Mangen Marie-Josée J, Bonten Marc J M, de Wit G Ardine
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Heidelberglaan 100, Utrecht 3584, CX, The Netherlands.
BMC Infect Dis. 2013 Dec 19;13:597. doi: 10.1186/1471-2334-13-597.
Vaccine effectiveness is usually determined in randomized controlled trials (RCT) and if effective, additional information, e.g. on cost-effectiveness, is required to allow evidence-based decision making. A prerequisite for proper health economic modelling is the availability of good quality data on health care resources use, health outcomes and quality-of-life (QoL) data. The "Collecting health outcomes and economic data on hospitalized Community Acquired Pneumonia (CHO-CAP)--a prospective cohort study" is executed alongside the Community Acquired Pneumonia Immunization Trial with Adults (CAPiTA trial) to capture health outcomes and economic data of elderly hospitalized with CAP and matched controls without CAP.
METHODS/DESIGN: CAPiTA is a placebo-controlled double-blind RCT evaluating the effectiveness of a 13-valent conjugated pneumococcal vaccine in preventing vaccine-type pneumococcal CAP in 84,496 elderly in the Netherlands. Participants of CAPiTA, who consented and provided information on health status (EQ-5D) and socio-demographic background at the time of vaccination, constitute the source population of CHO-CAP and are eligible for the nested matched cohort study. CHO-CAP patients hospitalized with CAP form the "diseased" cohort and the "non-diseased" cohort consists of unaffected persons (i.e. no CAP). Observations in the diseased cohort and in matched controls from the non-diseased cohort are used to determine excess costs and QoL changes attributable to CAP.Based on an estimated 2,000 CAPiTA participants being hospitalized with CAP and an assumed CHO-CAP participation rate of 30% of all CAPiTA participants (±25,000), 600 CAP episodes are expected among CHO-CAP participants (the "diseased" cohort). For each patient with CAP, two non-diseased CHO-CAP subjects will be selected from the CHO-CAP cohort, with matching for age, gender and EQ-5D baseline-score. Data on healthcare and non-healthcare resources use, quality-of-life (using EQ-5D and SF-36 questionnaires) and selected health outcomes will be collected at 0, 1, 6 and 12 months after hospitalization for CAP.The CHO-CAP study was approved by the Central Committee on Research involving Human Subjects in the Netherlands.
With an expected 600 CAP episodes this study will be one of the biggest prospectively studied cohorts of hospitalized elderly with CAP with regard to resources use and Qol data. Strengths of this study further include collection of out-of-pocket costs of patients and productivity losses of both patients and their caregivers and the follow-up period of up to one year post-discharge. This study is therefore expected to add more in-depth knowledge on the short and longer term outcomes of pneumonia in elderly.
ClinicalTrials.gov, NCT00812084.
疫苗有效性通常在随机对照试验（RCT）中确定，若疫苗有效，则需要其他信息，如成本效益信息，以支持基于证据的决策。进行恰当的健康经济模型分析的一个前提是要有关于医疗保健资源使用、健康结局和生活质量（QoL）的高质量数据。“收集社区获得性肺炎住院患者的健康结局和经济数据（CHO-CAP）——一项前瞻性队列研究”与成人社区获得性肺炎免疫试验（CAPiTA试验）同时开展，以获取因社区获得性肺炎（CAP）住院的老年人以及匹配的无CAP对照者的健康结局和经济数据。
方法/设计：CAPiTA是一项安慰剂对照双盲随机对照试验，评估13价结合肺炎球菌疫苗在荷兰84496名老年人中预防疫苗型肺炎球菌CAP的有效性。CAPiTA试验中同意参与并在接种疫苗时提供健康状况（EQ-5D）和社会人口学背景信息的参与者构成了CHO-CAP的源人群，并有资格参与嵌套匹配队列研究。因CAP住院的CHO-CAP患者组成“患病”队列，“未患病”队列由未受影响的人（即无CAP）组成。患病队列和来自未患病队列的匹配对照者的观察数据用于确定CAP所致的额外成本和生活质量变化。基于估计有2000名CAPiTA参与者因CAP住院，以及假设CHO-CAP参与率为所有CAPiTA参与者的30%（±25000），预计CHO-CAP参与者（“患病”队列）中会出现600例CAP发作。对于每例CAP患者，将从CHO-CAP队列中选择两名未患病的CHO-CAP受试者，按年龄、性别和EQ-5D基线评分进行匹配。将在CAP住院后0、1、6和12个月收集医疗保健和非医疗保健资源使用、生活质量（使用EQ-5D和SF-36问卷）以及选定的健康结局数据。CHO-CAP研究已获得荷兰人类受试者研究中央委员会的批准。
本研究预计有600例CAP发作，就资源使用和生活质量数据而言，将成为对因CAP住院的老年人进行前瞻性研究的最大队列之一。本研究的优势还包括收集患者的自付费用以及患者及其照料者的生产力损失，以及长达出院后一年 的随访期。因此，预计本研究将增加关于老年人肺炎短期和长期结局的更深入知识。
ClinicalTrials.gov，NCT00812084。
