Prompers Leonne, Huijberts Maya, Apelqvist Jan, Jude Edward, Piaggesi Alberto, Bakker Karel, Edmonds Michael, Holstein Per, Jirkovska Alexandra, Mauricio Didac, Tennvall Gunnel Ragnarson, Reike Heinrich, Spraul Maximilian, Uccioli Luigi, Urbancic Vilma, Van Acker Kristien, Van Baal Jeff, Van Merode Frits, Schaper Nicolaas
Division of Endocrinology, Department of Internal Medicine, University Hospital Maastricht, Maastricht, the Netherlands.
Int J Low Extrem Wounds. 2007 Mar;6(1):11-7. doi: 10.1177/1534734606297245.
This article describes the rationale and protocol of a large data collection study in patients with new diabetic foot ulcers by the Eurodiale study group, a consortium of centers of expertise in the field of diabetic foot disease within Europe. This study is a multicenter, observational, prospective data collection study. Its main aim is to determine the major factors determining clinical outcome and outcome in terms of health-related quality of life and health care consumption. Between September 1, 2003, and October 1, 2004, in 14 European centers, all consecutive patients with diabetes and a new foot ulcer were included in the study and followed until the end point or for a maximum of 1 year. End points were healing of the foot, major amputation, or death. Data were collected on patient, foot, and ulcer characteristics and on diagnostic and management procedures. Furthermore, data were collected on health care organization, quality of life, and resource use. A total of 1232 patients were included in the study. Sixty-three percent of the patients were referred by their general practitioner or were self-referrals. Twenty-seven percent of the patients were admitted at the time of inclusion; 1088 patients were followed until the end point. "Optimal Organization of Health Care in Diabetic Foot Disease" is one of the first large multicenter studies in the field of diabetic foot disease on clinical presentation, clinical outcome, quality of life, resource utilization, and health care organization and their interrelationships. These data will provide us with new insights that enable us to improve care for these patients and guide the development of new studies in this area. The results of this study are the subject of a separate presentation.
本文描述了欧洲糖尿病足病专家中心联盟Eurodiale研究小组针对新发糖尿病足溃疡患者开展的一项大型数据收集研究的基本原理和方案。这项研究是一项多中心、观察性、前瞻性数据收集研究。其主要目的是确定决定临床结局以及与健康相关的生活质量和医疗保健消耗方面结局的主要因素。在2003年9月1日至2004年10月1日期间，14个欧洲中心将所有连续性糖尿病患者及新发足部溃疡患者纳入研究，并随访至终点或最长1年。终点为足部愈合、大截肢或死亡。收集了患者、足部和溃疡特征以及诊断和治疗程序的数据。此外，还收集了医疗保健组织、生活质量和资源使用方面的数据。共有1232名患者纳入研究。63%的患者由其全科医生转诊或自行就诊。27%的患者在纳入时住院；1088名患者随访至终点。“糖尿病足病医疗保健的优化组织”是糖尿病足病领域首批关于临床表现、临床结局、生活质量、资源利用、医疗保健组织及其相互关系的大型多中心研究之一。这些数据将为我们提供新的见解，使我们能够改善对这些患者的护理，并指导该领域新研究的开展。本研究结果将另行发表。
