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

Benchmarking in the non-government sector

[extract] A Question to Ponder - How does your service compare to other similar services in the industry? How would knowing this help your organisation

A web-based tool for eliciting probability distributions from experts

We present a web-based probability distribution elicitation tool: The MATCH Uncertainty Elicitation Tool. The Tool is designed to help elicit probability distributions about uncertain model parameters from experts, in situations where suitable data is either unavailable or sparse. The Tool is free to use, and offers five different techniques for eliciting univariate probability distributions. A key feature of the Tool is that users can log in from different sites and view and interact with the same graphical displays, so that expert elicitation sessions can be conducted remotely (in conjunction with tele- or videoconferencing). This will make probability elicitation easier in situations where it is difficult to interview experts in person. Even when conducting elicitation remotely, interviewers will be able to follow good elicitation practice, advise the experts, and provide instantaneous feedback and assistance

Accurate neonatal heart rate monitoring using a new wireless, cap mounted device

© 2020 The Authors. Acta Paediatrica published by John Wiley & Sons Ltd on behalf of Foundation Acta Paediatrica Aim: A device for newborn heart rate (HR) monitoring at birth that is compatible with delayed cord clamping and minimises hypothermia risk could have advantages over current approaches. We evaluated a wireless, cap mounted device (fhPPG) for monitoring neonatal HR. Methods: A total of 52 infants on the neonatal intensive care unit (NICU) and immediately following birth by elective caesarean section (ECS) were recruited. HR was monitored by electrocardiogram (ECG), pulse oximetry (PO) and the fhPPG device. Success rate, accuracy and time to output HR were compared with ECG as the gold standard. Standardised simulated data assessed the fhPPG algorithm accuracy. Results: Compared to ECG HR, the median bias (and 95% limits of agreement) for the NICU was fhPPG −0.6 (−5.6, 4.9) vs PO −0.3 (−6.3, 6.2) bpm, and ECS phase fhPPG −0.5 (−8.7, 7.7) vs PO −0.1 (−7.6, 7.1) bpm. In both settings, fhPPG and PO correlated with paired ECG HRs (both R2=0.89). The fhPPG HR algorithm during simulations demonstrated a near-linear correlation (n=1266, R2=0.99). Conclusion: Monitoring infants in the NICU and following ECS using a wireless, cap mounted device provides accurate HR measurements. This alternative approach could confer advantages compared with current methods of HR assessment and warrants further evaluation at birth

Assessment of Community Event-Based Surveillance for Ebola Virus Disease, Sierra Leone, 2015.

In 2015, community event-based surveillance (CEBS) was implemented in Sierra Leone to assist with the detection of Ebola virus disease (EVD) cases. We assessed the sensitivity of CEBS for finding EVD cases during a 7-month period, and in a 6-week subanalysis, we assessed the timeliness of reporting cases with no known epidemiologic links at time of detection. Of the 12,126 CEBS reports, 287 (2%) met the suspected case definition, and 16 were confirmed positive. CEBS detected 30% (16/53) of the EVD cases identified during the study period. During the subanalysis, CEBS staff identified 4 of 6 cases with no epidemiologic links. These CEBS-detected cases were identified more rapidly than those detected by the national surveillance system; however, too few cases were detected to determine system timeliness. Although CEBS detected EVD cases, it largely generated false alerts. Future versions of community-based surveillance could improve case detection through increased staff training and community engagement

A laminated polymer film formulation for enteric delivery of live vaccine and probiotic bacteria

Live bacterial cells (LBC) are administered orally as attenuated vaccines, to deliver biopharmaceutical agents, and as probiotics to improve gastrointestinal health. However, LBC present unique formulation challenges and must survive gastrointestinal antimicrobial defenses including gastric acid after administration. We present a simple new formulation concept, termed Polymer Film Laminate (PFL). LBC are ambient dried onto cast acid-resistant enteric polymer films that are then laminated together to produce a solid oral dosage form. LBC of a model live bacterial vaccine and a probiotic were dried directly onto a cast film of enteric polymer. The effectiveness at protecting dried cells in a simulated gastric fluid (pH 2.0) depended on the composition of enteric polymer film used, with a blend of ethylcellulose plus Eudragit L100 55 providing greater protection from acid than Eudragit alone. However, although PFL made from blended polymers films completely released low molecular weight dye into intestinal conditions (pH 7.0), they failed to release LBC. In contrast, PFL made from Eudragit alone successfully protected dried probiotic or vaccine LBC from simulated gastric fluid for 2h, and subsequently released all viable cells within 60min of transfer into simulated intestinal fluid. Release kinetics could be controlled by modifying the lamination method

Cytokeratin 8/18 expression indicates a poor prognosis in squamous cell carcinomas of the oral cavity

BACKGROUND: Intermediary filaments are involved in cell motility and cancer progression. In a variety of organs, the expression of distinct intermediary filaments are associated with patient prognosis. In this study, we seeked to define the prognostic potential of cytokeratin and vimentin expression patterns in squamous cell carcinomas (SCC's) of the oral cavity. METHODS: 308 patients with histologically proven and surgically treated squamous cell carcinomas of the oral cavity were investigated for the immunohistochemical expression of a variety of intermediary filaments including high- and low-molecular weight cytokeratins (Ck's), such as Ck 5/6, Ck 8/18, Ck 1, CK 10, Ck 14, Ck 19 and vimentin, using the tissue microarray technique. Correlations between clinical features and the expression of Cytokeratins and vimentin were evaluated statistically by Kaplan-Meier curves and multivariate Cox regression analysis. RESULTS: The expression of Ck 8/18 and Ck 19 were overall significantly correlated with a poor clinical prognosis (Ck 8/18 p = 0.04; Ck19 p < 0.01). These findings could also be reproduced for Ck 8/18 in primary nodal-negative SCC's and held true in multivariate-analysis. No significant correlation with patient prognosis could be found for the expression of the other cytokeratins and for vimentin. CONCLUSION: The expression of Ck 8/18 in SCC's of the oral cavity is an independent prognostic marker and indicates a decreased overall and progression free survival. These results provide an extended knowledge about the role of intermediary filament expression patterns in SCC's