The clinical and cost-effectiveness of stratified care for patients with sciatica: the SCOPiC randomised controlled trial protocol (ISRCTN75449581).

BACKGROUND: Sciatica has a substantial impact on patients, and is associated with high healthcare and societal costs. Although there is variation in the clinical management of sciatica, the current model of care usually involves an initial period of 'wait and see' for most patients, with simple measures of advice and analgesia, followed by conservative and/or more invasive interventions if symptoms fail to resolve. A model of care is needed that does not over-treat those with a good prognosis yet identifies patients who do need more intensive treatment to help with symptoms, and return to everyday function including work. The aim of the SCOPiC trial (SCiatica Outcomes in Primary Care) is to establish whether stratified care based on subgrouping using a combination of prognostic and clinical information, with matched care pathways, is more effective than non-stratified care, for improving time to symptom resolution in patients consulting with sciatica in primary care. We will also assess the impact of stratified care on service delivery and evaluate its cost-effectiveness compared to non-stratified care. METHODS/DESIGN: Multicentre, pragmatic, parallel arm randomised trial, with internal pilot, cost-effectiveness analysis and embedded qualitative study. We will recruit 470 adult patients with sciatica from general practices in England and Wales, over 24 months. Patients will be randomised to stratified care or non-stratified care, and treated in physiotherapy and spinal specialist services, in participating NHS services. The primary outcome is time to first resolution of sciatica symptoms, measured on a 6-point ordered categorical scale, collected using text messaging. Secondary outcomes include physical function, pain intensity, quality of life, work loss, healthcare use and satisfaction with treatment, and will be collected using postal questionnaires at 4 and 12-month follow-up. Semi-structured qualitative interviews with a subsample of participants and clinicians will explore the acceptability of stratified care. DISCUSSION: This paper presents the details of the rationale, design and processes of the SCOPiC trial. Results from this trial will contribute to the evidence base for management of patients with sciatica consulting in primary care. TRIAL REGISTRATION: ISRCTN75449581 , date: 20.11.2014.

Development of an assessment schedule for patients with low back-associated leg pain in primary care: a Delphi consensus study.

PURPOSE: The objectives of this study were to develop consensus on (i) the content of a clinical assessment for adults presenting to primary care with low back and leg pain, and (ii) the most important items for diagnosing spinal nerve root involvement. METHODS: Existing literature and expert knowledge was used to compile a list of items pertaining to clinical history questions and examination tests employed in the assessment of patients with low back pain with suspected spinal nerve involvement. A Delphi consensus method was employed to rate the importance of items for clinical assessment and for diagnosis in two web-based rounds. A multidisciplinary group of 42, including GPs, physiotherapists, osteopaths, rheumatologists, spinal orthopaedic surgeons and chiropractors took part. Items were included in the final assessment when over 70% of participants rated them as important. RESULTS: Thirty-four items were included in the clinical assessment, and 15 items for diagnosis. History items included pain distribution in the leg, pain quality and behaviour, altered sensation, functional limitations and yellow flags, previous history of similar symptoms and outcome of previous treatment/management. Examination items included typical neurological tests including neural tension and 'demonstration of movement that produces symptoms'. CONCLUSIONS: We have developed a clinical assessment schedule for patients with low back pain and leg pain presenting in primary care. History and clinical items considered important for their contribution in the diagnosis of nerve root involvement were also established.

Clinical course, characteristics and prognostic indicators in patients presenting with back and leg pain in primary care. The ATLAS study protocol.

BACKGROUND: Low-back related leg pain with or without nerve root involvement is associated with a poor prognosis compared to low back pain (LBP) alone. Compared to the literature investigating prognostic indicators of outcome for LBP, there is limited evidence on prognostic factors for low back-related leg pain including the group with nerve root pain. This 1 year prospective consultation-based observational cohort study will describe the clinical, imaging, demographic characteristics and health economic outcomes for the whole cohort, will investigate differences and identify prognostic indicators of outcome (i.e. change in disability at 12 months), for the whole cohort and, separately, for those classified with and without nerve root pain. In addition, nested qualitative studies will provide insights on the clinical consultation and the impact of diagnosis and treatment on patients' symptom management and illness trajectory. METHODS: Adults aged 18 years and over consulting their General Practitioner (GP) with LBP and radiating leg pain of any duration at (n = 500) GP practices in North Staffordshire and Stoke-on-Trent, UK will be invited to participate. All participants will receive a standardised assessment at the clinic by a study physiotherapist and will be classified according to the clinically determined presence or absence of nerve root pain/involvement. All will undergo a lumbar spine MRI scan. All participants will be managed according to their clinical need. The study outcomes will be measured at 4 and 12 months using postal self-complete questionnaires. Data will also be collected each month using brief postal questionnaires to enable detailed description of the course of low back and leg pain over time. Clinical observations and patient interviews will be used for the qualitative aspects of the study. DISCUSSION: This prospective clinical observational cohort will combine self-reported data, comprehensive clinical and MRI assessment, together with qualitative enquiries, to describe the course, health care usage, patients' experiences and prognostic indicators in an adult population presenting in primary care with LBP and leg pain with or without nerve root involvement.

Assessing fidelity to integrated motivational interviewing and CBT therapy for psychosis and substance use: the MI-CBT fidelity scale (MI-CTS).

BACKGROUND: Guidelines for the psychological treatment of psychosis and substance use suggest integrated treatments to address both problems are necessary. One such treatment combines cognitive-behaviour therapy (CBT) and motivational interviewing (MI). While there are a number of scales to assess treatment fidelity to CBT and MI separately, none, to date, assess fidelity to integrated MI and CBT (MI-CBT) for psychosis and substance use. AIMS: This study aimed to develop a reliable and valid scale to assess fidelity to MI-CBT for people with psychosis and problematic substance use. METHOD: Items for a new scale (the MI-CTS fidelity scale) were selected from multiple relevant sources. Inter-rater reliability and validity (against the CTS-Psy and Motivational Interviewing Treatment Integrity (MITI)) scales were investigated. RESULTS: The scale had good inter-rater reliability when used to rate adherence versus non-adherence. In relation to validity, the scale related well to CBT and MI scales (the CTS-Psy and MITI). CONCLUSIONS: The MI-CTS is useful for assessing adherence to integrated MI-CBT for psychosis and substance misuse and could aid training and implementation of the approach.

Predicting therapeutic alliance in clients with psychosis and substance misuse.

The importance of therapeutic alliance in predicting treatment outcomes is well established, but less is known about client characteristics that predict alliance. Clients with co-occurring psychosis and substance misuse (n = 116) who received integrated motivational interviewing and cognitive behavior therapy in the context of a large randomized controlled trial completed the Working Alliance Inventory. Their trial therapists also completed Working Alliance Inventories. Rating perspectives were compared, and in a cross-sectional study, client predictors of therapeutic alliance were examined. As hypothesized, clients' negative attitudes to treatment, including lack of insight, were predictive of poorer alliance. Therapist-rated alliance was also predicted by the client's attitude to medication, self-reported depression, and living situation. Symptom severity and substance use measures were unrelated to alliance. Consistent with previous studies, rating perspectives differed, with clients rating alliance more positive than therapists.

Keele Aches and Pains Study protocol: validity, acceptability, and feasibility of the Keele STarT MSK tool for subgrouping musculoskeletal patients in primary care.

Musculoskeletal conditions represent a considerable burden worldwide, and are predominantly managed in primary care. Evidence suggests that many musculoskeletal conditions share similar prognostic factors. Systematically assessing patient's prognosis and matching treatments based on prognostic subgroups (stratified care) has been shown to be both clinically effective and cost-effective. This study (Keele Aches and Pains Study) aims to refine and examine the validity of a brief questionnaire (Keele STarT MSK tool) designed to enable risk stratification of primary care patients with the five most common musculoskeletal pain presentations. We also describe the subgroups of patients, and explore the acceptability and feasibility of using the tool and how the tool is best implemented in clinical practice. The study design is mixed methods: a prospective, quantitative observational cohort study with a linked qualitative focus group and interview study. Patients who have consulted their GP or health care practitioner about a relevant musculoskeletal condition will be recruited from general practice. Participating patients will complete a baseline questionnaire (shortly after consultation), plus questionnaires 2 and 6 months later. A subsample of patients, along with participating GPs and health care practitioners, will be invited to take part in qualitative focus groups and interviews. The Keele STarT MSK tool will be refined based on face, discriminant, construct, and predictive validity at baseline and 2 months, and validated using data from 6-month follow-up. Patient and clinician perspectives about using the tool will be explored. This study will provide a validated prognostic tool (Keele STarT MSK) with established cutoff points to stratify patients with the five most common musculoskeletal presentations into low-, medium-, and high-risk subgroups. The qualitative analysis of patient and health care perspectives will inform practitioners on how to embed the tool into clinical practice using established general practice IT systems and clinician-support packages.

Does change in cannabis use in established psychosis affect clinical outcome?

BACKGROUND: Cannabis use has been identified as a potent predictor of the earlier onset of psychosis, but meta-analysis has not indicated that it has a clear effect in established psychosis. AIM: To assess the association between cannabis and outcomes, including whether change in cannabis use affects symptoms and functioning, in a large sample of people with established nonaffective psychosis and comorbid substance misuse. METHODS: One hundred and sixty participants whose substance use included cannabis were compared with other substance users (n = 167) on baseline demographic, clinical, and substance use variables. The cannabis using subgroup was examined prospectively with repeated measures of substance use and psychopathology at baseline, 12 months, and 24 months. We used generalized estimating equation models to estimate the effects of cannabis dose on subsequent clinical outcomes and whether change in cannabis use was associated with change in outcomes. RESULTS: Cannabis users showed cross-sectional differences from other substances users but not in terms of positive symptoms. Second, cannabis dose was not associated with subsequent severity of positive symptoms and change in cannabis dose did not predict change in positive symptom severity, even when patients became abstinent. However, greater cannabis exposure was associated with worse functioning, albeit with a small effect size. CONCLUSIONS: We did not find evidence of an association between cannabis dose and psychotic symptoms, although greater cannabis dose was associated with worse psychosocial functioning, albeit with small effect size. It would seem that within this population, not everyone will demonstrate durable symptomatic improvements from reducing cannabis.

Integrated motivational interviewing and cognitive behavioural therapy for people with psychosis and comorbid substance misuse: randomised controlled trial.

OBJECTIVES: To evaluate the effectiveness of integrated motivational interviewing and cognitive behavioural therapy in addition to standard care for patients with psychosis and a comorbid substance use problem. DESIGN: Two centre, open, rater blind randomised controlled trial. SETTING: Secondary care in the United Kingdom. PARTICIPANTS: 327 patients with a clinical diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder and a diagnosis of dependence on or misuse of drugs, alcohol, or both according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition. INTERVENTION: The intervention was integrated motivational interviewing and cognitive behavioural therapy plus standard care, which was compared with standard care alone. Phase one of therapy-"motivation building"-concerns engaging the patient, then exploring and resolving ambivalence for change in substance use. Phase two-"action"-supports and facilitates change using cognitive behavioural approaches. Up to 26 therapy sessions were delivered over one year. MAIN OUTCOME MEASURES: The primary outcome was death from any cause or admission to hospital in the 12 months after completion of therapy. Secondary outcomes were frequency and amount of substance use (assessed using the timeline followback method), readiness to change, perceived negative consequences of use, psychotic symptom ratings, number and duration of relapses, and global assessment of functioning and deliberate self harm at 12 and 24 months, with additional timeline followback assessments at 6 and 18 months. Analysis was by intention to treat and robust treatment effect estimates were produced. RESULTS: 327 participants were randomly allocated to either the intervention (n=164) or treatment as usual (n=163). At 24 months, 326 (99.7%) were assessed on the primary outcome and 246 (75.2%) on the main secondary outcomes. Treatment had no beneficial effect on hospital admissions or death during follow-up, with 23.3% (38/163) of the therapy group and 20.2% (33/163) of controls deceased or admitted (adjusted odds ratio 1.16, 95% confidence interval 0.68 to 1.99; P=0.579). Therapy had no effect on the frequency of substance use or the perceived negative consequences of misuse, but did have a statistically significant effect on amount used per substance using day (adjusted ORs for main substance 1.50, 95% CI 1.08 to 2.09; P=0.016; and all substances 1.48, 95% CI 1.07 to 2.05; P=0.017). Treatment had a statistically significant effect on readiness to change use at 12 months (adjusted OR 2.05, 95% CI 1.26 to 3.31; P=0.004) that was not maintained at 24 months (0.78, 95% CI 0.48 to 1.28; P=0.320). There were no effects of treatment on clinical outcomes such as relapses, psychotic symptoms, functioning, and self harm. CONCLUSIONS: Integrated motivational interviewing and cognitive behavioural therapy for people with psychosis and substance misuse do not improve outcome in terms of hospitalisation, symptom outcomes, or functioning. This approach does reduce the amount of substance used for at least one year after completion of therapy. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN14404480.

Evaluating integrated MI and CBT for people with psychosis and substance misuse: recruitment, retention and sample characteristics of the MIDAS trial.

Major problems with existing RCTs evaluating psychosocial interventions for psychosis and substance misuse have been identified, in particular small sample sizes, high attrition rates, and short follow up periods. With a sample size of 327 and a follow up of 2 years, the MIDAS trial in the UK is to date the largest RCT for people with psychosis and substance use and is evaluating an integrated MI and CBT ("MiCBT") client therapy. Whilst the outcomes of the study are not yet available, data on recruitment and retention indicate that attrition rates in MIDAS are low and the majority of those allocated to treatment received a substantial number of therapy sessions. Sample characteristics are in line with those reported in epidemiological studies and are indicative of the challenges facing mental health services attempting to manage the client group: substance use is often longstanding, with frequent use at moderate or severe level and low motivation for change, and seen in the context of low levels of functioning and significant psychopathology. We conclude that this is a methodologically robust study that will have results generalisable to mental health services.