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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,000
University of Florida - Shands Hospital
Gainesville, Florida, United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Orlando Health - Arnold Palmer Hospital for Children
Orlando, Florida, United States
Johns Hopkins - All Children's Hospital (JHACH)
St. Petersburg, Florida, United States
Maine Medical Center
Portland, Maine, United States
Harvard University - Boston Children's Hospital (BCH)
Boston, Massachusetts, United States
Washington University - St. Louis Children's Hospital (WUSTL)
St Louis, Missouri, United States
Duke University - Duke Children's Hospital & Health Center
Durham, North Carolina, United States
Wake Forest University - Brenner Children's Hospital
Winston-Salem, North Carolina, United States
University of Texas at Houston - Children's Memorial Hermann Hospital
Houston, Texas, United States
...and 1 more locations
Speech: intelligibility
Utilizes the intelligibility in context scale (ICS)
Time frame: ~5 years of age
Speech: intelligibility
Utilizes the intelligibility in context scale (ICS)
Time frame: ~8 years of age
Speech: intelligibility
Utilizes the intelligibility in context scale (ICS)
Time frame: ~12 years of age
Speech: intelligibility
Utilizes the intelligibility in context scale (ICS)
Time frame: ~22 years of age
Speech: velopharyngeal competence
Time frame: ~5 years of age
Speech: velopharyngeal competence
Time frame: ~8 years of age
Speech: velopharyngeal competence
Time frame: ~12 years of age
Speech: velopharyngeal competence
Time frame: ~22 years of age
Speech: articulation
Utilizes the modified percent correct consonants (mPCC) scale
Time frame: ~5 years of age
Speech: articulation
Utilizes the modified percent correct consonants (mPCC) scale
Time frame: ~8 years of age
Speech: articulation
Utilizes the modified percent correct consonants (mPCC) scale
Time frame: ~12 years of age
Speech: articulation
Utilizes the modified percent correct consonants (mPCC) scale
Time frame: ~22 years of age
Speech: patient-reported outcomes related to speech and speaking
Utilizes the CLEFT-Q PROM
Time frame: ~8 years of age
Speech: patient-reported outcomes related to speech and speaking
Utilizes the CLEFT-Q PROM
Time frame: ~12 years of age
Speech: patient-reported outcomes related to speech and speaking
Utilizes the CLEFT-Q PROM
Time frame: ~22 years of age
Hearing: puretone average
Time frame: ~5 years of age
Dental: dmft and DMFT scores
Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
Time frame: ~5 years of age
Dental: dmft and DMFT scores
Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
Time frame: ~12 years of age
Dental: dmft and DMFT scores
Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
Time frame: ~22 years of age
Dental: occlusion (Uses modifications of the GOSLON scale)
Time frame: ~5 years of age
Dental: occlusion (Uses modifications of the Bauru scale)
Time frame: ~5 years of age
Dental: occlusion (Uses modifications of the GOSLON scale)
Time frame: ~12 years of age
Dental: occlusion (Uses modifications of the Bauru scale)
Time frame: ~12 years of age
Dental: occlusion (Uses modifications of the GOSLON scale)
Time frame: ~22 years of age
Dental: occlusion (Uses modifications of the Bauru scale)
Time frame: ~22 years of age
Dental: patient-reported outcomes related to mastication
Uses the CLEFT-Q PROM
Time frame: ~8 years of age
Dental: patient-reported outcomes related to mastication
Uses the CLEFT-Q PROM
Time frame: ~12 years of age
Dental: patient-reported outcomes related to mastication
Uses the CLEFT-Q PROM
Time frame: ~22 years of age
Dental: patient-reported outcomes related to oral health
Uses the COHIP PROM
Time frame: ~8 years of age
Dental: patient-reported outcomes related to oral health
Uses the COHIP PROM
Time frame: ~12 years of age
Dental: patient-reported outcomes related to oral health
Uses the COHIP PROM
Time frame: ~22 years of age
Patient-reported outcomes related to eating/drinking
Uses the CLEFT-Q PROM
Time frame: ~8 years of age
Patient-reported outcomes related to eating/drinking
Uses the CLEFT-Q PROM
Time frame: ~12 years of age
Patient-reported outcomes related to eating/drinking
Uses the CLEFT-Q PROM
Time frame: ~22 years of age
Breathing: Patient-reported outcomes related to nasal and oral breathing
Uses the NOSE PROM
Time frame: ~8 years of age
Breathing: Patient-reported outcomes related to nasal and oral breathing
Uses the NOSE PROM
Time frame: ~12 years of age
Breathing: Patient-reported outcomes related to nasal and oral breathing
Uses the NOSE PROM
Time frame: ~22 years of age
Aesthetics: Patient-reported outcomes related to appearance
Uses the CLEFT-Q PROM
Time frame: ~8 years of age
Aesthetics: Patient-reported outcomes related to appearance
Uses the CLEFT-Q PROM
Time frame: ~12 years of age
Aesthetics: Patient-reported outcomes related to appearance
Uses the CLEFT-Q PROM
Time frame: ~22 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Time frame: ~2 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Time frame: ~5 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Time frame: ~8 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Time frame: ~12 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Time frame: ~22 years of age
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.