Fistulising skin metastases in Crohn's disease: a case report and review of the literature.

BACKGROUND: Metastatic Crohn's disease is a rare disorder characterized by various granulomatous skin lesions that occur independently of gastrointestinal tract involvement. However, currently there is no standardized care or specific treatment. Therapeutic approaches include immunosuppressive agents, such as corticosteroids, azathioprine, and monoclonal antibodies targeting inflammatory cytokines like tumor necrosis factor (TNF). CASE PRESENTATION: We present a case of a 29-year-old western European woman with significant blind ending abdominal subcutaneous fistulas and abscesses, who sought evaluation in the dermatology department. Histological examination revealed multiple epithelioid cell granulomas. There was no evidence of infectious or rheumatologic diseases such as sarcoidosis. The tentative diagnosis was metastatic Crohn's disease, which was not related to an intestinal manifestation of the disease. The patient responded to infliximab but had to discontinue it due to an allergic reaction. Subsequent adalimumab treatment failed to induce clinical remission; thus, therapy was switched to ustekinumab, resulting in a positive response. Written informed consent for publication of their clinical details and clinical images was obtained from the patient. For our study more than 1600 publications were screened for cases of metastatic Crohn's disease on PubMed database. 59 case reports with 171 patients were included in the analysis and evaluated for localization, diagnostic and therapeutic approaches, and complications and were summarized in this review. CONCLUSION: The successful ustekinumab treatment of a patient with metastatic Crohn's disease underscores the potential of this minimally investigated therapeutic option, highlighting the need for future treatment guidelines given the increasing prevalence of such cases.

Feasibility and Preliminary Impact of a Web-Based Mind Body Intervention for Older Dementia Caregivers.

BACKGROUND: Mind-body interventions focused on intentional breathing and movement have been found to mitigate the negative effects of caregiving such as such as stress, psychosocial distress, and emotional distress associated for persons living with Alzheimer's disease and related dementias. OBJECTIVE: The objective was to assess the feasibility and acceptability and preliminary impacts of our 12-week mind body intervention "Gentle Yoga and Yogic Breathing" for caregivers of persons living with dementia on health outcomes including mutuality, depression and anxiety, loneliness and social support, quality of life, and physical function. METHODS: We conducted a single-group cohort study in which 20 caregivers were enrolled. Data were collected at baseline and at the 12-week post-intervention endpoint. RESULTS: The intervention was acceptable; 75% (n = 15/20) completed the study; 16 completed post-study questionnaires. Very few experienced technical issues; 31% (n = 3) most commonly reported as poor internet connectivity, 75% (n = 12/16) perceived a health benefit, 88% (n = 14/16) perceived improved day-to-day mood, and 100% (n = 16/16) would recommend the intervention to other caregivers. Although there was minimal change from baseline to 12 weeks, for health outcomes, there were very small improvements noted in anxiety and overall health. There were no reported adverse events. CONCLUSION: The intervention was well received and is feasible and acceptable for future studies of stress and health management interventions for caregivers of persons living with dementia.Registered with https://www.ClinicalTrials.gov (NCT03853148).

DISPLACE Study Shows Poor Quality of Transcranial Doppler Ultrasound for Stroke Risk Screening in Sickle Cell Anemia.

Children with sickle cell anemia (SCA) are at increased risk of stroke when compared to age-based counterparts. The Stroke Prevention Trial in Sickle Cell Anemia (STOP) previously demonstrated that with the use of transcranial Doppler ultrasound (TCD; Sickle Stroke Screen) and chronic red cell transfusion, the risk of stroke risk is reduced by over 90%. The STOP criteria detailed the type and method of measurement required; the time averaged mean maximum velocity (TAMMV). Unfortunately, it has been difficult to adhere to the appropriate TAMMV measurements. The objectives of this study were to assess the quality of TCD and transcranial Doppler imaging (TCDi) reports to determine report quality and accuracy. This is a sub-analysis of the DISPLACE (Dissemination and Implementation of Stroke Prevention Looking at the Care Environment) study. Over 12,000 TCD/TCDi reports were collected during this study from 28 institutions; 391 TCDs were reviewed for this sub-analysis. There was significant variation in which vessels were assessed, the velocities used to define abnormal results, and who was interpreting the scans. In 52% of reports, it was impossible to identify whether the TAMMV was what was measured. Similarly, it was only clear in 42% of reports that the TAMMV was used to interpret the exam as normal/abnormal. Given this inconsistency, we strongly recommend standardization of TCD/TCDi reporting, specialized training for those performing and interpreting the scans in the use of TCD/TCDi in patients with SCA, internal quality assurance, and institutional quality improvement work to ensure appropriate use of this potentially lifesaving technology.

Telemedicine for Routine Prenatal Care: Use and Satisfaction During the COVID-19 Pandemic.

INTRODUCTION: Telemedicine use in prenatal care has greatly expanded without substantial research. Optimizing user experiences can increase telemedicine's utilization to support care access. The purpose of this study was to explore patient and provider experiences using telemedicine for routine prenatal care during the COVID-19 pandemic, identifying factors affecting its utilization and satisfaction. METHODS: In this mixed methods study, online surveys and semi-structured interviews with pregnant and postpartum patients and perinatal providers across the United States were used to explore experiences with telemedicine and prenatal care during the COVID-19 pandemic. Data were collected from July to December 2021. Survey findings were analyzed using descriptive and inferential statistics, and interviews were thematically coded and analyzed, followed by mixed methods analysis. RESULTS: Results of 946 surveys (750 patients and 196 providers) and 30 interviews (15 patients and 15 providers) met inclusion for analysis. Telemedicine was utilized by 42% of patients and 72% of perinatal provider participants. The primary reason patients did not use telemedicine was because it was not offered. Patients and providers who did not use telemedicine expressed the following main concerns with virtual care: uncertainty about care quality, particularly when blood pressure and the fetal heart rate were not assessed, and potential challenges with developing trusting patient-provider relationships. Patients and providers who used telemedicine rated their experience as mild to moderate satisfaction across the 6 Telehealth Usability Questionnaire domains. Satisfaction scores were not dependent on whether physical examination components were included in virtual visits. DISCUSSION: Providing patients with the choice to use telemedicine as needed or combined with in-person visits for routine prenatal care may increase care utilization. Although not directly linked with satisfaction, interest in using telemedicine would likely increase for patients and providers concerned with care quality if blood pressure and fetal heart rate are assessed during virtual visits.

Working-Age Caregivers of Stroke Survivors: Needs, Concerns, and Quality of Life.

PURPOSE: The purpose of this study was to characterize the unmet needs and concerns of working-age caregivers of stroke survivors and to explore the relationships between these unmet needs and concerns and factors such as stroke survivor functional independence, caregiver strain, caregiver self-efficacy, caregiver perceived social support, and caregiver quality of life (QoL). DESIGN: Cross-sectional descriptive design was used in this study. METHODS: Participants ( N = 103) completed an online survey. Descriptive statistics, bivariate Pearson correlation, and linear regression analysis was performed. RESULTS: Negative correlations were found between caregiver needs and concerns and both stroke survivor functional independence and caregiver self-efficacy. Positive correlations were identified between caregiver needs and concerns and caregiver strain. In multiple regression models, stroke survivor functional independence, caregiver self-efficacy, race, and gender were statistically significantly associated with caregiver QoL. CLINICAL RELEVANCE TO THE PRACTICE OF REHABILITATION NURSING: Results of this study can inform nurses as they collaborate with informal caregivers and researchers in optimizing the rehabilitation and discharge process and aiding in the support of caregiver QoL. CONCLUSION: Working-age caregivers of stroke survivors expressed many needs and concerns. These needs, along with other factors, can affect outcomes including QoL in caregivers and stroke survivors.

Herding Cats in Pandemic Times - Towards Technological and Organizational Convergence of Heterogeneous Solutions for Investigating and Mastering the Pandemic in University Medical Centers.

To understand and handle the COVID-19 pandemic, digital tools and infrastructures were built in very short timeframes, resulting in stand-alone and non-interoperable solutions. To shape an interoperable, sustainable, and extensible ecosystem to advance biomedical research and healthcare during the pandemic and beyond, a short-term project called "Collaborative Data Exchange and Usage" (CODEX+) was initiated to integrate and connect multiple COVID-19 projects into a common organizational and technical framework. In this paper, we present the conceptual design, provide an overview of the results, and discuss the impact of such a project for the trade-off between innovation and sustainable infrastructures.

A Novel Approach to Monitoring Cognitive Adverse Events for Interventional Studies Involving Advanced Dementia Patients: Insights From the Electroconvulsive Therapy for Agitation in Dementia Study.

OBJECTIVE: To develop an individualized method for detecting cognitive adverse events (CAEs) in the context of an ongoing trial of electroconvulsive therapy for refractory agitation and aggression for advanced dementia (ECT-AD study). METHODS: Literature search aimed at identifying (a) cognitive measures appropriate for patients with advanced dementia, (b) functional scales to use as a proxy for cognitive status in patients with floor effects on baseline cognitive testing, and (c) statistical approaches for defining a CAE, to develop CAEs monitoring plan specifically for the ECT-AD study. RESULTS: Using the Severe Impairment Battery-8 (SIB-8), baseline floor effects are defined as a score of ≤5/16. For patients without floor effects, a decline of ≥6 points is considered a CAE. For patients with floor effects, a decline of ≥30 points from baseline on the Barthel Index is considered a CAE. These values were derived using the standard deviation index (SDI) approach to measuring reliable change. CONCLUSIONS: The proposed plan accounts for practical and statistical challenges in detecting CAEs in patients with advanced dementia. While this protocol was developed in the context of the ECT-AD study, the general approach can potentially be applied to other interventional neuropsychiatric studies that carry the risk of CAEs in patients with advanced dementia.

Pulmonologists' Perspectives on and Access to Palliative Care for Patients With Idiopathic Pulmonary Fibrosis in South Carolina.

Background: Idiopathic pulmonary fibrosis (IPF) is a serious illness with an unpredictable disease course and survival rates comparable with some cancers. Patients with IPF suffer considerable symptom burden, declining quality of life, and high health care resource utilization. Patients and caregivers report many unmet needs, including a desire for more education regarding diagnosis and assistance with navigating disease trajectory. Compelling evidence suggests that palliative care (PC) provides an extra layer of support for patients with serious illness. Research Question: The purpose of this survey was to gain perspectives regarding PC for patients with IPF by board-certified pulmonologists in South Carolina (SC). Study Design and Methods: A 24-item survey was adapted (with permission) from the Pulmonary Fibrosis Foundation PC Survey instrument. Data were analyzed and results are presented. Results: Pulmonologists (n = 32, 44%) completed the survey; 97% practice in urbanized settings. The majority agreed that PC and hospice do not provide the same service. There were varying views about comfort in discussing prognosis, disease trajectory, and addressing advance directives. Options for ambulatory and inpatient PC are limited and early PC referral does not occur. None reported initiating a PC referral at time of initial IPF diagnosis. Interpretation: Pulmonologists in SC who participated in this survey are aware of the principles of PC in providing comprehensive care to patients with IPF and have limited options for PC referral. PC educational materials provided early in the diagnosis can help facilitate and guide end-of-life planning and discussions. Minimal resources exist for patients in underserved communities.

Practice Patterns for Addressing Developmental-Behavioral Concerns in Sickle Cell Specialty Care.

Objective: Children with sickle cell disease (SCD) are at elevated risk for neurodevelopmental and behavioral disorders. This report describes developmental-behavioral practice patterns among sites who were part of the Dissemination and Implementation of Stroke Prevention Looking at the Care Environment (DISPLACE) consortium in the context of current guidelines for addressing these concerns. Methods: An internal survey was developed for the Principal Investigators of the DISPLACE study to identify developmental-behavioral clinical practices across the 28-site consortium, including methods for identification, referral practices, access to psychologists, and barriers to services. Descriptive data were pulled from the survey to describe practice patterns. Results: Most sites used informal methods to detect developmental-behavioral concerns, though over 1/3 of sites were using a structured protocol. The most common referral indications for further developmental and neuropsychological evaluation were parent, provider, or school concerns or stroke. Evaluations were predominantly completed by pediatric neuropsychologists and pediatric psychologists. Despite most sites reporting access to a psychologist within the SCD clinic, sites also reported long waitlists and difficulty accessing providers for evaluation and treatment services. Insurance difficulties were also a common barrier. A range of additional barriers were reported at the patient, provider, organizational, and policy/socio-environmental levels. Conclusions: Many sites in the DISPLACE consortium were adhering to existing care guidelines for pediatric SCD; however, there was also wide variation in practices for which guidelines are absent or unclear. Additional work is needed to inform guidelines, to specify the role of psychology within specialty SCD care, and to overcome barriers to care. Implications for Impact Statement: Optimal developmental-behavioral care for children with SCD involves collaboration among specialty care providers and pediatric psychologists; however, these efforts may be hampered by dispersed or unclear guidelines and several barriers to care. Future studies and guidelines have the potential to improve care by providing clear, consistent, and unified care recommendations specific to psychologists and related care professionals who are supporting children with SCD.

Self-Administered Gentle Yoga and Yoga Breathing Intervention Improves Burden and Stress Biomarkers in Caregivers of Persons Living with Dementia.

Family caregivers of adults with Alzheimer's disease and related dementias (ADRD) are the fastest growing group of informal healthcare providers in the United States. These individuals experience high levels of stress and physical and psychosocial symptoms related to their caregiving role. We provided 20 ADRD caregivers (≥ 55 years of age) with training and access to a mobile health app for at-home practice of gentle yoga and yoga breathing exercises. Here, we report secondary outcomes, including changes in caregiver physical and mental function, burden, fatigue, sleep, and biological stress markers (salivary cortisol and 1,5-anhydroglucitol [1,5-AG] assays) from Baseline (Week 1) to Study End (Week 12). Self-reported questionnaire data were collected online via the Research Electronic Data Capture system, and biomarker data were collected via saliva samples. Results supported indications for slight improvement in outcomes of caregiving burden among ADRD caregivers using the gentle yoga and yoga breathing app. Furthermore, slight improvements in mental health were observed; the greatest gains were made by those reporting higher burden and having family members with more severe dementias. Findings indicate that those experiencing the greatest improvement in caregiver burden scores spent the most time doing gentle yoga and yoga breathing exercises. Salivary stress biomarkers moved in a favorable direction (decreased cortisol; increased 1,5-AG) among caregivers practicing the exercises most often. This is among the first studies of gentle yoga and yoga breathing exercises for relieving ADRD caregiver burden and the first we are aware of to incorporate stress biomarker measurement.

Disparities in Cancer Screening in Sexual and Gender Minority Populations: A Secondary Analysis of Behavioral Risk Factor Surveillance System Data.

OBJECTIVES: To describe cancer screening characteristics and better understand individual-, environmental-, and organizational-level barriers of sexual and gender minority (SGM) populations. . SAMPLE & SETTING: This study was conducted using a combined sample from the Behavioral Risk Factor Surveillance System (BRFSS) national dataset from 2014 and 2016. METHODS & VARIABLES: Chi-square tests for independence and logistic regression analysis tests were performed to determine whether relationships existed between SGM status and demographics. RESULTS: Black respondents or those who reported their race as other, were female, had some college or technical school or more, and had healthcare coverage were less likely to present for cancer screening. SGM respondents who were in good or better health; were unmarried; were aged 18-44 years or 45-55 years; or were Asian, Native American, or Hawaiian, or reported their race as other, had higher odds of screening for cancer. IMPLICATIONS FOR NURSING: Disparities in cancer screening among SGM populations are not well documented. These findings will inform structured education and preventative interventions to improve screening participation among SGM populations.

Comparison of home-based palliative care delivered by community health workers versus usual care: research protocol for a pilot randomized controlled trial.

BACKGROUND: Research studies demonstrate that palliative care can improve patient outcomes such as quality of life, symptom burden and patient satisfaction with care (Gomes B, et al. Effectiveness and cost-effectiveness of home palliative care services for adults with advanced illness and their caregivers. Cochrane Database Syst Rev. 2013(6):CD00776) (World Health Organization. Palliative Care. Published 2020.). While 76% of patients who need palliative care live in limited-resource countries, access to high quality palliative services in these countries is minimal (Worldwide Hospice and Palliative Care Association and World Health Organization. Global Atlas of Palliative Care (2nd ed). 2020.). In 2014 the Worldwide Hospice Palliative Care Alliance, with strong endorsement by the WHO, released the Palliative Care Toolkit to provide a training and implementation toolkit for empowering community members to deliver palliative care in resource poor settings (Worldwide Hospice and Palliative Care Association and World Health Organization. Global Atlas of Palliative Care at the End of Life. Geneva, Switzerland 2014.). They encouraged researchers and public health practitioners to conduct rigorous evaluation of the toolkit in diverse settings and contexts. To address this need, we will conduct a pilot randomized controlled trial (RCT) to examine implementation and explore potential effect of an intervention based upon the Palliative Care Toolkit, as adapted and used by community health workers (CHWs) working with a cancer center in Kolkata, India to deliver home-based palliative care for rural patients. METHODS: Utilizing a randomized controlled trial design, intervention patients (n = 45) receive home-based palliative services (Pal-Care) delivered by community health workers (CHWs), with comparison against a control group of patients (n = 45) who receive usual cancer-center-based palliative services. Primary outcome measures include evaluation of CHW training outcomes, roles and responsibilities of the CHWS and how they assist patients, trial recruitment, stakeholder perceptions of the intervention, and fidelity to study protocol. Secondary outcomes measure patient self-report of health-related quality of life, symptom burden, palliative needs and patient care experience, outcomes The RE-AIM framework guides our evaluation plan to measure the reach, effectiveness, adoption, implementation and maintenance of the Pal-Care intervention (Gaglio B, et al. The RE-AIM framework: a systematic review of use over time. Am J Public Health. 2013;103(6):e38?46.). Data will be analyzed in SAS. All measures will be evaluated overall and by patient age, gender and cancer type and by CHW caseload. DISCUSSION: Pal-Care is a RCT funded by the NCI to explore utilization of CHWs to deliver a home-based palliative care intervention built upon the WHO Palliative Care toolkit (PCT), as compared to a usual care control group. The long-term goal of this research is to develop an effective and sustainable model for delivering home-based palliative care for cancer patients in underserved areas. TRIAL REGISTRATION (TRN): ClinicalTrials.gov ID# NCT04972630.

Changes in self-reported suicidal ideation during treatment with electroconvulsive therapy: A retrospective cohort study.

OBJECTIVE: Suicidal ideation (SI) is common in patients with depressive symptoms, who are the most common recipients of electroconvulsive therapy (ECT). We sought to quantify changes in self-reported SI occurring during treatment with ECT, and to identify factors associated with persistence of SI in patients beginning treatment with SI. METHOD: Retrospective, single-center cohort study of patients receiving ECT and who self-reported symptoms using Quick Inventory of Depressive Symptomatology (QIDS) prior to ECT and after treatment #5 or #10. Changes in QIDS-reported SI over the course of ECT were calculated, and logistic regression models were performed to assess factors associated with reporting SI at the end of treatment. RESULTS: 2554 provided baseline and follow-up SI scores, of whom, 1931 (75.6%) endorsed SI at baseline. There was a reduction in SI with ECT treatment (McNemar's test; df = 1, Χ2 = 803.7; p < 0.001), and in adjusted models 64.0% of individuals with baseline SI reported resolution of SI with ECT treatment, while 3.3% without baseline SI reported SI at the end of treatment. Higher baseline SI severity and outpatient treatment were associated with a higher odds of persistent SI among individuals beginning treatment with SI. CONCLUSION: Electroconvulsive therapy treatment was associated with reductions in self-reported SI. These results support the use of ECT in the treatment of patients with SI, but further research is needed to determine the effects of ECT on suicidal behavior.

Identifying Comorbid Subtypes of Patients With Acute Respiratory Failure.

BACKGROUND: Patients with acute respiratory failure have multiple risk factors for disability following their intensive care unit stay. Interventions to facilitate independence at hospital discharge may be more effective if personalized for patient subtypes. OBJECTIVES: To identify subtypes of patients with acute respiratory failure requiring mechanical ventilation and compare post-intensive care functional disability and intensive care unit mobility level among subtypes. METHODS: Latent class analysis was conducted in a cohort of adult medical intensive care unit patients with acute respiratory failure receiving mechanical ventilation who survived to hospital discharge. Demographic and clinical medical record data were collected early in the stay. Clinical characteristics and outcomes were compared among subtypes by using Kruskal-Wallis tests and χ2 tests of independence. RESULTS: In a cohort of 934 patients, the 6-class model provided the optimal fit. Patients in class 4 (obesity and kidney impairment) had worse functional impairment at hospital discharge than patients in classes 1 through 3. Patients in class 3 (alert patients) had the lowest magnitude of functional impairment (P < .001) and achieved the earliest out-of-bed mobility and highest mobility level of all subtypes (P < .001). CONCLUSIONS: Acute respiratory failure survivor subtypes identified from clinical data available early in the intensive care unit stay differ in post-intensive care functional disability. Future research should target high-risk patients in early rehabilitation trials in the intensive care unit. Additional investigation of contextual factors and mechanisms of disability is critical to improving quality of life in acute respiratory failure survivors.

Feasibility of a Community-Based, Online, Peer-Supported Spinal Cord Injury Self-management Intervention: Protocol for a Pilot Wait-Listed Randomized Trial.

BACKGROUND: People with spinal cord injury (SCI) report feeling unprepared to manage their disability upon discharge to the community. This situation is exacerbated when they return to settings where self-management support and resources are sparse, thus increasing the risk of costly secondary conditions and rehospitalizations. These factors make a compelling case for implementing innovative community-based SCI self-management programs that empower and engage individuals with SCI. Using a community-engaged research (CEnR) approach, we developed a peer-supported SCI self-management intervention, known as PHOENIX (Peer-supported Health Outreach, Education, and Information Exchange), which integrates online educational content and support from peer navigators (PNs) through telehealth, to promote health and community participation after SCI. OBJECTIVE: The objective of this pilot study is to evaluate the feasibility and acceptability of PHOENIX and the study design, and to obtain estimates of the variability of relevant outcome measures. METHODS: We conducted a pilot randomized waitlist-controlled trial (n=30) in collaboration with the South Carolina Spinal Cord Injury Association (SCSCIA), our long-standing community-based nonprofit organization research partner. We recruited 4 PNs through our SCSCIA collaboration using its existing network of trained peer mentors. Our study design supported comparison of the following 2 randomly assigned groups: PHOENIX intervention group and waitlist enhanced usual care (EUC) group. The PHOENIX intervention was administered online by PNs over 16 weeks through scheduled "video visits." The EUC group participated in the study for 16 weeks with usual community services and no navigation, and received 4 monthly newsletters from the SCSCIA on a variety of SCI-relevant topics. At the end of the waitlist period, the waitlist EUC group received the full PHOENIX intervention. Measures of feasibility included PN and participant recruitment and retention, PN workload, protocol adherence, and incidence of technical issues. We conducted qualitative interviews with participants and PNs to evaluate the acceptability of PHOENIX and the study design. Outcome measures, including community participation, quality of life, and the occurrence and subjective impact of medically serious secondary conditions and rehospitalizations, were assessed at baseline after randomization and at subsequent time points to allow between-group comparisons. RESULTS: PN hiring and training were completed in August 2018. Recruitment began in November 2018. A total of 30 participants were recruited across South Carolina, and 28 participants completed follow-up by August 2020. An analysis of the results is being finalized, and the results are expected to be published in 2023. CONCLUSIONS: This study will provide valuable information to guide future research seeking to address unmet self-management needs and improve outcomes in individuals with SCI. Feasibility findings of this study will provide evidence from CEnR guided by people with SCI and SCI service providers to inform further development, testing, and dissemination of effective and scalable self-management strategies for people with SCI. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/42688.

Detection of SARS-CoV-2 IgA and IgG in human milk and breastfeeding infant stool 6 months after maternal COVID-19 vaccination.

OBJECTIVE: Assess presence, durability, and neutralization capacity of SARS-CoV-2-specific antibodies in breastfeeding infants' stool, mother's plasma and milk following maternal vaccination. DESIGN: Thirty-seven mothers and 25 infants were enrolled between December 2020 and November 2021 for this prospective observational study. All mothers were vaccinated during lactation except three, which were vaccinated during pregnancy. Milk, maternal plasma, and infants' stool was collected pre-vaccination and at periods up to 6 months following COVID-19 vaccine series initiation/completion. SARS-CoV-2 antibody levels and their neutralization capacities were assessed. RESULTS: SARS-CoV-2-specific IgA and IgG levels were higher in infant stool post-maternal vaccination amongst milk-fed compared to controls. Maternal SARS-CoV-2-specific IgA and IgG concentrations decreased over 6 months post-vaccination but remained higher than pre-vaccination levels. We observed improved neutralization capacity in milk and plasma after COVID-19 vaccination. CONCLUSIONS: The presence of SARS-CoV-2-specific antibodies in infant stool following maternal vaccination offers further evidence of the lasting transfer of these antibodies through breastfeeding.

Design and rationale of a pilot randomized clinical trial investigating the use of a mHealth app for sarcoidosis-associated fatigue.

Fatigue is the most reported symptom in patients with sarcoidosis (SPs) and is a significant predictor of decreased quality of life that is strongly associated with stress and negative mood states. Few medications exist for treating fatigue in SPs, and outpatient physical rehabilitation programs are limited by availability and cost. Sarcoidosis in the US predominantly impacts minorities and underserved populations who are of working age and often have limited resources (e.g., financial, transportation, time off work) that may prevent them from attending in-person programs. The use of mobile health (mHealth) is emerging as a viable alternative to provide access to self-management resources to improve quality of life. The Sarcoidosis Patient Assessment and Resource Companion (SPARC) App is a sarcoidosis-specific mHealth App intended to improve fatigue and stress in SPs. It prompts SPs to conduct breathing awareness meditation (BAM) and contains educational modules aimed at improving self-efficacy. Herein we describe the design and methods of a 3-month randomized control trial comparing use of the SPARC App (10-min BAM twice daily) to standard care in 50 SPs with significant fatigue (FAS ≥22). A Fitbit® watch will provide immediate heartrate feedback after BAM sessions to objectively monitor adherence. The primary outcomes are feasibility and usability of the SPARC App (collected monthly). Secondary endpoints include preliminary efficacy at improving fatigue, stress, and quality of life. We expect the SPARC App to be a useable and feasible intervention that has potential to overcome barriers of more traditional in-person programs.

Barriers and Facilitators to Chronic Red Cell Transfusion Therapy in Pediatric Sickle Cell Anemia.

Background: Chronic red cell transfusion (CRCT) therapy is one of a few effective disease-modifying therapies for children with sickle cell anemia (SCA). CRCT is recommended for primary and secondary stroke prevention for at-risk children with SCA and is sometimes used for other disease-related complications. However, CRCT can be resource- and time-intensive for patients/families, providers, and organizations. This study was conducted to provide a comprehensive, multilevel examination of barriers and facilitators to transfusion therapy in children with SCA from health care provider and caregiver perspectives. Methods: A qualitative descriptive approach was used to conduct key informant interviews in a sample of 26 caregivers and 25 providers across the United States. Interviews were analyzed using directed content analysis with the Multilevel Ecological Model of Health as an initial coding framework and the constant comparison method. Results: Ten barrier themes and 10 facilitator themes emerged across all ecological levels. Themes most commonly occurred on the patient and organizational levels. Key barriers themes included Logistical Challenges, Obtaining and Maintaining Venous Access, Alloantibodies/Alloimmunization and Reactions, and Iron Overload and Adherence to Chelation Therapy. Key facilitator themes included Nursing and Non-nursing Staff Support, Positive Child/Family Experiences, Logistical Help and Social Resources, Blood Bank and Access to Blood, and Transfusion-Specific Resources. Discussion: The comprehensive understanding of multilevel barriers and facilitators to transfusion therapy, including the role of nursing, in children with SCA can inform strategies to improve CRCT for patients/families and providers and can also be applied by organizations seeking to implement transfusion services for SCA.

Efficacy of a Self-managed Cooling Intervention for Pain and Physical Activity in Individuals With Recently Healed Chronic Venous Leg and Diabetic Foot Ulcers: A Randomized Controlled Trial.

PURPOSE: This aim of this study was to evaluate the clinical efficacy of a self-managed cooling intervention in individuals with recently healed venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs) on pain reduction and physical activity improvement. DESIGN: A 6-month longitudinal randomized controlled trial. SUBJECTS AND SETTING: The sample comprised 140 individuals with previously healed VLU and DFU who received care in 3 outpatient wound centers in the Southeastern region of the United States. Participants were randomized to the MUSTCOOL or a placebo cooling patch intervention. METHODS: The cooling and placebo interventions comprised cooling or cotton-filled patch application to recently healed skin for 30 minutes, 3 times weekly plus standard of care including compression and leg elevation (participants with VLU) or therapeutic footwear and hygiene (participants with DFU) over a 6-month period. Pain severity and intensity were measured with the Brief Pain Inventory and physical activity with the International Physical Activity Questionnaire, which assessed metabolic equivalent of tasks (METs) in minutes per week. Minutes in walking time per week were assessed with an accelerometer. Data were descriptively analyzed for difference changes in scores from baseline to 6 months post-intervention. RESULTS: Data were analyzed for 81 participants randomized to cooling and placebo groups (VLUs, n = 26/29) and DFU (n = 12/16). Slight reductions in VLU pain severity (-0.5, -0.2) and interference (-0.4, -0.5) and minimal reductions in DFU pain severity (0, -0.1) and interference (0.4/0.1) were achieved. However, pain scores were low to moderate at baseline (mean 4, 0-10 with 10 worst pain possible) in both groups. For physical activity, the MET values showed low physical activity in both groups at baseline with slight improvements noted in VLU cooling and placebo groups (73/799) and DFU (1921/225), respectively. Walking time for the VLU groups improved by 1420/2523 minutes; the DFU groups improved 135/157 minutes, respectively. Findings for outcomes were not statistically significant within or between groups. CONCLUSIONS: Application of the cooling pack compared to placebo was minimally efficacious in reducing posthealing pain and improving function in this posthealed ulcer population. However for pain, scores were initially low; thus outcomes on pain, while lower, were marginal. TRIAL REGISTRATION: The study was prospectively registered with ClinicalTrials.gov on December 10, 2015 (Identifier: NCT02626156), https://clinicaltrials.gov/ct2/show/NCT02626156 .