bluuebunny/crossref_metadata_2025 huggingface dataset:
Closing the Accountability Gap in Corporate Supply Chains for Violations of the Trafficking Victims Protection Act
Authors: GREEN Jennifer
Published: December 2021

Over 40 million people around the world are victims of modern forms of slavery: forced labour and human trafficking. People are tricked into working under onerous conditions, and unable to leave or return home due to physical, psychological or financial coercion, and many of these trafficking victims produce goods for United States (US) and other multinational corporations that profit by relying on the lower wages earned by workers in their global supply chains. Well-developed legal standards prohibit these practices, and governments, intergovernmental organizations, business associations and non-governmental organizations have developed mechanisms to prevent, detect and provide redress to victims. Some businesses lead or comply with the standards and enforcement mechanisms, but too many do not. US law offers a powerful but under-utilized tool to address trafficking: the 2008 Trafficking Victims Protection Reauthorization Act (TVPRA), which imposes civil liability on those who ‘knew or should have known’ about forced labour or human trafficking in their corporate ventures. Unfortunately, courts have ignored or misinterpreted this standard, at times confusing civil and criminal provisions of the statute. Correct and vigorous legal enforcement is key to addressing the accountability gap between the well-developed standards and the continuing use of forced labour and human trafficking. This article is the first to demonstrate that, with regard to the TVPRA standard, corporations have long been on notice of both the obligation to effectively monitor labour conditions and the mechanisms that would accomplish that task. US courts must enforce the ‘knew or should have known’ standard to protect workers – the most vulnerable people in the supply chain – and to prevent an unfair competitive advantage over companies that have established compliance programmes that actually prevent and punish human trafficking and forced labour.
CRISPR-Cas9 and Food in the European Union: An Organic Solution to an Undetectable Problem for Food Business Operators
Authors: Hughes Shane Michael
Published: December 2021

Various methods of genetic modification have been applied to plant breeding as an integral part of agriculture. This article examines a method of targeted mutagenesis – CRISPR-Cas9 – and its dysregulation in the European Union (EU). It provides clarity for food business operators relating to the traceability and labelling of food products induced using this biotechnology. In addition, it outlines policy recommendations to improve the regulation of such food products in the EU.
Knowledge, attitudes, and behaviours towards schizophrenia, bipolar disorder, and autism: a pilot study
Authors: Mothersill David , Loughnane Gerard , Grasso Gabriela , Hargreaves April
Published: December 2021

Objectives:

Lack of knowledge and discriminatory attitudes and behaviours towards individuals with mental disorders is a worldwide problem but may be particularly damaging for young people. This pilot study examined knowledge, attitudes and behaviours towards schizophrenia, bipolar disorder and autism within a large sample of adults in Ireland, a country with the youngest population in Europe, in order to better understand public views on these groups.

Methods:

In a correlational, cross-sectional design, 307 adults in Ireland over the age of 18 completed a questionnaire over Google Forms examining knowledge, attitudes and behaviours towards schizophrenia, bipolar disorder and autism. Responses to questions specifically relating to each diagnosis were compared using trimmed mean ANOVA to examine whether responses to questions differed depending on diagnosis.

Results:

Results indicate varied knowledge, attitudes and behaviours towards these groups, but a majority believe it should be a research priority. ANOVA and post hoc tests revealed significant differences in knowledge, attitudes and behaviours towards each of schizophrenia, bipolar disorder, and autism (p < 0.005), and reported attitudes and behaviours towards schizophrenia were more negative than either bipolar disorder or autism. A majority of participants (54.8%) felt not informed enough about mental health by the media.

Conclusions:

In our Irish sample, type and level of stigma varies according to mental health diagnosis. Our sample also report feeling inadequately informed about mental health by the media. Thus future policy and campaigns could consider targeting individual mental health diagnoses, with a focus on increasing familiarity and knowledge.
Turbulence modulation in buoyancy-driven bubbly flows
Authors: Pandey Vikash , Mitra Dhrubaditya , Perlekar Prasad
Published: December 2021

We present a direct numerical simulation (DNS) study of buoyancy-driven bubbly flows in the presence of large-scale driving that generates turbulence. On increasing the turbulence intensity: (a) the bubble trajectories become more curved and (b) the average rise velocity of the bubbles decreases. We find that the energy spectrum of the flow shows a pseudo-turbulence scaling for length scales smaller than the bubble diameter and a Kolmogorov scaling for scales larger than the bubble diameter. We conduct a scale-by-scale energy budget analysis to understand the scaling behaviour observed in the spectrum. Although our bubbles are weakly buoyant, the statistical properties of our DNS are consistent with the experiments that investigate turbulence modulation by air bubbles in water.
Investigation of internal intermittency by way of higher-order spectral moments
Authors: Lortie S. , Mydlarski L.
Published: December 2021

The analysis of turbulence by way of higher-order spectral moments is uncommon, despite the relatively frequent use of such statistical analyses in other fields of physics and engineering. In this work, higher-order spectral moments are used to investigate the internal intermittency of the turbulent velocity and passive-scalar (temperature) fields. This study first introduces the theory behind higher-order spectral moments as they pertain to the field of turbulence. Then, a short-time Fourier-transform-based method is developed to estimate these higher-order spectral moments and provide a relative, scale-by-scale measure of intermittency. Experimental data are subsequently analysed and consist of measurements of homogeneous, isotropic, high-Reynolds-number, passive and active grid turbulence over the Reynolds-number range$35\leq R_{\lambda } \leq ~731$. Emphasis is placed on third- and fourth-order spectral moments using the definitions formalised by Antoni (Mech. Syst. Signal Pr., vol. 20 (2), 2006, pp. 282–307), as such statistics are sensitive to transients and provide insight into deviations from Gaussian behaviour in grid turbulence. The higher-order spectral moments are also used to investigate the Reynolds (Péclet) number dependence of the internal intermittency of velocity and passive-scalar fields. The results demonstrate that the evolution of higher-order spectral moments with Reynolds number is strongly dependent on wavenumber. Finally, the relative levels of internal intermittency of the velocity and passive-scalar fields are compared and a higher level of internal intermittency in the inertial subrange of the scalar field is consistently observed, whereas a similar level of internal intermittency is observed for the velocity and passive-scalar fields for the high-Reynolds-number cases as the Kolmogorov length scale is approached.
Complex singularity analysis for vortex layer flows
Authors: Caflisch R.E. , Gargano F. , Sammartino M. , Sciacca V.
Published: December 2021

We study the evolution of a 2D vortex layer at high Reynolds number. Vortex layer flows are characterized by intense vorticity concentrated around a curve. In addition to their intrinsic interest, vortex layers are relevant configurations because they are regularizations of vortex sheets. In this paper, we consider vortex layers whose thickness is proportional to the square-root of the viscosity. We investigate the typical roll-up process, showing that crucial phases in the initial flow evolution are the formation of stagnation points and recirculation regions. Stretching and folding characterizes the following stage of the dynamics, and we relate these events to the growth of the palinstrophy. The formation of an inner vorticity core, with vorticity intensity growing to infinity for larger Reynolds number, is the final phase of the dynamics. We display the inner core's self-similar structure, with the scale factor depending on the Reynolds number. We reveal the presence of complex singularities in the solutions of Navier–Stokes equations; these singularities approach the real axis with increasing Reynolds number. The comparison between these singularities and the Birkhoff–Rott singularity seems to suggest that vortex layers, in the limit

$Re\rightarrow \infty$

, behave differently from vortex sheets.
OP128 Improving Literature Searching For Evidence On Health Apps: The National Institute For Health And Care Excellence (NICE) MEDLINE And Embase (Ovid) Health Apps Search Filters
Authors: Ayiku Lynda , Glover Sarah
Published: December 2021

Introduction

Literature searching for evidence on apps in bibliographic databases is challenging because they are often described with inconsistent terminology. Information Specialists from the United Kingdom's National Institute for Health and Care Excellence (NICE) have developed validated search filters for retrieving evidence about apps from MEDLINE and Embase (Ovid) reliably.

Methods

Medical informatics journals were hand-searched to create a ‘gold standard’ set of app references. The gold standard set was divided into two sets. The development set provided the search terms for the filters. The filters were validated by calculating their recall against the validation set. Target recall was >90%.

A case study was then conducted to compare the number-needed-to-read (NNR) of the filters with previous non-validated MEDLINE and Embase app search strategies used for the ‘MIB214 myCOPD app’ NICE topic. NNR is the number of references screened to find each relevant reference.

Results

The MEDLINE and Embase filters achieved 98.6 percent and 98.5 percent recall against the validation set, respectively. In the case study they achieved 100 percent recall, reducing NNR from 348 to 147 in MEDLINE and from 456 to 271 in Embase.

Conclusions

The novel NICE health apps search filters retrieve evidence on apps from MEDLINE and Embase effectively and more efficiently than previous non-validated search strategies used at NICE.
OP199 From Pilot Studies To System-Wide Innovation: Challenges And Opportunities For Clinical Decision Support Systems (CDSS) Implementation In Australia
Authors: Laka Mah , Milazzo Adriana , Carter Drew , Merlin Tracy
Published: December 2021

Introduction

The clinical data is increasing at a considerably higher rate than the capacity of the healthcare system and clinicians to manage this data. Digital tools such as clinical decision support systems (CDSS) provide opportunities for evidence-based patient care by intelligently filtering and presenting the information required for clinical decision making at the point of care. Despite the success of pilot projects, CDSS have had limited implementation in broader health systems. We aimed to identify challenges faced by policymakers for CDSS implementation and to provide policy recommendations.

Methods

We conducted eleven semi-structured interviews with Australian policymakers from state and national committees involved in digital health activities. The data were analyzed using reflexive thematic analysis to identify policy priorities.

Results

Our findings indicate that fragmentation of care processes and structures in the digital health ecosystem is one of the main impediments to delivering coordinated care using CDSS. Five themes for policy action were identified: (i) establishing a shared conceptual framework for user-centered design of CDSS that is aligned with stakeholders’ priorities, (ii) maintaining the right balance between the customization and standardization of systems, (iii) developing mutually agreed semantic interoperability standards at the local, state and national level, allowing generation and exchange of information across the health system without changing its context and meaning, (iv) reorienting organizational structures to build capacity to foster change, and (v) developing collaborative care models to avoid conflicting interests between stakeholders.

Conclusions

Findings highlight the importance of developing system-wide guidance to establish a clear vision for CDSS implementation and alignment of organizational processes across all levels of health care. There is a need to build a shared policy framework for modelling the innovative activities such as CDSS implementation across the digital health landscape which minimizes the operational and strategic fragmentation of different organizations.
OP218 Searching Preprint Repositories For COVID-19 Therapeutics Using A Semi-Automated Text-Mining Tool
Authors: Gonzalez-Moral Sonia Garcia , Al-Assaf Aalya , Pandey Savitri , Ogunbayo Oladapo , Craig Dawn
Published: December 2021

Introduction

The COVID-19 pandemic led to a significant surge in clinical research activities in the search for effective and safe treatments. Attempting to disseminate early findings from clinical trials in a bid to accelerate patient access to promising treatments, a rise in the use of preprint repositories was observed. In the UK, NIHR Innovation Observatory (NIHRIO) provided primary horizon-scanning intelligence on global trials to a multi-agency initiative on COVID-19 therapeutics. This intelligence included signals from preliminary results to support the selection, prioritisation and access to promising medicines.

Methods

A semi-automated text mining tool in Python3 used trial IDs (identifiers) of ongoing and completed studies selected from major clinical trial registries according to pre-determined criteria. Two sources, BioRxiv and MedRxiv are searched using the IDs as search criteria. Weekly, the tool automatically searches, de-duplicates, excludes reviews, and extracts title, authors, publication date, URL and DOI. The output produced is verified by two reviewers that manually screen and exclude studies that do not report results.

Results

A total of 36,771 publications were uploaded to BioRxiv and MedRxiv between March 3 and November 9 2020. Approximately 20–30 COVID-19 preprints per week were pre-selected by the tool. After manual screening and selection, a total of 123 preprints reporting clinical trial preliminary results were included. Additionally, 50 preprints that presented results of other study types on new vaccines and repurposed medicines for COVID-19 were also reported.

Conclusions

Using text mining for identification of clinical trial preliminary results proved an efficient approach to deal with the great volume of information. Semi-automation of searching increased efficiency allowing the reviewers to focus on relevant papers. More consistency in reporting of trial IDs would support automation. A comparison of accuracy of the tool on screening titles/abstract or full papers may help to support further refinement and increase efficiency gains.

This project is funded by the NIHR [(HSRIC-2016-10009)/Innovation Observatory]. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
OP236 Evidence Synthesis Of Time-To-Event Outcomes In The Presence Of Non-Proportional Hazards
Authors: Freeman Suzanne , Cooper Nicola , Sutton Alex , Crowther Michael , Carpenter James , Hawkins Neil
Published: December 2021

Introduction

Synthesis of clinical effectiveness is a well-established component of health technology assessment (HTA) combining data from multiple trials to obtain an overall pooled estimate of clinical effectiveness, which may inform an associated economic evaluation. Time-to-event outcomes are often synthesized using effect measures from Cox proportional hazards models assuming a constant hazard ratio over time. However, where treatment effects vary over time an assumption of proportional hazards is not always valid. Several methods have been proposed for synthesizing time-to-event outcomes in the presence of non-proportional hazards. However, guidance on choosing between these methods and the implications for HTA is lacking.

Methods

We applied five methods for estimating treatment effects from time-to-event outcomes, which relax the proportional hazards assumption to a network of melanoma trials, reporting overall survival: restricted mean survival time, an accelerated failure time generalized gamma model, piecewise exponential, fractional polynomial and Royston-Parmar models. We conducted a simulation study to compare these five methods. Simulated individual patient data was generated from a mixture Weibull distribution assuming a treatment-time interaction. Each simulated meta-analysis consisted of five trials with varying numbers of patients and length of follow-up across trials. For each model fitted to each dataset, we calculated the restricted mean survival time at the end of observed follow-up and following extrapolation to a 20-year time horizon.

Results

All models fitted the melanoma data reasonably well with some variation in the treatment rankings and differences in the survival curves. The simulation study demonstrated the potential for different conclusions from different modelling approaches.

Conclusions

The restricted mean survival time, generalized gamma, piecewise exponential, fractional polynomial and Royston-Parmar models can all accommodate non-proportional hazards and differing lengths of trial follow-up within an evidence synthesis of time-to-event outcomes. Further work is needed in this area to extend the simulation study to the network meta-analysis setting and provide guidance on the key considerations for informing model choice for the purposes of HTA.
OP348 Assessing The Potential Value Of Wearable Digital Health Technologies In Chronic Kidney Disease Using Early Health Technology Assessment Methods
Authors: Gc Vijay S. , Manca Andrea , Casson Alexander J. , Antrobus Steven , Iglesias Cynthia
Published: December 2021

Introduction

Wearable digital health technologies (WDHTs) offer several solutions in terms of disease monitoring, management and delivery of specific interventions. In chronic conditions, WDHTs can be used to support individuals’ self-management efforts, potentially improving adherence to (and outcomes resulting from) interventions. Early health technology assessment (HTA) methods can inform considerations about the potential clinical and economic benefits of technology in the initial phases of the product's lifecycle, facilitating identification of those Research & Development (R&D) investments with the greatest potential stakeholders’ payoff. We report our experience of using early HTA methods to support R&D decisions relating to novel WDHT being designed to support self-management of chronic kidney disease (CKD).

Methods

We performed a literature review, focus-group interviews with patients, and qualitative interviews with the prototype development team to understand the relevant characteristics of WDHTs, quantify relevant clinical indications and existing technological constraints. An early economic evaluation was used to identify the key drivers of value for money, and a discrete choice experiment shed light onto patient preferences towards what key features the WDHT should have for the users to adopt it. Then a model-based cost-effectiveness analysis was undertaken incorporating headroom analysis, return on investment, one-way sensitivity analysis and scenario analyses using data from secondary sources.

Results

The review of the literature, focus groups with CKD patients, and qualitative interviews with technology developers helped to understand relevant characteristics of WDHT and user preferences helped inform the next R&D iteration. Compared to the standard care, WDHT that support stage ≥3 CKD patients self-management at home by measuring blood pressure and monitor mobility has the potential to be cost-effective at conventional cost-effectiveness threshold levels. From the headroom analysis, novel WDHT can be priced up to GBP280 (EUR315, USD360) and still be cost-effective compared to standard home blood pressure monitoring.

Conclusions

Our study provides valuable information for the further development of the WDHT, such as defining a go/no-go decision, as well as providing a template for performing early HTA of Digital Health Interventions.
PP119 Innovative Screening System For COVID-19 Using Application Of Artificial Intelligence For Telemedicine
Authors: Galvan Pedro , Fusillo Jose , Gonzalez Felipe , Vukujevic Oraldo , Rivas Ronald , Recalde Luciano , Ortellado Jose , Portillo Juan , Mazzoleni Julio , Hilario Enrique
Published: December 2021

Introduction

Artificial intelligence (AI) and innovative technology offer opportunities for enhanced health care during the COVID-19 pandemic. Populations living in low-income countries do not have access to reverse transcription polymerase chain reaction (RT-PCR) testing for COVID-19 and, thus, depend on the scarce resources of their health system. In this context, an automated screening system for COVID-19 based on AI for a telemedicine platform could be directed towards alleviating the current lack of trained radiologists who can interpret computed tomography images at countryside hospitals.

Methods

This descriptive study was carried out in Paraguay by the Telemedicine Unit of the Ministry of Public Health and Social Welfare in collaboration with the Department of Biomedical Engineering and Imaging of the Health Science Research Institute and the University of the Basque Country. The utility of the screening system for COVID-19 was analyzed by dividing the results from two tailored AI systems implemented in 14 public hospitals into four likelihood levels for COVID-19.

Results

Between March and October 2020, 911 COVID-19 diagnoses were performed in 14 regional hospitals (62.6% were men and 37.4% were women). The average age of the patients diagnosed with COVID-19 was 50.7 years; 59.1% were aged 19 to 59 years. The two AI systems used have different background information for detecting COVID-19. The most common findings were severe pneumonia and bilateral pneumonia with pleural effusions. The role of computed tomography was to find lesions and evaluate the effects of treatment. The sensitivity of AI for detecting COVID-19 was 93%.

Conclusions

AI technology could help in developing a screening system for COVID-19 and other respiratory pathologies. It could speed up medical imaging diagnosis at regional hospitals for patients with suspected infection during the COVID-19 pandemic and rationalize scarce RT-PCR and specialized human resources in low-income countries. These results must be contextualized with the local or regional epidemiological profile before widespread implementation.
PP140 Barriers And Prospects For The Development Of Hospital-Based Health Technology Assessment In Kazakhstan
Authors: Avdeyev Andrey , Benberin Valeriy , Shanazarov Nasrulla , Makalkina Larissa , Kaptagayeva Aigul , Akhmedullin Ruslan , Hailey David
Published: December 2021

Introduction

The experience of implementing a hospital-based health technology assessment (HB-HTA) system in Kazakhstan is currently represented by only one organization, an independent HB-HTA unit established in 2015 in the Medical Center Hospital of the President's Affairs Administration (the Hospital). Despite the demonstrated positive experience of the Hospital, the widespread implementation of the HB-HTA system in Kazakhstan has experienced some barriers that must be considered before further development can occur.

Methods

To determine the barriers to developing and implementing HB-HTA in Kazakhstani hospitals, data from the Hospital's experience were obtained through a survey of Kazakhstan hospitals, conducted on behalf of the Ministry of Health Care. An official response was received from 29 hospitals. During the survey and discussions with hospital staff using the “brainstorming” method, several barriers to the development of HB-HTA in Kazakhstan were identified.

Results

Barriers at the system level included the lack of monitoring of the HB-HTA system at the national and regional levels and a lack of methodological support. Organizational barriers included a critically small number of HTA experts and the need for additional logistical support and funding from hospitals. The subjective factors we attributed to the rejection of the HB-HTA system by hospital management were the underestimation of lost profits and that HTA is a tool for promoting a transparent and open system for making managerial decisions.

Conclusions

Despite some barriers, the development of HB-HTA in Kazakhstan is a promising area. The heads of key hospitals in Kazakhstan demonstrated a readiness and understanding of the need to use the principles of health technology assessment and clinical and economic analysis to promote the active transfer and implementation of innovative medical technologies.
PP146 Use Of Carbon Dioxide In Endovascular Surgery To Prevent Contrast-Induced Nephropathy
Authors: Akhmedullin Ruslan , Benberin Valeriy , Avdeyev Andrey , Shanazarov Nasrulla , Bektassova Perizat , Okesh Makhabbat , Aimanova Tansolpan , Bariyeva Gulzada
Published: December 2021

Introduction

Interventional procedures often use iodinated contrast media (ICM) to visualize the area of interest. However, the use of ICM can cause contrast-induced nephropathy (CIN), which is a frequent complication after catheterization and is associated with morbidity and mortality. CIN is also a common complication in patients with pre-existing chronic kidney disease, diabetes, and heart failure. The purpose of this analysis was to compare carbon dioxide (CO2) with conventional contrast agents.

Methods

To assess the clinical effectiveness of CO2 in preventing CIN, a systematic review of relevant literature, including international guidelines, from the Medline database was conducted. Imaging of the chest, aorta, coronary arteries, and cerebral circulation with CO2 is limited, so effectiveness was determined in the field of renal and peripheral artery angioplasty. The effect on intervention cost was the main outcome.

Results

Use of CO2 generally reduced renal toxicity and anaphylactic reaction, but the benefits remain controversial. Angiography with CO2 is reasonable when image accuracy is not crucial due to its low informative value. Strategies for preventing acute kidney injury demonstrated the effectiveness of sodium chloride administration before and after the procedure. Additionally, the absence of risk factors for kidney disease significantly reduced the risk of impaired renal function.

Conclusions

Although CO2 is one of the alternative methods for visualization, it is not pivotal in preventing CIN, even though the manufacturers recommend CO2 as the preferred contrast agent in patients with renal insufficiency who are allergic to ICM. The economic indicators for the use of CO2 are similar to traditional visualization methods.
PP184 Twenty Years of Health Technology Assessments on Robotic Assisted Surgery: A Summary
Authors: Forrest Ben , Sahai Nikhil , Song Chao
Published: December 2021

Introduction

Da Vinci robotic-assisted surgery (RAS) has been evaluated by health technology assessment (HTA) organizations across the world. This study aimed to analyze the existing HTA reports over years, countries, and procedures.

Methods

Publicly available health technology appraisal reports on RAS published from January 2000 to November 2020 were identified via a targeted literature search. The literature search was conducted in PubMed, the Centre for Reviews and Dissemination database, the International Network of Agencies for Health Technology Assessment database, and Google scholar. Reports related to the da Vinci RAS were included. Full texts of reports were used for the analysis.

For the HTAs that recommended RAS, the directional conclusion was considered as positive. For HTA reports that discouraged the use of RAS, the directional conclusion was considered as negative. The rest were considered as neutral. The reports were analyzed by year, country, and procedure.

Results

We identified 65 HTA reports comprising 128 procedure-level assessments of RAS by 42 HTA organizations in 21 countries over 20 years. The annual number of assessments increased over time. The countries that completed the most assessments were Sweden (14 reports, including 15 procedure-level assessments: 13% positive and 80% neutral) and Canada (11 reports, including 20 procedure-level assessments: 65% positive).

The topics of the assessments covered 27 surgical indications in urology, gynecology, thoracic, general, and ear, nose, and throat. The conclusions of the HTAs varied by surgical indication. Prostatectomy (33 reports: 85% neutral or positive) was the most widely assessed surgical indication, followed by hysterectomy (16 reports: 81% neutral or positive), nephrectomy (15 reports: 73% neutral or positive), and rectal resection (10 reports: 100% neutral or positive).

Conclusions

The number and breadth of HTAs on RAS have grown at an increasing rate over the last 20 years. The directional conclusion of assessments varied by procedure and country. Further analysis is warranted to understand the factors contributing to HTA conclusions on RAS.
PP195 Cost Utility Of Transcatheter Aortic Valve Implantation For Patients With Inoperable Severe Aortic Stenosis In Brazil
Authors: Magliano Carlos , Padilla Matheus Piccin , França Ana , Meirelles Isandra , Magliano Carlos , Fernandes Ricardo , Santos Marisa
Published: December 2021

Introduction

Transcatheter aortic valve implantation (TAVI) represents a new treatment option for aortic stenosis. This study aimed to evaluate the cost utility of TAVI, compared with clinical treatment, in patients with inoperable severe aortic stenosis from the perspective of the Brazilian public health system.

Methods

A Markov model with monthly cycles and a five percent annual discount rate was constructed. A five-year time horizon was chosen, to minimize the uncertainties inherent with data extrapolations, based on the only randomized head-to-head trial, Placement of AoRTic TraNscathetER Valve Trial (PARTNER B). All costs were obtained from Brazil's official healthcare data. Utilities for clinical treatment 0.6 (range 0.56–0.63) and TAVI 0.71 (range 0.69–0.72) were based on studies that used the EuroQol-5D instrument. TAVI's utility measures were penalized by 25 percent in the first month, based on the estimate of the procedure's impact on quality of life provided by the National Institute of Health and Care Excellence in the United Kingdom. Lastly, deterministic and probabilistic sensitivity analyses were used to evaluate the robustness of the results.

Results

The incremental cost-effectiveness ratio was USD35,880 per quality-adjusted life-year (QALY), a result that was mainly sensitive to TAVI's cost in the univariate analysis. In the probabilistic analysis, all values were above the reference willingness-to-pay threshold of three times the Brazilian per capita gross domestic product (USD18,042 per QALY).

Conclusions

In conclusion, even though there is no established willingness-to-pay threshold in Brazil, the cost of TAVI may represent an obstacle for its incorporation into the Brazilian public health system.
PP209 Analysis Of The Efficacy And Safety Of Robotic Spinal Surgery
Authors: del Mar Polo-deSantos María , Luengo-Matos Setefilla , Hijas-Gómez Ana Isabel , García-Carpintero Esther Elena , Sánchez-Gómez Luis María
Published: December 2021

Introduction

Robotic surgery (RS) can offer benefits compared to freehand surgery (FS) in the treatment of patients with spinal diseases. The aim of this study was to assess efficacy and safety of RS versus FS in spinal fusion. The outcomes considered were accuracy in the placement of pedicle screws, surgical times, hospital stay, exposure to radiation, and complications.

Methods

A systematic review and meta-analysis were performed by researchers at the Instituto de Salud Carlos III (ISCIII). Studies published until June 2019 in the English, Spanish, or French languages were retrieved. The data analyses and risk of bias assessments were undertaken using RevMan 5.3.

Results

Eight randomized controlled trials including 610 patients (RS: 308, FS: 302) were found. The mean age of the patients ranged from 56 to 68 years in the FS group and from 55 to 68 years in the RS group. The percentage of women included ranged from 46 to 73 percent undergoing FS and from 33 to 70 percent undergoing RS. The main diagnosis was degenerative spine disease. The number of screws implanted ranged from 22 to 584 for FS and 23 to 532 for RS. The robots used were the SpineAssist and Renaissance Guidance System (Mazor Robotics, Ltd) and the TiRobot® Orthopaedic Robotic System (Beijing Tinavi Medical Technologies Co., Ltd). Pedicle screw placement within the safety zone (Grades A and B on the Gertzbein and Robbins scale) ranged from 93 to 100 percent in FS and from 85 to 100 percent in RS (relative risk 1.0, 95% confidence interval [CI] 0.99–1.03; p = 0.36) (I2=75%; p = 0.0005). Regarding intervention time, the meta-analysis showed a mean difference (MD) of 15.2 minutes (95% CI 5.35–25.05; p = 0.002) (I2 = 0%; p = 0.39) in favor of FS. The MD in hospital stay was 0.36 days (95% CI -1.03–0.31; p = 0.30) (I2 = 62%; p = 0.07), which was not statistically significant. Contradictory results were found for fluoroscopy time, although RS was associated with a lower radiation dose than FS (p < 0.05). In relation to safety, studies only reported on rates of surgical revision, which ranged from 0 to 2 after FS and from 0 to 10 after RS. The risk or bias was unclear in most studies.

Conclusions

We found no conclusive results suggesting benefits for spinal fusion using RS compared with FS. Further research with adequate selection of patients, type of robot, and comparator is needed.
PP215 An Evaluation Of The Scottish Medicine Consortium Detailed Advice Document
Authors: Zibaite Solveiga , Andrews Pamela , McTaggart Fiona , McGuire Pauline , Hill Scott
Published: December 2021

Introduction

The Scottish Medicines Consortium (SMC) conducts early health technology assessment (HTA) of new medicines. The advice is implemented at the local level by 14 Health Board Area Drug and Therapeutics Committees (ADTCs). The primary output is a published document, the Detailed Advice Document (DAD), which aims to describe the strengths and weaknesses of the evidence considered and the rationale for the decision. We examined how the DAD is being used to determine areas for improvement.

Methods

We conducted semi-structured interviews with a purposive sample of SMC and ADTC members and formulary pharmacists, who are one of the key audiences. Interviews were recorded and transcribed using Microsoft Teams and coded in NVivo. The results were assessed via thematic analysis, which included major themes such as the structure and content of the DAD and its usefulness in supporting implementation of the advice from an ADTC perspective.

Results

Following initial interviews (n = 7), some early themes have emerged. The DAD is a valued tool describing the assessment of a medicine's clinical and cost effectiveness. The current length of the DADs and the technical language used can limit the accessibility of information, and there have been suggestions on how to improve the structure and content. Additional interviews are still being completed and full interview results (available early 2021) will be analyzed to identify key themes.

Conclusions

The DAD is the primary output of SMC's HTA process, which includes decisions on whether a medicine can be routinely prescribed in the National Health Service Scotland. DADs have increased in length over the years, reflecting the increasing complexity of new medicines and a corresponding increase in the size of pharmaceutical company submissions. The interviews conducted to date suggest that the DADs are highly regarded and support implementation of new medicines advice by the ADTC. The findings of this evaluation will lead to an action plan for improvement.
PP275 Incorporating Quality-Of-Care Indicators In Health Economic Modelling: A Case-Study On Surgical Site Infections In Cardiac Surgery
Authors: Saunders Rhodri , Pervolaraki Eleftheria
Published: December 2021

Introduction

Surgical site infections (SSIs) are preventable adverse events placing a large burden on service providers. Reusable electrocardiogram lead-and-wire systems can hold infection vectors after cleaning. Single-patient-use cable-and-lead systems (spECG) may help prevent cross-contamination and SSIs. SSIs are commonly included in incentive schemes as quality-of-care indicators. Readmissions within 30 days due to SSI are not reimbursed by the UK's National Health Service (NHS). Reducing SSIs could improve patient care and result in cost-of-care savings. The cost-benefit of implementing spECG was investigated in this study.

Methods

NHS Digital 2019 data for cardiac surgeries were assessed for SSIs occurring during the index event or 90 days post discharge. Data from 88 centers performing 1,000 surgeries or more were used to update a published health economic model of the cardiac surgery care pathway. The population was on average 68 years old, 18 percent female, 33 percent obese, and 28 percent diabetic. Costs are reported in 2019 GBP (2019 EUR) and were sourced from NHS reports.

Results

In total, 2,580 in-hospital SSIs were reported from 317,825 cardiac surgeries, resulting in an increased length-of-stay (LOS) of between 4.4 to 29.4 days. The 1,975 SSI-related, post-discharge readmissions’ mean LOS was 13.9 days. Cost-of-care was GBP8,127 (EUR9,259) per patient, in line with NHS data. Implementing spECG reduced per-case-costs to GBP8,094 (EUR9,221), saving GBP33 (EUR38): a 3.5-fold return-on-investment. Savings-drivers were fewer SSIs, reduced LOS, and fewer readmissions (a reduction of 29% within 30-days, resulting in cost-offsets of approximately GBP230 (EUR262)/readmission).

Conclusions

This study suggests that the implementation of spECG could provide cost-benefit in reducing the burden of SSIs related to cardiac surgery. In addition to cost-of-care, the readmissions would have additionally burdened hospitals, as 29 percent would not have been reimbursed. Health-economic analyses should consider not only potential cost-savings of innovative products, but also incorporate quality-of-care indicators. This further aligns payer considerations with the common end-goal of providing maximum benefit to patients.
PP414 Improving The Accessibility Of Scottish Medicines Consortium Advice
Authors: Pierre Miranda , McCormack Jackie , Dickson Jennifer , Lockhart Lindsay , Downes Noreen
Published: December 2021

Introduction

The Scottish Medicines Consortium (SMC) provides advice on which new medicines should be accepted for routine use by the NHS in Scotland. To help increase the accessibility of the advice, SMC produces public information summaries, which have been published on the SMC website since 2018. We conducted an evaluation to investigate if the public summaries are achieving their purpose and subsequently help inform improvements from a user perspective. The objectives were to determine how the public summaries are being used; what users like and what could be improved; and if they have achieved a greater understanding of decisions.

Methods

The first stage of the evaluation involved surveying patient groups (organizations that represent the interests of patients, families and carers) to investigate how they use the public summaries. We then conducted workshops with patient groups and Public Partners (members of the public that volunteer with Healthcare Improvement Scotland) to gather perspectives on the content, language and layout of a selection of public summaries.

Results

The survey responses (n = 14) illustrate that the public summaries are being used in a variety of ways. The majority (n = 10) of patient groups reported using the public summaries to help explain SMC decisions to the people they support.

The workshops highlighted that participants found the public summaries clear and helpful. In general, patient groups felt the level of detail and language used in the public summaries improved their understanding of SMC decisions compared to other sources of information, such as the press release or Detailed Advice Document.

There were a number of suggested improvements, including changing the layout (so the SMC decision appears first) and providing definitions for some technical terms. Where actionable, these recommendations have been implemented.

Conclusions

Working in partnership with patient groups and Public Partners has enabled SMC to further strengthen public summaries, and patient engagement more broadly. Improvements have ensured that SMC's decisions are communicated clearly, helping to increase accessibility.
Tevelev degrees and Hurwitz moduli spaces
Authors: CELA A. , PANDHARIPANDE R. , SCHMITT J.
Published: December 2021

We interpret the degrees which arise in Tevelev’s study of scattering amplitudes in terms of moduli spaces of Hurwitz covers. Via excess intersection theory, the boundary geometry of the Hurwitz moduli space yields a simple recursion for the Tevelev degrees (together with their natural two parameter generalisation). We find exact solutions which specialise to Tevelev’s formula in his cases and connect to the projective geometry of lines and Castelnuovo’s classical count of
$g^1_d$
’s in other cases. For almost all values, the calculation of the two parameter generalisation of the Tevelev degree is new. A related count of refined Dyck paths is solved along the way.
The objects and effects of non-party intervention before the International Court of Justice
Authors: Crespi Reghizzi Zeno
Published: December 2021

The International Court of Justice recognized the legitimacy of ‘non-party intervention’ under Article 62 of the Statute in its 1990 landmark decision on Nicaragua’s intervention in the Land, Island and Maritime Frontier Dispute (El Salvador v. Honduras). Such form of intervention ‘is not intended to enable a third State to tack on a new case, to become a new party, and so have its own claims adjudicated by the Court’. Its purpose is ‘protecting a State’s “interest of a legal nature” that might be affected by a decision in an existing case’. Whereas non-party intervention under Article 62 now forms part of the law in action within the Court’s system, its precise features and regime remain uncertain. Doubts concern the identification of its precise objects and the potential binding effects for a non-party intervener of the judgment issued between the original parties. The present article explores these issues in the light of the Court’s case law and state practice. It demonstrates that non-party intervention can have various potential objects, depending on how the intervener intends to influence the future judgment between the original parties. Building on the identification of these objects, it then questions the traditional construction denying any binding effect of the decision for a non-party intervener and argues that a judgment issued following intervention is binding as between the original parties and the intervener in so far as this judgment, whether expressly or by implication, decides issues related to the object of intervention.
Factors associated with breast-feeding initiation and continuation in Canadian-born and non-Canadian-born women: a multi-centre study
Authors: Chooniedass Rishma , Tarrant Marie , Turner Sarah , Lok Fan Heidi Sze , Del Buono Katie , Masina Stephanie , Becker Allan B , Mandhane Piushkumar , Turvey Stuart E , Moraes Theo , Sears Malcolm R , Subbarao Padmaja , Azad Meghan B
Published: December 2021

Objective:

To identify factors associated with breast-feeding initiation and continuation in Canadian-born and non-Canadian-born women.

Design:

Prospective cohort of mothers and infants born from 2008 to 2012: the Canadian Healthy Infant Longitudinal Development (CHILD) Cohort Study.

Setting:

General community setting in four Canadian provinces.

Participants:

In total, 3455 pregnant women from Vancouver, Edmonton, Winnipeg and Toronto between 2008 and 2012.

Results:

Of 3010 participants included in the current study, the majority were Canadian-born (75·5 %). Breast-feeding initiation rates were high in both non-Canadian-born (95·5 %) and Canadian-born participants (92·7 %). The median breast-feeding duration was 10 months in Canadian-born participants and 11 months in non-Canadian-born participants. Among Canadian-born participants, factors associated with breast-feeding initiation and continuation were older maternal age, higher maternal education, living with their partner and recruitment site. Rooming-in during the hospital stay was also associated with higher rates of breast-feeding initiation, but not continuation at 6-month postpartum. Factors associated with non-initiation of breast-feeding and cessation at 6-month postpartum were maternal smoking, living with a current smoker, caesarean birth and early-term birth. Among non-Canadian-born participants, maternal smoking during pregnancy was associated with lower odds of breast-feeding initiation and lower odds of breast-feeding continuation at 6 months, and older maternal age and recruitment site were associated with breast-feeding continuation at 6 months.

Conclusions:

Although Canadian-born and non-Canadian-born women in the CHILD cohort have similar breast-feeding initiation rates, breast-feeding initiation and continuation are more strongly associated with socio-demographic characteristics in Canadian-born participants. Recruitment site was strongly associated with breast-feeding continuation in both groups and may indicate geographic disparities in breast-feeding rates nationally.
Resisting autocratization: the protest–repression nexus in Hong Kong's Anti-ELAB Movement
Authors: Tung Hans H. , Kasuya Yuko
Published: December 2021

This introductory essay outlines the core themes of the special issue on the rise and fall of Hong Kong's Anti-Extradition Law Amendment Bill Movement. In the essay, we highlight several theoretical and empirical contributions the featured papers make to our understanding of the protest–repression nexus from the onset of the movement to the imposition of the National Security Law. First, we describe the political and social contexts of the movement. Second, we present our empirical findings on Hong Kongers' political preferences. Finally, we highlight new research avenues arising from this special issue.