Supervised walking in comparison with fitness training for chronic back pain in physiotherapy: results of the SWIFT single-blinded randomized controlled trial (ISRCTN17592092).

Effectiveness of brief/minimal contact self-activation interventions that encourage participation in physical activity (PA) for chronic low back pain (CLBP >12 weeks) is unproven. The primary objective of this assessor-blinded randomized controlled trial was to investigate the difference between an individualized walking programme (WP), group exercise class (EC), and usual physiotherapy (UP, control) in mean change in functional disability at 6 months. A sample of 246 participants with CLBP aged 18 to 65 years (79 men and 167 women; mean age ± SD: 45.4 ± 11.4 years) were recruited from 5 outpatient physiotherapy departments in Dublin, Ireland. Consenting participants completed self-report measures of functional disability, pain, quality of life, psychosocial beliefs, and PA were randomly allocated to the WP (n = 82), EC (n = 83), or UP (n = 81) and followed up at 3 (81%; n = 200), 6 (80.1%; n = 197), and 12 months (76.4%; n = 188). Cost diaries were completed at all follow-ups. An intention-to-treat analysis using a mixed between-within repeated-measures analysis of covariance found significant improvements over time on the Oswestry Disability Index (Primary Outcome), the Numerical Rating Scale, Fear Avoidance-PA scale, and the EuroQol EQ-5D-3L Weighted Health Index (P < 0.05), but no significant between-group differences and small between-group effect sizes (WP: mean difference at 6 months, 6.89 Oswestry Disability Index points, 95% confidence interval [CI] -3.64 to -10.15; EC: -5.91, CI: -2.68 to -9.15; UP: -5.09, CI: -1.93 to -8.24). The WP had the lowest mean costs and the highest level of adherence. Supervised walking provides an effective alternative to current forms of CLBP management.

Utilities and disutilities for attributes of injectable treatments for type 2 diabetes.

INTRODUCTION: Although cost-utility models are frequently used to estimate treatment outcomes for type 2 diabetes, utilities are not available for key attributes of injectable treatments. The purpose of this study was to identify the utility or disutility of three injection-related attributes (dose frequency, dose flexibility, injection site reaction) that may influence patient preference. METHODS: Patients with type 2 diabetes in Scotland completed standard gamble (SG) interviews to assess the utility of hypothetical health states and their own current health state. The EQ-5D, PGWB, IWQOL-Lite, and QIDS were also administered. Construct validity and differences among health states were examined. RESULTS: A total of 151 patients completed interviews. Of the three injection-related attributes, dose frequency was the only attribute with a statistically significant impact on utility (in a multiple regression model, p = 0.01). Weekly injections were associated with an average added utility of 0.023 in comparison to everyday injections. Flexible dosing and injection site reactions resulted in somewhat smaller utility shifts that were in the expected directions (+0.006 and -0.011, respectively). SG utility of current health (mean = 0.897) demonstrated construct validity through statistically significant correlations with patient-reported outcome measures. DISCUSSION: The three injection attributes were associated with small utility shifts in the expected directions. Dose frequency appears to be the most important of the three attributes from the patients' perspective. The vignette-based SG approach was feasible and useful for assessing added utility or disutility of injection-related attributes associated with treatments for type 2 diabetes.

Survival as a function of HbA(1c) in people with type 2 diabetes: a retrospective cohort study.

BACKGROUND: Results of intervention studies in patients with type 2 diabetes have led to concerns about the safety of aiming for normal blood glucose concentrations. We assessed survival as a function of HbA(1c) in people with type 2 diabetes. METHODS: Two cohorts of patients aged 50 years and older with type 2 diabetes were generated from the UK General Practice Research Database from November 1986 to November 2008. We identified 27 965 patients whose treatment had been intensified from oral monotherapy to combination therapy with oral blood-glucose lowering agents, and 20 005 who had changed to regimens that included insulin. Those with diabetes secondary to other causes were excluded. All-cause mortality was the primary outcome. Age, sex, smoking status, cholesterol, cardiovascular risk, and general morbidity were identified as important confounding factors, and Cox survival models were adjusted for these factors accordingly. FINDINGS: For combined cohorts, compared with the glycated haemoglobin (HbA(1c)) decile with the lowest hazard (median HbA(1c) 7.5%, IQR 7.5-7.6%), the adjusted hazard ratio (HR) of all-cause mortality in the lowest HbA(1c) decile (6.4%, 6.1-6.6) was 1.52 (95% CI 1.32-1.76), and in the highest HbA(1c) decile (median 10.5%, IQR 10.1-11.2%) was 1.79 (95% CI 1.56-2.06). Results showed a general U-shaped association, with the lowest HR at an HbA(1c) of about 7.5%. HR for all-cause mortality in people given insulin-based regimens (2834 deaths) versus those given combination oral agents (2035) was 1.49 (95% CI 1.39-1.59). INTERPRETATION: Low and high mean HbA(1c) values were associated with increased all-cause mortality and cardiac events. If confirmed, diabetes guidelines might need revision to include a minimum HbA(1c) value. FUNDING: Eli Lilly and Company.

Characteristics of patients with type 2 diabetes mellitus initiating insulin therapy: baseline data from the INSTIGATE study.

OBJECTIVE: To describe the characteristics at baseline of patients with type 2 diabetes mellitus who are initiating insulin. METHODS: Prospective, observational multi-centre, open-label study in five European countries of patients with type 2 diabetes who were initiating insulin as part of their usual care. RESULTS: A total of 1172 patients were enrolled, with mean age 63.3 years and body mass index 29.9 kg/m(2). The majority (90%) of patients were taking one or more oral anti-diabetic agents; the percentage not taking anti-diabetic medication in the previous four weeks was highest in Germany (23.4%) and Spain (15.1%). The prevalence of microvascular diseases (range: 16.1%-36.1%) varied considerably between countries but for macrovascular (30.4%-38.6%) and other diabetes-related diagnoses (72.6%-76.6%) such as hypertension and dyslipidaemia the differences were less pronounced. In Germany, reported use of lipid-lowering (26.7%) and anti-platelet (27.1%) therapies was much less than in other countries (ranges: 53.2%-78.1% and 48.3%-61.1%, respectively). The majority of evaluable patients in each country had demonstrated poor control over a long period of time. Prior to initiating insulin, the most recent mean (+/-SD) HbA1(c) was 9.58 +/- 1.81%, fasting plasma glucose was 12.18 +/- 4.32 mmol/L and 78.5% had metabolic syndrome. IDF targets for HDL- and LDL-cholesterol, and blood pressure were met in 76.8%, 33.1% and 18.9% of patients, respectively. CONCLUSIONS: Insulin treatment was only initiated after HbA1(c) values were considerably higher than recommended in treatment guidelines for a sustained period of time.

Characterization of patients in the European Forsteo Observational Study (EFOS): postmenopausal women entering teriparatide treatment in a community setting.

OBJECTIVE: The European Forsteo Observational Study (EFOS) study was primarily designed to assess fracture incidence, degree of pain, health-related quality of life (HRQoL) and compliance in women prescribed teriparatide in a community setting. This report describes the design of the study and characteristics of the patients at entry. METHODS: At entry, 1645 postmenopausal women with a diagnosis of osteoporosis and about to initiate teriparatide treatment were enrolled in eight European countries. Baseline data were collected on demographic characteristics, medical and osteoporosis history, disease status, prior use of medications and HRQoL. RESULTS: The mean (standard deviation [SD]) age of patients was 71.5 (8.4) years, lumbar spine bone mineral density (BMD) T-score was -3.3 (1.2), the mean number of previous fractures reported after 40 years of age was 2.9 (2.0), 70% had two or more vertebral deformities and 91.7% were pre-treated with bisphosphonates. HRQoL, evaluated by the health state value (HSV) (median: 0.59, Q1; Q3: 0.08; 0.71) and visual analogue scale (VAS) (median 50.0, Q1; Q3: 35.0; 69.0) status of the European quality of life questionnaire (EQ-5D) was poor. Extreme problems were reported by 31% of patients for the pain/discomfort dimension, mobility was limited in 69% and anxiety/depression was reported by 57% of patients. Chronic or intermittent back pain was reported by 91% of patients, which occurred every day or almost every day within the last month in 66% of patients. CONCLUSIONS: The post-menopausal women prescribed teriparatide were severely osteoporotic, with a high fracture risk and poor HRQoL, despite previous therapy for osteoporosis. Moderate to severe back pain was very common.

Adherence of Irish general practitioners to European guidelines for acute low back pain: a prospective pilot study.

There are no national low back pain (LBP) clinical guidelines in Ireland, and neither the level of adherence of General Practitioners (GPs) to the European guidelines, nor the cost of LBP to the patient and the state, have been investigated. A prospective pilot study was conducted on 54 consenting patients (18M, 36F: mean age (SD): 40.5 (14.3) years) with a new episode of acute LBP (<3 months) attending one of nine participating GPs. Baseline demographic, LBP classification [i.e. simple back ache (SBA), nerve root pain (NRP), serious spinal pathology (SSP)] and primary care management data were recorded over a three month period. Adherence and costs were estimated based on: medication prescription, referral for investigations, treatment or consultations, and wage replacement costs (time signed off work). For both SBA and NRP, medication prescriptions were consistent with European guideline recommendations, but not for referral for further treatment (39% of SBA patients were referred on first visit), secondary care (54% of NRP patients were referred on first visit), or discontinuation of work (50% NRP patients on first GP visit). The average total cost (direct and wage replacement) for a single episode of LBP over 12 weeks was 20,531 Euros (20,300-20,762). Direct costs accounted for 43% [8874.36 Euros, (8643.37-9105.37 Euros)] and wage replacement costs 57% (11,657 Euros). In conclusion, management of acute LBP in a cohort of GPs in Ireland was not consistent with European clinical guideline recommendations, and warrants higher levels of postgraduate education among GPs, as well as restructuring of primary care services, which should improve patient outcome and reduce costs.

COPD: illness severity, resource utilisation and cost.

COPD is a major source mortality and morbidity International evidence suggests the associated financial burden substantial. This research was undertaken to capture the costs associated with COPD in an Irish secondary care setting. 150 COPD patients attending a respiratory clinic were interviewed. Data on healthcare utilisation were collected. Prescription data and clinical severity data were collected from patient notes. The average direct cost of COPD was estimated at 4,730 euros. Secondary care costs accounted for 44% of total costs. Lost productivity averaged 668 euros. The main direct cost driver was in-patient admissions. A positive relationship was found between average direct costs and both clinical and symptom severity. The costs of COPD increased with increasing illness severity driven mainly by secondary care in-patient costs. If illness progression can be slowed and symptom severity can be reduced it may be possible to achieve significant reductions in expenditure and free resources within the healthcare system.