Abstract
Rationale: It has been suggested that patients with chronic obstructive pulmonary disease (COPD) experience considerable daily respiratory symptom fluctuation. A standardized measure is needed to quantify and understand the implications of day-to-day symptom variability. Objectives: To compare standard deviation with other statistical measures of symptom variability and identify characteristics of individuals with higher symptom variability. Methods: Individuals in the SubPopulations and InteRmediate Outcome Measures In COPD Study (SPIROMICS) Exacerbations sub-study completed an Evaluating Respiratory Symptoms in COPD (E-RS) daily questionnaire. We calculated within-subject standard deviation (WS-SD) for each patient at week 0 and correlated this with measurements obtained 4 weeks later using Pearson’s r and Bland Altman plots. Median WS-SD value dichotomized participants into higher versus lower variability groups. Association between WS-SD and exacerbation risk during 4 follow-up weeks was explored. Measurements and Main Results: Diary completion rates were sufficient in 140 (68%) of 205 sub-study participants. Reproducibility (r) of the WS-SD metric from baseline to week 4 was 0.32. Higher variability participants had higher St George’s Respiratory Questionnaire (SGRQ) scores (47.3±20.3 versus 39.6±21.5, p=.04) than lower variability participants. Exploratory analyses found no relationship between symptom variability and health care resource utilization-defined exacerbations. Conclusions: WS-SD of the E-RS can be used as a measure of symptom variability in studies of patients with COPD. Patients with higher variability have worse health-related quality of life. WS-SD should be further validated as a measure to understand the implications of symptom variability.
Original language | English (US) |
---|---|
Pages (from-to) | 195-208 |
Number of pages | 14 |
Journal | Chronic Obstructive Pulmonary Diseases |
Volume | 9 |
Issue number | 2 |
DOIs | |
State | Published - 2022 |
Keywords
- EXACT
- chronic obstructive pulmonary disease
- exacerbations
- patient-reported outcomes
- symptom variation
ASJC Scopus subject areas
- Pulmonary and Respiratory Medicine
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Characterizing COPD Symptom Variability in the Stable State Utilizing the Evaluating Respiratory Symptoms in COPD Instrument. / SPIROMICS Investigators.
In: Chronic Obstructive Pulmonary Diseases, Vol. 9, No. 2, 2022, p. 195-208.Research output: Contribution to journal › Article › peer-review
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TY - JOUR
T1 - Characterizing COPD Symptom Variability in the Stable State Utilizing the Evaluating Respiratory Symptoms in COPD Instrument
AU - SPIROMICS Investigators
AU - Krishnan, Jamuna K.
AU - Ancy, Kayley M.
AU - Oromendia, Clara
AU - Hoffman, Katherine L.
AU - Easthausen, Imaani
AU - Leidy, Nancy K.
AU - Han, Mei Lan K.
AU - Bowler, Russell P.
AU - Christenson, Stephanie A.
AU - Couper, David J.
AU - Criner, Gerard J.
AU - Curtis, Jeffrey L.
AU - Dransfield, Mark T.
AU - Hansel, Nadia N.
AU - Iyer, Anand S.
AU - Paine, Robert
AU - Peters, Stephen P.
AU - Wedzicha, Jadwiga A.
AU - Woodruff, Prescott G.
AU - Ballman, Karla V.
AU - Martinez, Fernando J.
AU - Alexis, Neil E.
AU - Anderson, Wayne H.
AU - Arjomandi, Mehrdad
AU - Barjaktarevic, Igor
AU - Graham Barr, R.
AU - Bateman, Lori A.
AU - Bhatt, Surya P.
AU - Bleecker, Eugene R.
AU - Boucher, Richard C.
AU - Comellas, Alejandro P.
AU - Cooper, Christopher B.
AU - Crystal, Ronald G.
AU - Doerschuk, Claire M.
AU - Drummond, Brad
AU - Freeman, Christine M.
AU - Galban, Craig
AU - Hastie, Annette T.
AU - Hoffman, Eric A.
AU - Huang, Yvonne
AU - Kaner, Robert J.
AU - Kanner, Richard E.
AU - Kleerup, Eric C.
AU - Krishnan, Jerry A.
AU - LaVange, Lisa M.
AU - Lazarus, Stephen C.
AU - Meyers, Deborah A.
AU - Moore, Wendy C.
AU - Newell, John D.
AU - Rennard, Stephen I.
N1 - Funding Information: JKK reports grants from NIH T32 HL134629, during the conduct of the study; non-financial support from GlaxoSmithKline, outside the submitted work. NKL reports other from Evidera, outside the submitted work. MKH reports personal fees from GlaxoSmithKline, AstraZeneca, Boehringer Ingelheim, Cipla, Chiesi, Novartis, Pulmonx, Teva, Verona, Merck, Mylan, Sanofi, DevPro, Aerogen, Polarian, Regeneron, United Therapeutics, UpToDate, Medscape, and Integrity. She has received either in-kind research support or funds paid to the institution from the NIH, Novartis, Sunovion, Nuvaira, Sanofi, Astrazeneca, Boehringer Ingelheim, Gala Therapeutics, Biodesix, the COPD Foundation, and the American Lung Association. She has participated in Data Safety Monitoring Boards for Novartis and Medtronic with funds paid to the institution. She has received stock options from Meissa Vaccines. RP reports grants from the NHLBI, grants from the COPD Foundation during the conduct of this study; grants from Department of Veterans Affairs, outside the submitted work. SAC. reports personal fees from AstraZeneca, personal fees from GlaxoSmithKline, personal fees from Amgen, personal fees from Glenmark, personal fees from Sunovion, personal fees from Genentech, personal fees from UpToDate, outside the submitted work. DJC reports grants from the NHLBI, grants from the COPD Foundation, during the conduct of the study. GJC reports grants and personal fees from GlaxoSmithKline, grants and personal fees from Boehringer Ingelheim, grants and personal fees from Chiesi, grants and personal fees from Mereo, personal fees from Verona, grants and personal fees from AstraZeneca, grants and personal fees from Pulmonx, grants and personal fees from Pneumrx, personal fees from BTG, grants and personal fees from Olympus, grants and personal fees from Broncus, personal fees from EOLO, personal fees from NGM, grants and personal fees from Lungpacer, grants from Alung, grants and personal fees from Nuvaira, grants and personal fees from ResMed, grants and personal fees from Respironics, grants from Fisher Paykel, grants and personal fees from Patara, grants from Galapgos, outside the submitted work. JLC reports a grant from the NIH/ NHLBI, during the conduct of the study; grants from the Department of Veterans Affairs and the Department of Defense, personal fees and non-financial support from AstraZeneca, and personal fees from Novartis, outside the submitted work. MTD reports grants from the NIH, during the conduct of the study; personal fees and other from Boehringer Ingelheim, personal fees and other from GlaxoSmithKline, other from Novartis, personal fees and other from AstraZeneca, other from Yungjin, personal fees and other from PneumRx/ BTG, non-financial support and other from Pulmonx, other from Boston Scientific, personal fees from Quark Pharmaceuticals, personal fees from Mereo, grants from American Lung Association, grants from the NIH, grants from the Department of Veterans Affairs, other from Gala, other from Nuvaira, grants from the Department of Defense, outside the submitted work. NNH reports grants from the NIH, grants from the COPD Foundation, grants and personal fees from AstraZeneca, grants and personal fees from GlaxoSmithKline, grants from Boehringer Ingelheim, personal fees from Mylan during the conduct of the study. ASI reports grants from Agency for Healthcare Research and Quality and salary support from the University of Alabama at Birmingham Center for Outcomes and Effectiveness Research and Education, during the conduct of the study. SP reports grants from the NIH, the NHLBI, and the COPD Foundation, during the conduct of the study. JAW reports grants from GlaxoSmithKline, other from Novartis, other from Boehringer Ingelheim, other from Astra Zeneca, other from Chiesi outside the submitted work. PGW reports personal fees from Sanofi, personal fees from Regeneron, personal fees from Glenmark Pharmaceuticals, personal fees from Theravance,personal fees from GlaxoSmithKline, personal fees from NGM Pharma, from Amgen, personal fees from Genentech, outside the submitted work. KVB reports personal fees from Johnson and Johnson, personal fees from Janssen Oncology, personal fees from Eli Lilly, personal fees from Takada, outside the submitted work. FJM reports grants from the NHLBI, during the conduct of the study; personal fees, non-financial support and other from AstraZeneca, other from Afferent/Merck, personal fees, non-financial support, and other from Boheringer Ingelheim, other from Bristol Myers Squibb, other from Chiesi, personal fees and non-financial support from Canadian Respiratory Society, personal fees and non-financial support from CME Outfitters, personal fees and non-financial support from CSL Behring, personal fees from Dartmouth University, personal fees from France Foundation, personal fees from Gala, personal fees and non-financial support from Genentech, grants, personal fees, non-financial support, and other from GlaxoSmithKline, personal fees and nonfinancial support from Inova Fairfax, personal fees and non-financial support from MDMagazine, personal fees and non-financial support from NYP Methodist Hospital Brooklyn, personal fees and non-financial support from Miller Communications, personal fees and non-financial support from National Association for Continuing Education/Integritas, other from Nitto, personal fees and non-financial support from Novartis, personal fees from New York University, personal fees and non-financial support from Patara/Respivant, personal fees from Pearl, personal fees and non-financial support from Peer View, personal fees from Physicians Education Resource, personal fees from ProMedior, personal fees and nonfinancial support from Rare Diseases Healthcare Communications, personal fees from Rockpointe Communications, personal fees and non-financial support from Sanofi/Regeneron, other from Biogen, personal fees and non-financial support from Sunovion, personal fees and non-financial support from Teva, other from twoXAR, personal fees from University of Alabama at Birmingham, personal fees from UpToDate, non-financial support from Veracyte, personal fees from Vindico, personal fees and non-financial support from WebMD/MedScape, non-financial support and other from Zambon, non-financial support from ProTerrix Bio, personal fees from IQVIA, personal fees from Raziel, from Abvie, from Verona, outside the submitted work. CO, IE, and RPB report have no conflicts to disclose. Funding Information: Abbreviations: SubPopulations and InteRmediate Outcome Measures In COPD Study, SPIROMICS; Evaluating Respiratory Symptoms in COPD, E-RS; within-subject standard deviation, WS-SD; St George’s Respiratory Questionnaire, SGRQ; patient-reported outcome, PRO; Exacerbations in Chronic Pulmonary Disease Tool, EXACT; square root of the wall area of a hypothetical airway with an internal perimeter of 10 mm, Pi10; health care resource utilization, HCRU; interquartile range, IQR; modified Medical Research Council, mMRC; Pittsburgh Sleep Quality Index, PSQ; hospital anxiety and depression scale, HADS; parametric response mapping, PRM; Global initiative for chronic Obstructive Lung Disease, GOLD; confidence interval, CI; correlation, corr; Body mass index-airway Obstruction-Dyspnea-Exercise capacity, BODE Funding Support: The SubPopulations and InteRmediate Outcome Measures In COPD Study (SPIROMICS) was supported by contracts from the National Institutes of Health (NIH) / National Heart, Lung, and Blood Institute (NHLBI) (HHSN268200900013C, HHSN268200900014C, HHSN268200900015C, HHSN268200900016C, HHSN268200900017C, HHSN268200900018C, HHSN268200900019C, HHSN268200900020C), grants from the NIH/NHLBI (U01 HL137880 and U24 HL141762), and supplemented by contributions made through the Foundation for the NIH and the COPD Foundation from AstraZeneca/MedImmune, Bayer, Bellerophon Therapeutics, Boehringer-Ingelheim Pharmaceuticals, Inc., Chiesi Farmaceutici S.p.A., Forest Research Institute, Inc., GlaxoSmithKline, Grifols Therapeutics, Inc., Ikaria, Inc., Novartis Pharmaceuticals Corporation, Nycomed GmbH, ProterixBio, Regeneron Pharmaceuticals, Inc., Sanofi, Sunovion, Takeda Pharmaceutical Company, and Theravance Biopharma and Mylan. Dr. Krishnan is supported by the NIH T32 HL134629. Date of Acceptance: April 7, 2022 | Published Online Date: April 9, 2022 Citation: Krishnan JK, Ancy KM, Oromendia C, et al. Characterizing COPD symptom variability in the stable state utilizing the Evaluating Respiratory Symptoms in COPD instrument. Chronic Obstr Pulm Dis. 2022;9(2):195-208. doi: https://doi.org/10.15326/ jcopdf.2021.0263 Publisher Copyright: © 2022 COPD Foundation. All rights reserved.
PY - 2022
Y1 - 2022
N2 - Rationale: It has been suggested that patients with chronic obstructive pulmonary disease (COPD) experience considerable daily respiratory symptom fluctuation. A standardized measure is needed to quantify and understand the implications of day-to-day symptom variability. Objectives: To compare standard deviation with other statistical measures of symptom variability and identify characteristics of individuals with higher symptom variability. Methods: Individuals in the SubPopulations and InteRmediate Outcome Measures In COPD Study (SPIROMICS) Exacerbations sub-study completed an Evaluating Respiratory Symptoms in COPD (E-RS) daily questionnaire. We calculated within-subject standard deviation (WS-SD) for each patient at week 0 and correlated this with measurements obtained 4 weeks later using Pearson’s r and Bland Altman plots. Median WS-SD value dichotomized participants into higher versus lower variability groups. Association between WS-SD and exacerbation risk during 4 follow-up weeks was explored. Measurements and Main Results: Diary completion rates were sufficient in 140 (68%) of 205 sub-study participants. Reproducibility (r) of the WS-SD metric from baseline to week 4 was 0.32. Higher variability participants had higher St George’s Respiratory Questionnaire (SGRQ) scores (47.3±20.3 versus 39.6±21.5, p=.04) than lower variability participants. Exploratory analyses found no relationship between symptom variability and health care resource utilization-defined exacerbations. Conclusions: WS-SD of the E-RS can be used as a measure of symptom variability in studies of patients with COPD. Patients with higher variability have worse health-related quality of life. WS-SD should be further validated as a measure to understand the implications of symptom variability.
AB - Rationale: It has been suggested that patients with chronic obstructive pulmonary disease (COPD) experience considerable daily respiratory symptom fluctuation. A standardized measure is needed to quantify and understand the implications of day-to-day symptom variability. Objectives: To compare standard deviation with other statistical measures of symptom variability and identify characteristics of individuals with higher symptom variability. Methods: Individuals in the SubPopulations and InteRmediate Outcome Measures In COPD Study (SPIROMICS) Exacerbations sub-study completed an Evaluating Respiratory Symptoms in COPD (E-RS) daily questionnaire. We calculated within-subject standard deviation (WS-SD) for each patient at week 0 and correlated this with measurements obtained 4 weeks later using Pearson’s r and Bland Altman plots. Median WS-SD value dichotomized participants into higher versus lower variability groups. Association between WS-SD and exacerbation risk during 4 follow-up weeks was explored. Measurements and Main Results: Diary completion rates were sufficient in 140 (68%) of 205 sub-study participants. Reproducibility (r) of the WS-SD metric from baseline to week 4 was 0.32. Higher variability participants had higher St George’s Respiratory Questionnaire (SGRQ) scores (47.3±20.3 versus 39.6±21.5, p=.04) than lower variability participants. Exploratory analyses found no relationship between symptom variability and health care resource utilization-defined exacerbations. Conclusions: WS-SD of the E-RS can be used as a measure of symptom variability in studies of patients with COPD. Patients with higher variability have worse health-related quality of life. WS-SD should be further validated as a measure to understand the implications of symptom variability.
KW - EXACT
KW - chronic obstructive pulmonary disease
KW - exacerbations
KW - patient-reported outcomes
KW - symptom variation
UR - http://www.scopus.com/inward/record.url?scp=85130906376&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85130906376&partnerID=8YFLogxK
U2 - 10.15326/jcopdf.2021.0263
DO - 10.15326/jcopdf.2021.0263
M3 - Article
C2 - 35403414
AN - SCOPUS:85130906376
SN - 2372-952X
VL - 9
SP - 195
EP - 208
JO - Chronic Obstructive Pulmonary Diseases
JF - Chronic Obstructive Pulmonary Diseases
IS - 2
ER -