0
selected
-
1.
Type 2 diabetes remission: economic evaluation of the DiRECT/Counterweight-Plus weight management programme within a primary care randomized controlled trial.
Xin, Y, Davies, A, McCombie, L, Briggs, A, Messow, CM, Grieve, E, Leslie, WS, Taylor, R, Lean, MEJ
Diabetic medicine : a journal of the British Diabetic Association. 2019;(8):1003-1012
Abstract
AIM: The Counterweight-Plus weight management programme achieved 46% remission of Type 2 diabetes at 1 year in the DiRECT trial. We estimated the implementation costs of the Counterweight-Plus programme and its 1-year cost-effectiveness in terms of diabetes remission, compared with usual care, from the UK National Health Service (NHS) perspective. METHODS Within-trial total costs included programme set-up and running costs (practitioner appointment visits, low-energy formula diet sachets and training), oral anti-diabetes and anti-hypertensive medications, and healthcare contacts. Total costs were calculated for aggregated resource use for each participant and 95% confidence intervals (CI) were based on 1000 non-parametric bootstrap iterations. RESULTS One-year programme costs under trial conditions were estimated at £1137 per participant (95% CI £1071, £1205). The intervention led to a significant cost-saving of £120 (95% CI £78, £163) for the oral anti-diabetes drugs and £14 (95% CI £7.9, £22) for anti-hypertensive medications compared with the control. Deducting the cost-savings of all healthcare contacts from the intervention cost resulted an incremental cost of £982 (95% CI £732, £1258). Cost per 1 year of diabetes remission was £2359 (95% CI £1668, £3250). CONCLUSIONS Remission of Type 2 diabetes within 1-year can be achieved at a cost below the annual cost of diabetes (including complications). Providing a reasonable proportion of remissions can be maintained over time, with multiple medical gains expected, as well as immediate social benefits, there is a case for shifting resources within diabetes care budgets to offer support for people with Type 2 diabetes to attempt remission. (Clinical Trial Registry No.: ISRCTN03267836).
-
2.
The Diabetes Remission Clinical Trial (DiRECT): protocol for a cluster randomised trial.
Leslie, WS, Ford, I, Sattar, N, Hollingsworth, KG, Adamson, A, Sniehotta, FF, McCombie, L, Brosnahan, N, Ross, H, Mathers, JC, et al
BMC family practice. 2016;:20
Abstract
BACKGROUND Despite improving evidence-based practice following clinical guidelines to optimise drug therapy, Type 2 diabetes (T2DM) still exerts a devastating toll from vascular complications and premature death. Biochemical remission of T2DM has been demonstrated with weight loss around 15kg following bariatric surgery and in several small studies of non-surgical energy-restriction treatments. The non-surgical Counterweight-Plus programme, running in Primary Care where obesity and T2DM are routinely managed, produces >15 kg weight loss in 33% of all enrolled patients. The Diabetes UK-funded Counterpoint study suggested that this should be sufficient to reverse T2DM by removing ectopic fat in liver and pancreas, restoring first-phase insulin secretion. The Diabetes Remission Clinical Trial (DiRECT) was designed to determine whether a structured, intensive, weight management programme, delivered in a routine Primary Care setting, is a viable treatment for achieving durable normoglycaemia. Other aims are to understand the mechanistic basis of remission and to identify psychological predictors of response. METHODS/DESIGN Cluster-randomised design with GP practice as the unit of randomisation: 280 participants from around 30 practices in Scotland and England will be allocated either to continue usual guideline-based care or to add the Counterweight-Plus weight management programme, which includes primary care nurse or dietitian delivery of 12-20weeks low calorie diet replacement, food reintroduction, and long-term weight loss maintenance. Main inclusion criteria: men and women aged 20-65 years, all ethnicities, T2DM 0-6years duration, BMI 27-45 kg/m(2). Tyneside participants will undergo Magnetic Resonance (MR) studies of pancreatic and hepatic fat, and metabolic studies to determine mechanisms underlying T2DM remission. Co-primary endpoints: weight reduction ≥ 15 kg and HbA1c <48 mmol/mol at one year. Further follow-up at 2 years. DISCUSSION This study will establish whether a structured weight management programme, delivered in Primary Care by practice nurses or dietitians, is a viable treatment to achieve T2DM remission. Results, available from 2018 onwards, will inform future service strategy. TRIAL REGISTRATION Current Controlled Trials ISRCTN03267836 . Date of Registration 20/12/2013.
-
3.
Implementing guidelines to routinely prevent chronic vascular disease in primary care: the Preventive Evidence into Practice cluster randomised controlled trial.
Harris, MF, Parker, SM, Litt, J, van Driel, M, Russell, G, Mazza, D, Jayasinghe, UW, Del Mar, C, Lloyd, J, Smith, J, et al
BMJ open. 2015;(12):e009397
Abstract
OBJECTIVE To evaluate an intervention to improve implementation of guidelines for the prevention of chronic vascular disease. SETTING 32 urban general practices in 4 Australian states. RANDOMISATION Stratified randomisation of practices. PARTICIPANTS 122 general practitioners (GPs) and practice nurses (PNs) were recruited at baseline and 97 continued to 12 months. 21,848 patient records were audited for those aged 40-69 years who attended the practice in the previous 12 months without heart disease, stroke, diabetes, chronic renal disease, cognitive impairment or severe mental illness. INTERVENTION The practice level intervention over 6 months included small group training of practice staff, feedback on audited performance, practice facilitation visits and provision of patient education and referral information. OUTCOME MEASURES Primary: 1. Change in proportion of patients aged 40-69 years with smoking status, alcohol intake, body mass index (BMI), waist circumference (WC), blood pressure (BP) recorded and for those aged 45-69 years with lipids, fasting blood glucose and cardiovascular risk in the medical record. 2. Change in the level of risk for each factor. SECONDARY change in self-reported frequency and confidence of GPs and PNs in assessment. RESULTS Risk recording improved in the intervention but not the control group for WC (OR 2.52 (95% CI 1.30 to 4.91)), alcohol consumption (OR 2.19 (CI 1.04 to 4.64)), smoking status (OR 2.24 (1.17 to 4.29)) and cardiovascular risk (OR 1.50 (1.04 to 2.18)). There was no change in recording of BP, lipids, glucose or BMI and no significant change in the level of risk factors based on audit data. The confidence but not reported practices of GPs and PNs in the intervention group improved in the assessment of some risk factors. CONCLUSIONS This intervention was associated with improved recording of some risk factors but no change in the level of risk at the follow-up audit. TRIAL REGISTRATION NUMBER Australian and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000578808, results.
-
4.
Randomised controlled trial of the effectiveness of community group and home-based falls prevention exercise programmes on bone health in older people: the ProAct65+ bone study.
Duckham, RL, Masud, T, Taylor, R, Kendrick, D, Carpenter, H, Iliffe, S, Morris, R, Gage, H, Skelton, DA, Dinan-Young, S, et al
Age and ageing. 2015;(4):573-9
-
-
Free full text
-
Abstract
BACKGROUND exercise can reduce osteoporotic fracture risk by strengthening bone or reducing fall risk. Falls prevention exercise programmes can reduce fall incidence, and also include strengthening exercises suggested to load bone, but there is little information as to whether these programmes influence bone mineral density (BMD) and strength. OBJECTIVE to evaluate the skeletal effects of home (Otago Exercise Programme, OEP) and group (Falls Exercise Management, FaME) falls prevention exercise programmes relative to usual care in older people. METHODS men and women aged over 65 years were recruited through primary care. They were randomised by practice to OEP, FaME or usual care. BMD, bone mineral content (BMC) and structural properties were measured in Nottingham site participants before and after the 24-week intervention. RESULTS participants were 319 men and women, aged mean(SD) 72(5) years. Ninety-two percentage of participants completed the trial. The OEP group completed 58(43) min/week of home exercise, while the FaME group completed 39(16) and 30(24) min/week of group and home exercise, respectively. Femoral neck BMD changes did not differ between treatment arms: mean (95% CI) effect sizes in OEP and FaME relative to usual care arm were -0.003(-0.011,0.005) and -0.002(-0.010,0.005) g cm(-2), respectively; P = 0.44 and 0.53. There were no significant changes in BMD or BMC at other skeletal sites, or in structural parameters. CONCLUSIONS falls prevention exercise programmes did not influence BMD in older people. To increase bone strength, programmes may require exercise that exerts higher strains on bone or longer duration.