Irritable Bowel SyndromeNCT05144594
Direct Medical Costs Associated With Negative Diagnosis of IBS.
An observational study of Irritable Bowel Syndrome, run by Region Örebro County.
Trial summary
The purpose of this study is to calculate the unnecessary costs that are associated with a negative IBS diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 29 Nov 2021to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients diagnosed with IBS within primary care of Region Örebro County 2013-2017.
Who may be able to join
- All adult patients (both sexes) who were diagnosed with IBS according to ICD-10 within primary care of Region Örebro County 2013-2017.
Who cannot join
- Patients < 18 years or > 65 years
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome, Rome IV, Functional gastrointestinal disorders
- Medical subject headings
- Irritable Bowel Syndrome, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Direct medical costs of diagnostic tools associated with a negative diagnosis of IBS.
Unnecessary costs of diagnostic tools, e.g. endoscopy and radiology in SEK that are associated with a negative IBS diagnosis
Measured: 2013-2017
Direct medical costs of laboratory tests associated with a negative diagnosis of IBS.
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
Measured: 2013-2017
Direct medical costs of referrals to specialists associated with a negative diagnosis of IBS.
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.
Measured: 2013-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start29 Nov 2021 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michiel van Nieuwenhoven, M.D. Ph.D., Principal investigator, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144594
- Sponsor's protocol ID
- 277075
- Status last verified
- Nov 2021
- First submitted
- 22 Nov 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Direct Medical Costs Associated With Making a Negative Diagnosis of IBS.
- ClinicalTrials.gov ID
- NCT05144594
- Acronym / sponsor ID
- 277075
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome, Rome IV, Functional gastrointestinal disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 29 Nov 2021 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to calculate the unnecessary costs that are associated with a negative IBS diagnosis.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with IBS | – | –Patients diagnosed with IBS within primary care in Region Örebro County between 2013-2017, identified by ICD-code K.58. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with IBS within primary care of Region Örebro County 2013-2017.
Key inclusion criteria (1 listed)
- All adult patients (both sexes) who were diagnosed with IBS according to ICD-10 within primary care of Region Örebro County 2013-2017.
Key exclusion criteria (1 listed)
- Patients < 18 years or > 65 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michiel van Nieuwenhoven, M.D. Ph.D. principal investigator
Region Örebro County
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by Region Örebro County.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jussi Rauma, M.D. (+460702484167, jussi.rauma@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Direct medical costs of diagnostic tools associated with a negative diagnosis of IBS. (time frame: 2013-2017). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2021.