Surgical Care for School-Aged Youth With Cleft: Results From a Multicenter, Prospective Observational Study.

OBJECTIVE: To explore factors related to completion of surgery recommendations among children with cleft lip and palate (CLP) or cleft palate only (CPO). DESIGN: Multicenter prospective longitudinal cohort study (2009-2015). SETTING: Six cleft centers in the United States. PATIENTS/PARTICIPANTS: A diverse sample of 1186 youth aged 7.5 to 18.5 years with CLP or CPO and a caregiver. RESULTS: Data were collected from child-caregiver dyads at baseline and up to 3 follow-up visits. Of the 765 surgeries recommended during the study period, 83 were postponed and 597 were completed; this represents a completion rate of 78%. There were multiple reasons identified by patients for why the remaining 85 recommended surgeries were not completed. Children with nonprivate insurance were more likely to postpone recommended surgeries. Hispanic/Latino and Asian children had fewer surgeries compared to whites/Caucasians. Greater severity in rated speech differences was associated with more surgeries. Among participants who had completed all recommended surgeries, providers rated over 86% as having normal or mildly different facial appearance and 83% as having a normal or mild speech intelligibility rating. Similarly, caregivers rated 80% of facial appearance and 78% of speech positively. Approximately 25% of children had an additional surgical recommendation at the end of the study. CONCLUSIONS: The majority of surgical recommendations were completed with positive outcomes in facial appearance and speech intelligibility by provider and caregiver ratings. Several factors contributed to surgical recommendations not being completed and the results underscore the importance of examining socioeconomic and demographic disparities in surgical care.

Oral health-related quality of life in youth receiving cleft-related surgery: self-report and proxy ratings.

PURPOSE: This paper evaluated the impact of cleft-related surgery on the oral health-related quality of life (OHRQoL) of youth with cleft over time. METHODS: Data were derived from a 5-year, multi-center, prospective, longitudinal study of 1196 youth with cleft lip and/or palate and their caregivers. Eligible youth were between 7.5 and 18.5 years old, spoke English or Spanish, and were non-syndromic. During each observational period, which included baseline, and 1- and 2-year post-baseline follow-up visits, youths and their caregivers completed the Child Oral Health Impact Profile, a validated measure of OHRQoL. Multilevel mixed-effects models were used to analyze the effects of receipt of craniofacial surgery on OHRQoL over time. RESULTS: During the course of this study a total of 516 patients (43 %) received at least one surgery. Youth in the surgery recommendation group had lower self- (ß = -2.18, p < 0.05) and proxy-rated (ß = -2.92, p < 0.02) OHRQoL when compared to non-surgical self- and proxy-rated OHRQoL at baseline. Both surgical and non-surgical youth (ß = 3.73, p < 0.001) and caregiver (ß = 1.91, p < 0.05) ratings of OHRQoL improved over time. There was significant incremental improvement (time × surgery interaction) in self-reported OHRQoL for youth postsurgery (ß = 1.04, p < 0.05), but this postsurgery increment was not seen in the caregiver proxy ratings. CONCLUSIONS: Surgical intervention impacts OHRQoL among youth with cleft. Youth who were surgical candidates had lower baseline self- and caregiver-rated OHRQoL when compared to non-surgical youth. Youth who underwent cleft-related surgery had significant incremental improvements in self-rated but not caregiver (proxy)-rated OHRQoL after surgery.

Minimally important difference of the Child Oral Health Impact Profile for children with orofacial anomalies.

BACKGROUND: The Child Oral Health Impact Profile (COHIP) is an instrument designed to measure the self-reported oral health-related quality of life of children between the ages of 8 and 15, including domains for oral health, functional well-being, social-emotional well-being, school environment and self-image. The purpose of this study was to estimate the minimally important difference (MID) of the COHIP for patients with cleft lip/palate. METHODS: Data from a 6-year, prospective, longitudinal cohort study of children with cleft lip/palate were analyzed to estimate the MID. Analysis was restricted to patients with data at baseline and first follow-up and not receiving a surgical intervention in the intervening years (N = 281). MIDs were estimated via the anchor-based method, using the Global Assessment of Change, and the effect size distribution method. RESULTS: Based on the distributional method, the minimally important differences were 0.16 (oral health), 0.12 (functional), 0.22 (social-emotional), 0.21 (school environment) and 0.19 (self-image). MID anchor estimates for COHIP domains ranged from -0.32 to 0.84. The anchor-based and effect size MID estimates for the overall COHIP score were 2.95 and 0.25, respectively. CONCLUSION: The minimally important difference of the Child Oral Health Impact Profile is recommended for interpreting clinically meaningful change in patients with cleft lip/palate.

Oral Health-Related Quality of Life and Self-Rated Speech in Children With Existing Fistulas in Mid-Childhood and Adolescence.

OBJECTIVE: To report the associations of oro-nasal fistulae on the patient-centered outcomes oral health-related quality of life and self-reported speech outcomes in school aged-children. DESIGN: Prospective, nonrandomized multicenter design. SETTING: Six ACPA-accredited cleft centers. PARTICIPANTS: Patients with cleft palate at the age of mixed dentition. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Prevalence of fistula and location of fistula (Pittsburgh Classification System). Patients were placed into one of three groups based on the following criteria: alveolar cleft present, no previous repair (Group 1); alveolar cleft present, previously repaired (Group 2); no congenital alveolar cleft (Group 3). Presence of fistula and subgroup classification were correlated to oral health-related quality of life (Child Oral Health Impact Profile [COHIP]) and perceived speech outcomes. RESULTS: The fistula rate was 5.52% (62 of 1198 patients). There was a significant difference in fistula rate between the three groups: Group 1 (11.15%), Group 2 (4.44%), Group 3 (1.90%). Patients with fistula had significantly lower COHIP scores (F1,1188 = 4.79; P = .03) and worse self-reported speech scores (F1,1197 = 4.27; P = .04). Group 1 patients with fistula had the lowest COHIP scores (F5,1188 = 4.78, P =.02) and the lowest speech scores (F5,1188 = 3.41, P = .003). CONCLUSIONS: Presence of palatal fistulas was associated with lower oral health-related quality of life and perceived speech among youth with cleft. The poorest outcomes were reported among those with the highest fistula rates, including an unrepaired alveolar cleft.

Assessment of presurgical clefts and predicted surgical outcome in patients treated with and without nasoalveolar molding.

Obtaining an esthetic and functional primary surgical repair in patients with complete cleft lip and palate (CLP) can be challenging because of tissue deficiencies and alveolar ridge displacement. This study aimed to describe surgeons' assessments of presurgical deformity and predicted surgical outcomes in patients with complete unilateral and bilateral CLP (UCLP and BCLP, respectively) treated with and without nasoalveolar molding (NAM). Cleft surgeon members of the American Cleft Palate-Craniofacial Association completed online surveys to evaluate 20 presurgical photograph sets (frontal and basal views) of patients with UCLP (n = 10) and BCLP (n = 10) for severity of cleft deformity, quality of predicted surgical outcome, and likelihood of early surgical revision. Five patients in each group (UCLP and BCLP) received NAM, and 5 patients did not receive NAM. Surgeons were masked to patient group. Twenty-four percent (176/731) of surgeons with valid e-mail addresses responded to the survey. For patients with UCLP, surgeons reported that, for NAM-prepared patients, 53.3% had minimum severity clefts, 58.9% were anticipated to be among their best surgical outcomes, and 82.9% were unlikely to need revision surgery. For patients with BCLP, these percentages were 29.8%, 38.6%, and 59.9%, respectively. Comparing NAM-prepared with non-NAM-prepared patients showed statistically significant differences (P < 0.001), favoring NAM-prepared patients. This study suggests that cleft surgeons assess NAM-prepared patients as more likely to have less severe clefts, to be among the best of their surgical outcomes, and to be less likely to need revision surgery when compared with patients not prepared with NAM.

Coping With Cleft: A Conceptual Framework of Caregiver Responses to Nasoalveolar Molding.

OBJECTIVE: To present a conceptual framework of caregiver coping and adaptation to early cleft care using nasoalveolar molding. DESIGN: In-depth interviews were conducted at three time points with caregivers of infants with cleft lip or cleft lip and palate whose children had nasoalveolar molding to treat their cleft. Qualitative data were analyzed using modified grounded theory. RESULTS: Most caregivers expressed initial apprehension and anxiety about the responsibilities of care associated with nasoalveolar molding (e.g., changing and positioning tapes, cleaning the appliance). In subsequent interviews, caregivers often reported positive feelings related to their active participation in their child's treatment for cleft. These positive feelings were associated with increased self-esteem and feelings of empowerment for the caregivers. Although caregivers also identified burdens associated with nasoalveolar molding (e.g., stress related to lip taping, concerns about the appliance causing sores in their child's mouth, travel to weekly appointments), they tended to minimize the impact of these issues in comparison with the perceived benefits of nasoalveolar molding. CONCLUSIONS: Despite the increased burden of care, many caregivers of infants with cleft used nasoalveolar molding as a problem-focused coping strategy to deal with their child's cleft. Completing nasoalveolar molding was often associated with positive factors such as increased empowerment, self-esteem, and bonding with their infant.

Parent-Reported Family Functioning Among Children With Cleft Lip/Palate.

OBJECTIVE: To examine family functioning related to sociodemographic and clinical characteristics in youth with cleft lip and/or palate (CL/P). DESIGN: Cross-sectional, multi-site investigation. SETTING: Six U.S. cleft centers. PATIENTS/PARTICIPANTS: A diverse sample of 1200 children with CL/P and their parents. MAIN OUTCOME MEASURE: Parents completed the Family Environment Scale (FES), which assesses three domains of family functioning: cohesion (or closeness), expressiveness (open expression of feelings), and conflict. Demographic and clinical characteristics were also assessed including race, ethnicity, type of insurance, and surgical recommendations. RESULTS: The FES scores for families seeking team evaluations for their youth with CL/P (mean age = 11.6 years) fall within the average range compared with normative samples. Families receiving surgical recommendations for their youth also had FES scores in the average range, yet families of children recommended for functional surgery reported greater cohesion, expressiveness, and less conflict compared with those recommended for aesthetic surgery (P < .05). For cohesion and expressiveness, significant main effects for race (P = .012, P < .0001, respectively) and ethnicity (P = .004, P < .0001, respectively) were found but not for their interaction. No significant differences were found on the conflict domain. Families with private insurance reported significantly greater cohesion (P < .001) and expressiveness (P < .001) than did families with public insurance. CONCLUSIONS: Family functioning across domains was in the average range. However, observed differences by race, ethnicity, type of insurance, and surgical recommendation may warrant consideration in clinical management for patients and families.

Examination of a theoretical model for oral health-related quality of life among youths with cleft.

OBJECTIVES: We evaluated relationships among physical and psychological indicators and oral health-related quality of life (OHRQOL) in youths with cleft. METHODS: We recruited youths aged 7 to 18 years with cleft palate (n = 282) or cleft lip and palate (n = 918) and their caregivers into a 5-year observational investigation at 6 US treatment centers from 2009 to 2011. At baseline, youths completed surveys to assess psychological status. After clinical evaluation, 433 youths received a recommendation for surgery. We developed structural models from the baseline data incorporating age, gender, race, and cleft diagnosis to examine direct relationships between depressive symptoms and, in separate models, self-concept and sense of mastery and OHRQOL. Subsequent models examined the possible mediating effect of surgical recommendation. RESULTS: Depressive symptoms were negatively and self-concept and self-efficacy were positively associated with OHRQOL. Surgical recommendation appeared to mediate the effect of psychological well-being, but not depression, on OHRQOL, even after adjustment for cleft diagnosis. In some models, individual-level characteristics were significant. CONCLUSIONS: Path analyses support the theoretical model and underscore the importance of examining positive psychosocial characteristics such as resiliency and self-concept in this patient population.

Evaluation of the similarities and differences in response patterns to the Pediatric Quality of Life Inventory and the Child Oral Health Impact Scores among youth with cleft.

PURPOSE: To examine (a) the pattern of responses to a generic health-related quality of life (HRQL) measure (Pediatric Quality of Life Inventory--PedsQL) and an oral health-related quality of life (OHRQoL) measure (Child Oral Health Impact Profile--COHIP), and (b) the associations of these scores with surgical recommendation status among youth with cleft. METHODS: Cross-sectional data (baseline) regarding clinicians' surgical recommendations and quality of life (QoL) measures were examined from an ongoing observational study on treatment outcomes. Approximately one-third of the racially and geographically diverse sample (N = 1,200; mean = 11.6 years) received surgical recommendations to correct either visible (aesthetic) or invisible (functional) defects. Effect sizes were used to quantify differences in QoL based on surgical recommendation and to compare the sensitivity of the PedsQL and COHIP subscales. Using Pearson coefficients, the scores of those recommended for surgery were compared with those without a surgical recommendation. RESULTS: A moderate correlation (0.52) was found between the total scores on the PedsQL and COHIP (p < 0.0001). Subscale correlations between the QoL measures ranged from 0.19 to 0.48 with the strongest correlation between the PedsQL Emotional (r = 0.47) and COHIP Socioemotional Well-being subscale. The effect size for the COHIP Socioemotional Well-being (0.39) was larger than the PedsQL Social/Emotional (0.07/0.11) subscale (Z = 5.30/Z = 4.64, p < 0.0001, respectively), and the total COHIP (0.31) was significantly greater than the total PedsQL scale (0.15, z = 2.65, p = 0.008). CONCLUSIONS: A significant relationship was found between generic HRQL, OHRQoL, and surgical needs among youth with cleft with the COHIP having larger effect sizes than the PedsQL among surgical groups.

International confederation for cleft lip and palate and related craniofacial anomalies task force report: holistic outcomes.

Objective : This paper describes the process and outcomes of the 2013 American Cleft Palate-Craniofacial Association task force on Holistic Outcomes. The goals and membership of the task force are presented. Methods : Using internet communication, the group introduced themselves, shared ideas and information related to holistic assessment and implementation of using a validated holistic measure, the Child Oral Health Impact Profile (COHIP) at participating international sites. Results : Data from the sites were analyzed using descriptive statistics. Administration of the COHIP was successful. It varied from self-completion as well as verbal presentation due to language differences and a function of the short time period to complete collection. Additionally qualitative comments were reported by the task force site directors. Conclusions : Future directions for holistic assessment and communication among task force members and sites were discussed at the Congress and are presented in this report.

Health disparities among children with cleft.

Oral health-related quality of life (OHRQoL) is a multidimensional construct that measures well-being associated with the teeth, mouth, and face. This cross-sectional study examined OHRQoL, demographic data, and clinical indicators in 839 treatment-seeking youths with cleft from 6 geographically diverse cleft treatment centers. Individuals without health insurance and representing ethnic minorities had lower OHRQoL scores on the Child Oral Health Impact Profile and a higher rate of surgical recommendations. These findings imply a risk factor for reduced OHRQoL and unmet needs among vulnerable youths with clefts.

Nasoalveolar molding: prevalence of cleft centers offering NAM and who seeks it.

INTRODUCTION: Nasoalveolar molding (NAM) is a treatment option available for early cleft care. Despite the growing debate about the efficacy of nasoalveolar molding, questions remain regarding its prevalence and the demographic characteristics of families undergoing this technique prior to traditional cleft surgery. OBJECTIVES: To determine the number of teams currently offering nasoalveolar molding and to identify salient clinical and sociodemographic variables in infants and families who choose nasoalveolar molding compared with those who choose traditional cleft care across three well-established cleft centers. RESULTS: Via phone surveys, 89% of the U.S. cleft teams contacted revealed that nasoalveolar molding is available at 37% of these centers. Chart reviews and phone correspondence with caregivers indicate that the average distance to the cleft center was 65.5 miles and caregiver age averaged 30.9 ± 5.7 years. Of families who chose nasoalveolar molding, 85% received total or partial insurance coverage. No difference in caregiver education, income, or distance to the clinic between treatment groups was found. On average, infants receiving nasoalveolar molding and cleft surgery had larger clefts and had more clinic visits than infants receiving traditional cleft surgery. Infants who were firstborn and those who did not have other siblings were more likely to receive nasoalveolar molding than were infants who were residing with other siblings. CONCLUSIONS: Currently more than one-third of U.S. cleft centers offer nasoalveolar molding. Although the cleft size was larger in the nasoalveolar molding group, no treatment group differences in education, income, and distance to the clinic were found.

A Comparison of Three Child OHRQoL Measures.

Comparing oral health-related quality of life (OHRQoL) measures can facilitate selecting the most appropriate one for a particular research question/setting. Three child OHRQoL measures Child Perceptions Questionnaire (CPQ11⁻14), the Child Oral Health Impact Profile (COHIP) and the Caries Impacts and Experiences Questionnaire for Children (CARIES-QC) were used with 335 10- to 13-year-old participants in a supervised tooth-brushing programme in New Zealand. The use of global questions enabled their validity to be examined. Assessments were conducted at baseline and after 12 months. All three measures had acceptable internal consistency reliability. There were moderate, positive correlations among their scores, and all showed differences in the impact of dental caries on OHRQoL, with children with the highest caries experience having the highest scale scores. Effect sizes were used to assess meaningful change. The CPQ11⁻14 and the CARIES-QC showed meaningful change. The COHIP-SF score showed no meaningful change. Among children reporting improved OHRQoL, baseline and follow-up scores differed significantly for the CPQ11⁻14 and CARIES-QC measures, although not for the COHIP-SF. The three scales were broadly similar in their conceptual basis, reliability and validity, but responsiveness of the COHIP-SF was questionable, and the need to compute two different scores for the CARIES-QC meant that its administrative burden was considerably greater than for the other two measures. Replication and use of alternative approaches to measuring meaningful change are suggested.

Oral-Health-Related Quality of Life in Children and Adolescents.

This article describes child oral health-related quality of life measures and provides some examples of their use in determining the effect of clinical interventions, such as dental treatment under general anesthesia, orthodontic treatment, and treatment of orofacial clefting.

Reliability and convergent and discriminant validity of the Child Oral Health Impact Profile (COHIP Child's version).

OBJECTIVES: The purpose of the current study was to assess the reliability as well as the convergent and discriminant validity of the Child Oral Health Impact Profile (COHIP). The questionnaire consisted of five domains that assessed oral health, functional well-being, social-emotional well-being, school environment, and self-image. COHIP was designed to measure self-reported oral health-related quality of life (OHRQoL) of children between ages 8 and 15 years old, using both positively and negatively worded items. METHODS: Children were recruited from pediatric, orthodontic, and craniofacial clinical settings in the USA and Canada. A comparison group of children not seeking dental treatment was recruited from two US elementary schools. Participants included 157 pediatric, 152 orthodontic and 110 patients with craniofacial anomalies, and 104 community-based participants. Scale reliability was assessed with Cronbach's alpha coefficient. Retest reliability was examined by intraclass correlation and paired t-test for a subset of participants who did not report a health change. Discriminant validity was assessed in two ways: (i) the COHIP scores of the four groups of children (three clinical and one community-dwelling) were compared by anova and (ii) for two of the clinical groups, the association between COHIP scores and clinical indices was calculated. Convergent validity was examined using partial Spearman correlations between COHIP scores and Global Health Ratings controlling for demographic variables. RESULTS: The children (n = 523) averaged 11.6 years (SD = 1.60); 51.6 % were female; and represented diverse ethnicities (black = 22.4%, Latino = 32.1%, white = 35.1%, other 10.4%). Overall COHIP scores ranged from 28 to 135 (mean +/- SD, 99.0 +/- 19.2) for the children. Scale reliability for the overall COHIP was excellent: Cronbach's alpha coefficient = 0.91 for the overall score. The test-retest reliability of the overall COHIP was also excellent (ICC = 0.84) and there was no statistically significant shift in scores over time. Discriminant validity was supported by significant differences (P = 0.003 overall COHIP) among the three clinical groups: the craniofacial group reported the lowest overall COHIP quality of life scores of the clinical groups. Within the pediatric dental group, children with greater dental decay reported lower COHIP scores suggesting a lower OHRQoL (r = -0.26, P = 0.02) and within the orthodontic group, children with larger overjet reported lower COHIP scores (r = -0.25, P = 0.005). Controlling for the effect of the participants' age, gender, and ethnicity, the association between the overall COHIP score and Global Health rating was statistically significant (P < 0.05) and similar in strength for the three clinical groups (pediatric dental = 0.29, orthodontic = 0.23, and craniofacial = 0.24) and highest for the community group (0.36). CONCLUSION: The overall COHIP showed excellent scale reliability overall and test-retest reliability. Both discriminant and convergent validity of the COHIP were supported by the comparisons among and within the four groups of children. Further testing will examine the utility of the instrument in both clinical and epidemiological samples.

Concurrent validity of the COHIP.

OBJECTIVES: This study examined the relationship between children's perception of their OHRQOL and their perceptions of their dentofacial image, social anxiety, and self-concept as an assessment of the concurrent validity for the Child Oral Health Impact Profile (COHIP). METHODS: A nonrandom, consecutive sample of children, ages nine to 14 years, was recruited for this observational validation study. Participants had been accepted for treatment in the University of North Carolina Graduate Orthodontic clinic. Data were collected after gathering initial orthodontic records and prior to delivery of any fixed or removable orthodontic appliances. Participants completed the COHIP and standardized dimension-specific questionnaires with known psychometric properties designed to assess self-concept, social anxiety, and perception of facial image. Child assent with caregiver consent was obtained prior to data collection. Pearson's correlations between each of the domains of the COHIP and the Dento-facial Image, the Social Anxiety Scale, and the self-concept domains of the Multidimensional Self Concept Scale (MSCS) were calculated. Criteria for support of concurrent validity was established based on directionality of expected relationships and strength of the observed correlation coefficient. Each correlation was assessed as meeting or not meeting the criteria. A one-tailed one sample Z-test was used to test the null hypothesis that 58% of the calculated correlations would meet the criteria (expected a priori) with an alterative that less than 58% would meet the criteria. RESULTS: The average age of the 52 subjects enrolled was 11.8; 40% were male; and 85% were Caucasian. The hypothesis that 58% of the calculated correlations defined a priori as expected relationships would meet the criteria was supported by the data (P = 0.63). The perception of dentofacial appearance was positively correlated (range = 0.39 to 0.45; with all of the COHIP domains except for the School domain. Overall, the COHIP domains, particularly Self-Image and Social Emotional subscales, were positively correlated (0.32-0.52) with the MSCS self-concept domain scores, except Family Self-Concept. The COHIP domains, particularly Functional Well-being and Social Emotional subscales, were negatively correlated (-0.76 to -0.33) with the three Social Anxiety subscales that include both fear of negative evaluation and social avoidance. CONCLUSIONS: The findings in this study lend support to the validity of the COHIP since 77% of the expected relationships between the domains of the COHIP and the domains of general, standardized dimension-specific instruments were observed. The decision to use condition-specific, dimension-specific, or general quality of life (QOL) measures is dependent on the purpose of the study. For investigations in children on the effect of dental treatments or in epidemiologic studies of an oral health outcome, the use of condition-specific QOL measures like the COHIP have the advantages of increased patient responsiveness since the assessment is focused on a specific condition, oral health, and increased sensitivity to treatment effects.

Questionnaire development: face validity and item impact testing of the Child Oral Health Impact Profile.

OBJECTIVE: The Child Oral Health Impact Profile (COHIP) was designed to assess oral-facial well-being in school-age children as reported by the child and via proxy report from a caregiver. This article describes the development of the COHIP using a multi-staged impact approach recommended by Guyatt et al. (Quality of life and pharmacoeconomics in clinical trials. Philadelphia, PA: Lippincott-Raven; 1996. p. 41). METHODS: There were multiple phases to the development of the questionnaire: (i) initial pool of items developed from the literature and expert review; (ii) face validity of items; (iii) impact evaluation of the initial item pool; (iv) development of positive items and face validity of new items; (v) impact evaluation of the revised questionnaire and (vi) factor analysis and final revision of the questionnaire. Factor analysis was completed on the final questionnaire using data from the impact evaluation in order to evaluate whether the COHIP measured independent conceptual domains. RESULTS: Factor analysis identified five domains: oral health, functional well-being, social/emotional well-being, school environment and self-image. Readability was calculated using the Flesch-Kinkaid readability score that was finalized at a 3.5 grade reading level. Finally, two response sets, and a revised format (e.g., including pictures, increasing font size, and shading every other item) were implemented to decrease respondent fatigue and increase accuracy of participant responses. CONCLUSIONS: The final questionnaire consisted of 34 items and five conceptually distinct subscales: oral health, functional well-being, social/emotional well-being, school environment and self-image. Subsequent papers present the validity and reliability of the COHIP.

Concordance between caregiver and child reports of children's oral health-related quality of life.

OBJECTIVE: This study sought to assess child-caregiver concordance regarding children's oral health related quality of life (OHRQoL) using the Child Oral Health Impact Profile (COHIP). METHODS: The sample comprised treatment-seeking children aged 8-15 with pediatric (n = 141), orthodontic (n = 135), and craniofacial (n = 100) needs and their caregivers. Children and their caregivers were queried concerning the child's Oral health, Functional Well-being, Social/Emotional Well-being, School environment and Self-image. These combined subscales yielded an overall OHRQoL rating. The dyads were distributed at recruitment locations as follows: Montreal (50 pediatric, 13 orthodontic, 15 craniofacial), UMDNJ (45 pediatric, 15 orthodontic, 0 craniofacial), and NYU (46 pediatric, 107 orthodontic, 85 craniofacial). Concordance was assessed with Spearman and intraclass correlations and Kruskal-Wallis testing of categories of agreement. RESULTS: Low to modest rates of agreement between child and caregiver were found for the sample overall. Rates of concordance between child and caregiver varied between clinical groups-craniofacial patients were more likely to rate OHRQoL higher than they were to agree with their caregivers' ratings. In contrast, pediatric and orthodontic patients were more likely either agree with or rate their OHRQoL lower than their caregivers' ratings. CONCLUSION: These findings of child-caregiver concordance using the COHIP supported previous work suggesting the usefulness of obtaining both child and caregiver reports of the child's QoL.

Challenges in conducting multicentre, multidisciplinary, longitudinal studies in children with chronic conditions.

OBJECTIVES: Conducting longitudinal, multicentre, multidisciplinary research for individuals with chronic conditions can be challenging. Despite careful planning, investigative teams must adapt to foreseen and unforeseen problems. Our objective is to identify challenges encountered and solutions sought in a recently completed observational, longitudinal study of youth with cleft lip and palate as well as their caregivers. METHODS: Data for analysis were derived from a 6-year, multicentre, prospective, longitudinal study of youth with cleft conducted from 2009 to 2015 that examined oral health-related quality of life and other related clinical observations over time in youth who had cleft-related surgery compared to those who did not. Youth and their caregivers participating in this study were followed at one of six geographically diverse, multidisciplinary cleft treatment centres in the USA. RESULTS: Establishing effective communication, ensuring protocol adherence, safeguarding data quality, recognizing and managing differences across sites, maximizing participant retention, dealing with study personnel turnover, and balancing/addressing clinical and research tasks were particularly exigent issues that arose over the course of the study. Attending to process, ongoing communication within and across sites, and investigator and clinician commitment and flexibility were required to achieve the stated aims of the research. CONCLUSION: Studying children with cleft and their caregivers over time created both foreseen and unforeseen challenges. Solutions to these challenges are presented to aid in the design of future longitudinal research in individuals with chronic conditions.

Oral health, related behaviors and oral health impacts among homeless adults.

OBJECTIVE: To assess the oral health needs, related behavior and oral health impact among homeless persons in Newark, New Jersey. METHODS: Participants represented a convenience sample of adults (n=46) participating in Homeless Services Day, an annual event sponsored by the Homeless Services Division of the Newark, NJ Department of Health and Human Services. Their mean age was 40.4 yr (SD=10.0), and 51.1% were female. The majority (76%) reported African-American ethnicity; remaining participants self-identified as Hispanic, White or Asian. Participants reported being homeless for a median of 11 months, with a range of 1 to 108 months. RESULTS: The 46 participants had 745 teeth (averaged 16.2 per person) that were either missing, had fillings or had untreated decay. Diseased teeth averaged 3.8 per person; missing teeth averaged 8.6 per person; and filled teeth averaged 3.7 per person. Only 28.3% had a dental visit in the past year. Approximately 87% reported negative oral health impacts impact: over half (55.6%) had current oral facial pain and two-thirds of our participants reported having dental-related face pain during the past year. Additional oral health impacts included: eating (42%), smiling (33%), concentrating (18%) and talking (16%). CONCLUSIONS: Consistent with other studies, this homeless sample presented with considerable oral health needs. Newark's homeless, like other homeless cohorts, face access to care and negative oral health impacts. This study informs the need for future research that can provide substantive evidence for care providers and policy makers.