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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Diagnostic test: Diagnosis of IBS

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

• Study Contact: Name: Jussi Rauma, Ph.D. student, M.D.; Phone Number: +46702484167; Email: jussi.rauma@regionorebrolan.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with IBS within primary care of Region Örebro County 2015-2019.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients diagnosed with IBS; Patients diagnosed with IBS within primary care in Region Örebro County between 2015- 2019, identified by ICD-code K.58.	Diagnostic test: Diagnosis of IBS; Diagnosis of IBS according to ICD-10

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of diarrhea-predominant IBS and IBS without diarrhea.	Proportion of patients with diarrhea-predominant IBS versus IBS without diarrhea	2015-2019
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
The proportion of IBS patients with post-infectious IBS.	The presence of gastroenteritis (A09.9) that precedes the diagnosis of IBS.	2015-2019
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

Collaborators and Investigators

• Sponsor: Region Örebro County
• Investigators: Principal Investigator: Michiel van Nieuwenhoven, Associate Professor, M.D. PhD., Region Örebro County

Study record dates

Study Major Dates

• Study Start (Anticipated): November 22, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 22, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Functional gastrointestinal disorders; Rome IV
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome
• Other Study ID Numbers: 277069

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No