Insights into RC time curve fit analysis of pulmonary artery pressure decay.

The notion of a constant relationship between resistance and capacitance (RC time) in the pulmonary circulation has been challenged by more recent research. The RC time can be obtained using either a simplified empirical approach or a semilogarithmic equation. Although direct curve-fit analysis is a feasible and ostensibly reference approach for RC analysis, it remains largely unexplored. We aimed to study the relationship between various RC methods in different states of pulmonary hemodynamics. Methods In total, 182 patients underwent clinically indicated right heart catheterization. The pressure curves were exported and processed using the MATLAB software. We calculated the RC time using the empirical method (RCEST), semilogarithmic approach (RCSL), and direct measurement of curve fit (RCFIT). Results Among 182 patients, 137 had pulmonary hypertension due to left heart disease (PH-LHD), 35 had pulmonary arterial hypertension (PAH), and 10 demonstrated normal hemodynamics (non-PH). RCEST consistently overestimated the RCFIT and RCSL measurements by a mean of 75%. With all three methods, the RC values were longer in the PAH (RCFIT = 0.36 ± 0.14 s) than in the PH-LHD (0.27 ± 0.1 s) and non-PH (0.27 ± 0.09 s) groups (p < 0.001). Although the RCSL and RCFIT values were similar among the three subgroups, they exhibited broad limits of agreement. Finally, the RCEST demonstrated a strong discriminatory ability (AUC = 0.86, p < 0.001, CI = 0.79-0.93) in identifying PAH. Conclusion RC time in PAH patients was substantially prolonged compared to that in PH-LHD and non-PH patients. The use of the empirical formula yielded systematic RC overestimation. In contrast, the semilogarithmic analysis provided reliable RC estimates, particularly for group comparisons.

Quality of Life Outcomes for Parotid Malignancies.

BACKGROUND: This study describes patient-reported outcome measures (PROMs) and associated factors in patients who underwent surgery for malignant parotid tumors (MPT). METHODS: This is a retrospective study of all surgically treated MPT patients in a multidisciplinary head and neck cancer (HNC) survivorship clinic (2017-2023). PROMs included University of Washington Quality of Life Questionnaire (UW-QOL), Eating Assessment Tool (EAT-10), Patient Health Questionnaire (PHQ-8), Generalized Anxiety Disorder (GAD-7), Neck Disability Index (NDI), and Insomnia Severity Index. Multivariable regression analysis was used to investigate clinical predictors associated with PROMs. RESULTS: In 62 MPT patients, the prevalence of clinically relevant dysphagia symptoms (EAT-10), elevated symptoms of depression (PHQ-8), moderate/severe symptoms of anxiety (GAD-7), moderate/severe neck pain with activities of daily living (NDI), and moderate/severe symptoms of insomnia at last follow-up was 32.3%, 15.5%, 7.1%, 17.7%, and 7.2%, respectively. Nonparametric one-sided test revealed that patients treated with adjuvant CRT had significantly worse physical QOL, social-emotional QOL, and swallowing scores than patients treated with surgery alone (p = 0.01, p = 0.02, p = 0.03, respectively); that patients treated with surgery and adjuvant RT had significantly worse physical QOL and social-emotional QOL than patients treated with surgery alone (p < 0.01, p = 0.01, respectively) and that patients treated with surgery and adjuvant CRT had significantly worse swallowing and neck pain than patients treated with surgery and adjuvant RT (p = 0.03, p = 0.05, respectively). CONCLUSIONS: In patients with surgically treated MPT, adjuvant CRT and RT were associated with worse PROMs. LEVEL OF EVIDENCE: 4 Laryngoscope, 2024.

Patient, family caregiver, and economic outcomes of an integrated screening and novel stepped collaborative care intervention in the oncology setting in the USA (CARES): a randomised, parallel, phase 3 trial.

BACKGROUND: The current standard of care of screening and referring patients for treatment for symptoms, such as depression, pain, and fatigue, is not effective. This trial aimed to test the efficacy of an integrated screening and novel stepped collaborative care intervention versus standard of care for patients with cancer and at least one of the following symptoms: depression, pain, or fatigue. METHODS: This randomised, parallel, phase 3 trial was conducted in 29 oncology outpatient clinics associated with the UPMC Hillman Cancer Center in the USA. Patients (aged ≥21 years) with any cancer type and clinical levels of depression, pain, or fatigue (or all of these) were eligible. Eligible family caregivers were aged 21 years or older and providing care to a patient diagnosed with cancer who consented for this study. Patients were randomly assigned (1:1) to stepped collaborative care or standard of care using a central, permuted block design (sizes of 2, 4, and 6) stratified by sex and prognostic status. The biostatistician, oncologists, and outcome assessors were masked to treatment assignment. Stepped collaborative care was once-weekly cognitive behavioural therapy for 50-60 min from a care coordinator via telemedicine (eg, telephone or videoconferencing). Pharmacotherapy for symptoms might be initiated or changed if recommended by the treatment team or preferred by the patient. Standard of care was screening and referral to a health-care provider for treatment of symptoms. The primary outcome was health-related quality of life in patients at 6 months. Maintenance of the treatment benefits was assessed at 12 months. Participants included in the primary analysis were per intention to treat, which included patients missing one or both follow-up assessments. This trial was registered with ClinicalTrials.gov (NCT02939755). FINDINGS: Between Dec 5, 2016, and April 8, 2021, 459 patients and 190 family caregivers were enrolled. 222 patients were assigned to standard of care and 237 to stepped collaborative care. Of 459 patients, 201 (44%) were male and 258 (56%) were female. Patients in the stepped collaborative care group had a greater 0-6-month improvement in health-related quality of life than patients in the standard-of-care group (p=0·013, effect size 0·09). Health-related quality of life was maintained for the stepped collaborative care group (p=0·74, effect size 0·01). Patients in the stepped collaborative care group had greater 0-6-month improvements than the standard-of-care group in emotional (p=0·012), functional (p=0·042), and physical (p=0·033) wellbeing. No adverse events were reported by patients in either group and deaths were considered unrelated to the study. INTERPRETATION: An integrated screening and novel stepped collaborative care intervention, compared with the current standard of care, is recommended to improve health-related quality of life. The findings of this study will advance the implementation of guideline concordant care (screening and treatment) and has the potential to shift the practice of screening and treatment paradigm nationwide, improving outcomes for patients diagnosed with cancer. FUNDING: US National Cancer Institute.

Prognostic Factors and Outcomes Associated With Neck Lymphedema in Head and Neck Cancer Survivors.

OBJECTIVES: The purpose of this study is to determine the predictors of neck lymphedema and to explore its association with symptoms and patient-reported outcomes (PROs) in Head and Neck Cancer (HNC) patients who underwent non-operative treatment. METHODS: This study involved a cross-sectional secondary analysis of data from patients diagnosed with head and neck squamous cell carcinoma who underwent radiation therapy (±chemotherapy). Patients with visits <6 weeks or >2 years following completion of radiation and those with recurrent or metastatic cancer were excluded. Presence of post-treatment lymphedema, demographics, clinical characteristics, health-related behaviors, and symptoms were collected. PROs were obtained using validated questionnaires that assessed depression, anxiety, swallowing dysfunction, and quality of life (QOL). Multivariable regression models were used to examine the relationship between lymphedema with predictors and symptoms. RESULTS: Of the 203 patients included, 88 (43.4%) developed post-treatment lymphedema. In multivariable analysis, pre-treatment Body Mass Index (BMI) (odds ratio [OR] = 1.07, 95% confidence interval [CI] [1.01, 1.14] p = 0.016) and N stage (OR = 1.96, 95% CI [1.06, 3.66], p = 0.032) were found to be independently associated with lymphedema. Regarding PROs, lymphedema was associated with greater swallowing dysfunction (3.48, 95% CI [0.20, 6.75], p = 0.038), decreased mouth opening (-3.70, 95% CI [-7.31, -0.10], p = 0.044), and increased fatigue (1.88, 95% CI [1.05, 3.38], p = 0.034). CONCLUSION: Higher pre-treatment BMI and greater N stage are identified as independent predictors for lymphedema development in non-operative HNC patients. Additionally, patients experiencing lymphedema reported worsening swallowing dysfunction and increased symptoms related to trismus and fatigue. Recognizing patients at elevated risk for lymphedema allows for early intervention, alleviation of symptom burden, and optimization of health care resources. LEVEL OF EVIDENCE: 4 Laryngoscope, 2024.

Electromyography findings in radiation-induced unilateral tongue immobility.

BACKGROUND: We used electromyography to characterize hypoglossal nerve function among radiation-treated head and neck cancer survivors with later onset unilateral tongue immobility. METHODS: Patients with unilateral tongue immobility without evidence of recurrent cancer were seen at a tertiary academic institution between February and September 2021. All patients were at least 2 years post-treatment with radiation therapy for head and neck squamous cell carcinoma. Participants were under annual surveillance and displayed no evidence of operative injury to the hypoglossal nerve. RESULTS: The median symptom-free interval for the 10 patients included in this study was 13.2 years (range 2-25 years). Myokymia alone was present in 3 of 10 patients, fibrillation potentials alone were present in 3 of 10 patients, and 1 subject displayed both fibrillation and myokymia. Three out of 10 patients had normal hypoglossal nerve function. DISCUSSION: These findings highlight how disparate mechanisms may underlie similar clinical presentations of radiation-induced neuromuscular dysfunction.

The female self-advocacy in Cancer Survivorship scale is a psychometrically sound measure of self-advocacy in male cancer survivors.

OBJECTIVE: To develop and psychometrically evaluate an adapted version of the Female Self-Advocacy in Cancer Survivorship (FSACS) Scale in men with a history of cancer. METHODS: This psychometric instrument development and validation study used a two-phase approach to first adapt the FSACS Scale items to reflect the experience of men with a history of cancer and then evaluate the psychometric properties of the adapted scale compared to the original FSACS Scale. The study was conducted from December 2018 through April 2022 through cancer clinics, patient registries, and national advocacy organizations. We evaluated scale reliability and validity using reliability coefficients, exploratory and confirmatory factor analyses, and item analyses to determine a final set of scale items. RESULTS: Item responses from N = 171 men with a history of cancer were evaluated to determine scale validity. After removing poor-performing items based on item-level analyses, factor analyses confirmed that a 3-factor structure of both the adapted and original FSACS Scale best fit the scale. The 10 new items did not outperform the original 20-item scale and were therefore excluded from the final scale. The final 20-item scale explained 87.94% of item variance and subscale's Cronbach α varied from 0.65 to 0.86. CONCLUSION: The SACS Scale can be used in research and clinical contexts to assess the propensity of men and women to get their needs, values, and priorities met in the face of a challenge.

Automated quantitative evaluation of fetal atrioventricular annular plane systolic excursion before and after intrauterine blood transfusion in pregnancies affected by red blood cell alloimmunization.

INTRODUCTION: Maternal red blood cell alloimmunization during pregnancy can lead to hemolysis and various degrees of fetal anemia, which can be treated with intrauterine blood transfusion (IUT) to prevent adverse outcomes. Knowledge about fetal myocardial function and adaptation is limited. The aim of the present study was to measure fetal atrioventricular plane displacement before and after IUT and compare these measurements with previously established reference ranges. MATERIAL AND METHODS: An observational study was conducted on pregnant women affected by red blood cell alloimmunization. Fetal echocardiography was performed before and after IUT. The atrioventricular plane displacement of the left and right ventricular walls and interventricular septum, described as mitral, septal, and tricuspid annular plane systolic excursion (MAPSE, SAPSE, and TAPSE, respectively), was assessed using color tissue Doppler imaging with automated analysis software. A Mann-Whitney U test was used to compare the z scores to the normal mean before and after IUT. RESULTS: Twenty-seven fetuses were included. The mean z score for pre-IUT MAPSE was significantly increased compared with the reference ranges, +0.46 (95% confidence interval [CI] +0.17 to +0.75; p = 0.039), while the mean z scores for post-IUT SAPSE and TAPSE were significantly decreased, -0.65 (95% CI -1.11 to -0.19; p < 0.001) and -0.60 (95% CI -1.04 to -0.17; p = 0.003), respectively. The difference in atrioventricular plane displacement z scores before and after IUT was statistically significant in all three locations. The median difference between the pre-IUT and post-IUT z scores was -0.66 (95% CI -1.03 to -0.33, p < 0.001) for MAPSE, -1.05 (95% CI -1.43 to -0.61, p < 0.001) for SAPSE, and -0.60 (95% CI -1.19 to -0.01, p = 0.046) for TAPSE. CONCLUSIONS: This study suggests that atrioventricular plane displacement, when determined using automated analysis software, may represent a quantitative parameter, describing fetal myocardial function and adaptation before and after IUT.

Longitudinal Analysis of Caregiver Burden in Head and Neck Cancer.

Importance: Despite the critical role of caregivers in head and neck cancer (HNC), there is limited literature on caregiver burden (CGB) and its evolution over treatment. Research is needed to address evidence gaps that exist in understanding the causal pathways between caregiving and treatment outcomes. Objective: To evaluate the prevalence of and identify risk factors for CGB in HNC survivorship. Design, Setting, and Participants: This longitudinal prospective cohort study took place at the University of Pittsburgh Medical Center. Dyads of treatment-naive patients with HNC and their caregivers were recruited between October 2019 and December 2020. Eligible patient-caregiver dyads were 18 years or older and fluent in English. Patients undergoing definitive treatment identified a caregiver as the primary, nonprofessional, nonpaid person who provided the most assistance to them. Among 100 eligible dyadic participants, 2 caregivers declined participation, resulting in 96 enrolled participants. Data were analyzed from September 2021 through October 2022. Main Outcomes and Measures: Participants were surveyed at diagnosis, 3 months postdiagnosis, and 6 months postdiagnosis. Caregiver burden was evaluated with the 19-item Social Support Survey (scored 0-100, with higher scores indicating more support), Caregiver Reaction Assessment (CRA; scored 0-5, with higher scores on 4 subscales [disrupted schedule, financial problems, lack of family support, and health problems] indicating negative reactions, and higher scores on the fifth subscale [self-esteem] indicating favorable influence); and 3-item Loneliness Scale (scored 3-9, with higher scores indicating greater loneliness). Patient health-related quality of life was assessed using the University of Washington Quality of Life scale (UW-QOL; scored 0-100, with higher scores indicating better QOL). Results: Of the 96 enrolled participants, half were women (48 [50%]), and a majority were White (92 [96%]), married or living with a partner (81 [84%]), and working (51 [53%]). Of these participants, 60 (63%) completed surveys at diagnosis and at least 1 follow-up. Of the 30 caregivers, most were women (24 [80%]), White (29 [97%]), married or living with a partner (28 [93%]), and working (22 [73%]). Caregivers of nonworking patients reported higher scores on the CRA subscale for health problems than caregivers of working patients (mean difference, 0.41; 95% CI, 0.18-0.64). Caregivers of patients with UW-QOL social/emotional (S/E) subscale scores of 62 or lower at diagnosis reported increased scores on the CRA subscale for health problems (UW-QOL-S/E score of 22: CRA score mean difference, 1.12; 95% CI, 0.48-1.77; UW-QOL-S/E score of 42: CRA score mean difference, 0.74; 95% CI, 0.34-1.15; and UW-QOL-S/E score of 62: CRA score mean difference, 0.36; 95% CI, 0.14-0.59). Woman caregivers had statistically significant worsening scores on the Social Support Survey (mean difference, -9.18; 95% CI, -17.14 to -1.22). The proportion of lonely caregivers increased over treatment. Conclusions and Relevance: This cohort study highlights patient- and caregiver-specific factors that are associated with increased CGB. Results further demonstrate the potential implications for negative health outcomes for caregivers of patients who are not working and have lower health-related quality of life.

Hidden Otolaryngology Malpractice Claims: An Internal Review From 2000 to 2020.

OBJECTIVE: To report key characteristics and patterns of captive insurance claims not publicly reported in otolaryngology across a large tertiary-level academic health system over the previous 2 decades. STUDY DESIGN: Case series. SETTING: The tertiary care health system. METHODS: The internal captive insurance database at a tertiary level healthcare system was queried to identify otolaryngology-related malpractice claims regardless of final disposition (settled or dismissed) filed from 2000 to 2020. The date of the incident, date of claim, error type, patient outcome, provider subspecialty, total expenses, disposition, and final reward amount were recorded. RESULTS: Twenty-eight claims were identified. There were 11 (39.3%) claims from 2000 to 2010 and 17 (60.7%) claims from 2011 to 2020. Head and neck surgery was the most frequently implicated subspecialty (n = 9, 32.1% of all cases), followed by general otolaryngology (n = 7, 25.0%), pediatrics (n = 5, 17.9%), skull base/rhinology (n = 4, 14.3%), and laryngology (n = 1, 3.6%). Improper surgical performance was cited in 35.7% of cases (n = 10), followed by failure to diagnose (n = 8, 28.6%), to treat (n = 4, 14.3%), and to obtain informed consent (n = 3, 10.7%). While 2 cases are ongoing, a total of 17/26 (65.4%) cases were settled and 20/26 (76.9%) dismissed some or all parties. Dismissed claims had significantly higher expenses (p = .022) and duration from incident to disposition (p = .013) compared to settled claims. CONCLUSION: This study expands the malpractice landscape in otolaryngology by including data not readily available through public sources and compares it to national trends. These findings encourage otolaryngologists to better gauge current quality and safety measures that best protect patients from harm.

Health Literacy and Adherence to Clinical Recommendations in Head and Neck Cancer.

BACKGROUND: After definitive cancer treatment, survivors of head and neck cancer (HNC) are commonly recommended to participate in therapies aimed at reducing the burden of treatment-related side effects. OBJECTIVE: In this study, we evaluated whether adherence to referral to physical therapy (PT) and speech-language pathology therapy (SLPT) is related to patient health literacy (HL). METHODS: This is a retrospective cohort analysis of patients attending a multidisciplinary HNC survivorship clinic between 2017 and 2019. HL was measured using the Brief Health Literacy Screen, with scores below 10 indicating inadequate HL. Chi-square and logistic regression were used to evaluate the association between HL and adherence to PT or SLPT referral. KEY RESULTS: From the overall cohort (N = 454), 80 patients (18%) had inadequate HL. Compared to those with adequate HL, patients with inadequate HL were significantly less likely to complete initial PT evaluation (74% vs. 58%, p = .034) but were not significantly less likely to complete initial SLPT evaluation (70% vs. 61%, p = .37). After adjusting for age, primary tumor site, and treatment stage, we found that patients with inadequate HL were half as likely to follow up for initial PT evaluation (odds ratio 0.45, p = .032). CONCLUSION: Overall, inadequate HL is associated with reduced adherence to PT but is not associated with adherence to SLPT among HNC survivors. These results highlight the clinical importance of HL and underscore the need for interventions to facilitate adherence to treatment for patients with inadequate HL. [HLRP: Health Literacy Research and Practice. 2023;7(1):e52-e60.].

Impact of the COVID-19 pandemic on women's perinatal mental health and its association with personality traits: An observational study.

INTRODUCTION: The burden of perinatal mental health problems was expected to increase during the COVID-19 pandemic. We prospectively investigated the impact of the COVID-19 pandemic on the mental health of pregnant and postpartum women in Norway and explored associations with their sociodemographic characteristics and personality traits. MATERIAL AND METHODS: Sociodemographic information and the self-reported impact of pandemic on wellbeing of pregnant women was collected using an online survey. To assess women's mental health, two validated questionnaires, the Edinburgh Postpartum Depression Scale (EPDS) and the Generalized Anxiety Disorder-7 item Scale (GAD-7), were used prenatally and postnatally. Personality traits were evaluated using HumanGuide, a web-based ipsative psychological evaluation instrument. RESULTS: 772 women were included prenatally, of which 526 also responded to the survey 4-6 weeks postnatally. The median age was 29 years, 53.6% of the women were nulliparous when enrolled, and 35.1% worked in the healthcare sector. The median EPDS (6.0; interquartile range [IQR] 3.0-10.0 vs 6.0; IQR: 3.0-10.0) and the median GAD-7 (5.0; IQR 2.0-9.0 vs 5.0; IQR 2.0-9.0) were similar pre-and postnatally. Prenatally, the proportion of women scoring ≥13 on EPDS and ≥10 on GAD-7 was 14.5% (112/772) and 21.5% (166/772), whereas the postnatal figures were 15.6% (82/526) and 21.5% (113/526), respectively. The differences were not significant (P = 0.59 and P = 0.99). Being <25 years of age, being on pre-pregnancy psychotherapy or psychotropic medication, frequent voluntary isolation, perception of maternity care not proceeding normally, avoiding seeking medical assistance due to fear of infection and having negative economic consequences during the COVID19 pandemic significantly increased the risk of both anxiety (GAD-7 ≥10) and depression (EPDS ≥13). Nullipara had a higher risk of anxiety, whereas being a healthcare worker had a lower risk. The personality trait factors Power (P = 0.008), Quality (P = 0.008), Stability (P < 0.001) and Contacts (P < 0.001) were significant predictors of depression among pregnant women, whereas the Quality (P = 0.005) and Contacts (P = 0.003) were significant predictors of anxiety. CONCLUSIONS: During the initial phase of the COVID-19 pandemic, the prevalence of depression (EPDS ≥ 13) and anxiety (GAD-7 ≥ 10) was 14.5% and 21.5%, respectively, among Norwegian pregnant women. Certain sociodemographic characteristics and personality traits were significant predictors of depression and anxiety.

Association of Routine Preoperative Frailty Assessment With 1-Year Postoperative Mortality.

Importance: Patient frailty is a known risk factor for adverse outcomes following surgery, but data are limited regarding whether systemwide interventions related to frailty are associated with improved patient outcomes. Objective: To evaluate whether a frailty screening initiative (FSI) is associated with reduced late-term mortality after elective surgery. Design, Setting, and Participants: This quality improvement study with an interrupted time series analysis used data from a longitudinal cohort of patients in a multihospital, integrated health care system in the US. Beginning in July 2016, surgeons were incentivized to measure frailty with the Risk Analysis Index (RAI) for all patients considering elective surgery. Implementation of the BPA occurred in February 2018. The cutoff for data collection was May 31, 2019. Analyses were conducted between January and September 2022. Exposures: The exposure of interest was an Epic Best Practice Alert (BPA) used to identify patients with frailty (RAI ≥42) and prompt surgeons to document a frailty-informed shared decision-making process and consider additional evaluation by a multidisciplinary presurgical care clinic or the primary care physician. Main Outcomes and Measures: The primary outcome was 365-day mortality after the elective surgical procedure. Secondary outcomes included 30-day and 180-day mortality as well as the proportion of patients referred for additional evaluation based on documented frailty. Results: A total of 50 463 patients with at least 1 year of postsurgical follow-up (22 722 before intervention implementation and 27 741 after) were included (mean [SD] age, 56.7 [16.0] y; 57.6% women). Demographic characteristics, RAI score, and operative case mix, as defined by Operative Stress Score, were similar between time periods. After BPA implementation, the proportion of frail patients referred to a primary care physician and presurgical care clinic increased significantly (9.8% vs 24.6% and 1.3% vs 11.4%, respectively; both P < .001). Multivariable regression analysis demonstrated an 18% reduction in the odds of 1-year mortality (0.82; 95% CI, 0.72-0.92; P < .001). Interrupted time series models demonstrated a significant slope change in the rate of 365-day mortality from 0.12% in the preintervention period to -0.04% in the postintervention period. Among patients triggering the BPA, estimated 1-year mortality changed by -4.2% (95% CI, -6.0% to -2.4%). Conclusions and Relevance: This quality improvement study found that implementation of an RAI-based FSI was associated with increased referrals of frail patients for enhanced presurgical evaluation. These referrals translated to a survival advantage among frail patients of similar magnitude to those observed in a Veterans Affairs health care setting, providing further evidence for both the effectiveness and generalizability of FSIs incorporating the RAI.

Quality of Life in Patients With Recurrent and Second Primary Head and Neck Cancer.

OBJECTIVE: In the setting of similar outcomes, quality of life (QOL) measures can be utilized to compare treatment modalities in head and neck squamous cell carcinoma (HNSCC). We evaluate QOL and symptoms in patients treated for primary, second primary, and recurrent HNSCC. STUDY DESIGN: Retrospective cohort study. SETTING: Head and neck cancer survivorship clinic. METHODS: We identified patients seen between 2016 and 2019. QOL and symptoms were assessed with the University of Washington Quality of Life (UW-QOL) questionnaire, 10-item Eating Assessment Tool, 8-item Patient Health Questionnaire, 7-item Generalized Anxiety Disorder, and Neck Disability Index. Regression analysis was utilized to explore associations and compare QOL outcomes. RESULTS: Our cohort comprised 662 patients: 546 with primary HNSCC, 34 with second primary HNSCC, and 82 with recurrent HNSCC. Multimodality therapy was associated with lower UW-QOL Physical Subscale (UW-QOL-PS) vs single modality: chemoradiation therapy (-12.17 [95% CI, -16.57 to -7.78]) and surgery + postadjuvant treatment (-12.11 [-16.06 to -8.16]). Multimodality therapy was also associated with lower UW-QOL Social-Emotional Subscale (UW-QOL-SS): chemoradiation therapy (-6.70 [-11.41 to -1.99]) and surgery + postadjuvant treatment (-7.41 [-11.63 to -3.19]). Recurrence (-14.42 [-18.80 to -10.04]) and second primary (-11.15 [-17.71 to -4.59]) demonstrated lower UW-QOL-PS vs primary. Radiation for recurrence or second primary had worse UW-QOL-PS (-10.43 [-19.27 to -1.59]) and UW-QOL-SS (-10.58 [-18.76 to -1.54]) and higher Eating Assessment Tool (6.08 [1.39-10.77]) than surgery alone. Surgery + postadjuvant treatment showed worse UW-QOL-PS (-12.65 [-23.76 to -1.54]) and UW-QOL-SS (-12.20 [-22.38 to -2.03]). CONCLUSION: Multimodality therapy, particularly with recurrent and second primary HNSCC, is more likely to contribute to diminished QOL and symptoms. This important consideration should play a role in framing informed discussions with patients regarding treatment.

Hearing screening and amplifier uptake results in a multidisciplinary head and neck cancer survivorship clinic.

PURPOSE: Hearing loss and tinnitus are prevalent among survivors of head and neck cancer (HNC), but auditory issues are under-addressed in the survivorship literature. The purpose of this study was to describe the hearing loss and management experience of a group of survivors provided with a hearing screening and amplifier assistance if needed during their visit. METHODS: A retrospective chart review of 1176 individuals seen in the HNC Survivorship Clinic between December 2016 and October 2020 who interacted with audiology was performed. RESULTS: Of these survivors, 72% failed the 30-dB HL hearing screening at one or more frequencies. Thirty-three percent of the sample reported tinnitus. Consistent with the general population, this group has a low prevalence of hearing aid use. In this clinic, individuals who fail the hearing screening at all frequencies are offered a simple, non-custom amplifier for use during their visit. Thirty-one percent of individuals offered the amplifier used it during their Survivorship Clinic visit to enhance communication and reduce listening effort. Only 54% of individuals who failed the hearing screening self-reported hearing loss. The poor sensitivity and specificity associated with the self-perception of hearing loss data support the need for hearing screening that consists of responding to tones. Of individuals who received a recommendation for a comprehensive hearing test, 21% received a hearing test with 68% of these individuals receiving the hearing test the same day of their Survivorship Clinic visit. CONCLUSIONS: The data from 1176 survivors of HNC seen by audiology over the past few years as part of the UPMC HNC Survivorship Clinic support the need for hearing management in this population to improve communication during and after the Survivorship Clinic visit. IMPLICATIONS FOR CANCER SURVIVORS: Survivors of HNC have a high prevalence of greater than mild hearing loss and tinnitus (both issues known to negatively impact health-related communication and quality of life). This manuscript describes a hearing screening program within a Survivorship Clinic that identifies individuals in need of non-custom amplification during their appointment to support effective communication. Survivors should be referred to audiologists for evaluation and management of treatment-related issues of hearing.

A phase â ¡ prospective trial of photobiomodulation therapy in limiting oral mucositis in the treatment of locally advanced head and neck cancer patients.

Objective: This study aimed to compare the historical incidence rate of severe oral mucositis (OM) in head and neck cancer patients undergoing definitive concurrent chemoradiation therapy (CRT) versus a prospective cohort of patients with locally advanced head and neck squamous cell carcinoma (HNSCC) treated with prophylactic photobiomodulation therapy (PBMT). Methods: This US-based, institutional, single-arm, phase Ⅱ prospective clinical trial was initiated in 50 patients (age ≥ 18 years, Karnofsky Performance Scale Index > 60, with locally advanced HNSCC (excluding oral cavity) receiving definitive or adjuvant radiation therapy (RT) with concurrent platinum-based chemotherapy (CT). PBMT was delivered three times per week throughout RT utilizing both an intraoral as well extraoral delivery system. Primary outcome measure was incidence of severe OM utilizing both the National Cancer Institute Common Toxicity Criteria, version 4.0 (NCI-CTCAE) Grade ≥3 and the World Health Organization Mucositis Grading Scale (WHO) Grade ≥3 versus historical controls; secondary outcome measures included time to onset of severe OM following therapy initiation. Results: At baseline, all patients included in final analysis (N = 47) had OM Grade 0. Average RT and CT dose was (66.3 ± 5.1) Gy and (486.1 ± 106.8) mg/m2, respectively. Severe OM was observed in 11 of 47 patients (23%, confidence interval: 12, 38). OM toxicity grade trended upward during treatment, reaching a maximum at 7 weeks (WHO: 1.8 vs. NCI-CTCAE: 1.7). Subsequently, OM grade returned to baseline 3 months following completion of RT. The mean time to onset of severe OM was (35 ± 12) days. The mean time to resolution of severe OM was (37 ± 37) days. Conclusions: Compared to historical outcomes, PBMT aides in decreasing severe OM in patients with locally advanced HNSCC. PBMT represents a minimally invasive, prophylactic intervention to decrease OM as a major treatment-related side effect.

Evaluation of Neck Disability Using Computed-Tomography in Head and Neck Cancer Survivors.

Objective: We have previously reported that 55% of head and neck cancer survivors have neck disability. However, it is unclear what factors contribute to their neck disability. Our study aim is to determine if survivors with neck disability have evidence of cervical spine degenerative disease assessed by computed tomography (CT). Materials/Methods: Cross-sectional analysis of patient-reported neck disability, prospectively collected on survivors of squamous cell carcinomas without recurrence or metastasis over one-year post-treatment. Neck disability and its impact on daily life was measured using the Neck Disability Index (NDI) and compared with cervical CT scans within 6 months. Scans were evaluated for degeneration of the disc and facet of the cervical vertebrae rated on a 5-point scale where 5 indicates more severe disease. Multivariable linear regression was used to analyze the association between NDI and radiographic findings. Results: 116 survivors of oropharyngeal carcinomas were identified, predominantly male (81.9%) with an average age of 62.8 ± 8.2 (range 43.8-81.4). Most survivors had advanced stage III-IVa cancer (94.0%) with treatment modalities including surgery (n=26, 52.0%), chemotherapy (n = 45, 90.0%), and radiation therapy (n = 49, 98.0%). Absence of neck disability was observed in 44.0% of survivors, 39.7% had mild disability, and 16.4% moderate disability. The time from treatment to clinic visit was an average of 3.1 ± 2.7 years (range 1.1-13.4). Multivariable analysis of NDI controlling for age, time since treatment, and treatment modality identified an inverse association between NDI and spinal degenerative disease examining cervical discs (-1.46 95% confidence interval (CI) [-2.86, -0.06], p = 0.041) and age (-0.24 95% CI[-0.40, -0.08], p = 0.004). Conclusions: Our study shows that neck impairment and pain in head and neck cancer survivors is not sufficiently explained by cervical degeneration related to age or trauma, supporting the theory that post-treatment neck disability occurs as a side effect of treatment. These results support the further assessment of structure and function of cervical musculature and degeneration following HNC treatment.

Definitive local therapy to head and neck squamous cell carcinoma with distant metastasis.

Objectives: Data on the efficacy of including definitive local therapy to the primary site for head and neck squamous cell carcinoma (HNSCC) patients with synchronous distant metastasis are lacking. In multiple different solid tumor types, there has been benefit when using systemic therapy followed by local consolidative therapy (stereotactic ablative radiotherapy or surgery) directed at metastases. We proposed to retrospectively evaluate patients at our institution that received definitive treatment to the primary. Methods: Single institution retrospective study evaluating 40 patients with metastatic HNSCC treated with definitive surgery (55%) or chemoradiation (45%) to the primary site from 2000 to 2020. The major endpoints were overall survival (OS) and progression-free survival (PFS) for the total population and multiple sub-groups. Some variables were evaluated with multiple covariates Cox model. Results: The median PFS was 8.6 months (95% CI, 6.4-11.6), and OS was 14.2 months (95% CI, 10.9-27.5). In 28% of patients that received induction therapy, there was a twofold increase in median overall survival to 27.5 months. In the 33% of patients that received anti-PD-1 mAb as part of their treatment course, the median OS was significantly increased to 41.7 months (95% CI, 8.7-NR) versus 12.1 months (95% CI, 8.4-14.4) with a 5-year OS of 39%. Multivariate analysis for OS showed significance for age at diagnosis, use of IO, and number of metastatic sites. Conclusion: We observed impressive survival outcomes in metastatic HNSCC patients treated with definitive local therapy to the primary site in addition to induction and/or immunotherapy. Further study is warranted.Level of Evidence: 3.

Flourishing in head and neck cancer survivors.

BACKGROUND: There is a growing cohort of head and neck cancer (HNC) patients affected by late- and long-term posttreatment side effects. Our study evaluates the relationship between the demographics, clinical characteristics, and posttreatment symptom burden with the subjective sense of flourishing among HNC survivors. METHODS: A cross-sectional, single-center study of adult survivors of squamous cell cancer of the oral cavity, oropharynx, and larynx/hypopharynx who completed the Secure Flourishing Index (SFI) and patient-reported outcomes related to depression, anxiety, swallowing dysfunction, neck disability, and insomnia between November 2020 and April 2021. RESULTS: A total of 100, predominantly male (86%), survivors with an average age of 63.0 ± 9.6 were included in the study. Univariable analysis showed a significant association between higher flourishing scores and advanced age (95% CI: [0.011, 0.84], p = 0.0441), normal diet (95% CI: [5.79, 31.18], p = 0.0149), employment (95% CI: [1.24, 17.20], p = 0.0239), higher income (95% CI: [7.30, 27.72], p = 0.0248), and decreased reported difficulty paying for needs (95% CI: [-33.46, -18.88], p < 0.001). Flourishing was inversely associated with higher symptoms of depression (95% CI: [-2.23, -1.15], p < 0.001), anxiety (95% CI: [-1.92,-0.86], p < 0.001), swallowing dysfunction (95% CI: [-0.77, -0.26], p < 0.001), neck disability (95% CI: [-1.05, -0.35], p < 0.001), and insomnia (95% CI: [-1.12, -0.22], p = 0.004) in the multivariable analysis. CONCLUSIONS: Common late- and long-term side effects of HNC treatment and financial hardship are associated with lower levels of flourishing or a more negative perception of life after treatment. Results highlight the importance of symptom burden for survivors' overall evaluation of their quality of life.

The impact of frailty on mortality in non-surgical head and neck cancer treatment: Shifting the clinical paradigm.

OBJECTIVE: Compare survival of head and neck cancer (HNC) patients treated with surgical or non-surgical management according to frailty, quantify frailty with the Risk Analysis Index (RAI), a validated 14-item instrument. MATERIALS AND METHODS: Prospective cohort study of newly diagnosed HNC patients (≥18 years) who had frailty assessment from April 13, 2016 to September 30, 2016. Primary outcome was overall survival at 1- and 3-years. Cox proportional hazard models were utilized to examine mortality with predictor variables. Adjusted and unadjusted (Kaplan-Meier) survival curves stratified by either RAI scores or treatment modality were plotted. Kruskal-Wallis and likelihood ratio chi-square tests were used for comparing clinicodemographic variables. RESULTS: Of 165 patients, 54 (32.7%) were managed non-surgically, 49 (29.7%) were treated with definitive surgery only, and 62 (37.6%) were treated with multimodality (surgery + adjuvant) therapy. Among the full cohort and subgroup analysis of the frail/very frail (RAI ≥ 37), non-surgical patients had worse or similar 3-year survival than those treated with surgery +/- adjuvant therapy. Multivariable Cox proportional hazard models demonstrate that frail patients treated non-surgically experienced worse survival than their counterparts treated with surgery (HR = 2.50, p = 0.015, 95% CI: 1.19, 5.23) or multimodality therapy (HR = 3.91, p < 0.001, 95% CI: 1.94-7.89). CONCLUSION: Across all levels of frailty, long term survival of HNC patients treated without surgery is either worse than or like those treated with surgery. These findings (1) challenge current practices of steering patients "too frail for surgery" towards non-surgical, "non-invasive" therapy, and (2) suggest equipoise warranting randomized trials to clarify treatment of frail patients.