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1.
Am Heart J ; 275: 62-73, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-38795793

RESUMO

The limitations of the explanatory clinical trial framework include the high expense of implementing explanatory trials, restrictive entry criteria for participants, and redundant logistical processes. These limitations can result in slow evidence generation that is not responsive to population health needs, yielding evidence that is not generalizable. Clinically integrated trials, which integrate clinical research into routine care, represent a potential solution to this challenge and an opportunity to support learning health systems. The operational and design features of clinically integrated trials include a focused scope, simplicity in design and requirements, the leveraging of existing data structures, and patient participation in the entire trial process. These features are designed to minimize barriers to participation and trial execution and reduce additional research burdens for participants and clinicians alike. Broad adoption and scalability of clinically integrated trials are dependent, in part, on continuing regulatory, healthcare system, and payer support. This analysis presents a framework of the strengths and challenges of clinically integrated trials and is based on a multidisciplinary expert "Think Tank" panel discussion that included representatives from patient populations, academia, non-profit funding agencies, the U.S. Food and Drug Administration, and industry.


Assuntos
Ensaios Clínicos como Assunto , Humanos , Projetos de Pesquisa
2.
Artigo em Inglês | MEDLINE | ID: mdl-38895976

RESUMO

BACKGROUND: The use of intranasal dexmedetomidine is hampered by a limited understanding of its absorption pharmacokinetics. METHODS: We examined the pharmacokinetics and feasibility of intranasal dexmedetomidine administered in the supine position to adult patients undergoing general anaesthesia. Twenty-eight patients between 35 and 80 years of age, ASA 1-3 and weight between 50 and 100 kg, who underwent elective unilateral total hip or knee arthroplasty under general anaesthesia were recruited. All patients received 100 µg of intranasal dexmedetomidine after anaesthesia induction. Six venous blood samples (at 0, 5, 15, 45, 60, 240 min timepoints from dexmedetomidine administration) were collected from each patient and dexmedetomidine plasma concentrations were measured. Concentration-time profiles after nasal administration were pooled with earlier data from a population analysis of intravenous dexmedetomidine (n = 202) in order to estimate absorption parameters using nonlinear mixed effects. Peak concentration (CMAX) and time (TMAX) were estimated using simulation (n = 1000) with parameter estimates and their associated variability. RESULTS: There were 28 adult patients with a mean (SD) age of 66 (8) years and weight of 83 (10) kg. The mean weight-adjusted dose of dexmedetomidine was 1.22 (0.15) µg kg-1. CMAX 0.273 µg L-1 was achieved at 98 min after intranasal administration (TMAX). The relative bioavailability of dexmedetomidine was 80% (95% CI 75-91%). The absorption half-time (TABS = 120 min; 95% CI 90-147 min) was slower than that in previous pharmacokinetic studies on adult patients. Perioperative haemodynamics of all patients remained stable. CONCLUSIONS: Administration of intranasal dexmedetomidine in the supine position during general anaesthesia is feasible with good bioavailability. This administration method has slower absorption when compared to awake patients in upright position, with consequent concentrations attained after TMAX for several hours.

3.
BMC Health Serv Res ; 24(1): 65, 2024 Jan 12.
Artigo em Inglês | MEDLINE | ID: mdl-38216977

RESUMO

BACKGROUND: Quality indicators are standardized, evidence-based measures of health care quality. Currently, there is no basic set of quality indicators for chiropractic care published in peer-reviewed literature. The goal of this research is to develop a preliminary set of quality indicators, measurable with administrative data. METHODS: We conducted a scoping review searching PubMed/MEDLINE, CINAHL, and Index to Chiropractic Literature databases. Eligible articles were published after 2011, in English, developing/reporting best practices and clinical guidelines specifically developed for, or directly applicable to, chiropractic care. Eligible non-peer-reviewed sources such as quality measures published by the Centers for Medicare and Medicaid Services and the Royal College of Chiropractors quality standards were also included. Following a stepwise eligibility determination process, data abstraction identified specific statements from included sources that can conceivably be measured with administrative data. Once identified, statements were transformed into potential indicators by: 1) Generating a brief title and description; 2) Documenting a source; 3) Developing a metric; and 4) Assigning a Donabedian category (structure, process, outcome). Draft indicators then traversed a 5-step assessment: 1) Describes a narrowly defined structure, process, or outcome; 2) Quantitative data can conceivably be available; 3) Performance is achievable; 4) Metric is relevant; 5) Data are obtainable within reasonable time limits. Indicators meeting all criteria were included in the final set. RESULTS: Literature searching revealed 2562 articles. After removing duplicates and conducting eligibility determination, 18 remained. Most were clinical guidelines (n = 10) and best practice recommendations (n = 6), with 1 consensus and 1 clinical standards development study. Data abstraction and transformation produced 204 draft quality indicators. Of those, 57 did not meet 1 or more assessment criteria. After removing duplicates, 70 distinct indicators remained. Most indicators matched the Donabedian category of process (n = 35), with 31 structure and 4 outcome indicators. No sources were identified to support indicator development from patient perspectives. CONCLUSIONS: This article proposes a preliminary set of 70 quality indicators for chiropractic care, theoretically measurable with administrative data and largely obtained from electronic health records. Future research should assess feasibility, achieve stakeholder consensus, develop additional indicators including those considering patient perspectives, and study relationships with clinical outcomes. TRIAL REGISTRATION: Open Science Framework, https://osf.io/t7kgm.


Assuntos
Quiroprática , Idoso , Humanos , Estados Unidos , Indicadores de Qualidade em Assistência à Saúde , Medicare , Qualidade da Assistência à Saúde
4.
Paediatr Anaesth ; 34(9): 934-940, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-38655874

RESUMO

Australia and New Zealand are two countries in the Southern Pacific region. They share many pediatric anesthesia similarities in terms of medical organizational systems, education, training, and research, however there are important differences between the two nations in relation to geography, the First Nations populations and the history of colonization. While the standards for pediatric anesthesia and the specialty training requirements are set by the Australian and New Zealand College of Anesthetists and the Society for Pediatric Anesthesia in New Zealand and Australia, colonization has created distinct challenges that each nation now faces in order to improve the anesthetic care of its pediatric population. Australia generally has a high standard of living and good access to health care; disparities exist for First Nations People and for those living in rural or remote areas. Two influences have shaped training within New Zealand over the past 40 years; establishment of a national children's hospital in 1990 and, more importantly, acknowledgement that the First Nations people of New Zealand (Maori) have suffered because of failure to recognize their rights consequent to establishing a partnership treaty between Maori and the British Crown in 1840. Health inequities among Maori in New Zealand and First Nations People in Australia have implications for the health system, culturally appropriate approaches to treatment, and the importance of having an appreciation of First Nations people's history and culture, language, family structure, and cultural safety. Trainees in both countries need to be adequately supported in these areas in order for the sub-specialty of pediatric anesthesia to develop further and improve the anesthetic and surgical outcomes of our children.


Assuntos
Anestesia , Anestesiologia , Disparidades em Assistência à Saúde , Havaiano Nativo ou Outro Ilhéu do Pacífico , Humanos , Nova Zelândia , Austrália , Criança , Disparidades em Assistência à Saúde/etnologia , Pediatria , Anestesia Pediátrica , Povo Maori
5.
J Cardiovasc Nurs ; 2024 Mar 21.
Artigo em Inglês | MEDLINE | ID: mdl-38509035

RESUMO

BACKGROUND: Sleep disruption, a common symptom among patients requiring cardiovascular surgery, is a potential risk factor for the development of postoperative delirium. Postoperative delirium is a disorder of acute disturbances in cognition associated with prolonged hospitalization, cognitive decline, and mortality. OBJECTIVE: The aim of this study was to evaluate the feasibility and acceptability of using polysomnography (PSG) to capture sleep in patients with scheduled cardiothoracic surgery. METHODS: Wireless limited PSG assessed sleep at baseline (presurgery at home), postoperatively in the intensive care unit, and at home post hospital discharge. Primary outcomes were quality and completeness of PSG signals, and acceptability by participants and nursing staff. RESULTS: Among 15 patients, PSG data were of high quality, and mean percentage of unscorable data was 5.5% ± 11.1%, 3.7% ± 5.4%, and 3.7% ± 8.4% for baseline, intensive care unit, and posthospitalization measurements, respectively. Nurses and patients found the PSG monitor acceptable. CONCLUSIONS: Wireless, limited PSG to capture sleep across the surgical continuum was feasible, and data were of high quality. Authors of future studies will evaluate associations of sleep indices and development of postoperative delirium in this high-risk population.

6.
Cogn Emot ; 38(5): 834-840, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38427425

RESUMO

To find a target in visual search, it is often necessary to filter out task-irrelevant distractors. People find the process of distractor filtering effortful, exerting physical effort to reduce the number of distractors that need to be filtered on a given search trial. Working memory demands are sufficiently costly that people are sometimes willing to accept aversive heat stimulation in exchange for the ability to avoid performing a working memory task. The present study examines whether filtering distractors in visual search is similarly costly. The findings reveal that individuals are sometimes willing to accept an electric shock in exchange for the ability to skip a single trial of visual search, increasingly so as the demands of distractor filtering increase. This was true even when acceptance of shock resulted in no overall time savings, although acceptance of shock was overall infrequent and influenced by a plurality of factors, including boredom and curiosity. These findings have implications for our understanding of the mental burden of distractor filtering and why people seek to avoid cognitive effort more broadly.


Assuntos
Atenção , Memória de Curto Prazo , Humanos , Feminino , Masculino , Adulto Jovem , Adulto , Percepção Visual , Tédio , Estimulação Luminosa , Comportamento Exploratório , Eletrochoque/psicologia , Tempo de Reação
7.
J Acoust Soc Am ; 155(5): 3233-3241, 2024 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-38742962

RESUMO

Focusing waves with a spatial extent smaller than a half wavelength (i.e., super resolution or sub diffraction limit) is possible using resonators placed in the near field of time reversal (TR) focusing. While a two-dimensional (2D) Helmholtz resonator array in a three-dimensional reverberant environment has limited ability to produce a high-resolution spatial focus in the TR focusing of audible sound, it is shown that acoustic waves propagating out-of-plane with the resonator array are not as strongly affected by the smaller effective wavelength induced by the resonator array, partially negating the effect of the resonators. A physical 2D waveguide is shown to limit the out-of-plane propagation, leading to improved resolution. It is also shown that post processing using an orthogonal particle velocity decomposition of a spatial scan of the focusing can filter out-of-plane particle motion in the near field of the array, which bypasses the effect of the unwanted third spatial dimension of propagation. The spatial resolution in a reverberant environment is shown to improve in the presence of a 2D Helmholtz resonator array and then further improve by adding a 2D waveguide. The resolution among the resonator array is better still without using a waveguide and instead using the partial-pressure reconstruction.

8.
Cogn Emot ; 38(5): 789-800, 2024 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-38411172

RESUMO

Attentional bias to threat has been almost exclusively examined after participants experienced repeated pairings between a conditioned stimulus (CS) and an aversive unconditioned stimulus (US). This study aimed to determine whether threat-related attentional capture can result from observational learning, when participants acquire knowledge of the aversive qualities of a stimulus without themselves experiencing aversive outcomes. Non-clinical young-adult participants (N = 38) first watched a video of an individual (the demonstrator) performing a Pavlovian conditioning task in which one colour was paired with shock (CS+) and another colour was neutral (CS-). They then carried out visual search for a shape-defined target. Oculomotor measures evidenced an attentional bias toward the CS+ colour, suggesting that threat-related attentional capture can ensue from observational learning. Exploratory analyses also revealed that this effect was positively correlated with empathy for the demonstrator. Our findings extend empirical and theoretical knowledge about threat-driven attention and provide valuable insights to better understand the formation of anxiety disorders.


Assuntos
Viés de Atenção , Condicionamento Clássico , Medo , Humanos , Masculino , Feminino , Viés de Atenção/fisiologia , Condicionamento Clássico/fisiologia , Adulto Jovem , Medo/psicologia , Empatia/fisiologia , Adulto , Adolescente , Aprendizagem , Estimulação Luminosa
9.
J Appl Clin Med Phys ; 25(6): e14359, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38689502

RESUMO

PURPOSE: AAPM Task Group No. 263U1 (Update to Report No. 263 - Standardizing Nomenclatures in Radiation Oncology) disseminated a survey to receive feedback on utilization, gaps, and means to facilitate further adoption. METHODS: The survey was created by TG-263U1 members to solicit feedback from physicists, dosimetrists, and physicians working in radiation oncology. Questions on the adoption of the TG-263 standard were coupled with demographic information, such as clinical role, place of primary employment (e.g., private hospital, academic center), and size of institution. The survey was emailed to all AAPM, AAMD, and ASTRO members. RESULTS: The survey received 463 responses with 310 completed survey responses used for analysis, of whom most had the clinical role of medical physicist (73%) and the majority were from the United States (83%). There were 83% of respondents who indicated that they believe that having a nomenclature standard is important or very important and 61% had adopted all or portions of TG-263 in their clinics. For those yet to adopt TG-263, the staffing and implementation efforts were the main cause for delaying adoption. Fewer respondents had trouble adopting TG-263 for organs at risk (29%) versus target (44%) nomenclature. Common themes in written feedback were lack of physician support and available resources, especially in vendor systems, to facilitate adoption. CONCLUSIONS: While there is strong support and belief in the benefit of standardized nomenclature, the widespread adoption of TG-263 has been hindered by the effort needed by staff for implementation.  Feedback from the survey is being utilized to drive the focus of the update efforts and create tools to facilitate easier adoption of TG-263.


Assuntos
Radioterapia (Especialidade) , Terminologia como Assunto , Humanos , Radioterapia (Especialidade)/normas , Inquéritos e Questionários , Planejamento da Radioterapia Assistida por Computador/métodos , Planejamento da Radioterapia Assistida por Computador/normas , Neoplasias/radioterapia , Órgãos em Risco/efeitos da radiação , Guias de Prática Clínica como Assunto , Percepção
10.
Perfusion ; : 2676591231226291, 2024 Jan 03.
Artigo em Inglês | MEDLINE | ID: mdl-38171494

RESUMO

BACKGROUND: The effect of the anticoagulant, dabigatran, and its antagonist, idarucizumab, on coagulation remains poorly quantified. There are few pharmacokinetic-pharmacodynamic data available to determine dabigatran dose in humans or animals undergoing cardiopulmonary bypass. METHODS: Five sheep were given intravenous dabigatran 4 mg/kg. Blood samples were collected for thromboelastometric reaction time (R-time) and drug assay at 5, 15, 30, 60, 120, 240, 480 min, and 24 h. Plasma dabigatran concentrations and R-times were analyzed using an integrated pharmacokinetic-pharmacodynamic model using non-linear mixed effects. The impact of idarucizumab 15 mg/kg administered 120 min after dabigatran 4 mg/kg and its effect on R-time was observed. RESULTS: A 2-compartment model described dabigatran pharmacokinetics with a clearance (CL 0.0453 L/min/70 kg), intercompartment clearance (Q 0.268 L/min/70 kg), central volume of distribution (V1 2.94 L/70 kg), peripheral volume of distribution (V2 9.51 L/70 kg). The effect compartment model estimates for a sigmoid EMAX model using Reaction time had an effect site concentration (Ce50 64.2 mg/L) eliciting half of the maximal effect (EMAX 180 min). The plasma-effect compartment equilibration half time (T1/2keo) was 1.04 min. Idarucizumab 15 mg/kg reduced R-time by approximately 5 min. CONCLUSIONS: Dabigatran reversibly binds to the active site on the thrombin molecule, preventing activation of coagulation factors. The pharmacologic target concentration strategy uses pharmacokinetic-pharmacodynamic information to inform dose. A loading dose of dabigatran 0.25 mg/kg followed by a maintenance infusion of dabigatran 0.0175 mg/kg/min for 30 min and a subsequent infusion dabigatran 0.0075 mg/kg/min achieves a steady state target concentration of 5 mg/L in a sheep model.

11.
JAMA ; 331(3): 245-249, 2024 01 16.
Artigo em Inglês | MEDLINE | ID: mdl-38117493

RESUMO

Importance: Given the importance of rigorous development and evaluation standards needed of artificial intelligence (AI) models used in health care, nationwide accepted procedures to provide assurance that the use of AI is fair, appropriate, valid, effective, and safe are urgently needed. Observations: While there are several efforts to develop standards and best practices to evaluate AI, there is a gap between having such guidance and the application of such guidance to both existing and new AI models being developed. As of now, there is no publicly available, nationwide mechanism that enables objective evaluation and ongoing assessment of the consequences of using health AI models in clinical care settings. Conclusion and Relevance: The need to create a public-private partnership to support a nationwide health AI assurance labs network is outlined here. In this network, community best practices could be applied for testing health AI models to produce reports on their performance that can be widely shared for managing the lifecycle of AI models over time and across populations and sites where these models are deployed.


Assuntos
Inteligência Artificial , Atenção à Saúde , Laboratórios , Garantia da Qualidade dos Cuidados de Saúde , Qualidade da Assistência à Saúde , Inteligência Artificial/normas , Instalações de Saúde/normas , Laboratórios/normas , Parcerias Público-Privadas , Garantia da Qualidade dos Cuidados de Saúde/normas , Atenção à Saúde/normas , Qualidade da Assistência à Saúde/normas , Estados Unidos
14.
Paediatr Anaesth ; 2024 Jul 16.
Artigo em Inglês | MEDLINE | ID: mdl-39011727
16.
Vision Res ; 217: 108366, 2024 04.
Artigo em Inglês | MEDLINE | ID: mdl-38387262

RESUMO

The control of attention was long held to reflect the influence of two competing mechanisms of assigning priority, one goal-directed and the other stimulus-driven. Learning-dependent influences on the control of attention that could not be attributed to either of those two established mechanisms of control gave rise to the concept of selection history and a corresponding third mechanism of attentional control. The trichotomy framework that ensued has come to dominate theories of attentional control over the past decade, replacing the historical dichotomy. In this theoretical review, I readily affirm that distinctions between the influence of goals, salience, and selection history are substantive and meaningful, and that abandoning the dichotomy between goal-directed and stimulus-driven mechanisms of control was appropriate. I do, however, question whether a theoretical trichotomy is the right answer to the problem posed by selection history. If we reframe the influence of goals and selection history as different flavors of memory-dependent modulations of attentional priority and if we characterize the influence of salience as a consequence of insufficient competition from such memory-dependent sources of priority, it is possible to account for a wide range of attention-related phenomena with only one mechanism of control. The monolithic framework for the control of attention that I propose offers several concrete advantages over a trichotomy framework, which I explore here.


Assuntos
Atenção , Recompensa , Humanos , Aprendizagem , Motivação , Tempo de Reação
17.
Cognition ; 250: 105862, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-38880064

RESUMO

Individuals exhibit limited awareness of when their attention is captured by salient but irrelevant stimuli, and it has long been argued that involuntary attentional capture by such stimuli is minimally disruptive to information processing. Yet, robust mechanisms of distractor suppression are hypothesized to support the control of attention, which presumably serve in the interest of managing distraction. In the present study, I examine whether participants are aware of the cost of distraction with respect to task performance, and whether they are motivated to manage this cost even when it is effortful to do so. Across three experiments, participants were willing to exert physical effort in order to reduce the frequency with which they encountered physically salient distractors, and in a fourth experiment tended to prefer trials with fewer distractors when given a choice over distractor frequency. Importantly, the amount of physical effort exerted varied as a function of the degree to which task-irrelevant distractors impaired search performance, suggesting that people are sensitive to the cost of distraction.


Assuntos
Atenção , Motivação , Humanos , Atenção/fisiologia , Motivação/fisiologia , Masculino , Feminino , Adulto Jovem , Adulto , Tempo de Reação/fisiologia , Conscientização/fisiologia
18.
Neuropsychopharmacology ; 49(1): 96-103, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37479859

RESUMO

The clinical investigation of psychedelic medicines has blossomed over the last 5 years. Data from a Phase 3 industry trial and a multicenter Phase 2 industry trial, in addition to multiple early phase investigator-initiated and industry trials, have now been published in peer-reviewed journals. This narrative review summarizes both the recent data and the current clinical trials that are being conducted with various classes of "psyche-manifesting" substances, which may prove beneficial in the treatment of a broad range of conditions. Methodological considerations, unique challenges, and next steps for research are discussed in keeping with the uniquely "experiential" nature of these therapies.


Assuntos
Alucinógenos , Alucinógenos/farmacologia , Alucinógenos/uso terapêutico , Estudos Multicêntricos como Assunto
19.
J Chiropr Educ ; 2024 Apr 16.
Artigo em Inglês | MEDLINE | ID: mdl-38621691

RESUMO

OBJECTIVE: To evaluate the association between basic science curriculum delivery method with other academic and demographic factors on National Board of Chiropractic Examiners (NBCE) part I pass rates. METHODS: This was a retrospective cohort study of students from 3 campuses of 1 chiropractic institution who matriculated in 2018 or 2020. COVID-19 regulations required online delivery of a basic science curriculum for students in the 2020 cohorts, whereas students in the 2018 cohorts experienced a traditional classroom delivery. A general linear model estimated odds ratios for passing NBCE part I, comparing individual online cohorts with the combined classroom cohort while adjusting for academic and demographic variables. RESULTS: A total of 968 students were included, 55% from the classroom cohort. The spring 2020 cohort had the fewest students with bachelors' degrees (59%) and more students with high in-program grade point averages (GPA; 61%) along with the lowest estimated odds ratio [0.80 (95% CI: 0.73-0.87)] for passing vs the classroom cohort. The fall 2020 cohort had significantly higher odds [1.06 (95% CI: 1.00-1.03)] of passing vs the classroom cohort. Additional predictors included main campus matriculation, white ethnicity, bachelors' degree, no alternative admission status, and in-program GPA. Students with high in-program GPA (vs low) had a 36% increased odds of passing. CONCLUSION: Compared to the classroom cohort, the spring 2020 cohort had the lowest odds while the fall 2020 cohort had the highest odds of passing part I. In-program GPA had the highest association with passing. These results provide information on how curriculum delivery impacts board exam performance.

20.
bioRxiv ; 2024 Feb 27.
Artigo em Inglês | MEDLINE | ID: mdl-38464286

RESUMO

In the field of psychological science, behavioral performance in computer-based cognitive tasks often exhibits poor reliability. The absence of reliable measures of cognitive processes contributes to non-reproducibility in the field and impedes investigation of individual differences. Specifically in visual search paradigms, response time-based measures have shown poor test-retest reliability and internal consistency across attention capture and distractor suppression, but one study has demonstrated the potential for oculomotor measures to exhibit superior reliability. Therefore, in this study, we investigated three datasets to compare the reliability of learning-dependent distractor suppression measured via distractor fixations (oculomotor capture) and latency to fixate the target (fixation times). Our findings reveal superior split-half reliability of oculomotor capture compared to that of fixation times regardless of the critical distractor comparison, with the reliability of oculomotor capture in most cases falling within the range that is acceptable for the investigation of individual differences. We additionally find that older adults have superior oculomotor reliability compared with young adults, potentially addressing a significant limitation in the aging literature of high variability in response time measures due to slower responses. Our findings highlight the utility of measuring eye movements in the pursuit of reliable indicators of distractor processing and the need to further test and develop additional measures in other sensory domains to maximize statistical power, reliability, and reproducibility.

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