Consumer Use of Over-the-Counter PPIs in Patients With GERD
Consumer Use of Over-the-Counter PPIs in Patients With GERD
During a continuous 4-month period in 2011, consecutive patients visiting five socioeconomically diverse multispecialty clinics across Cuyahoga County Ohio that are affiliated with The MetroHealth Medical System, a major teaching affiliate of Case Western Reserve University, were surveyed regarding several parameters. They included prior diagnosis of GERD, use of OTC or prescription PPIs, temporal information on dosing, demographics, and the Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS), an internationally validated GERD severity and distress scale ( Appendix A ). The survey's content and ease of use was verified by a gastroenterologist (GI), internist, and registered nurse independent of the study. The protocol and survey were approved by our Institutional Review Board, participation was voluntary, and participants completed the survey without the assistance of clinic staff.
Respondents were classified into three categories: optimal, suboptimal, and excessive PPI users. Optimal users were defined as once or twice daily: before breakfast, or second dose before dinner. Suboptimal users were intermittent, as needed, or meal-independent users. Excessive users utilized PPIs more than twice daily.
Patients were surveyed regarding the diagnosis of GERD or GERD-related symptoms, use of OTC or prescription PPIs, dosing characteristics, demographics, and all items from GSAS. As a self-administered questionnaire, GSAS measures independent scores for number, severity, and frequency, based on up to 15 symptom choices ( Appendix A ). Each of the three scales—number, severity, and frequency—are independently scored for the 15 symptoms. First, a patient indicates the presence and frequency of each symptom. The score for the symptom and frequency is 0 if absent during the preceding week. For each symptom present, the severity (on a 4-point scale ranging from 1=slight to 4=very severe) is rated. The sum of severity scale is added across symptoms and divided by the total number of symptoms, provided 12 were scored by the patient. Any questionnaire with 4 absent symptom scores is considered incomplete.
Responses were collected on categorical or ordinal scales. Subjects who denied GERD symptoms (1,150, 59%) had responded "no" to the initial survey question regarding the prior diagnosis of GERD or presence of GERD symptoms. Incomplete surveys (199, 10%) emanated from patients who identified themselves as having a prior diagnosis of GERD or presence of GERD symptoms; these patients, however, also denied 4 symptom scores on the GSAS questionnaire or did not use PPIs for GERD symptoms. The Kruskal–Wallis test for nonnormally distributed continuous variables and the Pearson's χ test for categorical variables, respectively, were used to compare the three PPI sources on demographics, dosing characteristics, and GSAS scores. A multivariable logistic regression was used to assess the association between optimal users (yes or no) and PPI sources, adjusting for age, gender, race, and education.
R Foundation for Statistical Computing (Vienna, Austria) was used for all analyses. A two-sided P value of 0.05 was considered significant.
Design
During a continuous 4-month period in 2011, consecutive patients visiting five socioeconomically diverse multispecialty clinics across Cuyahoga County Ohio that are affiliated with The MetroHealth Medical System, a major teaching affiliate of Case Western Reserve University, were surveyed regarding several parameters. They included prior diagnosis of GERD, use of OTC or prescription PPIs, temporal information on dosing, demographics, and the Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS), an internationally validated GERD severity and distress scale ( Appendix A ). The survey's content and ease of use was verified by a gastroenterologist (GI), internist, and registered nurse independent of the study. The protocol and survey were approved by our Institutional Review Board, participation was voluntary, and participants completed the survey without the assistance of clinic staff.
Respondents were classified into three categories: optimal, suboptimal, and excessive PPI users. Optimal users were defined as once or twice daily: before breakfast, or second dose before dinner. Suboptimal users were intermittent, as needed, or meal-independent users. Excessive users utilized PPIs more than twice daily.
Survey Content
Patients were surveyed regarding the diagnosis of GERD or GERD-related symptoms, use of OTC or prescription PPIs, dosing characteristics, demographics, and all items from GSAS. As a self-administered questionnaire, GSAS measures independent scores for number, severity, and frequency, based on up to 15 symptom choices ( Appendix A ). Each of the three scales—number, severity, and frequency—are independently scored for the 15 symptoms. First, a patient indicates the presence and frequency of each symptom. The score for the symptom and frequency is 0 if absent during the preceding week. For each symptom present, the severity (on a 4-point scale ranging from 1=slight to 4=very severe) is rated. The sum of severity scale is added across symptoms and divided by the total number of symptoms, provided 12 were scored by the patient. Any questionnaire with 4 absent symptom scores is considered incomplete.
Statistical Analysis
Responses were collected on categorical or ordinal scales. Subjects who denied GERD symptoms (1,150, 59%) had responded "no" to the initial survey question regarding the prior diagnosis of GERD or presence of GERD symptoms. Incomplete surveys (199, 10%) emanated from patients who identified themselves as having a prior diagnosis of GERD or presence of GERD symptoms; these patients, however, also denied 4 symptom scores on the GSAS questionnaire or did not use PPIs for GERD symptoms. The Kruskal–Wallis test for nonnormally distributed continuous variables and the Pearson's χ test for categorical variables, respectively, were used to compare the three PPI sources on demographics, dosing characteristics, and GSAS scores. A multivariable logistic regression was used to assess the association between optimal users (yes or no) and PPI sources, adjusting for age, gender, race, and education.
R Foundation for Statistical Computing (Vienna, Austria) was used for all analyses. A two-sided P value of 0.05 was considered significant.
Source...