| BackgroundFunctional constipation(FC) is one of the common diseases among children. Although it rarely results in life loss, constipation may produce great physical and mental pressure on the FC children and families, thus undermining the health related quality of life(HRQOL). Up to now, there are no literatures reporting the influence and impact of FC on HRQOL of preschool children diagnosed of FC and their families.Objectives1.This study was designed to test and validate the applicability of the Chinese versions of the Peds QLTM 4.0 Generic Core Scale and the Family Impact Module(FIM) on assessing the preschool children diagnosed with FC.2.The study also evaluates the health-related quality of life(HRQOL) inpreschool FC children and the impact of the condition on affected families through the comparison with healthy children.3.In addition, we analyzed and investigated the major factors affecting the FC children, the caregivers and families so as to provide scientific evidence and references for the improvement of the HRQOL of FC children and their families.Materials and MethodologyIn this cross-sectional, case-control study, 152 children aged 3–6 years with FC, 176 healthy children aged 3–6 years without FC, and their primary caregivers were included. Chinese versions of the Peds QLTM 4.0 Generic Core Scale and the Family Impact Module(FIM) were used to assess childhood HRQOL and the impact of FC on family members, respectively. HRQOL scores were compared between FC children and healthy children. In addition, a multiple step-wise regression with demographic variables of children and their caregivers, family economic status, duration and symptoms of FC, as independent variables, was employed to determine the factors that may influence HRQOL in children and impact caregivers.ResultsFor the FC children, the Peds QLTM 4.0 Generic Core Scale has favorable reliability, and the inter consistency assessment shows a Cronbach’s α factor of 0.91. Meanwhile, the correlation of medium degree to high degree among different items and dimensions shows a high-rated content applicability of the Peds QLTM 4.0 Generic Core Scale(Pearson coefficient is from 0.47 to 0.73,P<0.05). In addition, the proper differentiating applicability is also proved in that the multi-dimensional scores and total score are significantly lower than those of the healthy children(P<0.05). The Family Impact Module(FIM) scale demonstrates favorable reliability(Cronbach’s α factor is 0.89), content applicability(Pearson coefficient is from 0.50 to 0.85,P<0.05), and differentiating applicability(P<0.05).In terms of the scores of physical, emotional, social and school functions of the Peds QLTM 4.0 Generic Core Scale, the study has shown a significant positivecorrelation of these scores with the corresponding scores of the Family Impact Module(FIM) scale(P <0.05). However, a significant negative correlation was also discovered concerning the score of concern of the Family Impact Module(FIM) scale(P <0.05).Compared with the healthy children, the defecation frequency and occurrence rate of non-specific abdominalgia has shown a significance increase(P < 0.05). Scores of physical, emotional, social and school functions, and summary scales were significantly lower in children with FC than in healthy children(P< 0.05). Physical, emotional, social, cognitive, and communication scores for caregivers, as well as daily activities and relationships for families of children with FC, were significantly lower than those of caregivers and families with healthy children(p<0.05). Besides, the score of concern of parents of FC children is significantly higher than that of parents of healthy children(88.9 ± 7.5 vs 60.7 ± 8.1,P <0.05).Children’s ages, duration of FC, symptoms of FC, the child-caregiver relationship, family economic status, and caregiver education level emerged as the main factors influencing HRQOL in children, caregivers, and family members.ConclusionsAs for the investigation of FC of children, it has been proved that the Peds QLTM 4.0 Generic Core Scale and the Family Impact Module(FIM) bears both reliability and applicability which could reasonably be used in the assessment of studying HRQOL of children with FC. Compared with the healthy children, FC had a significant impact on HRQOL of affected children and their caregivers, as well as their family functions. Social characteristics of children and caregivers, duration and symptoms of FC and family economic status significantly affected HRQOL of children and caregivers, as well as family functions of children with FC. |