Cross Cultural Adaptation and Validation of Orthognathic Quality of Life Questionnaire (OQLQ)

Health-related Quality of Life Clinical Trial

Official title:

Cross Cultural Adaptation and Validation of Chilean Version of Orthognathic Quality of Life Questionnaire (OQLQ)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04863170
• Other study ID #: ORD 2436 / 30-11-18
• Status: Completed
• Start date: November 21, 2018
• Est. completion date: March 3, 2020

Study information

• Verified date: April 2021
• Source: Hospital Carlos Van Buren
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study was to develop a Spanish version of the Orthognathic Quality of Life Questionnaire (OQLQ) that is conceptually equivalent to the original questionnaire, as well as acceptable, reliable, valid, and responsive for use in Chilean patients with dentofacial deformities.The cross cultural adaptation process was carried out according to the recommended standard methodology with direct and back-translation.

Description:

A prospective longitudinal multicenter study of adult patients diagnosed with dentofacial deformity was carried out, self-administrating OQLQ, OHIP-14 (Oral Health Impact Profile), and SF-36 (Short Form 36 Health Survey) during the presurgery visit in order to examine construct validity. To evaluate reproducibility, questionnaires were re-administered 4 weeks later to subjects with a stable dental condition. Responsiveness was assessed among subjects followed up until 3 months after surgery and finally changes in health-related quality of life was assessed comparing baseline pre-surgery to 3 and 6 months post-surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: March 3, 2020
• Est. primary completion date: March 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults patients over 18 years old with dentofacial deformity.

Exclusion Criteria:

• Patients with congenital abnormalities such as craniofacial syndrome or cleft lip/palate and sequels due to maxillofacial trauma were excluded

Related Conditions & MeSH terms

• Congenital Abnormalities
• Dentofacial Deformities
• Health-related Quality of Life

Intervention

Procedure:
• orthognathic surgery
surgical intervention of the maxilla and / or mandible that includes orthodontic treatment before and after surgery

Locations

Country	Name	City	State
Chile	Valentina Duarte	Valparaíso

Sponsors (7)

Lead Sponsor	Collaborator
Hospital Carlos Van Buren	Hospital del Mar Research Institute (IMIM), Hospital San Borja-Arriaran, Pontificia Universidad Catolica de Valparaiso, Universidad de la Frontera, Universidad de Valparaiso, University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metric properties of Orthognathic Quality of Life Questionnaire (OQLQ): Reliability	To measure this metric property, internal consistency and test-retest reproducibility were assessed. The orthognathic quality of life questionnaire (OQLQ) was applied twice, with four weeks between tests.; To assess reliability, the internal consistency was estimated by the Cronbach alpha coefficient, and the test-retest reproducibility was estimated by the intraclass correlation coefficient.; The orthognathic quality of life questionnaire is a condition specific instrument for assessment oral health quality of life in dentofacial deformities patients 22 ítems values: min = 0 / max = 88 higher scores mean a worse outcome	4 weeks follow-up
Primary	Metric properties of Orthognathic Quality of Life Questionnaire (OQLQ): Validity	Validity refers to the degree to which the instrument measures what it purports to measure.; Construct validity was evaluated analyzing the hypothesized relationships between scores by calculating the Spearman correlation coefficients.; The orthognathic quality of life questionnaire is a condition specific instrument for assessment oral health quality of life in dentofacial deformities patients 22 ítems values: min = 0 / max = 88 higher scores mean a worse outcome	baseline
Primary	Metric properties of Orthognathic Quality of Life Questionnaire (OQLQ): Responsiveness to change	Responsiveness refers to an instrument's ability to detect change. To evaluate responsiveness of the orthognathic quality of life questionnaire (OQLQ) we applied twice: first one week before surgery (T1), and then three months after surgery (T2) To evaluate responsiveness, a paired t-test was used to assess the score changes in patients undergoing orthognathic surgery. The magnitude of the change was evaluated calculating the standardized response mean.; The orthognathic quality of life questionnaire is a condition specific instrument for assessment oral health quality of life in dentofacial deformities patients 22 ítems values: min = 0 / max = 88 higher scores mean a worse outcome	baseline - 3 months follow-up
Primary	changes in oral health related quality of life after orthognathic surgery assessed with Orthognathic Quality of Life Questionnaire (OQLQ)	Orthognathic quality of life questionnaire (OQLQ) was applied at 3 times: baseline, one week before surgery (T1), three months after surgery (T2) and 6 months after surgery (T3).; A paired t-test was used to assess the mean (SD) changes in patients undergoing orthognathic surgery. The magnitude of the change was evaluated calculating the standardized response mean (SRM).; The orthognathic quality of life questionnaire is a condition specific instrument for assessment oral health quality of life in dentofacial deformities patients 22 ítems values: min = 0 / max = 88 higher scores mean a worse outcome	baseline to 3 and 6 months follow-up
Primary	changes in oral health related quality of life after orthognathic surgery assessed with Short form Oral Health Impact Profile (OHIP-14)	Short form Oral Health Impact Profile (OHIP-14) was applied at 3 times: baseline, one week before surgery (T1), three months after surgery (T2) and 6 months after surgery (T3).; A paired t-test was used to assess the mean (SD) changes in patients undergoing orthognathic surgery. The magnitude of the change was evaluated calculating the standardized response mean (SRM).; The Short Form Oral Health Impact Profile (OHIP-14) is an instrument for assessment oral health-related quality of life.; 14 ítems values: min = 0 / max = 56 higher scores mean a worse outcome	baseline to 3 and 6 months follow-up
Primary	changes in health related quality of life after orthognathic surgery assessed with Short Form Health Survey (SF-36)	The Short Form Health Survey (SF-36) was applied at 3 times: baseline, one week before surgery (T1), three months after surgery (T2) and 6 months after surgery (T3).; A paired t-test was used to assess the mean (SD) changes in patients undergoing orthognathic surgery. The magnitude of the change was evaluated calculating the standardized response mean (SRM).; The Short Form Health Survey (SF-36) is a generic health-related quality of life questionnaire 36 ítems in addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved.; higher scores mean a better outcome	baseline to 3 and 6 months follow-up