Translation, transcultural adaptation, and validation of PedsQL 3.0 Sickle Cell Disease Module into Brazilian Portuguese.

INTRODUCTION: Despite the high prevalence of sickle cell disease (SCD) in Brazil, no studies have described the validation of an SCD-specific health-related quality-of-life (HRQoL) instrument in children. We validated PedsQL 3.0 Sickle Cell Disease Module (PedsQL-SCD) for Brazilian Portuguese, and cross-validated it with PedsQL 4.0 Generic Core Scale (PedsQL-GCS) in children with SCD. METHODS: PedsQL-SCD was translated and culturally adapted using forward and reverse translations. PedsQL-SCD and PedsQL-GCS were tested in children and adolescents with SCD aged 2-18 years and their caregivers. Validity was assessed using the Pearson and intraclass correlation coefficients, and reliability measured with Cronbach's alpha. RESULTS: PedsQL-SCD was validated in 206 children with SCD (median age 14 years, range: 8-18) and 201 caregivers. Among patients and caregivers, the mean total score for PedsQL-SCD was 65.7 and 64.1, respectively. The mean total score for PedsQL-GCS was 73.1 and 68.9 among patients and caregivers, respectively. The internal consistency for PedsQL-SCD and PedsQL-GCS was good; Cronbach's alpha coefficients ranged from .59-.93 to .64-.83 among patients and from .60-.95 to .65-.85 among caregivers, respectively. Most intercorrelations between PedsQL-SCD and PedsQL-GCS, for patients and caregivers, had medium to large effect sizes (range: .23-.63 and .27-.64, respectively). Pain and pain impact domains of PedsQL-SCD and physical dimension of PedsQL-GCS had the highest cross-correlation (.63 and .6 for patients; .63 and .64 for caregivers, respectively), confirming convergent construct validity. CONCLUSION: PedsQL-SCD is a valid, culturally appropriate measure to assess HRQoL in children with SCD in Brazil and is well-correlated PedsQL-GCS.

A curriculum for behaviour and oral healthcare management for dentally anxious children-Recommendations from the Children Experiencing Dental Anxiety: Collaboration on Research and Education (CEDACORE).

BACKGROUND: Dentists need training in the management of children's anxiety (DA), fear (DF) and behaviour management problems (DBMP) but little is known of their competence on this topic. AIM: To report dentists' opinions and attitudes about protective stabilisation and pharmacological techniques for the management of children with DA/DF/DBMP; to propose a postgraduate curriculum focussing on DA/DF/DBMP. DESIGN: A survey of 301 Brazilian dentists and later a modified Delphi process to outline the curriculum in two phases: (a) face-to-face discussions with 33 early career researchers mentored by six researchers, both from UK and Brazil; (b) online discussions by eight early and senior researchers on the knowledge, experience, and competencies necessary for a specialist in paediatric dentistry in Brazil that should be included in the core curriculum of postgraduate courses. RESULTS: Almost all (99.0%) of the survey respondents provide treatment to children with DA/DF/DBMP, and 91.2% do not systematically diagnose these conditions; 94.3% use protective stabilisation, and 20.0%-30.0% have training in pharmacological techniques. The four-domain framework supporting the proposed curriculum is as follows: DA/DF/DBMP assessment, non-pharmacological and pharmacological approaches, and decision-making. CONCLUSION: Dental curricula should be customised to solve the misconceptions and promote a comprehensive and positive attitude to DA/DF/DBMP by paediatric oral healthcare practitioners.

Perceived medication adherence barriers mediating effects between gastrointestinal symptoms and health-related quality of life in pediatric inflammatory bowel disease.

OBJECTIVES: The primary objective was to investigate the mediating effects of patient-perceived medication adherence barriers in the relationship between gastrointestinal symptoms and generic health-related quality of life (HRQOL) in adolescents with inflammatory bowel disease (IBD). The secondary objective explored patient health communication and gastrointestinal worry as additional mediators with medication adherence barriers in a serial multiple mediator model. METHODS: The Pediatric Quality of Life Inventory™ Gastrointestinal Symptoms, Medicines, Communication, Gastrointestinal Worry, and Generic Core Scales were completed in a 9-site study by 172 adolescents with IBD. Gastrointestinal Symptoms Scales measuring stomach pain, constipation, or diarrhea and perceived medication adherence barriers were tested for bivariate and multivariate linear associations with HRQOL. Mediational analyses were conducted to test the hypothesized mediating effects of perceived medication adherence barriers as an intervening variable between gastrointestinal symptoms and HRQOL. RESULTS: The predictive effects of gastrointestinal symptoms on HRQOL were mediated in part by perceived medication adherence barriers. Patient health communication was a significant additional mediator. In predictive analytics models utilizing multiple regression analyses, demographic variables, gastrointestinal symptoms (stomach pain, constipation, or diarrhea), and perceived medication adherence barriers significantly accounted for 45, 38, and 29 percent of the variance in HRQOL (all Ps < 0.001), respectively, demonstrating large effect sizes. CONCLUSIONS: Perceived medication adherence barriers explain in part the effects of gastrointestinal symptoms on HRQOL in adolescents with IBD. Patient health communication to healthcare providers and significant others further explain the mechanism in the relationship between gastrointestinal symptoms, perceived medication adherence barriers, and HRQOL.

Dental caries remains as the main oral condition with the greatest impact on children's quality of life.

PURPOSE: The objective of this study was to assess the negative impact of dental caries on the OHRQoL of 8- to 10-year-old Brazilian children. METHODS: This population-based case-control study involved 546 children (8-10 years old), 182 cases with a high negative impact on OHRQoL and 364 controls with a low negative impact on OHRQoL. Children's OHRQOL was measured using the Child Perceptions Questionnaire (CPQ8-10). Cases and controls (1x2 ratio) were individually matched by school and gender. Dental caries experience, malocclusion, and traumatic dental injuries were used as independent variables. Dental examinations were carried out at school during daytime hours by two calibrated examiners (Kappa = 0.93-interexaminer and 0.95- intraexaminer). The data were analyzed by descriptive statistics, conditional bivariate and multiple logistic regression, with the significance level set at 5%. RESULTS: There was no significant difference in traumatic dental injuries and malocclusion between the case and control groups (p>0.05). Children with DMFT/dmft ≥3 had a 2.06-fold (95%CI = 1.28-3.31, p = 0.003) greater chance of experiencing a high negative impact on OHRQoL than those with DMFT/dmft = 0. CONCLUSION: Children with high dental caries experience are more likely to present a high negative impact on OHRQoL than those with no dental caries experience.

Patient Health Communication Mediating Effects Between Gastrointestinal Symptoms and Gastrointestinal Worry in Pediatric Inflammatory Bowel Disease.

BACKGROUND: To investigate the effects of patient health communication regarding their inflammatory bowel disease (IBD) to their health care providers and significant others in their daily life as a mediator in the relationship between gastrointestinal symptoms and gastrointestinal worry in pediatric patients. METHODS: The Pediatric Quality of Life Inventory Gastrointestinal Symptoms, Gastrointestinal Worry, and Communication Scales, and Pediatric Quality of Life Inventory 4.0 Generic Core Scales were completed in a 9-site study by 252 pediatric patients with IBD. Gastrointestinal Symptoms Scales measuring stomach pain, constipation, or diarrhea and patient communication were tested for bivariate and multivariate linear associations with Gastrointestinal Worry Scales specific to patient worry about stomach pain or bowel movements. Mediational analyses were conducted to test the hypothesized mediating effects of patient health communication as an intervening variable in the relationship between gastrointestinal symptoms and gastrointestinal worry. RESULTS: The predictive effects of gastrointestinal symptoms on gastrointestinal worry were mediated in part by patient health communication with health care providers/significant others in their daily life. In predictive models using multiple regression analyses, the full conceptual model of demographic variables, gastrointestinal symptoms (stomach pain, constipation, or diarrhea), and patient communication significantly accounted for 46, 43, and 54 percent of the variance in gastrointestinal worry (all Ps < 0.001), respectively, reflecting large effect sizes. CONCLUSIONS: Patient health communication explains in part the effects of gastrointestinal symptoms on gastrointestinal worry in pediatric patients with IBD. Supporting patient disease-specific communication to their health care providers and significant others may improve health-related quality of life for pediatric patients with IBD.

Gastrointestinal symptoms predictors of health-related quality of life in pediatric patients with functional gastrointestinal disorders.

OBJECTIVES: To investigate the patient-reported multidimensional gastrointestinal symptoms predictors of generic health-related quality of life (HRQOL) in pediatric patients with functional gastrointestinal disorders (FGIDs). METHODS: The Pediatric Quality of Life Inventory™ (PedsQL™) Gastrointestinal Symptoms Scales and PedsQL™ 4.0 Generic Core Scales were completed in a 9-site study by 259 pediatric patients with functional constipation, functional abdominal pain (FAP), or irritable bowel syndrome (IBS). Gastrointestinal Symptoms Scales measuring stomach pain, stomach discomfort when eating, food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea were identified as clinically important symptom differentiators from healthy controls based on prior findings, and subsequently tested for bivariate and multivariate linear associations with overall HRQOL. RESULTS: Gastrointestinal symptoms were differentially associated with decreased HRQOL in bivariate analyses for the three FGIDs. In predictive models utilizing hierarchical multiple regression analyses controlling for age, gender, and race/ethnicity, gastrointestinal symptoms differentially accounted for an additional 47, 40, and 60 % of the variance in patient-reported HRQOL for functional constipation, FAP, and IBS, respectively, reflecting large effect sizes. Significant individual gastrointestinal symptoms predictors were identified after controlling for the other gastrointestinal symptoms in the FGID-specific predictive models. CONCLUSIONS: Gastrointestinal symptoms represent potentially modifiable predictors of generic HRQOL in pediatric patients with FGIDs. Identifying the condition-specific gastrointestinal symptoms that are the most important predictors from the patient perspective facilitates a patient-centered approach to targeted interventions designed to ameliorate impaired overall HRQOL.

Gastrointestinal Symptoms Predictors of Health-Related Quality of Life in Patients With Inflammatory Bowel Disease.

OBJECTIVES: The aim of the study was to investigate the multidimensional gastrointestinal symptoms predictors of generic health-related quality of life (HRQOL) in pediatric patients with inflammatory bowel disease from the perspectives of pediatric patients and parents. METHODS: The Pediatric Quality of Life Inventory Gastrointestinal Symptoms Scales and Pediatric Quality of Life Inventory 4.0 Generic Core Scales were completed in a 9-site study by 260 families of patients with inflammatory bowel disease. Gastrointestinal Symptoms Scales measuring stomach pain, food and drink limits, gas and bloating, constipation, blood in stool, and diarrhea were identified as clinically important symptom differentiators from healthy controls based on prior findings, and subsequently tested for bivariate and multivariate linear associations with overall HRQOL (Generic Core Scales). RESULTS: Stomach pain, food and drink limits, gas and bloating, constipation, blood in stool, and diarrhea were significantly associated with decreased HRQOL in bivariate analyses (P < 0.001). In predictive models utilizing hierarchical multiple regression analyses controlling for age, sex, and race/ethnicity, gastrointestinal symptoms accounted for an additional 40% of the variance in patient self-reported HRQOL (P < 0.001) and 37% of the variance in parent proxy-reported HRQOL (P < 0.001), reflecting large effect sizes. Stomach pain, food and drink limits, and constipation were significant individual patient-reported predictors after controlling for the other gastrointestinal symptoms in the predictive models. CONCLUSIONS: Patient-reported gastrointestinal symptoms differentially predicted HRQOL. Identifying the specific gastrointestinal symptoms from a standardized multidimensional gastrointestinal symptoms profile that are the most important predictors from the patient perspective facilitates a patient-centered approach for interventions designed to ameliorate impaired HRQOL.

Impact of wearing fixed orthodontic appliances on quality of life among adolescents: Case-control study.

OBJECTIVE: To investigate the impact of wearing a fixed orthodontic appliance on oral health-related quality of life (OHRQoL) among adolescents. MATERIALS AND METHODS: A case-control study (1 ∶ 2) was carried out with a population-based randomized sample of 327 adolescents aged 11 to 14 years enrolled at public and private schools in the City of Brumadinho, southeast of Brazil. The case group (n  =  109) was made up of adolescents with a high negative impact on OHRQoL, and the control group (n  =  218) was made up of adolescents with a low negative impact. The outcome variable was the impact on OHRQoL measured by the Brazilian version of the Child Perceptions Questionnaire (CPQ 11-14) - Impact Short Form (ISF:16). The main independent variable was wearing fixed orthodontic appliances. Malocclusion and the type of school were identified as possible confounding variables. Bivariate and multiple conditional logistic regressions were employed in the statistical analysis. RESULTS: A multiple conditional logistic regression model demonstrated that adolescents wearing fixed orthodontic appliances had a 4.88-fold greater chance of presenting high negative impact on OHRQoL (95% CI: 2.93-8.13; P < .001) than those who did not wear fixed orthodontic appliances. A bivariate conditional logistic regression demonstrated that malocclusion was significantly associated with OHRQoL (P  =  .017), whereas no statistically significant association was found between the type of school and OHRQoL (P  =  .108). CONCLUSIONS: Adolescents who wore fixed orthodontic appliances had a greater chance of reporting a negative impact on OHRQoL than those who did not wear such appliances.

Pediatric Functional Constipation Gastrointestinal Symptom Profile Compared With Healthy Controls.

OBJECTIVES: Patient-reported outcomes are necessary to evaluate the gastrointestinal symptom profile of patients with functional constipation. Study objectives were to compare the gastrointestinal symptom profile of pediatric patients with functional constipation with matched healthy controls with the Pediatric Quality of Life Inventory Gastrointestinal Symptoms and Gastrointestinal Worry Scales and to establish clinical interpretability in functional constipation through identification of minimal important difference (MID) scores. The secondary objective compared the symptom profile of patients with functional constipation with patients with irritable bowel syndrome (IBS). METHODS: Gastrointestinal Symptoms and Worry Scales were completed in a 9-site study by 116 pediatric patients with functional constipation and 188 parents. Gastrointestinal Symptoms Scales measuring stomach pain, stomach discomfort when eating, food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea were administered along with Gastrointestinal Worry Scales. A total of 341 families with healthy children and 43 families with patients with IBS completed the scales. RESULTS: A broad profile of gastrointestinal symptoms and worry were reported by patients with functional constipation in comparison with healthy controls (P < 0.001) with large effect sizes (>0.80) across the majority of symptom domains. Patients with IBS manifested a broader symptom profile than functional constipation, with differences for stomach pain, stomach discomfort when eating, and worry about stomachaches, with similar constipation scores. CONCLUSIONS: Pediatric patients with functional constipation report a broad gastrointestinal symptom profile in comparison with healthy controls and only somewhat fewer symptoms than patients with IBS, highlighting the critical need for more efficacious interventions to achieve healthy functioning.

Symptom Profiles in Patients With Irritable Bowel Syndrome or Functional Abdominal Pain Compared With Healthy Controls.

OBJECTIVES: Patient-reported outcome (PRO) measures of gastrointestinal symptoms are recommended to determine treatment effects for irritable bowel syndrome (IBS) and functional abdominal pain (FAP). Study objectives were to compare the symptom profiles of pediatric patients with IBS or FAP with healthy controls and with each other using the PedsQL Gastrointestinal Symptoms and Gastrointestinal Worry Scales, and to establish clinical interpretability of PRO scale scores through identification of minimal important difference (MID) scores. METHODS: Gastrointestinal Symptoms and Worry Scales were completed in a 9-site study by 154 pediatric patients and 161 parents (162 families; IBS n = 46, FAP n = 119). Gastrointestinal Symptoms Scales measuring stomach pain, stomach discomfort when eating, food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea were administered along with Gastrointestinal Worry Scales. A matched sample of 447 families with healthy children completed the scales. RESULTS: Gastrointestinal Symptoms and Worry Scales distinguished between patients with IBS or FAP compared with healthy controls (P < 0.001), with larger effect sizes (>1.50) for symptoms indicative of IBS or FAP, demonstrating a broad multidimensional gastrointestinal symptom profile and clinical interpretability with MID scores for individual PRO scales. Patients with IBS manifested more symptoms of constipation, gas and bloating, and diarrhea than patients with FAP. CONCLUSIONS: Patients with IBS or FAP manifested a broad gastrointestinal symptom profile compared with healthy controls with large differences, indicating the critical need for more effective interventions to bring patient functioning within the range of healthy functioning.

PedsQL gastrointestinal symptoms scales and gastrointestinal worry scales in pediatric patients with inflammatory bowel disease in comparison with healthy controls.

BACKGROUND: Patient-reported outcomes are essential in determining the broad impact of inflammatory bowel disease (IBD) and treatments from the patient's perspective. The primary study objectives were to compare the gastrointestinal symptoms and worry of pediatric patients with IBD with matched healthy controls and to compare Crohn's disease and ulcerative colitis with each other using the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms and Gastrointestinal Worry Scales. METHODS: PedsQL Gastrointestinal Symptoms and Worry Scales were completed in a 9-site study by 256 pediatric patients with IBD and 259 parents of patients (263 families; Crohn's disease [n = 195], ulcerative colitis [n = 68]). Ten Gastrointestinal Symptoms Scales measuring stomach pain, stomach discomfort when eating, food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood in poop, and diarrhea were administered along with 2 Gastrointestinal Worry Scales. A matched group of 384 healthy children families completed the PedsQL in an Internet survey. RESULTS: PedsQL Gastrointestinal Symptoms and Worry Scales distinguished between pediatric patients with IBD in comparison with healthy controls (P < 0.001), with larger effect sizes for symptoms indicative of IBD, supporting known-groups validity and clinical interpretability including minimal important difference scores. Patients with Crohn's disease or ulcerative colitis did not demonstrate significantly different gastrointestinal symptoms or worry in comparison with each other. CONCLUSIONS: The PedsQL Gastrointestinal Symptoms and Worry Scales may be used as common metrics across pediatric patients with IBD, including Crohn's disease and ulcerative colitis separately to measure gastrointestinal-specific symptoms in clinical research and practice.

Interpretability of the PedsQL™ Gastrointestinal Symptoms Scales and Gastrointestinal Worry Scales in Pediatric Patients With Functional and Organic Gastrointestinal Diseases.

OBJECTIVE: The present study investigates the clinical interpretability of the Pediatric Quality of Life Inventory™ (PedsQL™) Gastrointestinal Symptoms Scales and Worry Scales in pediatric patients with functional gastrointestinal disorders or organic gastrointestinal diseases in comparison with healthy controls. METHODS: The PedsQL™ Gastrointestinal Scales were completed by 587 patients with gastrointestinal disorders/diseases and 685 parents, and 513 healthy children and 337 parents. Minimal important difference (MID) scores were derived from the standard error of measurement (SEM). Cut-points were derived based on one and two standard deviations (SDs) from the healthy reference means. RESULTS: The percentages of patients below the scales' cut-points were significantly greater than the healthy controls (most p values ≤ .001). Scale scores 2 SDs from the healthy reference means were within the range of scores for pediatric patients with a gastrointestinal disorder. MID values were generated using the SEM. CONCLUSIONS: The findings support the clinical interpretability of the new PedsQL™ Gastrointestinal Symptoms Scales and Worry Scales.

Health-related quality of life in pediatric patients with functional and organic gastrointestinal diseases.

OBJECTIVE: To compare health-related quality of life (HRQOL) in pediatric patients with functional gastrointestinal disorders (FGIDs) and organic gastrointestinal (GI) diseases with an age-, sex-, and race/ethnicity-matched healthy sample across GI diagnostic groups and with one another. STUDY DESIGN: The Pediatric Quality of Life Inventory 4.0 Generic Core Scales were completed in a 9-site study by 689 families. Patients had 1 of 7 physician-diagnosed GI disorders: chronic constipation, functional abdominal pain, irritable bowel syndrome, functional dyspepsia, Crohn's disease, ulcerative colitis, and gastroesophageal reflux disease. The healthy control sample included 1114 families. School days missed, days in bed and needing care, parent missed workdays, work impact, and healthcare utilization were compared as well. RESULTS: Patients with an FGID or organic GI disease demonstrated lower HRQOL than the healthy controls across all dimensions (physical, emotional, social, and school; P < .001 for all), with larger effect sizes for patients with an FGID. Patients with an FGID manifested lower HRQOL than those with an organic GI disease. Patients with an FGID or organic GI disease missed more school, spent more days in bed and needing care, had greater healthcare utilization, and had parents who missed more workdays with greater work impact (P < .001 for most), with larger effect sizes for the patients with an FGID. CONCLUSION: Patients with an FGID or organic GI disease demonstrate impaired HRQOL compared with healthy children. HRQOL can be used as a common metric to compare patient outcomes in clinical research and practice both within and across groups of patients with FGIDs and organic GI diseases.

PedsQL™ Gastrointestinal Symptoms Scales and Gastrointestinal Worry Scales in pediatric patients with functional and organic gastrointestinal diseases in comparison to healthy controls.

OBJECTIVE: The primary objective was to compare the gastrointestinal (GI) symptoms and worry of pediatric patients with functional GI disorders (FGIDs) and organic GI diseases to healthy controls utilizing the Pediatric Quality of Life Inventory™ (PedsQL™) Gastrointestinal Symptoms and Worry Scales for patient self-reports ages 5-18 years and parent proxy-reports for ages 2-18 years. The secondary objective was to compare FGIDs and organic GI diseases to each other. METHODS: The PedsQL™ Gastrointestinal Symptoms and Worry Scales were completed in a 9-site study by 587 pediatric patients with GI disorders and 685 parents of patients. Patients had physician-diagnosed GI disorders (chronic constipation, functional abdominal pain, irritable bowel syndrome, functional dyspepsia, Crohn's disease, ulcerative colitis, and gastroesophageal reflux disease). Ten Gastrointestinal Symptoms Scales measuring Stomach Pain, Stomach Discomfort When Eating, Food and Drink Limits, Trouble Swallowing, Heartburn and Reflux, Nausea and Vomiting, Gas and Bloating, Constipation, Blood, and Diarrhea were administered along with two Gastrointestinal Worry Scales. Five hundred and thirteen healthy children and 337 parents of healthy children completed the PedsQL™ Gastrointestinal Scales in an Internet panel survey. RESULTS: The PedsQL™ Gastrointestinal Symptoms and Worry Scales distinguished between pediatric patients with FGIDs and organic GI diseases in comparison with healthy controls, supporting known-groups validity. Patients with FGIDs reported more GI symptoms and worry than patients with organic GI diseases. CONCLUSIONS: The PedsQL™ Gastrointestinal Symptoms and Worry Scales may be utilized as common metrics across pediatric patient groups with FGIDs and organic GI diseases and healthy samples to measure GI-specific symptoms in clinical research and practice.

PedsQL gastrointestinal symptoms module: feasibility, reliability, and validity.

OBJECTIVE: The objective of this study was to report on the measurement properties of the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Module for patients with functional gastrointestinal (GI) disorders (FGIDs) and organic GI diseases, hereafter referred to as "GI disorders," for patient self-report ages between 5 and 18 and parent proxy-report for ages between 2 and 18 years. METHODS: The 74-item PedsQL GI Module and 23-item PedsQL Generic Core Scales were completed in a 9-site study by 584 patients and 682 parents. Patients had physician-diagnosed GI disorders (such as chronic constipation, functional abdominal pain, irritable bowel syndrome, functional dyspepsia, Crohn disease, ulcerative colitis, gastroesophageal reflux disease). RESULTS: Fourteen unidimensional scales were derived measuring stomach pain, stomach discomfort when eating, food and drink limits, trouble swallowing, heartburn and reflux, nausea and vomiting, gas and bloating, constipation, blood, diarrhea, worry, medicines, and communication. The PedsQL GI Module Scales evidenced excellent feasibility, excellent reliability for the Total Scale Scores (patient self-report α = 0.97, parent proxy-report α = 0.97), and good-to-excellent reliability for the 14 individual scales (patient self-report α = 0.67-0.94, parent proxy-report α = 0.77-0.95). Intercorrelations with the Generic Core Scales supported construct validity. Individual Symptoms Scales known-groups validity across 7 GI disorders was generally supported. Factor analysis supported the unidimensionality of the individual scales. CONCLUSIONS: The PedsQL GI Module Scales demonstrated acceptable-to-excellent measurement properties and may be used as common metrics to compare GI-specific symptoms in clinical research and practice both within and across patient groups for FGIDs and organic GI diseases.

PedsQL™ Multidimensional Fatigue Scale in sickle cell disease: feasibility, reliability, and validity.

BACKGROUND: Sickle cell disease (SCD) is an inherited blood disorder characterized by a chronic hemolytic anemia that can contribute to fatigue and global cognitive impairment in patients. The study objective was to report on the feasibility, reliability, and validity of the PedsQL™ Multidimensional Fatigue Scale in SCD for pediatric patient self-report ages 5-18 years and parent proxy-report for ages 2-18 years. PROCEDURE: This was a cross-sectional multi-site study whereby 240 pediatric patients with SCD and 303 parents completed the 18-item PedsQL™ Multidimensional Fatigue Scale. Participants also completed the PedsQL™ 4.0 Generic Core Scales. RESULTS: The PedsQL™ Multidimensional Fatigue Scale evidenced excellent feasibility, excellent reliability for the Total Scale Scores (patient self-report α = 0.90; parent proxy-report α = 0.95), and acceptable reliability for the three individual scales (patient self-report α = 0.77-0.84; parent proxy-report α = 0.90-0.97). Intercorrelations of the PedsQL™ Multidimensional Fatigue Scale with the PedsQL™ Generic Core Scales were predominantly in the large (≥0.50) range, supporting construct validity. PedsQL™ Multidimensional Fatigue Scale Scores were significantly worse with large effects sizes (≥0.80) for patients with SCD than for a comparison sample of healthy children, supporting known-groups discriminant validity. Confirmatory factor analysis demonstrated an acceptable to excellent model fit in SCD. CONCLUSIONS: The PedsQL™ Multidimensional Fatigue Scale demonstrated acceptable to excellent measurement properties in SCD. The results demonstrate the relative severity of fatigue symptoms in pediatric patients with SCD, indicating the potential clinical utility of multidimensional assessment of fatigue in patients with SCD in clinical research and practice.

Impact of traumatic dental injuries among adolescents on family's quality of life: a population-based study.

AIM: To evaluate the impact of traumatic dental injury (TDI) among Brazilian adolescents on their families' quality of life (QoL). DESIGN: A cross-sectional study was carried out with a population-based sample of 1122 schoolchildren aged 11-14 years selected using a multistage sampling procedure. Parents/caregivers answered the Brazilian version of the 14-item Family Impact Scale (B-FIS) to assess the impact on family's QoL. The main independent variable was TDI, which was diagnosed using the Andreasen classification. Malocclusion, dental caries, gender and socio-economic classification were the other independent variables. Poisson regression analyses were carried out (P<0.05). RESULTS: The prevalence of TDI was 14.8%. The multivariate model demonstrated that families of adolescents diagnosed with fracture involving the dentine or dentine/pulp were more likely to report a negative impact on the overall B-FIS score [rate ratio (RR)=1.44; 95% confidence interval (CI): 1.10-1.88] as well on the Parental/Family Activity (RR=1.45; 95% CI: 1.09-1.94), Parental Emotions (RR=1.45; 95% CI: 1.03-2.04) and Family Conflict (RR=1.46; 95% CI: 1.01-2.11) subscales in comparison with those who had no signs of TDI. CONCLUSIONS: Families of adolescents with more severe TDI were more likely to report a negative impact on QoL, affecting family activities and emotions, which can result in family conflicts.

Oral health-related quality of life and traumatic dental injuries in Brazilian adolescents.

OBJECTIVES: To evaluate the impact of traumatic dental injuries (TDI) on oral health-related quality of life (OHRQoL) among Brazilian adolescents. METHODS: A population-based case-control study was carried out, which was nested to a cross-sectional study with a sample of 1215 adolescents aged 11-14 years from Belo Horizonte, Brazil. OHRQoL was measured using the Brazilian version of the Child Perceptions Questionnaire (CPQ11-14 )--Impact Short Form (ISF:16). Two-step cluster analysis was performed to define cases and controls based on CPQ11-14--ISF:16 scores. This method considers the pattern of responses for each item separately and how important each item is to the formation of clusters. The case group included those adolescents who presented higher negative impact on OHRQoL (n=405), while the control group included those with lower negative impact (n=810). Two controls for each case were individually matched from the same school and gender. The main independent variable was TDI, diagnosed by the Andreasen's classification. Untreated dental caries, malocclusion, and age were confounding variables. Conditional logistic regression analysis was performed with the significance level set at 5%. RESULTS: A multiple conditional logistic regression model demonstrates that adolescents diagnosed with fracture involving dentin and/or pulp had a 2.40-fold greater chance of presenting high negative impact on QHRQoL [95% CI=1.26-4.58; P=0.008] than those without evidence of fractures. Enamel fracture only [P=0.065] and restored fractures [P=0.072] were not statistically associated with OHRQoL. CONCLUSIONS: Adolescents with more severe untreated TDI, such as fractures involving dentin and/or pulp, were more likely to self-report a higher negative impact on their OHRQoL than those without TDI.

PedsQL eosinophilic esophagitis module: feasibility, reliability, and validity.

OBJECTIVE: Eosinophilic esophagitis (EoE) is a chronic esophageal inflammatory condition with a paucity of information on health-related quality of life (HRQOL). The objective of the study was to report on the measurement properties of the PedsQL EoE Module. METHODS: The PedsQL EoE Module was completed in a multisite study by 196 pediatric patients with EoE and 262 parents of patients with EoE. RESULTS: The PedsQL EoE Module scales evidenced excellent feasibility (0.6%-3.1% missing), excellent group comparison reliability across total scale scores (patient α 0.93; parent proxy α 0.94), good reliability for the 7 individual scales (patient α 0.75-0.87; parent proxy α 0.81-0.92), excellent test-retest reliability (patient intraclass correlation coefficient 0.88; parent intraclass correlation coefficient 0.82), demonstrated no floor effects and low ceiling effects, and demonstrated a high percentage of scaling success for most scales. Intercorrelations with the PedsQL Generic Core Scales were in the medium (0.30) to large (0.50) range. PedsQL EoE Module scores were worse among patients with active histologic disease (≥ 5 eos/hpf) compared with those in remission (patient self-report: 63.3 vs 69.9 [P < 0.05]; parent proxy report: 65.1 vs 72.3 [P < 0.01]), and those treated with dietary restrictions compared with those with no restrictions (patient self-report: 61.6 vs 74.3 [P < 0.01]; parent proxy report: 65.5 vs 74.7 [P < 0.01]). CONCLUSIONS: The results demonstrate excellent measurement properties of the PedsQL EoE Module. Patients with active histologic disease and those treated with dietary restrictions demonstrated worse PedsQL scores. The PedsQL EoE Module may be used in the evaluation of pediatric EoE disease-specific HRQOL in clinical research and practice.

PedsQL™ sickle cell disease module: feasibility, reliability, and validity.

BACKGROUND: Sickle cell disease (SCD) is an inherited chronic disease that is characterized by complications such as recurrent painful vaso-occlusive events that require frequent hospitalizations and contribute to early mortality. The objective of the study was to report on the initial measurement properties of the new PedsQL™ SCD Module for pediatric patient self-report ages 5-18 years and parent proxy-report for ages 2-18 years. PROCEDURE: The 43-item PedsQL™ SCD Module was completed in a multisite study by 243 pediatric patients with SCD and 313 parents. Participants also completed the PedsQL™ 4.0 Generic Core Scales and PedsQL™ Multidimensional Fatigue Scale. RESULTS: The PedsQL™ SCD Module Scales evidenced excellent feasibility, excellent reliability for the Total Scale Scores (patient self-report α = 0.95; parent proxy-report α = 0.97), and good reliability for the nine individual scales (patient self-report α = 0.69-0.90; parent proxy-report α = 0.83-0.97). Intercorrelations with the PedsQL™ Generic Core Scales and PedsQL™ Multidimensional Fatigue Scales were medium (0.30) to large (0.50) range, supporting construct validity. PedsQL™ SCD Module Scale Scores were generally worse for patients with severe versus mild disease. Confirmatory factor analysis demonstrated an acceptable to excellent model fit. CONCLUSIONS: The PedsQL™ SCD Module demonstrated acceptable measurement properties. The PedsQL™ SCD Module may be utilized in the evaluation of SCD-specific health-related quality of life in clinical research and practice. In conjunction with the PedsQL™ Generic Core Scales and the PedsQL™ Multidimensional Fatigue Scale, the PedsQL™ SCD Module will facilitate the understanding of the health and well-being of children with SCD.