慢性阻塞性肺疾病患者的疲劳：荷兰多中心纵向观察性研究方案
Fatigue in patients with chronic obstructive pulmonary disease: protocol of the Dutch multicentre, longitudinal, observational study.
作者信息
Goërtz Yvonne M J, Looijmans Milou, Prins Judith B, Janssen Daisy J A, Thong Melissa S Y, Peters Jeannette B, Burtin Chris, Meertens-Kerris Yvonne, Coors Arnold, Muris Jean W M, Sprangers Mirjam A G, Wouters Emiel F M, Vercoulen Jan H, Spruit Martijn A
机构信息
Department of Research and Education, Ciro, Centre of Expertise for Chronic Organ Failure, Horn, The Netherlands.
Department of Medical Psychology and Department of Pulmonary Diseases, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
出版信息
BMJ Open. 2018 Apr 10;8(4):e021745. doi: 10.1136/bmjopen-2018-021745.
INTRODUCTION
Fatigue is the second most common symptom in patients with chronic obstructive pulmonary disease (COPD). Despite its high prevalence, fatigue is often ignored in daily practice. For this reason, little is known about the underlying determinants of fatigue in patients with COPD. The primary objectives of this study are to chart the course of fatigue in patients with COPD, to identify the physical, systemic, psychological and behavioural factors that precipitate and perpetuate fatigue in patients with COPD, to evaluate the impact of exacerbation-related hospitalisations on fatigue and to better understand the association between fatigue and 2-year all-cause hospitalisation and mortality in patients with COPD. The secondary aim is to identify diurnal differences in fatigue by using ecological momentary assessment (EMA). This manuscript describes the protocol of the study and gives an overview of the possible strengths, weaknesses and clinical implications.
METHODS AND ANALYSIS
A 2-year longitudinal, observational study, enrolling 400 patients with clinically stable COPD has been designed. Fatigue, the primary outcome, will be measured by the subjective fatigue subscale of the Checklist Individual Strength (CIS-Fatigue). The secondary outcome is the day-to-day/diurnal fatigue, registered in a subsample (n=60) by EMA. CIS-Fatigue and EMA will be evaluated at baseline, and at 4, 8 and 12 months. The precipitating and perpetuating factors of fatigue (physical, psychological, behavioural and systemic) will be assessed at baseline and at 12 months. Additional assessments will be conducted following hospitalisation due to an exacerbation of COPD that occurs between baseline and 12 months. Finally, at 18 and 24 months the participants will be followed up on their fatigue, number of exacerbations, exacerbation-related hospitalisation and survival.
ETHICS AND DISSEMINATION
This protocol was approved by the Medical research Ethics Committees United, Nieuwegein, the Netherlands (NL60484.100.17).
TRIAL REGISTRATION NUMBER
NTR6933; Pre-results.
引言
疲劳是慢性阻塞性肺疾病（COPD）患者第二常见的症状。尽管其患病率很高，但在日常实践中疲劳常常被忽视。因此，关于COPD患者疲劳的潜在决定因素知之甚少。本研究的主要目的是描绘COPD患者疲劳的病程，确定引发并使COPD患者疲劳持续存在的身体、全身、心理和行为因素，评估与加重相关的住院对疲劳的影响，并更好地理解COPD患者疲劳与2年全因住院及死亡率之间的关联。次要目的是通过使用生态瞬时评估（EMA）来确定疲劳的昼夜差异。本手稿描述了该研究的方案，并概述了可能的优势、劣势及临床意义。
方法与分析
已设计一项为期2年的纵向观察性研究，纳入400例临床稳定的COPD患者。主要结局疲劳将通过个体力量检查表（CIS - 疲劳）的主观疲劳子量表进行测量。次要结局是通过EMA在一个子样本（n = 60）中记录的日常/昼夜疲劳。将在基线以及4、8和12个月时评估CIS - 疲劳和EMA。将在基线和12个月时评估疲劳的引发和持续因素（身体、心理、行为和全身因素）。在基线至12个月期间因COPD加重而住院后将进行额外评估。最后，在18和24个月时将对参与者的疲劳、加重次数、与加重相关的住院情况和生存情况进行随访。
伦理与传播
本方案已获得荷兰乌得勒支联合医学研究伦理委员会（NL60484.100.17）的批准。
试验注册号
NTR6933；预结果。
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