PBM Module 4b Evidence-tabel

MacIntyre, 2011

Type of study: cluster randomized clinical trial

Setting and country: frontline HCW Beijing, China

Funding and conflicts of interest:
MacIntyre receives funding from influenza vaccine manufacturers GSK and CSL Biotherapies and has also been on advisory boards for Wyeth, GSK and Merck. Cauchemez received consulting fees from Sanofi-Pasteur MSD on the modelling of varicella zoster virus

Inclusion criteria:
Any nurse, doctor or ward clerk who worked full time in the emergency or respiratory wards at the hospital

Exclusion criteria:
- unable or refused consent;
- beards/long moustaches/long facial hair;
- a current respiratory illness, rhinitis ⁄ allergy and worked part-time

N total at baseline:
949 from 15 hospitals
N95 fit tested: 461
N95 non-fit tested: 488
No mask: 481

Important prognostic factors:
Age (95%CI):
Fit tested:35.3 (34.4–36.2)
Not fit tested: 33 (32.2–33.8)

Sex:
Fit tested: 9.8% M
Not fit tested: 8.2% M

Influenza vaccination status (2007)
Fit tested:9.5%
Not fit tested:21.5%

Influenza vaccination status (2008)
Fit tested:14.8%
Not fit tested: 21.5%

Groups comparable at baseline?
Not for influenza vaccination status, no information available on no mask group

Describe intervention (treatment / procedure / test):

- N95 respirator and Bitrex Fit Test (Qualitative test)
- N95 respirator

Participants wore the respirator (N95) on every shift for 4 consecutive weeks after being shown when to wear it and how to fit it correctly.

Describe control (treatment / procedure/ test):

No mask

Participants wore the respirator (N95) on every shift for 4 consecutive weeks after being shown when to wear it and how to fit it correctly.

Length of follow-up:
4 weeks of wearing the respirators and an extra week of non-wearing for development of respiratory symptom

Loss-to-follow-up:
NA

Incomplete outcome data:

NA

Outcome measures and effect size (include 95%CI and p-value if available):

Clinical respiratory illness (CRI)
Fit tested: 21 ⁄ 461 (4.6%)
OR 0.58 (0.18–1.89)
P = 0.37
Not fit tested: 16 ⁄ 488 (3.3%)
OR: 0.36 (0.14–0.94)
P = 0.038

Influenza-like illness (ILI)
Fit tested: 1⁄ 461 (0.2%)
OR 0.19 (0.02–1.78)
P = 0.14)
Not fit tested: 2 ⁄ 488 (0.4%)
OR 0.33 (0.06–1.72)
P = 0.19

Laboratory confirmed respiratory virus infection
Fit tested: 8 ⁄ 461 (1.7%)
OR 0.55 (0.22–1.35)
P = 0.19
Not fit tested: 5 ⁄ 488 (1%)
OR: 0.33 (0.12–0.89)
P = 0.03

Influenza
Fit tested: 3 ⁄ 461 (0.7%)
OR 0.52 (0.13–2.09)
P = 0.36
Not fit tested: 0 ⁄ 488 (0%)
OR 0

Participants wore respirators during the entire work shift

Fit-test failure 5/461 is extremely low

Lawrence, 2006

Type of study: observational

Setting and country: USA

Funding and conflicts of interest: NA

Inclusion criteria:
None reported

Exclusion criteria:
None reported

N total at baseline:
N=37
25 participants performed a fittest

Important prognostic factors:
Sex:
20 female, 17 male

Age
19-48 years old

Groups comparable at baseline?
Only one group

Describe intervention (treatment/procedure/test):

Qualitative fit test:
-Bitrex
-Saccharine

Quantitative:
-Companion

Describe control (treatment/procedure/test):

No fit test

From the 150 overall SWPF values, the GM and the 5th percentile SWPF values for each device were calculated, which are referred to as “without fit testing.

Length of follow-up:
Not relevant

Loss-to-follow-up:
NA

Incomplete outcome data:
NA

Outcome measures and effect size (include 95%CI and p-value if available):

5th percentile SWPF (≥10 pass)
No fit test: 3,3

Bitrex pass: 7.9 (2.8-39.2)
fail: 3.0 (1.0-12.6)

Saccharine pass: 11.0 (1.2-49.8)
fail: 3.0 (1.1-13.4)

N95-Companion pass: 20.5 (12.6- 35.9)
fail: 2.7 (1.1-11.9)

Coffey, 2004

Type of study: observational

Setting and country: USA

Funding and conflicts of interest: NA

Inclusion criteria:
None reported

Exclusion criteria:
None reported

N total at baseline:
N=33
25 performed the fittest

Important prognostic factors:
Sex:
18 female, 15 male

Age
Not reported

Groups comparable at baseline?
Only one group

Describe intervention (treatment/procedure/test):

Qualitative fit test:

-Bitrex

-Saccharine

Quantitative:

-Companion

-PortaCount Plus

-Generated aerosol

Describe control (treatment/procedure/test):

No fit test

Length of follow-up:
Not relevant

Loss-to-follow-up:
NA

Incomplete outcome data:
N=1; no information available

Outcome measures and effect size (include 95%CI and p-value if available):

5th percentile SWPF (≥10 pass)
No fit test: 2.9 (3.6-56.9)

Bitrex pass 7.4(4.4-33.5)
fail 2.1(1.3-48)

Saccharine pass 6.9(1.3-5.6)
fail 1.9(1.1-4.7)

Companion pass 74.5(2.2-122.1)
fail 2.3(1.3-48.0)

PortCount Plus pass 14.6(6.7-43.8)
fail 2.7(1.0-67.2);

GenAer pass 21.6(11.8-43.7)
fail 4.7(2.0-74.7)