Applying normal PedEyeQ thresholds to define reduced quality of life.

Patient-reported outcome measures such as the Pediatric Eye Questionnaire (PedEyeQ) are increasingly recognized as important in healthcare assessment. Defining normal PedEyeQ thresholds would allow classification of individual children as having reduced versus normal domain scores. We prospectively enrolled visually normal children (aged 0-17 years; n = 310) to calculate normal PedEyeQ domain thresholds. In addition, 48 children with bilateral visual impairment (VI; best-eye acuity worse than 20/70 or 20/70 or better with limited visual fields) were enrolled for validation. The Child PedEyeQ (four domains) was completed by 5- to 17-year-olds. Parents completed Proxy (five domains) and Parent PedEyeQ (four domains). Each domain was Rasch scored (converted to 0-100); normal thresholds were defined as the 5th percentile of scores in visually normal controls. For Child 5-11 PedEyeQ, 39%-78% of VI children had reduced domain scores, and 88%-100% for 12- to 17-year-olds. For Proxy PedEyeQ, proportions ranged from 55% to 100% and for Parent PedEyeQ ≥83% had reduced scores. High prevalence of reduced PedEyeQ domain scores in the VI cohort, validates the use of normal thresholds. Nevertheless, variability in child self-reporting creates challenges for identifying individual 5- to 11-year-olds with reduced scores.

Quality of life and functional vision across pediatric eye conditions assessed using the PedEyeQ.

PURPOSE: To evaluate eye-related quality of life (ER-QOL) and functional vision across a wide range of pediatric eye conditions, using the Pediatric Eye Questionnaires (PedEyeQ). METHODS: A total of 1,037 children with an eye condition and 254 visually normal controls, across 0-4, 5-11, and 12-17 years age groups, completed the following questionnaires: Child PedEyeQ (Functional Vision, Bothered by Eyes/Vision, Social, Frustration/Worry domains), Proxy PedEyeQ (same domains plus Eye Care), and Parent PedEyeQ (Impact on Parent and Family, Worry about Child's Eye Condition, Worry about Child's Self-perception and Interactions, and Worry about Functional Vision domains). The primary eye condition was classified as amblyopia (n = 171), cataract (n = 99), cerebral visual impairment (CVI; n = 50), cornea (n = 20), eyelid (n = 35), glaucoma (n = 24), nystagmus (n = 57), orbital (n = 19), pupil/iris (n = 7), refractive error (n = 119), retina (n = 82), strabismus (n = 332), and uveitis (n = 22). RESULTS: PedEyeQ domain scores (scaled 0-100) were significantly worse across eye conditions, compared with controls. Child PedEyeQ greatest differences were on the Bothered by Eyes/Vision domain (nystagmus 5-11 years, -26 points [95% CI, -39 to -12]; nystagmus 12-17 years, -45 [95% CI, -61 to -28]). Proxy PedEyeQ differences were greatest on Functional Vision (CVI 0-4 years, -45 [95% CI, -56 to -34]; CVI 5-11 years, -58 [95% CI, -72 to -43]; nystagmus 12-17 years, -50 [95% CI, -69 to -31]). Parent PedEyeQ differences were greatest on Worry about Child's Functional Vision (CVI 0-4 years, -64; 95% CI -77 to -50). CONCLUSIONS: The PedEyeQ detects reduced ER-QOL and functional vision across pediatric eye conditions, and across age groups, indicating its utility for clinical practice and clinical trials.

Association of Visual Acuity with Eye-Related Quality of Life and Functional Vision Across Childhood Eye Conditions.

PURPOSE: We evaluated relationships between visual acuity (VA) and eye-related quality of life and functional vision in children, across a spectrum of pediatric eye conditions, using the Pediatric Eye Questionnaire (PedEyeQ). DESIGN: Cross-sectional study. METHODS: Three hundred ninety-seven children (5-11 years of age) with an eye condition and 104 visually normal control subjects completed the Child PedEyeQ (functional vision, bothered by eyes/vision, social, and frustration/worry domains). One parent for each child completed the Proxy PedEyeQ (same domains as child plus eye care) and parent PedEyeQ (impact on parent and family, worry about child's eye condition, worry about child's self-perception and interactions, and worry about functional vision domains). Each domain was Rasch-scored and Spearman rank correlations were calculated to evaluate relationships between better-seeing-eye and worse-seeing-eye VA and PedEyeQ domain score. RESULTS: There was a significant relationship between poorer better-seeing-eye VA and lower (worse) PedEyeQ score on 2 of 4 child domains (e.g., functional vision, r = -0.1474; P = .005), on 2 of 5 proxy PedEyeQ domains (e.g., functional vision, r = -0.2183; P < .001), and on 2 of 4 parent PedEyeQ domains (e.g., impact on parent and family, r = -0.1607; P = .001). Worse-seeing-eye VA was associated with lower PedEyeQ scores across all child, proxy and parent domains (P < .01 for each) with the exception of the child social domain (P = .15). CONCLUSIONS: Both better-seeing-eye and worse-seeing-eye VA were associated with functional vision and eye-related quality of life in children, assessed using the PedEyeQ, although other factors may also influence relationships. These data further validate using the PedEyeQ across pediatric eye conditions.

Self-perception in Preschool Children With Deprivation Amblyopia and Its Association With Deficits in Vision and Fine Motor Skills.

Importance: Although the development of self-perception and self-esteem has been investigated in children with strabismic and anisometropic amblyopia, we know little about how self-perception is affected in deprivation amblyopia. Deprivation amblyopia from a dense, unilateral cataract is the least common and typically most severe form of amblyopia. After cataract extraction, optical correction, and patching treatment for amblyopia, visual acuity almost always remains abnormal, and except in rare cases, stereoacuity is nearly always nil. Objective: To determine whether deprivation amblyopia is associated with altered self-perception in preschool children and to determine whether any differences in self-perception are associated with vision or motor skill deficits. Design, Setting, and Participants: Cross-sectional study conducted from 2016 to 2019 at a pediatric vision research laboratory. Children aged 3 to 6 years were enrolled, including 15 children with deprivation amblyopia and 20 control children. Main Outcomes and Measures: Self-perception was assessed using the Pictorial Scale of Competence and Acceptance for Young Children, which includes 4 specific domains: cognitive competence, peer acceptance, physical competence, and maternal acceptance. Fine motor skills were evaluated with the Manual Dexterity and Aiming & Catching Scales of the Movement ABC-2 test. Visual acuity and stereoacuity also were assessed. Results: Of the 35 children included, 13 of 35 were girls (37%) and 28 of 35 were non-Hispanic White (80%). Children with deprivation amblyopia had significantly lower peer acceptance and physical competence scores compared with control children (mean [SD], 2.80 [0.44] vs 3.25 [0.33]; mean difference, 0.45; 95% CI for difference, 0.19-0.71; P = .002 and 2.94 [0.45] vs 3.41 [0.37]; mean difference, 0.47; 95% CI for difference, 0.19-0.75; P = .002, respectively). Among children with amblyopia, moderate associations were found between self-perception domain scores and motor skills, including peer acceptance and manual dexterity (r = 0.68; 95% CI, 0.26-0.89; P = .005), peer acceptance and aiming (r = 0.54; 95% CI, 0.03-0.82; P = .03), and physical competence and aiming (r = 0.55; 95% CI, 0.06-0.83; P = .03). Conclusions and Relevance: Lower self-perception of peer acceptance and physical competence were associated with early visual deprivation in children in their everyday life.

Associations of Eye-Related Quality of Life With Vision, Visuomotor Function, and Self-Perception in Children With Strabismus and Anisometropia.

Purpose: To evaluate associations between eye-related quality of life (ER-QOL) assessed by the Child Pediatric Eye Questionnaire (Child PedEyeQ) and functional measures (vision, visuomotor function, self-perception) in children with strabismus, anisometropia, or both. Our hypothesis was that children with functional deficits would have lower ER-QOL, and if so, these associations would support the convergent construct validity of the Child PedEyeQ. Methods: We evaluated 114 children (ages 5-11 years) with strabismus, anisometropia, or both. Each child completed the Child PedEyeQ to assess four Rasch-scored domains of ER-QOL: Functional Vision, Bothered by Eyes/Vision, Social, and Frustration/Worry. In addition, children completed one or more functional tests: visual acuity (n = 114), Randot Preschool Stereoacuity (n = 92), contrast balance index (suppression; n = 91), Readalyzer reading (n = 44), vergence instability (n = 50), Movement Assessment Battery for Children-2 manual dexterity (n = 57), and Pictorial Scale of Perceived Competence and Social Acceptance for Young Children (n = 44). Results: Child PedEyeQ Functional Vision domain scores were correlated with self-perception of physical competence (rs = 0.65; 95% confidence interval [CI], 0.35-0.96) and reading speed (rs = 0.47; 95% CI, 0.16-0.77). Bothered by Eyes/Vision domain scores were correlated with self-perception of physical competence (rs = 0.52; 95% CI, 0.21-0.83). Moderate correlations were observed between Social domain scores and vergence instability (rs = -0.46; 95% CI, -0.76 to -0.15) and self-perception of physical competence (rs = 0.43; 95% CI, 0.12-0.73) and peer acceptance (rs = 0.49; 95% CI, 0.18-0.80). Frustration/Worry domain scores were moderately correlated with self-perception of physical competence (rs = 0.41; 95% CI, 0.10-0.71) and peer acceptance (rs = 0.47; 95% CI, 0.16-0.77). Conclusions: Strong and moderate correlations were observed between functional measures and Child PedEyeQ domain scores. These associations provide supporting evidence that the Child PedEyeQ has convergent construct validity.

Understanding the Impact of Residual Amblyopia on Functional Vision and Eye-related Quality of Life Using the PedEyeQ.

PURPOSE: To evaluate the effect of residual amblyopia on functional vision and eye-related quality of life (ER-QOL) in children and their families using the Pediatric Eye Questionnaire (PedEyeQ). DESIGN: Prospective cross-sectional study. METHODS: Seventeen children with residual amblyopia (no current treatment except glasses), 48 visually normal controls without glasses, and 19 controls wearing glasses (aged 8-11 years) completed the Child 5-11 year PedEyeQ. One parent for each child completed the Proxy 5-11 PedEyeQ, Parent PedEyeQ. Rasch-calibrated domain scores were calculated for each questionnaire domain and compared between amblyopic children and controls. RESULTS: PedEyeQ scores were significantly lower (worse) for children with residual amblyopia than for controls without glasses across all domains: Child PedEyeQ greatest mean difference 18 points worse on Functional vision domain (95% confidence interval [CI] -29 to -7; P < .001); Proxy PedEyeQ greatest mean difference 31 points worse on Functional vision domain (95% CI -39 to -24; P < .001); Parent PedEyeQ greatest mean difference 34 points worse on the Worry about child's eye condition domain (95% CI -46 to -22; P < .001). Compared with controls wearing glasses, PedEyeQ scores were lower for residual amblyopia on the Child Frustration/worry domain (P = .03), on 4 of 5 Proxy domains (P ≤ .05), and on 3 of 4 Parent domains (P ≤ .05). CONCLUSIONS: Residual amblyopia affects functional vision and ER-QOL in children. Parents of amblyopic children also experience lower quality of life. These data help broaden our understanding of the everyday-life impact of childhood residual amblyopia.

Eye-related quality of life and functional vision in children wearing glasses.

PURPOSE: To evaluate eye-related quality of life (ER-QOL) and functional vision in children wearing glasses using the Pediatric Eye Questionnaire (PedEyeQ). METHODS: Children 5-17 years of age with normal visual acuity who wore glasses for correction of refractive error and with no other eye condition or treatment and control subjects who did not wear glasses, along with 1 parent for each child, were prospectively enrolled. Children completed the Child 5-11 or 12-17 PedEyeQ (four domains); parents completed the Proxy 5-11 or 12-17 questionnaires (perceived effect on child; five domains) and also the Parent questionnaire (effect on parent themselves; four domains). Each domain was Rasch-scored (converted to 0-100), and scores between groups were compared. RESULTS: A total of 40 subjects and 99 non-glasses-wearing controls, along with 1 parent for each child, were included. Children 5-11 and 12-17 years of age who wore glasses had lower PedEyeQ scores across all domains compared with controls (mean differences, -6 to -15; P ≤ 0.04 for each domain). Proxy scores were also lower for glasses wearers across age groups and domains (mean differences, -4 to -18; P ≤ 0.02), and Parent scores were lower for parents of children wearing glasses (mean differences, -6 to -18; P < 0.001 for each domain). CONCLUSIONS: In this study, glasses wearers had reduced ER-QOL and functional vision compared with control subjects. Parents of children wearing glasses also experience reduced quality of life.

Association of Strabismus With Functional Vision and Eye-Related Quality of Life in Children.

Importance: Strabismus is common, affecting 2% to 4% of children, but how children and their families are affected in everyday life is poorly understood. Objective: To evaluate the association of strabismus with functional vision and eye-related quality of life in children and their families using the Pediatric Eye Questionnaire (PedEyeQ). Design, Setting, and Participants: This cross-sectional study was conducted between December 2017 and October 2019 and included 91 children with strabismus and 166 visually normal controls across 3 age groups (0-4, 5-11, and 12-17 years) who were enrolled at Mayo Clinic, Rochester, Minnesota, and Retina Foundation of the Southwest, Dallas, Texas. Exposures: Children completed the child PedEyeQ (5 to 11- and 12 to 17-year versions: functional vision, bothered by eyes/vision, social, and frustration/worry domains); parents completed the proxy (0 to 4-, 5 to 11-, and 12 to 17-year versions: functional vision, bothered by eyes/vision, social, frustration/worry, and eye care domains) and the parent PedEyeQ (impact on parent and family, worry about child's eye condition, worry about child's self-perception and interactions, and worry about child's functional vision domains). Rasch-calibrated PedEyeQ scores were calculated for each domain and converted to 0 (worst) to 100. Main Outcomes and Measures: PedEyeQ domain scores. Results: Of 91 participants with strabismus, 41 (45.1%) were girls, 74 (81.3%) were white, 4 (4.4%) were Asian, 5 (5.5%) were more than 1 race, 5 (5.5%) were African American, and 2 (2.2%) were American Indian/Alaska Native. Child PedEyeQ domain scores were lower with strabismus vs visually normal controls among children ages 5 to 11 years and the greatest mean (SD) difference was in functional vision (12 [14] points; 95% CI, 6-18; P = .001), and among children ages 12 to 17 years, the greatest mean (SD) difference was in frustration/worry (27 [13] points; 95% CI, 18-36; P < .001). Proxy PedEyeQ domain scores were also lower with strabismus. The greatest difference among children ages 0 to 4 years was in functional vision (13 [9] points; 95% CI, 9-16; P < .001), among children ages 5 to 11 years was in functional vision (26 [10] points; 95% CI, 22-30; P < .001); and among children ages 12 to 17 years was in functional vision (21 [12] points; 95% CI, 12-30; P < .001), social (21 [13] points; 95% CI, 12-30; P < .001), and frustration/worry (21 [13] points; 95% CI, 12-30; P < .001). Parent PedEyeQ domain scores were lower with strabismus; the greatest difference was in worry about child's eye condition (38 [14] points; 95% CI, 34-42; P < .001). Conclusions and Relevance: Strabismus is associated with reduced functional vision and eye-related quality of life in children. Parents of children with strabismus also experience a reduced quality of life. These findings advance our understanding of how strabismus affects children and their families and should be considered when defining patient management goals.

Validation of the Pediatric Eye Questionnaire in Children with Visual Impairment.

PURPOSE: To evaluate the recently developed Pediatric Eye Questionnaire (PedEyeQ) in visually impaired and visually normal children, as an initial validation of the PedEyeQ. DESIGN: Questionnaire validation study. METHODS: A total of 48 children with visual impairment (retinal, cortical, and corneal conditions) and 59 visually normal controls were enrolled at 2 centers. Five- to 17-year-old children completed the Child PedEyeQ (5-11- and 12-17-year-old versions), and parents completed the Proxy PedEyeQ (0-4-, 5-11-, and 12-17-year-old versions) and the Parent PedEyeQ. Rasch scores were calculated by age group for each distinct domain within each age-specific PedEyeQ (converted to 0-100 for interpretation). Domains for the Child PedEyeQ are functional vision, bothered by eyes/vision, social, and frustration/worry. Proxy PedEyeQ domains are functional vision, bothered by eyes/vision, social, frustration/worry, and eye care. Parent PedEyeQ domains are impact on parent and family, worry about child's eye condition, worry about child's self-perception/interactions, and worry about child's functional vision. For each domain, median PedEyeQ scores were compared between visually impaired and visually normal cohorts. RESULTS: Child 5-11 and 12-17 PedEyeQ scores were significantly lower (worse) for visually impaired children than for controls for each domain (P < .007), except for the social domain in 5-11-year-old children (P = .13). In addition, Proxy 0-4-, 5-11-, and 12-17-year-old PedEyeQ scores, and Parent PedEyeQ scores, were lower for visually impaired children across all domains (P < .001). CONCLUSIONS: Visually impaired children and their parents had significantly lower (worse) PedEyeQ scores than visually normal controls, across functional vision and eye-related quality of life domains, demonstrating known-group validity of the PedEyeQ in children with visual impairment.

Self-perception in Children Aged 3 to 7 Years With Amblyopia and Its Association With Deficits in Vision and Fine Motor Skills.

Importance: Deficits in fine motor skills and slow reading speed have been reported in school-aged children and adults with amblyopia. These deficits were correlated with lower self-perception of athletic and cognitive competence. Although perceived competence and social acceptance are key determinants of developing self-perception in young children, the association of amblyopia with self-perception and the association of altered self-perception with fine motor skills to date have not been reported for young children aged 3 to 7 years. Objectives: To investigate whether amblyopia is associated with altered self-perception in young children and to assess whether any differences in self-perception are associated with deficits in vision and fine motor skills. Design, Setting, and Participants: In this cross-sectional study, conducted at a pediatric vision laboratory from January 10, 2016, to May 4, 2018, healthy children aged 3 to 7 years (preschool to second grade) were enrolled, including 60 children with amblyopia; 30 children who never had amblyopia but had been treated for strabismus, anisometropia, or both; and 20 control children. Main Outcomes and Measures: Self-perception was assessed using the Pictorial Scale of Perceived Competence and Social Acceptance for Young Children, which includes the following 4 specific domains: cognitive competence, peer acceptance, physical competence, and maternal acceptance (total score range, 1-4; higher scores indicate higher perceived competence or acceptance). Fine motor skills were evaluated with the Manual Dexterity and Aiming and Catching scales of the Movement Assessment Battery for Children, second edition (score range, 1-19; higher scores indicate better skill performance). Visual acuity and stereoacuity also were assessed. Results: Children with amblyopia (28 girls and 32 boys; mean [SD] age, 6.3 [1.3] years) had significantly lower mean (SD) peer acceptance and physical competence scores compared with the control children (peer acceptance, 2.74 [0.66] vs 3.11 [0.36]; mean difference, 0.37; 95% CI for difference, 0.06-0.68; P = .04; and physical competence, 2.86 [0.60] vs 3.43 [0.52]; mean difference, 0.57; 95% CI for difference, 0.27-0.87; P = .009). Among the children with amblyopia, self-perception of physical competence was significantly correlated with aiming and catching skills (r = 0.43; 95% CI, 0.10-0.67; P = .001) and stereoacuity (r = -0.39; 95% CI, -0.05 to -0.65; P = .02). Children treated for strabismus or anisometropia, but who never had amblyopia, also had significantly lower mean (SD) physical competence scores compared with control children (2.89 [0.54] vs 3.43 [0.52]; 95% CI for difference, 0.23-0.85; P = .03). Conclusions and Relevance: These findings suggest that lower self-perception of peer acceptance and physical competence identify the broad effects of altered visual development in the everyday life of children with amblyopia.

Development of Pediatric Eye Questionnaires for Children With Eye Conditions.

PURPOSE: To develop patient-derived Pediatric Eye Questionnaires (PedEyeQ) to separately assess eye-related quality of life (ER-QOL) and functional vision in children with eye conditions. DESIGN: Questionnaire development study. METHODS: A total of 444 children (0 to <18 years old), across 10 diagnostic categories, were enrolled at 2 sites. All parents (n = 444) and 277 children (5 to <18 years old) completed master questionnaires, developed from patient-derived concerns. Factor analysis was performed to identify unidimensional domains (eigenvalue >1.0) and Rasch analyses (differential item functioning, targeting, fit) to reduce items (separate analyses for subjects aged 0-4, 5-11, and 12-17 years and for each factor). RESULTS: The Child 5- to 11-year-old PedEyeQ consisted of 4 unidimensional domains/questionnaires: functional vision, bothered by eyes/vision, social, frustration/worry (10 items each). The Child 12- to 17-year-old PedEyeQ consisted of the same 4 domains (total 39 items). The Proxy 0- to 4-year-old PedEyeQ consisted of 3 questionnaires/domains: functional vision, bothered by eyes/vision, social (total 29 items). The Proxy 5- to 11-year-old PedEyeQ consisted of 5 questionnaires/domains: functional vision, bothered by eyes/vision, social, frustration/worry, eye care (total 39 items), as did the Proxy 12- to 17-year-old PedEyeQ (total 42 items). The Parent PedEyeQ consisted of 4 questionnaires/domains: impact on parent/family, worry regarding child's eye condition, worry regarding child's self-perception and interactions, worry regarding child's visual function (total 35 items). Rasch look-up tables were created for scoring. CONCLUSIONS: By following a rigorous approach, we have developed Pediatric Eye Questionnaires for separately assessing functional vision and ER-QOL domains in children of any age and with any eye condition.

Self-perception of School-aged Children With Amblyopia and Its Association With Reading Speed and Motor Skills.

Importance: Reading and eye-hand coordination deficits in children with amblyopia may impede their ability to demonstrate their knowledge and skills, compete in sports and physical activities, and interact with peers. Because perceived scholastic, social, and athletic competence are key determinants of self-esteem in school-aged children, these deficits may influence a child's self-perception. Objective: To determine whether amblyopia is associated with lowered self-perception of competence, appearance, conduct, and global self-worth and whether the self-perception of children with amblyopia is associated with their performance of reading and eye-hand tasks. Design, Setting, and Participants: This cross-sectional study was conducted from January 2016 to June 2017 at the Pediatric Vision Laboratory of the Retina Foundation of the Southwest and included healthy children in grades 3 to 8, including 50 children with amblyopia; 13 children without amblyopia with strabismus, anisometropia, or both; and 18 control children. Main Outcomes and Measures: Self-perception was assessed using the Self-perception Profile for Children, which includes 5 domains: scholastic, social, and athletic competence; physical appearance; behavioral conduct; and a separate scale for global self-worth. Reading speed and eye-hand task performance were evaluated with the Readalyzer (Bernell) and Movement Assessment Battery for Children, 2nd Edition. Visual acuity and stereoacuity also were assessed. Results: Of 50 participants, 31 (62%) were girls, 31 (62%) were non-Hispanic white, 6 (12%) were Hispanic white, 3 (6%) were African American, 4 (8%) were Asian/Pacific Islander, and 3 (6%) were more than 1 race/ethnicity, and the mean [SD] age was 10.6 [1.3] years. Children with amblyopia had significantly lower scores than control children for scholastic (mean [SD], 2.93 [0.74] vs 3.58 [0.24]; mean [SD] difference, 0.65 [0.36]; 95% CI, 0.29-1.01; P = .004), social (mean [SD], 2.95 [0.64] vs 3.62 [0.35]; mean [SD] difference, 0.67 [0.32]; 95% CI, 0.35-0.99] P < .001), and athletic (mean [SD], 2.61 [0.65] vs 3.43 [0.52]; mean [SD] difference, 0.82 [0.34]; 95% CI, 0.48-1.16; P = .001) competence domains. Among children with amblyopia, a lower self-perception of scholastic competence was associated with a slower reading speed (r = 0.49, 95% CI, 0.17-0.72; P = .002) and a lower self-perception of scholastic, social, and athletic competence was associated with worse performance of aiming and catching (scholastic r = 0.48; 95% CI, 0.16-0.71; P = .007; social r = 0.63; 95% CI, 0.35-0.81; P < .001; athletic r = 0.53; 95% CI, 0.21-0.75; P = .003). No differences in the self-perception of physical appearance (mean [SD], 3.32 [0.63] vs 3.64 [0.40]), conduct (mean [SD], 3.09 [0.56] vs 3.34 [0.66]), or global self-worth (mean [SD], 3.42 [0.42] vs 3.69 [0.36]) were found between the amblyopic and control groups. Conclusions and Relevance: These findings suggest that lower self-perception is associated with slower reading speed and worse motor skills and may highlight the wide-ranging effects of altered visual development for children with amblyopia in their everyday lives.

Patient-derived questionnaire items for patient-reported outcome measures in pediatric eye conditions.

PURPOSE: To identify specific health-related quality of life (HRQOL) and functional vision concerns of children with eye conditions, and create comprehensive lists of potential questionnaire items as a first step in developing patient-reported outcome measures. METHODS: Children experiencing a range of pediatric eye conditions, along with one of their parents, were interviewed to identify specific concerns. Transcribed interviews were reviewed, and specific HRQOL and functional vision concerns were coded independently by two reviewers. Coded concerns were reviewed to formulate questions to address specific child concerns (derived from child and parent interviews) and specific parent concerns. Questions were grouped into bins of like questions. Two comprehensive lists of questions were formulated, one addressing child-related concerns and one addressing parent-related concerns. RESULTS: This study included 180 children and 328 parents. A total of 614 individual child questions were grouped into 36 bins (eg, appearance, coordination, glasses, learning), and 589 parent questions were formulated and grouped into 61 bins (eg, having to assist the child, worry about deterioration, time off work, safety). CONCLUSIONS: Using rigorous methods based on individual interviews, we identified a comprehensive list of patient- and parent-derived questionnaire items that address functional vision and HRQOL concerns of children with eye conditions and of their parents. We plan to use this large pool of potential questionnaire items to develop a formal set of pediatric outcome measures, and this pool of questions may also be a resource for future research.

Bilateral childhood visual impairment: child and parent concerns.

PURPOSE: To identify specific health-related quality of life and visual function concerns affecting children with bilateral visual impairment as expressed by children or one of their parents (proxy) and concerns affecting the parents themselves. METHODS: A total of 37 children <16 years of age with visual impairment (visual acuity worse than 20/70 in the better eye) and one parent for each child were prospectively enrolled. Semistructured individual interviews were performed with children 5-15 years of age (n = 16) and with one parent for each child (ages 0-15 years, N = 37). Interview transcripts were analyzed using NVivo software. Categories of concern were identified from both child and parent interviews, from which broad themes were identified. The frequencies of the themes and specific categories of concerns were calculated. RESULTS: Regarding the child's experience, categories of concern were grouped into 6 themes: visual function (expressed by 13 of 16 children [81%] and 33 of 37 parents [89%]), treatment (63% and 54%), emotions (50% and 68%), social (50% and 70%), physical discomfort (50% and 22%), and worry (38% and 8%). Concerns expressed regarding the parents' own experience were grouped into 5 themes: worry (100%), compensate-adjust for condition (89%), treatment (84%), emotions (81%), and affects family (46%). CONCLUSIONS: Individual interviews identified a wide spectrum of concerns in children with visual impairment and their parents, affecting functional, emotional, social and physical domains. Specific concerns will be used to develop patient-derived questionnaires for quantifying the effects of visual impairment on children and parents in everyday life.

Childhood esotropia: child and parent concerns.

PURPOSE: To identify specific health-related quality of life (HRQOL) concerns affecting children with esotropia as expressed by children or one of their parents (proxy) and concerns affecting the parents themselves. METHODS: Sixty children with esotropia (0-17 years of age) and 1 parent for each child were prospectively enrolled. Individual semistructured interviews were conducted with children aged 5-17 years (n = 40) and 1 parent each for child ages 0-17 years. Transcripts of recorded interviews were evaluated using NVivo software. Specific concerns were identified from both child and parent interviews and coded. From these specific codes, broad themes were identified. Frequency of each theme was calculated, along with the frequency of specific codes within each theme. RESULTS: Regarding the child's experience 6 broad themes were identified: visual function (mentioned by 32 of 40 children (80%) and by 50 of 60 parents (proxy assessment of child, 83%), treatment (78% and 85%), emotions (65% and 67%), social (58% and 68%), physical (58% and 32%), and worry (45% and 7%). Regarding the parents' own experience, 5 broad themes were identified: treatment (59 of 60 parents, 98%), worry (97%), emotions (82%), compensation for condition (80%), and affects family (23%). CONCLUSIONS: A wide range of concerns were identified from interviews of children with esotropia and their parents. Concerns reflect the impact of esotropia in physical, emotional, and social domains, and specific concerns will be used for the development of questionnaires to quantify the effects of esotropia on children's and parents' quality of life.

A randomized trial of DHA intake during infancy: school readiness and receptive vocabulary at 2-3.5 years of age.

BACKGROUND: Studies investigating the effects of docosahexaenoic acid (DHA) in infant formula on language development yield conflicting results. No study to date has investigated the effects of DHA in infant formula on school readiness. AIM: To determine the effects of different dietary concentrations of DHA provided during the first 12 months of life on language development and school readiness. DESIGN: This was a double-masked, randomized, controlled, prospective trial. A total of 182 infants were enrolled at 1-9 days of age and assigned randomly to receive infant formula with one of four levels of DHA: control (0% DHA), 0.32% DHA, 0.64% DHA, or 0.96% DHA. All formulas with DHA also contained 0.64% arachidonic acid. One hundred forty-one children completed the 12-month feeding trial and were eligible for this study. Consent was obtained from 131 participants. School readiness was assessed at 2.5 years using the Bracken Basic Concept Scale-Revised (BBCS-R) and receptive vocabulary was assessed at 2 and 3.5 years using the Peabody Picture Vocabulary Test-Third Edition (PPVT-III). RESULTS: There were no diet group differences on any of the BBCS-R subscales. On the PPVT-III, the control group had higher raw scores and standard scores than both the 0.32% and 0.96% groups at 2 years of age. These differences were not evident at 3.5 years. CONCLUSIONS: Dietary DHA during the first year of life did not enhance school readiness or language development. Children who consumed infant formula with 0.32% and 0.96% DHA showed lower receptive vocabulary scores than controls at 2 but not 3.5 years of age.

Cognitive function in 18-month-old term infants of the DIAMOND study: a randomized, controlled clinical trial with multiple dietary levels of docosahexaenoic acid.

BACKGROUND: Studies investigating cognitive outcomes following docosahexaenoic acid (DHA) supplementation of infant formula yield conflicting results, perhaps due to inadequate dietary concentrations. AIM: To determine the optimal DHA concentration in term formula to support cognitive maturation. DESIGN: This was a double-masked, randomized, controlled, prospective trial. A total of 181 infants were enrolled at 1-9 days of age and assigned randomly to receive one of four term infant formulas with one of four levels of docosahexaenoic acid: Control (0% DHA), 0.32% DHA, 0.64% DHA, or 0.96% DHA. All DHA-supplemented formulas contained 0.64% arachidonic acid (ARA). Infants were fed the assigned formulas until 12 months of age. One hundred forty-one children completed the 12-month feeding trial and were eligible for this study. Cognitive function was assessed in 131 children at 18 months of age using the Bayley Scales of Infant Development II (BSID II). RESULTS: There were no diet group differences on the Mental Development Index (MDI), the Psychomotor Development Index (PDI), or the Behavior Rating Scale (BRS) of the BSID II. However, when the scores of children who received any of the three DHA-supplemented formulas were combined and compared to control children, a significant difference emerged: the MDI scores of DHA-supplemented children were higher (104.1 v. 98.4; p=0.02). CONCLUSIONS: These results suggest that dietary supplementation of DHA during the first year of life leads to enhanced cognitive development at 18 months of age. DHA concentration of 0.32% is adequate to improve cognitive function; higher concentrations did not confer additional benefit.

The impact of early nutrition on incidence of allergic manifestations and common respiratory illnesses in children.

OBJECTIVE: To investigate the incidence of allergic and respiratory diseases through age 3 years in children fed docosahexaenoic acid (DHA)- and arachidonic acid (ARA)-supplemented formula during infancy. STUDY DESIGN: Children who completed randomized, double-blind studies of DHA/ARA-supplemented (0.32%-0.36%/0.64%-0.72% of total fatty acids, respectively) versus nonsupplemented (control) formulas, fed during the first year of life, were eligible. Blinded study nurses reviewed medical charts for upper respiratory infection (URI), wheezing, asthma, bronchiolitis, bronchitis, allergic rhinitis, allergic conjunctivitis, otitis media, sinusitis, atopic dermatitis (AD), and urticaria. RESULTS: From the 2 original cohorts, 89/179 children participated; 38/89 were fed DHA/ARA formula. The DHA/ARA group had significantly lower odds for developing URI (odds ratio [OR], 0.22; 95% confidence interval [CI], 0.08-0.58), wheezing/asthma (OR, 0.32; 95% CI, 0.11-0.97), wheezing/asthma/AD (OR, 0.25; 95% CI, 0.09-0.67), or any allergy (OR, 0.28; 95% CI, 0.10-0.72). The control group had significantly shorter time to first diagnosis of URI (P = .006), wheezing/asthma (P = .03), or any allergy (P = .006). CONCLUSIONS: DHA/ARA supplementation was associated with delayed onset and reduced incidence of URIs and common allergic diseases up to 3 years of age.

The DIAMOND (DHA Intake And Measurement Of Neural Development) Study: a double-masked, randomized controlled clinical trial of the maturation of infant visual acuity as a function of the dietary level of docosahexaenoic acid.

BACKGROUND: The range of human milk docosahexaenoic acid (DHA) concentrations worldwide is much broader than the range explored in randomized clinical trials to date. OBJECTIVE: The primary objective was to determine the effect of 4 amounts of DHA supplementation on the visual acuity of formula-fed infants at 12 mo of age. Secondary objectives were to evaluate visual acuity maturation, red blood cell fatty acids, tolerance, anthropometric measures, and adverse events. DESIGN: This double-masked, randomized trial was conducted at 2 sites (Dallas and Kansas City). Three hundred forty-three healthy, term, formula-fed infants were enrolled at 1-9 d of age and were randomly assigned to be fed 1 of the following 4 infant formulas containing equivalent nutrient amounts, except for long-chain polyunsaturated fatty acids: control (0% DHA), 0.32% DHA, 0.64% DHA, or 0.96% DHA; DHA-supplemented formulas also provided 0.64% arachidonic acid. Visual acuity was measured by visual evoked potentials in 244 infants who completed the 12-mo primary outcome examination. RESULTS: Infants fed control formula had significantly poorer visual evoked potential visual acuity at 12 mo of age than did infants who received any of the DHA-supplemented formulas (P < 0.001). There were no significant differences in visual evoked potential visual acuity between the 3 amounts of DHA supplementation for either site at any age tested. CONCLUSIONS: DHA supplementation of infant formula at 0.32% of total fatty acids improves visual acuity. Higher amounts of DHA supplementation were not associated with additional improvement of visual acuity. This trial was registered at clinicaltrials.gov as NCT00753818.