Diabetes and necrotizing soft tissue infections - A prospective observational cohort study: Statistical analysis plan

A Rosén; P Arnell; M B Madsen; B G Nedrebø; A Norrby-Teglund; O. Hyldegaard; V M Dos Santos; F Bergey; E Saccenti; INFECT Study Group; S Skrede

doi:10.1111/aas.13130

Diabetes and necrotizing soft tissue infections - A prospective observational cohort study: Statistical analysis plan

A Rosén, P Arnell, M B Madsen, B G Nedrebø, A Norrby-Teglund, O. Hyldegaard, V M Dos Santos, F Bergey, E Saccenti, INFECT Study Group, S Skrede

Department of Clinical Medicine

2 Citations (Scopus)

Abstract

BACKGROUND: Necrotizing soft tissue infections (NSTIs) are rare but carry a high morbidity and mortality. The multicenter INFECT project aims to improve the understanding of the pathogenesis, clinical characteristics, diagnosis, and prognosis of NSTIs. This article describes the study outline and statistical analyses that will be used.

METHODS: Within the framework of INFECT project, patients with NSTI at 5 Scandinavian hospitals are enrolled in a prospective observational cohort study. The goal is to evaluate outcome and characteristics for patients with NSTI and diabetes compared to patients with NSTI without diabetes. The primary outcome is mortality at 90 days after inclusion. Secondary outcomes include days alive and out of ICU and hospital, SAPS II, SOFA score, infectious etiology, amputation, affected body area, and renal replacement therapy. Comparison in mortality between patients with diabetes type 1 and 2 as well as between insulin-treated and non-insulin-treated diabetes patients will be made. Clinical data for diabetic patients with NSTI will be reported.

CONCLUSION: The study will provide important data on patients with NSTI and diabetes.

Original language	English
Journal	Acta Anaesthesiologica Scandinavica
Volume	62
Issue number	8
Pages (from-to)	1171-1177
ISSN	0001-5172
DOIs	https://doi.org/10.1111/aas.13130
Publication status	Published - Sept 2018

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Rosén, A., Arnell, P., Madsen, M. B., Nedrebø, B. G., Norrby-Teglund, A., Hyldegaard, O., Dos Santos, V. M., Bergey, F., Saccenti, E., INFECT Study Group, & Skrede, S. (2018). Diabetes and necrotizing soft tissue infections - A prospective observational cohort study: Statistical analysis plan. Acta Anaesthesiologica Scandinavica, 62(8), 1171-1177. https://doi.org/10.1111/aas.13130

Rosén, A, Arnell, P, Madsen, MB, Nedrebø, BG, Norrby-Teglund, A, Hyldegaard, O, Dos Santos, VM, Bergey, F, Saccenti, E, INFECT Study Group & Skrede, S 2018, 'Diabetes and necrotizing soft tissue infections - A prospective observational cohort study: Statistical analysis plan', Acta Anaesthesiologica Scandinavica, vol. 62, no. 8, pp. 1171-1177. https://doi.org/10.1111/aas.13130

@article{29448f84b2224b318531867855de70f8,

title = "Diabetes and necrotizing soft tissue infections - A prospective observational cohort study: Statistical analysis plan",

abstract = "BACKGROUND: Necrotizing soft tissue infections (NSTIs) are rare but carry a high morbidity and mortality. The multicenter INFECT project aims to improve the understanding of the pathogenesis, clinical characteristics, diagnosis, and prognosis of NSTIs. This article describes the study outline and statistical analyses that will be used.METHODS: Within the framework of INFECT project, patients with NSTI at 5 Scandinavian hospitals are enrolled in a prospective observational cohort study. The goal is to evaluate outcome and characteristics for patients with NSTI and diabetes compared to patients with NSTI without diabetes. The primary outcome is mortality at 90 days after inclusion. Secondary outcomes include days alive and out of ICU and hospital, SAPS II, SOFA score, infectious etiology, amputation, affected body area, and renal replacement therapy. Comparison in mortality between patients with diabetes type 1 and 2 as well as between insulin-treated and non-insulin-treated diabetes patients will be made. Clinical data for diabetic patients with NSTI will be reported.CONCLUSION: The study will provide important data on patients with NSTI and diabetes.",

author = "A Ros{\'e}n and P Arnell and Madsen, {M B} and Nedreb{\o}, {B G} and A Norrby-Teglund and O. Hyldegaard and {Dos Santos}, {V M} and F Bergey and E Saccenti and {INFECT Study Group} and S Skrede",

note = "{\textcopyright} 2018 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.",

year = "2018",

month = sep,

doi = "10.1111/aas.13130",

language = "English",

volume = "62",

pages = "1171--1177",

journal = "Acta Anaesthesiologica Scandinavica",

issn = "0001-5172",

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}

TY - JOUR

T1 - Diabetes and necrotizing soft tissue infections - A prospective observational cohort study

T2 - Statistical analysis plan

AU - Rosén, A

AU - Arnell, P

AU - Madsen, M B

AU - Nedrebø, B G

AU - Norrby-Teglund, A

AU - Hyldegaard, O.

AU - Dos Santos, V M

AU - Bergey, F

AU - Saccenti, E

AU - INFECT Study Group

AU - Skrede, S

PY - 2018/9

Y1 - 2018/9

N2 - BACKGROUND: Necrotizing soft tissue infections (NSTIs) are rare but carry a high morbidity and mortality. The multicenter INFECT project aims to improve the understanding of the pathogenesis, clinical characteristics, diagnosis, and prognosis of NSTIs. This article describes the study outline and statistical analyses that will be used.METHODS: Within the framework of INFECT project, patients with NSTI at 5 Scandinavian hospitals are enrolled in a prospective observational cohort study. The goal is to evaluate outcome and characteristics for patients with NSTI and diabetes compared to patients with NSTI without diabetes. The primary outcome is mortality at 90 days after inclusion. Secondary outcomes include days alive and out of ICU and hospital, SAPS II, SOFA score, infectious etiology, amputation, affected body area, and renal replacement therapy. Comparison in mortality between patients with diabetes type 1 and 2 as well as between insulin-treated and non-insulin-treated diabetes patients will be made. Clinical data for diabetic patients with NSTI will be reported.CONCLUSION: The study will provide important data on patients with NSTI and diabetes.

AB - BACKGROUND: Necrotizing soft tissue infections (NSTIs) are rare but carry a high morbidity and mortality. The multicenter INFECT project aims to improve the understanding of the pathogenesis, clinical characteristics, diagnosis, and prognosis of NSTIs. This article describes the study outline and statistical analyses that will be used.METHODS: Within the framework of INFECT project, patients with NSTI at 5 Scandinavian hospitals are enrolled in a prospective observational cohort study. The goal is to evaluate outcome and characteristics for patients with NSTI and diabetes compared to patients with NSTI without diabetes. The primary outcome is mortality at 90 days after inclusion. Secondary outcomes include days alive and out of ICU and hospital, SAPS II, SOFA score, infectious etiology, amputation, affected body area, and renal replacement therapy. Comparison in mortality between patients with diabetes type 1 and 2 as well as between insulin-treated and non-insulin-treated diabetes patients will be made. Clinical data for diabetic patients with NSTI will be reported.CONCLUSION: The study will provide important data on patients with NSTI and diabetes.

U2 - 10.1111/aas.13130

DO - 10.1111/aas.13130

M3 - Journal article

C2 - 29671865

SN - 0001-5172

VL - 62

SP - 1171

EP - 1177

JO - Acta Anaesthesiologica Scandinavica

JF - Acta Anaesthesiologica Scandinavica

IS - 8

ER -

Diabetes and necrotizing soft tissue infections - A prospective observational cohort study: Statistical analysis plan

Abstract

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