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These 10 guiding principles are intended to lay the foundation for developing Good Machine Learning Practice that addresses the unique nature of these products. They will also help cultivate future growth in this rapidly progressing field. The 10 guiding principles identify areas where the International Medical Device Regulators Forum (IMDRF), international standards organizations and other collaborative bodies could work amoxil online no prescription to advance GMLP. Areas of collaboration include research, creating educational tools and resources, international harmonization, and consensus standards, which may help inform regulatory policies and regulatory guidelines.

We envision these guiding principles may be used to. Adopt good practices that have been proven in other sectors Tailor practices from other sectors so they are applicable to medical technology and the health care sector Create new practices specific for medical technology amoxil online no prescription and the health care sector As the AI/ML medical device field evolves, so too must GMLP best practice and consensus standards. Strong partnerships with our international public health partners will be crucial if we are to empower stakeholders to advance responsible innovations in this area. Thus, we expect this initial collaborative work can inform our broader international engagements, including with the IMDRF.

We welcome your continued feedback through the public docket (FDA-2019-N-1185) at Regulations.gov, and we look amoxil online no prescription forward to engaging with you on these efforts. The Digital Health Center of Excellence is spearheading this work for the FDA. Contact us directly at Digitalhealth@fda.hhs.gov, software@mhra.gov.uk, and mddpolicy-politiquesdim@hc-sc.gc.ca. Guiding principles Multi-Disciplinary amoxil online no prescription Expertise Is Leveraged Throughout the Total Product Life Cycle.

In-depth understanding of a model's intended integration into clinical workflow, and the desired benefits and associated patient risks, can help ensure that ML-enabled medical devices are safe and effective and address clinically meaningful needs over the lifecycle of the device. Good Software Engineering and Security Practices Are Implemented. Model design is implemented with attention to the "fundamentals" amoxil online no prescription. Good software engineering practices, data quality assurance, data management, and robust cybersecurity practices.

These practices include methodical risk management and design process that can appropriately capture and communicate design, implementation, and risk management decisions and rationale, as well as ensure data authenticity and integrity. Clinical Study Participants and Data Sets Are Representative of the Intended Patient Population. Data collection protocols should ensure that the relevant characteristics of the intended patient population (for example, in terms of age, gender, sex, race, and ethnicity), use, and measurement inputs are sufficiently represented in a sample of adequate size in the clinical amoxil online no prescription study and training and test datasets, so that results can be reasonably generalized to the population of interest. This is important to manage any bias, promote appropriate and generalizable performance across the intended patient population, assess usability, and identify circumstances where the model may underperform.

Training Data Sets Are Independent of Test Sets. Training and test datasets are selected and maintained to be appropriately independent of one another amoxil online no prescription. All potential sources of dependence, including patient, data acquisition, and site factors, are considered and addressed to assure independence. Selected Reference Datasets Are Based Upon Best Available Methods.

Accepted, best available methods for developing a reference dataset (that is, a reference standard) ensure that clinically relevant and well characterized data are collected and the amoxil online no prescription limitations of the reference are understood. If available, accepted reference datasets in model development and testing that promote and demonstrate model robustness and generalizability across the intended patient population are used. Model Design Is Tailored to the Available Data and Reflects the Intended Use of the Device. Model design is suited to the available data and supports the active mitigation of known risks, like overfitting, performance degradation, and security amoxil online no prescription risks.

The clinical benefits and risks related to the product are well understood, used to derive clinically meaningful performance goals for testing, and support that the product can safely and effectively achieve its intended use. Considerations include the impact of both global and local performance and uncertainty/variability in the device inputs, outputs, intended patient populations, and clinical use conditions. Focus Is Placed on the Performance of the amoxil online no prescription Human-AI Team. Where the model has a "human in the loop," human factors considerations and the human interpretability of the model outputs are addressed with emphasis on the performance of the Human-AI team, rather than just the performance of the model in isolation.

Testing Demonstrates Device Performance During Clinically Relevant Conditions. Statistically sound test plans are developed and executed to generate clinically relevant device performance information independently of the training data set amoxil online no prescription. Considerations include the intended patient population, important subgroups, clinical environment and use by the Human-AI team, measurement inputs, and potential confounding factors. Users Are Provided Clear, Essential Information.

Users are provided ready access to clear, contextually relevant amoxil online no prescription information that is appropriate for the intended audience (such as health care providers or patients) including. The product's intended use and indications for use, performance of the model for appropriate subgroups, characteristics of the data used to train and test the model, acceptable inputs, known limitations, user interface interpretation, and clinical workflow integration of the model. Users are also made aware of device modifications and updates from real-world performance monitoring, the basis for decision-making when available, and a means to communicate product concerns to the developer. Deployed Models Are Monitored for Performance and Re-training Risks Are Managed.

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Read fast-track articles.Editorial BoardInformation for AuthorsSubscribe to this TitleInternational Journal of Tuberculosis and Lung DiseasePublic Health ActionIngenta Connect is not responsible for the content or http://mccarthyschoolofirishdance.com/about-me/dresses-for-sale/ availability amoxil online no prescription of external websitesNo AbstractNo Reference information available - sign in for access. No Supplementary Data.No Article MediaNo MetricsDocument Type. EditorialAffiliations:1. Center for Global Health, Division of Infectious amoxil online no prescription Diseases, Department of Medicine, Weill Cornell Medical College, New York, NY, USA, Les Centres GHESKIO, Port-au-Prince, Haiti 2. Adolfo Lutz Institute, SÃ£o Paulo, SP, Brazil, Instituto Oswaldo Cruz/FundaÃ§Ã£o Oswaldo Cruz, Rio de Janeiro, RJ, Brazil 3.

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In the early 19th century, a new idea about care for the mentally ill called âmoral treatmentâ emerged, which focused on the belief that kindness and quietness in treatment would help with recovery. In the 1840âs, Thomas Kirkbride developed the âKirkbride Planâ for moral treatment that included sunshine, fresh air, privacy and comfort. Throughout the 1850s and â60s Dorothea Dix traveled throughout the country promoting this approach.

By the 1870s virtually all states had such asylums. By the 1890s, private almhouses were sending people to the asylums. This influx overwhelmed both space and resources of the asylums and threatened their attempts at humane treatment.

The Great Depression in the 1930s drastically cut state appropriations and World War II created acute shortages of personnel. A move began to reduce costs. The large psychiatric hospitals began to be reduced to units within general hospitals.

Some psychiatrists turned to the new Mental Hygiene movement and created outpatient clinics that focused on preventing psychiatric hospitalizations. Others focused on the brain pathology and experimented with electric shock therapies, psychosurgery and different kinds of medications. By the 1950s, with the rise of nursing homes for the elderly, the asylum period came to an end.

In Michigan, it was University of Michigan Professor William Herdman that set the wheels in motion to build a psychopathic hospital, which opened its doors in 1906, one of the first in the nation. The hospital has lead in cutting-edge research on brain function and the genetic underpinnings of mental illness symptoms ever since, including the development of the biopsychosocial model that is the foundation of psychiatry today. It is out of this same reductionist approach that Partial Hospitalization was born.

Doctors in the 1950s recognized that not all people being treated for mental illness needed overnight stays, even if they needed something more than a weekly appointment in an outpatient clinic. In the early 1960s a group of clinicians involved in the relatively new treatment approach of âday hospitalâ began to discuss the challenges of this approach. By the end of that decade they had organized the American Association for Partial Hospitalization (AAPH).

In 1988, Congress approved a major benefit change for Medicare by including reimbursement for PHP that met a strict definition â treatment five days a week, six hours a day. By the early 1990s, the group had grown to more than 1,200 members and published standards and guidelines for this mode of treatment. In the mid-1990s, the organization became the Association for Ambulatory Behavioral Healthcare (AABH) and now represents hundreds of providers and professionals in the United States, and is the leading advocate for Partial Hospitalization Programs (PHP) and Intensive Outpatient Programs (IOP) nationally.

PHP is often used as a step down from an inpatient stay, or as a way to prevent an inpatient stay. Partial is appropriate for people who are experiencing psychiatric symptoms that interfere with their daily functioning, but are not of imminent danger to themselves or others. The development of the IOP has followed a different route, one steered by the treatment of addictions.

Addiction treatment began in an organized way between 1750 and 1850 through âmutual aid societies.â The asylum model was followed with the opening of âinebriate homesâ throughout the 19th century. Outpatient treatment for addiction began with the opening of the Charles B. Towns Hospital in 1901 in New York.

In 1906, a church-based therapy program began at Bostonâs Emmanuel Clinic, which laid the foundations for the Alcoholics Anonymous movement, which began in earnest 25 years later. Outpatient addiction treatment options grew from 1920s through the 1950s. In the 1960s, insurances began to reimburse for treatments, which lead to continued growth in options.

The famous Betty Ford Clinic was founded in 1982. With the recognition that addictions often have co-occurring mental illness symptoms, by the 1990s addiction programs were expanding to include treatment for mental illness symptoms also, either as dual diagnosis with addictions or stand-alone diagnoses. Now there are IOP programs that specialize in addictions and those that treat specific mental illnesses, such as eating disorders, bipolar, PTSD, as well as general mental illness.

There are also IOPs that serve specific age-related populations such as geriatrics, adolescents and children, as well as general adult programs. IOP may be anywhere from three to five days a week, from three to five hours a day, depending on the program. Michigan has 25 Partial Programs.

MidMichigan Medical Center â Gratiotâs PHP began in 1995. It is one of only three such programs in Michigan north of Lansing. The Gratiot program is an adult program and operates Monday through Friday, 9 a.m.

Â 3 p.m. The average length of stay is seven days. Insurance coverage is the same as other hospitalization coverage.

MidMichigan also has an IOP program for seniors in Gladwin called Senior Life Solutions, which operates three days a week. Depression and anxiety are the most common mental health conditions in the U.S. And the most common conditions treated in Gratiotâs PHP.

According to the Anxiety and Depression Association of America, depression affects about 7.1 percent of the U.S adult population, while anxiety affects about 18 percent of U.S. Population. Adults with depression have a 64 percent greater risk of coronary artery disease.

Depression often co-occurs with medical conditions. 25 percent of cancer patients experience depression, 10 to 27 percent of post-stroke patients, 30 percent of heart attack survivors, 50 percent of patients with Parkinsonâs disease, 30 percent of diabetes patients, and 40 to 70 percent of adult caregivers of the elderly struggle with depression. Women are twice as likely as men to have depression.

Research shows that people with anxiety are three to five times more likely to go to the doctor. In fiscal year 2021, depression was the most common diagnosis seen at Gratiotâs PHP with nearly 83 percent of patients having this diagnosis. Thirty percent of those with depression had a secondary diagnosis of anxiety, with an addition 5 percent of patients having a primary anxiety diagnosis.

Over 100 years of moderntreatment of depression and anxiety has made it clear that these commonconditions are very treatable. In the 25 years of treating them in a daytreatment setting the process has been clarified and refined and is now quitesuccessful. For those who arestruggling with depression or anxiety, the Psychiatric Partial HospitalizationProgram at MidMichigan Medical Center â Gratiot may be reached at (989)466-3253.

Senior Life Solutions can be reached at (989) 246-6339. Thoseinterested in more information on MidMichiganâs comprehensive behavioral healthprograms may visit www.midmichigan.org/mentalhealth..

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Her mentalhealth. This latest example of thecourage of an athlete to stand up and let the world know that mental health ishealth has brought incredible awareness to the importance of mental health inall people, even Olympians. If youâre an athlete, or if youhave kids who play sports, you might be worried and wondering what you can doto address potential mental health amoxil online no prescription struggles related to sports.

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Haveregular, open and honest conversations about how theyâre feeling, both mentallyand physically. Watch for amoxil online no prescription warning signs. Thisis especially important if you have a child or adolescent in sports.

Keep aneye out for things like mood, sleep, or behavior changes that seem concerning. Find balance amoxil online no prescription. Itâsokay to admit that you need help or that you need to take a break frompracticing or competing.

If you feel overwhelmed consider meditation, amoxil online no prescription tryingnew things or giving your body a rest.Ask for help. Thereis no shame in seeking out help, whether it be with a therapist, psychiatristor other medical health professional. Treating a mental illness is just asimportant as treating a physical one.

Protecting and amoxil online no prescription prioritizing youroverall health is essential for all levels of athletes. Itâs not rare to havean athlete pull out of a race, game or event due to a physical injury. Seeingan athlete withdraw for mental health reasons is much less common, however, itsrecognition is just as important.

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Similar to how an unhealthy diet and lack of exercise can lead to disease, exposure to air pollution could be added to this risk factor list as well. âIn this study, we created an environment that mimicked a polluted day in New Delhi or Beijing,â said Sanjay Rajagopalan, MD, first author on the study, Chief of Cardiovascular amoxicillin amoxil Medicine at University Hospitals Harrington Heart and Vascular Institute, and Director of the Case Western Reserve University Cardiovascular Research Institute. ÂWe concentrated fine particles of air pollution, called PM2.5 (particulate matter component <. 2.5 microns) amoxicillin amoxil.

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This study is the first-of-its-kind to compare genome-wide epigenetic changes in response to air pollution, compare and contrast these changes with that of eating an unhealthy diet, and examine the impact of air pollution cessation on these changes.âThe good news is that these effects were reversible, at least in our experimentsâ added Dr. Rajagopalan. ÂOnce the air pollution was removed from the environment, the mice appeared healthier and the pre-diabetic state seemed amoxicillin amoxil to reverse.â Dr. Rajagopalan explains that if you live in a densely polluted environment, taking actions such as wearing an N95 mask, using portable indoor air cleaners, utilizing air conditioning, closing car windows while commuting, and changing car air filters frequently could all be helpful in staying healthy and limiting air pollution exposure.Next steps in this research involve meeting with a panel of experts, as well as the National Institutes of Health, to discuss conducting clinical trials that compare heart health and the level of air pollution in the environment.

For example, if someone has a heart attack, should they be wearing an N95 mask or using a portable air filter at home during recovery?. Dr amoxicillin amoxil. Rajagopalan and his team believe that it is important to address the environment as a population health risk factor and continue to diligently research these issues. The authors also note that these findings should encourage policymakers to enact measures aimed at reducing air pollution.Shyam Biswal, PhD, Professor in the Department of Environmental Health and Engineering at Johns Hopkins University School of Public Health, is the joint senior amoxicillin amoxil author on the study.

Drs. Rajagopalan and Biswal are co-PIs on the NIH grant that supported this work.###Rajagopalan, S., Biswal, S., et al. ÂMetabolic effects of amoxicillin amoxil air pollution exposure and reversibility.â Journal of Clinical Investigation. DOI.

10.1172/JCI137315. This work was supported by the National Institute of Environmental Health Sciences TaRGET II Consortium grant U01ES026721, as well as grants R01ES015146 and R01ES019616.About one in five women experience some form of depression during pregnancy, with poorly understood effects on the fetus. Prenatal depression is linked to behavioural and developmental issues in children as well as an increased risk for depression as young adults. But how prenatal depression leads to these changes remains unclear.

UCalgary researcher Dr. Catherine Lebel, PhD, is helping understand what may be happening in the developing brains of these children. The research team has shown that young children whose mothers experienced more numerous symptoms of depression in pregnancy have weakened connectivity in brain pathways involved in emotion. These structural changes can be related to increased hyperactivity and aggression in boys.

The research is based on diffusion magnetic resonance imaging, an imaging technique that probes the strength of structural connections between brain regions. The findings are published in The Journal of Neuroscience. Catherine Lebel, senior author and investigator. Riley Brandt, University of Calgary âThe results help us understand how depression can have multigenerational impacts, and speaks to the importance of helping mothers who may be experiencing depression during pregnancy,â says Lebel, an associate professor at the Cumming School of Medicine, and researcher in the Alberta Childrenâs Hospital Research Institute.

She holds the Canada Research Chair in Paediatric Neuroimaging. Lebel and her team studied 54 Calgary mothers and their children. They were enrolled from the ongoing, prospective study called the Alberta Pregnancy Outcomes and Nutrition study. Mothers answered a survey about their depression symptoms at several points during their pregnancy.

Their children were followed after birth and undertook an MRI scan at the Alberta Childrenâs Hospital at around age four. As well, the childrenâs behaviour was assessed within six months of their MRI scan. The team found a significant reduction in structural brain connectivity between the amygdala, a structure essential for emotional processing, and the frontal cortex. Weakened connectivity between the amygdala and frontal cortex is associated with disruptive behaviours and vulnerability to depression.

The first author on the study, Dr. Rebecca Hay, MD, stresses the importance of recognition of depression and intervention in prenatal health. ÂThese results suggest complex associations between the prenatal environment and childrenâs brain development, and may help us to understand why children of depressed mothers are more vulnerable to depression themselves,â says Hay, a resident physician in paediatrics and recent Cumming School of Medicine graduate. The main clinical takeaway from this is to emphasize the importance of recognizing, treating prenatal depression and supporting mothers, both for better maternal outcomes and to help future child development.

Rebecca Hay, the study's first author. Courtesy Rebecca Hay Current study looks at stress during amoxil Lebel and her research team are currently trying to understand how stress and mental health are affecting pregnant women during the buy antibiotics amoxil. She is examining how factors such as social supports might mitigate stress, and how this may influence pregnancy and birth outcomes. If you are interested, you can get involved here in the Pregnancy During the buy antibiotics amoxil study at the University of Calgary.

So far, approximately 7,500 women from across Canada are enrolled and supplying information through questionnaires. ÂIt is critical to appropriately recognize and treat prenatal maternal mental health problems, both for the mothers and to improve child outcomes,â says Lebel. ÂNow more than ever, with increased stress, anxiety and depression during the buy antibiotics amoxil, we should do more to support mothers to positively impact the health of their children.â Lebel is an associate professor in the Department of Radiology at the Cumming School of Medicine, adjunct associate professor in the Werklund School of Education and a member of The Mathison Centre for Mental Health Research &. Education, Owerko Centre at ACHRI, Hotchkiss Brain Institute and Alberta Children's Hospital Research Institute.

The study was funded by the Canadian Institute of Health Research, Alberta Innovates - Health Solutions, the Alberta Children's Hospital Foundation, the National Institute of Environmental Health Sciences, the Mach-Gaensslen Foundation, and an Eyes High University of Calgary Postdoctoral Scholar. Led by the Hotchkiss Brain Institute, Brain and Mental Health is one of six research strategies guiding the University of Calgary toward its Eyes High goals. The strategy provides a unifying direction for brain and mental health research at the university..

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âIn this study, we created an environment that mimicked a polluted day in New Delhi or Beijing,â said Sanjay Rajagopalan, MD, first author on the study, Chief of Cardiovascular Medicine at University Hospitals Harrington Heart and Vascular amoxil online no prescription Institute, and Director of the Case Western Reserve University Cardiovascular Research Institute. ÂWe concentrated fine particles of air pollution, called PM2.5 (particulate matter component <. 2.5 microns) amoxil online no prescription. Concentrated particles like this develop from human impact on the environment, such as automobile exhaust, power generation and other fossil fuels.â These particles have been strongly connected to risk factors for disease. For example, cardiovascular effects of air pollution can lead to heart attack and stroke.

The research team has shown exposure to air pollution can increase the likelihood amoxil online no prescription of the same risk factors that lead to heart disease, such as insulin resistance and type 2 diabetes. In the mouse model study, three groups were observed. A control group receiving clean filtered air, a group exposed to polluted air for 24 weeks, and a group fed a high-fat diet. Interestingly, the researchers found that amoxil online no prescription being exposed to air pollution was comparable to eating a high-fat diet. Both the air pollution and high-fat diet groups showed insulin resistance and abnormal metabolism â just like one would see in a pre-diabetic state.

These changes were associated with changes in the epigenome, a layer of control that can masterfully turn on and turn off thousands of genes, representing a critical buffer in response amoxil online no prescription to environmental factors. This study is the first-of-its-kind to compare genome-wide epigenetic changes in response to air pollution, compare and contrast these changes with that of eating an unhealthy diet, and examine the impact of air pollution cessation on these changes.âThe good news is that these effects were reversible, at least in our experimentsâ added Dr. Rajagopalan. ÂOnce the air pollution was removed from the environment, the mice appeared healthier and the pre-diabetic amoxil online no prescription state seemed to reverse.â Dr. Rajagopalan explains that if you live in a densely polluted environment, taking actions such as wearing an N95 mask, using portable indoor air cleaners, utilizing air conditioning, closing car windows while commuting, and changing car air filters frequently could all be helpful in staying healthy and limiting air pollution exposure.Next steps in this research involve meeting with a panel of experts, as well as the National Institutes of Health, to discuss conducting clinical trials that compare heart health and the level of air pollution in the environment.

For example, if someone has a heart attack, should they be wearing an N95 mask or using a portable air filter at home during recovery?. Dr amoxil online no prescription. Rajagopalan and his team believe that it is important to address the environment as a population health risk factor and continue to diligently research these issues. The authors also note that these findings should amoxil online no prescription encourage policymakers to enact measures aimed at reducing air pollution.Shyam Biswal, PhD, Professor in the Department of Environmental Health and Engineering at Johns Hopkins University School of Public Health, is the joint senior author on the study. Drs.

Rajagopalan and Biswal are co-PIs on the NIH grant that supported this work.###Rajagopalan, S., Biswal, S., et al. ÂMetabolic effects amoxil online no prescription of air pollution exposure and reversibility.â Journal of Clinical Investigation. DOI. 10.1172/JCI137315. This work was supported by the National Institute of Environmental Health Sciences TaRGET II Consortium grant U01ES026721, as well as grants R01ES015146 and R01ES019616.About one in five women experience some form of depression during pregnancy, with poorly understood effects on the fetus.

Prenatal depression is linked to behavioural and developmental issues in children as well as an increased risk for depression as young adults. But how prenatal depression leads to these changes remains unclear. UCalgary researcher Dr. Catherine Lebel, PhD, is helping understand what may be happening in the developing brains of these children. The research team has shown that young children whose mothers experienced more numerous symptoms of depression in pregnancy have weakened connectivity in brain pathways involved in emotion.

These structural changes can be related to increased hyperactivity and aggression in boys. The research is based on diffusion magnetic resonance imaging, an imaging technique that probes the strength of structural connections between brain regions. The findings are published in The Journal of Neuroscience. Catherine Lebel, senior author and investigator. Riley Brandt, University of Calgary âThe results help us understand how depression can have multigenerational impacts, and speaks to the importance of helping mothers who may be experiencing depression during pregnancy,â says Lebel, an associate professor at the Cumming School of Medicine, and researcher in the Alberta Childrenâs Hospital Research Institute.

As well, the childrenâs behaviour was assessed within six months of their MRI scan. The team found a significant reduction in structural brain connectivity between the amygdala, a structure essential for emotional processing, and the frontal cortex. Weakened connectivity between the amygdala and frontal cortex is associated with disruptive behaviours and vulnerability to depression. The first author on the study, Dr. Rebecca Hay, MD, stresses the importance of recognition of depression and intervention in prenatal health.

ÂThese results suggest complex associations between the prenatal environment and childrenâs brain development, and may help us to understand why children of depressed mothers are more vulnerable to depression themselves,â says Hay, a resident physician in paediatrics and recent Cumming School of Medicine graduate. The main clinical takeaway from this is to emphasize the importance of recognizing, treating prenatal depression and supporting mothers, both for better maternal outcomes and to help future child development. Rebecca Hay, the study's first author. Courtesy Rebecca Hay Current study looks at stress during amoxil Lebel and her research team are currently trying to understand how stress and mental health are affecting pregnant women during the buy antibiotics amoxil. She is examining how factors such as social supports might mitigate stress, and how this may influence pregnancy and birth outcomes.

If you are interested, you can get involved here in the Pregnancy During the buy antibiotics amoxil study at the University of Calgary. So far, approximately 7,500 women from across Canada are enrolled and supplying information through questionnaires. ÂIt is critical to appropriately recognize and treat prenatal maternal mental health problems, both for the mothers and to improve child outcomes,â says Lebel. ÂNow more than ever, with increased stress, anxiety and depression during the buy antibiotics amoxil, we should do more to support mothers to positively impact the health of their children.â Lebel is an associate professor in the Department of Radiology at the Cumming School of Medicine, adjunct associate professor in the Werklund School of Education and a member of The Mathison Centre for Mental Health Research &. Education, Owerko Centre at ACHRI, Hotchkiss Brain Institute and Alberta Children's Hospital Research Institute.

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