bluuebunny/crossref_metadata_2025 huggingface dataset:
Introduction: a new agenda for women's and gender history in Ireland
Authors: Nolan Frances , McShane Bronagh
Published: December 2022

In the thirty years since the publication of ‘An agenda for women's history in Ireland’, the study of women's and gender history has been transformed. The introduction to this special issue contextualises the ‘Agenda’ within this evolving landscape, underlining the significant role it played in stimulating scholarship by outlining some of the major developments in the field since 1992. The introduction also points to developments that the authors, Margaret MacCurtain, Mary O'Dowd and Maria Luddy, could not have foreseen when writing the ‘Agenda’, such as rapid technological advances and the possibilities they have opened up for scholars of women and gender in Irish history. By tracing these developments, the introduction serves as a gateway into the articles that form the special issue: contributions that demonstrate the wide-reaching and multifaceted impact of the ‘Agenda’ and the three pioneering scholars who authored it, and that provide thought-provoking analysis of existing and future scholarship in the field.
‘From a woman's point of view’: the Presbyterian archive as a source for women's and gender history in eighteenth- and nineteenth-century Ireland
Authors: Calvert Leanne
Published: December 2022

This article responds to ‘An agenda for women's history in Ireland, 1500–1900’ by highlighting the explanatory potential of the Presbyterian archive in extending and reshaping our understanding of women, gender and the family in Ireland. Discussed here as the ‘Presbyterian archive’, the records of the Presbyterian church offer a tantalising insight into the intimate worlds of women and men in eighteenth- and nineteenth-century Ireland. Although Presbyterians were a minority religious community in Ireland, their records provide much more than a marginalised picture. Instead, the Presbyterian archive casts fresh light on the wider Irish evidence, enriching our knowledge of the everyday lives of women and men in Ireland. The article begins by introducing the Presbyterian archive and the community responsible for its creation. Next, it considers how the Presbyterian archive both meets and advances the aims of the ‘Agenda’ and reveals what it can tell us about the lives of women and men as gendered subjects. Overall, the article underlines the importance of the Presbyterian archive as a source for Irish historians because it underscores why all history is gender history.
Río Chico: A Multicomponent Site Precursor of Té Zulay
Authors: Cabrero Ferran , Aguirre Edwin , Romero Martha , Leib Simon
Published: December 2022

This report presents survey and excavation results from the site of Río Chico, located near the city of Puyo, Ecuador. Currently, Río Chico is the oldest multicomponent village-type mound site of the Pastaza drainage, one of the great rivers of the Amazon basin. It is part of a series of monumental sites in the Upper Amazon of Ecuador but is unique in the area because of its evidence of consumption of certain plants and interregional trade.
A census of compact sources at 162 MHz: First data release from the MWA Phase II IPS Survey
Authors: Morgan J. S. , Chhetri R. , Ekers R.
Published: December 2022

We present a catalogue of over 7000 sources from the GLEAM survey which have significant structure on sub-arcsecond scales at 162 MHz. The compact nature of these sources was detected and quantified via their Interplanetary Scintillation (IPS) signature, measured in interferometric images from the Murchison Widefield Array. The advantage of this approach is that all sufficiently compact sources across the survey area are included down to a well-defined flux density limit. The survey is based on

${\sim}250\times 10\hbox{-}\mathrm{min}$

observations, and the area covered is somewhat irregular, but the area within

$1\,\mathrm{h}<\mathrm{RA}<11\,\mathrm{h}$

;

$-10^\circ<\mathrm{Decl.}<+20^\circ$

is covered entirely, and over 85% of this area has a detection limit for compact structure below 0.2 Jy. 7839 sources clearly showing IPS were detected (

${>}5\sigma$

confidence), with a further 5550 tentative (

${>}2\sigma$

confidence) detections. Normalised Scintillation Indices (NSI; a measure of the fraction of flux density coming from a compact component) are reported for these sources. Robust and informative upper limits on the NSI are reported for a further 31081 sources. This represents the largest survey of compact sources at radio frequencies ever undertaken.
TREE-RING-RADIOCARBON DATING PARAFFIN-CONSERVED CHARCOAL AT THE MISSISSIPPIAN CENTER OF KINCAID, ILLINOIS, USA
Authors: Kessler Nicholas V , Hodgins Gregory L , Butler Brian M , Kartha Pulari S , Welch Paul D , Brennan Tamira K
Published: December 2022

Archival charcoal tree-ring segments from the Mississippian center of Kincaid Mounds provide chronometric information for the history of this important site. However, charcoal recovered from Kincaid was originally treated with a paraffin consolidant, a once common practice in American archaeology. This paper presents data on the efficacy of a solvent pretreatment protocol and new wiggle-matched14C dates from the largest mound (Mound 10) at Kincaid. FTIR and14C analysis on known-age charcoal intentionally contaminated with paraffin, as well as archaeological material, show that a chloroform pretreatment is effective at removing paraffin contamination. Wiggle-matched cutting dates from the final construction episodes on Mound 10 at Kincaid, indicate that the mound was used in the late 1300s with the construction of a unique structure on the apex occurring around 1390. This study demonstrates the potential for museum collections of archaeological charcoal to contribute high-resolution chronological information despite past conservation practices that complicate14C dating.
The social contract and industrial citizenship: Nigerian trade unions’ role in the recurring fuel subsidy protests
Authors: Houeland Camilla
Published: December 2022

This article brings new perspectives on state–citizen relations in African petro-states by analysing the role of Nigerian trade unions in the recurring fuel subsidy protests. Nigerian trade unions have played an instrumental role in protests against fuel subsidy removals since the mid-1980s, most recently in the massive 2012 protest known as ‘Occupy Nigeria’. Based on the idea that the fuel subsidy forms part of a social contract in Nigeria, and through revisiting T. H. Marshall’s seminal work on citizenship and industrial citizenship, I propose that the protests are sites for popular assertions of broader citizenship, as people rally behind the fuel subsidy as a social right and affirm political rights to participate and civil rights to bargain. This article further argues that the trade unions act as a mediator between state and citizens – that is, embedded in their industrial citizenship with collective forms of representation, organizing and bargaining. In this way, Nigerian trade unions have kept their relevance for workers and beyond, despite eroded labour rights. However, this social contract is fragile, contextual and contradictory, and the mediating role of the unions carries challenges and ambiguities, which became particularly clear in the 2012 protest.
A history of ‘Yan haƙiƙa, a revisionist Islamic group in northern Nigeria
Authors: Isa Kabiru Haruna
Published: December 2022

‘Yan haƙiƙa are a Sufi group that has come to prominence in the second decade of the twenty-first century in northern Nigeria, with a significant following in Kano. Although members of the group perceive themselves to be bona fide followers of the path of Shaykh Ibrahim Niasse (Senegalese Islamic scholar and founder of Tijaniyya-Ibrahimiyya), they are considered by Sunni Muslims (both Salafis and Sufis) as a heretical faction. The basic ideology of this group is that Niasse Allah ne (Niasse is God); they also apotheosize their members. Their ideology stems from the concepts of Wahadat al-Wujud (oneness of being and unity of existence) and Tarbiyya (spiritual training), which is a method used by Sufi shaykhs to guide their disciples on the mystical journey to direct experiences of the Divine Essence – a method popularized by Tijaniyya-Ibrahimiyya. Initially, the group operated clandestinely, but in recent years its members have attracted public attention through Mawlid Baaye (celebrating the birthday of Niasse). During the celebration, they shower praises on Niasse and rank him above the Prophet Muhammad. Their comments generate violent reactions from Salafi and Sufi communities. While Salafis consider the creed of ‘Yan haƙiƙa as typical Sufi heresy, the Sufis not only disown them but also question their ‘Muslimness’. The emergence of
‘Yan haƙiƙa has changed the contours and composition of Tijaniyya in Kano because its defining ideology of deifying Niasse and its members contradict the teaching and doctrine of the mainstream Tijaniyya. This article unpacks the place of ‘Yan haƙiƙa in the highly contested and tense religious geography of Kano, exploring how its emergence complicates the category of ‘Muslim’ within mainstream Sunni Islam.
The politics of literature in Malawi: Filemon Chirwa, Nthanu za Chitonga and the battle for the Atonga tribal council
Authors: Cochrane Thandeka
Published: December 2022

In 1932, as Nyasaland (present-day Malawi) was heading to indirect rule, a small vocal community in the north of the country resisted the colonial government’s attempts to assign them a Native Authority. Instead, they proposed their own form of government: a council of thirty-two mafumu (chiefs) who would make decisions on an egalitarian basis, the Atonga tribal council. The champion of this alternative form of governance was a Tonga intellectual named Filemon K. Chirwa. At the height of the political manoeuvring to institute the Atonga tribal council, Filemon wrote and published his only book: Nthanu za Chitonga (Folktales in Chitonga). This article argues that this book was – and still is – an important piece of political literature. Through an exploration of the context of the creation of the Atonga tribal council, it sets out the stakes that were at play in the construction of local traditions and customs, and then shows how the book was part of a project of producing an image of these. It then explores the ‘afterlife’ of the book, as it became a symbolic force in contemporary village communities, not only articulating the sense of political marginalization experienced, but also capturing a new form of political agency. The article concludes by suggesting that Filemon Chirwa’s collection of stories is an astounding example of the deeply political role that folktale literature can play within colonial and (post)colonial Africa.
Censorship, citizenship and cosmopolitan unity in Muslim and Christian creative responses to repression in northern Nigeria
Authors: McCain Carmen
Published: December 2022

Nigeria is often portrayed as having a ‘Muslim north’ and a ‘Christian south’. Such representations oversimplify the complicated interrelationships between the two religious communities and their geographic locations. Similarly, while much has been written on the conflict between Muslims and Christians in Nigeria’s Middle Belt region, there has been less scholarly attention to the philosophical and communal relationships between adherents of the two religions in northern Nigeria. I argue that there are parallels in the way in which Hausa-speaking Muslim artists responded to a censorship crisis in Kano State in 2007–11 and in the way in which Hausa-speaking Christian musicians from Nigeria’s north-east responded a few years later to the Boko Haram crisis. I examine Muslim filmmaker Hamisu Lamido Iyantama’s response to the Kano State Censorship Board, alongside Christian musician Saviour Y. Inuwa’s response to Boko Haram. Iyantama and Inuwa both counter repressive forces by expressing parallel understandings of their identities as citizens in the pluralistic state of Nigeria and as righteous members of universal religious communities that emphasize God’s justice in the end times. I argue that these Hausa-language artists present a vision of cosmopolitan unity across ethnicity and religion, as an alternative to the repressive forces of both state censorship and the anarchic violence of Boko Haram.
-REGULAR PARTITIONS AND MODULAR FORMS WITH COMPLEX MULTIPLICATION
Authors: PENNISTON DAVID
Published: December 2022

A partition of a positive integer n is called
$\ell $
-regular if none of its parts is divisible by
$\ell $
. Denote by
$b_{\ell }(n)$
the number of
$\ell $
-regular partitions of n. We give a complete characterisation of the arithmetic of
$b_{23}(n)$
modulo
$11$
for all n not divisible by
$11$
in terms of binary quadratic forms. Our result is obtained by establishing a relation between the generating function for these values of
$b_{23}(n)$
and certain modular forms having complex multiplication by
${\mathbb Q}(\sqrt {-69})$
.
Cyclospora cayetanensis comprises at least 3 species that cause human cyclosporiasis
Authors: Barratt Joel Leonard Nicholas , Shen John , Houghton Katelyn , Richins Travis , Sapp Sarah G. H. , Cama Vitaliano , Arrowood Michael J. , Straily Anne , Qvarnstrom Yvonne
Published: December 2022

The apicomplexan parasite Cyclospora cayetanensis causes seasonal foodborne outbreaks of the gastrointestinal illness cyclosporiasis. Prior to the coronavirus disease-2019 pandemic, annually reported cases were increasing in the USA, leading the US Centers for Disease Control and Prevention to develop a genotyping tool to complement cyclosporiasis outbreak investigations. Thousands of US isolates and 1 from China (strain CHN_HEN01) were genotyped by Illumina amplicon sequencing, revealing 2 lineages (A and B). The allelic composition of isolates was examined at each locus. Two nuclear loci (CDS3 and 360i2) distinguished lineages A and B. CDS3 had 2 major alleles: 1 almost exclusive to lineage A and the other to lineage B. Six 360i2 alleles were observed – 2 exclusive to lineage A (alleles A1 and A2), 2 to lineage B (B1 and B2) and 1 (B4) was exclusive to CHN_HEN01 which shared allele B3 with lineage B. Examination of heterozygous genotypes revealed that mixtures of A- and B-type 360i2 alleles occurred rarely, suggesting a lack of gene flow between lineages. Phylogenetic analysis of loci from whole-genome shotgun sequences, mitochondrial and apicoplast genomes, revealed that CHN_HEN01 represents a distinct lineage (C). Retrospective examination of epidemiologic data revealed associations between lineage and the geographical distribution of US infections plus strong temporal associations. Given the multiple lines of evidence for speciation within human-infecting Cyclospora, we provide an updated taxonomic description of C. cayetanensis, and describe 2 novel species as aetiological agents of human cyclosporiasis: Cyclospora ashfordi sp. nov. and Cyclospora henanensis sp. nov. (Apicomplexa: Eimeriidae).
A high-accuracy hollowness inspection system with sensor fusion of ultra-wide-band radar and depth camera
Authors: Kang Haoran , Zhang Wentao , Ge Yangtao , Liao Haiou , Huang Bangzhen , Wu Jing , Yan Rui-Jun , Chen I-Ming
Published: December 2022

With the dangerous and troublesome nature of hollow defects inside building structures, hollowness inspection has always been a challenge in the field of construction quality assessment. Several methods have been proposed for inspecting hollowness inside concrete structures. These methods have shown great advantages compared to manual inspection but still lack autonomy and have several limitations. In this paper, we propose a range-point migration-based non-contact hollowness inspection system with sensor fusion of ultra-wide-band radar and laser-based depth camera to extract both outer surface and inner hollowness information accurately and efficiently. The simulation result evaluates the performance of the system based on the original range-point migration algorithm, and our proposed one and the result of our system show great competitiveness. Several simulation experiments of structures that are very common in reality are carried out to draw more convincing conclusions about the system. At the same time, a set of laboratory-made concrete components were used as experimental objects for the robotic system. Although still accompanied by some problems, these experiments demonstrate the availability of an automated hollow-core detection system.
OP01 Convergent Validity Between Discrete Choice Experiment And Other Stated Preference Methods: A Multistudy Comparison
Authors: Veldwijk Jorien , Tervonen Tommi , de Bekker-Grob Esther , Hauber Brett , Groothuis-Oudshoorn Catharina G.M.
Published: December 2022

Introduction

To assess convergent validity of stated preference methods in studies where they were used to elicit patient preferences for informing medical product decisions.

Methods

In four studies, two stated preference methods were used to elicit preferences of patients with neuromuscular diseases (NMD; n = 140, Discrete Choice Experiment [DCE] and Best-Worst Scaling [BWS] case 2), diabetes (n = 495, DCE and swing weighting [SW]), myocardial infarction (MI; n = 335, DCE and BWS case 1), and rheumatoid arthritis (RA; n = 982, DCE and probabilistic threshold technique [PTT]). In each study, results of the two methods were compared using a normalized preference measure for which confidence intervals (CIs) were estimated using nonparametric bootstrapping of 500 samples. Normalized preference measures comprised of mean relative attribute importance weights (NMD and diabetes studies), attribute uptake probability (MI study), or maximum acceptable risk (RA study).

Results

In all four studies, attribute ranking showed similar patterns between DCE and other methods for the most important attributes. The same attribute had highest importance in three out of four studies. Significant differences were found in ranges of normalized preference measures of each study between DCE and the other methods: 4.1–43.4 versus 8.9–24.7 for DCE and BWS case 2 in NMD; 3.8–49.7 versus 11.9–16.8 for DCE and SW in diabetes; 2.0–85.5 versus 0.2–69.0 for DCE and BWS case 1 in MI; -3.5–49.2 versus 1.1–18.1 for DCE and PTT in RA.

Conclusions

Preferences differed significantly between DCE and other preference methods implying limited convergent validity. The substantially larger ranges in normalized outcome measures in DCE compared to other methods, are likely due to differences in mechanics and bias related to the methods. Since none of the methods is considered the golden standard for measuring stated preferences as true preferences are unknown, further studies are necessary to compare stated preference methods, determine internal validity and data quality, and potentially measure external validity.
OP05 The Role Of Conditional Reimbursement In The Lifecycle Approach
Authors: Schelleman Hedi , van Montfort Simone , Sicking Lenneke , Haasnoot-Volker Daniëlle
Published: December 2022

Introduction

In 2012, the Netherlands introduced a conditional reimbursement (CR) program to give patients earlier access to promising treatments (i.e., drugs and medical devices). After completion of the CR-study the results are used to (re)assess whether the treatment fulfills the criteria for reimbursement.

Methods

Promising treatments were identified via a bottom-up (physicians/researchers initiated) or top-down process (after the Dutch National Health Care Institute (Zorginstituut Netherland; ZIN) concluded that the intervention did not fulfill the criteria for reimbursement but the initial results seemed promising). A CR-grant was only approved if a committee determined the treatment had an added (health, social, ethical or organizational) benefit compared to Standard of Care (SoC) and the grant proposal was of good quality and fit for purpose. After approval from the Dutch Ministry of Health, all Dutch insurance companies were obliged to reimburse the treatment for patients participating in the CR-study. Researchers could also apply for a research grant (maximum EUR 400,000) from the Netherlands Organization for Health Research and Development (ZonMw), if there was no ‘wealthy’ manufacturer.

Results

Currently, there are 23 (ongoing and completed) CR-studies. All of them are closely monitored by ZIN, ZonMw, and stakeholders. The results of all completed CR-studies (n = 11) have been used in a (re)assessment. ZIN concluded that five treatments were not effective compared to SoC. Six interventions were effective and cost-effective compared to SoC and are now reimbursed. In most cases (>80%) the physician and patient groups agreed with the conclusion about reimbursement. In some cases there were additional requirements to maintain the clinical effectiveness and cost-effectiveness in clinical practice (such as training of new physicians).

Conclusions

Data from CR-studies are important for reassessments. Factors with a positive influence are: a maximum duration for a CR-study, close monitoring, possibility to adapt the study design (only with approval from ZIN and ZonMw), and active involvement of stakeholders (physician and patient groups). A negative influence was: the legal requirements to ensure only reimbursement for patients participating in a CR-study.
OP06 Percutaneous Transforaminal Endoscopic Discectomy: From Insufficient Evidence To Reimbursement
Authors: Schelleman Hedi , de Groot Ingrid , Haasnoot-Volker Daniëlle , Jellema Petra
Published: December 2022

Introduction

The standard surgical technique for lumbosacral radicular syndrome in the Netherlands is open microdiscectomy (OM). An alternative technique, preferred by some Dutch physicians, is percutaneous transforaminal endoscopic discectomy (PTED). However, in 2006 the Dutch National Health Care Institute (Zorginstituut Netherland [ZIN]) concluded that the available evidence was insufficient, and a high quality randomized controlled trial (RCT) was needed to assess the cost-effectiveness of PTED compared to OM. The relevant physician group agreed with this conclusion, but they were unable to perform this RCT due to lack of funding and high treatment costs.

Methods

In 2012, the Netherlands introduced a conditional reimbursement (CR) program to give patients earlier access to promising treatments. Researchers, in collaboration with physicians and patients, submitted a grant proposal and in 2016 the Dutch Ministry of Health approved the CR of PTED. Due to this decision, insurance companies were obliged to reimburse PTED for patients participating in the PTED-study (NCT02602093). The Netherlands Organization for Health Research and Development (ZonMw) also provided a research grant to fund the PTED-study. In total, 682 adult patients with greater than 10 weeks of radiating pain, or greater than 6 weeks of excessive radiating pain and an indication for surgery were included. After 4 years and 5 months the PTED-study was completed.

Results

Outcomes of published studies and the unpublished PTED-study were used in the HTA reassessment. Results showed that PTED was noninferior to OM with regards to leg pain (Visual Analogue Scale: mean difference (MD) -0.73; 95% confidence interval [CI] -5.04, 3.59), functional status (Oswestry Disability Index: MD -2.07; 95% CI -3.61, -0.53), and rate of complications (relative risk 0.45; 95% CI 0.18, 1.12) after 6 months (GRADE level ‘moderate’). Furthermore PTED was, after the surgeons’ learning-curve, cost-effective.

Conclusions

This CR project was successful and PTED is now reimbursed as part of the Dutch healthcare package. However, in order to maintain high quality care in clinical practice, safeguards should be developed (including the appropriate training of surgeons). This example shows that CR programs are essential for promising treatments without ‘wealthy’ manufacturers. Additionally, all stakeholders are needed to make a CR-study successful.
OP12 Post-Launch Evidence Generation Among Health Technology Assessment Bodies In Europe
Authors: Lema Leonor Varela , Puñal-Riobóo Janet , Guilhaume Chantal , Galbraith Maggie , Bélorgey Chantal , Faraldo Vallés Maria José , Amélie Amélie Meillassoux
Published: December 2022

Introduction

The need for timely access to innovative technologies has placed a special focus on the development of policies and practices that can guarantee the availability whilst ensuring the safety of these technologies after launch or licensure. The aim of this paper is to present and discuss Post-Launch Evidence Generation (PLEG) practices among health technology assessment (HTA) bodies at the European level to explore cross-border collaboration opportunities.

Methods

In December 2019, a survey composed of nine closed-ended questions with multiple choice answers about the PLEG practices in each country was sent to 25 partners of the European Network of Health Technology Assessment (EUnetHTA) Joint Action 3. In addition to the survey, the national practices were discussed during a face-to-face meeting with all partners of the dedicated work package. A quantitative analysis and a qualitative synthesis of the results was carried out.

Results

Twelve HTA bodies completed the survey. Of these, 11 reported procedures in place for official PLEG requests. In nine of the agencies, the requests are made at the time of the assessment/appraisal. Data collection and analysis mainly lies with companies for pharmaceuticals (60%) while it is more the responsibility of the HTA body for medical devices (75%). Only one agency reported owning the data and being able to exchange the data without asking permission. During the face-to face discussions, it was acknowledged that PLEG practices differ between countries depending on the topic concerned, but most rely on the usage of registries (mainly disease registries) for data collection. Most agencies estimated that a European collaboration could take place.

Conclusions

PLEG practices are in the remit of many European HTA bodies. Data sharing should be anticipated as only some own the data and can exchange them without asking permission. European collaboration on PLEG could commence once the evidence gaps have been defined or during the production of the HTA reports in the case of joint assessments.
OP15 Improving The Osteoporosis Care Trajectory By Collaboration Between Clinicians, Patients And Health Insurers Within the Appropriate Care Program
Authors: Groeneveld Iris , Witteveen Janneke , Boonzajer-Flaes Saskia , Mullenders Pé , Leenen Celine
Published: December 2022

Introduction

The cyclic appropriate care program of the National Health Care Institute aims at enhancing quality of care in the Netherlands. A full cycle consists of four phases: (i) screening each ICD-10 chapter and selecting a care trajectory, (ii) in-depth analysis of the care trajectory and formulating actions for improvement, (iii) implementation, and (iv) evaluation. Collaboration with and between relevant parties from the field is key to its success. We describe the 2nd and 3th phase of this cycle, aimed at osteoporosis.

Methods

First, nine clinicians, one nurse practitioner, two physiotherapists and one pharmacist representing scientific organizations, two patient representatives and one health insurer, defined research questions. Second, by in-depth analysis on declaration data of health care activities, and comparing the results to the guidelines, research questions were addressed. Last, results were discussed among all parties and actions for making wiser choices and improving the appropriateness of care were formulated. For each action, the parties defined who would take the lead and who would be involved.

Results

The analyses showed that only 26 percent of Dutch fracture patients 50 years of age and above underwent dexa-scanning, as opposed to more than 80 percent in the guideline. All parties underlined this percentage should be increased. Possible actions were defined: to describe the care trajectory in the update of the multidisciplinary guideline; to better inform fracture patients about the importance of dexa-scanning; and to make adjustments to the hospital electronic system in order to facilitate the ordering of dexa-scans. For these actions, medical specialists were in the lead. Other data-analyses showed that half of osteoporosis patients stopped using medication within two years. For the jointly defined actions aimed at raising medication adherence, such as better patient education, the general practitioner and pharmacist were in the lead. Currently, the National Health Care Institute facilitates implementation and monitors improvement.

Conclusions

Close collaboration with relevant parties led to well-considered actions on improvement of osteoporosis care.
OP20 Is The Quality Of Evidence In Health Technology Assessment Deteriorating Over Time?: A Case Study On Cancer Drugs In Australia
Authors: Gao Yuan , Laka Mah , Merlin Tracy
Published: December 2022

Introduction

Recently, there have been concerns regarding a trend toward poorer quality evidence being accepted by regulatory institutions and the consequent impact on health technology assessment (HTA) decision-making. This study aimed to determine whether there has been a change in the quality of evidence provided on cancer drugs proposed for listing on the Pharmaceutical Benefits Scheme, using data solely extracted from public summary documents (PSD) published by the Australian government.

Methods

PSDs published from July 2005–2020 were reviewed. Metrics associated with quality of evidence were extracted, including the directness of comparison, study design, sample size, and risk of bias (RoB). Additional data were extracted to provide greater context to any observed trends in quality of evidence. Analyses were performed across different time periods. Associations between the quality of evidence and time periods were explored using logistic regression analysis.

Results

In total, 214 PSDs were included in the analysis. Only 13 percent of submissions provided a single arm study or observational study as the key evidence; however, 37 percent of submissions did not contain a direct (‘head-to-head’) comparison relevant to Pharmaceutical Benefits Advisory Committee (PBAC) decision-making. Among all submissions containing direct evidence, about half had findings of a moderate/high/unclear RoB. Among all submissions containing indirect comparisons, over half had transitivity issues. In submissions containing direct comparisons, there was an increase in the RoB over time even after adjusting for trial data maturity and the rareness of the drug indication (odds ratio [OR] 1.30; 95% confidence interval [CI] 0.99, 1.70). There were no clear time trends observed in sample size, directness, study design, or transitivity issues during any of the observed time periods.

Conclusions

In the last 7 years, a high proportion of cancer drug submissions presented findings with a high RoB and transitivity issues. As the evidence dossiers provided to the PBAC are often congruent with submissions made elsewhere, this poor evidence quality is of concern and can only lead to higher levels of decision-maker uncertainty.
OP37 Lifecycle Evaluation Models And Frameworks Used To Assess Medical Devices: A Qualitative Evidence Synthesis
Authors: Harkin Kathleen , Sorensen Jan , Thomas Steve
Published: December 2022

Introduction

Due to the iterative nature of medical device innovation and development, a single once-off assessment does not provide all the answers that decision-makers need over the device’s lifetime. Consequently, a lifecycle approach is frequently recommended. However, there is no lifecycle model recognized internationally for conducting such evaluations, nor is there explicit agreement regarding what is meant by, or evaluated over, the lifecycle. The purpose of this review was to identify and explore the range of models/frameworks used for evaluating medical devices across their lifetime – to determine what people mean by ‘the lifecycle’, what is evaluated, how, and why.

Methods

A qualitative evidence synthesis of lifecycle models described in the literature from a wide variety of disciplines was performed. Literature searching and selection of models iterated with analysis. Similarities, differences, and patterns were identified, from which themes became apparent, and explanatory theories were developed.

Results

Fifty-three models are included in the synthesis. The dimensions of difference include, amongst others, the lifecycle scope, level of application, evaluation timepoints and methods, factors included in the models, and the focus of interest. These are each influenced by the purpose of the lifecycle evaluation, which depends on the perspective and the decision or activity the evaluation is intended to inform. Few models provide a lifecycle approach to evaluating safety or efficacy. Theories explaining the differences are postulated.

Conclusions

Lifecycle evaluation means different things to different actors, with varied reasons for evaluation and different variables included in the models. Thus, discussions between different actors on lifecycle evaluation may be inadvertently at cross-purposes. Without first defining what is meant by the lifecycle (including the stages or phases of activity it covers) and the variables included in an evaluation, care must be exercised when discussing a lifecycle evaluation approach – to ensure that the meaning (and intended objective) is not lost in translation. Indeed, promoting lifecycle evaluation may result in necessary evidence not being generated early enough, being deferred instead until later.
OP42 Increasing Access To Real-World Data To Move From Health Technology Assessment To Health Technology Management
Authors: Rowark Shaun , Jonsson Pall , Kent Seamus
Published: December 2022

Introduction

When assessing existing or emerging technologies using a one-off health technology assessment (HTA) we do not take into consideration the effects on people who will receive the technology once approved. Developments in real-world data (RWD) can help to address this by moving to ongoing health technology management (HTM).

Methods

To move to HTM, we first need to develop HTM data requirements. We undertook user interviews with National Institute for Health and Care Excellence (NICE) HTA developers to develop a list of requirements. We surveyed the types of data that NICE currently has access to and performed a gap analysis to understand where further data is needed. We then worked with external systems partners to identify and review available data sources that could support HTM.

Results

From our user interviews we established eight HTM data requirements. Data needed to be linked, cover full care pathways, contain data from new collections, be shareable, have direct access, be of high quality, have comprehensive coverage, and be responsive to technological developments (such as artificial intelligence). The review of data sources revealed a fragmented landscape of health data in the United Kingdom (UK). We identified National Health Service Digital’s (NHSD) Trusted Research Environment as the main data source that could address HTM requirements. This addresses challenges with fragmented data by providing approved researchers with timely and secure access to a range of linked health and care data. We also identified that a large national data collection would not capture all technologies, such as orphan technologies for rare conditions. We therefore established a process for accessing data from smaller data collections such as disease specific registries. To address how we can use this data, we developed the NICE Real-World Evidence (RWE) Framework that provides clear guidance on the expectations for the planning, conduct, reporting, and appraisal of RWE studies.

Conclusions

We have established requirements for the type of data that will help to deliver HTM as well as developed a process for accessing several suitable data sources that meet these requirements.
OP46 Assessing The Quality Of Pharmacoeconomic Evaluations About Type 2 Diabetes Mellitus Drugs In National Reimbursement Drug List
Authors: Bao Shi-Yi , Liu Liu , Li Fuming , Yang Yi , Wei Yan , Shao Hui , Ming Jian , Yan Juntao , Chen Yingyao
Published: December 2022

Introduction

With the disease spectrum changing in China, type 2 diabetes mellitus (T2DM) has become the main chronic disease which affects people’s health severely, bring patients serious economic burden of disease. For T2DM patients, reliable quality of evidence in decision-making are significant, improving the efficiency of the adjustment of the National Reimbursement Drug List (NRDL). Based on the Consolidated Health Economic Evaluation Reporting Standards (CHEERS), we aimed to evaluate the quality of all published pharmacoeconomic evaluations on T2DM drugs in 2020 NRDL.

Methods

Because the 2020 NRDL came into effect on 1 March 2021, we searched all published pharmacoeconomic evaluations about T2DM drugs in 2020 NRDL before March 2021 in China National Knowledge Infrastructure (CNKI), Wan fang Data, China Science and Technology Journal Database (VIP), PubMed, and Web of Science. According to the criterion of inclusion and exclusion, all documents were screened and then relevant basic information of targeted documents was extracted. The quality was evaluated by calculating the final scores based on CHEERS. Two reviewers assessed each publication’s quality using the CHEERS instrument and summarized study quality.

Results

A total of 910 papers were searched, and 24 papers were included. These involved six T2DM drugs, specifically IDegAsp, exenatide, liraglutide, lixisenatide, dapagliflozin and empagliflozin. The average score was 18.31, the standard deviation was 3.67, and the average scoring rate was 77.41 percent. Among all items, “characterizing heterogeneity” scored 0.04, least satisfied with requirements. “Setting and location”, “choice of health outcomes” and “assumptions” scored one, most satisfied with requirements. Among the average scores of all parts, “results” scored lowest at 0.55, and “methods” scored highest at 0.85. The Wilcoxon sum-rank tests showed that score rate which represented reporting quality of economic evaluation (EE) was significantly related to “journal type”, “EEs type”, “model choice” and “study perspective”.

Conclusions

The methodological quality of pharmacoeconomic evaluations about T2DM drugs in 2020 NRDL needs to be improved. Improving the quality of literature is the basic guarantee of scientific decision-making in national medical insurance negotiation.
OP49 A Systematic Review Of The Activities Of Early Advice, Early Dialogue, Scientific Advice By HTA Doers
Authors: Ibargoyen-Roteta Nora , Benguria-Arrate Gaizka , Galnares-Cordero Lorea , Guevara Claudia , De la Hoz Siegler Ilich Herbert , Chacon Kelly Rocio , Low Eduardo , Otte Maximiliam , Dauben Hans Peter , Gutierrez-Ibarluzea Iñaki
Published: December 2022

Introduction

There is a range of activities that health technology assessment (HTA) doers have started to improve the process of generation of required evidence for new technologies, and the alignment of regulatory and reimbursement processes that retard the access to patients to them. Different organizations call those processes early advice, early dialogue, or scientific advice to those activities.

Methods

We performed a systematic review of the activities named scientific advice (SA), early advice (EA) and early dialogue (ED). Major databases and HTA organizations were explored. The protocol and search strategy were published in PROSPERO. The selection of final articles and documents was done in pairs, and when discrepancies were found a third person resolved with the consensus of the others. A matrix was used to define the commonalities and differences of the described processes.

Results

We initially retrieved 949 documents, after the analysis of duplications and the full text reading of the selected ones, we finally selected 39 documents and described: the type of technologies, the process, the stakeholders, the duration, the costs, and the impact. Big HTA agencies such as the Canadian Agency for Drugs and Technologies in Health (CADTH) or the National Institute for Health and Care Excellence (NICE) included EA or SA among their portfolio of activities as well as networks (European Network for HTA (EUnetHTA) or smaller agencies such as HTA Wales or Basque Office for HTA (Osteba) among others. The type of activity, the process, duration, purpose and costs differ among HTA doers.

Conclusions

There is a need to define what we meant when we are talking about SA, ED, and EA. In fact, regulators used the same processes with different purposes. Our systematic review and the lessons learnt from the European-funded SAFENMEDTECH project will propose a detailed framework that can be useful to better understanding the needs of each of the involved parties and how to make the processes involved more efficient.
OP71 PriTec Tool 2: Adaptation For Selection Of Technologies To Be Assessed For Inclusion Into The Health Care System
Authors: Lema Leonor Varela , Maceira-Rozas Maria , Puñal-Riobóo Janet , Faraldo-Vallés Maria José
Published: December 2022

Introduction

The PriTec Tool is an automatically executable multicriteria web application developed in 2009 by the Galician Health Knowledge Agency (avalia-t; ACIS) for the prioritization of technologies susceptible of post-introduction observation or obsolescence. Currently, the tool has been updated and improved to support the selection process of technologies to be assessed for inclusion into the National Public Health Care Portfolio. The aim of this work is to present the updated version of the tool (PriTec Tool 2) with the new functionalities.

Methods

The development of the tool was based on a mixed-method approach, comprising a systematic review, followed by a five-step process: (i) development of the preliminary proposal of prioritization criteria and domains; (ii) contextualization and validation of the criteria and domains by a multidisciplinary group of key stakeholders; (iii) assessment of validity, reliability and suitability of criteria; (iv) weighting of domains; and (v) evaluation of applicability, reliability and reproducibility of the tool.

Results

The tool consists of 15 criteria categorized in 5 domains. The web application ranks the technologies through automatic computation of the weighted average of the different criteria and generates a comparative analysis of the individual or working group results. The application allows access to different options: working groups, case studies or technology comparison. It allows for individual prioritizations or managing working groups. When applied to prioritize the Spanish Network of Health Technology Assessment (HTA) Agencies yearly workplan it achieved an intraclass correlation coefficient of 0.71 (95% confidence interval 0.62, 0.88).

Conclusions

The updated PriTec Tool-2 can be very useful to guide decision-making regarding the assessments that would be mostly needed to ensure health, equity and sustainability. The tool stands out for its simplicity and ease of application. It is acknowledged that the tool could be of great interest to policy makers, HTA bodies and other health decision-makers worldwide.
OP74 Assessing Public Confidence Towards COVID-19 Vaccines Through Social Media Insights Leveraged Using Artificial Intelligence Techniques
Authors: Green Rhiannon , Lanyi Kate , Marshall Christopher , Craig Dawn
Published: December 2022

Introduction

In areas where public confidence is low and there is a lack of understanding around behaviors, such as COVID-19 vaccine hesitancy, there is a need to explore novel sources of evidence. When leveraged using artificial intelligence (AI) techniques, social media data may offer rich insights into public concerns around vaccination. Currently, sources of ‘soft-intelligence’ are underutilized by policy makers, health technology assessment (HTA) and other public health research agencies. In this work, we used an AI platform to rapidly detect and analyze key barriers to vaccine uptake from a sample of geo-located tweets.

Methods

An AI-based tool was deployed using a robust search strategy to capture tweets associated with COVID-19 vaccination, posted from users in London, United Kingdom. The tool’s algorithm automatically clustered tweets based on key topics of discussion and sentiment. Tweets contained within the 12 most populated topics with negative sentiment were extracted. The extracted tweets were mapped to one of six pre-determined themes (safety, mistrust, under-representation, complacency, ineffectiveness, and access) informed using the World Health Organization’s 3Cs vaccine hesitancy model. All collated tweets were anonymized.

Results

We identified 91,473 tweets posted between 30 November 2020 and 15 August 2021. A sample of 913 tweets were extracted from the twelve negative topic clusters. Of these, 302 tweets were coded to a vaccine hesitancy theme. ‘Safety’ (29%) and ‘mistrust’ (23%) were the most commonly coded themes; the least commonly coded was ‘under-representation’ (3%). Within the main themes, adverse reactions, inadequate assessment, and rushed development of the vaccines as key findings. Our analysis also revealed widespread sharing of misinformation.

Conclusions

Using an AI-based text analytics tool, we were able to rapidly assess public confidence in COVID-19 vaccination and identify key barriers to uptake from a corpus of geo-located tweets. Our findings support a growing body of evidence and confidence surrounding the use of AI tools to efficiently analyze early sources of soft-intelligence evidence in public health research.
OP80 ‘Green Metrics’ - Incorporating Environmental Dimensions In Health Technology Assessment
Authors: Schuitmaker-Warnaar Tjerk Jan , Fruytier Sevgi , Gunn Callum
Published: December 2022

Introduction

Climate change as the result of human action and the risks it poses to human health are well established. In healthcare there is increasing attention to climate and environmental impacts of the use of medical and health technologies. As part of a lifecycle approach, health technology assessment (HTA) needs to take climate and environmental impacts into account. In 2020, the new definition of HTA added the dimension ‘environmental aspects’, with which the value of health technologies can be determined and assessed in terms of their impact on the environment. This led several HTA organizations to explore opportunities for including environmental impacts in HTA procedures. It is, however, yet unclear how many researchers and HTA organizations are already working on this sustainability dimension, in what way, with which (international) partners, and what they have achieved as of now. Furthermore, the complex relations between the climate crisis, environmental pollution, health and care are difficult to trace, and methods are scarce. In HTA, there is an increasing need for outcome measures that, in addition to clinical utility, effectiveness, efficiency or satisfaction, also quantify the environmental impact of medical interventions (i.e., green metrics).

Methods

We report on (i) a scoping of international (research) groups and (HTA) organizations that are working on green metrics; (ii) a literature review into the state of affairs with regard to metrics and methods; and (iii) an impact analysis of possible future inclusion of green metrics in HTA procedures. We supplemented a review of (grey) literature with interviews with HTA organizations pioneering with green metrics, and we have conducted a review of available scientific literature, yielding examples of incorporation of environmental aspects into HTA and reports on practical implications.

Results

Carbon dioxide emissions and pollution by the health sector are currently being explored as green metrics. Differences between direct and indirect environmental impacts complicate the evaluation.

Conclusions

Green metrics should eventually make it possible to assess sustainability in healthcare as part of a lifecycle approach.