Volume-outcome relationships in open and endovascular repair of abdominal aortic aneurysm: administrative data 2006-2018.

BACKGROUND: The aim of this study was to use recent evidence to investigate and update volume-outcome relationships after open surgical repair (OSR) and endovascular repair (EVAR) of abdominal aortic aneurysm in England. METHODS: Hospital Episode Statistics (HES) data from April 2006 to March 2018 were obtained. The primary outcome was in-hospital death. Other outcomes included duration of hospital stay, readmissions within 30 days, and critical care requirements. Case-mix adjustment included age, sex, HES year, deprivation index, weekend admission, mode of admission, type of procedure and co-morbidities. RESULTS: Annual volume of all repairs combined appeared to be an appropriate measure of volume. After case-mix adjustment, a significant relationship between volume and in-hospital mortality was seen for OSR (P < 0·001) but not for EVAR (P = 0·169 for emergency and P = 0·363 for elective). The effect appeared to extend beyond 60 repairs per year to volumes above 100 repairs per year. There was no significant relationship between volume and duration of hospital stay or 30-day readmissions. In patients receiving emergency OSR, higher volume was associated with longer stay in critical care. CONCLUSION: Higher annual all-procedure volumes were associated with significantly lower in-hospital mortality for OSR, but such a relationship was not significant for EVAR. There was not enough evidence for a volume effect on other outcomes.

Sex differences in national rates of repair of emergency abdominal aortic aneurysm.

BACKGROUND: The aim of this study was to assess the sex differences in both the rate and type of repair for emergency abdominal aortic aneurysm (AAA) in England. METHODS: Hospital Episode Statistics (HES) data sets from April 2002 to February 2015 were obtained. Clinical and administrative codes were used to identify patients who underwent primary emergency definitive repair of ruptured or intact AAA, and patients with a diagnosis of AAA who died in hospital without repair. These three groups included all patients with a primary AAA who presented as an emergency. Sex differences between repair rates and type of surgery (endovascular aneurysm repair (EVAR) versus open repair) over time were examined. RESULTS: In total, 15 717 patients (83·3 per cent men) received emergency surgical intervention for ruptured AAA and 10 276 (81·2 per cent men) for intact AAA; 12 767 (62·0 per cent men) died in hospital without attempted repair. The unadjusted odds ratio for no repair in women versus men was 2·88 (95 per cent c.i. 2·75 to 3·02). Women undergoing repair of ruptured AAA were older and had a higher in-hospital mortality rate (50·0 versus 41·0 per cent for open repair; 30·9 versus 23·5 per cent for EVAR). After adjustment for age, deprivation and co-morbidities, the odds ratio for no repair in women versus men was 1·34 (1·28 to 1·40). The in-hospital mortality rate after emergency repair of an intact AAA was also higher among women. CONCLUSION: Women who present as an emergency with an AAA are less likely to undergo repair than men. Although some of this can be explained by differences in age and co-morbidities, the differences persist after case-mix adjustment.

Looking beyond the forest: Using harvest plots, gap analysis, and expert consultations to assess effectiveness, engage stakeholders, and inform policy.

We describe a combination of methods for assessing the effectiveness of complex interventions, especially where substantial heterogeneity with regard to the population, intervention, comparison, outcomes, and study design of interest is expected. We applied these methods in a recent systematic review of the effectiveness of reinforced home-based palliative care (rHBPC) interventions, which included home-based care with an additional and explicit component of lay caregiver support. We first summarized the identified evidence, deemed inappropriate for statistical pooling, graphically by creating harvest plots. Although very useful as a tool for summary and presentation of overall effectiveness, such graphical summary approaches may obscure relevant differences between studies. Thus, we then used a gap analysis and conducted expert consultations to look beyond the aggregate level at how the identified evidence of effectiveness may be explained. The goal of these supplemental methods was to step outside of the conventional systematic review and explore this heterogeneity from a broader perspective, based on the experience of palliative care researchers and practitioners. The gap analysis and expert consultations provided valuable input into possible underlying explanations in the evidence, which could be helpful in the further adaptation and testing of existing rHBPC interventions or the development and evaluation of new ones. We feel that such a combination of methods could prove accessible, understandable, and useful in informing decisions and could thus help increase the relevance of systematic reviews to the decision-making process.

Cost-effectiveness of population-based, community, workplace and individual policies for diabetes prevention in the UK.

AIM: To analyse the cost-effectiveness of different interventions for Type 2 diabetes prevention within a common framework. METHODS: A micro-simulation model was developed to evaluate the cost-effectiveness of a range of diabetes prevention interventions including: (1) soft drinks taxation; (2) retail policy in socially deprived areas; (3) workplace intervention; (4) community-based intervention; and (5) screening and intensive lifestyle intervention in individuals with high diabetes risk. Within the model, individuals follow metabolic trajectories (for BMI, cholesterol, systolic blood pressure and glycaemia); individuals may develop diabetes, and some may exhibit complications of diabetes and related disorders, including cardiovascular disease, and eventually die. Lifetime healthcare costs, employment costs and quality-adjusted life-years are collected for each person. RESULTS: All interventions generate more life-years and lifetime quality-adjusted life-years and reduce healthcare spending compared with doing nothing. Screening and intensive lifestyle intervention generates greatest lifetime net benefit (£37) but is costly to implement. In comparison, soft drinks taxation or retail policy generate lower net benefit (£11 and £11) but are cost-saving in a shorter time period, preferentially benefit individuals from deprived backgrounds and reduce employer costs. CONCLUSION: The model enables a wide range of diabetes prevention interventions to be evaluated according to cost-effectiveness, employment and equity impacts over the short and long term, allowing decision-makers to prioritize policies that maximize the expected benefits, as well as fulfilling other policy targets, such as addressing social inequalities.

The impact of Type 2 diabetes prevention programmes based on risk-identification and lifestyle intervention intensity strategies: a cost-effectiveness analysis.

AIMS: To develop a cost-effectiveness model to compare Type 2 diabetes prevention programmes targeting different at-risk population subgroups with a lifestyle intervention of varying intensity. METHODS: An individual patient simulation model was constructed to simulate the development of diabetes in a representative sample of adults without diabetes from the UK population. The model incorporates trajectories for HbA1c , 2-h glucose, fasting plasma glucose, BMI, systolic blood pressure, total cholesterol and HDL cholesterol. Patients can be diagnosed with diabetes, cardiovascular disease, microvascular complications of diabetes, cancer, osteoarthritis and depression, or can die. The model collects costs and utilities over a lifetime horizon. The perspective is the UK National Health Service and personal social services. We used the model to evaluate the population-wide impact of targeting a lifestyle intervention of varying intensity to six population subgroups defined as high risk for diabetes. RESULTS: The intervention produces 0.0003 to 0.0009 incremental quality-adjusted life years and saves up to £1.04 per person in the general population, depending upon the subgroup targeted. Cost-effectiveness increases with intervention intensity. The most cost-effective options are to target individuals with HbA1c > 42 mmol/mol (6%) or with a high Finnish Diabetes Risk (FINDRISC) probability score (> 0.1). CONCLUSION: The model indicates that diabetes prevention interventions are likely to be cost-effective and may be cost-saving over a lifetime. In the model, the criteria for selecting at-risk individuals differentially impact upon diabetes and cardiovascular disease outcomes, and on the timing of benefits. These findings have implications for deciding who should be targeted for diabetes prevention interventions.

The cost-effectiveness of weight management programmes in a postnatal population.

OBJECTIVES: The aim of the study was to estimate the cost-effectiveness of a weight management programme including elements of physical exercise and dietary restriction which are designed to help women lose excess weight gained during pregnancy in the vulnerable postnatal period and inhibit the development of behaviours which could lead to future excess weight gain and obesity. STUDY DESIGN: A mathematical model based on a regression equation predicting change in weight over a fifteen year postnatal period was developed. METHODS: The model included programme effectiveness and resource data based on a randomized controlled trial of a weight management programme implemented in a postnatal population in the United States. Utility and mortality data based on body mass index categories were also included. The model adopted a National Health Service (NHS) and personal social services (PSS) perspective, a lifetime time horizon and estimated the cost effectiveness of a weight management programme against a no change comparator in terms of an incremental cost-effectiveness ratio (ICER). RESULTS: The baseline results show that the difference in weight between women who received the weight management programme and women who received the control intervention was 3.02 kg at six months and 3.53 kg at fifteen years following childbirth. This results in an ICER of £7355 per quality adjusted life year (QALY) for women who were married at childbirth. CONCLUSION: The estimated ICER would suggest that such a weight management programme is cost-effective at a NICE threshold of £20,000 per QALY. However significant structural and evidence based uncertainty is present in the analysis.

Guaiac faecal occult blood test performance at initial and repeat screens in the English Bowel Cancer Screening Programme.

BACKGROUND: In many countries, screening for colorectal cancer (CRC) relies on repeat testing using the guaiac faecal occult blood test (gFOBT). This study aimed to compare gFOBT performance measures between initial and repeat screens. METHODS: Data on screening uptake and outcomes from the English Bowel Cancer Screening Programme (BCSP) for the years 2008 and 2011 were used. An existing CRC natural history model was used to estimate gFOBT sensitivity and specificity, and the cost-effectiveness of different screening strategies. RESULTS: The gFOBT sensitivity for CRC was estimated to decrease from 27.35% at the initial screen to 20.22% at the repeat screen. Decreases were also observed for the positive predictive value (8.4-7.2%) and detection rate for CRC (0.19-0.14%). Assuming equal performance measures for both the initial and repeat screens led to an overestimate of the cost effectiveness of gFOBT screening compared with the other screening modalities. CONCLUSIONS: Performance measures for gFOBT screening were generally lower in the repeat screen compared with the initial screen. Screening for CRC using gFOBT is likely to be cost-effective; however, the use of different screening modalities may result in additional benefits. Future economic evaluations of gFOBT should not assume equal sensitivities between screening rounds.

Modelling the economics of type 2 diabetes mellitus prevention: a literature review of methods.

Our objective was to review modelling methods for type 2 diabetes mellitus prevention cost-effectiveness studies. The review was conducted to inform the design of a policy analysis model capable of assisting resource allocation decisions across a spectrum of prevention strategies. We identified recent systematic reviews of economic evaluations in diabetes prevention and management of obesity. We extracted studies from two existing systematic reviews of economic evaluations for the prevention of diabetes. We extracted studies evaluating interventions in a non-diabetic population with type 2 diabetes as a modelled outcome, from two systematic reviews of obesity intervention economic evaluations. Databases were searched for studies published between 2008 and 2013. For each study, we reviewed details of the model type, structure, and methods for predicting diabetes and cardiovascular disease. Our review identified 46 articles and found variation in modelling approaches for cost-effectiveness evaluations for the prevention of type 2 diabetes. Investigation of the variables used to estimate the risk of type 2 diabetes suggested that impaired glucose regulation, and body mass index were used as the primary risk factors for type 2 diabetes. A minority of cost-effectiveness models for diabetes prevention accounted for the multivariate impacts of interventions on risk factors for type 2 diabetes. Twenty-eight cost-effectiveness models included cardiovascular events in addition to type 2 diabetes. Few cost-effectiveness models have flexibility to evaluate different intervention types. We conclude that to compare a range of prevention interventions it is necessary to incorporate multiple risk factors for diabetes, diabetes-related complications and obesity-related co-morbidity outcomes.

Community-based dietary and physical activity interventions in low socioeconomic groups in the UK: a mixed methods systematic review.

OBJECTIVE: Low socioeconomic status (SES) is a risk factor for type 2 diabetes and changes in diet and physical activity can prevent diabetes. We assessed the effectiveness and acceptability of community-based dietary and physical activity interventions among low-SES groups in the UK. METHOD: We searched relevant databases and web resources from 1990 to November 2009 to identify relevant published and grey literature using an iterative approach, focusing on UK studies. RESULTS: Thirty-five relevant papers (nine quantitative, 23 qualitative and three mixed methods studies) were data extracted, quality assessed and synthesised using narrative synthesis and thematic analysis. The relationship between interventions and barriers and facilitators was also examined. Dietary/nutritional, food retail, physical activity and multi-component interventions demonstrated mixed effectiveness. Qualitative studies indicated a range of barriers and facilitators, which spanned pragmatic, social and psychological issues. The more effective interventions used a range of techniques to address some surface-level psychological and pragmatic concerns, however many deeper-level social, psychological and pragmatic concerns were not addressed. CONCLUSION: Evidence on the effectiveness of community-based dietary and physical activity interventions is inconclusive. A range of barriers and facilitators exist, some of which were addressed by interventions but some of which require consideration in future research.

Laparoscopic adjustable gastric banding vs standard medical management in obese patients with type 2 diabetes: a budget impact analysis in the UK.

OBJECTIVE: To evaluate the financial consequences of using laparoscopic adjustable gastric banding (LAGB) in place of standard medical management (SMM) in obese patients with type 2 diabetes from a UK healthcare payer perspective. DESIGN AND METHODS: A budget impact model was constructed to evaluate the budgetary implications of LAGB in obese patients with type 2 diabetes in the UK. For patients undergoing LAGB, the model captured pre-, peri-, and post-operative costs including consultations with physicians, psychologists, nurses, and dieticians, the cost of surgery, and costs associated with post-surgical complications. The model also captured costs associated with medication for diabetes, asthma, hypertension, and hyperlipidemia, costs of diabetes complications, sleep apnea, and asthma, and costs of diagnostic tests. The SMM arm also captured costs associated with very low calorie diet products. Costs were modeled in a simulated UK cohort of 100 obese patients with newly-diagnosed diabetes. Future costs were discounted at 3.5% per annum and all costs were reported in 2010 pounds sterling. RESULTS: Over the 5-year time horizon, the cohort of 100 patients who underwent LAGB incurred costs £91,287 lower than an equivalent cohort receiving SMM (£818,668 and £909,955, respectively). Costs of surgery and post-surgical complications (£254,000 and £40,981, respectively) were more than offset by savings arising from reduced diabetes, asthma, and sleep apnea medication costs, reduced incidence of diabetes complications, and fewer healthcare professional contacts. Sensitivity analysis (SA) showed that the model was most sensitive to assumptions around diabetes medication use, although none of the SA findings showed LAGB to be more costly than SMM. LIMITATIONS: In order to capture the diverse resource use and medical care costs arising in obese patients with type 2 diabetes, the analysis made use of a range of heterogeneous data sources. While the vast majority of data were applicable to obese patients with recently-diagnosed diabetes in the UK setting, some surrogate data (e.g. from different geographies) were used in cases where data in the target population were unavailable. Additionally, given the largely uncharacterized long-term risk profile in patients with remission of type 2 diabetes, remission was captured using a transparent and highly conservative approach. CONCLUSIONS: Based on the findings of the present analysis, the high initial costs of performing LAGB are offset within 5 years after surgery when compared with SMM in a population of obese patients with type 2 diabetes. The high up-front costs associated with surgery should not therefore be a barrier to its reimbursement in this patient group.

National audit of the use of fibrinogen concentrate to correct hypofibrinogenaemia.

BACKGROUND: Massive haemorrhage occurs in a variety of clinical settings resulting in consumptive and dilutional coagulopathies leading to hypofibrinogenaemia. METHODS/MATERIALS: A prospective observational national cohort study was performed between November 2008 and June 2010 to collect safety data on the off-label use of a fibrinogen concentrate to treat acquired hypofibrinogenaemia. RESULTS: A prospective cohort of 63 patients with varying causes of hypofibrinogenaemia resulted from this data collection. A single infusion of fibrinogen concentrate was given in 49 (77%) of patients studied and 12 received more than one infusion. The median inter-quartile range (IQR) dose of fibrinogen infused was 49 (26-61) mg kg(-1). The median (IQR) fibrinogen level before and after infusion was 0.9 (0.6-1.3) and 1.8 (1.4-4.3) g L(-1), respectively (P < 0.001). In 31 patients (67%), bleeding stopped within 4 h and fibrinogen was reported to have contributed to this outcome by the treating clinicians. In 84% of cases the treating clinician reported that the use of fibrinogen concentrate reduced the rate of bleeding. Fibrinogen was associated with a statistically significant reduction in red blood cell transfusion (median 4 units before and 0 units after, P < 0.001) and fresh frozen plasma infusion (median 4 units before and 0 units after, P < 0.001). Three venous and one arterial non-fatal thrombotic events were recorded in the patients treated with fibrinogen. CONCLUSION: Fibrinogen concentrate can be used to correct hypofibrinogenaemia and may reduce blood product usage.

Reappraisal of the options for colorectal cancer screening in England.

AIM: The aim was to use newly available data to estimate the cost effectiveness and endoscopy requirements of screening options for colorectal cancer (CRC) to inform screening policy in England. METHODS: A state transition model simulated the life experience of a cohort of individuals in the general population of England with normal colon/rectal epithelium through to the development of adenomas and CRC and subsequent death. CRC natural history model parameters and screening test characteristics were estimated simultaneously by a process of model calibration. This process was fitted to observed data on CRC incidence in the absence of screening, data from existing screening programmes, and data from the UK flexible sigmoidoscopy (FS) screening trial. The costs, effects and resource impact were evaluated for a range of screening options involving the guaiac or immunochemical faecal occult blood test (gFOBT/iFOBT) and FS. RESULTS: The model suggests that screening strategies involving FS or iFOBT may produce additional benefits compared with the current policy of biennial gFOBT for 60-74-year-olds. The age at which a single FS screen results in the greatest quality-adjusted life year gain was 55, with similar gains for ages between 52 and 58. Strategies which combined FS and iFOBT showed further benefits and improved economic outcomes. CONCLUSIONS: Strategies which combine different screening modalities may provide greater clinical and economic benefits. The collection of comprehensive screening data using a uniform format will enable comparative analysis across screening programmes in different countries, will improve our understanding of the disease and will allow identification of optimal screening modalities.

Cost-effectiveness of population-based screening for colorectal cancer: a comparison of guaiac-based faecal occult blood testing, faecal immunochemical testing and flexible sigmoidoscopy.

BACKGROUND: Several colorectal cancer-screening tests are available, but it is uncertain which provides the best balance of risks and benefits within a screening programme. We evaluated cost-effectiveness of a population-based screening programme in Ireland based on (i) biennial guaiac-based faecal occult blood testing (gFOBT) at ages 55-74, with reflex faecal immunochemical testing (FIT); (ii) biennial FIT at ages 55-74; and (iii) once-only flexible sigmoidoscopy (FSIG) at age 60. METHODS: A state-transition model was used to estimate costs and outcomes for each screening scenario vs no screening. A third party payer perspective was adopted. Probabilistic sensitivity analyses were undertaken. RESULTS: All scenarios would be considered highly cost-effective compared with no screening. The lowest incremental cost-effectiveness ratio (ICER vs no screening euro 589 per quality-adjusted life-year (QALY) gained) was found for FSIG, followed by FIT euro 1696) and gFOBT (euro 4428); gFOBT was dominated. Compared with FSIG, FIT was associated with greater gains in QALYs and reductions in lifetime cancer incidence and mortality, but was more costly, required considerably more colonoscopies and resulted in more complications. Results were robust to variations in parameter estimates. CONCLUSION: Population-based screening based on FIT is expected to result in greater health gains than a policy of gFOBT (with reflex FIT) or once-only FSIG, but would require significantly more colonoscopy resources and result in more individuals experiencing adverse effects. Weighing these advantages and disadvantages presents a considerable challenge to policy makers.

The effectiveness of training and support for carers and other professionals on the physical and emotional health and well-being of looked-after children and young people: a systematic review.

Looked-after children and young people (LACYP) are recognized as a high-risk group for behavioural and emotional problems, and additional specialist training for foster carers may reduce such problems. This systematic review aimed to identify and synthesize evidence on the effectiveness of additional training and support provided to approved carers, professionals and volunteers on the physical and emotional health and well-being of LACYP (including problem behaviours and placement stability). Searches of health and social science databases were conducted and records were screened for inclusion criteria. Citation and reference list searches were conducted on included studies. Included studies were synthesized and critically appraised. Six studies were included (five randomized controlled trials and one prospective cohort study), all of which focused on foster carers. Three studies reported a benefit of training and three reported no benefit but no detriment. Those reporting a benefit of training were conducted in the USA, and had longer-duration training, shorter follow-up assessment and recruited carers of younger children than studies that reported no benefit of training, which were conducted in the UK. Whether the difference in results is due to the type of training or to cultural or population differences is unclear. The findings suggest a mixed effect of training for foster carers on problem behaviours of LACYP. The evidence identified appears to suggest that longer-duration training programmes have a beneficial effect on the behaviour problems of LACYP, although future research should examine the impact of training durations and intensity on short-medium and longer-term outcomes of LACYP of different ages. Only training and support for foster carers was identified.