Article
Ethics
Nut Koonrungsesomboon, Pimlak Charoenkwan, Rungrote Natesirinilkul, Kanda Fanhchaksai, Wannachai Sakuludomkan, Nimit Morakote
Summary: This study aimed to determine the elements and extent of information that child participants and their parents desire to read in an informed assent form/informed consent form of a pediatric drug trial. The results showed that risk-benefit aspects were perceived as the most concerning items. The findings can help stakeholders arrange essential information in order of importance and customize informed assent/consent forms for pediatric drug trials involving children with hematology or oncology diseases.
BMC MEDICAL ETHICS
(2022)
Article
Pediatrics
Ryan Brewster, Melissa Wong, Christopher J. Magnani, Hailey Gunningham, Madison Hoffer, Samuel Showalter, Katherine Tran, Jecca R. Steinberg, Brandon E. Turner, Steven N. Goodman, Alan R. Schroeder
Summary: This study found that early discontinuation and nonreporting/nonpublication of findings are still common in registered pediatric clinical trials, and they are associated with funding source and other trial features.
Article
Pediatrics
Ryan C. L. Brewster, Jecca R. Steinberg, Christopher J. Magnani, Jasmyne Jackson, Bonnie O. Wong, Nishma Valikodath, Justin MacDonald, Anna Li, Paula Marsland, Steven N. Goodman, Alan Schroeder, Brandon Turner
Summary: This study evaluates the reporting and representation of racial and ethnic minoritized populations in all US pediatric clinical trials on ClinicalTrials.gov. The results show that the representative enrollment of minoritized populations in children's clinical trials is still a challenge.
Article
Psychology, Clinical
Cody Morris, Jessica J. Detrick, Stephanie M. Peterson
Summary: Obtaining assent from research participants is crucial, particularly when working with individuals who may not be able to provide traditional consent, such as those with ASD and DDs. Despite a lack of clear guidelines in behavior-analytic literature, it is essential to identify strategies and models for obtaining assent from these populations.
JOURNAL OF APPLIED BEHAVIOR ANALYSIS
(2021)
Article
Multidisciplinary Sciences
Rebecca A. Slotkowski, Shirley F. Delair, Kari A. Neemann
Summary: Research registries are effective in boosting recruitment for clinical trials. This study aimed to understand how parents make the decision to enroll their children in a pediatric participant research registry (PPRR). The results showed that parents have positive attitudes towards PPRRs, with a preference for recruitment by primary care providers or nurses in clinics rather than through social media.
Review
Clinical Neurology
Rajeev D. Sen, Amy Lee, Samuel R. Browd, Richard G. Ellenbogen, Jason S. Hauptman
Summary: Understanding the concepts of consent and assent is crucial in caring for pediatric neurosurgery patients, as it is recommended to involve pediatric patients in their own care despite their legal capacity limitations. Obtaining consent and assent in the pediatric population is complex due to varying cognitive and psychological developments, requiring pediatric neurosurgeons to simplify complex procedures and recognize children's dissent or refusal when necessary. Empowering children to be involved in their neurosurgical care is vital for successful interventions.
CHILDS NERVOUS SYSTEM
(2021)
Article
Ethics
Ghiath Alahmad, Muneera AlSaqabi, Hala Alkamli, Mona Aleidan
Summary: The majority of participants preferred both parents to give consent, with a simple and short assent form for the child. They emphasized consideration for the child's well-being and maturity level over age in decision making.
DEVELOPING WORLD BIOETHICS
(2022)
Article
Medicine, General & Internal
Peter Knapp, Thirimon Moe-Byrne, Jacqueline Martin-Kerry, Rebecca Sheridan, Jenny Roche, Elizabeth Coleman, Peter Bower, Steven Higgins, Catherine Stones, Jonathan Graffy, Jenny Preston, Carrol Gamble, Bridget Young, Daniel Perry, Annegret Dahlmann-Noor, Mohamed Abbas, Payal Khandelwal, Siobhan Ludden, Augusto Azuara-Blanco, Emma McConnell, Nicky Mandall, Anna Lawson, Chris A. Rogers, Helena J. M. Smartt, Rachael Heys, Simon R. Stones, Danielle Horton Taylor, Sophie Ainsworth, Jenny Ainsworth
Summary: By comparing multimedia information (MMI) and printed participant information sheets (PIS), the study found that MMI can increase the recruitment rate of trials, but has no effect on the quality of decision-making. MMI is a useful tool for recruiting children and young people in trials.
Article
Medicine, Research & Experimental
Julia Wade, Elka Humphrys, Alba X. Realpe, Daisy M. Gaunt, Jenni Burt
Summary: The participatory and informed consent (PIC) measure was developed to assess recruiter information provision and patient understanding in recruitment discussions. The measure was evaluated and revised within the context of the OPTiMISE trial, demonstrating good feasibility, content validity, and reliability.
Article
Critical Care Medicine
Katie O'Hearn, Florence Cayouette, Saoirse Cameron, Dori-Ann Martin, Anne Tsampalieros, Kusum Menon
Summary: This study surveyed four stakeholder groups involved in research in Canadian PICUs to understand their perspectives and barriers to obtaining assent. It was found that a significant percentage of participants believed that obtaining assent during the first 48 hours of PICU admission was difficult and that there were unique barriers to assent at the time of enrollment. There was a lack of consensus on the operationalization of the assent process, but most stakeholders agreed that children should have the opportunity to decide if their samples could stay in a biobank once they are old enough to do so.
PEDIATRIC CRITICAL CARE MEDICINE
(2023)
Article
Cell Biology
Mehdi Ghasemi, Charles P. Emerson, Lawrence J. Hayward
Summary: Facioscapulohumeral muscular dystrophy (FSHD) is a debilitating disease with variable age of onset, severity, and progression. Research progress in understanding the underlying mechanisms and developing novel therapies targeting DUX4 expression has accelerated in recent years, providing hope for future clinical trials to improve patient outcomes.
Article
Clinical Neurology
Olivia M. Bernstein, Joshua D. Grill, Daniel L. Gillen
Summary: Early study exit in Alzheimer's disease clinical trials can reduce statistical power and increase bias risk. The type of study partner may influence the completion rate of the trial.
ALZHEIMERS RESEARCH & THERAPY
(2021)
Article
Medicine, General & Internal
Luke S. Bothun, Scott E. Feeder, Gregory A. Poland
Summary: This study found that the informed consent forms and informational documents from recent phase 3 COVID-19 vaccine clinical trials in the United States did not meet readability standards at the recommended 7th grade level. The average English-speaking vaccine trial volunteer would have great difficulty comprehending the information provided in these documents. To ensure study subjects receive and fully comprehend information and can provide reliable consent, greater attention should be given to simplified consent forms, multimedia formatting, personal discussion, and comprehension assessments.
MAYO CLINIC PROCEEDINGS
(2021)
Article
Psychology, Multidisciplinary
Kevin J. Munro, William M. Whitmer, Antje Heinrich
Summary: Clinical trials are crucial for evaluating interventions in preventing, diagnosing, or treating health conditions, with a focus on improving practice in healthcare. The lack of high-quality evidence in hearing health practice highlights the importance of understanding key elements defining trial quality, such as design, blinding, and outcome measures. The complexity of outcome measures within hearing health emphasizes the need to consider how measurement instruments impact interpretation, accuracy estimation, and the meaningfulness of differences to individuals with hearing loss.
FRONTIERS IN PSYCHOLOGY
(2021)
Article
Allergy
Nidhya Navanandan, Talia Thompson, Laura Pyle, Todd A. Florin
Summary: This study aimed to develop a consensus definition of treatment response for clinical trials of pediatric acute asthma. A multidisciplinary panel of experts reached a consensus on a definition that includes Clinical Severity Score, need for additional therapies, and hospitalization. This consensus definition can help standardize outcome measurement and reporting in clinical trials.
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE
(2023)
Article
Biochemistry & Molecular Biology
Yong Gyu Lee, Jong Jin Jeong, Sharmilee Nyenhuis, Evgeny Berdyshev, Sangwoon Chung, Ravi Ranjan, Manjula Karpurapu, Jing Deng, Feng Qian, Elizabeth A. B. Kelly, Nizar N. Jarjour, Steven J. Ackerman, Viswanathan Natarajan, John W. Christman, Gye Young Park
AMERICAN JOURNAL OF RESPIRATORY CELL AND MOLECULAR BIOLOGY
(2015)
Review
Medicine, Research & Experimental
Steven J. Ackerman, Gye Young Park, John W. Christman, Sharmilee Nyenhuis, Evgeny Berdyshev, Viswanathan Natarajan
BIOMARKERS IN MEDICINE
(2016)
Article
Allergy
Alan P. Baptist, Sharmilee Nyenhuis
IMMUNOLOGY AND ALLERGY CLINICS OF NORTH AMERICA
(2016)
Article
Allergy
Molly A. Martin, Valerie G. Press, Sharmilee M. Nyenhuis, Jerry A. Krishnan, Kim Erwin, Giselle Mosnaim, Helen Margellos-Anast, S. Margaret Paik, Stacy Ignoffo, Michael McDermott
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
(2016)
Article
Health Care Sciences & Services
Kim Erwin, Molly A. Martin, Tara Flippin, Sarah Norell, Ariana Shadlyn, Jie Yang, Paula Falco, Jaime Rivera, Stacy Ignoffo, Rajesh Kumar, Helen Margellos-Anast, Michael McDermott, Kate McMahon, Giselle Mosnaim, Sharmilee M. Nyenhuis, Valerie G. Press, Jessica E. Ramsay, Kenneth Soyemi, Trevonne M. Thompson, Jerry A. Krishnan
JOURNAL OF COMPARATIVE EFFECTIVENESS RESEARCH
(2016)
Letter
Allergy
Scott T. Benken, Sharmilee M. Nyenhuis, Sean Dunne
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY-IN PRACTICE
(2017)
Article
Nursing
Susan J. Corbridge, Sharmilee M. Nyenhuis
JNP-JOURNAL FOR NURSE PRACTITIONERS
(2017)
Article
Health Care Sciences & Services
Guilherme M. Balbim, Isabela G. Marques, David X. Marquez, Darshilmukesh Patel, Lisa K. Sharp, Spyros Kitsiou, Sharmilee M. Nyenhuis
Summary: This paper discusses the key challenges associated with using Fitbit PA trackers in research studies, including technological, operational, and logistical aspects, and provides solutions. Researchers should be prepared to address challenges and issues in a timely fashion to ensure that Fitbit effectively assists participants and researchers in achieving research goals.
JMIR MHEALTH AND UHEALTH
(2021)
Article
Health Care Sciences & Services
Sharmilee Nyenhuis, Emily Cramer, Matthew Grande, Luz Huntington-Moskos, Kathryn Krueger, Olivia Bimbi, Barbara Polivka, Kamal Eldeirawi
Summary: This study aims to assess residential environmental exposures and asthma symptoms in adults with asthma using ecological momentary assessment (EMA) and explore the associations between self-reported and objective measures. By recruiting 50 adults with asthma and providing indoor air quality monitors and home spirometers, data collection and evaluation will be conducted. The results of this study are expected to provide support for addressing the impact of home environmental exposures on asthma symptoms and developing tailored interventions.
JMIR RESEARCH PROTOCOLS
(2022)
Editorial Material
Public, Environmental & Occupational Health
Deborah Salvo, Lisa Sharp, Sharmilee Nyenhuis
JOURNAL OF PHYSICAL ACTIVITY & HEALTH
(2023)
Article
Medicine, General & Internal
Evelyn Angulo, Sydney Joyner, Nasma K. Majeed, Sharmilee Nyenhuis
SAGE OPEN MEDICAL CASE REPORTS
(2020)
Review
Respiratory System
Margaret M. Kuder, Sharmilee M. Nyenhuis
THERAPEUTIC ADVANCES IN RESPIRATORY DISEASE
(2020)
Article
Medicine, Research & Experimental
Jerry A. Krishnan, Molly A. Martin, Cortland Lohff, Giselle S. Mosnaim, Helen Margellos-Anast, Julie A. DeLisa, Kate McMahon, Kim Erwin, Leslie S. Zun, Michael L. Berbaum, Michael McDermott, Nina E. Bracken, Rajesh Kumar, S. Margaret Paik, Sharmilee M. Nyenhuis, Stacy Ignoffo, Valerie G. Press, Zachary E. Pittsenbarger, Trevonne M. Thompson
CONTEMPORARY CLINICAL TRIALS
(2017)
Article
Health Care Sciences & Services
Sharmilee M. Nyenhuis, Guilherme Moraes Balbim, Jun Ma, David X. Marquez, JoEllen Wilbur, Lisa K. Sharp, Spyros Kitsiou
JMIR FORMATIVE RESEARCH
(2020)
