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临床试验/NCT05144594
NCT05144594尚未招募不适用

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

Region Örebro County0 个研究点目标入组 3,000 人开始时间: 2021年11月29日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
3,000
主要终点
Direct medical costs of laboratory tests associated with a negative diagnosis of IBS.

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Patients < 18 years or > 65 years

结局指标

主要结局

Direct medical costs of laboratory tests associated with a negative diagnosis of IBS.

时间窗: 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 diagnostic tools associated with a negative diagnosis of IBS.

时间窗: 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 referrals to specialists associated with a negative diagnosis of IBS.

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Region Örebro County
申办方类型
Other
责任方
Sponsor

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