Direct Medical Costs Associated With Negative Diagnosis of IBS.

November 22, 2021 updated by: Region Örebro County

Assessment of Direct Medical Costs Associated With Making a Negative Diagnosis of IBS.

The purpose of this study is to calculate the unnecessary costs that are associated with a negative IBS diagnosis.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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 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 diagnosis of IBS.

A study planned ahead of this study by the same research group will focus on adherence to guidelines of making a positive diagnosis of IBS. This data will be used for this study as well.

Data will be collected retrospectively over the period 2013-2017 using the the electronic patient register in Örebro Region. 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.

A detailed analysis of the collected data will focus on the proportion of patients who received a negative diagnosis. We will only include patients with age >40 years without "red flags", since in these patients additional diagnostics are seldom warranted and generally not useful. Red flags are, for example, blood in the stool, fever, anemia or involuntary weight loss. In patients over 40 years, certain additional diagnostics may be important. For example, changes in bowel habits may be caused by colorectal cancer and for this reason these patients are routinely referred for a colonoscopy according to the guidelines for the "standardized care chain".

For each patient, data regarding the used diagnostic tools will be collected and at the end the costs of these diagnostic tools will be calculated. If a patient is referred to a specialist, the costs for the associated diagnostics will be calculated as well.

The results of the diagnostic tests will be evaluated as well, in order to confirm that these tests were not indicated, as one may expect. If a patient was referred to a specialist, the costs for the associated diagnostics will be calculated as well. Diagnostic tools include gastroscopy, colonoscopy, abdominal ultrasound, vaginal ultrasound, abdominal x-ray and abdominal MRI. Laboratory testing includes liver tests, tests for lactose intolerance, stool samples, food allergy tests and autoimmune serology.

The two groups (positive vs negative diagnosis) will be compared regarding the costs of diagnostic tools and laboratory testing, in order to establish the total amount of costs that are associated with making a negative IBS diagnosis.

Descriptive statistical analysis of the economic costs for IBS patients receiving a positive diagnosis will be compared to those receiving a negative diagnosis. The total cost of all diagnostic procedures will be analyzed, as well as various cost components. A separate analysis will be performed to confirm the expected negative results of the additional diagnostic tests, associated with a negative IBS diagnosis.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with IBS within primary care of Region Örebro County 2013-2017.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients < 18 years or > 65 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients diagnosed with IBS
Patients diagnosed with IBS within primary care in Region Örebro County between 2013-2017, identified by ICD-code K.58.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Direct medical costs of diagnostic tools associated with a negative diagnosis of IBS.
Time Frame: 2013-2017
Unnecessary costs of diagnostic tools, e.g. endoscopy and radiology in SEK that are associated with a negative IBS diagnosis
2013-2017
Direct medical costs of laboratory tests associated with a negative diagnosis of IBS.
Time Frame: 2013-2017
Unnecessary costs of laboratory tests, e.g. liver tests, tests for lactose intolerance, stool samples, food allergy tests and autoimmune serology, in SEK that are associated with a negative IBS diagnosis
2013-2017
Direct medical costs of referrals to specialists associated with a negative diagnosis of IBS.
Time Frame: 2013-2017
Unncessary costs of referrals to specialist care. If a patient was referred to a specialist, the costs for the associated diagnostics will be calculated as well.
2013-2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Örebro County

Investigators

  • Principal Investigator: Michiel van Nieuwenhoven, M.D. Ph.D., Region Örebro County

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 29, 2021

Primary Completion (Anticipated)

May 31, 2024

Study Completion (Anticipated)

May 31, 2025

Study Registration Dates

First Submitted

November 22, 2021

First Submitted That Met QC Criteria

November 22, 2021

First Posted (Actual)

December 3, 2021

Study Record Updates

Last Update Posted (Actual)

December 3, 2021

Last Update Submitted That Met QC Criteria

November 22, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 277075

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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