Gastric reflux of short duration is a normal physiological event for all infants less than six to seven weeks old. When gastric reflux occurs more frequently and past the age of seven weeks, it becomes a clinically significant problem that is diagnosed as pediatric gastroesophageal reflux disease (GERD). Symptoms of pediatric GERD include pain, irritability, frequent spitting-up or vomiting, constant or sudden crying, poor sleep habits and frequent waking. At present, these symptoms represent a clinically significant problem for one of every 500 infants between the ages of six weeks and 18 months [1
]. Although these symptoms are not uncommon in childhood, few symptomatic children are treated [2
The prevalence of symptoms consistent with pediatric GERD varies with age and depends upon the type of symptoms. When referring solely to regurgitation symptoms, over 80% of children experience spontaneous remission by age 18 months [4
]. In comparison, findings in the literature indicate that remission of GERD symptoms occurs in 70% of the population at three years of age [8
]. In fact, research suggests that among children three to nine years of age, only 2.3%, 1.8% and 7.2% will experience symptoms of regurgitation, heartburn and epigastric pain, respectively [18
]. Interestingly, despite large variation in prevalence rates by age group, differences in prevalence have not been reported across gender, ethnic groups or socio-economic classes.
Many health care professionals (HCPs) specializing in the treatment of GERD feel that published prevalence rates underestimate the extent of the condition [6
]. Interviews with HCPs suggest that pediatric GERD is under-treated because many pediatricians are not aware of how to effectively diagnose and treat the condition [8
]. Furthermore, many specialists and caregivers believe that GERD is often "missed" by physicians, since it is "normal and common for infants to spit up several times a day" [4
]. Failure to properly diagnose, lack of treatment, or sub-optimal treatment of these symptoms can lead to serious complications such as failure to thrive, anemia, esophagitis and respiratory disorders [4
In addition to having serious consequences for infants and young children, reports from parent advocacy groups suggest that untreated or ineffectively treated pediatric GERD exerts a substantial negative impact on the life of the child's primary caregiver [4
]. Caregivers of pediatric GERD patients report sleep loss and psychological and physical strain related to the ineffective or inadequate treatment of pediatric GERD [4
]. The burden of care appears to affect every facet of the caregiver's life, including daily activities, social interactions, professional pursuits and family relationships. This burden results in changes in the caregiver's physical and psychological health, quality of life and financial well-being.
The current study had two objectives related to the assessment of the impact of pediatric GERD on the caregiver's daily life. The first objective was to determine if there was an existing instrument suitable for measuring the impact of caring for an infant or child with GERD. If no instrument could be identified, the second objective was to develop an instrument suitable to quantify the impact of pediatric GERD on caregivers, thereby providing a means to improve public awareness of the issue.
Questionnaire development rationale
A focused literature review was conducted to determine if a caregiver-reported outcome measure that assesses the impact of caring for an infant or child with GERD had been developed. This review included a search of commercial and Mapi Values in-house medical databases of published literature from 1990 to the present in order to identify available instruments and studies relevant to caregiver burden in pediatric GERD. Additionally, the review examined whether generic quality of life measures had been previously applied to the assessment of the impact of caring for a pediatric GERD patient. The literature review uncovered numerous instruments developed for caregivers of adult, elderly or terminally ill patients (i.e., cancer or AIDS patients) [9
]. In contrast, few instruments or studies were identified that specifically assess the impact of a child's illness on the primary caregiver. Common approaches to assessing the impact of caring for a chronically ill child included asking caregivers open-ended questions about family strain [10
], evaluating the effect of the child's illness on family resources [10
] and measuring the impact of the child's illness on the caregiver's well-being and quality of life [11
]. No instruments that explore the impact on the caregiver's quality of life of caring for a child with GERD were identified during this review. Nor were any generic measures identified as having been used to quantify the impact of caring for a pediatric GERD patient on the primary caregiver. Furthermore, no single disease-specific instrument was found that assesses the economic, emotional, psychosocial and physical burden experienced by the caregiver of a chronically ill child.
The "Pediatric GERD Caregiver Impact Questionnaire" (PGCIQ) was developed in American English and American Spanish to address the need for an instrument to assess the impact of caring for a child with GERD. This instrument was developed for use in observational studies and multi-national clinical trials to systematically assess and document the physical, psychosocial, psychological and financial impact of caring for pediatric GERD patients. In addition, items in the PGCIQ were specifically developed to capture changes in caregiver burden in response to successful treatment. This instrument will allow documentation of the impact of caring for a child with GERD and provide evidence to increase public and physician awareness of the condition.
The PGCIQ was developed simultaneously in American English and American Spanish to accommodate the rapidly changing population composition of the United States (U.S.). The U.S. Hispanic population grew by 61% from 1970 to 1980 and by another 53% in the following 10 years [12
]. Between 1990 and 2000, Hispanics were the fastest growing ethnic group in the country [13
]. Because the PGCIQ is intended for use predominantly in the U.S., it was deemed critical that the instrument be sensitive within Spanish-speaking as well as English-speaking populations. Utilizing the simultaneous development approach reduces risk factors that threaten the validity of cross-cultural comparisons in the two language groups.
Although the questionnaire was initially developed in American English and American Spanish, it was designed to be suitable for cross-cultural and linguistic adaptation into multiple languages. Thus, the PGCIQ was developed to provide valuable information in multi-national clinical evaluations regarding the value of different GERD treatments from the caregiver's perspective. Information obtained from the PGCIQ can be used to inform and educate health care providers and payers about the needs of caregivers of pediatric GERD patients.