The clinical and cost-effectiveness of patient education models for diabetes : a systematic review and economic evaluation

Description of the proposed service This systematic review examines the clinical and cost-effectiveness of patient education models for adults with Type 1 or Type 2 diabetes. Epidemiology and background Diabetes mellitus (diabetes) is characterised by a state of chronic hyperglycaemia (raised blood sugar). There are two main types of diabetes: Type 1 and Type 2. Type 1 diabetes is an autoimmune condition involving a process of destruction of the beta cells of the pancreas, leading to severe insulin deficiency. About one-fifth of patients with diabetes in England and Wales have Type 1 diabetes. Type 2 diabetes is characterised by insulin resistance and relative insulin deficiency and is linked to being overweight or obese, and to physical inactivity. Type 2 diabetes primarily affects people aged over 40 years. The basic target in the treatment of diabetes is the normalisation of blood glucose levels. Poor control of diabetes can in the short term result in diabetic ketoacidosis, a serious and potentially fatal condition, and in the long term can increase the risk of complications such as diabetic retinopathy and nephropathy. However, studies have shown that good diabetic control is associated with a reduced risk of these complications. Diabetic control is affected by both lifestyle factors such as diet, and by pharmacological treatments, and the management of diabetes is largely the responsibility of patients. A key component in empowering patients to manage their own diabetes is education. Education of patients with diabetes is considered a fundamental aspect of diabetes care and aims to empower patients by improving knowledge and skills. Structured educational programmes for diabetes self-management are often multifaceted interventions providing patients with information not only about diabetes but also management issues such as diet, exercise, self-monitoring of blood glucose and medication use. Methods A systematic review of the literature and an economic evaluation were undertaken. Data sources Electronic databases were searched, including the Cochrane Library, MEDLINE, EMBASE, PubMed, Science Citation Index, Web of Science Proceedings, DARE and HTA databases, PsychINFO, CINAHL, NHS Economic Evaluation Database and EconLit. References of all retrieved articles were checked for relevant studies, and experts were contacted for advice and peer review and to identify additional published and unpublished references. Sponsor submissions to the National Institute for Clinical Excellence were reviewed. Study selection Studies were included if they fulfilled the following criteria: Interventions: educational interventions compared with usual care or another educational intervention. Participants: adults with Type 1 or Type 2 diabetes mellitus. Outcomes: must report glycated haemoglobin, hypoglycaemic episodes, diabetic complications or quality of life. Other reported outcomes from included studies were discussed. Evaluation of outcomes >12 months from inception of intervention. Design: randomised clinical trials (RCTs), and controlled clinical trial (CCTs) with a concurrent control were included. Reporting: studies were only included if they reported sufficient detail of the intervention to be reproducible (e.g. topics covered, who provided the education, how many sessions were available). Studies in non-English language or available only as abstracts were excluded. Titles and abstracts were checked by two reviewers. Full texts of selected studies were assessed for inclusion by one reviewer and checked by a second. Differences in opinion were resolved through discussion. Data extraction and quality assessment Data extraction and quality assessment were undertaken by one reviewer and checked by a second, with any disagreement resolved through discussion involving a third reviewer if necessary. The quality of included studies was assessed in accordance with Centre for Reviews and Dissemination Report 4. Data synthesis Data on clinical effectiveness were synthesised through a narrative review with tabulation of results from included studies. Studies were too diverse to be combined in a meta-analysis. Cost-effectiveness analyses were reported in a narrative review. Number and quality of studies Searches identified 24 studies comparing education with either a control group or with another educational intervention. These were 18 RCTs and six CCTs. Four studies included adults with Type 1 diabetes, 16 studies included adults with Type 2 diabetes and four studies included adults with either Type 1 or Type 2 diabetes. The quality of reporting and methodology of the studies was generally poor by today’s standards with only two RCTs reporting adequate randomisation procedures and none demonstrating adequate allocation concealment. Economic evaluations Literature searches identified only two studies reporting cost-effectiveness results: one cost-utility analysis and one cost-effectiveness analysis using intermediate outcomes only. Summary of benefits Studies of education in Type 1 diabetes suggest that education programmes offered as a part of intensified treatment interventions can result in significant and long-lasting improvements in metabolic control and reductions in complications. These are studies in which education is part of a package of care also including treatment changes (for example diet and insulin) and therefore it is not possible to draw conclusions about potential effects of education per se in Type 1 diabetes. Diverse educational programmes in Type 2 diabetes did not yield consistent results. Although some trials reported significant improvements in metabolic control and/or quality of life or other psychological outcomes, many others did not report significant effects of educational interventions. No clear characterisation is possible as to what features of education may be beneficial in this patient group. Studies that included patients with either Type 1 or Type 2 diabetes also produced mixed results with only poorer quality studies reporting significant effects. Costs Literature searches identified a small number of studies offering cost data in relation to patient education models. These were all studies undertaken outside the UK and they covered a variety of methodologies. We are not able to generalise from these studies as to the cost-effectiveness of patient education models. Patient education models will predominantly consist of direct costs for resource inputs to particular education packages, for example staff time (diabetes specialist nurse, dietitian and/or consultant) and education materials. The Dose Adjustment for Normal Eating (DAFNE) intervention is estimated to cost approximately £545 per person attending. Costs per life year gained Owing to the absence of accurate data on health outcomes, we are not able to provide cost-effectiveness summary statistics. The evidence base does indicate that improved glycaemic control is likely to have a positive impact on the incidence of long-term diabetic complications. Therefore, where the costs associated with patient education are assumed to be in the region of £500–600 per patient, the benefits over time would have to be very modest to offer an attractive cost-effectiveness profile for the intervention. The submission from the DAFNE study group predicts a scenario in which the DAFNE intervention results in cost savings and added health benefits over time, when compared with usual practice. Implications The main implication for the NHS would be staff time, particularly of diabetes specialist nurses, but also dietitians. Provision of increased education may be hindered by a shortage of trained specialist nurses, which will take some years to resolve. Future research needs The paucity of high-quality trials that have tested education per se in diabetes reveals a need for more research. Such research should focus on RCTs with clear designs based on explicit hypotheses and with a range of outcomes evaluated after long follow-up intervals. In order to draw conclusions about the effects of education alone, such trials should manipulate only education rather than confounding education with other factors

OnabotulinumtoxinA in the treatment of overactive bladder: a cost-effectiveness analysis versus best supportive care in England and Wales

The cost-effectiveness of onabotulinumtoxinA (BOTOX®) 100 U + best supportive care (BSC) was compared with BSC alone in the management of idiopathic overactive bladder in adult patients who are not adequately managed with anticholinergics. BSC included incontinence pads and, for a proportion of patients, anticholinergics and/or occasional clean intermittent catheterisation. A five-state Markov model was used to estimate total costs and outcomes over a 10-year period. The cohort was based on data from two placebo-controlled trials and a long-term extension study of onabotulinumtoxinA. After discontinuation of initial treatment, a proportion of patients progressed to downstream sacral nerve stimulation (SNS). Cost and resource use was estimated from a National Health Service perspective in England and Wales using relevant reference sources for 2012 or 2013. Results showed that onabotulinumtoxinA was associated with lower costs and greater health benefits than BSC in the base case, with probabilistic sensitivity analysis indicating an 89 % probability that the incremental cost-effectiveness ratio would fall below £20,000. OnabotulinumtoxinA remained dominant over BSC in all but two scenarios tested; it was also economically dominant when compared directly with SNS therapy. In conclusion, onabotulinumtoxinA appears to be a cost-effective treatment for overactive bladder compared with BSC alone

Comparative assessment of onabotulinumtoxinA and mirabegron for overactive bladder: an indirect treatment comparison

CONTEXT: OnabotulinumtoxinA and mirabegron have recently gained marketing authorisation to treat symptoms of overactive bladder (OAB). OBJECTIVE: To evaluate the relative efficacy of mirabegron and onabotulinumtoxinA in patients with idiopathic OAB. DESIGN: Network meta-analysis. DATA SOURCES: A search of 9 electronic databases, review documents, guidelines and websites. METHODS: Randomised trials comparing any licensed dose of onabotulinumtoxinA or mirabegron with each other, anticholinergic drugs or placebo were eligible (19 randomised trials were identified). 1 reviewer extracted data from the studies and a second reviewer checked the data. Candidate trials were assessed for similarity and networks were developed for each outcome. Bayesian network meta-analysis was conducted using both fixed-effects and random-effects models. When there were differences in mean baseline values between mirabegron and onabotulinumtoxinA trials they were adjusted for using network meta-regression (NMR). RESULTS: No studies directly comparing onabotulinumtoxinA to mirabegron were identified. A network was created for each of the 7 outcomes, with 3-9 studies included in each individual network. The trials included in the networks were broadly similar. Patients in the onabotulinumtoxinA trials had more urinary incontinence and urgency episodes at baseline than patients in the mirabegron trials and these differences were adjusted for using NMR. Both onabotulinumtoxinA and mirabegron were more efficacious than placebo at reducing the frequency of urinary incontinence, urgency, urination and nocturia. OnabotulinumtoxinA was more efficacious than mirabegron (50 and 25 mg) in completely resolving daily episodes of urinary incontinence and urgency and in reducing the frequency of urinary incontinence, urgency and urination. NMR supported the results of the network meta-analysis. CONCLUSIONS: In the absence of head-to-head trials comparing onabotulinumtoxinA to mirabegron, this indirect comparison indicates that onabotulinumtoxinA may be superior to mirabegron in improving symptoms of urinary incontinence, urgency and urinary frequency in patients with idiopathic OAB

Splitting of the Dipole and Spin-Dipole Resonances

Cross sections for the 90,92,94Zr(p,n) reactions were measured at energies of 79.2 and 119.4 MeV. A phenomenological model was developed to describe the variation with bombarding energy of the position of the L=1 peak observed in these and other (p,n) reactions. The model yields the splitting between the giant dipole and giant spin dipole resonances. Values of these splittings are obtained for isotopes of Zr and Sn and for 208Pb.Comment: 14 pages, 4 figure

Web 2.0 systems supporting childhood chronic disease management: A pattern language representation of a general architecture

<p>Abstract</p> <p>Background</p> <p>Chronic disease management is a global health concern. By the time they reach adolescence, 10–15% of all children live with a chronic disease. The role of educational interventions in facilitating adaptation to chronic disease is receiving growing recognition, and current care policies advocate greater involvement of patients in self-care. Web 2.0 is an umbrella term for new collaborative Internet services characterized by user participation in developing and managing content. Key elements include Really Simple Syndication (RSS) to rapidly disseminate awareness of new information; weblogs (blogs) to describe new trends, wikis to share knowledge, and podcasts to make information available on personal media players. This study addresses the potential to develop Web 2.0 services for young persons with a chronic disease. It is acknowledged that the management of childhood chronic disease is based on interplay between initiatives and resources on the part of patients, relatives, and health care professionals, and where the balance shifts over time to the patients and their families.</p> <p>Methods</p> <p>Participatory action research was used to stepwise define a design specification in the form of a pattern language. Support for children diagnosed with diabetes Type 1 was used as the example area. Each individual design pattern was determined graphically using card sorting methods, and textually in the form <it>Title, Context, Problem, Solution, Examples and References</it>. <it>Application references </it>were included at the lowest level in the graphical overview in the pattern language but not specified in detail in the textual descriptions.</p> <p>Results</p> <p>The design patterns are divided into functional and non-functional design elements, and formulated at the levels of organizational, system, and application design. The design elements specify access to materials for development of the competences needed for chronic disease management in specific community settings, endorsement of self-learning through online peer-to-peer communication, and systematic accreditation and evaluation of materials and processes.</p> <p>Conclusion</p> <p>The use of design patterns allows representing the core design elements of a Web 2.0 system upon which an 'ecological' development of content respecting these constraints can be built. Future research should include evaluations of Web 2.0 systems implemented according to the architecture in practice settings.</p

Specialist nursing and community support for the carers of people with dementia living at home: an evidence synthesis.

Specialist nurses are one way of providing support for family carers of people with dementia, but relatively little is known about what these roles achieve, or if they are more effective than roles that do not require a clinical qualification. The aim of this review was to synthesise the literature on the scope and effectiveness of specialist nurses, known as Admiral Nurses, and set this evidence in the context of other community-based initiatives to support family carers of people with dementia. We undertook a systematic review of the literature relating to the scope and effectiveness of Admiral Nurses and a review of reviews of interventions to support the family carers of people with dementia. To identify studies, we searched electronic databases, undertook lateral searches and contacted experts. Searches were undertaken in November 2012. Results are reported narratively with key themes relating to Admiral Nurses identified using thematic synthesis. We included 33 items relating to Admiral Nurses (10 classified as research) and 11 reviews evaluating community-based support for carers of people with dementia. There has been little work to evaluate specific interventions provided by Admiral Nurses, but three overarching thematic categories were identified: (i) relational support, (ii) co-ordinating and personalising support and (iii) challenges and threats to the provision of services by Admiral Nurses. There was an absence of clearly articulated goals and service delivery was subject to needs of the host organisation and the local area. The reviews of community-based support for carers of people with dementia included 155 studies but, in general, evidence that interventions reduced caregiver depression or burden was weak, although psychosocial and educational interventions may reduce depression in carers. Community support for carers of people with dementia, such as that provided by Admiral Nurses, is valued by family carers, but the impact of such initiatives is not clearly established

Systematic review and economic analysis of the comparative effectiveness of different inhaled corticosteroids and their usage with long-acting beta2 agonists for the treatment of chronic asthma in adults and children aged 12 years and over

Meta-AnalysisResearch Support, Non-U.S. Gov'tReviewThis is a freely-available open access publication. Please cite the published version which is available via the DOI link in this recordOBJECTIVES: To assess the clinical and cost-effectiveness of inhaled corticosteroids (ICS) alone and ICS used in combination with a long-acting beta2 agonist (LABA) in the treatment of chronic asthma in adults and children aged over 12 years. DATA SOURCES: Major electronic bibliographic databases, e.g. MEDLINE and EMBASE, were searched up to February/March 2006 (and updated again in October 2006). REVIEW METHODS: A systematic review of clinical and cost-effectiveness studies was conducted. Cost comparison and cost-consequence analyses were performed where appropriate. RESULTS: The assessment of clinical effectiveness was based on the 67 randomised controlled trials selected from the 5175 reports identified through the systematic literature search. The most frequently reported relevant outcomes were lung function, symptoms, use of rescue medication and adverse events. The trials varied considerably. In the trials that compared low-dose ICS versus ICS and high-dose ICS versus ICS, there were few significant differences in clinical effectiveness, although a few of the trials had assessed non-inferiority between the comparators rather than superiority. At doses of 400, 800 and 'high-level' doses of 1500 or 1600 microg/day, beclometasone dipropionate (BDP) appears to be the current cheapest ICS product both with the inclusion and exclusion of chlorofluorocarbon (CFC)-propelled products. A significant treatment benefit for combination ICS/LABA therapy across a range of outcomes compared with ICS alone was identified [when the ICS was double the accepted clinically equivalent dose of the ICS in the combination inhaler, and dry powder inhalers (DPIS) were used to deliver the drugs]. When a formoterol fumarate (FF)/salmeterol (SAL) combination inhaler and a budesonide (BUD)/FF combination inhaler were each compared with their constituent drugs delivered in separate inhalers, there were very few statistically significant differences between the treatments across the various efficacy outcomes and the rate of adverse events. Combination inhalers were more often cheaper than doubling the dose of ICS alone. However, the costs were highly variable and dependent on both the dose required and the preparation used in the trials. The estimated mean annual cost of FP/SAL combination varied from being 94 pounds cheaper to 109 pounds more expensive than the alternative of BUD at a higher dose. The BUD/FF combination varied from being 163 pounds cheaper to 66 pounds more expensive than the higher dose of either BUD or FP. When the combination inhalers were compared to each other, the results were mixed, with the FP/SAL combination significantly superior on some outcomes and the BUD/FF combination superior on others; however, meta-analysis showed that there were no significant differences between the two treatments in the rate of adverse events. Taking an ICS with a LABA as either of the two currently available combination products, FP/SAL and BUD/FF, is usually cheaper than taking the relevant constituent drugs in separate inhalers. At very high doses of BUD (1600 microg/day), however, the BUD/FF combination inhaler can be up to 156 pounds more expensive than having the same drugs in separate inhalers. In terms of the relative costs associated with taking one of the combination inhalers, at low dose (400 microg BUD or 200 microg FP/day) the cheapest combination inhaler is FP/SAL as a pressurised metered dose inhaler (pMDI) (Seretide Evohaler). However, this is only slightly cheaper than using BUD/FF as a DPI (Symbicort Turbohaler). At higher dose levels (800 microg BUD or 500 microg FP/day) FP/SAL as either pMDI aerosol (Seretide Evohaler) or a DPI (Seretide Accuhaler) is the cheapest combination product available, but again only slightly cheaper than the DPI BUD/FF combination (Symbicort Turbohaler). It should be highlighted, however, that the three head-to-head trials that compared the effects of FP/SAL with BUD/FF used the FP/SAL DPI combination inhaler, Seretide Accuhaler. CONCLUSIONS: The evidence indicates that there are few consistent significant differences in effects between the five ICS licensed for use in adults and adolescents over the age of 12 years, at either low or high dose. On average, BDP products currently tend to be the cheapest ICS available and tend to remain so as the daily ICS dose required increases. There is evidence that the addition of a LABA to an ICS is potentially more clinically effective than doubling the dose of ICS alone, although consistent significant differences between the two treatment strategies are not observed for all outcome measures. The cost differences between combination therapy compared with ICS monotherapy are highly variable and dependent on the dose required and the particular preparations used. For the combination therapies of ICS/LABA there are potential cost savings with the use of combination inhalers compared with separate inhalers, with few differences between the two treatment strategies in terms of effects. The only exception to this cost saving is with BUD/FF at doses higher than 1200 microg/day, where separate inhaler devices can become equivalent to or cheaper than combination inhalers. Neither of the two combination inhalers (FP/SAL or BUD/FF) is consistently superior in terms of treatment effect. A comparison of the costs associated with each combination therapy indicates that at low dose FP/SAL delivered via a pMDI is currently the cheapest combination inhaler but only marginally cheaper than BUD/FF delivered as a DPI. At higher doses, both the FP/SAL combination inhalers (PMDI and DPI) are marginally cheaper than BUD/FF (DPI). Future trials of treatment for chronic asthma should standardise the way in which outcome measures are defined and measured, with a greater focus on patient-centred outcomes. For informing future cost-utility and cost-effectiveness analyses from a UK NHS perspective, there is a need for longitudinal studies that comprehensively track the care pathways followed when people experience asthma exacerbations of different severity. Further research synthesis, quantifying the adverse effects of the different ICS, is required for treatment choices by patients and clinicians to be fully informed.HTA Programme, NIC

Abdominal obesity and metabolic syndrome: exercise as medicine?

Background: Metabolic syndrome is defined as a cluster of at least three out of five clinical risk factors: abdominal (visceral) obesity, hypertension, elevated serum triglycerides, low serum high-density lipoprotein (HDL) and insulin resistance. It is estimated to affect over 20% of the global adult population. Abdominal (visceral) obesity is thought to be the predominant risk factor for metabolic syndrome and as predictions estimate that 50% of adults will be classified as obese by 2030 it is likely that metabolic syndrome will be a significant problem for health services and a drain on health economies.Evidence shows that regular and consistent exercise reduces abdominal obesity and results in favourable changes in body composition. It has therefore been suggested that exercise is a medicine in its own right and should be prescribed as such. Purpose of this review: This review provides a summary of the current evidence on the pathophysiology of dysfunctional adipose tissue (adiposopathy). It describes the relationship of adiposopathy to metabolic syndrome and how exercise may mediate these processes, and evaluates current evidence on the clinical efficacy of exercise in the management of abdominal obesity. The review also discusses the type and dose of exercise needed for optimal improvements in health status in relation to the available evidence and considers the difficulty in achieving adherence to exercise programmes. Conclusion: There is moderate evidence supporting the use of programmes of exercise to reverse metabolic syndrome although at present the optimal dose and type of exercise is unknown. The main challenge for health care professionals is how to motivate individuals to participate and adherence to programmes of exercise used prophylactically and as a treatment for metabolic syndrome

Nursing sensitive outcomes in patients with rheumatoid arthritis: A systematic literature review

© 2017 Elsevier Ltd Background Although rheumatology nursing has been shown to be effective in managing patients with rheumatoid arthritis, patient outcomes sensitive to nursing interventions (nursing sensitive outcomes) have not been systematically studied. Objectives The objective of this study was to identify and delineate relevant patient outcomes measured in studies that reported nursing interventions in patients with rheumatoid arthritis. Design A systematic search was conducted from 1990 to 2016. Inclusion criteria were (i) patients with rheumatoid arthritis, (ii) adult population age ≥16 years, (iii) nurse as part of the care team or intervention delivery, (iv) primary research only, (v) English language, and (vi) quantitative studies with nursing sensitive outcomes. Data sources Medline, CINAHL, Ovid nursing, Cochrane library and PsycINFO databases were searched for relevant studies. Review methods Using the predetermined inclusion/exclusion criteria, nine reviewers working in pairs assessed the eligibility of the identified studies based on titles and abstracts. Papers meeting the inclusion criteria were retrieved and full texts were further assessed. Critical Appraisal Skills Programme tools were used to assess the quality of the included studies. Data on nursing sensitive outcomes were extracted independently by two reviewers. The Outcome Measures in Rheumatology comprehensive conceptual framework for health was used to contextualise and present findings. Results Of the 820 articles retrieved, 7 randomised controlled trials and 3 observational studies met the inclusion criteria. Seventeen nursing sensitive outcomes were identified (disease activity, clinical effects, pain, early morning stiffness duration, fatigue, patient safety issues, function, knowledge, patient satisfaction, confidence in care received, mental health status, self-efficacy, patient attitude/perception of ability to control arthritis, quality of life, health utility, health care resources, death). These fitted into 10 health intervention domains in keeping with the pre-specified conceptual framework for health: disease status, effectiveness, safety, function, knowledge, satisfaction, psychological status, quality of life, cost, death. A total of 59 measurement instruments were identified comprising patient reported outcome measures (n = 31), and biologic measures and reports (n = 28). Conclusions This review is notable in that it is the first to have identified, and reported, a set of multidimensional outcome measures that are sensitive to nursing interventions in rheumatology specifically. Further research is required to determine a core set of outcomes to be used in all rheumatology nursing intervention studies