Article Text
Abstract
Introduction The aim of the study was to identify the sociodemographic and clinical factors associated with death after the first lower-extremity amputation (LEA), minor and major separately, using data from regional health administrative databases.
Research design and methods We carried out a population-based cohort study including patients with diabetes residing in the Lazio region and undergoing a primary amputation in the period 2012–2015. Each individual was followed up for at least 2 years. Kaplan-Meier analysis was used to evaluate long-term survival; Cox proportional regression models were applied to identify factors associated with all-cause mortality.
Results The cohort included 1053 patients, 72% were male, 63% aged ≥65 years, and 519 (49%) died by the end of follow-up. Mortality rates at 1 and 4 years were, respectively, 33% and 65% for major LEA and 18% and 45% for minor LEA. Significant risk factors for mortality were age ≥65, diabetes-related cardiovascular complications, and chronic renal disease for patients with minor LEA, and age ≥75 years, chronic renal disease and antidepressant drug consumption for subjects with major LEA.
Conclusions The present study confirms the high mortality rates described in patients with diabetes after non-traumatic LEA. It shows differences between minor and major LEA in terms of mortality rates and related risk factors. The study highlights the role of depression as specific risk factor for death in patients with diabetes after major LEA and suggests including its definition and management in strategies to reduce the high mortality rate observed in this group of patients.
- foot ulcer
- mortality
- adult diabetes
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Footnotes
Contributors AMB, SC, NA, MD and LU contributed to conception and design of the study. SC, AMB, and CM wrote the protocol. SC, AMB, LU, MM and LG managed the literature searches and analyses. SC performed the statistical analysis. All authors contributed to the interpretation of the results. SC and AMB wrote the first draft of the manuscript. All authors took part in revising the article critically for important intellectual content; gave final approval of the version to be published; and agree to be accountable for all aspects of the work. NA is the guarantor of this work and as such had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The Department of Epidemiology, Regional Health Service Lazio Region, is the regional referral center for epidemiological research and has full access to anonymized health information systems. Consent was not necessary because the authors used data already collected at the beginning of the study and the data were analyzed anonymously through a standardized methodology according to the national privacy law (national legislative decree on privacy policy n. 196/30 June 2003). Individuals cannot be identified directly or through identifiers and results are shown in aggregate form.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request. Data related to the findings reported in our manuscript are available to all interested researchers upon request due to stringent legal restrictions regarding privacy policy on personal information in Italy (national legislative decree on privacy policy n. 196/30 June 2003). For these reasons our data set cannot be made available on public data deposition. All interested researchers can contact the following persons to request the data: Nera Agabiti, Department of Epidemiology, Lazio Regional Health Service, Rome, Italy (email: n.agabiti@deplazio.it); Damiano Lanzi, Department of Epidemiology, Lazio Regional Health Service, Rome, Italy (email: d.lanzi@deplazio.it).