Treatment of IBS in Primary Health Care.

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT05144581
• Lead Sponsor: Region Örebro County

Brief Summary

The purpose of this study is to retrospectively evaluate treatment strategies for IBS used within primary Health care in Örebro Region.

Detailed Description

The defining features of IBS comprise the presence of recurrent abdominal pain in association with altered bowel habits (diarrhea, constipation or both), as stated in the Rome IV criteria. The spectrum, duration and severity of symptoms can range from inconvenient to incapacitating, and can prevent individuals from participating in everyday activities. Despite the prevalence of IBS, its management remains a challenge for global healthcare systems.

Treatment of IBS comprises, in summary, information to patients, dietary treatment, pharmacological treatment and psychological treatment. Pharmacological treatment includes antidepressants, bulking agents or fiber supplements, rifaximin, linaclotide, eluxadoline, loperamide, antispasmodics, prokinetics and probiotics.

Since the majority of patients with irritable bowel syndrome (IBS) are diagnosed and treated in primary care, the aim of this project is to investigate the adherence of general practitioners (GPs) to recommended therapeutic approaches for IBS.

In this study, data regarding therapeutic approaches will be collected retrospectively over the period of 2013-2019 by using the electronic patient register in Örebro Region. Patients will be identified by ICD-code K.58. The used treatments will be categorized in grade of recommendation as well as in strength of evidence. The efficacy of the used treatments will be evaluated, if possible. Over the counter agents, and lifestyle adjustments will not be evaluated.

The used treatments will be categorized in grade of recommendation (weak and strong) as well as in strength of evidence /very low, low, moderate and high). The eventual use of inappropriate treatments will be recorded as well. The efficacy of the used treatments will be, if possible, evaluated from the patient registers. The standardized and validated questionnaires IBS-Symptom Severity Score and IBS-Quality of Life scores are not routinely used within the primary health care. For this reason, the efficacy of the treatments will be categorized in "no effect, moderate effect and good effect".

Descriptive statistics will be used.

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-11-22
• Last Update Submitted: 2021-11-22
• Study Start: 2021-11-29
• Study First Posted: 2021-12-03
• Last Update Posted: 2021-12-03
• Primary Completion: 2023-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• All adult patients (both sexes) who were diagnosed with IBS according to ICD-10 in Region Örebro County 2013-2017.

Exclusion Criteria

• Patients < 18 years or > 65 years.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adherence to guidelines of pharmacological treatment of IBS within primary care	2013-2017	The proportion of patients that have received pharmacological treatment according to guidelines for IBS within primary care.
Adherence to guidelines of non-pharmacological treatment of IBS within primary care	2013-2017	The proportion of patients that have received non-pharmacological treatment according to guidelines for IBS within primary care.

Secondary Outcome Measures

Name	Time	Method
Use of inappropriate treatments of IBS	2013-2017	The prevalence of inappropriate treatment strategies of IBS within primary care will be recorded.
Efficacy of treatment of IBS	2013-2017	Used treatments of IBS will be categorized in grade of recommendation as well as in strenght of evidence.