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临床试验/NCT05939271
NCT05939271进行中(未招募)不适用

Lower Extremity Amputations in Persons With Diabetes Mellitus in the Netherlands, a Retrospective Study Using an All-payer Claims Database

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 2,808 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
2,808
试验地点
1
主要终点
- What is the incident amputation rate in persons with and without DM in the Netherlands in the period 2011-2020?

研究概览

简要总结

This is a retrospective, observational study based on an all-payer claims database (APCD) in the period 2011 to 2020) managed by the Vektis Health Care Information Center. In 2006, Vektis was established by Dutch health insurers aiming to combine and interpret reimbursement data and enable the main players in the Dutch healthcare market to base decisions and policy on reliable, essential, and timely information. Vektis receives data from all Dutch health care insurers. The APCD covers health care claims of 99.9% of the Dutch population. This study is part of the DUtch Diabetes Estimates (DUDE) initiative. We aim to perform different predefined analyses with the available data:

  • What is the incident amputation rate in persons with and without DM in the Netherlands in the period 2011-2020?
  • What defines persons with DM who need an amputation as compared to matched persons with DM but without an amputation in 2016, both in aspects of health care use and costs?
  • What defines persons with DM who need an amputation as compared to matched persons without DM with an amputation?
  • Does Social Economic Status (SES) play a role in amputation incidence and level, or on longer term outcome in persons with DM in the Netherlands?
  • Does the presence of a formal multidisciplinary foot clinic / team in a hospital make a difference, especially when comparing previous and actual macrovascular complication rates?

研究设计

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

入排标准

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

入选标准

  • All persons aged ≥ 18 years, diagnosed with type 1 DM (T1DM) or type 2 DM (T2DM) identified in the Vektis data met the inclusion criteria

排除标准

  • 未提供

结局指标

主要结局

- What is the incident amputation rate in persons with and without DM in the Netherlands in the period 2011-2020?

时间窗: dec 23

次要结局

  • - What defines persons with DM who need an amputation as compared to matched persons with DM but without an amputation in 2016, both in aspects of health care use and costs?(dec 23)
  • - Does the presence of a formal multidisciplinary foot clinic / team in a hospital make a difference, especially when comparing previous and actual macrovascular complication rates?(dec24)
  • - What defines persons with DM who need an amputation as compared to matched persons without DM with an amputation?(dec23)
  • - Does Social Economic Status (SES) play a role in amputation incidence and level, or on longer term outcome in persons with DM in the Netherlands?(dec 23)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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