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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| uCL(A) | Children with unilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). |
| |
| uCL(A)P | 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). |
| |
| bCL(A) | Children with bilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). |
| |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cleft lip repair | Procedure |
|
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients born with cleft lip and/or palate are eligible for inclusion in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Alexander C Allori, MD, MPH | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida - Shands Hospital | Gainesville | Florida | 32608 | United States | ||
| Joe DiMaggio Children's Hospital |
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| Label | URL |
|---|---|
| Duke Cleft \& Craniofacial Center | View source |
| Official web site for ICHOM Standard Set for cleft lip and/or palate, upon which the Duke project is based | View source |
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This is a collaborative research network. All data processing happens at the coordinating center, with results reviewed by the participating centers.
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| bCL(A)P |
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). |
|
| CP | Children with cleft secondary palate only, but intact lip and alveolus. Subgroup analysis by severity (submucous, Veau-I, or Veau-II). |
|
| cleft palate repair | Procedure |
|
|
| oronasal fistula repair | Procedure |
|
| pharyngoplasty | Procedure |
|
|
| gingivoperiosteoplasty | Procedure |
|
| LeFort-1 maxillary repositioning | Procedure |
|
|
| rhinoplasty | Procedure |
|
| myringotomy and tympanostomy tube placement | Procedure |
|
| speech therapy | Other |
|
| orthodontia | Procedure |
|
| presurgical orthopedics | Procedure |
|
|
| sound amplification for hearing | Device |
|
|
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 |
| Hollywood |
| Florida |
| 33021 |
| United States |
| Orlando Health - Arnold Palmer Hospital for Children | Orlando | Florida | 32806 | United States |
| Johns Hopkins - All Children's Hospital (JHACH) | St. Petersburg | Florida | 33701 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| Harvard University - Boston Children's Hospital (BCH) | Boston | Massachusetts | 02115 | United States |
| Washington University - St. Louis Children's Hospital (WUSTL) | St Louis | Missouri | 63110 | United States |
| Duke University - Duke Children's Hospital & Health Center | Durham | North Carolina | 27710 | United States |
| Wake Forest University - Brenner Children's Hospital | Winston-Salem | North Carolina | 27157 | United States |
| University of Texas at Houston - Children's Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
| Dalhousie University - IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| ACCQUIREnet web site |
| View source |
| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| D002972 | Cleft Palate |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007569 | Jaw Abnormalities |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D019767 | Maxillofacial Abnormalities |
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
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| ID | Term |
|---|---|
| D013105 | Sphincterotomy, Transduodenal |
| D057909 | Orthognathic Surgery |
| D012225 | Rhinoplasty |
| D008876 | Middle Ear Ventilation |
| D013070 | Speech Therapy |
| D009970 | Orthodontics |
| D000084982 | Nasoalveolar Molding |
| D001299 | Audiometry |
| D006310 | Hearing Aids |
| ID | Term |
|---|---|
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D000074432 | Sphincterotomy |
| D000074433 | Myotomy |
| D013515 | Surgery, Oral |
| D003813 | Dentistry |
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D059747 | Nasal Surgical Procedures |
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D019651 | Plastic Surgery Procedures |
| D010030 | Ostomy |
| D013506 | Otologic Surgical Procedures |
| D012049 | Rehabilitation of Speech and Language Disorders |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011300 | Preoperative Care |
| D019990 | Perioperative Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D006320 | Hearing Tests |
| D003939 | Diagnostic Techniques, Otological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D012682 | Sensory Aids |
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