Department of Primary and Community Care, Radboud University Nijmegen Medical Centre, The Netherlands.
BMC Pediatr. 2012 Aug 30;12:137. doi: 10.1186/1471-2431-12-137.
Asthma is one of the major chronic health problems in children in the Netherlands. The Pelican is a paediatric asthma-related quality of life instrument for children with asthma from 6-11 years old, which is suitable for clinical practice in primary and specialized care. Based on this instrument, we developed a self-management treatment to improve asthma-related quality of life. The Pelican intervention will be investigated in different health care settings. Results of intervention studies are often extrapolated to other health care settings than originally investigated. Because of differences in organization, disease severity, patient characteristics and care provision between health care settings, extrapolating research results could lead to unnecessary health costs without the desired health care achievements. Therefore, interventions have to be investigated in different health care settings when possible. This study is an example of an intervention study in different health care settings. In this article, we will present the study protocol of the Pelican study in primary and specialized care.
METHOD/DESIGN: This study consists of two randomized controlled trials to assess the effectiveness of the Pelican intervention in primary and specialized care. The trial in primary care is a multilevel design with 170 children with asthma in 16 general practices. All children in one general practices are allocated to the same treatment group. The trial in specialized care is a multicentre trial with 100 children with asthma. Children in one outpatient clinic are randomly allocated to the intervention or usual care group. In both trials, children will visit the care provider four times during a follow-up of nine months. This study is registered and ethically approved.
This article describes the study protocol of the Pelican study in different health care settings. If the Pelican intervention proves to be effective and efficient, implementation in primary and specialized care for paediatric asthma in the Netherlands will be recommended.
This study is registered by clinicaltrial.gov (NCT01109745).
哮喘是荷兰儿童的主要慢性健康问题之一。Pelican 是一种针对 6-11 岁哮喘儿童的与哮喘相关的生活质量工具，适用于初级保健和专科护理的临床实践。在此基础上，我们开发了一种自我管理治疗方法来改善哮喘相关的生活质量。Pelican 干预措施将在不同的医疗保健环境中进行研究。干预研究的结果通常会外推到与最初研究不同的其他医疗保健环境中。由于医疗保健环境之间在组织、疾病严重程度、患者特征和护理提供方面存在差异，因此外推研究结果可能会导致不必要的医疗费用，而无法实现预期的医疗保健效果。因此，在可能的情况下，干预措施应在不同的医疗保健环境中进行研究。本研究就是在不同医疗保健环境中进行干预研究的一个范例。在本文中，我们将介绍 Pelican 研究在初级保健和专科保健中的研究方案。
方法/设计：本研究包括两项在初级保健和专科保健中评估 Pelican 干预措施有效性的随机对照试验。初级保健中的试验采用多层次设计，纳入了 16 家普通诊所的 170 名哮喘儿童。同一普通诊所的所有儿童都被分配到相同的治疗组。专科保健中的试验为多中心试验，纳入了 100 名哮喘儿童。一家门诊诊所的儿童随机分配到干预组或常规护理组。在两项试验中，儿童将在 9 个月的随访期间四次就诊于医疗服务提供者。本研究已注册并经伦理批准。
本文描述了 Pelican 研究在不同医疗保健环境中的研究方案。如果 Pelican 干预措施被证明有效且高效，将建议在荷兰的初级保健和专科保健中实施针对儿科哮喘的 Pelican 干预措施。
本研究已在 clinicaltrial.gov（NCT01109745）注册。
