On the integration of early health technology assessment in the innovation process: reflections from five stakehol

Early health technology assessment (HTA), which includes all methods used to inform industry and other stakeholders about the potential value of new medical products in development, including methods to quantify and manage uncertainty, has seen many applications in recent years. However, it is still unclear how such early value assessments can be integrated into the technology innovation process. This commentary contributes to the discussion on the purposes early HTA can serve. Similarities and differences in the perspectives of five stakeholders (i.e., the hospital, the patient, the assessor, the medical device industry, and the policy maker) on the purpose, value, and potential challenges of early HTA are described. All five stakeholders agreed that integrating early HTA in the innovation process has the possibility to shape and refine an innovation, and inform research and development decisions. The early assessment, using a variety of methodologies, can provide insights that are relevant for all stakeholders but several challenges, for example, feasibility and responsibility, need to be addressed before early HTA can become standard practice. For early evaluations to be successful, all relevant stakeholders including patients need to be involved. Also, nimble, flexible assessment methods are needed that fit the dynamics of medical technology. Best practices should be shared to optimize both the innovation process and the methods to perform an early value assessment

The Problem of Mixing up of Leishmania Isolates in the Laboratory: Suggestion of ITS1 Gene Sequencing for Verification of Species

Background: Leishmaniasis is endemic in Iran. Different species of Leishmania (L.) parasites are causative agents of this disease. Correct identification of Leishmania species is important for clinical studies,prevention, and control of the diseases. Mix up of Leishmania isolates is possible in the laboratory, so there is need for verification of species for isolates of uncertain identity. Different methods may be used for this purpose including isoenzyme electrophoresis and molecular methods. The isoenzyme lectrophoresis, due to its drawbacks, is feasible only in specialized laboratories while molecular methods may be more feasible. The aim of this research was to study the application of the internal transcribedspacer 1 (ITS1) sequencing method, in comparison to isoenzyme electrophoresis method, for verification of Leishmania species.Methods: Six Leishmania isolates were received from different research institutions in Iran. The species of these isolates were known by donating institution according to their isoenzyme profile. The species of these isolates were re-identified in Pasteur Institute of Iran by PCR amplification of ITS1 followed bysequencing and comparison of these sequences with Leishmania sequences in GenBank. Isoenzyme electrophoresis was performed for confirmation of the results of ITS1.Results: ITS1 sequence showed that some isolates were mixed up or contaminated with Crithidia. Isoenzyme electrophoresis confirmed the results of ITS1 sequences.Conclusion: ITS1 sequencing is relatively more feasible than the traditional isoenzyme electrophoresismethod and is suggested for verification of Leishmania species

Best practice considerations on the assessment of robotic assisted surgical systems:results from an international consensus expert panel

Background Health technology assessments (HTAs) of robotic assisted surgery (RAS) face several challenges in assessing the value of robotic surgical platforms. As a result of using different assessment methods, previous HTAs have reached different conclusions when evaluating RAS. While the number of available systems and surgical procedures is rapidly growing, existing frameworks for assessing MedTech provide a starting point, but specific considerations are needed for HTAs of RAS to ensure consistent results. This work aimed to discuss different approaches and produce guidance on evaluating RAS. Methods A consensus conference research methodology was adopted. A panel of 14 experts was assembled with international experience and representing relevant stakeholders: clinicians, health economists, HTA practitioners, policy makers, and industry. A review of previous HTAs was performed and seven key themes were extracted from the literature for consideration. Over five meetings, the panel discussed the key themes and formulated consensus statements. Results A total of ninety-eight previous HTAs were identified from twenty-five total countries. The seven key themes were evidence inclusion and exclusion, patient- and clinician-reported outcomes, the learning curve, allocation of costs, appropriate time horizons, economic analysis methods, and robotic ecosystem/wider benefits. Conclusions Robotic surgical platforms are tools, not therapies. Their value varies according to context and should be considered across therapeutic areas and stakeholders. The principles set out in this paper should help HTA bodies at all levels to evaluate RAS. This work may serve as a case study for rapidly developing areas in MedTech that require particular consideration for HTAs.</p

Possible association of vitamin D status with lung involvement and outcome in patients with COVID-19: a retrospective study

Purpose: Vitamin D deficiency has been reported as a key factor in the development of infectious diseases such as respiratory tract infections and inflammatory processes like acute respiratory distress syndrome. However, the impact of vitamin D on the severity and outcome of COVID-19 is still not fully known. Herein, we aimed to evaluate the prognostic role of serum vitamin D concentration on the extent of lung involvement and final outcome in patients with COVID-19. Methods: Seventy-three subjects with confirmed diagnosis of COVID-19 were investigated in this study. The patients had been admitted to our academic hospital from February 28, 2020 to April 19, 2020. Demographic and clinical data, serum 25(OH)D levels, and findings of initial chest computed tomography were recorded. Linear and binary logistic regression, cox regression and ROC curve tests were used for statistical analysis. Results: The mean age of patients was 55.18 ± 14.98 years old; 46.4 were male. Mean serum 25(OH)D concentration was significantly lower in the deceased (13.83 ± 12.53 ng/ mL compared with discharged patients (38.41 ± 18.51 ng/mL) (P < 0.001). Higher levels of 25(OH)D were associated with significantly less extent of total lung involvement (β = � 0.10, P = 0.004). In addition, vitamin D deficiency 25(OH) D < 25 ng/mL was associated with a significant increase in the risk of mortality (hazard ratio = 4.15, P = 0.04). Conclusion: This study suggests that serum vitamin D status might provide useful information regarding the clinical course, extent of lung involvement and outcome of patients with COVID-19. However, further studies with larger sample size are needed to confirm these findings. © 2020, Springer-Verlag GmbH Germany, part of Springer Nature

Bond of 13 mm prestressing steel strands in pretensioned concrete members

This paper presents an experimental research work to determine both the transmission and the anchorage lengths of seven-wire prestressing steel strands in different concrete mixes. A testing technique based on a bond behavior analysis by measuring the force supported by the prestressing strand on a series of specimens with different embedment lengths has been used. Relationships between the average bond stress for both the transmission length and anchorage length as a function of the concrete compressive strength have been found. Equations to compute transmission and anchorage lengths of 13 mm prestressing strands have been obtained. The experimental results have been compared with the theoretical prediction from proposed equations in the literature and with experimental results from other authors. 2012 Elsevier Ltd. All rights reserved.The content of this article forms part of the research work that the Institute of Concrete Science and Technology (ICITECH) is presently conducting in conjunction with PREVALESA and ISOCRON. This study has been funded by the Spanish Ministry of Education and Science and ERDF (Project BIA2006-05521). The authors wish to thank the above companies as well as the concrete structures laboratory technicians at the Universitat Politecnica de Valencia for their cooperation. Finally, the authors also wish to pay their respects to C.A. Arbelaez.Martí Vargas, JR.; Serna Ros, P.; Navarro Gregori, J.; Pallarés Rubio, L. (2012). Bond of 13 mm prestressing steel strands in pretensioned concrete members. Engineering Structures. 41:403-412. https://doi.org/10.1016/j.engstruct.2012.03.056S4034124

Moving Towards Accountability for Reasonableness – A Systematic Exploration of the Features of Legitimate Healthcare Coverage Decision-Making Processes Using Rare Diseases and Regenerative Therapies as a Case Study

Background: The accountability for reasonableness (A4R) framework defines 4 conditions for legitimate healthcare coverage decision processes: Relevance, Publicity, Appeals, and Enforcement. The aim of this study was to reflect on how the diverse features of decision-making processes can be aligned with A4R conditions to guide decision-making towards legitimacy. Rare disease and regenerative therapies (RDRTs) pose special decision-making challenges and offer therefore a useful case study. Methods: Features operationalizing each A4R condition as well as three different approaches to address these features (cost-per-QALY-focused and multicriteria-based) were defined and organized into a matrix. Seven experts explored these features during a panel run under the Chatham House Rule and provided general and RDRT-specific recommendations. Responses were analyzed to identify converging and diverging recommendations. Results: Regarding Relevance, recommendations included supporting deliberation, stakeholder participation and grounding coverage decision criteria in normative and societal objectives. Thirteen of 17 proposed decision criteria were recommended by a majority of panelists. The usefulness of universal cost-effectiveness thresholds to inform allocative efficiency was challenged, particularly in the RDRT context. RDRTs raise specific issues that need to be considered; however, rarity should be viewed in relation to other aspects, such as disease severity and budget impact. Regarding Publicity, panelists recommended transparency about the values underlying a decision and value judgements used in selecting evidence. For Appeals, recommendations included a life-cycle approach with clear provisions for re-evaluations. For Enforcement, external quality reviews of decisions were recommended. Conclusion: Moving coverage decision-making processes towards enhanced legitimacy in general and in the RDRT context involves designing and refining approaches to support participation and deliberation, enhancing transparency, and allowing explicit consideration of multiple decision criteria that reflect normative and societal objectives

Strand bond performance in prestressed concrete accounting for bondslip

This paper presents the results of an experimental research program addressing the bond behavior of prestressing strands in pretensioned prestressed concrete members after anchorage failure has occurred. A test methodology based on measuring the prestressing strand force and strand end slip at the specimens free end was employed. Transmission- and anchorage-length tests were performed on several series of prestressed specimens with different embedment lengths using twelve concrete mixes. Average bond stresses along the transmission length and the anchorage length were obtained for specimens with release strengths ranging from 24 MPa to 55 MPa. For the anchorage analysis, a parameter was developed that includes strand slip to be used in determining anchorage length. Based on the test results, an analysis to experimentally substantiate the Stress Waves Theory of Janney has been proposed. Additionally, the potential bond performance of prestressing strands after anchorage failure at the end regions has been suggested.The content of the present paper is based on tests which were conducted in the Institute of Concrete Science and Technology (ICITECH), at Universitat Politecnica of Valencia (Spain), in collaboration with the companies PREVALESA and ISOCRON. Funding for this experimental research work was provided by the Spanish Ministry of Education and Science/Science and Innovation and ERDF (Project BIA2006-05521 and Project BIA2009-12722). The authors wish to thank the above companies as well as the concrete structures laboratory technicians at the Universitat Politecnica of Valencia for their cooperation. Finally, the authors also wish to pay their respects to C.A. Arbelaez.Martí Vargas, JR.; Serna Ros, P.; Hale, WM. (2013). Strand bond performance in prestressed concrete accounting for bondslip. Engineering Structures. 51:236-244. doi:10.1016/j.engstruct.2013.01.023S2362445

Time-dependent behaviour of cracked, partially bonded reinforced concrete beams under repeated and sustained loads

This paper compares the flexural behaviour of cracked partially bonded (in the mid-span, maximum moment zone) reinforced concrete beams subjected to (i) static sustained load and (ii) static sustained with cyclically repeating load. Information relating to surface strains and mid-span deflections were continuously recorded for a period of 90 days. The sustained load level represented that which produced the stabilized crack pattern. The amplitude of the superimposed cyclic load was considered to be a small fraction of the sustained load. The experimental outcome shows that under sustained load alone, the long-term mid-span deflection of reinforced concrete beams with artificially debonded reinforcement is substantially higher than that of normally bonded equivalent beams. For the cyclically exerted load addition there was no substantial difference between the observed ultimate deformations of bonded and debonded beams. Nonlinear finite element software (Midas FEA) was used to simulate these results and it was found that a numerical-experimental match can be achieved after applying necessary modifications to the distribution of shrinkage down through the beams’ cross-section