Introduction: Most adults with head and neck cancer (HNC) are older.Treatment -either through (extensive) surgery with (lengthy) hospital admission or (chemo)radiotherapy is intense.Frailty assessment at initial presentation allows for early interventions or alterations in the diagnostic work-up or treatment choice.Objectives: To improve standard of care for older adults with HNC by identifying frail patients at initial presentation, thereby enabling early interventions or alterations in treatment plan.Methods: Adults ≥ 60 years, referred to our tertiary outpatient HNC department were assessed for frailty using G8 and (I)ADL during a 12 month period in 2022-2023.Patients who were considered potentially frail based on either G8 or (I)ADL and for whom treatment with extensive surgery or (chemo)radiotherapy was considered were referred for a Comprehensive Geriatric Assessment (CGA) and discussed at the Geriatric Oncology MDT.Descriptive statistics were used and delirium, place of discharge and death within 3 months were registered.Results: 371 patients were aged ≥ 60 years.Of these 46 patients were considered potentially frail and received a CGA (mean age 77 years (62-94)).In 26% of these patients the treatment plan was adapted, most often palliative radiotherapy instead of radiotherapy with curative intent.In total 18 patients were treated with surgery with curative intent.Of these 16.6% experienced delirium, 16.6% was not discharged home and 1 patient died within 3 months.Conclusion: Geriatric co-management changes the treatment plan in 26% of patients.When thoroughly selected and supported by both head and neck surgeon and geriatrician extensive surgery can be performed safely in older adults with HNC.

269 Background: Older adults with advanced cancer are at increased risk of treatment-related toxicities, which can compromise physical performance and independence in daily functioning. However, studies evaluating the relationship of toxicities with functional capacity in this population are scarce. The aim of this analysis is to assess the effect of clinician-reported toxicities (CRTs) and patient-reported symptomatic toxicities (PRSTs) on physical performance and independence in daily functioning. Methods: This is a secondary analysis of GAP 70+ (NCT02054741, n = 718), a cluster randomized trial of older patients (70+ years) with advanced cancer initiating a new systemic therapy regimen. Impairments in physical performance [measured by Short Physical Performance Battery (SPPB)], and functional independence [measured by activities of daily living (ADL), and instrumental ADL (IADL)] were classified by established cut points. CRTs were collected by Common Terminology Criteria for Adverse Events (CTCAE) and PRSTs by Patient-Reported Outcome version of CTCAE (PRO-CTCAE). PRST grade was determined by severity of the items (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe). To count as a PRST event, symptom severity had to increase from pre-treatment level (baseline adjusted method). Patients without baseline impairment in SPPB, IADL, and ADL (n = 104, 308, 461, respectively), who provided data after baseline were included in the analysis. To assess the association of experiencing toxicity within 3 months and developing functional impairment within 6 months, generalized estimating equation (GEE) modeling was used. Models were adjusted for practice sites (random effect) and the study arm. Results: Patients were 70-96 years old (mean 77), 56% were male, and majority (87%) were white. Gastrointestinal (34%) and lung (25%) were the most common cancer types. During treatment, impairments in SPPB developed in 57.7% (60/104), in IADL 47.4% (146/308), and in ADL 31.0% (143/461). There was no association of CRT grade with developing impairment in SPPB (p = 0.92). A greater proportion of patients who experienced grade ≥ 3 CRT, compared to those with grade 2 and grade ≤ 1 CRT, developed impairment in IADL (54.4 vs 38.3 vs 25.2%, p = 0.01) and also in ADL (34.8 vs 23.9 vs 22.7%, p = 0.02). Patients who experienced grade ≥ 3 PRST, compared to those with grade 2 and grade ≤ 1 PRST, were more likely to developed impaired SPPB (73.6 vs 50.4 vs 27.8%, p = 0.01), IADL (50.8 vs 45.4 vs 31.5%, p = 0.20), and ADL (38.1 vs 18.5 vs 19.7%, p < 0.01). Conclusions: Assessing both patient- and clinician-reported toxicity provides insight into loss of independent functioning. Information patients provide about symptoms can help with early detection of decline in physical performance in older adults. These findings may help to guide interventions to mitigate functional decline. Clinical trial information: NCT02054741.

The female reproductive tract (FRT) microbiome plays a vital role in maintaining vaginal health. Viruses are key regulators of other microbial ecosystems, but little is known about how the FRT viruses (virome), particularly bacteriophages that comprise the phageome, impact FRT health and dysbiosis. We hypothesize that bacterial vaginosis (BV) is associated with altered FRT phageome diversity, transkingdom interplay, and bacteriophage discriminate taxa. Here, we conducted a retrospective, longitudinal analysis of vaginal swabs collected from 54 BV-positive and 46 BV-negative South African women. Bacteriome analysis revealed samples clustered into five distinct bacterial community groups (CGs), and further, bacterial alpha diversity was significantly associated with BV. Virome analysis on a subset of baseline samples showed FRT bacteriophages clustering into novel viral state types (VSTs), a viral community clustering system based on virome composition and abundance. Distinct BV bacteriophage signatures included increased alpha diversity along with discriminant Bacillus, Burkholderia, and Escherichia bacteriophages. Bacteriophage-bacteria transkingdom associations were also identified between Bacillus and Burkholderia viruses and BV-associated bacteria, providing key insights for future studies elucidating the transkingdom interactions driving BV-associated microbiome perturbations. In this cohort, bacteriophage-bacterial associations suggest complex interactions, which may play a role in the establishment and maintenance of BV.

ObjectivePatients with advanced epithelial ovarian cancer (EOC) alive without progression at a landmark time-point of 10 years from diagnosis are likely cured. We report the proportion of patients with Stage III EOC who were long-term disease-free survivors (LTDFS≥10 years) following either intraperitoneal (IP) or intravenous (IV) chemotherapy as well as the predictors of LTDFS.MethodsData from 3 mature NRG/GOG trials (104, 114, 172) were analyzed and included demographics, clinicopathologic details, route of administration, and survival outcomes of patients living ≥10 years assessed according to the Kaplan-Meier method. Cox regression survival analysis was performed to evaluate independent prognostic predictors of LTDFS.ResultsOf 1174 patients randomized, 10-year overall survival (OS) was 26% (95% CI, 23–28%) and LTDFS ≥10 years was 18% (95% CI, 16–20%). Patients with LTDFS ≥10 years had a median age of 54.6 years (p < 0.001). Younger age (p < 0.001) was the only independent prognostic factor for LTDFS≥10 years on multivariate Cox analysis.ConclusionsApproximately 18% of patients were LTDFS ≥10 years. They form the tail end of the survival curve and are likely cured. Our results provide a comparative benchmark to evaluate the impact of PARP inhibitors in 1st line maintenance trials on survival outcomes.

Introduction Technology-based interventions that can function within real-world practice and improve outcomes without increasing provider burden are needed, yet few successfully cross the research-to-practice divide. This paper describes the process of developing a clinically integrated smartphone-telemedicine program for adults with asthma and results from proof-of-concept testing. Methods We used a contextually grounded intervention development approach and May's implementation theory to design the intervention, with emphasis on systems capabilities and stakeholder needs. The intervention incorporated symptom monitoring by smartphone, smartphone telemedicine visits and self-management training with a nurse, and clinical decision-support software, which provided automated calculations of asthma severity, control and step-wise therapy. Seven adults (aged 18–40 y) engaged in a 3-month beta-test. Asthma outcomes (control, quality of life, FEV1) and healthcare utilisation patterns were measured at baseline and end-of-study. Results Each participant averaged four telemedicine visits (94% patient satisfaction). All participants had uncontrolled asthma at baseline; end-of-study 5/7 classified as well-controlled. Mean asthma control improved 1.55 points (CI = 0.59–2.51); quality of life improved 1.91 points (CI = 0.50–3.31), FEV1 percent predicted increased 14.86% (CI = −3.09–32.80): effect sizes of d = 1.16, 1.09, and 0.96, respectively. Preventive healthcare utilisation increased significantly (1.86 visits/year vs. 0.28/year prior, CI 0.67–2.47) as did prescriptions for controller medications (9.29 prescriptions/year vs. 1.57 prescriptions/year, CI 4.85–10.58). Discussion Smartphone telemedicine may be an effective means to improve outcomes and deliver asthma care remotely. However, careful attention to systems capabilities and stakeholder acceptability is needed to ensure successful integration with practice. Clinical Trials registration #: NCT03648203

BACKGROUND:Respiratory syncytial virus (RSV) is a leading cause of infant respiratory disease. Infant airway microbiota has been associated with respiratory disease risk and severity. The extent to which interactions between RSV and microbiota occur in the airway, and their impact on respiratory disease susceptibility and severity, are unknown.METHODS:We carried out 16S rRNA microbiota profiling of infants in the first year of life from (1) a cross-sectional cohort of 89 RSV-infected infants sampled during illness and 102 matched healthy controls, and (2) a matched longitudinal cohort of 12 infants who developed RSV infection and 12 who did not, sampled before, during, and after infection.RESULTS:We identified 12 taxa significantly associated with RSV infection. All 12 taxa were differentially abundant during infection, with 8 associated with disease severity. Nasal microbiota composition was more discriminative of healthy vs infected than of disease severity.CONCLUSIONS:Our findings elucidate the chronology of nasal microbiota dysbiosis and suggest an altered developmental trajectory associated with RSV infection. Microbial temporal dynamics reveal indicators of disease risk, correlates of illness and severity, and impact of RSV infection on microbiota composition.

The majority of adults with persistent asthma have chronically uncontrolled disease and interventions to improve outcomes are needed. We evaluated the efficacy, feasibility, and acceptability of a multi-component smartphone-telemedicine program (TEAMS) to deliver asthma care remotely, support provider adherence to asthma management guidelines, and improve patient outcomes. TEAMS utilized: (1) remote symptom monitoring, (2) nurse-led smartphone-telemedicine with self-management training for patients, and (3) Electronic medical record-based clinical decision support software. Adults aged 18-44 (N = 33) and primary care providers (N = 4) were recruited from a safety-net practice in Upstate New York. Asthma control, quality of life, and FEV1 were measured at 0, 3 and 6 months. Acceptability was assessed via survey and end-of-study interviews. Paired t-test and mixed effects modeling were used to evaluate the effect of the intervention on asthma outcomes. At baseline, 80% of participants had uncontrolled asthma. By 6-months, 80% classified as well-controlled. Improvements in control and quality of life were large (d = 1.955, d = 1.579). FEV%pred increased 4.2% (d = 1.687) with the greatest gain in males, smokers, and lower educational status. Provider adherence to national guidelines increased from 43.3% to 86.7% (CI = 22.11-64.55) and patient adherence to medication increased from 45.58% to 85.29% (CI = 14.79-64.62). Acceptability was 95.7%; In follow up interviews, 29/30 patients and all providers indicated TEAMS worked better than usual care, supported effective self-management, and reduced symptoms over time, which led to greater self-efficacy and motivation to manage asthma. Based on these findings, we conclude that smartphone telemedicine could substantially improve clinical asthma management, adherence to guidelines, and patient outcomes.

Young adults (ages 18‐44) have increased emergency department use for asthma and poor adherence to medications. The objective of this mixed‐methods study was to understand experiences with and approaches to managing asthma, of which little is known in this age group.

The authors regret that there was some conflict of interest information missing from their original article. The conflict of interest statement for Dr. Robert Wenham has now been updated in the online version and can be found below: Dr. Wenham reports being a research fund recipient, consultant, advisor, steering committee or DSMB member, or speaker for Tesaro, Clovis, Genentech, Merck, Ovation Diagnostics, Janseen, Mersana, and Tapimmune. The authors would like to apologise for any inconvenience caused. Does adjuvant chemotherapy dose modification have an impact on the outcome of patients diagnosed with advanced stage ovarian cancer? An NRG Oncology/Gynecologic Oncology Group studyGynecologic OncologyVol. 151Issue 1PreviewTo determine the relationship between chemotherapy dose modification (dose adjustment or treatment delay), overall survival (OS) and progression-free survival (PFS) for women with advanced-stage epithelial ovarian carcinoma (EOC) and primary peritoneal carcinoma (PPC) who receive carboplatin and paclitaxel. Full-Text PDF

OBJECTIVE:To develop a valid research tool to measure infant respiratory illness severity using parent-reported symptoms. STUDY DESIGN:Nose and throat swabs were collected monthly for 1 year and during respiratory illnesses for 2 years in a prospective study of term and preterm infants in the Prematurity, Respiratory Outcomes, Immune System and Microbiome study. Viral pathogens were detected using Taqman Array Cards. Parents recorded symptoms during respiratory illnesses using a Childhood Origins of Asthma (COAST) scorecard. The COAST score was validated using linear mixed effects regression modeling to evaluate associations with hospitalization and specific infections. A data-driven method was also used to compute symptom weights and derive a new score, the Infant Research Respiratory Infection Severity Score (IRRISS). Linear mixed effects regression modeling was repeated with the IRRISS illness data. RESULTS:From April 2013 to April 2017, 50 term, 40 late preterm, and 28 extremely low gestational age (<29 weeks of gestation) infants had 303 respiratory illness visits with viral testing and parent-reported symptoms. A range of illness severity was described with 39% of illness scores suggestive of severe disease. Both the COAST score and IRRISS were associated with respiratory syncytial virus infection and hospitalization. Gestational age and human rhinovirus infection were inversely associated with both scoring systems. The IRRISS and COAST scores were highly correlated (r = 0.93; P < .0001). CONCLUSIONS:Using parent-reported symptoms, we validated the COAST score as a measure of respiratory illness severity in infants. The new IRRISS score performed as well as the COAST score.

PURPOSE:To compare patient/tumor characteristics and outcomes of Asians to Caucasian patients with epithelial ovarian cancer. METHODS:Ancillary data were pooled and analyzed from ten prospective randomized front-line Gynecologic Oncology Group clinical trials from 1996 to 2011. Demographic, clinicopathologic features, disease-specific and all-cause survival were analyzed. RESULTS:Of 7914 patients, 7641 were Caucasian and 273 Asian. When compared to Caucasians, Asians were younger at trial enrollment, had a better performance status, earlier-stage cancers (17.2% vs. 8.1% with stage I; p < 0.001), and were more likely to be of clear cell (15.8% vs. 6.2%, p < 0.001) and mucinous (3.3% vs. 1.9%, p < 0.001) histology. Asians had an improved 5-year disease-specific survival of 54.1% compared to 46.1% for Caucasians, p = 0.001. In multivariate analysis, the Asian race remained a significant prognostic factor for all-cause survival (HR: 0.84; 95% CI: 0.72-0.99; p = 0.04). Other factors predictive of improved survival included younger age, better performance status, optimal cytoreduction, earlier stage, non-clear cell histology, and lower grade tumors. CONCLUSION:Asians enrolled into phase III ovarian cancer clinical trials were younger, with better performance status, earlier-stage of disease, and have a greater number of clear cell and mucinous tumors. After adjusting for these prognostic factors, Asians have a better survival compared to Caucasians.

Table S4. Operational taxonomic units (OTUs) exhibiting a significant association with the CST of a body site in which they are not observed. (XLSX 10 kb)

BACKGROUND:Accurate symptom assessment remains challenging in teen populations. Little is known of usual symptom/response patterns, and self-reported paper diaries have traditionally low compliance rates. Therefore, we used concurrent digital voice diaries to capture daily asthma experiences. OBJECTIVE:(a) To qualitatively explore usual symptom patterns and self-management responses and (b) to quantitatively explore relationships between symptom severity and sentiment scores (a marker of emotional response to events). METHODS:Fourteen minority and nonminority teenagers (age 13-17) with controlled (50%) and uncontrolled asthma used digital recorders to report about their asthma once daily over 14 days. Dairy entries were coded for symptom frequency, severity, type, and self-management responses, while sentiment analysis was used to evaluate the emotional valence of diary entries and to explore whether increased symptom levels correlated with greater negative sentiment. RESULTS:Symptom frequency and severity recorded in voice diaries were much higher than teens indicated at baseline and were discordant with clinical assessments of asthma control. Of 175 entries, teens had symptoms 69.1% of days (121/175) and severe symptoms on one-third of these. Atypical symptoms (coughing, throat clearing) were reported twice as often as traditional symptoms (wheezing, chest tightness) and often not recognized as asthma, but rather attributed to being "sick" (25.6% of symptom days). Teens frequently minimized symptoms, used rescue and controller medication inconsistently, and resorted to alternative strategies to manage symptoms. Sentiment was not significantly correlated with assessed control (β = 0.14, P = 0.28), but for teens reporting severe symptoms, sentiment scores decreased by 0.31 relative to teens without symptoms (P = 0.006). CONCLUSIONS AND CLINICAL RELEVANCE:Teens may minimize symptoms and have greater symptom frequency and severity than is recognized by themselves or providers. Screening for specific symptoms including coughing, throat clearing, and respiratory illness may be needed to identify those experiencing burden from asthma.

OBJECTIVE: Tolerance of and complications caused by minimally invasive hysterectomy and staging in the older endometrial cancer population is largely unknown despite the fact that this is the most rapidly growing age group in the United States. The objective of this retrospective review was to compare operative morbidity by age in patients on the Gynecologic Oncology Group Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus (LAP2) trial. STUDY DESIGN: This is a retrospective analysis of patients from Gynecologic Oncology Group LAP2, a trial that included clinically early-stage uterine cancer patients randomized to laparotomy vs laparoscopy for surgical staging. Differences in the rates and types of intraoperative and perioperative complications were compared by age. Specifically complications between patients <60 vs >= 60 years old were compared caused by toxicity analysis showing a sharp increase in toxicity starting at age 60 years in the laparotomy group. RESULTS: LAP2 included 1477 patients >= 60 years old. As expected, with increasing age there was worsening performance status and disease characteristics including higher rates of serous histology, high-stage disease, and lymphovascular space invasion. There was no significant difference in lymph node dissection rate by age for the entire population or within the laparotomy or laparoscopy groups. Toxicity analysis showed a sharp increase in toxicity seen in patients >= 60 years old in the laparotomy group. Further analysis showed that when comparing laparotomy with laparoscopy in patients <60 years old vs >= 60 years old and controlling for race, body mass index, stage, grade, and performance status, patients <60 years old undergoing laparotomy had more hospital stays >2 days (odds ratio, 17.48; 95% confidence interval, 11.71-27.00, P<.001) compared with patients <60 years old undergoing laparoscopy. However, when comparing laparotomy with laparoscopy in patients >= 60 years old, in addition to hospital stay >2 days (odds ratio, 12.77; 95% confidence interval, 8.74-19.32, P<.001), there were higher rates of the following postoperative complications: antibiotic administration (odds ratio, 1.63; 95% confidence interval, 1.24-2.14, P<.001), ileus (odds ratio, 2.16; 95% confidence interval, 1.42-3.31, P < 0.001), pneumonias (odds ratio, 2.36; 95% confidence interval, 1.01-5.66, P = .048), deep vein thromboses (odds ratio, 2.87; 95% confidence interval, 1.08-8.03, P = .035), and arrhythmias (odds ratio, 3.21; 95% confidence interval, 1.60-6.65, P = .001) in the laparotomy group. CONCLUSION: Laparoscopic staging for uterine cancer is associated with decreased morbidity in the immediate postoperative period in patients >= 60 years old. These results allow for more accurate preoperative counseling. A minimally invasive approach to uterine cancer staging may decrease morbidity that could affect long-term survival.

Objective. Microscopic residual disease following complete cytoreduction (R0) is associated with a significant survival benefit for patients with advanced epithelial ovarian cancer (EOC). Our objective was to develop a prediction model for R0 to support surgeons in their clinical care decisions. Methods. Demographic, pathologic, surgical, and CA125 data were collected from GOG 182 records. Patients enrolled prior to September 1, 2003 were used for the training model while those enrolled after constituted the validation data set. Univariate analysis was performed to identify significant predictors of R0 and these variables were subsequently analyzed using multivariable regression. The regression model was reduced using backward selection and predictive accuracy was quantified using area under the receiver operating characteristic area under the curve (AUC) in both the training and the validation data sets. Results. Of the 3882 patients enrolled in GOG 182, 1480-had complete clinical data available for the analysis The training data set consisted of 1007 patients (234 with R0) while the validation set was comprised of 473 patients (122 with R0). The reduced multivariable regression model demonstrated several variables predictive of R0 at cytoreduction: Disease Score (DS) (p < 0.001), stage (p = 0.009), CA125 (p < 0.001), ascites (p < 0.001), and stage-age interaction (p = 0.01). Applying the prediction model to the validation data resulted in an AUC of 0.73 (0.67 to 0.78, 95% CI). Inclusion of DS enhanced the model performance to an AUC of 0.83 (0.79 to 0.88, 95% CI). Conclusions, We developed and validated a prediction model for R0 that offers improved performance over previously reported models for prediction of residual disease. The performance of the prediction model suggests additional factors (i.e. imaging, molecular profiling, etc.) should be explored in the future for a more clinically actionable tool. (C) 2017 Elsevier Inc. All rights reserved.

BackgroundPostnatal development of early life microbiota influences immunity, metabolism, neurodevelopment, and infant health. Microbiome development occurs at multiple body sites, with distinct community compositions and functions. Associations between microbiota at multiple sites represent an unexplored influence on the infant microbiome. Here, we examined co-occurrence patterns of gut and respiratory microbiota in pre- and full-term infants over the first year of life, a period critical to neonatal development.ResultsGut and respiratory microbiota collected as longitudinal rectal, throat, and nasal samples from 38 pre-term and 44 full-term infants were first clustered into community state types (CSTs) on the basis of their compositional profiles. Multiple methods were used to relate the occurrence of CSTs to temporal microbiota development and measures of infant maturity, including gestational age (GA) at birth, week of life (WOL), and post-menstrual age (PMA). Manifestation of CSTs followed one of three patterns with respect to infant maturity: (1) chronological, with CST occurrence frequency solely a function of post-natal age (WOL), (2) idiosyncratic to maturity at birth, with the interval of CST occurrence dependent on infant post-natal age but the frequency of occurrence dependent on GA at birth, and (3) convergent, in which CSTs appear first in infants of greater maturity at birth, with occurrence frequency in pre-terms converging after a post-natal interval proportional to pre-maturity. The composition of CSTs was highly dissimilar between different body sites, but the CST of any one body site was highly predictive of the CSTs at other body sites. There were significant associations between the abundance of individual taxa at each body site and the CSTs of the other body sites, which persisted after stringent control for the non-linear effects of infant maturity. Canonical correlations exist between the microbiota composition at each pair of body sites, with the strongest correlations between proximal locations.ConclusionThese findings suggest that early microbiota is shaped by neonatal innate and adaptive developmental responses. Temporal progression of CST occurrence is influenced by infant maturity at birth and post-natal age. Significant associations of microbiota across body sites reveal distal connections and coordinated development of the infant microbial ecosystem.