing the Start Back Screening Tool's Subgroup Allocation of Individual Patients With That of Independent Clinical Experts

ObjectivesThe STarT Back Screening Tool (SBST) is validated to subgroup primary care patients with back pain into risk groups relevant to initial decision-making. However, it remains unclear how the tools allocation of individuals compares with subjective clinical decision-making. We evaluated agreement between clinicians and the SBSTs allocation to risk subgroups, and explored reasons for differences observed. MethodsTwelve primary care back pain patients underwent a video-recorded clinical assessment. The SBST was completed on the same day. Clinical experts (3 general practitioners, 3 physiotherapists, and 3 pain management specialists) individually reviewed the patient videos (4 each), blind to SBST allocation. Their task was to subgroup patients into low, medium, or high-risk groups. ResultsInterrater agreement between clinicians was “fair” (κ=0.28), with consistent allocation between experts in 4 of 12 patients. There was observed agreement with the SBST in 17 of 36 cases (47%) and Cohens weighted κ was 0.22, indicating fair agreement. Two reasons for differences emerged. Clinicians tailor their decisions according to patient expectations and demands for treatment and clinicians use knowledge of difficult life circumstances that may be unrelated back pain. DiscussionClinicians make inconsistent risk estimations for primary care patients with back pain when using intuition alone, with little agreement with a formal subgrouping tool. Unlike clinicians, the SBST could not make a sophisticated synthesis of patient preferences, expectations, and previous treatment history. Although acknowledging the limitations of back pain subgrouping tools, more research is needed to test whether their use improves consistency in primary care decision-making.

The Knee Clinical Assessment Study – CAS(K). A prospective study of knee pain and knee osteoarthritis in the general population: baseline recruitment and retention at 18 months

BackgroundSelective non-participation at baseline (due to non-response and non-consent) and loss to follow-up are important concerns for longitudinal observational research. We investigated these matters in the context of baseline recruitment and retention at 18 months of participants for a prospective observational cohort study of knee pain and knee osteoarthritis in the general population.MethodsParticipants were recruited to the Knee Clinical Assessment Study – CAS(K) – by a multi-stage process involving response to two postal questionnaires, consent to further contact and medical record review (optional), and attendance at a research clinic. Follow-up at 18-months was by postal questionnaire. The characteristics of responders/consenters were described for each stage in the recruitment process to identify patterns of selective non-participation and loss to follow-up. The external validity of findings from the clinic attenders was tested by comparing the distribution of WOMAC scores and the association between physical function and obesity with the same parameters measured directly in the target population as whole.Results3106 adults aged 50 years and over reporting knee pain in the previous 12 months were identified from the first baseline questionnaire. Of these, 819 consented to further contact, responded to the second questionnaire, and attended the research clinics. 776 were successfully followed up at 18 months. There was evidence of selective non-participation during recruitment (aged 80 years and over, lower socioeconomic group, currently in employment, experiencing anxiety or depression, brief episode of knee pain within the previous year). This did not cause significant bias in either the distribution of WOMAC scores or the association between physical function and obesity.ConclusionDespite recruiting a minority of the target population to the research clinics and some evidence of selective non-participation, this appears not to have resulted in significant bias of cross-sectional estimates. The main effect of non-participation in the current cohort is likely to be a loss of precision in stratum-specific estimates e.g. in those aged 80 years and over. The subgroup of individuals who attended the research clinics and who make up the CAS(K) cohort can be used to accurately estimate parameters in the reference population as a whole. The potential for selection bias, however, remains an important consideration in each subsequent analysis.