Using health technology assessment to set priority, inform target product profiles, and design clinical study for health innovation
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ABSTRACT:
SUBMITTER: Wang Y
PROVIDER: S-EPMC8524319 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe RTS,S/AS01 vaccine for Plasmodium falciparum malaria demonstrated moderate efficacy in 5-17-month-old children in phase 3 trials, and from 2018, the vaccine will be evaluated through a large-scale pilot implementation program. Work is ongoing to optimise this vaccine, with higher efficacy for a different schedule demonstrated in a phase 2a challenge study. The objective of our study was to investigate the population-level impact of a modified RTS,S/AS01 schedule and dose amount in order to inform the target product profile for a second-generation malaria vaccine.MethodsWe used a mathematical modelling approach as the basis for our study. We simulated the changing anti-circumsporozoite antibody titre following vaccination and related the titre to vaccine efficacy. We then implemented this efficacy profile within an individual-based model of malaria transmission. We compared initial efficacy, duration and dose timing, and evaluated the potential public health impact of a modified vaccine in children aged 5-17 months, measuring clinical cases averted in children younger than 5 years.ResultsIn the first decade of delivery, initial efficacy was associated with a higher reduction in childhood clinical cases compared to vaccine duration. This effect was more pronounced in high transmission settings and was due to the efficacy benefit occurring in younger ages where disease burden is highest. However, the low initial efficacy and long duration schedule averted more cases across all age cohorts if a longer time horizon was considered. We observed an age-shifting effect due to the changing immunological profile in higher transmission settings, in scenarios where initial efficacy was higher, and the fourth dose administered earlier.ConclusionsOur findings indicate that, for an imperfect childhood malaria vaccine with suboptimal efficacy, it may be advantageous to prioritise initial efficacy over duration. We predict that a modified vaccine could outperform the current RTS,S/AS01, although fourth dose timing will affect the age group that derives the greatest benefit. Further, the outcome measure and timeframe over which a vaccine is assessed are important when prioritising vaccine elements. This study provides insight into the most important characteristics of a malaria vaccine for at-risk groups and shows how distinct vaccine properties translate to public health outcomes. These findings may be used to prioritise target product profile elements for second-generation childhood malaria vaccines.
| S-EPMC6044028 | biostudies-literature
Project description:BACKGROUND:The Health Product Profile Directory (HPPD) is an online database describing 8-10 key characteristics (such as target population, measures of efficacy and dosage) of product profiles for medicines, vaccines, diagnostics and other products that are intended to be accessed by populations in low- and middle-income countries. The HPPD was developed by TDR on behalf of WHO and launched on 15 May 2019. METHODS:The contents of the HPPD were downloaded into an Excel™ spreadsheet via the open access interface and analysed to identify the number of health product profiles by type, disease, year of publication, status, author organization and safety information. RESULTS:The HPPD contains summaries of 215 health product profiles published between 2008 and May 2019, 117 (54%) of which provide a hyperlink to the detailed publication from which the summary was extracted, and the remaining 98 provide an email contact for further information. A total of 55 target disease or health conditions are covered, with 210 profiles describing a product with an infectious disease as the target. Only 5 product profiles in the HPPD describe a product for a non-communicable disease. Four diseases account for 40% of product profiles in the HPPD; these are tuberculosis (33 profiles, 15%), malaria (31 profiles, 14%), HIV (13 profiles, 6%) and Chagas (10 profiles, 5%). CONCLUSION:The HPPD provides a new tool to inform priority-setting in global health - it includes all product profiles authored by WHO (n = 51). There is a need to standardise nomenclature to more clearly distinguish between strategic publications (describing research and development (R&D) priorities or preferred characteristics) compared to target product profiles to guide a specific candidate product undergoing R&D. It is recommended that all profiles published in the HPPD define more clearly what affordability means in the context where the product is intended to be used and all profiles should include a statement of safety. Combining the analysis from HPPD to a mapping of funds available for R&D and those products in the R&D pipeline would create a better overview of global health priorities and how they are supported. Such analysis and increased transparency should take us a step closer to measuring and improving coordination of efforts in global health R&D.
| S-EPMC6909642 | biostudies-literature
Project description:In the era of rapid product iteration, companies need simple and effective methods to guide the entire process of product innovation design and enhance their product innovation capabilities. Most research focused on improving one or several steps in the product design process. Although some scholars have proposed methods that guided the entire process, they combined more than three different theories, which increased the difficulty of theoretical learning and the complexity of practical implementation. This paper proposed a product innovation design process composed of three theoretical methods: Kano, Axiomatic Design (AD), and Theory of the Solution of Inventive Problems (TRIZ). This new process guided the entire product design process with fewer theoretical methods, reducing the difficulty of learning and implementation. The paper demonstrated the effectiveness of this method through the design practice of a portable two-wheeled self-balancing vehicle. Additionally, the discussion section explored the method's potential from the design management perspective.
| S-EPMC10977887 | biostudies-literature
Project description:We undertook a systematic review evaluating the effectiveness and cost of health-focused innovation design contests. We followed Cochrane guidance and systematically searched eight databases. Articles were included if they reported an open contest focused on improving health, required participants submit finished design solutions and contained a prize structure. We searched 3579 citations, identifying 29 health-focused innovation design contests which collectively received 15494 contest submissions. Contests solicited submissions worldwide (7) and exclusively from North America (13), Asia (4), Africa (2), Australia (2) and Europe (1). Submissions per contest ranged from 3 to 11354 (median of 73). Contest entrants were tasked with helping develop health promotion messages (HPM) (25) and improve predictive clinical models, protocols and/or algorithms (4). Two types of contests emerged-those focused on high-quality, innovative outcomes and those focused on the process of mass community engagement. All outcome-oriented contests had innovation design contest solutions equivalent or superior to the comparator (100%; 7/7). Two of two studies found that innovation design contests saved money (100%; 2/2). Five of seven process-oriented contests concluded the contest improved at least one health indicator (71%; 5/7). Innovation design contests are an effective way to solicit innovative solutions to health problems and spur mass community engagement.
| S-EPMC5863925 | biostudies-literature
Project description:BackgroundLong-lasting insecticidal nets (LLINs) and indoor residual sprays (IRS) have decimated malaria transmission by killing indoor-feeding mosquitoes. However, complete elimination of malaria transmission with these proven methods is confounded by vectors that evade pesticide contact by feeding outdoors.MethodsFor any assumed level of indoor coverage and personal protective efficacy with insecticidal products, process-explicit malaria transmission models suggest that insecticides that repel mosquitoes will achieve less impact upon transmission than those that kill them outright. Here such models are extended to explore how outdoor use of products containing either contact toxins or spatial repellents might augment or attenuate impact of high indoor coverage of LLINs relying primarily upon contact toxicity.ResultsLLIN impact could be dramatically enhanced by high coverage with spatial repellents conferring near-complete personal protection, but only if combined indoor use of both measures can be avoided where vectors persist that prefer feeding indoors upon humans. While very high levels of coverage and efficacy will be required for spatial repellents to substantially augment the impact of LLINs or IRS, these ambitious targets may well be at least as practically achievable as the lower requirements for equivalent impact using contact insecticides.ConclusionsVapour-phase repellents may be more acceptable, practical and effective than contact insecticides for preventing outdoor malaria transmission because they need not be applied to skin or clothing and may protect multiple occupants of spaces outside of treatable structures such as nets or houses.
| S-EPMC3298720 | biostudies-literature
Project description:BackgroundWhat constitutes innovation in health technologies can be defined and measured in a number of ways and it has been widely researched and published about. However, while many countries mention it as a criterion for pricing or reimbursement of health technologies, countries differ widely in how they define and operationalise it.MethodsWe performed a literature review, using a snowballing search. In this paper, we explore how innovation has been defined in the literature in relation to health technology assessment. We also describe how a selection of countries (England, France, Italy, Spain and Japan) take account of innovation in their health technology assessment frameworks and explore the key methodologies that can capture it as a dimension of value in a new health technology. We propose a way of coming to, and incorporating into health technology assessment systems, a definition of innovation for health technologies that is independent of other dimensions of value that they already account for in their systems, such as clinical benefit. We use Spain as an illustrative example of how innovation might be operationalised as a criterion for decision making in health technology assessment.ResultsThe countries analysed here can be divided into 2 groups with respect to how they define innovation. France, Japan and Italy use features such as severity, unmet need and therapeutic added value as indicators of the degree of innovation of a health technology, while England, Spain consider the degree of innovation as a separate and additional criterion from others. In the case of Spain, a notion of innovation might be constructed around concepts of `step-change', `convenience', `strength of evidence base' and `impact on future research & development'.ConclusionsIf innovation is to be used as operational criteria for adoption, pricing and reimbursement of health technologies, the concept must be clearly defined, and it ought to be independent from other value dimensions already captured in their health technology assessment systems.
| S-EPMC8725438 | biostudies-literature
Project description:The development of pericoital (on demand) vaginal HIV prevention technologies remains a global health priority. Clinical trials to date have been challenged by nonadherence, leading to an inability to demonstrate product efficacy. The work here provides new methodology and results to begin to address this limitation. We created validated scales that allow users to characterize sensory perceptions and experiences when using vaginal gel formulations. In this study, we sought to understand the user sensory perceptions and experiences (USPEs) that characterize the preferred product experience for each participant. Two hundred four women evaluated four semisolid vaginal formulations using the USPE scales at four randomly ordered formulation evaluation visits. Women were asked to select their preferred formulation experience for HIV prevention among the four formulations evaluated. The scale scores on the Sex-associated USPE scales (e.g., Initial Penetration and Leakage) for each participant's selected formulation were used in a latent class model analysis. Four classes of preferred formulation experiences were identified. Sociodemographic and sexual history variables did not predict class membership; however, four specific scales were significantly related to class: Initial Penetration, Perceived Wetness, Messiness, and Leakage. The range of preferred user experiences represented by the scale scores creates a potential target range for product development, such that products that elicit scale scores that fall within the preferred range may be more acceptable, or tolerable, to the population under study. It is recommended that similar analyses should be conducted with other semisolid vaginal formulations, and in other cultures, to determine product property and development targets.
| S-EPMC5067921 | biostudies-other
Project description:Recent data indicates limited awareness and compliance on infection prevention procedures by dental offices and by dental laboratories. Guidelines for infection prevention in dentistry have been published by Centres for Disease Control and Prevention since 2003; the section "IX-Special consideration" includes a subsection concerning the prevention in dental laboratories, but it has not been modernised in later versions to fit the needs of traditional and computer-aided technology. Traditional techniques required disinfecting items (impression, chewing waxes, and appliances) with well-suited products, which are also chosen for limiting impression changes or appliance deterioration. Effective procedures are available with difficulties. Some of these contain irritant or non-eco-friendly disinfectants. The transport of impression, to dental laboratories, is often delayed with limited precautions for limiting cross-infection. Gypsum casts are frequently contaminated mainly by bacteria and their antibiotic-resistant strains and even stored for long periods during dental implant supported restoration and orthodontic therapy, becoming a hidden source of infection. Nowadays, computer-aided design/computer-aided manufacturing technology seems to be an interesting way to promote both business and safety, being more comfortable for patients and more accurate than traditional technology. A further advantage is easier infection prevention since, for the most part, mainly digital impression and casts are not a source of cross-infection and the transport of contaminated items is reduced and limited to try-in stages. Nevertheless, a peculiar feature is that a digital electronic file is of course unalterable, but may be ruined by a computer virus. Additionally, the reconditioning of scanner tips is determinant for the optical characteristics and long term use of the scanner, but information for its reconditioning from producers is often limited. This study focuses on some critical points including (a) insufficient guidelines, (b) choice of proper procedure for scanner reconditioning, and (c) data protection in relation to patient privacy.
| S-EPMC6699473 | biostudies-other
Project description:ObjectiveTo expand an emerging classification for problems with health information technology (HIT) using reports submitted to the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database.DesignHIT events submitted to MAUDE were retrieved using a standardized search strategy. Using an emerging classification with 32 categories of HIT problems, a subset of relevant events were iteratively analyzed to identify new categories. Two coders then independently classified the remaining events into one or more categories. Free-text descriptions were analyzed to identify the consequences of events.MeasurementsDescriptive statistics by number of reported problems per category and by consequence; inter-rater reliability analysis using the ? statistic for the major categories and consequences.ResultsA search of 899?768 reports from January 2008 to July 2010 yielded 1100 reports about HIT. After removing duplicate and unrelated reports, 678 reports describing 436 events remained. The authors identified four new categories to describe problems with software functionality, system configuration, interface with devices, and network configuration; the authors' classification with 32 categories of HIT problems was expanded by the addition of these four categories. Examination of the 436 events revealed 712 problems, 96% were machine-related, and 4% were problems at the human-computer interface. Almost half (46%) of the events related to hazardous circumstances. Of the 46 events (11%) associated with patient harm, four deaths were linked to HIT problems (0.9% of 436 events).ConclusionsOnly 0.1% of the MAUDE reports searched were related to HIT. Nevertheless, Food and Drug Administration reports did prove to be a useful new source of information about the nature of software problems and their safety implications with potential to inform strategies for safe design and implementation.
| S-EPMC3240763 | biostudies-literature
Project description:In view of the high homogeneity of tourism products all over the country, an attempt is made to design virtual visit tourism products with cultural experience background, which can reflect the characteristics of culture + tourism in different scenic spots, so that tourists can deeply experience the local culture. Combined with computer aided design (CAD), the virtual three-dimensional (3D) modeling system of scenic spots is designed, and VR real scene visit interactive tourism products suitable for different scenic spots are designed. 360° VR panoramic display technology is used for 360° VR panoramic video shooting and visiting system display production of Elephant Trunk Hill park scenery. A total of 157 images are collected and 720 cloud panoramic interactive H5 tool is selected to produce a display system suitable for 360° VR panoramic display of scenic spots. Meanwhile, based on single view RGB-D image, the latest convolutional neural network (CNN) algorithm and point cloud processing algorithm are used to design the indoor 3D scene reconstruction algorithm based on semantic understanding. Experiments show that the pixel accuracy and mean intersection over union of the indoor scene layout segmentation network segmentation results are 89.5% and 60.9%, respectively, that is, it has high accuracy. The VR real scene visit interactive tourism product can make tourists have a more immersive sense of interaction and experience before, during and after the tour.
| S-EPMC7769442 | biostudies-literature