Health-Related Quality of Life of Children Aged 11 to 14 Years With Orofacial Conditions

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1 Health-Related Quality of Life of Children Aged 11 to 14 Years With Orofacial Conditions DAVID LOCKER, B.D.S., PH.D. ALEKSANDRA JOKOVIC, B.D.S., M.H.SC., PH.D. BRYAN TOMPSON, D.D.S., M.SC. Objective: To assess the health-related quality of life (HRQoL) of 11- to 14- year-old children with orofacial conditions. Design: Thirty-nine patients with orofacial conditions were compared with 32 patients with dental caries. Outcome Measure: The multidimensional 37-item Child Perceptions Questionnaire for 11- to 14-year-old children (CPQ ). This forms one component of the Child Oral Health Quality of Life Questionnaire. Results: The orofacial group had slightly higher scores on the CPQ than the dental group (p.05). The scores were slightly to moderately higher on the functional limitations (p.01) and social well-being (p.01) domains. The groups did not differ with respect to oral symptoms or emotional wellbeing. Mouth breathing, problems with speech, missing school, being teased, and being asked questions about their condition were the only issues reported more frequently by the orofacial group (p.01). There was no evidence of social inhibition or withdrawal in the orofacial group. The children with orofacial conditions rated their oral health better than the children with dental decay (p.05). In both groups, the majority of children reported that their condition had little impact on their life overall. Conclusions: Based on CPQ scores, there were few differences in the HRQoL of 11- to 14-year-old children with orofacial conditions, compared with children with dental caries. This suggests that the majority of these children are well adjusted and able to cope with the adversities they experience as a result of their conditions. This may reflect the quality of the team approach used at the treatment setting at which they were recruited. KEY WORDS: children, orofacial conditions, quality of life Children are affected by numerous oral and orofacial disorders, all of which have the potential to compromise functioning, well-being, and the quality of life (Surgeon General s Report, 2000). These range from common conditions such as dental caries and malocclusions to relatively rare conditions such as cleft lip, cleft palate, or both, and craniofacial anomalies. Recent estimates indicate that 35% of Canadian children aged 13 to 14 years have experienced dental decay (Locker, 2002), as have 57% of U.S. children aged 5 to 17 years (Surgeon General s Report, 2000). Estimates of the prevalence of malocclusions vary but suggest that between 10% and 33% Dr. Locker and Dr. Jokovic are with the Community Dental Health Services Research Unit, Faculty of Dentistry, University of Toronto, Canada. Dr. Tompson is with the Department of Orthodontics, Faculty of Dentistry, University of Toronto, and Craniofacial Clinic, Hospital for Sick Children, Toronto, Canada. Supported by The Hospital for Sick Children Foundation, Grant XG Submitted May 2003; Accepted May Address correspondence to: Dr. David Locker, Faculty of Dentistry, University of Toronto, Toronto, Ontario M5G 1G6, Canada. david.locker@ utoronto.ca. have conditions sufficiently severe to warrant treatment (Brunelle et al., 1996; Mitchell and Carter, 1996). Cleft lip and palate is observed in 1.2 per 1000 births in the United States (Schulman et al., 1993) and craniofacial anomalies such as hemifacial microsomia in 1 per 5000 births (Mitchell and Carter, 1996). Because these latter conditions are more clinically severe and can affect facial appearance throughout life, it has been assumed, not unreasonably, that they will have a correspondingly greater impact on the quality of life. Consequently, there have been numerous studies of the psychosocial wellbeing of children with oro- and craniofacial conditions, fewer studies of children with malocclusion, and almost no studies of children with dental caries. Studies of children with cleft lip and palate indicate that, although they usually have positive self-concepts, some, but by no means all, may experience psychosocial problems (Broder, 2001; Strauss, 2001). These include anxiety (Pope and Ward, 1997), depression and social inhibition (Richman, 1978; Kapp-Simon et al., 1992), low self-esteem (Broder and Strauss, 1989), self-consciousness about their appearance (Richman and Eliason, 1982), and social adjustment problems (Leonard 260

2 Locker et al., QUALITY OF LIFE IN CHILDREN WITH OROFACIAL CONDITIONS 261 et al., 1991). Reduced acceptance by peers (Schneiderman and Harding, 1984) and behavioral and learning problems at school (Tobiasen et al., 1987; Broder et al., 1998) have also been reported. Although fewer studies of adults with oro- and craniofacial conditions have been undertaken, they report broadly similar findings (Marcusson et al., 2001). To date, few studies of the health-related quality of life of individuals with orofacial or craniofacial conditions have been undertaken. When assessing the outcomes of diseases and disorders of various kinds, a health-related quality-of-life perspective has the advantage that it is multidimensional and considers symptoms, physical functioning, and emotional and social well-being. It goes beyond psychological functioning to encompass clinical, psychosocial, and behavioral concerns (Corson et al., 1999). Consequently, measures of health-related quality of life can be used to assess both the needs for and outcomes of clinical and psychosocial interventions from the perspective of the individual concerned. As such, they have the potential to improve the quality of clinical and psychosocial care (Marcusson et al., 2001). Because they rely on the individual s own assessment of their well-being and quality of life as it is affected by a particular health condition, these measures are usually referred to as patient based (Locker, 1997). The health-related quality-of-life perspective has its origins in the original World Health Organization definition of health as a complete state of physical, mental and social well-being and not just the absence of disease and infirmity. It is also derived from theoretical models of disease/disorder and their consequences, all of which integrate biophysical and psychosocial concerns by linking biological variables with self-perceived health and quality-of-life outcomes. For example, a model described by Wilson and Cleary (1995) suggests that diseases and disorders of various kinds may result in symptoms, affect physical and psychosocial functioning, and lead to negative health perceptions and dissatisfaction with health status. In turn, these may have a negative impact on overall well-being and quality of life. A more complex interactive model is offered by the recently developed International Classification of Functioning, Disability and Health (Gray and Hendershot, 2000). Here health conditions (defined as disease, disorder, injuries, or trauma) are linked in various ways to problems with respect to body structure and functioning, activity limitations, and participation in life situations. Although the two models differ in many respects, they are similar in that the relationships between the component parts are influenced by contextual factors such as the characteristics of the individual and the characteristics of the environment in which the individual lives. The former include coping styles and capacities and psychological assets, and the latter includes social and organizational structures and attitudes and ideologies. By integrating body, individual, and society into broad explanatory frameworks, these models identify strategies by means of which the well-being and quality of life of those with health conditions may be enhanced. Numerous generic and disease-specific measures that can be used to assess health-related quality of life and to explore the explanatory models described above have been developed. All document the nature and frequency of the functional and psychosocial problems experienced by people with various health conditions. However, commonly used generic measures such as the Sickness Impact Profile (Bergner et al., 1981), the Nottingham Health Profile (Hunt et al., 1980), and the SF-36 (Ware and Sherbourne, 1992) are not appropriate for use with oral or orofacial conditions because they fail to capture the main concerns of individuals with these types of disorders (Allen et al., 1999). For example, Bressman et al. (1999) found that a generic quality-of-life measure was not sufficiently sensitive to the specific problems of people with cleft lip and palate. Measures have been developed specifically for assessing the health-related quality-of-life outcomes of oral conditions. However, it is not known whether the most commonly used measures, such as the Oral Health Impact Profile (Slade and Spencer, 1994), the Geriatric Oral Health Assessment Index (Atchison and Dolan, 1990), and the Oral Impacts on Daily Living (Adulyanon et al., 1996), are sensitive to the concerns of individuals with orofacial and craniofacial disorders. Certainly, because these measures were developed for use with adult and elderly populations, their form and content make them inappropriate for use in studies of children. Assessment of the health-related quality of life of children with oral and orofacial conditions has been limited by the lack of a measure applicable to these conditions in this population group. Consequently, we developed the Child Oral Health Quality of Life Questionnaire (COHQoL) (Jokovic et al., 2002). This was intended to be applicable to children with a wide variety of oral and orofacial conditions, to conform to contemporary concepts of child health, and to accommodate developmental differences among children of different ages (French and Christie, 1996; Pal, 1996). Accordingly, it consists of several components: a Parental Perceptions Questionnaire, designed to obtain parental reports of a child s oral health related quality of life; a Family Impact Scale, also to be completed by parents and intended to assess the impact of the child s oral/orofacial condition on the family; and three agespecific Child Perception Questionnaires for children aged 6 to 7 years, 8 to 10 years, and 11 to 14 years (CPQ ). This article briefly describes the development and evaluation of the CPQ It also uses data from this study to compare the health-related quality of life of children with orofacial and dental conditions. Participants MATERIALS AND METHODS Participants in the development and evaluation process were children aged 11 to 14 years with pediatric dentistry conditions (e.g., dental caries), orthodontic conditions, and orofacial/craniofacial conditions. All were otherwise healthy. They were recruited from clinics at the Faculty of Dentistry, University

3 262 Cleft Palate Craniofacial Journal, May 2005, Vol. 42 No. 3 of Toronto; The Hospital for Sick Children, Toronto; and clinics operated by Toronto Public Health Department. Development of the CPQ The CPQ was constructed using the process described by Guyatt et al. (1986) and Juniper et al. (1996). A preliminary pool of items was developed by a review of existing patientbased oral health and child health outcome measures. The comprehensiveness and relevance of these items were assessed during semiqualitative interviews with health professionals who treat children with oral and orofacial/craniofacial disorders, parents of child patients with these conditions, and child patients. On the basis of their comments, a modified item pool was developed by writing additional items and excluding irrelevant items. Items for the final questionnaire were selected using an item impact study. This identifies items of most importance to the patient population in question. Data were collected using a questionnaire constructed from the modified item pool and administered in face-to-face interviews. Eighty-three children from the three clinical groups defined above were asked if in the past 3 months they had experienced the problem described by each item. Those responding positively rated the importance of the problem on a 3-point Likert scale ranging from 0, Does not bother me at all to 3, Bothers me very much. An impact score was calculated for each item by multiplying the percent of children giving a positive response to the item by its mean importance rating. For each clinical group, items were ranked according to their impact scores. Those that were rated the most frequent and bothersome were selected for the final questionnaire. The final questionnaire consists of 37 items falling into four domains: symptoms, functional limitations, emotional well-being, and social well-being. The latter encompasses peer relationships, schooling, and social activities. Each question asks about the frequency of events in the previous 3 months. The exact wording of items is: Over the last 3 months, how often have you... been teased by other children... because of your teeth, mouth, lips, or jaws? The response options are: Never 0; Once or twice 1; Sometimes 2; Often 3; Every day or almost every day 4. Global ratings of oral health and the extent to which the oral or orofacial condition in question affected overall well-being were also obtained. The former asked Would you say that the health of your teeth, lips, jaws, or mouth was...? ;the latter asked How much does the condition of your teeth, lips, jaws, or mouth affect your life overall? These global ratings had a 5-point response format ranging from Excellent to Poor for oral health and from Not at all to Very much for well-being. The wording of all questions and their response options were based on consultations with child psychologists, teachers, and manuals for writers for children. They were modified where necessary following pretests with children in the clinical groups of interest. Evaluation of the CPQ The performance of the questionnaire was assessed in a validity and test-retest reliability study. A new sample of 123 children completed an initial copy of the questionnaire. After a period of 2 weeks, a subgroup of 70 children completed a second copy of the questionnaire. The questionnaires were self-administered. The first copy was completed during visits to the clinics at which treatment was provided, and the second copy was mailed to participants and completed at home. Clinical data pertaining to the oral or orofacial conditions in question were abstracted from the dental charts of the child participants. Overall scale scores and scores for its four domains, generated by summing the response codes for the items comprising the questionnaire, were used in assessments of construct validity and test-retest reliability. Validity and Reliability of the CPQ The CPQ showed excellent technical properties in terms of sensitivity, construct validity, and internal consistency and test-retest reliability. There were no floor or ceiling effects because there were no children with zero or maximum scores, respectively. Evidence of construct validity was obtained from associations between the scores and the global ratings of oral health and well-being, with rank correlations being 0.23 (p.05) and 0.40 (p.001). Cronbach s alpha for the overall scale was 0.91, and alphas for the four domains ranged from 0.64 to Test-retest reliability of the overall scale was excellent, with an intraclass correlation coefficient (ICC) of ICCs for the domains ranged from 0.79 to Health-Related Quality of Life of Children With Orofacial Disorders Data from the evaluation of the CPQ were used to assess the health-related quality of life of children with orofacial conditions. The overall and domain scores of children with these conditions were compared with those of children from pediatric dental clinics. The magnitude of the difference between groups was assessed using the effect size. This is derived from the mean difference in scores between groups divided by the pooled SD of scores. Because this is similar to an effect size calculation for paired observations, a value of 0.2 was taken to be small, 0.5 to be moderate, and 0.8 to be large (Cohen, 1988). The two groups were also compared with respect to their responses to individual items comprising the questionnaire and to global ratings of oral health and overall wellbeing. Differences between groups were assessed using nonparametric statistics and considered significant if p.05. RESULTS Data were obtained from 39 children with orofacial and craniofacial conditions and 32 children with dental conditions. Of the former, 11 had isolated cleft lip or palate, 14 unilateral

4 Locker et al., QUALITY OF LIFE IN CHILDREN WITH OROFACIAL CONDITIONS 263 TABLE 1 Group Scores CPQ Overall and Domain Scores by Clinical Dental (n 32) Mean Median Orofacial (n 39) Mean Median p* ES Overall scale Subscales Oral symptoms Functional limitations Emotional well-being Social well-being ES Effect sizes, difference in group means/pooled SD. * p values obtained from Mann-Whitney U tests NS.01 NS clefts, 5 bilateral clefts, and 9 craniofacial anomalies. All of the latter were treated for dental caries, with the mean number of decayed teeth being 4.5 (SD 4.0). Seven of these children also had malocclusion sufficiently severe to warrant a referral for orthodontic consultation. The mean age of the two groups was the same at 12.2 years. The orofacial group consisted of 25 boys and 14 girls, and in the dental group, there were 16 boys and 16 girls. CPQ Overall and Domain Scores The mean and median CPQ scores for the overall sample were 27.8 and 23.0, respectively. Both were small, compared with the possible maximum score of 148. Scores above the overall median value of 23.0 were observed in 59.0% of the orofacial group and 37.5% of the dental group (p.059; median split chi-square test). The overall scores ranged from 6 to 80 in the orofacial group and from 1 to 70 in the dental group. The mean score in the former (31.4) was significantly higher than in the latter group (23.2) (Table 1). However, the effect size of 0.45 was only moderate and indicated that the difference between groups was small in relation to the variability within the sample as a whole. There were significant differences between the groups for the functional limitations and social well-being domains, although effect sizes were moderate at 0.42 and 0.59, respectively. Responses to Individual CPQ Items When responses to individual items were examined, the orofacial group had significantly higher scores then the dental group for only five, with two being from the functional limitations domain and three from the social well-being domain (Mann-Whitney U test). These were: breathing though the mouth (p.01), difficulties with speech (p.01), missing school (p.01), being teased by other children (p.01), and being asked questions about their condition by other children (p.001). The dental group had higher scores than the orofacial group for the oral symptoms item concerning sensitivity of teeth to hot, cold, and sweet foods (p.05). TABLE 2 Distribution of Responses to the Social Well-Being Items in the Orofacial Group (%): During the Last 3 Months, How Often Have You... Because of Your Teeth, Mouth, Lips, or Jaws... Never Once or Twice Sometimes Often (Almost) Every Day Missed school* Had difficulty paying attention in school* Had difficulty doing homework* Avoided reading/speaking in class* Avoided social activities Avoided smiling Avoided other children Been teased by other children Been left out by other children Been asked questions by other children Avoided talking to other children Argued with friends or family * Schooling subscale. Social withdrawal/inhibition subscale. Reactions of others subscale. Emotional and Social Well-Being CPQ Domains Arguably the emotional and social well-being domains are of most importance with respect to overall quality of life and deserve more detailed consideration. The number of items in these domains with responses of sometimes, often, or every day was counted and the two groups compared. When scores were calculated in this way, 50.7% of the children in the dental group reported no emotional concerns, compared with 41.1% of the children in the orofacial group (ns; chi-square test). The mean number of items with these responses was 1.7 for the former and 2.0 for the latter group (ns; Mann-Whitney U test). Three-fifths (59.4%) of the dental group reported no problems with respect to social well-being, compared with 23.1% of the orofacial group (p.01: chisquare test). Means were 1.2 for the former and 2.5 for the latter (p.01; Mann-Whitney U test). Further analysis was undertaken by creating three social well-being subscales labeled schooling, social withdrawal, and reactions of others. The items comprising each subscale are indicated in Table 2. This subscale structure was confirmed by factor analysis using the principal components extraction method and varimax rotation with Kaiser normalization. The orofacial group had significantly higher scores than the dental group (p.001; Mann-Whitney U test) on the reactions of others subscale, indicating the greater frequency with which they reported being teased, asked questions, left out by other children, or arguing with others because of their condition. However, the scores on the social withdrawal subscale were not significantly different. The orofacial group

5 264 Cleft Palate Craniofacial Journal, May 2005, Vol. 42 No. 3 TABLE 3 Global Ratings of Oral Health in the Dental and Orofacial Groups TABLE 4 Global Ratings of the Extent to Which Life Overall Was Affected in the Dental and Orofacial Groups Rating Dental, % (n 32) Orofacial, % (n 39) Rating Dental, % (n 32) Orofacial, % (n 39) Excellent Very good Good Fair/poor * Significant group difference (p.05; chi-square test) * Not at all Very little Some A lot Very much had significantly higher scores on the schooling subscale (p.05; Mann-Whitney U test), but this was wholly accounted for by the item concerning absence from school. Table 2 shows the distribution of the responses to the social well-being items in the orofacial group. These data indicate that, although all of the concerns described by the items were reported, for most children they occurred on an infrequent or sporadic basis. For example, the responses provide little evidence of social withdrawal or inhibition. However, experiences emanating from the reactions of other people were encountered relatively frequently because the proportion of children responding often or every day or almost every day to the items in this subscale was between 7.7% and 18.0%. Global Ratings of Oral Health and Well-Being There was a significant difference between the two groups in their global ratings of the health of their teeth and mouth, with the orofacial group perceiving it as somewhat better than the dental group (Table 3). One third of the dental group reported that the health of their teeth and mouth was only fair or poor, compared with just over one tenth of the orofacial group (p.05; chi-square 4.68; df 1). There was no difference between the two groups in their ratings of the extent to which their oral or orofacial condition affected their life overall (Table 4). The majority in both groups reported that their condition had little or no effect. In the orofacial group, only seven children reported that it had some effect on their life overall, and only one child reported that his/her life was affected a lot. In the dental group the numbers were eight and zero, respectively (ns: chi-square 2.65; df 1). No children in either group indicated that their life was affected very much by their condition. DISCUSSION AND CONCLUSION This study used a recently developed instrument, the COHQoL, to provide some preliminary data on the healthrelated quality of life of a small sample of children with orofacial conditions. The comparison group was a sample of children with a relatively common dental condition (i.e., dental decay). The CPQ used in the study was developed in such a way that it included only items that were the most prevalent among children with oral and orofacial conditions and that they regarded as being important. Analysis of scores derived from the CPQ indicated that the health-related quality of life of the children participants with orofacial conditions was not markedly different from that of the children with dental conditions. Although the difference in scores was statistically significant, the effect size suggested that the magnitude of the difference in mean scores for the two groups was at best moderate in relation to the variability among the study participants as a whole. Moreover, the mean difference between the groups was only 8.2 on a scale that could range from 0 to 148. In addition, significant differences between groups were noted for only two of the four subscales. Again, the effect sizes were at best moderate. When individual items were examined, the orofacial groups had higher scores for only 5 of the 37 items comprising the questionnaire. Guyatt et al. (1987) and Juniper et al. (1994) have suggested that differences in scores on health-related quality-of-life questionnaires can be properly interpreted only once minimally important differences have been established. The minimally important difference is defined as the smallest difference in scores that patients perceive as being important and that would suggest a change in the patient s management (Jaeschke et al., 1989). This score can be determined only following longitudinal studies in which some individuals change and some do not, either as the result of therapy or natural fluctuations in the disorder. This work has yet to be undertaken with respect to the measure used in this study. However, evidence that the higher scores of the orofacial groups may not be that important is to be found in the responses to the two global items. The orofacial group rated the health of their teeth and mouth more favorably than the dental group and was no different in ratings of the extent to which their condition affected their lives overall. This leads to the conclusion that although the orofacial group may encounter more challenges in daily life, their overall quality of life is no different from that of children with more common oral conditions such as dental decay. This confirms the results of an earlier study that used a German quality-of-life instrument to measure the outcomes of cleft lip, cleft palate, or both in children aged 10 to 16 years (Bressman et al., 1999). The quality of life of the participants with clefts was similar to that of noncleft controls. Identical findings were reported in a comparison of the quality of life of adults with cleft lip, cleft palate, or both and that of noncleft controls (Marcusson et al., 2001). Although the cleft group rated some aspects of their life lower than the control group, there was no difference in overall quality of life. These studies are consistent with the observation by Strauss (2001) that, although appearance and speech may remain problematic for some people with orofacial

6 Locker et al., QUALITY OF LIFE IN CHILDREN WITH OROFACIAL CONDITIONS 265 conditions, the majority are productive, contributing, happy, satisfied individuals. There are two ways in which the lack of a marked difference in the health-related quality of life of the dental and orofacial groups may be explained. Both suggest that the latter have received high-quality clinical and psychosocial care at the clinical setting at which they were recruited. This clinical setting uses a team approach involving clinicians, psychologists, and social workers that provides social and emotional support to children and their families from birth as well as surgical and orthodontic intervention. First, previous studies have found an association between satisfaction with facial appearance and psychosocial functioning in children with cleft lip and palate (Thomas et al., 1997). Although we did not measure satisfaction with appearance in this study, responses to the items in the emotional well-being domain indicated that the children in the orofacial group were no more likely than the children in the dental group to report feeling less attractive than other people. Consequently, it is not unreasonable to suggest that the two groups were equally satisfied with their appearance. Second, the results can also be interpreted in terms of the contemporary models of health outcomes described earlier. That is, outcomes such as well-being and quality of life are the product of an interaction between health conditions and contextual factors. The utility of these models has been demonstrated in numerous studies of both adults and children with chronic conditions (Locker, 1997). These have indicated that physical and psychosocial functioning are not a direct product of the nature or severity of the underlying health condition (Locker, 1983; Heller et al., 1985; Harper et al., 1986; Williams and Bury, 1989). Rather, levels of disadvantage and deprivation consequent to any health condition are determined by the material, social, and psychological resources available to individuals and families and the way these are used in coping with the challenges posed by disease, disorder, or injury. In the context of research into oro- and craniofacial conditions, Strauss (2001), Broder (2001), and Eiserman (2001) have suggested that psychological assets such as optimism and resilience are major determinants of the health and well-being of individuals with these conditions. They have also suggested that research in orofacial and craniofacial conditions should be changed from a focus on deficits to a focus on strengths. Although we did not measure psychological attributes such as optimism and resilience in this study, the scores on the emotional well-being domain and its constituent items suggest a certain psychological robustness on the part of the children with orofacial conditions who participated in the study. Even though difficulties with speech, being teased, and being asked questions about their condition were aspects of their daily life, few reported being concerned with what other people think and few reported feeling different from or less healthy than other children. There was also no evidence of social withdrawal on the part of these children. This may explain why their global ratings of their oral health and life overall were better and no worse, respectively, than those of children with more common dental disorders. Although the reactions of others constitute the main challenge to individuals with a facial difference (Pruzinsky, 1992), the limited data presented here suggested that the children who participated in this study have the capacity to manage this challenge in ways that do not compromise their quality of life. Whether the psychological characteristics that promote adjustment to orofacial differences are inherent or learned in family or therapeutic contexts is not yet clear. Consequently, Strauss (2001) has called for the development of theory and research to explore the links between psychological capacities such as resilience and quality-of-life outcomes and the origins and genesis of these assets. Qualitative studies suggest that family support, humor, sense of self, coping skills, determination, and networking with others are important sources of resilience and contribute to personal and occupational success (Meyerson, 2001). Eiserman (2001) has suggested that, although we should be concerned about the minority of children who do not function as well as their peers, the majority who are not compromised by their condition should be given equal attention. Healthrelated quality-of-life measures can be used to identify the minority of children whose health and well-being is not optimal and who need additional care and attention. At the same time, they can be used to identify the majority of children who are happy and satisfied and, by careful comparisons of the social and psychological characteristics and contexts of the two groups, cast light on the determinants of these outcomes. Such research is likely to make an important contribution to the design of practices to help all children thrive (Eiserman, 2001). In this respect, theories of craniofacial health (Strauss, 2001) and the contemporary model of health and its determinants overlap to a considerable degree. Although the study suggests that children treated at the clinical settings from which they were recruited are well adjusted, it does have methodological shortcomings. Because the sample size for the study was based on the requirements for validity and reliability testing, the number of children in the orofacial and dental groups was relatively small. Further work needs to be undertaken with larger sample sizes. Second, as with many studies of this type, participants were a convenience sample of children attending treatment facilities, making generalization problematic. Third, the conclusions are valid only if it is accepted that children being treated for dental caries are an appropriate comparison group (Broder, 2001). Fourth, the study is descriptive only, and further studies should include the measurement of factors that may account for the variation in health-related quality of life observed within each of the two study groups. The CPQ and the COHQoL of which it is a part is the first instrument specifically developed to assess the health-related quality of life of children with different oral and orofacial conditions. Our aim in developing the instrument was to facilitate our understanding of the nature and origins of differences in well-being and quality of life between and within groups of children with these conditions. It was also intended to be used in studies evaluating the outcomes of the clinical and psychosocial care provided to these children. Although its

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