Prioritization of Randomized Clinical Trial Questions for Children Hospitalized With Common Conditions: A Consensus Statement.

Importance: There is a lack of randomized clinical trial (RCT) data to guide many routine decisions in the care of children hospitalized for common conditions. A first step in addressing the shortage of RCTs for this population is to identify the most pressing RCT questions for children hospitalized with common conditions. Objective: To identify the most important and feasible RCT questions for children hospitalized with common conditions. Design, Setting, and Participants: For this consensus statement, a 3-stage modified Delphi process was used in a virtual conference series spanning January 1 to September 29, 2022. Forty-six individuals from 30 different institutions participated in the process. Stage 1 involved construction of RCT questions for the 10 most common pediatric conditions leading to hospitalization. Participants used condition-specific guidelines and reviews from a structured literature search to inform their development of RCT questions. During stage 2, RCT questions were refined and scored according to importance. Stage 3 incorporated public comment and feasibility with the prioritization of RCT questions. Main Outcomes and Measures: The main outcome was RCT questions framed in a PICO (population, intervention, control, and outcome) format and ranked according to importance and feasibility; score choices ranged from 1 to 9, with higher scores indicating greater importance and feasibility. Results: Forty-six individuals (38 who shared demographic data; 24 women [63%]) from 30 different institutions participated in our modified Delphi process. Participants included children's hospital (n = 14) and community hospital (n = 13) pediatricians, parents of hospitalized children (n = 4), other clinicians (n = 2), biostatisticians (n = 2), and other researchers (n = 11). The process yielded 62 unique RCT questions, most of which are pragmatic, comparing interventions in widespread use for which definitive effectiveness data are lacking. Overall scores for importance and feasibility of the RCT questions ranged from 1 to 9, with a median of 5 (IQR, 4-7). Six of the top 10 selected questions focused on determining optimal antibiotic regimens for 3 common infections (pneumonia, urinary tract infection, and cellulitis). Conclusions and Relevance: This consensus statementhas identified the most important and feasible RCT questions for children hospitalized with common conditions. This list of RCT questions can guide investigators and funders in conducting impactful trials to improve care and outcomes for hospitalized children.

Genomic sequencing research in pediatric cancer care: Decision-making, attitudes, and perceived utility among adolescents and young adults and their parents.

PURPOSE: Professional guidelines recommend engaging adolescents and young adults (AYAs) in medical decision-making (DM), including whether to undergo genomic sequencing (GS). We explored DM around GS and attitudes after return of GS results among a diverse group of AYAs with cancer and their parents. METHODS: We surveyed AYAs with cancer (n=75) and their parents (n=52) six months after receiving GS results through the Texas KidsCanSeq Study. We analyzed AYAs' DM role in GS research enrollment and their satisfaction with that role. We compared AYAs' and parents' self-reported understanding of, attitudes toward, and perceived utility of the AYAs' GS results. RESULTS: Most AYAs reported equally sharing DM with their parents (55%) or leading DM (36%) about GS research. Compared to their cancer care DM role, 56% of AYAs reported the same level of involvement in GS research DM while 32% were more involved and 13% were less involved (p=0.011). AYAs were satisfied (99%) with their DM role regarding GS study participation. AYAs and parents had similar self-reported understanding of, attitudes toward, and perceived utility of the GS results. CONCLUSION: Our results support engaging AYAs in DM about GS research and provide insights into AYAs' DM preferences and positive attitudes toward GS.

A Qualitative Intervention Evaluation of Neonatal Virtual Family-Centered Rounds.

OBJECTIVE: To conduct an implementation evaluation of the virtual family-centered rounds (FCR) intervention by exploring the perceptions and experiences of parents and care team providers. METHODS: We conducted a qualitative descriptive study using a thematic analysis of unobtrusive observations of rounding encounters and semi-structured interviews with the parents of discharged infants and members of the neonatal care team. Eligible participants had used virtual FCR at least once. Five research team members independently performed focused coding and memo writing of transcripts and observation fieldnotes. The team met weekly to compare and refine codes, update the interview guide, develop tentative categories, and discuss the theoretical direction. RESULTS: We conducted 406 minutes of unobtrusive observations and 21 interviews with parents, physicians, neonatal nurse practitioners, bedside nurses, dieticians, and pharmacists. Three themes and 13 subthemes emerged from the analysis: (1) virtual FCR improved perceived care delivery and clinical outcomes through increased opportunities for parent engagement, (2) the acceptance of virtual FCR by providers grew over time despite the persistent presence of technical challenges, and (3) the implementation of virtual FCR should be standardized and delivered by the care team to enhance usability, effectiveness, and sustainability. CONCLUSIONS: Virtual FCR is perceived by NICU parents and care team providers to be a valuable intervention that can enhance family centered care. The identified virtual FCR implementation strategies should be tested in further studies.

Evaluating Screening to Assess Endorsement of Food Insecurity in the Inpatient Setting.

OBJECTIVE: Rates of food insecurity (FI) from screening in the inpatient setting is often not reflective of community prevalence, indicating that screening likely misses families with FI. We aimed to determine the combination of FI screening questions and methods that would result in identifying a percentage of FI families that matched or exceeded our area prevalence (approximately 20%). METHODS: Research staff approached eligible English- and Spanish-speaking families across 4 inpatient units once weekly and screened for FI using a randomly selected method (face-to-face, phone, paper, and tablet). We asked questions from the 6-Item USDA Survey, Hunger Vital Sign screener, and questions utilized by our social workers. RESULTS: We screened 361 families; 19.4% (N = 70) endorsed FI. Differences in rates were not significant by method. Differences in FI rates based on screening questions were: 17.7% for the 6-item USDA survey, 16.0% for Hunger Vital Sign, and 3.1% for the social work questions. When considering method and screening questions together, the 6-Item USDA on paper had the highest positivity rate of 20.9%. A higher percentage of Spanish-speaking families endorsed FI (61.1%) compared to 17.2% of English-speaking families (P < .01). Positivity also varied significantly by self-identified race (P < .01). Caregivers that identified as Hispanic or Latino were significantly more likely to endorse FI than those that did not (P < .01). CONCLUSIONS: The positivity rate for FI while screening inpatient families using the 6-Item screening questions on paper matched our community prevalence of FI (approximately 20%).

Telemedicine vs Telephone Consultations and Medication Prescribing Errors Among Referring Physicians: A Cluster Randomized Crossover Trial.

Importance: Critically ill children presenting to emergency departments (EDs) in non-children's hospitals are at high risk for experiencing medical errors, including medication errors. Video telemedicine consultations with pediatric specialists have the potential to reduce the risk of medication errors beyond the current standard of care, telephone consultations. Objective: To compare the rates of ED physician-related medication errors among critically ill children randomized to receive either video telemedicine or telephone consultations. Design, Setting, and Participants: This cluster randomized, unbalanced crossover trial was conducted at 15 community EDs in northern California between September 2014 and March 2018. Analyses were conducted from May 2022 to January 2023. Participants included acutely ill children younger than 15 years presenting to a participating ED. Interventions: Participating EDs were randomized to use video telemedicine or telephone for consultations with pediatric critical care physicians according to 1 of 4 unbalanced (3 telemedicine to 1 telephone) crossover treatment assignment sequences. Main Outcomes and Measures: Pharmacists reviewed medical records to document physician-related medication errors using a previously validated instrument. Multilevel logistic regression analyses were performed to create models with the medication order as the unit of analysis and adjusting for age, the log-transformed Revised Pediatric Emergency Assessment Tool score, and hospital study period. Results: A total of 696 patient encounters were included in the trial (mean [SD] age, 4.2 [4.6] years; median [IQR] age, 2.1 [0.5-2.1] years; 304 female [43.7%]), with 537 patient encounters (77.2%) assigned to video telemedicine and 159 patient encounters (22.8%) assigned to telephone. At least 1 physician-related medication error occurred for 87 patients (12.5%), including 20 of 159 patients (12.6%) in the telephone cohort and 67 of 537 patients (12.5%) in the telemedicine cohort. Of the 2414 medication orders, errors occurred in 124 cases (5.1%), including 26 of 513 orders (5.1%) in the telephone cohort and 98 of 1901 orders (5.2%) in the telemedicine cohort. In the multivariable analysis, the adjusted odds ratio of experiencing a medication error among those assigned to telemedicine was 0.86 (95% CI, 0.49-1.52; P = .61). Conclusions and Relevance: This cluster randomized crossover trial found no statistically significant differences in physician-related medication errors between critically ill children assigned to receive telephone consultations vs video telemedicine consultations. Trial Registration: ClinicalTrials.gov Identifier: NCT02877810.

The motivation and process for developing a consortium-wide time and motion study to estimate resource implications of innovations in the use of genome sequencing to inform patient care.

Costs of implementing genomic testing innovations extend beyond the cost of sequencing, affecting personnel and infrastructure for which little data are available. We developed a time and motion (T&M) study within the Clinical Sequencing Evidence-Generating Research (CSER) consortium to address this gap, and herein describe challenges of conducting T&M studies within a research consortium and the approaches we developed to overcome them. CSER investigators created a subgroup to carry out the T&M study (authors). We describe logistical and administrative challenges associated with resource use data collection across heterogeneous projects conducted in real-world clinical settings, and our solutions for completing this study and harmonizing data across projects. We delineate processes for feasible data collection on workflow, personnel, and resources required to deliver genetic testing innovations in each CSER project. A critical early step involved developing detailed project-specific process flow diagrams of innovation implementation in projects' clinical settings. Analyzing diagrams across sites, we identified common process-step themes, used to organize project-specific data collection and cross-project analysis. Given the heterogeneity of innovations, study design, and workflows, which affect resources required to deliver genetic testing innovations, flexibility was necessary to harmonize data collection. Despite its challenges, this heterogeneity provides rich insights about variation in clinical processes and resource implications for implementing genetic testing innovations.

Impact of Tele-Emergency Consultations on Pediatric Interfacility Transfers: A Cluster-Randomized Crossover Trial.

Importance: Pediatric referral centers are increasingly using telemedicine to provide consultations to help care for acutely ill children presenting to rural and community emergency departments (EDs). These pediatric telemedicine consultations may help improve physician decision-making and may reduce the frequency of overtriage and interfacility transfers. Objective: To examine the use of pediatric critical care telemedicine vs telephone consultations associated with risk-adjusted transfer rates of acutely ill children from community and rural EDs. Design, Setting, and Participants: A cluster-randomized crossover trial was conducted between November 18, 2015, and March 26, 2018. Analyses were conducted from January 19, 2018, to July 23, 2022, 2022. Participants included acutely ill children aged 14 years and younger presenting to a participating ED in 15 rural and community EDs in northern California. Interventions: Participating EDs were randomized to use telemedicine or telephone for consultations with pediatric critical care physicians according to 1 of 4 unbalanced (3 telemedicine:1 telephone) crossover treatment assignment sequences. Main Outcomes and Measures: Intention-to-treat, treatment-received, and per-protocol analyses were performed to determine the risk of transfer using mixed effects Poisson regression analyses with random intercepts for presenting EDs to account for hospital-level clustering. Results: A total of 696 children (392 boys [56.3%]; mean [SD] age, 4.2 [4.6] years) were enrolled. Of the 537 children (77.2%) assigned to telemedicine, 251 (46.7%) received the intervention. In the intention-to-treat analysis, patients assigned to the telemedicine arm were less likely to be transferred compared with patients assigned to the telephone arm after adjusting for patient age, severity of illness, and hospital study period (risk rate [RR], 0.93; 95% CI, 0.88-0.99). The adjusted risk of transfer was significantly lower in the telemedicine arm compared with the telephone arm in both the treatment-received analysis (RR, 0.81; 95% CI, 0.71-0.94) and the per-protocol analysis (RR, 0.79; 95% CI, 0.68-0.92). Conclusions and Relevance: In this randomized trial, the use of telemedicine to conduct consultations for acutely ill children in rural and community EDs resulted in less frequent overall interfacility transfers than consultations done by telephone. Trial Registration: ClinicalTrials.gov Identifier: NCT02877810.

Early post-operative neurodevelopment and visual assessment in neonates with congenital heart disease undergoing cardiac surgery.

OBJECTIVE: Assessment of neurobehavior and visual function of newborns with congenital heart disease during the post-operative period to identify infants at risk of neurodevelopmental and visual impairment. STUDY DESIGN: Prospective study that included 45 newborns who underwent cardiac surgery. Newborn Behavioral Observations test (NBO) and "ML Battery of Optotypes" were used for assessment. RESULTS: The median NBO global score was 2.4 [2.1-2.6]. Total days of oral morphine [p = 0.005] and total days of sedation [p = 0.009] were strongly related to abnormal evaluations. Time of cerebral regional oxygen saturation (CrSO2) under 40% during surgery and increased lactate were related to abnormal motor evaluation. Only 14.5% of patients presented pathological results in visual evaluation. CONCLUSIONS: We have demonstrated alterations in attention, autonomic, motor, and oral motor function. Duration of sedative medication, time of CrSO2 under 40% during surgery, and increased lactate are the most important risk factors. No significant visual impairment was detected.

Prophylactic and Therapeutic Potential Zinc Metallodrugs Drug Discovery: Identification of SARS-CoV-2 Replication and Spike/ACE2 Inhibitors.

BACKGROUND: The emergence of severe acute respiratory syndrome coronavirus 2 (SARSCoV- 2) variants with novel spike protein mutations has been shown to be influencing the epidemiological and clinical aspects of the COVID-19 pandemic. OBJECTIVE: Due to studies showing various dietary benefits of zinc as a viral replication inhibitor as well as an immunity enhancer, organometallic complexes incorporating zinc ions can be ideal antiviral candidates due to their structural variation and diverse stereochemistry. METHODS: In silico studies were conducted for the virtual screening of zinc complexes with SARSCoV- 2 and host proteins to explore their effect on viral entry and replication activity. Molegro Virtual Docker along with AutoDock was used for the identification of potential SARS-CoV-2 inhibitor complexes from the Cambridge Structural Database (CSD). Molecular dynamics (MD), density functional theory (DFT), chemical absorption, distribution, metabolism, excretion, and toxicity properties (ADMET) were used to support the findings from virtual screening. RESULTS: In correlation with SARS-CoV-2 RNA-dependent RNA polymerase and spike receptorbinding domain bound with ACE2 docking results, the compound (bis(3,5-dimethyl-1H-pyrazole)- bis(2-furoato)-zinc(ii)) (CSD code ECOZAA) occurs to be a potential metal complex SARS-CoV-2 receptor inhibitor. The compound ECOZAA was observed (in silico binding affinity = - 179.29kcal/mol) to behave better than the clinically approved drug Remdesivir (in silico binding affinity = -62.69kcal/mol) against SARS-CoV-2 RNA-dependent RNA polymerase. The large HOMO- LUMO gap for the ECOZAA compound is an indication of the low chemical reactivity as well as the great kinetic stability of the compound. CONCLUSION: Thus, this study highlights the potential use of zinc metal complexes as SARS-CoV-2 viral entry and replication inhibitors.

Communicating regulatory high-throughput sequencing data using BioCompute Objects.

This project demonstrates the use of the IEEE 2791-2020 Standard (BioCompute Objects [BCO]) to enable the complete and concise communication of results from next generation sequencing (NGS) analysis. One arm of a clinical trial was replicated using synthetically generated data made to resemble real biological data and then two independent analyses were performed. The first simulated a pharmaceutical regulatory submission to the US Food and Drug Administration (FDA) including analysis of results and a BCO. The second simulated an FDA review that included an independent analysis of the submitted data. Of the 118 simulated patient samples generated, 117 (99.15%) were in agreement in the two analyses. This process exemplifies how a template BCO (tBCO), including a verification kit, facilitates transparency and reproducibility, thereby reinforcing confidence in the regulatory submission process.

Examining access to care in clinical genomic research and medicine: Experiences from the CSER Consortium.

INTRODUCTION: Ensuring equitable access to health care is a widely agreed-upon goal in medicine, yet access to care is a multidimensional concept that is difficult to measure. Although frameworks exist to evaluate access to care generally, the concept of "access to genomic medicine" is largely unexplored and a clear framework for studying and addressing major dimensions is lacking. METHODS: Comprised of seven clinical genomic research projects, the Clinical Sequencing Evidence-Generating Research consortium (CSER) presented opportunities to examine access to genomic medicine across diverse contexts. CSER emphasized engaging historically underrepresented and/or underserved populations. We used descriptive analysis of CSER participant survey data and qualitative case studies to explore anticipated and encountered access barriers and interventions to address them. RESULTS: CSER's enrolled population was largely lower income and racially and ethnically diverse, with many Spanish-preferring individuals. In surveys, less than a fifth (18.7%) of participants reported experiencing barriers to care. However, CSER project case studies revealed a more nuanced picture that highlighted the blurred boundary between access to genomic research and clinical care. Drawing on insights from CSER, we build on an existing framework to characterize the concept and dimensions of access to genomic medicine along with associated measures and improvement strategies. CONCLUSIONS: Our findings support adopting a broad conceptualization of access to care encompassing multiple dimensions, using mixed methods to study access issues, and investing in innovative improvement strategies. This conceptualization may inform clinical translation of other cutting-edge technologies and contribute to the promotion of equitable, effective, and efficient access to genomic medicine.

Disconnection in Information Exchange During Pediatric Trauma Transfers: A Qualitative Study.

Pediatric patients experiencing an emergency department (ED) visit for a traumatic injury often transfer from the referring ED to a pediatric trauma center. This qualitative study sought to evaluate the experience of information exchange during pediatric trauma visits to referring EDs from the perspectives of parents and referring and accepting clinicians through semi-structured interviews. Twenty-five interviews were conducted (10 parents and 15 clinicians) and analyzed through qualitative thematic analysis. A 4-person team collaboratively identified codes, wrote memos, developed major themes, and discussed theoretical concepts. Three interdependent themes emerged: (1) Parents' and clinicians' distinct experiences result in a disconnect of information exchange needs; (2) systems factors inhibit effective information exchange and amplify the disconnect; and (3) situational context disrupts the flow of information contributing to the disconnect. Individual-, situational-, and systems-level factors contribute to disconnects in the information exchanged between parents and clinicians. Understanding how these factors' influence information disconnect may offer avenues for improving patient-clinician communication in trauma transfers.

Genetic testing in ambulatory cardiology clinics reveals high rate of findings with clinical management implications.

PURPOSE: Cardiovascular disease (CVD) is the leading cause of death in adults in the United States, yet the benefits of genetic testing are not universally accepted. METHODS: We developed the "HeartCare" panel of genes associated with CVD, evaluating high-penetrance Mendelian conditions, coronary artery disease (CAD) polygenic risk, LPA gene polymorphisms, and specific pharmacogenetic (PGx) variants. We enrolled 709 individuals from cardiology clinics at Baylor College of Medicine, and samples were analyzed in a CAP/CLIA-certified laboratory. Results were returned to the ordering physician and uploaded to the electronic medical record. RESULTS: Notably, 32% of patients had a genetic finding with clinical management implications, even after excluding PGx results, including 9% who were molecularly diagnosed with a Mendelian condition. Among surveyed physicians, 84% reported medical management changes based on these results, including specialist referrals, cardiac tests, and medication changes. LPA polymorphisms and high polygenic risk of CAD were found in 20% and 9% of patients, respectively, leading to diet, lifestyle, and other changes. Warfarin and simvastatin pharmacogenetic variants were present in roughly half of the cohort. CONCLUSION: Our results support the use of genetic information in routine cardiovascular health management and provide a roadmap for accompanying research.

A Co-Crystallised Cobalt(II) Cluster of Pyridinedicarboxylic Acid (PDC) as a Luminescent Material for Selective Sensing of Methanol.

A luminescent Cobalt(II) co-crystal [Co13(PDC)16(H2O)24.7H2O] 1 (where H2PDC = 2,6-pyridinedicarboxylic acid) have been prepared by oven-heating and slow evaporation of solvent. Single crystal X-ray diffraction (SCXRD) analysis revealed that 1 is a mixture of complexes that crystallizes in the triclinic space group P-1 and the geometry around the Co(II) ions is octahedral. The structure is extensively imbued with hydrogen bonding that helps in stabilizing the complex. Thermogravimetric analysis indicates that 1 is thermally stable up to 364 οC. The luminescence properties of 1 revealed a strong emission centered at 437 nm (λex = 345 nm) assigned to ligand to metal charge transfer (LMCT). The luminescence sensing of 1 towards volatile organic molecules were also examined. However, 1 displayed a turn off towards methanol compared to other molecules with high quenching efficiency and low limit of detection (3.5 × 10-4 vol%). The results show excellent selectively and high sensitivity. Powder X-ray diffraction studies revealed that the structural integrity of the complex was maintained after exposure to methanol vapour. Theoretical studies also revealed small binding energy (-413.2 au) and low energy gap (1.19) for 1-CH3OH adduct.

Virtual Family-Centered Rounds in the Neonatal Intensive Care Unit: A Randomized Controlled Pilot Trial.

OBJECTIVES: To measure the feasibility, reach, and potential impact of a virtual family-centered rounds (FCR) intervention in the neonatal intensive care unit. METHODS: We conducted a randomized controlled pilot trial with a 2:1 intervention-to-control arm allocation ratio. Caregivers of intervention arm neonates were invited to participate in virtual FCR plus standard of care. We specified 5 feasibility objectives. We profiled intervention usage by neonatal and maternal characteristics. Exploratory outcomes included FCR caregiver attendance, length of stay, breast milk feeding at discharge, caregiver experience, and medical errors. We performed descriptive analyses to calculate proportions, means, and rates with 95% confidence intervals (CI). RESULTS: We included 74 intervention and 36 control subjects. Three of the five feasibility objectives were met based on the point estimates. The recruitment and intervention uptake objectives were not achieved. Among intervention arm subjects, recruitment of a caregiver occurred for 47 (63.5%, 95% CI 51.5%-74.4%) neonates. Caregiver use of the intervention occurred for 36 (48.6%, 95% CI 36.8%-60.6%) neonates in the intervention arm. Feasibility objectives assessing technical issues, burden, and data collection were achieved. Among the attempted virtual encounters, 95.0% (95% CI 91.5%-97.3%) had no technical issues. The survey response rate was 87.5% (95% CI 78.2%-93.8%). Intervention arm neonates had 3.36 (95% CI 2.66%-4.23) times the FCR caregiver attendance rate of subjects in the control arm. CONCLUSIONS: A randomized trial to compare virtual FCR to standard of care in neonatal subjects is feasible and has potential to improve patient and caregiver outcomes.

Improving Pediatric Resident Safety Event Reporting Using Quality Improvement Methods.

BACKGROUND AND OBJECTIVES: Safety event reporting systems facilitate identification of system-level targets to improve patient safety. Resident physicians report few safety events despite their role as frontline providers and the frequent occurrence of events. The objective of this study is to increase the number of pediatric resident safety event submissions from <1 to 4 submissions per 14-day period within 12 months. METHODS: We conducted an iterative quality improvement process with 39 pediatric residents at a children's hospital. Interventions focused on 4 key drivers: user-friendly event submission process, resident buy-in, nonpunitive safety culture, and data transparency. The primary outcome measure of number of pediatric resident event submissions was analyzed by using statistical process control. Balancing measures included time from submission to feedback, duplicate submissions, and nonevent submissions. As a control, the primary outcome measure was monitored for nonpediatric residents during the same period. RESULTS: The mean number of pediatric resident event submissions increased from 0.9 to 5.7 submissions per 14 days. Impactful interventions included a designated space in the resident workroom to list safety events to submit, monthly project updates, and an interresident competition. There were no duplicate submissions or nonevent submissions in the postintervention period. Time to feedback in the postintervention period had both upward and downward shifts, with >8 consecutive points above and below the baseline period's centerline. The control group showed no sustained change in event submissions. CONCLUSIONS: Our improvement process was associated with significant increase in pediatric resident safety event submissions without an increase in the number of submissions categorized as duplicates or nonevents.

Disclosure of familial implications of pathogenic variants in breast-cancer genes to patients: Opportunity for prompting family communication.

Familial communication of pathogenic genetic variants is necessary to maximize the clinical utility of genetic testing and its public health benefits. Insights to family communication considerations may be obtained from existing clinical documentation available in medical records. The goal of this study was to describe and characterize information about family communication of pathogenic variants and cascade genetic testing from genetic counseling summary notes. We completed structured content analysis of 656 summary notes describing pathogenic variants in breast cancer genes, for patients seen at a tertiary cancer center. Patients were 89.5% female, median age of 49 years, 32.6% non-White, and were counseled by 23 unique genetic counselors (GCs) with mean post-certification experience of 3.7 years. Cascade genetic testing was documented in 92.2% of all notes. Specific relatives (i.e., relationship to patient) who would benefit from genetic counseling and cascade testing were referenced in 33.1% of notes. Specific risk messaging was 2.5 times more likely to be present in notes of high- compared to moderate-risk genes (OR=2.53, 95% CI: 1.71-3.80), and when summary notes indicated the presence of a friend or relative (OR=2.29, 95% CI: 1.50-3.48). Summary notes frequently attempted to contextualize the patients' familial relationships by referencing positive family communication patterns (41.6%) or negative communication issues (2.4%) and included various strategies to address barriers to communication and assist relatives with cascade testing. Overall, GCs consistently documented family communication recommendations when pathogenic variants are identified on patients' genetic testing, albeit with heterogeneous use of specific communication prompts.

Testing Pediatric Emergency Telemedicine Implementation Strategies Using Quality Improvement Methods.

Background: Despite the recognized benefits of telemedicine use for pediatric emergency consultations, there are barriers to the widespread uptake of this technology. Quality improvement methods can be used to rapidly test implementation strategies. Our objective was to test telemedicine implementation strategies in real-world application using quality improvement methods. Our quality improvement aim was to achieve high rates of telemedicine use for pediatric transfer consultations. Methods: A multidisciplinary multisite improvement team identified that key drivers of increasing telemedicine use included telemedicine resource awareness, streamlined telemedicine workflow, provider buy-in, and data transparency. Interventions focused on telemedicine trainings, disseminating telemedicine uptake data, telemedicine reminders, telemedicine test calls, and preparing for telemedicine use for every transfer consultation. The outcome measure was percentage of pediatric emergency transfer consultations that used telemedicine. The balancing measure was time (minutes) from the initial transfer center call to completion of the consultation. Results: Multiple plan-do-study-act cycles were associated with special cause variation, with an upward shift in mean percentage of telemedicine use from 5% to 22%. Time from initial call to consultation completion remained unchanged. Conclusion: Our study supports the use of quality improvement methods to test telemedicine implementation strategies for pediatric telemedicine emergency consultations.

Impact of a Parent Video Viewing Program in the Neonatal Intensive Care Unit.

Purpose: Video visits, or televisits, have become increasingly popular across various medical subspecialties. Within the University of California, Davis, Neonatal Intensive Care Unit, a video visitation program known as FamilyLink allows families to remotely view their babies when they are otherwise unable to visit. This study aimed to explore parents' perceived effects of video camera use as well as the relationship of video visit use with rates of breast milk feedings at hospital discharge. Materials and Methods: Families enrolled in this study completed a series of two identical surveys that gathered self-reported data on their experiences during their infant's hospitalization. Comparisons were made considering whether the FamilyLink program was utilized during the admission as well as changes in self-reported experiences over the time course of the hospital admission. The type of enteral feeding at discharge was recorded and reviewed for each baby. Results: Of 100 families enrolled in the study, 30 were found to have used FamilyLink to visit with their baby. The use of FamilyLink was associated with survey findings of sustained intention to breastfeed or provide breast milk to the baby, as well as increased perceived parental involvement in the baby's care. Improved rates of breast milk feedings at the time of discharge were also found among babies whose families conducted televisits using FamilyLink. Conclusions: Video viewing in the NICU has effected a positive impact on breast milk feedings and parents' feelings of involvement during the admission, with the potential to further improve on families' experiences with a hospitalized baby.

Cost-effectiveness of Population-Wide Genomic Screening for Hereditary Breast and Ovarian Cancer in the United States.

Importance: Genomic screening for hereditary breast and ovarian cancer (HBOC) in unselected women offers an opportunity to prevent cancer morbidity and mortality, but the potential clinical impact and cost-effectiveness of such screening have not been well studied. Objective: To estimate the lifetime incremental incidence of HBOC and the quality-adjusted life-years (QALYs), costs, and cost-effectiveness of HBOC genomic screening in an unselected population vs family history-based testing. Design, Setting, and Participants: In this study conducted from October 27, 2017, to May 3, 2020, a decision analytic Markov model was developed that included health states for precancer, for risk-reducing mastectomy (RRM) and risk-reducing salpingo-oophorectomy (RRSO), for earlier- and later-stage HBOC, after cancer, and for death. A complimentary cascade testing module was also developed to estimate outcomes in first-degree relatives. Age-specific RRM and RRSO uptake probabilities were estimated from the Geisinger MyCode Community Health Initiative and published sources. Parameters including RRM and RRSO effectiveness, variant-specific cancer risk, costs, and utilities were derived from published sources. Sensitivity and scenario analyses were conducted to evaluate model assumptions and uncertainty. Main Outcomes and Measures: Lifetime cancer incidence, QALYs, life-years, and direct medical costs for genomic screening in an unselected population vs family history-based testing only were calculated. The incremental cost-effectiveness ratio (ICER) was calculated as the difference in cost between strategies divided by the difference in QALYs between strategies. Earlier-stage and later-stage cancer cases prevented and total cancer cases prevented were also calculated. Results: The model found that population screening of 30-year-old women was associated with 75 (95% credible range [CR], 60-90) fewer overall cancer cases and 288 QALYs (95% CR, 212-373 QALYs) gained per 100 000 women screened, at an incremental cost of $25 million (95% CR, $21 millon to $30 million) vs family history-based testing; the ICER was $87 700 (78% probability of being cost-effective at a threshold of $100 000 per QALY). In contrast, population screening of 45-year-old women was associated with 24 (95% CR, 18-29) fewer cancer cases and 97 QALYs (95% CR, 66-130 QALYs) gained per 100 000 women screened, at an incremental cost of $26 million (95% CR, $22 million to $30 million); the ICER was $268 200 (0% probability of being cost-effective at a threshold of $100 000 per QALY). A scenario analysis without cascade testing increased the ICER to $92 600 for 30-year-old women and $354 500 for 45-year-old women. A scenario analysis assuming a 5% absolute decrease in mammography screening in women without a variant was associated with the potential for net harm (-90 QALYs per 100 000 women screened; 95% CR, -180 to 10 QALYs). Conclusions and Relevance: The results of this study suggest that population HBOC screening may be cost-effective among younger women but not among older women. Cascade testing of first-degree relatives added a modest improvement in clinical and economic value. The potential for harm conferred by inappropriate reduction in mammography among noncarriers should be quantified.