ABSTRACT
Introduction: Pre-emptive access to the kidney transplant (KT) waiting list remains limited in France, with only 3.9% of patients on pre-emptive KT and 5.6% of patients registered at the time of initiation of dialysis. A similar trend was observed in Aquitaine. The aim of this study was to assess the impact of a regional program in terms of access to the waiting list for patients initiating a kidney replacement therapy (KRT). Methods: We included all patients assessed for registration on the list between 2017 and 2020, 2017 being the reference year and 2018 the beginning of the program. Using the CRISTAL and REIN registries, we assessed changes in the number of patients on the list at the time of initiation of dialysis or transplantation. Results: The number of new assessed candidates increased gradually each year from 255 in 2017 to 352 in 2020 (+38%). The number of patients on the list sharply increased in 2018 from 229 in 2017 to 319 in 2018 (+39.3%) and then remained stable. At the initiation of KRT, the proportion of patients registered on the waiting list increased gradually from 7.1% in 2017 to 18.2% in 2020. The proportion of pre-emptive KT remained stable between 2017 and 2021 (around 7%) with a decrease in 2020 (4.6%). Approximately 60% of patients had a contraindication to transplantation throughout the study. Conclusion: This study showed that a regional program aimed at providing better information to healthcare professionals and patients and encouraging rapid assessment of transplant candidates could increase the rate of pre-emptive registration on the KT waiting list for eligible patients over 4 years.
Introduction: L'accès préemptif à la liste d'attente de transplantation rénale (TR) reste limité en France, avec seulement 3,9 % de TR préemptives et 5,6 % de patients inscrits lors de l'initiation de la dialyse. Une tendance similaire était observée en Aquitaine. L'objectif de cette étude était d'évaluer l'impact d'un programme régional en termes d'accès à la liste d'attente chez les patients débutant un traitement de suppléance. Méthodes: Nous avons inclus l'ensemble des patients évalués pour une inscription sur liste entre 2017 et 2020, 2017 étant l'année de référence et 2018 l'année de début du programme régional. Nous avons évalué de façon annuelle, grâce aux registres CRISTAL et REIN, l'évolution du nombre de patients inscrits sur liste lors de l'initiation du traitement de suppléance par dialyse ou transplantation. Résultats: Le nombre de nouveaux candidats évalués a augmenté graduellement chaque année, passant de 255 en 2017 à 352 en 2020 (+ 38 %). Le nombre de patients inscrits sur la liste a fortement augmenté en 2018 passant de 229 en 2017 à 319 en 2018 (+39,3 %), puis est resté stable. À l'initiation du traitement de suppléance, la proportion de patients inscrits a augmenté graduellement passant de 7,1 % en 2017 à 18,2 % en 2020. La proportion de TR préemptive est restée stable entre 2017 et 2021 (environ 7 %) avec une baisse en 2020 (4,6 %). Environ 60 % des patients présentaient une contre-indication à la transplantation tout au long de cette étude. Conclusion: Cette étude a montré qu'un programme régional visant à mieux informer les professionnels de santé et les patients et favorisant l'évaluation rapide des candidats à la greffe permet d'augmenter en 4 ans le taux d'inscription préemptive sur liste d'attente de TR chez les patients éligibles.
ABSTRACT
BACKGROUND: Soft palate defects created during oral cancer surgery may prevent complete palatal closure and trigger palatopharyngeal insufficiency. One current treatment employs a rigid obturator prosthesis; an extension of acrylic resin at the level of the hard palate ensures surface contact with the remaining musculature. Unfortunately, airflow escape often causes hypernasality, compromises speech intelligibility, and creates swallowing problems (including leakage of food and fluid into the nasal airway). We plan to test a new removable denture featuring a thick dental dam that serves as a membrane obturator. The principal objective of the clinical trial is a comparison of speech handicap levels after 1 month in patients with acquired velar insufficiencies who wear either the new device or a conventional, rigid obturator. The secondary objectives are between-device comparisons of the swallowing handicaps and the health-related qualities of life. METHODS: The VELOMEMBRANE trial is a superiority, open-labeled, two-way, random crossover clinical trial. Adult patients exhibiting velar or palatovelar substance loss after tumor excision and who are indicated for rigid obturator-mediated prosthetic rehabilitation will be recruited in two teaching hospitals in France. Fourteen participants will be randomly allocated to wear both prostheses for 1-month periods in either order. The new membrane obturator is a removable resin prosthesis incorporating a rigid extension that holds a dental dam to restore the soft palate. The primary outcome will be the extent of phonation-related disability (the overall score on the Voice Handicap Index [VHI]). The secondary outcomes will be the Deglutition Handicap Index and health-related quality of life scores of the European Organization for Research and Treatment of Cancer (EORTC). DISCUSSION: High-quality evidence will be provided to document the utility of a new medical device that may greatly improve the management and quality of life of patients with acquired velar insufficiency. TRIAL REGISTRATION: ClinicalTrials.gov NCT04009811 . Registered on 4 July 2019.
