跳至主要内容
临床试验/NCT05144581
NCT05144581Unknown不适用

Treatment of IBS in Primary Health Care: Adherence to Guidelines

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
发起方
入组人数
3,000
主要终点
Adherence to guidelines of pharmacological treatment of IBS within primary care

研究概览

简要总结

The purpose of this study is to retrospectively evaluate treatment strategies for IBS used within primary Health care in Örebro Region.

详细描述

The defining features of IBS comprise the presence of recurrent abdominal pain in association with altered bowel habits (diarrhea, constipation or both), as stated in the Rome IV criteria. The spectrum, duration and severity of symptoms can range from inconvenient to incapacitating, and can prevent individuals from participating in everyday activities. Despite the prevalence of IBS, its management remains a challenge for global healthcare systems.

Treatment of IBS comprises, in summary, information to patients, dietary treatment, pharmacological treatment and psychological treatment. Pharmacological treatment includes antidepressants, bulking agents or fiber supplements, rifaximin, linaclotide, eluxadoline, loperamide, antispasmodics, prokinetics and probiotics.

Since the majority of patients with irritable bowel syndrome (IBS) are diagnosed and treated in primary care, the aim of this project is to investigate the adherence of general practitioners (GPs) to recommended therapeutic approaches for IBS.

In this study, data regarding therapeutic approaches will be collected retrospectively over the period of 2013-2019 by using the electronic patient register in Örebro Region. Patients will be identified by ICD-code K.58. The used treatments will be categorized in grade of recommendation as well as in strength of evidence. The efficacy of the used treatments will be evaluated, if possible. Over the counter agents, and lifestyle adjustments will not be evaluated.

The used treatments will be categorized in grade of recommendation (weak and strong) as well as in strength of evidence /very low, low, moderate and high). The eventual use of inappropriate treatments will be recorded as well. The efficacy of the used treatments will be, if possible, evaluated from the patient registers. The standardized and validated questionnaires IBS-Symptom Severity Score and IBS-Quality of Life scores are not routinely used within the primary health care. For this reason, the efficacy of the treatments will be categorized in "no effect, moderate effect and good effect".

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 in Region Örebro County 2013-2017.

排除标准

  • Patients < 18 years or > 65 years.

结局指标

主要结局

Adherence to guidelines of pharmacological treatment of IBS within primary care

时间窗: 2013-2017

The proportion of patients that have received pharmacological treatment according to guidelines for IBS within primary care.

Adherence to guidelines of non-pharmacological treatment of IBS within primary care

时间窗: 2013-2017

The proportion of patients that have received non-pharmacological treatment according to guidelines for IBS within primary care.

次要结局

  • Efficacy of treatment of IBS(2013-2017)
  • Use of inappropriate treatments of IBS(2013-2017)

研究者

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

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