xRead - Swallowing Disorders in the Adult Patient (October 2024)

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Center. 9,10 REDCap is a secure, web-based software plat form designed to support data capture for research studies. Demographics. Data including age, sex, com orbidities, and duration of disease were taken during the preinjection visit. Eating assessment tool 10 (EAT-10). The EAT-10 is a 10-question patient-reported survey to assess dyspha gia severity and quality of life impact. 11 The questions evaluate swallowing problems and related issues, rated on a 5-point scale (0 = no problem, 4 = severe problem), with a total possible score of 40. Generalized anxiety disorder-7 scale (GAD-7). The GAD-7 scale is a valid and reliable seven-question tool that evaluates anxiety severity using the frequency (0: not at all to 3: nearly every day) of symptoms, with a total possible score of 21. A total score of 0 – 4 indicates minimal anxiety, 5 – 9 is mild anxiety, 10 – 14 is moderate anxiety, and ≥ 15 indicates severe anxiety. RCPD questionnaire. The RCPD Questionnaire has been created to evaluate the severity of RCPD symp toms and the effects on daily life. It is an 11-question sur vey that separately evaluates all major (inability to burp, bloating, gurgling sounds, and fl atulence) and minor (inability to vomit, regurgitation, and heartburn) symp toms and effects on daily life such as ‘ I am embarrassed with my symptoms ’ or ‘ I avoid social interactions. ’ All questions were answered according to frequency of symp toms (1: never, 5: always). The last question of the survey is a 10-point Likert scale that measures the overall sever ity of the impact of symptoms on patients ’ quality of life (0: not a problem, 10: unbearable). Please see Table I for the entire questionnaire. Study Design Patients meeting inclusion and exclusion criteria as noted above were consented for the study and then emailed the preinjection questionnaire. After completion of treatment in the of fi ce or in the OR, patients were emailed automated surveys via RedCAP at 1 week, 2 weeks, 3 weeks, and 3 months postinjection. All data were collected and kept anonymously online via RedCAP. On February 27th, 2024 the data were extracted as an Excel spreadsheet for statistical analyses. Statistics Linear mixed models were used in analysis to account for repeated measures, with separate modelling examining change in total RCPD score, GAD score, and EAT10 score. This generated data point totals of 296 (RCPD), 170 (GAD), and 372 (EAT10) for analysis. RESULTS Totally 108 patients (F:55, M:53) completed the ini tial survey and consent form, with an average age of 29.1 (18 – 63). Demographics are displayed in Table II. Of those, 53 participants (OR:31, IO:22) completed the

Current literature on RCPD consists of case series and retrospective chart analyses. Although all published studies report success rates of varying approaches (e.g. different dosage and techniques), the de fi nition of ‘ success ’ is subjective and further studies with objective parameters are required to compare IO and OR injec tions. Additionally, detailed analysis of posttreatment dysphagia has not been reported despite being an extremely common side effect, nor has the effect of RCPD treatment on patient anxiety been published. The aim of this study is to compare the success rates of IO and OR injections prospectively using objective methodology, to analyze the severity and duration of postinjection dyspha gia, and to observe the effects of treatment on both RCPD symptoms and patient anxiety. MATERIAL AND METHOD This study was designed as a prospective cohort study and was approved by the Columbia University Institutional Review Board (protocol number: IRB AAAT9154, New York, NY, USA). All methods followed the principles of the Declaration of Helsinki. All study participants provided written consent. Patients All patients presenting for RCPD evaluation at The Center for Voice and Swallowing at Columbia University Medical Center between August 2022 and February 2024 were screened. Inclusion criteria included age ≥ 18 and having the four major symptoms of RCPD. Patients were then consented and offered the pretreatment question naire. Exclusion criteria included incompletion of study consent and questionnaires, prior treatment with BTX, and presentation with atypical symptoms (i.e. pretreatment dysphagia). Patient preference deter mined whether they received BTX in the of fi ce or in theOR. Injections In-of fi ce injections. All injections were performed by the senior author (MJP) with EMG guidance as described previously. 7 Patients were treated with unilat eral 30 U of Onabotulinum toxin A at a dilution of 10 U/0.1 mL. OR injections. All injections were performed by or under supervision of the senior author under general anesthesia. Patients were treated with 80U of Onabotulinum toxin A at a dilution of 10 U/0.1 mL divided into three injections across the length of the mus cle: 30U at the center and 25 U at the lateral aspect of the muscle bilaterally.

Data Collection Study data were collected and managed using RED Cap (Research Electronic Data Capture) electronic data capture tools hosted at Columbia University Medical

Laryngoscope 00: 2024

Doruk et al.: Botulinum Toxin Injection for RCPD

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