Confidence, Accuracy, and Reliability of Penetration-Aspiration Scale Ratings on Flexible Endoscopic Evaluations of Swallowing by Speech Pathologists.

This study investigated rater confidence when rating airway invasion with the penetration-aspiration scale (PAS) on flexible endoscopic evaluations of swallowing (FEES), raters' accuracy against a referent-standard, inter-rater reliability, and potential associations between clinician confidence, experience, and accuracy. Thirty-one clinicians who use FEES in their daily practice were asked to judge airway invasion with the PAS and to rate their confidence that their score was correct (0-100) for 40 video clips, five in each of the 8 PAS categories. We found that raters were most confident in rating PAS 1, 7, and 8. The average confidence score across all videos was 76/100. Confidence did not have a significant relationship with accuracy against the referent-standard. Accuracy was highest for PAS 1 (92%), followed by PAS 8 (80%), PAS 7 (77%), and PAS 4 (72%). Accuracy was below 60% for PAS 2, 3, 5, and 6, the lowest being for PAS 3 (49%). Mean accuracy for all ratings, compared to referent-standard ratings, was highest for the intermediate group (71%), followed by expert (68%) and novice (65%). In general, we found that certain PAS scores tend to be rated more accurately, and that participating SLPs had varied confidence in PAS ratings on FEES. Potential reasons for these findings as well as suggested next steps are discussed.

A systematic review and meta-analysis of neuromodulators to treat chronic airway hypersensitivity.

OBJECTIVES: Chronic laryngitis can present with numerous symptoms, including chronic cough. Patients who do not respond to standard treatment are sometimes diagnosed with chronic airway hypersensitivity (CAH). In many centers, neuromodulators are prescribed off-label despite limited evidence of efficacy. A previous meta-analysis suggested neuromodulator therapy improved cough-related quality-of-life (QoL). This current updated and expanded meta-analysis examined whether neuromodulators reduced cough frequency, reduced cough severity, and/or improved QoL in CAH patients. DATA SOURCES: PubMed, Embase, Medline, Cochrane Review, and publication bibliographies were searched from 01/01/2000 to 07/31/2021 using MESH terms. REVIEW METHODS: PRISMA guidelines were followed. 999 abstracts were identified/screened, 28 studies were fully reviewed, and 3 met inclusion criteria. Only randomized controlled trials (RCT) investigating CAH patients with comparable cough-related outcomes were included. Three authors reviewed potentially eligible papers. Fixed-effect models and calculated pooled estimates using the Inverse-Variance method were used. RESULTS: The estimated difference in change in log coughs per hour (from baseline to intervention end) between treatment and control groups was -0.46, 95%CI [-0.97; 0.05]. Estimated change-from-baseline in VAS scores was -12.24, 95 % CI [-17.84; -6.65] lower for patients who received treatment vs placebo. Estimated change-from-baseline for LCQ scores was 2.15, 95 % CI [1.49-2.80] higher for patients who receive treatment vs placebo. Only change in LCQ score was clinically significant. CONCLUSIONS: This study tentatively suggests that neuromodulators have the potential to reduce cough symptoms associated with CAH. However, high-quality evidence is lacking. This could be due to limited treatment effect or significant limitations in the design and comparability of existing trials. A well-designed and properly powered RCT is needed to authoritatively test the efficacy of neuromodulators for the treatment of CAH. LEVEL OF EVIDENCE: Level I, evidence from a systematic review or meta-analysis of all relevant RCTs (randomized controlled trial) or evidence-based clinical practice guidelines based on systematic reviews of RCTs or three or more RCTs of good quality that have similar results.

Correlating muscle resection with functional swallow outcomes: An anatomic framework informed systematic review of the literature.

OBJECTIVE: To perform a systematic review of studies reporting swallow-associated outcomes in patients who received surgery for head and neck cancer (HNC), informed by an anatomic and physiologic framework of pharyngeal phase of swallowing (Pearson's dual-sling model). METHODS: PUBMED and Google Scholar databases were searched for peer-reviewed papers published between 1990 and 2019 using relevant MeSH terms. Exclusion criteria were 1) discussions comparing reconstruction techniques, 2) case-report/series (n < 10), 3) perspective articles, 4) papers comparing objective instrumental methods of swallowing evaluation, 5) animal/cadaver studies, 6) no instrumental or validated swallow assessment tools used, 7) papers that discuss/include radiotherapy treatment, 8) systematic reviews, 9) papers that discuss swallow training or rehabilitation methods. Two investigators reviewed papers meeting inclusion/exclusions criteria. Muscles resected, anatomic resection site, swallow outcomes, and patient treatment variables were collected. RESULTS: A total of 115,020 peer-reviewed papers were identified. 74 papers were relevant to this review, 18 met inclusion and exclusion criteria, and none discussed surgical impact on the pharyngeal phase of swallowing using Pearson's dual-sling model. Most papers discussed the effect of tongue-base, supraglottic, or regional anatomic resection. Post-surgical resection Follow-up times ranged from 1 to 13 months. 67% of studies used objective instrumental swallow studies; 22% used patient reported outcome measures. Follow up time since surgical resection, time to feeding tube removal, feeding tube present/absent, aspiration severity were used to define dysphagia endpoints. CONCLUSIONS: To date, no surgical HNC studies have used the dual-sling mechanism to guide study design, and dysphagia assessment has been inconsistent. To counsel patients on the effects of surgery on pharyngeal phase of swallow function, specialists need physiologically grounded research that correlates muscles resected with consistent measures of swallow function.

Abnormalities of Aspiration and Swallowing Function in Survivors of Acute Respiratory Failure.

The mechanisms responsible for aspiration are relatively unknown in patients recovering from acute respiratory failure (ARF) who required mechanical ventilation. Though many conditions may contribute to swallowing dysfunction, alterations in laryngeal structure and swallowing function likely play a role in the development of aspiration. At four university-based tertiary medical centers, we conducted a prospective cohort study of ARF patients who required intensive care and mechanical ventilation for at least 48 h. Within 72 h after extubation, a Fiberoptic Flexible Endoscopic Evaluation of Swallowing (FEES) examination was performed. Univariate and multivariable analyses examined the relationship between laryngeal structure and swallowing function abnormalities. Aspiration was the primary outcome, defined as a Penetration- Aspiration Scale (PAS) score of 6 or greater. Two other salient signs of dysphagia-spillage and residue-were secondary outcomes. A total of 213 patients were included in the final analysis. Aspiration was detected in 70 patients (33%) on at least one bolus. The most commonly aspirated consistency was thin liquids (27%). In univariate analyses, several abnormalities in laryngeal anatomy and structural movement were significantly associated with aspiration, spillage, and residue. In a multivariable analysis, the only variables that remained significant with aspiration were pharyngeal weakness (Odds ratio = 2.57, 95%CI = 1.16-5.84, p = 0.019) and upper airway edema (Odds ratio = 3.24, 95%CI = 1.44-7.66, p = 0.004). These results demonstrated that dysphagia in ARF survivors is multifactorial and characterized by both anatomic and physiologic abnormalities. These findings may have important implications for the development of novel interventions to treat dysphagia in ARF survivors.Clinical Trials Registration ClinicalTrials.gov Identifier: NCT02363686, Aspiration in Acute Respiratory Failure Survivors.

The Association Between Endotracheal Tube Size and Aspiration (During Flexible Endoscopic Evaluation of Swallowing) in Acute Respiratory Failure Survivors.

OBJECTIVES: To determine whether a modifiable risk factor, endotracheal tube size, is associated with the diagnosis of postextubation aspiration in survivors of acute respiratory failure. DESIGN: Prospective cohort study. SETTING: ICUs at four academic tertiary care medical centers. PATIENTS: Two hundred ten patients who were at least 18 years old, admitted to an ICU, and mechanically ventilated with an endotracheal tube for longer than 48 hours were enrolled. INTERVENTIONS: Within 72 hours of extubation, all patients received a flexible endoscopic evaluation of swallowing examination that entailed administration of ice, thin liquid, thick liquid, puree, and cracker boluses. Patient demographics, treatment variables, and hospital outcomes were abstracted from the patient's medical records. Endotracheal tube size was independently selected by the patient's treating physicians. MEASUREMENTS AND MAIN RESULTS: For each flexible endoscopic evaluation of swallowing examination, laryngeal pathology was evaluated, and for each bolus, a Penetration Aspiration Scale score was assigned. Aspiration (Penetration Aspiration Scale score ≥ 6) was further categorized into nonsilent aspiration (Penetration Aspiration Scale score = 6 or 7) and silent aspiration (Penetration Aspiration Scale score = 8). One third of patients (n = 68) aspirated (Penetration Aspiration Scale score ≥ 6) on at least one bolus, 13.6% (n = 29) exhibited silent aspiration, and 23.8% (n = 50) exhibited nonsilent aspiration. In a multivariable analysis, endotracheal tube size (≤ 7.5 vs ≥ 8.0) was significantly associated with patients exhibiting any aspiration (Penetration Aspiration Scale score ≥ 6) (p = 0.016; odds ratio = 2.17; 95% CI 1.14-4.13) and with risk of developing laryngeal granulation tissue (p = 0.02). CONCLUSIONS: Larger endotracheal tube size was associated with increased risk of aspiration and laryngeal granulation tissue. Using smaller endotracheal tubes may reduce the risk of postextubation aspiration.

Relationship Between Laryngeal Sensation, Length of Intubation, and Aspiration in Patients with Acute Respiratory Failure.

Dysphagia is common in hospitalized patients post-extubation and associated with poor outcomes. Laryngeal sensation is critical for airway protection and safe swallowing. However, current understanding of the relationship between laryngeal sensation and aspiration in post-extubation populations is limited. Acute respiratory failure patients requiring intensive care unit admission and mechanical ventilation received a Flexible Endoscopic Evaluation of Swallowing (FEES) within 72 h of extubation. Univariate and multivariable analyses were performed to examine the relationship between laryngeal sensation, length of intubation, and aspiration. Secondary outcomes included pharyngolaryngeal secretions, pneumonia, and diet recommendations. One-hundred and three patients met inclusion criteria. Fifty-one patients demonstrated an absent laryngeal adductor reflex (LAR). Altered laryngeal sensation correlated with the presence of secretions (p = 0.004). There was a significant interaction between the LAR, aspiration, and duration of mechanical ventilation. Altered laryngeal sensation was significantly associated with aspiration on FEES only in patients with a shorter length of intubation (p = 0.008). Patients with altered laryngeal sensation were prescribed significantly more restricted liquid (p = 0.03) and solid (p = 0.001) diets. No relationship was found between laryngeal sensation and pneumonia. There is a high prevalence of laryngeal sensory deficits in mechanically ventilated patients post-extubation. Altered laryngeal sensation was associated with secretions, aspiration, and modified diet recommendations especially in those patients with a shorter length of mechanical ventilation. These results demonstrate that laryngeal sensory abnormalities impact the development of post-extubation dysphagia.

Emergency Airway Response Team (EART) Documentation: Criteria, Feasibility, and Usability.

Patients in an acute care hospital who experience a difficult airway event outside the operating room need a specialized emergency airway response team (EART) immediately. This designated team manages catastrophic airway events using advanced airway techniques as well as surgical intervention. Nurses respond as part of this team. There are no identified difficult airway team documentation instruments in the literature, and the lack of metrics limits the quality review of the team response. This study identified EART documentation criteria and incorporated them into a nursing documentation instrument to be completed by a nurse scribe during the event. The EART instrument was tested by nurses for usability, feasibility, and completeness. Twenty-one critical care nurses participated in this study. The results confirmed good usability, positive feasibility, and 79% documentation completeness using this tool. These criteria and this instrument can be important in documenting the EART and in evaluating the quality of the team performance.

Impact of Compliance on Dysphagia Rehabilitation in Head and Neck Cancer Patients: Results from a Multi-center Clinical Trial.

A 5-year, 16-site, randomized controlled trial enrolled 170 HNC survivors into active (estim + swallow exercise) or control (sham estim + swallowing exercise) arms. Primary analyses showed that estim did not enhance swallowing exercises. This secondary analysis determined if/how patient compliance impacted outcomes. A home program, performed 2 times/day, 6 days/week, for 12 weeks included stretches and 60 swallows paired with real or sham estim. Regular clinic visits ensured proper exercise execution, and detailed therapy checklists tracked patient compliance which was defined by mean number of sessions performed per week (0-12 times) over the 12-week intervention period. "Compliant" was defined as performing 10-12 sessions/week. Outcomes were changes in PAS, HNCI, PSS, OPSE, and hyoid excursion. ANCOVA analyses determined if outcomes differed between real/sham and compliant/noncompliant groups after 12 weeks of therapy. Of the 170 patients enrolled, 153 patients had compliance data. The mean number of sessions performed was 8.57/week (median = 10.25). Fifty-four percent of patients (n = 83) were considered "compliant." After 12 weeks of therapy, compliant patients in the sham estim group realized significantly better PAS scores than compliant patients in the active estim group (p = 0.0074). When pooling all patients together, there were no significant differences in outcomes between compliant and non-compliant patients. The addition of estim to swallowing exercises resulted in worse swallowing outcomes than exercises alone, which was more pronounced in compliant patients. Since neither compliant nor non-compliant patients benefitted from swallowing exercises, the proper dose and/or efficacy of swallowing exercises must also be questioned in this patient population.

Nurse Residency Program Designed for a Large Cohort of New Graduate Nurses: Implementation and Outcomes.

A nurse residency program was designed to train a large group of new graduate nurses hired into multiple specialty areas. The program included a generalist 1 month 5 day/week clinical orientation followed by specialty clinical orientation with ongoing generalist education. Retention rate after 1 year was 91%.

A Novel In Vivo Protocol for Molecular Study of Radiation-Induced Fibrosis in Head and Neck Cancer Patients.

OBJECTIVES: Radiation-induced fibrosis is a common complication for patients following head and neck cancer treatment. This study presents a novel minimally invasive protocol for molecular study of fibrosis in the stromal tissues. METHODS: Subjects with radiation-induced fibrosis in the head and neck who were at least 6 months post treatment received submental core needle biopsies, followed by molecular processing and quantification of gene expression for 14 select pro-inflammatory and pro-fibrotic genes. Control biopsies from the upper arm were obtained from the same subjects. Patients were followed up at 1 and 2 weeks to monitor for safety and adverse outcomes. RESULTS: Six subjects were enrolled and completed the study. No subjects experienced adverse outcomes or complication. An 18 gauge core biopsy needle with a 10 mm notch inserted for up to 60 seconds was needed. Subcutaneous tissue yielded 3 ng of RNA, amplified to 6 µg of cDNA, allowing for adequately sensitive quantitative polymerase chain reaction (qPCR) analysis of approximately 28 genes. CONCLUSIONS: This study demonstrates the safety and utility of a novel technique for the molecular study of fibrosis in head and neck cancer patients. Longitudinal studies of patients undergoing radiation therapy will allow for identification of molecular targets that contribute to the process of fibrosis in the head and neck.

A comparison of 2 methods of endoscopic laryngeal sensory testing: a preliminary study.

OBJECTIVE: This study examined the association between laryngeal sensory deficits and penetration or aspiration. Two methods of testing laryngeal sensation were carried out to determine which was more highly correlated with Penetration-Aspiration Scale (PAS) scores. METHODS: Healthy participants and patients with dysphagia received an endoscopic swallowing evaluation including 2 sequential laryngeal sensory tests-air pulse followed by touch method. Normal/impaired responses were correlated with PAS scores. RESULTS: Fourteen participants completed the endoscopic swallowing evaluation and both sensory tests. The air pulse method identified sensory impairment with greater frequency than the touch method (P<.0001). However, the impairment identified by the air pulse method was not associated with abnormal PAS scores (P=.46). The sensory deficits identified by the touch method were associated with abnormal PAS scores (P=.05). CONCLUSION: Sensory impairment detected by the air pulse method does not appear to be associated with risk of penetration/aspiration. Significant laryngeal sensory loss revealed by the touch method is associated with compromised airway protection.

Effect of Lidocaine on Swallowing During FEES in Patients With Dysphagia.

PURPOSE: The aims of this study were to assess the effects of 0.2 mL of 4% atomized lidocaine on swallowing and tolerability during Fiberoptic Endoscopic Evaluation of Swallowing (FEES). METHODS: A single blinded study was conducted with 17 dysphagic patients, who received 4 standardized boluses in 2 sequential FEES exams under 2 conditions: non-anesthetized (decongestant only) and anesthetized (lidocaine 4%+decongestant). After each procedure, patients rated their pain on the Wong Baker FACES Pain Rating Scale. Clinicians scored each swallow with the Penetration Aspiration Scale (PAS) and an author-developed Residue Rating Scale. Because the assessments were ordinal, a series of Wilcoxon signed-rank tests were conducted to detect differences between the 2 conditions. RESULTS: No significant differences were detected between groups on PAS or residue in the 4 boluses. Pain scores, however, were significantly lower in the anesthetized condition than the decongested-only condition (P=.035). CONCLUSION: The findings of this study indicated that 0.2 mL of 4% lidocaine enhanced exam tolerability and did not impair the swallow in dysphagic patients.

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.

Implementing Dysphagia Outcome Assessments into Clinical Settings: Leveraging Principles of Implementation, Dissemination, and Psychometrics.

PURPOSE: Myriad dysphagia assessment tools have been designed, but their application is variable. This is partly due to a lack of implementation and dissemination strategy as well as to limited guidance regarding which instruments are optimally designed and best used for clinical and research applications. METHOD: This tutorial provides a high-level overview of implementation and dissemination, their interaction with psychometrics and knowledge coproduction, and how these concepts relate to proper development and widespread application of contextually relevant, psychometrically optimized, evidence-based dysphagia assessment instruments. RESULTS: A review of the literature identified two dysphagia assessment instruments that purposefully integrated implementation and dissemination processes after measurement development. Application of knowledge coproduction was not identified in any papers reporting development and testing of dysphagia assessment instruments. A better understanding of coproduction and psychometrics when developing measures, while simultaneously applying implementation science and dissemination strategies, can result in the development of optimal dysphagia assessment tools that are more consistently adopted into clinical practice. CONCLUSIONS: Clinicians and researchers should promote the development of psychometrically sound measures, and employ principles of implementation science and effective dissemination strategies to advocate for, and promote the use of, well-designed instruments within their appropriate clinical contexts. Support from governing bodies and funding agencies could enhance future efforts to develop, and encourage widespread uptake of, optimally developed dysphagia assessment tools.

A Survey of Manual Therapy Techniques and Protocols Used to Prevent or Treat Dysphagia in Head and Neck Cancer Patients During and after Radiation Therapy.

Background: Authoritative research demonstrating efficacy of traditional dysphagia therapy for Head & Neck Cancer (HNC) patients is limited. A 2019 survey reported speech-language-pathologists (SLPs) have started using Manual Therapy (MT) to prevent or rehabilitate dysphagia in HNC patients. This application of MT is supported theoretically but no research has established efficacy. Further, specific contents of MT protocols employed in this setting remain unknown. Objectives: In the absence of HNC dysphagia specific MT protocols, this study aimed to better understand MT protocols employed by SLPs to prevent and treat dysphagia in HNC patients during and after Radiation Therapy (RT). Methods: An internet-based questionnaire for SLPs who use MT with HNC patients was developed and tested for face/content validity. It was sent to SLPs practicing in the USA, twice, through three national listservs (ASHA-SIG13, ASHA-SIG3, University of Iowa Voiceserv). Results: Of 64 respondents, 44 completed the survey. Of the 44, 15(34%) provided proactive MT during RT, 37(84%) provided proactive MT after RT (to prevent dysphagia), and 44(100%) provided reactive MT after RT (to treat dysphagia). 40(91%) were trained in MT through a CE course and 25(57%) had HNC-specific MT training. The most common MT techniques were laryngeal manipulation (LM) and myofascial release (MFR). During RT, MT protocols are gentler and highly tailored, with simple home programs of mild intensity. After RT, protocols are more regimented and aggressive, but still highly customized, with more diverse home programs of at least moderate intensity. Conclusion: MT for HNC patients lacks a standard protocol or approach, but MFR and LM, or components of those techniques, are used most frequently. Given the frequency with which MFR and LM are employed to treat dysphagia during and post-RT, and the lack of empirical evidence supporting or refuting their use, a collaboratively designed RCT is warranted to establish the safety and efficacy of MT for HNC patients.

The Boston Residue and Clearance Scale: preliminary reliability and validity testing.

BACKGROUND: There is no appropriately validated scale with which to rate the problem of residue after swallowing. The Boston Residue and Clearance Scale (BRACS) was developed to meet this need. Initial reliability and validity were assessed. METHODS: BRACS is an 11-point ordinal residue rating scale scoring three aspects of residue during a fiberoptic endoscopic evaluation of swallowing (FEES): (1) the amount and location of residue, (2) the presence of spontaneous clearing swallows, and (3) the effectiveness of clearing swallows. To determine inter-rater and test-retest reliability, 63 swallows from previously recorded FEES procedures were scored twice by 4 raters using (1) clinical judgment (none, mild, mild-moderate, moderate, moderate-severe, severe) and (2) BRACS. Concurrent validity was tested by correlating clinical judgment scores with BRACS scores. Internal consistency of the items in BRACS was examined. A factor analysis was performed to identify important factors that suggest grouping within the 12 location items in BRACS. RESULTS: BRACS showed excellent inter-rater reliability (intraclass correlation coefficient, ICC = 0.81), test-retest reliability (ICC: 0.82-0.92), high concurrent validity (Pearson's r = 0.76), and high internal consistency (Cronbach's α = 0.86). Factor analysis revealed 3 main latent factors for the 12 location items. CONCLUSION: BRACS is a valid and reliable tool that can rate the severity of residue.

Survey of usual practice: dysphagia therapy in head and neck cancer patients.

There is no standardized dysphagia therapy for head and neck cancer patients and scant evidence to support any particular protocol, leaving institutions and individual speech-language pathologists (SLPs) to determine their own protocols based on "typical" practices or anecdotal evidence. To gain an understanding of current usual practices, a national internet-based survey was developed and disseminated to SLPs who treat head and neck cancer (HNC) patients. From a random sample of 4,000 ASHA SID13 members, 1,931 fit the inclusion criteria, and 759 complete responses were recorded for a 39.3 % response rate. Results were analyzed by institution type as well as by individual clinical experience. While some interesting trends emerged from the data, a lack of uniformity and consensus regarding best practices was apparent. This is undoubtedly due to a paucity of research adequately addressing the efficacy of any one therapy for dysphagia in the HNC population.

Does PEG use cause dysphagia in head and neck cancer patients?

Percutaneous endoscopic gastrostomy (PEG) use is common in patients who undergo radiotherapy (RT) for head and neck cancer to maintain weight and nutrition during treatment. However, the true effect of PEG use on weight maintenance and its potential impact on long-term dysphagia outcomes have not been adequately studied. This retrospective study looked at swallowing-related outcomes among patients who received prophylactic PEG vs. those who did not, and among patients who maintained oral diets vs. partial oral diets vs. those who were nil per os (NPO). Outcomes were assessed at the end of RT and at 3, 6, and 12 months post RT. A comprehensive review of patients' medical charts for a 6-year period yielded 59 subjects with complete data. Results showed no difference in long-term percent weight change between the prophylactic PEG patients vs. all others, or between patients who, during RT, had oral diets vs. partial oral diets vs. NPO. However, those who did not receive prophylactic PEGs and those who maintained an oral or a partial oral diet during RT had significantly better diet outcomes at all times post RT. Dependence on a PEG may lead to adverse swallowing ability in post-irradiated head and neck cancer patients possibly due to decreased use of the swallowing musculature.

Development of Two Patient Self-Reported Measures on Functional Health Status (FOD) and Health-Related Quality of Life (QOD) in Adults with Oropharyngeal Dysphagia Using the Delphi Technique.

Introduction. Patient self-evaluation is an important aspect in the assessment of dysphagia and comprises both Functional Health Status (FHS) and Health-Related Quality of Life (HR-QoL). As many measures combine both FHS and HR-QoL, disease-related functioning cannot be distinguished from disease-related quality of life as experienced by the patient. Moreover, current patient self-reported measures are limited by poor and incomplete data on psychometric properties. Objective. This study aimed to establish content validity for the development of two new self-reported measures on FHS and HR-QoL in adults with oropharyngeal dysphagia (OD), in line with the psychometric taxonomy and guidelines from the COSMIN group (COnsensus-based Standards for the selection of health Measurement INstruments). Methods. Using the Delphi technique, international expert consensus was achieved; participants and patients with dysphagia evaluated relevance, comprehensiveness, and comprehensibility of definitions of relevant constructs (i.e., dysphagia, FHS and HR-QoL) and potential items. Results. A total of 66 Delphi participants from 45 countries achieved consensus across two rounds. The Delphi study resulted in two prototype measures, the Functional health status measure of Oropharyngeal Dysphagia (FOD) and the health-related Quality of life measure of Oropharyngeal Dysphagia (QOD), consisting of 37 and 25 items, respectively. Minimal revisions were required based on feedback by patients. Conclusions. This study provides evidence of good content validity for both newly developed prototype measures FOD and QOD. Future studies will continue the process of refining the measures, and evaluate the remaining psychometric properties using both Classic Test Theory (CTT) and Item Response Theory (IRT) models.