Improving type 2 diabetes mellitus glycaemic outcomes is possible without spending more on medication: Lessons from the UK National Diabetes Audit.

AIMS: To determine the factors at general practice level that relate to glycaemic control outcomes in people with type 2 diabetes (T2DM). METHODS: Data were accessed from 4050 general practices (50% of total) covering 1.6 million patients with T2DM in the UK National Diabetes Audit 2013 to 2014 and 2014 to 2015. This audit reported characteristics, services and outcomes in the T2DM population, including percentage of patients who had total glycaemic control (TGC), defined as glycated haemoglobin (HbA1c) ≤7.5% (58 mmol/mol), and the percentage who were at higher glycaemic risk (HGR), defined as HbA1c >10% (86 mmol/mol); the respective figures were 67.2% and 6.2%. The medication data were examined in terms of annual defined daily doses (DDDs). Multivariate linear regression analysis was used to identify associations between DDD and patient and practice characteristics. RESULTS: Over the period 2012/2013 to 2015/2016, patient numbers grew 4% annually and annual medication expenditure by 8%, but glycaemic control outcomes did not improve. The main findings were that practices with better outcomes: had a higher percentage of patients aged >65 years; provided more effective diabetes services (including case identification, care checks, patient education, percentage of patients with blood pressure and cholesterol under control and more patients with type 1 diabetes achieving target HbA1c levels); spent less overall on prescribing per patient with T2DM; and on average, prescribed fewer sulphonylureas, less insulin (for patients with T2DM), fewer glucagon-like peptide-1 agonists, more metformin, more dipeptidyl peptidase-4 inhibitors, and more blood glucose monitoring strips. Ethnicity and social disadvantage and levels of thiazolidinedione (glitazone) prescribing had no significant impact on outcomes. Sodium-glucose co-transporter-2 inhibitor use was too low for an effect to be observed in the period examined. CONCLUSIONS: If all practices brought their service and medication to the level of the top decile practices, they could achieve 74.7% compared with the median of 67.3% of patients achieving TGC, showing an increase of 213 000 in patients achieving TGC, while reducing the number at HGR to 3.8% compared with 6.1%, benefiting 62 000 patients. This could have a major impact on the overall consequent healthcare costs of managing diabetes complications with their attendant mortality risks.

An evaluation of the impact of the key information summary on GPs and out-of-hours clinicians in NHS Scotland.

BACKGROUND AND AIMS: Key information summary is one of the first national shared electronic patient records enabling GPs to share clinical information with unscheduled care providers, including out-of-hours. Implemented during 2013, over 90,000 patient records have been created. This evaluation identified the impact of key information summary on healthcare services. METHODS: Evidence was collected using online questionnaires and structured telephone interviews. Opinions providing a numerical estimate of value were analysed using statistical methods, while qualitative responses were synthesised using thematic analysis. RESULTS: The vast majority of respondents from 441 GP practices and 33 out-of-hours clinicians show that key information summary enhances patient safety, improves clinical management, reduces hospital admissions, empowers clinicians, aids communication across services and enables decisions to be responsive to patients' wishes. CONCLUSIONS: Patients willingly consent to share data with unscheduled care clinicians. Patients benefitting include those with palliative, complex or multiple conditions, at high risk of using emergency services. Out-of-hours clinicians would welcome more key information summaries, all well-completed and including social care information. Improvements include software enhancements and wider sharing of information with all unscheduled care services.

Collaborating with front-line healthcare professionals: the clinical and cost effectiveness of a theory based approach to the implementation of a national guideline.

BACKGROUND: Clinical guidelines are an integral part of healthcare. Whilst much progress has been made in ensuring that guidelines are well developed and disseminated, the gap between routine clinical practice and current guidelines often remains wide. A key reason for this gap is that implementation of guidelines typically requires a change in the behaviour of healthcare professionals - but the behaviour change component is often overlooked. We adopted the Theoretical Domains Framework Implementation (TDFI) approach for supporting behaviour change required for the uptake of a national patient safety guideline to reduce the risk of feeding through misplaced nasogastric tubes. METHODS: The TDFI approach was used in a pre-post study in three NHS hospitals with a fourth acting as a control (with usual care and no TDFI). The target behavior identified for change was to increase the use of pH testing as the first line method for checking the position of a nasogastric tube. Repeat audits were undertaken in each hospital following intervention implementation. We used Zou's modified Poisson regression approach with robust standard errors to estimate risk ratios for the use of pH testing. The projected return on investment (ROI) was also calculated. RESULTS: Following intervention implementation, the use of pH first line increased significantly across intervention hospitals [risk ratio (95% CI) ranged from 3.1 (1.14 to8.43) p < .05, to 8.14 (3.06 to21.67) p < .001] compared to the control hospital, which remained unchanged [risk ratio (CI) = .77 (.47-1.26) p = .296]. The estimated savings and costs in the first year were £2.56 million and £1.41 respectively, giving an ROI of 82%, and this was projected to increase to 270% over five years. CONCLUSION: The TDFI approach improved the uptake of a patient safety guideline across three hospitals. The TDFI approach is clinically and cost effective in comparison to the usual practice.

Systematic review and meta-analysis of the additional benefit of local prophylactic antibiotic therapy for infection rates in open tibia fractures treated with intramedullary nailing.

PURPOSE: This analysis compared the rate of deep wound infections in patients with open tibia fractures, treated with intramedullary nails, receiving additional locally-delivered antibiotics to those receiving standard care. METHODS: Two systematic literature searches identified studies reporting infection rates in patients treated with intramedullary nails for tibia fractures receiving systemic antibiotics only (search one) and in patients receiving adjunctive locally-administered antibiotics peri-operatively at the tissue-implant interface (search two). After applying inclusion and exclusion criteria, 14 and seven papers from searches one and two, respectively, were included in meta-analyses. RESULTS: The absolute rate of infection was lower for all Gustilo-Anderson grades of tibia fractures when local antibiotics were administered as adjunctive prophylactic therapy. For severe fractures, classified as GAIII fractures, patients receiving systemic antibiotics only had an infection rate of 14.4 % [95 % CI: 10.5 %, 18.5 %]; adding local antibiotics reduced the rate to 2.4 % [0.0 %, 9.4 %], with an odds ratio of 0.17. Risk of deep wound infections increased with severity of fracture, rising to over 31 % in GIIIB&C fractures for patients receiving systematic antibiotics only, but to below 9 % with additional local antibiotics. CONCLUSION: The findings support consideration of augmenting the antibiotic prophylaxis regimen to include locally-delivered antibiotics. Patients with severe fractures will obtain greatest benefit from infections avoided. No trial directly compared the two treatments for open tibia fractures, limiting the ability to attribute the differences in observed infection rates directly to the treatments themselves. A large comparative study to improve the evidence on relative effect size is merited. LEVEL OF EVIDENCE: Level III.

Economic evaluation of covered stents for transjugular intrahepatic portosystemic stent shunt in patients with variceal bleeding and refractory ascites secondary to cirrhosis.

OBJECTIVES: Transjugular intrahepatic portosystemic stent shunt (TIPSS) is clinically effective in variceal bleeding and refractory ascites; however, the cost-effectiveness of TIPSS has yet to be evaluated in the UK. This study aimed to establish the cost-effectiveness of (i) pre-emptive TIPSS versus endoscopic band ligation (EBL) in populations with variceal bleeding and (ii) TIPSS versus large volume paracentesis (LVP) in refractory ascites. METHODS: A cost-utility analysis was conducted with the perspective including healthcare costs and quality-adjusted life years (QALYs). A Markov model was constructed with a 2-year time horizon, health states for mortality and survival and probabilities for the development of variceal bleeding, ascites and hepatic encephalopathy. A survival analysis was conducted to extrapolate 12-month to 24-month mortality for the refractory ascites indication. Uncertainty was analysed in deterministic and probabilistic sensitivity analyses. RESULTS: TIPSS was cost-effective (dominant) and cost saving for both indications. For variceal bleeding, pre-emptive TIPSS resulted in 0.209 additional QALYs, and saved £600 per patient compared with EBL. TIPSS had a very high probability of being cost-effective (95%) but was not cost saving in scenario analyses driven by rates of variceal rebleeding. For refractory ascites, TIPSS resulted in 0.526 additional QALYs and saved £17 983 per patient and had a 100% probability of being cost-effective and cost saving when compared with LVP. CONCLUSIONS: TIPSS is a cost-effective intervention for variceal bleeding and refractory ascites. TIPSS is highly cost-saving for refractory ascites. Robust randomised trial data are required to confirm whether pre-emptive TIPSS is cost saving for variceal bleeding.

Economic Evaluation of Senshio® (Ospemifene) for the Treatment of Vulvovaginal Atrophy in Scotland.

BACKGROUND: Local oestrogens, the current treatment for vulvar and vaginal atrophy (VVA), are not suitable for all women. Standard of care (SoC) consists of over-the-counter lubricants and moisturisers. Senshio® (ospemifene) provides a treatment option for postmenopausal women who are not candidates for local vaginal oestrogen therapy who would otherwise have an unmet clinical need. OBJECTIVES: The aim of this study was to estimate the cost-effectiveness of ospemifene, a selective oestrogen receptor modulator, for the treatment of moderate to severe symptomatic VVA in postmenopausal women who are not candidates for local vaginal oestrogen therapy. METHODS: The Scottish Medicines Consortium (SMC) recently evaluated the clinical and cost-effectiveness evidence of ospemifene plus SoC compared with SoC alone. A cost-effectiveness study, from a National Health Service (NHS) Scotland perspective over a lifetime time horizon, was submitted to the SMC. The cohort-based Markov model used robust clinical evidence from two large pivotal phase III randomised controlled studies and included four health states classified by dyspareunia symptom severity: none, mild, moderate and severe. The movement of women between health states was dependent on the effectiveness of treatment in reducing dyspareunia. Extensive sensitivity analyses were undertaken to assess the level of confidence associated with the base-case results. RESULTS: Treatment with ospemifene was associated with an additional cost of £847 per patient and an increase in quality-adjusted life-years (QALY) of 0.06 per patient. Ospemifene had an incremental cost-effectiveness ratio of £14,138 per QALY. In the probabilistic sensitivity analysis, there was a probability of 89% that ospemifene was cost-effective at a threshold of £20,000 per QALY gained. Ospemifene remained cost-effective under all scenario analyses. The SMC reviewed the clinical and economic evidence and judged that the evidence demonstrated a robust case to support prescribing ospemifene in NHS Scotland. CONCLUSION: Ospemifene is a cost-effective intervention that has recently been accepted by the SMC for the treatment of postmenopausal women with moderate to severe VVA who are not candidates for local oestrogen.

Correction to: Use of Expert Judgement Across NICE Guidance­Making Programmes: A Review of Current Processes and Suitability of Existing Tools to Support the Use of Expert Elicitation.

In Sect. 3.3.1, the second sentence of the second paragraph.

Economic Value of Improved Accuracy for Self-Monitoring of Blood Glucose Devices for Type 1 and Type 2 Diabetes in England.

OBJECTIVE: The objective was to model clinical and economic outcomes of self-monitoring blood glucose (SMBG) devices with varying error ranges and strip prices for type 1 and insulin-treated type 2 diabetes patients in England. METHODS: We programmed a simulation model that included separate risk and complication estimates by type of diabetes and evidence from in silico modeling validated by the Food and Drug Administration. Changes in SMBG error were associated with changes in hemoglobin A1c (HbA1c) and separately, changes in hypoglycemia. Markov cohort simulation estimated clinical and economic outcomes. A SMBG device with 8.4% error and strip price of £0.30 (exceeding accuracy requirements by International Organization for Standardization [ISO] 15197:2013/EN ISO 15197:2015) was compared to a device with 15% error (accuracy meeting ISO 15197:2013/EN ISO 15197:2015) and price of £0.20. Outcomes were lifetime costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs). RESULTS: With SMBG errors associated with changes in HbA1c only, the ICER was £3064 per QALY in type 1 diabetes and £264 668 per QALY in insulin-treated type 2 diabetes for an SMBG device with 8.4% versus 15% error. With SMBG errors associated with hypoglycemic events only, the device exceeding accuracy requirements was cost-saving and more effective in insulin-treated type 1 and type 2 diabetes. CONCLUSIONS: Investment in devices with higher strip prices but improved accuracy (less error) appears to be an efficient strategy for insulin-treated diabetes patients at high risk of severe hypoglycemia.

Use of Expert Judgement Across NICE Guidance-Making Programmes: A Review of Current Processes and Suitability of Existing Tools to Support the Use of Expert Elicitation.

OBJECTIVES: This study aimed to review current use of experts within National Institute for Health and Care Excellence (NICE) guidance-making programmes, identify improvements in use of expert judgement, and to assess tools and protocols to support the elicitation of information from experts for use by NICE. METHODS: The study comprised a review of NICE process guides; semi-structured interviews with individuals representing each NICE guidance-making programme and a comparison of the suitability of currently available tools and protocols for expert elicitation to the requirements of NICE programmes. RESULTS: Information elicited from experts and the way in which it is used varies across NICE guidance-making programmes. Experts' involvement can be as intensive as being a member of a committee and thus having direct influence on recommendations or limited one-off consultations on specific parameters. We identified 16 tools for expert elicitation that were potentially relevant. None fully met the requirements of NICE, although an existing tool could be potentially adapted. Ongoing research to develop a reference protocol for expert elicitation in healthcare decision making may be of use in future. CONCLUSIONS: NICE uses expert judgement across all its guidance-making programmes, but its uses vary considerably. There is no currently available tool for expert elicitation suitable for use by NICE. However, adaptation of an existing tool or ongoing research in the area could address this in the future.

The Memokath-051 Stent for the Treatment of Ureteric Obstruction: A NICE Medical Technology Guidance.

Memokath-051 is a thermo-expandable, nickel-titanium alloy spiral stent used to treat ureteric obstruction resulting from malignant or benign strictures. The National Institute for Health and Care Excellence (NICE) selected Memokath-051 for evaluation. The company, PNN Medical, claimed Memokath-051 has clinical superiority and cost savings compared with double-J stents. It identified five studies reporting clinical evidence on Memokath-051 and constructed a de novo cost model comparing Memokath-051 to double-J stents. Results indicated that Memokath-051 generated cost savings of £4156 per patient over 2.5 years. The External Assessment Centre (EAC) critiqued the company's submission and completed substantial additional work. Sixteen studies were identified assessing Memokath-051 and all listed comparators in the scope (double-J stents, reconstructive surgery and metallic and alloy stents) except nephrostomy. Similar success rates were reported for Memokath-051 compared with double-J and Resonance stents and worse outcomes compared with other options with evidence available. The EAC updated the company's cost model structure and modified several inputs. The EAC's model estimated that Memokath-051 generated savings of at least £1619 per patient over 5 years compared with double-J stents, was cost neutral compared with other metallic stents and was cost saving compared with surgery up to month 55. Overall, Memokath-051 is likely to be cost saving in patients not indicated for reconstructive surgery and those expected to require a ureteral stent for at least 30 months. The Medical Technologies Advisory Committee (MTAC) reviewed the evidence and supported the case for adoption, issuing partially supportive recommendations published after public consultation as Medical Technologies Guidance 35.

Spectra Optia® for Automated Red Blood Cell Exchange in Patients with Sickle Cell Disease: A NICE Medical Technology Guidance.

The Spectra Optia® automated apheresis system, indicated for red blood cell exchange in people with sickle cell disease, underwent evaluation by the National Institute for Health and Care Excellence, which uses its Medical Technologies Advisory Committee to make recommendations. The company (Terumo Medical Corporation) produced a submission making a case for adoption of its technology, which was critiqued by the Newcastle and York external assessment centre. Thirty retrospective observational studies were identified in their clinical submission. The external assessment centre considered these were of low methodological and reporting quality. Most were single-armed studies, with only six studies providing comparative data. The available data showed that, compared with manual red blood cell exchange, Spectra Optia reduces the frequency of exchange procedures as well as their duration, but increases the requirement for donor blood. However, other clinical and patient benefits were equivocal because of an absence of robust clinical evidence. The company provided a de novo model to support the economic proposition of the technology, and reported that in most scenarios Spectra Optia was cost saving, primarily through reduced requirement of chelation therapy to manage iron overload. The external assessment centre considered that although the cost-saving potential of Spectra Optia was plausible, the model and its clinical inputs were not sufficiently robust to demonstrate this. However, taking the evidence together with expert and patient advice, the Medical Technologies Advisory Committee considered Spectra Optia was likely to save costs, provide important patient benefits, and reduce inequality, and gave the technology a positive recommendation in Medical Technology Guidance 28.

The XprESS Multi-Sinus Dilation System for the Treatment of Chronic Sinusitis: A NICE Medical Technology Guidance.

The XprESS multi-sinus dilation system (XprESS) is a minimally invasive alternative to functional endoscopic sinus surgery (FESS) used in the treatment of people with chronic or recurrent acute sinusitis refractory to medical treatment. The manufacturer of XprESS, Entellus Medical, claims the technology is as effective as FESS in improving quality of life and is associated with quicker recovery times and reduced costs. The Medical Technologies Advisory Committee (MTAC) at the National Institute for Health and Care Excellence (NICE) selected XprESS for evaluation. Nine trials published in 13 papers were correctly identified by the company as relevant to the decision problem, including one randomised controlled trial (REMODEL study). From this evidence, the company concluded that XprESS is as beneficial as FESS for a range of clinical endpoints. The External Assessment Centre (EAC) agreed with the company's conclusion in a subgroup of patients, but judged that the evidence did not generalise to patients within the NHS fully. The company constructed a de novo costing model. XprESS generated cost-savings of £1302 per patient compared with FESS. The EAC critiqued and updated the model's inputs, with differences in results driven by changes in assumptions on procedure duration, length of hospital stay and the proportion of procedures undertaken in an outpatient setting under local anaesthetic. Although cost-incurring in the base case, XprESS generated cost savings under certain scenarios. The MTAC reviewed the evidence and supported the case for adoption, issuing positive draft recommendations. After public consultation NICE published this as Medical Technologies Guidance 30.

A Patient-Focused Technology-Enabled Program Improves Outcomes in Primary Total Hip and Knee Replacement Surgery.

BACKGROUND: A patient-engagement and pathway-management program for patients undergoing primary total hip and knee replacement was evaluated. Health-service and multimedia features supported by technology were integrated with existing enhanced recovery after surgery (ERAS) practices. The primary objective was to demonstrate the impact on length of stay. The secondary objective was to assess the impact on clinical, patient-focused, and financial outcomes. METHODS: Two thousand and eighty consecutive patients undergoing primary total hip replacement (n = 1,034) and total knee replacement (n = 1,046) were classified into "pre-program" (retrospectively assessed [n = 1,038]) and "program" (prospectively assessed [n = 1,042]) cohorts. Patients in the program cohort were subdivided according to those who were eligible for criteria-based outreach support (OS) (n = 401) and those who were ineligible for this service (NOS) (n = 641). Clinical outcomes were assessed for all patients, and patient-focused outcomes were assessed for a subset (n = 223). RESULTS: The mean reduction in length of stay ranged from 20% (1.2 days) to 42% (2.5 days) following total hip replacement and from 9% (0.6 day) to 31% (2 days) following total knee replacement (p < 0.001). Clinical outcomes (readmissions, complications, emergency department re-attendance rates) were not significantly negatively impacted. The Oxford Hip Score had numerically larger improvement after total hip replacement in the OS group than in the pre-program group (4.1-point increase), and the Oxford Knee Score had numerically larger improvement after total knee replacement in the NOS group than in the pre-program group (0.8-point increase). The patients in the program cohort (either OS or NOS) rated overall health gain as higher than those in the pre-program cohort (gain in numerical rating scale, 1.4 points for patients managed with total hip replacement, 0.6 points for patients managed with total knee replacement). Older patients and those with higher comorbidity indices benefited most with respect to length of stay and multiple clinical outcomes. Patient experience was significantly improved across domains (p < 0.001 to p = 0.003). Potential savings for patients managed with total hip replacement (£401.64 [$267.76] per patient) exceeded estimated program charges of £50 [$33.33] to £60 [$40] per patient, whereas the potential savings for patients managed with total knee replacement (£76.67 [$51.11] per patient) were sufficient to achieve a reduction of total system costs. CONCLUSIONS: Technology-enabled programs may deliver enhanced care at lower costs for patients undergoing lower-limb arthroplasty. Shorter durations of inpatient stay without a negative impact on clinical outcomes and improved patient-focused outcomes and experience can deliver substantial value that can be especially beneficial for older patients and those with greater medical complexity. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

The ultrastructure of the parasitophorous vacuole formed by Leishmania major.

Protozoan parasites of Leishmania spp. invade macrophages as promastigotes and differentiate into replicative amastigotes within parasitophorous vacuoles. Infection of inbred strains of mice with Leishmania major is a well-studied model of the mammalian immune response to Leishmania species, but the ultrastructure and biochemical properties of the parasitophorous vacuole occupied by this parasite have been best characterized for other species of Leishmania. We examined the parasitophorous vacuole occupied by L. major in lymph nodes of infected mice and in bone marrow-derived macrophages infected in vitro. At all time points after infection, single L. major amastigotes were wrapped tightly by host membrane, suggesting that amastigotes segregate into separate vacuoles during replication. This small, individual vacuole contrasts sharply with the large, communal vacuoles occupied by Leishmania amazonensis. An extensive survey of the literature revealed that the single vacuoles occupied by L. major are characteristic of those formed by Old World species of Leishmania, while New World species of Leishmania form large vacuoles occupied by many amastigotes.

Tegaderm CHG IV Securement Dressing for Central Venous and Arterial Catheter Insertion Sites: A NICE Medical Technology Guidance.

Catheters are widely used for vascular access and for the administration of drugs or fluids in critically ill patients. This exposes patients to an infection risk. Tegaderm chlorhexidine gluconate (CHG) (developed by 3M)-a transparent securement dressing-covers and protects catheter sites and secures devices to the skin. It comprises a transparent adhesive dressing to act as a barrier against external contamination and an integrated gel pad containing an antiseptic agent. The Medical Technologies Advisory Committee (MTAC) at the National Institute for Health and Care Excellence (NICE) selected Tegaderm CHG for evaluation. One study was identified by the sponsor as relevant to the decision problem. From this, the sponsor concluded that compared with standard dressings, Tegaderm CHG is associated with lower rates of catheter-related infection, but increased dermatitis incidence. The External Assessment Centre (EAC) identified four paired comparative studies between Tegaderm CHG, other CHG dressings or standard dressings. The EAC agreed with the sponsor's conclusion, finding that CHG dressings reduce infections compared with standard dressings. The sponsor constructed a de novo costing model. Tegaderm CHG generated cost savings of £77.26 per patient compared with standard dressings and was cost saving in 98.5 % of a sample of sets of inputs (2013 prices). The EAC critiqued and updated the model's inputs, yielding similar results to those the sponsor estimate. The MTAC reviewed the evidence and decided to support the case for adoption, issuing a positive draft recommendation. After a public consultation, NICE published this as Medical Technology Guidance 25.

Partnership working between the Fire Service and NHS: delivering a cost-saving service to improve the safety of high-risk people.

BACKGROUND: The Scottish Fire and Rescue Service and NHS Tayside piloted partnership working. A Community Fire Safety Link Worker provided Risk Assessments to adults, identified by community health teams, at high risk of fires, with the aim of reducing fires. An existing evaluation shows the Service developed a culture of 'high trust' between partners and had high client satisfaction. This paper reports on an economic evaluation of the costs and benefits of the Link Worker role. METHODS: An economic evaluation of the costs and benefits of the Link Worker role was undertaken. Changes in the Risk Assessment score following delivery of the Service were used to estimate the potential fires avoided. These were valued using a national cost of a fire. The estimated cost of delivering the Service was deducted from these savings. RESULTS: The pilot was estimated to save 4.4 fires, equivalent to £286 per client. The estimated cost of delivering the Service was £55 per client, giving net savings of £231 per client. The pilot was cost-saving under all scenarios, with results sensitive to the probability of a fire. CONCLUSIONS: We believe this is the first evaluation of Fire Safety Risk Assessments. Partnership working, delivering joint Risk Assessments in the homes of people at high risk of fire, is modelled to be cost saving. Uncertainties in data and small sample are key limitations. Further research is required into the ex ante risk of fire by risk category. Despite these limitations, potential savings identified in this study supports greater adoption of this partnership initiative.

The EASY (Early Access to Support for You) sickness absence service: a four-year evaluation of the impact on absenteeism.

OBJECTIVES: In May 2008, the National Health Service (NHS) Lanarkshire (NHSL) implemented a unique telephone-based sickness absence management service entitled "EASY" (Early Access to Support for You). The EASY service supplements existing absence policies and enables telephone communication between the absentee, their line manager, and the EASY service from the first day of absence and referral to occupational health services at day ten. The aim of this study was to determine if the EASY service was effective between May 2008 and May 2012 in reducing sickness absence in NHSL compared to normal occupational healthcare in NHS Scotland and is, as such, a cost-saving intervention. METHODS: This study included time-series analysis of health board sickness absence data and analyses of the EASY service database (survival analyses and Cox's proportional hazards model). RESULTS: The EASY service was effective in reducing sickness absence by 21% in NHSL, whereas the nonspecific tightening of the sickness absence policies across the rest of Scottish NHS health boards reduced sickness absence by approximately 9%. The richness of the EASY database gave detailed information on absentees by cause, duration, job family, and reporting compliance. The mean duration of musculoskeletal absences was significantly shorter in years 2, 3, and 4 compared to year 1. Those absentees contacted by phone on the first day of absence were more likely to return to work than those contacted on subsequent days. The EASY service improves economic efficiency; the value of the hours saved from the reduced sickness absence exceeds the cost of operating the service. CONCLUSION: The study highlights the importance of an early telephone-based intervention for sickness absence management.

ViibraTip for Testing Vibration Perception to Detect Diabetic Peripheral Neuropathy: A NICE Medical Technology Guidance.

VibraTip™ was selected by the Medical Technologies Advisory Committee (MTAC) to undergo evaluation through the National Institute for Health and Care Excellence (NICE). VibraTip™ provides a vibratory stimulus for the purpose of detecting diabetic peripheral neuropathy (DPN) in patients with type 1 or 2 diabetes mellitus, and is intended to replace the current practice of using the 128 Hz tuning fork or 10 g monofilament (comparators). The sponsor (McCallan Medical) provided clinical and economic submissions which were evaluated by an External Assessment Centre (EAC). Of six diagnostic studies identified, the EAC considered that only one was directly relevant to the assessment. This study indicated VibraTip™ had a sensitivity of 0.79 (95 % CI 0.69-0.90) and specificity of 0.82 (95 % CI 0.74-0.90) for DPN using a neurothesiometer at 25 V as a reference standard. This was non-inferior to the comparators, but the sample size (n = 141) was too small to draw unequivocal conclusions and it is unclear how generalisable results were to clinical practice. The sponsor presented a de facto cost-minimisation model that in the base case showed minimal cost savings and, in sensitivity analysis which assumed diagnostic superiority of VibraTip™, showed large savings. The EAC appraised this model and concluded it was flawed as it was not evidence based and costs were likely to be unrealistic. The MTAC considered that the technology showed promise but decided the case for adoption was not proven, and therefore made a research recommendation as is reflected in NICE Medical Technology Guidance 22.

A review of the economic tools for assessing new medical devices.

Whereas the economic evaluation of pharmaceuticals is an established practice within international health technology assessment (HTA) and is often produced with the support of comprehensive methodological guidance, the equivalent procedure for medical devices is less developed. Medical devices, including diagnostic products, are a rapidly growing market in healthcare, with over 10,000 medical technology patent applications filed in Europe in 2012-nearly double the number filed for pharmaceuticals. This increase in the market place, in combination with the limited, or constricting, budgets that healthcare decision makers face, has led to a greater level of examination with respect to the economic evaluation of medical devices. However, methodological questions that arise due to the unique characteristics of medical devices have yet to be addressed fully. This review of journal publications and HTA guidance identified these characteristics and the challenges they may subsequently pose from an economic evaluation perspective. These unique features of devices can be grouped into four categories: (1) data quality issues; (2) learning curve; (3) measuring long-term outcomes from diagnostic devices; and (4) wider impact from organisational change. We review the current evaluation toolbox available to researchers and explore potential future approaches to improve the economic evaluation of medical devices.

WatchBP Home A for opportunistically detecting atrial fibrillation during diagnosis and monitoring of hypertension: a NICE Medical Technology Guidance.

The Microlife(®) 'WatchBP Home A' oscillometric blood pressure monitor detects irregular pulse, suggestive of atrial fibrillation (AF). Early detection of AF can prevent thromboembolic stroke via anticoagulation therapy. The device was considered by the Medical Technologies Evaluation Programme of the UK National Institute for Health and Care Excellence (NICE). The sponsor (Microlife) identified 10 studies. These were reviewed by an External Assessment Centre (EAC) which considered three relevant to the decision problem, including one which found the device detected AF more accurately (sensitivity 96.8%, specificity 88.8%) than pulse palpation (87.2, 81.3%). The EAC concluded the technology had potential to improve detection of AF, but the three studies had uncertain external validity. From a cost-consequence model with a 1-year timeframe, the sponsor calculated the device would reduce electrocardiogram (ECG) referrals and prevent strokes, but incur anticoagulation therapy costs, with net NHS savings of £11.6 million and prevention of 221 strokes, annually. The EAC criticised the model for its limited time horizon, and its consideration of symptomatic AF patients who were outside the scope issued by NICE. The EAC applied a de novo Markov model, with a 10-year timeframe. The per use saving was calculated as £2.98 for asymptomatic patients aged 65-74 years and £4.26 for those aged 75-84 years, with the prevention of 53-117 nonfatal and 28-65 fatal strokes per 100,000 people screened. Following consideration by the NICE Medical Technologies Advisory Committee, NICE judged that the case for adoption was supported by the evidence (Medical Technologies Guidance 13; MTG13).