16:30 pm
Cultures and Cures: Neurodiversity and Brain Organoids
Andrew J. Barnhart | KU Leuven | Belgium
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Authors:
Andrew J. Barnhart | KU Leuven | Belgium
Prof. Dr. Kris Dierickx | KU Leuven | Belgium
Introduction: Research with cerebral organoids is beginning to make significant progress in understanding the etiology of autism spectrum disorder (ASD). Brain organoid models can be grown from the cells of donors with ASD. Researchers can explore the genetic, developmental, and other factors that may give rise to the varieties of autism. Researchers could study all of these factors together with brain organoids grown from cells originating from ASD individuals. This makes brain organoids unique from other forms of ASD research. There is significant hope that brain organoids could one day be used for ASD precision medicine.
Methods/Outcomes: Brain organoid researchers often incorporate the medical model of disability when researching the origins of ASD or potentially developing tailored clinical treatments. The neurodiversity movement will potentially disagree with approaches or aims of ASD cerebral organoid research. Neurodiversity advocates incorporate a social model of disability into their movement, which focuses more on the social, attitudinal, and environmental barriers rather than biophysical or psychological deficits. Therefore, a potential conflict may arise between these perspectives on how to proceed with cerebral organoid research regarding neurodevelopmental conditions, especially ASD.
Conclusions: Here, we present these perspectives and give at least three initial recommendations to achieve a more holistic and inclusive approach to ASD cerebral organoid research. First, neurodiverse individuals should be included as co-creators in both the scientific process and research communication. Second, clinicians and neurodiverse communities should have open and respectful communication. Finally, we suggest a continual reconceptualization of illness, impairment, disability, behavior, and person.
16:39 pm
Moral Distress and Ethical Issues within Undergraduate Nursing Education: Student Perspectives on Resilience and Coping
Cynthia Paidipati | Loyola University Chicago | United States
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Authors:
Cynthia Paidipati | Loyola University Chicago | United States
Neelam Lakhani | Children's Memorial Hermann Hospital | United States
Dr. Connie Ulrich | University of Pennsylvania | United States
Introduction
In the United States, 68% of undergraduate nursing students have experienced moral distress in their educational programs. Major ethical issues included: 1) compromised best practices; 2) disrespect for human dignity; 3) gender and sexuality issues; 4) racism or cultural/language exclusion; 5) academic integrity, and 6) other ethical issues. Resilience and coping strategies have been less frequent in the literature. The purpose of this presentation is to explore resilience and coping with moral distress and ethical issues from the perspectives of nursing students.
Methods
This presentation is part of a sequential mixed methods study of N = 679 undergraduate nursing students who participated in surveys and interviews on moral distress, depression, and suicide risk. Qualitative data from n = 19 students were obtained through semi-structured interviews and analyzed using content analyses.
Outcome
Major themes emerged in the data derived from interview questions selected for this analysis. In summary, students relied on supportive networks, including peers, faculty and preceptors, and family. Despite thoughts to leave their nursing programs, students demonstrated resilience and persevered in their pursuit to become nurses. Students developed coping strategies to manage distress, including physical activity, eating healthy, being in nature, arts or creative outlets, and mindfulness practices, such as meditation and yoga. These will be expanded in the presentation.
Conclusion
The high prevalence of moral distress and ethical issues among undergraduate nursing students is concerning. Understanding students’ perspectives on resilience and coping is a first step in developing evidence-based strategies to improve student mental health and well-being.
16:48 pm
Lost in Transition: Medical Accounts on Caring for Intersex Youth
Dr. Eva De Clercq | Universität Basel | Switzerland
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Authors:
Dr. Eva De Clercq | Universität Basel | Switzerland
Nina Reber | Switzerland
Introduction:
The diagnosis of intersex or DSD (difference of sexual development) often has a big impact on families who fear social stigmatization. Research has shown that psycho-social care is particularly relevant during adolescence and young adulthood. The present study aimed to contribute to the improvement of psycho-social care by exploring healthcare providers awareness of patients’ support needs; their attitudes towards available support models; their beliefs regarding barriers to implement psycho-social support, as well as their recommendations for improvement.
Methods:
We conducted semi-structured interviews with Swiss healthcare providers involved in the care of youth born with an intersex variation. The qualitative data were analyzed using reflexive thematic analysis.
Outcome:
All participants recognized the importance of professional psycho-social support for young persons with DSD. This ideal clinical practice however often clashed with reality. All physicians reported significant gaps in the transition process from pediatric to adult healthcare services. Aside from lack of medical specialization, participants also believed that the social, ethical and medical complexity of DSD scares many of their colleagues off. Despite the crucial role of psycho-social care, participants were rather skeptical about informal support services provided by intersex advocacy groups and peers. In their desire to “normalize” intersex, participants often risked misrecognizing the sexual healthcare needs of their patients.
Conclusion:
An important step towards the development of psycho-social support consists in integrating the lived experience of intersex youth in the medical curriculum rather than focusing merely on clinical case studies.
16:57 pm
Social value of pediatric Phase 1 trials in oncology
Prof. Dr. Marcin Waligóra | Jagiellonian University Medical College | Poland
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Authors:
Prof. Dr. Marcin Waligóra | Jagiellonian University Medical College | Poland
Mateusz Wasylewski | Jagiellonian University Medical College
Karolina Strzebonska | Poland
Magdalena Koperny
Dr. Maciej Polak
Prof. Jonathan Kimmelman
Objectives
Drug development trials must fulfill social value requirement but no estimates of value provided by pediatric Phase 1 trials in oncology exist. These trials involve a particularly vulnerable population. Our objective was to assess of surrogates of social value of Phase 1 trials performed in pediatric oncology: rates of approval of tested interventions, transition to further phases of testing and citation in subsequent primary research reports.
Methods
We performed an analysis on a subset of eligible trials included in a previous meta-analysis. That study systematically searched EMBASE and PubMed for small sample size, non-randomized, dose escalation pediatric cancer Phase 1 studies of any malignancy, assessing chemotherapy and/or targeted therapy and looked at risk and benefit. The current analysis assessed all studies in that review published between January 1st 2004 and December 31st 2013 for predictors of social value. This time range allowed for at least five years of subsequent development activity. Sources of data included FDA and EMA medicine databases (for approval), ClinicalTrials.gov and EU Clinical Trials Register (for transition) and Google Scholar (for citation).
Results
One hundred thirty-nine trials enrolling 3814 patients met the eligibility criteria. Seven trials (5%) led to drugs being registered for pediatric use in therapy of cancer. Fifty-two (37%) transitioned to later phases of pediatric oncology trials according to ClinicalTrials.gov and/or EU Register. Over 90% of trials were cited by at least one subsequent primary research report or systematic review. Most of the citations were preclinical studies.
Conclusions
Children are a unique group of participants and are considered vulnerable. Pediatric trials are evaluated with enhanced caution and must adhere to stricter standards than their counterparts with adult participants. Most regulations allow only minimal risk or require the prospect of direct benefit for participants. At the same time all drug development trials must fulfill social value requirement.Our analysis shows that treatments tested in pediatric Phase 1 trials in oncology have low rates of regulatory approval. However, a large proportion of Phase 1 trials inform further testing and development of tested interventions. Our data, coupled with careful ethical analysis, provide an empirical basis for further discussions about the nature of Phase I trials in children.
17:06 pm
Training for judging with a gender perspective in the agrarian courts in Mexico: A contribution to the health care of rural women.
Dr. Georgina Mota-Valtierra | UNIVERSIDAD AUTONOMA DE QUERÉTARO | Mexico
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Authors:
Dr. Georgina Mota-Valtierra | UNIVERSIDAD AUTONOMA DE QUERÉTARO | Mexico
Dr. Humberto Aguirre-Becerra | UNIVERSIDAD AUTONOMA DE QUERETARO | Mexico
Dr. Hilda Romero-Zepeda | Mexico
Dr. Jose-Salvador Arellano-Rodriguez | UNIVERSIDAD AUTONOMA DE QUERETARO
A latent problem in the Mexican agrarian system is related to the distribution of productive activities between men and women. This distribution is not equitable due to cultural, religious, and social issues; for example, men have the right to legally possess the land, however, women only have the responsibility to make it produce without the right of possession. This inequality and segregation between women and men in rural areas are also present in their rights to justice, education, health, and free exercise of sexuality which are generally denied, causing the life expectancy of rural women to be less by up to 10 years compared to women in urban areas. For these reasons, it is necessary to recognize these differences and the need to implement public policies and ethical, real, effective, and, efficient regulations within the Mexican agrarian state and livestock system, allowing a gender perspective in the judgments of the agrarian courts that lead to decisions in lawsuits with equal opportunities for men and women of the Mexican countryside. It is also important to properly train the authorities in charge of the administration of justice and to eliminate the moral prejudices established by society itself against women.
17:15 pm
Philosophical Reflections on Value of Intractable Diseases
Dr. Mitsuru Sasaki-Honda | Kyoto University | Japan
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Authors:
Dr. Tsutomu Sawai | Kyoto University | Japan
Dr. Mitsuru Sasaki-Honda | Kyoto University | Japan
Dr. Kyoko Akatsuka | Kyoto University | Japan
One of the goals of modern life science is developing treatments for hereditary and other intractable diseases. With the rise of cutting-edge life sciences in recent years, the treatment of intractable diseases is becoming more realistic, and in the future, the various intractable diseases that exist in the world may become treatable. However, behind these intractable disease treatments lies an uncritical expectation for science and a sense of value that intractable diseases are "negative entities" that should be eliminated from society. On the other hand, patients with intractable diseases have contributed to modern society in various ways through their diverse physical and mental characteristics. There are examples of patients with intractable diseases who use them as a driving force to achieve self-realization, and the process of clarifying the disease itself is the source of the development of life science. Herein lies a contradiction between the fact that science-oriented toward the development of society accelerates the biological homogeneity of humans and the general idea that human diversity is necessary for the development of society. In between these conflicting trends, "intractable disease patients who cannot fully benefit from science" often experience social and psychological alienation. In this presentation, to overcome such patients' alienation, the authors will elucidate the value of intractable diseases in the literature of disability studies and bioethics that have appeared since the 1980s.
17:24 pm
A Learning Healthcare System for pregnant and breastfeeding people: what do women during preconception, pregnancy, and nursing think? – A qualitative study
Marieke Hollestelle | University Medical Center Utrecht | Netherlands
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Authors:
Marieke Hollestelle | University Medical Center Utrecht | Netherlands
Dr. Rieke van der Graaf | University Medical Center Utrecht
Prof. Dr. Miriam Sturkenboom | University Medical Center Utrecht
Prof. Dr. Johannes van Delden | University Medical Center Utrecht
Background: Most medications lack evidence-based information about its safety and efficacy during pregnancy and breastfeeding. Another way to generate evidence is by transforming the field of pregnant and breastfeeding women into a Learning System (LHS). For the success of a LHS, it is of crucial importance to understand what women think of this approach and what their concerns are. Therefore, this paper explores their views on a LHS for pregnancy and breastfeeding.
Method: In this qualitative study, we interviewed 20 women during preconception, pregnancy, or nursing to explore their views on an ethically responsible LHS for pregnant and breastfeeding women. The pseudonymized transcripts were analyzed thematically.
Results: We identified four themes describing women’s views on LHSs. The first theme describes that respondents considered LHSs to function as a central point for information about their medication, which they felt is currently lacking. The second theme shows that respondents want to contribute to and engage in a LHS because they want to help others and contribute to scientific research. The third theme shows that respondents regard their healthcare professional essential in the translation and interpretation of information. The last theme describes that respondents will trust a learning healthcare system more if the medical community supports it, and when data collection and processing is transparent.
Conclusions: The obtained insights from this interview study provide valuable stepping-stones for the development of a successful and ethically responsible LHS. Furthermore, these insights can help with encouraging the engagement of women in the development of a LHS.
17:33 pm
On the importance of acting solidaristic to improve knowledge of medications used during pregnancy
Marieke Hollestelle | UMC Utrecht | Netherlands
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Authors:
Marieke Hollestelle | UMC Utrecht | Netherlands
Dr. Rieke Graaf | UMC Utrecht
Prof. Miriam Sturkenboom | UMC Utrecht
Prof. Johannes Delden | UMC Utrecht
Introduction
There is still a lack of knowledge concerning medications used during pregnancy. It has been argued that solidarity is of key importance in changing the status quo for medical domains where a poor evidence base exists regarding treatments. This paper explores whether and how enactment of solidarity can be stimulated to improve knowledge of medications used during pregnancy.
Method
We apply the concept of solidarity formulated by Prainsack and Buyx to the situation of pregnant women who use medication.
Outcome
Although solidarity cannot be imposed, currently in the case of pregnant women, there is an ethical imperative to be solidaristic. Knowledge about solidaristic actions may lead to enactment of solidarity. We propose that actions of solidarity can be stimulated by perceiving solidarity as empowerment, meaning that relevant stakeholders explain what certain groups can do to improve their own situation by acting solidaristic. For the context of pregnant women, empowerment means 1) to create awareness about their status quo, 2) to explain how scientific research can help close the knowledge gap, and 3) to explain how pregnant women themselves can contribute. In particular, they can contribute to the collection of data. We explain how data collection can strengthen the evidence base by illustrating the way data is currently collected in the private-public partnership ConcePTION.
Conclusions
Acting solidaristic can help to change the status quo for pregnant women who use medication, and enactment of solidarity can be stimulated among pregnant women and other relevant stakeholders, when solidarity is understood as empowerment.