Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: cleft lip repair, cleft palate repair, oronasal fistula repair, pharyngoplasty.
- Кому может быть актуально
- Состояния в реестре: Cleft Lip, Cleft Palate, Cleft Lip and Palate. Базовые параметры: 1 Day — 22 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet): Prospective Data-collection System and Learning Health-care Network for the Comprehensive Appraisal of Cleft and Craniofacial Care
Обзор
The Allied Cleft \& Craniofacial Quality-Improvement and Research Network (ACCQUIREnet) is a group of multidisciplinary cleft teams that have implemented a system for prospective collection of outcomes data, based on the ICHOM Standard Set for the Comprehensive Appraisal of Cleft Care, CLEFT-Q, and other outcomes instruments. Participating cleft teams may analyze clinical and psychosocial outcomes related to care of the child with cleft lip and/or palate (CL/P), compare its performance with those of other cleft centers, and identify opportunities for quality improvement.
Подробное описание
The purpose of this project is to implement a system of prospective, standardized data collection for all patients with cleft lip and/or palate (CL/P) treated by the cleft and craniofacial centers that participate in ACCQUIREnet.
Adoption of this prospective data-collection system has two principal goals:
1. To enable on-demand and scheduled review of cleft-care-related safety and outcomes data and team performance for the purpose of internal audits and continuous quality improvement; and 2. To permit participation in multi-site, collaborative quality-improvement projects and/or research networks that require usage of these standardized data-collection methods. (These collaborations are described in corresponding IRB protocols and data-transfer agreements. Patient privacy and confidentiality is protected at all times.)
All patients with CL/P treated at cleft and craniofacial centers participating in ACCQUIREnet will be invited to participate in this project. Duke University serves as the coordinating center and statistical support center for the study. Data are maintained in a local, secured database.
The IRB protocol details methods of quality assurance, data monitoring, and auditing. Data dictionaries employed in ACCQUIREnet include the CleftCap REDCap project template, CleftKit Common Data Model (an extension of the PCORnet Common Data Model), the ICHOM Standard Set for the Comprehensive Appraisal of Cleft Care, and the CLEFT-Q patient-reported outcome manual, maintained by the International Consortium for Health Outcomes Measurement (ichom.org) and McMaster University, respectively.
Вмешательства
- Процедура cleft lip repair
- Процедура cleft palate repair
- Процедура oronasal fistula repair
- Процедура pharyngoplasty
- Процедура gingivoperiosteoplasty
- Процедура LeFort-1 maxillary repositioning
- Процедура rhinoplasty
- Процедура myringotomy and tympanostomy tube placement
- Другое speech therapy
- Процедура orthodontia
Первичные конечные точки
- Speech: intelligibility [Срок оценки: ~5 years of age]
- Speech: intelligibility [Срок оценки: ~8 years of age]
- Speech: intelligibility [Срок оценки: ~12 years of age]
- Speech: intelligibility [Срок оценки: ~22 years of age]
- Speech: velopharyngeal competence [Срок оценки: ~5 years of age]
- Speech: velopharyngeal competence [Срок оценки: ~8 years of age]
- Speech: velopharyngeal competence [Срок оценки: ~12 years of age]
- Speech: velopharyngeal competence [Срок оценки: ~22 years of age]
- Speech: articulation [Срок оценки: ~5 years of age]
- Speech: articulation [Срок оценки: ~8 years of age]
Критерии участия
Критерии включения
- Typical orofacial clefts, of which subtypes are:
- Unilateral or bilateral cleft lip
- Unilateral or bilateral cleft lip and alveolus
- Unilateral or bilateral cleft lip and alveolus and palate
- Unilateral or bilateral cleft lip and palate
- Overt cleft palate
- Occult cleft palate
Критерии исключения
- Atypical (Tessier) facial clefts
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 10 центров
- University of Florida - Shands Hospital — Gainesville
- Joe DiMaggio Children's Hospital — Hollywood
- Orlando Health - Arnold Palmer Hospital for Children — Orlando
- Johns Hopkins - All Children's Hospital (JHACH) — St. Petersburg
- Maine Medical Center — Portland
- Harvard University - Boston Children's Hospital (BCH) — Boston
- Washington University - St. Louis Children's Hospital (WUSTL) — St Louis
- Duke University - Duke Children's Hospital & Health Center — Durham
- … и ещё 2 центра
Канада · 1 центр
- Dalhousie University - IWK Health Centre — Halifax
Идентификаторы
NCT: NCT02702869 · Pro00104806