Clinical trial NCT01489735: The Use of International GerdQ Questionnaire
Official title: Observational Non-interventional Study on the Use of International GerdQ Questionnaire for the Diagnosis of Gastroesophageal Reflux Disease in the Russian Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
GERD Q QUESTIONNAIRE
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-12-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CLINICAL PRACTICE

Brief summary: There are three main directions for use GerdQ in practice. First of all, GerdQ can be used to diagnose GERD with an accuracy comparable to the accuracy of diagnosis of GERD by the specialist (gastroenterologist). Using GerdQ can evaluate the impact of disease on the patient's life and help in choosing treatment of GERD, as well as direct assessment of treatment efficacy.

In connection with mentioned above, this study is devoted to the estimation of possibility to use GerdQ in routine practice of Russian physicians.

Detailed description: Observational non-interventional study on the use of international GerdQ questionnaire for the diagnosis of gastroesophageal reflux disease in the Russian practice

Eligibility criteria: Inclusion Criteria:

* Signing of informed consent to participate in the study
* patients of both sexes, 18 years and older
* planned esophagogastroduodenoscopy

Exclusion Criteria:

* Surgical intervention for upper digestive tract (surgery for gastroesophageal reflux disease, peptic ulcer disease, etc.) In the past
* the presence of contraindications for esophagogastroduodenoscopy or pH-metry
* refusal to sign informed consent
* acceptance of antisecretory drugs (proton pump inhibitors, h2-receptor blockers), antacids and prokinetics for 7 days before enrollment
* Pregnancy
* Confirmed or suspected malignancy
* Impairment of the mental sphere
* Acceptance of nsaids (including acetylsalicylic acid at a dose of 150 mg / day), cytostatics, antibiotics (tetracyclines, lincosamides) at enrollment and during the preceding 30 days

Primary outcomes:
measure: Sensitivity of GerdQ questionnaire = rate of GERD by GerdQ questionnaire (total score ≥8) / number of patients whose GERD was confirmed by instrumental examinations.
timeFrame: Up to 6 months
measure: Specificity of GerdQ questionnaire = rate of GERD by GerdQ questionnaire (total score <8) / number of patients whose GERD diagnosis was excluded on the basis of instrumental examination
timeFrame: Up to 6 months
Secondary outcomes:
measure: Sensitivity of GERD diagnosis made by gastroenterologist = result of completion of GerdQ questionnaire / the results of clinical assessment by gastroenterologist.
timeFrame: Up to 6 months
measure: Frequency of GERD diagnosis based on instrumental examination (endoscopy, pH-metry) in studied patients.
timeFrame: Up to 6 months
measure: Prevalence of GERD with the completed GerdQ questionnaire, which corresponds to the proportion (%) of patients with a total score of ≥ 8 in the questionnaire, among study patients.
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Research site
Study officials:
affiliation: AstraZeneca
name: Alexey Stepanov, Prof
role: STUDY_DIRECTOR
affiliation: Head of Inner Disease Department of First Moscow State Medical University named after I.M. Sechenov
name: Vladimir Ivashkin, Prof
role: PRINCIPAL_INVESTIGATOR
References: