How Well do Primary Care Doctors in Region Örebro County, Sweden Follow Diagnostic Guidelines of IBS?

Irritable Bowel Syndrome Clinical Trial

Official title:

Adherence of Primary Care Doctors to Guidelines of Making a Positive Diagnosis of IBS.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04859972
• Other study ID #: 277069
• Status: Not yet recruiting
• Start date: November 22, 2021
• Est. completion date: May 2023

Study information

• Verified date: March 2021
• Source: Region Örebro County
• Contact: Jussi Rauma, Ph.D. student, M.D.
• Phone: +46702484167
• Email: jussi.rauma[@]regionorebrolan.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this project is to investigate the implementation of the Rome criteria in daily primary care clinical practice and adherence of general practitioners (GPs) to recommended diagnostic approaches for IBS.

Description:

Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder. To diagnose IBS, the so-called Rome Criteria combined with limited laboratory tests should be used. However, within the primary care, too much unnecessary diagnostics, for example radiology and endoscopy, are used. This is meaningless, stressful for the patient and they also cost a lot of money.

In Örebro Region there are 29 public general health centers. Approximately 300.000 inhabitants are listed within these health centers. Approximately 150 doctors are currently working within the primary health care of Örebro Region. The software program Medrave and the electronic patient register in Örebro Region allows to search for the International Statistical Classification of Diseases (ICD-10) for IBS (K58.9 and K58.0) This allows retrospective research regarding diagnosing IBS, the used diagnostic tools, comorbidities, as well as the different treatments that were used.

Patients diagnosed with IBS will be identified by ICD-code K.58. By evaluating their patient register it will be determined how the GP has made the IBS diagnosis. Patients will fall into three categories: those who received a positive IBS diagnosis using the Rome criteria, those who received a negative IBS diagnosis and those whose patient record is lacking sufficient information.

Data will also include demographics, number of GP contacts and referrals to specialists, diagnostic procedures, treatments, and relevant somatic, psychological and psychiatric comorbidities. Data regarding substance abuse will be collected as well.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: May 2023
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• All adult patients (both sexes) who were diagnosed with IBS according to ICD-10 in Region Örebro County 2015-2019.

Exclusion Criteria:

• Patients < 18 years or > 65 years

Related Conditions & MeSH terms

• Irritable Bowel Syndrome

Intervention

Diagnostic Test:
• Diagnosis of IBS
Diagnosis of IBS according to ICD-10

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Region Örebro County

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to guidelines of making a positive diagnosis of IBS within primary care.	The proportion of patients that received a positive IBS diagnosis versus the proportion of patients that received a negative IBS diagnosis.	2015-2019
Secondary	Prevalence of diarrhea-predominant IBS and IBS without diarrhea.	Proportion of patients with diarrhea-predominant IBS versus IBS without diarrhea	2015-2019
Secondary	The proportion of IBS patients that have one or more comorbidities.	Data will be collected about the following comorbidities: depression (F32, F33 and F41.2), anxiety (F41), somatization syndrome (F45), posttraumatic stress syndrome (F43.1), sleeping disorder (G47.9), urinary incontinence (N39.3 and N39.4), fecal incontinence (R15.9), migraine (G43), headache (R51.9 and G44.2), menstruation symptoms (N92 and N94), fibromyalgia (M79.7), Ehlers Danlos syndrome (Q79.6), other unspecific muskuloskeletal pain (M79) and functional dyspepsia (K30.9).	2015-2019
Secondary	The proportion of IBS patients with post-infectious IBS.	The presence of gastroenteritis (A09.9) that precedes the diagnosis of IBS.	2015-2019
Secondary	The proportion of IBS patients with substance abuse.	Data will be collected regarding substance abuse which is defined by alcohol (F10), opioids (F11), cannabis (F12), sedatives and hypnotics (F13) and Tobacco (F17).	2015-2019