메뉴 건너뛰기




Volumn 15, Issue 1, 2014, Pages

Measuring respiratory symptoms of COPD: Performance of the EXACT- Respiratory Symptoms Tool (E-RS) in three clinical trials

Author keywords

Chest symptoms; Clinical trials; COPD; Cough; Dyspnoea; Respiratory symptoms; Sputum

Indexed keywords

ALVELESTAT; BUDESONIDE PLUS FORMOTEROL; LEVOFLOXACIN; TIOTROPIUM BROMIDE;

EID: 84978036879     PISSN: 14659921     EISSN: 1465993X     Source Type: Journal    
DOI: 10.1186/s12931-014-0124-z     Document Type: Article
Times cited : (89)

References (41)
  • 1
    • 36048998676 scopus 로고    scopus 로고
    • Chronic obstructive pulmonary disease: symptoms and signs
    • Calverley PM, Georgopopoulos D: Chronic obstructive pulmonary disease: symptoms and signs. Eur Respir Mon. 2006, 38: 7-23.
    • (2006) Eur Respir Mon , vol.38 , pp. 7-23
    • Calverley, P.M.1    Georgopopoulos, D.2
  • 2
    • 1842552109 scopus 로고    scopus 로고
    • Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper
    • Celli BR, MacNee W: Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper. Eur Respir J. 2004, 23: 932-946. 10.1183/09031936.04.00014304.
    • (2004) Eur Respir J , vol.23 , pp. 932-946
    • Celli, B.R.1    MacNee, W.2
  • 3
    • 0031410818 scopus 로고    scopus 로고
    • Bronchodilator therapy for chronic obstructive pulmonary disease
    • Chong-Chen LU: Bronchodilator therapy for chronic obstructive pulmonary disease. Respirology. 1997, 2: 317-322. 10.1111/j.1440-1843.1997.tb00096.x.
    • (1997) Respirology , vol.2 , pp. 317-322
    • Chong-Chen, L.U.1
  • 4
    • 84878506292 scopus 로고    scopus 로고
    • Draft guidance for industry on chronic obstructive pulmonary disease: developing drugs for treatment; availability
    • Draft guidance for industry on chronic obstructive pulmonary disease: developing drugs for treatment; availability. Fed Regist. 2007, 72: 63618-
    • (2007) Fed Regist. , vol.72 , pp. 63618
  • 5
    • 69549084350 scopus 로고    scopus 로고
    • Global Initiative for Chronic Obstructive Lung Disease: Global Strategy for the Diagnosis, Management, and Prevention of COPD
    • Global Initiative for Chronic Obstructive Lung Disease: Global Strategy for the Diagnosis, Management, and Prevention of COPD. [], [ http://www.goldcopd.org/uploads/users/files/GOLD_Report_2014_Jan23.pdf ]
  • 6
    • 84978175388 scopus 로고    scopus 로고
    • Overall management of stable chronic obstructive pulmonary disease
    • Siafakas NM, Celli B: Overall management of stable chronic obstructive pulmonary disease. Eur Respir Mon. 2006, 38: 258-265.
    • (2006) Eur Respir Mon , vol.38 , pp. 258-265
    • Siafakas, N.M.1    Celli, B.2
  • 8
    • 33748902214 scopus 로고    scopus 로고
    • The connection between chronic obstructive pulmonary disease symptoms and hyperinflation and its impact on exercise and function
    • Cooper CB: The connection between chronic obstructive pulmonary disease symptoms and hyperinflation and its impact on exercise and function. Am J Med. 2006, 119 (Suppl 1): 21-31. 10.1016/j.amjmed.2006.08.004.
    • (2006) Am J Med , vol.119 , pp. 21-31
    • Cooper, C.B.1
  • 9
    • 33748748560 scopus 로고    scopus 로고
    • Impact of chronic obstructive pulmonary disease on quality of life: the role of dyspnea
    • Ries AL: Impact of chronic obstructive pulmonary disease on quality of life: the role of dyspnea. Am J Med. 2006, 119 (Suppl 1): 12-20. 10.1016/j.amjmed.2006.08.003.
    • (2006) Am J Med , vol.119 , pp. 12-20
    • Ries, A.L.1
  • 10
    • 80052161591 scopus 로고    scopus 로고
    • Factors that influence disease-specific quality of life or health status in patients with COPD: a review and meta-analysis of Pearson correlations
    • Tsiligianni I, Kocks J, Tzanakis N, Siafakas N, van der Molen T: Factors that influence disease-specific quality of life or health status in patients with COPD: a review and meta-analysis of Pearson correlations. Prim Care Respir J. 2011, 20: 257-268. 10.4104/pcrj.2011.00029.
    • (2011) Prim Care Respir J , vol.20 , pp. 257-268
    • Tsiligianni, I.1    Kocks, J.2    Tzanakis, N.3    Siafakas, N.4    van der Molen, T.5
  • 11
    • 78650093203 scopus 로고    scopus 로고
    • Development of the EXAcerbations of Chronic Obstructive Pulmonary Disease Tool (EXACT): a patient-reported outcome (PRO) measure
    • Leidy NK, Wilcox TK, Jones PW, Murray L, Winnette R, Howard K, Petrillo J, Powers J, Sethi S: Development of the EXAcerbations of Chronic Obstructive Pulmonary Disease Tool (EXACT): a patient-reported outcome (PRO) measure. Value Health. 2010, 13: 965-975. 10.1111/j.1524-4733.2010.00772.x.
    • (2010) Value Health , vol.13 , pp. 965-975
    • Leidy, N.K.1    Wilcox, T.K.2    Jones, P.W.3    Murray, L.4    Winnette, R.5    Howard, K.6    Petrillo, J.7    Powers, J.8    Sethi, S.9
  • 12
    • 79958757060 scopus 로고    scopus 로고
    • Characterizing and quantifying the symptomatic features of COPD exacerbations
    • Jones PW, Chen WH, Wilcox TK, Sethi S, Leidy NK: Characterizing and quantifying the symptomatic features of COPD exacerbations. Chest. 2011, 139: 1388-1394. 10.1378/chest.10-1240.
    • (2011) Chest , vol.139 , pp. 1388-1394
    • Jones, P.W.1    Chen, W.H.2    Wilcox, T.K.3    Sethi, S.4    Leidy, N.K.5
  • 13
    • 79551538617 scopus 로고    scopus 로고
    • Standardizing measurement of chronic obstructive pulmonary disease exacerbations. Reliability and validity of a patient-reported diary
    • Leidy NK, Wilcox TK, Jones PW, Roberts L, Powers JH, Sethi S: Standardizing measurement of chronic obstructive pulmonary disease exacerbations. Reliability and validity of a patient-reported diary. Am J Respir Crit Care Med. 2011, 183: 323-329. 10.1164/rccm.201005-0762OC.
    • (2011) Am J Respir Crit Care Med , vol.183 , pp. 323-329
    • Leidy, N.K.1    Wilcox, T.K.2    Jones, P.W.3    Roberts, L.4    Powers, J.H.5    Sethi, S.6
  • 14
    • 84898713016 scopus 로고    scopus 로고
    • Performance of the EXAcerbations of chronic pulmonary disease tool patient-reported outcome measure in three clinical trials of chronic obstructive pulmonary disease
    • Leidy NK, Murray LT, Jones P, Sethi S: Performance of the EXAcerbations of chronic pulmonary disease tool patient-reported outcome measure in three clinical trials of chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014, 11: 316-325. 10.1513/AnnalsATS.201309-305OC.
    • (2014) Ann Am Thorac Soc , vol.11 , pp. 316-325
    • Leidy, N.K.1    Murray, L.T.2    Jones, P.3    Sethi, S.4
  • 15
    • 84878517366 scopus 로고    scopus 로고
    • Patient-reported outcome (PRO) measures for clinical trials of COPD: the EXACT and E-RS
    • Leidy NK, Murray LT: Patient-reported outcome (PRO) measures for clinical trials of COPD: the EXACT and E-RS. COPD. 2013, 10: 393-398. 10.3109/15412555.2013.795423.
    • (2013) COPD , vol.10 , pp. 393-398
    • Leidy, N.K.1    Murray, L.T.2
  • 16
    • 84978165948 scopus 로고    scopus 로고
    • Draft guidance for industry on qualification of exacerbations of chronic pulmonary disease tool for measurement of symptoms of acute bacterial exacerbations of chronic bronchitis in patients with chronic obstructive pulmonary disease
    • Draft guidance for industry on qualification of exacerbations of chronic pulmonary disease tool for measurement of symptoms of acute bacterial exacerbations of chronic bronchitis in patients with chronic obstructive pulmonary disease. Fed Regist. 2014, 79: 1873-1874.
    • (2014) Fed Regist. , vol.79 , pp. 1873-1874
  • 17
    • 77953575139 scopus 로고    scopus 로고
    • Guidance for industry on patient-reported outcome measures: use in medical product development to support labeling claims
    • Guidance for industry on patient-reported outcome measures: use in medical product development to support labeling claims. Fed Regist. 2009, 74: 65132-65133.
    • (2009) Fed Regist. , vol.74 , pp. 65132-65133
  • 18
    • 80055007179 scopus 로고    scopus 로고
    • Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1-eliciting concepts for a new PRO instrument
    • Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, Ring L: Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1-eliciting concepts for a new PRO instrument. Value Health. 2011, 14: 967-977. 10.1016/j.jval.2011.06.014.
    • (2011) Value Health , vol.14 , pp. 967-977
    • Patrick, D.L.1    Burke, L.B.2    Gwaltney, C.J.3    Leidy, N.K.4    Martin, M.L.5    Molsen, E.6    Ring, L.7
  • 19
    • 82955193739 scopus 로고    scopus 로고
    • Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2-assessing respondent understanding
    • Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, Ring L: Content validity-establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2-assessing respondent understanding. Value Health. 2011, 14: 978-988. 10.1016/j.jval.2011.06.013.
    • (2011) Value Health , vol.14 , pp. 978-988
    • Patrick, D.L.1    Burke, L.B.2    Gwaltney, C.J.3    Leidy, N.K.4    Martin, M.L.5    Molsen, E.6    Ring, L.7
  • 21
    • 84859373133 scopus 로고    scopus 로고
    • A randomised, placebo-controlled, dose-finding study of AZD9668, an oral inhibitor of neutrophil elastase, in patients with chronic obstructive pulmonary disease treated with tiotropium
    • Vogelmeier C, Aquino TO, O'Brien CD, Perrett J, Gunawardena KA: A randomised, placebo-controlled, dose-finding study of AZD9668, an oral inhibitor of neutrophil elastase, in patients with chronic obstructive pulmonary disease treated with tiotropium. COPD. 2012, 9: 111-120. 10.3109/15412555.2011.641803.
    • (2012) COPD , vol.9 , pp. 111-120
    • Vogelmeier, C.1    Aquino, T.O.2    O'Brien, C.D.3    Perrett, J.4    Gunawardena, K.A.5
  • 22
    • 84857911015 scopus 로고    scopus 로고
    • AZD9668, a neutrophil elastase inhibitor, plus ongoing budesonide/formoterol in patients with COPD
    • Kuna P, Jenkins M, O'Brien CD, Fahy WA: AZD9668, a neutrophil elastase inhibitor, plus ongoing budesonide/formoterol in patients with COPD. Respir Med. 2012, 106: 531-539. 10.1016/j.rmed.2011.10.020.
    • (2012) Respir Med , vol.106 , pp. 531-539
    • Kuna, P.1    Jenkins, M.2    O'Brien, C.D.3    Fahy, W.A.4
  • 23
    • 0037251165 scopus 로고    scopus 로고
    • Evaluating symptoms in chronic obstructive pulmonary disease: validation of the Breathlessness, Cough and Sputum Scale
    • Leidy NK, Schmier JK, Jones MK, Lloyd J, Rocchiccioli K: Evaluating symptoms in chronic obstructive pulmonary disease: validation of the Breathlessness, Cough and Sputum Scale. Respir Med. 2003, 97 (Suppl A): S59-S70. 10.1016/S0954-6111(03)80016-1.
    • (2003) Respir Med , vol.97 , pp. S59-S70
    • Leidy, N.K.1    Schmier, J.K.2    Jones, M.K.3    Lloyd, J.4    Rocchiccioli, K.5
  • 24
    • 0347624393 scopus 로고    scopus 로고
    • The breathlessness, cough, and sputum scale: the development of empirically based guidelines for interpretation
    • Leidy NK, Rennard SI, Schmier J, Jones MK, Goldman M: The breathlessness, cough, and sputum scale: the development of empirically based guidelines for interpretation. Chest. 2003, 124: 2182-2191. 10.1378/chest.124.6.2182.
    • (2003) Chest , vol.124 , pp. 2182-2191
    • Leidy, N.K.1    Rennard, S.I.2    Schmier, J.3    Jones, M.K.4    Goldman, M.5
  • 25
    • 0026871146 scopus 로고
    • A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire
    • Jones PW, Quirk FH, Baveystock CM, Littlejohns P: A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992, 145: 1321-1327. 10.1164/ajrccm/145.6.1321.
    • (1992) Am Rev Respir Dis , vol.145 , pp. 1321-1327
    • Jones, P.W.1    Quirk, F.H.2    Baveystock, C.M.3    Littlejohns, P.4
  • 26
    • 70449299442 scopus 로고
    • The significance of respiratory symptoms and the diagnosis of chronic bronchitis in a working population
    • Fletcher CM, Elmes PC, Fairbairn AS, Wood CH: The significance of respiratory symptoms and the diagnosis of chronic bronchitis in a working population. Br Med J. 1959, 2: 257-266. 10.1136/bmj.2.5147.257.
    • (1959) Br Med J , vol.2 , pp. 257-266
    • Fletcher, C.M.1    Elmes, P.C.2    Fairbairn, A.S.3    Wood, C.H.4
  • 27
    • 0032809582 scopus 로고    scopus 로고
    • Clinical validation of the Functional Performance Inventory in patients with COPD
    • Leidy NK, Knebel A: Clinical validation of the Functional Performance Inventory in patients with COPD. Respir Care. 1999, 44: 932-939.
    • (1999) Respir Care , vol.44 , pp. 932-939
    • Leidy, N.K.1    Knebel, A.2
  • 28
    • 84872236792 scopus 로고    scopus 로고
    • Assessing patient report of function: content validity of the Functional Performance Inventory-Short Form (FPI-SF) in patients with chronic obstructive pulmonary disease (COPD)
    • Leidy NK, Hamilton A, Becker K: Assessing patient report of function: content validity of the Functional Performance Inventory-Short Form (FPI-SF) in patients with chronic obstructive pulmonary disease (COPD). Int J Chron Obstruct Pulmon Dis. 2012, 7: 543-554. 10.2147/COPD.S32032.
    • (2012) Int J Chron Obstruct Pulmon Dis , vol.7 , pp. 543-554
    • Leidy, N.K.1    Hamilton, A.2    Becker, K.3
  • 29
    • 20144362569 scopus 로고    scopus 로고
    • St. George's Respiratory Questionnaire: MCID
    • Jones PW: St. George's Respiratory Questionnaire: MCID. COPD. 2005, 2: 75-79. 10.1081/COPD-200050513.
    • (2005) COPD , vol.2 , pp. 75-79
    • Jones, P.W.1
  • 31
    • 51249098976 scopus 로고    scopus 로고
    • Minimum clinically important improvement for the incremental shuttle walking test
    • Singh SJ, Jones PW, Evans R, Morgan MD: Minimum clinically important improvement for the incremental shuttle walking test. Thorax. 2008, 63: 775-777. 10.1136/thx.2007.081208.
    • (2008) Thorax , vol.63 , pp. 775-777
    • Singh, S.J.1    Jones, P.W.2    Evans, R.3    Morgan, M.D.4
  • 32
    • 0002366602 scopus 로고    scopus 로고
    • Assessing reliability and validity of measurement in clinical trials. Quality of Life Assessment in Clinical Trials: Methods and Practice
    • Edited by: Staquet MJ, Hays RD. 1998, Oxford University Press, New York
    • Hays RD, Anderson RT, Revicki DA: Assessing reliability and validity of measurement in clinical trials. Quality of Life Assessment in Clinical Trials: Methods and Practice. Edited by: Staquet MJ, Hays RD. 1998, Oxford University Press, New York, 169-182.
    • Hays, R.D.1    Anderson, R.T.2    Revicki, D.A.3
  • 33
    • 0003528130 scopus 로고
    • Psychometric Theory
    • McGraw-Hill, New York
    • Nunnally JC, Bernstein IH: Psychometric Theory. 1994, McGraw-Hill, New York
    • (1994)
    • Nunnally, J.C.1    Bernstein, I.H.2
  • 34
    • 0025876451 scopus 로고
    • Statistics in respiratory medicine. 2. Repeatability and method comparison
    • Chinn S: Statistics in respiratory medicine. 2. Repeatability and method comparison. Thorax. 1991, 46: 454-456. 10.1136/thx.46.6.454.
    • (1991) Thorax , vol.46 , pp. 454-456
    • Chinn, S.1
  • 35
    • 21344451536 scopus 로고    scopus 로고
    • Assessing Quality of Life in Clinical Trials: Methods and Practice
    • Oxford University Press, New York
    • Assessing Quality of Life in Clinical Trials: Methods and Practice. 2005, Oxford University Press, New York
    • (2005)
  • 36
    • 0032743024 scopus 로고    scopus 로고
    • An empirical comparison of the St George's Respiratory Questionnaire (SGRQ) and the Chronic Respiratory Disease Questionnaire (CRQ) in a clinical trial setting
    • Rutten-van Molken M, Roos B, Van Noord JA: An empirical comparison of the St George's Respiratory Questionnaire (SGRQ) and the Chronic Respiratory Disease Questionnaire (CRQ) in a clinical trial setting. Thorax. 1999, 54: 995-1003. 10.1136/thx.54.11.995.
    • (1999) Thorax , vol.54 , pp. 995-1003
    • Rutten-van Molken, M.1    Roos, B.2    Van Noord, J.A.3
  • 39
    • 79953660284 scopus 로고    scopus 로고
    • The promise of electronic data capture in respiratory medicine
    • Johnston N, O'Byrne P, Kolb M: The promise of electronic data capture in respiratory medicine. Eur Respir J. 2011, 37: 228-230. 10.1183/09031936.00141310.
    • (2011) Eur Respir J , vol.37 , pp. 228-230
    • Johnston, N.1    O'Byrne, P.2    Kolb, M.3
  • 41
    • 84880746971 scopus 로고    scopus 로고
    • Efficacy and safety of aclidinium bromide compared with placebo and tiotropium in patients with moderate-to-severe chronic obstructive pulmonary disease: results from a 6-week, randomized, controlled Phase IIIb study
    • Beier J, Kirsten AM, Mroz R, Segarra R, Chuecos F, Caracta C, Gil EG: Efficacy and safety of aclidinium bromide compared with placebo and tiotropium in patients with moderate-to-severe chronic obstructive pulmonary disease: results from a 6-week, randomized, controlled Phase IIIb study. COPD. 2013, 10: 511-522. 10.3109/15412555.2013.814626.
    • (2013) COPD , vol.10 , pp. 511-522
    • Beier, J.1    Kirsten, A.M.2    Mroz, R.3    Segarra, R.4    Chuecos, F.5    Caracta, C.6    Gil, E.G.7


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.