Valenta Sums up the 7х7 Observational Program for Gastroenterologists
Valenta has announced the results of its multicentral non-interventional observational program aimed at implementation in clinical practice of «7×7» Questionnaire («7 symptoms for 7 days») for dynamic assessment of symptoms of functional pathology: functional dyspepsia and irritable bowel syndrome.
Gastroenterologiсal disorders are one of the most widespread diseases in Russia — that is why the problem of effective treatment of such diseases is rather urgent. For today, the Ministry of Healthcare of the Russian Federation has approved the norm of general practitioner’s consultation time as 18 minutes per patient, which highlights the necessity for a professional to have a tool of prompt and qualitative assessment of the patient’s condition.
In 2014, Valenta together with the Russian Gastroenterology Association (RGA) developed «7×7» Questionnaire for prompt dynamic assessment of symptoms of functional dyspepsia (FD) and irritable bowel syndrome (IBS). It is used to estimate the frequency and severity of seven basic symptoms of gastrointestinal tract functional disorders for the last 7 days to objectively assess their dynamics in the process of treatment. «7×7» Questionnaire is based on algorithms set out in the Rome III Diagnostic Criteria. It includes estimation of frequency and severity of the patient’s 7 most often occurring symptoms (typical complaints) and is a simple and effective method of dynamic assessment of severity of the patient’s health condition.
In June 2015, Valenta started patient recruitment for its multicentral non-interventional observational «7×7» program. The program engaged 38 medical establishments of gastroenterologiсal profile in the Moscow region. More than 500 patients participated in the program — they got clinical diagnosis of «functional dyspepsia» and/or «irritable bowel syndrome», i.e. the functional pathology of gastrointestinal tract (FP GIT), including the associated pathology. The observational program was approved by the Independent Interdisciplinary Committee for Ethical Review of Clinical Trials.
The observational program is aimed at studying epidemiology of FP/FPS GIT and therapeutic approaches to correction of basic symptoms of the diseases in routine clinical practice, and «7×7» Questionnaire implementation in routine out-patient practice. A «digital» look at FP GIT symptoms and their dynamics is an important step on the way of assessment of treatment efficacy — in fact, there are no objective tools to measure the disease displays in case of FP GIT. The observational program became the first stage of implementation of a new tested version of the Questionnaire in routine clinical practice.
The results of the observational program showed that «7×7» Questionnaire was specific for patients of gastro profile, simple in use, well reflecting the patient’s current condition, didn’t need much time to fill-up and, the most important, was recommended by the Russian Gastroenterology Association for clinical application. In November 2015, the program of implementation of «7×7» Questionnaire in regions started. The program is a series of round tables arranged by Valenta in all cities of its presence to make doctors acquainted with the results of its «7×7» observational program. Besides, experts in the field of gastroenterology will tell doctors about the urgency of the Questionnaire implementation in routine medical practice. In 2016, we plan to introduce the Questionnaire into therapist routine clinical practice.
Development and implementation of «7×7» Questionnaire shows an example of Valenta collaboration with medical community. The Company monitors patients’ and healthcare professionals’ requirements on a continuous basis. Valenta plans to continue improvement of the Questionnaire, to expand the sphere of its application and to test the Questionnaire in interdisciplinary areas.
Ekaterina Zakharova, Medical Director, JSC «Valenta Pharm»: «Functional pathology of gastrointestinal tract features a wide range of subjective symptoms of disease, while objective signs are quite few in number. „7×7“ Questionnaire is aimed to objectify the group of subjective symptoms (patient’s complaints) and to develop a methodological approach to working out a therapy for each patient. Developed as a tool of dynamic assessment of therapy effectiveness, the Questionnaire provides additional grounds to make decision about changing the prescribed therapy or correcting the administered treatment.»