The use of pembrolizumab monotherapy for the management of head and neck squamous cell carcinoma (HNSCC) in the UK.

Pembrolizumab has received approval in the UK as first-line monotherapy for recurrent and/or metastatic HNSCC (R/M HNSCC) following the results of the KEYNOTE-048 trial, which demonstrated a longer overall survival (OS) in comparison to the EXTREME chemotherapy regimen in patients with a combined positive score (CPS) ≥1. In this article, we provide retrospective real-world data on the role of pembrolizumab monotherapy as first-line systemic therapy for HNSCC across 18 centers in the UK from March 20, 2020 to May 31, 2021. 211 patients were included, and in the efficacy analysis, the objective response rate (ORR) was 24.7%, the median progression-free survival (PFS) was 4.8 months (95% confidence interval [CI]: 3.6-6.1), and the median OS was 10.8 months (95% CI 9.0-12.5). Pembrolizumab monotherapy was well tolerated, with 18 patients having to stop treatment owing to immune-related adverse events (irAEs). 53 patients proceeded to second-line treatment with a median PFS2 of 10.2 months (95% CI: 8.8-11.5). Moreover, patients with documented irAEs had a statistically significant longer median PFS (11.3 vs. 3.3 months; log-rank p value = <.001) and median OS (18.8 vs. 8.9 months; log-rank p value <.001). The efficacy and safety of pembrolizumab first-line monotherapy for HNSCC has been validated using real-world data.

Patient-targeted education (ePRO-E) to increase ePRO intent within an Alliance clinical trial (A221805-SI1).

BACKGROUND: The Patient Cloud ePRO app was adopted by the National Cancer Institute National Clinical Trials Network (NCTN) to facilitate capturing electronic patient-reported (ePRO) outcome data, but use has been low. The study objectives were to test whether a patient-targeted ePRO educational resource (ePRO-E) would increase ePRO intent (number of users) and improve data quality (high quality: ≥80% of the required surveys submitted) within an ongoing NCTN study. METHODS: The ePRO-E intervention, a patient-targeted educational resource (written material and 6-minute animated YouTube video), was designed to address ePRO barriers. ePRO intent and data quality were compared between 2 groups (N = 69): a historical control group and a prospectively recruited intervention group exposed to ePRO-E. Covariates included technology attitudes, age, sex, education, socioeconomic status, and comorbidity. RESULTS: Intervention group ePRO intent (78.8%) was statistically significantly higher than historical control group intent (47.1%) (P = .03). Patients choosing ePRO versus paper surveys had more positive and higher technology attitudes scores (P = .03). The odds of choosing ePRO were 4.7 times higher (95% Confidence Interval [CI] = 1.2 to 17.8) (P = .02) among intervention group patients and 5.2 times higher (95% CI = 1.3 to 21.6) (P = .02) among patients with high technology attitudes scores, after controlling for covariates. However, the 80% submission rate (percentage submitting ≥80% of required surveys) in the ePRO group (30.6%) was statistically significantly lower than in the paper group (57.9%) (P = .05). CONCLUSIONS: ePRO-E exposure increased ePRO intent. High technology attitudes scores were associated with ePRO selection. Since the ePRO survey submission rate was low, additional strategies are needed to promote high-quality data submission.

Impact of an automated, remote monitoring and coaching intervention in reducing hospice cancer family caregiving burden: A multisite randomized controlled trial.

BACKGROUND: Care for those with life-limiting cancer heavily involves family caregivers who may experience significant physical and emotional burden. The purpose of this study was to test the impact of Symptom Care at Home (SCH), an automated digital family caregiver coaching intervention, during home hospice, when compared to usual hospice care (UC) on the primary outcome of overall caregiver burden. Secondary outcomes included Caregiver Burden at weeks 1 and 8, Mood and Vitality subscales, overall moderate-to-severe caregiving symptoms, and sixth month spouse/partner bereavement outcomes. METHODS: Using a randomized, multisite, nonblinded controlled trial, 332 cancer family caregivers were enrolled and analyzed (159 SCH vs. 173 UC). Caregivers were primarily White (92%), female (69%), and spouse caregivers (53%). Caregivers provided daily reports on severity levels (0-10 scale) for their anxiety, depressed mood, fatigue, disturbed sleep, and caregiving interference with normal activities. These scores combined constituted the Caregiver Burden primary outcome. Based on reported symptoms, SCH caregivers received automated, tailored coaching about improving their well-being. Reports of moderate-to-severe caregiving symptoms also triggered hospice nurse notification. Secondary outcomes of Mood and Vitality were subcomponents of the Caregiver Burden score. A combined bereavement adjustment tool captured sixth month bereavement. RESULTS: The SCH intervention reduced overall Caregiver Burden compared to UC (p < .001), with a 38% reduction at 8 weeks and a medium-to-large effect size (d = .61). SCH caregivers experienced less (p < .001) disruption in both Mood and Vitality. There were higher levels of moderate-to-severe caregiving symptoms overtime in UC (OR, 2.722). All SCH caregivers benefited regardless of caregiver: sex, caregiver relationship, age, patient diagnosis and family income. SCH spouse/partner caregivers achieved better sixth month bereavement adjustment than UC (p < .007). CONCLUSIONS: The SCH intervention significantly decreased caregiving burden over UC and supports the maintenance of family caregiver mood and vitality throughout caregiving with extended benefit into bereavement.

Seroprevalence and risk factors for Taenia spp infection in pigs in Kongwa and Songwe districts, Tanzania: A cross-sectional study.

Taenia solium porcine cysticercosis (PCC) is widespread in many low- and middle-income countries (LMICs) where free-range pig rearing is common and hygienic standards are subpar. A cross-sectional survey was conducted in 42 villages between June and September 2019 (14 in Songwe district, southwest Tanzania, and 28 in Kongwa district, central Tanzania). Using a commercial Ag-ELISA kit (apDia, Belgium), circulating antigens of Taenia spp in pig serum were identified and used to calculate the PCC seroprevalence. The study recruited 692 randomly selected households, sampling one pig per household. The relationship between each risk factor and the seroprevalence of PCC at the household and village levels was analysed using mixed logistic regression models. The findings showed that approximately 28% of the pigs were reared in free-range settings, the proportion of households with latrines across the districts was 92%. Twenty-seven percent of households with latrines had water and soap available for hand washing. Sixty-seven (9.7%) tested positive for PCC based on Ag-ELISA. The overall seroprevalence in Kongwa and Songwe districts was 7.3% and 14.0% respectively. In addition, the overall village Ag-ELISA positivity was 9.3%, with an interquartile range (IQR) of 4.6% - 14.1%. Increasing the age of the pig (OR = 3.13 95% CI = 1.48 - 6.60; p = 0.003), pig originating from outside the household (OR = 0.5 95% CI = 0.25 - 0.99; p = 0.05), and pigs kept in a household that practised deworming (OR = 2.23 95% CI = 1.08 - 4.61; p = 0.03) were important risk factors associated with PCC positivity. Therefore, the high seroprevalence of PCC, up to 14%, calls for rapid and effective control actions such as vaccination and treatment of pigs against PCC, and public health education emphasises on indoor pig rearing, hygienic practices and regular use of latrines. Our findings also point to a potential danger of Taenia. spp infection indicating the possibility of people carrying the adult parasite Taenia solium not only in the rural communities of Kongwa and Songwe districts but also in the urban areas of Tanzania, where pigs from these areas are transported for consumption. To develop effective management measures, further research on taeniasis and cysticercosis in the human population is required.

Use of Stroke Alert Sticker in the Field Decreases Time to Acute Interventions for Ischemic Stroke Patients.

ABSTRACT: BACKGROUND: Stroke is a medical emergency requiring timely intervention to optimize patient outcomes. The only treatments currently Food and Drug Administration approved for acute stroke are intravenous (IV) thrombolytics, which require obtaining specific medical history to be administered safely. This medical history may be overlooked in the prehospital setting or lost during patient handoff between emergency medical services (EMS) personnel and hospital staff, delaying treatment. We evaluated whether utilization of a "stroke alert sticker" by EMS to capture key information in the field would decrease door-to-needle (DTN) time. METHODS: Bright-orange "stroke alert stickers" were disseminated to our local EMS agency to be placed on all suspected stroke patients in the field prompting documentation of key elements needed for timely treatment decisions. The "stroke alert sticker" included time last known well, contact information, presenting symptoms, and relevant medications. We evaluated the impact of the "stroke alert sticker" on acute stroke metrics, including DTN time. RESULTS: The project included 220 consecutive stroke alert patients brought to our comprehensive stroke center by a single EMS agency from May 2021 through February 2022. Twenty-one patients were treated with an IV thrombolytic. Overall "stroke alert sticker" use compliance was 40%; for the subgroup of patients who were given an IV thrombolytic, the "stroke alert sticker" was used 60% of the time. In patients who received an IV thrombolytic, prehospital EMS notification was 100% with "stroke alert sticker" use, compared with 75% without (P = .13). In addition, with "stroke alert sticker" utilization, DTN time was reduced by 20 minutes (31 [11] minutes with sticker vs 51 [21] minutes without, P = .04). CONCLUSION: Utilization of the "stroke alert sticker" significantly improved DTN times compared with patients without the sticker. This evidence supports continued use of the "stroke alert sticker" to improve DTN times and patient outcomes.

What Is Most Important to Family Caregivers When Helping Patients Make Treatment-Related Decisions: Findings from a National Survey.

Prioritizing patient values-who/what matters most-is central to palliative care and critical to treatment decision making. Yet which factors are most important to family caregivers in these decisions remains understudied. Using data from a U.S. national survey of cancer caregivers (N = 1661), we examined differences in factors considered very important by caregivers when partnering with patients in cancer treatment decision making by cancer stage and caregiver sociodemographics. Fifteen factors were rated on a 4-point Likert-scale from 'very unimportant' to 'very important.' Descriptive statistics were used to characterize caregiver factors and tabulate proportions of importance for each. Generalized linear mixed effect modeling was used to examine the importance of factors by cancer stage, and chi-square analyses were performed to determine associations between caregiver sociodemographics and the five most commonly endorsed factors: quality of life (69%), physical well-being (68%), length of life (66%), emotional well-being (63%), and opinions/feelings of oncology team (59%). Significant associations (all p's < 0.05) of small magnitude were found between the most endorsed factors and caregiver age, race, gender, and ethnicity, most especially 'opinions/feelings of the oncology team'. Future work is needed to determine the best timing and approach for eliciting and effectively incorporating caregiver values and preferences into shared treatment decision making.

Cytopathologic features of epithelioid hemangioendothelioma including touch imprints for rapid on-site evaluation.

Objectives: Epithelioid hemangioendothelioma (EHE) is a vascular tumor of intermediate malignant potential, which presents as infiltrative lesions involving multiple organs. We reviewed our institutional experience with the cytologic diagnosis of this neoplasm including the performance of rapid on-site evaluation (ROSE). Material and Methods: From our institutional database, we identified 29 cytology specimens, obtained between 2012 and 2020, from 21 patients with biopsy confirmation of EHE. ROSE and final diagnosis were compared. All cytology slides were reviewed, and selected cytologic features were recorded. Results: The cohort included 29 specimens comprising 17 (59%) from liver, 6 (21%) from lung, 2 (7%) from lymph node, and 4 (14%) from other sites. At ROSE, 8/27 (30%) were reported inadequate, yet on review, all cases contained scattered cells typical of EHE in the touch imprint air-dried slides including two cases reported with a final diagnosis of non-diagnostic. All cases contained epithelioid and plasmacytoid cells with ovoid nuclei, fine chromatin, delicate (or biphasic) cytoplasm, and scattered cells with delicate, elongated cytoplasmic tails. The majority 26/29 (90%) of cases had multi-nucleated and multi-lobated nuclei. Intracytoplasmic lumens/blister cells were in 17/29 (59%), and a subset had erythrocytes therein (4/29, 14%). Metachromatic fibromyxoid or fibrotic stroma fragments were commonly seen (23/29, 79%). Mitoses and necrosis were absent in all cases. Of 11 tested cases, WWTR1::CAMTA1 and YAP1::TFE3 fusions were detected in nine and two cases, respectively. Conclusion: EHE has distinctive cytologic features which are often under-recognized during ROSE.

How Can a Trauma-Informed Care Approach Be Applied to Patients With Gynecologic Cancer?

The provision of trauma-informed care (TIC) is the clinical standard when caring for patients who have experienced sexual trauma. TIC encompasses five core principles (safety, choice, collaboration, trustworthiness, and empow.

Understanding mHealth Patient-Reported Priority Symptoms for Gynecologic Cancer During Chemotherapy: A Secondary Analysis.

OBJECTIVES: To determine the percentage of and the most prevalent moderate to severe symptoms and to analyze longitudinal patterns and co-occurrence of symptoms during the first three cycles of chemotherapy. SAMPLE & SETTING: A secondary analysis of 26 women with gynecologic cancer who reported daily symptoms. METHODS & VARIABLES: Moderate to severe symptom presence and severity levels were calculated as proportions. Symptoms for each patient were graphed during three cycles and analyzed for patterns of onset, duration, and clustering. RESULTS: Patients completed 1,562 calls to the remote symptom monitoring system. The most commonly reported moderate to severe symptoms were pain, fatigue, and trouble sleeping. Pain and fatigue co-occurred with trouble sleeping in one symptom pattern. Patterns included no moderate to severe symptoms, moderate to severe symptoms during one cycle, moderate to severe symptoms during two cycles, and moderate to severe symptoms during all cycles. IMPLICATIONS FOR NURSING: Nurses should consistently assess symptoms across cycles. To verify distinct classes of symptoms and better target interventions, further study is warranted.

The World Health Organization classification of pancreaticobiliary cytopathology stratifies risk of malignancy and outcome for endoscopic ultrasound-guided fine-needle aspiration of the pancreas.

BACKGROUND: The World Health Organization (WHO) has recently published a classification for reporting pancreaticobiliary cytopathology with differences compared to the Papanicolaou Society of Cytopathology (PSC) classification. METHODS: Retrospective data were collected from pancreatic endoscopic ultrasound-guided fine-needle aspirations from 2014 to 2017 at a pancreatic cancer center. Absolute risk of malignancy (AROM), relative risk (to benign), performance characteristics, and overall survival were calculated for the entire cohort with comparison of cysts and solid lesions. RESULTS: In total, 2562 cases were included: 16% cyst (n = 411) and 84% solid (n = 2151). The histologic confirmation rate was 43% (n = 1101) and the median follow-up (for benign) was 56 months. For WHO I-VII, overall AROM (%) was 23, 22, 62, 13, 65, 97, and 100; cyst AROM was 7, 0, 19, 13, 38, 78, and 100; and solid AROM was 50, 29, 70, 15, 100, 99, and 100. For PSC I-VI, overall AROM (%) was 23, 29, 64, 0 (IVa), 60 (IVb), 97, and 100; cyst AROM was 7, 0, 19, 0, 21, 78, and 100; and solid AROM was 50, 35, 73, 0, 92, 99, and 100. The difference in relative risk for a cyst (vs. solid) overall was 0.38 for WHO and 0.26 for PSC. WHO and PSC categories showed stratification for the probability of overall survival. CONCLUSIONS: Cystic versus solid lesion type can dramatically affect AROM, particularly for nondiagnostic (I), benign (II), atypical (III), and WHO V categories. WHO IV conveys a similarly low AROM for cystic and solid types. Both classifications stratify the probability of overall survival, including the newly introduced categories WHO IV and WHO V.

Is neighborhood deprivation index a risk factor for Staphylococcus aureus infections?

BACKGROUND: We assessed the association between neighborhood area deprivation index (ADI) and community-onset (co) and hospital-onset (ho) Staphylococcus aureus infection. METHODS: Demographic and clinical characteristics of patients admitted to 5 adult hospitals in the mid-Atlantic between 2016 and 2018 were obtained. The association of ADI with methicillin-resistant (MRSA) and methicillin-sensitive (MSSA) S aureus infections was assessed using logistic regression models adjusting for severity of illness and days of admission. RESULTS: Overall, increasing ADI was associated with higher odds of co- and ho-MRSA and MSSA infection. In univariate analysis, Black race was associated with 44% greater odds of ho-MRSA infection (odds ratio [OR] 1.44; 95% CI 1.18-1.76) and Asian race (co-MRSA OR 0.355; Confidence Interval (CI) 0.240-0.525; co-MSSA OR 0.718; CI 0.557-0.928) and unknown race (co-MRSA OR 0.470; CI 0.365-0.606; co-MSSA OR 0.699; CI 0.577-0.848) was associated with lower odds of co-MSSA and co-MRSA infections. When both race and ADI were included in the model, Black race was no longer associated with ho-MRSA infections whereas Asian and unknown race remained associated with lower odds of co-MRSA and co-MSSA infection. In the multivariable logistic regression, ADI was consistently associated with increased odds of S aureus infection (co-MRSA OR 1.132; CI 1.064-1.205; co-MSSA OR 1.089; CI 1.030-1.15; ho-MRSA OR 1.29; CI 1.16-1.43: ho-MSSA OR 1.215; CI 1.096-1.346). CONCLUSIONS: The area deprivation index is associated with community and hospital-onset MRSA and MSSA infections.

Community Health-Education Intervention Trial against Human Taenia solium Taeniasis/Cysticercosis in Central and Southern Zones of Tanzania.

Poor knowledge of human T. solium taeniasis/cysticercosis and insufficient sanitary and hygienic practices have been associated with the persistence of human T. solium infections in endemic areas. Community health education intervention measures were implemented in 42 villages of Kongwa and Songwe Districts to increase knowledge, improve good practices against infection and reduce incidences of human cysticercosis transmission using a health education package. The health education package comprised of leaflet, poster and a booklet The 42 villages were allocated into intervention group and control group, and each group consisted of 21 villages. Baseline and post-intervention information on social demography, knowledge, safe practices and incidences of human cysticercosis was collected from both village groups. The impact of the intervention was evaluated by comparing changes in knowledge, preventive practices related to human T. solium infections and the cumulative incidence of human cysticercosis between intervention and control villages. There was no significant difference in mean knowledge scores and preventive practice mean scores between the control and intervention groups at baseline. However, there were significantly higher knowledge mean scores in the intervention group compared to the control group at one year post-intervention (2.06 ± 1.45 vs. 0.94 ± 1.18, p < 0.001). There was no significant difference in the mean practice scores between the intervention and the control group at one year post-intervention (2.49 ± 1.13 vs. 2.40 ± 1.13, p = 0.31). Furthermore, there was no significant difference in the prevalence of human T. solium cysticercosis between the intervention and the control group at the baseline (1.4% vs. 1.4%, p = 0.97) by Ag-Elisa, and at one year post-intervention the cumulative incidence of human cysticercosis was 1.9 and 1.2 per cent in the control and intervention group, respectively. There was no significant difference in the cumulative incidence of human cysticercosis between the intervention and the control group at one year post-intervention (p > 0.05). Community health-education intervention is effective at improving the knowledge of human T. solium infections. The improvement in preventive practices and reduction in incidences of human cysticercosis are a gradual process, they may require sanitary and hygienic improvement and more time after the intervention to see improved changes. The study recommends a sustainable public health education on T. solium infections using the health education package through one health approach.

The Integration of Both Practice and Research Into Gynecologic Oncology Nursing.

A striking question from a woman with ovarian cancer leads a nurse to pursue both practice and research.

The impacts of adrenoleukodystrophy newborn screening on the evaluation of adrenal dysfunction in male children: An integrative literature review.

PROBLEM: Adrenoleukodystrophy (ALD) is an x-linked genetic condition with a high risk of adrenal dysfunction recommended for newborn screening. This review aims to critically appraise and synthesize existing literature identifying the impacts of ALD newborn screening in the United States on the evaluation and treatment of adrenal dysfunction in male children. ELIGIBILITYCRITERIA: An integrative literature review was conducted using the Embase, PubMed, and CINAHL databases. English-language primary source studies published in the past decade and seminal studies were included. SAMPLE: Twenty primary sources met the inclusion criteria, including five seminal studies. RESULTS: Three major themes emerged from the review: 1) prevention of adrenal crisis, 2) unexpected outcomes, and 3) ethical impacts. CONCLUSIONS: ALD screening increases disease identification. Serial adrenal evaluation prevents adrenal crisis and death; data is needed to establish predictive outcomes in ALD prognosis. Disease incidence and prognosis will become more apparent as states increasingly add ALD screening to their newborn panel. IMPLICATIONS FOR PRACTICE: Clinicians need awareness of ALD newborn screening and state screening protocols. Families first learning of ALD through newborn screening results will require education, support, and timely referrals for appropriate care.

Survivorship of high tibial osteotomy in the treatment of osteoarthritis of the knee: a retrospective cohort study with fourteen years' follow-up.

PURPOSE: This study was to evaluate the survivorship of HTO for the treatment of medial compartment osteoarthritis (OA) in young and active patients from two teaching hospitals in a single city. METHODS: This is a retrospective cohort multicenter study looking at HTO for treatment of medial compartment OA. We analyzed a case series of HTO's performed by four surgeons in two centres over a 14-year period. Failure was defined as conversion to total knee replacement (TKR). All cases where additional procedures for instability of the knee were performed at the time of the index surgery were excluded. Time to failure was recorded, and a Kaplan-Meir (KM) analysis was performed to evaluate survivorship. Univariate binary regression analysis was undertaken to identify associations between risk factors and failure. RESULTS: A total of 96 patients were included in the study with a median age was 45 years. The survivorship at five years post-op was 90.3%, and at ten years post-op, it was 82%. Patients that were 14 years after surgery had a survivorship of 65%. Also, 18.8% of patients required the removal of their metalwork. The overall complication rate was 6.3%. The univariate regression analysis showed that higher age (p = 0.02) and larger corrections requiring the use of bone graft increased the risk of failure (p = 0.02). There was no statistically significant correlation between laterality, gender, complication rate, and pre-operative alignment to survivorship. CONCLUSION: This is one of the largest reported case series of HTO's with comparable survivorship at five and ten year follow-up compared to the reported literature. There was an association found between increasing age and larger corrections requiring bone graft at index procedure to increasing failure rate.

Technology-Assisted mHealth Caregiver Support to Manage Cancer Patient Symptoms: A Randomized Controlled Trial.

CONTEXT: Caregivers managing symptoms of family members with cancer during home hospice care, often feel ill-prepared and need patient care coaching. OBJECTIVES: This study tested the efficacy of an automated mHealth platform that included caregiver coaching on patient symptom care and nurse notifications of poorly controlled symptoms. The primary outcome was caregiver perception of patients' overall symptom severity throughout hospice care and at weeks one, two, four, and eight. Secondary outcomes compared individual symptom severity. METHODS: Caregivers (n = 298) were randomly assigned to the Symptom Care at Home (SCH) intervention (n = 144) or usual hospice care (UC) (n = 154). All caregivers placed daily calls to the automated system that assessed the presence and severity of 11 end-of-life patient physical and psychosocial symptoms. SCH caregivers received automated coaching on symptom care based on reported patient symptoms and their severity. Moderate-to-severe symptoms were also relayed to the hospice nurse. RESULTS: The SCH intervention produced a mean overall symptom reduction benefit, over UC, of 4.89 severity points (95% CI 2.86-6.92) (P < 0.001), with a moderate effect size (d = 0.55). The SCH benefit also occurred at each timepoint (P < 0.001- 0.020). There was a 38% reduction in days reporting moderate-to-severe patient symptoms compared to UC (P < 0.001) with 10/11 symptoms significantly reduced in SCH compared to UC. CONCLUSION: Automated mHealth symptom reporting by caregivers, paired with tailored caregiver coaching on symptom management and nurse notifications, reduces cancer patients' physical and psychosocial symptoms during home hospice, providing a novel and efficient approach to improving end-of-life care.