Zamora 2006.
| Study characteristics | ||
| Methods | Randomised, 2‐arm, cross‐over, simulation study | |
| Participants | Clincians from Queen's Hospital, Kingston, ON, Canada volunteering to
participate. N = 50; PAPR‐first N = 27, age 34.3 ± 8.7 years, height 171.8 ± 8.1, weight 76.3 ± 16.7, male 16/27, anaesthetists 19/27, prior PAPR training 15/27 Enhanced respiratory and contact precautions (E‐RCP) first N = 23, age 36.8 ± 9.8, height 172.3 ± 7.6, male 11/23, anaesthetist 10/23, prior PAPR training 18/23 Location: Canada |
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| Interventions |
Intervention: different types of PPE compared: PAPR versus mask PPE with PAPR, consisting of Tyvek hood (3M), Bouffant hair cover, Spartan economy impact goggle, 3M air‐mate breathing tube, 3M HEPA filter unit, N95 mask, 3 pairs of gloves, Tyvek coverall with hood, 2 Tyvek boot covers, Astound impervious surgical gown. Doffing order: first gloves, turbo unit hose, hood, gown, second gloves, belt and battery, shoe covers, third gloves, wash hands, new gloves, coverall, second shoe covers, gloves, new gloves, goggles, hair cover, gloves, wash hands, new mask. Comparison: E‐RCP consisting of Bouffant hair cover, Spartan economy impact goggle, face shield (Splash shield), N95 mask, 2 pairs of gloves, Astound impervious gown. Doffing order: outer gloves, gown, inner gloves, wash hands, new gloves, face shield, hair cover, goggles, mask, gloves, wash hands. |
|
| Outcomes | 1. Number of participants with presence of contamination on base layer of
clothes or skin. Contamination measured with fluorescein solution (5 mL in
front of face shield and torso) plus invisible detection paste on forearms
and palms of the hands; assessment after removing of outer layer by
unblinded assessor with UV lamp; blinded evaluator then inspected all skin
and clothes and measured area of contamination. Secondary outcomes were:
contamination of inner layers of PAPR system, area size of contamination,
number of donning or doffing violations; time required for donning and
doffing. 2. Number of participants with donning or removal violation was defined as out of sequence removal, touching or tearing item of clothing, touching body part before hand washing. Used the Mainland‐Gart test for the analysis of cross‐over studies |
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| Notes | Funding: Physicians' Services Incorporated Foundation and Clinical Teachers' Association of Queen's University; no Conflict of Interest declared | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants randomised by coin tossing |
| Allocation concealment (selection bias) | Unclear risk | Once started, order was known, but unclear if participants could still change groups and if there would be an interest to do so. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants knew attire |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Evaluators blind for attire |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Apparently all data collected and usable |
| Selective reporting (reporting bias) | Unclear risk | Apparently all outcomes reported |
| Other bias | Low risk | No indication of other bias |
CDC: Center for Disease Control and Prevention; CFU: colony‐forming unit; ECDC: European Centre for Disease Prevention and Control; EMT: emergency medical technician; EVD: Ebola virus disease; HCW: healthcare worker; IgG: immunoglobulin G; IQR: interquartile range; LED: light‐emitting diode; MD: Doctor of Medicine; MPN: most probable number; MSF: Médecins Sans Frontières; n/a: not applicable; PAPR: powered, air‐purifying respirator; PFU: plaque‐forming unit; PLS: polystyrene latex beads; PPE: personal protection equipment; RCT: randomised controlled trial; RN: Registered Nurse; SARS: severe acute respiratory syndrome; SD: standard deviation; UV: ultraviolet WHO: World Health Organization