Evidence-Based Recommendations for Education Provided to Patients and Families Regarding the Adverse Events of ALK and MEK Inhibitors: A Systematic Review From the Children's Oncology Group.

Background: Pediatric oncology patients receive multiple modalities of therapy to treat their malignancies. These modalities have the potential for acute toxicity and late effects. In the last decade, a new modality known as targeted biological therapy, has become an integral part of treatment for pediatric cancers. As targeted therapy use has increased, adverse events specific to these targeted agents have emerged, requiring a new effort focused on providing education to patients and families regarding how best to report, monitor, and manage these adverse events. Method: A clinical question was developed to guide the systematic literature review. Anaplastic lymphoma kinase (ALK) and mitogen-activated protein kinase kinase (MEK) inhibitors were selected for review due to their frequency of use in pediatric oncology. The search was conducted to identify relevant articles published between January 1, 2000 and May 5, 2020. Articles were screened by two team members for inclusion/exclusion criteria using the web-based systematic review tool, Rayyan. Results: Twenty-seven articles met the eligibility criteria for inclusion and were evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation criteria. Adverse events for ALK and MEK inhibitors included manifestations of the gastrointestinal, hematologic, dermatologic, musculoskeletal, neurological, cardiovascular, and ocular systems. Recommendations for patient/family education were made for ALK and MEK inhibitors based on the reported adverse events. Conclusions: Adverse events of ALK and MEK inhibitors differ from the more common adverse events experienced with conventional treatment modalities used in pediatric oncology. It is important for nurses to include information regarding potential adverse events in patient/family education for children receiving these targeted agents.

We Are Done! Now What? Exploring End of Treatment Needs of Childhood Cancer Survivors and Their Parents.

Background: Increased childhood cancer survival rates have spurred a new body of research pertaining to the cancer-survivorship continuum. Literature suggests a lack of research and guidelines for care at the end of treatment (EOT). To improve the transition to survivorship and determine any posttreatment challenges, this study explored the experiences of childhood cancer survivors (CCSs), parents/caregivers, and pediatric oncology health care professionals (HCPs) at EOT. Method: This study employed a mixed methods design. EOT Questionnaires were completed by CCSs and parents/caregivers within 6 months of completing treatment, and by pediatric oncology HCPs. Results: A total of 75 CCSs and parents/caregivers and 21 HCPs completed the study. The majority of parents/caregivers (78%) and older CCSs (94%) recalled having an EOT "meeting." Most were satisfied with the meeting, but described unexpected worries/problems following EOT. Family members stating they were "very satisfied" with the EOT meeting increased significantly relative to the number of EOT topics addressed. In contrast, the omission of certain psychosocial discussion topics negatively correlated with satisfaction. Oncologists provided the majority of EOT services, with infrequent provision by other HCPs. Less than 20% of HCPs characterized families as "very satisfied" with EOT services and suggested improvements to meet families' needs. Discussion: This study found unmet psychosocial and anticipatory guidance needs, indicating a lack of preparedness. The results suggest that end of cancer treatment requires a more standardized, comprehensive, and multidisciplinary approach. Enhanced education and support services are needed to promote the successful navigation of all families through this period of transition.

Developing a Family Resource: Considerations for Family Member Research Participation.

When individuals participate in health care research, the choice often affects the entire family. Researchers are responsible for protecting participants and minimizing any burdens the research may place on them. Resources to educate potential study participants about these issues from a family perspective are lacking. A family-focused, evidence-based resource was created for individuals and families to prompt discussion prior to their consenting to enrollment in research. The resource includes key relevant questions to consider related to their study participation and was revised based on input from family nurse scientists and a hospital-based family advisory group. This resource raises awareness of the importance of employing a family lens when designing research and during the recruitment and enrollment of participants. Adopting a family lens in health care research will support the participant's ability to make an informed choice regarding participation and may ultimately enhance the experience of participants and their families and study outcomes.

Open Science Practices in Communication Sciences and Disorders: A Survey.

PURPOSE: Open science is a collection of practices that seek to improve the accessibility, transparency, and replicability of science. Although these practices have garnered interest in related fields, it remains unclear whether open science practices have been adopted in the field of communication sciences and disorders (CSD). This study aimed to survey the knowledge, implementation, and perceived benefits and barriers of open science practices in CSD. METHOD: An online survey was disseminated to researchers in the United States actively engaged in CSD research. Four-core open science practices were examined: preregistration, self-archiving, gold open access, and open data. Data were analyzed using descriptive statistics and regression models. RESULTS: Two hundred twenty-two participants met the inclusion criteria. Most participants were doctoral students (38%) or assistant professors (24%) at R1 institutions (58%). Participants reported low knowledge of preregistration and gold open access. There was, however, a high level of desire to learn more for all practices. Implementation of open science practices was also low, most notably for preregistration, gold open access, and open data (< 25%). Predictors of knowledge and participation, as well as perceived barriers to implementation, are discussed. CONCLUSION: Although participation in open science appears low in the field of CSD, participants expressed a strong desire to learn more in order to engage in these practices in the future. Supplemental Material and Open Science Form: https://doi.org/10.23641/asha.21569040.

Doctors and Disability: Improving Inclusion in Medical Education.

Description Disability is extremely common in the United States with 26% of adults identifying as having some type of disability. Oftentimes, people with disabilities need to access health care services frequently in order to receive adequate care and support. However, despite this need, medical students receive limited, if any, education about people with disabilities and how to appropriately provide medical care and interact with them. This lack of education exacerbates health care disparities experienced by people with disabilities. This article highlights these disparities as well as the history of disability and health care. Current advancements in medical education regarding people with disabilities are reviewed with suggestions for medical schools looking to improve or begin programming focused on people with disabilities. By covering the history and current difficulties experienced by people with disabilities accessing health care, as well as the best practices for educating medical students, this article takes steps to fill an important gap in the literature.

Remote Microphone System Use in Preschool Children With Autism Spectrum Disorder and Language Disorder in the Classroom: A Pilot Efficacy Study.

Purpose The present pilot study aimed to provide estimates of the feasibility and efficacy of a remote microphone (RM) system as an augmentative intervention to improve the functional listening performance of preschool children with autism spectrum disorder (ASD) and language disorder. Method Eight children with ASD and language disorder participated. Efficacy of the RM system was determined by evaluating participants' functional listening performance, as measured by an observational measure in RM-off and RM-on conditions. Responses were evaluated at the individual level using an alternating conditions design. Results Adequate feasibility was demonstrated as all participants were able to complete tasks in the RM-on condition. A subset of participants showed significant improvements in their functional listening performance in the RM-on condition, as demonstrated by visual inspection and effect sizes (nonoverlapping data points and percentage of data points exceeding the mean), indicating that there may be important sources of individual differences in responses to RM use in children with ASD. Conclusion The results of this pilot study provide support for future research on RM systems to target functional listening performance in children with ASD and language disorder.

Chlorhexidine gluconate bathing in children with cancer or those undergoing hematopoietic stem cell transplantation: A double-blinded randomized controlled trial from the Children's Oncology Group.

BACKGROUND: To the authors' knowledge, information regarding whether daily bathing with chlorhexidine gluconate (CHG) reduces central line-associated bloodstream infection (CLABSI) in pediatric oncology patients and those undergoing hematopoietic stem cell transplantation (HCT) is limited. METHODS: In the current multicenter, randomized, double-blind, placebo-controlled trial, patients aged ≥2 months and <22 years with cancer or those undergoing allogeneic HCT were randomized 1:1 to once-daily bathing with 2% CHG-impregnated cloths or control cloths for 90 days. The primary outcome was CLABSI. Secondary endpoints included total positive blood cultures, acquisition of resistant organisms, and acquisition of cutaneous staphylococcal isolates with an elevated CHG mean inhibitory concentration. RESULTS: The study was stopped early because of poor accrual. Among the 177 enrolled patients, 174 were considered as evaluable (88 were randomized to the CHG group and 86 were randomized to the control group). The rate of CLABSI per 1000 central line days in the CHG group was 5.44 versus 3.10 in the control group (risk difference, 2.37; 95% confidence interval, 0.05-4.69 [P = .049]). Post hoc conditional power analysis demonstrated a 0.2% chance that the results would have favored CHG had the study fully enrolled. The rate of total positive blood cultures did not differ between groups (risk difference, 2.37; 95% confidence interval, -0.41 to 5.14 [P = .078]). The number of patients demonstrating the new acquisition of resistant organisms did not differ between groups (P = .54). Patients in the CHG group were found to be more likely to acquire cutaneous staphylococcal isolates with an elevated CHG mean inhibitory concentration (P = .032). CONCLUSIONS: The data from the current study do not support the use of routine CHG bathing in children with cancer or those undergoing allogeneic HCT.

The end of cancer treatment experience for children, adolescents, and their parents: A systematic review of the literature.

PROBLEM IDENTIFICATION: To date, there is limited study of the end of treatment (EOT) transition experiences and needs of children/adolescents with cancer and their parents. LITERATURE SEARCH: A systematic search identified primary research focusing on EOT, describing child, adolescent, and parental perceptions, experiences, and needs during this transition period. Of 170 articles identified, 22 met inclusion criteria. DATA EVALUATION/SYNTHESIS: Studies were appraised for level and quality of evidence. Narrative synthesis was performed to extract themes and integrate the literature. Family members' perceived needs, factors influencing the EOT experience, and consequences of this transition emerged as themes. CONCLUSIONS: Uncertainty and heightened anxiety at EOT highlight the need for increased education and support for family members. Family functioning and distress influence the EOT experience, with variable effects on each family member. There is a call for individualized interventions to promote coping and positive outcomes.

Development and Content Validation of End of Treatment Questionnaires for Children With Cancer.

Purpose: To describe the development and content validation of measures to assess the psychoeducational needs of children, adolescents/young adults (AYAs), and their parents at the end of successful treatment for cancer. Method: Professional experts, which included pediatric oncology nurses and advanced practice registered nurses, conducted a systematic review of the literature to determine specific end of treatment (EOT) needs of children and AYAs with cancer and their parents and evaluate available tools to measure these needs. From this review, two EOT questionnaires were initially developed. Oncology Family Advisory Board (FAB) members served as experiential experts in refining and validating these questionnaires. FAB members participated in a content validation process, rating questionnaires online, and subsequently participating in a focus group to establish content validity (n = 6). Results: Three EOT questionnaires were ultimately developed. The Child/AYA questionnaire was divided into two separate measures for developmental and literacy considerations. The Parent/Caregiver and the AYA questionnaires each contain 38 items with a content validity index score of 100%. The Child questionnaire contains 37 items with a content validity index score of 100%. Conclusion: Content validity was established for three EOT questionnaires, each of which has the potential to elicit information regarding needs and potential gaps in services perceived by childhood cancer survivors and their parents. Further psychometric testing is needed to determine stability (test-retest reliability) and construct validity of the questionnaires.

HTX-019 via 2-min injection or 30-min infusion in healthy subjects.

AIM: HTX-019 (CINVANTI® [aprepitant injectable emulsion]) is a neurokinin 1 receptor antagonist approved for preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV). HTX-019 is free of polysorbate 80 and other synthetic surfactants and showed bioequivalence to and a more favorable safety profile than fosaprepitant when administered as a 30-min infusion in healthy subjects. The shortage of small-volume parenteral solutions led to a recommendation to administer HTX-019 by intravenous push. The objectives were to evaluate pharmacokinetics, tolerability and safety following HTX-019 administration by injection versus infusion. MATERIALS & METHODS: Study comprised Part A, a pilot Phase I, single-center, randomized, pharmacokinetic, safety and tolerability, open-label study, followed by Part B, a two-sequence crossover study of HTX-019 130 mg in healthy adults, via injection and infusion. Blood samples were evaluated for aprepitant pharmacokinetics and bioequivalence. Safety evaluations included treatment-emergent adverse events (TEAEs), vital signs, clinical laboratory testing and electrocardiograms. RESULTS: In Part A, 24 subjects were randomly assigned to three cohorts (n = 8 per cohort) and received HTX-019 130 mg, administered intravenously over 15 min (cohort 1), 5 min (cohort 2) or 2 min (cohort 3). Progression to Part B occurred after acceptable tolerability was established in cohorts 2 and 3. In Part B, 50 randomized subjects received a 2-min injection (9 ml/min) and 30-min infusion (296 ml/h) of HTX-019 130 mg. Bioequivalence was demonstrated for HTX-019 injection and infusion. Both administration methods via a peripheral line were well tolerated; eight subjects experienced 11 TEAEs (six related) following injection and nine experienced 14 TEAEs (nine related) following infusion. Headache and fatigue were the most prevalent treatment-related TEAEs; one subject per group experienced feeling hot ≤30 min after drug administration. CONCLUSION: Pharmacokinetic and tolerability profiles of 2-min HTX-019 injection support this potential alternative administration method for CINV prevention.

Safety of HTX-019 (intravenous aprepitant) and fosaprepitant in healthy subjects.

AIM: Evaluate safety of HTX-019, a novel polysorbate 80- and synthetic surfactant-free intravenous formulation of neurokinin 1 receptor antagonist aprepitant for chemotherapy-induced nausea and vomiting. METHODS: Two open-label, randomized, two-way crossover studies evaluated treatment-emergent adverse events (TEAEs) in 200 healthy subjects. Subjects received HTX-019 130 mg (30-min infusion) and fosaprepitant 150 mg (20- or 30-min infusion), with ≥7-day washout between doses. RESULTS: Less than or equal to 30 min after start of infusion, TEAEs occurred in 5 (3%) HTX-019 and 30 (15%) fosaprepitant recipients. No HTX-019 recipients had infusion-site adverse events, versus 15 (8%) fosaprepitant recipients. Treatment-related dyspnea occurred in one HTX-019 and six fosaprepitant recipients. No severe/serious TEAEs occurred; all TEAEs resolved. CONCLUSION: HTX-019 may provide a safer aprepitant formulation than fosaprepitant for chemotherapy-induced nausea and vomiting prevention.

Satellite sensor requirements for monitoring essential biodiversity variables of coastal ecosystems.

The biodiversity and high productivity of coastal terrestrial and aquatic habitats are the foundation for important benefits to human societies around the world. These globally distributed habitats need frequent and broad systematic assessments, but field surveys only cover a small fraction of these areas. Satellite-based sensors can repeatedly record the visible and near-infrared reflectance spectra that contain the absorption, scattering, and fluorescence signatures of functional phytoplankton groups, colored dissolved matter, and particulate matter near the surface ocean, and of biologically structured habitats (floating and emergent vegetation, benthic habitats like coral, seagrass, and algae). These measures can be incorporated into Essential Biodiversity Variables (EBVs), including the distribution, abundance, and traits of groups of species populations, and used to evaluate habitat fragmentation. However, current and planned satellites are not designed to observe the EBVs that change rapidly with extreme tides, salinity, temperatures, storms, pollution, or physical habitat destruction over scales relevant to human activity. Making these observations requires a new generation of satellite sensors able to sample with these combined characteristics: (1) spatial resolution on the order of 30 to 100-m pixels or smaller; (2) spectral resolution on the order of 5 nm in the visible and 10 nm in the short-wave infrared spectrum (or at least two or more bands at 1,030, 1,240, 1,630, 2,125, and/or 2,260 nm) for atmospheric correction and aquatic and vegetation assessments; (3) radiometric quality with signal to noise ratios (SNR) above 800 (relative to signal levels typical of the open ocean), 14-bit digitization, absolute radiometric calibration <2%, relative calibration of 0.2%, polarization sensitivity <1%, high radiometric stability and linearity, and operations designed to minimize sunglint; and (4) temporal resolution of hours to days. We refer to these combined specifications as H4 imaging. Enabling H4 imaging is vital for the conservation and management of global biodiversity and ecosystem services, including food provisioning and water security. An agile satellite in a 3-d repeat low-Earth orbit could sample 30-km swath images of several hundred coastal habitats daily. Nine H4 satellites would provide weekly coverage of global coastal zones. Such satellite constellations are now feasible and are used in various applications.

Bioequivalence of HTX-019 (aprepitant IV) and fosaprepitant in healthy subjects: a Phase I, open-label, randomized, two-way crossover evaluation.

INTRODUCTION: Fosaprepitant, an intravenous (IV) aprepitant prodrug for chemotherapy-induced nausea and vomiting prophylaxis, is associated with systemic and infusion-site reactions attributed in part to its surfactant, polysorbate 80. HTX-019 is an IV aprepitant formulation free of polysorbate 80 and other synthetic surfactants. MATERIALS AND METHODS: This open-label, single-dose, randomized, two-way crossover bioequivalence study compared pharmacokinetics and safety of HTX-019 and fosaprepitant. Healthy subjects received single-dose HTX-019 (130 mg) or fosaprepitant (150 mg) IV over 30 min, with ≥7-day washout between doses. Blood samples were evaluated for pharmacokinetics and bioequivalence; safety evaluation included treatment-emergent adverse events (TEAEs) and serious adverse events. Ninety-seven of one hundred enrolled subjects completed the study. RESULTS: Baseline characteristics were comparable between treatment sequences. For HTX-019, mean (percent coefficient of variation) area under the curve (AUC) from time 0 to time of last measurable plasma concentration (AUC0-t), AUC from time 0 to infinity (AUC0-inf), and plasma concentration at 12 h (C12 h) for HTX-019 were 43,729 h*ng/mL (32.7), 45,460 h*ng/mL (36.8), and 988.4 ng/mL (27.5), respectively; corresponding fosaprepitant values were 44,130 h*ng/mL (32.0), 46,163 h*ng/mL (36.6), and 1,022 ng/mL (28.5). Also, 90% CIs (94.186-101.354) were within bioequivalence bounds (80%-125%). Within 1 h following infusion start, one (1%) HTX-019 recipient reported one TEAE, while 20 (20%) fosaprepitant recipients reported 32 TEAEs. Dyspnea occurred in three fosaprepitant recipients (at <1 min in two subjects and at 18 min in one subject, considered study drug related) and one HTX-019 recipient (at 120 h, associated with a respiratory tract infection and considered not related to the study drug). No severe TEAEs, serious adverse events, or deaths occurred; all TEAEs resolved. CONCLUSION: HTX-019 was bioequivalent to fosaprepitant and may provide a safer alternative to fosaprepitant for chemotherapy-induced nausea and vomiting prophylaxis.

The potential of survivorship care plans in primary care follow-up of minority breast cancer patients.

BACKGROUND: When the clinical care of minority breast cancer survivors is transferred from oncology settings to primary care, quality of care may be compromised if their primary care providers do not have adequate cancer treatment records and follow-up care guidelines. Survivorship care plans (SCPs) given to survivors before they transition to primary care settings are designed to improve the transfer of this information. This study examined these issues in a sample of minority breast cancer survivors. DESIGN: During four focus groups with minority breast cancer survivors, data were collected about the types of information survivors remember receiving from their oncologists about follow-up health care needs. Survivors were also asked their opinions on the value and content of a survivorship care plan. RESULTS: Minority breast cancer survivors received variable amounts of information about their cancer treatments. They were dissatisfied with the amount of information they received on cancer-related side-effects, including race-specific information. The American Society of Clinical Oncology's breast cancer survivorship care plan was viewed as important, but too highly technical and limited in information on side-effects and self-care approaches. CONCLUSIONS: Survivorship care plans may help increase information transfer from oncologists to patients and primary care providers, but the content of care plans needs to be adapted to minority patients' concerns. Primary care physicians may be challenged by survivors to explain recommended surveillance guidelines and to respond to untreated physical and psychosocial problems.

Emotions involved in college students' sexual encounters.

The number of sexually transmitted infections continues to rise among late adolescents and young adults. One possible explanation is that an important variable, emotion, is missing from theories and programs promoting safer practices. This study performed a thorough examination of emotions involved during and after sexual encounters and how these related to risk and planning of the sexual encounter. Eighty-two college students were given recall instructions and a questionnaire designed to elicit detailed information about their recent or most memorable sexual encounter. Using content analysis, open-ended questions concerning emotions and thoughts about the sexual partner, the participant in the situation, the place of the encounter, and feelings after the encounter were analyzed. Major findings included individuals who experienced negative or mixed emotions expected certain sexual behaviors less than those who had positive emotions. Unlike previous studies, there were no differences in emotions and planning of the sexual encounter, type of partner, and sexual risk.

Sexuality among women recipients of a pancreas and kidney transplant.

Significant improvements in health and quality of life generally follow organ transplantation; however, there is evidence that women who have received transplants experience difficulty with sexual function. The specific nature and extent of this difficulty has not been documented. The purpose of this study was to describe sexual functioning and sexual self-esteem among women recipients of a simultaneous pancreas and kidney transplant. Perceived effect of the transplant on sexuality was also explored. Participants completed a questionnaire that measured their sexual functioning (including sexual difficulties), sexual self-esteem, illnesses, medications, and perceived effect of the transplant on sexuality. Data analysis revealed that only 39% of the women would be classified as having normal sexual functioning. The majority reported either some difficulty with sexual function (34%) or sexual dysfunction (27%). About one third of the women reported that transplantation had only positive effects on their sexuality, whereas 28% reported negative effects, and 29% reported no effect.

Situational factors involved in college students' safer and risky sexual encounters.

OBJECTIVE: To ascertain the differences between the situational factors of risky and safer sexual encounters in college students. DESIGN: Descriptive. SETTING: Community-dwelling college students from a large Midwestern university. PARTICIPANTS: Participants were 84 college students ages 18 to 20 years. Fifty-five were female (67.5%), the majority (95.2%) were White, and all reported being heterosexual. MAIN OUTCOME MEASURE: Use of safer or risky practices in last or most memorable sexual encounter. RESULTS: Important situational characteristics of safer encounters were negative ambiance of the place, type of partner, unattractive qualities of the partner, communication with the partner, and having the encounter because of feeling desire. Important situational characteristics of risky encounters were a cozy ambiance, partner's attractiveness inducing desire, asking directly for the encounter, and encounters occurring after celebration or partying. CONCLUSIONS: Many characteristics were similar for both risk groups. However, practitioners can tailor interventions to make clients aware of factors that were more prevalent in risky sexual encounters, such as having the encounter with a boyfriend or girlfriend and having an encounter after drinking alcohol and partying.

Cognitive function in community-dwelling elderly women. Attentional demands and capacity to direct attention.

As individuals get older, their capacity to direct attention (CDA) appears to decline. The decline in CDA may be caused by age-related changes in the brain and demands on attentional mechanisms. These demands require older adults to expend significant attentional effort to maintain focus and achieve mental clarity while negotiating activities of daily life. The purpose of this study was to examine the relationship between attentional demands and CDA among a convenience sample of 72 community-dwelling older women with normal mental status. Findings indicate attentional demands correlated significantly with CDA and accounted for a significant proportion of the variance. No relationship was found between depressive symptoms and CDA. Implications for practice are nursing interventions aimed at decreasing attentional demands, thereby supporting attentional processes and functioning by community-dwelling older adults.

Organ-specific changes in high-energy phosphates after hemorrhagic shock and resuscitation in the rat.

BACKGROUND: Adenosine nucleotides provide energy for many essential cellular functions. Liver and intestinal ATP and energy charge are known to decrease during hemorrhagic shock, and the ability to regenerate high-energy phosphates may have important implications for recovery. We measured organ-specific changes in energy charge after hemorrhagic shock and after shock followed by resuscitation. STUDY DESIGN: Anesthetized Sprague-Dawley rats were bled and maintained at a mean arterial pressure (MAP) of 40 mmHg for 1, 2, 3, or 4 hours. Some animals were resuscitated with normal saline and shed blood (1:1) to a mean arterial pressure of 80 to 90 mmHg for 1 hour. Control animals were anesthetized, but not hemorrhaged. At the conclusion, blood gases and adenine nucleotides were measured. RESULTS: Arterial pO2 and pCO2 were normal in all groups. Unresuscitated hemorrhage caused metabolic acidosis, but bicarbonate was normal in controls and after hemorrhage followed by resuscitation. Energy charge (EC) in the gastrocnemius was unaffected by hemorrhage or resuscitation. Liver EC decreased after hemorrhage (p = 0.0001), but recovered partially after resuscitation. Kidney EC was decreased after only 3 hours of hemorrhage and 1 hour of resuscitation (p = 0.005), but not with shorter periods of hemorrhage. Lung EC decreased with shock, but was substantially worse after resuscitation (p < 0.05). CONCLUSIONS: After hemorrhage and resuscitation, EC decreased in lung, liver, kidney, and intestine, but the time course, extent of decline, and ability to recover after resuscitation varied from organ to organ. Inability to regenerate high-energy phosphates after hemorrhagic shock may be a marker for more severe cellular damage.