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

Abstract

Hye Sook Choi,1 Yong Bum Park,2,3 Kyeong Cheol Shin,4 Seung Hun Jang,3,5 Kang Hyeon Choe,6 Young Sam Kim,7 Sun Young Kyung,8 Sung Ho Yoon,9 Ju Sang Kim,10 Sung Soo Jung11 1Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Kyung Hee University Medical Center, Seoul, Republic of Korea; 2Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Hallym University Sacred Heart Hospital-Kangdong, Seoul, Republic of Korea; 3Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Republic of Korea; 4Division of Pulmonology and Allergy, Department of Internal Medicine, Yeungnam University Hospital, Daegu, Republic of Korea; 5Division of Pulmonary, Allergy, and Critical Care Medicine, Department of Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang, Republic of Korea; 6Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, Republic of Korea; 7Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Yonsei University Health System, Seoul, Republic of Korea; 8Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Republic of Korea; 9Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Chosun University Hospital, Gwangju, Republic of Korea; 10Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, The Catholic University, Incheon St Mary’s Hospital, Incheon, Republic of Korea; 11Department of Internal Medicine, Division of Pulmonary and Critical Care Medicine, Chungnam National University College of Medicine, Daejeon, Republic of Korea 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. Keywords: The Exacerbations of Chronic Obstructive Pulmonary Disease Tool, EXACT, Patient-Reported Outcomes, PRO, COPD, exacerbation  

Keywords

• The Exacerbations of Chronic Obstructive Pulmonary Disease Tool (EXACT)
• Patient-Reported Outcomes (PRO)
• Chronic obstructive pulmonary disease (COPD)
• Exacerbation