Trial reportPloS one2019
A tolerability assessment of new respiratory protective devices developed for health care personnel: A randomized simulated clinical study.
Trial report in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.
- N95 Filtering Facepiece Respirator Use during Pregnancy: A Systematic Review.American journal of perinatology · 2020Pooled it
- Design considerations for protective mask development: A remote mask usability evaluation.Applied ergonomics · 2022Trial
- Health Care Workers' Comfort Ratings for Elastomeric Half-Mask Respirators Versus N95Workplace health & safety · 2024Article
- Physiological Impacts of Surgical Mask Coverage of Elastomeric Half-mask Respirator Exhalation Valves in Healthcare Workers.Annals of work exposures and health · 2022Article
- Self-reported impact of respirator use on health care worker ability to perform patient care.American journal of infection control · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundU.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.
methodsA 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.
resultsConducted 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.
conclusionsCompared 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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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.