Deploying a spreadsheet tool for early economic value assessment of medical device innovations with healthcare decision makers

Early stage evaluation of medical device innovations is important for healthcare decision-makers as much as for manufacturers, meaning that a wider application of a basic cost-effectiveness analysis is becoming necessary outside the usual expert base of health technology assessment specialists. Resulting from an academic-industry-healthcare professional collaboration, a spreadsheet tool is described that was designed to be accessible both to professionals in healthcare delivery organisations and to innovators in the healthcare technology industry who are non-experts in the field of health economics. The tool enables a basic cost-effectiveness analysis to be carried out, using a simplified decision-tree model to compare costs and patient benefit for a new device-related procedure with that of standard care employing an incumbent device or other alternative. Such a tool is useful to healthcare professionals because it enables them to rapidly elucidate the cost-effectiveness of heterogeneous innovations by means of the standard quality adjusted life year (QALY) measure of clinical outcome, which is intended to be broadly comparable across treatments. For the innovator or manufacturer it helps them focus on what is required for future stages of development, in order to fill gaps in the input data and so further strengthen their case from a health economics perspective. Results are presented of first experiences from deploying the tool on three medical device exemplars, in face-to-face meetings of the NHS National Innovation Centre (NIC) along with the innovator or clinical champion. The results show that mapping of device-related innovations to the tool is achievable in a short meeting between the NIC and the innovator using expected costs, outcomes data from the literature and estimates of ranges for unknown input data. Whilst the result of a simplified analysis is not expected to be definitive, the process of reasoning is found to be illuminating for the parties involved, enabling innovators to articulate the benefits of their innovations and for all parties to highlight gaps in data and evidence that will be required to take the innovation forward. The partnership model of the authors’ organisation supports the kind of cooperative design approach that is necessary to produce the kind of tool described.---------------------------7dd39101208fa Content-Disposition: form-data; name="c14_creators_1_name_family" Crave

Native Apps versus Web Apps: which is best for healthcare applications?

Smartphone applications (Apps) provide a new way to deliver healthcare, illustrated by the fact that healthcare Apps are estimated to make up over 30% of new Apps currently being developed; with this number seemingly set to increase as the benefits become more apparent. In this paper, using the development of an In Vitro Fertilisation (IVF) treatment stress study App as the exemplar, the alternatives of Native App and Web App design and implementa-tion are considered across several factors that include: user interface, ease of development, capabilities, performance, cost, and potential problems. Development for iOS and Android platforms and a Web App using JavaScript and HTML5 are discussed

Defining alcohol-related phenotypes in humans. The Collaborative Study on the Genetics of Alcoholism.

Alcoholism is a disease that runs in families and results at least in part from genetic risk factors. The Collaborative Study on the Genetics of Alcoholism (COGA) is a Federally funded effort to identify and characterize those genetic factors. The study involves more than 1,000 alcoholic subjects and their families, with researchers conducting comprehensive psychological, physiological, electrophysiological, and genetic analyses of the participants. These analyses have identified several traits, or phenotypes, that appear to be genetically determined, such as the presence of alcohol dependence, the level of response to alcohol, the presence of coexisting depression, or the maximum number of drinks a person consumes per occasion. Genetic analyses have identified regions on several chromosomes that are associated with these phenotypes and need to be studied further

Setting Priorities for Space Research: Opportunities and Imperatives

This report represents the first phase of a study by a task group convened by the Space Studies Board to ascertain whether it should attempt to develop a methodology for recommending priorities among the various initiatives in space research (that is, scientific activities concerned with phenomena in space or utilizing observations from space). The report argues that such priority statements by the space research community are both necessary and desirable and would contribute to the formulation and implementation of public policy. The report advocates the establishment of priorities to enhance effective management of the nation's scientific research program in space. It argues that scientific objectives and purposes should determine how and under what circumstances scientific research should be done. The report does not take a position on the controversy between advocates of manned space exploration and those who favor the exclusive use of unmanned space vehicles. Nor does the report address questions about the value or appropriateness of Space Station Freedom or proposals to establish a permanent manned Moon base or to undertake a manned mission to Mars. These issues lie beyond the charge to the task group

User requirements for the development of smartphone self-reporting applications in healthcare

Two case studies of the development of Smartphone self-reporting mHealth applications are described: a wellness diary for asthma management combined with Bluetooth pulse oximeter and manual peak flow measurements; and a questionnaire for ecological assessment of distress during fertility treat-ment. Results are presented of user experiences with the self-reporting applica-tion and the capture of physiological measurements in the case of the asthma diary project and the findings from a phone audit at an early stage of design in the case of the in vitro fertilisation (IVF) study. Issues raised by ethics commit-tees are also discussed. It is concluded that the optimal adoption of Smartphone self-reporting applications will require a good appreciation of user and ethics panel requirements at an early stage in their development, so that the correct de-sign choices can be made

Anti-confocal versus confocal assessment of the middle ear simulated by Monte Carlo methods

The ability to monitor the inflammatory state of the middle ear mucosa would provide clinical utility. To enable spectral measurements on the mucosa whilst rejecting background signal from the eardrum an anti-confocal system is investigated. In contrast to the central pinhole in a confocal system the anti-confocal system uses a central stop to reject light from the in-focus plane, the eardrum, with all other light detected. Monte Carlo simulations of this system show an increase in detected signal and improved signal-to-background ratio compared to a conventional confocal set-up used to image the middle ear mucosa. System parameters are varied in the simulation and their influence on the level of background rejection are presented

The mitochondrial permeability transition in cell death: a common mechanism in necrosis, apoptosis and autophagy

AbstractUsing confocal microscopy, onset of the mitochondrial permeability transition (MPT) in individual mitochondria within living cells can be visualized by the redistribution of the cytosolic fluorophore, calcein, into mitochondria. Simultaneously, mitochondria release membrane potential-indicating fluorophores like tetramethylrhodamine methylester. The MPT occurs in several forms of necrotic cell death, including oxidative stress, pH-dependent ischemia/reperfusion injury and Ca2+ ionophore toxicity. Cyclosporin A (CsA) and trifluoperazine block the MPT in these models and prevent cell killing, showing that the MPT is a causative factor in necrotic cell death. During oxidative injury induced by t-butylhydroperoxide, onset of the MPT is preceded by pyridine nucleotide oxidation, mitochondrial generation of reactive oxygen species, and an increase of mitochondrial free Ca2+, all changes that promote the MPT. During tissue ischemia, acidosis develops. Because of acidotic pH, anoxic cell death is substantially delayed. However, when pH is restored to normal after reperfusion (reoxygenation at pH 7.4), cell death occurs rapidly (pH paradox). This killing is caused by pH-dependent onset of the MPT, which is blocked by reperfusion at acidotic pH or with CsA. In isolated mitochondria, toxicants causing Reye’s syndrome, such as salicylate and valproate, induce the MPT. Similarly, salicylate induces a CsA-sensitive MPT and killing of cultured hepatocytes. These in vitro findings suggest that the MPT is the pathophysiological mechanism underlying Reye’s syndrome in vivo. Kroemer and coworkers proposed that the MPT is a critical event in the progression of apoptotic cell death. Using confocal microscopy, the MPT can be directly documented during tumor necrosis factor-α induced apoptosis in hepatocytes. CsA blocks this MPT and prevents apoptosis. The MPT does not occur uniformly during apoptosis. Initially, a small proportion of mitochondria undergo the MPT, which increases to nearly 100% over 1–3 h. A technique based on fluorescence resonance energy transfer can selectively reveal mitochondrial depolarization. After nutrient deprivation, a small fraction of mitochondria spontaneously depolarize and enter an acidic lysosomal compartment, suggesting that the MPT precedes the normal process of mitochondrial autophagy. A model is proposed in which onset of the MPT to increasing numbers of mitochondria within a cell leads progressively to autophagy, apoptosis and necrotic cell death

Head injury from falls in children younger than 6 years of age

The risk of serious head injury (HI) from a fall in a young child is ill defined. The relationship between the object fallen from and prevalence of intracranial injury (ICI) or skull fracture is described. Method Cross-sectional study of HIs from falls in children (<6 years) admitted to UK hospitals, analysed according to the object fallen from and associated Glasgow Coma Score (GCS) or alert, voice, pain, unresponsive (AVPU) and CT scan results. Results Of 1775 cases ascertained (median age 18 months, 54.7% boys), 87% (1552) had a GCS=15/AVPU=alert. 19.3% (342) had a CT scan: 32% (110/342) were abnormal; equivalent to 5.9% of the overall population, 16.9% (58) had isolated skull fractures and 13.7% (47) had ICI (49% (23/47) had an associated skull fracture). The prevalence of ICI increased with neurological compromise; however, 12% of children with a GCS=15/AVPU=alert had ICI. When compared to falls from standing, falls from a person's arms (233 children (mean age 1 year)) had a significant relative OR for a skull fracture/ICI of 6.94 (95% CI 3.54 to 13.6), falls from a building (eg, window or attic) (mean age 3 years) OR 6.84 (95% CI 2.65 to 17.6) and from an infant or child product (mean age 21 months) OR 2.75 (95% CI 1.36 to 5.65). Conclusions Most HIs from a fall in these children admitted to hospital were minor. Infants, dropped from a carer's arms, those who fell from infant products, a window, wall or from an attic had the greatest chance of ICI or skull fracture. These data inform prevention and the assessment of the likelihood of serious injury when the object fallen from is known