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Protocol - Existence of Cleft Lip or Palate

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Description:

These interviewer-administered questions ask the subject or biological parents of a child with cleft lip or palate for a description of the orofacial defects present, the extent of the defect, and if another family member has been diagnosed with the same condition.

Protocol:

Clefting

1. Have you been diagnosed with a cleft lip or palate?

[ ] No

[ ] Cleft lip

[ ] Cleft palate

[ ] Cleft lip and palate

[ ] Submucous cleft palate

[ ] Don't Know/Non-Applicable/Refused

Subject’s Right                                                                                      Subject’s Left

L

A

H

S

H

A

L

o      A

o      C

o      I

o      X

o      ?

o      *

o      A

o      C

o      I

o      X

o      ?

o      *

o      A

o      C

o      I

o      X

o      ?

o      *

o      A

o      C

o      I

o      X

o      ?

o      *

o      A

o      C

o      I

o      X

o      ?

o      *

o      A

o      C

o      I

o      X

o      ?

o      *

o      A

o      C

o      I

o      X

o      ?

o      *

Lip
Alveolus
Hard palate
Soft palate

A = yes, but unknown if “C” or “I”
C = complete
I = incomplete
X = not cleft
? = unknown
* = microform or submucous cleft

2. Has any relative in your family been diagnosed with a cleft lip or palate?

[ ] No

[ ] Yes

[ ] Don't Know/Non-Applicable/Refused

If yes, provide details on who has the condition: ____________________________

Protocol Name from Source:

The Expert Review Panel has not reviewed this measure yet.

Availability:

Publicly available

Personnel and Training Required

The interviewer must be trained to conduct personal interviews with individuals from the general population. The interviewer must be trained and found to be competent (i.e., tested by an expert) at the completion of personal interviews.

Equipment Needs

None

Requirements
Requirement CategoryRequired
Major equipment No
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Interviewer-administered questionnaire

Life Stage:

Infant, Toddler, Child, Adolescent, Adult, Senior, Pregnancy

Participants:

Participants ≥18 years of age or biological parents of children (birth through 18 years of age) who have/had cleft lip or palate.

Specific Instructions:

This protocol is administered by an interviewer asking questions of a subject or of an informant (usually a parent) if the subject is a young child. Question 1 should be asked as written. If the answer is not "no," then the LAHSHAL (Lip, Alveolus, Hard palate, Soft palate, Hard palate, Alveolus, Lip) is completed to characterize the defect. Then the LAHSHAL is completed from the perspective of the interviewer looking at the subject (i.e., right to left). The "? - unknown" variable should only be filled in if the interviewer has exhausted all other means to obtain this data. For each of the five components, fill in a bubble next to appropriate code (ACIX?*) - key provided. Many cleft defects are evident to the interviewer, but still the subject or the informant should be asked about each part of the defect (lip, alveolus, hard palate, and soft palate). Record a cleft uvula as a microform cleft of the soft palate. A cleft in the alveolus in addition to cleft palate should be recorded as a "cleft lip and palate." Question 2 is also asked of each subject (or informant regarding the subject) even if the subject does not have an orofacial cleft.

Selection Rationale

This protocol, from a national study, includes questions about the respondents and their family's history of cleft lip or palate.

Language

English

Standards
StandardNameIDSource
Common Data Elements (CDE) Person Cleft Lip Or Palate Text 2966284 CDE Browser
Logical Observation Identifiers Names and Codes (LOINC) Oral cleft lip or palate proto 62586-3 LOINC
Derived Variables

None

Process and Review

The Expert Review Panel has not reviewed this measure yet.

Source
National Institute of Dental and Craniofacial Research (NIDCR), Oral Facial Cleft Study of Cleft Lip and Palate, Demographics and Medical History. Retrieved on April 23, 2009.
General References

Kriens, O. (1989). LAHSHAL. A concise documentation system for cleft lip, alveolus, and palate diagnoses. In O. Kriens (Ed.), What is a cleft lip and palate? A multidisciplinary update (pp. 30–34). Stuttgart, West Germany: Thieme.

Mossey, P. A., Little, J., Munger, R. G., Dixon, M. J., & Shaw, W. C. (2009). Cleft lip and palate. Lancet, 374(9703), 1773–1785.

Weinberg, S. M., Neiswanger, K., Martin, R. A., Mooney, M. P., Kane, A. A., Wenger, S. L., Losee, J., Deleyiannis, F., Ma, L., de Salamanca, J. E., Czeizel, A. E. & Marazita, M. L. (2006). The Pittsburgh Oral-Facial Cleft (POFC) Study: Expanding the cleft phenotype. Background and justification. Cleft Palate-Craniofacial Journal, 43, 7–20.

Protocol ID:

80501

Variables:
Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX080501_Relative_Cleft_Lip_Palate PX080501020100 Has any relative in your family been diagnosed with a cleft lip or palate? 4 N/A
PX080501_Relative_Cleft_Lip_Palate_Details PX080501020200 (Has any relative in your family been diagnosed with a cleft lip or palate?) Details on who has the condition. 4 N/A
PX080501_Self_Cleft_Lip_Palate PX080501010100 Have you been diagnosed with a cleft lip or palate? 4 N/A
PX080501_Self_Cleft_Palate_Left_Alveolus PX080501010700 Subject's Left Alveolus 4 N/A
PX080501_Self_Cleft_Palate_Left_Hard PX080501010600 Subject's Left Hard palate 4 N/A
PX080501_Self_Cleft_Palate_Left_Lip PX080501010800 Subject's Left Lip 4 N/A
PX080501_Self_Cleft_Palate_Right_Alveolus PX080501010300 Subject's Right Alveolus 4 N/A
PX080501_Self_Cleft_Palate_Right_Hard PX080501010400 Subject's Right Hard palate 4 N/A
PX080501_Self_Cleft_Palate_Right_Lip PX080501010200 Subject's Right Lip 4 N/A
PX080501_Self_Cleft_Palate_Soft PX080501010500 Subject's Soft palate 4 N/A
Research Domain Information
Measure Name:

Existence of Cleft Lip or Palate

Release Date:

December 30, 2009

Definition

A measure to assess if an individual has a diagnosed cleft lip or palate, its location and if other relatives have the same condition.

Purpose

These questions provide information about whether a person has been diagnosed with cleft lip or palate and whether there is a family history of this condition.

Keywords

Oral health, Cleft lip, Cleft palate, Orofacial defects, Birth defects, Oral Facial Cleft, Study of Cleft Lip and Palate, Oral Facial Cleft Study of Cleft Lip and Palate, Demographics and Medical History