Disease : The Role of GERD Questionnaire and PPI Test

patients with GERD, showed no abnormalities in the endoscopic picture. This is what underlies the importance of a diagnostic tool in the form of assessment for the degree of severity of the disease based on symptoms, response to therapy and effect on the patients’ quality of life. This diagnostic tool is then formulated in the form of a questionnaire (GERD questionnaire). Response to treatment with proton pump inhibitor (PPI) drugs is also often used to support the diagnosis of this disease. Diamond study is a large study which aim to assess the accuration of the questionnaire and use of PPI value, which are relatively similar to the symptoms-based diagnoses performed by general practitioners or gastroenterologist, as well as when compared to endoscopy and esophageal pH monitoring. Although the diagnosis by methods of questionnaires and PPI test is not the most ideal test in term of accuracy, but these tests are not expensive, readily available and worked mainly on primary health care. These test methods are favored compared to other tests.


INTRODUCTION
Gastroesophageal reflux disease (GERD) is a gastrointestinal disease which fairly common but the prevalence very diverse worldwide. 1This disease is very common in Western Countries which occurs in 10-30% of population.In Singapore, the prevalence of sharply from 1,6% of population in 1994 to 10,6% in 2001. 1 In Indonesia, there has been no representative data to describe the incidence of this disease, but data from Rumah Sakit Cipto Mangunkusumo (RSCM) showed that there is increased of prevalence from 6% in 1997 to 26% in 2002 on patients which undergone upper gastrointestinal endoscopy.This increasing trend is predicted caused by many things, which one of them is the increased use of endoscopic modalities.
The increasing prevalence due to the use of endoscopic modalities is very helpful in describing the actual conditions, especially in big cities, but it became a distinctive obstacle for regions with less advanced health facilities.These conditions need to be addressed with a more simple modalities which able to reach all areas, validated and reliable.Of course, use of gastroand PPI test are expected to solve this problem.This paper will be presented the role and position of GERDQ and The purpose of this literature review is to know the position of GERDQ and PPI test use in the diagnosis also aims to provide a basis for the primary health care providers to not hesitate in diagnosing the

GASTROESOPHAGEAL REFLUX DISEASE
on the consensus of international experts group which known as Montreal definition.Gastroesophageal disease defined as a condition that arises due to symptoms and/or its complications. 1 What referred to irritating symptoms are any symptoms that lower the quality of life of patients.These symptoms need to be sentation in the chest.are based on American College of Gastroenterology (ACG), is symptoms or mucosal damage produced by 2 The latter definition can refer to the findings at endoscopy, but it is also need to keep in mind that not

Clinical Menifestations of Gastroesophageal
Most typical clinical manifestations of in the chest and regurgitation.Burning sensation in the Ummu Habibah, Achmad fauzi or hypopharynx.These two symptoms are assessed fairly descriptive to diagnose GERD.Dysphagia symptom is generally more often to appears if a burning sensation occurs long enough and in patients with erosive esophagitis.Dyspeptic symptoms mostly can be resolved with the administration of proton pump inhibitor (PPI).Slowly progressive dysphagia, especially for solid food with obstructive esophageal obstruction are suggestive for peptic stricture.Symptoms outside the esophagus which can chest pain, sleep disorders, cough, hoarseness and asthma. 4,5sease.Diagnostic tools which needed must meet of the disease; (2) Evaluating patients who have failed to be treated with empiric therapy. 2 Signs which make health practitioners should evaluated the empirical therapy in patients with suspected gastroesophageal reflux disease called alarm signs. 4Those alarm signs are vomiting, upper gastrointestinal bleeding, weight loss, dysphagia, anemia, and epigastric mass.Nevertheless, the evidence to support this, is very little.Another perspective found in a meta-analysis found that alarm signs in patients with upper gastrointestinal This prompted the need of endoscopic examination for follow-up alarm signs.
Endoscopic and 24-hour esophageal pH probe examination initially recommended as the gold disease. 1 However, it is estimated that more than 70% of patients with typical symptoms of gastroesophageal endoscopic examination.24-hour esophageal pH probe examination is not sensitive enough to be one of the diagnosis criteria.One study in China found that 63 of 102 patients with this disease is endoscopically positive, and 84 patients of the 115 patients who had a positive result on a 24-hour esophageal pH probe. 1 Futhermore, these two modalities are quite expensive and not readily available in small hospitals or clinics.Because of there are no gold standard assessment of symptoms is very important.

Endoscopy
in GERD diagnosis because of its capabilities to showed Barret metaplasia, stricture or diagnosis of another upper gastroinstetinal diseases in patients. 4However, symptoms is very weak.Endoscopy must be considered disease patients for more than 5 years, have alarm signs, and to search Barret esophagus.

Esophageal pH Monitoring Examination
Esophageal pH monitoring examination are invasive procedure which can be done after endoscopic and histopatologic examination showed normal result of this examination is varied, probe can be placed probe placed also varied (some said it can be done momentarily, but others said 24 hours examination is better).As with endoscopy, this modality also not readily available in primary health care centers so its use is very limited.

GERD Questionnaire
Some diagnostic tools have been tried to use in helping physicians in diagnose GERD.Dent et al reported a study entitled "Accuracy of the diagnosis of GERD by questionnaire, physicians and a trial of PPI treatment: The Diamond Study", the result on symptoms with questionnaire have the same accuracy as diagnosis based on symptoms by a general practitioner or gastroenterologist. 6

Proton Pump Inhibitor (PPI) Test
This test is one of the modalities to be considered when endoscopic diagnostic resources not available.Patients with typical symptoms will be given a double dose PPI for two weeks then the clinical response assessed.This test usually follow GERDQ or used alone as a diagnostic modality in places with limited resources.If this PPI test done after GERDQ, then the evaluation also use GERDQ.Administration of PPI will be continued with the usual doses if the patient had clinical improvement, and the patients will be is what underlies the importance of a diagnostic tool based on assessment for the degree of severity of the disease based on symptoms, response to therapy and effect on the patients' quality of life. 7This diagnostic tool is then formulated in the form of a questionnaire (GERD Questionnaire).
In general, symptom based questionnaire can be used as a discriminatory, predictive, or evaluative instrument.Discriminatory instrument is intended to distinguish this group of patients and to classify patients into a few degrees of severity and frequency of the disease.If used as a diagnostic instrument, the discriminatory questionnaire must have very has high probability prediction.Questionnaire as a predictive instrument is used if there is a gold standard examination.Evaluative questionnaire with a scale used to assess the magnitude of change in the degree of severity at certain times on individual and group.Of the three types of the questionnaire, GERDQ expected to meet three types.
There are several requirements that must be met for a good questionnaire, which are: (1) Sensitive to detect GERD patients; (2) Includes data on the frequency and intensity of symptoms of typical and atypical GERD; (3) Multidimensional (not only includes medical problems); (4) Have psychometric characteristics that (5) Practical and economical; (6) Can be done by the patient itself, without having to be accompanied (selfassesed); (7) Use language that easily understood by patients; (8) Provide a fast response to a change in the short term; (9) Can be used in daily settings to provide assessments during and after therapy; (10) Valid in different languages, for use on an international scale. 11ome questionnaires have been made to answer some of these requirements.In general, the questionnaires are divided into symptomatology questionnaires (based on symptoms), questionnaires based on effect of the disease on quality of life, and serta questionnaire that combines both.The grouping of the questionnaires can be seen in the following table 1.From many questionnaires which successfully documented, no one can be taken as the gold standard questionnaire. 3A systematic review conducted in 2004 showed that there are 5 pieces questionnaire that almost meets all the criterias of an ideal GERD questionnaire, but this study too long that a more contemporary study seen in the following table 2.
The big question is which questionnaire that can be widely or generaly used and how to choose the most appropriate questionnaire for the clinical situation in Indonesia, and how the actual role of this questionnaire some of these questions, there is a recent large study on the role of GERD questionnaire in 2009 which quite helpful to help answering doubts about the use of questionnaires disease.Details of the study will be discussed later.

Proton Pump Inhibitor (PPI) Test
Response to treatment with drugs from class of proton pump inhibitor (PPI), often used to support the , however the accuracy of this strategy is often questioned. 8mong some of the questions is whether this test can be applied in all cases, and whether this test can be used to replace other tests that are invasive and uncomfortable.Rationalization of the use of high-dose PPI drugs with a short duration as a diagnostic modality is its effect on gastric acid secretion to cope with erosive esophagitis and improve the symptoms of GERD. 9 In general, PPI drugs can provide the acid suppressive effect within 1-28 days, because it is used to help diagnosis, then high dose of PPI is used to boost the effects supresinya and immediately improve patient complaints.The high doses expected to give effect before 28 days.The dose used in several large studies are doubledose PPI, which are 40-80 mg omeprazole, 30-60 mg lansoprazole, and 40 mg rabeprazole. 10Duration which regarding this test procedure.
The type of PPI used varied, the most common is omeprazole, so this test once regarded as omeprazole test.New classes of drugs that are often used for research is omeprazole, but its effectiveness was similar to other drugs, if intended for PPI test.Large studies on this test using oral PPI, no one was using intravenous PPI with consideration of the application outpatients.The strategy for increasing the role of doctors in primary cares in improving diagnosis of GERD because the scope of this strategy is very simple and well tolerated by patients.
Disadvantages of this test is the absence of a standard test or the definitive gold standard for diagnosing GERD.In some studies, the PPI test is often compared to endoscopy and pH examination, by the fact that these two examinations also has many vary between studies, and the populations are different, which are 27-89% for sensitivity and 35-73% for specificity.Schindlbeck et al showed that 40 mg omeprazole per day for 7 days resulted in a sensitivity of 27% and will be increased to 83% when the drug dose was increased to 40 mg twice daily.Fass et al stated that the omeprazole dose lower than previous studies (60 mg); which are 40 mg before breakfast, 20 mg before dinner; for 7 days will result in 80% for sensitivity of 80%.Study by Fass use 50% symptoms reduction as a positive limit value, if the value of this limit was increased to 75% symptoms reduction (clinical improvement) then the sensitivity value will increased to 86% with 91% positive predictive value and accuracy of 81%. 10 A large study in India who studied algorithms combination of a PPI test, endoscopy and histology examination can identify all cases of gastroesophageal on their own. 11From the previous decription, it can be

DIAMOND STUDY AND ITS APLICATION IN INDONESIA
In 2009, there is a large study was done to assess the accuracy of the questionnaire and the use of PPI test, which expected to help the problem in diagnosing was released in 2010, and often used as a basis for adopting a new questionnaire which easier, simpler and validated in various countries, including in Indonesia.This study was named the Diamond study.
Diamond study was conducted in many centers in various countries, which Germany, Sweden, Canada, Denmark, Norway, and the United Kingdom.This sudy 73 family physicians, 22 specialist clinics and 308 patients.Patients who entered the inclusion criteria questionnaire (RDQ), gastrointestinal symptom rating impact scale (GIS). 12Based on input from these three questionnaires, some questions which are considered best describes the symptoms and the effect on quality of life are made.These set of questions compiled in disease questionnaire (GERDQ).This study also combined the questionnaire with PPI test to assess its role in assisting the diagnosis and simultaneously disease symptoms.The diagnostic algorithm illustrated above can also describe the role of PPI test in everyday clinical complained of, and if accompanied by signs of alarm, then the possibility of erosive esophagitis pathological features can be found is more likely.If the histological features is so clear then PPI test is not needed, but on the PPI test is more necessary to help establish the diagnosis.Eventually, this study mentioned that the sensitivity and specificity of gastroesophageal reflux disease diagnosis based on symptoms by questionnaire are out gastroenterologist, 54% and 65% if followed by PPI test for two weeks. 12Therefore, it can be concluded that the diagnostic method with questionnaire modality which followed by PPI test has the sensitivity and based diagnosis which done by general practicioners and gastroenterologist, as well as when compared with endoscopy and esophageal pH monitoring examination.
Although GERD diagnosis with questionnaire and PPI test are not tests with the most ideal accuracy, but these tests are not expensive, readily available options and can be done especially in primary health care centers.These tests are favored compared to more invasive and uncomfortable examinations, especially any alarm sign.
In Indonesia alone, the two diagnostic methods have been incorporated into the diagnostic algorithm have been translated into Indonesian and validation test have been done.This validation test is done in 2009, and named as Virginia study. 1 Result from this study is all questions in GERD questionnaire are valid and reliable in Indonesian GERD patients.degree of severity of symptoms which affected patients' quality of life and this examination is not readily available in all health care centers in peripehral areas.Initially, this examination became diagnostic gold standard of GERD, but because of its weakness until now there is no diagnosis standard in Some modalities which introduced recently are GERD questionnaire and PPI test.These two modalities usually simulatenously used, but sometime used separatedly.Some studies have shown similar validities when used by general practitioners or gastroenterologist.However, these test also have many limitations.Translation of questionnaire must be done carefully and the questionnaire must be revalidated at every place it was translated. 1 However, these two modalities very helpful to diagnose GERD, especially in remote areas.

Diagnostic
Approach to Gastroesophageal Reflux Disease: The Role of GERD Questionnaire and PPI Test ROLE OF GERD QUESTIONNAIRE AND PPI TEST GERD Questionnaire disease occurs quite often, but most patients do not

Tabel 1 .
Various questionnaires used to aid diagnose GERD used by Vigneri et al Chinese GERD Questionnaire (Chinese GERDQ) Score related to GERD Standardized esophageal symptom questionnaire Questionnaire by Andersen et al Gastrointestinal Symptoms Rating Scale (GSRS) Questionnaire by Ruth et al Ulcer esophagitis subjective symptoms scale (UESS) Digestive health status instrument (DHSI) related quality of life (GERD-HRQL) severity and impact questionnaire (N-GSSIQ)

Tabel 2 . 7 Name
Results of systematic review on various GERD questionnaires : ulcer oesophagitis subjective symptom scale *only parts of the scale Diagnostic Approach to Gastroesophageal Reflux Disease: The Role of GERD Questionnaire and PPI Test diagnosing GERD, especially if the test is combined with other diagnostic.Economic analysis test has also been used to determine the position of the PPI test in terms of stated that this test proven to reduce the cost of health expenditure because it can prevent the use of other diagnostic methods which are more expensive different.This test saves 64% expenditure when compared to endoscopy, and saves 53% expenditure when compared to the 24-hour pH measurement.10

Figure 3 .
Figure 3. Position of PPI test at GERD diagnosis algorithm with non-cardiac chest pain symptoms

Figure 5 .
Figure 5. GERD diagnostic algorithm according to the ACG

Table 5 . GERDQ in Indonesian have been proven to be valid dan reliable Questions Frequency score (points) for symptom in last 7 days 0 day 1 day 2-3 days 4-7 days Point
CONCLUSIONcommon gastrointestinal diseases.Prevalences of this disease are varied, while in Indonesia there has been no representative data to describe the magnitude of the problem in this disease.Diagnostic modality which known to be very helpful in diagnose gastroesophageal Weakness of this modality is the incapabilities to