Prosthetic leakage represents an unavoidable and recurrent complication in patients who have undergone total laryngectomy and use a tracheoesophageal voice prosthesis (TEP), with significant impacts on quality of life, clinical risk, and healthcare costs borne by the Italian National Health Service (NHS). This study examines the effectiveness of the speech-language therapy–led prosthetic screening protocol introduced in January 2025 at the Azienda Ospedale–Università di Padova. With the introduction of this protocol, the aim is to optimize the decision-making and operational pathway related to voice prosthesis management, reducing unnecessary interventions, improving the quality of rehabilitation, and strengthening the role of the speech-language therapist within the multidisciplinary care process. The screening consists of a structured speech-language therapy evaluation in all cases of suspected malfunction, with the objective of analyzing the causes of the problem, identifying the most suitable prosthesis based on the patient’s clinical-anatomical characteristics, and, when possible, prolonging device use through conservative interventions. For the purposes of the study, a dedicated database was created, including all patients followed at the center (104 total laryngectomy patients, 68 of whom were TEP users), containing all the information necessary to obtain a complete clinical profile for each individual. The analyses were structured as follows: 1. a clinical-economic analysis of the 74 visits recorded between 7 January and 4 November 2025; 2. a within-subject statistical analysis of the 35 patients who underwent at least one prosthesis replacement in both 2024 (pre-screening) and 2025 (post-screening). The Wilcoxon test revealed a statistically significant reduction in the number of prosthesis replacements following the introduction of the protocol (−28%; p = 0.0056; Cohen’s dz = −0.54, indicating a medium-large effect size). Among the 74 visits recorded in 2025, speech-language therapy intervention allowed the prosthesis to remain in place in 20.3% of cases, avoiding unnecessary replacements; meanwhile, in 45.95% of cases, it highlighted the need to replace the existing device with a prosthesis of a different type or size. From an economic perspective, avoiding an unnecessary replacement resulted in an average saving of approximately €340 per visit. Moreover, considering the high cost of the devices, it is clear that the adoption of conservative strategies and lower-cost accessory components provides both clinical and economic advantages. The results confirm the clinical effectiveness of the speech-language therapy screening protocol, which allowed for extended device lifespan and reduced early failures. This approach results not only in improved patient quality of life but also in more efficient allocation of healthcare resources, reducing the economic burden on the Italian National Health Service.
L‘incontinenza protesica rappresenta una complicanza obbligata e ricorrente nei pazienti sottoposti a laringectomia totale e portatori di protesi fonatoria tracheoesofagea (PTE), con impatti rilevanti sulla qualità della vita, sul rischio clinico e sui costi a carico del Sistema Sanitario Nazionale (SSN). Il presente studio analizza l’efficacia del protocollo di screening protesico logopedico introdotto nel gennaio 2025 presso l’Azienda Ospedale-Università di Padova. Con l’introduzione di tale protocollo si mira a ottimizzare il percorso decisionale e operativo legato alla gestione delle protesi fonatorie, riducendo gli interventi non necessari, migliorando la qualità della riabilitazione e rafforzando il ruolo del logopedista nella presa in carico multidisciplinare. Lo screening consiste in una valutazione logopedica strutturata in tutti i casi di sospetto malfunzionamento protesico, con l’obiettivo di analizzare le cause della problematica, individuare la tipologia di protesi più adeguata in base alle caratteristiche clinico-anatomiche del paziente e, quando possibile, prolungarne l’utilizzo mediante interventi conservativi. Per la conduzione dello studio è stato creato un database dedicato dei pazienti seguiti presso il centro (104 laringectomizzati, di cui 68 portatori di PTE), contenente tutte le informazioni necessarie ad avere il quadro clinico completo di ogni paziente. Le analisi sono state articolate in: 1. un’analisi clinico-economica relativa ai 74 accessi registrati tra il 7 gennaio e il 4 novembre 2025; 2. un’analisi statistica intra-soggetto dei 35 pazienti che hanno effettuato almeno un cambio protesico sia nel 2024 (pre-screening) che nel 2025 (post-screening). Il test di Wilcoxon ha evidenziato una riduzione statisticamente significativa del numero di cambi protesici dopo l’introduzione del protocollo (−28%; p = 0,0056; Cohen’s dz = −0,54, effetto di entità medio-grande). Tra i 74 accessi registrati nel 2025, l’intervento logopedico ha consentito di mantenere la protesi in uso nel 20,3% dei casi, evitando sostituzioni non necessarie; mentre nel 45,95% dei casi ha evidenziato la necessità di sostituzione della protesi in sede con una diversa per tipologia o dimensioni. Dal punto di vista economico, evitare un cambio protesico non necessario ha determinato un risparmio medio di circa €340 per accesso; inoltre, considerando il costo elevato dei dispositivi, risulta evidente come l’impiego di strategie conservative e di dispositivi accessori meno costosi rappresenti un vantaggio sia clinico che economico. I risultati confermano l’efficacia clinica dello screening logopedico, che ha consentito di prolungare la durata dei dispositivi e ridurre le perdite precoci. Tale approccio si traduce non solo in un miglioramento della qualità di vita dei pazienti, ma anche in una razionalizzazione dei costi, riducendo l’impatto economico sul Sistema Sanitario Nazionale.
Screening protesico: il ruolo del logopedista nella gestione della protesi fonatoria nel paziente laringectomizzato totale
LAZZARATO, SOFIA
2024/2025
Abstract
Prosthetic leakage represents an unavoidable and recurrent complication in patients who have undergone total laryngectomy and use a tracheoesophageal voice prosthesis (TEP), with significant impacts on quality of life, clinical risk, and healthcare costs borne by the Italian National Health Service (NHS). This study examines the effectiveness of the speech-language therapy–led prosthetic screening protocol introduced in January 2025 at the Azienda Ospedale–Università di Padova. With the introduction of this protocol, the aim is to optimize the decision-making and operational pathway related to voice prosthesis management, reducing unnecessary interventions, improving the quality of rehabilitation, and strengthening the role of the speech-language therapist within the multidisciplinary care process. The screening consists of a structured speech-language therapy evaluation in all cases of suspected malfunction, with the objective of analyzing the causes of the problem, identifying the most suitable prosthesis based on the patient’s clinical-anatomical characteristics, and, when possible, prolonging device use through conservative interventions. For the purposes of the study, a dedicated database was created, including all patients followed at the center (104 total laryngectomy patients, 68 of whom were TEP users), containing all the information necessary to obtain a complete clinical profile for each individual. The analyses were structured as follows: 1. a clinical-economic analysis of the 74 visits recorded between 7 January and 4 November 2025; 2. a within-subject statistical analysis of the 35 patients who underwent at least one prosthesis replacement in both 2024 (pre-screening) and 2025 (post-screening). The Wilcoxon test revealed a statistically significant reduction in the number of prosthesis replacements following the introduction of the protocol (−28%; p = 0.0056; Cohen’s dz = −0.54, indicating a medium-large effect size). Among the 74 visits recorded in 2025, speech-language therapy intervention allowed the prosthesis to remain in place in 20.3% of cases, avoiding unnecessary replacements; meanwhile, in 45.95% of cases, it highlighted the need to replace the existing device with a prosthesis of a different type or size. From an economic perspective, avoiding an unnecessary replacement resulted in an average saving of approximately €340 per visit. Moreover, considering the high cost of the devices, it is clear that the adoption of conservative strategies and lower-cost accessory components provides both clinical and economic advantages. The results confirm the clinical effectiveness of the speech-language therapy screening protocol, which allowed for extended device lifespan and reduced early failures. This approach results not only in improved patient quality of life but also in more efficient allocation of healthcare resources, reducing the economic burden on the Italian National Health Service.| File | Dimensione | Formato | |
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https://hdl.handle.net/20.500.12608/99898