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Protocol - Existence of Cleft Lip or Palate

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Protocol Name from Source:

The Expert Review Panel has not reviewed this measure yet.

Availability:

Publicly available

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: ____________________________

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
Average time of greater than 15 minutes in an unaffected individualNo
Major equipmentNo
Specialized requirements for biospecimen collectionNo
Specialized trainingNo

Mode of Administration

Self-administered

Life Stage:

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

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.

Research Domain Information

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.

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 Text2966284CDE Browser
Logical Observation Identifiers Names and Codes (LOINC)Oral cleft lip or palate proto62586-3LOINC

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_Self_Cleft_Lip_PalatePX080501010100Have you been diagnosed with a cleft lip or palate?4N/A
PX080501_Self_Cleft_Palate_Right_LipPX080501010200Subject's Right Lip4N/A
PX080501_Self_Cleft_Palate_Right_AlveolusPX080501010300Subject's Right Alveolus4N/A
PX080501_Self_Cleft_Palate_Right_HardPX080501010400Subject's Right Hard palate4N/A
PX080501_Self_Cleft_Palate_SoftPX080501010500Subject's Soft palate4N/A
PX080501_Self_Cleft_Palate_Left_HardPX080501010600Subject's Left Hard palate4N/A
PX080501_Self_Cleft_Palate_Left_AlveolusPX080501010700Subject's Left Alveolus4N/A
PX080501_Self_Cleft_Palate_Left_LipPX080501010800Subject's Left Lip4N/A
PX080501_Relative_Cleft_Lip_PalatePX080501020100Has any relative in your family been diagnosed with a cleft lip or palate?4N/A
PX080501_Relative_Cleft_Lip_Palate_DetailsPX080501020200(Has any relative in your family been diagnosed with a cleft lip or palate?) Details on who has the condition.4N/A