Andonian 2019.
Study characteristics | ||
Methods |
Study design: RCT Study grouping: parallel group For simulation study, what was used for the exposure (virus, fluorescent fluid etc): 1. The optimised fluorescent slurry consisted of fluorescent powder (Glitter Bug, Brevis Corporation, Salt Lake City, UT; 75 mg/mL) in a viscous suspension of grape‐seed oil and water (1:6 oil‐to‐water ratio) 2. Fluorescent 2‐μm polystyrene latex bead (PLSs) (G0200, Thermo Fisher Scientific, Waltham, MA) diluted in water. PLSs are commonly utilised in aerosol research and were used to simulate pathogens Exposure simulation: 1. Fluorescent tracer mixture was applied to PPE using 1000 mL in a pesticide hand sprayer (RL Flo‐Master, Lowell, MI; 2000 mL capacity) and 5 sweeping passes of sprayer from head to feet on the front and back of the HCW. 2. A PLS suspension (25 mL) was aerosolised using a 3‐jet Collison nebuliser (Mesa Laboratories, Inc, Butler, NJ) for 4 min of continuous aerosol generation while the HCW turned 90° every 60 s |
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Participants |
Baseline characteristics 48 participants were included in the study Enhanced doffing protocol
CDC doffing protocol
Overall
Inclusion criteria: not reported, but study authors included: adults (male/female) with no prior experience doffing enhanced PPE Excluded criteria: not reported |
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Interventions |
Intervention characteristics Enhanced doffing protocol: doffing with extra instructions
CDC doffing protocol
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Outcomes |
How the outcome was measured: from the fluorescent tracer slurry ‐
detection was by direct visualisation in a dark room using ultraviolet
light. (1) The number of body sites contaminated and (2) the extent of
contamination at each site were recorded. PLS detection was performed by (3)
counting via epifluorescent microscopy and (4) quantifying the number PLSs
per cm² of skin or per m3 of sampled air. (5) Teamwork dynamics
were assessed via video and coded using a task analysis of the process sets
and subsets (checklist). (6) The National Aeronautics and Space
Administration (NASA) Task Load Index (NASA‐TLX) questionnaire assessed
perceptions of workload during doffing (7) The Team Strategies and Tools to
Enhance Performance and Patient Safety Teamwork Attitudes Questionnaire
(T‐TAQ) assessed attitudes toward teamwork Body sites with fluorescent marker
Body sites with PLS
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Notes | Outcomes Median and IQR of 22 possible contaminated sites reported. For Fluor Marker: intervention 1 (1‐2) control 5 (2‐5) For PLS out of 12 possible contaminated sites: intervention 4 (2‐5) control 5 (5‐8). These were transformed to means and SDs for use in the data tables. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomly assigned to the control or intervention condition and then
to the role of HCW or DA." Judgement comment: method of random assignment not reported |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: method of allocation concealment was not reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "role as either HCW or DA." Quote: "After training, all participants were given the opportunity to ask questions and were informed about their randomly assigned" Quote: "Study participants were blind to their group assignment." Judgement comment: group assignment (intervention and control) was blinded; role was blinded to participants until after training and before the doffing intervention |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The contamination forms were deidentified and assigned randomized
numbers for scoring purposes. Two IPs, blinded to experimental assignment,
independently scored each form" Judgement comment: infection preventionists were the outcome assessors and were blinded to intervention group |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Forty‐eight study participants (35 females, 13 males) were randomly
assigned to the control (n = 22) or intervention group (n = 26)." Quote: "Participants in each study arm were randomly assigned to the role of control HCW (n = 11), control DA (n = 11), intervention HCW (n = 13), or intervention DA (n = 13). For the fluorescent tracer, 11 HCWs (84.6%) in the intervention group and all 13 control HCWs (100%) contaminated at least 1 body area." Quote: "Coding and scoring of teamwork behaviors exhibited in the videotaped doffing sessions were completed for 10 intervention and 11 control teams. Technical difficulties resulted in missing videotapes for 3 intervention teams." Judgement comment: main outcomes were listed within the methods (but scattered and hard to find). All recruited participants completed the interventions and outcomes were collected. 1 typographical error (I assume) in reporting fluorescent tracer contamination (they reported 13 control HCWs but there were only 11). 3 sets of teamwork behaviour outcomes recorded in videos from the intervention group were lost. However, despite the missing data, there was a plausible difference in median (IQR) between groups that may not have impacted the observed effect size. |
Selective reporting (reporting bias) | Low risk | Judgement comment: the availability of the study protocol is not reported in the paper, but it is clear that the published report includes all expected outcomes for this type of study. |
Other bias | Low risk | Judgement comment: no other bias detected |