Ndosi M.,University of Leeds |
Lewis M.,Keele University |
Hale C.,University of Leeds |
Quinn H.,University of Leeds |
And 4 more authors.
Annals of the Rheumatic Diseases | Year: 2013
Objective: To determine the clinical effectiveness and cost-effectiveness of nurse-led care (NLC) for people with rheumatoid arthritis (RA).Methods: In a multicentre pragmatic randomised controlled trial, the assessment of clinical effects followed a non-inferiority design, while patient satisfaction and cost assessments followed a superiority design. Participants were 181 adults with RA randomly assigned to either NLC or rheumatologist-led care (RLC), both arms carrying out their normal practice. The primary outcome was the disease activity score (DAS28) assessed at baseline, weeks 13, 26, 39 and 52; the non-inferiority margin being DAS28 change of 0.6. Mean differences between the groups were estimated controlling for covariates following per-protocol (PP) and intention-to-treat (ITT) strategies. The economic evaluation (NHS and healthcare perspectives) estimated cost relative to change in DAS28 and quality-adjusted life-years (QALY) derived from EQ5D. Results: Demographics and baseline characteristics of patients under NLC (n=91) were comparable to those under RLC (n=90). Overall baseline-adjusted difference in DAS28 mean change (95% CI) for RLC minus NLC was -0.31 (-0.63 to 0.02) for PP and -0.15 (-0.45 to 0.14) for ITT analyses. Mean difference in healthcare cost (RLC minus NLC) was £710 (-£352, £1773) and -£128 (-£1263, £1006) for PP and ITT analyses, respectively. NLC was more cost-effective with respect to cost and DAS28, but not in relation to QALY utility scores. In all secondary outcomes, significance was met for non-inferiority of NLC. NLC had higher 'general satisfaction' scores than RLC in week 26.Conclusions: The results provide robust evidence to support non-inferiority of NLC in the management of RA. © 2013 BMJ Publishing Group Ltd & European League Against Rheumatism.
Kingsley G.H.,Kings College London |
Kingsley G.H.,University of London |
Kowalczyk A.,Kings College London |
Taylor H.,Kings College London |
And 11 more authors.
Rheumatology (United Kingdom) | Year: 2012
Objective: MTX is widely used to treat synovitis in PsA without supporting trial evidence. The aim of our study was to test the value of MTX in the first large randomized placebo-controlled trial (RCT) in PsA. Methods: A 6-month double-blind RCT compared MTX (15 mg/week) with placebo in active PsA. The primary outcome was PsA response criteria (PsARC). Other outcomes included ACR20, DAS-28 and their individual components. Missing data were imputed using multiple imputation methods. Treatments were compared using logistic regression analysis (adjusted for age, sex, disease duration and, where appropriate, individual baseline scores).Results. Four hundred and sixty-two patients were screened and 221 recruited. One hundred and nine patients received MTX and 112 received placebo. Forty-four patients were lost to follow-up (21 MTX, 23 placebo). Twenty-six patients discontinued treatment (14 MTX, 12 placebo). Comparing MTX with placebo in all randomized patients at 6 months showed no significant effect on PsARC [odds ratio (OR) 1.77, 95% CI 0.97, 3.23], ACR20 (OR 2.00, 95% CI 0.65, 6.22) or DAS-28 (OR 1.70, 95% CI 0.90, 3.17). There were also no significant treatment effects on tender and swollen joint counts, ESR, CRP, HAQ and pain. The only benefits of MTX were reductions in patient and assessor global scores and skin scores at 6 months (P = 0.03, P < 0.001 and P = 0.02, respectively). There were no unexpected adverse events.Conclusions. This trial of active PsA found no evidence for MTX improving synovitis and consequently raises questions about its classification as a disease-modifying drug in PsA. © The Author(s) 2012.
Meader N.,National Collaborating Center for Mental Health |
Mitchell A.J.,University of Leicester |
Chew-Graham C.,University of Manchester |
Goldberg D.,Kings College London |
And 8 more authors.
British Journal of General Practice | Year: 2011
Background: Depression is more likely in patients with chronic physical illness, and is associated with increased rates of disability and mortality. Effective treatment of depressionmay reduce morbidity andmortality. The use of two stem questions for case finding in diabetes and coronary heart disease is advocated in the Quality and Outcomes Framework, and has become normalised into primary care. Aim: To define themost effective tool for use in consultations to detect depression in people with chronic physical illness. Design: Meta-analysis. Method: The following data sources were searched: CENTRAL, CINAHL, Embase, HMIC, MEDLINE, PsycINFO, Web of Knowledge, from inception to July 2009. Three authors selected studies that examined identification tools and used an interview-based ICD (International Classification of Diseases) or DSM (Diagnostic and statistical Manual of Mental Disorders) diagnosis of depression as reference standard. At least two authors independently extracted study characteristics and outcome data and assessed methodological quality. Results: A total of 113 studies met the eligibility criteria, providing data on 20 826 participants. It was found that two stemquestions, PHQ-9 (Patient Health Questionnaire), the Zung, and GHQ-28 (General Health Questionnaire) were the optimal measures for case identification, but nomethod was sufficiently accurate to recommend as a definitive case-finding tool. Limitations were the moderate-to-high heterogeneity formost scales and the facts that few studies used ICD diagnoses as the reference standard, and that a variety ofmethods were used to determine DSM diagnoses. Conclusion: Assessing both validity and ease of use, the two stemquestions are the preferred method. However, clinicians should not rely on the two-questions approach alone, but should be confident to engage in amore detailed clinical assessment of patients who score positively. © British Journal of General Practice.
Bowes J.,University of Manchester |
Orozco G.,University of Manchester |
Flynn E.,University of Manchester |
Ho P.,University of Manchester |
And 17 more authors.
Annals of the Rheumatic Diseases | Year: 2011
Objectives: To investigate a shared genetic aetiology for skin involvement in psoriasis and psoriatic arthritis (PsA) by genotyping single-nucleotide polymorphisms (SNPs), reported to be associated in genome-wide association studies of psoriasis, in patients with PsA. Methods: SNPs with reported evidence for association with psoriasis were genotyped in a PsA case and control collection from the UK and Ireland. Genotype and allele frequencies were compared between PsA cases and controls using the Armitage test for trend. Results: Seven SNPs mapping to the IL1RN, TNIP1, TNFAIP3, TSC1, IL23A, SMARCA4 and RNF114 genes were successfully genotyped. The IL23A and TNIP1 genes showed convincing evidence for association (rs2066808, p = 9.1 x 10-7; rs17728338, p = 3.5 x 10-5, respectively) whilst SNPs mapping to the TNFAIP3, TSC1 and RNF114 genes showed nominal evidence for association (rs610604, p = 0.03; rs1076160, p = 0.03; rs495337, p = 0.0025). No evidence for association with IL1RN or SMARCA4 was found but the power to detect association was low. Conclusions: SNPs mapping to previously reported psoriasis loci show evidence for association to PSA, thus supporting the hypothesis that the genetic aetiology of skin involvement is the same in both PsA and psoriasis.
Hunter S.M.,Keele University |
Hammett L.,St Georges, University of London |
Ball S.,Haywood Hospital |
Smith N.,Neuro Matters |
And 4 more authors.
Neurorehabilitation and Neural Repair | Year: 2011
Background. Physical therapy doses may need to be higher than provided in current clinical practice, especially for patients with severe paresis. The authors aimed to find the most effective and feasible dose of Mobilisation and Tactile Stimulation (MTS), which includes joint and soft-tissue mobilization and passive or active-assisted movement to enhance voluntary muscle contraction. Methods. This 2-center, randomized, controlled, observer-blinded feasibility trial compared conventional rehabilitation but no extra therapy (group 1) with conventional therapy plus 1 of 3 daily doses of MTS, up to 30 (group 2), 60 (group 3), or 120 (group 4) minutes for 14 days. The 76 participants had substantial paresis (Motricity Index [MI] < 61) a mean of 30 days (standard deviation [SD] = 20 days) after anterior circulation stroke. MTS was delivered using a standardized schedule of techniques (eg, sensory input, active-assisted movement). The primary outcome was the Motricity Index (MI) and secondary outcome was the Action Research Arm Test (ARAT) tested on day 16. Adverse events were monitored daily. Results. No difference was found in the change in control group MI compared with each of the 3 intervention groups (P = .593) or in the ARAT. Mean actual daily treatment time for all MTS groups was less than expected. The attrition rate was 1.3%. No adverse events related to overuse occurred. Conclusion. The authors were not able to deliver a maximum dose of 120 minutes of daily therapy each day. The mean daily dose of MTS feasible for subsequent evaluation is between 37 and 66 minutes. © The Author(s) 2011.