EXACT-PRO Initiative® Development and Validation Studies
- EXACT and E-RS Overview
- Leidy NK, Murray LT. Patient-reported outcome (PRO) measures for clinical trials of COPD: the EXACT and E-RS. COPD. Jun 2013;10(3):393-398. PubMed.
- EXACT Qualitative Content Validity
- Leidy NK, Wilcox TK, Jones PW, et al. Development of the EXAcerbations of Chronic Obstructive Pulmonary Disease Tool (EXACT): a patient-reported outcome (PRO) measure. Value Health. Dec 2010;13(8):965-975. PubMed.
- EXACT Quantitative Content Validity – Rasch Analyses
- Jones PW, Chen WH, Wilcox TK, Sethi S, Leidy NK. Characterizing and quantifying the symptomatic features of COPD exacerbations. Chest. Jun 2011;139(6):1388-1394. Chest Article.
- EXACT Reliability, Validity, Responsiveness
- Leidy NK, Wilcox TK, Jones PW, et al. Standardizing measurement of chronic obstructive pulmonary disease exacerbations. Reliability and validity of a patient-reported diary. Am J Respir Crit Care Med. Feb 2011;183(3):323-329. PubMed.
- Leidy NK, Murray LT, Jones PW, Sethi S. Performance of the EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) in three randomized controlled trials of COPD. Ann Am Thorac Soc. Mar 2014;11(3):316-325. PubMed.
- E-RS Development and Validation
- Leidy NK, Sexton CC, Jones P, et al. Measuring respiratory symptoms in clinical trials of COPD: reliability and validity of a daily diary. Thorax. May 2014;69(5):424-430. Thorax Article and Supplement.
- Leidy NK, Murray LT, Monz BU, et al. Measuring respiratory symptoms of COPD: performance of the EXACT-Respiratory Symptoms Tool (E-RS) in three clinical trials. Respir Res. Oct 2014;15(1):124. Respir Res Article and Supplement.
- Nordenmark LH, Taylor R, Jorup C. Feasibility of computed tomography in a multicenter COPD trial: a study of the effect of AZD9668 on structural airway changes. Adv Ther. 2015 Jun;32(6):548-66. PubMed.
- Vanaparthy R, Mota P, Khan R, et al. A longitudinal assessment of sleep variables during exacerbations of chronic obstructive pulmonary disease. Chron Respir Dis. 2015 May 31. [Epub ahead of print]. PubMed.
- Jones PW, Lamarca R, Chuecos F, et al. Characterisation and impact of reported and unreported exacerbations: results from ATTAIN. Eur Respir J. Nov 2014;44(5):1156-1165. PubMed.
- Wedzicha JA, Singh D, Vestbo J, et al. Extrafine beclomethasone/formoterol in severe COPD patients with history of exacerbations. Respir Med. Aug 2014;108(8):1153-1162. Respir Med Article.
- Mackay AJ, Donaldson GC, Patel AR, et al. Detection and severity grading of COPD exacerbations using the exacerbations of Chronic Obstructive Pulmonary Disease Tool (EXACT). Eur Respir J. Mar 2014;43(3):735-744. PubMed.
- Mohan A, Sethi S. The reliability and validity of patient-reported chronic obstructive pulmonary disease exacerbations. Curr Opin Pulm Med. Mar 2014;20(2):146-152. PubMed.
- Ehsan M, Khan R, Wakefield D, et al. A longitudinal study evaluating the effect of exacerbations on physical activity in patients with chronic obstructive pulmonary disease. Ann Am Thorac Soc. Dec 2013;10(6):559-564. PubMed.
- 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. Aug 2013;10(4):511-522. COPD Article
- Singh D, Kampschulte J, Wedzicha JA, et al. A trial of beclomethasone/formoterol in COPD using EXACT-PRO to measure exacerbations. Eur Respir J. Jan 2013;41(1):12-17. PubMed.
- Halpin DM, Laing-Morton T, Spedding S, et al. A randomised controlled trial of the effect of automated interactive calling combined with a health risk forecast on frequency and severity of exacerbations of COPD assessed clinically and using EXACT PRO. Prim Care Respir J. Sep 2011;20(3):324-331. Prim Care Respir J Article.
- Petrillo J, Cairns J. Development of the EXACT-U: a preference-based measure to report COPD exacerbation utilities. Value Health. Jun 2011;14(4):546-554. PubMed.
- Mori Y, Ishizaki T. Is an EXACT score applicable Japanese patients with COPD? Poster presented at: European Respiratory Society Annual Congress; September, 2013; Barcelona, Spain. ERS Abstract.
- Beier J, Kirsten AM, Mroz R, et al. Improvements in COPD symptoms and rescue medication use with aclidinium bromide compared with tiotropium and placebo: a phase IIIb study. Poster presented at: American Thoracic Society International Conference; May, 2013; Philadelphia, PA. ATS Abstract.
- Jones P, Singh D, Agusti A, et al. Aclidinium bromide in patients with chronic obstructive pulmonary disease (COPD): reduction in exacerbations as defined by health-care utilization and the EXACT diary card. Poster presented at: CHEST 2011; October, 2011; Honolulu, HI. Chest Abstract.
- Jones P, Agusti A, Bateman E, et al. Aclidinium bromide in patients with chronic obstructive pulmonary disease: improvement in symptoms and health status in the ATTAIN study. Poster presented at: CHEST 2011; October, 2011; Honolulu, HI. Chest Abstract.