bluuebunny/crossref_metadata_2025 huggingface dataset:
PP38 Immersion in water during childbirth: A survey to the Spanish National Health System
Authors: Reviriego-Rodrigo Eva , Ibargoyen-Roteta Nora , Carreguí-Vilar Soledad , Mediavilla-Serrano Luis , Uceira-Rey Sonia , Iglesias-Casás Susana , Martín-Casado Ana María , Toledo-Chávarri Ana , Ares-Mateos Gonzalo , Montero-Carcaboso Sonia , Castelló-Zamora Belén , Burgos-Alonso Natalia , Moreno-Rodríguez Anai , Hernández-Tejada Naiara , Koetsenruyter Carmen , Gutiérrez-Ibarluzea Iñaki
Published: December 2023

Introduction

Certain doubts about immersion in water during birth mainly regarding the safety of the infant, warrant analysis of the data to determine whether immersion in water during childbirth is safe and effective. The aim is to describe the situation regarding the use of water immersion during childbirth in hospitals of the Spanish National Health System across Spanish Autonomous Regions and Cities.

Methods

A questionnaire was developed to assess the use of water immersion on maternity wards of National Health System hospitals. The survey was reviewed by several categories of health professionals and stakeholders. The online questionnaire was distributed via email. A database was created using the Microsoft Excel 365® computer program. Quantitative results were described through percentages and frequency distributions. In the case of free responses, a content analysis was performed, coding the responses into different categories.

Results

Regarding the status of water birth in Spain, the availability of the option of water birth varies across hospitals of the National Health System. Forty-six hospitals in 13 autonomous regions indicated that they had birthing pools on their delivery wards. Among these hospitals, 20 percent reported having more than 10 years of experience in water births, 45 percent between five and 10 years and 35 percent less than five years. Of the 46 responses received, 78 percent of the hospitals indicated that there was a demand for information on waterbirth by pregnant women. Regarding the existence of criteria for the adequate selection of pregnant women who could opt for immersion in water during childbirth, 89 percent of the hospitals indicated that these did exist, while 11 percent indicated that they did not have agreed criteria for the selection of candidates for water birth.

Conclusions

The availability of the option of water birth varies in hospitals across the Spanish National System. All the hospitals that have birthing pools offer them in the first stage of labor (dilation), while 32 percent also use them in the pushing stage and 15 percent during delivery of the placenta. It would be advisable to have standardized protocols and training to ensure the possibility that all pregnant women, regardless of their place of residence, can safely opt for water immersion during childbirth with satisfactory results.
PP48 Cardiac Implantable Electronic Device (CIED) Infections In New South Wales, Australia: A Non-Interventional Study Utilizing Linked Secondary data
Authors: Shawon Shajedur Rahman , Sotade Oluwadamisola , Hill Michelle , Strachan Liesl , Challis Gabrielle , King Kate , Jorm Louisa
Published: December 2023

Introduction

Cardiac Implantable Electronic Device (CIED) infection is a serious complication associated with morbidity, mortality and high healthcare costs. Internationally, the published rate of CIED infection ranges from 1.0 percent to 1.6 percent. There is a lack of data on CIED infection rates in Australia; the reported range is from less than 1 percent at 30 days to 7 percent over 5 years. Due to the variability within the limited number of studies there is a need for further analyses of CIED infection rates in Australia.

Methods

This was a retrospective cohort study using secondary linked hospital (the NSW Admitted Patient Data Collection) and mortality data for patients who underwent CIED procedures between July 2017 and June 2020 in NSW. Overall and procedure-and patient-specific incidence of infection was calculated.

Results

A total of 23,786 CIED procedures were performed among 22,404 patients and 422 CIED infections were identified, giving an overall infection rate of 1.77 percent. When infections were limited to those following a CIED procedure in the period July 2017-June 2020 (n=309), the procedure-specific CIED infection rate was 1.30 percent, ranging from 1.01 percent for permanent pacemaker (PPM) to 2.71 percent for cardiac resynchronization therapy-defibrillator (CRT-D). The proportion of patients undergoing CIED procedures in this period who had a subsequent CIED infection was 1.29 percent, ranging from 0.97 percent for permanent pacemaker (PPM) to 3.05 percent for cardiac resynchronization therapy defibrillator (CRT-D). Procedure-based infection rate in high-risk patients (generator replacement; system upgrade; revision; or CRT-D procedure) was 1.47 percent and patient-based infection rate was 1.68 percent. Infection rate was highest within the first month following the CIED procedure that dropped significantly over time.

Conclusions

Rates of infection were highest among patients with cardiac resynchronization therapy (CRT) devices, and those who underwent revision or upgrade procedures. Ongoing monitoring of CIED infection rates and preventative measures are necessary, especially for high-risk patients. This study highlights the important role linked secondary data has in reducing uncertainty and removing the reliance on international estimates by providing targeted, local data for health technology assessment.
PP49 Cost Of Cardiac Implantable Electronic Device (CIED) Infections In Australia: A Private And Public Sector Payer Perspective
Authors: Hill Michelle , Gordois Adam
Published: December 2023

Introduction

In Australia, approximately 200,000 patients have a cardiac implantable electronic device (CIED), and in an aging population that number is rising. CIED-related infections are also increasing, causing considerable morbidity and mortality, and substantial healthcare costs. Internationally, the rate of CIED infection ranges from 1.0 percent to 1.6 percent, while in Australia, the reported range is from less than 1 percent to 7.0 percent. The average hospital cost to treat an infection in the US ranges between USD48,000–USD83,000. To date, few publications have estimated the cost of CIED infections in Australia. Critical appraisal of these studies has highlighted issues in their methodology, making them unreliable sources for use in economic evaluations. The purpose of this study was to utilize Australian routinely collected health data to robustly model costs of CIED infections to reduce uncertainty for future health technology assessment (HTA).

Methods

The cost of treating a CIED infection was modeled for the public and private sector including cost of system removal and re-implantation procedures, hospital and intensive care unit (ICU) stay, and outpatient follow-up. Cost inputs were obtained from the Australian Prostheses List, Medicare Benefits Schedule, Australian Institute of Health and Welfare, and Private Hospital Data Bureau. Other inputs were obtained by surveying Australian clinicians, which were validated with published data. Phone interviews and online surveys were conducted with clinicians to elicit specific Australian practice pathways for patients with a CIED infection.

Results

The majority of patients with a CIED have their device system removed (95-100%) and re-implanted (83%) once the infection has cleared. In the private sector, cost of infection ranged from AUD80,869 (USD54,384) for a single chamber pacemaker (PM), to AUD140,103 (USD94,248) for a dual chamber Implantable Cardioverter-defibrillator (ICD). Modeled costs of CIED infection were slightly lower in the public sector (AUD73,643-AUD88,446 (USD49,555 – USD59,516) for the same devices).

Conclusions

The cost of a CIED infections to the healthcare system is high and differs by device type. Utilizing local real-world data to estimate costs will improve accuracy of economic evaluations and reduce uncertainty for decision makers.
PP54 Machine Learning For Accelerating Screening In Literature Reviews
Authors: Chappell Mary , Edwards Mary , Watkins Deborah , Marshall Christopher , di Ruffano Lavinia Ferrante , Fitzgerald Anita , Graziadio Sara
Published: December 2023

Introduction

Systematic reviews are important for informing decision-making and primary research, but they can be time consuming and costly. With the advent of machine learning, there is an opportunity to accelerate the review process in study screening. We aimed to understand the literature to make decisions about the use of machine learning for screening in our review workflow.

Methods

A pragmatic literature review of PubMed to obtain studies evaluating the accuracy of publicly available machine learning screening tools. A single reviewer used ‘snowballing’ searches to identify studies reporting accuracy data and extracted the sensitivity (ability to correctly identify included studies for a review) and specificity, or workload saved (ability to correctly exclude irrelevant studies).

Results

Ten tools (AbstractR, ASReview Lab, Cochrane RCT classifier, Concept encoder, Dpedia, DistillerAI, Rayyan, Research Screener, Robot Analyst, SWIFT-active screener) were evaluated in a total of 16 studies. Fourteen studies were single arm where, although compared with a reference standard (predominantly single reviewer screening), there was no other comparator. Two studies were comparative, where tools were compared with other tools as well as a reference standard. All tools ranked records by probability of inclusion and either (i) applied a cut-point to exclude records or (ii) were used to rank and re-rank records during screening iterations, with screening continuing until most relevant records were obtained. The accuracy of tools varied widely between different studies and review projects. When used in method (ii), at 95 percent to 100 percent sensitivity, tools achieved workload savings of between 7 percent and 99 percent. It was unclear whether evaluations were conducted independent of tool developers.

Conclusions

Evaluations suggest the potential for tools to correctly classify studies in screening. However, conclusions are limited since (i) tool accuracy is generally not compared with dual reviewer screening and (ii) the literature lacks comparative studies and, because of between-study heterogeneity, it is not possible to robustly determine the accuracy of tools compared with each other. Independent evaluations are needed.
PP68 When Evidence Takes A Backseat To Politics – The Rise Of Robot Surgery In Australia
Authors: Fennessy Paul
Published: December 2023

Introduction

A 2018 health technology assessment (HTA) on robot-assisted surgery (RAS) led to a national committee recommendation, which some state Health Ministers adopted as policy, which stated: (i) no further public investment in RAS until subsequent HTAs demonstrate improved evidence; and (ii) clinical and patient outcomes from existing platforms should inform future decisions. This work also identified the Royal Australasian College of Surgeons (RACS) does not accredit any RAS training program for Australian surgeons, nor is there any nationally agreed or consistent credentialing mechanism, which creates ambiguity for hospitals (can this surgeon safely deliver?). Some state governments are ignoring its own policy and investing in RAS. At the same time, some public hospitals are ignoring the policy and procuring RAS through affiliated private hospitals. While market competition is expected to reduce price, governments responding to ‘squeaky wheels’ sets a dangerous precedent for high-cost technology procurement, especially if it needs to be replaced, and cost of delivery may not offset revenue generated.

Methods

Australia’s states and territories can collaborate to commission HTAs. Since 2015, they have, jointly or independently, commissioned HTAs to monitor RAS evidence, which led to the 2018 HTA and policy. However, this policy is being ignored by hospitals and governments.

Results

RACS is working with local agencies to develop accredited training programs for different RAS platforms, which should offer comfort to provider hospitals regarding surgeon credentialing. Surgeons and patients are increasingly vocal regarding RAS, resulting in some governments investing in RAS. Not consulting with all stakeholders has led to confusion and a questionable role for policy makers. Private hospitals operated by public hospitals are procuring RAS in contravention of the policy and with no consequences, creating further confusion.

Conclusions

While accredited surgeon training will improve skills and outcomes, governments ignoring their own policy is resulting in unplanned technology introduction, which led to the need for HTA in the first place. Do we need to rethink the role of HTA, or should we accept that politics trumps evidence?
PP69 Health Technology Assessment And University Health Center Affiliation Agreement: Current Situation And Potential Developments In Quebec
Authors: Rhainds Marc , Mbemba Gisèle , Roche Daniel La , Gagnon Marie-Pierre
Published: December 2023

Introduction

According to the Quebec law on health and social services, health technology assessment (HTA) is part of university hospital centers’ mission, together with training, research and care. However, unlike these other functions, HTA is not covered in current affiliation agreements that bind a university with academic health institutions. Université Laval and its affiliated health institutions set up a consultation committee whose mandate is to propose the terms of an agreement to specify collaboration regarding HTA between the university and its affiliated institutions. This study investigates perceptions and needs of stakeholders from Université Laval and its affiliated health institutions with respect to the HTA mission.

Methods

Semi-structured interviews were conducted with four types of participants, namely university faculty members, health professionals and managers from institutions with and without HTA units, as well as external partners. Interview guides were developed based on the integrated analysis framework of Greenhalgh et al., and adapted to each group of respondents. Most interviews were conducted in groups and were facilitated by a research associate and a senior investigator. Interviews were recorded and uploaded to NVivo 1.6.2 software for codification and analysis.

Results

A total of 57 people were interviewed (nine group interviews and 35 individual interviews). Three main themes emerged, namely knowledge of HTA, factors related to the relevance of the HTA function, and organizational factors. Results showed that half of the respondents have a vague knowledge of HTA or have never heard of it. Most of the respondents agreed that the HTA function fits well with the mission of a health institution. They would accept getting involved with HTA activities at different levels if all conditions are met. Nevertheless, almost half of respondents believed that others strategies than including HTA into contracts of affiliation should be explored to regulate this function. Finally, organizational obstacles such as the lack of funding, shortage of staff and the lack of well-structured collaborations were highlighted by respondents.

Conclusions

Despite recognition of the importance of the HTA function in university health centers, interventions will be required at different levels to support the development of local HTA capacity. In particular, popularization of the HTA function and collaboration networks through specific projects should be developed.
PP80 The Value of Intraoperative Neural Monitoring During Thyroid Surgery In China: A Literature Review
Authors: Yang Yutong , Song Yin
Published: December 2023

Introduction

Recurrent laryngeal nerve (RLN) injury has been a frequent source of malpractice litigation following thyroid surgery. Intraoperative neural monitoring (IONM) has been widely applied to avoid RLN injury in thyroid surgery in developed countries, but China cannot achieve the same application rate currently. To improve the recognition and application of IONM in China, this literature review aims to synthesize the evidence on the value of IONM in China.

Methods

A comprehensive literature review was conducted by searching through PubMed, CNKI and Wan Fang to identify studies about the IONM technology for protecting RLN during thyroid surgery in Chinese clinical data.

Results

Nineteen Chinese clinical trials of IONM during thyroid surgery published from 2012 to 2022 were included for review. Almost all studies recruited adults who need thyroid surgery and only one study enrolled geriatric patients. There were three (3/19) prospective studies and two were randomized controlled trials that both showed that IONM helped surgeons to detect the RLN with less time and reduce the injury of RLN in reoperative thyroid surgery. Major studies (16/19) conducted retrospective analysis and six of them (6/16) only had an IONM group that showed that IONM technology can avoid damage to the RLN. The remaining ten studies (10/16) compared patients with and without IONM during the surgery. Compared with the non-IONM group, nine studies (9/10) stated IONM technology has an advantage in the reduction of RLN injury rate and seven studies (7/10) claimed IONM was helpful in reducing the time of surgery. One study believed IONM was beneficial to reducing bleeding during the surgery and another study reported a lower incidence of hypoparathyroidism with the IONM group.

Conclusions

The value of IONM for protecting RLN during thyroid surgery and improving operation efficiency has been thoroughly proven by the above Chinese clinical trials. Further economic evaluations and patient-reported outcomes research of IONM with Chinese hospital data will help better assess the value of IONM.
PP84 Evaluation Of The Evidence Level Of Scrambler Therapy For Musculoskeletal Pain Relief: A Systematic Literature Review
Authors: Eom Hye Eun , Han Seung Jin , Kim Kyoung-Hoon
Published: December 2023

Introduction

Non-invasive Scrambler Therapy (ST) reduces pain by attaching electrodes to neural pathways of major nerves, transmitting information along with microcurrent to the nerves to induce a painless sensation. The ST has been widely used to reduce pain for patients with musculoskeletal pain. However, little is known about the musculoskeletal pain relief effect of the ST. Therefore, this study aims to evaluate the treatment effectiveness of the ST.

Methods

A systematic literature review was conducted based on the following search strategy and databases, and all studies published before August 2021 were included in Pubmed, Embase, and Cochrane library, Ovid Medline, Koreamed, kmbase, and Science On. The subjects were patients with intractable and musculoskeletal pain, excluding cancer pain, and intervention methods included non-invasive ST alone or in combination with physical therapy. In addition, the comparative method was not limited. The outcome variables were the degree of pain relief, total analgesic use, health-related quality of life, pressure pain threshold, pain intensity and functional interference scales, and pain sensitivity. Safety-related outcome variables were all side effects. Cochrane Risk of Bias 1.0 was used to assess the risk of bias in the literature.

Results

Two hundred forty-one articles were retrieved using a pre-determined search strategy. Of these, 15 duplicate articles, 215 articles after reviewing the abstract and title, and nine articles after checking the full text were excluded. Two studies with randomized controlled trials (RCTs) were finally selected. When comparing ST and placebo groups for musculoskeletal pain, the pain reduction effect of ST lasted for three weeks. Moreover, patients with neuropathic pain treated with ST had a lower pain intensity for one to three months compared to the drug treatment group.

Conclusions

Based on this systematic review, the effectiveness of ST is yet sufficient owing to small sample size and possibility of selective report bias. More studies with well-designed RCTs are required to further assess the effectiveness of the ST.
PP101 Clinical And Economic Impact Of Flushing Vascular Access Devices With Pre-filled versus Manually-Prepared Saline Flush Syringes In Korea
Authors: Gala Smeet , Xian Tan Kristin Hui , Ma Yan
Published: December 2023

Introduction

Around 90 percent of hospitalized patients require vascular access devices (VADs) during hospitalization to administer fluids, medications and facilitate blood transfusions. After insertion, it is essential to maintain VADs to achieve optimal dwell time and reduce complications. Flushing of VADs is an integral part of catheter maintenance practices. With increasing cost burden on healthcare systems and nursing shortages, it is crucial to use time-and cost-saving technologies such as pre-filled flush syringes for common procedures namely VAD maintenance. This study aims to compare the clinical and economic impact of using pre-filled saline syringes versus manually-prepared saline syringes for flushing VADs in Korea.

Methods

A budget impact analysis was developed using Microsoft Excel to estimate the annual clinical and economic impact of pre-filled saline syringes and a base case scenario of flushing 100,000 VADs was modeled. Clinical impact was estimated for peripheral intravenous catheter (PIVC) failure, central line-associated bloodstream infections (CLABSIs), central line occlusion and nurse time. Economic impact was estimated for costs associated with flushing materials, additional length of stay (LOS) due to CLABSI, VAD replacement, and nurse-time. Global and local data sources were used for inputs. Assumptions include: (i) Distribution of 95 percent peripheral and 5 percent central VADs; (ii) 50 percent peripheral and 50 percent central VADs on intermittent therapy; and (iii) 3 flushes/catheter-day.

Results

Over a one-year timeframe, the model estimated 3,344 fewer PIVC failures, 15 fewer CLABSIs and 157 fewer occlusions with adoption of pre-filled saline syringes. Nurse time was reduced by 3,465 hours. Potential net annual savings from lower device cost, reduced complications, shortened LOS and increased nurse efficiency were estimated to be KRW23.7 million (USD178,957).

Conclusions

Using pre-filled saline syringes instead of manually-prepared syringes for flushing VADs may result in fewer complications, lower VAD utilization, nurse time saving and cost savings in Korea. This can potentially help improve patient outcomes, relieve nurses’ stress to some extent and help healthcare decision-makers to reallocate these cost savings to other life-saving technologies.
PP104 Impact Of New Permbrolizumab Indications After Initial Registration By Brazilian Health Regulatory Agency (ANVISA)
Authors: Kelles Silvana , Pereira Camila , Martins Carina , Reis Daniel , Azevedo Ernesto , Ribeiro Geraldo , Zocrato Karina , Carvalho Lélia , Freitas Marcela , Horta Maria , Barbosa Mariana , Talim Mariza , Borin Marcus
Published: December 2023

Introduction

Most new drugs have only clinical studies focused on a single population at the time of first registration, hence their indications for use are restricted to this population. For clinical conditions when there are no other treatments available, new drugs have higher costs in Brazil. There is no review of prices when these medications broaden their therapeutic areas, and this can have a significant financial impact. This study’s objective is to assess the financial implications of pembrolizumab’s incremental indication after its initial registration.

Methods

We calculated the annual cost to treat all Brazilian patients with indications for use in the first registration and all incremental indications of pembrolizumb. Populations were estimated by epidemiological data from the pembrolizumab clinical trials called, KEYNOTE studies, and the INCA 2023 cancer estimate for the Brazilian population. Costs were calculated by CMED-ANVISA price value and considering the dosing of 200mg every 3 weeks.

Results

In 2016, pembrolizumab was granted registration in Brazil was restricted to patients with advanced melanoma. In 2022 the indication was expanded to more than 20 new indications, with several studies in progress that potentially will lead to further inclusions. The estimate of patients eligible for indications increase of 1,796 to 99,544 patients with an increased total cost from BRL625,802,837 to BRL34,685,366,192 (USD121,185,677.4 to USD6,716,763,399.04).

Conclusions

The financial burden of pembrolizumab’s expanded uses after it was first approved could significantly rise, endangering the long-term viability of healthcare systems. In Brazil, where medicine costs are not regularly monitored, the annual inflation adjustment is the only factor that causes prices to change. In order to lower medicine prices in response to the addition of new indications, the expansion of therapeutic options for the same condition, or even obsolescence, regulations are required.
PP106 Integrating Organizational Impacts Into Health Technology Assessment: How To Take Them Into Account For Medical Devices?
Authors: Piotto Estelle , Fouteau Emmanuelle , Marguerite Camille , Galmiche Hubert , Adenot Isabelle
Published: December 2023

Introduction

The organizational impact (OI) of new technologies is becoming a major driver for our healthcare systems and for modernizing the care pathway for the benefit of users and professionals. Some technologies give rise to a reorganization of the healthcare system, particularly in the case of connected medical devices.

The Medical Device Committee at Haute Autorité de Santé (HAS) appraises medical devices (MD) in view of their reimbursement by the French health insurance scheme. The Committee’s evaluation criteria take account of the therapeutic benefit of the MD and its public health benefit. OI-related aspects are frequently claimed by health technology developers (HTD) in their MD submission dossiers. However, this aspect is rarely documented. Therefore, guidance explaining how HTD should support and structure any claim of an OI was needed.

Methods

This work was based on the HAS OI Map for Health Technology Assessment published in 2020, the analyses of specific HAS opinions, hearings with concerned stakeholders (HTD, service providers and patients), and a committee meeting focused on OI.

Results

The HTD guide for MD submission was updated with guidance to support OI claims. For each claimed OI, the HTD should identify the criterion corresponding to the most relevant OI, the indicator to describe each selected criterion, the stakeholders concerned, and the data to be provided. The choice of method is according to the OI: if the indicator is measurable, data from validated measurement tools are expected. If not, especially in cases where the use of the MD requires a specific organization before its deployment, the absence of data must be justified and a detailed impact analysis is necessary. In this case, the development plan for the demonstration of the OI is needed.

Conclusions

With this updated guide for HTDs, claimed OI dimension shall be better supported in future MD dossiers submitted to HAS in view of their reimbursement in France.
PP125 Why Understanding The Burden Of The Population Is Fundamental
Authors: Schöb Franziska J. , Hahn-Pedersen Julie Hviid
Published: December 2023

Introduction

Despite intense efforts in development of new treatments over the last two decades, symptomatic treatments remain the only option for the vast majority patients diagnosed with dementia due to Alzheimer’s disease (AD). There remains a significant unmet need for disease modifying therapies (DMTs) to slow or stop AD progression. DMTs in development are targeting early stages of AD (pre-clinical, mild cognitive impairment and mild dementia stages), thereby creating an entirely new treatment paradigm for patients, clinicians, and payers. A key challenge will be in identifying the appropriate patient for treatment in a very heterogenous population. We have performed a literature review to better understand and define the AD population, with a view to enabling more targeted treatment in future.

Methods

Embase, MEDLINE and the Cochrane Library were searched to identify publications between 2010-2021 on observational studies reporting evidence on prevalence and subgroup identification, including clinical feasibility of identification. The search was restricted to English language.

Results

We identified 45 studies, mostly from Europe, USA and Asia. Populations were primarily grouped based on generic demographic factors (e.g., age, sex, gender), AD staging, comorbidities or biomarkers. Prevalence data was available for six subpopulations: pre-dementia stage, mild dementia, age, Apolipoprotein E (APOE) genotype, comorbid obesity and hypertension. Across these, data on prevalence were heterogenous depending on study design and country of origin, and ranging between 66 million to 102 million for people with mild AD dementia, or as another example, ranging between 46 million to 92 million for APOE genotype carriers worldwide.

Conclusions

The heterogeneity and the uncertainty in prevalence of the AD population represent big challenges to clinicians and payers. Future discussions on target patient identification for new treatments should be aligned and integrated with current clinical practice e.g. leveraging validated biomarkers as diagnostic tools. Additional research on an integrated approach to identify patients who would benefit the most from DMTs will be needed.
PP131 Health Technology Assessment Agencies’ Expectations Regarding Patient Experience Data in Europe
Authors: Zschocke Juergen , Alonzo Carolina , Ding Ding , Poon Jiat-Ling , Vonarx Lillbrith , Avitabile Arianna , Myrick Shane , Hill Jennifer , Molero Alberto , Perez Nancy , Delbecque Laure
Published: December 2023

Introduction

Health technology assessment (HTA) agencies are increasingly embracing patient experience data (PED) to support reimbursement decisions. This study aimed to describe the European Network for HTA (EUnetHTA) and HTA agencies expectations regarding PED to support reimbursement in France, Germany, Italy, Spain and the UK.

Methods

Published HTA guidance documents were reviewed to identify recommendations related to clinical outcomes assessment (COA) (including disease-specificity, validation, analyses, endpoints and interpretation) and other forms of PED (e.g., patient preference information) in HTA decision-making. Insights from guidance documents were supplemented with a review of literature and published HTA cases and interviews with key opinion leaders (KOLs) focused on current and future states.

Results

The German and French guidance documents include PED recommendations focused on relevant COA and health-related quality of life data, without detailing preferred COA measures. However, key differences were noted between these two countries in the methodological approaches regarding responder definitions, acceptable missing data threshold and multiplicity analyses. These differences were reinforced by the case studies and the KOLs. UK’s sources also focused on COA, in general proposing specific use of the EQ-5D to derive utility values for modelling, but included limited details on other PED-related elements. The Italian and Spanish guidance documents do not detail COA or other PED expectations, but the Italian KOL described that COA is considered if submitted. The currently developed EUnetHTA21 guidelines include PED-related information that bear the signature of certain individual HTA bodies. Globally, there is limited interest in PED beyond COA across the agencies.

Conclusions

The level of expectations with regards to PED varies across EUnetHTA and several European HTA agencies. Interest in PED derived from non-COA sources is limited across the countries. Knowing each agency’s expectations with regards to PED is key when submitting HTA evidence dossiers and should be considered early in clinical trial design to integrate market access perspectives and optimize drug development. Global harmonization would help advancing PED measurement standards.
PP151 HTA Of Fast Track Hip And Knee Joint Replacement
Authors: Banfi Giuseppe , Borghi Stefano , Bernareggi Susan , Restelli Umberto , Vitale Jacopo
Published: December 2023

Introduction

This retrospective study was conducted, in accordance with the STROBE guidelines, (Vandenbroucke et al., 2007), considering patients receiving surgical interventions for hip and knee replacement at the IRCCS Orthopedic Institute Galeazzi, located in Milan (Italy), between 1 January 2016 and 31 December 2019 (two years of traditional procedure, and two years of new one).

Methods

We evaluated 10,922 patients treated for hip or knee joint replacement; there were 5,085 treated following the traditional procedure and 5,837 treated by fast track procedure. Excluding cases which could not satisfy the study criteria we evaluated finally 697 with traditional procedure and 1120 with the new one.

Results

With the new fast track procedure, knee replacement mean costs were decreased by an average of EUR1,112.4 (-19.9%). Excluding the cost of prostheses from the analysis, the mean costs in the pre fast-track period for knee replacement are equal to EUR3,918.1, while the mean cost of the intervention in the fast-track period was equal to EUR3,245.8, being EUR572.3 lower (-17.2%). Considering the number of days of hospitalization, the adoption of fast-track leads to a decrease of -2.8 days (-37.6%) in knee replacement, from a mean number of days of 7.6 (± 2.8), to a mean number of days of 4.8 (± 1.8), and of – 2.9 days (-39.2%) in hip replacement, from a mean number of days of 7.3 (± 2.7) to a mean number of days of 4.4 (± 2.0).

Conclusions

We performed a study over four years, with a wide number of cases treated by various teams in the hospital having the highest workload on hip and knee joint replacements in Italy.

The new fast-track procedure is efficient; the length of stay was decreased by the procedure; the direct and indirect costs were decreased; the hospital organization was improved; the increase of care intensity did not modify efficiency and costs; the effectiveness was similar to the traditional procedure as defined by outcomes collected in a registry, including patient reported outcome measures (PROMs); legal and social effects were not modified.
Desegregation is Not a Black and White Issue: Latino Advocacy for Equal Schooling before and after Brown
Authors: THOMAS LORRIN
Published: December 2023

This article argues for the importance of reframing the history of school desegregation in the United States beyond Black and white and beyond the regional frames through which this history has been interpreted. In Western states, most Latino children attended schools segregated not by law but by custom starting in the early twentieth century; Latino students also encountered de facto segregation in the Eastern and Midwestern cities with large Puerto Rican populations by the 1950s. Parents, students, advocates, and activists protested the inequality of educational outcomes for Latino children over many decades, developing distinctive strategies to address the combination of racial and language-based discrimination faced by Latino students. Yet, because they were marginalized in political debates in the 1960s and 1970s and because most national-level historical scholarship on school desegregation focuses on Black and white participants, Latinos’ role in this aspect of our national civil rights history has remained obscured.
THE EXEGETICAL WORLD THAT PAVED THE WAY FOR THE GLOSSA ORDINARIA: A STUDY OF MANUSCRIPTS, GLOSSES, AND COMMENTARIES ON MATTHEW IN THE TWELFTH CENTURY
Authors: LARSON ATRIA A. , KILLION CLAYTON
Published: December 2023

Recent scholarship has shown a revived interest in twelfth-century biblical commentaries and exegesis, particularly in and around Laon. In this essay, we argue that a certain kind of exegetical world was being forged in twelfth-century Laon which prepared the way for the widespread success of the Glossa ordinaria, both as a book form and as a bearer of certain theological ideas and exegetical techniques. Based on our examination of the manuscript evidence, two main versions of the Matthew Gloss are discernible in that century. This discovery makes it possible for scholars to reconstruct a primitive version of the Gloss which existed prior to the one used by Comestor and others, should such an edition be deemed useful. By examining the relationship between pre-Glossa ordinaria glossed manuscripts of Matthew and various stand-alone commentaries like Cum post ascensionem, our work clarifies existing understandings of how the Matthew Gloss originated and developed. Although the Gloss initially drew from patristic and Carolingian sources and contemporary masters, the mise-en-page of the gloss-form invited continued modification, with later scribes adding or subtracting material and interweaving their own insights with received tradition. As masters, students, and scribes glossed manuscripts of Matthew from Laon near and far, they left a lasting impact on how Latin Christendom read, studied, discussed, preached from, copied, and wrote in their Bibles.
Authigenic Iron Is a Significant Component of Oceanic Labile Particulate Iron Inventories
Authors: Sofen Laura E. , Antipova Olga A. , Buck Kristen N. , Caprara Salvatore , Chacho Lauren , Johnson Rodney J. , Kim Gabriella , Morton Peter , Ohnemus Daniel C. , Rauschenberg Sara , Sedwick Peter N. , Tagliabue Alessandro , Twining Benjamin S.
Published: December 2023

Particulate phases transport trace metals (TM) and thereby exert a major control on TM distribution in the ocean. Particulate TMs can be classified by their origin as lithogenic (crustal material), biogenic (cellular), or authigenic (formed in situ), but distinguishing these fractions analytically in field samples is a challenge often addressed using operational definitions and assumptions. These different phases require accurate characterization because they have distinct roles in the biogeochemical iron cycle. Particles collected from the upper 2,000 m of the northwest subtropical Atlantic Ocean over four seasonal cruises throughout 2019 were digested with a chemical leach to operationally distinguish labile particulate material from refractory lithogenics. Direct measurements of cellular iron (Fe) were used to calculate the biogenic contribution to the labile Fe fraction, and any remaining labile material was defined as authigenic. Total particulate Fe (PFe) inventories varied <15% between seasons despite strong seasonality in dust inputs. Across seasons, the total PFe inventory (±1SD) was composed of 73 ± 13% lithogenic, 18 ± 7% authigenic, and 10 ± 8% biogenic Fe above the deep chlorophyll maximum (DCM), and 69 ± 8% lithogenic, 30 ± 8% authigenic, and 1.1 ± 0.5% biogenic Fe below the DCM. Data from three other ocean regions further reveal the importance of the authigenic fraction across broad productivity and Fe gradients, comprising ca. 20%–27% of total PFe.
Climate Warming Favoring Sublimation on a Westerlies‐Controlled Glacier of Tibetan Plateau
Authors: Guo Shuhai , Li Yueping , Chen Rensheng
Published: December 2023

During the past few decades, the climate over the entire TP changed obviously with general warming and the decreasing trends in wind speed and air humidity. As an important hydrological process of mass losses on the TP glaciers, especially during the cold period, sublimation may be influenced deeply by the climate changes. Therefore, it is imperative to identify the crucial factors controlling and limiting glacier sublimation and analyze its possible changes in the future. The sublimation on a flat‐topped glacier of TP was found to be more intense in spring (0.41 mm d−1) and autumn (0.34 mm d−1) and weak in winter (0.27 mm d−1) and summer (0.16 mm d−1). At yearly scale, sublimation was most sensitive to the surface temperature, followed by air temperature and humidity, and was relatively insensitive to wind speed. However, the main influencing factor was air humidity during summer, showing a strong inhibition on sublimation. The very low surface temperature was the most crucial variable limiting winter sublimation with the highest sensitivity coefficient than other variables. Current sublimation was also found to be more sensitive to the increasing temperature than the decreased air humidity and wind speed. If the climate trends continue, and the glacier climate has the relatively consistent change trend with that of entire TP, glacier sublimation will be more likely to increase, especially during winter.
Quantitatively mapping local quality of super-resolution microscopy by rolling Fourier ring correlation
Authors: Zhao Weisong , Huang Xiaoshuai , Yang Jianyu , Qu Liying , Qiu Guohua , Zhao Yue , Wang Xinwei , Su Deer , Ding Xumin , Mao Heng , Jiu Yaming , Hu Ying , Tan Jiubin , Zhao Shiqun , Pan Leiting , Chen Liangyi , Li Haoyu
Published: December 2023

In fluorescence microscopy, computational algorithms have been developed to suppress noise, enhance contrast, and even enable super-resolution (SR). However, the local quality of the images may vary on multiple scales, and these differences can lead to misconceptions. Current mapping methods fail to finely estimate the local quality, challenging to associate the SR scale content. Here, we develop a rolling Fourier ring correlation (rFRC) method to evaluate the reconstruction uncertainties down to SR scale. To visually pinpoint regions with low reliability, a filtered rFRC is combined with a modified resolution-scaled error map (RSM), offering a comprehensive and concise map for further examination. We demonstrate their performances on various SR imaging modalities, and the resulting quantitative maps enable better SR images integrated from different reconstructions. Overall, we expect that our framework can become a routinely used tool for biologists in assessing their image datasets in general and inspire further advances in the rapidly developing field of computational imaging.
Temporal differences and commonalities between hand and tool neural processing
Authors: Amaral L. , Besson G. , Caparelli-Dáquer E. , Bergström F. , Almeida J.
Published: December 2023

Object recognition is a complex cognitive process that relies on how the brain organizes object-related information. While spatial principles have been extensively studied, less studied temporal dynamics may also offer valuable insights into this process, particularly when neural processing overlaps for different categories, as it is the case of the categories of hands and tools. Here we focus on the differences and/or similarities between the time-courses of hand and tool processing under electroencephalography (EEG). Using multivariate pattern analysis, we compared, for different time points, classification accuracy for images of hands or tools when compared to images of animals. We show that for particular time intervals (~ 136–156 ms and ~ 252–328 ms), classification accuracy for hands and for tools differs. Furthermore, we show that classifiers trained to differentiate between tools and animals generalize their learning to classification of hand stimuli between ~ 260–320 ms and ~ 376–500 ms after stimulus onset. Classifiers trained to distinguish between hands and animals, on the other hand, were able to extend their learning to the classification of tools at ~ 150 ms. These findings suggest variations in semantic features and domain-specific differences between the two categories, with later-stage similarities potentially related to shared action processing for hands and tools.
On effects of freezing and thawing cycles of concrete containing nano-$$\mathbf {SiO_2}$$: experimental study of material properties and crack simulation
Authors: Arasteh-Khoshbin O. , Seyedpour S. M. , Brodbeck M. , Lambers L. , Ricken T.
Published: December 2023

Construction during cold weather can lead to freezing accidents in concrete, causing significant hidden threats to the project’s performance and safety by affecting the mechanical properties and durability reduction. This study aims to deduce the compressive strength and durability of the concrete containing nano-$$\mathrm{SiO}_2$$

SiO
2

under freezing-thawing cycles with the Caspian seawater curing condition. The specimens were subjected to freezing-thawing cycles according to ASTM C666. Furthermore, crack propagation in the concrete after freezing-thawing cycles is simulated. The results reveal that adding until nano-$$\mathrm{SiO}_2$$

SiO
2

until 6% improved compressive strength before and after freezing-thaw cycles. The water permeability experiences a substantial reduction as the amount of nano-$$\mathrm{SiO}_2$$

SiO
2

increases. Furthermore, the water permeability exhibits a positive correlation with the number of cycles, resulting in significantly higher values after 150 cycles compared to the initial sample. Moreover, adding 8% nano-$$\mathrm{SiO}_2$$

SiO
2

reduced the depth of water permeability and chloride ion penetration after 150 cycles by 57% and 86%, respectively. The crack simulation results indicate that concrete containing 6% nano-$$\mathrm{SiO}_2$$

SiO
2

shows an optimal resistance against crack formation. Concrete with 6% nano-$$\mathrm{SiO}_2$$

SiO
2

requires 13.88% less force for crack initialization after 150 freezing and thawing cycles. Among different nano-$$\mathrm{SiO}_2$$

SiO
2

percentages, 6% shows the best crack resistance and 8% the minimum water permeability and chloride ion penetration.
Enhanced photocatalytic degradation of methylene blue dye using eco-friendly synthesized rGO@ZnO nanocomposites
Authors: Negash Asfaw , Mohammed Said , Weldekirstos Hulugirgesh Degefu , Ambaye Abera D. , Gashu Minbale
Published: December 2023

Industrial chemical pollutants such as methylene blue (MB) dye are released into the water body and potentially cause harm to the human and aquatic biosphere. Therefore, this study aims to synthesize eco-friendly nanocatalysts, i.e., reduced graphene oxide (rGO), zinc oxide (ZnO), and reduced graphene oxide-zinc oxide (rGO@ZnO) nanocomposites, for efficient photocatalytic degradation of MB dye. A graphite rod was obtained from waste dry cell batteries for the electrochemical exfoliation synthesis of graphene oxide (GO) and rGO. For the eco-friendly synthesis of ZnO and rGO@ZnO nanocatalysts, Croton macrostachyus leaf extract was used as a reducing and capping agent. The synthesized nanocatalysts were characterized using a UV–Vis spectrophotometer, Fourier transform infrared spectroscopy, X-ray diffraction, and scanning electron microscopy with energy-dispersive X-ray. The eco-friendly synthesized rGO, ZnO, and rGO@ZnO nanocatalysts were applied for the photocatalytic degradation of MB dye using direct sunlight irradiation. At optimum parameters, photocatalytic degradation of MB dye efficiency reached up to 66%, 96.5%, and 99.0%, respectively. Furthermore, kinetics of the photodegradation reaction based on rGO, ZnO, and rGO@ZnO nanocatalysts follow pseudo-first-order with a rate constant of 2.16 × 10–3 min−1, 4.97 × 10−3 min−1, and 5.03 × 10−3 min−1, respectively. Lastly, this study promotes a low catalyst load (20 mg) for the efficient photodegradation of MB dye.