We use cookies to distinguish you from other users and to provide you with a better experience on our websites. Close this message to accept cookies or find out how to manage your cookie settings.
To save content items to your account,
please confirm that you agree to abide by our usage policies.
If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account.
Find out more about saving content to .
To save content items to your Kindle, first ensure no-reply@cambridge.org
is added to your Approved Personal Document E-mail List under your Personal Document Settings
on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part
of your Kindle email address below.
Find out more about saving to your Kindle.
Note you can select to save to either the @free.kindle.com or @kindle.com variations.
‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi.
‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.
To systematize the information and perspectives shared during the 2024 LATAM policy forum, which explored advancements in horizon scanning and early dialogue processes in the region, by analyzing the main discussion and identifying the main lessons.
Methods
This article is based on the discussions and background materials provided during the 1.5 days in-person 2024 Latin American Policy Forum (59 representatives from 11 countries). We gathered and systematized the information shared during the forum, including the results of a pre-forum survey. The Forum agenda included keynote presentations, breakout group activities, and plenary discussions to identify the main lessons and key messages from all different stakeholders’ points of view.
Results
The forum highlighted the growing recognition of the need for structured horizon scanning and early dialogue processes in Latin America. Key barriers were identified, including the absence of clear legal frameworks, limited data availability, and the need for capacity-building. Potential solutions included fostering regional cooperation, improving transparency, and creating pilot programs for early engagement. Engaging patients and the pharmaceutical industry was deemed essential for trust and foster alignment between HTA agencies and regulators.
Conclusions
Horizon scanning and early dialogue represent critical tools for improving health system preparedness and aligning innovation with local needs. Their implementation, however, requires coordinated efforts across multiple stakeholders, enhanced dialogue, and the development of supportive legal and regulatory frameworks.
Weed seeds are potential contaminants of composts derived from biowastes. We assessed the effect of steam treatment alone and in combination with composting on the mortality of barnyardgrass [Echinochloa crus-galli (L.) P. Beauv.] seeds in a biowaste substrate consisting of a mixture of onion (Allium spp.) waste (60%), horse (Equus spp.) manure (20%), and wood shavings (20%). In the first study, seeds of six populations of E. crus-galli exposed to temperatures ranging from ca. 60 to 99 C followed by a 3-min residence time exhibited a decline in seed germination from approximately 25% to 0%. The E. crus-galli populations varied greatly in germinability and responded differently to high temperatures. Samples with lower germinability as assessed in controls were killed at lower temperatures than samples with higher initial germinability. However, to ensure an almost 100% kill of all seeds in the populations, a mean temperature of 100 C was necessary. In another study, seed germination was assessed after steaming the biowaste mixture to a mean temperature of about 60 C and subsequently composting. A short steaming period of the biowaste mixture at approximately 60 C before composting was unnecessary, as all composted seed samples, including the non-steamed control seeds, died during the composting process.
Effective health intervention coverage decision-making hinges on understanding budget impact (BI). Despite progress in estimating cost-effectiveness thresholds, a standardized approach for defining BI, particularly high BI, remains elusive. Addressing this gap, our systematic review aims to identify existing BI thresholds and establish universally applicable BI categories, providing a much-needed framework for global health policy.
Methods
In our systematic review, we adhered to Cochrane methods and PRISMA reporting guidelines (PROSPERO protocol CRD42020221652). We included articles that detailed current BI or affordability thresholds used by national or regional healthcare systems, sourcing from PubMed, Embase, and International Network of Agencies for Health Technology Assessment (INAHTA) communications. To address variability across jurisdictions, we normalized BI/affordability thresholds to a fraction of each country’s total healthcare expenditure. This approach enabled us to categorize BI thresholds into four distinct levels (low, moderate, high, and very high) and apply these categories universally across countries.
Results
We retrieved 1,592 records, identifying affordability thresholds and their underlying rationales in 12 countries: Argentina, Australia, England, Canada, Germany, France, Netherlands, USA, Taiwan, Ukraine, Scotland, and Singapore. Utilizing this data, we established four BI threshold levels relative to the total health budget: low (below 0.00005), moderate (0.00005 to <0.0001), high (0.0001 to <0.0002), and very high (>=0.0002). We then extrapolated these thresholds, along with their uncertainty ranges, to 174 countries, using 2022 World Bank data.
Conclusions
Our study provides a comprehensive overview of current global affordability thresholds and their implications for healthcare coverage and reimbursement. We found that explicit BI thresholds are predominantly established in high-income countries. Our findings offer critical, evidence-based guidance on affordability decision rules, applicable to health systems in 174 countries, thereby contributing significantly to the standardization and informed policymaking in global healthcare.
Health technology assessment (HTA) applications in low- and middle-income countries face limited technical capacities. The Institute for Clinical Effectiveness and Health Policy (IECS) is a key player in strengthening HTA expertise in the region and offers a variety of courses. Over 200 students from across Latin America have undertaken our introductory course on HTA and economic evaluation in the last four years.
Methods
The IECS provides a nine-week introductory online course focused on the fundamentals of HTA and economic evaluation. The course is designed for healthcare professionals (doctors, administrators, auditors, nurses, pharmacists, lawyers, etc.). The materials are available in Spanish and Portuguese on a virtual campus with asynchronous activities. Students are guided by instructors through an exchange forum. This study aimed to showcase the outcomes of this HTA course. Our analysis encompassed quantitative and qualitative data from a survey administered to nine student cohorts over the last four years. The surveys featured eight question categories covering materials, activities, quizzes, course dynamics, forum usage, tutoring, and satisfaction.
Results
A total of 234 students from Latin America were enrolled in the course. More than half came from Argentina (68%). Of the initial enrollees, 212 (91%) started the course and 192 (91%) of them passed. The satisfaction survey was completed by 168 students. Ninety-six percent of students were satisfied or very satisfied with the course overall, and the same percentage would recommend it to a colleague. Eighty-six percent felt that they could adequately follow the course, and 40 percent of students dedicating an average of two to four hours per week to the course.
Conclusions
Having accessible and feasible training opportunities in the region is important. The IECS HTA and economic course enhances HTA expertise in Latin America, as evidenced by its high rates of enrolment, completion, and satisfaction, with over 90 percent of participants recommending it. This underscores its effectiveness in reinforcing health decision-making knowledge in Latin America and contributing to the advancement of health policy.
Advances in next-generation sequencing/comprehensive genomic profiling (NGS/CGP) diagnostics require a value framework (VF) for accurate assessment within cancer care in Europe. Building on a previously established VF for diagnostic technologies in Latin America by the Institute for Clinical Effectiveness and Health Policy (IECS), this study synthesizes insights from a systematic literature review and stakeholder perspectives to inform the co-creation of an NGS/CGP diagnostic framework for healthcare decision-making.
Methods
The study utilized a mixed methods approach including a systematic literature review (SLR) and web-Delphi panel. The SLR identified and mapped existing VFs against the IECS VF, extracting non-overlapping criteria relevant to NGS/CGP in Europe. A Delphi panel further adapted and validated the framework, ensuring comprehensive stakeholder contribution and engagement. The Delphi´s first round was qualitative and involved open-ended feedback from participants to adapt the indicators and domains. Rounds two through four involved Likert-scale judgments of importance of each indicator. In rounds three and four, participants were shown the distribution of responses across stakeholders and could reconsider their answers.
Results
The SLR revealed 42 VFs with an 83 percent criterion overlap with the IECS VF, resulting in 46 indicators forming the literature-adapted framework. Thirty-four participants completed the Delphi. In round one, 14 indicators and 22 descriptions were adapted, 11 indicators were merged, 14 were deleted, and one was kept the same resulting in 29 indicators for scoring in round two. The final VF has 27 indicators: 23 essential and four complementary; two indicators did not reach consensus. The domains included clinical impact, test performance, scientific evidence quality, non-clinical impact, health system integration, economic aspects, ethical/governance concerns, and health system priorities.
Conclusions
This approach has yielded a robust, stakeholder co-created VF for NGS/CGP diagnostics in oncology, tailored to the European setting. It offers a comprehensive set of criteria that extends beyond traditional health technology assessments, incorporating novel aspects like post-test data governance. This framework sets the stage for improving patient access to high-value technologies by aligning European stakeholder values across health systems.
Value frameworks play a crucial role in bridging the gap between evidence and decision-making in health care, particularly in settings with limited budgets. In this study, we present the results of an implemented value framework (VF) to provide coverage recommendations in rapid health technology assessment (HTA) reports.
Methods
A search was performed to identify existing HTA frameworks. Relevant criteria and methods of assessment were then selected. A color-coded system was applied to categorize each criterion. A Delphi panel was conducted to determine the overall recommendations and to weigh the criteria and correlate them with the recommendations. To assess the performance, we reviewed the results of rapid HTA reports from the last five years.
Results
The value framework had three domains. We adapted widely used methodologies for the quality of evidence and net benefit domains. The economic impact domain was the most complex to assess, so a customized method was developed. Analysis of 265 HTAs revealed the distribution of recommendations across various criteria and technology types. Most recommendations were for drugs (40.5%) or for therapeutic procedures (36%). Among the final recommendations, 0.8 percent were favorable, 19.7 percent were uncertain, and 44 percent were unfavorable.
Conclusions
The VF demonstrated its versatility and practicality in meeting the needs of rapid HTA requesters and facilitating evidence-informed decision-making. The VF serves as a valuable tool for conducting adaptive rapid HTAs and supports decision-making processes in Argentina and similar contexts.
We study single bubble deformation statistics in an homogeneous and isotropic turbulent flow by means of direct numerical simulations. We consider bubbles at low Weber number ($We <3$) that have not been broken. We show that we can reproduce bubble deformations with a linear dynamics for each spherical harmonic mode. Inferring the coefficients of the linear model from the DNS data, we find that the natural frequency corresponds to the Rayleigh frequency, derived in a quiescent flow. However, the effective damping increases by a factor 7 compared with the quiescent case, at Taylor Reynolds number $\textit {Re}_\lambda = 55$. Looking at the flow structure around the bubble, we argue that the enhanced damping originates from a thick boundary layer surrounding the bubble. We demonstrate that the effective forcing, originating from the turbulent flow forcing on the bubble surface, is independent of bubble deformability. Therefore, the interface deformations are only one-way coupled to the flow. From this model we conclude that bubbles break rather from turbulent fluctuations than from a resonant mechanism. Eventually, we investigate the pressure modes’ statistics in the absence of bubbles and compare them with the effective forcing statistics. We show that both fields share the same probability distribution function, characterized by exponential tails, and a characteristic time scale corresponding to the eddy turnover time at the mode scale.
Healthcare stakeholders in Latin America, including payers, manufacturers, and patients, seek to expedite access to technologies. However, uncertainty sometimes surrounds their true benefits and budgetary implications. Managed entry agreements (MEAs) are proposed to address this uncertainty by redistributing risks among key actors.
Objectives
The objective of Health Technology Assessment International’s 2023 Latin American Policy Forum was to examine the potential utility of MEA in technology reimbursement and decision-making processes in the region.
Methods
This article is based on a background document, a survey, and the deliberative work of the country representatives and others who participated in the Policy Forum.
Results
Interest in MEA in Latin America is increasing, with financial agreements being more prevalent than those based on clinical outcomes. During the Policy Forum, potential barriers to MEA implementation were identified, such as the lack of legal frameworks, insufficient reliable data, and, in some cases, distrust among stakeholders. Some potential solutions were also identified, including early stakeholder involvement to enhance dialogue and understanding, and piloting shorter-duration MEA to facilitate the revision of agreement terms, especially in situations of epidemiological uncertainty.
Conclusions
The Policy Forum served as a valuable platform for discussing the importance of flexible MEA implementation that acknowledges data uncertainty, promotes transparent dialogue to incorporate opinions and values from all stakeholders, and develops legal frameworks to support effective technology access schemes in Latin America.
The principle of democracy is one of equal dignity for all cultures. But today the relationship between culture and politics, though close, often appears tense and occasionally contradictory. The introduction to this issue of Diogenes sketches the work done by UNESCO in the frame of the ‘Pathways of Thought' Programme, particularly relating to the way in which a pluralist identity is created in multicultural nations, and to the relationship between non-material heritage, democracy and the quest for new forms of governance.
The Health Technology Assessment (HTA) process aims to optimize health system funding of technologies. In recent years there has been an increase in what is known as Real-World Evidence (RWE) as a complement to clinical trials. The objective of Health Technology Assessment International’s Latin American Policy Forum 2022 was to explore the utility of incorporating RWE into HTA and decision-making processes in the region.
Methods
This article is based on a background document, survey, and the deliberative work of the country representatives who participated in the Forum.
Results
There is a growing interest in the use of Real-World Data / Real-World Evidence in HTA processes in Latin America, although currently there are no specific local guidelines for RWE use by HTA agencies. At present, its use is limited to certain areas such as adding context to HTA reports, the evaluation of adverse events, or cost estimation.
Potential future uses of RWE were identified, including the creation of risk-sharing agreements, the assessment of technology performance in routine practice, providing information on outcomes that are not so easily evaluated in clinical trials (e.g., the identification of specific subpopulations or quality of life), and the estimation of input parameters for economic evaluations.
Conclusions
The participants agreed that there are several areas presenting significant potential to expand the application of RWD/RWE and that the development of normative frameworks for its use could be helpful.
To investigate current practice of collateral history-taking on inpatient adult and older person wards in Leicestershire Partnership Trust. COVID-19 visiting restrictions raised concerns that the collateral history may be side-lined due to the physical absence of carers. Collateral history is important in developing a working diagnosis and assessing level of function, and is part of ongoing assessment and formulation.
Methods
An initial audit of 46 patient records from 3 inpatient wards (2 adult and 1 functional old age) was carried out in January 2021 when visiting restrictions were in place. In response, a questionnaire was distributed and 2 focus groups of junior doctors conducted later in 2021; the aim being to explore factors affecting collateral history taking. A re-audit was completed in October 2022 when visiting was reinstated. 48 patient records were audited. Old Age organic wards for dementia assessment were not included in data collection, as collateral history-taking is unavoidable for initial assessment of those presenting with significant cognitive impairment.
Results
In 2021 and 2022, 33% and 38% of sampled patients had a collateral history taken in the first 14 days of admission. Where a collateral history was omitted, only 10% and 13% were attempted and 46% and 27% planned. Associated themes were identified from the questionnaire and focus groups including consent; accessibility of contact details; lack of confidence and variability in history-taking; accountability/ clarity on whose role it is to complete the task; lack of time/space and poor consensus on how to document a collateral history.
Conclusion
The results of the re-audit continue to show poor collateral history completion early in admission for both old age and adult inpatient wards despite reinstatement of visiting after the COVID-19 pandemic. Numerous issues affect the completion and documentation of good quality of collateral histories within inpatient settings of Leicestershire Partnership Trust. These have been categorised into staff, system, environmental and other factors.
This audit forms part of a wider quality improvement project. The proposed actions are as follows:
1. To share findings locally via the Trust Audit and Quality Improvement department, Trust email and Consultant Medical Advisory Committee;
2. To improve education through Trust induction, regular bitesize teaching and development of a crib sheet to be placed on each ward;
3. To consider wider quality improvement projects in line with themes identified above;
4. To undertake a further re-audit in November 2023.
The objective of Health Technology Assessment International’s 6th Latin America Policy Form, held in 2021, was to explore the implementation of deliberative processes in the framework of health technology assessment (HTA) and how agencies in the region could involve stakeholders in this process.
Methods
This paper is based on a preparatory survey, a background document, and the deliberative work of participants at the virtual Forum conducted in 2021. There were ninety-one participants in the open session and fifty-two in the closed sessions, representing twelve countries and diverse areas of the health sector.
Results
While there are mechanisms in most countries in Latin America to consider stakeholder involvement to some degree, it remains reduced or limited to a consultative role, making true participative involvement rare. There are significant barriers and structural and contextual limitations that have impeded or slowed progress toward deliberative processes. Relatively low levels of institutionalization and knowledge about HTA, as well as the lack of trust among stakeholders are important challenges. This situation has impacted health systems by diminishing the legitimacy of decisions and the very structures and processes of HTA.
Conclusion
The Forum’s broad group of participants identified barriers, facilitators, and recommendations to improve the use of deliberative processes in Latin America to foster improved fairness and reasonableness in HTA and decision making.
We present experiments on large air cavities spanning a wide range of sizes relative to the Hinze scale $d_{H}$, the scale at which turbulent stresses are balanced by surface tension, disintegrating in turbulence. For cavities with initial sizes $d_0$ much larger than $d_{H}$ (probing up to $d_0/d_{H} = 8.3$), the size distribution of bubbles smaller than $d_{H}$ follows $N(d) \propto d^{-3/2}$, with $d$ the bubble diameter. The capillary instability of ligaments involved in the deformation of the large bubbles is shown visually to be responsible for the creation of the small bubbles. Turning to dynamical, three-dimensional measurements of individual break-up events, we describe the break-up child size distribution and the number of child bubbles formed as a function of $d_0/d_{H}$. Then, to model the evolution of a population of bubbles produced by turbulent bubble break-up, we propose a population balance framework in which break-up involves two physical processes: an inertial deformation to the parent bubble that sets the size of large child bubbles, and a capillary instability that sets the size of small child bubbles. A Monte Carlo approach is used to construct the child size distribution, with simulated stochastic break-ups constrained by our experimental measurements and the understanding of the role of capillarity in small bubble production. This approach reproduces the experimental time evolution of the bubble size distribution during the disintegration of large air cavities in turbulence.
Deliberative processes for health technology assessment (HTA) are intended to facilitate participatory decision making, using discussion and open dialogue between stakeholders. Increasing attention is being given to deliberative processes, but guidance is lacking for those who wish to design or use them. Health Technology Assessment International (HTAi) and ISPOR—The Professional Society for Health Economics and Outcomes Research initiated a joint Task Force to address this gap.
Methods
The joint Task Force consisted of fifteen members with different backgrounds, perspectives, and expertise relevant to the field. It developed guidance and a checklist for deliberative processes for HTA. The guidance builds upon the few, existing initiatives in the field, as well as input from the HTA community following an established consultation plan. In addition, the guidance was subject to two rounds of peer review.
Results
A deliberative process for HTA consists of procedures, activities, and events that support the informed and critical examination of an issue and the weighing of arguments and evidence to guide a subsequent decision. Guidance and an accompanying checklist are provided for (i) developing the governance and structure of an HTA program and (ii) informing how the various stages of an HTA process might be managed using deliberation.
Conclusions
The guidance and the checklist contain a series of questions, grouped by six phases of a model deliberative process. They are offered as practical tools for those wishing to establish or improve deliberative processes for HTA that are fit for local contexts. The tools can also be used for independent scrutiny of deliberative processes.
To clarify the concept of disruptive technologies in health care, provide examples and consider implications of potentially disruptive technologies for health technology assessment (HTA).
Methods
We conducted a systematic review of conceptual and empirical papers on healthcare technologies that are described as “disruptive.” We searched MEDLINE and Embase from 2013 to April 2019 (updated in December 2021). Data extraction was done in duplicate by pairs of reviewers utilizing a data extraction form. A qualitative data analysis was undertaken based on an analytic framework for analysis of the concept and examples. Key arguments and a number of potential predictors of disruptive technologies were derived and implications for HTA organizations were discussed.
Results
Of 4,107 records, 28 were included in the review. Most of the papers included conceptual discussions and business models for disruptive technologies; only few papers presented empirical evidence. The majority of the evidence is related to the US healthcare system. Key arguments for describing a technology as disruptive include improvement of outcomes for patients, improved access to health care, reduction of costs and better affordability, shift in responsibilities between providers, and change in the organization of health care. A number of possible predictors for disruption were identified to distinguish these from “sustaining” innovations.
Conclusions
Since truly disruptive technologies could radically change technology uptake and may modify provision of care patterns or treatment paths, they require a thorough evaluation of the consequences of using these technologies, including economic and organizational impact assessment and careful monitoring.
Argentina has a fragmented healthcare system with social security covering almost two thirds of the population. Its benefit package—called compulsory medical program (PMO; by its Spanish acronym Programa Médico Obligatorio)—has not been formally and widely updated since 2005. However, laws, clinical practice guidelines (CPGs), and a high-cost technology reimbursement fund complement it. Our objective was to comprehensively review such a PMO and propose an update considering the corresponding complementary sources.
Methods
We followed four steps: (i) identification of health technologies from the current PMO and complementary sources, (ii) prioritization, (iii) assessment through rapid health technology assessment (HTA), and (iv) appraisal and recommendations. We evaluated three value domains: quality of evidence, net benefit, and economics, which were summarized in a five-category recommendation traffic-light scale ranging from a strong recommendation in favor of inclusion to a strong recommendation for exclusion.
Results
Eight hundred fifty technologies were identified; 164 of those, considered as high priority, were assessed through rapid HTAs. Those technologies mentioned in laws and CPGs were mostly outpatient essential medicines, whereas those from the reimbursement system were mostly high-cost drugs; of these 101 technologies, 50 percent were recommended to be kept in the PMO. The other 63 (identified by the Superintendence of Health Services, technology producers, and patients) were mostly medical procedures and high-cost drugs; only 25 percent of those resulted in a favorable recommendation.
Conclusions
A methodology based on four clearly identified steps was used to carry out a comprehensive review of an outdated and fragmented benefit package. The use of rapid HTAs and a traffic-light recommendation framework facilitated the deliberative evidence-based update.
In this era of spatially resolved observations of planet-forming disks with Atacama Large Millimeter Array (ALMA) and large ground-based telescopes such as the Very Large Telescope (VLT), Keck, and Subaru, we still lack statistically relevant information on the quantity and composition of the material that is building the planets, such as the total disk gas mass, the ice content of dust, and the state of water in planetesimals. SPace Infrared telescope for Cosmology and Astrophysics (SPICA) is an infrared space mission concept developed jointly by Japan Aerospace Exploration Agency (JAXA) and European Space Agency (ESA) to address these questions. The key unique capabilities of SPICA that enable this research are (1) the wide spectral coverage $10{-}220\,\mu\mathrm{m}$, (2) the high line detection sensitivity of $(1{-}2) \times 10^{-19}\,\mathrm{W\,m}^{-2}$ with $R \sim 2\,000{-}5\,000$ in the far-IR (SAFARI), and $10^{-20}\,\mathrm{W\,m}^{-2}$ with $R \sim 29\,000$ in the mid-IR (SPICA Mid-infrared Instrument (SMI), spectrally resolving line profiles), (3) the high far-IR continuum sensitivity of 0.45 mJy (SAFARI), and (4) the observing efficiency for point source surveys. This paper details how mid- to far-IR infrared spectra will be unique in measuring the gas masses and water/ice content of disks and how these quantities evolve during the planet-forming period. These observations will clarify the crucial transition when disks exhaust their primordial gas and further planet formation requires secondary gas produced from planetesimals. The high spectral resolution mid-IR is also unique for determining the location of the snowline dividing the rocky and icy mass reservoirs within the disk and how the divide evolves during the build-up of planetary systems. Infrared spectroscopy (mid- to far-IR) of key solid-state bands is crucial for assessing whether extensive radial mixing, which is part of our Solar System history, is a general process occurring in most planetary systems and whether extrasolar planetesimals are similar to our Solar System comets/asteroids. We demonstrate that the SPICA mission concept would allow us to achieve the above ambitious science goals through large surveys of several hundred disks within $\sim\!2.5$ months of observing time.