Clinical trial NCT04859972: How Well do Primary Care Doctors in Region Örebro County, Sweden Follow Diagnostic Guidelines of IBS?
Official title: Adherence of Primary Care Doctors to Guidelines of Making a Positive Diagnosis of IBS.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
Rome IV
Functional gastrointestinal disorders
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with IBS within primary care of Region Örebro County 2015-2019.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adherence to guidelines of making a positive diagnosis of IBS within primary care.
timeFrame: 2015-2019
Secondary outcomes:
measure: Prevalence of diarrhea-predominant IBS and IBS without diarrhea.
timeFrame: 2015-2019
measure: The proportion of IBS patients that have one or more comorbidities.
timeFrame: 2015-2019
measure: The proportion of IBS patients with post-infectious IBS.
timeFrame: 2015-2019
measure: The proportion of IBS patients with substance abuse.
timeFrame: 2015-2019
Other outcomes:
Locations:
Study officials:
affiliation: Region Örebro County
name: Michiel van Nieuwenhoven, Associate Professor, M.D. PhD.
role: PRINCIPAL_INVESTIGATOR
References: