A paradigm shift in understanding vulvovaginal melanoma as a distinct tumor type compared with cutaneous melanoma.

OBJECTIVE: Our goal was to compare molecular and immune profiles of vulvovaginal melanoma (VVM) with cutaneous melanoma (CM) and explore the significance of immune checkpoint inhibitor (ICI) agents on survival. METHODS: Samples from VVM and CM tumors underwent comprehensive molecular and immune profiling. Treatment and survival data were extracted from insurance claims data and OS was calculated from time of ICI treatment to last contact. Statistical significance was determined using chi-square and Wilcoxon rank sum test and adjusted for multiple comparisons. RESULTS: Molecular analysis was performed on 142 VVM and 3823 CM tumors. VVM demonstrated significantly (q < 0·01) less frequent BRAF and more frequent KIT, ATRX, and SF3B1 mutations. Alterations in pathways involving DNA damage and mRNA splicing were more common in VVM, while alterations in cell cycle and chromatin remodeling were less common. Immunogenicity of VVM was lower than CM, with an absence of high TMB (0% vs 46.9%) and lower PD-L1 positivity (18·0% vs 29·5%). Median immune checkpoint gene expression was lower in VVM, as were cell fractions for type I macrophages and CD8+ T-cells(q < 0·01). Myeloid dendritic cells were increased in VVM(q < 0·01). Median OS was shorter for VVM than for CM patients treated with ICIs (17·6 versus 37·9 months, HR:1·65 (95% CI 1·02-2·67) p = 0·04). CONCLUSIONS: VVM has a distinct molecular and immune profile compared to CM, which may contribute to the worse survival in VVM compared to CM patients treated with ICI therapy. Though ICIs have been a mainstay of treatment in recent years, our findings suggest that new therapeutic strategies are needed.

Human papillomavirus vaccine beliefs and intentions Post-COVID-19 vaccine release among mothers in Alabama.

PURPOSE: The current study sought to determine if the release of COVID-19 vaccines influenced Alabama mothers' attitudes and behaviors regarding HPV vaccination of their adolescent children. METHODS: A social media survey was conducted August - September 2022 among mothers of adolescents ages 9-18, who self-identified as Alabama residents and their child(ren)'s primary medical decision maker. The survey assessed demographics, vaccine knowledge and opinions, vaccination history, influences on vaccination decisions, and how COVID-19 vaccine release affected vaccine opinions. Univariable and multivariable analyses were conducted. RESULTS: Of 241 responses, most participants were white (82.0 %, n = 196), non-Hispanic (96.6 %, n = 230), and privately insured (64.5 %, n = 151), with annual household incomes ≥$61,000 (45.4 %, n = 103). The majority (60.8 %) reported that their child either had or planned to receive the HPV vaccine. The release of COVID-19 vaccines did not change the majority of parental opinions towards HPV, with 78.5 % (n = 161) reporting no change. Among those who experienced a change, 25 % (n = 5) reported an increased likelihood of having their child vaccinated for HPV and 75 % (n = 15) reported a decrease in likelihood. Moderate and high HPV knowledge scores were associated in multivariable analysis with increased likelihood of having their child vaccinated for HPV ("moderate" knowledge AOR: 12.4, 95 % CI: 1.98-78.1; "high" knowledge AOR: 12.8, 95 % CI: 2.00-82.1). Positive HPV opinion scores in the univariable analysis similarly showed increased odds (AOR = 1.5). CONCLUSIONS: These findings indicate that, in this population, COVID-19 vaccine release did not significantly impact subsequent HPV vaccination decision making. Parental perceptions regarding vaccination are critical to informing future interventions.

Engagement Among Diverse Patient Backgrounds in a Remote Symptom Monitoring Program.

PURPOSE: Previous randomized controlled trials have demonstrated benefit from remote symptom monitoring (RSM) with electronic patient-reported outcomes. However, the racial diversity of enrolled patients was low and did not reflect the real-world racial proportions for individuals with cancer. METHODS: This secondary, cross-sectional analysis evaluated engagement of patients with cancer in a RSM program. Patient-reported race was grouped as Black, Other, or White. Patient address was used to map patient residence to determine rurality using Rural-Urban Commuting Area Codes and neighborhood disadvantage using Area Deprivation Index. Key outcomes included (1) being approached for RSM enrollment, (2) declining enrollment, (3) adherence with RSM via continuous completion of symptom surveys, and (4) withdrawal from RSM participation. Risk ratios (RR) and 95% CI were estimated from modified Poisson models with robust SEs. RESULTS: Between May 2021 and May 2023, 883 patients were approached to participate, of which 56 (6%) declined RSM. Of those who enrolled in RSM, a total of 27% of patients were Black or African American and 67% were White. In adjusted models, all patient population subgroups of interest had similar likelihoods of being approached for RSM participation; however, Black or African American patients were more than 3× more likely to decline participation than White participants (RR, 3.09 [95% CI, 1.73 to 5.53]). Patients living in more disadvantaged neighborhoods were less likely to decline (RR, 0.49 [95% CI, 0.24 to 1.02]), but less likely to adhere to surveys (RR, 0.81 [95% CI, 0.68 to 0.97]). All patient populations had a similar likelihood of withdrawing. CONCLUSION: Black patients and individuals living in more disadvantaged neighborhoods are at risk for lower engagement in RSM. Further work is needed to identify and overcome barriers to equitable participation.

An updated evaluation of reported no-observed adverse effect levels for chrysotile, amosite, and crocidolite asbestos for lung cancer and mesothelioma.

This analysis updates two previous analyses that evaluated the exposure-response relationships for lung cancer and mesothelioma in chrysotile-exposed cohorts. We reviewed recently published studies, as well as updated information from previous studies. Based on the 16 studies considered for chrysotile (<10% amphibole), we identified the "no-observed adverse effect level" (NOAEL) for lung cancer and/or mesothelioma; it should be noted that smoking or previous or concurrent occupational exposure to amphiboles (if it existed) was not controlled for. NOAEL values ranged from 2.3-<11.5 f/cc-years to 1600-3200 f/cc-years for lung cancer and from 100-<400 f/cc-years to 800-1599 f/cc-years for mesothelioma. The range of best-estimate NOAELs was estimated to be 97-175 f/cc-years for lung cancer and 250-379 f/cc-years for mesothelioma. None of the six cohorts of cement or friction product manufacturing workers exhibited an increased risk at any exposure level, while all but one of the six studies of textile workers reported an increased risk at one or more exposure levels. This is likely because friction and cement workers were exposed to much shorter chrysotile fibers. Only eight cases of peritoneal mesothelioma were reported in all studies on predominantly chrysotile-exposed cohorts combined. This analysis also proposed best-estimate amosite and crocidolite NOAELs for mesothelioma derived by the application of relative potency estimates to the best-estimate chrysotile NOAELs for mesothelioma and validated by epidemiology studies with exposure-response information. The best-estimate amosite and crocidolite NOAELs for mesothelioma were 2-5 f/cc-years and 0.6-1 f/cc-years, respectively. The rate of peritoneal mesothelioma in amosite- and crocidolite-exposed cohorts was between approximately 70- to 100-fold and several-hundred-fold higher than in chrysotile-exposed cohorts, respectively. These findings will help characterize potential worker and consumer health risks associated with historical and current chrysotile, amosite, and crocidolite exposures.

A Rare Presentation of Lichen Sclerosus Involving the Vaginal Canal After Radiation Therapy: A Case Report and Review of the Literature.

Vaginal lichen sclerosus (LS) is an extremely rare entity. Classically, LS is referred to as a chronic, inflammatory skin disease with a distinct predilection for the anogenital skin that is observed in post-menopausal women and typically manifests clinically as white, atrophic plaques. Here, we report a case of a 61-year-old patient who presented for a follow-up visit three years after vaginal brachytherapy as an adjuvant treatment for endometrial adenocarcinoma. This lesion was biopsied and confirmed to be vaginal LS on histological analysis. While LS has been previously observed to impact mucosal areas outside of the anogenital region, such as the mouth, reported cases of vaginal LS are very rare in the literature. Our case highlights both the underrecognized location of this disease as well as radiation as a potential risk factor.

Occupational exposure to cosmetic talc and mesothelioma in barbers, hairdressers, and cosmetologists: A systematic review of the epidemiology.

Inhalation exposure to cosmetic talc has generated much scientific debate regarding its potential as a risk factor for mesothelioma, a rare, but fatal cancer. Barbers, hairdressers, and cosmetologists have regularly used cosmetic talc-containing products, but the collective epidemiological evidence for mesothelioma in these occupations has yet to be described. As such, we conducted a systematic review of PubMed and the National Institute for Occupational Safety and Health's (NIOSH) Numbered Publications list to identify original epidemiological literature reporting measures of association between these occupations and incidence of or death from mesothelioma. Literature screening was performed independently twice, the results of which were summarized and tabulated and underwent a review for their accuracy. A total of 12 studies met our inclusion criteria, including three cohort, six case-control, and three proportionate mortality/registration studies. The data from these studies were collected in 13 European and North American countries, spanning more than 50 years. We supplemented this review with queries of occupational mortality databases that are managed by the Washington State Department of Health and NIOSH for 26 U.S. states. Most findings were null and if statistically significant, nearly all showed an inverse relationship, indicative of a protective effect of these occupations on mesothelioma risk. Overall, the epidemiological evidence does not support an increased risk of mesothelioma for these occupations. This research fills an important data gap on the etiology of mesothelioma in barbers, hairdressers, and cosmetologists, and provides a benchmark for those with comparatively less exposure, such as non-occupational users of similar cosmetic talc-containing products.

Evaluating Nurses' Time to Response by Severity and Cancer Stage in a Remote Symptom Monitoring Program for Patients With Breast Cancer.

PURPOSE: Remote symptom monitoring (RSM) using electronic patient-reported outcomes enables patients with cancer to communicate symptoms between in-person visits. A better understanding of key RSM implementation outcomes is crucial to optimize efficiency and guide implementation efforts. This analysis evaluated the association between the severity of patient-reported symptom alerts and time to response by the health care team. METHODS: This secondary analysis included women with stage I-IV breast cancer who received care at a large academic medical center in the Southeastern United States (October 2020-September 2022). Symptom surveys with at least one severe symptom alert were categorized as severe. Response time was categorized as optimal if the alert was closed by a health care team member within 48 hours. Odds ratios (ORs), predicted probabilities, and 95% CIs were estimated using a patient-nested logistic regression model. RESULTS: Of 178 patients with breast cancer included in this analysis, 63% of patients identified as White and 85% of patients had a stage I-III or early-stage cancer. The median age at diagnosis was 55 years (IQR, 42-65). Of 1,087 surveys included, 36% reported at least one severe symptom alert and 77% had an optimal response time by the health care team. When compared with surveys that had no severe symptom alerts, surveys with at least one severe symptom alert had similar odds of having an optimal response time (OR, 0.97; 95% CI, 0.68 to 1.38). The results were similar when stratified by cancer stage. CONCLUSION: Response times to symptom alerts were similar for alerts with at least one severe symptom compared with alerts with no severe symptoms. This suggests that alert management is being incorporated into routine workflows and not prioritized based on disease or symptom alert severity.

ACR Appropriateness Criteria® Soft Tissue Masses: 2022 Update.

Imaging should be performed in patients with a suspected soft tissue mass that cannot be clinically confirmed as benign. Imaging provides essential information necessary for diagnosis, local staging, and biopsy planning. Although the modalities available for imaging of musculoskeletal masses have undergone progressive technological advancements in recent years, their overall purpose in the setting of a soft tissue mass remains unchanged. This document identifies the most common clinical scenarios related to soft tissue masses and the most appropriate imaging for their assessment on the basis of the current literature. It also provides general guidance for those scenarios that are not specifically addressed. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision process support the systematic analysis of the medical literature from peer reviewed journals. Established methodology principles such as Grading of Recommendations Assessment, Development, and Evaluation or GRADE are adapted to evaluate the evidence. The RAND/UCLA Appropriateness Method User Manual provides the methodology to determine the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where peer reviewed literature is lacking or equivocal, experts may be the primary evidentiary source available to formulate a recommendation.

Early and recent exposure to adversity, TLR-4 stimulated inflammation, and diurnal cortisol in women with interstitial cystitis/bladder pain syndrome: A MAPP research network study.

Both early (ELA) and recent life adversity (RLA) have been linked with chronic pain conditions and persistent alterations of neuroendocrine and inflammatory responses. Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) is a chronic urologic disorder characterized by bladder and/or pelvic pain, and excessive urinary frequency and/or urgency. IC/BPS has been associated with high levels of ELA as well as a distinct inflammatory signature. However, associations between ELA and RLA with inflammatory mechanisms in IC/BPS that might underlie the link between adversity and symptoms have not been examined. Here we investigated ELA and RLA in women with IC/BPS as potential risk factors for inflammatory processes and hypothalamic-pituitaryadrenal (HPA) abnormalities using data from the Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network. Women with IC/BPS and healthy controls (n = 154 and 32, respectively) completed surveys, collected salivary cortisol at awakening and bedtime for 3 days, and gave a blood sample which was analyzed for 7 LPS-stimulated cytokines and chemokines (IL-6, TNFα, IL-1ß, MIP1α, MCP1, IL-8, and IL-10). Two cytokine/chemokine composites were identified using principal components analysis. Patients with greater exposure to RLA or cumulative ELA and RLA of at least moderate severity showed elevated levels of a composite of all cytokines, adjusting for age, body mass index, and study site. Furthermore, there was a trending relationship between ELA and the pro-inflammatory composite score. Nocturnal cortisol and cortisol slope were not associated with ELA, RLA, or inflammation. The present findings support the importance of adverse events in IC/BPS via a biological mechanism and suggest that ELA and RLA should be assessed as risk factors for inflammation as part of a clinical workup for IC/BPS.

Knowledge, Perceptions, and Use of Psychedelics among Individuals with Fibromyalgia.

Fibromyalgia (FM) is a difficult to treat chronic pain condition for which there is strong interest in alternative treatments. There is growing interest in the potential of psychedelic substances (e.g., psilocybin) in conjunction with psychotherapy to treat chronic pain. Via a cross-sectional, anonymous, online survey, we aimed to characterize knowledge, perceptions, and past use of serotonergic ("classic") and non-serotonergic psychedelics among a population of individuals with FM, and to investigate interest in psychedelic-based FM treatments. Among a North American population of 354 participants with FM, 29.9% reported past use of a psychedelic, with lysergic acid diethylamide (LSD) and psilocybin mushrooms being most commonly used. Perceptions of benefit from psychedelic use were generally neutral (59.4%) or positive (36.8%), with <3% reporting negative impacts on overall health or pain symptoms. Among 12 participants who used psychedelics with intentions of treating chronic pain, 11 reported improved symptoms. Regardless of past use, the majority of participants believed that psychedelics have potential for chronic pain treatments and would be willing to participate in a psychedelic-based clinical trial for their pain. These findings support the need for additional studies to understand the potential and effectiveness of psychedelic substances in managing FM symptoms.

ACR Appropriateness Criteria® Malignant or Aggressive Primary Musculoskeletal Tumor-Staging and Surveillance: 2022 Update.

Malignant or aggressive primary musculoskeletal tumors are rare and encompass a wide variety of bone and soft tissue tumors. Given the most common site for metastasis from these primary musculoskeletal tumors is to the lung, chest imaging is integral in both staging and surveillance. Extrapulmonary metastases are rarely encountered with only a few exceptions. Following primary tumor resection, surveillance of the primary tumor site is generally recommended. Local surveillance imaging recommendations differ between primary tumors of bone origin versus soft tissue origin. This document consolidates the current evidence and expert opinion for the imaging staging and surveillance of these tumors into five clinical scenarios. The ACR Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision process support the systematic analysis of the medical literature from peer-reviewed journals. Established methodology principles such as Grading of Recommendations Assessment, Development, and Evaluation or GRADE are adapted to evaluate the evidence. The RAND/UCLA Appropriateness Method User Manual provides the methodology to determine the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances in which peer-reviewed literature is lacking or equivocal, experts may be the primary evidentiary source available to formulate a recommendation.

Evaluation of asbestos exposure resulting from simulated application of spiked talcum powders.

This study characterizes airborne asbestos exposures resulting from the adult application of cosmetic talc body powders spiked with known concentrations of tremolite. Raw talc ores were spiked with 0.005% and 0.1% asbestiform or non-asbestiform tremolite. Personal samples were collected during 16 simulated events, including puff and shaker application and associated clean-up activities. Airborne fiber levels (PCM) were not significantly different for simulations involving talc spiked with asbestiform and non-asbestiform tremolite (p = 0.6104). For application and clean-up of talc spiked with 0.005% asbestiform tremolite, 2 of 24 (8.3%) samples were above the LOD for TEM (0.003 f/cc). For application of talc spiked with 0.1% asbestiform tremolite, 21 of 24 (87.5%) were above the LOD for TEM. The corresponding mean PCME asbestos concentrations were 0.016 f/cc for puff and shaker for samples collected in the first 15 min, 0.002 f/cc for puff and 0.004 f/cc for shaker in the second 15 min, and 0.005 f/cc for puff and 0.013 f/cc for shaker for the full 30 min. Mean PCME concentrations for samples collected during clean-up following application of talc spiked with 0.1% asbestiform tremolite were 0.003 f/cc for samples collected in the first 15 min following puff application, 0.005 f/cc for samples collected in the second 15 min following shaker application, and 0 f/cc for the remaining clean-up samples. Using the EPA's exposure factors, we determined the range of cumulative asbestiform fiber exposures that would result from product use, assuming asbestiform tremolite was present at 0.1%.

Adherence to the TQIP Palliative Care Guidelines Among Patients With Serious Illness at a Level I Trauma Center in the US.

Importance: The American College of Surgeons Trauma Quality Improvement Program (TQIP) guidelines encourage trauma service clinicians to deliver palliative care in parallel with life-sustaining treatment and recommend goals of care (GOC) discussions within 72 hours of admission for patients with serious illness. Objective: To measure adherence to TQIP guidelines-recommended GOC discussions for trauma patients with serious illness, treated at a level I trauma center in the US. Design, Setting, and Participants: This retrospective cohort study included 674 adults admitted to a trauma service center for 3 or more days between December 2019 and June 2020. The medical records of 486 patients who met the criteria for serious illness using a consensus definition adapted to the National Trauma Data Bank were reviewed for the presence of a GOC discussion. Patients were divided into 2 cohorts based on admission before or after the guidelines were incorporated into the institutional practice guidelines on March 1, 2020. Main Outcomes and Measures: The primary outcomes were GOC completion within 72 hours of admission and during the overall hospitalization. Patient and clinical factors associated with GOC completion were assessed. Other palliative care processes measured included palliative care consultation, prior advance care planning document, and do-not-resuscitate code status. Additional end-of-life processes (ie, comfort care and inpatient hospice) were measured in a subset with inpatient mortality. Results: Of 674 patients meeting the review criteria, 486 (72.1%) met at least 1 definition of serious illness (mean [SD] age, 60.9 [21.3] years; mean [SD] Injury Severity Score, 16.9 [12.3]). Of these patients, 328 (67.5%) were male and 266 (54.7%) were White. Among the seriously ill patients, 92 (18.9%) had evidence of GOC completion within 72 hours of admission and 124 (25.5%) during the overall hospitalization. No differences were observed between patients admitted before and after institutional guideline publication in GOC completion within 72 hours (19.0% [47 of 248 patients] vs 18.9% [45 of 238]; P = .99) or during the overall hospitalization (26.2% [65 of 248 patients] vs 24.8% [59 of 238]; P = .72). After adjusting for age, GOC completion was found to be associated with the presence of mechanical ventilation (odds ratio [OR], 6.42; 95% CI, 3.49-11.81) and meeting multiple serious illness criteria (OR, 4.07; 95% CI, 2.25-7.38). Conclusions and Relevance: The findings of this cohort study suggest that, despite the presence of national guidelines, GOC discussions for patients with serious illness were documented infrequently. This study suggests a need for system-level interventions to ensure best practices and may inform strategies to measure and improve trauma service quality in palliative care.

Distribution of microbiota in cervical preneoplasia of racially disparate populations.

BACKGROUNDS: Microbiome dysbiosis is an important contributing factor in tumor development and thus may be a risk predictor for human malignancies. In the United States, women with Hispanic/Latina (HIS) and African American (AA) background have a higher incidence of cervical cancer and poorer outcomes than Caucasian American (CA) women. METHODS: Here, we assessed the distribution pattern of microbiota in cervical intraepithelial neoplasia (CIN) lesions obtained from HIS (n = 12), AA (n = 12), and CA (n = 12) women, who were screened for CC risk assessment. We employed a 16S rRNA gene sequencing approach adapted from the NIH-Human Microbiome Project to identify the microbial niche in all CIN lesions (n = 36). RESULTS: We detected an appreciably decreased abundance of beneficial Lactobacillus in the CIN lesions of the AA and HIS women compared to the CA women. Differential abundance of potentially pathogenic Prevotella, Delftia, Gardnerella, and Fastidiosipila was also evident among the various racial groups. An increased abundance of Micrococcus was also evident in AA and HIS women compared to the CA women. The detection level of Rhizobium was higher among the AA ad CA women compared to the HIS women. In addition to the top 10 microbes, a unique niche of 27 microbes was identified exclusively in women with a histopathological diagnosis of CIN. Among these microbes, a group of 8 microbiota; Rubellimicrobium, Podobacter, Brevibacterium, Paracoccus, Atopobium, Brevundimonous, Comamonous, and Novospingobium was detected only in the CIN lesions obtained from AA and CA women. CONCLUSIONS: Microbial dysbiosis in the cervical epithelium represented by an increased ratio of potentially pathogenic to beneficial microbes may be associated with increased CC risk disparities. Developing a race-specific reliable panel of microbial markers could be beneficial for CC risk assessment, disease prevention, and/or therapeutic guidance.

Adaptation of Remote Symptom Monitoring Using Electronic Patient-Reported Outcomes for Implementation in Real-World Settings.

PURPOSE: Despite evidence of clinical benefits, widespread implementation of remote symptom monitoring has been limited. We describe a process of adapting a remote symptom monitoring intervention developed in a research setting to a real-world clinical setting at two cancer centers. METHODS: This formative evaluation assessed core components and adaptations to improve acceptability and fit of remote symptom monitoring using Stirman's Framework for Modifications and Adaptations. Implementation outcomes were evaluated in pilot studies at the two cancer centers testing technology (phase I) and workflow (phase II and III) using electronic health data; qualitative evaluation with semistructured interviews of clinical team members; and capture of field notes from clinical teams and administrators regarding barriers and recommended adaptations for future implementation. RESULTS: Core components of remote symptom monitoring included electronic delivery of surveys with actionable symptoms, patient education on the intervention, a system to monitor survey compliance in real time, the capacity to generate alerts, training nurses to manage alerts, and identification of personnel responsible for managing symptoms. In the pilot studies, while most patients completed > 50% of expected surveys, adaptations were identified to address barriers related to workflow challenges, patient and clinician access to technology, digital health literacy, survey fatigue, alert fatigue, and data visibility. CONCLUSION: Using an implementation science approach, we facilitated adaptation of remote symptom monitoring interventions from the research setting to clinical practice and identified key areas to promote effective uptake and sustainability.

The Project ENABLE Cornerstone randomized controlled trial: study protocol for a lay navigator-led, early palliative care coaching intervention for African American and rural-dwelling advanced cancer family caregivers.

BACKGROUND: Family caregivers play a vital, yet stressful role in managing the healthcare needs and optimizing the quality of life of patients with advanced cancer, from the time they are newly diagnosed until end of life. While early telehealth palliative care has been found to effectively support family caregivers, little work has focused on historically under-resourced populations, particularly African American and rural-dwelling individuals. To address this need, we developed and are currently testing Project ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone, a lay navigator-led, early palliative care coaching intervention for family caregivers of African American and rural-dwelling patients with newly diagnosed advanced cancer. METHODS: This is a 2-site, single-blind, hybrid type I implementation-effectiveness trial of the Cornerstone intervention versus usual care. Cornerstone is a multicomponent intervention based on Pearlin's Stress-Health Process Model where African American and/or rural-dwelling family caregivers of patients with newly diagnosed advanced cancer (target sample size = 294 dyads) are paired with a lay navigator coach and receive a series of six, brief 20-60-min telehealth sessions focused on stress management and coping, caregiving skills, getting help, self-care, and preparing for the future/advance care planning. Subsequent to core sessions, caregivers receive monthly follow-up indefinitely until the patient's death. Caregiver and patient outcomes are collected at baseline and every 12 weeks until the patient's death (primary outcome: caregiver distress at 24 weeks; secondary outcomes: caregiver: quality of life and burden; patient: distress, quality of life, and healthcare utilization). Implementation costs and the intervention cost effectiveness are also being evaluated. DISCUSSION: Should this intervention demonstrate efficacy, it would yield an implementation-ready model of early palliative care support for under-resourced family caregivers. A key design principle that has centrally informed the Cornerstone intervention is that every caregiving situation is unique and each caregiver faces distinct challenges that cannot be addressed using a one-size-fits all approach. Hence, Cornerstone employs culturally savvy lay navigator coaches who are trained to establish a strong, therapeutic alliance with participants and tailor their coaching to a diverse range of individual circumstances. TRIAL REGISTRATION: ClinicalTrials.gov NCT04318886 . Registered on 20 March, 2020.

Evaluating the implementation and impact of navigator-supported remote symptom monitoring and management: a protocol for a hybrid type 2 clinical trial.

BACKGROUND: Symptoms in patients with advanced cancer are often inadequately captured during encounters with the healthcare team. Emerging evidence demonstrates that weekly electronic home-based patient-reported symptom monitoring with automated alerts to clinicians reduces healthcare utilization, improves health-related quality of life, and lengthens survival. However, oncology practices have lagged in adopting remote symptom monitoring into routine practice, where specific patient populations may have unique barriers. One approach to overcoming barriers is utilizing resources from value-based payment models, such as patient navigators who are ideally positioned to assume a leadership role in remote symptom monitoring implementation. This implementation approach has not been tested in standard of care, and thus optimal implementation strategies are needed for large-scale roll-out. METHODS: This hybrid type 2 study design evaluates the implementation and effectiveness of remote symptom monitoring for all patients and for diverse populations in two Southern academic medical centers from 2021 to 2026. This study will utilize a pragmatic approach, evaluating real-world data collected during routine care for quantitative implementation and patient outcomes. The Consolidated Framework for Implementation Research (CFIR) will be used to conduct a qualitative evaluation at key time points to assess barriers and facilitators, implementation strategies, fidelity to implementation strategies, and perceived utility of these strategies. We will use a mixed-methods approach for data interpretation to finalize a formal implementation blueprint. DISCUSSION: This pragmatic evaluation of real-world implementation of remote symptom monitoring will generate a blueprint for future efforts to scale interventions across health systems with diverse patient populations within value-based healthcare models. TRIAL REGISTRATION: NCT04809740 ; date of registration 3/22/2021.

Reasons for Preoperative Opioid Use Are Associated with Persistent Use following Surgery Among Patients Undergoing Total Knee and Hip Arthroplasty.

OBJECTIVE: Most studies on preoperative opioid use only describe whether or not patients use opioids without characterizing reasons for use. Knowing why patients use opioids can help inform perioperative opioid management. The objective of this study was to explore pain specific reasons for preoperative opioid use prior to total hip and knee arthroplasty (THA and TKA) and their association with persistent use. METHODS: This is a prospective study of 197 patients undergoing THA (n = 99) or TKA (n = 98) enrolled in the Analgesic Outcomes Study between December 2015 and November 2018. All participants reported preoperative opioid use. RESULTS: Reasons for preoperative opioid use were categorized as surgical site pain only (81 [41.1%]); pain in other body areas only (22 [11.2%]); and combined pain (94 [47.7%]). Compared to patients taking opioids for surgical site pain, those with combined reasons for use had 1.24 (P = .40) and 2.28 (P = .16) greater odds of persistent use at 3 and 6 months postoperatively, adjusting for relevant covariates. CONCLUSIONS: This study provides novel insights into the heterogeneity of reasons for presurgical opioid use in patients undergoing a THA or TKA. One key take away is that not all preoperative opioid use is the same and many patients are taking opioids preoperatively for more than just pain at the surgical site. Combined reasons for use was associated with long-term use, suggesting nonsurgical pain, in part, drives persistent opioid use after surgery. Future directions in perioperative care should focus on pain and non-pain reasons for presurgical opioid use to create tailored postoperative opioid weaning plans.

HPV Vaccination Champions: Evaluating a Technology-Mediated Intervention for Parents.

Human papillomavirus (HPV) vaccination prevents 6 HPV-related cancers in men and women. Yet, rates of HPV vaccination among adolescents in the United States lag behind other developed nations, revealing a significant public health issue. This feasibility study tested a collaborative online learning environment to cultivate HPV vaccination champions. A 3-month training program recruited parents to serve as proponents and social media influencers to identify solutions to overcome barriers to HPV vaccination. A mixed methods study design included a pretest survey, three online asynchronous focus groups, a posttest survey, as well as a longitudinal follow-up survey at 6 months. Participants included 22 parents who self-identified as female (95.4%) and white (90.9%). Overall, there was a statistically significant difference in knowledge of HPV and HPV vaccination between pretest and posttest (p = 0.0042). This technology-mediated intervention increased parents' confidence and motivated them to speak more freely about HPV vaccination in-person and online with others in their social networks. Participants identified prevalent misinformation about HPV vaccination and learned how to effectively craft messages to address concerns related to safety and side effects, gender, understanding of risk, and sexual activity. Objective measures and qualitative open-ended assessment showed high intervention engagement and treatment satisfaction. All participants (100%) indicated that they enjoyed participating in the intervention. The effectiveness of this feasibility study suggests that social media is an appropriate platform to empower parents to counter vaccine hesitancy and misinformation through HPV vaccination information that is simple and shareable in-person and online.