Abstract
BackgroundVaccine 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/DesignCAPiTA 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.DiscussionWith 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.Trial registrationClinicalTrials.gov, NCT00812084.
Highlights
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
The Community Acquired Pneumonia Immunization Trial in Adults (CAPiTA) is a randomized placebo-controlled double-blind trial to determine the efficacy of a 13Valent Pneumococcal Conjugate Vaccine (13vPnC) in the prevention of vaccine-serotype pneumococcal communityacquired pneumonia (CAP) and invasive pneumococcal disease (IPD) [1]
The sample size of the different cohorts in CHO-CAP is determined by the expected number of CAP episodes occurring in the CAPiTA trial (i.e. ~ 2,000 cases, see [1]), as well as by the response rate obtained for the baseline CHO-CAP questionnaire and the willingness of patients with CAP and controls to participate in the nested matched cohort study
Summary
The infrastructure of the CAPiTA trial offers a unique opportunity for prospective collection of health outcomes, QoL and cost data of patients hospitalized with CAP. Such data will facilitate the construction and validation of health economic models on cost-effectiveness and costutility of 13vPnC in the future, should this become necessary if vaccine efficacy and safety is demonstrated. GAdW made substantial contributions to conception and design of the study, has been involved in drafting the approved study protocol, and critically revised the current manuscript.
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