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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.
Attachment, the relationship between caregiver and child, is a crucial factor in an infant's ability to develop healthy relationships. Research has identified different types of attachment relationships. There are also two different attachment disorders. A disorganised attachment pattern and attachment disorders were found to predict psychiatric illness, anxiety disorders and depression in later life. The government strategy to promote emotional wellbeing during the early years of a child's life includes promoting secure attachment through interventions aimed at parents. This study will use systematic review strategies to determine which interventions are clinically and cost effective among the parents of children with severe attachment problems (or who are at high risk of developing such problems). We propose to review the literature to answer several questions: 1) How are severe attachment disorders in children currently measured and how accurate are these measures in identifying the problem? 2) How many children suffer from severe attachment disorders and what are the associated long term risks? 3) How clinically effective are interventions for parents of children with severe attachment disorder (or who are at high risk of developing such problems)? 4) How cost effective are interventions for parents of children with these problems? 5) How can further research benefit the study of effective interventions for parents of children with these problems? The review has been divided into six key phases, with each phase proposing to answer one of the study aims. The success of the research will be judged by its ability to answer each of these questions, and on the basis of this answer the overall questions that are set out in the HTA brief. Another indicator of the success of the research will be whether the findings are appropriately disseminated so that they can influence future research, policy and practice.
PURPOSE: The purpose of this paper is to observe and analyse the effects of the use of telemedicine in care homes on the use of acute hospital resources.
DESIGN/METHODOLOGY/APPROACH: The study was an uncontrolled retrospective observational review of data on emergency hospital admissions and Emergency Department (ED) visits for care home residents in Airedale, Wharfedale and Craven. Acute hospital activity for residents was observed before and after the installation of telemedicine in 27 care homes. Data from a further 21 care homes that did not use telemedicine were used as a control group, using the median date of telemedicine installation for the "before and after" period. Patient outcomes were not considered.
FINDINGS: Care homes with telemedicine showed a 39 per cent reduction in the costs of emergency admissions and a 45 per cent reduction in ED attendances after telemedicine installation. In the control group reductions were 31 and 31 per cent, respectively. The incremental difference in costs between the two groups of care homes was almost £1.2 million. The cost of telemedicine to care commissioners was £177,000, giving a return on investment over a 20-month period of £6.74 per £1 spent.
RESEARCH LIMITATIONS/IMPLICATIONS: The results should be interpreted carefully. There is inherent bias as telemedicine was deployed in care homes with the highest use of acute hospital resources and there were some methodological limitations due to poor data. Nevertheless, controlling the data as much as possible and adopting a cautious approach to interpretation, it can be concluded that the use of telemedicine in these care homes was cost-effective.
Originality/value
There are very few telemedicine studies focused on care homes.
Problems with intimacy in patients with cancer of the head and neck may not be recognised. Our aim was to review published papers on patient-reported outcomes that record concerns about intimacy, sex, and function, to help develop a tool for use in head and neck cancer. We specifically looked for instruments with evidence of validation in patients with cancer, which could be used to identify problems with intimacy and sexuality. After evaluating 2563 papers, we identified 20 that satisfied our inclusion criteria, and these have been presented in a tabulated form. This review has shown the need to develop a questionnaire on intimacy that is specific to patients with cancer of the head and neck. It is an important issue that must be addressed by clinical and research teams, and will be done most effectively if it is linked to specific interventions.
BACKGROUND: In the UK, NHS hospitals receive large amounts of evidence-based recommendations for care delivery from the National Institute for Health and Care Excellence (NICE) and other organisations. Little is known about how NHS organisations implement such guidance and best practice for doing so. This study was therefore designed to examine the dissemination, decision-making, and monitoring processes for NICE interventional procedures (IP) guidance and to investigate the barriers and enablers to the implementation of such guidance.
METHODS: A cross-sectional survey questionnaire was developed and distributed to individuals responsible for managing the processes around NICE guidance in all 181 acute NHS hospitals in England, Scotland, Wales and Northern Ireland. A review of acute NHS hospital policies for implementing NICE guidance was also undertaken using information available in the public domain and from organisations' websites.
RESULTS: The response rate to the survey was 75 % with 135 completed surveys received. Additionally, policies from 25 % of acute NHS hospitals were identified and analysed. NHS acute hospitals typically had detailed processes in place to implement NICE guidance, although organisations recognised barriers to implementation including organisational process barriers, clinical engagement and poor targeting with a large number of guidance issued. Examples of enablers to, and good practice for, implementation of guidance were found, most notably the value of shared learning experiences between NHS hospitals. Implications for NICE were also identified. These included making improvements to the layout of guidance, signposting on the website and making better use of their shared learning platform.
CONCLUSIONS: Most organisations have robust processes in place to deal with implementing guidance. However, resource limitations and the scope of guidance received by organisations create barriers relating to organisational processes, clinician engagement and financing of new procedures. Guidance implementation can be facilitated through encouragement of shared learning by organisations such as NICE and open knowledge transfer between organisations.
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.
OBJECTIVES: To undertake a network meta-analysis (NMA) to assess the effectiveness of licensed interventions (aflibercept 2q8, ranibizumab PRN, pegaptanib and photodynamic therapy (PDT)) in the treatment of neovascular (wet) age-related macular degeneration (wet AMD).
METHODS: A systematic review was undertaken to identify trials comparing any of the interventions to treat neovascular AMD reporting change in best corrected visual acuity (BCVA). A NMA of the studies was carried out using WinBugs. Identified studies often reported results at multiple time points. Hence, a number of models were applied accounting for the time structure in the data. The deviance information criterion (DIC) was used to select the most appropriate model. Multiple separate networks were applied to the data to account for the fact that posologies were equivalent at some time points.
RESULTS: 21 trials were included in the network. Aflibercept and ranibizumab were found to be statistically superior to PDT and pegaptanib at 12 and 24 months. The mean change from baseline BVCA estimated between ranibizumab and PDT at 12 months was 18.85 [15.42 to 22.26] and at 24 months was 20.62 [17.25 to 23.96]. The mean change from baseline BVCA estimated between ranibizumab and pegaptanib at 12 months was 11.16 [2.93, 20.63] and at 24 months was 11.71 [3.31, 25.06]. Results for aflibercept were quantitatively similar. There was minimal difference in the effectiveness of ranibizumab and aflibercept at any time point: mean difference at 12 months numerically favoured ranibizumab by 0.05 [-1.33 to 1.52] and at 24 months by 0.02 [-1.36 to 1.44].
CONCLUSIONS: Aflibercept and ranibizumab are effective treatments for neovascular AMD demonstrating a clinically and statistically significant difference in BVCA compared with PDT and Pegaptanib. There were only minimal (non-statistically significant) differences in the relative effectiveness of aflibercept and ranibizumab at any time point.
