湿疹婴幼儿及青少年生活质量测量工具的测量属性：系统评价方案
Measurement properties of quality of life measurement instruments for infants, children and adolescents with eczema: protocol for a systematic review.
作者信息
Heinl Daniel, Prinsen Cecilia A C, Drucker Aaron M, Ofenloch Robert, Humphreys Rosemary, Sach Tracey, Flohr Carsten, Apfelbacher Christian
机构信息
Medical Sociology, Department of Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany.
Department of Epidemiology and Biostatistics, EMGO+ Institute for Health and Care Research, VU University Medical Center, Amsterdam, The Netherlands.
出版信息
Syst Rev. 2016 Feb 9;5:25. doi: 10.1186/s13643-016-0202-z.
BACKGROUND
Eczema is a common chronic or chronically relapsing, inflammatory skin disease that exerts a substantial negative impact on quality of life (QoL). The Harmonising Outcome Measures for Eczema (HOME) initiative has used a consensus-based process which identified QoL as one of the four core outcome domains to be assessed in all eczema clinical trials. A number of measurement instruments exist to measure QoL in infants, children, and adolescents with eczema, and there is a great variability in both content and quality of the instruments used. Therefore, the objective of the proposed research is to comprehensively and systematically assess the measurement properties of the existing measurement instruments that were developed and/or validated for the measurement of patient-reported QoL in infants, children, and adolescents with eczema.
METHODS/DESIGN: This study is a systematic review of the measurement properties of patient-reported measures of QoL developed and/or validated for infants, children, and adolescents with eczema. A systematic literature search will be carried out in MEDLINE via PubMed and EMBASE using a selection of relevant search terms. Eligible studies will be primary empirical studies evaluating, describing, or comparing measurement properties of QoL instruments for infants, children, and adolescents with eczema. Two reviewers will independently perform eligibility assessment and data abstraction. Evidence tables will be used to record study characteristics, instrument characteristics, measurement properties, and interpretability. The adequacy of the measurement properties will be assessed using predefined criteria. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist will be used to evaluate the methodological quality of included studies. A best evidence synthesis will be undertaken if more than one study has examined a particular measurement property.
DISCUSSION
The proposed systematic review will yield a comprehensive assessment of measurement properties of existing QoL instruments in infants, children, and adolescents with eczema. The results will serve as a basis to recommend a QoL measurement instrument for infants, one for children, and one for adolescents for use in future clinical trials.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42015023483.
背景
湿疹是一种常见的慢性或慢性复发性炎症性皮肤病，对生活质量（QoL）产生重大负面影响。湿疹协调结局测量（HOME）倡议采用了基于共识的流程，将生活质量确定为所有湿疹临床试验中要评估的四个核心结局领域之一。有多种测量工具可用于测量患有湿疹的婴儿、儿童和青少年的生活质量，且所使用工具的内容和质量存在很大差异。因此，本研究的目的是全面、系统地评估现有测量工具的测量特性，这些工具是为测量患有湿疹的婴儿、儿童和青少年患者报告的生活质量而开发和/或验证的。
方法/设计：本研究是对为患有湿疹的婴儿、儿童和青少年开发和/或验证的患者报告的生活质量测量工具的测量特性进行系统评价。将通过PubMed和EMBASE在MEDLINE中使用一系列相关检索词进行系统文献检索。符合条件的研究将是评估、描述或比较患有湿疹的婴儿、儿童和青少年生活质量工具测量特性的原发性实证研究。两名评审员将独立进行资格评估和数据提取。证据表将用于记录研究特征、工具特征、测量特性和可解释性。将使用预定义标准评估测量特性的充分性。将使用基于共识的健康测量工具选择标准（COSMIN）清单来评估纳入研究的方法学质量。如果有多项研究考察了特定的测量特性，将进行最佳证据综合分析。
讨论
拟议的系统评价将对现有用于患有湿疹的婴儿、儿童和青少年的生活质量工具的测量特性进行全面评估。研究结果将作为推荐一种用于婴儿、一种用于儿童、一种用于青少年的生活质量测量工具供未来临床试验使用的依据。
系统评价注册
PROSPERO CRD42015023483
Zotero 插件