TY - JOUR
T1 - Standardized Treatment of Pulmonary Exacerbations (STOP) study
T2 - Physician treatment practices and outcomes for individuals with cystic fibrosis with pulmonary Exacerbations
AU - on behalf of the STOP investigators
AU - West, Natalie E.
AU - Beckett, Valeria V.
AU - Jain, Raksha
AU - Sanders, Don B.
AU - Nick, Jerry A.
AU - Heltshe, Sonya L.
AU - Dasenbrook, Elliott C.
AU - VanDevanter, Donald R.
AU - Solomon, George M.
AU - Goss, Christopher H.
AU - Flume, Patrick A.
N1 - Funding Information:
This study was supported by grants from the Cystic Fibrosis Foundation Therapeutics (SANDERS14A0, HELTSH13A1, GOSS13A0, FLUME13A1, CLANCY09Y0, SORSCH15RO, ORENST14Y0, NICKR0, DAINES14Y0), the National Institutes of Health (KL2 TR000428, P30 DK089507), and the University of Wisconsin-Madison ICTR (NIH UL1 TR000427). This project was also supported by the South Carolina Clinical & Translational Research (SCTR) Institute, with an academic home at the Medical University of South Carolina through National Institutes of Health grant UL1TR001450. The study sponsors had no role in study design, analysis, the writing of this manuscript, or the decision to submit for publication.
Publisher Copyright:
© 2017 European Cystic Fibrosis Society
PY - 2017/9
Y1 - 2017/9
N2 - Background Pulmonary Exacerbations (PEx) are associated with increased morbidity and mortality in individuals with CF. PEx management practices vary widely, and optimization through interventional trials could potentially improve outcomes. The object of this analysis was to evaluate current physician treatment practices and patient outcomes for PEx. Methods The Standardized Treatment of Pulmonary Exacerbations (STOP) observational study enrolled 220 participants ≥ 12 years old admitted to the hospital for PEx at 11 U.S. CF centers. Spirometry and daily symptom scores were collected during the study. Physicians were surveyed on treatment goals and their management practices were observed. Treatment outcomes were compared to stated goals. Results The mean (SD) duration of IV antibiotic treatment was 15.9 (6.0) days. Those individuals with more severe lung disease (< 50% FEV1) were treated nearly two days longer than those with > 50% FEV1. Physician-reported FEV1 improvement goals were 10% (95% CI: 5%, 14%) lower for patients with 6-month baseline FEV1 ≤ 50% predicted compared with those with 6-month baseline FEV1 > 50% predicted. There were clinically and statistically significant improvements in symptoms from the start of IV antibiotic treatment to the end of IV antibiotic treatment and 28 days after the start of treatment. The mean absolute increase in FEV1 from admission was 9% predicted at end of IV antibiotic treatment, and 7% predicted at day 28. Only 39% fully recovered lost lung function, and only 65% recovered at least 90% of lost lung function. Treatment was deemed successful by 84% of clinicians, although 6-month baseline FEV1 was only recovered in 39% of PEx. Conclusions In this prospective observational study of PEx, treatment regimens and durations showed substantial variation. A significant proportion of patients did not reach physician's treatment goals, yet treatment was deemed successful.
AB - Background Pulmonary Exacerbations (PEx) are associated with increased morbidity and mortality in individuals with CF. PEx management practices vary widely, and optimization through interventional trials could potentially improve outcomes. The object of this analysis was to evaluate current physician treatment practices and patient outcomes for PEx. Methods The Standardized Treatment of Pulmonary Exacerbations (STOP) observational study enrolled 220 participants ≥ 12 years old admitted to the hospital for PEx at 11 U.S. CF centers. Spirometry and daily symptom scores were collected during the study. Physicians were surveyed on treatment goals and their management practices were observed. Treatment outcomes were compared to stated goals. Results The mean (SD) duration of IV antibiotic treatment was 15.9 (6.0) days. Those individuals with more severe lung disease (< 50% FEV1) were treated nearly two days longer than those with > 50% FEV1. Physician-reported FEV1 improvement goals were 10% (95% CI: 5%, 14%) lower for patients with 6-month baseline FEV1 ≤ 50% predicted compared with those with 6-month baseline FEV1 > 50% predicted. There were clinically and statistically significant improvements in symptoms from the start of IV antibiotic treatment to the end of IV antibiotic treatment and 28 days after the start of treatment. The mean absolute increase in FEV1 from admission was 9% predicted at end of IV antibiotic treatment, and 7% predicted at day 28. Only 39% fully recovered lost lung function, and only 65% recovered at least 90% of lost lung function. Treatment was deemed successful by 84% of clinicians, although 6-month baseline FEV1 was only recovered in 39% of PEx. Conclusions In this prospective observational study of PEx, treatment regimens and durations showed substantial variation. A significant proportion of patients did not reach physician's treatment goals, yet treatment was deemed successful.
KW - Antibiotic therapy
KW - Cystic fibrosis
KW - Physician treatment practices
KW - Pulmonary Exacerbations
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U2 - 10.1016/j.jcf.2017.04.003
DO - 10.1016/j.jcf.2017.04.003
M3 - Article
C2 - 28457954
AN - SCOPUS:85018192527
SN - 1569-1993
VL - 16
SP - 600
EP - 606
JO - Journal of Cystic Fibrosis
JF - Journal of Cystic Fibrosis
IS - 5
ER -