Gastroesophageal Reflux
Conditions
Keywords
symptom
Brief summary
Consecutive patients aged 18-65 years who go to the gastroenterology clinic presented with upper gastrointestinal discomfort would be included. All patients underwent upper endoscopy or an ambulatory 24-h pH(Potential Of Hydrogen) monitoring.Pathologic esophageal acid reflux was defined as the percentage total time for which a pH value \< 4 was \>4.2 % in the distal esophagus. Then, patients were treated with esomeprazole 20 mg twice daily for 28 days. The symptom scores were measured by the frequency score multiplied by the severity scores of the predominant symptom before and at the end of the treatment, and the PPI test was defined as positive if the overall scores of the predominant dyspeptic symptom in the fourth week decreased by \>50 % compared with those of the baseline. GERD is defined by either 24-hour impedance-pH monitoring or positive PPI(proton pump inhibitor) test or positive result from endoscopy. The percentage of each symptom of GERD in the symptom questionnaire in Chinese outpatients in Gastroenterology department will be calculated. The symptom of the highest percentage will be the primary symptom.
Detailed description
Primary Objective：To define the primary symptom of GERD in Chinese outpatients in Gastroenterology department Secondary Objective：1. To investigate the symptom distribution of patients who present with symptoms originated from upper gastrointestinal tract and have pathologic esophageal reflux established by 24-hour impedance-pH monitoring, upper endoscopy, or proton pump inhibitor test. 2\. To evaluate the life quality of patients with atypical GERD symptoms (symptoms except heartburning and regurgitation) 3. To investigate the diagnostic value of proton pump inhibitor trial to diagnose GERD with atypical reflux symptoms 4. To investigate the predictive value of Gerd Q to diagnose GERD with atypical reflux symptoms with heartburn or regurgitation
Interventions
DRUGEsomeprazole MUPS, 20 mg
According to the guidelines, the PPI treatment duration would be 8 weeks(Esomeprazole MUPS, 20 mg bid) for patients with reflux esophagitis and 4 weeks (Esomeprazole MUPS, 20 mg bid) for patients with normal findings on endoscopy.
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Consecutive patients aged 18-65 years who go to the gastroenterology clinic presented with upper gastrointestinal discomfort, such as heartburn, regurgitation, dysphagia, substernal pain, epigastric pain, epigastric burning, early satiety, postprandial fullness. * Whose previous symptoms should last for at least 3 months and be at least 3 days per week in frequency with moderate severity. * Able to fill in the questionaires.
Exclusion criteria
* gastric or duodenal ulcers, upper GI neoplasms on upper endoscopy * severe cardiac or pulmonary diseases, diabetes or rheumatic diseases * history of operations in the upper GI tract * renal failure or abnormal liver function * use of non-steroidal anti-inflammatory drugs (NSAIDs) * allergy to esomeprazole * Pregnancy or lactating mother
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | over 3 years | GERD can be diagnosed by more than one different criteria (i.e.reflux esophagitis on endoscopy; positive acid exposure time (AET) on reflux monitoring;Either reflux esophagitis on endoscopy or positive AET on reflux monitoring) in a single participant. When different criteria was used to diagnose GERD, the percentage of GERD patients with different predominant symptom will be calculated. The symptom of the highest percentage will be the primary symptom. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Participants Diagnosed With Pathological Acid Reflux Using Reflux Monitoring Among Participants With Different Main Baseline Symptoms | over 3 years | The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with different main baseline symptom in the symptom questionnaire in Chinese outpatients in Gastroenterology department will be calculated. |
| The Life Quality of GERD Patients Who Were Diagnosed by Either Reflux Esophagitis on Endoscopy or Positive Acid Exposure Time(AET) on Reflux Monitoring and Presented With Different Main Baseline Symptoms | over 3 years | The life quality of GERD patients with different main symptoms before PPI test will be measured via the MOS 36-item short form health survey (SF-36), in which higher scores mean a better quality of life. Its maximum score is 796.5, and the minimum score is 36.5. |
| The Sensitivity of PPI Test for Diagnosis of GERD | over 3 years | The sensitivity of PPI test for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the gold standard for the diagnosis of GERD. |
| The Percentage of Participants Diagnosed With Reflux Esophagitis Using Endoscopy Among Participants With Different Main Baseline Symptoms | over 3 years | The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with different main symptom in the symptom questionnaire in Chinese outpatients in Gastroenterology department will be calculated. |
| The Sensitivity of GERDQ for Diagnosis of GERD | over 3 years | The sensitivity of GERDQ for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the gold standard for the diagnosis of GERD. |
| The Specificity of GERDQ for Diagnosis of GERD | over 3 years | The specificity of GERDQ for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the gold standard for the diagnosis of GERD. |
| The Specificity of PPI Test for Diagnosis of GERD | over 3 years | The specificity of PPI test for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the gold standard for the diagnosis of GERD. |
Countries
China
Participant flow
Recruitment details
Four hundred consecutive patients with upper gastrointestinal (GI) symptoms were screened, 19 patients who didn't meet the inclusion criteria and 7 patients with major motility disorders on high resolution manometry were excluded. Thus, a total of 374 patients were finally enrolled in the current study.
Pre-assignment details
The current study was a single Arm study where all participants with upper GI symptoms were enrolled and tested for gastro-esophageal reflux disease (GERD) via endoscopy and 24-hour reflux monitoring. Participants were then given proton pump inhibitor(PPI) treatment and the course was decided base on the endoscopy findings.
Participants by arm
| Arm | Count |
|---|---|
| Patients With Predominant Heartburn Patients with predominant heartburn were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ. | 87 |
| Patients With Predominant Regurgitation Patients with predominant regurgitation were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ. | 82 |
| Patients With Predominant Chest Pain Patients with predominant chest pain were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ. | 63 |
| Patients With Predominant Dysphagia Patients with predominant dysphagia were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ. | 12 |
| Patients With Predominant Epigastric Pain Patients with predominant epigastric pain were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ. | 35 |
| Patients With Predominant Epigastric Burning Patients with predominant epigastric burning were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ. | 29 |
| Patients With Predominant Postprandial Fullness Patients with predominant postprandial fullness were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ. | 64 |
| Patients With Predominant Early Satiety Patients with predominant early satiety were evaluated for GERD using different methods (i.e., reflux esophagitis on endoscopy or positive acid exposure time (AET) on reflux monitoring). They also recieved PPI test and finished GERDQ. | 2 |
| Total | 374 |
Baseline characteristics
| Characteristic | Patients With Predominant Heartburn | Patients With Predominant Regurgitation | Patients With Predominant Chest Pain | Patients With Predominant Dysphagia | Patients With Predominant Epigastric Pain | Patients With Predominant Epigastric Burning | Patients With Predominant Postprandial Fullness | Patients With Predominant Early Satiety | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 46.90 years STANDARD_DEVIATION 12.25 | 40.96 years STANDARD_DEVIATION 14.06 | 43.27 years STANDARD_DEVIATION 10.7 | 41.83 years STANDARD_DEVIATION 13.29 | 42.54 years STANDARD_DEVIATION 14.56 | 43.83 years STANDARD_DEVIATION 14.34 | 39.88 years STANDARD_DEVIATION 13.31 | 30.50 years STANDARD_DEVIATION 12.02 | 42.88 years STANDARD_DEVIATION 12.31 |
| Body Mass Index (BMI) | 22.22 kg/m^2 STANDARD_DEVIATION 3.21 | 22.07 kg/m^2 STANDARD_DEVIATION 3.17 | 22.69 kg/m^2 STANDARD_DEVIATION 3.42 | 21.20 kg/m^2 STANDARD_DEVIATION 3.22 | 21.95 kg/m^2 STANDARD_DEVIATION 3.31 | 22.78 kg/m^2 STANDARD_DEVIATION 3.05 | 21.39 kg/m^2 STANDARD_DEVIATION 2.81 | 17.98 kg/m^2 STANDARD_DEVIATION 1.12 | 22.09 kg/m^2 STANDARD_DEVIATION 3.15 |
| Race and Ethnicity Not Collected | — | — | — | — | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 42 Participants | 40 Participants | 32 Participants | 7 Participants | 24 Participants | 18 Participants | 31 Participants | 2 Participants | 196 Participants |
| Sex: Female, Male Male | 45 Participants | 42 Participants | 31 Participants | 5 Participants | 11 Participants | 11 Participants | 33 Participants | 0 Participants | 178 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 357 |
| other Total, other adverse events | 42 / 357 |
| serious Total, serious adverse events | 1 / 357 |
Outcome results
Primary
The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department
GERD can be diagnosed by more than one different criteria (i.e.reflux esophagitis on endoscopy; positive acid exposure time (AET) on reflux monitoring;Either reflux esophagitis on endoscopy or positive AET on reflux monitoring) in a single participant. When different criteria was used to diagnose GERD, the percentage of GERD patients with different predominant symptom will be calculated. The symptom of the highest percentage will be the primary symptom.
Time frame: over 3 years
Population: GERD is diagnosed based on different criteria among 374 enrolled patients, and then the percentage of GERD patients with different predominant symptom will be calculated. The symptom of the highest percentage will be the primary symptom.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GERD Patients Defined by Reflux Esophagitis on Endoscopy | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Heartburn | 19 Participants |
| GERD Patients Defined by Reflux Esophagitis on Endoscopy | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Regurgitation | 23 Participants |
| GERD Patients Defined by Reflux Esophagitis on Endoscopy | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Chest pain | 9 Participants |
| GERD Patients Defined by Reflux Esophagitis on Endoscopy | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Dysphagia | 2 Participants |
| GERD Patients Defined by Reflux Esophagitis on Endoscopy | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Epigastric pain | 9 Participants |
| GERD Patients Defined by Reflux Esophagitis on Endoscopy | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Epigastric burning | 4 Participants |
| GERD Patients Defined by Reflux Esophagitis on Endoscopy | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Postprandial fullness | 13 Participants |
| GERD Patients Defined by Reflux Esophagitis on Endoscopy | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Early satiety | 0 Participants |
| GERD Patients Defined by Positive AET on Reflux Monitoring | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Chest pain | 16 Participants |
| GERD Patients Defined by Positive AET on Reflux Monitoring | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Postprandial fullness | 15 Participants |
| GERD Patients Defined by Positive AET on Reflux Monitoring | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Dysphagia | 4 Participants |
| GERD Patients Defined by Positive AET on Reflux Monitoring | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Epigastric pain | 5 Participants |
| GERD Patients Defined by Positive AET on Reflux Monitoring | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Epigastric burning | 11 Participants |
| GERD Patients Defined by Positive AET on Reflux Monitoring | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Heartburn | 30 Participants |
| GERD Patients Defined by Positive AET on Reflux Monitoring | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Regurgitation | 30 Participants |
| GERD Patients Defined by Positive AET on Reflux Monitoring | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Early satiety | 0 Participants |
| GERD Patients Defined by Either Endoscopy or Reflux Monitoring | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Chest pain | 23 Participants |
| GERD Patients Defined by Either Endoscopy or Reflux Monitoring | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Regurgitation | 38 Participants |
| GERD Patients Defined by Either Endoscopy or Reflux Monitoring | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Heartburn | 42 Participants |
| GERD Patients Defined by Either Endoscopy or Reflux Monitoring | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Dysphagia | 4 Participants |
| GERD Patients Defined by Either Endoscopy or Reflux Monitoring | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Postprandial fullness | 23 Participants |
| GERD Patients Defined by Either Endoscopy or Reflux Monitoring | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Epigastric burning | 13 Participants |
| GERD Patients Defined by Either Endoscopy or Reflux Monitoring | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Epigastric pain | 11 Participants |
| GERD Patients Defined by Either Endoscopy or Reflux Monitoring | The Primary Symptom of GERD in Chinese Outpatients in Gastroenterology Department | Early satiety | 0 Participants |
Secondary
The Life Quality of GERD Patients Who Were Diagnosed by Either Reflux Esophagitis on Endoscopy or Positive Acid Exposure Time(AET) on Reflux Monitoring and Presented With Different Main Baseline Symptoms
The life quality of GERD patients with different main symptoms before PPI test will be measured via the MOS 36-item short form health survey (SF-36), in which higher scores mean a better quality of life. Its maximum score is 796.5, and the minimum score is 36.5.
Time frame: over 3 years
Population: The analysis population for this outcome measure was patients with a GERD diagnosis by either reflux esophagitis on upper endoscopy or positive acid exposure time(AET) on reflux monitoring.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GERD Patients Defined by Reflux Esophagitis on Endoscopy | The Life Quality of GERD Patients Who Were Diagnosed by Either Reflux Esophagitis on Endoscopy or Positive Acid Exposure Time(AET) on Reflux Monitoring and Presented With Different Main Baseline Symptoms | 565.04 score on a scale | Standard Deviation 163.59 |
| GERD Patients Defined by Positive AET on Reflux Monitoring | The Life Quality of GERD Patients Who Were Diagnosed by Either Reflux Esophagitis on Endoscopy or Positive Acid Exposure Time(AET) on Reflux Monitoring and Presented With Different Main Baseline Symptoms | 582.55 score on a scale | Standard Deviation 128.87 |
| GERD Patients Defined by Either Endoscopy or Reflux Monitoring | The Life Quality of GERD Patients Who Were Diagnosed by Either Reflux Esophagitis on Endoscopy or Positive Acid Exposure Time(AET) on Reflux Monitoring and Presented With Different Main Baseline Symptoms | 606.35 score on a scale | Standard Deviation 134.44 |
| Patients With Predominant Dysphagia | The Life Quality of GERD Patients Who Were Diagnosed by Either Reflux Esophagitis on Endoscopy or Positive Acid Exposure Time(AET) on Reflux Monitoring and Presented With Different Main Baseline Symptoms | 706.67 score on a scale | Standard Deviation 18.35 |
| Patients With Predominant Epigastric Pain | The Life Quality of GERD Patients Who Were Diagnosed by Either Reflux Esophagitis on Endoscopy or Positive Acid Exposure Time(AET) on Reflux Monitoring and Presented With Different Main Baseline Symptoms | 581.15 score on a scale | Standard Deviation 193.52 |
| Patients With Predominant Epigastric Burning | The Life Quality of GERD Patients Who Were Diagnosed by Either Reflux Esophagitis on Endoscopy or Positive Acid Exposure Time(AET) on Reflux Monitoring and Presented With Different Main Baseline Symptoms | 545.8 score on a scale | Standard Deviation 176.79 |
| Patients With Predominant Postprandial Fullness | The Life Quality of GERD Patients Who Were Diagnosed by Either Reflux Esophagitis on Endoscopy or Positive Acid Exposure Time(AET) on Reflux Monitoring and Presented With Different Main Baseline Symptoms | 618.18 score on a scale | Standard Deviation 152.35 |
Secondary
The Percentage of Participants Diagnosed With Pathological Acid Reflux Using Reflux Monitoring Among Participants With Different Main Baseline Symptoms
The percentage of paticipants diagnosed with pathological acid reflux using reflux monitoring among patients with different main baseline symptom in the symptom questionnaire in Chinese outpatients in Gastroenterology department will be calculated.
Time frame: over 3 years
Population: Among 374 enrolled patients presented with different main symptom, the percentage of patients with pathological acid reflux was calculated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GERD Patients Defined by Reflux Esophagitis on Endoscopy | The Percentage of Participants Diagnosed With Pathological Acid Reflux Using Reflux Monitoring Among Participants With Different Main Baseline Symptoms | 30 Participants |
| GERD Patients Defined by Positive AET on Reflux Monitoring | The Percentage of Participants Diagnosed With Pathological Acid Reflux Using Reflux Monitoring Among Participants With Different Main Baseline Symptoms | 30 Participants |
| GERD Patients Defined by Either Endoscopy or Reflux Monitoring | The Percentage of Participants Diagnosed With Pathological Acid Reflux Using Reflux Monitoring Among Participants With Different Main Baseline Symptoms | 16 Participants |
| Patients With Predominant Dysphagia | The Percentage of Participants Diagnosed With Pathological Acid Reflux Using Reflux Monitoring Among Participants With Different Main Baseline Symptoms | 4 Participants |
| Patients With Predominant Epigastric Pain | The Percentage of Participants Diagnosed With Pathological Acid Reflux Using Reflux Monitoring Among Participants With Different Main Baseline Symptoms | 5 Participants |
| Patients With Predominant Epigastric Burning | The Percentage of Participants Diagnosed With Pathological Acid Reflux Using Reflux Monitoring Among Participants With Different Main Baseline Symptoms | 11 Participants |
| Patients With Predominant Postprandial Fullness | The Percentage of Participants Diagnosed With Pathological Acid Reflux Using Reflux Monitoring Among Participants With Different Main Baseline Symptoms | 15 Participants |
| Patients With Predominant Early Satiety | The Percentage of Participants Diagnosed With Pathological Acid Reflux Using Reflux Monitoring Among Participants With Different Main Baseline Symptoms | 0 Participants |
Secondary
The Percentage of Participants Diagnosed With Reflux Esophagitis Using Endoscopy Among Participants With Different Main Baseline Symptoms
The percentage of paticipants diagnosed with reflux esophagitis on endoscopy among patients with different main symptom in the symptom questionnaire in Chinese outpatients in Gastroenterology department will be calculated.
Time frame: over 3 years
Population: Among 374 enrolled patients presented with different main symptom, the percentage of patients with reflux esophagitis was calculated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GERD Patients Defined by Reflux Esophagitis on Endoscopy | The Percentage of Participants Diagnosed With Reflux Esophagitis Using Endoscopy Among Participants With Different Main Baseline Symptoms | 19 Participants |
| GERD Patients Defined by Positive AET on Reflux Monitoring | The Percentage of Participants Diagnosed With Reflux Esophagitis Using Endoscopy Among Participants With Different Main Baseline Symptoms | 23 Participants |
| GERD Patients Defined by Either Endoscopy or Reflux Monitoring | The Percentage of Participants Diagnosed With Reflux Esophagitis Using Endoscopy Among Participants With Different Main Baseline Symptoms | 9 Participants |
| Patients With Predominant Dysphagia | The Percentage of Participants Diagnosed With Reflux Esophagitis Using Endoscopy Among Participants With Different Main Baseline Symptoms | 2 Participants |
| Patients With Predominant Epigastric Pain | The Percentage of Participants Diagnosed With Reflux Esophagitis Using Endoscopy Among Participants With Different Main Baseline Symptoms | 9 Participants |
| Patients With Predominant Epigastric Burning | The Percentage of Participants Diagnosed With Reflux Esophagitis Using Endoscopy Among Participants With Different Main Baseline Symptoms | 4 Participants |
| Patients With Predominant Postprandial Fullness | The Percentage of Participants Diagnosed With Reflux Esophagitis Using Endoscopy Among Participants With Different Main Baseline Symptoms | 13 Participants |
| Patients With Predominant Early Satiety | The Percentage of Participants Diagnosed With Reflux Esophagitis Using Endoscopy Among Participants With Different Main Baseline Symptoms | 0 Participants |
Secondary
The Sensitivity of GERDQ for Diagnosis of GERD
The sensitivity of GERDQ for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the gold standard for the diagnosis of GERD.
Time frame: over 3 years
Population: This outcome measure is the sensitivity of GERDQ for GERD diagnosis, so the whole analysis population would be patients who finished GERDQ. Note: typical reflux symptoms are heartburn and regurgitation; atypical reflux symptoms are chest pain, dysphagia, epigastric pain, epigastric burning, postprandial fullness, and early satiety.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GERD Patients Defined by Reflux Esophagitis on Endoscopy | The Sensitivity of GERDQ for Diagnosis of GERD | 0.84 Percentage of true positive |
| GERD Patients Defined by Positive AET on Reflux Monitoring | The Sensitivity of GERDQ for Diagnosis of GERD | 0.43 Percentage of true positive |
Secondary
The Sensitivity of PPI Test for Diagnosis of GERD
The sensitivity of PPI test for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the gold standard for the diagnosis of GERD.
Time frame: over 3 years
Population: This outcome measure is the sensitivity of PPI test for GERD diagnosis, so the whole analysis population would be patients who finished PPI treatment. Note: typical reflux symptoms are heartburn and regurgitation; atypical reflux symptoms are chest pain, dysphagia, epigastric pain, epigastric burning, postprandial fullness, and early satiety.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GERD Patients Defined by Reflux Esophagitis on Endoscopy | The Sensitivity of PPI Test for Diagnosis of GERD | 0.64 Percentage of true positive |
| GERD Patients Defined by Positive AET on Reflux Monitoring | The Sensitivity of PPI Test for Diagnosis of GERD | 0.51 Percentage of true positive |
Secondary
The Specificity of GERDQ for Diagnosis of GERD
The specificity of GERDQ for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the gold standard for the diagnosis of GERD.
Time frame: over 3 years
Population: This outcome measure is the specificity of GERDQ for GERD diagnosis, so the whole analysis population would be patients who finished GERDQ. Note: typical reflux symptoms are heartburn and regurgitation; atypical reflux symptoms are chest pain, dysphagia, epigastric pain, epigastric burning, postprandial fullness, and early satiety.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GERD Patients Defined by Reflux Esophagitis on Endoscopy | The Specificity of GERDQ for Diagnosis of GERD | 0.24 Percentage of true negative |
| GERD Patients Defined by Positive AET on Reflux Monitoring | The Specificity of GERDQ for Diagnosis of GERD | 0.63 Percentage of true negative |
Secondary
The Specificity of PPI Test for Diagnosis of GERD
The specificity of PPI test for the diagnosis of GERD in patients with typical or atypical reflux symptoms will be calculated. The presence of reflux esophagitis on upper endoscopy and/or pathological acid reflux on 24-hour pH monitoring are considered as the gold standard for the diagnosis of GERD.
Time frame: over 3 years
Population: This outcome measure is the specificity of PPI test for GERD diagnosis, so the whole analysis population would be patients who finished PPI treatment. Note: typical reflux symptoms are heartburn and regurgitation; atypical reflux symptoms are chest pain, dysphagia, epigastric pain, epigastric burning, postprandial fullness, and early satiety.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GERD Patients Defined by Reflux Esophagitis on Endoscopy | The Specificity of PPI Test for Diagnosis of GERD | 0.40 Percentage of true negative |
| GERD Patients Defined by Positive AET on Reflux Monitoring | The Specificity of PPI Test for Diagnosis of GERD | 0.62 Percentage of true negative |