Lower Extremity Amputations in Persons With Diabetes Mellitus in the Netherlands

Study Overview
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Brief Summary
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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?

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

Conditions
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Lower Extremity Amputations, Diabetes Mellitus

Intervention / Treatment
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* Procedure: lower extremity amputation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| persons with DM who underwent a lower extremity amputation<br> | Procedure: lower extremity amputation<br>* persons are defined as having a lower extremity amputation when an operation with removal of an extremity below the hips took place. To identify those people with diabetes who underwent amputation, the following DBC's claims were extracted from the system: 038590; amputation upper leg, 038690; amputation lower leg, 038691; exarticulation of the lower leg, 038790; amputation of the tarsus, 038791; amputation or exarticulation of a toe, 038793; exarticulation of the foot, 038794; Chopart exarticulation, Lisfranc, respectively trans metatarsal amputation. Amputations were categorized into minor (038790, 038791, 038793, 038794) and major (038590, 038690,038691) amputations<br>|
| persons with DM who did not underwent a lower extremity amputation<br> | |
| persons without DM who underwent a lower extremity amputation<br> | Procedure: lower extremity amputation<br>* persons are defined as having a lower extremity amputation when an operation with removal of an extremity below the hips took place. To identify those people with diabetes who underwent amputation, the following DBC's claims were extracted from the system: 038590; amputation upper leg, 038690; amputation lower leg, 038691; exarticulation of the lower leg, 038790; amputation of the tarsus, 038791; amputation or exarticulation of a toe, 038793; exarticulation of the foot, 038794; Chopart exarticulation, Lisfranc, respectively trans metatarsal amputation. Amputations were categorized into minor (038790, 038791, 038793, 038794) and major (038590, 038690,038691) amputations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - What is the incident amputation rate in persons with and without DM in the Netherlands in the period 2011-2020? |  | dec 23 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - 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 | 
| - 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 | 
| - 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 |