Outcome measures and patient reported outcomes.

Introduction
Intermittent claudication is a peripheral artery disease caused by arteriosclerosis. People with intermittent claudication experience leg cramping during walking, with relief of symptoms during rest. Evidence shows that by participating in supervised exercise therapy and smoking cessation programs, people with intermittent claudication can reduce those symptoms and improve health-related quality of life and maximal walking distance while minimizing the need for an operation. However, implementation of such health-promoting initiatives in clinical practice in Denmark and other countries is limited. This is a protocol presenting the implementation process of supervised exercise therapy and smoking cessation in a region of Denmark.
Methods and analysis
The implementation process is a collaboration between the municipalities in the Region of Zealand and the Department of Vascular Surgery at University Hospital Zealand. The study uses a convergent mixed-methods prospective clinical cohort design, and the theoretical frame of this implementation process follows the framework for Adapting an existing intervention to a new context (ADAPT). The process involves stakeholder engagement, ongoing evaluation through key performance indicators and relevant outcomes that will inform the implementation process across and within each municipality.
Dissemination
Dissemination will happen throughout the process through continued meetings with stakeholders and dissemination of performance indicators and outcome results obtained through a database. All information about the study and material will be freely available. The project is registred on Clinicalgov (NCT06299956).

引言
间歇性跛行（intermittent claudication）是一种由动脉硬化引发的外周动脉疾病。此类患者在行走过程中会出现腿部痉挛症状，休息后症状可得到缓解。研究证据表明，参与监督式运动疗法（supervised exercise therapy）与戒烟项目（smoking cessation programs）的间歇性跛行患者，能够减轻相关症状，提升健康相关生活质量（health-related quality of life），延长最大步行距离（maximal walking distance），同时降低手术需求。然而，在丹麦及其他国家的临床实践中，此类健康促进举措的推广实施仍存在局限。本方案旨在介绍丹麦某区域内监督式运动疗法与戒烟项目的实施流程。

方法与分析
本实施流程由西兰大区（Region of Zealand）各市政当局与西兰大学医院（University Hospital Zealand）血管外科部门合作开展。本研究采用收敛性混合方法前瞻性临床队列设计，其实施流程的理论框架遵循「将现有干预方案适配至新场景（Adapting an existing intervention to a new context, ADAPT）」框架。该流程涵盖利益相关方参与（stakeholder engagement）、通过关键绩效指标（key performance indicators）与相关结局指标开展的持续评估，这些评估结果将为各市政当局内部及跨市政的实施流程提供决策依据。

传播推广
本研究将在实施全程通过与利益相关方的持续会议，以及发布数据库获取的绩效指标与结局结果开展成果传播。所有研究相关信息与材料均将免费公开。本项目已在Clinicalgov注册（登记号：NCT06299956）。