The Staffordshire Arthritis, Musculoskeletal, and Back Assessment (SAMBA) Study: a prospective observational study of patient outcome following referral to a primary-secondary care musculoskeletal interface service

<p>Abstract</p> <p>Background</p> <p>Recent healthcare policy has shifted the management of musculoskeletal conditions in the UK away from secondary care towards Clinical Assessment and Treatment Services at the primary-secondary care interface. However, little is known about the outcome of patients with musculoskeletal conditions referred from primary care to Clinical Assessment and Treatment Services or how best to identify those patients at high risk of poor outcome in this setting. We describe the protocol for a twelve-month prospective observational study which aims to describe the outcome of patients referred to musculoskeletal and back pain services at the primary-secondary care interface and to develop simple prognostic measures to guide clinical prioritisation and triage.</p> <p>Methods/Design</p> <p>All patients referred over a twelve-month period from primary care to musculoskeletal and back pain clinics in the primary-secondary care interface Clinical Assessment and Treatment Service in North Staffordshire will be mailed a postal questionnaire prior to their consultation. This will collect information on quality of life, general health, anxiety and depression, pain, healthcare utilisation including medication use, occupational characteristics, and socio-demographics. At the consultation in the interface clinic, the clinical diagnosis, investigations requested, and clinical interventions will be recorded. Follow-up data for the twelve-month period subsequent to recruitment will be collected via mailed follow-up questionnaires at 6 and 12 months, and review of medical records.</p> <p>Discussion</p> <p>This twelve-month prospective observational study of patients referred to a musculoskeletal Clinical Assessment and Treatment Service will assess the management and outcome of musculoskeletal care at the primary-secondary care interface as proposed in the Musculoskeletal Services Framework.</p

Biomarkers of oxidant stress, insulin sensitivity and endothelial activation in rheumatoid arthritis: a cross-sectional study of their association with accelerated atherosclerosis

<p>Abstract</p> <p>Background</p> <p>Women with rheumatoid arthritis (RA) have increased morbidity and mortality due to coronary heart disease. Chronic systemic inflammation is known to accelerate atherosclerosis and increase arterial stiffness in patients, but other mechanisms may also be involved. Biomarkers of oxidant stress, inflammation, insulinaemia and endothelial dysfunction were measured in blood and urine from 46 RA patients and 48 age-matched controls. Plaque formation and intima-medial thickness (IMT) were measured using B-mode carotid Doppler scan.</p> <p>Findings</p> <p>The prevalence of plaque was increased (p = 0.042) in RA patients between 50–59 years old compared to the same age group in controls. 8-isoprostane (p = 0.004), C-reactive protein (p < 0.001), interleukin-6 (p < 0.001), insulin (p = 0.035), adiponectin (p = 0.012), vascular cell adhesion molecule (VCAM) (p = 0.029) and E-selectin (p < 0.001) were all increased while selenium (p = 0.003) and LDL-cholesterol (p = 0.025) were both decreased in all RA patients. 8-isoprostane correlated with 10 year cardiac risk (r = 0.55, p < 0.001), VCAM with IMT (r = 0.37, p = 0.012) and E-selectin with rheumatoid factor titre (r = 0.43, p = 0.003) in RA patients. In the control group, age, carotid IMT, VCAM, systolic blood pressure and smoking status were all associated with plaque development whereas in RA patients only age was associated with plaque.</p> <p>Conclusion</p> <p>The burden of atherosclerosis is particularly increased in middle-aged women with RA. Patients with RA have increased levels of oxidant stress, inflammation, insulin and soluble adhesion molecules. As the association between classical risk factors was much weaker in RA patients compared to controls, these additional factors may be more important in the accelerated development of atheroma in RA.</p

Challenges of diagnosis and management of giant cell arteritis in general practice: a multimethods study

BACKGROUND: In the UK, general practitioners (GPs) are usually the first medical contact for patients with suspected giant cell arteritis (GCA). While rare, it is critical not to miss, as delayed treatment can lead to significant complications including permanent visual loss. To date, little is known about the approach and challenges to diagnosis and management of GCA by GPs. OBJECTIVE: To investigate the diagnosis and management of patients with suspected GCA in UK general practice. DESIGN AND PARTICIPANTS: A multimethods approach was taken, comprising a postal survey of 5000 randomly selected UK GPs and semistructured telephone interviews of 24 GPs from across the UK. SETTING: UK general practice. RESULTS: 1249 questionnaires were returned. 879 responders (70%) indicated that they had diagnosed and managed a patient with GCA. A variety of clinical features were used to identify GCA. 21.9% suggested that they would exclude GCA as a diagnosis if headache was absent and around one-third do not routinely initiate glucocorticoid treatment prior to referral. Significant regional variations in referral pathways were reported. Thematic analysis of interview transcripts highlighted fears relating to a missed diagnosis of GCA and the non-specific nature of early GCA presentation. Accessing specialist care was highlighted as challenging by many GPs and that a national standard fast-track pathway is lacking to support this patient group. Additionally there were significant concerns regarding potential adverse effects relating to long-term treatment with glucocorticoids. CONCLUSION: GPs appear to over-rely on headache to identify GCA and marked geographical differences in management, with conflicting referral pathways and difficulties in accessing appropriate services exist in the UK. A national standard for fast-tracking patients with suspected GCA to relevant specialists would be beneficial to improve care and outcomes for patients with GCA

Longitudinal clusters of pain and stiffness in polymyalgia rheumatica: 2-year results from the PMR Cohort study

Objectives. To investigate potential subgroups of primary care diagnosed patients with polymyalgia rheumatica (PMR) based on self-reported pain and stiffness severity over time.Methods. 652 people with an incident PMR diagnosis were recruited from English general practices and completed a baseline postal questionnaire. They were followed-up with a further six questionnaires over a two-year period. 446 people completed 2-year follow-up. Pain and stiffness were reported on 0-10 numerical rating scales. Latent class growth analysis was used to estimate the joint trajectories of pain and stiffness overtime. A combination ofstatistical and clinical considerations was used to choose the number of clusters. Characteristics of the classes were described. Results. Five clusters were identified. One cluster represented the profile of ‘classical’ PMR symptoms and one represented sustained symptoms that may not be PMR. The other three clusters displayed a partial recovery, a recovery followed by worsening and a slow, but sustained recovery. Those displaying classical PMR symptoms were in better overall health at diagnosis than the other groups.Conclusions. PMR is a heterogeneous condition, with a number of phenotypes. The spectrum of presentation, as well as varying responses to treatment, may be related to underlying health status at diagnosis. Future research should seek to stratify patients at diagnosis to identify those likely to have a poor recovery and in need of an alternative treatment pathway. Clinicians should be aware of the different experiences of patients and monitor symptoms closely, even where there is initial improvement

A pilot study of a nurse-led integrated care review (the INCLUDE review) for people with inflammatory rheumatological conditions in primary care: feasibility study findings.

BACKGROUND: People with inflammatory rheumatological conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polymyalgia rheumatica and giant cell arteritis are at an increased risk of common comorbidities including cardiovascular disease, osteoporosis and mood problems, leading to increased morbidity and mortality. Identifying and treating these problems could lead to improved patient quality of life and outcomes. Despite these risks being well-established, patients currently are not systematically targeted for management interventions for these morbidities. This study aimed to assess the feasibility of conducting a randomised controlled trial (RCT) of a nurse-led integrated care review in primary care to identify and manage these morbidities. METHODS: A pilot cluster RCT was delivered across four UK general practices. Patients with a diagnostic Read code for one of the inflammatory rheumatological conditions of interest were recruited by post. In intervention practices (n = 2), eligible patients were invited to attend the INCLUDE review. Outcome measures included health-related quality of life (EQ-5D-5L), patient activation, self-efficacy and treatment burden. A sample (n = 24) of INCLUDE review consultations were audio-recorded and assessed against a fidelity checklist. RESULTS: 453/789 (57%) patients responded to the invitation, although 114/453 (25%) were excluded as they either did not fulfil eligibility criteria or failed to provide full written consent. In the intervention practices, uptake of the INCLUDE review was high at 72%. Retention at 3 and 6?months both reached pre-specified success criteria. Participants in intervention practices had more primary care contacts than controls (mean 29 vs 22) over the 12?months, with higher prescribing of all relevant medication classes in participants in intervention practices, particularly so for osteoporosis medication (baseline 29% vs 12?month 46%). The intervention was delivered with fidelity, although potential areas for improvement were identified. CONCLUSIONS: The findings of this pilot study suggest it is feasible to deliver an RCT of the nurse-led integrated care (INCLUDE) review in primary care. A significant morbidity burden was identified. Early results suggest the INCLUDE review was associated with changes in practice. Lessons have been learnt around Read codes for patient identification and refining the nurse training. TRIAL REGISTRATION: ISRCTN, ISRCTN12765345

Antibiotic use and the risk of rheumatoid arthritis: a population-based case-control study

Background: Antibiotic-induced disturbances of the human microbiota have been implicated in the development of chronic autoimmune conditions. This study aimed to assess whether antibiotic use is associated with the onset of rheumatoid arthritis (RA). Methods: A nested case-control study was conducted utilising data from the primary care Clinical Practice Research Datalink (CPRD). Patients with an incident diagnosis of RA were identified (1995–2017). Each case was matched on age, gender, and general practice to ≥ 5 controls without RA. Conditional logistic regression was used to examine previous antibiotic prescriptions and RA onset after controlling for confounding factors. Results: We identified 22,677 cases of RA, matched to 90,013 controls, with a median follow-up of 10 years before RA diagnosis. The odds of developing RA were 60% higher in those exposed to antibiotics than in those not exposed (OR 1.60; 95% CI 1.51–1.68). A dose- or frequency-dependent association was observed between the number of previous antibiotic prescriptions and RA. All classes of antibiotics were associated with higher odds of RA, with bactericidal antibiotics carrying higher risk than bacteriostatic (45% vs. 31%). Those with antibiotic-treated upper respiratory tract (URT) infections were more likely to be RA cases. However, this was not observed for URT infections not treated with antibiotics. Antifungal (OR = 1.27; 95% CI 1.20–1.35) and antiviral (OR = 1.19; 95% CI 1.14–1.24) prescriptions were also associated with increased odds of RA. Conclusion: Antibiotic prescriptions are associated with a higher risk of RA. This may be due to microbiota disturbances or underlying infections driving risk. Further research is needed to explore these mechanisms

Concurrent Oral 1 - Rheumatoid Arthritis: Treatment [OP4-OP9]: OP4. Inhibition of Radiographic Progression and Improvements in Physical Function at 2 Years, with Increasing Clinical Efficacy Over Time, in Rheumatoid Arthritis (Ra) Patients Treated with Tocilizumab (Tcz): The Lithe Study

Background: Patients with moderate to severe RA who remained on methotrexate (MTX) despite inadequate response were treated with TCZ in a double-blind, randomized, controlled phase 3 trial. Results of a 2-year planned analysis from this study are presented. Methods: Patients were randomized to treatment with TCZ 4 mg/kg + MTX (TCZ4), TCZ 8 mg/kg + MTX (TCZ8) or placebo + MTX (CON) every 4 weeks. If patients failed to respond ( 60% of patients and the DAS28 remission (DAS28 < 2.6) rate was 48% at week 52 and continued to increase to week 104. By week 52, patients treated with TCZ8 had clinically significant improvements in SJC that were maintained through week 104. Rates per 100 PY for adverse events (AEs) were higher in TCZ8 and TCZ4 (263.6, 275.4) vs CON patients (251.4) while rates for serious AEs were comparable (11.4, 12.1, 10.9, respectively). Rates per 100 PY of AEs leading to withdrawal (7.4, 32.5, 4.8) and treatment modification (8.4, 30.7, 20.4) were higher in TCZ8 and TCZ4 vs CON patients, respectively and death rates were comparable (0.6, 0.2, 0.4). Conclusions: Treatment with TCZ + MTX inhibits radiographic progression over 2 years and improves physical function as shown by DAS28 remission, LDAS and low SJC, with a manageable safety profile. Disclosure statement: E.A., F. Hoffmann-La Roche - Employee. P.A., F. Hoffmann-La Roche - Employee. R.B.-V., F. Hoffmann-La Roche - Honoraria. R.F., Genentech - Research Funding, Honoraria. J.K., F. Hoffmann-La Roche - Research funding, Honorari

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

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