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      Exacerbations of Chronic Obstructive Pulmonary Disease Tool to assess the efficacy of acute treatment

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          Abstract

          Background and objective

          The Exacerbations of Chronic Obstructive Pulmonary Disease Tool-Patient-Reported Outcomes (EXACT-PRO) has been suggested as a reliable and valid measure for early assessment of COPD exacerbations and perceived recovery. However, there has been no evidence for EXACT-PRO efficacy in assessing recovery from treatment in a randomized controlled trial. The study evaluated the reliability, validity, and responsiveness of EXACT-PRO for the evaluation of the efficacy of acute treatment in patients with COPD exacerbation.

          Methods

          In a Phase III randomized controlled study for assessing the efficacy of antibiotic treatment on COPD exacerbation, EXACT-PRO was evaluated in the responders and non-responders.

          Results

          A total of 295 patients were analyzed (259 responders and 37 non-responders). Cronbach’s α was 0.96 for EXACT total, 0.96 for the breathlessness domain, 0.89 for the cough and sputum domain, and 0.93 for the chest symptoms domain. The EXACT score correlated with the COPD assessment test (CAT) score ( r=0.8, P<0.01). A stronger decrease in the EXACT score was found in the responder group than in the non-responder group from the fifth day after treatment. The difference in the EXACT score from exacerbation onset to recovery was -6.3 in responders and -1.9 in non-responders ( P=0.01).

          Conclusion

          EXACT-PRO is a comprehensive and sensitive method for assessing symptomatic resolution of COPD exacerbations during treatment.

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          Most cited references 13

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          Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) Workshop summary.

           ,  Suzanne Hurd,  P Calverley (2001)
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            Underreporting exacerbation of chronic obstructive pulmonary disease in a longitudinal cohort.

            Unreported exacerbations and failure to seek medical attention may have consequences on the health of patients with chronic obstructive pulmonary disease. This study aims to determine the incidence of reported and unreported exacerbations, to identify predictors of reporting, and to compare the impact of reported and unreported exacerbations on health status. The study is based on a multicenter Canadian cohort of patients with chronic obstructive pulmonary disease. Patients completed a daily diary from which exacerbations were defined as a worsening of at least one key symptom (dyspnea, sputum amount, sputum color) recorded on at least 2 consecutive days. Patients were asked to contact the study center if there was a sustained worsening of symptom. Reported exacerbations were events that led to contacting study center or health care visit. The study enrolled 421 patients. The overall incidence of diary exacerbations was 2.7 per person per year, but only 0.8 per person per year was reported. Predictors of reporting included age (HR [hazard ratio], 0.90; 95% confidence interval [CI], 0.81-0.98 per 5-yr increase), FEV(1)% predicted (HR, 0.84; 95% CI, 0.70-0.99 per 10% increase), number of symptoms at onset (HR, 1.59; 95% CI, 1.37-1.84 per additional symptom), and time of the week (HR, 0.35; 95% CI, 0.22-0.56 weekend vs. weekday). There was a clinically important decline in health status for 52% of patients with reported exacerbation and 43% with unreported exacerbations. This study has shown that less than one-third of the exacerbations were reported. The number of symptoms at onset was the most important predictor of reporting an exacerbation, and both reported and unreported exacerbations had an impact on health status.
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              Development of the EXAcerbations of Chronic Obstructive Pulmonary Disease Tool (EXACT): a patient-reported outcome (PRO) measure.

              This article describes the qualitative methods used to develop the EXAcerbation of Chronic Pulmonary Disease Tool (EXACT), a new patient-reported outcome (PRO) instrument for evaluating frequency, severity, and duration of exacerbations of chronic obstructive pulmonary disease (COPD). Focus groups and interviews were conducted in the United States with COPD patients treated for exacerbations during the past 6 months. Participants were asked to describe exacerbation attributes, care-seeking cues, and indications of progression and recovery. An iterative process was used to identify themes in the data to inform instrument content and structure. Cognitive debriefing interviews were performed to evaluate and revise the draft item pool. Experts in COPD, instrument development, and clinical research participated in the process. Eighty-three subjects participated in elicitation focus groups or interviews (n=48); elicitation interviews with cognitive debriefing (n=23), or cognitive interviews alone (n=12). Mean age of the sample was 65 years (SD=10); 45% were male; mean FEV-1% predicted was 44% (SD=16). Participants characterized exacerbations as a persistent increase in the severity of respiratory symptoms and other systemic manifestations accompanied by a dramatic reduction in activity. Specific attributes included shortness of breath, chest congestion, cough, sputum, chest discomfort, feeling weak or tired, sleep disturbances, and concern or worry. The diary card of 23 candidate items was debriefed in booklet and electronic format. Qualitative data from patients and input from experts formed the basis of the EXACT's structure and item pool, ready for empirically based item reduction and reliability and validity testing. © 2010, International Society for Pharmacoeconomics and Outcomes Research (ISPOR).
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                Author and article information

                Journal
                Int J Chron Obstruct Pulmon Dis
                Int J Chron Obstruct Pulmon Dis
                International Journal of COPD
                International Journal of Chronic Obstructive Pulmonary Disease
                Dove Medical Press
                1176-9106
                1178-2005
                2019
                25 February 2019
                : 14
                : 471-478
                Affiliations
                [1 ]Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Kyung Hee University Medical Center, Seoul, Republic of Korea
                [2 ]Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Hallym University Sacred Heart Hospital-Kangdong, Seoul, Republic of Korea
                [3 ]Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Republic of Korea
                [4 ]Division of Pulmonology and Allergy, Department of Internal Medicine, Yeungnam University Hospital, Daegu, Republic of Korea
                [5 ]Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Republic of Korea
                [6 ]Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, Republic of Korea
                [7 ]Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Yonsei University Health System, Seoul, Republic of Korea
                [8 ]Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea
                [9 ]Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Chosun University Hospital, Gwangju, Republic of Korea
                [10 ]Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, The Catholic University, Incheon St Mary’s Hospital, Incheon, Republic of Korea
                [11 ]Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine, Chungnam National University College of Medicine, Daejeon, Republic of Korea, sungsoojung09@ 123456cnu.ac.kr
                Author notes
                Correspondence: Sung Soo Jung, Division of Pulmonary and Critical Care Medicine, Chungnam National University School of Medicine, 282 Munhwa-ro, Jung-gu Daejeon 35015, Republic of Korea, Tel +82 42 280 8103, Fax +82 42 257 5753, Email sungsoojung09@ 123456cnu.ac.kr
                Article
                copd-14-471
                10.2147/COPD.S189300
                6394236
                © 2019 Choi et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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