Article

The Infant Gastroesophageal Reflux Questionnaire Revised: Development and Validation as an Evaluative Instrument

DOI:10.1016/j.cgh.2006.02.016

Source
PubMed

Authors:

Leah Kleinman

United BioSource Corporation

Margaret Rothman

Johnson & Johnson

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Gastroesophageal reflux disease (GERD) is frequently experienced by infants, and disease-specific measures are needed to evaluate treatment benefits. We revised the Infant Gastroesophageal Reflux Questionnaire (I-GERQ) on the basis of information from parents of infants with GERD and physicians and subjected it to a psychometric evaluation. A 3-week, multi-country observational study of 185 caregivers of infants younger than 18 months with GERD and 93 caregivers of control infants was conducted. Caregivers completed the I-GERQ-R weekly and recorded symptoms in a Daily Diary. Caregivers and physicians rated global disease severity and change in overall GERD symptoms. Slightly more than half of infants were male with a mean age of 6.7 months, and most infants had been diagnosed with GERD for a little more than 2 months (mean, 66.7 days). Internal consistency reliability for the I-GERQ-R ranged from 0.86 to 0.87, and test-retest reliability was 0.85. Construct validity was demonstrated by significant differences between cases and controls on all item scores (all P<.01) and the total score (P<.0001), correlations with relevant Daily Diary symptoms, and both physician-rated (P<.05) and caregiver-rated disease severity (P<.05). Mean baseline to 3-week I-GERQ-R change scores for those infants whose caregivers reported improvement was -5.7 compared with -0.3 for those whose caregivers reported worse/same (P<.001). Physician ratings of change resulted in similar findings, with mean changes of -5.7 for those rated improved and -0.1 for those rated as worse/same (P<.0001). This study demonstrated the I-GERQ-R is a reliable, valid, and clinically responsive measure of infant GERD symptoms.

The Gastrointestinal and Gastroesophageal Reflux (GIGER) Scale for Infants and Toddlers

Article

Full-text available

Jul 2021

The purpose of this study was to describe the development of the Gastrointestinal and Gastroesophageal Reflux (GIGER) Scale for Infants and Toddlers, and determine its factor structure and psychometric properties. Items were developed to comprehensively assess gastrointestinal (GI) and gastroesophageal reflux (GER) symptoms observable by a parent. Exploratory factor analysis on 391 responses from parents of children under 2 years old resulted in a 36-item scale with 3 subscales. Internal consistency reliability was acceptable (α = .78-.94). The GIGER total score and all 3 subscales were correlated with the Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R) ( P < .05) and Infant Gastrointestinal Symptoms Questionnaire (IGSQ) ( P < .05). GIGER total score was higher in infants with a diagnosis of GER ( P < .05) or constipation ( P < .05) compared to those without. The GIGER is a parent-report measure of GI and GER symptoms in children under 2 years old with adequate psychometric properties.

Neonatal Eating Assessment Tool - Mixed Breastfeeding and Bottle-Feeding (NeoEAT - Mixed Feeding): factor analysis and psychometric properties

Article

Full-text available

Jul 2019

Background: Early identification of feeding difficulty in infancy is critical to supporting breastfeeding and ensuring optimal nutrition for brain development. The Neonatal Eating Assessment Tool (NeoEAT) is a parent-report assessment that currently has two versions: NeoEAT - Breastfeeding and NeoEAT - Bottle-feeding for use in breast and bottle-fed infants, respectively. There are currently no valid and reliable parent-report measures to assess feeding through a combination of both breast and bottle delivery. The purpose of this study was to conduct a factor analysis and test the psychometric properties of a new measure, the NeoEAT - Mixed Breastfeeding and Bottle-Feeding (NeoEAT - Mixed Feeding), including internal consistency reliability, test-retest reliability, construct validity and known-groups validity. Methods: Parents of infants younger than 7 months who had fed by both bottle and breast in the previous 7 days were invited to participate. Internal consistency reliability was tested using Cronbach's α. Test-retest reliability was tested between scores on the NeoEAT - Mixed Feeding completed 2 weeks apart. Construct validity was tested using correlations between the NeoEAT - Mixed-Feeding, the Infant Gastroesophageal Reflux Questionnaire - Revised (I-GERQ-R), and the Infant Gastrointestinal Symptoms Questionnaire (IGSQ). Known-groups validation was tested between healthy infants and infants with feeding problems. Results: A total of 608 parents participated. Exploratory factor analysis revealed a 68-item scale with 5 sub-scales. Internal consistency reliability (Cronbach's α = .88) and test-retest reliability (r = 0.91; p < .001) were both acceptable. Construct validity was demonstrated through correlations with the I-GERQ-R (r = 0.57; p < .001) and IGSQ (r = 0.5; p < .001). Infants with feeding problems scored significantly higher on the NeoEAT - Mixed Feeding, indicating more problematic feeding symptoms, than infants without feeding problems (p < .001), supporting known-groups validity. Conclusions: The NeoEAT - Mixed Feeding is a 68-item parent-reported measure of breast- and bottle-feeding behavior for infants less than 7 months old that now has evidence of validity and reliability for use in clinical practice and research. The NeoEAT - Mixed Feeding can be used to identify infants with problematic feeding, guide referral decisions, and evaluate response to interventions.

Factor Structure and Psychometric Properties of the Neonatal Eating Assessment Tool–Breastfeeding

Article

Apr 2018
J Obstet Gynecol Neonatal Nurs

The purpose of this study was to identify the factor structure of the Neonatal Eating Assessment Tool-Breastfeeding (NeoEAT-Breastfeeding) and to assess its psychometric properties, including internal consistency reliability, test-retest reliability, and construct validity as measured by concurrent and known-groups validity. Exploratory factor analysis conducted on responses from 402 parents of breastfeeding infants younger than 7 months old showed a 62-item measure with seven subscales and acceptable internal consistency reliability (Cronbach's α = .92). Test-retest reliability was also acceptable (r = .91). The NeoEAT-Breastfeeding has evidence of concurrent validity with the Infant Gastroesophageal Reflux Questionnaire (r = .69) and Infant Gastrointestinal Symptoms Questionnaire (r = .62). The NeoEAT-Breastfeeding total score and all subscale scores were higher in infants with feeding problems than in typically feeding infants (p < .001, known-groups validity). The NeoEAT-Breastfeeding is a parent-report assessment of breastfeeding in infants from birth to 7 months old with good initial evidence of reliability and validity.

Symptoms of Gastroesophageal Reflux in Healthy, Full-Term Infants Younger Than 7 Months Old

Article

Feb 2020

Objective To describe the range of symptoms of gastroesophageal reflux in healthy, full-term infants in the first 7 months of life. Design Cross-sectional, descriptive study. Median and percentile scores for the Infant Gastroesophageal Reflux Questionnaire–Revised (I-GERQ-R) were calculated for each of the following age groups of infants: 0 to 2, 2 to 4, 4 to 6, and 6 to 7 months. Psychometric properties, including internal consistency reliability and concurrent validity of the I-GERQ-R, were also tested. Setting Online. Participants Primary caregivers of 559 healthy, full-term (≥37 weeks gestational age) infants younger than 7 months. Measurements Participants were asked to answer questions about themselves, their family, and their infant and to complete the I-GERQ-R, the Infant Gastrointestinal Symptoms Questionnaire, and the Neonatal Eating Assessment Tool. Results Symptoms of gastroesophageal reflux decreased over the first 7 months of life. Scores in the 95th percentile decreased from 19 in infants 0 to 2 months old to 16.7 in infants 6 to 7 months old. Internal consistency reliability of the I-GERQ-R was acceptable (Cronbach’s α = .71). The I-GERQ-R had evidence of concurrent validity with the Infant Gastrointestinal Symptoms Questionnaire (rs = .69, p < .001) and Neonatal Eating Assessment Tool–Breastfeeding Gastroesophageal Function subscale (rs = .52, p < .001). Conclusions Authors of prior studies used a cutoff score of 16 for the diagnosis of gastroesophageal reflux disease in infants younger than 18 months. Our results indicate that symptoms of reflux change with age over the first 7 months of life and that using more age-specific reference values may be more appropriate. Health care providers can use these age-specific percentile scores, together with clinical assessment, to identify significant symptomatology related to gastroesophageal reflux disease.

Clinically Meaningful Difference for the Infant Gastroesophageal Questionnaire Revised version (I-GERQ-R): A Quantitative Synthesis

Article

Full-text available

Mar 2020

Background: Gastroesophageal reflux disease (GORD) is a common condition affecting 30% of infants aged 0-23 months. The Infant Gastroesophageal Questionnaire Revised version (I-GERQ-R) is an observer-reported outcome measures (ObsRO) developed to evaluate the impact of GORD on young infants. However, evidence regarding the clinically important difference (CID) for the I-GERQ-R is limited. The aim of this study was to determine a CID for the I-GERQ-R. Methods: A literature review was undertaken (PsycInfo, Embase, MedLine and EconLit databases) for longitudinal studies involving the I-GERQ-R. Articles were not limited by language or publication date. A random effects model was applied to calculate an overall CID, along with I2 and Q statistics. Publication bias was also assessed. Results: The search identified 42 articles; 11 were selected for full-text review and 7 articles were identified for full data extraction. The studies included a total of 661 infants (range: 30 to 313); 424 infants had been diagnosed with GORD (64%). The age range of the infants across the studies was from birth to 7 months. The overall CID was -6.54 (95% confidence interval: -4.35 to -8.74), Q = 17.96, p=0.08 and I2=22.04. Conclusion: This study derived a CID for the I-GERQ-R and indicated a threshold around 6 could signify a clinically important difference for this instrument. The lower limit of the 95% confidence interval suggested a threshold of 3 to 4 could represent a minimally important difference. These results may help inform clinical decisions in evaluating meaningful change in symptom severity in children affected by GORD.

Role of feeding strategy bundle with acid-suppressive therapy in infants with esophageal acid reflux exposure: a randomized controlled trial

Article

Full-text available

May 2020

To test the hypothesis that a feeding bundle concurrent with acid suppression is superior to acid suppression alone in improving gastroesophageal reflux disease (GERD) attributed-symptom scores and feeding outcomes in neonatal ICU infants. Infants (N = 76) between 34 and 60 weeks’ postmenstrual age with acid reflux index > 3% were randomly allocated to study (acid-suppressive therapy + feeding bundle) or conventional (acid-suppressive therapy only) arms for 4 weeks. Feeding bundle included: total fluid volume < 140 mL/kg/day, fed over 30 min in right lateral position, and supine postprandial position. Primary outcome was independent oral feeding and/or ≥6-point decrease in symptom score (I-GERQ-R). Secondary outcomes included growth (weight, length, head circumference), length of hospital stay (LOHS, days), airway (oxygen at discharge), and developmental (Bayley scores) milestones. Of 688 screened: 76 infants were randomized and used for the primary outcome as intent-to-treat, and secondary outcomes analyzed for 72 infants (N = 35 conventional, N = 37 study). For study vs. conventional groups, respectively: (a) 33% (95% CI, 19−49%) vs. 44% (95% CI, 28−62%), P = 0.28 achieved primary outcome success, and (b) secondary outcomes did not significantly differ (P > 0.05). Feeding strategy modifications concurrent with acid suppression are not superior to PPI alone in improving GERD symptoms or discharge feeding, short-term and long-term outcomes. Conservative feeding therapies are thought to modify GERD symptoms and its consequences. However, in this randomized controlled trial in convalescing neonatal ICU infants with GERD symptoms, when controlling for preterm or full-term birth and severity of esophageal acid reflux index, the effectiveness of acid suppression plus a feeding modification bundle (volume restriction, intra- and postprandial body positions, and prolonged feeding periods) vs. acid suppression alone, administered over a 4-week period was not superior in improving symptom scores or feeding outcomes. Restrictive feeding strategies are of no impact in modifying GERD symptoms or clinically meaningful outcomes. Further studies are needed to define true GERD and to identify effective therapies in modifying pathophysiology and outcomes. The improvement in symptoms and feeding outcomes over time irrespective of feeding modifications may suggest a maturational effect. This study justifies the use of placebo-controlled randomized clinical trial among NICU infants with objectively defined GERD.

Comparison the Effect of Omeprazole, Esomeprazole and Lansoprazole on Treatment of Gastroesophageal Reflux Disease in Infants

Article

Full-text available

Jul 2020

Effect of frenotomy on breastfeeding and reflux: results from the BRIEF prospective longitudinal cohort study

Article

Full-text available

Jun 2021
CLIN ORAL INVEST

Objectives To assess the Efficacy of Frenotomy with regard to Breastfeeding and Reflux Improvement (BRIEF) in infants with breastfeeding problems. Materials and methods A cohort of 175 consecutive breastfeeding women with breastfeeding and reflux problems related to a tongue-tie or lip-tie fulfilling the inclusion criteria was longitudinally followed for 6 months. The effect of frenotomy on these problems was studied by a standardized oral assessment and completing the validated Breastfeeding Self-Efficacy Short Form (BSES-SF), nipple pain score (Visual Analogue Scale, VAS), and Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) questionnaires pre-frenotomy and at 1 week, 1 month, and 6 months’ post frenotomy. Results All 175 women completed the 1-month follow-up and 146 women the 6 months’ follow-up. Frenotomy resulted in a significant improvement of BSES-SF, nipple pain score, and I-GERQ-R after 1 week, which improvement maintained to be significant after 1 month for BSES-SF and I-GERQ-R, and after 6 months for I-GERQ-R. The improvements were irrespective of the type lip-tie or tongue-tie underlying the breast feeding and reflux problems. No post-operative complications were observed. About 60.7% of infants still was breastfed 6 months after treatment. Conclusions Frenotomy is a safe procedure with no post-operative complications and resulting in significant improvement of breastfeeding self-efficacy, nipple pain, and gastro-oesophageal reflux problems. Clinical relevance Frenotomy of a tongue-tie and or lip-tie can lead to improvement of breastfeeding and reflux problems irrespective of the type of tongue-tie or lip-tie and should be considered by clinicians as a proper tool to resolve these problems if non-interventional support did not help. International trial register ISRCTN64428423

Natural history of gastroesophageal reflux in infancy: new data from a prospective cohort.

Preprint

Full-text available

Mar 2020

Background: Gastroesophageal reflux (GER) is common in infants. Gastroesophageal reflux disease (GERD) is defined as GER leading to troublesome symptoms that affect daily functioning and/or complications. This study is aimed at determining the prevalence and progression of GER and GERD in a cohort of healthy term infants from birth to 12 months old. Methods: We conducted a prospective cohort study including all full-term living neonates born at Besançon Teaching Hospital, France. Parents completed a clinical report form and the Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R) at 1, 3, 6, 10, and 12 months of age. GER was defined as score ≥1 to the first question with I-GERQ-R score < 16, and GERD as score ≥1 to the first question with I-GERQ-R score ≥ 16. Regurgitation was based on the answer to the first question of the I-GERQ-R as anything coming out of the mouth daily. Results: 157/347 births were included (83 boys). The prevalence of regurgitation at least once a day was 45.7% overall. In total: 72%, 69%, 56%, 18%, and 13% of infants regurgitated at least once a day at 1, 3, 6, 10, and 12 months of age, respectively. Physiological GER affected 53%, 59%, 51%, 16%, and 12% of infants; GERD, 19%, 9%, 5%, 2%, and 2%, respectively. Two risk factors were identified: family history of GER and exposure to passive smoking. Treatment included dietary modification (14%) and pharmacotherapy (5%). Conclusion: Physiological GER peaked at 3 months, GERD at 1 month. Most cases resolved on their own. GER and GERD are very common in the infant’s population and parents should be reassured/educated regarding symptoms, warning signs, and generally favorable prognosis. I-GERQ-R is useful to the clinical screening and follow up for GER and GERD.

Natural history of gastroesophageal reflux in infancy: new data from a prospective cohort

Article

Full-text available

Apr 2020
BMC Pediatr

Background: Gastroesophageal reflux (GER) is common in infants. Gastroesophageal reflux disease (GERD) is defined as GER leading to troublesome symptoms that affect daily functioning and/or complications. This study is aimed at determining the prevalence and progression of GER and GERD in a cohort of healthy term infants from birth to 12 months old. Methods: We conducted a prospective cohort study including all full-term living neonates born at Besançon Teaching Hospital, France. Parents completed a clinical report form and the Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R) at 1, 3, 6, 10, and 12 months of age. GER was defined as score ≥ 1 to the first question with I-GERQ-R score < 16, and GERD as score ≥ 1 to the first question with I-GERQ-R score ≥ 16. Regurgitation was based on the answer to the first question of the I-GERQ-R as anything coming out of the mouth daily. Results: 157/347 births were included (83 boys). The prevalence of regurgitation at least once a day was 45.7% overall. In total: 72, 69, 56, 18, and 13% of infants regurgitated at least once a day at 1, 3, 6, 10, and 12 months of age, respectively. Physiological GER affected 53, 59, 51, 16, and 12% of infants; GERD, 19, 9, 5, 2, and 2%, respectively. Two risk factors were identified: family history of GER and exposure to passive smoking. Treatment included dietary modification (14%) and pharmacotherapy (5%). Conclusion: Physiological GER peaked at 3 months, GERD at 1 month. Most cases resolved on their own. GER and GERD are very common in the infant's population and parents should be reassured/educated regarding symptoms, warning signs, and generally favorable prognosis. I-GERQ-R is useful to the clinical screening and follow up for GER and GERD.

Nissen fundoplication and combined procedures to reduce recurrence of gastroesophageal reflux disease in neurologically impaired children

Article

Full-text available

Jul 2020

Neurologically impaired children account for almost half of the fundoplication procedures performed for gastroesophageal reflux disease. Aim of the present study was to report results of antireflux surgery in neurologically impaired children. A retrospective study of neurologically impaired children who underwent fundoplication over a 13-year period (1999–2012) was performed. Recurrence rate, major complications and parents/caregivers perceptions of their child's quality of life following antireflux surgery were analyzed. A total of 122 children (median age: 8 years 9 months; range: 3 months to 18 years) had open “tension-free” Nissen fundoplication, gastrostomy + /− pyloroplasty. Gastroesophageal reflux disease was in all cases documented by at least two diagnostic exams. Median duration of follow-up was 9.7 (1.9–13) years. Three (2.4%) recurrences were documented and required surgery re-do. Major complications were 6%. Seventy-nine of 87 (90%) caregivers reported that weight gain was improved after fundoplication with a median score of 1 (IQR: 1–2). Significant improvement was perceived in postoperative overall quality of life. In this series of fundoplication recurrence incidence was low, serious complications were uncommon and caregivers’ satisfaction with surgery was high. Accurate patient’s selection and creating a “low-pressure” surgical system are mandatory to obtain these results.

Is Gastroesophageal Reflux Disease a Common Complication in Infants with Congenital Heart Disease?

Article

Full-text available

Jan 2019

Correlation of Gastroesophageal reflux disease Assessment Symptom Questionnaire to impedance-pH measurements in children

Article

Full-text available

Dec 2017

Background Esophageal multichannel intraluminal impedance-pH monitoring has become one of the preferred tests to correlate observed reflux-like behaviors with esophageal reflux events. The Gastroesophageal reflux disease Assessment Symptom Questionnaire is a validated tool used to distinguish infants with gastroesophageal reflux disease from healthy children. The aim of this study was to determine whether the Gastroesophageal reflux disease Assessment Symptom Questionnaire composite symptom scores and individual symptom scores correlate with outcomes in esophageal multichannel intraluminal impedance-pH monitoring. Methods A total of 26 patients with gastroesophageal reflux disease–associated symptoms, aged 0–2 years, for whom both esophageal multichannel intraluminal impedance-pH monitoring and Gastroesophageal reflux disease Assessment Symptom Questionnaire survey results were available were included in the study. Gastroesophageal reflux disease Assessment Symptom Questionnaire score data were collected from a 7-day recall of parent’s responses about the frequency and severity of gastroesophageal reflux disease symptoms, which determined the individual symptom scores. The composite symptom scores is the sum of all individual symptom scores. Multichannel intraluminal impedance-pH study results were compared to Gastroesophageal reflux disease Assessment Symptom Questionnaire data using Pearson correlation. Results Among 26 patients, a total number of 2817 (1700 acid and 1117 non-acid) reflux episodes and 845 clinical reflux behaviors were recorded. There were significant correlations between the reflux index and the individual symptom scores for coughing/gagging/choking (r² = 0.2842, p = 0.005), the impedance score and individual symptom scores for coughing/gagging/choking (r² = 0.2482, p = 0.009), the reflux symptom index for acid reflux-related coughing/gagging/choking and the individual symptom scores for coughing/gagging/choking (r² = 0.1900, p = 0.026), the impedance score and individual symptom scores for vomiting (r² = 0.1569, p = 0.045), and the impedance score and the composite symptom scores (r² = 0.2916, p = 0.004). However, there were no significant correlations between fussiness, irritability, or abdominal pain–related multichannel intraluminal impedance-pH results and the individual symptom scores for abdominal pain. Conclusion The impedance scores from multichannel intraluminal impedance-pH studies correlate with coughing/gagging/choking and vomiting in infants with gastroesophageal reflux disease. There are no significant correlations among the reflux index and impedance score versus the Gastroesophageal reflux disease Assessment Symptom Questionnaire scores for abdominal pain. We conclude that in infants with gastroesophageal reflux disease, multichannel intraluminal impedance-pH studies are more likely to demonstrate an association between gastroesophageal reflux disease and symptoms of coughing, gagging, or choking compared to an association between gastroesophageal reflux disease and pain in infants.

Gastroesophageal Reﬂ ux Disease: Psychological Assessment of Children and Caregivers

Article

Full-text available

Jun 2019

Gastroesophageal Reflux Disease (GERD) with high prevalence and incidence in the pediatric population is a relevant issue in public health. The literature associates family psychosocial aspects with chronic childhood illness. The present study examined the psychological alterations and peculiarities of caregivers and of children with GERD (n = 26) and healthy children (n = 30) from 3 to 12 years of age. Instruments: Sociodemographic Questionnaire and Assessment of Risk Factors for Child Illness; Hospital Anxiety and Depression Scale; and Rutter's Child Behavior Scale (A2), all of which were administered to the caregivers. Quantitative data analysis (χ2 test, Fisher's exact test and ANOVA) was performed, respecting each instrument's respective criteria. In the group of children with GERD, we observed both a higher incidence of alcohol and/or drug use/abuse and higher levels of anxiety and depression on the part of the caregivers, as well as psychosocial problems involving the child. In light of the developmental level expected for this age group, greater frequency of behavioral problems was also observed. We thus conclude that there is a correlation between family psychological traits and GERD in children, stressing the need for conducting further studies and for supervising interdisciplinary clinical practices in the health care of this population.

A Clinical Trial of Proton Pump Inhibitors to Treat Children with Chronic Otitis Media with Effusion

Article

Full-text available

Jul 2018

Objective: Gastroesophageal reflux (GER) is considered a cause of otitis media with effusion (OME). This study aimed to investigate whether OME can be effectively treated with a proton pump inhibitor (PPI), therefore implicating GER as a causative factor of OME. Materials and methods: A PPI or placebo was randomly administered to enrolled subjects for 4-8 weeks. To monitor effusion status, subjects underwent monthly pneumatic otoscopy and acoustic reflectometry. At enrollment and at completion of treatment, subjects underwent an audiogram and tympanogram for assessing changes in hearing due to altered fluid levels in the middle ear. After the treatment period, tympanostomy tube placement was recommended for subjects with unresolved effusion. Results: This study enrolled 16 patients with an average age of 5.17 years. Between the treatment and placebo groups, there was no significant difference in the need for tympanostomy tubes. At completion of this study, patients receiving Lansoprazole demonstrated a significant improvement in pure tone average (p<0.01) and speech recognition thresholds (p=0.04). Four patients (25%) from the cohort dropped out of the study. Eight patients (50%) from the cohort required tympanostomy tube placement. Conclusion: Owing to difficulties with recruitment and small sample size, this study was unable to demonstrate the use of PPI in treating OME. A larger study is needed for further evaluation of this process.

Characterization of Upper Gastrointestinal Motility in Infants with Persistent Distress and Non-IgE-Mediated Cow's Milk Protein Allergy

Article

Dec 2019
J PEDIATR GASTR NUTR

Background: Persistent crying in infancy is common and may be associated with gastroesophageal reflux disease (GERD) and/or non-IgE mediated cow's milk protein allergy (CMPA). We aimed to document upper gastrointestinal motility events in infants with CMPA and compare these to findings in infants with functional GERD. Methods: Infants aged 2-26 weeks with persistent crying, GERD symptoms and possible CMPA were included. Symptoms were recorded by 48-hour cry-fuss chart and validated reflux questionnaire (IGERDQ). Infants underwent a blinded milk elimination-challenge sequence to diagnose CMPA. GERD parameters and mucosal permeability were assessed by 24-hour pH-impedance monitoring before and after cow's milk protein (CMP) elimination. C-octanoate breath testing for gastric emptying dynamics, dual-sugar intestinal permeability, fecal calprotectin and serum vitamin D were also measured. Results: Fifty infants (mean age 13 ± 7 weeks; 27 male) were enrolled. Based on CMP elimination-challenge outcomes, 14 (28%) were categorized as non-IgE-mediated CMPA, and 17 (34%) were not allergic to milk; 12 infants with equivocal findings and 7 with incomplete data were excluded. There were no baseline differences in GERD parameters between infants with and without CMPA. In the CMPA group, CMP elimination resulted in a significant reduction in reflux symptoms, esophageal acid exposure (reflux index), acid clearance time, and an increase in esophageal mucosal impedance. Conclusions: In infants with persistent crying, upper gastrointestinal motility parameters did not reliably differentiate between non-IgE-mediated CMPA and functional GERD. In the group with non-IgE-mediated CMPA, elimination of CMP significantly improved GERD symptoms, esophageal peristaltic function and mucosal integrity.

Genetic Predictors of Long-term Response to Anti-TNF Agents in Pediatric Inflammatory Bowel Disease

Article

Jul 2020
J PEDIATR GASTR NUTR

Objectives: Inflammatory bowel disease (IBD) is more complex in children and they will have to live with the disease for much longer. For this reason, it is necessary to optimize treatment. The polymorphisms associated with the response to anti-tumor necrosis factor (TNF) drugs in adults with IBD have not been analyzed in children. The aim of the study was to identify genetic variants associated with the long-term response to anti-TNF drugs in children with IBD. Methods: An observational, longitudinal, ambispective cohort's study was conducted. We recruited 209 anti-TNF-treated children diagnosed with IBD and genotyped 21 polymorphisms previously studied in adults with Crohn disease (CD) using real-time PCR. The association between single-nucleotide polymorphisms (SNPs) and time-to-failure was analyzed using the log-rank test. Results: After multivariate analysis, 3 SNPs in IL10, IL17A and IL6 were significantly associated with response to anti-TNF treatment among patients diagnosed with CD (rs1800872-HR, 4.749 (95% confidence interval [CI] 1.156–19.517), P value < 0.05; rs2275913-HR, 0.320 [95% CI 0.111–0.920], P value < 0.05; and rs10499563-HR, 0.210 [95% CI 0.047–0.947], P value 0.05, respectively). None of these SNPs were associated with response to infliximab in adults diagnosed with CD. Among patients diagnosed with ulcerative colitis (UC), 1 SNP in LY96 was significantly associated with response to anti-TNF treatment (rs-11465996-HR, 10.220 [95% CI 1.849–56.504] P value < 0.05). Conclusions: Genotyping of these DNA variants before starting treatment may help to identify children who are long-term responders to anti-TNF drugs, and thus tailor treatment of pediatric IBD.

The statistical investigation between stress factors and GERD symptoms

Article

Full-text available

Feb 2018

This study was a statistical investigation to elucidate the correlation between stress factors and the symptoms of acid reflux-related diseases, represented by gastroesophageal reflux disease (GERD). We used the frequency scale for the symptoms of GERD (FSSG) for the assessment of reflux esophagitis (RE) and the Public Health Research Foundation (PHRF) stress check list for the assessment of stress. The FSSG is a questionnaire with 12 questions, with 7 related to symptoms of gastroesophageal reflux (reflux), and 5 to symptoms of dysmotility-like dyspepsia (dysmotility). The PHRF Stress Check List rates 4 stress factors, anxiety/uncertainty, tiredness/physical responses, autonomic symptoms and depression/feelings of inadequacy. We obtained the consent of potential subjects with an FSSG total score ≥ 8, treated their acid-related disease symptoms and evaluated the relationship between stress factors and GERD symptoms using the FSSG and PHRF Stress Check List. A correlation was suggested between dysmotility symptoms and both tiredness/physical responses and autonomic symptoms. A correlation was seen in males between the FSSG reflux score and tiredness/physical responses. In particular, a consistent correlation was seen between autonomic symptoms and the dysmotility score. A correlation was also seen between the FSSG dysmotility score, the PHRF Stress Check List and age, and a negative correlation between the dysmotility score and depression/feelings of inadequacy. We found a correlation between the PHRF Stress Check List and the FSSG scale. Our results suggest the possibility that age and the PHRF Stress Check List may be used to perform risk classification of gastroesophageal reflux disease, in particular, the symptoms of dysmotility-like dyspepsia (FSSG dysmotility score).

Neonatal Eating Assessment Tool-Mixed Breastfeeding and Bottle-feeding: Reference values and factors associated with problematic feeding symptoms in healthy, full-term infants

Article

Aug 2020

Background: The Neonatal Eating Assessment Tool-Mixed Breastfeeding and Bottle-feeding (NeoEAT-Mixed Feeding) is a parent-report assessment of symptoms of problematic feeding in infants who are feeding by both breast and bottle. Purpose: To establish reference values for the NeoEAT-Mixed Feeding and evaluate factors that contribute to symptoms of problematic feeding in healthy, full-term infants. Methods: Parents of 409 infants less than 7 months old completed an online survey. Median and percentile scores are presented for infants aged 0-2, 2-4, 4-6, and 6-7 months old. Results: Neonatal Eating Assessment Tool-Mixed Feeding total score and scores for the Gastrointestinal Tract Function and Energy & Physiologic Stability subscales decreased with increasing infant age. Infant Regulation and Feeding Flexibility subscale scores remained stable over time, whereas Sensory Responsiveness subscale scores increased with increasing infant age. Infants with more gastrointestinal symptoms had higher NeoEAT-Mixed Feeding total scores. Implications for practice: The reported reference values may be used to identify infants in need of further assessment, referral, and intervention. In healthy, full-term infants with concurrent gastrointestinal symptoms and problematic feeding, interventions targeted at gastrointestinal symptoms may help to improve symptoms of problematic feeding as well.

Gastrointestinal Symptoms in Infants of Mothers With a Psychiatric History and the Role of Depression and Bonding

Article

Sep 2019
J PEDIATR GASTR NUTR

Objectives: Gastroesophageal reflux (GER), excessive crying, and constipation are common gastrointestinal symptoms in infancy of multifactorial origin in which psychosocial stress factors play an important role. The aims of this observational study were to investigate the presence of gastrointestinal symptoms in infants of mothers with or without a history of a psychiatric disorder, their association with maternal depressive symptoms, and the possible mediating role of bonding. Methods: 101 mothers with a history of a psychiatric disorder ("PD mothers") and 60 control mothers were included. Infant gastrointestinal symptoms, maternal depressive symptoms, and mother-infant bonding were assessed using validated questionnaires and diagnostic criteria at 1.5 month postpartum. Results: The mean total score on the Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) reported in infants of PD mothers (13.4 SD 5.4) was significantly higher than in infants of control mothers (10.8 SD 5.4; P = .003). No significant differences were found in the presence of excessive crying (modified Wessel's criteria and subjective experience) and constipation (ROME IV criteria) between both groups. Infant GER was associated with maternal depressive symptoms (P = 0.027) and bonding problems (P = <0.001). Constipation was related to maternal depressive symptoms (P = 0.045), and excessive crying (Wessel and subjective criteria) was associated with bonding problems (respectively P = 0.022 and P = 0.002). The effect of maternal depressive symptomatology on infant GER symptoms and excessive crying was mediated by bonding problems. Conclusion: Maternal psychiatric history is associated with infant gastrointestinal symptoms, in which mother-infant bonding is a mediating factor.

Feed thickeners in gastro-oesophageal reflux in infants

Article

Full-text available

Jun 2018

Revision Lingual Frenotomy Improves Patient-Reported Breastfeeding Outcomes: A Prospective Cohort Study

Article

Full-text available

May 2018

Background: Lingual frenotomy improves patient-reported outcome measures, including infant reflux and maternal nipple pain, and prolongs the nursing relationship; however, many mother-infant dyads continue to experience breastfeeding difficulty despite having had a frenotomy. Research aim: The aim of this study was to determine how incomplete release of the tethered lingual frenulum may result in persistent breastfeeding difficulties. Methods: A one-group, observational, prospective cohort study was conducted. The sample consisted of breastfeeding mother-infant (0-9 months of age) dyads ( N = 54) after the mothers self-elected completion lingual frenotomy and/or maxillary labial frenectomy following prior lingual frenotomy performed elsewhere. Participants completed surveys preoperatively, 1-week postoperatively, and 1-month postoperatively consisting of the Breastfeeding Self-Efficacy Scale-Short-Form (BSES-SF), Visual Analog Scale (VAS) for nipple pain severity, and the Revised Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R). Results: Significant postoperative improvements were reported between mean preoperative scores compared with 1-week and 1-month scores of the BSES-SF, F(2) = 41.2, p < .001; the I-GERQ-R, F(2) = 22.7, p < .001; and VAS pain scale, F(2) = 46.1, p < .001. Conclusion: We demonstrated that besides nipple pain, measures of infant reflux symptoms and maternal breastfeeding self-confidence can improve following full release of the lingual frenulum. Additionally, a patient population was identified that could benefit from increased scrutiny of infant tongue function when initial frenotomy fails to improve breastfeeding symptoms.

The Safety and Efficacy of Lansoprazole plus Metoclopramide among Neonates with Gastroesophageal Reflux Disease Resistant to Conservative Therapy and Monotherapy: A Clinical Trial

Article

Full-text available

Jan 2021

Background. Gastroesophageal reflux disease (GERD) is one of the most common problems in neonates. The main clinical manifestations of neonatal GERD are frequent regurgitation or vomiting associated with irritability, crying, anorexia or feeding refusal, failure to thrive, arching of the back, and sleep disturbance. Aims. The efficacy and safety of ranitidine plus metoclopramide and lansoprazole plus metoclopramide in reducing clinical GERD symptoms based on I-GERQ-R scores in neonatal GERD resistant to conservative and monotherapy. Study Design. This study was a randomized clinical trial of term neonates with GERD diagnosis (according to the final version of the I-GERQ-R), resistant to conservative and monotherapy admitted to Bahrami Children Hospital during 2017-2019. Totally, 120 term neonates (mean age days; girls 54.63%) were randomly assigned to a double-blind trial with either oral ranitidine plus metoclopramide (group A) or oral lansoprazole plus metoclopramide (group B). The changes of the symptoms and signs were recorded after one week and one month. At the end, fifty-four neonates in each group completed the study and their data were analyzed. Results. There was no significant difference in demographic and baseline characteristics between the two groups. The response rate of “lansoprazole plus metoclopramide” was significantly higher than “ranitidine plus metoclopramide” ( score vs. score, ) after one week and ( score vs. score, ) after one month (primary outcome). There were no drug adverse effects in either group during intervention (secondary outcome). Conclusions. The response rate was significant in each group after one week and one month of treatment, but it was significantly higher in the “lansoprazole plus metoclopramide” group compared with the “ranitidine plus metoclopramide” group. The combination of each acid suppressant with metoclopramide led to a higher response rate in comparison with monotherapy used before intervention. This study has been registered at the Iranian Registry of Clinical Trails (RCT20160827029535N3). 1. Introduction Gastroesophageal reflux (GER) is a physiologic reverse passage of gastric contents into the esophagus with or without regurgitation and/or vomiting [1, 2]. It is commonly observed during the first year of life and almost happens in 65% of infants at the age of 3–6 months [2]. Gastroesophageal reflux disease (GERD) occurs when troublesome symptoms or conditions complicate the physiologic GER [1–4]. The main clinical manifestations of neonatal GERD include frequent regurgitation or vomiting associated with irritability, excessive crying, anorexia or feeding refusal, hematemesis, failure to thrives, Sandifer syndrome, anemia, sleep disturbance, coughing, choking, wheezing, stridor, apnea spells, recurrent pneumonia aspiration, recurrent otitis media, or upper respiratory tract symptoms [1, 5, 6]. Malformations of the central nervous system (CNS) and gastrointestinal tract (e.g., esophageal atresia and congenital diaphragmatic hernia), a positive family history of GERD, cystic fibrosis, hiatal hernia, family history of severe GERD, neurologic impairment, drugs (e.g., sedatives and muscle relaxants), and prematurity are factors that increase the risk of GERD in infants [3, 4]. Acid suppressants, including histamine-2 receptor antagonists (H2RAs) and proton pump inhibitors (PPIs), have been used as a pharmacologic treatment of pediatric GERD to induce symptomatic relief and normal growth and to prevent its complications and recurrence [7]. According to the recent guidelines, a 2-4-week trial of a PPI or H2RA is recommended for infants with significant regurgitation accompanied with symptoms such as unexplained feeding problems, troubled behavior, and poor weight gain [4]. PPIs (e.g., lansoprazole) facilitate gastric emptying and inactivate H+/K+-ATPase in the gastric parietal cells canaliculi, leading to inhibition of gastric acid production and secretion [8, 9]. PPIs induce a more vigorous inhibition of acid secretion, have a longer duration of action, and cause fewer complications and no tachyphylaxis compared to H2RAs [5, 10]. Prokinetics increase the LES tone and gastric emptying [11]. Among prokinetics, although metoclopramide may induce irritability, drowsiness, oculogyric crisis, dystonic reaction, apnea, and emesis in infants, these adverse reactions are only induced with prolonged or high-dose metoclopramide exposure [12]. On the other hand, two other prokinetics including domperidone and cisapride may induce cardiac arrhythmia and are prohibited to be used in the USA [13, 14]. Macrolides are known as prokinetics, but they may also induce cardiac arrhythmia in long-term exposure [15]. Totally, metoclopramide is a safe prokinetic if it is administered with short-duration and low-dose amount, so we preferred to use it in this study. There are still controversies about the management of neonatal GERD. To the best of our knowledge, very few clinical trials have compared the effectiveness of PPIs and H2RAs in pediatric GERD, especially in neonates and infants [16, 17]. Since no study has compared the efficacy and safety of metoclopramide plus ranitidine with metoclopramide plus lansoprazole in the management of neonatal GERD resistant to conservative therapy and monotherapy, this study was carried out. 2. Patients and Methods This double-blind randomized controlled trial was conducted to compare the effectiveness of metoclopramide plus lansoprazole and metoclopramide plus ranitidine for GERD in term neonates. 2.1. Subjects One hundred and twenty term neonates (postnatal days, gestational age: 38-40 weeks) that presented to Bahrami Children’s Hospital during 2016-2019 with a clinical diagnosis of GERD were enrolled in this study. The participants in both groups were fed with breast milk. The frequency of feeding was every two hours. All patients were resistant to conservative therapy plus ranitidine or conservative therapy plus lansoprazole as the first line of treatment before intervention. The clinical improvement was <50% as defined as <50% reduction rate in the I-GERQ-R score (Table 1) before intervention. The conservative therapy included postural change, reduction of the feeding volume, and increasing the frequency of feedings (Table 1). Metoclopramide was added to ranitidine in patients of group A who had received ranitidine before intervention. On the other hand, metoclopramide was added to lansoprazole in patients of group B who had received lansoprazole before intervention. I-GERQ-R items Scoring Daily symptom diary Item 1. How often did baby spit up? 0-3 Item 2. How much did baby spit up? 0-4 Item 4. How often was spitting up uncomfortable for the baby? 0-4 Item 5. How often did the baby refuse a feeding when hungry? 0-4 Item 6. How often did the baby stop eating soon after eating even when hungry? 0-4 Item 8. Did the baby cry a lot during or within 1 hour after feedings? 0-4 Item 9. Did the baby cry or fuss more than usual? 0-4 Item 10. On average how long did the baby cry or fuss during a 24-hour period? 0-3 Item 11. How often did the baby have hiccups? 0-4 Item 12. How often did the baby have episodes of arching back? 0-4 Item 13. Has the baby stopped breathing while awake or struggled to breathe? 0-4 Item 14. Has the baby turned blue or purple? 0-2 Regurgitation and crying items comprise ~50% of total possible points; >> needed for diagnosis. Total possible scoring: 42 (22); cut .

Factor Structure and Psychometric Properties of the Neonatal Eating Assessment Tool—Bottle-Feeding (NeoEAT—Bottle-Feeding)

Article

May 2018
Adv Neonatal Care

Background: Feeding difficulties are common in infancy. There are currently no valid and reliable parent-report measures to assess bottle-feeding in infants younger than 7 months. The Neonatal Eating Assessment Tool (NeoEAT)-Bottle-feeding has been developed and content validated. Purpose: To determine the factor structure and psychometric properties of the NeoEAT-Bottle-feeding. Methods: Parents of bottle-feeding infants younger than 7 months were invited to participate. Exploratory factor analysis was used to determine factor structure. Internal consistency reliability was tested using Cronbach α. Test-retest reliability was tested between scores on the NeoEAT-Bottle-feeding completed 2 weeks apart. Construct validity was tested using correlations between the NeoEAT-Bottle-feeding, the Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R), and the Infant Gastrointestinal Symptoms Questionnaire (IGSQ). Known-groups validation was tested by comparing scores between healthy infants and infants with feeding problems. Results: A total of 441 parents participated. Exploratory factor analysis revealed a 64-item scale with 5 factors. Internal consistency reliability (α= .92) and test-retest reliability (r = 0.90; P < .001) were both excellent. The NeoEAT-Bottle-feeding had construct validity with the I-GERQ-R (r = 0.74; P < .001) and IGSQ (r = 0.64; P < .001). Healthy infants scored lower on the NeoEAT-Bottle-feeding than infants with feeding problems (P < .001), supporting known-groups validity. Implications for practice: The NeoEAT-Bottle-feeding is an available assessment tool for clinical practice. Implications for research: The NeoEAT-Bottle-feeding is a valid and reliable measure that can now be used in feeding research.Video Abstract Available at https://journals.lww.com/advancesinneonatalcare/Pages/videogallery.aspx.

Preterm infants born prior to 32 weeks gestation experience more symptoms of gastroesophageal reflux in the first 6 months of life than infants born at later gestational ages

Article

May 2021

Background: Preterm infants hospitalized in the neonatal intensive care unit (NICU) often display symptoms of gastroesophageal reflux (GER). Little is known about symptoms of GER in this population after neonatal discharge. The purpose of this study was to describe symptoms of GER across the first 6 months of life in infants based on gestational age at birth and to explore factors associated with GER symptoms. Methods: This was a descriptive, cross-sectional study. Parents of 582 infants less than 6 months old participated in an online survey about their child's symptoms of GER. Gestational age at birth, corrected age at time of study, infant sex, mode of birth, and family history of allergy were explored for their relationships to symptoms of GER. Results: Infants born at <32 weeks gestation had more symptoms of GER than infants born at later gestational ages. While full-term infants showed a decrease in symptoms across the first 6 months of life, infants born at 32-36 6/7 weeks showed no improvement, and infants born at <32 weeks gestation showed worsening symptoms over time. Infant sex and mode of birth were not associated with GER symptoms. Infants with a family history of allergy had more symptoms of GER than infants without a family history of allergy. Conclusions: Infants born prior to 32 weeks gestation experience more symptoms of GER than infants born at later gestation, with worsening of symptoms over the first 6 months of life. Preterm infants (<37 weeks gestation at birth) do not show the same improvement in symptoms over the first 6 months as full-term infants. Infants born 32 0/7-36 6/7 weeks, who may otherwise may be considered lower risk for morbidity than infants born before 32 weeks, did not experience the same improvement in symptoms over the first 6 months as full-term infants. Family history of allergy is related to increased symptoms of GER. Additional research is needed on the underlying mechanisms and evolution of GER symptoms in preterm infants.

Diagnosis and Management of Gastro-esophageal Reflux Disease in Children: Recommendations of Pediatric Gastroenterology Chapter of Indian Academy of Pediatrics, Indian Society of Pediatric Gastroenterology, Hepatology and Nutrition (ISPGHAN)

Article

Jun 2021
Indian Pediatr

Justification: Gastroesophageal reflux (GER) related symptoms are a major cause of parental concern and referrals at all ages. These guidelines have been framed to inform pediatricians regarding current diagnosis and management of gastro-esophageal reflux disease (GERD). Process: A group of experts from the pediatric gastroenterology sub-specialty chapter of Indian Academy of Pediatrics (ISPGHAN) discussed various issues relating to the subject online on 25 October, 2020. A consensus was reached on most aspects and a writing committee was constituted. This committee had three meetings for a detailed discussion. The statement was sent to the entire group and their approval obtained. Objective: To formulate a consensus statement to enable proper diagnosis and management of GERD in children. Recommendations: GER is physiological in most infants and it improves as age advances. The pathological form, called GERD causes distressing symptoms that affect daily activities and may result in complications. The presentation would vary from regurgitation to severe symptoms due to esophageal or respiratory tract disease. In older children, esophagitis is the commonest manifestation of GERD. A careful history and clinical examination are adequate to make a diagnosis in most patients, but judicious investigations are necessary in a few. Upper gastro intestinal tract endoscopy may be required in those with esophageal manifestations, dysphagia and hematemesis. In children with extra-esophageal symptoms, MII-pH monitoring and scintigraphy are necessary. Empirical treatment with a Proton pump inhibitor (PPI) has not been proven useful in infants, but a four-week trial is recommended in older children without complications. While positioning and feed thickening have limited benefit in infants, life-style modifications are important in older children.

Maternal Perceptions of Infant Behavior as a Potential Indicator of Parents or Infants in Need of Additional Support and Intervention

Article

Full-text available

Oct 2021

The goal of the present study is to examine the relationship between early infant behaviors, which can be easily reported by parents, with parent-infant bonding and maternal mental health. It has long been established that child characteristics and behaviors have a significant impact on parent well-being and how parents respond to their infants. Examining parent perceptions of challenging infant behaviors may help health professionals identify high risk infants in need of intervention and mothers in need of additional support. Mothers of 73 infants between the ages of 3.5 weeks and 6 months filled out questionnaires. Infant stomach issues were positively correlated with bonding issues, maternal anxiety and maternal depression. Infant crying issues were also positively correlated with bonding issues, maternal anxiety and maternal depression. Potential clinical and research applications of the instrument include early identification of caregivers in need of support and screening for further clinical assessment and care.

The significance of different methods for detection of gastroesophageal reflux in children

Article

Full-text available

Jan 2018

Symptom-based diagnosis of gastroesophageal reflux disease (GERD) is not specific due to high prevalence of disorders that can mimic GERD. Conventional pH monitoring, combined pH-MII (multiple intraluminal impedance) monitoring and esophagogastroduodenoscopy are diagnostic methods most frequently used in children. Combined pH-MII monitoring is the most accurate diagnostic method for detecting GERD in children, which tends to become the gold standard. In infants and probably in children with extraesophageal symptoms, MII gives the greatest contribution to the validity of pH-MII monitoring. High prevalence of functional heartburn, in children older than 8 years, suggests the importance of pH-MII monitoring in this age group as well. The majority of studies showed age differences in the chemical composition of refluxate. Weakly acid reflux is more common in infants and is often associated with symptoms, whereas acid reflux is more common in older children and adolescent. Sensitivity of endoscopy is very low compared to pH-MII monitoring as a reference test. Although endoscopy is the method of choice for the confirmation of reflux esophagitis, pH-MII parameters are promising indicators of mucosal integrity, but further studies are needed. The major problem with pH-MII monitoring is a lack of normative data for children. Therefore, the standardization is mandatory. For the present pH-MII monitoring has limited impact on treatment due to the absence of effective therapy for weakly acid reflux, suggesting that further studies should be directed in this direction.

Magnesium Alginate in Gastro-Esophageal Reflux: A Randomized Multicenter Cross-Over Study in Infants

Article

Full-text available

Dec 2019
Int J Environ Res Publ Health

The aims of this study were to evaluate the efficacy of magnesium alginate in decreasing functional regurgitation symptoms in infants, and to assess the cost–benefit ratio of magnesium alginate compared to a thickened formula. A multicenter perspective cross-over study was conducted in formula-fed infants with persisting regurgitation, randomly assigned to receive two weeks of a magnesium-alginate-based formulation followed by two weeks of thickened formula, or vice-versa. Infants, exclusively breast-fed, were followed up for two weeks while receiving magnesium alginate. Symptoms of gastroesophageal reflux (GER) were evaluated through the Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R). Direct cost of treatments was also calculated. Seventy-two infants completed the study. We found a significant reduction of I-GERQ-R scores over time (F = 55.387; p < 0.001) in all groups with no difference between the sequences of administration (F = 0.268; p = 0.848) in formula-fed infants and between exclusively breast-fed and formula-fed infants receiving magnesium alginate (t = 1.55; p = 0.126). The mean cost savings per infant was € 4.60 (±11.2) in formula-fed infants treated with magnesium alginate compared to thickened formula (t = 2.91, p < 0.0005). Conclusions were that the magnesium-alginate formulation reduces GER symptoms both in formula-fed and breast-fed infants. In formula-fed infants, clinical efficacy is similar to thickened formulas with a slightly lower cost of treatment.

Gastroesophageal Reflux Disease in the Neonatal Intensive Care Unit Infant

Article

Feb 2019
Pediatr Clin

Gastroesophageal reflux (GER) and GER disease (GERD) pertaining to infants in the neonatal intensive care unit (NICU) are reviewed, based on research in this specific population. The developmental biology of the gastroesophageal junction, physiology of GER, and pathophysiology of GERD in this setting are summarized, and risk factors for GER and GERD identified. The epidemiology, economic burden, and controversies surrounding GERD in NICU infants are addressed, and an approach to GER and GERD in these patients formulated. Recent advancements in individual assessment of GER and GERD in the NICU infant are examined, and evidence-based guidelines for their adoption provided.

Neonatal Eating Assessment Tool–Bottle-Feeding: Norm-Reference Values for Infants Less Than 7 Months Old

Article

Apr 2019

The Neonatal Eating Assessment Tool (NeoEAT)–Bottle-feeding is a parent-report assessment of bottle-feeding behavior in infants less than 7 months old with evidence of validity and reliability. The purpose of this study was to establish norm-reference values to guide score interpretation and clinical decision making. Parents of 478 healthy, typically developing infants completed the NeoEAT–Bottle-feeding. Descriptive statistics were calculated for the following age groups: 0 to 2, 2 to 4, 4 to 6, and 6 to 7 months. NeoEAT–Bottle-feeding total scores decreased with increasing infant age. The Infant Regulation subscale contributed the most to the total score and remained high across the first 6 months of life, then decreased dramatically in the 6- to 7-month age group. The 90th and 95th percentile values for the total score and subscale scores can be used to identify infants with problematic feeding, guide referral, tailor treatment, and assess response to treatment.

Combined multichannel intraluminal impedance and pH monitoring is helpful in managing children with suspected gastro-oesophageal reflux disease

Article

Apr 2018
DIGEST LIVER DIS

Background Gastro-oesophageal reflux is very common in the paediatric age group. There is no single and reliable test to distinguish between physiologic and pathological gastro-oesophageal reflux, and this lack of clear distinction between disease and normal can have a negative impact on the management of children. Aims To evaluate the usefulness of 24-h oesophageal pH-impedance study in infants and children with suspected gastro-oesophageal reflux disease. Methods Patients were classified by age groups (A–C) and reflux-related symptoms (typical and atypical). All underwent pH-impedance study. If the latter suggested an abnormal reflux, patients received therapy in accordance with NASPGHAN/ESPGHAN recommendations, while those with normal study had an additional diagnostic work-up. The efficacy of therapy was evaluated with a specific standardized questionnaire for different ages. Results The study was abnormal in 203/428 patients (47%) while normal in 225/428 (53%). Of those with abnormal study, 109 exhibited typical symptoms (54%), and 94 atypical (46%). The great majority of the patients with abnormal study were responsive to medical anti-reflux therapy. Conclusions We confirm the utility of prolonged oesophageal pH-impedance study in detecting gastro-oesophageal reflux disease in children and in guiding therapy. Performing oesophageal pH-impedance monitoring in children with suspected gastro-oesophageal reflux disease is helpful to establish the diagnosis and avoid unnecessary therapy.

The Role of Reflux in Childhood Otorhinolaryngological Disorders

Article

Full-text available

Mar 2018

Haytham Kubba

Purpose of Review This article seeks to review the current literature on the role of laryngopharyngeal reflux in the development of various disorders of the ear, nose and throat in infants and children including otitis media, chronic rhinosinusitis and airway disorders. The aim is to guide the otolaryngology clinician in investigation and management of reflux and to identify priorities for future research in this area. Recent Findings Many otolaryngological disorders coexist with reflux more often than might be expected by chance, but evidence of causality is weak. Although many otolaryngologists are convinced that treatment of reflux can make a significant difference to the clinical course of many upper airway disorders, the evidence to support this is lacking. In part, this is due to inadequate tools for describing the symptoms and endoscopic signs of laryngopharyngeal reflux and the lack of a sensitive, specific and reliable objective test. Summary Further research demonstrating simple associations between otolaryngological diseases and reflux is unlikely to be of much value. Instead, researchers should concentrate their efforts on studies to develop and validate better means of recording symptoms and signs of laryngopharyngeal reflux and investigating the clinical utility of salivary pepsin, oropharyngeal pH monitoring and multichannel intraluminal impedance.

Prospective Risk Stratification Identifies Healthcare Utilization Associated with Home Oxygen Therapy for Infants with Bronchopulmonary Dysplasia

Article

Aug 2022
J Pediatr

Objective To test whether prospective classification of infants with bronchopulmonary dysplasia (BPD) identifies lower-risk infants for discharge with home oxygen who have fewer rehospitalizations by 1 year after neonatal intensive care unit (NICU) discharge. Methods Prospective single-center cohort from 2016-2019 of infants with BPD defined as respiratory support at 36 weeks’ postmenstrual age. “Lower-risk” infants were receiving ≤2 liters/minute nasal cannula flow, did not have pulmonary hypertension or airway comorbidities, and had blood gas partial pressure of carbon dioxide <70 mm Hg. We compared 3 groups by discharge status: lower-risk room air, lower-risk home oxygen, and higher-risk home oxygen. Primary outcome was rehospitalization 1-year post-discharge; secondary outcomes were determined by chart review and parent questionnaire. Results Among 145 infants, 32 (22%) were lower-risk discharged in room air, 49 (32%) were lower-risk using home oxygen, and 64 (44%) were higher-risk. Lower-risk infants using home oxygen had similar rehospitalization rates compared with lower-risk infants on room air (18% vs. 16%, p=0.75), and lower rates than higher-risk infants (39%, p=0.018). Lower-risk infants using home oxygen had more specialty visits (median 10, IQR 7-14, vs 6, IQR 3-11, p=0.028) than those on room air. Classification tree analysis identified risk status as significantly associated with rehospitalization, along with distance from home to hospital, inborn, parent-reported race, and siblings in the home. Conclusions Prospectively identified lower-risk infants discharged with home oxygen had fewer rehospitalizations than higher-risk infants and used more specialty care than lower-risk infants discharged in room air.

Neonatal Eating Assessment Tool—Breastfeeding: Reference Values for Infants Less Than 7 Months old

Article

Aug 2019

Background The Neonatal Eating Assessment Tool—Breastfeeding is a valid and reliable 62-item parent-report assessment of symptoms of problematic breastfeeding behavior intended for infants less than 7 months old. Research aim The aim of this study was to describe the Neonatal Eating Assessment Tool—Breastfeeding total score and subscale scores within a sample of full-term, healthy, typically-developing infants under 7 months old. Methods Parents of healthy, full-term breastfeeding infants ( N = 475) less than 7 months old completed the Neonatal Eating Assessment Tool – Breastfeeding through an online survey. Descriptive statistics were calculated for the total score and seven subscale scores within each age group: 0–2, 2–4, 4–6, and 6–7 months. Results Neonatal Eating Assessment Tool—Breastfeeding total scores were highest (i.e., more problematic symptoms) at 0–2 months and decreased in older infant age groups. All subscale scores also had a downward trajectory in symptoms of problematic breastfeeding except the subscale Compelling Symptoms of Problematic Feeding, which was very low across age groups. Scores on the Infant Regulation subscale remained elevated for the first 6 months of life, then declined markedly in the 6–7 month age group. Conclusion The Neonatal Eating Assessment Tool—Breastfeeding now has reference values to facilitate interpretation of scores and guide decision-making, personalization of interventions, and assessment of response to interventions. For research, the Neonatal Eating Assessment Tool—Breastfeeding can be used to follow longitudinal development of breastfeeding as well as to test efficacy of breastfeeding interventions.

Gastroesophageal Reflux Disease in the NICU Neonate: Controversies, Current Understanding and Future Directions

Article

Feb 2020
CLIN PERINATOL

Gastroesophageal reflux (GER) is considered physiologic and is a normal process; whereas, when aerodigestive consequences are associated, it is often interpreted as GER disease (GERD). However, the distinction between them remains a challenge in infants in the NICU. Reflux-type of symptoms are heterogeneous, and often managed with changes in diet, feeding methods, and acid-suppressive therapy; all these empiric therapies lack objectivity; hence, practice variation is universal. We clarify the current controversies, explain the potential role of GERD in causing symptoms and complications, and highlight current advances. The evidence basis for the diagnostic strategies is discussed.

Natural history of gastroesophageal reflux in infancy: new data from a prospective cohort.

Preprint

Full-text available

Dec 2019

Objective Gastroesophageal reflux (GER) is common in infants. Gastroesophageal reflux disease (GERD) is defined as GER leading to troublesome symptoms that affect daily functioning and/or complications. This study aimed at determining the prevalence and progression of GER and GERD in a cohort of healthy term infants from birth to 12 months old. Methods We conducted a prospective cohort study including all full-term living neonates born at Besançon Teaching Hospital, France. Exclusion criteria were: congenital anomaly. Parents completed a clinical report form and the Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) at 1, 3, 6, 10, and 12 months of age. GER was defined as score ≥1 to the first question with I-GERQ-R score < 16 ; and GERD as score ≥1 to the first question with I-GERQ-R score ≥ 16.Findings 157/347 births were included (83 boys). The prevalence of regurgitation at least once a day was 45.7% overall. In total: 72%, 69%, 56%, 18% and 13% of infants regurgitated at least once a day at 1, 3, 6, 10, and 12 months of age, respectively. Physiological GER affected 53%, 59%, 51%, 16%, and 12% of infants; GERD, 19%, 9%, 5%, 2%, and 2%, respectively. Two risk factors were identified: family history of GER and exposure to passive smoking. Treatment included dietary modification (14%) and pharmacotherapy (5%). Conclusion Physiological GER peaked at 3 months, GERD at 1 month. Most cases resolved on their own. Parents should be reassured/educated regarding symptoms, warning signs, and generally favorable prognosis. Pharmacologic agents are justified only for ascertained GERD. I-GERQ-R does not replace more invasive investigations to confirm diagnosis in selected cases.

Diagnosis of GERD

Chapter

Jun 2022

Michiel van Wijk

Despite the existence of internationally approved guidelines, the diagnosis of gastroesophageal reflux (GER)-disease remains difficult (Rosen et al. J Pediatr Gastroenterol Nutr. 66:516-54, 2018). GER-disease is generally considered a clinical diagnosis. However, differentiation between physiologic GER, functional regurgitation, and GER-disease in infants and between functional heartburn, hypersensitive esophagus, rumination syndrome, symptoms of esophageal dysfunction, and GER-disease in older children can be difficult based on clinical grounds alone. In addition, some patients present with extra-esophageal problems such as chronic respiratory disease, chronic cough, or ENT problems. Many diagnostic tests have been proposed, but none of them can truly be seen as a gold standard. Upper gastrointestinal endoscopy with biopsies can show erosive esophagitis and Barrett’s esophagus and is able to differentiate between reflux esophagitis and eosinophilic esophagitis, but cannot show or exclude non-erosive GER-disease. In theory, 24-h pH-impedance testing allows for detecting all GER events and establishing a temporal association between individual GER events and symptoms. However, no true normative data are available and its analysis can be difficult, especially in severe cases with low impedance baselines. Additionally, the statistical calculation of an association between GER and symptoms is dependent on sufficient symptoms and their adequate objective monitoring. A trial with acid suppression can be helpful to diagnose acid-related disease in older children, but not in patients where weakly acidic GER is predominant. The placebo effect of such a trial carries the risk of chronic over-treatment in functional heartburn. Several less invasive tests have been studied, but their diagnostic value is, as yet, limited.

Distress in Infants and Young Children: Don’t Blame Acid Reflux

Article

Jul 2020
J PEDIATR GASTR NUTR

Objective: The role of gastroesophageal reflux (GER) causing distress in infants is controversial but acid inhibitors are often empirically prescribed. We evaluated the relation between distress assessed by the Face, Legs, Activity, Cry, Consolability (FLACC) scale and GER in infants. Methods: We analyzed esophageal impedance-pH monitoring (MII-pH) tracings of infants with persistent unexplained fussiness or distress. Symptoms occurring during investigation were scored by parents using the FLACC scale and were grouped as "distress" episodes. Results: We recruited 62 children (age 15 days - 23 months, median age 3.5 months). During MII-pH 452 episodes of distress were registered: 217 (48%) were temporally associated with GER and 235 (52%) were not, with no difference in the median value of FLACC between the two groups. Infants with abnormal acid exposure index had a significantly lower FLACC compared to the group with acid reflux index <7% (p < 0.001). When associated with symptoms, GER occurred significantly more often before than simultaneously or after an episode of distress (p = 0.001). Age, proximal extension and duration of GER did not correlate with FLACC scores. Episodes of distress associated with non-acid reflux presented a significant higher FLACC compared to the ones with acid content (FLACC 6 vs 5, p = 0.011). In infants episodes of distress do not significantly correlate with GER. Conclusion: No difference in infant distress noted between proximal and distal GER. Non-acid reflux is perceived at least as painful than acid GER. Our results stress that acid inhibitors should not be started in infants presenting distress unless a clear association with acid GER is demonstrated.

Symptoms of problematic feeding in infants under 1 year of age undergoing frenotomy: A review article

Article

Jul 2020

Aim The aims of this systematic review were to first identify and summarize original research that compared symptoms of problematic feeding in infants with tongue tie before and after frenotomy and then evaluate the quality of measures used to assess problematic feeding. Methods CINAHL and PubMed were searched for ((tongue‐tie) or (ankyloglossia)) and ((feeding) or (breastfeeding) or (bottle‐feeding)) and ((frenotomy) or (frenectomy) or (frenulectomy) or (frenulotomy)). Original research reporting on feeding before and after frenotomy in infants under 1 year old were included. Results Maternal nipple pain, breastfeeding self‐efficacy, and LATCH scores improved after frenotomy. Few data are available on the effect of frenotomy on infant feeding. The measures used to assess infant feeding were not comprehensive and did not possess strong psychometric properties. Conclusion Literature suggests that maternal nipple pain, self‐efficacy, and LATCH scores improve in breastfeeding mother‐infant dyads after frenotomy. However, current literature does not provide adequate data regarding the effect of frenotomy on the infant’s ability to feed or which infants benefit from the procedure. Future research should utilize comprehensive, psychometrically‐sound measures to assess infants for tongue‐tie and to evaluate infant feeding to provide stronger evidence for the effect of frenotomy on feeding in infants with tongue‐tie.

Does Combined Multichannel Intraluminal Impedance and pH (MII-pH) Testing Improve Clinical Outcomes in Children With Gastroesophageal Reflux Disease?

Article

Jul 2020
J PEDIATR GASTR NUTR

Objectives: To investigate the role of combined multichannel intraluminal impedance and pH (MII-pH) testing in clinical management of children with gastroesophageal reflux disease (GERD) by exploring the impact of treatment changes made based on MII-pH testing results on symptoms and quality of life outcomes. Methods: All patients (< 18 years) referred to the Sydney Children's Hospital (SCH) for MII-pH testing were recruited. Patients were classified by acid suppression therapy (AST) status (on AST and off AST) and changes in medical and surgical management were evaluated. Validated questionnaires (PGSQ and I-GERQ-R) were administered at baseline at the time of MII-pH testing, and 4 weeks after treatment changes were made and questionnaire scores were compared. Results: Of the 45 patients recruited, 24 patients (53.3%) were off AST and 21 patients (46.7%) were on AST. MII-pH testing led to medication changes in 30 patients (66.7%). This included 15/24 (62.5%) in those off AST and 15/21 (71.4%) in those on AST. Over 98% of patients who had treatment changes showed a significant improvement in both symptoms and quality of life scores. Conclusions: Our study is one of the first pediatric studies to evaluate the clinical validity of MII-pH testing in the pediatric population referred for suspected GERD, and its ability in guiding clinical management. Our study has shown that treatment decisions guided by and based on results of MII-pH testing led to a significant improvement in symptoms and quality of life in infants and children with GERD.

Bottle-Feeding Challenges in Preterm-Born Infants in the First 7 Months of Life

Article

Full-text available

Sep 2020

Preterm infants frequently experience oral feeding challenges while in the neonatal intensive care unit, with research focusing on infant feeding during this hospital stay. There is little data on symptoms of problematic feeding in preterm-born infants in the months after discharge. The purpose of this study was to describe symptoms of problematic bottle-feeding in the first 7 months of life in infants born preterm, compared to full-term infants. Parents of infants less than 7 months old completed an online survey that included the Neonatal Eating Assessment Tool-Bottle-feeding and questions about the infant's medical and feeding history. General linear models were used to evaluate differences in NeoEAT-Bottle-feeding total score and subscale scores by preterm category, considering other significant factors. Very preterm infants had more symptoms of problematic bottle-feeding than other infants. Current age, presence of gastroesophageal reflux, and anomalies of the face/mouth were associated with problematic bottle-feeding.

(Rad 8)Caffeine prophylaxis to improve intermittent hypoxaemia in infants born late preterm: a randomised controlled dosage trial (Latte Dosage Trial)

Article

Full-text available

Oct 2020

Introduction Infants born late preterm (34+0 to 36+6 weeks’ gestational age) have frequent episodes of intermittent hypoxaemia compared with term infants. Caffeine citrate reduces apnoea and intermittent hypoxaemia and improves long-term neurodevelopmental outcomes in infants born very preterm and may have similar effects in late preterm infants. Clearance of caffeine citrate increases with gestational age and late preterm infants are likely to need a higher dose than very preterm infants. Our aim is to determine the most effective and best-tolerated dose of caffeine citrate to reduce transient intermittent hypoxaemia events in late preterm infants. Methods and analysis A phase IIB, double-blind, five-arm, parallel, randomised controlled trial to compare the effect of four doses of oral caffeine citrate versus placebo on the frequency of intermittent hypoxaemia. Late preterm infants will be enrolled within 72 hours of birth and randomised to receive 5, 10, 15 or 20 mg/kg/day caffeine citrate or matching placebo daily until term corrected age. The frequency of intermittent hypoxaemia (events/hour where oxygen saturation concentration is ≥10% below baseline for ≤2 min) will be assessed with overnight oximetry at baseline, 2 weeks after randomisation (primary outcome) and at term corrected age. Growth will be measured at these timepoints, and effects on feeding and sleeping will be assessed by parental report. Data will be analysed using generalised linear mixed models. Ethics and dissemination This trial has been approved by the Health and Disability Ethics Committees of New Zealand (reference 18/NTA/129) and the local institutional research review committees. Findings will be disseminated to peer-reviewed journals to clinicians and researchers at local and international conferences and to the public. The findings of the trial will inform the design of a large multicentre trial of prophylactic caffeine in late preterm infants, by indicating the most appropriate dose to use and providing information on feasibility. Trial registration number ACTRN12618001745235; Pre-results.

Overlapping Symptoms of Gastroesophageal Reflux and Aspiration Highlight the Limitations of Validated Questionnaires

Article

Nov 2020
J PEDIATR GASTR NUTR

Objectives: Infants frequently present with feeding difficulties and respiratory symptoms, which are often attributed to gastroesophageal reflux but may be due to oropharyngeal dysphagia with aspiration. The Infant Gastroesophageal Reflux Questionnaire Revised (I-GERQ-R) is a clinical measure of gastroesophageal reflux disease but now there is greater understanding of dysphagia as a reflux mimic. We aimed to determine the degree of overlap between I-GERQ-R and evidence of dysphagia, measured by Pediatric Eating Assessment Tool-10 (Pedi-EAT-10) and videofluoroscopic swallow study (VFSS). Methods: We performed a prospective study of subjects <18 months old with feeding difficulties. All parents completed Pedi-EAT-10 and I-GERQ-R as a quality initiative to address parental feeding concerns. I-GERQ-R results were compared to Pedi-EAT-10 and, when available, results of prior VFSS. Pearson correlation coefficients were calculated to determine the relationship between scores. Groups were compared with one-way ANOVA and Fisher's exact test. ROC analysis was completed to compare scores with VFSS results. Results: 108 subjects with mean age 7.1 ± 0.5 months were included. Pedi-EAT-10 and I-GERQ-R were correlated (r = 0.218, p = 0.023) in all subjects and highly correlated in the 77 subjects who had prior VFSS (r = 0.369, p = 0.001). The blue spell questions on I-GERQ-R had relative risk 1.148 (95% CI 1.043-1.264, p = 0.142) for predicting aspiration/penetration on VFSS, with 100% specificity. Scores on the question regarding crying during/after feedings were also higher in subjects with abnormal VFSS (1.1 ± 0.15 vs 0.53 ± 0.22, p = 0.04). Conclusions: I-GERQ-R and the Pedi-EAT-10 are highly correlated. I-GERQ-R results may actually reflect oropharyngeal dysphagia and not just gastroesophageal reflux disease in infants.

Gastroesophageal Reflux

Chapter

Jan 2021

Yvan Vandenplas

Esophageal reflux is a common finding in infants and children. The European Society for Paediatric Gastroenterology, Hepatology and Nutrition and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition have developed guidelines for the management of infants and children with this condition. In children with prolonged or severe symptoms, determination of the underlying etiology enables appropriate therapeutic intervention.

Gastroesophageal Reflux

Chapter

Jan 2022

The guidelines of the North American and European Societies for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN/ESPGHAN) define gastroesophageal reflux (GER) as the physiologic passage of gastric contents into the esophagus and GER disease (GERD) as reflux associated with troublesome symptoms or complications. Although there is overlap between GER and GERD, their recognition is important to implement best management practice across all pediatric age groups. Clinical manifestations of GER and GERD in term infants, children, and adolescents allow to identify patients who can be managed with conservative treatment or who need referral for a diagnostic workup. History and physical examination including elimination of alarm symptoms remain the cornerstones and are important to rule out differential diagnoses. Endoscopy and histology are the standard diagnostic tool for esophagitis, enabling the diagnosis of eosinophilic esophagitis. Esophageal impedance measures acid and nonacid reflux episodes and allows to better evaluate a time association between symptoms and GER. The diagnosis of nonacid GERD avoids the unneeded administration of acid-blocking medication. Similar to the adult population, there is an increasing but inappropriate prescription rate of proton-pump inhibitors in pediatrics, but especially in infants when presenting with inconsolable crying. Adverse effects on proton-pump inhibitors such as dysbiosis, small bowel bacterial overgrowth, increased respiratory and gastrointestinal tract infections, nutritional consequences, hypomagnesemia, etc. have been highlighted. The management of nonacid GER(D) remains a challenge as long as there is no effective drug. Conservative recommendations such as reassurance, dietary, and positional treatment are indicated in patients with uncomplicated troublesome regurgitation and GERD. In infants, GER(D) may be difficult to distinguish from cow’s milk protein allergy as the presenting symptoms may be very similar. Children with acid GERD may benefit from acid-blocking medication. Laparoscopic surgery is indicated to manage more severe cases, such as children with intractable symptoms or who are at risk for severe complications of GERD.

Prevalence, risk factors and parental perceptions of gastroesophageal reflux disease in Asian infants in Singapore

Article

Mar 2022
ANN ACAD MED SINGAP

Introduction: Infant gastroesophageal reflux disease (GERD) is a significant cause of concern to parents. This study seeks to describe GERD prevalence in infants, evaluate possible risk factors and assess common beliefs influencing management of GERD among Asian parents. Methods: Mother-infant dyads in the Singapore PREconception Study of long-Term maternal and child Outcomes (S-PRESTO) cohort were prospectively followed from preconception to 12 months post-delivery. GERD diagnosis was ascertained through the revised Infant Gastroesophageal Reflux Questionnaire (I-GERQ-R) administered at 4 time points during infancy. Data on parental perceptions and lifestyle modifications were also collected. Results: The prevalence of infant GERD peaked at 26.5% at age 6 weeks, decreasing to 1.1% by 12 months. Infants exclusively breastfed at 3 weeks of life had reduced odds of GERD by 1 year (adjusted odds ratio 0.43, 95% confidence interval 0.19-0.97, P=0.04). Elimination of "cold or heaty food" and "gas producing" vegetables, massaging the infant's abdomen and application of medicated oil to the infant's abdomen were quoted as major lifestyle modifications in response to GERD symptoms. Conclusion: Prevalence of GERD in infants is highest in the first 3 months of life, and the majority outgrow it by 1 year of age. Infants exclusively breastfed at 3 weeks had reduced odds of GERD. Cultural-based changes such as elimination of "heaty or cold" food influence parental perceptions in GERD, which are unique to the Asian population. Understanding the cultural basis for parental perceptions and health-seeking behaviours is crucial in tailoring patient education appropriately for optimal management of infant GERD.

Prevalence of Gastroesophageal Reflux Disease in Infants With Congenital Muscular Torticollis: A Prospective Cohort Study

Article

Apr 2022
Pediatr Phys Ther

Purpose: Clinical experience suggests that gastroesophageal reflux disease (GERD) occurs commonly in infants with congenital muscular torticollis (CMT). However, this is an understudied topic and prospective studies are absent. We determine the prevalence of GERD in infants with CMT, comparing clinical characteristics between CMT infants with and without GERD, and identifying infants with potentially undiagnosed GERD. Methods: A prospective cohort study of 155 infants with CMT younger than 12 months with and without GERD was evaluated by pediatric physical therapists. Results: GERD prevalence was 30.3%, including 6 (3.9%) infants with undiagnosed GERD. Demographic and clinical characteristics were similar in CMT infants with and without GERD. Conclusions: This is the first prospective cohort study determining the prevalence of GERD in infants referred for evaluation of CMT. Further prospective studies are needed to determine whether early intervention and treatment of GERD improves outcomes in infants with CMT (see Supplemental Digital Content 1, available at: http://links.lww.com/PPT/A369).

Symptoms of GER

Chapter

Jan 2022

Gastrointestinal Symptoms in Healthy, Full-Term Infants Under 7 Months of Age

Article

Jul 2020
J Pediatr Nurs

Purpose To describe symptoms of gastrointestinal distress experienced by healthy, full-term infants in the first 7 months of life and test the psychometric properties of the Infant Gastrointestinal Symptoms Questionnaire (IGSQ). Design and methods Parents of infants <7 months (n = 320) completed the IGSQ, the Infant Gastroesophageal Reflux Questionnaire – Revised (I-GERQ-R), and the Neonatal Eating Assessment Tool (NeoEAT) – Breastfeeding and/or Bottle-feeding. Median and percentile scores were calculated for the IGSQ scores for each age group: 0–2, 2–4, 4–6, and 6–7 months. Change in IGSQ scores with age were evaluated using the Kruskal-Wallis test with Mann-Whitney U tests for post-hoc comparisons. Internal consistency reliability was assessed using Cronbach's alpha. Concurrent validity was tested using Spearman's rho between the IGSQ and the I-GERQ-R and NeoEAT. Results IGSQ scores decreased significantly with increased infant age, from a median of 28 at 0–2 months to 23 at 6–7 months old. The IGSQ had acceptable internal consistency reliability (Cronbach's alpha = 0.74). IGSQ total score was significantly correlated with I-GERQ-R total score (Spearman's rho (rs) = 0.69, p < .001), NeoEAT – Breastfeeding: Gastrointestinal Function subscale score (rs = 0.46, p < .001), and NeoEAT – Bottle-feeding: Gastrointestinal Tract Function subscale score (rs = 0.47, p < .001). Conclusions Gastrointestinal symptoms decrease with increasing age in the first 7 months of life. The IGSQ has evidence of acceptable internal consistency reliability and concurrent validity. Practice implications These data can be used to guide IGSQ score interpretation.

The Meaning and Use of the Area Under a Receiver Operating Characteristic (ROC) Curve

Article

Full-text available

May 1982

A representation and interpretation of the area under a receiver operating characteristic (ROC) curve obtained by the "rating" method, or by mathematical predictions based on patient characteristics, is presented. It is shown that in such a setting the area represents the probability that a randomly chosen diseased subject is (correctly) rated or ranked with greater suspicion than a randomly chosen non-diseased subject. Moreover, this probability of a correct ranking is the same quantity that is estimated by the already well-studied nonparametric Wilcoxon statistic. These two relationships are exploited to (a) provide rapid closed-form expressions for the approximate magnitude of the sampling variability, i.e., standard error that one uses to accompany the area under a smoothed ROC curve, (b) guide in determining the size of the sample required to provide a sufficiently reliable estimate of this area, and (c) determine how large sample sizes should be to ensure that one can statistically detect differences in the accuracy of diagnostic techniques.

Reflux Symptoms in 100 Normal Infants: Diagnostic Validity of the Infant Gastroesophageal Reflux Questionnaire

Article

Full-text available

Dec 1996

To identify the prevalence of reflux symptoms in normal infants, to characterize the diagnostic validity of a previously described 138-item Infant Gastroesophageal Reflux Questionnaire (I-GERQ) for separating normal infants from those with gastroesophageal reflux disease (GERD), and to identify potentially provocative caretaking practices, we administered the questionnaire to 100 infants attending a well-baby clinic (normals) and to 35 infants referred to the Gastroenterology Division for evaluation for GERI) and testing positive on esophageal pH probe or biopsy (GERD infants). Differences were analyzed by Chi-square, and odds ratios were defined. The diagnostic validity of a 25-point I-GERQ GERD score based on 11 items on the questionnaire was evaluated by calculating its sensitivity, specificity, and positive and negative predictive values. We found that normal infants had a high prevalence of reflux symptoms, such as daily regurgitation (40%), respiratory symptoms, crying more than an hour a day (17%), arching (10%), or daily hiccups (36%) but that many symptoms were significantly more prevalent in the GERD than in the normal infants (Chi-square P < .05), and odds ratios were above 3 for nearly 20 items. The positive and negative predictive values for the 25-point I-GERQ score were 1.00 and .94-.98, respectively. Environmental smoke exposure did not quite reach significance as a provocative factor for GERD. Although normal infants have a high prevalence of symptoms suggesting GERD, a simple questionnaire-based score is a valid diagnostic test with high positive and negative predictive values.

A critical appraisal of current management practices for infant regurgitation—recommendations of a working party of the European Society of Pediatric Gastroenterology and Nutrition

Article

Full-text available

Jun 1997

Regurgitation is a common manifestation in infants below the age of 1 year and a frequent reason of counselling of general practitioners and paediatricians. Current management starts with postural and dietary measures, followed by antacids and prokinetics. Recent issues such as an increased risk of sudden infant death in the prone sleeping position and persistent occult gastro-oesophageal reflux in a subset of infants receiving milk thickeners or thickened "anti-regurgitation formula" challenge the established approach. Therefore, the clinical practices for management of infant regurgitation have been critically evaluated with respect to their efficacy, safety and practical implications. The updated recommendations reached by the working party on the management of infant regurgitation contain five phases: (1 A) parental reassurance; (1 B) milk-thickening agents; (2) prokinetics; (3) positional therapy as an adjuvant therapy; (4 A) H2-blockers; (4 B) proton pump inhibitors; (5) surgery.

Excessive Infant Crying: The Impact of Varying Definitions

Article

Full-text available

Oct 2001
Pediatrics

To assess the impact of varying definitions of excessive crying and infantile colic on prevalence estimates and to assess to what extent these definitions comprise the same children. Parents of 3345 infants aged 1, 3, and 6 months (response: 96.5%) were interviewed on the crying behavior of their infant in a Dutch cross-sectional national population-based study. We computed the prevalence of excessive crying according to 10 published definitions regarding parent-reported duration of infant crying and the parents' experience. We measured concordance between pairs of definitions by Cohen's kappa (agreement adjusted for chance agreement). Overall prevalence rates of excessive crying varied strongly between definitions, from 1.5% to 11.9%. They were always highest in 1-month-old infants. Concordance between definitions was only excellent (kappa > 0.75) if they were closely related, such as crying for >3 hours/day for >3 days/week for the preceding 2 or 3 weeks. Concordance between less closely related definitions was much weaker. Concordance between definitions that were based on duration and on parental experience was mostly poor (kappa: 0.17-0.53 for infants aged 1 and 3 months). Different definitions of excessive crying lead to the inclusion of very dissimilar groups of infants. We recommend presenting study results using clearly described definitions, preferably concerning both duration of crying and parental distress. This may improve the comparability of studies on the cause and treatment of excessive infant crying. The impact of the method of data collection on this comparability needs additional study.colic, preventive child health care, prevention, infancy.

Symptoms of gastroesophageal reflux during infancy: A pediatric practice-based survey.

Article

Apr 1996
GASTROENTEROLOGY

Reliability and validity (including reponsiveness)

Article

Jan 2005

Initial validation of a diagnostic questionnaire for gastroesophageal reflux disease

Article

Jan 2001

Shaw MJ

OBJECTIVES:Brief, reliable, and valid self-administered questionnaires could facilitate the diagnosis of gastroesophageal reflux disease in primary care. We report the development and validation of such an instrument.METHODS:Content validity was informed by literature review, expert opinion, and cognitive interviewing of 50 patients resulting in a 22-item survey. For psychometric analyses, primary care patients completed the new questionnaire at enrollment and at intervals ranging from 3 days to 3 wk. Multitrait scaling, test–retest reliability, and responsiveness were assessed. Predictive validity analyses of all scales and items used specialty physician diagnosis as the “gold standard.”RESULTS:Iterative factor analyses yielded three scales of four items each including heartburn, acid regurgitation, and dyspepsia. Multitrait scaling criteria including internal consistency, item interval consistency, and item discrimination were 100% satisfied. Test–retest reliability was high in those reporting stable symptoms. Scale scores significantly changed in those reporting a global change. Regressing specialty physician diagnosis on the three scales revealed significant effects for two scales (heartburn and regurgitation). Combining the two significant scales enhanced the strength of the model. Symptom response to self-directed treatment with nonprescription antisecretory medications was highly predictive of the diagnosis also, although the item demonstrated poor validity and reliability.CONCLUSIONS:A brief, simple 12-item questionnaire demonstrated validity and reliability and seemed to be responsive to change for reflux and dyspeptic symptoms.

Infantile Reflux

Article

Jan 1997

Susan R Orenstein

Prevalence of Symptoms of Gastroesophageal Reflux During Childhood

Article

Jan 2000
Arch Pediatr Adolesc Med

symptoms 5.2%, 5.0%, and 8.2% of the time, respec- tively. Complaints of abdominal pain ("stomachache") were most common, reported by 23.9% and 14.7% of par- ents of 3- to 9-year-old and 10- to 17-year-old children and by 27.9% of children aged 10 to 17 years. In those aged 10 to 17 years, heartburn reported by the children was associated with reported cigarette use (odds ratio, 6.5; 95% confidence interval, 2-21); no other complaint was associated with cigarette, alcohol, or caffeine con- sumption or passive smoking exposure. In 3- to 9-year- old children, no complaint was associated with caffeine consumption or passive smoking exposure. Reported treatment in the past week with antacids was 0.5% ac- cording to parents of children aged 3 to 9 years and 1.9% and 2.3% according to parents of children aged 10 to 17 years and children aged 10 to 17 years, respectively. Treat- ment with over-the-counter histamine receptor block- ers was 0% for children aged 3 to 9 years and 10 to 17 years, as reported by their parents, and 1.3% for those aged 10 to 17 years, as reported by themselves. Conclusions: Symptoms suggestive of GER are not rare in childhood, yet only a fraction of children with symp- toms are treated with over-the-counter antacids or his- tamine2 antagonists. Prospective longitudinal data are needed to determine which children with symptoms of GER actually have GER disease and are at risk of devel- oping complications.

Language and Translation Issues

Chapter

Jan 1996

Guidelines for Evaluation and Treatment of Gastroesophageal Reflux in Infants and Children: Recommendations of the North American Society for Pediatric Gastroenterology and Nutrition

Article

Jan 2001
J PEDIATR GASTR NUTR

Gastroesophageal reflux (GER), defined as passage of gastric contents into the esophagus, and GER disease (GERD), defined as symptoms or complications of GER, are common pediatric problems encountered by both primary and specialty medical providers. Clinical manifestations of GERD in children include vomiting, poor weight gain, dysphagia, abdominal or substernal pain, esophagitis and respiratory disorders. The GER Guideline Committee of the North American Society for Pediatric Gastroenterology and Nutrition has formulated a clinical practice guideline for the management of pediatric GER. The GER Guideline Committee, consisting of a primary care pediatrician, two clinical epidemiologists (who also practice primary care pediatrics) and five pediatric gastroenterologists, based its recommendations on an integration of a comprehensive and systematic review of the medical literature combined with expert opinion. Consensus was achieved through Nominal Group Technique, a structured quantitative method. The Committee examined the value of diagnostic tests and treatment modalities commonly used for the management of GERD, and how those interventions can be applied to clinical situations in the infant and older child. The guideline provides recommendations for management by the primary care provider, including evaluation, initial treatment, follow-up management and indications for consultation by a specialist. The guideline also provides recommendations for management by the pediatric gastroenterologist. This document represents the official recommendations of the North American Society for Pediatric Gastroenterology and Nutrition on the evaluation and treatment of gastroesophageal reflux in infants and children. The American Academy of Pediatrics has also endorsed these recommendations. The recommendations are summarized in a synopsis within the article. This review and recommendations are a general guideline and are not intended as a substitute for clinical judgment or as a protocol for the management of all patients with this problem.

Symptoms Associated with Gastroesophageal Reflux Disease

Article

Jan 2001

Many persons who suffer from GERD report additional symptoms, e.g., chest pain, dyspepsia, dysphagia, that are often not measured in clinical trials even though they may be distressing to the GERD sufferer. The primary goal of this study was to develop and assess the psychometric characteristics of a new GERD symptom scale measuring frequency, severity, and distress. The GERD Symptom Assessment Scale (GSAS) was administered to a sample of 169 GERD sufferers at baseline and two weeks. Internal consistency, construct validity, and test–retest reliability were assessed. Responsiveness was evaluated using clinical trial data assessing drug efficacy. Results: Internal consistency was >0.80 for the symptom severity and distress scales. All three scales showed stability over two weeks (ICC >0.70). Both validity hypotheses were supported. Comparison of effect sizes showed the GSAS is sensitive to changes in severity of symptoms. In conclusion, the GSAS is a reliable, valid, and responsive measure of GERD symptoms.

Coefficient Alpha and Internal Structure of Tests

Article

Sep 1951

Lee J. Cronbach

A general formula (α) of which a special case is the Kuder-Richardson coefficient of equivalence is shown to be the mean of all split-half coefficients resulting from different splittings of a test. α is therefore an estimate of the correlation between two random samples of items from a universe of items like those in the test. α is found to be an appropriate index of equivalence and, except for very short tests, of the first-factor concentration in the test. Tests divisible into distinct subtests should be so divided before using the formula. The index [`(r)]ij\bar r_{ij} , derived from α, is shown to be an index of inter-item homogeneity. Comparison is made to the Guttman and Loevinger approaches. Parallel split coefficients are shown to be unnecessary for tests of common types. In designing tests, maximum interpretability of scores is obtained by increasing the first-factor concentration in any separately-scored subtest and avoiding substantial group-factor clusters within a subtest. Scalability is not a requisite.

Guyatt G, Walter S, Norman G. Measuring change over time: assessing the usefulness of evaluative instruments. J Chron Dis 40, 171-178

Article

Feb 1987
J Chron Dis

Reliability, the ratio of the variance attributable to true differences among subjects to the total variance, is an important attribute of psychometric measures. However, it is possible for instruments to be reliable, but unresponsive to change: conversely, they may show poor reliability but excellent responsiveness. This is especially true for instruments in which items are tailored to the individual respondent.Therefore, we suggest a new index of responsiveness to assess the usefulness of instruments designed to measure change over time. This statistic, which relates the minimal clinically important difference to the variability in stable subjects, has direct sample size implications. Responsiveness should join reliability and validity as necessary requirements for instruments designed primarily to measure change over time.

Symptom and Health-Related Quality-of-Life Measures for Use in Selected Gastrointestinal Disease Studies

Article

Apr 2001
PHARMACOECONOMICS

Patient-rated symptom and health-related quality-of-life (HR-QOL) outcomes are important end-points for clinical trials of medical treatments for gastrointestinal (GI) disorders. Based on this review, patient outcomes research is focused on gastroesophageal reflux disease and dyspepsia, with a growing interest in irritable bowel syndrome but little research in gastroparesis. State-of-the-art for patient-rated symptom scales is rudimentary with an abundance of scales and little attention to systematic instrument development or comprehensive psychometric evaluation. Generally, disease-specific HR-QOL measures have been more systematically developed and evaluated psychometrically, but few have been incorporated into clinical trials. More comprehensive outcome assessments are needed to determine the effectiveness of new medical treatments for functional GI disorders. Future clinical trials of GI disorders should combine clinician assessments of outcomes and symptoms with patient-rated symptom and HR-QOL end-points.

Effect Sizes for Interpreting Changes in Health Status

Article

Apr 1989
MED CARE

Health status measures are being used with increasing frequency in clinical research. Up to now the emphasis has been on the reliability and validity of these measures. Less attention has been given to the sensitivity of these measures for detecting clinical change. As health status measures are applied more frequently in the clinical setting, we need a useful way to estimate and communicate whether particular changes in health status are clinically relevant. This report considers effect sizes as a useful way to interpret changes in health status. Effect sizes are defined as the mean change found in a variable divided by the standard deviation of that variable. Effect sizes are used to translate "the before and after changes" in a "one group" situation into a standard unit of measurement that will provide a clearer understanding of health status results. The utility of effect sizes is demonstrated from four different perspectives using three health status data sets derived from arthritis populations administered the Arthritis Impact Measurement Scales (AIMS). The first perspective shows how general and instrument-specific benchmarks can be developed and how they can be used to translate the meaning of clinical change. The second perspective shows how effect sizes can be used to compare traditional clinical measures with health status measures in a standard clinical drug trial. The third application demonstrates the use of effect sizes when comparing two drugs tested in separate drug trials and shows how they can facilitate this type of comparison. Finally, our health status results show how effect sizes can supplement standard statistical testing to give a more complete and clinically relevant picture of health status change. We conclude that effect sizes are an important tool that will facilitate the use and interpretation of health status measures in clinical research in arthritis and other chronic diseases.

Developing and evaluating cross-cultural instruments from minimum requirements to optimal models

Article

Jan 1994

In the age of increased international collaboration in medical research, the necessity of having at hand cross-culturally applicable instruments for the assessment of health-related quality of life (HRQL) in clinical trials has been voiced. Several important theoretical bases leading to cultural bias in HRQL measurement include differences in definitions of HRQL across national and cultural contexts, levels of observation relied upon to indicate HRQL states, and the significance or weight placed upon the various HRQL states or dimensions measured. Despite a growing literature on the development and evaluation of existing HRQL measures in other cultures, comprehensive sets of procedures or requirements for the international part of development and evaluation are lacking. This paper reviews major approaches to developing international HRQL measures, and discusses various methods and criteria that have been recommended for evaluating measurement equivalence in comparisons of research across national and cultural contexts. A summary of recent trends and advances in international HRQL assessment is presented.

A New Questionnaire for Gastroesophageal Reflux Disease

Article

Jul 1994

To develop a questionnaire to measure gastroesophageal reflux disease in the community and to test its reliability and validity. The reliability of the questionnaire was measured by a test-retest procedure in 38 outpatients and 77 community residents 25 to 74 years of age, whereas concurrent validity was evaluated by comparing findings from a physician interview with self-report data from 51 patients. For statistical analysis of the reliability of each question, the kappa statistic and the 95% confidence interval were calculated. The questionnaire was easy to understand and well accepted. The reliability (median kappa for outpatients, 0.70 [interquartile range, 0.59 to 0.81]; median kappa for population sample, 0.70 [interquartile range, 0.60 to 0.81]) and validity (median kappa, 0.62 [interquartile range, 0.49 to 0.74]) were acceptable. Our initial results suggest that this questionnaire is valid and should be applicable in population-based studies to assess gastroesophageal reflux disease.

Reliability and Validity of an Infant Gastroesophageal Reflux Questionnaire

Article

Sep 1993

To improve history-taking of infants with suspected gastroesophageal reflux, we developed an Infant Gastroesophageal Reflux Questionnaire consisting of 161 items covering demographics, symptoms (regurgitation, weight deficit, respiratory difficulties, fussiness, apnea, and pain or bleeding of esophagitis), and possible causes (feeding volume and frequency, allergy, infection, colic, central nervous system abnormalities, positioning, and smoke exposure). The questionnaire was completed by primary caretakers of 69 infants aged 1 to 58 weeks suspected of having reflux. Median time to complete the questionnaire was 20 minutes. The median internal consistency of 29 pairs of redundant questions was 0.94. Median test-retest consistency of 110 items for nine respondents was 0.88. Median interobserver consistency, evaluated for 129 items in 35 questionnaires also filled out by secondary caretakers, was 0.85. The median accuracy of four externally validated items was 1.00. This questionnaire can aid pediatricians in making decisions regarding diagnoses and treatment in this common but complex disorder.

Multilingual translation of the Functional Assessment of Cancer Therapy (FACT) quality of life measurement system

Article

Jul 1996

There is need for multilingual cross-culturally valid quality of life (QOL) instrumentation to assess the QOL endpoint in international oncology clinical trials. We therefore initiated a multilingual translation of the Functional Assessment of Cancer Therapy (FACT) Quality of Life Measurement System (Version 3) into the following languages: Dutch, French, German, Italian, Norwegian and Swedish. Prior to this project, the FACT Measurement System was available in English, Spanish and Canadian French. The FACT is a self-report instrument which measures multidimensional QOL. The FACT (Version 3) evaluation system uses a 29-49 item compilation of a generic core (29 Likert-type items) and numerous subscales (9-20 items each) which reflect symptoms associated with different diseases, symptom complexes and treatments. The FACT-G (general version) and eight of 18 available cancer-related subscales were translated using an iterative forward-backward translation sequence. After subsequent review by 21 bilingual health professionals, all near final language versions underwent pretesting with a total of 95 patients in the native countries. Available results indicate good overall comprehensibility among native language-speakers. Equivalent foreign language versions of the FACT will permit QOL evaluation of people from diverse cultural backgrounds.

Prevalence of symptoms of gastroesophageal reflux during infancy. A pediatric practice-based survey. Pediatric Practice Research Group

Article

Jun 1997
Arch Pediatr Adolesc Med

To determine the prevalence of symptoms associated with overt gastroesophageal reflux (GER) during the first year of life, to describe when most infants outgrow these symptoms, and to assess the prevalence of parental reports of various symptoms associated with GER and the percentages of infants who have been treated for GER. Cross-sectional survey. Nineteen Pediatric Practice Research Group practices in the Chicago, Ill, area (urban, suburban, and semirural). A total of 948 parents of healthy children 13 months old and younger. None. Reported frequency of regurgitation. Regurgitation of at least 1 episode a day was reported in half of 0- to 3-month-olds. This symptom decreased to 5% at 10 to 12 months of age (P < .001). Peak reported regurgitation was 67% at 4 months; the prevalence of symptoms decreased dramatically from 61% to 21% between 6 and 7 months of age. Infants with at least 4 episodes daily of regurgitation showed a similar pattern (P < .001). Peak regurgitation reported as a "problem" was most often seen at 6 months (23%); this prevalence decreased to 14% at 7 months of age. Parental perception that regurgitation was a problem was associated with the frequency and volume of regurgitation, increased crying or fussiness, reported discomfort with spitting up, and frequent back arching. Reported treatment for regurgitation included a change in formula in 8.1%, thickened feedings in 2.2%, termination of breast-feeding in 1.1%, and medication in 0.2%. Complaints of regurgitation are common during the first year of life, peaking at 4 months of age. Many infants "outgrow" overt GER by 7 months and most by 1 year. Parents view this symptom as a problem more often than medical intervention is given.

A critical appraisal of current management practices for infant regurgitation

Article

May 1997
Acta Paediatr Sin

Yvan Vandenplas

Regurgitation is a common manifestation in infants below the age of one year and a frequent reason of counseling of general practitioners and paediatricians. Current management starts with postural and dietary measures, followed by antacids and prokinetics. Recent issues such as an increased risk of sudden infant death in the prone sleeping position and persistent occult gastro-oesophageal reflux in a subset of infants receiving milk thickeners or thickened "anti-regurgitation formula" challenge the established approach. Therefore, the clinical practices for management of infant regurgitation have been critically evaluated with respect to their efficacy, safety and practical implications. The updated recommendations on the management of infant regurgitation contain 5 phases: (1A) parental reassurance; (1B) milk-thickening agents; (2) prokinetics; (3) positional therapy as an adjuvant therapy; (4A) H2-blockers; (4B) proton pump inhibitors; (5) surgery.

Infantile RefluxDifferent from Adult Reflux

Article

Dec 1997
AM J MED

Susan R. Orenstein

Reliability and Validity of the Gastrointestinal Symptom Rating Scale in Patients with Gastroesophageal Reflux Disease

Article

Jan 1998

The objective of this study was to evaluate the reliability and validity of the Gastrointestinal Symptom Rating Scale (GSRS) in US patients with gastroesophageal reflux disease (GERD). Five hundred and sixteen adults with predominant heartburn symptoms of GERD were recruited from gastroenterologist and family physician practices and treated with 6 weeks of 150mg ranitidine twice daily to identify poorly responsive symptomatic GERD. The GSRS, the Medical Outcomes Study Short Form-36 (SF-36) Health Survey and the Psychological General Well-being (PGWB) scale were administered at baseline and after 6 weeks of treatment. Reported ratings of GERD-related symptoms from physician and patient diaries were measured. The GSRS contains five scales: reflux syndrome, abdominal pain, constipation syndrome, diarrhoea syndrome and indigestion syndrome. The internal consistency reliabilities for the GSRS scales ranged from 0.61 to 0.83 and the intraclass correlation coefficients ranged from 0.42 to 0.60. The GSRS scale scores were correlated with the SF-36 and PGWB scales and with the number and severity of heartburn symptoms. Patients with two or three clinician-rated GERD-related symptoms reported worse GSRS scale scores compared with patients with fewer symptoms (p GERD symptom severity and are responsive to treatment. The GSRS is a useful patient-rated symptom scale for evaluating the outcomes of treatment for GERD.

Linking Clinical Relevance and Statistical Significance in Evaluating Intra-Individual Changes in Health-Related Quality of Life

Article

May 1999
MED CARE

To compare the standard error of measurement (SEM) with established standards for clinically relevant intra-individual change in an evaluation of health-related quality of life. Secondary analysis of data from a randomized controlled trial. Six hundred and five outpatients with a history of cardiac problems attending the general medicine clinics of a major academic medical center. Baseline and follow-up interviews included a modified version of the Chronic Heart Failure Questionnaire (CHQ) and the SF-36. The SEM values corresponding to established standards for minimal clinically important differences (MCIDs) on the CHQ were determined. Individual change on the SF-36 was explored using the same SEM criterion. One-SEM changes in this population corresponded well to the patient-driven MCID standards on all CHQ dimensions (weighted kappas (0.87; P < 0.001). The distributions of outpatients who improved, remained stable, or declined (defined by the one-SEM criterion) were generally consistent between CHQ dimensions and SF-36 subscales. The use of the SEM to evaluate individual patient change should be explored among other health-related quality of life instruments with established standards for clinically relevant differences. Only then can it be determined whether the one-SEM criterion can be consistently applied as a proxy for clinically meaningful change.

Initial validation of a diagnostic questionnaire for gastroesophageal reflux disease

Article

Feb 2001

Brief, reliable, and valid self-administered questionnaires could facilitate the diagnosis of gastroesophageal reflux disease in primary care. We report the development and validation of such an instrument. Content validity was informed by literature review, expert opinion, and cognitive interviewing of 50 patients resulting in a 22-item survey. For psychometric analyses, primary care patients completed the new questionnaire at enrollment and at intervals ranging from 3 days to 3 wk. Multitrait scaling, test-retest reliability, and responsiveness were assessed. Predictive validity analyses of all scales and items used specialty physician diagnosis as the "gold standard." Iterative factor analyses yielded three scales of four items each including heartburn, acid regurgitation, and dyspepsia. Multitrait scaling criteria including internal consistency, item interval consistency, and item discrimination were 100% satisfied. Test-retest reliability was high in those reporting stable symptoms. Scale scores significantly changed in those reporting a global change. Regressing specialty physician diagnosis on the three scales revealed significant effects for two scales (heartburn and regurgitation). Combining the two significant scales enhanced the strength of the model. Symptom response to self-directed treatment with nonprescription antisecretory medications was highly predictive of the diagnosis also, although the item demonstrated poor validity and reliability. A brief, simple 12-item questionnaire demonstrated validity and reliability and seemed to be responsive to change for reflux and dyspeptic symptoms.

Symptom and health-related quality-of-life measures for use in selected gastrointestinal disease studies: A review and synthesis of the literature

Article

Feb 2001

Symptoms associated with gastroesophageal reflux disease: development of a questionnaire for use in clinical trials

Article

Aug 2001

Unlabelled: Many persons who suffer from GERD report additional symptoms, e.g., chest pain, dyspepsia, dysphagia, that are often not measured in clinical trials even though they may be distressing to the GERD sufferer. The primary goal of this study was to develop and assess the psychometric characteristics of a new GERD symptom scale measuring frequency, severity, and distress. The GERD Symptom Assessment Scale (GSAS) was administered to a sample of 169 GERD sufferers at baseline and two weeks. Internal consistency, construct validity, and test-retest reliability were assessed. Responsiveness was evaluated using clinical trial data assessing drug efficacy. Results: Internal consistency was >0.80 for the symptom severity and distress scales. All three scales showed stability over two weeks (ICC >0.70). Both validity hypotheses were supported. Comparison of effect sizes showed the GSAS is sensitive to changes in severity of symptoms. In conclusion, the GSAS is a reliable, valid, and responsive measure of GERD symptoms.

Development and psychometric evaluation of the patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) in patients with upper gastrointestinal disorders

Article

Jan 2005

Describe the development and evaluation of a new self-report instrument, the patient assessment of upper gastrointestinal disorders-symptom severity index (PAGI-SYM) in subjects with gastroesophageal reflux disease (GERD), dyspepsia, or gastroparesis. Recruited subjects with GERD (n=810), dyspepsia (n = 767), or gastroparesis (n = 169) from the US, France, Germany, Italy, the Netherlands, and Poland. Subjects completed the PAGI-SYM, SF-36, a disease-specific HRQL measure (PAGI-QOL), and disability day questions. Two-week reproducibility was evaluated in 277 stable subjects. We evaluated construct validity by correlating subscale scores with SF-36, PAGI-QOL, disability days, and global symptom severity scores. The final 20-item PAGI-SYM has six subscales: heartburn/regurgitation, fullness/early satiety, nausea/vomiting, bloating, upper abdominal pain, and lower abdominal pain. Internal consistency reliability was good (alpha = 0.79-0.91); test-retest reliability was acceptable (Intraclass correlation coefficients alpha=0.60-0.82). PAGI-SYM subscale scores correlated significantly with SF-36 scores (all p < 0.0001), PAGI-QOL scores (all p < 0.0001), disability days (p < 0.0001), and global symptom severity (p < 0.0001). Mean PAGI-SYM scores varied significantly in groups defined by disability days (all p < 0.0001), where greater symptom severity was associated with more disability days. Results suggest the PAGI-SYM, a brief symptom severity instrument, has good reliability and evidence supporting construct validity in subjects with GERD, dyspepsia, or gastroparesis.

We would also like to thank the members of the Pediatric GERD Measurement Advisory Committee not previously mentioned: Dr El-Serag, Baylor College of Medicine, Texas; Dr Ben-jamin Gold

Dr Gunasekaran
Child Center
Health
Park

Dr Thirumashisai Gunasekaran, Center for Child Digestive Health, Park Ridge. We would also like to thank the members of the Pediatric GERD Measurement Advisory Committee not previously mentioned: Dr El-Serag, Baylor College of Medicine, Texas; Dr Ben-jamin Gold, Emory University School of Medicine, Georgia; Dr Eric Hassall, BC Children's Hospital, Vancouver; Dr Silvia Salvatore, Pediatric Department University of Insubria, Italy; Dr Raanan Shamir, Meyer Children's Hospital, Israel.

Reliability and validity (includ-ing responsiveness) In: Fayers PM, Hays RD, eds. Assessing quality of life in clinical trials

Jan 2005

Anderson Rt Da

Hays RD, Anderson RT, Revicki DA. Reliability and validity (includ-ing responsiveness). In: Fayers PM, Hays RD, eds. Assessing quality of life in clinical trials. 2nd ed. Oxford: Oxford University Press, 2005.

Guidelines for evaluation and treatment of gastroesophageal reflux in infants and children

Jan 2001
S1

Rudolph

Excessive infant crying

Jan 2001
893

Reijneveld

Reflux symptoms in 100 normal infants

Jan 1996
607

Orenstein

Measuring change over time

Jan 1987
171

Guyatt

The Infant Gastroesophageal Reflux Questionnaire Revised: Development and Validation as an Evaluative Instrument

Abstract

No full-text available

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