Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05144594 |
| Other study ID # |
277075 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 29, 2021 |
| Est. completion date |
May 31, 2025 |
Study information
| Verified date |
November 2021 |
| Source |
Region Örebro County |
| Contact |
Jussi Rauma, M.D. |
| Phone |
+460702484167 |
| Email |
jussi.rauma[@]regionorebrolan.se |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to calculate the unnecessary costs that are associated with a
negative IBS diagnosis.
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.
