[Health Technology Assessment: a value-based tool for the evaluation of healthcare technologies. Reassessment of the cell-culture-derived quadrivalent influenza vaccine: Flucelvax Tetra® 2.0].
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ABSTRACT:
SUBMITTER: Calabro GE
PROVIDER: S-EPMC10079375 | biostudies-literature | 2022 Dec
REPOSITORIES: biostudies-literature
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[Health Technology Assessment: a value-based tool for the evaluation of healthcare technologies. Reassessment of the cell-culture-derived quadrivalent influenza vaccine: Flucelvax Tetra<sup>®</sup> 2.0].
Calabrò Giovanna Elisa GE Boccalini Sara S Bechini Angela A Panatto Donatella D Domnich Alexander A Lai Piero Luigi PL Amicizia Daniela D Rizzo Caterina C Pugliese Andrea A DI Pietro Maria Luisa ML Zanella Beatrice B Parente Flavio F Trombetta Carlo Simone CS Saraceno Giovanni G Sottile Sara S Abreha Fasika Molla FM Giacchetta Irene I Properzi Sara S Santolini Giulia G D'Ambrosio Floriana F Maida Ada A Scardigno Anna A LA Gatta Emanuele E Petrella Luigi L Bonanni Paolo P DE Waure Chiara C
Journal of preventive medicine and hygiene 20221201 4 Suppl 1
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Project description:Manufacturing influenza virus vaccines using a mammalian cell line rather than embryonated chicken eggs may carry certain advantages. A quadrivalent inactivated influenza virus vaccine produced using the Madin Darby canine kidney cell line has been approved in the EU (Flucelvax® Tetra) and USA (Flucelvax Quadrivalent®; QIVc hereafter) for the prevention of influenza in adults and children. The clinical development of QIVc has built upon that of a cell-based trivalent influenza virus vaccine (TIVc) manufactured using the same processes; the additional influenza B strain contained in QIVc reduces the risk of the strain in the vaccine not matching that in circulation. Pivotal phase III clinical trials in adult and paediatric participants have demonstrated the immunogenicity of QIVc to be noninferior to that of TIVc formulations against shared strains and superior against the influenza B strain absent from each TIVc formulation. Protective efficacy data for TIVc is considered foundational for QIVc and, in a phase III clinical trial, TIVc was effective in protecting adults against antigenically matched influenza strains. Large real-world studies from the 2017/2018 US influenza season further support the prophylactic effectiveness of QIVc, with possible benefits over egg-based vaccines. QIVc was generally well tolerated in clinical trials. In adult and paediatric QIVc recipients, the most common solicited adverse reactions were injection site pain and headache. Reactogenicity was comparable to that of TIVc; no safety signals unique to QIVc emerged. Through circumventing concerns around egg adaptation, QIVc has the potential to be more effective than currently available egg-based quadrivalent vaccines.
| S-EPMC6874518 | biostudies-literature
Project description:ObjectivesThe research evaluated participant satisfaction with the content and format of the "Web 2.0 101: Introduction to Second Generation Web Tools" course and measured the impact of the course on participants' self-evaluated knowledge of Web 2.0 tools.MethodsThe "Web 2.0 101" online course was based loosely on the Learning 2.0 model. Content was provided through a course blog and covered a wide range of Web 2.0 tools. All Medical Library Association members were invited to participate. Participants were asked to complete a post-course survey. Respondents who completed the entire course or who completed part of the course self-evaluated their knowledge of nine social software tools and concepts prior to and after the course using a Likert scale. Additional qualitative information about course strengths and weaknesses was also gathered.ResultsRespondents' self-ratings showed a significant change in perceived knowledge for each tool, using a matched pair Wilcoxon signed rank analysis (P<0.0001 for each tool/concept). Overall satisfaction with the course appeared high. Hands-on exercises were the most frequently identified strength of the course; the length and time-consuming nature of the course were considered weaknesses by some.ConclusionLearning 2.0-style courses, though demanding time and self-motivation from participants, can increase knowledge of Web 2.0 tools.
| S-EPMC2759158 | biostudies-literature
Project description: Not available
| S-EPMC6219245 | biostudies-literature
Project description:BackgroundHealth Technology Reassessment (HTR) is a structured, evidence-based assessment of the clinical, social, ethical and economic effects of a technology currently used in the health care system, to inform optimal use of that technology in comparison to its alternatives. Little is known about current international HTR practices. The objective of this research was to summarize experience-based information gathered from international experts on the development, initiation and implementation of a HTR program.MethodsA mixed methods approach, using a survey and in-depth interviews, was adopted. The survey covered 8 concepts: prioritization/identification of potentially obsolete technologies; program development; implementation; mitigation; program championing; stakeholder engagement; monitoring; and reinvestment. Members of Health Technology Assessment International (HTAi) and the International Network of Agencies for Health Technology Assessment (INAHTA) formed the sampling frame. Participation was solicited via email and the survey was administered online using SurveyMonkey. Survey results were analyzed using descriptive statistics. To gather more in-depth knowledge, semi-structured interviews were conducted among organizations with active HTR programs. Interview questions were developed using the same 8 concepts. The hour-long interviews were recorded, transcribed and analyzed using constant comparative analysis.ResultsNinety-five individuals responded to the survey: 49 were not discussing HTR, 21 were beginning to discuss HTR, nine were imminently developing a program, and 16 participants had programs and were completing reassessments. The survey results revealed that methods vary widely and that although HTR is a powerful tool, it is currently not being used to its full potential. Of the 16 with active programs, nine agreed to participate in follow-up interviews. Interview participants identified early and extensive stakeholder engagement as the most important factors for success. A lack of top-down support and financial and human resources are inhibiting program development.DiscussionHTR is in its infancy. Although HTRs are being conducted, there are no standardized approaches. However, much can be learned from current international work. Future work should focus on developing a comprehensive methodology, reporting the processes of reassessments and sharing successes and challenges in a common platform.
| S-EPMC3542085 | biostudies-literature
Project description:BackgroundThe use of low-value care (LVC) is a persistent challenge in health care. Health technology reassessment (HTR) assesses the effects of technologies currently used in the health care system to guide optimal use of these technologies. Consequently, HTR holds promises for identifying and reducing, i.e., de-implementing, the use of LVC. There is limited research on how HTR is executed to support the de-implementation of LVC and whether and how HTR outcomes are translated into practical application. The aim of this study is to investigate how HTR is conducted to facilitate de-implementation of LVC and to investigate how the results of HTR are received and acted on in health care settings.MethodsThis study is a qualitative interview study with representatives from health technology assessment agencies (n = 16) that support the regional health care organizations in Sweden and with representatives from the health care organizations (n = 7). Interviews were analysed with qualitative content analysis.ResultsWe identified three overarching categories for how HTR facilitates de-implementation of LVC and how the results are received and acted on in health care settings: (1) involving key stakeholders to facilitate de-implementation of LVC in identifying potential LVC practices, having criteria for accepting HTR targets, ascertaining high-quality reports and disseminating the reports; (2) actions taken by health care organization to de-implement LVC by priority setting and decision-making, networking between health care organizations and monitoring changes in the use of LVC practices; and (3) sustaining use of LVC by not questioning continued use, continued funding of LVC and by creating opinion against de-implementation.ConclusionsEvidence is not enough to achieve de-implementation of LVC. This has made health technology assessment agencies and health care organizations widen the scope of HTR to encompass strategies to facilitate de-implementation, including involving key stakeholders in the HTR process and taking actions to support de-implementation. Despite these efforts, there can still be resistance to de-implementation of LVC in passive forms, involving continued use of the practice and more active resistance such as continued funding and opinion-making opposing de-implementation. Knowledge from implementation and de-implementation research can offer guidance in how to support the execution phase of HTR.
| S-EPMC11613514 | biostudies-literature
Project description:BackgroundMalaria transmission in Zanzibar has dramatically reduced in recent years but vector control interventions such as long-lasting insecticidal nets (LLIN) must continue to reach malaria elimination. To achieve this, the Zanzibar Malaria Elimination Programme needs actionable evidence of the durability of the LLIN brands distributed. This study compared physical and insecticidal durability of two LLIN brands: Olyset® and PermaNet© 2.0 in two similar districts on the islands of Unguja and Pemba.MethodsThis was a prospective cohort study of representative samples of households from two districts, recruited at baseline 4 months after the mass campaign. All campaign nets in these households were labelled and followed up over a period of 33 months. Primary outcome was the "proportion of nets surviving in serviceable condition" based on attrition and integrity measures and the median survival in years. The outcome for insecticidal durability was determined by bio-assay from sub-samples of campaign nets.ResultsA total of 834 campaign nets (121% of target) from 299 households were included in the study. Definite outcomes could be determined for 86% of the cohort nets in Unguja (PermaNet® 2.0) and 89% in Pemba (Olyset®). After 33 months, physical survival in serviceable condition was 55% in Unguja and 51% in Pemba. Estimated median survival was lower in Pemba at all time points with 2.3-2.7 years compared to 3.1-3.3 yeas in Unguja. Multivariable Cox proportionate hazard models confirmed the difference between brands (p < 0.0001) and identified household net-care attitude (p = 0.007) and folding of hanging nets during the day (p < 0.0001) as significant determinants, in addition to exclusive use of nets by adults (p = 0.03) and use only over a finished bedframe (p = 0.01). Optimal insecticidal effectiveness was 80% or higher for both brands at all time points when both cone bio-assays and tunnel tests were applied.ConclusionsAfter 3 years of follow-up, Olyset® LLIN showed significantly lower physical survival compared to PermaNet® 2.0 LLIN even after adjusting for other variables of net-use environment and net handling. This suggests that the differences were driven by the textile characteristics of the LLIN brands.
| S-EPMC7247136 | biostudies-literature
Project description:BackgroundActive management of existing health technologies (e.g., devices, diagnostic, and/or medical procedures) to ensure the delivery of high value care is increasingly recognized around the world. A number of initiatives have raised awareness of technologies that may be overused, mis-used, or potentially harmful by compiling them into lists of low value care. However, despite the growing number of lists, changes to local healthcare practices remain challenging for many systems. The objective of this study was to develop and implement a process, leveraging existing initiatives and data assets, to produce a list of prioritized low value technologies for health technology reassessment (HTR).MethodsAn expert advisory committee comprised of clinical experts and health system decision-makers was convened to determine key process requirements. Once developed, the process was piloted to assess feasibility in the Canadian province of British Columbia (BC).ResultsThe expert advisory committee identified five required attributes for the process: data-driven, routine and replicable, actionable, stakeholder collaboration, and high return on investment. Guided by these attributes, a 5-step process was developed. First, over 1300 published low value technologies (i.e., from the National Institute for Health and Care Excellence [NICE] "do not do" recommendations, low value technologies in the Australian Medical Benefits Schedule, and Choosing Wisely "Top 5" lists) were identified. Using appropriate coding systems for BC's administrative health data (e.g., International Classification of Diseases [ICD]), the low value technologies were queried to examine frequencies and costs of technology use. This information was used to rank potential candidates for reassessment based on high annual budgetary impact. Lastly, clinical experts reviewed the ranked technologies prior to broad dissemination and stakeholder action. Pilot testing of the process in BC resulted in the prioritization of 9 initial candidate technologies for reassessment.ConclusionsThis is the first account of a systematic approach to move a collective body of low value technology recommendations into action in a healthcare setting. This work demonstrates the feasibility and strength of using administrative data to identify and prioritize low value technologies for HTR at a population-level.
| S-EPMC6094474 | biostudies-literature
Project description:ObjectivesThe human specific commercially available STRs system are often not tested in non human primates for their cross applicability. The aim of this study is to test Cross-species validation of two commercially available human specific STR kits i.e. SureID® 21G and SureID® 23comp (Health Gene Technologies) for their positive application in Chimpanzee (Pan troglodytes).ResultIn SureID® 21G, 19 loci amplified and while 20 loci amplified in SureID® 23comp. All the amplified loci in both STR kits were found polymorphic and the locus Amelogenin showed differential banding patterns between male and female revealing their known gender. The present study validates the applicability of these human specific STR kits in Chimpanzee that can be used in forensics analysis, paternity testing and population genetic studies.
| S-EPMC6862757 | biostudies-literature
Project description:We evaluated the performance of the BioFire® FilmArray® Pneumonia panel (PN-panel) in detecting bacterial pathogens by comparing it to cultures and to the usefulness of the leukocyte esterase (LE) urine strip test. Between January and June 2022, a total of 67 sputum specimens were obtained from community-acquired pneumonia patients. The PN-panel and LE test were performed simultaneously with conventional cultures. The pathogen detection rates of the PN-panel and culture were 40/67 (59.7%) and 25/67 (37.3%), respectively. The concordance rate between the PN-panel and culture was high (76.9%) when the bacterial burden was high (107 copies/mL), but it was low (8.6%) when it was 104-6 copies/mL, irrespective of the sputum quality. According to the LE positivity, the overall culture positive rate and PN-panel positive rate were significantly higher among the LE-positive specimens (23/45, 31/45) than among the LE-negative specimens (2/21, 8/21). Moreover, the difference in concordance rate between the PN-panel test and culture was significant according to the LE positivity, but not the Gram stain grading. In conclusion, the PN-panel showed high concordance when the bacterial burden was high (107 copies/mL) and ancillary use of LE test will be helpful in interpreting the PN-panel results, especially when the copy number of bacterial pathogens is low.
| S-EPMC10252269 | biostudies-literature
Project description:BackgroundMammaPrint® is a microarray-based gene expression test cleared by the US Food and Drug Administration to assess recurrence risk in early-stage breast cancer, aimed to guide physicians in making neoadjuvant and adjuvant treatment decisions. The increase in the incidence of invasive lobular carcinomas (ILCs) over the past decades and the modest representation of ILC in the MammaPrint development data set calls for a stratified survival analysis dedicated to this specific subgroup.Study aimThe current study aimed to validate the prognostic value of the MammaPrint test for breast cancer patients with early-stage ILCs.Materials and methodsUnivariate and multivariate survival associations for overall survival (OS), distant metastasis-free interval (DMFI), and distant metastasis-free survival (DMFS) were studied in a study population of 217 early-stage ILC breast cancer patients from five different clinical studies.Results and discussionA significant association between MammaPrint High Risk and poor clinical outcome was shown for OS, DMFI, and DMFS. A subanalysis was performed on the lymph node-negative study population. In the lymph node-negative study population, we report an up to 11 times higher change in the diagnosis of an event in the MammaPrint High Risk group. For DMFI, the reported hazard ratio is 11.1 (95% confidence interval = 2.3-53.0).ConclusionStudy results validate MammaPrint as an independent factor for breast cancer patients with early-stage invasive lobular breast cancer. Hazard ratios up to 11 in multivariate analyses emphasize the independent value of MammaPrint, specifically in lymph node-negative ILC breast cancers.
| S-EPMC5153320 | biostudies-literature