bluuebunny/crossref_metadata_2025_split huggingface dataset:
Comparing the Transfer Effects of Three Neurocognitive Training Protocols in Children With Attention-Deficit/Hyperactivity Disorder: A Single-Case Experimental Design
Authors: Zhang Da-Wei , Johnstone Stuart J. , Li Hui , Luo Xiangsheng , Sun Li 
Published: December 2021

AbstractThe current study used behavioural and electroencephalograph measures to compare the transferability of three home-based interventions — cognitive training (CT), neurofeedback training (NFT), and CT combined with NFT — for reducing symptoms in children with attention-deficit/hyperactivity disorder (AD/HD). Following a multiple-baseline single-case experimental design, twelve children were randomised to a training condition. Each child completed a baseline phase, followed by an intervention phase. The intervention phase consisted of 20 sessions of at-home training. Tau-U analysis and standardised visual analysis were adopted to detect effects. Results showed that CT improved inhibitory function and NFT improved alpha EEG activity and working memory. The combined condition, which was a reduced ‘dose’ of CT and NFT, did not show any improvements. The three conditions did not alleviate AD/HD symptoms. While CT and NFT may have transfer effects on executive functions, considering the lack of improvement in symptoms, this study does not support CT and NFT on their own as a treatment for children with AD/HD.
Rus detachment in Dammam Dome, Eastern Saudi Arabia: a new soft-sediment structure as a ‘sensitive stress sensor’ for the Zagros collision
Authors: Tranos Markos D. , Osman Mutasim S. 
Published: December 2021

AbstractThis paper describes in detail hydroplastic structures, which are ‘odd’ kinematic indicators in the basal part of the Eocene Middle Rus Formation. Such structures were previously ignored or falsely interpreted. These hydroplastic structures are found in the massive limestone exposures on the King Fahd University of Petroleum and Minerals (KFUPM) campus. They occur in relation to a principal displacement zone along the boundary/interface between the Lower/Middle Rus, which is referred to as the Rus soft-sediment detachment. The structures are fist-sized vugs associated with carrot- or comet-trail imprints (VCT structures) which were previously translated calcite geodes that have been weathered out. VCT structures show transport/slip towards the NNW (345°) and are found on flat to low-dipping surfaces classified as Y, R and P shears with respect to the orientation of the Rus detachment. Palaeostress analysis indicates an Andersonian transtension stress regime, though it does not facilitate the activation of the Rus soft-sediment detachment. Detachment activity occurred due to the negative effective principal stressσ3′ and the abnormally low frictional coefficient caused by fluid pressure. The soft-sediment Rus detachment can be considered a ‘sensitive stress sensor’ for the Zagros collision since it indicates the Arabian platform’s instability in the wider area of the Dammam Dome during the Late Eocene. This instability is attributed to the inception of the Zagros collision, which was previously considered to occur during the Oligocene based on the well-established pre-Neogene unconformity.
Lessons from rhinology and facial plastic surgery clinical negligence claims in England 2013–2018
Authors: Navaratnam A V , Pendolino A L , Kaura A , Nijim J , Machin J T , Briggs T W R , Marshall A , Randhawa P S , Andrews P J 
Published: December 2021

AbstractObjectiveThis study reviewed all rhinology clinical negligence claims in the National Health Service in England between 2013 and 2018.MethodAll clinical negligence claims held by National Health Service Resolution relating to rhinology in England between 1 April 2013 and 1 April 2018 were reviewed.ResultsThere were 171 rhinology related claims with a total estimated potential cost of £13.6 million. There were 119 closed claims (70 per cent) with a total cost of £2.3 million, of which 55 claims resulted in payment of damages. Over three quarters of all rhinology claims were associated with surgery (n = 132). Claims associated with endoscopic sinus surgery had the highest mean cost per claim (£172 978). Unnecessary pain (33.9 per cent) and unnecessary operation (28.1 per cent) were the most commonly cited patient injuries.ConclusionPatient education and consent have been highlighted as key areas for improvement from this review of rhinology related clinical negligence claims. A shift in clinical practice towards shared decision making could reduce litigation in rhinology.
The impact of audio on the reading of intralingual versus interlingual subtitles: Evidence from eye movements
Authors: Liao Sixin , Yu Lili , Kruger Jan-Louis , Reichle Erik D. 
Published: December 2021

AbstractThis study investigated how semantically relevant auditory information might affect the reading of subtitles, and if such effects might be modulated by the concurrent video content. Thirty-four native Chinese speakers with English as their second language watched video with English subtitles in six conditions defined by manipulating the nature of the audio (Chinese/L1 audio vs. English/L2 audio vs. no audio) and the presence versus absence of video content. Global eye-movement analyses showed that participants tended to rely less on subtitles with Chinese or English audio than without audio, and the effects of audio were more pronounced in the presence of video presentation. Lexical processing of subtitles was not modulated by the audio. However, Chinese audio, which presumably obviated the need to read the subtitles, resulted in more superficial post-lexical processing of the subtitles relative to either the English or no audio. On the contrary, English audio accentuated post-lexical processing of the subtitles compared with Chinese audio or no audio, indicating that participants might use English audio to support subtitle reading (or vice versa) and thus engaged in deeper processing of the subtitles. These findings suggest that, in multimodal reading situations, eye movements are not only controlled by processing difficulties associated with properties of words (e.g., their frequency and length) but also guided by metacognitive strategies involved in monitoring comprehension and its online modulation by different information sources.
OP117 Digital Real-World Evidence In Times Of General Data Protection Regulation
Authors: Saunders Rhodri , Torres Rafael Torrejon , Blüher Maximilian 
Published: December 2021

IntroductionReal-world evidence (RWE) is a useful supplement to a product's evidence base especially for medical devices, which are often unsuitable for randomized controlled trials. Generally, RWE is analyzed retrospectively (for example, healthcare records), which lack granularity for health-economic analysis. Prospective collection of RWE in hospitals can promote device-specific endpoint assessment. The advent of the General Data Protection Regulation (GDPR) requires a privacy-by-design approach. This work describes a workflow for a GDPR-compliant device-specific RWE collection as part of quality improvement initiatives (QII).MethodsA literature review identifies relevant clinical and quality markers as endpoints to the investigated technology. A panel of experts grade these endpoints on their clinical significance, privacy sensitivity, analytic value, and feasibility for collection. Endpoints meeting a predefined cut-off are considered quality markers for the QII. Finally, an RWE data collection app is designed to collect the quality markers using either longitudinal, pseudonymized data or single time-point anonymized data to ensure data protection by design.ResultsUsing this approach relevant clinical markers were identified in a GDPR-compliant manner. The data collection app design ensured that patient data were protected, while maintaining minimum requirements on patient information and consent. The pilot QII collected data on over 5,000 procedures, which represents the largest single data set available for the tested technology. Due to its prospective nature this programme was the first to collect patient outcomes in sufficient quantity for analysis, while previous studies only recorded adverse events.ConclusionsGDPR and RWE can co-exist in harmony. A design approach, which has data protection in mind from the start can combine high quality RWE collection of efficacy and safety data with maximum patient privacy.
OP129 The Use Of A Text-Mining Screening Tool For Systematic Review Of Treatments For Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Authors: Carey Niamh , Harte Marie , McCullagh Laura 
Published: December 2021

IntroductionHuman screening of title and abstracts in a systematic literature review (SLR) is labor intensive and time-consuming. In many instances, thousands of citations may be retrieved; the vast majority excluded upon screening. Text-mining semi-automates and accelerates screening by identifying patterns in relevant and irrelevant citations, as labelled by the screener. One such text-mining tool, Abstrackr, uses an algorithm within an active-learning framework to predict the likelihood of citations being relevant. The objective of this study was to assesses the performance of Abstrackr for title and abstract screening in an SLR of treatments for relapsed/refractory diffuse large B-cell lymphoma.MethodsCitations identified from searches of electronic databases were imported to Abstrackr. An investigator-selected database of terms indicating relevance of title and abstract to the research question were uploaded. These terms were partly informed by the SLR inclusion/exclusion criteria. Citations deemed most relevant by Abstrackr were screened first (screening prioritization). Screening was carried out until a maximum prediction score of 0.4 or less, based on previous experience in the literature, was reached. Remaining citations were deemed unlikely to be relevant and did not undergo screening (screening truncation). Separately, a single-human screener screened all citations using Covidence.ResultsA total of 7,723 citations and 154 initial terms were uploaded to Abstrackr. Of these citations, 2,572 (33 percent) were screened before a prediction score of 0.39 was reached. Compared to single-human screening (conducted on all citations), the workload saving associated with Abstrackr was 5 days. A total of 451 (6 percent) citations proceeded to full-text screening; ten (0.1 percent) were included in the final evidence base. No citations predicted to be irrelevant by Abstrackr were included in the final evidence base.ConclusionsText-mining tools such as Abstrackr have the potential to reduce workload associated with title and abstract screening, without missing relevant citations.
OP135 Impact Of Updated Trial Data On The Cost-effectiveness Of Health Technologies: A Case Study On Percutaneous Mitral Repair
Authors: Armoiry Xavier , Auguste Peter , Obadia Jean-François , Grinberg Daniel , Connock Martin 
Published: December 2021

IntroductionExtrapolation methods are commonly used to model the cost-effectiveness of health technologies beyond observed data. Reassessing cost-effectiveness estimates using updated clinical trial data has the potential to reduce uncertainty and optimize decision-making. We present a case study based on percutaneous repair (PR) with the Mitraclip system, a technology to treat severe secondary mitral regurgitation (MR). For the study purpose, we considered the COAPT trial that evaluated the effectiveness of adding PR to medical treatment versus medical treatment alone.MethodsWe developed a time-varying Markov model to assess the cost-effectiveness of PR. Clinical inputs were based on reconstructed individual patient data from the COAPT trial results reported at 2 years, and at 3 years.We developed parametric modeling for overall survival (OS) and heart failure hospitalizations (HFH) to obtain clinically plausible extrapolations beyond observed data. We adopted the French perspective and used a 30-year time horizon. We expressed incremental cost-effectiveness ratios (ICERs) as cost per quality-adjusted life year (QALY).ResultsBased on 2 year-data, preferred parametric models for OS and HFH were exponential and log-logistic respectively, yielding an ICER of EUR21,918/QALY and >0.5 probability of PR being cost-effective (EUR50,000/QALY threshold).Updated analyses at 3 years showed a change of OS trajectory for PR that justified the use of piecewise modelling, yielding an updated ICER that went up to EUR77,904/QALY (base-case), and to a minimum of EUR58,175/QALY (scenario analysis). Using data at 3 years, PR had <0.5 probability of being cost-effective.ConclusionsIn this case study, the availability of updated survival analyses of the main trial is likely to have some impact on decision-making and/or pricing discussion as part of health-technology assessment (HTA). We aim to provide further updated analyses as 4 years results of the COAPT study become available.More broadly, original technology appraisals are frequently undertaken when mid/long-term follow-up trial data may be lacking. Our example suggests the need for continuous HTA review as new clinical data are released.
OP164 Extracorporeal Cytokine Adsorption Therapy: An Update Systematic Review Of Clinical Efficacy And Safety For Two Indications
Authors: Goetz Gregor , Hawlik Katharina , Wild Claudia 
Published: December 2021

IntroductionThe idea of using extracorporeal cytokine adsorption therapy (ECAT) is to remove cytokines from the blood in order to restore a balanced immune response. Yet, it is unclear as to whether the use of ECAT improves patient-relevant outcomes. Hence, the aim of this article is to synthesize the currently available evidence with regard to a potential clinical benefit of ECAT used in cardiac surgery or sepsis.MethodsWe conducted an updated systematic review summarizing the body of evidence with regard to a potential clinical benefit of ECAT. The study followed the PRISMA statement and the European Network for Health Technology Assessment (EUnetHTA) guidelines. The quality of the individual studies and the strength of the available evidence was assessed using the Cochrane risk of bias tool (v.1) and the GRADE approach respectively. Mortality, organ function, length of stay in the intensive care unit and length of hospitalization, as well as adverse events, were defined as critical outcomes.ResultsFor the preventive treatment of ECAT in patients undergoing cardiac surgery, we found very low-quality inconclusive evidence for mortality (5 randomized controlled trials (RCTs), n = 163), length of stay in the intensive care unit (5 RCTs, n = 163), and length of hospitalization (3 RCTs, n = 101). In addition, very low-quality inconclusive evidence was found for (serious) adverse events (4 RCTs, n = 148). For the therapeutic treatment of ECAT in patients with sepsis/ septic shock, we found very low-quality inconclusive evidence for mortality up to 60-day follow-up (2 RCTs, n = 117), organ function (2 RCTs, n = 117) and length of stay in the intensive care unit (1 study, n = 20). Similarly, very low-quality inconclusive evidence was found for (serious) adverse events (2 RCTs, n = 117). There are currently eighteen ongoing RCTs on the use of ECAT.ConclusionsThere is a lack of reliable data on the clinical benefit of using ECAT as an add-on treatment preventively in cardiac surgery and therapeutically in patients with sepsis or septic shock. While theoretical advantages are anticipated, the current available evidence is inconclusive and was not able to establish the efficacy and safety of ECAT in combination with standard care in the investigated indications. In light of the available RCTs, we strongly recommend the consideration of studies with patient-relevant endpoints and adequate statistical power, instead of investing further research funds on small studies that may not shed more light onto the potential clinical benefit of ECAT. The results of ongoing RCTs are awaited to guide the decision on whether further research funds should be invested in ECAT research or to conclude that the intervention may not show clinical benefits for patients.
OP179 Quantitative Evidence Synthesis Methods For Assessing The Effectiveness Of Treatment Sequences For Clinical And Economic Decision-Making: Methodology Review
Authors: Lewis Ruth , Hughes Dyfrig , Sutton Alex , Wilkinson Clare 
Published: December 2021

IntroductionThe sequential use of alternative treatments for chronic conditions represents a complex, dynamic intervention pathway; previous treatment and patient characteristics affect both choice and effectiveness of subsequent treatments. Evidence synthesis methods that produce the least biased estimates of treatment-sequencing effects are required to inform reliable clinical and policy decision-making. A comprehensive review was conducted to establish what existing methods are available, outline the assumptions they make, and identify their shortcomings.MethodsThe review encompassed both meta-analytic techniques and decision-analytic modelling, any disease condition, and any type of treatment sequence, but not diagnostic tests, screening, or treatment monitoring. It focused on the estimation of clinical effectiveness and did not consider the impact of treatment sequencing on the estimation of costs or utility values.ResultsThe review included ninety-one studies. Treatment-sequencing is usually dealt with at the decision-modelling stage and is rarely addressed using evidence synthesis methodology for clinical effectiveness. Most meta-analyses are of discrete treatments, sometimes stratified by line of therapy. Prospective sequencing trials are scarce. In their absence, there is no single best way to evaluate treatment sequences, rather there is a range of approaches, each of which has advantages and disadvantages and is influenced by the evidence available and the decision problem. Due to the scarcity of data on sequential treatments, modelling studies generally apply simplifying assumptions to data on discrete treatments. A taxonomy for all possible assumptions was developed, providing a unique resource to aid the critique of decision-analytic models.ConclusionsThe evolution of network meta-analysis in HTA demonstrates that clinical and policy decision-making should account for the multiple treatments available for many chronic conditions. However, treatment-sequencing has yet to be accounted for within clinical evaluations. Economic modelling is often based on the simplifying assumption of treatment independence. This can lead to misrepresentation of the true level of uncertainty, potential bias in estimating the effectiveness and cost effectiveness of treatments and, eventually, the wrong decision.
OP181 Adapting Evidence To Produce A Health Technology Assessment Of Mammography Screening: An Example From The West Bank
Authors: Heupink Lieke Fleur , Isbeih Mervett , Qaddomi Sharif , Peacocke Elizabeth , Sæterdal Ingvil , Salman Rand , Chola Lumbwe 
Published: December 2021

IntroductionHealth technology assessment (HTA) can play a key role in evidence-based decision-making. However, HTA requires resources that might be lacking in low-income settings. To test the feasibility of adapting existing evidence as part of the HTA process, this project evaluated the effectiveness and economic impact of breast cancer screening programs for women over 40 years in the West Bank, where mammography screening is provided for free in governmental clinics.MethodsWe conducted a search for systematic reviews, HTAs and guidelines in electronic databases. We included the most recent global systematic review and meta-analysis that fulfilled our inclusion criteria. The European Network for Health Technology Assessment (EUnetHTA) adaptation toolkit was used to guide adaptation and undertake a budget impact analysis of the economic impact of mammography screening. We build capacity by working as a team of HTA experts and first-time HTA researchers. The results were disseminated to raise awareness for HTA.ResultsThe European Commission Guidelines on Breast Cancer Screening were identified as most recent global systematic review with meta-analyses, out of 2,365 references. The adapted evidence may inform policies on screening in the West Bank. Our experience is that adaption requires extensive skills and resources, including finding, assessing, and adapting relevant evidence. The EUnetHTA toolkit is useful, but also adds to the workload. Furthermore, local stakeholder engagement is important in topic selection, to access information, and to contextualize global evidence to the local setting.ConclusionsThis study is currently ongoing, but preliminary findings show that producing an HTA by adapting existing evidence in resource-limited settings is feasible. There is a need for nuanced guidance on transferability of evidence from other settings. Future studies should investigate innovative methods to optimize the adaption process. Capacity building in adaptation is important to ensure the production of quality HTA products. Inclusion of local team members and stakeholders is important for future development of HTA in the region.
OP220 What Factors Do Clinicians Value Most In Selecting Physician Preference Items? A Survey Among Italian Orthopaedists
Authors: Armeni Patrizio , Meregaglia Michela , Borsoi Ludovica , Callea Giuditta , Torbica Aleksandra 
Published: December 2021

IntroductionPhysician preference items (PPIs) are high-cost medical devices on which clinicians express firm preferences with respect to a particular manufacturer and a specific product. The aim of this research is to understand what are the most important factors, as well as their relative importance, in the choice of new PPIs (that is, hip or knee prosthesis) adoption on behalf of orthopaedic clinicians in Italy.MethodsBased on a literature review and clinical experts’ opinions, we identified a number of key factors (for example, health technology assessment (HTA) recommendation) and their corresponding levels (for example positive HTA recommendation). We administered an online survey to hospital orthopaedists using two experimental techniques for preference elicitation (that is, discrete choice experiment (DCE) and case 1 best-worst scaling (BWS)). BWS data were analysed through descriptive statistics (that is, best-minus-worst score) and conditional logit model. A mixed logit model was applied to DCE data, and a willingness-to-pay (WTP) was estimated. All analyses were conducted using Stata 16.ResultsA total of ninety orthopaedists (95% male; mean age: 52.8 years) were enrolled in the survey. In BWS, the most important factor was ‘clinical evidence’, followed by ‘quality of products’, ‘HTA recommendations’ and ‘previous experience’, while the least important was ‘cost’. DCE results suggested that orthopaedists prefer high-quality products with robust clinical evidence, positive HTA recommendation and affordable cost, and for which clinicians have a consolidated experience of use and a good relationship with the sales representative. The WTP for a high-quality product was estimated at EUR1,733, and for a good relationship at EUR2,843.ConclusionsThis is the first study aimed at analysing the multidimensionality of clinician's decision-making process in selecting new PPIs in orthopaedics in Italy. Despite the quality of products being declared as one of the most important dimensions in BWS, when other factors populate a hypothetical DCE scenario, physicians are not willing to accept quality at any cost (for example, high quality and very bad support from the producer or with uncertain clinical evidence).