Cleft Lip, Cleft Lip and Palate, Cleft Palate
Conditions
Keywords
cleft lip, cleft palate, cleft lip and palate, cleft alveolus, multidisciplinary team, interdisciplinary team
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREpresurgical orthopedics
DEVICEsound amplification for hearing
PROCEDUREcleft lip repair
PROCEDUREcleft palate repair
PROCEDUREoronasal fistula repair
PROCEDUREpharyngoplasty
PROCEDUREgingivoperiosteoplasty
PROCEDURELeFort-1 maxillary repositioning
PROCEDURErhinoplasty
PROCEDUREmyringotomy and tympanostomy tube placement
OTHERspeech therapy
PROCEDUREorthodontia
Sponsors
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 22 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Atypical (Tessier) facial clefts
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech: intelligibility | ~5 years of age | Utilizes the intelligibility in context scale (ICS) |
| Speech: velopharyngeal competence | ~5 years of age | — |
| Speech: articulation | ~5 years of age | Utilizes the modified percent correct consonants (mPCC) scale |
| Speech: patient-reported outcomes related to speech and speaking | ~8 years of age | Utilizes the CLEFT-Q PROM |
| Hearing: puretone average | ~5 years of age | — |
| Dental: dmft and DMFT scores | ~5 years of age | Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth |
| Dental: occlusion (Uses modifications of the GOSLON scale) | ~5 years of age | — |
| Dental: occlusion (Uses modifications of the Bauru scale) | ~5 years of age | — |
| Dental: patient-reported outcomes related to mastication | ~8 years of age | Uses the CLEFT-Q PROM |
| Dental: patient-reported outcomes related to oral health | ~8 years of age | Uses the COHIP PROM |
| Patient-reported outcomes related to eating/drinking | ~8 years of age | Uses the CLEFT-Q PROM |
| Breathing: Patient-reported outcomes related to nasal and oral breathing | ~8 years of age | Uses the NOSE PROM |
| Aesthetics: Patient-reported outcomes related to appearance | ~8 years of age | Uses the CLEFT-Q PROM |
| Aesthetics: Clinical assessment of nasolabial and facial aesthetics | ~2 years of age | — |
Countries
Canada, United States
Outcome results
None listed