A tolerability assessment of new respiratory protective devices developed for health care personnel: A randomized simulated clinical study

Lewis J. Radonovich*, Kerri Wizner, Sherri L. LaVela, Martin L. Lee, Kimberly Findley, Patrick Yorio

*Corresponding author for this work

Research output: Contribution to journalArticle

Abstract

Background U.S. health care personnel (HCP) have reported that some respiratory protective devices (RPD) commonly used in health care have suboptimal tolerability. Between 2012 and 2016, the U.S. National Institute for Occupational Safety and Health, and the Veterans Health Administration collaborated with two respirator manufacturers, Company A and B, to bring new RPD with improved tolerability to the U.S. health care marketplace. The purpose of this study was to compare the tolerability of four new prototype RPD to two models commonly used in U.S. health care delivery. Methods A randomized, simulated workplace study was conducted to compare self-reported tolerability of four new prototype RPD (A1, A2, B1, and B2) worn by HCP and two N95 control respirators commonly used in U.S. health care delivery, the 1870 and 1860, manufactured by 3M Corporation. A new survey tool, the Respirator Comfort, Wearing Experience, and Function Instrument (R-COMFI), developed previously in part for the current study, was used as the primary outcome metric. With a maximum total score of 47, lower R-COMFI scores reflected better self-reported tolerability. Poisson regression analyses were used to estimate prototype relative risks compared to controls. Results Conducted between 2014 and 2015 in two inpatient care rooms at the North Florida/South Georgia Veterans Health System, among 383 participants who enrolled, 335 (87.5%) completed the study. Mean total R-COMFI scores for the 3M 1870, 3M 1860, and prototypes A1, A2, B1, and B2 were 8.26, 9.36, 5.79, 7.70, 6.09, and 5.71, respectively. Compared to the 3M 1870, total R-COMFI unadjusted relative risks (RR) and 95 percent confidence intervals (CI) were A1 (RR 0.70, CI 0.60, 0.82), A2 (RR 0.93, CI 0.82, 1.06), B1 (RR 0.74, CI 0.64, 0.85), and B2 (RR 0.69, CI 0.60, 0.80). Compared to the 3M 1860, prototype total R-COMFI unadjusted RR and 95 percent CI were A1 (RR 0.62, CI 0.53, 0.72), A2 (RR 0.82, CI 0.73, 0.93), B1 (RR 0.65, CI 0.57, 0.74), and B2 (RR 0.61, CI 0.53, 0.70). Similarly, models adjusted for demographic characteristics showed that prototypes A1, B1, and B2 significantly improved tolerability scores compared to both controls, while prototype A2 was significantly improved compared to the 3M 1860. Conclusions Compared to the 3M 1870 and 3M 1860, two RPDs commonly used in U.S. health care delivery, tolerability improved for three of four newly developed prototypes in this simulated workplace study. The R-COMFI tool, used in this study to assess tolerability, should be useful for future comparative studies of RPD.

Original languageEnglish (US)
Article numbere0209559
JournalPloS one
Volume14
Issue number1
DOIs
StatePublished - Jan 2019

Fingerprint

Respiratory Protective Devices
Respirators
relative risk
health care workers
Health care
Health Personnel
clinical trials
confidence interval
Mechanical Ventilators
Personnel
prototypes
Delivery of Health Care
Confidence Intervals
varespladib methyl
health services
veterans
Veterans Health
Health
working conditions
Workplace

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)
  • Agricultural and Biological Sciences(all)
  • General

Cite this

Radonovich, Lewis J. ; Wizner, Kerri ; LaVela, Sherri L. ; Lee, Martin L. ; Findley, Kimberly ; Yorio, Patrick. / A tolerability assessment of new respiratory protective devices developed for health care personnel : A randomized simulated clinical study. In: PloS one. 2019 ; Vol. 14, No. 1.
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title = "A tolerability assessment of new respiratory protective devices developed for health care personnel: A randomized simulated clinical study",
abstract = "Background U.S. health care personnel (HCP) have reported that some respiratory protective devices (RPD) commonly used in health care have suboptimal tolerability. Between 2012 and 2016, the U.S. National Institute for Occupational Safety and Health, and the Veterans Health Administration collaborated with two respirator manufacturers, Company A and B, to bring new RPD with improved tolerability to the U.S. health care marketplace. The purpose of this study was to compare the tolerability of four new prototype RPD to two models commonly used in U.S. health care delivery. Methods A randomized, simulated workplace study was conducted to compare self-reported tolerability of four new prototype RPD (A1, A2, B1, and B2) worn by HCP and two N95 control respirators commonly used in U.S. health care delivery, the 1870 and 1860, manufactured by 3M Corporation. A new survey tool, the Respirator Comfort, Wearing Experience, and Function Instrument (R-COMFI), developed previously in part for the current study, was used as the primary outcome metric. With a maximum total score of 47, lower R-COMFI scores reflected better self-reported tolerability. Poisson regression analyses were used to estimate prototype relative risks compared to controls. Results Conducted between 2014 and 2015 in two inpatient care rooms at the North Florida/South Georgia Veterans Health System, among 383 participants who enrolled, 335 (87.5{\%}) completed the study. Mean total R-COMFI scores for the 3M 1870, 3M 1860, and prototypes A1, A2, B1, and B2 were 8.26, 9.36, 5.79, 7.70, 6.09, and 5.71, respectively. Compared to the 3M 1870, total R-COMFI unadjusted relative risks (RR) and 95 percent confidence intervals (CI) were A1 (RR 0.70, CI 0.60, 0.82), A2 (RR 0.93, CI 0.82, 1.06), B1 (RR 0.74, CI 0.64, 0.85), and B2 (RR 0.69, CI 0.60, 0.80). Compared to the 3M 1860, prototype total R-COMFI unadjusted RR and 95 percent CI were A1 (RR 0.62, CI 0.53, 0.72), A2 (RR 0.82, CI 0.73, 0.93), B1 (RR 0.65, CI 0.57, 0.74), and B2 (RR 0.61, CI 0.53, 0.70). Similarly, models adjusted for demographic characteristics showed that prototypes A1, B1, and B2 significantly improved tolerability scores compared to both controls, while prototype A2 was significantly improved compared to the 3M 1860. Conclusions Compared to the 3M 1870 and 3M 1860, two RPDs commonly used in U.S. health care delivery, tolerability improved for three of four newly developed prototypes in this simulated workplace study. The R-COMFI tool, used in this study to assess tolerability, should be useful for future comparative studies of RPD.",
author = "Radonovich, {Lewis J.} and Kerri Wizner and LaVela, {Sherri L.} and Lee, {Martin L.} and Kimberly Findley and Patrick Yorio",
year = "2019",
month = "1",
doi = "10.1371/journal.pone.0209559",
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A tolerability assessment of new respiratory protective devices developed for health care personnel : A randomized simulated clinical study. / Radonovich, Lewis J.; Wizner, Kerri; LaVela, Sherri L.; Lee, Martin L.; Findley, Kimberly; Yorio, Patrick.

In: PloS one, Vol. 14, No. 1, e0209559, 01.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A tolerability assessment of new respiratory protective devices developed for health care personnel

T2 - A randomized simulated clinical study

AU - Radonovich, Lewis J.

AU - Wizner, Kerri

AU - LaVela, Sherri L.

AU - Lee, Martin L.

AU - Findley, Kimberly

AU - Yorio, Patrick

PY - 2019/1

Y1 - 2019/1

N2 - Background U.S. health care personnel (HCP) have reported that some respiratory protective devices (RPD) commonly used in health care have suboptimal tolerability. Between 2012 and 2016, the U.S. National Institute for Occupational Safety and Health, and the Veterans Health Administration collaborated with two respirator manufacturers, Company A and B, to bring new RPD with improved tolerability to the U.S. health care marketplace. The purpose of this study was to compare the tolerability of four new prototype RPD to two models commonly used in U.S. health care delivery. Methods A randomized, simulated workplace study was conducted to compare self-reported tolerability of four new prototype RPD (A1, A2, B1, and B2) worn by HCP and two N95 control respirators commonly used in U.S. health care delivery, the 1870 and 1860, manufactured by 3M Corporation. A new survey tool, the Respirator Comfort, Wearing Experience, and Function Instrument (R-COMFI), developed previously in part for the current study, was used as the primary outcome metric. With a maximum total score of 47, lower R-COMFI scores reflected better self-reported tolerability. Poisson regression analyses were used to estimate prototype relative risks compared to controls. Results Conducted between 2014 and 2015 in two inpatient care rooms at the North Florida/South Georgia Veterans Health System, among 383 participants who enrolled, 335 (87.5%) completed the study. Mean total R-COMFI scores for the 3M 1870, 3M 1860, and prototypes A1, A2, B1, and B2 were 8.26, 9.36, 5.79, 7.70, 6.09, and 5.71, respectively. Compared to the 3M 1870, total R-COMFI unadjusted relative risks (RR) and 95 percent confidence intervals (CI) were A1 (RR 0.70, CI 0.60, 0.82), A2 (RR 0.93, CI 0.82, 1.06), B1 (RR 0.74, CI 0.64, 0.85), and B2 (RR 0.69, CI 0.60, 0.80). Compared to the 3M 1860, prototype total R-COMFI unadjusted RR and 95 percent CI were A1 (RR 0.62, CI 0.53, 0.72), A2 (RR 0.82, CI 0.73, 0.93), B1 (RR 0.65, CI 0.57, 0.74), and B2 (RR 0.61, CI 0.53, 0.70). Similarly, models adjusted for demographic characteristics showed that prototypes A1, B1, and B2 significantly improved tolerability scores compared to both controls, while prototype A2 was significantly improved compared to the 3M 1860. Conclusions Compared to the 3M 1870 and 3M 1860, two RPDs commonly used in U.S. health care delivery, tolerability improved for three of four newly developed prototypes in this simulated workplace study. The R-COMFI tool, used in this study to assess tolerability, should be useful for future comparative studies of RPD.

AB - Background U.S. health care personnel (HCP) have reported that some respiratory protective devices (RPD) commonly used in health care have suboptimal tolerability. Between 2012 and 2016, the U.S. National Institute for Occupational Safety and Health, and the Veterans Health Administration collaborated with two respirator manufacturers, Company A and B, to bring new RPD with improved tolerability to the U.S. health care marketplace. The purpose of this study was to compare the tolerability of four new prototype RPD to two models commonly used in U.S. health care delivery. Methods A randomized, simulated workplace study was conducted to compare self-reported tolerability of four new prototype RPD (A1, A2, B1, and B2) worn by HCP and two N95 control respirators commonly used in U.S. health care delivery, the 1870 and 1860, manufactured by 3M Corporation. A new survey tool, the Respirator Comfort, Wearing Experience, and Function Instrument (R-COMFI), developed previously in part for the current study, was used as the primary outcome metric. With a maximum total score of 47, lower R-COMFI scores reflected better self-reported tolerability. Poisson regression analyses were used to estimate prototype relative risks compared to controls. Results Conducted between 2014 and 2015 in two inpatient care rooms at the North Florida/South Georgia Veterans Health System, among 383 participants who enrolled, 335 (87.5%) completed the study. Mean total R-COMFI scores for the 3M 1870, 3M 1860, and prototypes A1, A2, B1, and B2 were 8.26, 9.36, 5.79, 7.70, 6.09, and 5.71, respectively. Compared to the 3M 1870, total R-COMFI unadjusted relative risks (RR) and 95 percent confidence intervals (CI) were A1 (RR 0.70, CI 0.60, 0.82), A2 (RR 0.93, CI 0.82, 1.06), B1 (RR 0.74, CI 0.64, 0.85), and B2 (RR 0.69, CI 0.60, 0.80). Compared to the 3M 1860, prototype total R-COMFI unadjusted RR and 95 percent CI were A1 (RR 0.62, CI 0.53, 0.72), A2 (RR 0.82, CI 0.73, 0.93), B1 (RR 0.65, CI 0.57, 0.74), and B2 (RR 0.61, CI 0.53, 0.70). Similarly, models adjusted for demographic characteristics showed that prototypes A1, B1, and B2 significantly improved tolerability scores compared to both controls, while prototype A2 was significantly improved compared to the 3M 1860. Conclusions Compared to the 3M 1870 and 3M 1860, two RPDs commonly used in U.S. health care delivery, tolerability improved for three of four newly developed prototypes in this simulated workplace study. The R-COMFI tool, used in this study to assess tolerability, should be useful for future comparative studies of RPD.

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