A protocol for stakeholder engagement in head and neck cancer pragmatic trials.

Meaningful engagement with stakeholders in research demands intentional approaches. This paper describes the development of a framework to guide stakeholder engagement as research partners in a pragmatic trial proposed to evaluate behavioral interventions for dysphagia in head and neck cancer patients. We highlight the core principles of stakeholder engagement including representation of all perspectives, meaningful participation, respectful partnership with stakeholders, and accountability to stakeholders; and describe how these principles were operationalized to engage relevant stakeholders throughout the course of a large clinical trial.

Accuracy of Dysphagia Screening by Non-clinical Research Staff in the Emergency Department.

Although the emergency department (ED) is the initial care setting for the majority of older adults requiring hospital admission, there is a paucity of ED-based dysphagia research in this at-risk population. This is driven by barriers to dysphagia evaluation in this complex care environment. Therefore, we assessed the reliability of trained, non-clinical ED research staff in administering dysphagia screening tools compared to trained speech pathologists (SLPs). We also aimed to determine perceptual screening discrepancies (e.g. voice change) between clinical and non-clinical staff. Forty-two older adults with suspected pneumonia were recruited during an ED visit and underwent dysphagia (Toronto Bedside Swallow Screening Tool; TOR-BSST©) and aspiration (3-oz water swallow test; 3-oz WST) screening by trained non-clinical research staff. Audio-recordings of screenings were re-rated post-hoc by trained, blinded SLPs with discrepancies resolved via consensus. Cohen's kappa (unweighted) revealed moderate agreement in pass/fail ratings between clinical and non-clinical staff for both the TOR-BSST© (k = 0.75) and the 3 oz WST (k = 0.66) corresponding to excellent sensitivity and good specificity for both the TOR-BSST (SN = 94%, SP = 85%) and the 3 oz WST (SN = 90%, SP = 81%). Further analysis of TOR-BSST perceptual parameters revealed that most discrepancies between clinicians and non-clinicians resulted from over-diagnosis of change in vocal quality (53%). These results support the feasibility of non-clinical research staff administering screening tools for dysphagia and aspiration in the ED. Dysphagia screening may not necessitate clinical staff involvement, which may improve feasibility of large-scale ED research. Future training of research staff should focus on perceptual assessment of vocal quality.

Telemedicine-enabled biofeedback electropalatography rehabilitation (TEBER): A pilot study for patients treated with surgery for oral cavity carcinoma.

BACKGROUND: To address the rehabilitative barriers to frequency and precision of care, we conducted a pilot study of a biofeedback electropalatography (EPG) device paired with telemedicine for patients who underwent primary surgery +/- adjuvant radiation for oral cavity carcinoma. We hypothesized that lingual optimization followed by telemedicine-enabled biofeedback electropalatography rehabilitation (TEBER) would further improve speech and swallowing outcomes after "standard-of-care" SOC rehabilitation. METHOD: Pilot prospective 8-week (TEBER) program following 8 weeks of (SOC) rehabilitation. RESULTS: Twenty-seven patients were included and 11 completed the protocol. When examining the benefit of TEBER independent of standard of care, "range-of-liquids" improved by +0.36 [95% CI, 0.02-0.70, p = 0.05] and "range-of-solids" improved by +0.73 [95% CI, 0.12-1.34, p = 0.03]. There was a positive trend toward better oral cavity obliteration; residual volume decreased by -1.2 [95% CI, -2.45 to 0.053, p = 0.06], and "nutritional-mode" increased by +0.55 [95% CI, -0.15 to 1.24, p = 0.08]. CONCLUSION: This pilot suggests that TEBER bolsters oral rehabilitation after 8 weeks of SOC lingual range of motion.

Transoral Robotic Surgery and Radiation Volume Deintensification in Unknown Primary Squamous Cell Carcinoma of the Neck: The Phase 2 FIND Nonrandomized Controlled Trial.

Importance: Patients with unknown primary squamous cell carcinoma (CUP) with cervical metastases typically receive comprehensive radiotherapy (RT) of the pharynx and bilateral neck. Typically, these patients receive comprehensive RT of the pharynx and bilateral neck that may produce treatment-related toxic effects. Objective: To determine whether localization of occult oropharyngeal cancers with transoral robotic surgery (TORS) combined with reduced pharyngeal and neck RT volumes provides acceptable disease control. Design, Setting, and Participants: This phase 2, single-group nonrandomized controlled trial at a single institution accrued 32 prospective participants with p16-positive CUP without a primary squamous cell carcinoma on examination and imaging from 2017 to 2019, and 24-month follow-up. The data analysis was conducted from January 2021 to June 2022. Intervention: Diagnostic- (n = 13) or therapeutic-intent (n = 9) TORS, with pharyngeal-sparing radiotherapy (PSRT) prescribed for negative margins or pT0, and unilateral neck RT (UNRT) prescribed for unilateral lymphadenopathy with lateralized primary tumor or pT0. Main Outcomes and Measures: Out-of-radiation treatment volume failure (<15% was hypothesized to be acceptable) and reports of local and regional recurrence, overall survival, toxic effects, swallowing outcomes (per the MD Anderson Dysphagia Inventory), and videofluoroscopic swallow (per Dynamic Imaging Grade of Swallowing Toxic Effects [DIGEST]) ratings. Results: The study sample comprised 22 patients (mean [SD] age, 59.1 [5.7] years; 3 [14%] females and 19 [86%] male) with CUP. Of these, 19 patients (86%) had tumor stage cN1; 2 (9%), cN2; and 1 (5%), cN3. Five patients (23%), 14 patients (64%), and 3 patients (13%) had 0, 1, or 2 primary tumors, respectively. Twenty patients received RT; of these, 9 patients (45%) underwent PSRT and 10 patients (50%), UNRT. In the diagnostic-intent group, 8 patients (62%) and 5 patients (38%) underwent RT and RT-concurrent chemotherapy, respectively. In the therapeutic-intent group, 6 patients (67%) and 1 patient (11%) received adjuvant RT-concurrent chemotherapy, respectively; 2 patients declined RT. Two-year out-of-radiation treatment volume failure, locoregional control, distant metastasis control, and overall survival were 0%, 100%, 95%, and 100%, respectively. Grade 3 or 4 surgical, acute, and late toxic effects occurred in 2 (9%), 5 (23%), and 1 (5%) patients, respectively. PSRT was associated with lower RT dose to superior constrictors (37 vs 53 Gy; mean difference, 16 Gy; 95% CI, 6.4, 24.9), smaller decline in swallowing scores during treatment (19.3 vs 39.7; mean difference, -20.4; 95% CI, -34.1 to -6.1), and fewer patients with worsening DIGEST grade on findings of videofluoroscopic swallow studies at 2 years (0% vs 60%; difference, 60%; 95% CI, 30% to 90%). Conclusions and Relevance: These findings indicate that TORS for p16-positive CUP allows RT volume deintensification with excellent outcomes and support future investigation in randomized clinical trials. Trial Registration: ClinicalTrials.gov Identifier: NCT03281499.

The Quantification of Radiation Fibrosis Using Clinically Indicated Magnetic Resonance Imaging for Head and Neck Cancer Patients.

Currently, no objective method exists to measure the extent of fibrosis in swallowing musculature in head and neck cancer (HNC) patients. We developed and psychometrically tested a method of quantifying fibrosis volume using magnetic resonance imaging (MRI). The overall aim of this study was to determine if clinical MRI is a reliable tool to measure fibrosis of the pharyngeal musculature in patients with HNC managed with RT and to assess its potential to capture changes in fibrosis over time. Eligible participants were adults with HNC treated with radiation therapy (RT) who received minimally two MRIs and videofluoroscopic swallow (VFS) studies from baseline (pre-RT) up to 1-year post-RT. Two neuroradiologists independently contoured fibrosis volume in batches from MRIs using Vitrea™. Sufficient inter-rater reliability was set at Intraclass Correlation Coefficient (ICC) > 0.75. Two speech-language pathologists independently rated VFSs for swallowing impairment using standardized scales, with discrepancies resolved by consensus. MRI and VFS scores were correlated using Spearman's rank coefficient. Participants included 42 adults (male = 33); mean age 59 (SD = 8.8). ICC (95% Confidence Interval) for fibrosis volume was 0.34 (0, 0.76) for batch one and 0.43 (0, 0.82) for batch two. Consensus meetings were held after each batch. Sufficient reliability was reached by batch three (ICC = 0.95 (0.79, 0.99)). Fibrosis volume increased significantly from 3 to 12 months (mean change = 1.28 mL (SD = 5.21), p = 0.006), as did pharyngeal impairment from baseline to 12 months (mean score change = 3.05 (SD = 3.02), p = 0.003). Fibrosis volume moderately correlated with pharyngeal impairment at 3 and 12 months (0.49, p = 0.004 and 0.59, p = 0.005, respectively). We demonstrated a reliable measure of fibrosis volume in swallowing musculature from existing clinical MRIs and identified that larger fibrosis volume was associated with worse swallowing function. The reliable capture of fibrosis volume offers a pragmatic method for early detection of fibrosis and concomitant dysphagia.

A pilot observation using ultrasonography and vowel articulation to investigate the influence of suspected obstructive sleep apnea on upper airway.

Failure to employ suitable measures before administering full anesthesia to patients with obstructive sleep apnea (OSA) who are undergoing surgery may lead to developing complications after surgery. Therefore, it is very important to screen OSA before performing a surgery, which is currently done by subjective questionnaires such as STOP-Bang, Berlin scores. These questionnaires have 10-36% specificity in detecting sleep apnea, along with no information given on anatomy of upper airway, which is important for intubation. To address these challenges, we performed a pilot study to understand the utility of ultrasonography and vowel articulation in screening OSA. Our objective was to investigate the influence of OSA risk factors in vowel articulation through ultrasonography and acoustic features analysis. To accomplish this, we recruited 18 individuals with no risk of OSA and 13 individuals with high risk of OSA and asked them to utter vowels, such as /a/ (as in "Sah"), /e/ (as in "See"). An expert ultra-sonographer measured the parasagittal anterior-posterior (PAP) and transverse diameter of the upper airway. From the recorded vowel sounds, we extracted 106 features, including power, pitch, formant, and Mel frequency cepstral coefficients (MFCC). We analyzed the variation of the PAP diameters and vowel features from "See: /i/" to "Sah /a/" between control and OSA groups by two-way repeated measures ANOVA. We found that, there was a variation of upper airway diameter from "See" to "Sah" was significantly smaller in OSA group than control group (OSA: ∆12.8 ± 5.3 mm vs. control: ∆22.5 ± 3.9 mm OSA, p < 0.01). Moreover, we found several vowel features showed the exact same or opposite trend as PAP diameter variation, which led us to build a machine learning model to estimate PAP diameter from vowel features. We found a correlation coefficient of 0.75 between the estimated and measured PAP diameter after applying four estimation models and combining their output with a random forest model, which showed the feasibility of using acoustic features of vowel sounds to monitor upper airway diameter. Overall, this study has proven the concept that ultrasonography and vowel sounds analysis may be useful as an easily accessible imaging tool of upper airway.

Patient-reported outcome measures for dysphagia in head and neck cancer: A systematic review and appraisal of content validity and internal structure.

Dysphagia is a major head and neck cancer (HNC) issue. Dysphagia-related patient-reported outcome measures (PROMs) are critical for patient-centred assessment and intervention tailoring. This systematic review aimed to derive a comprehensive inventory of HNC dysphagia PROMs and appraise their content validity and internal structure. Six electronic databases were searched to February 2023 for studies detailing PROM content validity or internal structure. Eligible PROMs were those developed or validated for HNC, with ≥20% of items related to swallowing. Two independent raters screened citations and full-text articles. Critical appraisal followed COSMIN guidelines. Overall, 114 studies were included, yielding 39 PROMs (17 dysphagia-specific and 22 generic). Of included studies, 33 addressed PROM content validity and 78 internal structure. Of all PROMs, only the SOAL met COSMIN standards for both sufficient content validity and internal structure. Notably, the development of 18 PROMs predated the publication of COSMIN standards. In conclusion, this review identified 39 PROMs addressing dysphagia in HNC, of which only one met COSMIN quality criteria. Given that half of PROMs were developed prior to COSMIN guidelines, future application of current standards is needed to establish their psychometric quality.

A core outcome set for patient-reported dysphagia for use in head and neck cancer clinical trials: An international multistakeholder Delphi study.

BACKGROUND: Measuring dysphagia-related patient-reported outcomes (PROs) in Head and Neck Cancer (HNC) patients is challenging due to dysphagia's multidimensional impact, causing inconsistency in outcome reporting. To address this issue, this study derived a consensus-based core outcome set (COS) for patient-reported dysphagia in HNC clinical trials where swallowing is a primary or secondary endpoint. METHODS: A sample of HNC clinicians, researchers, patients, and caregivers participated in a 2-Round Delphi technique. A Delphi survey, containing a comprehensive list of dysphagia-related PROs, was developed. In Round 1, participants rated item importance on a 5-point scale. Items rated ≥4 by >70% advanced to Round 2, where a consensus meeting addressed items with varied opinions, and the Delphi survey with remaining items was completed. Items rated ≥4 by >70% formed the final COS. RESULTS: Forty-five participants from nine countries were recruited. After Round 1, 40 items were excluded and 64 advanced to Round 2. After Round 2, a 7-outcome COS was established, comprising the domains of dysphagia symptoms, health status and quality of life. CONCLUSION: This study achieved consensus among HNC stakeholders on essential dysphagia PROs for HNC clinical trials. It is advisable to include these 7-core concepts in clinical trials involving people with HNC to facilitate treatment comparisons and data synthesis.

Shared Neuroanatomical Substrates for Co-occurring Swallowing and Communication Impairments after Acute Stroke.

INTRODUCTION: Post-stroke dysphagia and communication impairments occur in two-thirds of acute stroke survivors. Identifying the shared neuroanatomical substrate for related impairments could facilitate the development of cross-system therapies. Our purpose was to elucidate discrete brain regions predictive of the combined presence of dysphagia alongside dysarthria and/or aphasia post-stroke. METHODS: We included 40 right (RHS) and 67 left hemisphere (LHS) patients from an acute ischemic stroke cohort with lesions demarcated on diffusion weighted imaging. We undertook binary non-parametric voxel-lesion symptom mapping with a false discovery rate of p <0.05 for co-occurring dysphagia, dysarthria, and aphasia (LHS only). If no voxels survived the threshold, a cluster analysis of >20 voxels involving an uncorrected p <0.01 was applied to identify brain regions associated with the co-occurring impairments. RESULTS: Cluster analyses revealed that dysphagia and dysarthria were associated with insular and superior temporal gyrus (STG) involvement after RHS and with basal ganglia (BG), internal capsule, and thalamic involvement after LHS. Co-occurring dysphagia, dysarthria, and aphasia were associated with BG, STG, and insular cortex involvement. DISCUSSION: Our findings highlight the role of the insula and structures of the BG in co-occurrence patterns involving dysphagia, dysarthria, and aphasia. These newly identified biomarkers may inform new rehabilitation therapeutic targets for treating cross-system functions.

Efficacy of the Rehabilitation Planning Consult for Survivors of Head and Neck Cancer: A Phase 2 Randomized Controlled Trial.

PURPOSE: Survivors of head and neck cancer may have significant lasting impairments and poor access to rehabilitation. To address this, our group developed and evaluated a rehabilitation planning consult (RPC). The RPC is conducted through an initial consultation and a single follow-up session with a rehabilitation professional. During the initial consultation, rehabilitation needs are determined and the survivor sets individualized goals and plans. They then implement their plans independently and are facilitated to evaluate and modify plans as necessary during the follow-up session. METHODS AND MATERIALS: We used a waitlist control design to compare the proportion of participants attaining a minimally importantly different change in quality of life (QOL) on the Short Form 36 Physical Health Summary Score from baseline to 3 months after study enrollment, between patients randomized to receive (n = 77) or wait 14 ± 3 weeks to receive (n = 76) the RPC. Additional outcomes included goal attainment indicators measured using the Brief Rehabilitation Assessment for Survivors of Head and Neck Cancer (BRASH). RESULTS: Of 153 participants recruited, 95 (62%) completed the intervention; 57 were in the immediate (RPC) group and 38 were in the waiting list control (WLC) group. No significant between-group differences were seen in the proportion of patients achieving a minimally important improvement (2.5 units) on the Physical Health Summary Score from baseline to 3 months after recruitment. No between-group differences were seen on any secondary QOL indicators. Among the 67 (RPC n = 42, WLC n = 22) participants who set individualized rehabilitation goals, BRASH scores on goal performance and satisfaction with goal performance were significantly better in the RPC group. CONCLUSIONS: Our results suggest that the RPC may provide benefit in patients' individualized domains of choice among those who set goals, without affecting overall QOL. Future work could refine the subset of patients who benefit and explore the optimal timing and intensity of the intervention.

The Acceptability of Behavioural Swallowing Interventions for Head and Neck Cancer Patients During Radiotherapy: A Qualitative Study Exploring Experiences of Clinical Trial Speech-Language Pathologists.

The PRO-ACTIVE randomized clinical trial offers 3 swallowing therapies to Head and Neck Cancer (HNC) patients during radiotherapy (RT) namely: reactive, proactive low- ("EAT-RT" only) and high-intensity ("EAT-RT + exercises"). Understanding the experiences of the trial Speech-Language Pathologists (SLPs) will be useful to inform clinical implementation. This study assessed SLP opinions of acceptability and clinical feasibility of the 3 trial therapies. 8 SLPs from 3 Canadian PRO-ACTIVE trial sites participated in individual interviews. Using a qualitative approach, data collection and thematic analysis were guided by the Theoretical Framework of Acceptability. Member checking was conducted through a follow-up focus group with willing participants. Seven themes were derived: intervention coherence, burden, barriers/facilitators, self-efficacy, attitude, ethicality, and perceived effectiveness. SLPs felt all 3 therapies had potential benefit yet perceived more advantages of proactive therapies compared to reactive. Compared to exercises, SLPs particularly endorsed the EAT-RT component. A major barrier was keeping patients motivated, which was impacted by acute toxicity and sometimes conflicting instructions from the healthcare team. Strategies utilized by to overcome barriers included: scaling exercises and/or diet up/down according to the changing patient needs and communicating therapy goals with healthcare team. A model was derived describing the perceived acceptability of the swallowing therapies according to SLPs, based on the interconnection of main themes. Proactive therapies were perceived as more acceptable to trial SLPs, for facilitating patient engagement. The perceived acceptability of the swallowing therapies was related to seven interconnected aspects of providers' experience. These findings will inform the implementation and potential uptake of the PRO-ACTIVE swallowing therapies in clinical practice.

Exploring the Acceptability of Behavioral Swallowing Interventions for Head and Neck Cancer Patients During Radiotherapy: A Qualitative Study of Patients' Experience.

The PRO-ACTIVE randomized clinical trial offers 3 swallowing therapies to Head and Neck Cancer (HNC) patients during radiotherapy namely: reactive, proactive low- ("EAT-RT" only), and high-intensity ("EAT-RT + exercises"). Understanding the perceived acceptability of these interventions is important to inform eventual implementation into clinical practice. This study explored patients' perspectives using qualitative methodology. At 2 Canadian PRO-ACTIVE trial sites, 24 trial participants were recruited for individual semi-structured interviews, representing each of the 3 trial arms. Data collection and thematic analysis were guided by the Theoretical Framework of Acceptability (TFA). Member checking was conducted through follow-up focus groups. Seven themes were derived reflecting the TFA constructs. Overall, regardless of trial arm, patients reported a positive experience with therapy. Patients identified benefits of EAT-RT therapy, reporting that it provided meaningful feedback on diet progress and supported goal setting for oral intake. Patients who received proactive therapies valued the opportunity to set expectations early, build mealtime routine iteratively over time, and have an extended engagement with the SLP. Regardless of trial arm, patients agreed proactive therapy aligned with what they think is best and that therapy intensity should accommodate individual needs. This study identified the value to HNC patients of receiving swallowing interventions during RT and setting realistic expectations around swallowing. Compared to reactive care, proactive therapies were perceived helpful in consolidating habits early, establishing realistic expectations around swallowing and building an extended rapport with the SLP. These findings will inform the implementation of proactive versus reactive swallowing therapies in clinical practice.

Amyotrophic Lateral Sclerosis-Bulbar Dysfunction Index-Remote: Test-Retest and Interrater Reliability of Candidate Items.

PURPOSE: The primary aim of this study was to establish the reliability of candidate items as a step in the development of the Amyotrophic Lateral Sclerosis-Bulbar Dysfunction Index-Remote (ALS-BDI-Remote), a novel tool being developed for the detection and monitoring of bulbar signs and symptoms in remote settings. METHOD: The set of candidate items included 40 items covering three domains: cranial nerve examination, auditory-perceptual evaluation, and functional assessment. Forty-eight participants diagnosed with ALS and exhibiting a range of bulbar disease severity were included. Data collection for each participant took place on Zoom over three sessions. During Session 1, the participants were instructed to adjust their Zoom settings and to optimize their recording environment (e.g., lighting, background noise). Their cognition and eating were screened to determine their ability to follow instructions and their eligibility to perform the swallowing and chewing tasks. During Session 2, two speech-language pathologists (SLPs) administered the tool consecutively to determine the items' interrater reliability. During Session 3, one of the SLPs readministered the tool within 2 weeks of Session 1 to assess test-retest reliability. The reliability of each item was estimated using weighted kappa and the percentage of agreement. To be considered reliable, the items had to reach a threshold of 0.5 weighted kappa or 80% percentage agreement (if skewed distribution of the scores) for both interrater and test-retest reliability. RESULTS: In total, 33 of the 40 candidate items reached the reliability cutoff for both reliability analyses. All assessment domains included reliable items. Items requiring very good visualization of structures or movements were generally less reliable. CONCLUSIONS: This study resulted in the selection of reliable items to be included in the next version of the ALS-BDI-Remote, which will undergo psychometric evaluation (reliability, validity, and responsiveness analyses). Additionally, the results contributed to our understanding of the remote administration of SLP assessments for telehealth applications.

Changes in Cardiac Function During a Swallow Exercise Program in Patients with Coronary Artery Disease.

Research regarding risks of swallow treatment suggests that patients with coronary artery disease (CAD) experience changes in heart rate/rhythm when completing the supraglottic swallow and super-supraglottic swallow. The current study evaluated cardiac function during multiple swallowing exercises in patients with dysphagia and CAD. Eligible patients had CAD and confirmed pharyngeal dysphagia from VFS and sufficient cognitive ability to follow direction. The protocol included an a priori concealed randomized order of seven swallowing exercises (supraglottic swallow, super-supraglottic swallow, Mendelsohn and Masako maneuvers, effortful swallow with and without breath hold, and jaw opening exercise). Objective measures of heart rate/rhythm, oxygen saturation, and blood pressure were compared before vs after the overall session and each exercise using the Wilcoxon signed-rank test, and McNemar's and Cochran's Q tests with alpha at 0.05 and power at 0.80. Participants were 20 adults (15 male), aged 28-88 (median 76.5 years). 90% were intubated during their hospital stay (44% > 1 intubation) and 20% suffered post-op stroke. Severe dysphagia, marked by NPO status, occurred in 30% of patients. Sessions were 26 min long (mean; SD = 2.29). With few exceptions, objective measures were stable pre vs post overall and after each exercise. Potential vulnerability was noted with increased heart rate after the super-supraglottic swallow and increased arrhythmias after the effortful swallow (p < 0.05 for both). The order that swallowing exercises were completed did not significantly impact cardiovascular function. Telemetry and pulse oximetry proved to be feasible tools to monitor for subtle changes in cardiovascular function during completion of swallowing exercises.

Generating Items for a Novel Bedside Dysphagia Screening Tool Post Acute Pediatric Stroke.

Bedside dysphagia assessment protocols are not well developed in acute pediatric stroke unlike adults. The objective of this study was to identify items deemed relevant and feasible by expert consensus to inform the development of a bedside dysphagia screening tool for acute pediatric stroke. A two-phase study was conducted: (1) literature review and expert consultation generated a comprehensive list of dysphagia assessment items; (2) items were formatted in an online survey asking respondents opinion of relevance to acute pediatric stroke and feasibility for bedside administration by a trained health professional. The Dillman Tailored Design approach optimized response rate. Respondents were identified using the snowball method. Speech-language pathologists with > 2 years in pediatric dysphagia were invited to complete the survey. Demographic and practice variables were compared using univariate statistics. Item relevance and feasibility were made using binary or ordinal responses, combined to derive item-content validity indices (I-CVI) to guide item reduction. Items with I-CVI > 0.78 (excellent content validity) were moved forward to tool development. Of the 71 invited respondents, 57(80.3%) responded, of which 34(59.6%) were from North America. Sixty-one items were generated of which 4(6.6%) items were rated 'to keep'. These were face symmetry (I-CVI:0.89), salivary control (I-CVI:0.95), alertness (I-CVI:0.89) and choking (I-CVI:0.84). Of all respondents, 31(54.4%) endorsed swallowing trials, of which 25(80.6%) endorsed thin liquid by teaspoon (n = 17, 68%) or open cup (n = 20, 80%). We identified candidate items for bedside dysphagia screening with excellent content validity for acute pediatric stroke patients. Next steps include assessment of the psychometric value of each item in identifying dysphagia in children in the acute stage of recovery from stroke.

Adhering to Eat and Exercise Status During Radiotherapy for Oropharyngeal Cancer for Prevention and Mitigation of Radiotherapy-Associated Dysphagia.

Importance: Previously published work reported independent benefit of maintenance of oral intake (eat) and swallowing exercise adherence (exercise) during radiotherapy (RT) on diet and functional outcomes. The current study seeks to validate the authors' previously published findings in a large contemporary cohort of patients with oropharynx cancer (OPC) and address limitations of the prior retrospective study using prospective, validated outcome measures. Objective: To examine the longitudinal association of oral intake and swallowing exercise using validated, clinician-graded and patient-reported outcomes. Design, Setting, and Participants: Secondary analysis of a prospective OPC registry including patients who underwent primary RT/chemoradiotherapy (CRT) or primary transoral robotic surgery plus RT/CRT for OPC at a single-institution comprehensive cancer center. Exposures: Adherence to speech pathology swallowing intervention during RT coded as (1) eat: oral intake at end of RT (nothing by mouth [NPO]; partial oral intake [PO], with feeding tube [FT] supplement; full PO); and (2) exercise: swallowing exercise adherence (nonadherent vs partial/full adherence). Main Outcomes and Measures: Feeding tube and diet (Performance Status Scale for Head and Neck Cancer) patient-reported swallowing-related quality of life (MD Anderson Dysphagia Inventory; MDADI) and clinician-graded dysphagia severity grade (videofluoroscopic Dynamic Imaging Grade of Swallowing Toxicity; DIGEST) were collected at baseline, 3 to 6 months, and 18 to 24 months post-RT. Results: A total of 595 patients (mean [SD] age, 65 [10] years; 532 [89%] male) who underwent primary RT (111 of 595 [19%]), CRT (434 of 595 [73%]), or primary transoral robotic surgery plus RT/CRT (50 of 595 [8%]) were included in this cohort study. At the end of RT, 55 (9%) patients were NPO, 115 (19%) were partial PO, 425 (71%) were full PO, and 340 (57%) reported exercise adherence. After multivariate adjustment, subacute return to solid diet and FT were independently associated with oral intake (odds ratio [OR], 2.0; 95% CI, 1.0-4.1; OR, 0.1; 95% CI, 0.0-0.2, respectively) and exercise (OR, 2.9; 95% CI, 1.9-4.5; OR, 0.3; 95% CI, 0.1-0.5, respectively). Subacute MDADI (ß = 6.5; 95% CI, 1.8-11.2), FT duration (days; ß = -123.4; 95% CI, -148.5 to -98.4), and less severe dysphagia per DIGEST (OR, 0.6; 95% CI, 0.3-1.0) were independently associated with oral intake, while exercise was independently associated with less severe laryngeal penetration/aspiration per DIGEST-safety (OR, 0.7; 95% CI, 0.4-1.0). DIGEST grade associations with oral intake were not preserved long-term; however, exercise was associated with a higher likelihood of solid diet intake and better swallow safety per DIGEST. Conclusions and Relevance: The findings of this cohort study extend the authors' previously published findings that oral intake and swallowing exercise during RT are associated with favorable functional outcomes, now demonstrated with broader domains of function using validated measures. Patterns of benefit differed in this study. Specifically, better subacute recovery of swallow-related quality of life and less severe dysphagia were found among patients who maintained oral intake independent of exercise adherence, and shorter FT utilization and better long-term diet and swallowing safety were found among those who exercised independent of oral intake.

Every Story Is Different: Experiences With Body Changes Related to Cancer.

One of the important aspects of stakeholder engagement in cancer care and system planning is hearing from individuals who have been diagnosed with cancer about the impact of the diagnosis and treatment on their lives. Hearing stories from the perspectives of cancer survivors offers opportunity to gain new insight and understanding about experiences of being diagnosed and treated for cancer. This article presents ten short narratives about survivors' perspectives on body image and cancer. Each story is unique but, taken together, the picture they create is one of facing challenges, discovering personal resilience, and moving forward to engage in living. The stories emphasize the importance of communication and support from healthcare providers and understanding needs for a person-centered cancer care system.

Dysphagia is a strong predictor of death and functional dependence at three months post-stroke / Disfagia é um forte preditor de morte e dependência funcional três meses após acidente vascular cerebral

ABSTRACT Background: Few Brazilian studies investigated risk factors for dysphagia and associated complications in a large cohort. Objective: To investigate frequency, predictors, and associated outcomes of dysphagia in patients up to three months post-stroke. Methods: Prospective cohort study of consecutively admitted patients in a specialized center for acute stroke. Patients with a transient ischemic attack, subarachnoid hemorrhage, cerebral venous thrombosis, hemorrhagic stroke with secondary cause, non-acute stroke, or those who did not consent to participate were excluded. Swallowing was evaluated by speech language pathologists using Volume-Viscosity Swallow Test. General function at three months post-stroke was assessed using the following instruments: Modified Rankin scale, Barthel Index and Functional Independence Measure. Results: A total of 831 patients were admitted and 305 patients were included according to the inclusion and exclusion criteria. The mean age of patients was 63.6±13.3 years, mean time from stroke to swallowing assessment was 4.2±4.1 days, and 45.2% of the patients had dysphagia. Age (OR=1.02; 95%CI 1.00-1.04; p=0.017), known medical history of obstructive sleep apnea (OR=5.13; 95%CI 1.74-15.15; p=0.003), and stroke severity at hospital admission (OR=1.10; 95%CI 1.06-1.15; p<0.001) were independently associated with dysphagia. Dysphagia (OR=3.78; 95%CI 2.16-6.61; p<0.001) and stroke severity (OR=1.05; 95%CI 1.00-1.09; p=0.024) were independently associated with death or functional dependence at three months. Conclusions: Dysphagia was present in almost half of stroke patients. Age, obstructive sleep apnea, and stroke severity were predictors of dysphagia, which was independently associated with death or functional dependence at three months.

RESUMO Antecedentes: Poucos estudos brasileiros investigaram fatores de risco para disfagia e suas complicações associadas em uma grande coorte. Objetivo: Investigar frequência, preditores e desfechos associados da disfagia em pacientes até três meses após acidente vascular cerebral (AVC). Métodos: Selecionamos pacientes admitidos consecutivamente em um centro especializado em AVC agudo. Excluímos pacientes com ataque isquêmico transitório, hemorragia subaracnóidea, trombose venosa cerebral, AVC hemorrágico de causa secundária, AVC não agudo ou aqueles que não consentiram em participar. A deglutição foi avaliada por fonoaudiólogos, por meio do teste de deglutição de volume-viscosidade. A função geral foi avaliada usando-se escala de Rankin modificada, índice de Barthel e medida de independência funcional. Resultados: Foram admitidos 831 pacientes e incluídos 305. A idade média foi 63,6±13,3 anos, o tempo médio da avaliação foi 4,2±4,1 dias e 45,2% apresentavam disfagia. Idade (razão de chances [OR] 1,02; intervalo de confiança [IC95%] 1,00-1,04; p=0,017), história médica conhecida de apneia obstrutiva do sono (OR=5,13; IC95% 1,74-15,15; p=0,003) e gravidade do AVC na admissão hospitalar (OR=1,10; IC95% 1,06-1,15; p<0,001) foram independentemente associados à disfagia. Disfagia (OR=3,78; IC95% 2,16-6,61; p<0,001) e gravidade do AVC (OR=1,05; IC95% 1,00-1,09; p=0,024) foram independentemente associadas com morte ou dependência funcional em três meses. Conclusões: A disfagia esteve presente em quase metade dos pacientes com AVC. Idade, apneia obstrutiva do sono e gravidade do AVC foram preditores de disfagia, que esteve independentemente associada com morte ou dependência funcional em três meses.

Protocol for psychometric evaluation of the Amyotrophic Lateral Sclerosis - Bulbar Dysfunction Index (ALS-BDI): a prospective longitudinal study.

INTRODUCTION: Early detection and tracking of bulbar dysfunction in amyotrophic lateral sclerosis (ALS) are critical for directing management of the disease. Current clinical bulbar assessment tools are lacking, while existing physiological instrumental assessments are often inaccessible and cost-prohibitive for clinical application. The goal of our research is to develop and validate a brief and reliable, clinician-administered assessment tool-the ALS-Bulbar Dysfunction Index (ALS-BDI). This publication describes the study protocol that has been established to ascertain the tools' psychometric properties. METHODS AND ANALYSIS: The ALD-BDI's development closely follows guidelines outlined by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). Through the proposed study protocol, we expect to establish psychometric properties of both individual test items of the ALS-BDI as well as the final version of the entire tool, including test-retest and inter-rater reliability, construct validity using gold-standard assessment methods and responsiveness. ETHICS AND DISSEMINATION: This study has been reviewed and approved by research ethics boards at two data collection sites: Sunnybrook Health Science Centre, primary (Toronto, Canada; ID3080) and Mass General Brigham (#2013P001746, Boston, USA). Prior to participation in the study, the participants sign the informed consent in accordance with the Declaration of Helsinki. Once validated, the ALS-BDI will be disseminated to key stakeholders. Following validation, the ALS-BDI and any required training material will be implemented for clinical use in a context of a multidisciplinary ALS clinic and used as an outcome measure for clinical trials in ALS research.

Psychometric properties of patient-reported outcome measures for dysphagia in head and neck cancer: a systematic review protocol using COSMIN methodology.

BACKGROUND: Dysphagia (swallowing difficulty) is one of the most common and debilitating sequelae of head and neck cancer (HNC). Patient-reported outcome measures (PROMs) are a fundamental component of dysphagia outcomes evaluation, as they inform treatment consequences that cannot be captured by objective clinician measures. Many PROMs for dysphagia in HNC are available, but their validity is unclear. As a consequence, the selection of the most appropriate PROM for dysphagia in HNC is complex and often based on the clinician's personal preferences, rather than on valid psychometric properties. This protocol describes a systematic review aiming at (1) identifying PROMs specific to dysphagia symptoms, swallowing functional status, swallowing-related health status, and swallowing-related quality of life in HNC, (2) mapping them to our conceptual framework of dysphagia-related PROs, and (3) appraising their psychometric properties using the Consensus Based Standards for the Selection of Health Measurement Instrument (COSMIN) methodology. METHODS: Six electronic databases will be searched from inception to December 2020 for all primary studies in any language and design detailing PROM development, reliability, validity, feasibility, interpretability, and/or cross-cultural adaptation. Eligibility criteria will target PROMs for patients with HNC (≥ 90% of the study sample) with ≥ 20% of their items pertaining to swallowing. Two independent raters will screen abstract and full texts and a third rater will resolve discrepancies. Data will be extracted on study, sample and PROM characteristics, and results of psychometric testing. PROMs will be mapped to our conceptual framework. The methodological quality of included PROMs and their psychometric properties will be appraised using the COSMIN risk of bias checklist and evidence will be summarized using a modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. DISCUSSION: This systematic review will provide a summary of existing dysphagia-related PROMs for people with HNC and a comprehensive account of their psychometric properties. We will provide recommendations on PROMs selection which will aid healthcare professionals to the most appropriate PROM based on its validity, reliability, feasibility, interpretability and suitability for clinical and research settings. Further recommendations will be made on areas of measurement property requiring further testing. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration ID: CRD42021237877.