Labor Law Reviewer Chan Robles.pdf
detected healthcare-associated sars-cov-2 by following over 500 participants for eight weeks. that is almost 25 times the number of subjects that the original study had recruited, and it meant that we were able to monitor outcomes at a far greater rate of incidence. even the most conservative estimate of the value of masking the rt-pcr data is $1380 per patient (e.g., the value of masking is $1.38 x 150, which amounts to $218,000 per site), but the rate of incident infections even in the absence of masking would have been low. therefore, the value of masking and still being able to collect data on over 50,000 subjects far surpassed the value of the data. in addition, the reported rt-pcr rate
per study is probably conservative. infection rates in hcp are generally higher than the reported rates, and the reported rates probably underestimate the rate of infection in hcp. the masking will also have reduced compliance among hcp. in some settings, the masking will have increased the compliance among hcp. through a combination of masking of rt-pcr results and the use of nonsterile masking facemasks with half-mask respirators, we have been able to maintain compliance in the setting of hcp exposed to sars-cov-2 with the masking of rt-pcr results. all reports of adverse events were reported even with the masking of rt-pcr results. we are not aware of any known circumstance in which hcp would have refused to adopt the suggested standard precautions under the circumstances of this study.
the adverse event committee (aec) met weekly, and cdes reported all adverse events. unmasked data were pooled, and the statistical analysis of adverse events was performed by site. unmasked data were reviewed independently by a second investigator blinded to the initially masked rt-pcr results. both investigators agreed on all adverse event determinations. the consensus was a point of separation between a real adverse event and a
to track potential exposures as well as the adherence behavior of hcp to recommended ppe usage, we surveyed participants at the beginning and end of the surveillance period on a work-related questionnaire to rate the exposures, and completion of the survey prompted the participant to self-sample for viral testing on the day they completed the surveillance period.
this descriptive study is based on data collected from approximately 673 hcp with the goal of exploring whether wearing ppe and adherence to ppe use at the time of an exposure are associated with the risk of sars-cov-2 infection as confirmed by a viral test. our primary outcome was confirmed diagnosis of sars-cov-2 infection. odds ratios (ors) for confirmed infection were calculated for primary exposures for hcp intubating a sars-cov-2 patient, as well as non-intubated sars-cov-2 patients and controls in real-time rt-pcr monitoring. non-inferiority comparisons were performed for non-intubated patients. adherence to ppe use was evaluated by self-report. statistical analysis was performed using stata 15.1. this study was approved by the institutional review board of the duke university medical center, durham, nc; the west los angeles veterans affairs medical center, los angeles, ca; the indiana university school of medicine, indianapolis, in; the johns hopkins school of medicine, baltimore, md; and the university of louisville, louisville, ky. no consent procedures were required because of the retrospective nature of the study.
prior to this study, the authors had no financial relationships to disclose. no funding was received for this study. on the basis of literature reviews and the centers for disease control and prevention guidance for healthcare providers, ppe guidelines were created for the present study. the authors also wish to thank the health and safety committee for their generous support of this study. these guidelines apply to all personnel performing self-monitoring. work visits were made to workplaces to provide information on the basis of what they told us and by asking them to explain their practices, to disseminate information, and to provide reinforcement of their safety practices (both as hcp and as employer). all data were self-reported on the study survey. data privacy was provided for responders.