Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet)

Study Overview
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Brief Summary
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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
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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: 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 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.

Official Title
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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

Conditions
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Cleft Lip, Cleft Palate, Cleft Lip and Palate

Intervention / Treatment
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* Procedure: cleft lip repair
* Procedure: cleft palate repair
* Procedure: oronasal fistula repair
* Procedure: pharyngoplasty
* Procedure: gingivoperiosteoplasty
* Procedure: LeFort-1 maxillary repositioning
* Procedure: rhinoplasty
* Procedure: myringotomy and tympanostomy tube placement
* Other: speech therapy
* Procedure: orthodontia
* Procedure: presurgical orthopedics
* Device: sound amplification for hearing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| uCL(A)<br>Children with unilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). | Procedure: cleft lip repair<br> <br> * Other names: cheiloplasty;Procedure: gingivoperiosteoplasty<br> <br> Procedure: LeFort-1 maxillary repositioning<br> <br> * Other names: orthognathic surgery;Procedure: rhinoplasty<br> <br> Other: speech therapy<br> <br> Procedure: orthodontia<br> <br> Procedure: presurgical orthopedics<br> <br> * Other names: Latham appliance;|
| uCL(A)P<br>Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, or Veau-III). | Procedure: cleft lip repair<br> <br> * Other names: cheiloplasty;Procedure: cleft palate repair<br> <br> * Other names: palatoplasty;Procedure: oronasal fistula repair<br> <br> Procedure: pharyngoplasty<br> <br> * Other names: sphincteroplasty;Procedure: gingivoperiosteoplasty<br> <br> Procedure: LeFort-1 maxillary repositioning<br> <br> * Other names: orthognathic surgery;Procedure: rhinoplasty<br> <br> Procedure: myringotomy and tympanostomy tube placement<br> <br> Other: speech therapy<br> <br> Procedure: orthodontia<br> <br> Procedure: presurgical orthopedics<br> <br> * Other names: Latham appliance;Device: sound amplification for hearing<br> <br> * Other names: hearing aid;|
| bCL(A)<br>Children with bilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). | Procedure: cleft lip repair<br> <br> * Other names: cheiloplasty;Procedure: gingivoperiosteoplasty<br> <br> Procedure: LeFort-1 maxillary repositioning<br> <br> * Other names: orthognathic surgery;Procedure: rhinoplasty<br> <br> Other: speech therapy<br> <br> Procedure: orthodontia<br> <br> Procedure: presurgical orthopedics<br> <br> * Other names: Latham appliance;|
| bCL(A)P<br>Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, Veau-III, or Veau-IV). | Procedure: cleft lip repair<br> <br> * Other names: cheiloplasty;Procedure: cleft palate repair<br> <br> * Other names: palatoplasty;Procedure: oronasal fistula repair<br> <br> Procedure: pharyngoplasty<br> <br> * Other names: sphincteroplasty;Procedure: gingivoperiosteoplasty<br> <br> Procedure: LeFort-1 maxillary repositioning<br> <br> * Other names: orthognathic surgery;Procedure: rhinoplasty<br> <br> Procedure: myringotomy and tympanostomy tube placement<br> <br> Other: speech therapy<br> <br> Procedure: orthodontia<br> <br> Procedure: presurgical orthopedics<br> <br> * Other names: Latham appliance;Device: sound amplification for hearing<br> <br> * Other names: hearing aid;|
| CP<br>Children with cleft secondary palate only, but intact lip and alveolus. Subgroup analysis by severity (submucous, Veau-I, or Veau-II). | Procedure: cleft palate repair<br> <br> * Other names: palatoplasty;Procedure: oronasal fistula repair<br> <br> Procedure: pharyngoplasty<br> <br> * Other names: sphincteroplasty;Procedure: LeFort-1 maxillary repositioning<br> <br> * Other names: orthognathic surgery;Procedure: myringotomy and tympanostomy tube placement<br> <br> Other: speech therapy<br> <br> Device: sound amplification for hearing<br> <br> * Other names: hearing aid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech: intelligibility | Utilizes the intelligibility in context scale (ICS) |  5 years of age | 
| Speech: intelligibility | Utilizes the intelligibility in context scale (ICS) |  8 years of age | 
| Speech: intelligibility | Utilizes the intelligibility in context scale (ICS) |  12 years of age | 
| Speech: intelligibility | Utilizes the intelligibility in context scale (ICS) |  22 years of age | 
| Speech: velopharyngeal competence |  |  5 years of age | 
| Speech: velopharyngeal competence |  |  8 years of age | 
| Speech: velopharyngeal competence |  |  12 years of age | 
| Speech: velopharyngeal competence |  |  22 years of age | 
| Speech: articulation | Utilizes the modified percent correct consonants (mPCC) scale |  5 years of age | 
| Speech: articulation | Utilizes the modified percent correct consonants (mPCC) scale |  8 years of age | 
| Speech: articulation | Utilizes the modified percent correct consonants (mPCC) scale |  12 years of age | 
| Speech: articulation | Utilizes the modified percent correct consonants (mPCC) scale |  22 years of age | 
| Speech: patient-reported outcomes related to speech and speaking | Utilizes the CLEFT-Q PROM |  8 years of age | 
| Speech: patient-reported outcomes related to speech and speaking | Utilizes the CLEFT-Q PROM |  12 years of age | 
| Speech: patient-reported outcomes related to speech and speaking | Utilizes the CLEFT-Q PROM |  22 years of age | 
| Hearing: puretone average |  |  5 years of age | 
| Dental: dmft and DMFT scores | Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth |  5 years of age | 
| Dental: dmft and DMFT scores | Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth |  12 years of age | 
| Dental: dmft and DMFT scores | Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth |  22 years of age | 
| 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: occlusion (Uses modifications of the GOSLON scale) |  |  12 years of age | 
| Dental: occlusion (Uses modifications of the Bauru scale) |  |  12 years of age | 
| Dental: occlusion (Uses modifications of the GOSLON scale) |  |  22 years of age | 
| Dental: occlusion (Uses modifications of the Bauru scale) |  |  22 years of age | 
| Dental: patient-reported outcomes related to mastication | Uses the CLEFT-Q PROM |  8 years of age | 
| Dental: patient-reported outcomes related to mastication | Uses the CLEFT-Q PROM |  12 years of age | 
| Dental: patient-reported outcomes related to mastication | Uses the CLEFT-Q PROM |  22 years of age | 
| Dental: patient-reported outcomes related to oral health | Uses the COHIP PROM |  8 years of age | 
| Dental: patient-reported outcomes related to oral health | Uses the COHIP PROM |  12 years of age | 
| Dental: patient-reported outcomes related to oral health | Uses the COHIP PROM |  22 years of age | 
| Patient-reported outcomes related to eating/drinking | Uses the CLEFT-Q PROM |  8 years of age | 
| Patient-reported outcomes related to eating/drinking | Uses the CLEFT-Q PROM |  12 years of age | 
| Patient-reported outcomes related to eating/drinking | Uses the CLEFT-Q PROM |  22 years of age | 
| Breathing: Patient-reported outcomes related to nasal and oral breathing | Uses the NOSE PROM |  8 years of age | 
| Breathing: Patient-reported outcomes related to nasal and oral breathing | Uses the NOSE PROM |  12 years of age | 
| Breathing: Patient-reported outcomes related to nasal and oral breathing | Uses the NOSE PROM |  22 years of age | 
| Aesthetics: Patient-reported outcomes related to appearance | Uses the CLEFT-Q PROM |  8 years of age | 
| Aesthetics: Patient-reported outcomes related to appearance | Uses the CLEFT-Q PROM |  12 years of age | 
| Aesthetics: Patient-reported outcomes related to appearance | Uses the CLEFT-Q PROM |  22 years of age | 
| Aesthetics: Clinical assessment of nasolabial and facial aesthetics |  |  2 years of age | 
| Aesthetics: Clinical assessment of nasolabial and facial aesthetics |  |  5 years of age | 
| Aesthetics: Clinical assessment of nasolabial and facial aesthetics |  |  8 years of age | 
| Aesthetics: Clinical assessment of nasolabial and facial aesthetics |  |  12 years of age | 
| Aesthetics: Clinical assessment of nasolabial and facial aesthetics |  |  22 years of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cleft lip, cleft palate, cleft lip and palate, cleft alveolus, multidisciplinary team, interdisciplinary team