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      Fatigue in patients with chronic obstructive pulmonary disease: protocol of the Dutch multicentre, longitudinal, observational FAntasTIGUE study

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          Abstract

          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 FAntasTIGUE 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.

          Related collections

          Most cited references 37

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          Development and testing of a short form of the patient activation measure.

          The Patient Activation Measure (PAM) is a 22-item measure that assesses patient knowledge, skill, and confidence for self-management. The measure was developed using Rasch analyses and is an interval level, unidimensional, Guttman-like measure. The current analysis is aimed at reducing the number of items in the measure while maintaining adequate precision. We relied on an iterative use of Rasch analysis to identify items that could be eliminated without loss of significant precision and reliability. With each item deletion, the item scale locations were recalibrated and the person reliability evaluated to check if and how much of a decline in precision of measurement resulted from the deletion of the item. The data used in the analysis were the same data used in the development of the original 22-item measure. These data were collected in 2003 via a telephone survey of 1,515 randomly selected adults. Principal Findings. The analysis yielded a 13-item measure that has psychometric properties similar to the original 22-item version. The scores for the 13-item measure range in value from 38.6 to 53.0 (on a theoretical 0-100 point scale). The range of values is essentially unchanged from the original 22-item version. Subgroup analysis suggests that there is a slight loss of precision with some subgroups. The results of the analysis indicate that the shortened 13-item version is both reliable and valid.
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            Dimensional assessment of chronic fatigue syndrome.

            The absence of laboratory tests and clear criteria to identify homogeneous (sub)groups in patients presenting with unexplained fatigue, and to assess clinical status and disability in these patients, calls for further assessment methods. In the present study, a multi-dimensional approach to the assessment of chronic fatigue syndrome (CFS) is evaluated. Two-hundred and ninety-eight patients with CFS completed a set of postal questionnaires that assessed the behavioural, emotional, social, and cognitive aspects of CFS. By means of statistical analyses nine relatively independent dimensions of CFS were identified along which CFS-assessment and CFS-research can be directed. These dimensions were named: psychological well-being, functional impairment in daily life, sleep disturbances, avoidance of physical activity, neuropsychological impairment, causal attributions related to the complaints, social functioning, self-efficacy expectations, and subjective experience of the personal situation. A description of the study sample on these dimensions is presented.
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              • Article: not found

              Validity of physical activity monitors during daily life in patients with COPD.

              Symptoms during physical activity and physical inactivity are hallmarks of chronic obstructive pulmonary disease (COPD). Our aim was to evaluate the validity and usability of six activity monitors in patients with COPD against the doubly labelled water (DLW) indirect calorimetry method. 80 COPD patients (mean ± sd age 68 ± 6 years and forced expiratory volume in 1 s 57 ± 19% predicted) recruited in four centres each wore simultaneously three or four out of six commercially available monitors validated in chronic conditions for 14 consecutive days. A priori validity criteria were defined. These included the ability to explain total energy expenditure (TEE) variance through multiple regression analysis, using TEE as the dependent variable with total body water (TBW) plus several physical activity monitor outputs as independent variables; and correlation with activity energy expenditure (AEE) measured by DLW. The Actigraph GT3X (Actigraph LLC, Pensacola, FL, USA), and DynaPort MoveMonitor (McRoberts BV, The Hague, the Netherlands) best explained the majority of the TEE variance not explained by TBW (53% and 70%, respectively) and showed the most significant correlations with AEE (r=0.71, p<0.001 and r=0.70, p<0.0001, respectively). The results of this study should guide users in choosing valid activity monitors for research or for clinical use in patients with chronic diseases such as COPD.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2018
                10 April 2018
                : 8
                : 4
                Affiliations
                [1 ] departmentDepartment of Research and Education , Ciro, Centre of Expertise for Chronic Organ Failure , Horn, The Netherlands
                [2 ] departmentDepartment of Medical Psychology and Department of Pulmonary Diseases , Radboud University Nijmegen Medical Centre , Nijmegen, The Netherlands
                [3 ] departmentCentre of Expertise for Palliative Care , Maastricht University Medical Centre (MUMC+) , Maastricht, The Netherlands
                [4 ] departmentDepartment of Medical Psychology , Academic Medical Centre University of Amsterdam, Amsterdam Public Health Research Institute , Amsterdam, The Netherlands
                [5 ] departmentREVAL - Rehabilitation Research Center, BIOMED - Biomedical Research Institute , Faculty of Medicine and Life Sciences, Hasselt University , Diepenbeek, Belgium
                [6 ] departmentPatient Advisory Board , Ciro, Centre of Expertise for Chronic Organ Failure , Horn, The Netherlands
                [7 ] departmentPatient Advisory Board , Radboud University Nijmegen Medical Centre , Nijmegen, The Netherlands
                [8 ] departmentDepartment of Family Medicine , CAPHRI Care and Public Health Research Institute, Maastricht University , Maastricht, The Netherlands
                [9 ] departmentDepartment of Respiratory Medicine , Maastricht University Medical Centre (MUMC+) , Maastricht, The Netherlands
                [10 ] departmentNUTRIM School of Nutrition and Translational Research in Metabolism , Maastricht University , Maastricht, The Netherlands
                Author notes
                [Correspondence to ] Yvonne M J Goërtz; yvonnegoertz@ 123456ciro-horn.nl
                Article
                bmjopen-2018-021745
                10.1136/bmjopen-2018-021745
                5898336
                29643168
                © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

                Product
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100004325, AstraZeneca;
                Funded by: FundRef http://dx.doi.org/10.13039/501100004344, Stichting Astma Bestrijding;
                Funded by: FundRef http://dx.doi.org/10.13039/100001003, Boehringer Ingelheim;
                Funded by: Lung Foundation Netherlands;
                Categories
                Respiratory Medicine
                Protocol
                1506
                1731
                Custom metadata
                unlocked

                Medicine

                fatigue, chronic obstructive pulmonary disease, underlying factors

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