Microsoft Word - Annex 6 2 21 .docx 1http://dx.doi.org/10.20396/bjos.v20i00.8661717 Volume 20 2021 e211717 Original Article 1 Orthodontics Program. UniCIEO University, Bogotá, Colombia. Corresponding author: Dr. Judith Patricia Barrera Chaparro, Assistant professor, Orthodontic Department, UniCIEO University. Cra. 5 #118-10, Bogotá, Colombia. e-mail: jp.barrera@unicieo.edu.co Phone: (+57) 3002123863 Received: October 27, 2020 Accepted: January 13, 2021 Modified short version of the oral health impact profile for patients undergoing orthodontic treatment Judith Patricia Barrera-Chaparro1,* , Sonia Patricia Plaza-Ruíz1 , Tania Camacho-Usaquén1 , Jairo Andrés Pasuy-Caicedo1 , Ada Katherine Villamizar-Rivera1 Aim: To derive and validate a short version of the Oral Health Impact Profile (OHIP) in Spanish to measure oral health quality of life (OHRQoL) for subjects wearing fixed orthodontic appliances. Methods: Cross-sectional study (data for sensitivity to change analysis were collected longitudinally). The data of 400 subjects (27.34 years, SD 11.66 years, 231 women, and 169 men) were used to develop a short-form instrument, and the data of 126 other subjects (25.95 years, SD 12.39 years, 62 women, and 64 men) were used for its validation. The original OHIPs were translated into Spanish using an iterative forward-backward sequence. After face and content validity were evaluated by an expert committee, an exploratory factorial analysis (EFA) was used to derive the Spanish short-form instrument (OHIP-S14 Ortho). To validate the OHIP-S14 Ortho, validity (content validity assessed by EFA, construct validity assessed by confirmatory factor analysis (CFA), discriminative validity assessed by the Kruskal-Wallis test, and reliability (internal consistency assessed by Cronbach’s α test-retest, and inter-observer reliability assessed by correlation coefficients) were evaluated. Sensitivity to change and usefulness of the scale were also evaluated. Results: The OHIP-S14 Ortho included only six of the items in Slade´s original OHIP-14 short-form. A two-factor structure with adequate discriminative validity was found. High internal consistency (α=0.912), excellent inter-observer (Lin’s correlation=0.97±0.011; rho= 0.97), test-retest agreement (Lin’s correlation=0.80±0.059) and adequate sensitivity to change were also found. Conclusions: The OHIP-S14 Ortho is a valid and reliable instrument to measure OHRQoL in Spanish-speaking patients with fixed orthodontic appliances. Keywords: Quality of Life. Reproducibility of results. Orthodontic appliances. https://orcid.org/0000-0002-6308-7241 https://orcid.org/0000-0002-4577-3096 https://orcid.org/0000-0002-7334-6606 https://orcid.org/0000-0002-3854-9205 https://orcid.org/0000-0002-9234-610X 2 Barrera-Chaparro et al. Introduction Oral health-related quality of life (OHRQoL) is multidimensional and impacts the func- tional, psychological, and social aspects of daily life1. Individuals seek orthodontic treatment mainly because they are dissatisfied with their appearance, dental malposi- tion, deformity of the teeth, or spaces between them2; therefore, OHRQoL after ortho- dontic treatment tends to improve3. However, wearing fixed orthodontic appliances can cause pain and difficulty with eating, speaking, or smiling, and the OHRQoL seems to deteriorate during orthodontic treatment4,5. The most widely used instrument to measure OHRQoL is the Oral Health Impact Pro- file (OHIP), which was proposed by Slade and Spencer6. The long-form of this instru- ment has 49 items (OHIP-49), the short form has 14 items (OHIP-14), and the instru- ment covers seven dimensions (i.e., functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap). A long questionnaire may not be feasible to administer in clinical settings because it has a high cost of administration and data provision, takes a long time to complete and score, and causes a burden on the respondent, which may lead to the exclusion of a substantial proportion of respondents or problems arising from the need to impute missing data7. Because of respondents’ different cultural backgrounds, short forms of the OHIP-49 have been derived and validated in different languages and countries8-13, and most of them were validated in an adult population with oral health or oral reha- bilitation needs. Although the World Health Organization (WHO)14 does not consider malocclusion an illness and most patients continue to have good oral health during orthodontic treatment, wearing fixed appliances may affect aspects of a patient’s quality of life in different ways when compared to patients who have caries, tooth loss, or peri- odontal disease. Pain is a near pervasive unpleasant experience encountered during orthodontic treatment. Numerous authors15-18 have linked orthodontic treatment to the experience of pain, finding that orthodontic patients are most likely to experience increased levels of pain for one to three days following the placement of their appli- ance and subsequent adjustment visits. To date, to the best of our knowledge, a short form of OHIP has not been developed for patients with orthodontic treatment. For this reason, the present research study aims to derive and validate a short form of the OHIP-49 (OHIP-S14 Ortho) in Spanish to measure OHRQoL in patients wearing orthodontic appliances. Materials and Methods This was a cross-sectional study. However, the data for sensitivity to change analysis was collected longitudinally. The study included individuals who were wearing fixed orthodontic appliances provided by UniCIEO University in Bogotá, Colombia, between January 2016 and November 2017. This study was approved by the UniCIEO Uni- versity Ethics Committee. All participants and parents/guardians of minors signed the informed consent form. The research was conducted in full accordance with the World Medical Association Declaration of Helsinki. 3 Barrera-Chaparro et al. From 1,151 eligible subjects during the study period, 400 were chosen by non-prob- abilistic sampling (for convenience) for the OHIP short version derivation. Addi- tionally, another 126 subjects were chosen for the OHIP-S14 Ortho validation. The sample size was estimated using the criterion recommended by Streiner19, which recommends that 5 to 10 subjects per variable be included in the sample. For the reliability assessment, the calculation of the sample size for the intraclass correla- tion coefficient (ICC) was considered to achieve an ICC equal to or greater than 0.6, a confidence interval (CI) of 95% (α = 0.05) and 90% power was calculated, resulting in a sample size of 25 subjects. A total of 126 subjects were included in the internal consistency analysis. Randomly (simple random sampling) selected were 40 for the test-retest reliability analysis, 30 for the inter-observer agreement analysis, 25 for the sensitivity to change analysis, and 50 for the analysis of the instrument’s usefulness. The inclusion criteria involved patients who had active orthodontic treatment with fixed orthodontic appliances, who were ≥12 years old, and whose native language is Spanish. Patients with a physical or mental disability that hindered administration of the survey and patients with other oral health conditions (e.g., cavities, muscle pain, periodontal pain) were excluded. The OHRQoL was measured by the OHIP-49 scale6. The questionnaire was self-administered by the participants on paper, except for the assessments related to the sensitivity to change (the scale was administered at three time points: T0=immediately before bracket placement, T1=24 to 48 hours after bracket place- ment, and T2=2 weeks after bracket placement), interobserver agreement (two observers administered the instrument in 5-minute intervals) and test-retest reli- ability (application of the instrument repeatedly, at two time points separated by 24 to 48 hours), which were completed through telephone interviews by three researchers previously trained in the implementation of the instrument (Kappa: 0.88). The time intervals were chosen because the changes in the short time of the status of patients wearing fixed orthodontic appliances, due to the activation of the devices, the type of arch, etc. Demographic variables (i.e., sex; age) were recorded at the time that the questionnaire was applied. Two clinical variables were retrieved from clinical records: the time hav- ing worn the fixed appliances at survey’s administration, in days, and time since the last orthodontic adjustment visit. Discriminative validity was evaluated by a Visual Analogue Scale for Pain (VAS Pain). Scores were assigned, with 0 corresponding to the absence of pain and 10 corresponding to the highest intensity of pain. The scores were categorized as mild (0 to 2), moderate (3 to 7), or intense (8 to 10). The time required to complete the questionnaire for both the long-form and the short-form was also recorded. As recommended by WHO, a systematic approach to translation and adaptation was conducted20. It requires five steps: forward-translation, expert panel discussion, back- ward translation, a pre-test, a cognitive briefing, and a consensus on the final version. The English version of the OHIP-496 was translated into Spanish by four bilingual profes- sionals (three Colombian and one British professional) using an iterative forward-back- ward sequence. Four orthodontists and four orthodontic patients assessed the face validity (i.e., Does the test “look like” a measure of the construct of interest?) and content 4 Barrera-Chaparro et al. validity (i.e., Does the test contain items from the desired “content domain”?). A subse- quent preliminary fit test was performed with 10 orthodontic patients. Statistical Analysis The statistical analysis was performed with STATA14 software (version 14.0; StataCorp, College Station, Tex). The statistical analysis process was conducted in consecutive steps as follows: 1. OHIP-S14 Ortho Derivation: To derive a subgroup of 14 questions, an exploratory fac- tor analysis (EFA) was used (assumptions previously verified: sphericity by using Bart- lett’s sphericity test (P<0.05) and sampling adequacy by using the Kaiser-Meyer-Olkin (KMO) >0.80). The factors to be extracted were determined by the percentage and vari- ance explained (minimum of 80%). The factor loads for each question were estimated to identify those that exceeded 0.4, which was the cutoff point for moderate to high loads. Then, the items that presented the highest factor loads were chosen, and no more than two items of each conceptual dimension were included. To determine whether the removal of the individual items affected the internal consistency of the derived OHIP short version, an analysis using Cronbach’s α coefficient was carried out. 2. OHIP-S14 Ortho Validation 2.1 Validity of the OHIP-S14 Ortho: Content validity was evaluated by exploratory factor analysis (EFA). Construct validity was evaluated by confirmatory factor analysis (CFA) using the maximum likelihood method. The fit of a model was considered adequate when the ratio of the chi-squared value to the degrees of freedom (χ2/df) <2.0, root mean square error of approximation (RMSEA) <0.10, comparative adjustment index (CFI) >0.90, Tucker-Lewis index (TLI) >0.9 and low values of the Akaike information criterion (AIC), Browne-Cudeck criterion and the Bayes information criterion (BIC) were obtained21. Discriminative validity was evaluated by comparing the OHIP-S14 Ortho with a VAS Pain categorized scale (mild, moderate, severe) by the Kruskal Wallis test. 2.2 Reliability of the OHIP-S14 Ortho: Internal consistency was evaluated by the Cronbach’s α coefficient. Intra-observer reliability (test-retest) was evaluated by Lin’s concordance correlation coefficient. The inter-observer reliability was evaluated by the Spearman correlation coefficient and Lin’s concordance correlation coefficient. 2.3 Sensitivity to change: This was evaluated by comparing the measurements at T0, T1, and T2 by the Wil- coxon signed-rank test for paired samples. Our approach to avoiding missing data was to maximize the data collection by explain- ing to participants the importance of their responses and motivating them to fill out the surveys. However, in the cases where missing data happened, a listwise deletion method was used. 5 Barrera-Chaparro et al. Results The descriptive statistics of the samples are shown in Table 1. The sample to deri- vate the OHIP-S14 Ortho was composed of 400 subjects (27.34 years, SD 11.66, 231 women, and 169 men). Another sample of 126 subjects was used for its validation (25.95 years, SD 12.39, 62 women, and 64 men). The mean time spent wearing fixed appliances was 420.76 (SD = 331.46) days for the short version derivation sample and 146.167 (SD = 262.43) days for the OHIP-S14 Ortho validation sample. The experts’ panel removed three of the OHIP-49 questions from the questionnaire; two referred to edentulous patients (Q17 and Q18), and one (Q3: a tooth that does not look good) was redundant and confusing for orthodontic patients. This is because patients seeking orthodontic treatment perceive that crowded teeth do not look good. A modification in the questions related to time was also made; the text was modified to 1 month to match the orthodontic appointment interval. Table 1. Demographic and clinical characteristics of the subjects Sample for short version derivation (n=400) Sample for OHIP-S14 Ortho validation (n=126) Categorical variables n % n % Sex Male 169 42.25 64 50.79 Female 231 57.75 62 49.21 Age categorized <18 years old 71 17.75 33 26.19 ≥ 18 years old 329 82.25 93 73.81 Quantitative variables mean (sd) median (min-max) mean (sd) median (min-max) Age Total sample 27.375 (11.633) 24 (12-66) 26.055 (12.440) 22 (12-66) <18 years old 15.154 (1.348) 15 (12-17) 14.654 (1.486) 14.71 (12-17) ≥ 18 years old 30.012 (11.177) 26 (18-66) 30.101 (12.097) 26 (18-66) Time wearing fixed appliances (days) 420.76 (331.46) 364 (1-1932) 146.167 (262.43) 80.5 (1-1334) Time since the last orthodontic adjustment visit (days) 28.81 (14.03) 28 (7-84) 32.18 (25.09) 28 (0-112) OHIP-49 total score 26.53 (19.591) 23 (0-108) - - <18 years old 21.452 (14.974) 19 (0-64) - - ≥ 18 years old 27.626 (20.304) 23 (0-108) - - OHIP-S14 Ortho total score - - 10.849 (9.138) 9 (0-45) <18 years old - - 8.333 (7.056) 6 (0-31) ≥ 18 years old - - 11.742 (9.647) 10 (0-45) VAS Pain total score (scale 10mm) - - 3.40 (2.43) 3 (0-10) 6 Barrera-Chaparro et al. 1. OHIP-S14 Ortho Derivation: EFA was performed after it was verified that the data met the assumptions (Bartlett’s sphericity test (X2 =9808.468, P<0.0001), KMO =0.911). Four factors were extracted by the percentage and variance explained (minimum of 80%); the first had an eigenvalue of 13.06, which accounted for 50.71% of the variance, and the four factors accounted for 80.34% of the variance (Table 2). Table 2. Exploratory factor analysis OHIP-49 and OHIP-S14 Ortho. The factors were extracted by the percentage and variance explained (minimum of 80%). OHIP-49 OHIP-S14 Ortho Factor Eigenvalue % of variability % of cumulative variability Factor Eigenvalue % of variability % of cumulative variability 1 13.06 50.71 50.71 1 6.50 78.9 78.9 2 3.6 13.98 64.69 2 1.02 12.4 91.23 3 2.46 9.55 74.24 4 1.57 6.1 80.34 Table 3 shows the non-response item frequency, item prevalence (% of responses cor- responding to occasionally, fairly often, or very often), item severity (item mean), and the OHIP-S14 Ortho development procedure with the highest factorial load questions. EFA correlation loads greater than 0.4 were represented almost entirely by factor 1, except for seven questions (Q2, Q11, Q12, Q25, Q44, Q45, Q48). The 14 items selected according to their factor loads were Q1, Q4, Q16, Q15, Q23, Q22, Q32, Q31, Q34, Q35, Q41, Q42, Q47, and Q46. Internal consistency (Cronbach’s α coefficient) for the OHIP-49 was in total of α= 0.93 (Annex 1). The comparison of the obtained questions of the OHIP-S14 Ortho with those of the OHIP-14 derived by Slade22 are shown in table 4. Only six items from Slade’s original OHIP-14 version were included in the OHIP-S14 Ortho. OHIP S14- Ortho agreed in six questions with the original OHIP-14 short form. Table 3. Prevalence, mean, exploratory factor analysis of OHIP long-form questions Item and conceptual dimension No response % % Prevalence Mean General factor load Functional limitation Q1 Difficulty chewing 0 46.25 1.28 0.53* Q2 Difficulty pronouncing words 0 17 0.6 0.4 Q3 Tooth that does not look good . . . . Q4 Affected appearance 0.25 20 0.657 0.58* Q5 Bad breath 0 28 0. 787 0.4 Q6 Worsened taste 0.25 7.25 0.276 0.47 Q7 Stuck Food 0.75 7.25 2.065 0.48 Q8 Digestion worsened 0 5.75 0.255 0.45 Continue 7 Barrera-Chaparro et al. Physical Pain Q9 Pain in a wound mouth 0 53 1.497 0.51 Q10 Discomfort in the jaw 0.50 21 0.693 0.50 Q11 Headaches 0 9 0. 32 0.38 Q12 Sensitive teeth 0.25 41 1.22 0.36 Q13 Pain in your teeth 0.25 53 1.464 0.45 Q14 Pain in your gums 0.25 24 0.819 0.47 Q15 Eating discomfort 0.25 58 1.569 0.59* Q16 Painful sites in the mouth 0 45.5 1.28 0.62* Q17 Unfitted dentures . . . . Q18 Uncomfortable dentures . . . . Psychological discomfort Q19 Worried 0 15 0.522 0.45 Q20 Self-conscious 0 12 0.42 0.65 Q21 Unhappy 0 7.25 0.23 0.60 Q22 Appearance of brackets 0 14.25 0.485 0.67* Q23 Tense 0 13.75 0.455 0.66* Physical disability Q24 Speak badly 0 15.75 0.545 0.49 Q25 People do not understand my words 0 14.75 0.482 0.37 Q26 Less flavor in food 0 8.25 0.307 0.51 Q27 Unable to brush your teeth 0 35.5 1.04 0.48 Q28 Avoid eating 0.25 61.25 1.697 0.53 Q29 Unsatisfactory diet 0 17.5 0.547 0.54 Q30 Unable to eat 0 17 0.597 0.61 Q31 Avoid smiling 0.50 19.75 0.623 0.67* Q32 Discontinuing meals 0 21.75 0.685 0.66* Psychological disability Q33 Interrupting sleep 0 6.25 0.26 0.56 Q34 Upset 0 17.25 0.55 0.72* Q35 Difficulty to relax 0.75 2.5 0.325 0.70* Q36 Depressed 0 3.75 0.147 0.62 Q37 Affected attention 0 2.25 0.157 0.54 Q38 Ashamed 0.25 11 0.383 0.69 Social disability Q39 Avoid leaving 0.50 2.75 0.131 0.58 Q40 Less tolerant with others 0.25 3.25 0.15 0.52 Q41 Interacting with others 0.25 3.75 0.15 0.61* Q42 Irritable with others 0.25 3.5 0.168 0.59* Q43 Difficulty of working 0.25 2.25 0.113 0.50 Handicap Q44 General affected health 0.25 1.25 0.078 0.31 Q45 Financial loss 0.25 5.75 0.215 0.23 Q46 Enjoy company 0.25 2.75 0.095 0.49* Q47 Unsatisfactory life 0.25 2.5 0.12 0.54* Q48 Unable to operate 0.25 0 0.03 0.34 Q49 Unable to work 0.25 1.5 0.083 0.43 * Highest factorial load questions (selected two for each dimension). Continuation 8 Barrera-Chaparro et al. Table 4. Comparison of OHIP-14 Original Slade questions and OHIP-S14 Ortho questions OHIP -14 (Original Slade) OHIP- S14 Ortho Question Functional limitation 2 Have you had trouble pronouncing any words because of problems with your teeth, mouth or dentures? 1 ¿En el último mes ha tenido dificultad para masticar algún tipo de comida debido a sus brackets? In the last month have you had difficulty chewing any type of food because of your brackets? 6 Have you felt that your sense of taste has worsened because of problems with your teeth, mouth or dentures? 4 ¿En el último mes ha tenido la sensación de que su apariencia se ve afectada debido a sus brackets? In the last month have you had the feeling that your appearance is affected due to your brackets? Physical Pain 9 Have you had painful aching in your mouth? 16 ¿En el último mes ha tenido sitios dolorosos en su boca debido a sus brackets? In the last month have you had painful sites in your mouth because of your brackets? 15 Have you found it uncomfortable to eat any foods because of your teeth, mouth or dentures? 15 ¿En el último mes ha sentido incomodidad al comer algunos alimentos debido a sus brackets? In the last month have you felt discomfort when eating some foods due to your brackets? Psychological discomfort 20 Have you been self-conscious because of your teeth, mouth or dentures? 22 ¿En el último mes se ha sentido incomodo debido a la apariencia de sus Brackets? In the last month, have you felt uncomfortable due to the appearance of your brackets? 23 Have you felt tense because of problems with your teeth, mouth or dentures? 23 ¿En el último mes se ha sentido tenso debido a sus brackets? In the last month, have you felt tense because of your brackets? Physical disability 29 Has your diet been unsatisfactory because of problems with your teeth, mouth or dentures? 31 ¿En el último mes ha evitado sonreír debido a sus brackets? In the last month have you avoided smiling because of your brackets? 32 Have you had to interrupt meals because of problems with your teeth, mouth or dentures? 32 ¿En el último mes ha tenido que interrumpir sus comidas debido a sus brackets? In the last month you had to interrupt your meals because of your brackets? Psychological disability 35 Have you found it difficult to relax because of problems with your teeth, mouth or dentures? 35 ¿En el último mes ha encontrado dificultad para relajarse debido a sus brackets? In the last month have you found difficulty relaxing due to your brackets? 38 Have you been a bit embarrassed because of problems with your teeth, mouth or dentures? 34 ¿En el último mes se ha sentido molesto debido a sus brackets? In the last month, have you felt upset due to your brackets? Social disability social 42 Have you been a bit irritable with other people because of problems with your teeth, mouth or dentures? 42 ¿En el último mes ha estado un poco irritable con otras personas debido a sus brackets? Have you been a bit irritable with other people because of problems with your teeth, mouth or dentures? 43 Have you had difficulty doing your usual jobs because of problems with your teeth, mouth or dentures? 41 ¿En el último mes ha tenido dificultad para interactuar con otras personas debido a sus brackets? In the last month have you had difficulty interacting with other people because of your brackets? Handicap 47 Have you felt that life in general was less satisfying because of problems with your teeth, mouth or dentures? 47 ¿En el último mes ha tenido la sensación que su vida en general ha sido menos satisfactoria debido a sus brackets? In the last month you have had the feeling that your life in general has been less satisfactory due to your brackets? 48 Have you been unable to function because of problems with your teeth, mouth or dentures? 46 ¿En el último mes ha sido incapaz de disfrutar de la compañía de otras personas debido a sus brackets? In the last month have you been unable to enjoy the company of other people because of your brackets? 9 Barrera-Chaparro et al. 2. OHIP-S14 Ortho Validation 2.1 Validity of the OHIP-S14 Ortho: Content validity was evaluated by an EFA, and the assumptions were previously verified (Bartlett sphericity test (X2 =981.003, P<0.0001), KMO=0.863). Two factors were extracted, which accounted for 91.23% of the variance (Table 2). Construct validity assessed by the CFA model showed two latent dimensions (functional and social) from the OHIPS14 Ortho. Three bi-dimensional models were evaluated by the chi-squared value (χ2/df), AIC and TLI. The third model, with associations (Q4, Q46, Q1, Q15, Q34, Q22, Q23) and covariances between most of the items, was deemed best, as it had strong item loadings and a strong model fit (AIC=3711.92; TLI=0.972, χ2/df=1.29, CFI=0.981, RMSA=0.049; SRMR=0.037) (Table 5 and Annex 2). Table 5. Confirmatory factor analysis (CFA) OHIP-S14 Ortho Chi2 X2/df RMSA AIC BIC CFI TLI SRMR AVE FUNC AVE SOCIAL Model 1 223.33 2.93 0.125 3895.58 3946.85 0.84 0.813 0.075 0.51 0.517 Model 2 186.84 2.70 0.117 3803.09 3944.1 0.87 0.835 0.054 0.531 0.533 Model 3 77.67 1.29 0.049 3711.92 3878.31 0.981 0.972 0.037 0.507 0.513 RMSEA (mean square error of approximation); AIC Akaike BIC information criterion (Bayesian information criterion); CFI (comparative adjustment index); TLI (Tucker-Lewis index); SRMR (Root square of the average of the sum of the squares of the residues); AVE (average variance extracted); FUNC (functional). The mean scores of OHIP-S14 Ortho that showed statistically significant differences by sex were Q15, Q16, and Q42, with higher values in females. The questions with the highest negative impact on the OHRQoL were Q15 and Q16 (Figure 1). 2.0 1.5 1.0 0.5 0 m ea n Q1 Q4 Q22 Q23 Q31 Q32 Q34 Q35 Q41 Q46 Q47Q15* Q16* Q42* Male mean Female Variables Figure 1. Mean scores of the OHIP-S14 Ortho questions by sex. 10 Barrera-Chaparro et al. Discriminative validity showed significantly (P<0.05) higher OHIP-S14 Ortho scores in the intense pain perception group (19.56) than in the moderate (13.45) and mild (6.1) pain perception groups. 2.2 Reliability of the OHIP-S14 Ortho: Internal consistency (Cronbach’s α coefficient) for the OHIP-S14 Ortho was in total of α= 0.91 (Annex 1). The intra-observer reliability assessment (test-retest) showed excel- lent correlation (Lin’s correlation=0.80±0.059; 95% CI:0.68;0.91). The inter-observer agreement analysis showed a high correlation (Lin’s correlation=0.97±0.011; 95% CI:0.68;0.91 and Spearman correlation coefficient=0.97). 2.3 Sensitivity to change: The OHIP-S14 Ortho scores recorded at different time points were T0=2.64, SD 6.59, T1=14, SD 10.27, and T2=11.92, SD 7.76, showing adequate sensitivity to change. There were significant differences (P=0.001) between the OHIP-S14 Ortho scores at T0-T1 and T0-T2, but there were no differences between T1 and T2 (P=0.0937) (Annex 3). Additionally, there was a 6.13-minute reduction in the scale administration time of the OHIP-S14 Ortho compared with that of the long form of the OHIP. Discussion OHIP-S14 Ortho Development According to our results, a version of OHIP-14 was extracted for subjects with fixed orthodontic appliances. The OHIP-S14 Ortho had eight items that were different from those in the original short-form OHIP developed by Slade22. Two were from the func- tional limitation dimension (Q1: difficulty chewing, Q4: “appearance affected”), and six were from each of the other six dimensions (Q16: “sore spots”, Q22: “appearance”, Q31: “avoid smiling”, Q34: “upset”, Q41: “trouble getting on with others”, and Q46: “unable to enjoy people’s company”). Compared with the OHIP-S14 Ortho, a different version in Spanish developed by Cas- trejón-Perez and Borges-Yañez9 had seven different items, and another version in Spanish developed by León et al.13 did not have any matching items. Likewise, other short forms of the OHIP derived by other authors8,23-26 differ from the original short- form OHIP derived by Slade22. The differences might be explained by the cultural distinctiveness of the populations studied, the short-form development methodolo- gies, or the specific impact that fixed orthodontic appliances have on the subject. The OHIP’s versions mentioned were about populations with dental needs other than patients wearing fixed orthodontic appliances. Fixed orthodontic appliances affect functional and physical dimensions, making it difficult to consume certain hard and sticky foods, which can cause pain or damage to the appliance. They can also affect appearance, which can generate a social impact on the daily life of patients, prevent- ing them from smiling, and participating in social activities27,28. 11 Barrera-Chaparro et al. One important aspect to be considered is the different statistical methods used to derive the different OHIP short forms. In our study, we used the statistical methods suggested by Slade and Spencer6 that were also applied by León et al.13, (reliability analysis, principal component factor analysis, and least squares regression analysis), whereas other studies used a statistically significant association about the clinical variables9, the item frequency method8, or EFA29. The sample’s age range is another important factor to consider. Most of the studies were conducted with subjects older than 60 years9,13,22 who had oral rehabilitation needs, while the sample in our research mainly included patients over 11 years old, as adolescents and young adults mostly represent the population undergoing orthodontic treatment. OHIP specifically evaluates problems with the mouth, teeth, or dentures, as proposed by Slade and Spencer6. However, as shown by the results of this study, the scale can be adapted by an appropriate method to another target population, such as patients undergoing orthodontic treatment. Likewise, the scale can be adapted to assess the impact on OHRQoL in the last month, which, in patients with orthodontic treatment, accounts for the most recent impact of orthodontic treatment, whereas, with the orig- inal OHIP-496,22,30, it was assessed over the previous year. The two items from each dimension from the original OHIP were maintained in the OHIP 14 S-Ortho. Also, the high Cronbach’s alpha (0.912) indicates that the scale mea- sures the same construct. Therefore, we suggest that this number of items satisfac- torily evaluates the OHRQoL construct for orthodontic patients31. OHIP-S14 Ortho Validation This study demonstrated appropriate validity of the OHIP-S14 Ortho scale across two main dimensions (functional limitation and social disability) and the associations and covariances between all the items. Santos et al.32 compared one-dimensional and tri-dimensional structures of the OHIP-14 and reported that the scale measures one single construct. John et al.33 compared the psychometric performance of three mod- els: a unidimensional model, a four-factor model, and a bifactor model, showing that the model with the best fit was the four-factor model. However, the other two models also showed a good fit, suggesting that one OHIP summary score is sufficient to char- acterize OHRQoL. The OHIP-S14 Ortho showed excellent discriminative validity compared with the Visual Analog Scale for Pain (VAS Pain). Other authors used clinical variables such as periodontal status, caries, or missing teeth to evaluate the discriminative validity8-11,13,22 because these variables affect OHRQoL. Moreover, in orthodontic patients, oral health must be at an optimum level to initiate tooth movement. Pain and discomfort occur as part of orthodontic mechanotherapy, but it is an individual and subjective response dependent on factors such as age, sex, individual pain thresholds, the magnitude of the force applied, the current emotional state and stress, cultural differences, and pre- vious pain experiences27. Thus, this research allows clinicians to improve communi- cation with patients so that they can plan treatment and use the OHIP-S14 Ortho in daily practice. 12 Barrera-Chaparro et al. According to the reliability results, the OHIP-S14 Ortho indicated to have very good internal consistency (Cronbach’s α coefficient = 0.912), a good level of test-retest agreement (Lin’s=0.80; ICC=0.894), and inter-observer agreement (Lin’s=0.97; Spear- man=0.97). Similar results were reported in other studies9,13,33. The scale also demonstrated good sensitivity to change in the initial stages of orthodontic treatment, showing that the OHIP-S14 Ortho has a good capacity to respond to changes in the OHRQoL that occur during orthodontic treatment, but more extensive testing of the measure’s responsiveness to change needs to be car- ried out to confirm this statement. Although in previous studies8-10,12,13,22 sensitivity to change has not been evaluated, it is important to measure the impact of ortho- dontic treatment on OHRQoL over time. Mansor et al.5, found that OHRQoL became highly deteriorated within 24 hours after the placement of fixed orthodontic appli- ances. Streiner19 and Johal et al.28 determined that the initial stages of fixed appli- ance treatment result in a negative impact on the quality of life and pain experience but that pain and discomfort intensity significantly decrease three days after the bracket’s placement and over the following three months. In our study, Q15 (eat- ing discomfort) and Q16 (painful sites in the mouth) had a higher negative impact on the OHRQoL, suggesting that pain and discomfort are the main impact during orthodontic treatment. To assess the impact on OHRQoL in a wide range of time wearing fixed orthodontic appliances since discomfort is experienced in the first 24 hours after brackets placement and subsequent adjustment visits5,19,28. However, this assessment could be a limitation due to the inaccuracy which is derived from this aspect, so future research with homogeneous ranges of time of wearing fixed orthodontic appliances is recommended. Within the limitations of the current study, the data did not show ceiling effects, as the maximum score of 56 of the OHIP-14 scale was not reported by any of the par- ticipants. Meanwhile, there were floor effects (scores of 0), which might suggest that the questionnaire is not picking up all the potential impacts of a fixed appliance, and it might be helpful to implement further qualitative work to determine this. Kettle et al.34 identified from young people a multi-dimensional social process of man- aging everyday life with an orthodontic appliance. This study only included subjects wearing buccal fixed appliances; therefore, the impact of other removable appliances, retainers, or lingual brackets was not measured with the OHIP-S14 Ortho, and the results are not generalizable to all kinds of orthodontic treatment. Although the original OHIP-14 version was derived from adult patients, in orthodontics, it has been widely used with patients under 18 years of age5,28 as it was with our study; however, it would be more appropriate to use the OHIP-14 with individuals’ questionnaires developed for young people as is the Child Oral Health Impact Profile (COHIP)35. In our results, both OHIP-49 and OHIP-S14 Ortho total scores were higher in adult patients (≥ 18 years old) than in younger patients, suggesting a different impact in the OHRQoL according to age. Further research considering important variables that were not examined in this study, such as socioeconomic status and psychological parameters (self-esteem, depression, and stress), must be done. Regarding the usefulness of the OHIP-14 scale, in our study, the time to completion of the long-form OHIP was 8.93 minutes, while for the OHIP-S14 Ortho, it was 2.8 13 Barrera-Chaparro et al. minutes. This shows that there was a significant decrease in the time to completion of the questionnaire. Currently, people’s time and their compliance with surveys are very important; therefore, long-form questionnaires must be avoided. However, other authors have suggested that reducing the number of questions in the instrument can affect their psychometric properties and that an excessive simplification of the scale can lead to negative interpretations7. Conversely, other studies3,31 have suggested that a reduction in the number of questions does not affect the responsiveness of the instrument, but it does affect its validity and reliability. Another factor to take into account is the response scale used in this study. Although it is easily quantifiable and understood, it might not measure the true attitudes of respondents, which could underestimates the effects of impacts of high concern to individuals, as the impact of the malocclusion is largely in the emotional and social well-being subscales34.On the other hand, our study analysis approach was by clas- sical test theory (CTT) instead of the item response theory (IRT), based on the notion that CTT does not invoke a complex theoretical model to relate an examinee’s abil- ity to succeed on a particular item and that is easier to apply in many testing situa- tions. However, readers must be aware of the weakness of CTT in terms of its circular dependency on item/person statistics. As the conclusions of the present study, the OHIP-S14 Ortho is a valid and reliable instrument to measure OHRQoL in Spanish-speaking patients with fixed orthodontic appliances, and the construct validity of the OHIP-S14 Ortho showed a two-dimen- sional structure with associations and covariances between all the items. Ethics statement: Individuals who were wearing fixed orthodontic appliances were provided by the UniCIEO University in Bogotá, Colombia. This study was approved by the UniCIEO University Ethics Committee. Conflicts of interest: None. References 1. Sischo L, Broder HL. Oral health-related quality of life: what, why, how, and future implications. J Dent Res. 2011 Nov;90(11):1264-70. doi: 10.1177/0022034511399918. 2. Bernabé E, Sheiham A, Tsakos G, Messias C. The impact of orthodontic treatment on the quality of life in adolescents: A case-control study. Eur J Orthod. 2008 Oct;30(5):515-20. doi: 10.1093/ejo/cjn026. 3. 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Reliability: Cronbach’s alpha values for OHIP-49 and OHIP-S14 Ortho OHIP-49 Questio n Item Cronbach´s α Question Item Cronbach´s α Q1 Difficulty chewing 0.93 Q27 Unable to brush your teeth 0.93 Q2 Difficulty pronouncing words 0.93 Q28 Avoid eating 0.93 Q4 Affected appearance 0.93 Q29 Unsatisfactory diet 0.93 Q5 Bad breath 0.93 Q30 Unable to eat 0.93 Q6 Worsened taste 0.93 Q31 Avoid smiling 0.93 Q7 Stuck food 0.93 Q32 Interrupting meals 0.93 Q8 Worsened Digestion 0.93 Q33 Interrupting sleep 0.93 Q9 Pain due to wounded mouth 0.93 Q34 Annoyed 0.93 Q10 Discomfort in the jaw 0.93 Q35 Difficulty to relax 0.93 Q11 Headaches 0.93 Q36 Depressed 0.93 Q12 Sensitive teeth 0.93 Q37 Affected attention 0.93 Q13 Pain in their teeth 0.93 Q38 Ashamed 0.93 Q14 Pain in your gums 0.93 Q39 Avoid leaving 0.93 Q15 Discomfort when eating 0.93 Q40 Less tolerant with others 0.93 Q16 Painful sites in the mouth 0.93 Q41 Interact with others 0.93 Q19 Worried 0.93 Q42 Irritable with others 0.93 Q20 Self-conscious 0.93 Q43 Difficulty working 0.93 Q21 Unhappy 0.93 Q44 General Health Affected 0.93 Q22 Appearance of the brackets 0.93 Q45 Financial loss 0.93 Q23 Tense 0.93 Q46 Enjoy company 0.93 Q24 Speaking badly 0.93 Q47 Unsatisfactory life 0.93 Q25 People do not understand their words 0.93 Q48 Unable to function 0.93 Q26 Less flavor in food 0.93 Q49 Unable to work 0.93 Total 0.93 OHIP-S14 Ortho Q1 Difficulty chewing 0.91 Q32 Interrupting meals 0.91 Q4 Affected appearance 0.90 Q34 Annoyed 0.90 Q15 Discomfort when eating 0.90 Q35 Difficulty to relax 0.91 Q16 Painful sites in the mouth 0.90 Q41 Interact with others 0.91 Q22 Appearance of the brackets 0.91 Q42 Irritable with others 0.91 Q23 Tense 0.91 Q46 Enjoy company 0.91 Q31 Avoid smiling 0.91 Q47 Unsatisfactory life 0.91 Total 0.91 Annex 2. Association between OHIP-49, OHIP- S14 Ortho and demographic and clinical characteristics Categorical Variables OHIP-49 Mean (ds) OHIP- S14 Ortho Mean (ds) Sex Male 24.89 (18.84) 7.53 (6.84) Female 27.72 (20.07) 9.16 (8.0) P value 0.120 0.059 Occupation Unemployed 25.92 (27.09) 7.65 (9.26) Independent worker 29.92 (27.09) 9.78 (7.89) Employee 27.21 (19.71) 8.70 (7.97) Depend on family resources 24.04 (17.42) 7.45 (6.39) P value 0.132 0.077 Education level Primary School 28.67 (20.45) 9.17 (6.71) Middle school 23.39 (15.10) 6.35 (5.72) High school 22.73 (19.10) 7.37 (7.52) Post-secondary education 26.71 (12.10) 8.14 (3.63) Technical education 25.85 (18.08) 8.02 (6.65) University education 30.69 (22.92) 10.34 (9.06) Specialization Course/Master 27.35 (16.59) 8.65 (6.55) Doctoral degree 12 (4.24) 4.5 (0.719) P value 0.190 0.128 Orthodontic Technique Standard 25.62 (17.62) 7.81 (6.54) Self-ligating 27.54 (20.55) 9.40 (8.55) MBT 26.60 (20.65) 8.33 (7.70) P value 0.889 0.558 Age 0.099 0.125 P value 0.048 0.013 Last Control Time -0.092 -0.062 P 0.067 0.216 Treatment Time -0.004 -0.062 P 0.937 0.216 Chi2 test for categorical variables and independent t-test for quantitative variables Annex 3. FCA model 1. FCA model 2. FCA model 3. Annex 4. Sensitivity to change. Mean (sd). T0 T1 T2 T0- T1 T0- T1 T1-T2 Mean 2.64 (6.59) 14 (10.27) 11.92 (7.76) 0.001a 0.001a 0.0937a T0 (Before treatment); T1 (24 and 48 hours); T2 (15 days). Signed Wilcoxon rank test of paired samples. a P <0. 05.