Книги з теми "Outcomes validation"

This article explores the role of the Internet in health behaviour, with particular emphasis on the issue of trust and trusting behaviours, as this is seen as key to determining the impact of the Internet on health outcomes. It is organized as follows. The first section discusses the role of the Internet in the context of health information and advice, exploring broader issues such as user motivation and outcomes in terms of perceived health benefits, as well as interactions with healthcare professionals. The article then goes on to examine the types of health websites available, and explores issues of advice and information quality. The following section examines the context of trust in relation to online health advice and information, and presents a staged model of trust that helps reconcile differences in the literature. The last section presents a validation of the staged model through in-depth, longitudinal qualitative work.

Acute kidney injury (AKI) is a common complication of critical illness and its occurrence has been independently associated with both short- and longer-term morbidity and mortality. However, conventional diagnosis of AKI, based on rises in serum creatinine, can be delayed and inaccurate, particularly in the context of critical illness. These diagnostic limitations potentially prevent timely intervention and appropriate follow-up of patients experiencing AKI. Recently, a number of novel urinary and serum biomarkers of AKI have been described that may provide earlier and more precise diagnosis. Importantly, a number of these substances are biologically-linked to the pathophysiology of acute tubular injury. However, true validation and widespread clinical uptake of these biomarkers is likely to require demonstration of improved patients’ outcomes as a consequence of biomarker-driven clinical interventions.

This handbook examines theoretical, structural, clinical and implementation aspects of dialectical behaviour therapy (DBT) for a variety of disorders such as borderline personality disorder (BPD), suicidal behaviour in the context of BPD, substance use disorders, cognitive disabilities, eating disorders, and post-traumatic stress disorder (PTSD). The volume considers the dialectical dilemmas of implementation with respect to DBT in both national and international systems, its adaptations in routine clinical settings, and its behavioural foundations. It also discusses evidence-based training in DBT, validation principles and practices in DBT, the biosocial theory of BPD, the structure of DBT programs, and the efficacy of DBT in college counseling centers. Finally, the book reflects on the achievements of DBT since the first treatment trial and considers challenges and future directions for DBT in terms of its theoretical underpinnings, clinical outcomes, adaptations and implementation in practice.

Due to their rarity, heterogeneity, and multispecialty nature, the myositis syndromes have limited data-driven consensus on appropriate outcome measures. Recently, two international, multispecialty consortia developed new tools and consensus on core set measures of myositis disease activity and damage, as well as response criteria that are now recommended for use as clinical trial endpoints but will also be useful in clinical practice. Magnetic resonance imaging, muscle ultrasound, selected laboratory tests, and immunological biomarkers—including cytokines, chemokines, lymphocyte flow cytometry, and endothelial activation markers—can all be helpful adjuncts to serum muscle enzyme levels in assessing disease activity and damage, but these have not yet been fully validated. Definitions of clinically inactive disease, complete clinical response, and remission have also been proposed but require further validation. These advances should enhance the development of therapies by standardizing our ability to demonstrate their efficacy in treating the idiopathic inflammatory myopathies.

This chapter describes the Korematsu, Hirabayashi, and Yasui coram nobis reopenings of the World War II curfew and exclusion cases. The mid-1980s coram nobis courts made startling findings of egregious unethical misconduct at the government’s highest levels in justifying the curfew, removal, and incarceration. A cache of previously hidden World War II government documents revealed frantic efforts by War and Justice Departments leaders to deliberately mislead the Supreme Court and American public and to alter and fabricate key evidence on national security. The chapter enfolds Acting U.S. Solicitor General Neal Katyal’s unprecedented 2012 “Confession of Error” acknowledging the World War II solicitor general’s deliberate and prejudicial misrepresentations to the Supreme Court. It closes by highlighting the outcome of pervasive government disinformation on security and court passivity: the judiciary’s legal validation of the political branches’ prolonged deprivation of a vulnerable group’s liberty on an unfounded claim of urgent need.

Development of new therapies for rheumatic diseases requires a series of randomized controlled trials (RCTs) progressing from phase 1, 'first-in-human' to generate initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data; to phase 2, proof of concept for efficacy with safety and PK/PD data; and phase 3, designed to demonstrate definitive efficacy and safety to support regulatory approval. Important aspects of RCT designs include sample size estimations, treatment allocation, rescue, blinding, and statistical analyses of prespecified endpoints to preserve trial integrity. Over the past 15 years, significant progress has been made in the design of RCTs in rheumatoid arthritis (RA). Similarly, development and validation of composite outcome measures in psoriatic arthritis, ankylosing spondylitis, gout, and osteoarthritis have furthered trial design and treatment approvals. RCTs in systemic lupus erythematosus and other multisystem, heterogeneous diseases pose more challenges. Trial design will continue to evolve as promising therapies are introduced into the clinic.

Development of new therapies for rheumatic diseases requires a series of randomized controlled trials (RCTs) progressing from phase 1, ’first-in-human’ to generate initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data; to phase 2, proof of concept for efficacy with safety and PK/PD data; and phase 3, designed to demonstrate definitive efficacy and safety to support regulatory approval. Important aspects of RCT designs include sample size estimations, treatment allocation, rescue, blinding, and statistical analyses of prespecified endpoints to preserve trial integrity. Over the past 15 years, significant progress has been made in the design of RCTs in rheumatoid arthritis (RA). Similarly, development and validation of composite outcome measures in psoriatic arthritis, ankylosing spondylitis, gout, and osteoarthritis have furthered trial design and treatment approvals. RCTs in systemic lupus erythematosus and other multisystem, heterogeneous diseases pose more challenges. Trial design will continue to evolve as promising therapies are introduced into the clinic.

Development of new therapies for rheumatic diseases requires a series of randomized controlled trials (RCTs) progressing from phase 1, ’first-in-human’ to generate initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data; to phase 2, proof of concept for efficacy with safety and PK/PD data; and phase 3, designed to demonstrate definitive efficacy and safety to support regulatory approval. Important aspects of RCT designs include sample size estimations, treatment allocation, rescue, blinding, and statistical analyses of prespecified endpoints to preserve trial integrity. Over the past 15 years, significant progress has been made in the design of RCTs in rheumatoid arthritis (RA). Similarly, development and validation of composite outcome measures in psoriatic arthritis, ankylosing spondylitis, gout, and osteoarthritis have furthered trial design and treatment approvals. RCTs in systemic lupus erythematosus and other multisystem, heterogeneous diseases pose more challenges. Trial design will continue to evolve as promising therapies are introduced into the clinic.

The nosology developed by Kraepelin at the end of the nineteenth century was the first comprehensive paradigm for psychiatric research. He conjectured that clinical features, experiment, and anatomy will validate psychiatric diagnoses, that these validators converge on natural disease units, and that there is a hierarchy of validators, with course and outcome being the most important. Current psychiatric research is still shaped by Kraepelin’s paradigm, and we continue to design experiments and studies based on the dogma of the natural disease unit. To make progress, we need a new strategy for psychiatric research. We need to determine the strength of evidence for each validator, rank the strength of evidence for each diagnosis, and build consensus for the value for validators. The current debate about the scientific status of psychiatric nosology is the result of conflicting value judgments regarding validators of psychiatric diagnoses.

Advances in basic science, translational, and clinical research have led to rapid improvements in our understanding of many disease processes. The randomized clinical trial (RCT) has played an important role in validating the benefits and harms of therapies thought to be potentially useful based on scientific theory or clinical observation, and has become the ‘gold standard’ for the demonstration of efficacy. As in all clinical study designs, the RCT has strengths and weaknesses that must be understood to appropriately interpret the study results. While randomization of the intended study population is the primary strength of such trials, choice of the study population, control condition, outcome measures, analysis procedure, and procedures for blinding the study participants can all affect the results. Understanding the requirements of a valid RCT and what can potentially go wrong will improve the conduct of palliative care research and the usefulness of published information in the care of patients.

These Guidelines are one of the results of the four-year research project “Open Online Learning for Digital and Networked Society” (2017-2021). The project objective was to enable university teachers to design open and online learning through open and online learning curriculum and environment applying learning analytics as a metacognitive tool and creating open and online learning assessment and recognition practices, responding to the needs of digital and networked society. The research of the project resulted in 10 scientific publications and 2 studies prepared by Vytautas Magnus university Institute of Innovative Studies research team in collaboration with their international research partners from Germany, Spain and Portugal. The final stage of the research attempted creating open and online learning assessment and recognition practices, responding to the learner needs in contemporary digital and networked society. The need for open learning recognition has been increasing during the recent decade while the developments of open learning related to the Covid 19 pandemics have dramatically increased the need for systematic and high-quality assessment and recognition of learning acquired online. The given time also relates to the increased need to offer micro-credentials to learners, as well as a rising need for universities to prepare for micro-credentialization and issue new digital credentials to learners who are regular students, as well as adult learners joining for single courses. The increased need of all labour - market participants for frequent and fast renewal of competences requires a well working and easy to use system of open learning assessment and recognition. For learners, it is critical that the micro-credentials are well linked to national and European qualification frameworks, as well as European digital credential infrastructures (e.g., Europass and similar). For employers, it is important to receive requested quality information that is encrypted in the metadata of the credential. While for universities, there is the need to properly prepare institutional digital infrastructure, organizational procedures, descriptions of open learning opportunities and virtual learning environments to share, import and export the meta-data easily and seamlessly through European Digital Hub service infrastructures, as well as ensure that academic and administrative staff has digital competencies to design, issue and recognise open learning through digital and micro-credentials. The first chapter of the Guidelines provides a background view of the European Qualification Framework and National Qualification frameworks for the further system of gaining, stacking and modelling further qualifications through open online learning. The second chapter suggests the review of current European policy papers and consultations on the establishment of micro-credentials in European higher education. The findings of the report of micro-credentials higher education consultation group “European Approach to Micro-credentials” is shortly introduced, as well as important policy discussions taking place. Responding to the Rome Bologna Comunique 2020, where the ministers responsible for higher education agreed to support lifelong learning through issuing micro-credentials, a joint endeavour of DG Employment, Social Affairs and Inclusion and DG Research and Innovation resulted in one of the most important political documents highlighting the potential of micro-credentials towards economic, social and education innovations. The consultation group of experts from the Member States defined the approach to micro-credentials to facilitate their validation, recognition and portability, as well as to foster a larger uptake to support individual learning in any subject area and at any stage of life or career. The Consultation Group also suggested further urgent topics to be discussed, including the storage, data exchange, portability, and data standards of micro-credentials and proposed EU Standard of constitutive elements of micro-credentials. The third chapter is devoted to the institutional readiness to issue and to recognize digital and micro-credentials. Universities need strategic decisions and procedures ready to be enacted for assessment of open learning and issuing micro-credentials. The administrative and academic staff needs to be aware and confident to follow these procedures while keeping the quality assurance procedures in place, as well. The process needs to include increasing teacher awareness in the processes of open learning assessment and the role of micro-credentials for the competitiveness of lifelong learners in general. When the strategic documents and procedures to assess open learning are in place and the staff is ready and well aware of the processes, the description of the courses and the virtual learning environment needs to be prepared to provide the necessary metadata for the assessment of open learning and issuing of micro-credentials. Different innovation-driven projects offer solutions: OEPass developed a pilot Learning Passport, based on European Diploma Supplement, MicroHE developed a portal Credentify for displaying, verifying and sharing micro-credential data. Credentify platform is using Blockchain technology and is developed to comply with European Qualifications Framework. Institutions, willing to join Credentify platform, should make strategic discussions to apply micro-credential metadata standards. The ECCOE project building on outcomes of OEPass and MicroHE offers an all-encompassing set of quality descriptors for credentials and the descriptions of learning opportunities in higher education. The third chapter also describes the requirements for university structures to interact with the Europass digital credentials infrastructure. In 2020, European Commission launched a new Europass platform with Digital Credential Infrastructure in place. Higher education institutions issuing micro-credentials linked to Europass digital credentials infrastructure may offer added value for the learners and can increase reliability and fraud-resistant information for the employers. However, before using Europass Digital Credentials, universities should fulfil the necessary preconditions that include obtaining a qualified electronic seal, installing additional software and preparing the necessary data templates. Moreover, the virtual learning environment needs to be prepared to export learning outcomes to a digital credential, maintaining and securing learner authentication. Open learning opportunity descriptions also need to be adjusted to transfer and match information for the credential meta-data. The Fourth chapter illustrates how digital badges as a type of micro-credentials in open online learning assessment may be used in higher education to create added value for the learners and employers. An adequately provided metadata allows using digital badges as a valuable tool for recognition in all learning settings, including formal, non-formal and informal.