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

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.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.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.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

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\u27s 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 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\u27s 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

Improving a Process to Obtain Hepatitis B Serology Among Patients Treated with Infliximab at a Large Urban Children\u27s Hospital

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 \u3c 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

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

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. 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. 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. 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