Clinical trial NCT05144581: Treatment of IBS in Primary Health Care.
Official title: Treatment of IBS in Primary Health Care: Adherence to Guidelines
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Irritable Bowel Syndrome
Keywords: Irritable bowel syndrome
Functional gastrointestinal disorders
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with IBS within primary care of Region Örebro County 2013-2017.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adherence to guidelines of pharmacological treatment of IBS within primary care
timeFrame: 2013-2017
measure: Adherence to guidelines of non-pharmacological treatment of IBS within primary care
timeFrame: 2013-2017
Secondary outcomes:
measure: Efficacy of treatment of IBS
timeFrame: 2013-2017
measure: Use of inappropriate treatments of IBS
timeFrame: 2013-2017
Other outcomes:
Locations:
Study officials:
affiliation: Region Örebro County
name: Michiel van Nieuwenhoven, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: