van Eck J W M, van Hemel N M, Grobbee D E, Buskens E, Moons K G M
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Europace. 2006 Jan;8(1):60-4. doi: 10.1093/europace/euj005.
This communication describes the design of the FOLLOWPACE study. The overall aim of FOLLOWPACE is to quantify the cost-effectiveness of routine follow-up visits in patients with a pacemaker (PM). Specific aims are (i) to quantify the incidence of complications and the quality of life 1 year after PM implantation; (ii) to quantify which baseline characteristics measured during implantation are predictors of the occurrence of complications and quality of life after 1 year; (iii) to determine the added predictive value of follow-up measurements to improve the efficiency of follow-up and to demonstrate which follow-up measurements are redundant.
FOLLOWPACE is a prospective, observational, prognostic cohort study. About 40 PM centres in the Netherlands will participate to include about 2,500 patients. Each patient aged >or=18 receiving a PM for the first time is eligible. At baseline, i.e. time of implantation, all potential predictors of complications and quality of life after 1 year are documented. After implantation, follow-up visits will be carried out conforming with routine care, usually three in the first year. At these visits, other potential prognostic predictors will be documented. Primary outcome is the incidence of PM- or cardiac complications at 1 year. Secondary outcome parameters are quality of life and costs after 1 year.
This study will lead to definition of a more efficient routine follow-up schedule for patients with a PM, aiming to reduce time and energy while preserving the safety of pacing therapy and the prognosis of the patient. The study will ultimately provide evidence-based guidelines for PM follow-up including knowledge of the responsibilities of cardiologists, technicians, and representatives of PM manufacturers.
本通讯介绍了FOLLOWPACE研究的设计。FOLLOWPACE的总体目标是量化起搏器（PM）患者常规随访的成本效益。具体目标包括：（i）量化PM植入后1年并发症的发生率和生活质量；（ii）量化植入时测量的哪些基线特征可预测1年后并发症的发生和生活质量；（iii）确定随访测量的附加预测价值，以提高随访效率，并证明哪些随访测量是多余的。
FOLLOWPACE是一项前瞻性、观察性、预后队列研究。荷兰约40个PM中心将参与，纳入约2500名患者。首次接受PM且年龄≥18岁的每位患者均符合条件。在基线时，即植入时，记录所有1年后并发症和生活质量的潜在预测因素。植入后，随访将按照常规护理进行，通常在第一年进行三次。在这些随访中，将记录其他潜在的预后预测因素。主要结局是1年时PM或心脏并发症的发生率。次要结局参数是1年后的生活质量和成本。
本研究将为PM患者定义更有效的常规随访方案，旨在减少时间和精力，同时保持起搏治疗的安全性和患者的预后。该研究最终将为PM随访提供循证指南，包括心脏病专家、技术人员和PM制造商代表的职责知识。
