bluuebunny/crossref_metadata_2025 huggingface dataset:
Sunni and Shia Muslim and Christian encounters in northern Nigeria
Authors: Ibrahim Musa
Published: December 2022

This article analyses how the circulation of ideas and hybrid rituals between Shia Muslims and Christians reveals a much more intentional political process whereby minority religious groups consciously create shared experiences and a sense of commonality in the face of political marginalization in northern Nigeria. One example is the Shia invention of Jesus’s Mawlid (Jesus’s birthday), which they perform in a different way from the conventional Christmas but that is attended by some Christians. Also, some Christians participate in the annual celebration of Mawlid al-Nabiy (the Prophet Muhammad’s birthday), organized by Shias. Despite the adherents of the two religions participating in mixed religious practices, they continue to see themselves separately as Muslims and Christians. Reactions to these hybrid rituals impact relationships among the mainline Sunni groups. Sufis (Tijanis and Qadiris), who were previously united in the face of the anti-Sufi reform movement (Izala), now diverge over how to respond to Shia Islam. While they disagree with Shias intellectually, not everyone supports the attacks against Shias by Salafi activists. These dynamics add to the understanding that the concept of ‘tolerance’ is not sophisticated enough to capture all forms of religious coexistence in Nigeria.
Major and trace mineral composition of milk from lactating women following vegan, vegetarian and omnivore diets
Authors: Perrin Maryanne T. , Pawlak Roman , Judd Nicholas , Cooper Jessica , Donati George L.
Published: December 2022

Approximately one-in-ten reproductive age adults in the USA follow a plant-based diet, yet there is limited information on the influence of vegan and vegetarian diets on the mineral composition of breast milk. This study explored the major and trace mineral composition in breast milk and associations with maternal diet patterns. We used a cross-sectional design to collect a single sample of breast milk from individuals following vegan (n23), vegetarian (n19) and omnivore (n21) diet patterns. Plant-based diet (n42) was defined as following either vegan or vegetarian diets. Sixteen minerals were assessed using inductively coupled plasma mass spectrometry and inductively coupled plasma optical emission spectrometry. Data were evaluated using traditional statistical techniques and five different machine learning approaches. The distribution of Se (median; quartile 1 and 3) was significantly different between groups (vegetarians 21, 18–26 µg/l; vegans 19, 18–25 µg/l and omnivores 17, 14–20 µg/l;P= 0·007) using a Kruskal–Wallis test. Machine learning techniques also identified Se as a potential biomarker for differentiating breast milk by maternal diet pattern. Individuals following a plant-based diet generally had a lower BMI, higher breast milk Se and lower breast milk I and Fe concentrations compared with those following omnivore diets. This suggests that maternal dietary pattern (plant-basedv. omnivore) may be helpful clinical information to consider when caring for the breast-feeding dyad, with the strongest evidence related to differences in Se concentration.
Chigger mite (Acariformes: Trombiculidae) infestation in reed passerine birds in Central Europe: a case of the bearded titPanurus biarmicus
Authors: Trnka Alfréd , Samaš Peter , Mąkol Joanna
Published: December 2022

Larval trombiculid (chigger) mites are common ectoparasites of terrestrial vertebrates including humans, causing itching and skin inflammation known as trombiculiasis. Investigation of their diversity, distribution and seasonal abundance is therefore important from a veterinary and public health point of view. Although researchers have paid increased attention to these parasites in recent years, there is still little ecological data available on chiggers associated with birds inhabiting different types of habitats such as wetlands, for example. In 2021, we investigated the mite fauna in a specialist reedbed passerine, the bearded tit (Panurus biarmicus), and their effects on this host in the south-west Slovakia, Central Europe. A total of 1134 larvae of 1 mite speciesBlankaartia acuscutellariswere found in 99 out of 267 examined bearded tits. Juveniles were more infested than adult birds, but no differences were found between sexes. The larvae of mites first appeared on the host during the second half of June and peaked in the second half of July. After that, their numbers decreased gradually until October. Despite the relatively high prevalence and intensity of mite infestation in the bearded tit, no differences in body condition between infested and uninfested birds suggest that infestation byB. acuscutellarismay not have serious negative effects on the host health. Bearded tits can therefore be a reliable indicator of the presence of the chigger mites in wetland habitats.
Socio-Economic Gaps in Workers’ Participation in Private Pension Programmes in Ten European Countries
Authors: Gonzales Sara , Fernández Juan J.
Published: December 2022

In recent decades, many European governments have passed pension reforms to incentivise participation in private pension plans. However, we still have minimal understanding of whether participation in such plans is concentrated in certain groups or spread uniformly across society, or what their stability over time is. To illuminate the social selectivity of these plans and potential changes in that selectivity over time, we analyse six waves of the Survey of Health, Ageing and Retirement in Europe (SHARE) in ten European countries: Austria, Belgium, Czech Republic, Denmark, France, Germany, Italy, Spain, Sweden and Switzerland. Specifically, we focus on participation gaps in individual and occupational plans of workers across six dimensions: gender, education, age, social class, income, and risk preference. The results indicate large and persistent social divides in participation rates. As expected, rates are significantly higher among workers who are not close to retirement, those with an upper service occupation and those with high income. Importantly, these divides did not shrink significantly over the period considered – 2006 to 2021. Social selectivity is not consistently smaller in contexts of more mature private pension provision, whereas it is consistently smaller in countries with more generous public pensions.
Measuring interaction forces in surgical telemanipulation using conventional instruments
Authors: Schäfer Max B. , Glöckner Anja M. , Friedrich Gerrit R. , Meiringer Johannes G. , Pott Peter P.
Published: December 2022

Minimally invasive surgery (MIS) has been an essential tool in the surgical sector for many years due to its crucial advantages compared to open surgery. To overcome remaining limitations, teleoperated MIS experienced a strong emergence. However, the widespread usage of such systems is hindered by the enormous financial hurdle. The use of standard components and conventional tools for teleoperated MIS can facilitate integration into existing hospital workflows and can be a cost-efficient and versatile approach for research purposes. To compensate for the lack of haptic feedback, some teleoperation setups inherit a sensor system allowing them to record interaction forces and display them at the user interface. In research and in commercially available systems, different positions for the sensor can be found. In this paper, mechanical interfaces for the guidance and actuation of non-wristed and wristed standard instruments are presented. Furthermore, a method for the extracorporeal measurement of interaction forces is presented, characterized, and discussed. The overall mean relative error of the magnitude of the interaction force is 9.4%, while the overall mean absolute error of the force vector is 14.4
$^{\circ }$
, both below the respective human differential perception threshold. The presented measurement method is a simple, yet sufficiently accurate approach to measure interaction forces in surgical telemanipulation.
Nonlinear model identification and statistical verification using experimental data with a case study of the UR5 manipulator joint parameters
Authors: Abedinifar Masoud , Ertugrul Seniz , Arguz Serdar Hakan
Published: December 2022

The identification of nonlinear terms existing in the dynamic model of real-world mechanical systems such as robotic manipulators is a challenging modeling problem. The main aim of this research is not only to identify the unknown parameters of the nonlinear terms but also to verify their existence in the model. Generally, if the structure of the model is provided, the parameters of the nonlinear terms can be identified using different numerical approaches or evolutionary algorithms. However, finding a non-zero coefficient does not guarantee the existence of the nonlinear term or vice versa. Therefore, in this study, a meticulous investigation and statistical verification are carried out to ensure the reliability of the identification process. First, the simulation data are generated using the white-box model of a direct current motor that includes some of the nonlinear terms. Second, the particle swarm optimization (PSO) algorithm is applied to identify the unknown parameters of the model among many possible configurations. Then, to evaluate the results of the algorithm, statistical hypothesis and confidence interval tests are implemented. Finally, the reliability of the PSO algorithm is investigated using experimental data acquired from the UR5 manipulator. To compare the results of the PSO algorithm, the nonlinear least squares errors (NLSE) estimation algorithm is applied to identify the unknown parameters of the nonlinear models. The result shows that the PSO algorithm has higher identification accuracy than the NLSE estimation algorithm, and the model with identified parameters using the PSO algorithm accurately calculates the output torques of the joints of the manipulator.
OP02 The Use Of Discrete Choice Experiments For Measuring Patient Preferences In Health Technology Assessment
Authors: Strauss Michael , George Gavin , Hirsch-Moverman Yael , Mantell Joanne , Rabkin Miriam , Kelvin Elizabeth
Published: December 2022

Introduction

Understanding patient preferences and the demand for healthcare interventions and technology is critical for health technology assessment (HTA). New health technologies have potential for savings and increased efficiency but even the most cost-effective and efficacious interventions can fail if patient preferences are not properly accounted for. Patient preferences in HTA are primarily limited to representation in appraisal committees; however, more robust methods are available and should be incorporated into the assessment of interventions.

Methods

Using data from three discrete choice experiments (DCEs), we reflect on the importance of patient preferences in the design of healthcare interventions. We draw insights from three studies which investigated preferences relating to HIV self-testing amongst long distance truck drivers in Kenya; differentiated antiretroviral therapy services amongst stable HIV patients in Zimbabwe; and tuberculosis preventive therapy for children in Eswatini.

Results

We highlight three key findings. First, understanding patient preferences is crucial when designing services, and providers sometimes underestimate behavioural barriers and overestimate the extent to which people are motivated simply by health benefits. Optimism is often driven by evidence showing high acceptability, but when preference structures are incorporated in intervention design, there are important insights into how patients plan to utilize services. Second, trade-offs matter in determining which characteristics are perceived to be most important to patients – a key strength of the DCE methodology. Understanding of these trade-offs can help prioritize which characteristics of interventions to target. Finally, disentangling the effect of different characteristics of service delivery models on preferences is important for rethinking how interventions are delivered. If services are designed to better align with preferences, implementers can ensure new interventions have the desired effect on health and economic outcomes.

Conclusions

These findings highlight the value of behavioural economic approaches for investigating preferences for health interventions and providing insights into the demand for services, which must feed into the HTA analyses. Incorporating DCEs into HTA is inexpensive and provides robust data for improving HTA.
OP13 EUnetHTA Relative Effectiveness Assessments Of Pharmaceutical And Other Technologies: Procedural Changes Implemented During Joint Action 3
Authors: Ettinger Sabine , Willemsen Anne , Erdos Judit , Helmink Catharina , Hviding Krystyna , Ormstad Sari Susanna
Published: December 2022

Introduction

The European Network for Health Technology Assessment (EUnetHTA) Joint Action 3 (JA3) aimed to develop a sustainable European model for scientific and technical collaboration on HTA. It succeeded EUnetHTA JA2, which focused on strengthening practical applications of approaches and tools in the European HTA collaboration. Compared to JA2, several changes in procedures and processes were undertaken throughout JA3 in order to improve the different steps in joint HTA production.

Methods

Findings and identified challenges regarding the assessment production processes from JA2 were considered as a basis. In JA3, vast majority of structured and informal feedback was gathered from the assessment teams and project managers via feedback surveys and meetings. Only limited informal feedback from stakeholders (such as patients, health care professionals, and health technology developers) that were involved in EUnetHTA assessments was collected. To this end, experiences were documented and recommendations for a future production process were developed.

Results

During the course of JA3, the joint production resulted in 16 pharmaceutical assessments and 27 assessments of other technologies. The latter included medical devices, diagnostics, interventions, and screening. Due to the different context of pharmaceuticals and other technologies, some technology-specific changes needed to be made in their production process. However, the majority of implemented changes were made for both types of technologies to ensure maximum possible alignment in processes. The implemented changes affected several steps in the production process as well as the involvement of stakeholders in EUnetHTA assessments. The production and related project management of assessments was fine-tuned and resulted in clearer, standardized, and comprehensible processes that facilitated transparency and inclusiveness.

Conclusions

The procedural changes led to further standardization and elaboration of assessment production processes in preparation for a future European HTA system under the EU HTA Regulation. However, some methodological challenges remained to be tackled further in the currently ongoing EUnetHTA 21 service contract.
OP24 Impact Of Patient Input On Cancer Drug Funding Recommendations In Canada
Authors: Wranik Wiesława Dominika , Vo Anh Thu , Hu Min
Published: December 2022

Introduction

Patient involvement in health technology assessment (HTA) has documented advantages, such as improved understanding of disease context, and increased legitimacy and transparency of the HTA process. In the absence of clear metrics, thresholds, or criteria, it is not clear how input regarding patient preferences influences HTA based recommendations of the pan Canadian Oncology Drug Review (pCODR).

Methods

This is a concurrent complementary mixed methods study. A quantitative model (logit) is used to estimate the impact of patient input and other HTA criteria on pCODR recommendations. A qualitative analysis of semi-structured interviews with Canadian HTA committee members is used to describe the mechanisms of action through which patient input influences recommendations.

Results

Patient input was considered important in providing context to the HTA discussion, but committee members were not able to explicate how any specific elements of patient submissions weighted into the committee’s recommendation. There was an element of mistrust in the patient input data. The estimated impact of patient input on funding recommendations is not statistically significant, recommendations remain driven by evidence of clinical benefit.

Conclusions

The commitment to inclusion of patient perspectives in HTA in Canada is strong, and procedurally Canada is among the leaders in this regard. The tangible impact of patient input could be increased with an improved system for collection of most relevant data, and clear guidelines about how patient input should weigh into HTA recommendations.
OP26 Policy Perspectives Of Health Technology Assessment In Ethiopia
Authors: Ararso Desalegn
Published: December 2022

Introduction

Health technology assessment (HTA) is defined as a multidisciplinary field of policy research that provides evidence on the consequences of adopting and using health technologies. A ministry of health with jurisdiction over HTA should determine the influence of public law on all HTA-related activities and the rules that apply. Therefore, health decision-makers interested in HTA must learn to navigate the legal system, starting by situating it in the legal apparatus of the country. As a result, establishing a national HTA system requires designing a legal pathway towards HTA. However, a historic overview of HTA, in the context of policy documents of Ethiopia is not clearly reported. Therefore, this review is warranted to understand the historic overview of HTA in the context of health policy documents of Ethiopia.

Methods

A review of online policy documents was conducted in advanced Google Scholars and websites of the Ministry of Health (MoH) of Ethiopia. Some of the policy documents were also obtained through contacting experts at MoH. The review findings were organized into six categories.

Results

Regulatory documents have emphasized the approval of new health technologies before selecting health technologies. Health Policy of Ethiopia and the Directive on Medical Equipment also clearly stated the importance of institutionalizing HTA and establishing HTA organizations. Additionally, the National Medical Device Policy clearly indicated the importance of establishing an HTA advisory team at MoH. Similarly, the Health Sector Transformation Plan II (HSTP II) stressed the need to build a national capacity to conduct HTA. Even though policy statements on HTA appear scattered across different policy documents, they were not put into a national HTA system.

Conclusions

It is important to refer to policy statements outlined in different policy documents when establishing a national HTA system in Ethiopia. Also, attention should be given to the development of policy documents related to HTA guidelines, strategic documents in HTA, and policy documents that can link HTA results to policy-making.
OP27 Health Technology Assessment Processes, Characteristics, And Key Differences In High, Middle, And Low-Income Countries Of Asia Pacific Region
Authors: Verma Ashish
Published: December 2022

Introduction

The healthcare sector in the Asia Pacific (APAC) region is in a period of rapid growth and exciting innovation. This has led to an increase in the number of APAC countries adopting and implementing health technology assessment (HTA) to assess the clinical, ethical, economic, and societal aspect of healthcare technology. The aim of this study is to provide an updated snapshot of the status of HTA and key differences in selected countries of APAC region.

Methods

HTA robustness and gap requirements, including its structure, process, use in decision-making and resource allocation processes were assessed through a review of published and gray literature for each of the selected country. A qualitative analysis was carried out by using a set of 15 principles of an International Working Group for HTA Advancement to identify the robustness and key differences in HTA based decision-making process in scoping countries.

Results

The finding of this study reveals that maturity of HTA determined by country-specific factors, such as presence of independent HTA agency, healthcare funding and expenditure, etcetera, and varies across the high-, middle-, and low-income countries of APAC region. Based on the study’s results, HTA ecosystem of selected countries categorized into rising HTA followed by advancing and mature HTA categories. In addition to the differences in HTA structure, the influence of stakeholder engagement differs among HTA bodies. The variation in the time frame of HTA decisions was significant among countries, with a general lack of awareness and transparency among health policy decision-makers and resulted in longer time for assessment for rising HTA category compared to the advance and mature HTA categories.

Conclusions

The vision of a comprehensive and robust HTA system can be achieved by implementing a transparent, independent, decision-making, and strongly integrated HTA process in the region. We recommend that efforts should be directed to promote a transparent and sustainable HTA, throughout the low- and middle-income countries of APAC region which eventually, lead to more effective HTA ecosystem.
OP34 Horizon Scanning A Matter Of Collaboration. A Description Of The Processes Of I-HTS Member Organizations
Authors: Gutierrez-Ibarluzea Iñaki , Otte Maximiliam , Dauben Hans-Peter , Blasco-Amaro Juan Antonio , Mohamed Ghazali Izzuna-Mudla , Bt Akmal Syaqirah , Gomes Pollyanna , Huang Grace , Kearney Brendon
Published: December 2022

Introduction

Horizon Scanning (HS) has been part of the health technology assessment (HTA) world since the end of 20th century. In accordance with the life cycle concept of heath technologies, there have been different organizations that have devoted part of their portfolio to HS’s so called Early Awareness and Alert Systems. In 2017, a legal entity international Health Tech Scan (iHTS) was created on the basis of the previous existing network EuroScan. Our aim is to describe the current achievements of the network, the methods used by its members, and their achievements.

Methods

In 2010, EuroScan decided to analyze its members’ methods and processes to perform HS. We used a previously defined questionnaire to revisit the analysis of methods, processes, and impact of the founded legal entity i-HTS. We analyzed the clients, stakeholders involved, impact on health systems and alliances, as well as the current achievements as a group.

Results

i-HTS is currently rooted mainly in Europe and Asia-Pacific with members in the Americas and with ambassador programmes in Africa. The individual members have continued their achievements with special focus on three main aspects: proactive approach to innovators, stakeholder involvement, and client orientation. In most cases, the members of i-HTS produce information that is used for decision-making purposes, some of which influences the national or regional benefit package. Methods did not differ but the level of involvement of stakeholders in the different phases of the process. Some members also include in their portfolio early advice to innovators.

Conclusions

Early Awareness and Alert Systems are key to inform health care systems around technologies that could impact the management of patients in different contexts. There is a need to better understand the needs of the clients and the importance of HS in order to improve their efficiency. iHTS is in the process of redesigning its methods toolkit with the participation of all its members.
OP44 Does The Health Economic Modelling Structure Matter? An External Validation Of Three Approaches Commonly Used In Obesity Modelling
Authors: Schwander Bjoern , Kaier Klaus , Hiligsmann Mickaël , Evers Silvia , Nuijten Mark
Published: December 2022

Introduction

Obesity, defined as a body mass index (BMI) greater than 30kg/m2, is a multifactorial disease with severe health and economic consequences. As obesity associated events impact long-term survival, health economic (HE) modelling is commonly used. However, the current set of modelling approaches are very diverse and lack external model validation. The aim of our research was to compare the event simulation and the HE outcomes of different structural approaches.

Methods

We performed an external validation of three main structural modelling approaches for estimating obesity-associated events: (i) continuous BMI-related risks; (ii) general risk equations; and (iii) categorical BMI-related risks. The Swedish Obese Subjects (SOS) intervention study was used for validation. Outcomes compared were mortality, cardiovascular events (CVE), and type 2 diabetes (T2D), over time using the long-term data from the SOS study, looking at both the surgery arm and the control arm. Concordance between modelling results and the external validation study was measured by visual examination of the best fitting linear regression lines, R2 coefficients, the root mean squared errors, and F-tests. Furthermore, we compared the HE modelling results, comparing surgery versus control, expressed as cost per quality-adjusted life-year (QALY) gained based on 1,000 Monte Carlo simulation samples.

Results

Mortality was overestimated by all approaches irrespective of the study arm. For CVE an overestimation by all structural approaches was observed for the control arm. The CVE surgery arm was overestimated by the categorical BMI approach and slightly underestimated by the others. For T2D an underestimation was observed for the continuous and the categorial BMI approaches, whereas there was an overestimation by the risk equation approach. Considering different confidence interval limits, the cost per QALY gained are comparable between all structural approaches.

Conclusions

None of the structural approaches provided perfect external event validation results although the risk equation approach showed the smallest deviations compared to the external validation study. The cost per QALY gained resulting from the three approaches were fairly comparable.
OP54 The Early Detection And Warning System ‘SINTESIS-New Technologies’: A Horizon Scanning Experience In Spain
Authors: Hijas-Gómez Ana Isabel , Luengo-Matos Setefilla , Arias-Pacheco Amparo , Rodriguez-Ortiz-de-Salazar Begoña , Sánchez-Gómez Luis Maria , del Mar Polo-de-Santos Maria
Published: December 2022

Introduction

SINTESIS-new technologies is the early warning system for new and emerging technologies of the Agencia de Evaluación de Tecnologías Sanitarias, Instituto de Salud Carlos III. SINTESIS is part of the Action Plan for the Early Detection of New and Emerging Technologies of the Spanish Network of Health Technology Assessment Agencies (RedETS). In RedETS, four agencies are responsible for the identification of innovative technologies. These agencies have been collaborating since 2016 according to the early awareness methods contained in the EuroScan Methods Toolkit. SINTESIS focuses on secondary information sources (i.e., experts and literature). This study describes the experience of SINTESIS in identifying and filtering new technologies in recent years.

Methods

Retrospective analysis of all new and emerging technologies notified by SINTESIS to RedETS since 2018. Technologies were analyzed on a year-by-year basis for their source of information, the clinical specialties involved, and whether technologies found in the identification phase were selected for further assessment.

Results

Between 2018–2020, SINTESIS identified 69 emerging and new technologies. Most of the information came from medical press news (35%), and medical web news (22%); other sources included experts (15%), licensing news search (12%), general press (12%), and scientific websites (6%). Almost 37 technologies (54%) were selected for further analysis. Reasons for exclusion included too early identification of technologies/prototypes without enough evidence (52%), technologies already implemented (28%), overlapping technologies between agencies (17%), and not being medical technologies (3%).

Conclusions

Experience suggests that news sections of general and medical journals, websites, and expert consultation are useful sources to identify new and emerging health technologies. The main limitation is that the technologies identified are often at too early a stage of development for further assessment. SINTESIS contributes, within a national horizon scanning system with other agencies, to broaden the information sources and provide useful data on early awareness of innovative technologies. Further studies are needed to assess the impact of emerging technologies detection on healthcare delivery.
OP55 Classification System For Innovative Medicines In The Pipeline: New Or Repurposed?
Authors: Ogunbayo Dapo , Coughlan Diarmuid , Fairbairn Ross , Akinbolade Sola
Published: December 2022

Introduction

While various criteria exist to define or categorize innovative medicines as new or repurposed, to our knowledge there are no standardized systems that sufficiently capture the range of pipeline products. The National Institute for Health and Care Research Innovation Observatory (NIHR IO) undertakes routine horizon scanning to support health technology assessment (HTA) in England and maintains a comprehensive Medicines Innovation Database (MInD). The aim of this project is to develop a ‘technology type’ (new versus repurposed) classification system for application within the MInD and to provide a high-level analysis of the emergent data.

Methods

We reviewed gray literature, regulatory websites, and drug repositories to identify existing ‘technology type’ classification criteria. Preliminary definitions and classifications for use on the MInD were discussed, refined, and agreed by consensus. Innovative medicines on the MInD were classified as either new or repurposed based on their regulatory approval status (Marketing Authorization) using data from the electronic medicines compendium. For repurposed medicines, further classification was undertaken using abbreviated new drug application (ANDA) data from the FDA Orange Book to identify generic medicines (patency and exclusivity status). We combined a range of semi-automated and manually derived data during this process.

Results

Six technology types were identified and applied to the MInD: (i) new technology; (ii) repurposed technology (on-patent/branded); (iii) repurposed drug (off-patent/generic); (iv) repurposed technology (never commercialized); (v) new and repurposed technology (combinations); and (vi) repurposed technology (combinations). Preliminary analysis of a subset of MInD records identified in July 2021 (n = 113) found mainly 52 percent new technologies, 27 percent new and repurposed technologies (combinations) and 14 percent repurposed technology (never commercialized). Further analysis of approximately 7000 MInD records are ongoing and will report temporal trends, regulatory status, and key challenges.

Conclusions

Our novel evidence-based approach to developing classifications for technology types of innovative medicines resulted in six mutually exclusive states that can be applied to a larger dataset. We believe this offers HTA stakeholders a mechanism to gain valuable insights into the innovation trends, gaps, and areas of unmet need.
OP60 Methodological Guidance And Doctrine Of The French National Authority For Health For Economic Evaluation
Authors: Raimond Véronique ,   Commission for Economic and Public Health Evaluation
Published: December 2022

Introduction

The French National Authority for Health (HAS) “defines and issues guidelines and medico-economic opinions on prevention, healthcare, prescription, and best care strategies, and contributes to their comparison or ranking to support public health and optimize health insurance spending.” Based on a decade of producing cost-effectiveness evaluations, the Economic Evaluation and Public Health Committee (CEESP) issued two documents to frame its activity related to the economic evaluation of health products: (i) the new guidance highlights the expectations of the CEESP regarding cost-effectiveness evaluations; (ii) the doctrine elucidates the grading of methodological reservations expressed during the technical appraisal of manufacturers’ submissions, the CEESP’s statements regarding its findings, and the key messages it wishes to convey to public decision-makers, especially to negotiate healthcare product prices.

Methods

We aim at sharing the content of these documents and describing the willingness of the CEESP to support decision-makers in implementing evidence-based pricing policies.

Results

The new guidance provided an opportunity for HAS to stress the importance of interpreting the evaluations, which are often perceived as highly technical. In this perspective, several guidelines call for more reasoned reflection on the objectives of the evaluation upon its conception, along with a constant effort to justify the methodological choices made and an extensive interpretation of the results produced.

The doctrine highlights two steps taken by the CEESP, mainly built on analyzing the cost-effectiveness evaluation’s uncertainty. First, the ability to characterize the level of the ICER in a context where no thresholds for willingness-to-pay exist in France; second, the suggestion of specific regulation schemes to increase the cost-effectiveness of the products.

Conclusions

The CEESP developed the new guidance and its doctrine as conditions to ensure the usefulness of the economic evaluation for decision-making.
OP64 NICE Listens: Engaging The Public On How To Address Health Inequalities In Health Technology Assessment And Guideline Development
Authors: Cresswell Katharine , Shah Koonal
Published: December 2022

Introduction

Involving and engaging the public is an essential step to engender trust and confidence in HTA organizations. In 2021 the National Institute for Health and Care Excellence (NICE) launched NICE Listens, a new programme of deliberative public engagement seeking to address topics that have complex social, moral, or ethical dimensions. Health inequalities (HI), defined as unfair and avoidable differences in health across populations, was the first topic. The aim was to understand how the public would like NICE to act in regard to HI. Despite repeated attempts to tackle HI in England, the gaps in life expectancy between the most and least deprived continue to widen. NICE has committed to addressing HI in its five-year strategy and NICE Listens forms part of a comprehensive engagement strategy to understand how best to do this.

Methods

Twenty-eight (28) members of the public from across England took part in four iterative two-hour online workshops, held fortnightly in late 2021. They consisted of both plenary and breakout sessions and incorporated a range of stimuli including trade-off exercises and interview clips with HI experts.

Results

The findings show clear public support for HI being a high priority for NICE, albeit with limits on how and when HI should be addressed. Actions towards reducing HI should focus on supporting a preventative and systemic response. Importantly, there is a need for a transparent process for incorporating HI within NICE guidance as well as rigorous staff training in understanding and addressing HI. Recommending technologies that benefit the majority even when not accessible for all is acceptable if there are clear plans to manage access gaps.

Conclusions

Reducing health inequalities should be a high priority for NICE and other HTA organizations. Organizations should seek to have clear processes for embedding HI in decision-making. Priority should be given to actions that focus on prevention of ill health and those that have wider system impacts.
OP65 An Overview Of Participatory Approaches, Stakeholders, Methods, Topics and Challenges In Medical Device Development: A Scoping Review
Authors: Woudstra Kas , Reuzel Rob , Rovers Maroeska , Tummers Marcia
Published: December 2022

Introduction

Stakeholder involvement in medical device development draws much attention. To make well-considered methodological choices while involving stakeholders, it is essential to know what approaches are available and what challenges they bring in practice. Therefore, the aim of this review was to study which participatory approaches are used in the early stages of the lifecycle of medical device development, and to describe the most important characteristics of these approaches.

Methods

We conducted a scoping review and searched PubMed, Embase and Web of Science for articles published between July 2014 – July 2019. Papers were included if they presented original research featuring any form of stakeholder participation in the development of medical devices. We used The Spectrum of Public Participation to categorise the approach of each paper. We describe four characteristics of each approach: the stakeholders involved, data-collection methods, topics addressed, and the challenges associated with the approaches as perceived by the researchers.

Results

From the 14,838 papers from the initial search, 278 were included. All papers could be categorized into three levels of participation: collaboration, involvement, and consultation. The results show that patients and healthcare professionals are most frequently engaged in all approaches, besides stakeholders like citizens, relatives, and experts. The most often used data-collection methods are workshops in the collaboration approach, and interviews in the involvement and consultation approach. Topics addressed in all approaches are: the initial problem, requirements of devices, design choices, testing of devices, and procedural aspects of the involvement. Challenges in the approaches are related to sampling, analysis, social dynamics, feasibility, and closure.

Conclusions

This review shows that despite the abundance of methods mentioned in literature, there are three main approaches to involving stakeholders in device development: collaboration, involvement, and consultation. These mainly differ in the degree of power that is granted to stakeholders, but are comparable in terms of data-collection methods, stakeholders, topics, and challenges.
OP67 Considerations Of Treatment Novelty In Health Technology Assessment
Authors: Synnott Patricia , Enright Daniel , Voehler Dominic , Kowal Stacey , Ollendorf Daniel
Published: December 2022

Introduction

A recent proliferation of value frameworks, as well as the emergence of innovative approaches to treating disease (e.g., cell/gene therapies) have been accompanied by an increased focus on nontraditional elements of value. We sought to understand whether and how health technology assessment (HTA) agencies consider novel aspects of treatment in value assessments.

Methods

We defined treatment novelty as follows: (i) a new mechanism of action or administration; (ii) addresses an unmet need; or (iii) confers a distinct benefit that transforms clinical practice or that is difficult to quantify. We reviewed technical guidance and peer-reviewed literature to investigate how organizations in eight countries (Australia, Canada, England, France, Norway, the Netherlands, Sweden, and the United States) consider aspects of this definition.

Results

All (n = 8) organizations give special consideration to interventions that address an unmet need, particularly in cancer, rare diseases, and other severe conditions. Nearly all (n = 5) organizations consider whether an intervention produces benefits that may not be adequately quantified. Organizations in England, Norway, and France sometimes recommend drugs with less favorable cost-effectiveness estimates than traditionally considered if the drug addresses rare or severe conditions, or if its quality-of-life benefit is thought to be inadequately quantified. The Institute for Clinical and Economic Review in the United States models cost-effectiveness in rare diseases using both a modified societal and health care system perspective. Importantly, the benefits of novel treatments are frequently considered uncertain, particularly treatments with a new mechanism of action. When uncertainty is high, organizations in Canada, England, France, the Netherlands, and Sweden sometimes issue conditional recommendations until additional evidence is submitted. England and Australia have used risk sharing agreements for drugs determined to be novel but uncertain.

Conclusions

The most widely considered aspects of treatment novelty in HTA are unmet needs and potential benefits that are not easily measured. The willingness to pay for novel treatments is often greater, despite inherent uncertainties about benefit and cost-effectiveness.
OP78 Taking A Societal Perspective In Health Technology Assessment: Is Environmental Impact A Special Case?
Authors: Kenny Juliet , Shah Koonal
Published: December 2022

Introduction

A source of debate among the health technology assessment (HTA) community is what perspective should be taken in health economic evaluations. Many stakeholders advocate that a societal perspective is taken in order to include a comprehensive range of costs and outcomes and (in theory) make societally optimal decisions. The Second Panel on Cost-Effectiveness in Health and Medicine recommended that a societal perspective be presented alongside a health sector one. The Second Panel included environment as one item on its impact inventory—alongside productivity, education, and others—intended to support the use of a societal perspective. However, many HTA agencies, including the National Institute for Health and Care Excellence (NICE), have continued to use health sector-specific evaluations to inform decision-making. The presentation seeks to examine whether consideration of the environmental impact of healthcare requires/implies the formal adoption of a societal perspective in health economic analyses.

Methods

The presentation will provide an overview of the societal perspective, explaining how it differs from a health sector perspective and describing its main strengths and weaknesses. We then present policy analysis undertaken by NICE’s Science Policy and Research team to identify reasons for measuring environmental impact in HTAs and examine whether these align with the broader arguments for or against adopting a societal perspective in economic analyses.

Results

Three reasons for considering environmental impact are identified: (i) to support parallel policies which demand healthcare system transformation against emissions targets; (ii) to ensure planetary and human health, in the future as well as the present; and (iii) to offset future healthcare resource use. We show that only the third reason aligns with arguments related to the choice of perspective for economic analyses. Moreover, this reason is arguably better aligned to maintaining a (potentially modified) health sector perspective. The implications of the results will be discussed with reference to updating reimbursement decision-making frameworks, such as those used by NICE, to account for the environmental consequences of healthcare.
OP81 Do Sustainable Healthcare Principles Inform Guidance Development? An Exemplary Case Study In Respiratory Care
Authors: Walpole Sarah , Khan Naba , Smith James , Rostkowska Olga , Miller Fiona
Published: December 2022

Introduction

At the United Nations Climate Change Conference (COP26) in 2021, over 40 countries made commitments to low carbon, sustainable health care. Respiratory care provides a case study to explore how existing evidenced-based guidance can inform progress towards more sustainable care pathways and technologies. Our aim is to identify whether environmental aspects of health technology assessment (HTA) are referenced in guidance and the extent to which the four principles of sustainable health care (prevention, self-care, streamlining, and low carbon technology) are promoted in guidance.

Methods

Internet searches enabled identification of current national guidance on management of respiratory diseases in English, French or Polish. Guidances were reviewed to identify references to environmental aspects of HTA and recommendations that align with each of the four sustainable healthcare principles.

Results

Guidance on respiratory care is produced by varied stakeholders globally. Some principles of sustainable health care are frequently reflected in guidance to improve quality of care, but others are missed where environment sustainability is not considered. Reference to HTAs incorporating environmental impacts is lacking. There is limited engagement with the environmental impacts of inhalers in guidance. Guidance created by clinician groups (e.g., Greener Practice) and research networks (e.g., Centre for Sustainable Health Systems) has responded more quickly to the need to address sustainability concerns compared to guidance produced by national public bodies.

Conclusions

HTA organizations may need to take a broader perspective, incorporating environmental impacts in assessments. This could have an influential role in enabling evidence-informed guidance and development of sustainable care pathways and technologies. Limitations of our study were lack of evaluation of local guidance due to limited capacity, language restrictions, and subjectivity in assessing whether each sustainable healthcare principle was addressed in guidance. There may be limited transferability of our results to other specialties or settings. Further research on the sustainability impacts and relative merits of different health technologies and care pathways is required to inform HTA and guidance.
OP83 Joining Efforts To Improve Patient Involvement In Health Technology Assessment: The Case Of The RedETS Patient Interest Group
Authors: Triñanes Yolanda , Reviriego-Rodrigo Eva , Prieto-Remón Lucía , Novellas-Arriba Blanca , Gallastegui Edurne , Molina-Linde Máximo , Palma-Ruiz Matilde , Toledo-Chavarri Ana
Published: December 2022

Introduction

Patient involvement (PI) has become a key priority to the Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS). As part of the national strategy to promote PI, an interest group was created in 2017 to share knowledge, develop methodologies and standardize PI processes. The aim of this work is to analyze the main activities of the Patient Interest Group 5 years after its launch and to reflect on possible needs and challenges.

Methods

Narrative description and an in-depth analysis of the main activities of the Interest Group from 2017 to the present.

Results

The group is composed of HTA researchers from the 8 regional agencies in Spain and is supported by the Ministry of Health and the RedETS council. It currently has the participation of 26 researchers, organized into different working subgroups. The initial lines of work were the analysis of the situation, the development of procedures, and the initiation of training materials for patients on HTA. At present, the main projects are the development of metrics for evaluating the impact of patient participation, the development of procedural materials to promote methodological process standardizaton (e.g., a flowchart with the main process steps, checklists, templates), and the design and piloting of virtual training for patients in HTA. New lines include the analysis of the ethical challenges of PI and the feasibility of setting up an HTA patient registration system and a patient forum to facilitate participation. In addition, the interest group has promoted the exchange of relevant information for PI and the organization of capacity building activities.

Conclusions

The RedETS Patient Interest Group is encouraging the development of activities, reflection on collective experiences, and tools that facilitate PI in Spain. Among the main challenges are the need to ensure the quality and applicability of PI and to analyze the views of patients who have actively participated in HTAs.