A Nocturnal GERD Symptom Severity and Impact Questionnaire for Adults
A Nocturnal GERD Symptom Severity and Impact Questionnaire for Adults
Background Current questionnaires for assessing gastro-oesophageal reflux disease (GERD) symptoms are limited in their ability to capture nocturnal symptoms.
Aim To develop and validate an instrument, the Nocturnal Gastro-oesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ), to assess severity and impact of nocturnal GERD symptoms.
Methods Two focus groups and 16 cognitive debriefing interviews were conducted among GERD patients to identify key issues about nocturnal symptoms. A draft instrument was tested in 196 patients at 11 clinics in the US to evaluate psychometric properties. Exploratory factor and item response theory analyses were conducted to finalize items and subscales. Internal consistency reliability, reproducibility and construct validity were examined.
Results Mean age was 45 (s.d. = 13.8) years; 76% were female and 68% were Caucasian. Patient-rated severity was mild–moderate for 69% of participants; 48% reported symptoms on two to three nights the past week. The final questionnaire includes 20 items and three subscales: Nocturnal GERD Symptoms, Morning Impact of Nocturnal GERD and Concern about Nocturnal GERD. The subscales demonstrated internal consistency reliability (Cronbach's alpha 0.84–0.94) and were significantly correlated with similar measures and disease severity (0.41–0.81; P < 0.0001).
Conclusion The results support the reliability and validity of the N-GSSIQ as a measure of severity, morning impact and concern about nocturnal GERD.
Gastro-oesophageal reflux disease (GERD) is among the most prevalent disorders of the gastrointestinal tract in the US, with an estimated 14–20% of the general population experiencing GERD symptoms at least once a week. Among patients with GERD, approximately 80% report heartburn symptoms at night, with 29% awakening with coughing or choking due to their reflux. Studies reveal that nocturnal symptoms have a strong impact on patients' health-related quality of life (HRQL) by affecting sleep and impairing ability to function the following day. Importantly, the negative impact on patient HRQL is greater in patients who experience nocturnal GERD symptoms than in those who experience daytime symptoms only. Dubois and colleagues showed that patients with nocturnal GERD experienced greater impairment of both work productivity and sleep than those with daytime symptoms only and also experienced significantly worse HRQL in every domain of the Short Form-36 Health Survey.
Despite its prevalence and impact, relatively little data regarding nocturnal GERD symptoms are currently available. Several surveys suggest that the impact of nocturnal heartburn is underestimated, indicating a need for further inquiry into this component of the condition, as well as the development of specific patient-reported measures to better assess its impact. While a number of symptom assessments of GERD are available and have been previously used in clinical trials, they are limited in their assessment of nocturnal symptoms due to GERD. The objective of this study was to identify the key issues and concerns related to nocturnal symptoms of GERD and to develop and validate an instrument that could be used to either supplement existing GERD instruments or as a standalone measure of nocturnal GERD symptoms and impact.
Abstract and Introduction
Abstract
Background Current questionnaires for assessing gastro-oesophageal reflux disease (GERD) symptoms are limited in their ability to capture nocturnal symptoms.
Aim To develop and validate an instrument, the Nocturnal Gastro-oesophageal Reflux Disease Symptom Severity and Impact Questionnaire (N-GSSIQ), to assess severity and impact of nocturnal GERD symptoms.
Methods Two focus groups and 16 cognitive debriefing interviews were conducted among GERD patients to identify key issues about nocturnal symptoms. A draft instrument was tested in 196 patients at 11 clinics in the US to evaluate psychometric properties. Exploratory factor and item response theory analyses were conducted to finalize items and subscales. Internal consistency reliability, reproducibility and construct validity were examined.
Results Mean age was 45 (s.d. = 13.8) years; 76% were female and 68% were Caucasian. Patient-rated severity was mild–moderate for 69% of participants; 48% reported symptoms on two to three nights the past week. The final questionnaire includes 20 items and three subscales: Nocturnal GERD Symptoms, Morning Impact of Nocturnal GERD and Concern about Nocturnal GERD. The subscales demonstrated internal consistency reliability (Cronbach's alpha 0.84–0.94) and were significantly correlated with similar measures and disease severity (0.41–0.81; P < 0.0001).
Conclusion The results support the reliability and validity of the N-GSSIQ as a measure of severity, morning impact and concern about nocturnal GERD.
Introduction
Gastro-oesophageal reflux disease (GERD) is among the most prevalent disorders of the gastrointestinal tract in the US, with an estimated 14–20% of the general population experiencing GERD symptoms at least once a week. Among patients with GERD, approximately 80% report heartburn symptoms at night, with 29% awakening with coughing or choking due to their reflux. Studies reveal that nocturnal symptoms have a strong impact on patients' health-related quality of life (HRQL) by affecting sleep and impairing ability to function the following day. Importantly, the negative impact on patient HRQL is greater in patients who experience nocturnal GERD symptoms than in those who experience daytime symptoms only. Dubois and colleagues showed that patients with nocturnal GERD experienced greater impairment of both work productivity and sleep than those with daytime symptoms only and also experienced significantly worse HRQL in every domain of the Short Form-36 Health Survey.
Despite its prevalence and impact, relatively little data regarding nocturnal GERD symptoms are currently available. Several surveys suggest that the impact of nocturnal heartburn is underestimated, indicating a need for further inquiry into this component of the condition, as well as the development of specific patient-reported measures to better assess its impact. While a number of symptom assessments of GERD are available and have been previously used in clinical trials, they are limited in their assessment of nocturnal symptoms due to GERD. The objective of this study was to identify the key issues and concerns related to nocturnal symptoms of GERD and to develop and validate an instrument that could be used to either supplement existing GERD instruments or as a standalone measure of nocturnal GERD symptoms and impact.
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