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

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

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.

Study Overview

• Status: Completed
• Conditions: Health-related Quality of Life; Dentofacial Deformities
• Intervention / Treatment: Procedure: orthognathic surgery

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 230

Contacts and Locations

Study Locations

• Chile
  • Valparaíso, Chile
    • Valentina Duarte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients over 18 years old with dentofacial deformity Class II or III in orthodontic-surgical treatment

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Hospital Carlos Van Buren
• Collaborators: Universidad de Valparaiso; University of Chile; Universidad de La Frontera; Hospital del Mar Research Institute (IMIM); Pontificia Universidad Catolica de Valparaiso; Hospital San Borja-Arriaran
• Investigators: Principal Investigator: Valentina Duarte, Hospital Carlos Van Buren

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2018
• Primary Completion (Actual): March 3, 2020
• Study Completion (Actual): March 3, 2020

Study Registration Dates

• First Submitted: April 2, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 23, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Health-related quality of life; Orthognathic surgery; Dentofacial deformities
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Dentofacial Deformities
• Other Study ID Numbers: ORD 2436 / 30-11-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO