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1.  Costs and advance directives at the end of life: a case of the ‘Coaching Older Adults and Carers to have their preferences Heard (COACH)’ trial 
Total costs associated with care for older people nearing the end of life and the cost variations related with end of life care decisions are not well documented in the literature. Healthcare utilisation and associated health care costs for a group of older Australians who entered Transition Care following an acute hospital admission were calculated. Costs were differentiated according to a number of health care decisions and outcomes including advance directives (ADs).
Study participants were drawn from the Coaching Older Adults and Carers to have their preferences Heard (COACH) trial funded by the Australian National Health and Medical Research Council. Data collected included total health care costs, the type of (and when) ADs were completed and the place of death. Two-step endogenous treatment-regression models were employed to test the relationship between costs and a number of variables including completion of ADs.
The trial recruited 230 older adults with mean age 84 years. At the end of the trial, 53 had died and 80 had completed ADs. Total healthcare costs were higher for younger participants and those who had died. No statistically significant association was found between costs and completion of ADs.
For our frail study population, the completion of ADs did not have an effect on health care utilisation and costs. Further research is needed to substantiate these findings in larger and more diverse clinical cohorts of older people.
Trial registration
This study was registered on 13/12/2007 with the Australian New Zealand Clinical Trial Registry (ACTRN12607000638437).
PMCID: PMC4673742  PMID: 26645745
End of life; Advance directives; Care plans; Costs
2.  Factors Predictive of Weight Gain and Implications for Modeling in Type 2 Diabetes Patients Initiating Metformin and Sulfonylurea Combination Therapy 
Diabetes Therapy  2015;6(4):495-507.
The objectives of this study were to (a) assess the factors associated with weight gain in a population of type 2 diabetes patients escalating from metformin (M) to M+ sulfonylurea (M + S) and (b) evaluate whether healthcare resource utilization associated with being overweight or obese is underestimated in typical health economic evaluations.
The study was a retrospective cohort study using UK Clinical Practice Research Datalink linked to Hospital Episode Statistics (CPRD/HES) data. The association between baseline phenotypic factors and weight gain was assessed using logistic regression. Hospitalization incidence rates per 1000 person-years for major diabetes-related complications according to body mass index (BMI) at baseline were estimated from the data (observed) and compared to those obtained from a validated diabetes model (predicted).
11,071 patients were included in the analysis; approximately 40% gained weight in the first year following escalation to M + S. Baseline age, HbA1c and gender were found to be predictors of weight gain [odds ratios 0.99 (1-year increment), 1.11 (1% increment) and 0.81 (female vs male), respectively, p < 0.001]. Observed vs predicted incidence rates of hospitalization were 265 vs 13 (normal), 297 vs 31 (overweight), 223 vs 50 (obese) and 378 vs 41 (severe obese).
This analysis suggests there are identifiable patient characteristics predictive of weight gain that may be informative to clinical and economic decision making in the context of patients escalating from M to an M + S regimen. Hospital admissions in people with type 2 diabetes were generally under-predicted. A particular focus of future research should be the need for diabetes models to make the likelihood of experiencing an event conditional on BMI.
Takeda Development Centre Europe Ltd., UK.
Electronic supplementary material
The online version of this article (doi:10.1007/s13300-015-0134-y) contains supplementary material, which is available to authorized users.
PMCID: PMC4674479  PMID: 26446552
Diabetes modeling; Therapy escalation; Type 2 diabetes; Weight gain
3.  Assessment of Unmet Clinical Need in Type 2 Diabetic Patients on Conventional Therapy in the UK 
Diabetes Therapy  2014;5(2):567-578.
Type 2 diabetes mellitus (T2DM) is an increasing problem worldwide and a leading risk factor for cardiovascular disease. As beta cell function declines, the management of T2DM typically comprises of escalations in treatment from diet and exercise to oral therapies and eventually insulin. Treatment algorithms based on the attainment of blood glucose targets may not account for changes in other cardiovascular risk factors. The objective of this study is to describe unmet clinical need, defined as failure to reduce weight or meet targets for blood pressure, total cholesterol or glycated hemoglobin (HbA1c) levels.
Anonymized UK patient data for those (1) initiating oral antidiabetic drug (OAD) monotherapy, (2) escalating to dual therapy, (3) escalating to triple therapy, and (4) escalating to insulin therapy over the study period (01/01/2005–31/12/2009) were obtained from The Health Improvement Network (THIN). Changes in risk factors were evaluated before and after therapy escalation, and the attainment of targets, assessed at the last recorded measurement, as follows: HbA1c <7.5%, systolic blood pressure (SBP) <140 mmHg, total cholesterol (TC) <5 mmol/L, and reduction in weight.
Prior to therapy escalation, mean HbA1c in each subgroup exceeded 7.5% and was higher respective to the number of OADs being used (monotherapy: 8.03%; double: 8.48%; triple: 8.71%). Insulin users displayed the highest HbA1c prior to treatment escalation (9.78%). Following escalation, a decline in HbA1c was observed in all subgroups. By contrast, mean SBP and TC levels decreased prior to the addition of a second and third oral therapy. Consistent improvements following treatment escalation were not observed across the other risk factors following therapy escalation. Overall, the proportion of subjects that attained all four targets ranged from 3% (monotherapy and insulin) to 6% (dual therapy).
The potential unmet clinical need among conventionally treated T2DM patients is significant, with respect to the control of blood glucose and other cardiovascular risk factors: SBP, TC, and weight. There clearly remains the need for new therapeutic approaches to alleviate the burden associated with T2DM.
Electronic supplementary material
The online version of this article (doi:10.1007/s13300-014-0079-6) contains supplementary material, which is available to authorized users.
PMCID: PMC4269656  PMID: 25185770
Routine clinical practice; Type 2 diabetes mellitus; Unmet need
4.  Evaluation of Insulin Use and Value for Money in Type 2 Diabetes in the United Kingdom 
Diabetes Therapy  2013;4(1):51-66.
It is unclear as to whether human or long-acting analog insulins represent the most efficient use of health and non-healthcare resources in the management of type 2 diabetes mellitus (T2DM). The aim of this study was to evaluate the value for money relationship associated with the use of these insulins in the UK setting.
A literature search was performed for studies reporting expenditure associated with the use of human and analog insulins. Data from this review informed a budget impact assessment model. Costs were converted to a common currency and results are reported in 2011 British pounds sterling (GBP) values.
Annual diabetes-related medication expenditure and patients total expenditure associated with the management of T2DM were estimated to be £397 million and £3,901 million, respectively. Substitution of human insulin for analog insulins was associated with a drug acquisition cost saving of between £5 million and £23 million each year. Overall, though, total expenditure increased significantly with increased use of human insulin by £34 million to £136 million each year depending on the degree of substitution.
On the face of it, analog insulins are more expensive, prompting questions about potential cost savings to health services in the UK from direct substitution to the less expensive human preparation. The current analysis illustrates that the increased use of human insulin and decreased use of analog insulin would, however, increase the overall net societal cost of managing insulin-treated patients with T2DM. Governments and decision makers should consider that total healthcare expenditure would not necessarily fall when decisions are based solely on the use of cheaper products.
PMCID: PMC3687091  PMID: 23296753
Costs and cost analysis; Diabetes mellitus; Human insulin; Insulin analog; Resource allocation; Type 2 diabetes
5.  Coaching Older Adults and Carers to have their preferences Heard (COACH): A randomised controlled trial in an intermediate care setting (study protocol) 
The Australasian Medical Journal  2012;5(8):444-454.
Frail older people who are considering movement into residential aged care or returning home following a hospital admission often face complex and difficult decisions.Despite research interest in this area, a recent Cochrane review was unable to identify any studies of interventions to support decision-making in this group that met the experimental or quasi-experimental study design criteria.
This study tests the impact of a multi-component coaching intervention on the quality of preparation for care transitions, targeted to older adults and informal carers. In addition, the study assesses the impact of investing specialist geriatric resources into consultations with families in an intermediate care setting where decisions about future care needs are being made.
This study was a randomised controlled trial of 230 older adults admitted to intermediate care in Australia. Masked assessment at 3 and 12 months examined physical functioning, health–related quality of life and utilisation of health and aged care resources. A geriatrician and specialist nurse delivered a coaching intervention to both the older person and their carer/family. Components of the intervention included provision of a Question Prompt List prior to meeting with a geriatrician (to clarify medical conditions and treatments, medications, ‘red flags’, end of life decisions and options for future health care) and a follow-up meeting with a nurse who remained in telephone contact. Participants received a printed summary and an audio recording of the meeting with the geriatrician.
The costs and outcomes of the intervention are compared with usual care. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12607000638437).
PMCID: PMC3442189  PMID: 23024719
Caregivers; continuity of patient care; cost-benefit analysis; health care costs; intermediate care facilities; patient-centred care; quality of life; randomised controlled trial
6.  Switching from premixed insulin to glargine-based insulin regimen improves glycaemic control in patients with type 1 or type 2 diabetes: a retrospective primary care-based analysis 
Insulin glargine (glargine) and premixed insulins (premix) are alternative insulin treatments. This analysis evaluated glycaemic control in 528 patients with type 1 (n = 183) or type 2 (n = 345) diabetes, after switching from premix to a glargine-based regimen, using unselected general practice (GP) data.
Data for this retrospective observational analysis were extracted from a UK GP database (The Health Improvement Network). Patients were required to have at least 12 months of available data, before and after, switching from premix to a glargine-based regimen. The principal analysis was the change in HbA1c after 12 months of treatment with glargine; secondary analyses included change in weight, bolus usage and total daily insulin dose. Inconsistent reporting of hypoglycemic episodes precludes reliable assessment of this outcome. Multivariate analyses were used to adjust for baseline characteristics and confounding variables.
Both cohorts showed significant reduction in mean HbA1c 12 months after the switch: by -0.67% (p < 0.001) in the type 1 cohort and by -0.53% (p < 0.001) in the type 2 cohort (adjusted data). The size of HbA1c improvement was positively correlated with baseline HbA1c; patients with a baseline HbA1c ≥ 10% had the greatest mean reduction in HbA1c, by -1.7% (p < 0.001) and -1.2% (p < 0.001), respectively. The proportion of patients receiving co-bolus prescriptions increased in the type 1 (mean 24.6% to 95.1%, p < 0.001) and type 2 (mean 16.2% to 73.9%, p < 0.001) cohorts. There was no significant change in weight in either cohort. Total mean insulin use increased in type 2 diabetes patients (from 0.67 ± 1.35 U/Kg to 0.88 ± 1.33 U/Kg, p < 0.001) with a slight decrease in type 1 diabetes patients (from 1.04 ± 2.51 U/Kg to 0.98 ± 2.58 U/Kg, p < 0.001).
In everyday practice, patients with type 1 or type 2 diabetes inadequately controlled by premix insulins experienced significant improvement in glycaemic control over 12 months after switching to a glargine-based insulin regimen. These findings support the use of a basal-bolus glargine-based regimen in patients poorly controlled on premix.
PMCID: PMC2646718  PMID: 19220880
7.  Improved glycaemic control by switching from insulin NPH to insulin glargine: a retrospective observational study 
Insulin glargine (glargine) and insulin NPH (NPH) are two basal insulin treatments. This study investigated the effect on glycaemic control of switching from a NPH-based regimen to a glargine-based regimen in 701 patients with type 1 (n= 304) or type 2 (n= 397) diabetes, using unselected primary care data.
Data for this retrospective observational study were extracted from a UK primary care database (The Health Improvement Network). Patients were required to have at least 12 months of data before and after switching from NPH to glargine. The principal analysis was the change in HbA1c after 12 months treatment with glargine; secondary analyses included change in weight and total daily insulin dose. Inconsistent reporting of hypoglycemic episodes precludes reliable reporting of this outcome. Multivariate analyses were used to adjust for baseline characteristics and confounding variables.
After adjustment, both diabetic cohorts showed statistically significant reductions in mean HbA1c 12 months after the switch, by 0.38% (p < 0.001) in type 1 patients and 0.31% (p < 0.001) in type 2 patients. Improvement in HbA1c was positively correlated with baseline HbA1c; patients with baseline HbA1c ≥ 8% had reductions of 0.57% (p < 0.001) and 0.47% (p < 0.001), respectively. There was no significant change in weight or total daily insulin dose while on glargine. The majority of patients received a basal-bolus regimen prior to and after the switch (mean 79.3% before and 77.2% after switch in type 1 patients, and 80.4% and 76.8%, respectively in type 2 patients, p > 0.05).
In routine clinical practice, switching from NPH to glargine provides the opportunity for improving glycaemic control in diabetes patients inadequately controlled by NPH.
PMCID: PMC2637245  PMID: 19152692

Results 1-7 (7)