Organisation and integrated healthcare approaches for people living with HIV, multimorbidity, or both: a systematic review.

BACKGROUND: Universal recommendation for antiretroviral drugs and their effectiveness has put forward the challenge of assuring a chronic and continued care approach to PLHIV (People Living with HIV), pressured by aging and multimorbidity. Integrated approaches are emerging which are more responsive to that reality. Studying those approaches, and their relation to the what of delivery arrangements and the how of implementation processes, may support future strategies to attain more effective organizational responses. METHODS: We reviewed empirical studies on either HIV, multimorbidity, or both. The studies were published between 2011 and 2020, describing integrated approaches, their design, implementation, and evaluation strategy. Quantitative, qualitative, or mixed methods were included. Electronic databases reviewed cover PubMed, SCOPUS, and Web of Science. A narrative analysis was conducted on each study, and data extraction was accomplished according to the Effective Practice and Organisation of Care taxonomy of health systems interventions. RESULTS: A total of 30 studies, reporting 22 different interventions, were analysed. In general, interventions were grounded and guided by models and frameworks, and focused on specific subpopulations, or priority groups at increased risk of poorer outcomes. Interventions mixed multiple integrated components. Delivery arrangements targeted more frequently clinical integration (n = 13), and care in proximity, community or online-telephone based (n = 15). Interventions reported investments in the role of users, through self-management support (n = 16), and in coordination, through multidisciplinary teams (n = 9) and continuity of care (n = 8). Implementation strategies targeted educational and training activities (n = 12), and less often, mechanisms of iterative improvement (n = 3). At the level of organizational design and governance, interventions mobilised users and communities through representation, at boards and committees, and through consultancy, along different phases of the design process (n = 11). CONCLUSION: The data advance important lessons and considerations to take steps forward from disease-focused care to integrated care at two critical levels: design and implementation. Multidisciplinary work, continuity of care, and meaningful engagement of users seem crucial to attain care that is comprehensive and more proximal, within or cross organizations, or sectors. Promising practices are advanced at the level of design, implementation, and evaluation, that set integration as a continued process of improvement and value professionals and users' knowledge as assets along those phases. TRIAL REGISTRATION: PROSPERO number CRD42020194117.

Inpatient COVID-19 vaccination rollout: Improving access to vaccination.

BACKGROUND: We were aware of high numbers of inpatients unvaccinated against COVID-19 at Guy's and St Thomas' NHS Foundation Trust (GSTT). Due to this, an inpatient vaccination protocol was set up in July 2021, with initially limited uptake. METHODS: From October 2021, a multidisciplinary team worked to improve the protocol for inpatient vaccination, with the development of a system that gave ownership to clinical teams. RESULTS: In 4 months (July 2021 to November 2021), 20 inpatients had been vaccinated at GSTT. Following our intervention, rates of uptake increased, and 34 patients were vaccinated in less than 2 months (November 2021 to January 2022). Forty-five patients who had been referred were discharged without vaccination; attempts were made to invite them to receive a vaccine. CONCLUSION: An improved pathway and referral process increased the number of inpatient vaccinations delivered. Further work is required in order to ensure that more patients who have been referred are vaccinated.

Prospective RandOmised Trial of Emergency Cardiac Computerised Tomography (PROTECCT).

OBJECTIVE: Many patients presenting with suspected acute coronary syndrome (ACS) have high-sensitivity cardiac troponin (hs-cTn) concentrations between rule-in and rule-out thresholds and hence need serial testing, which is time consuming. The Prospective RandOmised Trial of Emergency Cardiac Computerised Tomography (PROTECCT) assessed the utility of coronary CT angiography (CCTA) in patients with suspected ACS, non-ischaemic ECG and intermediate initial hs-cTn concentration. METHODS: Patients were randomised to CCTA-guided management versus standard of care (SOC). The primary outcome was hospital length of stay (LOS). Secondary outcomes included cost of in-hospital stay and major adverse cardiac events (MACE) at 12 months of follow-up. Data are mean (SD); for LOS harmonic means, IQRs are shown. RESULTS: 250 (aged 55 (14) years, 25% women) patients were randomised. Harmonic mean (IQR) LOS was 7.53 (6.0-9.6) hours in the CCTA arm and 8.14 (6.3-9.8) hours in the SOC arm (p=0.13). Inpatient cost was £1285 (£2216) and £1108 (£3573), respectively, p=0.68. LOS was shorter in the CCTA group in patients with <25% stenosis, compared with SOC; 6.6 (5.6-7.8) hours vs 7.5 (6.1-9.4) hours, respectively; p=0.021. More referrals for cardiology outpatient clinic review and cardiac CT-related outpatient referrals occurred in the SOC arm (p=0.01). 12-month MACE rates were similar between the two arms (7 (5.6%) in the CCTA arm and 8 (6.5%) in the SOC arm-log-rank p=0.78). CONCLUSIONS: CCTA did not lead to reduced hospital LOS or cost, largely because these outcomes were influenced by the detection of ≥25% grade stenosis in a proportion of patients. TRIAL REGISTRATION NUMBER: NCT03583320.

Cost-effectiveness in diagnosis of stable angina patients: a decision-analytical modelling approach.

OBJECTIVE: Given recent data on published diagnostic accuracies, this study sought to determine the most cost-effective diagnostic strategy for detection of significant coronary artery disease (CAD) in stable angina patients using invasive coronary angiography (ICA) and fractional flow reserve (FFR) as the reference standard. METHODS: A probabilistic decision-analytical model was developed which modelled a cohort of patients with stable angina. We investigated 17 diagnostic strategies between standalone and combination of different imaging tests to establish a correct diagnosis of CAD, using no testing as the baseline reference. These tests included CT coronary angiography (CTCA), stress echocardiography, CT-based FFR, single-photon emission computed tomography (SPECT), cardiovascular magnetic resonance (CMR), positron emission tomography, ICA, and ICA with FFR. Incremental cost-effectiveness ratios were calculated as the additional cost per correct diagnosis. RESULTS: SPECT followed by CTCA and ICA-FFR is the most cost-effective strategy between a cost-effectiveness threshold (CET) value of £1000-£3000 per correct diagnosis. CMR followed by CTCA and ICA-FFR is cost-effective within a CET range of £3000-£17 000 per correct diagnosis. CMR and ICA-FFR is cost-effective within a CET range of £17 000-£24 000. ICA-FFR as first line is the most-cost effective if the CET value exceeds the £24 000 per correct diagnosis. Sensitivity analysis showed that direct ICA-FFR may be cost-effective in patients with a high pre-test probability of CAD. CONCLUSION: First-line testing with functional imaging is cost-effective at low to intermediate value of correct diagnosis in patients with low to intermediate risk of CAD. ICA is not cost effective although ICA-FFR may be at higher CET.

Delivering outpatient virtual clinics during the COVID-19 pandemic: early evaluation of clinicians' experiences.

BACKGROUND: The COVID-19 pandemic has put health systems across the world under significant pressure. In March 2020, a national directive was issued by the National Health Service (NHS) England instructing trusts to scale back face-to-face outpatient appointments, and rapidly implement virtual clinics. METHODS: A multidisciplinary team of change managers, analysts and clinicians were assembled to evaluate initial implementation of virtual clinics at Guy's and St Thomas' NHS Foundation Trust. In-depth interviews were conducted with clinicians who have delivered virtual clinics during the pandemic. An inductive thematic approach was used to analyse clinicians' early experiences and identify enablers for longer term sustainability. RESULTS: Ninety-five clinicians from specialist services across the trust were interviewed between April and May 2020 to reflect on their experiences of delivering virtual clinics during Wave I COVID-19. Key reflections include the perceived benefits of virtual consultations to patients and clinicians; the limitations of virtual consultations compared with face-to-face consultations; and the key enablers that would optimise and sustain the delivery of virtual pathways longer term. CONCLUSIONS: In response to the pandemic, outpatient services across the trust were rapidly redesigned and virtual clinics implemented. As a result, services have been able to sustain some level of service delivery. However, clinicians have identified challenges in delivering this model of care and highlighted enablers needed to sustaining the delivery of virtual clinics longer term, such as patient access to diagnostic tests and investigations closer to home.

The Utilisation of Payment Models Across the HIV Continuum of Care: Systematic Review of Evidence.

The increasing chronicity and multimorbidities associated with people living with HIV have posed important challenges to health systems across the world. In this context, payment models hold the potential to improve care across a spectrum of clinical conditions. This study aims to systematically review the evidence of HIV performance-based payments models. Literature searches were conducted in March 2020 using multiple databases and manual searches of relevant papers. Papers were limited to any study design that considers the real-world utilisation of performance-based payment models applied to the HIV domain. A total of 23 full-text papers were included. Due to the heterogeneity of study designs, the multiple types of interventions and its implementation across distinct areas of HIV care, direct comparisons between studies were deemed unsuitable. Most evidence focused on healthcare users (83%), seeking to directly affect patients' behaviour based on principles of behavioural economics. Despite the variability between interventions, the implementation of performance-based payment models led to either a neutral or positive impact throughout the HIV care continuum. Moreover, this improvement was likely to be cost-effective or, at least, did not compromise the healthcare system's financial sustainability. However, more research is needed to assess the durability of incentives and its appropriate relative magnitude.

RESUMEN: La creciente cronicidad y multimorbilidades asociadas con las personas que viven con el VIH han planteado importantes desafíos para los sistemas de salud en todo el mundo. En este contexto, los modelos de pago tienen el potencial de mejorar la atención en un espectro de condiciones clínicas. Este estudio tiene como objetivo revisar sistemáticamente la evidencia de los modelos de pagos basados ​​en el desempeño aplicados al dominio del VIH. Las búsquedas bibliográficas se realizaron en marzo de 2020 utilizando múltiples bases de datos y búsquedas manuales de artículos relevantes. Los artículos se limitaron a cualquier diseño de estudio que considere la utilización en el mundo real de modelos de pago basados ​​en el desempeño aplicados al dominio del VIH. Se incluyeron un total de 23 artículos de texto completo. Debido a la heterogeneidad de los diseños de los estudios, los múltiples tipos de intervenciones y su implementación en distintas áreas de la atención del VIH, las comparaciones directas entre diferentes estudios se consideraron inadecuadas. La mayoría de la evidencia se centró en los usuarios de la salud (83%), buscando afectar directamente el comportamiento de los pacientes basándose en los principios de la economía del comportamiento. A pesar de la variabilidad entre las intervenciones, la implementación de modelos de pago basados ​​en el desempeño generó un impacto neutral o positivo en todo el proceso de atención del VIH. Además, es probable que esta mejora sea costo-efectiva o, al menos, no comprometa la sostenibilidad financiera del sistema de salud. Sin embargo, se necesita más investigación para evaluar la durabilidad de los incentivos y su magnitud relativa apropiada.

Cost-Effectiveness of Immediate Magnetic Resonance Imaging In the Management of Patients With Suspected Scaphoid Fracture: Results From a Randomized Clinical Trial.

OBJECTIVES: Given the limited diagnostic accuracy of radiographs on presentation to the emergency department (ED), the management of suspected scaphoid fractures remains clinically challenging and poses an unknown economic burden to healthcare systems. We aimed to evaluate the cost-effectiveness of immediate magnetic resonance imaging (MRI) in the management of patients presenting with suspected scaphoid fracture to an ED in England. METHODS: A pragmatic, randomized, single-center trial compared the use of immediate MRI in the ED against standard care with radiographs only. Participants' use of healthcare services and costs were estimated from primary care and secondary care databases and questionnaires at baseline, 1, 3, and 6 months postrecruitment. Costs were compared using generalized linear models and combined with quality-adjusted life years (QALYs, based on the EQ-5D-5L) to estimate cost-effectiveness at 6 months postrecruitment. Cost-effectiveness acceptability curves and bootstrapping techniques were used to estimate the probability of cost-effectiveness at different willingness-to-pay (WTP) thresholds. Four deterministic sensitivity scenarios were considered around key parameters. RESULTS: The MRI intervention dominated standard care in the base case and all 4 deterministic sensitivity scenarios, costing less and achieving more QALY gains, with a probability of 100% of being cost-effective at 6 months using the conventional United Kingdom WTP thresholds of £20 000 to £30 000 per QALY. CONCLUSION: The use of immediate MRI is a cost-effective intervention in the management of suspected scaphoid fractures in a Central Hospital in London. Routine clinical practice at our institution has been changed to include the intervention.

Management of chronic headache with referral from primary care to direct access to MRI compared with Neurology services: an observational prospective study in London.

OBJECTIVES: To evaluate the cost, accessibility and patient satisfaction implications of two clinical pathways used in the management of chronic headache. INTERVENTION: Management of chronic headache following referral from Primary Care that differed in the first appointment, either a Neurology appointment or an MRI brain scan. DESIGN AND SETTING: A pragmatic, non-randomised, prospective, single-centre study at a Central Hospital in London. PARTICIPANTS: Adult patients with chronic headache referred from primary to secondary care. PRIMARY AND SECONDARY OUTCOME MEASURES: Participants' use of healthcare services and costs were estimated using primary and secondary care databases and questionnaires quarterly up to 12 months postrecruitment. Cost analyses were compared using generalised linear models. Secondary outcomes assessed: access to care, patient satisfaction, headache burden and self-perceived quality of life using headache-specific (Migraine Disability Assessment Scale and Headache Impact Test) and a generic questionnaire (5-level EQ-5D). RESULTS: Mean (SD) cost up to 6 months postrecruitment per participant was £578 (£420) for the Neurology group (n=128) and £245 (£172) for the MRI group (n=95), leading to an estimated mean cost difference of £333 (95% CI £253 to £413, p<0.001). The mean cost difference at 12 months increased to £518 (95% CI £401 to £637, p<0.001). When adjusted for baseline and follow-up imbalances between groups, this remained statistically significant. The utilisation of brain MRI improved access to care compared with the Neurology group (p<0.001). Participants in the Neurology group reported higher levels of satisfaction associated with the pathway and led to greater change in care management. CONCLUSION: Direct referral to brain MRI from Primary Care led to cost-savings and quicker access to care but lower satisfaction levels when compared with referral to Neurology services. Further research into the use of brain MRI for a subset of patient population more likely to be reassured by a negative brain scan should be considered. TRIAL REGISTRATION NUMBER: NCT02753933.

Economic evaluation of a dedicated cardiac resynchronisation therapy preassessment clinic.

INTRODUCTION: Patient evaluation before cardiac resynchronisation therapy (CRT) remains heterogeneous across centres and it is suspected a proportion of patients with unfavourable characteristics proceed to implantation. We developed a unique CRT preassessment clinic (CRT PAC) to act as a final review for patients already considered for CRT. We hypothesised that this clinic would identify some patients unsuitable for CRT through updated investigations and review. The purpose of this analysis was to determine whether the CRT PAC led to savings for the National Health Service (NHS). METHODS: A decision tree model was made to evaluate two clinical pathways; (1) standard of care where all patients initially seen in an outpatient cardiology clinic proceeded directly to CRT and (2) management of patients in CRT PAC. RESULTS: 244 patients were reviewed in the CRT PAC; 184 patients were eligible to proceed directly for implantation and 48 patients did not meet consensus guidelines for CRT so were not implanted. Following CRT, 82.4% of patients had improvement in their clinical composite score and 57.7% had reduction in left ventricular end-systolic volume ≥15%. Using the decision tree model, by reviewing patients in the CRT PAC, the total savings for the NHS was £966 880. Taking into consideration the additional cost of the clinic and by applying this model structure throughout the NHS, the potential savings could be as much as £39 million. CONCLUSIONS: CRT PAC appropriately selects patients and leads to substantial savings for the NHS. Adopting this clinic across the NHS has the potential to save £39 million.

Healthcare professionals' perspectives on lung cancer screening in the UK: a qualitative study.

BACKGROUND: Lung cancer screening with low-dose computed tomography (LDCT) has been shown to decrease mortality. Low lung cancer survival rates in the UK, driven primarily by late-stage presentation, provide the impetus for implementing screening. Nascent guidance on screening in the UK recommends primary care case-finding. However, the potential impact and acceptability on primary care, and the opportunistic utilisation of other case-finding routes, such as pharmacies, smoking cessation services, and respiratory clinics, have not been fully explored. AIM: To explore healthcare professionals' views and perspectives about lung cancer screening and their preparedness and willingness to be involved in its implementation. DESIGN & SETTING: A qualitative study was carried out with semi-structured interviews conducted with GPs, pharmacists, staff from smoking cessation services within Southwark and Lambeth in London, and staff from respiratory clinics in Guys' and St Thomas' NHS Foundation Trust in London between April 2018 and December 2018. METHOD: Sixteen participants were interviewed and the interview transcripts were analysed thematically. RESULTS: Participants described lung cancer screening as an important diagnostic tool for capturing lung cancer at an earlier stage and in increasing survivorship. However, the majority expressed a lack of awareness and understanding, uncertainty and concerns about the validity of screening, and the potential impact on their patients and workload. CONCLUSION: Study participants had mixed opinions about lung cancer screening and expressed their concerns about its implementation. Addressing these concerns by providing resources and effective and detailed guidelines for their use may lead to greater engagement and willingness to be involved in lung cancer screening.

Healthcare professionals' perspectives on lung cancer screening in the UK: a qualitative study.

BACKGROUND: Lung cancer screening with low-dose CT has been shown to decrease mortality. Low lung cancer survival rates in the UK, driven primarily by late-stage presentation, provide the impetus for implementing screening. Nascent guidance on screening in the UK recommends primary care case-finding. However, the potential impact and acceptability on primary care, and the opportunistic utilisation of other case-finding routes such as pharmacies, smoking cessation services and respiratory clinics, have not been fully explored. AIM: To explore healthcare professionals' views and perspectives about lung cancer screening and their preparedness and willingness to be involved in its implementation. METHOD: A qualitative study was carried out with semi-structured interviews conducted with GPs, pharmacists and staff from smoking cessation services within Southwark and Lambeth and from respiratory clinics in Guy's and St. Thomas' NHS Trust in London in 2018. Sixteen participants were interviewed, and the interview transcripts were analysed thematically. RESULTS: Participants described lung cancer screening as an important diagnostic tool for capturing lung cancer at an earlier stage and in increasing survivorship. However, the majority expressed a lack of awareness and understanding, uncertainty and concerns about the validity of screening, its misuse and the potential impact on their patients and workload. CONCLUSION: Study participants had mixed opinions about lung cancer screening and expressed their concerns about its implementation. Addressing these concerns by providing resources and effective and detailed guidelines for their use may lead to greater engagement and willingness to be involved in lung cancer screening.

A cost effectiveness study establishing the impact and accuracy of implementing the NICE guidelines lowering plasma NTproBNP threshold in patients with clinically suspected heart failure at our institution.

AIMS: The 2014 National Institute of Clinical Excellence (NICE) guidelines on the management of acute heart failure recommended using a plasma NT-proBNP threshold of 300pg/ml to assist in ruling out the diagnosis of heart failure (HF), updating previous guidelines recommending using a threshold of 400pg/ml. NICE based their recommendations on 6 studies performed in other countries. This study sought to determine the diagnostic and economic implications of using these thresholds in a large unselected UK population. METHODS: Patient and clinical demographics were recorded for all consecutive suspected HF patients over 12months, as well as clinical outcomes including time to HF hospitalisation and time to death (follow up 15.8months). RESULTS: Of 1995 unselected patients admitted with clinically suspected HF, 1683 (84%) had a NTproBNP over the current NICE recommended threshold, of which 35% received a final diagnosis of HF. Lowering the threshold from 400 to 300pg/ml would have involved screening an additional 61 patients and only would have identified one new patient with HF (sensitivity 0.985, NPV 0.976, area under the curve (AUC) at 300pg/ml 0.67; sensitivity 0.983, NPV 0.977, AUC 0.65 at 400pg/ml). The economic implications of lowering the threshold would have involved additional costs of £42,842.04 (£702.33 per patient screened, or £ 42,824.04 per new HF patient). CONCLUSION: Applying the recent updated NICE guidelines to an unselected real world population increases the AUC but would have a significant economic impact and only identified one new patient with heart failure.

Rationale and design of the SMaRT trial: A randomised, prospective, parallel, non-blinded, one-centre trial to evaluate the use of magnetic resonance imaging in acute setting in patients presenting with suspected scaphoid fracture.

Background Wrist injury is a common presentation to the Emergency Department in the United Kingdom. Among these injuries, the scaphoid is the most common fractured carpal bone. However, given the limited ability of conventional radiography to accurately diagnose a suspected scaphoid fracture on presentation, its diagnosis and management remain challenging. Despite the vast clinical evidence supporting the superior accuracy of magnetic resonance imaging, there is little to no evidence around the real-world clinical and economic impact of immediate magnetic resonance imaging in the management of suspected scaphoid fractures. Methods Review of design and implementation challenges associated with the identification and subsequent recruitment of eligible patients, implementation of a novel clinical pathway in an acute setting, rationale behind the primary and secondary outcomes selected and measurement of the primary outcome. Results The Scaphoid Magnetic Resonance Imaging in Trauma trial is a single-site prospective, randomised, non-blinded, parallel design trial that aims to evaluate the use of immediate magnetic resonance imaging in the management of patients presenting to the acute setting with suspected scaphoid fractures. The primary outcome is the total 3-month cost per patient associated with the diagnosis and treatment of suspected scaphoid fractures. It is hypothesised that the immediate use of magnetic resonance imaging, a more accurate but expensive imaging modality, in patients with negative findings in the initial four-view radiography, will reduce the overall National Health Service costs by promoting definitive care and avoiding unnecessary diagnostic and treatment procedures. Other rationale design considerations in the recruitment, randomisation, data acquisition and intervention implementation are also discussed. Several of these challenges derive from real-world operational issues associated with the provision of magnetic resonance imaging in an intrinsically complex acute setting. Staff engagement during the trial's planning phase, combined with an extensive training programme rolled out prior to the trial's launch, were essential to raise staff awareness and engagement. Given the acute nature of the clinical condition, the latter was deemed essential as the eligibility assessment, recruitment, randomisation and treatment allocation processes all need to happen in a very tight time frame. Limitations Findings from the Scaphoid Magnetic Resonance Imaging in Trauma trial might not be generalisable to other National Health Service hospitals, foreign healthcare systems nor patient presentations outside normal magnetic resonance imaging working hours. Conclusion The Scaphoid Magnetic Resonance Imaging in Trauma trial was designed to evaluate the costs, patient satisfaction and clinical outcomes around the management of suspected scaphoid fractures and ultimately provide solid evidence on which to base the United Kingdom and international clinical practice. This article discusses the steps considered in the design of this novel trial, with particular emphasis on the issues and lessons learned during the planning and implementation stages.

The economic evidence for advanced imaging in the diagnosis of suspected scaphoid fractures: systematic review of evidence.

Given the limitations of conventional radiography in the diagnosis of suspected scaphoid fractures on presentation, advanced imaging, particularly magnetic resonance imaging, is a useful additional investigation. We carried out a systematic review of the economic evidence for the use of advanced imaging in the management of suspected scaphoid fractures. Fifteen articles were included in the review. Owing to the heterogeneity of study designs, the type and timing of interventions and the economic analyses performed, direct comparisons between the 15 studies were difficult. From a health care perspective, little could be concluded regarding the economic implications of the use of advanced imaging in clinical practice. However, from a societal perspective, the evidence favours the use of advanced imaging in the management of suspected scaphoid fractures as it does appear to lead to overall cost-savings.

Virtual Touch™ Quantification to Diagnose and Monitor Liver Fibrosis in Hepatitis B and Hepatitis C: A NICE Medical Technology Guidance.

Virtual Touch™ Quantification (VTq) is a software application used with Siemens Acuson ultrasound scanners to assess the stiffness of liver tissue. The National Institute for Health and Care Excellence (NICE) Medical Technologies Advisory Committee (MTAC) selected VTq for evaluation and invited the company to submit clinical and economic evidence. King's Technology Evaluation Centre, an External Assessment Centre (EAC) commissioned by NICE, independently assessed the evidence submitted. The EAC conducted its own systematic review, meta-analysis and economic analysis to supplement the company's submitted evidence. The meta-analyses comparing VTq and transient elastography (TE) with liver biopsy (LB) provided pooled estimates of liver stiffness and stage of fibrosis for the study populations (hepatitis B, hepatitis C or combined populations). When comparing significant fibrosis (Metavir score F ≥ 2) for both hepatitis B and C, VTq had slightly higher values for both sensitivity and specificity (77 and 81 %) than TE (76 and 71 %). The overall prevalence of cirrhosis (F4, combined populations) was similar with VTq and TE (23 vs. 23 %), and significant fibrosis (F ≥ 2) was lower for VTq than for TE (55 vs. 62 %). The EAC revised the company's de novo cost model, which resulted in a cost saving of £53 (against TE) and £434 (against LB). Following public consultation, taking into account submitted comments, NICE Medical Technology Guidance MTG27 was published in September 2015. This recommended the adoption of the VTq software to diagnose and monitor liver fibrosis in patients with hepatitis B or hepatitis C.

The geko™ electro-stimulation device for venous thromboembolism prophylaxis: a NICE medical technology guidance.

The geko™ device is a single-use, battery-powered, neuromuscular electrostimulation device that aims to reduce the risk of venous thromboembolism (VTE). The National Institute for Health and Care Excellence (NICE) selected the geko™ device for evaluation, and invited the manufacturer, Firstkind Ltd, to submit clinical and economic evidence. King's Technology Evaluation Centre, an External Assessment Centre (EAC) commissioned by the NICE, independently assessed the evidence submitted. The sponsor submitted evidence related to the geko™ device and, in addition, included studies of other related devices as further clinical evidence to support a link between increased blood flow and VTE prophylaxis. The EAC assessed this evidence, conducted its own systematic review and concluded that there is currently limited direct evidence that geko™ prevents VTE. The sponsor's cost model is based on the assumption that patients with an underlying VTE risk and subsequently treated with geko™ will experience a reduction in their baseline risk. The EAC assessed this cost model but questioned the validity of some model assumptions. Using the EACs revised cost model, the cost savings for geko™ prophylaxis against a 'no prophylaxis' strategy were estimated as £197 per patient. Following a second public consultation, taking into account a change in the original draft recommendations, the NICE medical technologies guidance MTG19 was issued in June 2014. This recommended the adoption of the geko™ for use in people with a high risk of VTE and when other mechanical/pharmacological methods of prophylaxis are impractical or contraindicated in selected patients within the National Health Service in England.

E-vita open plus for treating complex aneurysms and dissections of the thoracic aorta: a NICE medical technology guidance.

The E-vita open plus is a one-stage endoluminal stent graft system used for treating complex aneurysms and dissections of the thoracic aorta. The National Institute for Health and Care Excellence (NICE), as a part of its Medical Technologies Evaluation Programme (MTEP), selected this device for evaluation and invited the manufacturer, JOTEC GmbH, to submit clinical and economic evidence. King's Technology Evaluation Centre (KiTEC), an External Assessment Centre (EAC) commissioned by the NICE, independently critiqued the manufacturer's submissions. The EAC considered that the manufacturer had included most of the relevant evidence for the E-vita open plus, based on international E-vita open registry data for 274 patients, but had provided only limited evidence for the comparators. The EAC therefore conducted a systematic review and meta-analysis of all comparators to supplement the information, and found ten additional studies providing outcome data for the three two-stage comparators. The EAC noted that the cost model submitted by the manufacturer did not include key complications during the procedures. The EAC developed a new economic model incorporating data on complications along with their long-term costs. The revised model indicated that the E-vita open plus might not provide cost savings when compared with some of the comparators in the short-term (1 year), but would have high cost savings in the long-term, from the second year onwards. The NICE Medical Technologies Guidance MTG 16, issued in December 2013, recommended the adoption of the E-vita open plus in selected patients within the National Health Service in England.