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首页> 外文期刊>BMC Pediatrics >PELICAN: A quality of life instrument for childhood asthma: Study Protocol of two Randomized Controlled Trials in Primary and Specialized Care in the Netherlands
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PELICAN: A quality of life instrument for childhood asthma: Study Protocol of two Randomized Controlled Trials in Primary and Specialized Care in the Netherlands

机译：PELICAN：儿童哮喘的生活质量工具：荷兰初级和专科护理中两项随机对照试验的研究方案

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Background 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. Discussion 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. Trial registration This study is registered by clinicaltrial.gov (NCT01109745)
机译：背景技术哮喘是荷兰儿童主要的慢性健康问题之一。鹈鹕是6至11岁哮喘儿童的与小儿哮喘相关的生活质量检查工具，适用于初级和专业护理中的临床实践。基于此工具，我们开发了一种自我管理的治疗方法来改善与哮喘相关的生活质量。鹈鹕干预措施将在不同的医疗机构中进行调查。干预研究的结果通常被推算到原始调查之外的其他医疗机构中。由于医疗机构之间在组织，疾病严重程度，患者特征和医疗服务方面存在差异，因此推断研究结果可能会导致不必要的医疗费用，而无法获得理想的医疗保健成果。因此，在可能的情况下，必须在不同的医疗机构中研究干预措施。这项研究是在不同医疗机构中进行干预研究的一个例子。在本文中，我们将介绍鹈鹕研究在初级和专业护理中的研究方案。方法/设计这项研究包括两项随机对照试验，以评估Pelican干预在初级和专业护理中的有效性。初级保健试验是一项多层次设计，涉及16种常规做法的170名哮喘儿童。所有采用一种常规做法的儿童都被分配到同一治疗组。专业护理试验是一项针对100名哮喘患儿的多中心试验。将一个门诊中的儿童随机分配到干预组或常规护理组。在这两项试验中，在为期9个月的随访中，儿童将四次拜访护理人员。该研究已注册并获得道德批准。讨论本文介绍了在不同医疗机构中进行Pelican研究的研究方案。如果Pelican干预措施被证明是有效和高效的，则将建议在荷兰对小儿哮喘进行初级和专业护理。试验注册本研究由Clinicaltrial.gov（NCT01109745）注册

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