A Preliminary Validation of an Optimal Cutpoint in Total Number of Patient-Reported Symptoms in Head and Neck Cancer for Effective Alignment of Clinical Resources with Patients' Symptom Burden.

Background: Patients with head and neck cancer (HNC) often experience high symptom burden leading to lower quality of life (QoL). Objective: This study aims to conceptually model optimal cutpoint by examining where total number of patient-reported symptoms exceeds patients' coping capacity, leading to a decline in QoL in patients with HNC. Methods: Secondary data analysis of 105 individuals with HNC enrolled in a clinical usefulness study of the NYU Electronic Patient Visit Assessment (ePVA)©, a digital patient-reported symptom measure. Patients completed ePVA and European Organization for Research and Treatment of Cancer (EORTC©) QLQ-C30 v3.0. The total number of patient-reported symptoms was the sum of symptoms as identified by the ePVA questionnaire. Analysis of variance (ANOVA) was used to define optimal cutpoint. Results: Study participants had a mean age of 61.5, were primarily male (67.6%), and had Stage IV HNC (53.3%). The cutpoint of 10 symptoms was associated with significant decline of QoL (F= 44.8, P<.0001), dividing the population into categories of low symptom burden (< 10 symptoms) and high symptom burden (≥ 10 symptoms). Analyses of EORTC© function subscales supported the validity of 10 symptoms as the optimal cutpoint (Physical: F=28.3, P<.0001; Role: F=21.6, P<.0001; Emotional: F=9.5, P=.003; Social: F=33.1, P<.0001). Conclusions: In HNC, defining optimal cutpoints in the total number of patient-reported symptoms is feasible. Implications for Practice: Cutpoints in the total number of patient-reported symptoms may identify patients experiencing a high symptom burden from HNC. Foundational: Using optimal cutpoints of the total number of patient-reported symptoms may help effectively align clinical resources with patients' symptom burden.

A numbers game: Mosquito-based arbovirus surveillance in two distinct geographic regions of Latin America.

Aedes mosquitoes, as vectors of medically important arthropod-borne viruses (arboviruses), constitute a major public health threat that requires entomological and epidemiological surveillance to guide vector control programs to prevent and reduce disease transmission. In this study, we present the collaborative effort of one year of mosquito-based arbovirus surveillance in two geographically distinct regions of Latin America (Nicaragua and Ecuador). Adult female mosquitoes were collected using backpack aspirators in over 2,800 randomly selected households (Nicaragua, Ecuador) and 100 key sites (Nicaragua) from eight distinct communities (Nicaragua: 2, Ecuador: 6). A total of 1,358 mosquito female pools were processed for RNA extraction and viral RNA detection using real-time RT-PCR. Ten positive dengue virus (DENV) pools were detected (3 in Nicaragua and 7 in Ecuador), all of which were found during the rainy season and matched the serotypes found in humans (Nicaragua: DENV-1 and DENV-4; Ecuador: DENV-2). Infection rates ranged from 1.13 to 23.13, with the Nicaraguan communities having the lowest infection rates. Our results demonstrate the feasibility of detecting DENV-infected Aedes mosquitoes in low-resource settings and underscore the need for targeted mosquito arbovirus sampling and testing, providing valuable insights for future surveillance programs in the Latin American region.

The usefulness of the Electronic Patient Visit Assessment (ePVA)© as a clinical support tool for real-time interventions in head and neck cancer.

BACKGROUND: Patients with head and neck cancer (HNC) experience painful, debilitating symptoms and functional limitations that can interrupt cancer treatment, and decrease their health-related quality of life (HRQoL). The Electronic Patient Visit Assessment (ePVA) for head and neck is a web-based mHealth patient-reported measure that asks questions about 21 categories of symptoms and functional limitations common to HNC. This article presents the development and usefulness of the ePVA as a clinical support tool for real-time interventions for patient-reported symptoms and functional limitations in HNC. METHODS: Between January 2018 and August 2019, 75 participants were enrolled in a clinical usefulness study of the ePVA. Upon signing informed consent, participants completed the ePVA and the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) general (C30) questionnaire v3.0 (scores range from 0 to 100 with 100 representing best HRQoL). Clinical usefulness of the ePVA was defined as demonstration of reliability, convergent validity with HRQoL, and acceptability of the ePVA (i.e., >70% of eligible participants complete the ePVA at two or more visits and >70% of ePVA reports are read by providers). Formal focus group discussions with the interdisciplinary team that cared for patients with HNC guided the development of the ePVA as a clinical support tool. Qualitative and quantitative methods were used throughout the study. Descriptive statistics consisting of means and frequencies, Pearson correlation coefficient, and Student's t-tests were calculated using SAS 9.4 and STATA. RESULTS: The participants were primarily male (71%), White (76%), diagnosed with oropharyngeal or oral cavity cancers (53%), and undergoing treatment for HNC (69%). Data analyses supported the reliability (alpha =0.85), convergent validity with HRQoL scores, and acceptability of the ePVA. Participants with the highest number of symptoms and functional limitations reported significantly worse HRQoL (sum of symptoms: r=-0.50, P<0.0001; sum of function limitations: r=-0.56, P<0.0001). Ninety-two percent of participants (59 of 64) who had follow-up visits within the 6-month study period completed the ePVA at two or more visits and providers read 89% (169 of 189) of automated ePVA reports. The use of the ePVA as a clinical support tool for real-time interventions for symptoms and functional limitations reported by patients is described in a clinical exemplar. CONCLUSIONS: This research indicates that the ePVA may be a useful mHealth tool as a clinical support tool for real-time interventions for patient-reported symptoms and functional limitations in HNC. The study findings support future translational research to enhance the usefulness of the ePVA in real world settings for early interventions that decrease symptom burden and improve the QoL of patients with HNC.

The development, usability, and reliability of the Electronic Patient Visit Assessment (ePVA) for head and neck cancer.

BACKGROUND: Annually, over 65,000 persons are diagnosed with head and neck cancer in the United States. During treatment, up to 50% of patients become severely symptomatic with pain, fatigue, mouth sores, and inability to eat. Long term complications are lymphedema, fibrosis, dysphagia, and musculoskeletal impairment. Patients' ability to perform daily activities and to interact socially may be impaired, resulting in poor quality of life. A pragmatic, clinically useful assessment is needed to ensure early detection and intervention for patients to report symptoms and functional limitations over time. We developed the Electronic Patient Visit Assessment (ePVA) that enables patients to report 42 symptoms related to head and neck cancer and 17 limitations of functional status. This manuscript reports (I) the development of the ePVA, (II) the content validity of the ePVA, and (III) the usability and reliability of the ePVA. METHODS: Usability was evaluated using the "Think Aloud" technique to guide the iterative process to refine the ePVA based on participants' evaluations. After signing the informed consent, 30 participants with head and neck cancer completed the ePVA using digital tablet devices while thinking aloud about ease of use. All patient conversations were recorded and professionally transcribed. Reliability of the ePVA symptom and functional limitation measures was estimated using the Kuder-Richardson test. Convergent validity of the ePVA was evaluated using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 global QoL/health scale. Transcribed qualitative data were analyzed using directed content analysis approach. Quantitative analyses consisted of descriptive statistics and correlation analyses. RESULTS: Among participants, 90% strongly agreed or agreed that the ePVA system was easy to use and 80% were very satisfied. Only minor usability problems were reported due to formatting and software "bugs". Reporting of usability problems decreased in frequency over the study period and no usability problems were reported by the last 3 participants who completed the ePVA. Based on participants' suggestions during the iterative process, refinement of the ePVA included increased touch sensitivity of the touch screen technology and customized error messages to improve ease of use. The ePVA also recorded patient reported symptoms (mouth symptoms: 93%, fibrosis: 60%, fatigue: 60%). The ePVA demonstrated acceptable reliability (alpha =0.82-0.85) and convergent validity (ePVA total number of reported symptoms and function limitations was negatively correlated with EORTC QLQ-C30 global QOL/health scale: r=-0.55038, P<0.01). CONCLUSIONS: The ePVA was rigorously developed, accepted by patients with satisfaction, and demonstrated acceptable reliability and convergent validity. Future research will use data generated by the ePVA to determine the impact of symptom trajectories on functional status, treatment interruptions and terminations, and health resource use in head and neck cancer.

Reconstruction of expanding tracheoesophageal fistulae in post-radiation therapy patients who undergo total laryngectomy with a bipaddled radial forearm free flap: Report of 8 cases.

BACKGROUND: Our surgical approach describes a bipaddled radial forearm free flap (RFFF) for closure of chronic tracheoesophageal fistulae (TEF) in patients who underwent total laryngectomy. The desired functional results were achieved. METHODS: Eight patients underwent the procedure. The surgical approach includes exposure and resection of the fistula tract, and a bipaddled RFFF transfer. Key surgical maneuvers include: circumferential dissection and mobilization of the trachea; partial sternal resection in select cases; inset of flap's distal paddle into the anterior esophageal wall; and inset of the proximal skin paddle to the posterior tracheal wall and cervical skin. RESULTS: Successful reconstruction of all 8 cases was done to restore a normal diet and a widely patent tracheal opening. One patient developed a delayed esophageal stricture, which was successfully managed with home dilation. CONCLUSION: Several TEF treatment approaches have been reported. Our 87.5% esophageal lumen preservation success rate, reestablishment of adequate airway, and uncomplicated postoperative courses demonstrates the reliability of this surgical approach. © 2015 Wiley Periodicals, Inc. Head Neck 38: E172-E178, 2016.

Staged laryngeal reconstruction with a prefabricated flap for radiation recurrent glottic carcinoma.

OBJECTIVES/HYPOTHESIS: Although salvage total laryngectomy remains the definitive approach to recurrent/persistent glottic cancer following failed radiation therapy for favorable early-stage disease, it comes at the price of a permanent laryngostome and an impact on quality of life. We describe a three-stage method of laryngeal reconstruction for salvage partial laryngectomy to address the unique challenges of operating on radiation recurrent/persistent cancer. STUDY DESIGN: This was a single-surgeon retrospective case series of patients who underwent a three-stage laryngeal reconstruction for salvage partial laryngectomy. METHODS: We performed a comprehensive review of the clinical, pathologic, and radiologic files of all patients who underwent a three-stage laryngeal reconstruction for salvage partial laryngectomy. RESULTS: Seven male patients underwent a three-stage laryngeal reconstruction following open partial salvage laryngectomy. The average follow-up time since salvage surgery was 55 months. All patients were without evidence of recurrence and demonstrated satisfactory functional outcomes. CONCLUSION: Staged reconstruction provides a more controlled assessment of wound healing and valuable pathologic information regarding the specific disease virulence and adequacy of the margins. LEVEL OF EVIDENCE: 4. Laryngoscope, 126:1061-1070, 2016.

A survey of variables used by speech-language pathologists to assess function and predict functional recovery in oral cancer patients.

Oromotor and clinical swallow assessments are routinely performed by speech-language pathologists (SLPs) who see head and neck cancer (HNC) patients. However, the tools used to assess some of these variables vary. SLPs routinely identify and quantify abnormal functioning in order to rehabilitate the patient. However, function in terms of tongue range of motion (ROM) is typically described using a subjective severity rating scale. The primary objective of this study was to gain insight via survey into what variables SLPs consider important in assessing and documenting function after HNC treatment. A second objective was to seek feedback regarding a scale designed by the authors for assessing tongue ROM for this cohort of patients. This survey also was developed to elucidate salient factors that might have an impact on the prognosis for speech and swallow outcomes. Of the 1,816 SLPs who were sent the survey, 292 responded who work with HNC patients. Results revealed that although 95 % of SLPs assess tongue strength, only 13 % use instrumental methods. Although 98 % assess tongue ROM, 88 % estimate ROM based on clinical assessment. The majority of respondents agreed with the utility of the proposed tongue ROM rating scale. Several variables were identified by respondents as having an impact on overall prognosis for speech and swallow functioning. Tracking progress and change in function with treatment can be accomplished only with measurable assessment techniques. Furthermore, a consistent measuring system can benefit patients with other diagnoses that affect lingual mobility and strength.

Hypopharyngeal pharyngoplasty in the management of pharyngeal paralysis: a new procedure.

Dysphagia after a high vagal nerve injury may be associated with a patulous hypopharynx that serves as a reservoir for pharyngeal secretions, contributing to primary or secondary aspiration. We describe a new hypopharyngeal pharyngoplasty procedure for the paralyzed pharynx to improve swallow. The paralyzed pyriform sinus is resected to remove insensate and redundant mucosa. The inferior constrictor muscle is then advanced anterior to the oblique line of the thyroid cartilage to improve pharyngeal tone and prevent pharyngeal dilatation. The surgery is performed in conjunction with medialization laryngoplasty and arytenoid adduction. The utility of this procedure is reviewed retrospectively in 8 patients. They were evaluated by clinical evaluation, fiberoptic endoscopic evaluation of swallow, and modified barium swallow study. All had significant preoperative dysphagia. Three patients were gastrostomy tube-dependent. After operation, all patients had subjective and objective improvements in swallow and progressed to peroral feeding. There were no operative complications. We conclude that hypopharyngeal pharyngoplasty diminishes pyriform sinus pooling and improves pharyngeal transit. Dysphagia patients with unilateral pharyngeal paralysis secondary to cranial nerve palsies may benefit from this new procedure.

Comparison of functional and quality-of-life outcomes in patients with and without palatomaxillary reconstruction: a preliminary report.

BACKGROUND: Orodental rehabilitation of hemipalatomaxillectomy defects can be accomplished by using a prosthetic obturator or a vascularized bone-containing free flap. Whereas prosthetic obturation offers several advantages, including the opportunity for immediate dental restoration without the need for further surgery, vascularized bone grafts provide permanent closure of the oronasal communication and bone sufficient for the placement of osseointegrated implants. OBJECTIVE: To compare the functional and quality-of-life (QOL) outcomes in patients rehabilitated with a prosthetic obturator with defect-matched patients who underwent reconstruction with a vascularized bone-containing free flap. METHODS: Four hemipalatomaxillectomy patients rehabilitated with a tissue-borne prosthetic obturator were compared with 4 defect-matched hemipalatomaxillectomy patients who underwent reconstruction with a vascularized bone-containing free flap. All of the patients were objectively assessed for speech, mastication, and QOL. Functional status was assessed by mastication testing, voice analysis, and nasorhinometry. Swallowing-related QOL was assessed using a patient-reported, validated swallowing QOL questionnaire, and donor site morbidity was assessed using upper extremity and lower extremity questionnaires. RESULTS: Patients who underwent reconstruction with a vascularized bone-containing free flap achieved higher mastication and speech assessment scores with less oronasal reflux than defect-matched patients rehabilitated with a prosthetic obturator. Swallowing QOL and donor site assessments demonstrated that compared with their prosthetic counterparts, reconstruction patients enjoyed a better QOL without incurring significant donor site morbidity. CONCLUSIONS: Although palatomaxillary reconstruction with vascularized bone-containing free flaps requires a second operative site, this method of orodental rehabilitation of the hemipalatomaxillectomy defect can achieve superior functional and QOL outcomes relative to defect-matched patients rehabilitated with a prosthetic obturator.