Bioinspired Approaches to Engineer Antithrombogenic Medical Devices for Vascular Intervention.

Medical devices form a critical component of health care systems for treating and maintaining patient health. However, devices exposed to blood are prone to blood clotting (thrombosis) and bleeding complications leading to device occlusion, device failure, embolism and stroke, and increased morbidity and mortality. Over the years, developments in innovative material design strategies have been made to help reduce the occurrence of thrombotic events on medical devices, but complications persist. Here, we review material and surface coating technologies that have taken bioinspiration from the endothelium to reduce medical device thrombosis, either by mimicking aspects of the glycocalyx to prevent adhesion of proteins and cells to the material surface or mimicking the bioactive function of the endothelium through immobilized or released bioactive molecules to actively inhibit thrombosis. We highlight newer strategies that take inspiration from multiple aspects of the endothelium or are stimuli responsive, only releasing antithrombotic biomolecules when thrombosis is triggered. Emerging areas of innovation target inflammation to decrease thrombosis without increasing bleeding, and interesting results are coming from underexplored aspects of material properties, such as material interfacial mobility and stiffness, which show that increased mobility and decreased stiffness are less thrombogenic. These exciting new strategies require further research and development before clinical translation, including consideration of longevity, cost, and sterilization, but show capacity for the development of more sophisticated antithrombotic medical device materials.

Proposing a health-specific organizational impact framework to evaluate organizational impacts in health technology assessments.

OBJECTIVES: Health technology assessments (HTAs) have traditionally included clinical and cost-effectiveness evaluation of new health technologies (HTs). However, new HTs can generate important organizational impacts (OIs) that influence their overall value. OIs are currently not clearly identified and evaluated in HTA procedures and tools are limited. To address this issue, a comprehensive framework that allows to assess OIs of new HTs in HTAs is proposed. METHODS: A working and methodological group identified the Oslo Manual 2018, 4th edition, OECD/Eurostat, on the objectives and outcomes of commercial innovations as the basis for the OIs framework for HTAs. The Oslo Manual was translated to the healthcare sector and adapted to HTA procedures through a three-step process. RESULTS: The framework is composed of three main parts. Part I tackles the context of the evaluation, Part II the categories of impacts and the specific impacts - in total, 16 OIs were identified - and Part III the stakeholders involved. The central part of the framework is Part II, and consists of three categories of impacts: (i) on the care process, (ii) on the stakeholders' capabilities and skills, and (iii) on society or the community. CONCLUSIONS: This framework provides a comprehensive and structured basis to document OIs of new HTs. It thus contributes to the extension of HTA evaluation criteria to other dimensions than clinical and economic aspects, that is, organizational aspects. Some of its intrinsic limitations and the questions they raise in the field for policy-makers, practitioners, and researchers are discussed.

A critical assessment framework to identify, quantify and interpret the sources of uncertainty in cost-effectiveness analyses.

BACKGROUND: Using a standardized approach to describe the sources of uncertainty in cost-effectiveness analyses might bring added value to the local critical assessment procedure of reimbursement submissions in Hungary. The aim of this research is to present a procedural framework to identify, quantify and interpret sources of uncertainty, using the reimbursement dossier of darolutamide as an illustrative example. METHODS: In the procedural framework designed for the critical assessment of cost-effectiveness analyses, the quantifiability of an identified source of uncertainty is assessed through the input parameters of the originally submitted model, which is followed by the interpretation of its impact on estimates of costs and outcomes compared to the base case cost-effectiveness conclusion. RESULTS: Based on our experiences with the recent reimbursement dossier of darolutamide, the significant and quantifiable sources of uncertainty were the time horizon of the economic analysis; the restriction of the efficacy analysis population; long-term relative effectiveness of darolutamide; price discount on subsequent therapies. We identified resource use patterns for comparator and subsequent therapies as a quantifiable, yet non-significant source of uncertainty. The EQ-5D value set used to estimate utility values was identified as a non-quantifiable and potentially not significant source of uncertainty. CONCLUSIONS: The procedural framework, demonstrated with an example, was sufficiently flexible and coherent to document and structure the sources of uncertainty in cost-effectiveness analyses. The full-scale use of this framework is desirable during the decision-making process for reimbursement in Hungary. The further formalization of identifying sources of uncertainty is a possible subject of methodological development.

Integrating Empirical Analysis and Normative Inquiry in Health Technology Assessment: The Values in Doing Assessments of Health Technologies Approach.

Health technology assessment (HTA) aims, through empirical analysis, to shed light on the value of health technologies (O'Rourke et al. [2020, International Journal of Technology Assessment in Health Care 36, 187-90]). HTA is, then, where facts and values meet. But how, where, and when do facts and values meet in HTA? Currently, HTA is usually portrayed as a sequential process, starting with empirical analysis (assessment), followed by a deliberation on the implications of the findings for a judgment of a health technology's value (appraisal). In this paper, we will argue that in HTA, empirical analysis and normative inquiry are much more closely entwined. In fact, as we hope to show, normative commitments act as an indispensable guide for the collection and interpretation of empirical evidence. Drawing on policy sciences, we will suggest a concrete methodology that can help HTA practitioners to integrate empirical analysis and normative inquiry in a transparent way. The proposed methodology can be conceived as a concrete means for conducting a scoping exercise in HTA. Moreover, it offers a distinct way of giving stakeholders a structural and constructive role in HTA. This paper outlines the approach developed by the values in doing assessments of health technologies project, a project funded by the Erasmus+ program (contract number 2018-1-NL01-KA203-038960), which is the European Union's program to support education, training, youth, and sport in Europe. The project has resulted in an E-learning course, an accompanying handbook, and a consensus statement, all freely available from the project's website www.validatehta.eu.

Evidence-based searching for health technology assessment: keeping up to date with SuRe Info.

BACKGROUND: Evidence syntheses of all types have their foundation in literature searches. Literature searching is developing in line with the growing use of evidence synthesis and is also informed, as a field of work, by the spirit of being evidence-based. Increasing numbers of research papers about information retrieval are being published, and keeping up to date with the latest developments in this ever more wide-ranging field is demanding. METHODS: Summarized Research in Information Retrieval for HTA (SuRe Info) is a Web site (http://www.sure-info.org) that summarizes research-based information on effective and efficient evidence identification for the different aspects of health technology assessment (HTA) and evidence synthesis. This paper describes the rationale, processes, and challenges of producing SuRe Info and insights into the pace of development in the field of evidence-based information retrieval. The paper also provides scenarios suggesting how SuRe Info can help searchers in their daily work and with specific questions. RESULTS: SuRe Info currently comprises seventeen chapters, falling into two categories: (i) chapters about general search methods relating to all types of research and (ii) chapters summarizing the methods to use when searching for specific aspects of HTA (as defined in the HTA Core Model® by the European Network for Health Technology Assessment (EUnetHTA)). CONCLUSIONS: SuRe Info is not a substitute for methods handbooks, but by providing an overview of current research evidence for major issues in information retrieval in HTA, it helps searchers in this field to keep abreast of the latest research.

Peer review of searches for studies for health technology assessments, systematic reviews, and other evidence syntheses.

INTRODUCTION: Peer review of searches is a process whereby both the search strategies and the search process description are reviewed, ideally using an evidence-based checklist. RATIONALE: As the search strategy underpins any well-conducted evidence synthesis, its quality could affect the final result. Evidence shows, however, that search strategies are prone to error. FINDINGS: There is increasing awareness and use of the PRESS Evidence-Based Checklist and peer review of search strategies, at the outset of evidence syntheses, prior to the searches being run, and this is now recommended by a number of evidence synthesis organizations. RECOMMENDATIONS AND CONCLUSIONS: Searches for evidence syntheses should be peer reviewed by a suitably qualified and experienced librarian or information specialist after being designed, ideally, by another suitably qualified and experienced librarian or information specialist. Peer review of searches should take place at two important stages in the evidence synthesis process; at the outset of the project prior to the searches being run and at the prepublication stage. There is little empirical evidence, however, to support the effectiveness of peer review of searches. Further research is required to assess this. Those wishing to stay up to date with the latest developments in information retrieval, including peer review of searches, should consult the SuRe Info resource (http://www.sure-info.org), which seeks to help information specialists and others by providing easy access to the findings from current information retrieval methods research and thus support more research-based information retrieval practice.

[Risk of Publication Bias in Therapeutic Interventions for COVID-19Risco de viés de publicação em intervenções terapêuticas para a COVID-19]. / Riesgo de sesgo de publicación en intervenciones terapéuticas para la COVID-19.

This article describes publication bias, its most frequent causes, its characteristics, the regulatory tools to avoid it, and some statistical techniques to analyze it. These techniques are explained and applied to three therapeutic interventions related to the 2019 coronavirus disease (COVID-19): corticosteroids, ivermectin, and tocilizumab. Risk of publication bias was detected for ivermectin and tocilizumab. Systematic reviews and meta-analyses are secondary research designs that provide a reference to guide decision-making. They are prone to different types of bias, i.e., a systematic deviation in the results. Even if carried out with methodological rigor, their validity can be threatened by publication bias. This is defined as the act of concealing or delaying publication, withholding data arising from research studies, or both. Up to half of controlled trials remain unpublished. During the H1N1 virus pandemic, publication bias from industry-funded studies led to the recommendation and large-scale procurement of oseltamivir, a drug that later proved to have no relevant beneficial effects. Two-thirds of clinical trial funding for COVID-19 comes from the pharmaceutical industry. In the context of the COVID-19 pandemic, studies are published at an accelerated pace, making it very important to understand and identify publication bias. To reduce publication bias it is necessary to regulate the registration and publication of clinical trials, but this requires coordination among countries and international bodies. It is important to suspect and attempt to identify publication bias for decision making.

Este artigo descreve o viés de publicação, suas causas mais frequentes, suas características, as ferramentas regulatórias para evitá-lo e algumas técnicas estatísticas para analisá-lo. Essas técnicas são explicadas e aplicadas a três intervenções terapêuticas relacionadas à doença pelo coronavírus 2019 (COVID-19, na sigla em inglês): corticoides, ivermectina e tocilizumabe. Detectou-se risco de viés de publicação para ivermectina e tocilizumabe. As revisões sistemáticas e as meta-análises são delineamentos de pesquisa secundária que constituem uma referência para orientar a tomada de decisão. Estão propensas a diferentes tipos de viés, que é um desvio sistemático nos resultados. Mesmo tendo sido desenvolvidas com rigor metodológico, sua validade pode ser ameaçada pelo viés de publicação, que é definido como o ato de ocultar ou atrasar a publicação, reter dados de pesquisa ou ambos. Até metade dos estudos controlados realizados jamais são publicados. Durante a pandemia pelo vírus H1N1, o viés de publicação de estudos financiados pela indústria levou à recomendação e à compra, em grande escala, do medicamento oseltamivir que, mais tarde, ficou conhecido por não ter efeitos benéficos relevantes. Dois terços do financiamento para os ensaios clínicos referentes à COVID-19 vêm da indústria farmacêutica. No contexto da atual pandemia de COVID-19, os estudos vêm sendo publicados em ritmo acelerado; portanto, é fundamental conhecer e identificar o viés de publicação. Para reduzi-lo, é necessário regulamentar o registro de a publicação de ensaios clínicos, o que requer coordenação entre países e organismos internacionais. É importante suspeitar e tentar identificar o viés de publicação para a tomada de decisão.

Does a Sway-Based Mobile Application Predict Future Falls in People With Parkinson Disease?

OBJECTIVE: To determine whether Sway, a sway-based mobile application, predicts falls and to evaluate its discriminatory sensitivity and specificity relative to other clinical measures in identifying fallers in individuals with Parkinson disease (PD). DESIGN: Observational cross-sectional study. SETTING: Community. PARTICIPANTS: A convenience sample of subjects with idiopathic PD in Hoehn and Yahr levels I-III (N=59). INTERVENTIONS: Participants completed a balance assessment using Sway, the Movement Disorders Systems-Unified PD Rating Scale motor examination, Mini-BESTest, Activities-specific Balance Confidence (ABC) Scale, and reported 6-month fall history. Participants also reported falls for each of the following 6 months. Binomial logistic regression was used to identify significant predictors of future fall status. Cutoff scores, sensitivity, and specificity were based on receiver operating characteristic plots. MAIN OUTCOME MEASURES: Sway score. RESULTS: The most predictive logistic regression model included fall history, ABC Scale, and Sway (P<.001). This model explained 61% (Nagelkerke R2) of the variance in fall prediction and correctly classified 85% of fallers. However, only fall history and ABC Scale were statistically significant (P<.02). Participants were 32 times more likely to fall in the future if they fell in the past. The ABC Scale and Mini Balance Evaluation Systems Test (Mini-BESTest) demonstrated greater accuracy than Sway (area under the curve=0.76, 0.72, and 0.65, respectively). Cutoff scores to identify fallers were 85% for the ABC Scale and 21 of 28 for the Mini-BESTest. CONCLUSION: Sway did not improve the accuracy of predicting future fallers beyond common clinical measures and fall history.

Digital Biomarkers of Social Anxiety Severity: Digital Phenotyping Using Passive Smartphone Sensors.

BACKGROUND: Social anxiety disorder is a highly prevalent and burdensome condition. Persons with social anxiety frequently avoid seeking physician support and rarely receive treatment. Social anxiety symptoms are frequently underreported and underrecognized, creating a barrier to the accurate assessment of these symptoms. Consequently, more research is needed to identify passive biomarkers of social anxiety symptom severity. Digital phenotyping, the use of passive sensor data to inform health care decisions, offers a possible method of addressing this assessment barrier. OBJECTIVE: This study aims to determine whether passive sensor data acquired from smartphone data can accurately predict social anxiety symptom severity using a publicly available dataset. METHODS: In this study, participants (n=59) completed self-report assessments of their social anxiety symptom severity, depressive symptom severity, positive affect, and negative affect. Next, participants installed an app, which passively collected data about their movement (accelerometers) and social contact (incoming and outgoing calls and texts) over 2 weeks. Afterward, these passive sensor data were used to form digital biomarkers, which were paired with machine learning models to predict participants' social anxiety symptom severity. RESULTS: The results suggested that these passive sensor data could be utilized to accurately predict participants' social anxiety symptom severity (r=0.702 between predicted and observed symptom severity) and demonstrated discriminant validity between depression, negative affect, and positive affect. CONCLUSIONS: These results suggest that smartphone sensor data may be utilized to accurately detect social anxiety symptom severity and discriminate social anxiety symptom severity from depressive symptoms, negative affect, and positive affect.

[Narratives help disseminate medical technologies: the case of coronary interventions]. / Mechanistische Narrative als Mittel der Dissemination: das Beispiel koronarer Technologien.

Medical technologies are often disseminated and used although evidence demonstrating their effectiveness and safety is missing. Percutaneous intervention (PCI) in stable coronary artery disease (CAD) is an example. This raises the question of how these technologies get disseminated and on which basis they are accepted by clinicians, patients, and the wider public.Studies investigating the communication between clinicians and patients show that simple narratives play a decisive role here. In this paper I discuss how narratives contribute to the dissemination of medical technologies. Communication within the profession, which includes medical education, also relies on narratives to a large degree. They have the following characteristics in common: 1) extreme simplification, 2) reduction to biological processes, 3) deterministic logic, and 4) strong moral message. These narratives are always biased; narratives dealing with interventions paint an overoptimistic picture of their effectiveness and safety. Although they represent "modern" technologies, their logic and purpose are akin to archaic myths.Presumably education and persuasion cannot eschew narratives completely. But health professionals, patients and the public should be aware of the inevitable bias that comes with narratives and their potential for manipulation.

Methods Assessing Sociocultural Aspects of Health Technologies: Results of a Literature Review.

OBJECTIVES: Social and cultural aspects are rarely assessed in health technology assessments (HTA), despite being part of most HTA definitions. One hypothesis for the reason why they are hardly considered in HTA is that we lack relevant assessment methods. Accordingly, this review aims at providing an overview of methodological approaches to address social and cultural aspects related to health technologies in HTA. METHODS: We conducted a comprehensive literature search by searching fourteen databases and a hand-search of two pertinent journals. Additionally, we sent a query to all member agencies of the International Network of Agencies for Health Technology Assessment (INAHTA) asking them for methods they use to assess social and cultural aspects. RESULTS: A total of 125 publications met our inclusion criteria. We grouped the methodological approaches into checklists for experts, literature reviews, stakeholder participatory approaches, primary data collection methods, and combinations of methodological approaches. CONCLUSIONS: There is a wide variety of methods available for assessing social and cultural aspects of health technologies, some of which have been applied in HTA. The presented overview of the different approaches and their merits can facilitate the assessment of these aspects, and improve the knowledge regarding (potential) success and failure of the implementation of a health technology.

Stakeholder value judgments in decision-making on the incorporation, financing, and allocation of new health technologies in limited-resource settings: a potential Brazilian approach.

OBJECTIVE: To analyze the value judgments behind cost-benefit tradeoffs made by health stakeholders in deciding whether or not to incorporate new health technologies and how they should be financed and allocated in limited-resource settings in Brazil. METHOD: From June 2009 to January 2010, a sample of stakeholders in the public and private health sector was identified and invited to complete an online survey consisting of two questionnaires: one collecting socio-demographic/professional information and one capturing resource allocation preferences in four hypothetical scenarios for the incorporation of new health technologies. RESULTS: A total of 193 respondents completed the survey; more than half were male (53.9%) and the most common age group was 31-40 years (36.8%). Scenario 1 (incorporation of a new drug treatment for chronic disease, by reducing/eliminating resources for existing programs) was rejected by 49.2% of the survey sample, who preferred to maintain the status quo for existing programs. Scenario 2 (incorporation of the same new treatment, but financed by a new tax) was rejected by 58.0%. Scenario 3 (incorporation of a new treatment for a highly lethal disease, by age group-20-75 years versus 75+ years-by reducing/eliminating resources for existing programs), was rejected by 42.0%, while 20.7% supported allocations for both groups, 34.2% supported allocations exclusively for the 20-75-year age group, and 3.1% supported allocations exclusively for the 75+ year age group. For Scenario 4, which consisted of five different resource allocations for prevention and treatment programs for another highly lethal disease, the most preferred option (chosen by 50.8% of respondents) was 75%:25% (prevention versus treatment). CONCLUSIONS: When incorporating a new health technology requires reducing/eliminating other health programs, financing it through a tax, or having to choose certain age groups (e.g., younger, working people versus older people), respondents are likely to reject it. When offered the choice of limiting the scope of the program (e.g., prevention versus treatment), respondents are likely to favor prevention. This was the first study in Brazil to capture value judgments that affect stakeholder decision-making on various resource allocations for different scenarios for health technology introduction in limited-resource settings. Future research should investigate the perspective of society as a whole to determine the best approach for decision-making based on common values and consensus within a particular health care system.

COMPREHENSIVE ASSESSMENT OF COMPLEX TECHNOLOGIES: INTEGRATING VARIOUS ASPECTS IN HEALTH TECHNOLOGY ASSESSMENT.

OBJECTIVES: Despite recent development of health technology assessment (HTA) methods, there are still methodological gaps for the assessment of complex health technologies. The INTEGRATE-HTA guidance for effectiveness, economic, ethical, socio-cultural, and legal aspects, deals with challenges when assessing complex technologies, such as heterogeneous study designs, multiple stakeholder perspectives, and unpredictable outcomes. The objective of this article is to outline this guidance and describe the added value of integrating these assessment aspects. METHODS: Different methods were used to develop the various parts of the guidance, but all draw on existing, published knowledge and were supported by stakeholder involvement. The guidance was modified after application in a case study and in response to feedback from internal and external reviewers. RESULTS: The guidance consists of five parts, addressing five core aspects of HTA, all presenting stepwise approaches based on the assessment of complexity, context, and stakeholder involvement. The guidance on effectiveness, health economics and ethics aspects focus on helping users choose appropriate, or further develop, existing methods. The recommendations are based on existing methods' applicability for dealing with problems arising with complex interventions. The guidance offers new frameworks to identify socio-cultural and legal issues, along with overviews of relevant methods and sources. CONCLUSIONS: The INTEGRATE-HTA guidance outlines a wide range of methods and facilitates appropriate choices among them. The guidance enables understanding of how complexity matters for HTA and brings together assessments from disciplines, such as epidemiology, economics, ethics, law, and social theory. This indicates relevance for a broad range of technologies.

IMPACT OF HEALTH TECHNOLOGY ASSESSMENT IN LITIGATION CONCERNING ACCESS TO HIGH-COST DRUGS.

OBJECTIVES: The impact of health technology assessment (HTA) in the judicialization of the right of health has not been deeply studied in Latin American countries. The purpose of this study is to review the process of judicialization of the access to high cost drugs in Uruguay and assess the impact HTAs have had on this process. METHODS: The methodology used for this study included a comprehensive literature search in electronic databases, local journals, internal documents developed in the Ministry of Health, as well as conducting interviews with key informants. RESULTS: Judicialization of the access of high cost drugs has been increasing since 2010. The strategy of the Ministry of Health of Uruguay to decrease this problem included the organization of roundtables with judges and other stakeholders on the basis of HTA, the training of defense lawyers in the use and interpretation of HTA, and the participation of a professional who develops HTA in the preparation of the defense arguments. A year after the implementation of this strategy, 25 percent of writs of protection were won by the Ministry of Health. CONCLUSIONS: Even though the strategy implemented was effective in reducing the loss of litigations, it was not effective in reducing the growing number of writs of protection. It is essential to address this problem in a broad debate and to promote understanding between the parties.

[Validation of the Caprini risk assessment model for venous thromboembolism in Chinese hospitalized patients in a general hospital].

Objective: To assess the validity of Caprini risk assessment model in prediction of venous thromboembolism in Chinese hospitalized patients in a general hospital. Methods: Medical record review was performed in Beijing Shijitan Hosital for all eligible hospitalized patients who underwent screening for venous thromboembolism between January and December 2015. The Caprini score of patients with or without venous thromboemboilism and incidence of venous thromboembolism in patients with various Caprini risk levels, surgery and medical patients was compared. Results: A total of 6 966 inpatients were enrolled. Three hundred and ninety-six patients developed venous thromboembolism. The Caprini median score of patients with venous thromboemboilism was 5 (3-7), which higher than 3(2-5) of patients without venous thromboembolism(Z=-13.68, P<0.01). Incidence of venous thromboembolism of patients in low, moderate, high, highest risk level was 1.0%, 1.8%, 5.7%, 10.6%, respectively. There was no statistically significant difference of incidence between low and moderate risk patients (OR=1.88, 95%CI: 0.89-3.99, P>0.05), but significant difference between moderate and high risk (OR=3.23, 95%CI: 2.06-5.06, P<0.01), high and highest risk patients (OR=1.97, 95%CI: 1.59-2.45, P<0.01). There was no incidence difference of venous thromboembolism between surgery and medical patients in the same Caprini level of low (χ(2)=3.58 , P>0.05), moderate(χ(2)=2.89, P>0.05), high(χ(2)=0.46, P>0.05), highest risk(χ(2)=1.61, P>0.05). Conclusion: Caprini risk assessment model can effectively predict the occurence of venous thromboembolism in Chinese hospitalized patients with high risk of VTE(Caprini score >2)in a general hospital.

Current Status of Simulation and Training Models in Urological Surgery: A Systematic Review.

PURPOSE: Increased awareness of patient safety, advances in surgical technology and reduced working times have led to the adoption of simulation enhanced training. However, the simulators available need to be scientifically evaluated before integration into curricula. We identify the currently available training models for urological surgery, their status of validation and the evidence behind each model. MATERIALS AND METHODS: MEDLINE®, Embase® and the Cochrane Library databases were searched for English language articles published between 1990 and 2015 describing urological simulators and/or validation studies of these models. All studies were assessed for level of evidence, and each model was subsequently awarded a level of recommendation using a modified Oxford Centre for Evidence-Based Medicine classification, adapted for education by the European Association of Endoscopic Surgeons. RESULTS: A total of 91 validation studies were identified pertaining to training models in endourology (63), laparoscopic surgery (17), robot-assisted surgery (8) and open urological surgery (6), with a total of 55 models. Of the included studies 6 were classified Level 1b, 9 Level 2a, 39 Level 2b and 19 Level 2c. Of all the training models the URO Mentor™ was the only one to receive a level of recommendation of 1. CONCLUSIONS: UroSimulation is a growing field and increasing numbers of models are being produced. However, there are still too few validation studies with a high level of evidence demonstrating the transferability of skills. Nevertheless, efforts should be made to use the currently available models in curriculum based training programs.

Assessment of Silent T1-weighted head imaging at 7 T.

OBJECTIVES: This study aimed to assess the performance of a "Silent" zero time of echo (ZTE) sequence for T1-weighted brain imaging using a 7 T MRI system. METHODS: The Silent sequence was evaluated qualitatively by two neuroradiologists, as well as quantitatively in terms of tissue contrast, homogeneity, signal-to-noise ratio (SNR) and acoustic noise. It was compared to conventional T1-weighted imaging (FSPGR). Adequacy for automated segmentation was evaluated in comparison with FSPGR acquired at 7 T and 1.5 T. Specific absorption rate (SAR) was also measured. RESULTS: Tissue contrast and homogeneity in Silent were remarkable in deep brain structures and in the occipital and temporal lobes. Mean tissue contrast was significantly (p < 0.002) higher in Silent (0.25) than in FSPGR (0.11), which favoured automated tissue segmentation. On the other hand, Silent images had lower SNR with respect to conventional imaging: average SNR of FSPGR was 2.66 times that of Silent. Silent images were affected by artefacts related to projection reconstruction, which nevertheless did not compromise the depiction of brain tissues. Silent acquisition was 35 dB(A) quieter than FSPGR and less than 2.5 dB(A) louder than ambient noise. Six-minute average SAR was <2 W/kg. CONCLUSIONS: The ZTE Silent sequence provides high-contrast T1-weighted imaging with low acoustic noise at 7 T. KEY POINTS: • "Silent" is an MRI technique allowing zero time of echo acquisition • Its feasibility and performance were assessed on a 7 T MRI system • Image quality in several regions was higher than in conventional techniques • Imaging acoustic noise was dramatically reduced compared with conventional imaging • "Silent" is suitable for T1-weighted head imaging at 7 T.

Predicting the onset of end-stage knee osteoarthritis over two- and five-years using machine learning.

OBJECTIVE: Identifying participants who will progress to advanced stage in knee osteoarthritis (KOA) trials remains a significant challenge. Current tools, relying on total knee replacements (TKR), fall short in reliability due to the extraneous factors influencing TKR decisions. Acknowledging these limitations, our study identifies a critical need for a more robust metric to assess severe KOA. The end-stage KOA (esKOA) measure, which combines symptomatic and radiographic criteria, serves as a solid indicator. To enhance future trials that use esKOA as an endpoint, our study focuses on developing and validating a machine-learning tool to identify individuals likely to develop esKOA within 2 to 5 years. DESIGN: Utilizing the Osteoarthritis Initiative (OAI) data, we trained models on 3,114 participants and validated them with 606 participants for the right knee, and similarly for the left knee, with external validation from the Multicentre Osteoarthritis Study (MOST) involving 1,602 participants. We aimed to predict esKOA onset at 2-to-2.5 years and 4-to-5 years, defining esKOA by severe radiographic KOA with moderate/severe symptoms or mild/moderate radiographic KOA with persistent/intense symptoms. Our analysis considered 51 candidate predictors, including demographics, clinical history, physical examination, and X-ray evaluations. An online tool predicting esKOA progression, based on models with ten and nine predictors for the right and left knees, respectively, was developed. RESULTS: External validation (MOST) for the right knee at 2.5 years yielded an Area Under Curve (AUC) of 0.847 (95 % CI 0.811 to 0.882), and at 5 years, 0.853 (95 % CI 0.823 to 0.881); for the left knee at 2.5 years, AUC was 0.824 (95 % CI 0.782 to 0.857), and at 5 years, 0.807 (95 % CI 0.768 to 0.843). Models with fewer predictors demonstrated comparable performance. The online tool is available at: https://eskoa.shinyapps.io/webapp/. CONCLUSION: Our study unveils a robust, externally validated machine learning tool proficient in predicting the onset of esKOA over the next 2 to 5 years. Our tool can lead to more efficient KOA trials.

Early Prediction of Poststroke Rehabilitation Outcomes Using Wearable Sensors.

OBJECTIVE: Inpatient rehabilitation represents a critical setting for stroke treatment, providing intensive, targeted therapy and task-specific practice to minimize a patient's functional deficits and facilitate their reintegration into the community. However, impairment and recovery vary greatly after stroke, making it difficult to predict a patient's future outcomes or response to treatment. In this study, the authors examined the value of early-stage wearable sensor data to predict 3 functional outcomes (ambulation, independence, and risk of falling) at rehabilitation discharge. METHODS: Fifty-five individuals undergoing inpatient stroke rehabilitation participated in this study. Supervised machine learning classifiers were retrospectively trained to predict discharge outcomes using data collected at hospital admission, including patient information, functional assessment scores, and inertial sensor data from the lower limbs during gait and/or balance tasks. Model performance was compared across different data combinations and was benchmarked against a traditional model trained without sensor data. RESULTS: For patients who were ambulatory at admission, sensor data improved the predictions of ambulation and risk of falling (with weighted F1 scores increasing by 19.6% and 23.4%, respectively) and maintained similar performance for predictions of independence, compared to a benchmark model without sensor data. The best-performing sensor-based models predicted discharge ambulation (community vs household), independence (high vs low), and risk of falling (normal vs high) with accuracies of 84.4%, 68.8%, and 65.9%, respectively. Most misclassifications occurred with admission or discharge scores near the classification boundary. For patients who were nonambulatory at admission, sensor data recorded during simple balance tasks did not offer predictive value over the benchmark models. CONCLUSION: These findings support the continued investigation of wearable sensors as an accessible, easy-to-use tool to predict the functional recovery after stroke. IMPACT: Accurate, early prediction of poststroke rehabilitation outcomes from wearable sensors would improve our ability to deliver personalized, effective care and discharge planning in the inpatient setting and beyond.

Occupational therapy for persons with cognitive impairments.

Background: Damage to the central nervous system can occur in adulthood, for example, due to stroke, trauma, tumours, or chronic diseases. After damage to the central nervous system, cognitive impairments occur in addition to physical limitations. Occupational therapy is most often prescribed for neurological diagnoses, including stroke and traumatic brain injury. Methods: The health technology assessment (HTA) report this HTA article is based on investigates the clinical effectiveness, cost-effectiveness, and patient-related, social and ethical aspects of occupational therapy for patients with cognitive impairments compared to no occupational therapy. In addition, the effects of different occupational therapy interventions with and without cognitive components were compared in an explorative overview. Patients with moderate or severe dementia are excluded from the assessment. Systematic overviews, that is, systematic reviews of systematic reviews, were conducted. Results: For the evaluation of clinical effectiveness, a total of nine systematic reviews were included. No systematic review was identified for the assessment of costs or cost-effectiveness. Five systematic reviews were included for the assessment of patient and social aspects. For the assessment of clinical effectiveness compared with no occupational therapy, five systematic reviews comprising 20 randomised controlled trials with a total of 1,316 subjects reported small positive effects for the outcomes "global cognitive function" and "activities of daily living" as well as a non-quantified positive effect on the outcomes "health-related quality of life" and "behavioural control". No effect was found for individual components of cognition and measures of perception. The quality of the evidence for all outcomes is low due to a high risk of bias. In the supplementary presentations, no positive effects could be demonstrated on the basis of the available evidence. The quality of this evidence was not assessed. For the assessment of patient and social aspects, five systematic reviews on patients with a stroke or a traumatic brain injury - without specification regarding cognitive deficits or studies with their relatives - were included. It was reported that patients and family caregivers go through different phases of rehabilitation in which the discharge home is a decisive turning point. The discharge home represents a crucial breaking point. Regaining an active, self-determining role is a process that requires therapists to find the right level of support for patients and relatives. For the assessment of ethical aspects, nine documents were included. We identified ethical problem-solving models for occupational therapy and 16 ethical aspects in occupational therapy for cognitive deficits. The central theme of the analysis is the limited autonomy due to the consequences of the disease as well as the resulting tensions with those treating the patient. Conclusions: Based on this systematic overview, it can neither be proven nor excluded with certainty that occupational therapy for cognitive impairment is an effective therapy for adult patients with central nervous system injuries compared to no occupational therapy. There is a lack of randomised trials with sufficient sample size, well-defined interventions, and comparable concomitant therapies in the control groups, but there is also a lack of well-designed observational studies in routine care and health economic studies. The identified systematic reviews on patient and social aspects provide information on the needs of patients after stroke or traumatic brain injury and their relatives, but there is a lack of studies on this aspect in German-speaking countries. For the ethical assessment, in addition to the identified theoretical models for solving ethical conflicts in occupational therapy, more empirical studies on ethical aspects with patients with cognitive deficits and their relatives as well as occupational therapists are needed.