Copyright 2013 by ESPGHAN and NASPGHAN. Unauthorized reproduction of this article is prohibited. Conceptual Framework for Health-related Quality of Life Assessment in Acute Gastroenteritis  Bradley C. Johnston, z Rachel Donen, § Amrita Pooni, jj Julia Pond, y Feng Xie, jj Lucy Giglia, jj April Kam, § Amanpaul Bhamber, § Karan Bami, § Yashesh Patel, and y Gordon H. Guyatt ABSTRACT Background and Objectives: To date, most trials in pediatric acute gastroenteritis have evaluated short-term clinical disease activity (eg, duration of diarrhea or vomiting, level of dehydration), laboratory outcomes (eg, rotavirus, norovirus), or a composite of these outcomes. Measuring health-related quality of life may also be important in evaluating the effect of interventions for acute gastroenteritis in children. The objectives of this study were to conduct individual interviews and, when possible, focus group discussions, with parents of children with acute gastroenteritis; to determine how parent and child quality of life is negatively affected by acute gastro- enteritis; and, from the perspective of parents and children, to develop a conceptual framework for quality of life instrument specific to pediatric acute gastroenteritis. Methods: We conducted interviews and focus groups with parents of children (3 months–5 years of age) given a diagnosis of gastroenteritis in a hospital emergency department. Interviews and focus groups were conducted to determine the effect of gastroenteritis on quality of life in parents and children (as perceived by the parents). Results: Interviews and focus groups involving 25 parents suggested a conceptual framework that, for children, includes 2 domains (physical and emotional function) and 14 subdomains. For parents, our framework includes 3 domains (physical, emotional, and social function) with physical function including 4 subdomains, emotional function including 7 subdomains, and social function including 2 subdomains. The framework has been used to develop a preliminary quality of life questionnaire for parents and children. Conclusions: Acute gastroenteritis has an important adverse effect on health-related quality in both children and parents involving physical symptoms and restrictions in physical function and disturbed emotional function. Upon further research on the psychometric properties of the proposed questionnaires, future trials of effectiveness should consider measuring patient important outcomes such as health-related quality of life. Key Words: acute gastroenteritis, framework, pediatric, quality of life, questionnaire (JPGN 2013;56: 280–289) P ediatric acute diarrhea presents clinically as a change in normal bowel habits, including a substantial increase in stool frequency and/or a decrease in stool consistency. Severity can be related to the child’s age, nutritional status, and the underlying cause of diarrhea. Acute diarrhea is most frequently a result of a gastrointestinal infection, which is often accompanied by vomiting, fever, and dehydration. When diarrhea is accompanied by these symptoms, it is often referred to as acute gastroenteritis. A number of outcomes are important in evaluating the effect of interventions for acute gastroenteritis. In some situations, the most compelling evidence of an intervention’s effect may be a reduction in mortality (oral rehydration after severe dehyration), morbidity (possibly probiotics for reducing duration of symptoms), or frequency of disease occurrence (vaccine agents for preventing gastroenteritis). Alternatively, clinicians frequently rely on direct physiological or biochemical measures of disease severity and the way therapies influence these measures, for example, stool output and indicators of dehydration severity related to gastroenteritis, such as electrolyte levels. Patient-reported outcomes (PROs) are patients’ own assess- ment of their health. They include the ability to function normally and to be free of pain and physical, emotional, and social limitations or dysfunction. Sometimes, results from PRO measures and other outcome measures may suggest discrepant conclusions: physiologic measurements may change without people feeling better or an intervention may ameliorate symptoms without a measurable change in physiologic function (1–5). Most trials in pediatric diarrhea have evaluated short-term clinical disease activity (eg, duration of diarrhea, incidence of diarrhea), laboratory outcomes (eg, pathogen elimination: rotavirus, Clostridium difficile), or a composite of these endpoints (6). Few if any trials have used a health-related quality of life (HRQL) instru- ment as either their primary or secondary outcome. Given that acute gastroenteritis can lead to significant functional disability, especi- ally when accompanied by vomiting, fever, and dehydration, future trials should consider evaluating outcomes that may be of greater importance to parents and children (functional status, HRQL) (6). PRO measures such as HRQL cannot be directly measured in infants and toddlers; however, parents are in a position to provide information on the effect on young children, and rotavirus gastro- enteritis in children up to 36 months of age may affect parents’ HRQL (7). Received August 5, 2011; accepted September 7, 2012. From the  Child Health Evaluative Sciences, SickKids Research Institute, The Hospital for Sick Children, Toronto, the y Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, the z Division of Paediatric Urology, Hospital for Sick Children, Toronto, the § Faculty of Health Sciences, McMaster University, and the jj Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada. Address correspondence and reprint requests to Bradley C. Johnston, PhD, Child Health Evaluative Sciences, SickKids Research Institute, The Hospital for Sick Children, Room 2420, 555 University Ave, Toronto, ON M5G 1X8, Canada (e-mail: bradley.johnston@sickkids.ca). Supplemental digital content is available for this article. Direct URL citations appear in the printed text, and links to the digital files are provided in the HTML text of this article on the journal’s Web site (www.jpgn.org). Funding for the study was provided by Biocodex. The authors report no conflicts of interest. Copyright # 2013 by European Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition DOI: 10.1097/MPG.0b013e3182736f49 ORIGINAL ARTICLE:GASTROENTEROLOGY 280 JPGN  Volume 56, Number 3, March 2013