Atala-Acevedo et al. BMC Oral Health (2020) 20:6 https://doi.org/10.1186/s12903-019-0984-1 RESEARCH ARTICLE Open Access Adaptation and validation of the PEDSQL™ oral health scale for toddlers in Chilean population Claudia Atala-Acevedo1,2, Carlos Zaror1,2,3* , Gerardo Espinoza-Espinoza2,4, Patricia Muñoz-Millán1,2, Sergio Muñoz3,4, María José Martínez-Zapata5,6 and Montse Ferrer7,6* Abstract Background: The Pediatric Quality of Life Inventory™ (PedsQL™) Oral Health Scale was developed to measure oral health-related quality of life (OHRQoL). The aim of this study was to cross-culturally adapt the parent-reported version for toddlers of PedsQL™ Oral Health Scale into Spanish and to assess the acceptability, reliability and validity of this version in Chilean preschool population. Methods: The PedsQL™ Oral Health Scale for toddlers was cross-culturally adapted for the Spanish language using the recommended standards. To assess metric properties, a cross-sectional study was carried out with 301 children aged 2 to 5 years in Carahue, Chile. Chilean versions of the PedsQL™ Oral Health Scale, PedsQL™ 4.0 Generic Core Scales, and Early Childhood Oral Health Impact Scale (ECOHIS) were completed by the children’s parents. Dental caries, malocclusion and dental trauma were examined by trained dentists. The PedsQL™ Oral Health Scale was administrated a second time 14–21 days after. The reliability of the scale was verified by analysis of internal consistency (Cronbach’s alpha) and reproducibility (Intraclass correlation coefficient – ICC). The validity of the construct was assessed by confirmatory factor analysis and known groups method. The convergent validity was assessed by calculating the Spearman’s correlation with the ECOHIS questionnaire. Results: The PedsQL™ Oral Health Scale demonstrated good reliability, with Cronbach’s alpha coefficient of 0.79 and ICC of 0.85. A moderate-to-strong correlation was found between the PedsQL™ Oral Health Scale and the ECOHIS questionnaire (− 0.64); the PedsQL™ Oral Health Scale score was lower in children with poor than those with excellent/very good oral health (median 100 vs 85, p < 0.001); it also was lower in children with caries than in those caries-free (median 100 vs 90, p < 0.001). No statistically significant differences were found among groups according to malocclusion and traumatic dental injuries. Conclusions: The PedsQL™ Oral Health Scale for toddlers in Spanish showed to be equivalent to the original version, and its psychometric properties were satisfactory for application in a Chilean pre-school population. Keywords: Quality of life, Oral health, Child, preschool, Psychometrics * Correspondence: carlos.zaror@ufrontera.cl; mferrer@imim.es 1 Department of Pediatric Dentistry and Orthodontics, Faculty of Dentistry, Universidad de La Frontera, Temuco, Chile 7 Health Services Research Group, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain Full list of author information is available at the end of the article © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Atala-Acevedo et al. BMC Oral Health (2020) 20:6 Page 2 of 10 Background general health in Spanish which allows to monitor the Oral health is an integral part of general health, and oral impact of oral conditions on the quality of life of pre- conditions such as dental caries, gingivitis, malocclusions or school children. traumatic dental injuries can affect the life of an individual The aim of this study was to cross-culturally adapt the in areas including social, physical and emotional function- original parent-reported version for toddlers of the ing [1–3]. For this reason, the oral health of children and PedsQL™ Oral Health Scale into Chilean Spanish and to adolescents may be considered particularly crucial, given assess the acceptability, reliability and validity of this ver- that a poor state of oral health may have negative effects on sion, which allows discriminating between groups with their learning skills, growth, socialization and everyday ac- different oral health problems, in Chilean preschool tivities, affecting their quality of life [4–6]. population. Although the PedsQL™ Oral Health Scale Oral Health-Related Quality of Life (OHRQoL) has was developed to measure OHRQoL among children been defined as “a multidimensional construct that aged 2 to 18 years (with parent-reported form for 2–4 includes a subjective evaluation of the individual’s oral years, and with parent- and self- report forms for 5–7 health, functional well-being, emotional well-being, ex- years, 8–12 years, and 13–18 years), we only adapted the pectations and satisfaction with care, and sense of self” version for toddlers because they were the priority group [7]. Knowledge about OHRQoL allows the perceived of Chilean oral health policies and several public health needs of the child and its family to be assessed [8]; it programs have been implemented in this age group. therefore helps to improve the development of oral health programs by identifying groups with higher risk, Materials and methods and improving access to health services [9]. The study was carried out in two phases. First, the ver- In response to these potential benefits, several instru- sion for toddlers (2–4 years old) of the PedsQL™ Oral ments have been developed to measure OHRQoL, deter- Health Scale was translated into Spanish and adapted to mining the impact of dental diseases and treatment the Chilean culture. In the second phase, its psychomet- experiences in pre-school children. A recent systematic ric properties were evaluated in a Chilean pre-school review identified five instruments applicable to pre- sample. The study was approved by the Ethics Commit- schoolers, the development of which was published be- tee of Universidad de La Frontera (Decision 061/2015). tween 2002 and 2014 [10]. Only one of them, the Pediatric Quality of Life Inventory™ (PedsQL™) Oral Instrument Health Scale, was designed to measure children’s general The PedsQL™ Oral Health Scale is a questionnaire con- oral health status as a component of general health- taining five items with five response alternatives: 0 = related quality of life [11]. never a problem, 1 = almost never a problem, 2 = some- The PedsQL™ 4.0 questionnaire is a generic instrument times a problem, 3 = often a problem, 4 = almost always for evaluating the quality of life of children and adoles- a problem. The score for each item is reversed and cents aged between 2 and 18 years, originally developed transformed to a linear scale of 0–100 (0 = 100; 1 = 75; in English [12]. The version for pre-school children, 2 = 50; 3 = 25; 4 = 0). The scale scores are calculated as which is answered by their parents and/or guardians, the sum of the items divided by the number of items an- consists of 21 items divided into four sub-scales: Physical swered, such that a higher score indicates better OHR- Functioning (8 items), Emotional Functioning (5 items), QoL. The version for toddlers is completed by parents Social Functioning (5 items) and School Functioning (3 or guardians [11]. items). It was cross-culturally adapted and validated in Chile by Plaza and cols [13]., presenting adequate metric Cross-cultural adaptation properties. The cross-cultural adaptation of the PedsQL™ Oral The PedsQL™ 4.0 also has specific modules for various Health Scale into Chilean Spanish followed international chronic diseases and clinical situations such as asthma, standards for the development of new linguistic versions arthritis, diabetes or pain, which could be used along equivalent to the original instrument [16]. with the PedsQL™ 4.0 Generic Core Scale. It is directed The English version of the PedsQL™ Oral Health Scale at both children suffering chronic or acute diseases and was translated into Spanish independently by two profes- healthy ones. sional translators whose native language was Spanish. The One of those modules corresponds to the PedsQL™ translators were asked to maintain the conceptual equiva- Oral Health Scale. Few studies have assessed the psycho- lence of the original version, rather than a literal transla- metric properties of the PedsQL™ Oral Health Scale [14, tion (to obtain natural expressions which expressed the 15], and it had not previously been cross-culturally same concept), and to score the difficulty in finding the adapted into Spanish. It is therefore of vital importance conceptual equivalence for each item from 1 (minimum to have an OHRQoL assessment instrument linked to difficulty) to 10 (maximum difficulty). Atala-Acevedo et al. BMC Oral Health (2020) 20:6 Page 3 of 10 The two Spanish translations of the PedsQL™ Oral dental health status. These questionnaires were sent by Health Scale were compared by a panel consisting of: mail to the parents who did not attend the meeting. two experts in OHRQoL assessment, two pediatric den- Four previously trained and standardized researchers tists, and the two translators. The discrepancies were carried out the dental examinations in rooms specially discussed until a first unified version was obtained. This equipped and adapted for the study, under artificial light, unified Spanish translation was reviewed by a group of involving visual inspection of the oral cavity after parents of pre-school children (3 fathers and 4 mothers), in prophylactic brushing with a toothbrush. The examiners order to check its applicability and comprehensibility. This were blinded to the questionnaire answers. The caries preliminary version was translated back into English, separ- diagnosis was based on the criteria proposed by the ately, by two native English speakers who also evaluated the World Health Organization (WHO) for Oral Health Sur- difficulty in finding equivalent expressions. Finally, the veys [17]. The types of traumatic dental injuries were equivalence between the original version and these back- classified according to Andreasen and Andreasen [18], translations was evaluated by the expert panel who rated and malocclusion was assessed by the presence or ab- the items as: A = conceptually and linguistically equivalent sence of at least one of the following alterations: anterior to the original item; B = functionally equivalent, but with open bite, overjet> 4 mm and anterior cross-over bite grammatical differences; or C = equivalence is not obvious. [19]. The researcher standardization process consisted Expressions evaluated with category C were reviewed by first of a theoretical calibration on the study protocol, the expert panel to improve the Spanish wording to achieve diagnostic criteria, dental examination system, and filling equivalence. The report on equivalence between the ori- in a clinical record. Practical calibration was then carried ginal and back-translated versions was sent to the author of out on 15 children selected at random from a school lo- the original PedsQL™ Oral Health Scale for evaluation. cated in the same district, but not included in the study. A cognitive debriefing interview was applied to 15 par- The inter-examiner agreement was high with kappa co- ents (2 fathers and 13 mothers, aged between 24 and 37 efficients of 0.83 and 0.70 for caries and malocclusion years) of children aged between 2 and 5 years, to assess traits. A series of 20 images was used to evaluate the the clarity and comprehensibility of the Spanish version. reliability of traumatic dental injuries (kappa = 0.79). The The parents first self-completed the whole questionnaire global intra-examiner agreement was kappa = 0.81. and afterwards, to assess what the parents had under- The socio-economic status of the family was estimated stood, they were asked open questions about their re- through the healthcare provision level determined by the sponses. A set of questions was used during the interview state health insurance. Families were classified in the low in order to obtain standardized information. socio-economic status if they had no resources and a tax- able monthly income lower than or equal to USD 367.73. Evaluation of validity and reliability To assess the metric properties of the Chilean version of Statistical analysis the PedsQL™ Oral Health Scale, a cross-sectional study The sample size was estimated following the recom- was carried out in public preschools in the district of mended standard of 2 to 20 participants per item with a Carahue (Southern Chile). Eleven preschools funded by minimum of 100 to 250 subjects [20, 21]. Considering the Chilean government participated in the study, which this last number of participants recommended, and as- was carried out between April and October 2016. suming a 20% of potential missing answers, the sample Pre-school children aged 2 to 5 years were included, to- size required was of 300 children. gether with their parents. The inclusion criteria were: chil- The descriptive analysis of the socio-demographic and dren without any systemic diseases, long-term medication clinical characteristics of the sample was carried out cal- or special health needs, and that both children and parents culating frequencies and percentages. The feasibility and agreed to take part in the study. Authorization was ob- acceptability of the PedsQL™ Oral Health Scale was ex- tained through a written informed consent in the case of amined by calculating the percentage of parents who did the parents and the verbal consent of the children. The not respond to some items. If more than 50% of the parents were invited to a meeting in the preschool, during items on the scale were missing, the scale score was not which the participating children had their mouths exam- calculated. When 50% or fewer items were missing, we ined and parents were asked to complete three question- imputed them by the mean of the completed items [11]. naires regarding their child: the PedsQL™ 4.0 Generic Distribution of the PedsQL™ Oral Health Scale scores Core Scale, the PedsQL™ Oral Health Scale and the Early was assessed by obtaining the range, mean, standard Childhood Oral Scale (ECOHIS). The parents also com- deviation, and floor and ceiling effects (percentage of pleted a structured questionnaire to collect information patients with minimum and maximum theoretical scores, on the child’s age, gender, socio-economic status and his- respectively). Small floor or ceiling effects (< 15%) are tory of oral hygiene habits, as well as their general and considered acceptable [21]. Atala-Acevedo et al. BMC Oral Health (2020) 20:6 Page 4 of 10 Two approximations were applied to estimate reliabil- validity implies showing that different instruments meas- ity: a) internal consistency assessed by Cronbach’s alpha uring a similar concept present at least moderate corre- coefficient [22]; and b) test-retest reproducibility evalu- lations. We hypothesized that the correlation coefficients ated by the intraclass correlation coefficient (ICC) [23]. between ECOHIS and PedsQL™ Oral Health would be Cronbach’s alpha coefficient ranges from 0 to 1 with moderate-to-strong, since both were designed to meas- values > 0.70 being considered acceptable [21]. An ICC ure OHRQoL. The data were analyzed using Stata 15 of < 0.40 indicates poor to fair agreement, 0.41–0.60 (Stata Corp, College Station, TX, USA). moderate agreement, 0.61–0.80 good agreement and > 0.80 excellent agreement [24]. The PedsQL™ Oral Health Results Scale was re-administered between 2 and 4 weeks after Transcultural adaptation the first administration in a sub-sample of 50% of the The translation of the 5 items was considered of low level participants in each preschool, which were selected at difficulty (< 2.5). In the back-translation, the mean difficulty random. Test-retest analysis was performed with this was 6.5 for item 3, and less than or equal to 3.5 for the rest. sub-sample, after excluding participants who reported When the conceptual equivalence was compared between change in oral health. the back-translation and the original questionnaire, they Confirmatory factorial analysis (CFA) was carried out were considered conceptually and linguistically equivalent to confirm the single dimension of the Chilean version in four of the five items. Only for item 3, “Having teeth that proposed by developers of the PedsQL™ Oral Health are dark in color”, the conceptual equivalence was rated B Scale. For non-standardized solutions, the pattern of (conceptually equivalent, with grammatical differences): fixed and free factorial loads remained constant. Various thus, after discussion by the group of researchers and trans- fit indices were calculated to evaluate the model, includ- lators, the expression in Spanish was modified to “Having ing the Comparative Fit Index (CFI), the Tucker-Lewis some dark-colored teeth”. The cognitive interview showed Index (TLI) and the Root Mean Square Error Approach that the instructions, items and response options were eas- (RMSEA). CFI and TLI values greater than or equal to ily understood by the parents, and no problems were identi- 0.95 indicate an excellent fit of the model, while values fied in distinguishing between the items or the different between 0.90 and 0.95 suggest only an acceptable fit of response options. All the parents agreed that the questions the model. RMSEA values below or equal to 0.06 indi- were intended to assess OHRQoL, and no modifications cate a good fit of the model, while values between 0.06 were needed as a result of the cognitive interviews. and 0.08 suggest only acceptable fit of the model [25]. Construct validity was assessed by following a known Study of metric properties groups approach, comparing groups with presence or In total, 435 children aged between 2 and 5 years were absence of oral conditions (caries, traumatic dental in- contacted for the study, two of whom were excluded be- juries and/or malocclusion) and groups defined by re- cause they had special health needs; 12 parents declined sponses to the following questions: “In general, how to sign the informed consent form and 93 children did would you rate the general health of your child?”, and not attend the clinical examination. Of the 328 children “In general, how would you rate the dental health of examined, 26 parents did not reply to the questionnaire your child?”. The possible answers to these two ques- (response rate = 92.1%), and one questionnaire contained tions were: 1 = Excellent; 2 = Very good; 3 = Good; 4 = answers to fewer than 50% of the items and was there- Fair; 5 = Poor. We hypothesized lower scores (poorer fore excluded from the analysis. Finally, a total of 301 OHRQoL) in the PedsQL™ Oral Health Scale for the families (children and parents) took part in the study. children whose parents reported regular or poor oral The descriptive information details are shown in Table 1. health; also, lower scores in the PedsQL™ Oral Health The mean age of the children included was 47.8 months Scale among the groups of children with diagnosis of (4 years) (SD = 13.3), 54% were boys (n = 162), and 75.7% dental health problems in the oral examination. Com- presented low socio-economic status. Of the parents, parisons between groups were performed with non- 83.3% reported that their children had good or very parametric Mann Whitney tests due to the score distri- good general health and 70.4% reported good or very butions of the PedsQL™ scales. good oral health. Seventeen percent declared that their The convergent validity was assessed by examining the children brushed their teeth once a day or less often, correlation between the PedsQL™ Oral Health Scale and and 83.3% that the children brushed their teeth twice a ECOHIS, using Spearman’s correlation coefficients inter- day or more. The prevalence of caries experienced preted as follows: insignificant relation when r < 0.20; (dmft≥1) in the population examined was 53.8%, with a weak between 0.20 and 0.40; moderate between 0.40 and mean dmft of 2.52 (SD 3.71); the prevalence of maloc- 0.60; moderate-to-strong between 0.60 and 0.80; and clusions was 39.4%, and the traumatic dental injuries strong relation when r > 0.80 [26]. The convergent were 14.6%. Atala-Acevedo et al. BMC Oral Health (2020) 20:6 Page 5 of 10 Table 1 Demographic and clinical characteristics of the children Table 2 shows distribution statistics and Cronbach’s assessed in the study alpha coefficient of the PedsQL™ scales. The mean scores Variables n (%) in the PedsQL™ 4.0 Generic Core Scale and Oral Health Child’s age in years (mean ± SD) 4.0 (1.1) Scale were 82.2 (SD = 12.2) and 89.1 (SD = 16.1) respect- Child’s gender ively. No floor effect was observed, but a substantial ceiling effect was observed in the PedsQL™ Oral Health Male 162 (54.0) Scale (46.5%). Cronbach’s alpha was 0.87 for the Female 139 (46.0) PedsQL™ 4.0 Generic Core Scale and 0.79 for the Socioeconomic status PedsQL™ Oral Health Scale. The ICC was 0.86 (95% CI = Low 228 (75.7) 0.78–0.91) for the PedsQL™ Oral Health Scale among Medium-high 73 (24.3) the subsample of 84 parents who participated in the Child’s general health, reported by parents test-retest reliability study. Figure 1 shows results of the confirmatory factor ana- Very good/Good 251 (83.3) lysis (CFA) in which the five items of the PedsQL™ Oral Regular/Poor 50 (16.6) Health Scale loaded on a single latent variable. However, Child’s oral health, reported by parents the CFA model did not fit the data adequately: CFI = Very good/ Good 212 (70.4) 0.927, TLI = 0.855 and RMSEA = 0.160. To improve the Regular/ Poor 89 (29.5) overall model fit, a Lagrange multiplier test was applied Tooth brushing and covariances were incorporated between: item 1 (Having tooth pain) and 2 (Having tooth pain when eat- Once a day or less 50 (16.6) ing or drinking something hot, cold, or sweet); and item Twice or more 251 (83.3) 4 (Having gum pain) and 5 (Having blood on his or her Simplified Oral Hygiene Index toothbrush after brushing). The new model showed a Good 161 (53.5) better goodness of fit indices: CFI = 0.996, TLI = 0.987 Regular 125 (41.5) and RMSEA = 0.048. Poor 15 (5.0) Table 3 shows the results for the construct validity based on known groups. The children whose parents re- Decayed, missing and filled teeth index (mean ± SD) 2,52 (SD 3.71) ported poorer general and oral health obtained signifi- Dental Caries cantly lower scores in the PedsQL™ Oral Health Scale, Caries free (dmft = 0) 139 (46.1) meaning a lower quality of life (p < 0.05). Finally, al- Caries presence (dmft > 1) 162 (53.8) though the PedsQL™ Oral Health Scale score showed Malocclusion significant differences between children with and with- Absence 182 (60.6) out dental caries (p < 0.0001), differences were no statis- tically significant between those with and without Presence 119 (39.4) malocclusion (p < 0.142) or traumatic dental injuries Traumatic Dental Injuries (p < 0.126). An inverse moderate-to-strong (r = − 0.64) None 257 (85.4) correlation between the PedsQL™ Oral Health Scale and Infraction 27 (8.9) ECOHIS was found, while the correlation with the gen- Enamel fracture 4 (1.3) eric core scale was moderate (r = 0.25). Avulsion 2 (0.7) Discoloration 11 (3.7) Discussion The Spanish version of the PedsQL™ Oral Health Scale toddler form for Chile presented high reliability and val- All items of the PedsQL™ Oral Health Scale were com- idity for measuring the parents’ perception of the quality pleted by the participants, while 4.6% of them left some of life related with their children’s oral health, when used item without completion in the PedsQL™ 4.0 Generic Core together with the PedsQL™ 4.0 Generic Core Scale. The Scale. The school functioning sub-scale reported the high- results are consistent with those obtained for the original est percentage of missing replies by the respondents PedsQL™ oral health module and suggest that the Chilean (2.3%). The most reported problem was “having some version is conceptually and metrically equivalent. dark-colored teeth” (32.6% almost never, sometimes, often There was no data loss in the PedsQL™ Oral Health or almost always) in the PedsQL™ Oral Health Scale; and Scale, which was consistent with the findings of Bendo for the PedsQL™ 4.0 Generic Core Scale, “[ …] has feeling et al. [14]. These results suggest that the items making angry been a problem for your child” (80.9% almost never, up the scale were well understood and acceptable for sometimes, often or almost always). parents of pre-school children. In our study, none of the Atala-Acevedo et al. BMC Oral Health (2020) 20:6 Page 6 of 10 Table 2 Distribution and reliability of the PedsQL™ 4.0 Generic Core Scale and Oral Health Scale scores Scale Number of items Observed range Median (IQR) Mean (SD) Floor effect (%) Ceiling effect (%) Cronbach’s alpha Total Generic Core Scale 21 42.9–100 84.5 (14.3) 82.2 (12.2) 0 2.66 0.87 Physical Functioning 8 18.8–100 90.6 (21.9) 85.27 (16.47) 0 26.6 0.83 Emotional Functioning 5 25–100 80 (25) 76.58 (16.27) 0 9.6 0.75 Social Functioning 5 20–100 90 (20) 85.99 (14.99) 0 32.9 0.74 School Functioning 3 16.7–100 77 (25) 76.95 (18.26) 0 21.3 0.56 Oral Health Scale 5 5–100 95 (15) 89.05 (16.08) 0 46.5 0.79 Floor effect: percentage of patients with minimum score; Ceiling effect: percentage of patients with maximum score IQR Interquartile range; SD standard deviation parents asked for help in filling out the questionnaires. participants’ characteristics, since 54% of the children The sub-scale which presented the highest non-response were free of oral conditions. Furthermore, systemic path- rate was school functioning. As the questionnaire was ologies were considered exclusion criteria. We find these administered only to the parents, it is likely that they did results surprising, as our sample was drawn from state not have enough information about their children’s de- schools attending low socio-economic population, and velopment and behavior in preschool. Nevertheless, due the study zone (District of Carahue) has a large rural to the cognitive immaturity and parental dependence of component. However, various government programs pre-school children, the parents are the best source for have been implemented over the years to reduce the assessing their general and oral health [27]. gaps existing in this population, so this is a promising The mean total scores of the PedsQL™ Oral Health result for further progress towards improving these Scale and the PedsQL™ 4.0 Generic Core Scale were strategies. quite high, indicating good perception by the parents of The high ceiling effect observed (46.5%) is similar to their children’s quality of life related with oral (mean 89 that reported by Bendo et al. [14] (37.5%), and consistent points) and general health (mean 82 points), similar to with the low number of oral problems experienced by the study performed with the original scale (88 and 83 our sample. Pakpour et al. [15] in contrast, detected a respectively). These good results are explained by the low ceiling effect (< 15%), which may be due to the fact Fig. 1 Confirmatory factor analysis on the 5-item PedsQL™ Oral Health Scale Atala-Acevedo et al. BMC Oral Health Table 3 Construct validity of PedsQL™ Generic Core Scale and Oral Health Scale module based on known groups Scale Parents perception Parents perception dmft Median (IQR) Malocclusion TDI Median (IQR) (2020) 20:6 p p P P p of child’s general of child’s oral health Median (IQR) health Median (IQR) Median (IQR) Very good/ Regular/Poor Very good/Good Regular/Poor 0 >1 Absence Presence Absence Presence Good Physical Functioning 90.6 (21.9) 87.5 (31.3) 0.351 90.6 (18.8) 87.5 (28.1) 0.240 90.6 (21.9) 90.6 (25) 0.471 90.6 (21.9) 90.6 (25) 0.37 90.6 (21.9) 87.5 (18.8) 0.059 Emotional Functioning 80.0 (25) 75.0 (30) 0.032a 80.0 (20) 75 (25) 0.097 80.0 (20) 80.0 (25) 0.703 80.0 (25) 75 (25) 0.671 80 (25) 75 (27.5) 0.278 Social Functioning 90.0 (20) 90.0 (25) 0.555 90.0 (20) 90 (25) 0.607 90.0 (20) 90.0 (20) 0.605 90.0 (25) 90.0 (20) 0.54 90 (20) 85 (25) 0.437 School Functioning 83.3 (25) 75 (16.7) 0.063 83.3 (25) 75 (16.7) 0.206 77.0 (25) 77.0 (25) 0.489 83.3 (25) 75 (33.3) 0.167 77 (25) 75 (25) 0.278 Total Generic Core Scale 84.5 (15.4) 82.7 (21.4) 0.106 85.7 (15.5) 82.1 (20.2) 0.008a 83.3 (14.3) 85.4 (16.7) 0.454 85.4 (14.3) 84.5 (16.7) 0.334 85.7 (15.5) 81.5 (14.9) 0.227 a Oral Health Scale 95.0 (15) 90.0 (25) 0.025 100.0 (10) 85 (20) < 0.001a 100.0 (5) 90.0 (25) < 0.001a 97.5 (15) 95 (20) 0.142 95 (15) 90 (20) 0.126 a Mann Whitney test p value < 0.05 IQR Interquartile range; dmft decayed, missing and filled teeth index; TDI Traumatic Dental Injuries Page 7 of 10 Atala-Acevedo et al. BMC Oral Health (2020) 20:6 Page 8 of 10 that their study included older children (aged 8–18 years) showed that only very severe malocclusion could affect with greater oral damage. For this reason, the Chilean ver- the overall OHRQoL [30]. The type of traumatic dental sion needs to be tested in populations with higher levels injuries detected most frequently in our study was enamel of oral problems to evaluate its metric properties among fracture, which does not have a significant impact on the population with more severe oral problems. quality of life of pre-school children [3]. It is important to The internal consistency of the PedsQL™ Oral Health consider that the prevalence of TDI was low (14.5%) in Scale assessed by Cronbach’s alpha coefficient achieved our sample and only 2 preschoolers suffered complicated the recommended standard of > 0.70. When the original TDI (avulsion). On the other hand, although differences version of this scale was evaluated in USA, it was 0.68. per malocclusion or TDI were not statistically significant Our study presented slightly higher reliability values due to its small magnitude, in both cases the patients than the original study, which may be because we had a without these problems showed a better OHRQoL than larger sample, allowing a more precise estimate. Pakpour those with them. Studies based in schools have the advan- et al. [15], in their adaptation and evaluation of the psy- tage of including children with a wide range of good and chometric properties of these scales in an Iranian popula- poor oral health, and the disadvantage of including less se- tion, reported higher Cronbach’s alpha coefficient values vere oral problems than in clinical settings. than ours (0.89), with a considerably large sample (1053 As hypothesized a priori, the correlation between the children and 1026 parents) [15]. Bendo et al. [14], in a PedsQL™ Oral Health Scale and ECOHIS was high, since version adapted for Brazil, obtained Cronbach’s alpha co- their items are related principally with dental pain [31]. efficient values below the acceptable level (0.59). The test- Both are specific scales designed to measure the same con- retest reliability of the PedsQL™ Oral Health Scale in our struct, OHRQoL. Although moderate, the correlation found study was high (0.86), similar to that reported in other with the PedsQL™ Generic Core Scale was lower than re- validations (range 0.81–0.90) [15, 28, 29], indicating that ported in other studies [14, 15]. Generic HRQoL instru- the Chilean version presented good reproducibility when ments are unable to measure the impact of the small but administered at two different times. important impairment produced for a particular pathology. Our results of CFA supported that there was no discrep- Diseases may affect different functions and lead to different ancy between observed values and the values expected physical or emotional problems, or affect other aspects of under the theoretical model of the PedsQL™ Oral Health quality of life [32]. Our results are in line with other studies Scale. Similar results were previously reported after the in- which show that OHRQoL scales are more sensitive than corporation of covariances in other studies carried out in the PedsQL™ Generic Core Scale in measuring the impact schoolchildren from Brazil and Iran [14, 15]. No CFA has of oral problems in pre-school children [31]. been reported by the original USA instrument. One of the main limitations of the study was that the The PedsQL™ Oral Health Scale was capable of distin- sample was drawn from a location in southern Chile guishing between groups defined by the dental state of with high indices of low income and rural residence. It the children, as reported by the parents. These findings was therefore quite homogeneous in socio-economic were consistent with previous studies in which the par- terms. In addition, being a community-based sample, ents who perceived that their children’s oral health was not all conditions were well represented. Therefore, we poor had significantly lower scores in the Oral Health cannot recommend yet the use of the Chilean version of Scale [14, 15]. Also, the score on the PedsQL™ Oral the PedsQL™ Oral Health Scale to measure the impact of Health Scale was lower in children who presented dental TDI or malocclusions on OHRQoL. Further research is problems than those suffering no disease (dmft = 0), needed in other settings to explore the ability of the in- which is consistent with studies carried out in Iran [15] strument to discriminate between certain degrees of and Brazil [14]. It is interesting to remark that those these conditions. However, this is a priority population children whose parents reported worse oral health in for the implementation of public policies, and evaluation their child presented a significantly worse emotional of their OHRQoL can provide information to support functioning, measured with the PedsQL™ 4.0 Generic decision-making. Although the PedsQL form for tod- Core subscale. The same was observed in the study of dlers was developed for the age of 2–4 years, we decided the Brazilian version [14] where PedsQL™ was adminis- to include children up to and including five years old be- tered to both parents and children. cause we needed a tool that can be used in preschoolers The PedsQL™ Oral Health Scale was not able to meas- (2–5 years old). On the other hand, it is relevant to high- ure the impact of malocclusion problems or traumatic light that the parent-reported forms are the same for dental injuries in our sample. A recent systematic review each specific age group. Furthermore, the sensitivity to concluded that malocclusions in this age group are not change was not assessed, so further studies are needed perceived by the parents as a problem with impact on the to assess the ability of the Chilean version of the child’s quality of life [1]. Furthermore, a meta-analysis PedsQL™ Oral Health Scale to detect changes over time. Atala-Acevedo et al. BMC Oral Health (2020) 20:6 Page 9 of 10 Conclusions CIGES, Universidad de la Frontera, Temuco, Chile. 4Department of Public The results of the present study support the applicabil- Health, Faculty of Medicine, Universidad de Frontera, Temuco, Chile. 5 Iberoamerican Cochrane Centre, Biomedical Research Institute Sant Pau (IIB ity, reliability and validity of the Spanish language ver- Sant Pau), Barcelona, Spain. 6CIBER Epidemiología y Salud Pública (CIBERESP), sion of the PedsQL™ Oral Health Scale for Chilean Madrid, Spain. 7Health Services Research Group, IMIM (Hospital del Mar population, reported by the parents or guardians of chil- Medical Research Institute), Barcelona, Spain. dren aged 2 to 5 years. 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